REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Title of each class
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Trading Symbol(s)
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Name of each exchange on which registered
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* |
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Large accelerated filer ☐
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Accelerated filer ☐
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Emerging growth company
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† |
The term “new or revised financial accounting standard” refers to any update issued by the Financial Accounting Standards Board to its Accounting Standards Codification after April 5, 2012.
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Page
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PART I
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ITEM 1.
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4 | ||
ITEM 2.
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4 | ||
ITEM 3.
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4 | ||
A.
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4 | ||
B.
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4 | ||
C.
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4 | ||
D.
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4 | ||
ITEM 4.
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72 | ||
A.
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72 | ||
B.
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73 | ||
C.
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100 | ||
D.
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100 | ||
ITEM 4A.
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100 | ||
ITEM 5.
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100 | ||
A.
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101 | ||
B.
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110 | ||
C.
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115 | ||
D.
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115 | ||
E.
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115 | ||
ITEM 6.
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116 | ||
A.
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116 | ||
B.
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119 | ||
C.
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122 | ||
D.
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125 | ||
E.
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125 | ||
ITEM 7.
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125 | ||
A.
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125 | ||
B.
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127 | ||
C.
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128 | ||
ITEM 8.
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128 | ||
A.
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128 | ||
B.
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129 | ||
ITEM 9.
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129
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A.
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129
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B.
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129
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C.
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129
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D.
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129
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E.
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129
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F.
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130 | ||
ITEM 10.
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130 | ||
A.
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130 | ||
B.
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130 | ||
C.
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130 | ||
D.
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130 | ||
E.
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130 | ||
F.
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137 | ||
G.
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137 | ||
H.
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137 | ||
I.
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138 | ||
ITEM 11.
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138 | ||
ITEM 12.
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139 | ||
A.
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139 | ||
B.
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139 | ||
C.
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139 |
D.
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139 | ||
140 | |||
ITEM 13.
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140 | ||
ITEM 14.
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140 | ||
ITEM 15.
|
140 | ||
A.
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141 | ||
B.
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141 | ||
C.
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141 | ||
D.
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141 | ||
ITEM 16
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141 | ||
A.
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141 | ||
B.
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141 | ||
C.
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142 | ||
D.
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142 | ||
E.
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142 | ||
F.
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142 | ||
G.
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142 | ||
H.
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143 | ||
I.
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143 | ||
144 | |||
ITEM 17.
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144 | ||
ITEM 18.
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144 | ||
ITEM 19.
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144 |
• |
our ability to maintain regulatory approval of KIMMTRAK (tebentafusp-tebn) for metastatic uveal melanoma, or mUM, in the United States;
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• |
the timing of, and our ability to obtain and maintain regulatory approval of, KIMMTRAK in the European Union and respective European countries;
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• |
our expectations regarding the potential commercialization of, the marketing and therapeutic potential of KIMMTRAK for mUM;
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• |
our ability to build a sustainable pipeline of new medicine candidates, including but not limited to future generations of KIMMTRAK;
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• |
the expected clinical benefits of KIMMTRAK including extended overall survival benefit;
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• |
expectations regarding the timing of the commercial launch of KIMMTRAK, the timing of commercial availability and the ability to reach patients in a timely manner;
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• |
the value proposition of KIMMTRAK in mUM and benefit as an orphan indication including expectations regarding the potential market size opportunity;
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• |
our ability to successfully executed our sales and marketing strategy of KIMMTRAK in the United States, including continuing to successfully recruit and retain sales and marketing personnel and to
successfully build the market for our medicines;
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• |
our expectations about the willingness of healthcare providers to recommend KIMMTRAK to people with mUM;
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• |
the rate and degree of market acceptance of our product candidates among physicians, patients, patient advocacy groups, third-party payors and the medical community and our ability and our distribution and
marketing partners’ ability to obtain coverage and adequate reimbursement and pricing for, our medicines from government and third-party payers and risks relating to the success of our patient assistance programs;
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• |
the market opportunities for our product candidates may be smaller than we estimate and any approval that we obtain may be based on a narrower definition of the patient population;
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• |
the initiation, timing, progress and results of our current and future preclinical studies and clinical trials and related preparatory work and the period during which the results of
the trials will become available, as well as our research and development programs;
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• |
our estimates regarding expenses, future revenue, capital requirements and needs for additional financing;
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• |
our expectations regarding timing of regulatory filings for, or our ability to obtain regulatory approval of, tebentafusp in additional jurisdictions, or any of our other product
candidates;
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• |
our ability to obtain accelerated approval for current and future product candidates from the FDA and the EMA;
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• |
our ability to identify and develop additional product candidates using our ImmTAX platform;
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• |
business disruptions affecting the initiation, patient enrollment, clinical trial site monitoring, development and operation of our current and proposed clinical trials, including a
public health emergency, such as the ongoing coronavirus 2019, or COVID-19, pandemic;
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• |
the potential benefits of our product candidates;
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• |
our business strategies and goals;
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• |
our plans to collaborate, or statements regarding our current collaborations;
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• |
our ability to find future partners and collaborators;
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• |
the performance of our third-party suppliers and manufacturers,
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• |
our expectations regarding our ability to obtain, maintain and enforce intellectual property protection for our product candidates and our ability to operate our business without
infringing, misappropriating or otherwise violating the intellectual property rights of others;
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• |
the effects of competition with respect to KIMMTRAK or any of our other current or future product candidates, as well as innovations by current and future competitors in our industry;
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• |
regulatory developments in the United States and other countries, including potential changes in healthcare laws and regulations;
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• |
our financial performance and our ability to effectively manage our anticipated growth;
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• |
our ability to identify, recruit and retain qualified employees;
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• |
the loss of key commercial or management personnel;
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• |
whether we are classified as a PFIC for current and future periods;
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• |
our ability to raise additional capital; and
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• |
our estimates regarding the period of time for which our current capital resources will be sufficient to fund our
continued operations, future expenses, revenues and needs for additional financing and the accuracy thereof.
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Item 1. |
Identity of Directors, Senior Management and Advisers.
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Item 2. |
Offer Statistics and Expected Timetable.
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Item 3. |
Key Information.
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A. |
[Reserved]
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B. |
Capitalization and indebtedness.
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C. |
Reasons for the offer and use of proceeds.
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D. |
Risk factors.
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• |
The COVID-19 global pandemic has and may continue to adversely impact our business, including the commercialization of KIMMTRAK, our supply chain, our pre-clinical studies and our clinical trials, our
liquidity and access to capital markets and our business development activities.
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• |
We have incurred significant losses in every year since our inception. We expect to continue to incur losses over the next several years and may never achieve or maintain profitability.
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• |
Our ability to generate revenues from KIMMTRAK is subject to attaining significant market acceptance among physicians, patients and healthcare payers.
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• |
Our future prospects are highly dependent on our ability to successfully develop and execute a commercialization strategy for KIMMTRAK. Failure to do so would adversely impact our financial condition and
prospects.
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• |
We will require substantial additional funding to achieve our business goals. If we are unable to obtain this funding when needed and on acceptable terms, we could be forced to delay,
limit or terminate our product development efforts.
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• |
We are heavily dependent on the success of our ImmTAX platform to identify and develop product candidates. If we or our collaborators are unable to successfully develop and
commercialize our platforms or experience significant delays in doing so, our business may be harmed.
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• |
We may be unable to successfully complete additional large-scale, pivotal clinical trials for any product candidates we develop after KIMMTRAK.
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• |
Our product candidates utilize a novel mechanism of action and involve novel targets which may result in greater research and development expenses, regulatory issues that could delay or
prevent approval, or discovery of unknown or unanticipated adverse effects.
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• |
Clinical product development involves a lengthy and expensive process, with an uncertain outcome.
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• |
The effects of health epidemics, including the ongoing COVID-19 pandemic, in regions where we, or the third parties on which we rely, have business operations could adversely impact our
business, including our pre-clinical studies and clinical trials, as well as the business or operations of our CROs or other third parties with whom we conduct business.
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• |
Reports of adverse events or safety concerns involving KIMMTRAK or our product candidates could delay or prevent us from obtaining or maintaining regulatory approvals or could
negatively impact sales of our products or the prospects for our product candidates.
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• |
Even if we obtain regulatory approvals to market our current and any future approved products, we will remain subject to extensive ongoing regulatory obligations and oversight,
including post-approval requirements, that could result in significant additional expense and could negatively impact our ability to commercialize our current and any future approved products.
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• |
We are subject to manufacturing risks that could substantially increase our costs and limit supply of our products.
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• |
We face substantial competition, which may result in others developing or commercializing drugs before or more successfully than us.
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• |
Our existing collaborations are important to our business, and future collaborations may also be important to us. If we are unable to maintain any of these collaborations, or if these
collaborations are not successful, our business could be adversely affected.
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• |
If we are unable to adequately protect our proprietary technology or obtain, maintain, protect and enforce patent and other intellectual property protection for our technology and
products or if the scope of the protection obtained is not sufficiently broad, our competitors and other third parties could develop and commercialize technology and products similar or identical to ours, and our ability to successfully
commercialize our technology and products may be impaired.
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• |
Third parties may initiate legal proceedings alleging that we are infringing, misappropriating or otherwise violating their intellectual property or proprietary rights, the outcome of
which would be uncertain and could have a material adverse effect on the success of our business.
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• |
The FDA regulatory pathways can be difficult to predict and whether, for example, further unanticipated clinical trials are required, will depend on the data obtained in our ongoing
clinical trials.
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• |
Our future success depends on our ability to retain key executives and experienced scientists and to attract, retain and motivate qualified personnel.
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• |
As a company based outside of the United States, we are subject to economic, political, regulatory and other risks associated with international operations.
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• |
Failure or perceived failure to comply with existing or future laws, regulations, contracts, self-regulatory schemes, industry standards and other obligations related to data privacy and security (including
security incidents) could harm our business. Compliance or the actual or perceived failure to comply with such obligations could negatively affect our operating results and business.
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• |
continue to establish a sales, marketing, manufacturing and distribution capability to commercialize KIMMTRAK and any future product candidate for which we may obtain marketing approval
in the United States and expanded territories and countries;
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• |
continue our ongoing and planned development of our five clinical stage programs, including our Phase 1/2 clinical trial of IMC-F106C (PRAME) and our Phase 1/2 clinical trial of
IMC-C103C (MAGE-A4) in multiple solid tumors; and our ImmTAV molecules targeting Hepatitis B Virus, or HBV, or HIV;
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• |
initiate pre-clinical studies and clinical trials for any additional product candidates that we may pursue in the future;
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• |
seek regulatory approvals for tebentafusp in other jurisdictions, and any future product candidates that successfully complete clinical trials;
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• |
build a portfolio of product candidates through the discovery, development, or acquisition or in-license of drugs, product candidates or technologies;
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• |
maintain, protect, enforce and expand our intellectual property portfolio;
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• |
acquire or in-license other product candidates, intellectual property and technologies;
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• |
hire additional clinical, regulatory and scientific personnel;
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• |
add operational, financial and management information systems and personnel, including personnel to support commercial development of KIMMTRAK, our product development and planned
future commercialization efforts of existing and future product candidates; and
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• |
incur additional legal, accounting and other expenses associated with operating as a public company.
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• |
timing of market introduction of KIMMTRAK as well as competitive medicines;
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• |
efficacy and safety of KIMMTRAK;
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• |
continued projected growth of the markets in which KIMMTRAK competes;
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• |
the extent to which physicians diagnose and treat the conditions that KIMMTRAK is approved to treat;
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• |
prevalence and severity of any side effects;
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• |
if and when we are able to obtain regulatory approvals for additional indications for KIMMTRAK;
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• |
acceptance by patients, physicians and applicable specialists;
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• |
availability of, and ability to maintain, coverage and adequate reimbursement and pricing from government and other third-party payers;
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• |
potential or perceived advantages or disadvantages of KIMMTRAK over alternative treatments, including cost of treatment and relative convenience and ease of administration;
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• |
strength of sales, marketing and distribution support;
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• |
the price of KIMMTRAK, both in absolute terms and relative to alternative treatments;
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• |
impact of past and limitation of future medicine price increases;
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• |
our ability to maintain a continuous supply of KIMMTRAK for commercial sale;
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• |
the effect of current and future healthcare laws;
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• |
the extent and duration of the COVID-19 pandemic, including the extent to which physicians and patients delay visits or writing or filling prescriptions for KIMMTRAK;
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• |
the performance of third-party distribution partners, over which we have limited control; and
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• |
medicine labeling or medicine insert requirements of the FDA or other regulatory authorities.
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• |
our ability to successfully execute our commercialization strategies for KIMMTRAK and, if approved, our other product candidates;
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• |
progress, timing, scope and costs of our clinical trials, including the ability to timely initiate clinical sites, enroll subjects and manufacture soluble bispecific TCR product
candidates for our ongoing, planned and potential future clinical trials, including our clinical trials of IMC-F106C (PRAME) and IMC-C103C (MAGE-A4) in multiple solid tumors, and IMC-I109V targeting HBV;
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• |
time and costs required to perform research and development to identify and characterize new product candidates from our research programs;
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• |
the time and cost necessary to pursue regulatory authorizations and approvals that may be required by regulatory authorities to execute clinical trials or commercialize our products;
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• |
our ability to have clinical and commercial products successfully manufactured consistent with FDA, EMA and other authorities’ regulations;
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• |
amount of sales and other revenues from product candidates that we may commercialize, if any, including the selling prices for such potential products and the availability of adequate
third-party coverage and reimbursement for patients;
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• |
sales and marketing costs associated with commercializing our products, if approved, including the cost and timing of building our marketing and sales capabilities;
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• |
cost of building, staffing and validating our manufacturing processes, which may include capital expenditure;
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• |
terms and timing of any revenue from our existing collaborations;
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• |
costs of operating as a public company;
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• |
time and cost necessary to respond to technological, regulatory, political and market developments;
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• |
costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights;
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• |
costs, associated with, and terms and timing of, any future any potential acquisitions, strategic collaborations, licensing agreements or other arrangements that we may establish; and
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• |
inability of clinical sites to enroll patients as healthcare capacities are required to cope with natural disasters, epidemics or other health system emergencies, such as the COVID-19
pandemic.
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• |
the inability to recruit, train and retain adequate numbers of effective sales and marketing personnel;
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• |
the inability of sales personnel to obtain access to physicians or persuade adequate numbers of physicians to prescribe any future product that we may develop;
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• |
the lack of complementary treatments to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines; and
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• |
unforeseen costs and expenses associated with creating an independent sales and marketing organization.
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• |
delays or difficulties in enrolling and retaining patients in our clinical trials, including patients that may not be able or willing to comply with clinical trial protocols such as weekly dosing regimens
if quarantines impede patient movement or interrupt healthcare services;
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• |
delays or difficulties in clinical site initiation, including difficulties in recruiting and retaining clinical site investigators and clinical site staff;
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• |
increased rates of patients withdrawing from our clinical trials following enrollment as a result of risks of exposure to COVID-19, being forced to quarantine or being unable to visit clinical trial
locations or otherwise comply with clinical trial protocols;
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• |
diversion or prioritization of healthcare resources away from the conduct of clinical trials and towards the COVID-19 pandemic, including the diversion of hospitals serving as our clinical trial sites and
hospital staff supporting the conduct of our clinical trials, and because, who, as healthcare providers, may have heightened exposure to COVID-19 and adversely impact our clinical trial operations;
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• |
interruption of our clinical supply chain or key clinical trial activities, such as clinical trial site monitoring, due to limitations on travel imposed or recommended by federal, state/provincial or
municipal governments, employers and others; and
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• |
limitations in employee resources that would otherwise be focused on the conduct of our clinical trials, including because of sickness of employees or their families or the desire of employees to avoid
contact with large groups of people.
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• |
delays in receiving approval from local regulatory authorities to initiate our planned clinical trials;
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• |
delays in clinical sites receiving the supplies and materials needed to conduct our clinical trials;
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• |
interruption in global shipping that may affect the transport of clinical trial materials, such as investigational drug product and comparator drugs used in our clinical trials;
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• |
changes in federal, state/provincial or municipal regulations as part of a response to the COVID-19 coronavirus outbreak which may require us to change the ways in which our clinical trials are conducted,
which may result in unexpected costs, or to discontinue the clinical trials altogether;
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• |
delays in necessary interactions with local regulators, ethics committees and other important agencies and contractors due to limitations in employee resources or forced furlough of government employees;
and
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• |
the refusal of the FDA to accept data from clinical trials in these affected geographies.
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• |
the clinical indications for which our product candidates are approved;
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• |
physicians, hospitals, cancer treatment centers, and patients considering our product candidates as a safe and effective treatment;
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• |
hospitals and cancer treatment centers establishing the infrastructure required for the administration of the product candidate;
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• |
the potential and perceived advantages of our product candidates over alternative treatments;
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• |
the prevalence and severity of any side effects, including CRS, for which KIMMTRAK has a boxed warning recommending at least 16 hours of patient monitoring after each of the first three infusions, and as
clinically indicated thereafter;
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• |
product labeling or product insert requirements of the FDA, the EMA or other regulatory authorities;
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• |
limitations or warnings contained in the labeling approved by the FDA or the EMA;
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• |
the timing of market introduction of our product candidates as well as competitive products;
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• |
the cost of treatment in relation to alternative treatments;
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• |
the amount of upfront costs or training required for physicians to administer our product candidates;
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• |
the pricing of our products and the availability of coverage and adequate reimbursement by third-party payors and government authorities;
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• |
the willingness of patients to pay out-of-pocket in the absence of comprehensive coverage and adequate reimbursement by third-party payors and government authorities;
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• |
relative convenience and ease of administration, including as compared to alternative treatments and competitive therapies; and
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• |
the effectiveness of our sales and marketing efforts and distribution support.
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• |
be delayed in obtaining marketing approval for our product candidates;
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• |
not obtain marketing approval at all;
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• |
obtain approval for indications or patient populations that are not as broad as intended or desired;
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• |
be subject to post-marketing testing requirements; or
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• |
have the product removed from the market after obtaining marketing approval.
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• |
the research methodology used may not be successful in identifying potential indications and/or product candidates;
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• |
potential product candidates may, after further study, be shown to have harmful adverse effects or other characteristics that indicate they are unlikely to be effective products; or
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• |
it may take greater human and financial resources than we will possess to identify additional therapeutic opportunities for our product candidates or to develop suitable potential product candidates through
internal research programs, thereby limiting our ability to develop, diversify and expand our product portfolio.
|
• |
the FDA, EMA or comparable foreign regulatory authorities may disagree with the design or implementation of our clinical trials;
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• |
the FDA, EMA or comparable foreign regulatory authorities may disagree with the design or implementation of our clinical trials;
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• |
we may be unable to demonstrate to the satisfaction of the FDA, EMA or comparable foreign regulatory authorities that a product candidate is safe and effective for its proposed indication or a related
companion diagnostic is suitable to identify appropriate patient populations;
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• |
the results of clinical trials may not meet the level of statistical significance required by the FDA, EMA or comparable foreign regulatory authorities for approval;
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• |
we may be unable to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks;
|
• |
the FDA, EMA or comparable foreign regulatory authorities may disagree with our interpretation of data from pre-clinical studies or clinical trials;
|
• |
the data collected from clinical trials of our product candidates may not be sufficient to support the submission a BLA or other submission or to obtain regulatory approval in the United States or
elsewhere;
|
• |
the FDA, EMA or comparable foreign regulatory authorities may find deficiencies with or fail to approve the manufacturing processes or facilities of third-party manufacturers with which we contract for
clinical and commercial supplies; and
|
• |
the approval policies or regulations of the FDA, EMA or comparable foreign regulatory authorities may significantly change such that our clinical data are insufficient for approval.
|
• |
regulators or institutional review boards, or IRBs, or ethics committees may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site;
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• |
we may experience delays in reaching, or fail to reach, agreement on acceptable terms with prospective trial sites and prospective CROs, the terms of which can be subject to extensive negotiation and may
vary significantly among different CROs and trial sites;
|
• |
clinical trials of our product candidates may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional pre-clinical studies or clinical trials or we
may decide to abandon product development programs;
|
• |
the number of patients required for clinical trials of our product candidates may be larger than we anticipate, enrollment in these clinical trials may be slower than we anticipate or participants may drop
out of these clinical trials or fail to return for post-treatment follow-up at a higher rate than we anticipate;
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• |
our third-party contractors may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all, or may deviate from the clinical trial protocol or
drop out of the trial, which may require that we add new clinical trial sites or investigators;
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• |
we may elect to, or regulators or IRBs or ethics committees may require us or our investigators to, suspend or terminate clinical research for various reasons, including noncompliance with regulatory
requirements or a finding that the participants are being exposed to unacceptable health risks;
|
• |
the cost of clinical trials of our product candidates may be greater than we anticipate;
|
• |
the supply or quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates may be insufficient or inadequate; and
|
• |
our product candidates may have undesirable side effects or other unexpected characteristics, causing us or our investigators, regulators or IRBs or ethics committees to suspend or terminate the trials, or
reports may arise from pre-clinical or clinical testing of other cancer therapies that raise safety or efficacy concerns about our product candidates.
|
• |
the severity of the disease under investigation;
|
• |
the eligibility criteria for the clinical trial in question;
|
• |
the availability of an appropriate genomic screening test;
|
• |
the perceived risks and benefits of the product candidate under study;
|
• |
the efforts to facilitate timely enrollment in clinical trials;
|
• |
the patient referral practices of physicians;
|
• |
the ability to monitor patients adequately during and after treatment;
|
• |
the proximity and availability of clinical trial sites for prospective patients; and
|
• |
factors we may not be able to control, such as current or potential pandemics that may limit patients, principal investigators or staff or clinical site availability (e.g.,
of the impact of the COVID-19 pandemic).
|
• |
our available capital resources or capital constraints we experience;
|
• |
the rate of progress, costs, and results of our clinical trials and research and development activities, including the extent of scheduling conflicts with participating clinicians and collaborators;
|
• |
our ability to identify and enroll patients who meet clinical trial eligibility criteria;
|
• |
our receipt of approvals by the FDA, EMA and comparable foreign regulatory authorities, and the timing thereof;
|
• |
other actions, decisions, or rules issued by regulators;
|
• |
our ability to access sufficient, reliable, and affordable supplies of materials used in the manufacture of our product candidates;
|
• |
our ability to manufacture and supply clinical trial materials to our clinical sites on a timely basis;
|
• |
the efforts of our collaborators with respect to the commercialization of our approved products, if any; and
|
• |
the securing of, costs related to, and timing issues associated with, commercial product manufacturing, as well as sales and marketing activities.
|
• |
differing regulatory requirements in foreign countries;
|
• |
unexpected changes in tariffs, trade barriers, price and exchange controls and other regulatory requirements;
|
• |
differing standards for the conduct of clinical trials;
|
• |
increased difficulties in managing the logistics and transportation of storing and shipping product candidates produced in the United States or elsewhere and shipping the product candidate to patients in
other countries;
|
• |
import and export requirements and restrictions;
|
• |
economic weakness, including inflation, or political instability in foreign economies and markets;
|
• |
compliance with tax, employment, immigration and labor laws for employees living or traveling abroad;
|
• |
foreign taxes, including withholding of payroll taxes;
|
• |
foreign currency fluctuations, which could result in increased operating expenses and reduced revenue, and other obligations incident to doing business in another country;
|
• |
difficulties staffing and managing foreign operations;
|
• |
workforce uncertainty in countries where labor unrest is more common than in the United Kingdom or the United States;
|
• |
differing payor reimbursement regimes, governmental payors or patient self-pay systems, and price controls;
|
• |
potential liability under the Foreign Corrupt Practices Act of 1977, as amended, the U.K. Bribery Act 2010, or comparable foreign regulations;
|
• |
challenges enforcing or protecting our contractual and intellectual property rights, especially in those foreign countries that do not respect and protect intellectual property rights to the same extent as
the United States or the United Kingdom;
|
• |
the impacts Brexit may have with respect to the cross-border acknowledgment of clinical trial results and marketing authorizations as well as recruitment of scientific personnel;
|
• |
production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and
|
• |
business interruptions resulting from geo-political actions, including war and terrorism.
|
• |
the clinical indications for which our product candidates are approved;
|
• |
physicians, hospitals, cancer treatment centers, and patients considering our product candidates as a safe and effective treatment;
|
• |
hospitals and cancer treatment centers establishing the infrastructure required for the administration of the product candidate;
|
• |
the potential and perceived advantages of our product candidates over alternative treatments;
|
• |
the prevalence and severity of any side effects, including CRS, for which KIMMTRAK has a boxed warning recommending at least 16 hours of patient monitoring after each of the first three infusions, and as
clinically indicated thereafter;
|
• |
product labeling or product insert requirements of the FDA, the EMA or other regulatory authorities;
|
• |
limitations or warnings contained in the labeling approved by the FDA or the EMA;
|
• |
the timing of market introduction of our product candidates as well as competitive products;
|
• |
the cost of treatment in relation to alternative treatments;
|
• |
the amount of upfront costs or training required for physicians to administer our product candidates;
|
• |
the pricing of our products and the availability of coverage and adequate reimbursement by third-party payors and government authorities;
|
• |
the willingness of patients to pay out-of-pocket in the absence of comprehensive coverage and adequate reimbursement by third-party payors and government authorities;
|
• |
relative convenience and ease of administration, including as compared to alternative treatments and competitive therapies; and
|
• |
the effectiveness of our sales and marketing efforts and distribution support.
|
• |
the impairment of our business reputation;
|
• |
the withdrawal of clinical trial participants;
|
• |
costs due to related litigation;
|
• |
the distraction of management’s attention from our primary business;
|
• |
substantial monetary awards to patients or other claimants;
|
• |
the inability to commercialize our product candidates; and
|
• |
decreased demand for our product candidates, if approved for commercial sale.
|
• |
collaborators have significant discretion in determining the efforts and resources that they will apply to these collaborations;
|
• |
collaborators may not perform their obligations as expected;
|
• |
collaborators may not pursue development and commercialization of any product candidates that achieve regulatory approval or may elect not to continue or renew development or commercialization programs
based on clinical trial results, changes in the collaborators’ strategic focus or available funding, or external factors, such as an acquisition, that divert resources or create competing priorities;
|
• |
collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a product candidate, repeat or conduct new clinical trials or require a
new formulation of a product candidate for clinical testing;
|
• |
collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our products or product candidates if the collaborators believe that competitive
products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than ours; this may also happen if the collaborators’ development of competing products is substantially
faster than our development timelines;
|
• |
collaborators may not further develop product candidates developed by us or co-developed with us under the collaboration;
|
• |
product candidates discovered in collaboration with us may be viewed by our collaborators as competitive with their own product candidates or products, which may cause collaborators to cease to devote
resources to the commercialization of our product candidates;
|
• |
a collaborator with marketing and distribution rights to one or more of our product candidates that achieve regulatory approval may not commit sufficient resources to the marketing and distribution of such
product or products;
|
• |
disagreements with collaborators, including disagreements over proprietary rights, contract interpretation or the preferred course of development, might cause delays or termination of the research,
development or commercialization of product candidates, might lead to additional responsibilities for us with respect to product candidates, or might result in litigation or arbitration, any of which would be time-consuming and expensive;
|
• |
collaborators have certain defined rights to change or expand the scope of development programs during the course of the collaboration. This may lead to additional research work for us that may be
time-consuming and expensive. Such work may compete with our own development programs and may delay timelines to market or proof-of-concept for our product candidates. If development programs under the collaboration turn out to be more
costly and time-consuming, such unanticipated costs and work could likewise compete with our internal development programs;
|
• |
collaborators may not properly maintain, enforce or defend our intellectual property or proprietary information or may use them in such a way as to invite litigation that could jeopardize or invalidate our
intellectual property or proprietary information or expose us to potential litigation;
|
• |
collaborators may infringe, misappropriate or otherwise violate the intellectual property or proprietary rights of third parties, which may expose us to litigation and potential liability, and
collaborators may also allege that we are liable for potential infringement, misappropriation or other violations of third-party intellectual property or proprietary rights during the research and development work for the collaboration;
|
• |
certain collaborations may be terminated for the convenience of the collaborator and, if terminated, we could be required to raise additional capital to pursue further development or commercialization of
the applicable product candidates. For example, certain of our collaboration and license agreements may be terminated for convenience upon the completion of a specified notice period; and
|
• |
collaborators may discontinue the development of product candidates within the collaboration, for example if they consider the results achieved so far or the product candidates not promising enough or if
their development strategies change.
|
• |
have staffing difficulties;
|
• |
fail to comply with contractual obligations;
|
• |
experience regulatory compliance issues;
|
• |
undergo changes in priorities or become financially distressed; or
|
• |
form relationships with other entities, some of which may be our competitors.
|
• |
reliance on the third party for regulatory compliance and quality assurance;
|
• |
the possible breach of the manufacturing agreement by the third party;
|
• |
the possible misappropriation or unauthorized disclosure of our proprietary information, including our trade secrets and know-how; and
|
• |
the possible termination or nonrenewal of the agreement by the third party at a time that is costly or inconvenient for us.
|
• |
the scope of rights granted under the agreement and other interpretation-related issues;
|
• |
the extent to which our technology and processes infringe on intellectual property of the counterparty that is not subject to the agreement;
|
• |
the sublicensing of patent and other intellectual or proprietary rights under our collaborative development relationships;
|
• |
our diligence obligations under the agreement and what activities satisfy those diligence obligations;
|
• |
the inventorship and ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our counterparty and us and our partners; and
|
• |
the priority of invention of patented technology.
|
• |
others may be able to make products that are similar to our product candidates or utilize similar technology but that are not covered by the claims of the patents that we own or license now or in the
future;
|
• |
we or our licensors or collaborators might not have been the first to make the inventions covered by the issued patents or pending patent applications that we own or license now or in the future;
|
• |
we or our licensors or collaborators might not have been the first to file patent applications covering certain of our or their inventions;
|
• |
others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property rights or any intellectual property rights we may
license;
|
• |
it is possible that our present or future pending patent applications (whether owned or licensed) will not lead to issued patents;
|
• |
it is possible that there are or will be prior public disclosures that could invalidate our or our licensors’ or collaboration partners’ patents;
|
• |
issued patents that we hold rights to may fail to provide us with any competitive advantage, or may be held invalid or unenforceable, including as a result of legal challenges by our competitors or other
third parties;
|
• |
our competitors or other third parties might conduct research and development activities in countries where we do not have patent rights or in countries where research and development safe harbor laws
exist, and then use the information learned from such activities to develop competitive products for sale in our major commercial markets;
|
• |
we may not develop additional proprietary technologies that are patentable;
|
• |
the ownership, validity or enforceability of our patents or patent applications may be challenged by third parties;
|
• |
the patents or pending or future applications of others, if issued, may harm our business; and
|
• |
we may choose not to file a patent in order to maintain certain trade secrets or know-how, and a third party may subsequently file a patent covering such intellectual property.
|
• |
the FDA or comparable foreign regulatory authorities may disagree with the design or implementation of our or our collaborators’ clinical trials;
|
• |
we or our collaborators may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that our product candidates are safe, pure, potent and have a favorable
risk/benefit profile for any of their proposed indications;
|
• |
the results of clinical trials may not meet the level of statistical significance required by the FDA or comparable foreign regulatory authorities for approval;
|
• |
the FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from pre-clinical programs or clinical trials;
|
• |
data collected from clinical trials of product candidates may not be sufficient to the satisfaction of the FDA or comparable foreign regulatory authorities to support the submission of a BLA or other
comparable submission in foreign jurisdictions or to obtain regulatory approval in the United States or elsewhere;
|
• |
manufacturing processes or facilities or those of the third-party manufacturers we use may not be adequate to support approval of our product candidates; and
|
• |
the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.
|
• |
issuance of Form FDA 483 notices or Warning Letters by the FDA or other regulatory agencies;
|
• |
imposition of fines and other civil penalties;
|
• |
criminal prosecutions;
|
• |
injunctions, suspensions or revocations of regulatory approvals;
|
• |
suspension of any ongoing clinical trials;
|
• |
total or partial suspension of manufacturing;
|
• |
delays in commercialization;
|
• |
refusal by the FDA to approve pending applications or supplements to approved applications submitted by us;
|
• |
refusals to permit drugs to be imported into or exported from the United States;
|
• |
restrictions on operations, including costly new manufacturing requirements;
|
• |
product recalls or seizures; and
|
• |
requirements to conduct post-marketing studies or clinical trials.
|
• |
the demand for our current or future product candidates, if we obtain regulatory approval;
|
• |
our ability to set a price that we believe is fair for our products;
|
• |
our ability to obtain coverage and adequate reimbursement for a product;
|
• |
our ability to generate revenue and achieve or maintain profitability;
|
• |
the level of taxes that we are required to pay; and
|
• |
the availability of capital.
|
• |
the federal Anti-Kickback Statute prohibits, among other things, persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind,
to induce or reward either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made under federal and state healthcare programs such as Medicare and Medicaid. A
person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation;
|
• |
the federal civil and criminal false claims and civil monetary penalties laws, including the federal False Claims Act, or FCA, imposes criminal and civil penalties, including through civil whistleblower or
qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an
obligation to pay money to the federal government. In addition, the government may assert that a claim including items and services resulting from a violation of the federal Anti-Kickback Statute constitutes a false of fraudulent claim
for purposes of the False Claims Act;
|
• |
the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, imposes criminal and civil liability for executing a scheme to defraud any healthcare benefit program, or knowingly and
willfully falsifying, concealing or covering up a material fact or making any materially false statement in connection with the delivery of or payment for healthcare benefits, items or services; similar to the federal Anti-Kickback
Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation;
|
• |
the federal physician payment transparency requirements, sometimes referred to as the “Sunshine Act” under the Affordable Care Act, require manufacturers of drugs, devices, biologics and medical supplies
that are reimbursable under Medicare, Medicaid, or the Children’s Health Insurance Program to report to CMS information related to transfers of value made to physicians (currently defined to include doctors, dentists, optometrists,
podiatrists and chiropractors), other healthcare professionals (such as physician assistants and nurse practitioners), and teaching hospitals, as well as ownership and investment interests of such physicians and their immediate family
members;
|
• |
HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 and its implementing regulations, impose obligations on certain covered entity healthcare providers,
health plans, and healthcare clearinghouses as well as their business associates that perform certain services involving the use or disclosure of individually identifiable health information and their subcontractors that use, disclose or
otherwise process individually identifiable health information, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information; and
|
• |
analogous state laws and regulations, such as state anti-kickback and false claims laws may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by
non-governmental third-party payors, including private insurers. Some state laws require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance
promulgated by the federal government in addition to requiring drug manufacturers to report information related to payments to physicians and other healthcare providers or marketing expenditures. Further, many state laws governing the
privacy and security of health information in certain circumstances, differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.
|
• |
convey, sell, lease, transfer, assign, dispose of or otherwise make cash payments consisting of all or any part of our business or property;
|
• |
effect certain changes in our business, management, ownership or business locations;
|
• |
merge or consolidate with, or acquire all or substantially all of the capital stock or assets of, any other company;
|
• |
create, incur, assume or be liable for any additional indebtedness, or create, incur, allow or permit to exist any additional liens;
|
• |
pay cash dividends on, make any other distributions in respect of, or redeem, retire or repurchase, any shares of our capital stock;
|
• |
make certain investments; and
|
• |
enter into transactions with our affiliates.
|
• |
increased operating expenses and cash requirements;
|
• |
the assumption of additional indebtedness or contingent liabilities;
|
• |
assimilation of operations, intellectual property and products of an acquired company or product, including difficulties associated with integrating new personnel;
|
• |
the diversion of our management’s attention from our existing product programs and initiatives in pursuing such a strategic merger or acquisition;
|
• |
retention of key employees, the loss of key personnel, and uncertainties in our ability to maintain key business relationships;
|
• |
risks and uncertainties associated with the other party to such a transaction, including the prospects of that party and their existing products or product candidates and regulatory approvals; and
|
• |
our inability to generate revenue from acquired technology and/or products sufficient to meet our objectives in undertaking the acquisition or even to offset the associated acquisition and maintenance
costs.
|
• |
economic weakness, including inflation, or political instability in particular non-U.S. economies and markets;
|
• |
differing and changing regulatory requirements for product approvals;
|
• |
differing jurisdictions could present different issues for securing, maintaining or obtaining freedom to operate in such jurisdictions;
|
• |
potentially reduced protection for intellectual property and proprietary rights;
|
• |
difficulties in compliance with different, complex and changing laws, regulations and court systems of multiple jurisdictions and compliance with a wide variety of foreign laws, treaties and regulations;
|
• |
changes in non-U.S. regulations and customs, tariffs and trade barriers;
|
• |
changes in non-U.S. currency exchange rates of the pound sterling, U.S. dollar, euro and currency controls;
|
• |
changes in a specific country’s or region’s political or economic environment, including the longer-term implications of Brexit;
|
• |
trade protection measures, import or export licensing requirements or other restrictive actions by governments;
|
• |
differing reimbursement regimes and price controls in certain non-U.S. markets;
|
• |
negative consequences from changes in tax laws;
|
• |
compliance with tax, employment, immigration and labor laws for employees living or traveling abroad, including, for example, the variable tax treatment in different jurisdictions of options granted under
our share option schemes or equity incentive plans;
|
• |
workforce uncertainty in countries where labor unrest is more common than in the United States;
|
• |
litigation or administrative actions resulting from claims against us by current or former employees or consultants individually or as part of class actions, including claims of wrongful terminations,
discrimination, misclassification or other violations of labor law or other alleged conduct;
|
• |
difficulties associated with staffing and managing international operations, including differing labor relations;
|
• |
production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and
|
• |
business interruptions resulting from geo-political actions, including war and terrorism, or natural disasters including earthquakes, typhoons, floods and fires.
|
• |
our failure to successfully execute our commercialization strategy with respect to KIMMTRAK;
|
• |
actions or announcements by third-party or government payers with respect to coverage and reimbursement of KIMMTRAK;
|
• |
adverse regulatory decisions,, or our ability to obtain regulatory approval of, tebentafusp in other jurisdictions, or any of our other product candidates;
|
• |
adverse results or delays in pre-clinical studies or clinical trials;
|
• |
reports of adverse events in products similar or perceived to be similar to those we are developing or clinical trials of such products;
|
• |
an inability to obtain additional funding;
|
• |
failure by us to successfully develop and commercialize our product candidates;
|
• |
failure by us to maintain our existing strategic collaborations or enter into new collaborations;
|
• |
failure by us to identify additional product candidates for our pipeline;
|
• |
failure by us or our licensors and strategic partners to prosecute, maintain, protect or enforce our intellectual property and proprietary rights;
|
• |
disputes or other developments relating to intellectual and other proprietary rights, including litigation
|
• |
matters and our ability to obtain patent and other intellectual property protection for our technologies;
|
• |
changes in laws or regulations applicable to future products;
|
• |
an inability to obtain adequate product supply for our product candidates or the inability to do so at acceptable prices;
|
• |
the introduction of new products, services or technologies by our competitors;
|
• |
failure by us to meet or exceed financial projections we may provide to the public;
|
• |
failure by us to meet or exceed the financial projections of the investment community;
|
• |
the perception of the pharmaceutical industry by the public, legislatures, regulators and the investment community;
|
• |
changes in the structure of healthcare payment systems;
|
• |
inability to obtain adequate commercial supply for any approved product or inability to do so at acceptable prices;
|
• |
announcements of significant acquisitions, strategic partnerships, joint ventures or capital commitments by us, our strategic partner or our competitors;
|
• |
inability to comply with our debt covenants and to make payments as they become due;
|
• |
additions or departures of key scientific or management personnel;
|
• |
significant lawsuits, including patent or shareholder litigation;
|
• |
changes in the market valuations of similar companies;
|
• |
general economic, industry, political and market conditions, including, but not limited to, the ongoing impact of the COVID-19 pandemic;
|
• |
sales of our ADSs or ordinary shares by us or our shareholders in the future; and
|
• |
the trading volume of our ADSs; and
|
• |
other events or factors, many of which are beyond our control.
|
• |
delaying, deferring, or preventing a change in control;
|
• |
entrenching our management and/or the board of directors;
|
• |
impeding a merger, scheme of arrangement, takeover, or other business combination involving us; or
|
• |
discouraging a potential acquirer from making a takeover offer or otherwise attempting to obtain control of us.
|
• |
not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act, or Section 404;
|
• |
not being required to comply with any requirement that has or may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report
providing additional information about the audit and the financial statements;
|
• |
reduced disclosure obligations regarding executive compensation; and
|
• |
an exemption from the requirement to seek nonbinding advisory votes on executive compensation or golden parachute arrangements.
|
• |
In connection with a potential offer, if following an approach by or on behalf of a potential bidder, the company is “the subject of rumor or speculation” or there is an “untoward movement” in the
company’s share price, there is a requirement for the potential bidder to make a public announcement about a potential offer for the company, or for the company to make a public announcement about its review of a potential offer.
|
• |
When a person or group of persons acting in concert (a) acquires, whether by a series of transactions over a period of time or not, interests in shares carrying 30% or more of the voting rights of a
company (which percentage is treated by the Takeover Code as the level at which effective control is obtained) or (b) acquires an interest in any other shares which increases the percentage of shares carrying voting rights in which they
are interested when they are already interested in shares which carry not less than 30% of the voting rights but do not hold shares carrying more than 50% of such voting rights, they must make a cash offer to all other shareholders at the
highest price paid by them or any person acting in concert with them in the 12 months before the offer was announced.
|
• |
When interests in shares carrying 10% or more of the voting rights of a class have been acquired by an offeror (i.e., a bidder) and any person acting in concert with it in the offer period (i.e., before
the shares subject to the offer have been acquired) or within the previous 12 months, the offer must be in cash or be accompanied by a cash alternative for all shareholders of that class at the highest price paid by the offeror or any
person acting in concert with them in that period. Further, if an offeror or any person acting in concert with them acquires any interest in shares during the offer period, the offer for the shares must be in cash or accompanied by a cash
alternative at a price at least equal to the price paid for such shares during the offer period.
|
• |
If after an announcement is made, the offeror or any person acting in concert with them acquires an interest in shares in an offeree company (i.e., a target) at a price higher than the value of the offer,
the offer must be increased to not less than the highest price paid for the interest in shares so acquired.
|
• |
The board of directors of the offeree company must appoint a competent independent adviser whose advice on the financial terms of the offer must be made known to all the shareholders, together with the
opinion of the board of directors of the offeree company.
|
• |
Special or favorable deals for selected shareholders are not permitted, except in certain circumstances where independent shareholder approval is given and the arrangements are regarded as fair and
reasonable in the opinion of the financial adviser to the offeree.
|
• |
All shareholders must be given the same information.
|
• |
Each document published in connection with an offer by or on behalf of the offeror or offeree must state that the directors of the offeror or the offeree, as the case may be, accept responsibility for the
information contained therein.
|
• |
Profit forecasts, quantified financial benefits statements and asset valuations must be made to specified standards and must be reported on by professional advisers.
|
• |
Misleading, inaccurate or unsubstantiated statements made in documents or to the media must be publicly corrected immediately.
|
• |
Actions during the course of an offer by the offeree company, which might frustrate the offer are generally prohibited unless shareholders approve these plans. Frustrating actions would include, for
example, lengthening the notice period for directors under their service contract or agreeing to sell off material parts of the target group.
|
• |
Stringent and detailed requirements are laid down for the disclosure of dealings in relevant securities during an offer, including the prompt disclosure of positions and dealing in relevant securities by
the parties to an offer and any person who is interested (directly or indirectly) in 1% or more of any class of relevant securities.
|
• |
Employees of both the offeror and the offeree company and the trustees of the offeree company’s pension scheme must be informed about an offer. In addition, the offeree company’s employee representatives
and pension scheme trustees have the right to have a separate opinion on the effects of the offer on employment appended to the offeree board of directors’ circular or published on a website.
|
• |
under our articles of association, any resolution put to the vote of a general meeting must be decided exclusively on a poll. Under English law, it would be possible for our articles of association to be
amended such that each shareholder present at a meeting has only one vote unless demand is made for a vote on a poll, in which case each holder gets one vote per share owned. Under U.S. law, each shareholder typically is entitled to one
vote per share at all meetings;
|
• |
under English law, subject to certain exceptions and disapplications, each shareholder generally has preemptive rights to subscribe on a proportionate basis to any issuance of ordinary shares or rights to
subscribe for, or to convert securities into, ordinary shares for cash. Under U.S. law, shareholders generally do not have preemptive rights unless specifically granted in the certificate of incorporation or otherwise;
|
• |
under English law and our articles of association, certain matters require the approval of 75% of the shareholders who vote (in person or by proxy) on the relevant resolution (or on a poll of shareholders
representing 75% of the ordinary shares voting (in person or by proxy)), including amendments to the articles of association. This may make it more difficult for us to complete corporate transactions deemed advisable by our board of
directors. Under U.S. law, generally only majority shareholder approval is required to amend the certificate of incorporation or to approve other significant transactions;
|
• |
in the United Kingdom, takeovers may be structured as takeover offers or as schemes of arrangement. Under English law, a bidder seeking to acquire us by means of a takeover offer would need to make an
offer for all of our outstanding ordinary shares/ADSs. If acceptances are not received for 90% or more of the ordinary shares/ADSs under the offer, under English law, the bidder cannot complete a “squeeze out” to obtain 100% control of
us. Accordingly, acceptances of 90% of our outstanding ordinary shares/ADSs will likely be a condition in any takeover offer to acquire us, not 50% as is more common in tender offers for corporations organized under Delaware law. By
contrast, a scheme of arrangement, the successful completion of which would result in a bidder obtaining 100% control of us, requires the approval of a majority of shareholders voting at the meeting and representing 75% of the ordinary
shares voting for approval;
|
• |
under English law and our articles of association, shareholders and other persons whom we know or have reasonable cause to believe are, or have been, interested in our shares may be required to disclose
information regarding their interests in our shares upon our request, and the failure to provide the required information could result in the loss or restriction of rights attaching to the shares, including prohibitions on certain
transfers of the shares, withholding of dividends and loss of voting rights. Comparable provisions generally do not exist under U.S. law; and
|
• |
the quorum requirement for a shareholders’ meeting is a minimum of two shareholders entitled to vote at the meeting and present in person or by proxy or, in the case of a shareholder which is a
corporation, represented by a duly authorized representative. Under U.S. law, a majority of the shares eligible to vote must generally be present (in person or by proxy) at a shareholders’ meeting in order to constitute a quorum. The
minimum number of shares required for a quorum can be reduced pursuant to a provision in a company’s certificate of incorporation or bylaws, but typically not below one-third of the shares entitled to vote at the meeting.
|
Item 4. |
Information on the Company.
|
A. |
History and development of the company.
|
B. |
Business overview.
|
• |
KIMMTRAK (tebentafusp-tebn), our ImmTAC molecule targeting an HLA-A*02:01 gp100 antigen, is our first approved product. KIMMTRAK was approved by the FDA on January
26, 2022 for the treatment of HLA-A*02:01-positive adult patients with unresectable or mUM. KIMMTRAK demonstrated monotherapy activity and recently achieved the primary endpoint of superior overall survival in a randomized Phase 3
clinical trial in patients with previously untreated metastatic uveal melanoma against the investigator’s choice of treatment. The OS hazard ratio in the intent-to-treat population favored tebentafusp, HR=0.51 (95% CI: 0.37, 0.71); p<
0.0001, over investigator’s choice (82% pembrolizumab; 13% ipilimumab; 6% dacarbazine). The FDA reviewed KIMMTRAK under the Real-Time Oncology Review pilot program, an initiative of the FDA’s Oncology Center of Excellence designed to
expedite the delivery of safe and effective cancer treatments to patients, and the FDA’s Project Orbis initiative, which enables concurrent review by the health authorities in partner countries that have requested participation.
|
• |
Tebentafusp regulatory submissions have been submitted to additional regulatory agencies outside the United States requesting marketing authorization of tebentafusp
for the treatment of mUM. The EMA, the United Kingdom’s MHRA, Health Canada, and the Australian Government Department of Health Therapeutic Goods Administration have each accepted the submission of our MAA. In February 2022, we announced
that the CHMP, of the EMA has adopted a positive opinion recommending the approval of KIMMTRAK for the treatment of HLA-A*02:01-positive adult patients with unresectable or mUM. The CHMP positive opinion is one of the final steps before
marketing authorisation is granted by the European Commission, which has the authority to approve medicines for use throughout the European Union. Subject to regulatory approval from the European Commission, we anticipate launching
KIMMTRAK in Europe in the second quarter of 2022. We plan to pursue regulatory approval for the marketing authorization of KIMMTRAK in all 28-member states of the European Union.
|
• |
Continue to promote our global early access program to make KIMMTRAK readily available to mUM patients. We are focused on continuing to treat these patients with KIMMTRAK as regulatory approval is sought in
the European Union and their respective European countries. There are currently over 200 patients in 13 countries enrolled in our global early access program.
|
• |
Tebentafusp is also being developed in metastatic cutaneous melanoma (mCM). In 2021, Immunocore presented data from Phase 1b trial in metastatic cutaneous melanoma
(mCM) at the Society for Immunotherapy of Cancer (SITC) 36th Annual Meeting. Preliminary evidence of KIMMTRAK (tebentafusp-tebn) clinical activity in mCM patients who had prior anti-PD(L)1 therapy, currently an unmet medical need,
included 1-year overall survival (OS) rate of 76%. We anticipate initiating a mCM Phase 2 randomized trial with and without PD(L)1 therapies in the fourth quarter of 2022.
|
• |
IMC-C103C, our ImmTAC molecule targeting an HLA-A*02:01 MAGE-A4 antigen, is currently being evaluated in a first-in-human, Phase 1/2 dose escalation trial in patients
with solid tumor cancers including non-small-cell lung cancer, or NSCLC, gastric, head and neck, ovarian and synovial sarcoma. In December, we reported initial Phase 1 data from the trial at the European Society of Medical Oncology
Immuno-Oncology Congress. IMC-C103C demonstrated a manageable safety profile and clinical activity with confirmed durable responses in ovarian cancer and a confirmed durable response in head and neck squamous cell carcinoma, or HNSCC. We
initiated an expansion arm in high-grade serous ovarian carcinoma at 140 micrograms/week. We anticipate reporting additional data from the Phase 1 trial in the fourth quarter of 2022.
|
• |
IMC-F106C, our ImmTAC molecule targeting an optimal HLA-A*02:01 PRAME antigen is currently being evaluated in a first-in-human, Phase 1/2 dose escalation trial in
patients with multiple solid tumor cancers including NSCLC, SCLC, endometrial, ovarian, cutaneous melanoma, and breast cancers. As of December 31, 2021, we enrolled 39 patients in the Phase 1 clinical trial. Early pharmacodynamic data
indicate that IMC-F106C monotherapy is demonstrating biological activity at the doses currently under evaluation. We anticipate reporting Phase 1 initial data from the trial in the third quarter of 2022.
|
• |
IMC-I109V, our ImmTAV molecule targeting a conserved hepatitis B virus, or HBV, envelope antigen, is our most advanced ImmTAV program and is
currently being evaluated in a Phase 1/2 clinical trial in patients with chronic HBV who are non-cirrhotic, hepatitis B e-Antigen negative, and virally suppressed on chronic nucleot(s)ide analogue therapy. Our goal is to develop a
functional cure for HBV and we initiated dosing the first patient in our Phase 1 single ascending dose, or SAD, trial in the second quarter of 2021.
|
• |
IMC-M113V, our ImmTAV
molecule targeting the human immunosuppression virus, or HIV, gag antigen bispecific TCR molecule, is currently in pre-clinical development. Our goal is to develop a functional cure for HIV and we expect to begin dosing patients in the
UK and Europe in 2022. Our clinical trial application in the United Kingdom was accepted in December of 2021, and we anticipate dosing the first patient in this trial during the second quarter of 2022.
|
• |
The US commercial launch of KIMMTRAK in metastatic uveal melanoma (mUM).
|
• |
The European commercial launch of KIMMTRAK in mUM subject to regulatory approval.
|
• |
The initiation of a randomized trial in metastatic cutaneous melanoma.
|
• |
Phase 1 data from IMC-F106C targeting PRAME in multiple solid tumors.
|
• |
Phase 1 data from IMC-C103C targeting MAGE-A4 in multiple solid tumors, and expansion arm in ovarian carcinoma.
|
• |
First patient dosed in IMC-M113V Phase 1 study in HIV.
|
• |
ImmTAC - Immune mobilizing monoclonal TCRs Against Cancer
|
• |
ImmTAV - Immune mobilizing monoclonal TCRs Against Viruses
|
• |
ImmTAAI - Immune modulating monoclonal TCRs Against AutoImmune disease
|
•
|
AGC Biologics A/S, headquartered in Copenhagen, Denmark
|
•
|
Baxter Oncology GmbH, headquartered in Halle/Westfalen, Germany
|
• |
nonclinical laboratory tests, animal studies and formulation studies all performed in accordance with the FDA’s good laboratory practices, or GLP, regulations;
|
• |
submission to the FDA of an IND application for human clinical testing, which must become effective before human clinical trials may begin;
|
• |
approval by an institutional review board, or IRB, representing each clinical site before each clinical trial may be initiated;
|
• |
performance of adequate and well-controlled human clinical trials to establish the safety, potency and purity of the product candidate for each proposed indication, in accordance with Good Clinical
Practices, or GCP;
|
• |
preparation and submission to the FDA of a BLA for a biological product requesting marketing for one or more proposed indications, including submission of detailed information on the manufacture and
composition of the product in clinical development and proposed labeling;
|
• |
review of the product by an FDA advisory committee, if applicable;
|
• |
one or more FDA inspections of the manufacturing facility or facilities, including those of third parties, at which the product, or components thereof, are produced to assess compliance with current Good
Manufacturing Practices, or cGMP, requirements and to assure that the facilities, methods and controls are adequate to preserve the product’s identity, strength, quality and purity;
|
• |
FDA audits of the clinical study sites to assure compliance with GCPs, and the integrity of clinical data in support of the BLA;
|
• |
payment of user fees and securing FDA approval of the BLA and licensure of the new biological product; and
|
• |
compliance with any post-approval requirements, including the potential requirement to implement a Risk Evaluation and Mitigation Strategy, or REMS, and any post-approval studies required by the FDA.
|
• |
restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from the market or product recalls;
|
• |
fines, untitled letters or warning letters or holds on post-approval clinical trials;
|
• |
refusal of the FDA to approve pending applications or supplements to approved applications, or suspension or revocation of product license approvals;
|
• |
product seizure or detention, or refusal to permit the import or export of products; or
|
• |
injunctions or the imposition of civil or criminal penalties.
|
• |
the federal Anti-Kickback Statute, which prohibits, among other things, persons and entities from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in
cash or kind, in exchange for, or to induce, either the referral of an individual for, or the purchase, order or recommendation of, any good or service for which payment may be made, in whole or in part, under federal healthcare programs
such as the Medicare and Medicaid programs. This statute has been interpreted to apply to arrangements between pharmaceutical manufacturers, on the one hand, and prescribers, purchasers, formulary managers and other individuals and
entities on the other. The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, or collectively, the ACA, amended the intent requirement of the federal Anti-Kickback Statute such that
a person or entity no longer needs to have actual knowledge of this statute or specific intent to violate it in order to commit a violation;
|
• |
the federal civil and criminal false claims, including the civil False Claims Act, or the FCA, and civil monetary penalties laws, which prohibit, among other things, individuals or entities from knowingly
presenting, or causing to be presented, claims for payment from Medicare, Medicaid or other third-party payors that are false or fraudulent, or knowingly making, or causing to be made, a false record or statement material to a false or
fraudulent claim to avoid, decrease, or conceal an obligation to pay money to the federal government. Certain marketing practices, including off-label promotion, also may implicate the FCA. In addition, the ACA codified case law that a
claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the FCA.
|
• |
HIPAA imposes criminal and civil liability, among other things, for executing, or attempting to execute, a scheme to defraud any healthcare benefit program or making false statements relating to healthcare
matters;
|
• |
the federal Physician Payments Sunshine Act, which requires certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid, or the Children’s
Health Insurance Program, with specific exceptions, to report annually to the Centers for Medicare & Medicaid Services, or CMS, information related to payments and other transfers of value made to physicians (defined to include
doctors, dentists, optometrists, podiatrists and chiropractors), other healthcare professionals (such as physicians assistants and nurse practitioners), and teaching hospitals, and ownership and investment interests held by physicians and
their immediate family members;
|
• |
HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, and their implementing regulations, which imposes certain obligations, including mandatory contractual terms,
with respect to safeguarding the transmission, security and privacy of individually identifiable health information on covered entities, such as health plans, health care clearinghouses and certain healthcare providers, and their
respective business associates that create, receive, maintain or transmit individually identifiable health information for or on behalf of a covered entity, and their subcontractors that use, disclose, access, or otherwise process
individually identifiable protected health information; and
|
• |
state and foreign law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payor, including
commercial insurers; state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government that otherwise
restrict payments that may be made to healthcare providers and other potential referral sources; state laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other
healthcare providers, drug pricing and/or marketing expenditures; state and local laws requiring the registration of pharmaceutical sales representatives; and state laws governing the privacy and security of health information in certain
circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, and may not have the same effect, thus complicating compliance efforts.
|
• |
an annual, nondeductible fee on any entity that manufactures or imports specified branded prescription drugs and biologic agents, apportioned among these entities according to their market share in certain
government healthcare programs;
|
• |
an increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program to 23.1% and 13.0% of the average manufacturer price for most branded and generic drugs,
respectively;
|
• |
a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected;
|
• |
extension of a manufacturer’s Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations;
|
• |
expansion of eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to certain individuals with income at or below 133% of the federal poverty level,
thereby potentially increasing a manufacturer’s Medicaid rebate liability;
|
• |
a new Medicare Part D coverage gap discount program, in which manufacturers must now agree to offer 70% point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries
during their coverage gap period, as a condition for a manufacturer’s outpatient drugs to be covered under Medicare Part D;
|
• |
expansion of the entities eligible for discounts under the Public Health Service pharmaceutical pricing program; and
|
• |
a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research.
|
C. |
Organizational structure.
|
D. |
Property, plant and equipment.
|
Item 4A. |
Unresolved Staff Comments.
|
Item 5. |
Operating and Financial Review and Prospects.
|
A. |
Operating Results
|
• |
after reviewing trial results, our collaboration partners may abandon projects that might previously have been believed to be promising;
|
• |
we, our collaboration partners, or regulators may suspend or terminate clinical trials if the participating subjects or patients are being exposed to unacceptable health risks;
|
• |
our potential products may not have the desired effects or may include undesirable side effects or other characteristics that preclude regulatory approval or limit their commercial use if approved;
|
• |
manufacturers may not meet the necessary standards for the production of the product candidates or may not be able to supply the product candidates in a sufficient quantity;
|
• |
regulatory authorities may find that our clinical trial design or conduct does not meet the applicable approval requirements; and
|
• |
safety and efficacy results in various human clinical trials reported in scientific and medical literature may not be indicative of results we obtain in our clinical trials.
|
Year ended December 31,
|
||||||||||||
|
2021
|
2020
|
||||||||||
$
|
’000
|
£
|
’000
|
£
|
’000
|
|||||||
Revenue
|
35,802
|
26,520
|
30,114
|
|||||||||
Research and development expenses
|
(98,855
|
)
|
(73,226
|
)
|
(74,809
|
)
|
||||||
Administrative expenses
|
(119,339
|
)
|
(88,399
|
)
|
(45,740
|
)
|
||||||
Net other operating (loss) income
|
(77
|
)
|
(57
|
)
|
4,242
|
|||||||
Operating loss
|
(182,469
|
)
|
(135,162
|
)
|
(86,193
|
)
|
||||||
Finance income
|
63
|
47
|
2,208
|
|||||||||
Finance costs
|
(7,848
|
)
|
(5,813
|
)
|
(3,375
|
)
|
||||||
Non-operating expense
|
(7,785
|
)
|
(5,766
|
)
|
(1,167
|
)
|
||||||
Loss before taxes
|
(190,254
|
)
|
(140,928
|
)
|
(87,360
|
)
|
||||||
Income tax credit
|
12,697
|
9,405
|
13,267
|
|||||||||
Loss for the period
|
(177,557
|
)
|
(131,523
|
)
|
(74,093
|
)
|
Year ended December 31,
|
||||||||||||
|
2021
|
2020
|
||||||||||
$
|
’000
|
£
|
’000
|
£
|
’000
|
|||||||
Collaboration revenue
|
||||||||||||
GSK
|
8,212
|
6,083
|
6,356
|
|||||||||
Eli Lilly
|
—
|
—
|
3,522
|
|||||||||
Genentech
|
23,526
|
17,427
|
20,236
|
|||||||||
Total collaboration revenue
|
31,738
|
23,510
|
30,114
|
|||||||||
Pre-product revenue
|
4,064
|
3,010
|
—
|
|||||||||
Total revenue
|
35,802
|
26,520
|
30,114
|
Year ended December 31,
|
||||||||||||
|
2021
|
2020
|
||||||||||
$
|
’000
|
£
|
’000
|
£
|
’000
|
|||||||
External research and development expenses:
|
||||||||||||
Tebentafusp
|
33,724
|
24,981
|
31,373
|
|||||||||
IMC-F106C (PRAME)
|
6,850
|
5,074
|
2,388
|
|||||||||
IMC-C103C (MAGE-A4)
|
6,376
|
4,723
|
4,519
|
|||||||||
IMC-I109V (HBV)
|
2,232
|
1,653
|
3,264
|
|||||||||
Other expenses
|
10,323
|
7,647
|
7,258
|
|||||||||
Research expenses
|
636
|
471
|
485
|
|||||||||
Total external research and development expenses
|
60,141
|
44,549
|
49,287
|
|||||||||
Internal research and development expenses:
|
||||||||||||
Headcount related expenses
|
30,610
|
22,674
|
19,539
|
|||||||||
Laboratory consumables
|
5,574
|
4,129
|
4,331
|
|||||||||
Laboratory equipment expenses
|
2,406
|
1,782
|
1,589
|
|||||||||
Other
|
124
|
92
|
63
|
|||||||||
Total internal research and development expenses
|
38,714
|
28,677
|
25,522
|
|||||||||
Total research and development expenses
|
98,855
|
73,226
|
74,809
|
Year ended December 31,
|
||||||||||||
|
2021
|
2020
|
||||||||||
Administrative expenses:
|
$
|
’000
|
£
|
’000
|
£
|
’000
|
||||||
Share-based payment charge
|
43,120
|
31,941
|
8,162
|
|||||||||
Other employee related expenses
|
19,061
|
14,119
|
14,935
|
|||||||||
Pre-commercial costs
|
25,831
|
19,134
|
1,781
|
|||||||||
Legal and professional fees
|
9,993
|
7,402
|
3,901
|
|||||||||
Depreciation expenses
|
9,466
|
7,012
|
9,007
|
|||||||||
Other expenses
|
12,485
|
9,248
|
7,959
|
|||||||||
Foreign exchange gains
|
(617
|
)
|
(457
|
)
|
(5
|
)
|
||||||
Total administrative expenses
|
119,339
|
88,399
|
45,740
|
B. |
Liquidity and Capital Resources
|
Year ended December 31,
|
||||||||||||
|
2021
|
2020
|
||||||||||
$
|
’000
|
£
|
’000
|
£
|
’000
|
|||||||
Cash and cash equivalents at beginning of the year
|
175,117
|
129,716
|
73,966
|
|||||||||
Net cash flows used in operating activities
|
(129,749
|
)
|
(96,110
|
)
|
(61,250
|
)
|
||||||
Net cash flows from / (used in) investing activities
|
(495
|
)
|
(367
|
)
|
1,143
|
|||||||
Net cash flows from financing activities
|
276,252
|
204,631
|
115,941
|
|||||||||
Net foreign exchange difference on cash held
|
22
|
16
|
(84
|
)
|
||||||||
Cash and cash equivalents at end of the year
|
321,147
|
237,886
|
129,716
|
• |
pursue further approval and commercialization of tebentafusp outside the United States.;
|
• |
continue to advance the development of our clinical trials and pre-clinical programs;
|
• |
continue to invest in our soluble TCR platforms to conduct research to identify novel technologies;
|
• |
change or add additional suppliers;
|
• |
add additional infrastructure to our quality control, quality assurance, legal, compliance and other groups to support our operations as we progress product candidates toward commercialization;
|
• |
seek to attract and retain skilled personnel;
|
• |
create additional infrastructure to support our operations as a public company listed in the United States and our product development and planned future commercialization efforts;
|
• |
seek marketing approvals and reimbursement for our other product candidates;
|
• |
further develop a sales, marketing and distribution infrastructure to further commercialize any products for which we may obtain marketing approval;
|
• |
seek to identify and validate additional product candidates;
|
• |
acquire or in-license other product candidates and technologies;
|
• |
maintain, protect, defend, enforce and expand our intellectual property portfolio; and
|
• |
experience any delays, interruptions or encounter issues with any of the above, including any delays or other impacts as a result of the COVID-19 pandemic.
|
• |
the progress, timing, scope and costs of our clinical trials, including the ability to timely initiate clinical sites, enroll subjects and manufacture soluble bispecific TCR product candidates for our
ongoing, planned and potential future clinical trials;
|
• |
the time and costs required to perform research and development to identify and characterize new product candidates from our research programs;
|
• |
the time and cost necessary to obtain regulatory authorizations and approvals that may be required by regulatory authorities to execute clinical trials or commercialize our products;
|
• |
our ability to successfully commercialize KIMMTRAK in the U.S. and to obtain approval for the product outside the U.S.
|
• |
our ability to successfully commercialize our other product candidates;
|
• |
our ability to have clinical and commercial products successfully manufactured consistent with FDA, EMA and other authorities’ regulations;
|
• |
the amount of sales and other revenues from product candidates that we may commercialize, if any, including the selling prices for such potential products and the availability of adequate third-party
coverage and reimbursement for patients;
|
• |
the sales and marketing costs associated with commercializing our products, if approved, including the cost and timing of building our marketing and sales capabilities;
|
• |
the cost of building, staffing and validating our manufacturing processes, which may include capital expenditure;
|
• |
the terms and timing of any revenue from our existing collaborations;
|
• |
the costs of operating as a public company;
|
• |
the time and cost necessary to respond to technological, regulatory, political and market developments;
|
• |
the costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights;
|
• |
the costs, associated with, and terms and timing of, any future any potential acquisitions, strategic collaborations, licensing agreements or other arrangements that we may establish; and
|
• |
the inability of clinical sites to enroll patients as healthcare capacities are required to cope with natural disasters, epidemics or other health system emergencies, such as the COVID-19 pandemic.
|
C. |
Research and Development, Patents and Licenses, etc.
|
D. |
Trend Information
|
E. |
Critical Accounting Estimates
|
Item 6. |
Directors, Senior Management and Employees
|
A. |
Directors and senior management.
|
Name
|
Age
|
Position(s)
|
||
Executive Officers:
|
||||
Bahija Jallal, Ph.D.
|
60
|
Chief Executive Officer and Director
|
||
Brian Di Donato
|
55
|
Chief Financial Officer and Head of Strategy
|
||
David Berman, M.D., Ph.D.
|
51
|
Head of Research and Development
|
||
Tina St Leger
|
53
|
Chief Human Resources Officer
|
||
Non-Executive Directors:
|
||||
Professor Sir John Bell
|
69
|
Chairman of the Board of Directors
|
||
Travis Coy
|
41
|
Director
|
||
Roy S. Herbst, M.D., Ph.D
|
58
|
Director
|
||
Robert Perez
|
57
|
Director
|
||
Kristine Peterson
|
62
|
Director
|
||
Professor Sir Peter Ratcliffe
|
67
|
Director
|
Board Diversity Matrix (As of December 31, 2021)
|
||||
Country of Principal Executive Offices
|
United Kingdom
|
|||
Foreign Private Issuer
|
Yes
|
|||
Disclosure Prohibited under Home Country Law
|
No
|
|||
Total Number of Directors
|
7
|
|||
Female
|
Male
|
Non-Binary
|
Did Not Disclose Gender
|
|
Part I: Gender Identity
|
||||
Directors
|
2
|
5
|
-
|
-
|
Part II: Demographic Background
|
||||
Underrepresented Individual in Home Country Jurisdiction
|
1
|
|||
LGBTQ+
|
-
|
|||
Did Not Disclose Demographic Background
|
1
|
B. |
Compensation
|
Name
|
Salary and
Fees
$
|
Benefits
$
|
Pension
(401(k))
$
|
Total Fixed
Remuneration
$
|
Annual
Bonus
$
|
Total
Remuneration
$
|
Share-Based
Awards
Number (1)
|
|||||||||||||||||||||
Executive Director
|
||||||||||||||||||||||||||||
Bahija Jallal, Ph.D.
|
700,000
|
30,914
|
14,500
|
745,414
|
525,000(2)
|
|
1,270,414
|
2,076,080
|
||||||||||||||||||||
Non-Executive Directors
|
||||||||||||||||||||||||||||
Professor Sir John Bell
|
70,559
|
—
|
—
|
70,559
|
—
|
70,559
|
33,985
|
|||||||||||||||||||||
Travis Coy(3)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|||||||||||||||||||||
Roy Herbst, M.D., Ph.D.
|
46,890
|
—
|
—
|
46,890
|
—
|
46,890
|
10,620
|
|||||||||||||||||||||
Robert Perez(3)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|||||||||||||||||||||
Kristine Peterson
|
44,658
|
—
|
—
|
44,658
|
—
|
44,658
|
13,778
|
|||||||||||||||||||||
Professor Sir Peter Ratcliffe
|
60,370
|
—
|
—
|
60,370
|
—
|
60,370
|
—
|
|||||||||||||||||||||
Other Executive Officers
|
905,000
|
59,088
|
25,221
|
989,309
|
518,100
|
1,507,409
|
875,507
|
|||||||||||||||||||||
Total compensation
|
1,827,477
|
90,002
|
39,721
|
1,957,200
|
1,043,100
|
3,000,300
|
3,009,970
|
1. |
Represents number of options granted during the year ended December 31, 2021. Further information regarding these awards including date of grant, exercise price and expiration date is
disclosed in the table below. See Note 19 to our audited financial statements included elsewhere in this Annual Report for a discussion of the assumptions made by us in determining the share-based payment expense calculated in accordance
with IFRS 2.
|
2. |
Represents a performance-based cash bonus awarded to Dr. Jallal in connection with the achievement of 2021 annual performance milestones (paid in 2022) pursuant to the terms of her
amended and restated employment agreement. Dr. Jallal was assigned a target bonus expressed as a percentage of her base salary, and the target bonus amount for Dr. Jallal for 2021 was set 75%. For 2021, the Board determined to award Dr.
Jallal an annual bonus of $525,000 (reflecting an achievement level of 100%), as reflected in the “Annual Bonus” column of the table above.
|
3. |
Robert Perez and Travis Coy were originally nominated to our board of directors by Eli Lilly S.A. and General Atlantic, respectively, pursuant to our Series C Shareholders’ Agreement,
which granted a right to each of Eli Lilly S.A. and General Atlantic to appoint an individual to our board. Both directors elected to forgo remuneration in respect of their services as non-executive directors.
|
Name
|
Ordinary Share
Underlying
Option Award
|
Exercise
Price
($)
|
Grant Date
|
Expiration
Date
|
||||||||||||
Executive Director
|
||||||||||||||||
Bahija Jallal, Ph.D.(2)(3)
|
2,076,080
|
26.00
|
February 4, 2021
|
February 4, 2031
|
||||||||||||
28,345
|
17.46
|
October 30, 2020
|
October 30, 2030
|
|||||||||||||
2,079,470
|
17.46
|
January 7, 2019
|
January 7, 2029
|
|||||||||||||
Non-Executive Directors
|
||||||||||||||||
Professor Sir John Bell(4)
|
33,985
|
26.00
|
February 4, 2021
|
February 4, 2031
|
||||||||||||
18,215
|
17.46
|
November 16, 2020
|
November 16, 2030
|
|||||||||||||
1,335
|
40.93
|
December 13, 2016
|
December 12, 2026
|
|||||||||||||
1,335
|
40.93
|
September 9, 2016
|
September 8, 2026
|
|||||||||||||
6,915
|
11.83
|
June 12, 2015
|
June 11, 2025
|
|||||||||||||
Roy Herbst, M.D., Ph.D.(4)
|
10,620
|
26.00
|
February 4, 2021
|
February 4, 2031
|
||||||||||||
Kristine Peterson(4)
|
13,778
|
26.00
|
February 4, 2021
|
February 4, 2031
|
||||||||||||
11,520
|
17.46
|
November 16, 2020
|
November 16, 2030
|
|||||||||||||
Professor Sir Peter Ratcliffe(4)
|
—
|
—
|
—
|
—
|
||||||||||||
Other Executive Officers
|
875,507
|
26.00
|
February 4, 2021
|
February 4, 2031
|
||||||||||||
831,790
|
17.46
|
July 16, 2020
|
July 16, 2030
|
|||||||||||||
300,000
|
17.46
|
April 30, 2020
|
April 30, 2030
|
1. |
Options granted during 2021 were granted at the time of our IPO. The exercise price of $26.00 is equal to the price per ADS sold in the IPO, and the awards have no performance conditions attached.
|
2. |
Options granted to Dr. Jallal on February 4, 2021 and October 30, 2020 vest over a four-year period from the date of grant. Twenty-five percent of the shares subject to the February 4, 2021 award vested on
the first anniversary of the vesting commencement date, and the remaining shares vest in quarterly installments thereafter, subject to the officer’s continued service through each vesting date. The options granted on October 30, 2020 have
a vesting commencement date of April 1, 2020. Twenty-five percent of the shares subject to the October 30, 2020 award vest on the first anniversary of the vesting commencement date (April 1, 2021), and the remaining shares vest in
quarterly installments thereafter, subject to the officer’s continued service through each vesting date.
|
3. |
The options granted to Dr. Jallal on January 7, 2019 vesting over a five-year period were modified during 2020 and immediately prior to the IPO. The incremental fair values arising on these modifications
for accounting purposes were $3.84 and $5.19, respectively.
|
4. |
All option awards granted to our non-executive directors vest over a four-year period from the date of grant, with 25% of the award vesting on the first anniversary of the vesting commencement date and the
remaining shares vesting in quarterly installments thereafter, subject to the director’s continued service through each vesting date.
|
5. |
Robert Perez and Travis Coy were originally nominated to our board of directors by Eli Lilly S.A. and General Atlantic, respectively, pursuant to our Series C Shareholders’ Agreement, which granted a right
to each of Eli Lilly S.A. and General Atlantic to appoint an individual to our board. Both directors elected to forgo remuneration in respect of their services as non-executive directors.
|
Element, purpose and link to strategy
|
The Company adopted the 2021 Equity Incentive Plan (“EIP”) to enhance the Group’s ability to attract, retain and motivate persons who make (or are expected to make) important contributions to the Group by
providing these individuals with equity ownership opportunities.
The EIP facilitates share ownership to provide further alignment with shareholders.
Executive Directors may also hold awards granted under the predecessor plans to the EIP and may also participate in any future discretionary equity incentive plan that may be adopted from time to time to
replace the EIP.
|
How it operates
|
The EIP provides for the grant of market value options, share appreciation rights, restricted stock unit awards, dividend equivalents, performance awards (subject to performance conditions) and other
share-based awards. Awards vest at such times and as specified in the Award Agreement. If the participant violates the non-competition, non-solicitation, confidentiality or other similar restrictive covenant provisions of any employment
contract, the right of the participant to receive these shares on vesting shall terminate immediately. The Committee maintains discretion over the type and terms of equity awards granted. The EIP is administered by the Administrator.
EIP awards are not subject to any holding period.
All awards may be subject to malus and/or clawback under any malus and/or clawback policy that may be adopted in
the future.
Any share-based entitlements granted to an Executive Director under the Company’s share plans will be treated in accordance with the relevant plan rules or any applicable agreement. Under the good leaver
provisions unvested options lapse, but vested options can be exercised within a period as set out in the plan rules. The Committee retains the discretion to vest awards (and measure performance accordingly) on cessation and disapply time
prorating; however, it is envisaged that this would only be applied in exceptional circumstances.
|
Maximum opportunity
|
There is no maximum opportunity under the EIP. However, the Company’s Remuneration Committee will ensure that annual awards that are granted are guided by the market. The Committee will look at the position
at similar sized comparators to help inform its decision.
|
Performance-related framework
|
The Committee has the discretion to choose the form of EIP awards for each year, as well as each individual grant. Currently, awards are granted subject to time-based vesting only, but the Committee may
decide to introduce performance conditions for future awards and will be guided by the market in making any such decision.
|
Element, purpose and link to strategy
|
To facilitate share ownership by Non-Executive Directors in the Company and provide alignment with shareholders.
|
How it operates
|
The EIP provides for the grant of market value options, share appreciation rights, restricted stock unit awards, dividend equivalents, performance awards (subject to performance conditions) and other
share-based awards. Further, subject to the terms of the award agreement, awards can be granted in respect of ordinary shares, ADSs, cash or a combination thereof. However, performance awards (subject to performance conditions) are not
intended to be issued to Non-Executive Directors.
Awards vest in accordance with the vesting schedule set for the relevant award in its award agreement. The Committee maintains discretion over the type and terms of equity awards granted.
Non-Executive Directors usually receive options on joining the Board and annually as part of their remuneration with phased vesting. Under normal circumstances, initial share awards vest monthly over three
years and options awarded annually will usually vest upon the first anniversary of the date of grant.
Non-Executive Directors may also hold awards granted under the predecessor plans to the EIP and may also participate in any future discretionary equity incentive plan that may be adopted from time to time
to replace the EIP.
|
Maximum opportunity
|
There is no maximum number of equity incentive awards that may be awarded to individuals each year. However, when reviewing award levels, account is taken of market movements in equity incentive awards,
Board committee responsibilities, ongoing time commitments and the general economic environment.
|
Performance-related framework
|
Non-Executive Directors do not participate in performance based equity incentives.
|
C. |
Board Practices
|
• |
Class I consists of Travis Coy, Peter Ratcliffe and Roy S. Herbst, whose terms will expire at our first annual general meeting which will be held in May 2022;
|
• |
Class II consists of Robert Perez and Kristine Peterson, whose terms will expire at our second annual general meeting held in 2023; and
|
• |
Class III consists of John Bell and Bahija Jallal, whose terms will expire at our third annual general meeting held in 2024.
|
• |
determining whether to appoint, reappoint or remove any auditors, and making recommendations to the board of directors to be put to the shareholders for approval at the annual general meeting;
|
• |
reviewing audit plans, the adequacy of staffing and fees, whilst overseeing the negotiation and execution of any engagement letters on our behalf;
|
• |
at least annually, assessing the qualifications, performance, and independence of the auditors, or in the case of prospective auditors, before they are engaged;
|
• |
overseeing the policies and procedures governing how we may employ individuals who are or once were employed by the auditors;
|
• |
reviewing results of the annual audit, audited financial statements, periodic and annual reports, earnings announcements, proxy report, accounting principles and policies;
|
• |
evaluating management’s cooperation with the auditors during their audit examination;
|
• |
reviewing and reporting on policies on financial risk management and assessment;
|
• |
reviewing the audit plan of any internal audit team;
|
• |
reviewing the scope, design, adequacy and effectiveness of internal controls;
|
• |
reviewing correspondence with regulators or governmental agencies that raise material issues regarding our financial statements or accounting policies;
|
• |
overseeing procedures for receiving, retaining and investigating complaints;
|
• |
monitoring compliance with our Code of Business Conduct and Ethics and related party transactions rules; and
|
• |
reviewing with management legal and regulatory compliance and any actual, pending, or threatened legal or financial matters that could significantly affect our business or financial statements or as
otherwise deemed appropriate by the audit committee.
|
• |
reviewing, modifying and overseeing the company’s overall compensation strategy and policies;
|
• |
reviewing and approving the compensation and other terms of employment of our Chief Executive Officer;
|
• |
reviewing and approving all elements of the compensation and other terms of employment of the executive officers and other senior management reporting directly to the Chief Executive Officer;
|
• |
reviewing and recommending to the board of directors for its approval the type and amount of compensation to be paid or awarded to members of the board of directors;
|
• |
undertaking sole responsibility for the appointment, authority to select, retain, and terminate any compensation and oversight of the work of compensation consultants, legal counsel, or any other advisors
engaged for the purpose of advising the remuneration committee;
|
• |
exercising full power and authority to adopt, amend, terminate, and administer our equity award, pension, and profit sharing plans, incentive plans, bonus plans, executive benefit plans, stock purchase
plans, deferred compensation plans and other similar programs;
|
• |
when required, reviewing and discussing with management our Compensation Discussion and Analysis section of our annual reports, registration statements, proxy statements, or information statements filed
with the SEC;
|
• |
reviewing and discussing with management any conflicts of interest raised; and
|
• |
overseeing the preparation of any report required by applicable U.S. and U.K. rules and regulations to be included in our public filings relating to compensation policy and practices, including but not
limited to the directors’ remuneration report required under the Companies Act.
|
• |
identifying and evaluating candidates, including nomination of incumbent directors for re-election and nominees recommended by shareholders to serve on the board of directors;
|
• |
making recommendations to the board of directors regarding nominees for directors at the next annual general meeting;
|
• |
periodically reviewing the performance of the board of directors, including committees of the board of directors and management;
|
• |
overseeing the board of directors’ committee structure and operations, including authority to delegate to subcommittees and committee reporting to the board of directors;
|
• |
reviewing with the Chief Executive Officer the succession plans for our executive officers;
|
• |
instituting plans or programs for the continuing education of directors and orientation of new directors, as it deems appropriate; and
|
• |
periodically reviewing the processes and procedures to provide information to the board of directors and its committees.
|
D. |
Employees
|
|
At December 31,
|
|||||||||||
|
2019
|
2020
|
2021
|
|||||||||
Function:
|
||||||||||||
Administrative
|
67
|
55
|
77
|
|||||||||
Research and development
|
392
|
236
|
247
|
|||||||||
Total
|
459
|
291
|
324
|
|||||||||
Geography:
|
||||||||||||
United Kingdom
|
409
|
242
|
264
|
|||||||||
European Union
|
3
|
2
|
2
|
|||||||||
United States
|
47
|
47
|
58
|
|||||||||
Total
|
459
|
291
|
324
|
E. |
Share Ownership
|
Item 7. |
Major Shareholders and Related Party Transactions
|
A. |
Major Shareholders
|
• |
each beneficial owner of 5% or more of our outstanding ordinary shares and non-voting ordinary shares;
|
• |
each of our directors and executive officers; and
|
• |
all of our directors and executive officers as a group.
|
Name of Beneficial Owner
|
Number of
Ordinary Shares
Beneficially
Owned (#)
|
Percent of
Ordinary Shares
Beneficially
Owned (%)
|
||||||
5% or Greater Shareholders:
|
||||||||
Entities affiliated with General Atlantic (1)
|
4,922,575
|
11.2
|
%
|
|||||
Entities affiliated with Baker Brothers (2)
|
3,352,357
|
7.6
|
%
|
|||||
Eli Lilly S.A. (3)
|
2,548,145
|
5.8
|
%
|
|||||
Entities affiliated with Rock Springs Capital (4)
|
2,471,555
|
5.6
|
%
|
|||||
Malin Life Sciences Holdings Limited (5)
|
2,389,979
|
5.4
|
%
|
|||||
Ian Laing (6)
|
2,358,650
|
5.4
|
%
|
|||||
Executive Officers and Directors:
|
||||||||
Bahija Jallal, Ph.D. (7)
|
1,571,156
|
3.5
|
%
|
|||||
Brian Di Donato (8)
|
233,451
|
*
|
||||||
David Berman, M.D., Ph.D. (9)
|
792,991
|
1.8
|
%
|
|||||
Tina St. Leger
|
—
|
—
|
||||||
Professor Sir John Bell (10)
|
49,748
|
*
|
||||||
Travis Coy
|
—
|
—
|
||||||
Roy Herbst (11)
|
2,655
|
* |
||||||
Robert Perez
|
—
|
—
|
||||||
Kristine Peterson (12)
|
14,965
|
*
|
||||||
Professor Sir Peter Ratcliffe
|
—
|
—
|
||||||
All current directors and executive officers as a group (10 persons) (13)
|
2,664,966
|
5.7
|
%
|
* |
Represents beneficial ownership of less than one percent.
|
(1) |
Consists of 4,922,575 ADSs held by GA IMC Holding, L.P. The limited partners that share beneficial ownership of the shares held by GA IMC Holding are the following General Atlantic investment funds: General
Atlantic Partners (Bermuda) EU, L.P. (“GAP EU”), General Atlantic Partners (Bermuda) IV, L.P. (“GAP IV”) , GAP Coinvestments III, LLC (“GAPCO III”), GAP Coinvestments IV, LLC (“GAPCO IV”), GAP Coinvestments V, LLC (“GAPCO V”) and GAP
Coinvestments CDA, LLC (“GAPCO CDA”). The general partner of GAP EU and GAP IV is General Atlantic GenPar (Bermuda), L.P. (“GenPar Bermuda”). GAP (Bermuda) Limited (“GAP (Bermuda) Limited”) is the general partner of GenPar Bermuda.
General Atlantic’s address is c/o Conyers Client Services (Bermuda) Limited, Clarendon House, 2 Church Street, Hamilton MM II, Bermuda.
|
(2) |
The information shown is based, in part, upon disclosures filed on a Schedule 13D on May 20, 2021 filed jointly by Baker Bros. Advisors LP (the “Adviser”), Baker Bros. Advisors (GP) LLC (the “Adviser GP”),
Felix J. Baker and Julian C. Baker (collectively, the “Reporting Persons”). The number reported consists of 2,520,730 ADSs and 831,627 ordinary shares issuable upon conversion of 831,627 non-voting ordinary shares directly held by the
funds. 3,104,143 ADSs are held by Baker Brothers Life Sciences, L.P. and 248,214 ADSs are held by 667,L.P.The address of Baker Bros. Advisors LP is 860 Washington Street, 3rd Floor, New York, NY 10014, United States.
|
(3) |
Consists of 2,548,145 ADSs held by Eli Lilly S.A. Eli Lilly S.A.’s address is 16, Chemin des Coquelicots, 12 Geneva, Switzerland.
|
(4) |
Consists of 2,455,155 ADSs held by Rock Springs Capital Management LP (“RSCM”), Rock Springs Capital LLC (“RSC”), and Rock Springs Capital Management LP (“Master Fund”)The address of Rock Springs Capital
Management LP and Rock Springs Capital LLC is 650 South Exeter, Suite 1070, Baltimore, MD 21202.
|
(5) |
Consists of 2,389,979 ADSs held by Malin Life Sciences Holdings Limited. Malin Life Sciences Holdings Limited’s address is The Lennox Building, 50 Richmond Street South, Dublin D02 FK02, Ireland.
|
(6) |
Consists of 2,358,650 ADSs held by Ian Michael Laing and Caroline Elizabeth Laing.
|
(7) |
Consists of 1,571,156 ordinary shares underlying options that are exercisable within 60 days of December 31, 2021 held by Dr. Jallal.
|
(8) |
Consists of (a) 19,230 ADSs held by Mr. Di Donato and (b) 214,221 ordinary shares underlying options that are exercisable within 60 days of December 31, 2021 held by Mr Di Donato.
|
(9) |
Consists of 792,991 ordinary shares underlying options that are exercisable within 60 days of December 31, 2021 held by Dr. Berman.
|
(10) |
Consists of (a) 13,452 ADSs and (b) options to purchase 36,296 ordinary shares that are or will be immediately exercisable
within 60 days of December 31, 2021 held by Professor Sir John Bell.
|
(11) |
Consists of 2,655 ordinary shares underlying options that are or will be immediately exercisable within 60 days of December 31, 2021 held by Dr.
Herbst.
|
(12) |
Consists of 14,965 ordinary shares underlying options that are exercisable within 60 days of December 31, 2021 held by Ms. Peterson.
|
(13) |
Consists of (a) 32,682 ADSs and (b) options to purchase 2,632,284 ordinary shares that are or will be immediately exercisable within 60 days of
December 31, 2021.
|
B. |
Related Party Transactions
|
Purchaser
|
Number of ADSs
|
|||
Entities affiliated with General Atlantic
|
950,000
|
|||
Entities affiliated with Baker Brothers
|
1,689,102
|
|||
Entities affiliated with Fidelity
|
1,350,000
|
C. |
Interests of Experts and Counsel
|
Item 8. |
Financial Information.
|
A. |
Consolidated Statements and Other Financial Information
|
B. |
Significant Changes
|
Item 9. |
The Offer and Listing.
|
A. |
Offer and Listing Details
|
B. |
Plan of Distribution
|
C. |
Markets
|
D. |
Selling Shareholders
|
E. |
Dilution
|
F. |
Expenses of the Issue
|
Item 10. |
Additional Information.
|
A. |
Share Capital
|
B. |
Memorandum and Articles of Association
|
C. |
Material Contracts
|
D. |
Exchange Controls
|
E. |
Taxation
|
• |
banks, insurance companies, and certain other financial institutions;
|
• |
U.S. expatriates and certain former citizens or long-term residents of the United States;
|
• |
dealers or traders in securities who use a mark-to-market method of tax accounting;
|
• |
persons holding ordinary shares or ADSs as part of a hedging transaction, “straddle,” wash sale, conversion transaction or integrated transaction or persons entering into a constructive sale with respect to
ordinary shares or ADSs;
|
• |
persons whose “functional currency” for U.S. federal income tax purposes is not the U.S. dollar;
|
• |
brokers, dealers or traders in securities, commodities or currencies;
|
• |
tax-exempt entities or government organizations;
|
• |
S corporations, partnerships, or other entities or arrangements classified as partnerships for U.S. federal income tax purposes (and investors therein);
|
• |
regulated investment companies or real estate investment trusts;
|
• |
persons who acquired our ordinary shares or ADSs pursuant to the exercise of any employee stock option or otherwise as compensation;
|
• |
persons holding shares or ADSs in connection with a trade or business outside the United States;
|
• |
persons that own or are deemed to own ten percent or more of our shares (by vote or value); and
|
• |
persons holding our ordinary shares or ADSs in connection with a trade or business, permanent establishment, or fixed base outside the United States.
|
(1) |
an individual who is a citizen or resident of the United States;
|
(2) |
a corporation, or other entity taxable as a corporation for U.S. federal income tax purposes, created or organized in or under the laws of the United States, any state therein or the District of Columbia;
|
(3) |
an estate the income of which is subject to U.S. federal income taxation regardless of its source; or
|
(4) |
a trust if (1) a U.S. court is able to exercise primary supervision over the administration of the trust and one or more U.S. persons have authority to control all substantial decisions of the trust or (2)
the trust has a valid election to be treated as a U.S. person under applicable U.S. Treasury Regulations.
|
• |
the excess distribution or gain will be allocated ratably over a U.S. Holder’s holding period for the ordinary shares or ADSs;
|
• |
the amount allocated to the taxable year of the disposition or distribution (as applicable), and any taxable year prior to the first taxable year in which we became a PFIC, will be treated as ordinary
income; and
|
• |
the amount allocated to each other year will be subject to the highest tax rate in effect for that year and the interest charge generally applicable to underpayments of tax will be imposed on the resulting
tax attributable to each such year.
|
• |
persons who are connected with the company;
|
• |
financial institutions;
|
• |
insurance companies;
|
• |
charities or tax-exempt organizations;
|
• |
collective investment schemes;
|
• |
pension schemes;
|
• |
market makers, intermediaries, brokers or dealers in securities;
|
• |
persons who have (or are deemed to have) acquired their ADSs by virtue of an office or employment or who are or have been officers or employees of the company or any of its affiliates; and
|
• |
individuals who are subject to U.K. taxation on a remittance basis
|
F. |
Dividends and Paying Agents
|
G. |
Statement by Experts
|
H. |
Documents on Display
|
I. |
Subsidiary Information
|
Item 11. |
Quantitative and Qualitative Disclosures About Market Risk.
|
Item 12. |
Description of Securities Other than Equity Securities.
|
A. |
Debt Securities
|
B. |
Warrants and Rights
|
C. |
Other Securities
|
D. |
American Depositary Shares
|
Service
|
Fee
|
|
Issuance of ADSs (e.g., an issuance of ADS upon a deposit of ordinary shares or upon a change in the ADS(s)-to-ordinary shares ratio, or for any other reason),
excluding ADS issuances as a result of distributions of ordinary shares
|
Up to $0.05 per ADS issued
|
|
Cancellation of ADSs (e.g., a cancellation of ADSs for delivery of deposited property or upon a change in the ADS(s)-to-ordinary shares ratio, or for any other
reason)
|
Up to $0.05 per ADS cancelled
|
|
Distribution of cash dividends or other cash distributions (e.g., upon a sale of rights and other entitlements)
|
Up to $0.05 per ADS held
|
|
Distribution of ADSs pursuant to (i) share dividends or other distributions, or (ii) exercise of rights to purchase additional ADSs
|
Up to $0.05 per ADS held
|
|
Distribution of securities other than ADSs or rights to purchase additional ADSs (e.g., upon a spin-off)
|
Up to $0.05 per ADS held
|
|
ADS services
|
Up to $0.05 per ADS held on the applicable record date(s) established by the depositary
|
• |
taxes (including applicable interest and penalties) and other governmental charges;
|
• |
the registration fees as may from time to time be in effect for the registration of ordinary shares on the share register and applicable to transfers of ordinary shares to or from the name of the custodian,
the depositary or any nominees upon the making of deposits and withdrawals, respectively;
|
• |
certain cable, telex and facsimile transmission and delivery expenses;
|
• |
the expenses and charges incurred by the depositary in the conversion of foreign currency;
|
• |
the fees and expenses incurred by the depositary in connection with compliance with exchange control regulations and other regulatory requirements applicable to ordinary shares, ADSs and ADRs; and
|
•
|
the fees and expenses incurred by the depositary, the custodian, or any nominee in connection with the servicing or delivery of deposited property.
|
Item 13. |
Defaults, Dividend Arrearages and Delinquencies.
|
Item 14. |
Material Modifications to the Rights of Security Holders and Use of Proceeds.
|
A. |
Not applicable.
|
B. |
Not applicable.
|
C. |
Not applicable.
|
D. |
Not applicable.
|
E. |
Use of Proceeds.
|
Item 15. |
Controls and Procedures.
|
A. |
Disclosure Controls and Procedures
|
B. |
Management’s Annual Report on Internal Control Over Financial Reporting
|
C. |
Attestation Report of the Registered Public Accounting Firm
|
D. |
Changes in Internal Control Over Financial Reporting
|
Item 15T. |
Controls and Procedures.
|
Item 16. |
[Reserved]
|
Item 16A. |
Audit Committee Financial Expert.
|
Item 16B. |
Code of Ethics.
|
Item 16C. |
Principal Accountant Fees and Services.
|
Year Ended December 31,
|
||||||||
2021
|
2020
|
|||||||
£
|
’000
|
£
|
’000
|
|||||
Audit fees
|
|
650
|
|
470
|
||||
Audit-related fees
|
125
|
237
|
||||||
Total
|
|
775
|
|
707
|
Item 16D. |
Exemptions from the Listing Standards for Audit Committees.
|
Item 16E. |
Purchases of Equity Securities by the Issuer and Affiliated Purchasers.
|
Item 16F. |
Change in Registrant’s Certifying Accountant.
|
Item 16G. |
Corporate Governance.
|
• |
Exemption from filing quarterly reports on Form 10-Q containing unaudited financial and other specified information or current reports on Form 8-K upon the occurrence of specified significant events;
|
• |
Exemption from Section 16 rules requiring insiders to file public reports of their securities ownership and trading activities and providing for liability for insiders who profit from trades in a short
period of time;
|
• |
Exemption from quorum requirements for shareholder meetings. In accordance with usual practice in England and Wales, our articles of association will provide alternative quorum requirements that are
generally applicable to shareholder meetings;
|
• |
Exemption from the Nasdaq rules applicable to domestic issuers requiring disclosure within four business days of any determination to grant a waiver of the code of business conduct and ethics to directors
and officers;
|
• |
Exemption from the requirement to obtain shareholder approval for certain issuances of securities, including shareholder approval of share option plans;
|
• |
Exemption from the requirement that our audit committee have review and oversight responsibilities over all “related party transactions,” as defined in Item 7.B of Form 20-F;
|
• |
Exemption from the requirement that our board have a compensation committee that is composed entirely of independent directors with a written charter addressing the committee’s purpose and responsibilities;
and
|
• |
Exemption from the requirements that director nominees are selected, or recommended for selection by our board, either by (1) independent directors constituting a majority of our board’s independent
directors in a vote in which only independent directors participate, or (2) a committee comprised solely of independent directors, and that a formal written charter or board resolution, as applicable, addressing the nominations process is
adopted.
|
Item 16H. |
Mine Safety Disclosure.
|
Item 17. |
Financial Statements.
|
Item 18. |
Financial Statements.
|
Item 19. |
Exhibits
|
Exhibit
|
Description
|
Incorporation by Reference
|
||||||||
Schedule/
Form
|
File
Number
|
Exhibit
|
File Date
|
|||||||
Articles of Association of Immunocore Holdings plc.
|
20-F
|
001-39992
|
1.1
|
03/25/21
|
||||||
Deposit Agreement.
|
20-F
|
001-39992
|
2.2
|
03/25/21
|
||||||
Form of American Depositary Receipt (included in Exhibit 2.2).
|
20-F
|
001-39992
|
2.3
|
03/25/21
|
||||||
Description of Securities.
|
20-F
|
001-39992
|
2.4
|
03/25/21
|
||||||
Subscription Agreement between the Registrant and the Bill & Melinda Gates Foundation, dated February 3, 2021.
|
F-1/A
|
333-252166
|
4.3
|
02/03/21
|
||||||
Research Collaboration and License Agreement, dated as of June 14, 2013, by and among the Registrant, Genentech, Inc. and F. Hoffman-La Roche Ltd, as amended on September 27, 2016.
|
F-1
|
333-252166
|
10.5
|
01/15/21
|
||||||
Collaboration and License Agreement, dated as of June 29, 2013, between the Registrant and GlaxoSmithKline Intellectual Property Development Ltd.
|
F-1
|
333-252166
|
10.6
|
01/15/21
|
||||||
Development and License Agreement, dated as of July 11, 2014, between the Registrant and Eli Lilly and Company, as amended on December 21, 2016, September 20, 2017 and December 19, 2018.
|
F-1
|
333-252166
|
10.7
|
01/15/21
|
||||||
License Agreement, dated as of September 27, 2016, between the Registrant and Genentech, Inc.
|
F-1
|
333-252166
|
10.8
|
01/15/21
|
License and Collaboration Agreement, dated as of November 15, 2018, by and among the Registrant, Genentech, Inc. and F. Hoffman-La Roche Ltd.
|
F-1
|
333-252166
|
10.9
|
01/15/21
|
||||||
Convertible Loan Note Purchase Agreement, dated as of September 13, 2017, between the Registrant and the Bill & Melinda Gates Foundation.
|
F-1
|
333-252166
|
10.10
|
01/15/21
|
||||||
Amended and Restated Global Access Commitments Agreement, dated as of March 2, 2020, between the Registrant and the Bill & Melinda Gates Foundation.
|
F-1
|
333-252166
|
10.11
|
01/15/21
|
First Amendment to the Amended and Restated Global Access Commitments Agreement, dated as of February 3, 2021, between the Registrant and the Bill & Melinda Gates Foundation.
|
F-1/A
|
333-252166
|
10.12
|
02/03/21
|
||||||
Lease, dated as of March 28, 2017, between the Registrant and MEPC MILTON PARK NO. 1 LIMITED and MEPC MILTON PARK NO. 2 LIMITED, on behalf of MEPC Milton LP.
|
F-1
|
333-252166
|
10.13
|
01/15/21
|
||||||
Lease, dated as of December 28, 2017, between the Registrant and MEPC MILTON PARK NO. 1 LIMITED and MEPC MILTON PARK NO. 2 LIMITED, on behalf of MEPC Milton LP.
|
F-1
|
333-252166
|
10.14
|
01/15/21
|
||||||
Lease, dated as of March 28, 2017, between the Registrant and MEPC MILTON PARK NO. 1 LIMITED and MEPC MILTON PARK NO. 2 LIMITED, on behalf of MEPC Milton LP.
|
F-1
|
333-252166
|
10.15
|
01/15/21
|
||||||
Assignment and Exclusive License, dated as of January 28, 2015, between the Registrant and Adaptimmune Limited.
|
F-1
|
333-252166
|
10.16
|
01/15/21
|
Loan and Security Agreement, dated as of November 6, 2020, among the Registrant, Oxford Finance Luxembourg S.a r.l., and the
lenders listed on Schedule 1.1 thereof.
|
F-1
|
333-252166
|
10.17
|
01/15/21
|
||||||
Employment Agreement between the Registrant and Bahija Jallal, Ph.D., dated January 29, 2021.
|
F-1/A
|
333-252166
|
10.18
|
02/01/21
|
||||||
Deed of Termination of Convertible Loan Note Purchase Agreement, dated as of February 3, 2021, between the Registrant and the Bill & Melinda Gates Foundation.
|
F-1/A
|
333-252166
|
10.19
|
02/03/21
|
||||||
Form of Deed of Indemnity between the Registrant and each of its directors.
|
F-1
|
333-252166
|
10.1
|
01/15/21
|
||||||
Form of Deed of Indemnity between the Registrant and each of its executive officers.
|
F-1
|
333-252166
|
10.2
|
01/15/21
|
||||||
Immunocore Holdings plc 2021 Equity Incentive Plan. and
Non-Employee Sub Plan to the Immunocore Holdings plc 2021 Equity Incentive Plan
|
20-F
|
001-39992
|
4.20
|
03/25/21
|
||||||
Notice of Termination Letter from GlaxoSmithKline Intellectual Property Development Ltd. to the Registrant with respect to NY-ESO,
dated February 8, 2021.
|
||||||||||
First Amendment to Loan and Security Agreement, dated January 22, 2021, among the Registrant, Oxford Finance Luxembourg S.à r.l.,
and the lenders listed on Schedule 1.1 thereof.
|
||||||||||
Second Amendment to Loan and Security Agreement, dated September 10, 2021, among the Registrant, Oxford Finance Luxembourg S.à
r.l., and the lenders listed on Schedule 1.1 thereof.
|
||||||||||
4.24*† |
Notice of Termination Letter from GlaxoSmithKline Intellectual Property Development Ltd. to the Registrant with respect to the Collaboration and License Agreement,
dated October 8, 2021.
|
|||||||||
Subsidiaries of the Registrant.
|
20-F
|
001-39992
|
8.1
|
03/25/21
|
||||||
Certification by the Principal Executive Officer pursuant to Securities Exchange Act Rules 13a-14(a) and 15d-14(a) as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
||||||||||
Certification by the Principal Financial Officer pursuant to Securities Exchange Act Rules 13a-14(a) and 15d-14(a) as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
||||||||||
Certification by the Principal Executive Officer and the Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
||||||||||
15.1* |
Consent of KPMG LLP.
|
101.INS*
|
Inline XBRL Instance Document (the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document)
|
||
101.SCH*
|
Inline XBRL Taxonomy Extension Schema Document
|
||
101.CAL*
|
Inline XBRL Taxonomy Extension Calculation Linkbase Document
|
||
101.DEF*
|
Inline XBRL Taxonomy Extension Definition Linkbase Document
|
||
101.LAB*
|
Inline XBRL Taxonomy Extension Label Linkbase Document
|
||
101.PRE*
|
Inline XBRL Taxonomy Extension Presentation Linkbase Document
|
||
104
|
Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101)
|
* |
Filed herewith.
|
** |
Furnished herewith.
|
† |
Certain portions of this exhibit (indicated by asterisks) have been redacted in accordance with Regulation S-K, Item 601(b)(10).
|
# |
Indicates a management contract or any compensatory plan, contract or arrangement.
|
IMMUNOCORE HOLDINGS PLC
|
||
By:
|
/s/ Bahija Jallal
|
|
Bahija Jallal, Ph.D.
|
||
Chief Executive Officer
(Principal Executive Officer)
|
||
Date: March 3, 2022
|
Page
|
|
F‑2
|
|
F‑3
|
|
F‑4
|
|
F‑5
|
|
F‑6
|
|
F‑7
|
2021
|
2020
|
2019
|
||||||||||||||
Notes
|
|
£’000
|
|
£’000
|
|
£’000
|
||||||||||
Revenue
|
2
|
|
|
|
||||||||||||
Total revenue
|
|
|
|
|||||||||||||
Net other operating (loss) / income
|
5
|
(
|
)
|
|
|
|||||||||||
Research and development costs
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||||
Administrative expenses
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||||
Operating loss
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||||
Finance income
|
6
|
|
|
|
||||||||||||
Finance costs
|
7
|
(
|
)
|
(
|
)
|
(
|
)
|
|||||||||
Non-operating expense
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||||
Loss before taxation
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||||
Income tax credit
|
8
|
|
|
|
||||||||||||
Loss for the year
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||||
Other comprehensive (expense) / income
|
||||||||||||||||
Other comprehensive (expense) / income that are or may be reclassified to profit or loss in subsequent periods (net of tax):
|
||||||||||||||||
Exchange differences on translation of foreign operations
|
(
|
)
|
|
(
|
)
|
|||||||||||
Total other comprehensive (expense) / income for the year, net of tax
|
(
|
)
|
|
(
|
)
|
|||||||||||
Total comprehensive loss for the year, net of tax
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||||
Basic and diluted loss per share - £
|
9
|
(
|
)
|
(
|
)
|
(
|
)
|
2021
|
2020
(Adjusted)
|
|||||||||||
Notes
|
|
£’000
|
|
£’000
|
||||||||
Non-current assets
|
||||||||||||
Property, plant and equipment
|
11
|
|
|
|||||||||
Right of use assets
|
12
|
|
|
|||||||||
Investment in sub-lease
|
12
|
|
|
|||||||||
Other non-current financial assets
|
13
|
|
|
|||||||||
Deferred tax asset
|
8
|
|
|
|||||||||
Total non-current assets
|
|
|
||||||||||
Current assets
|
||||||||||||
Trade and other receivables
|
14
|
|
|
|||||||||
Tax receivable
|
8
|
|
|
|||||||||
Cash and cash equivalents
|
|
|
|
|||||||||
Total current assets
|
|
|
||||||||||
Total assets
|
|
|
||||||||||
Equity
|
||||||||||||
Share capital
|
15
|
|
|
|||||||||
Share premium
|
15
|
|
|
|||||||||
Foreign currency translation reserve
|
15
|
|
|
|||||||||
Other reserves |
15 |
|||||||||||
Share-based payment reserve
|
15, 19
|
|
|
|||||||||
Accumulated deficit
|
(
|
)
|
(
|
)
|
||||||||
Total equity
|
|
|
||||||||||
Non-current liabilities
|
||||||||||||
Interest-bearing loans and borrowings
|
16
|
|
|
|||||||||
Deferred revenue
|
2
|
|
|
|||||||||
Lease liabilities
|
12
|
|
|
|||||||||
Provisions
|
17
|
|
|
|||||||||
Total non-current liabilities
|
|
|
||||||||||
Current liabilities
|
||||||||||||
Trade and other payables
|
18
|
|
|
|||||||||
Deferred revenue
|
2
|
|
|
|||||||||
Lease liabilities
|
12
|
|
|
|||||||||
Provisions
|
17
|
|
|
|||||||||
Total current liabilities
|
|
|
||||||||||
Total liabilities
|
|
|
||||||||||
Total equity and liabilities
|
|
|
Note |
Share
capital - adjusted
|
Share
premium - adjusted
|
Foreign
currency
translation
reserve
|
Share-
based
payment
reserve
|
Other
reserves - adjusted
|
Accumulated
deficit
|
Total
equity
|
|||||||||||||||||||||||||
|
£’000
|
|
£’000
|
|
£’000
|
|
£’000
|
|
£’000
|
|
£’000
|
|
£’000
|
|||||||||||||||||||
At January 1, 2019 - adjusted
|
15 |
|
|
|
|
|
(
|
)
|
|
|||||||||||||||||||||||
Loss for the year
|
15,19 |
|
|
|
|
|
(
|
)
|
(
|
)
|
||||||||||||||||||||||
Other comprehensive loss
|
|
|
(
|
)
|
|
|
|
(
|
)
|
|||||||||||||||||||||||
Total comprehensive loss for the year
|
|
|
(
|
)
|
|
|
(
|
)
|
(
|
)
|
||||||||||||||||||||||
Issue of share capital
|
15 |
|
|
|
|
|
|
|
||||||||||||||||||||||||
Equity-settled share-based payment transactions
|
15,19 |
|
|
|
|
|
|
|
||||||||||||||||||||||||
At December 31, 2019
|
15 |
|
|
(
|
)
|
|
|
(
|
)
|
|
||||||||||||||||||||||
Loss for the year
|
15,19 |
|
|
|
|
|
(
|
)
|
(
|
)
|
||||||||||||||||||||||
Other comprehensive loss
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||
Total comprehensive loss for the year
|
|
|
|
|
|
(
|
)
|
(
|
)
|
|||||||||||||||||||||||
Conversion of interest-bearing loan | ( |
) | ( |
) | ||||||||||||||||||||||||||||
Derecognition of derivative liability | ||||||||||||||||||||||||||||||||
Issue of share capital
|
15 |
|
|
|
|
|
|
|
||||||||||||||||||||||||
Equity-settled share-based payment transactions
|
15,19 |
|
|
|
|
|
|
|
||||||||||||||||||||||||
At December 31, 2020
|
|
|
|
|
|
(
|
)
|
|
||||||||||||||||||||||||
Loss for the year
|
|
|
|
|
|
(
|
)
|
(
|
)
|
|||||||||||||||||||||||
Other comprehensive income
|
|
|
(
|
)
|
|
|
|
(
|
)
|
|||||||||||||||||||||||
Total comprehensive loss for the year
|
|
|
(
|
)
|
|
|
(
|
)
|
(
|
)
|
||||||||||||||||||||||
Issue of share capital
|
15 |
|
|
|
|
|
|
|
||||||||||||||||||||||||
Exercise of share options | 15 |
|||||||||||||||||||||||||||||||
Equity-settled share-based payment transactions
|
15,19 |
|
|
|
|
|
|
|
||||||||||||||||||||||||
At December 31, 2021
|
15 |
|
|
|
|
|
(
|
)
|
|
2021
|
2020
|
2019
|
||||||||||||||
Notes
|
£
|
’000
|
£
|
’000
|
£
|
’000
|
||||||||||
Cash flows from operating activities
|
||||||||||||||||
Loss for the year
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||||
Adjustments for:
|
||||||||||||||||
Depreciation of property, plant and equipment
|
11
|
|
|
|
||||||||||||
Depreciation of right of use assets
|
12
|
|
|
|
||||||||||||
Remeasurement of leases |
3 |
( |
) | ( |
) | |||||||||||
Amortization of intangible assets
|
|
|
|
|||||||||||||
Write-off of intangible assets
|
3 |
|
|
|
||||||||||||
Loss on disposal of property, plant and equipment
|
3
|
|
|
|
||||||||||||
Profit on derecognition of leases
|
3
|
|
(
|
)
|
|
|||||||||||
Net finance costs
|
|
|
|
|||||||||||||
Unrealized foreign exchange differences
|
|
(
|
)
|
(
|
)
|
|||||||||||
Equity settled share-based payment expenses
|
19
|
|
|
|
||||||||||||
Income tax credit
|
8
|
(
|
)
|
(
|
)
|
(
|
)
|
|||||||||
Working capital adjustments:
|
||||||||||||||||
(Increase) / decrease in trade and other receivables
|
|
(
|
)
|
(
|
)
|
|
||||||||||
Increase / (decrease) in trade and other payables
|
|
|
(
|
)
|
|
|||||||||||
Movement in provisions and other charges |
( |
) | ( |
) | ||||||||||||
Decrease in deferred liabilities
|
|
(
|
)
|
(
|
)
|
(
|
)
|
|||||||||
Cash used in operations
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||||
Net taxation received
|
8
|
|
|
|
||||||||||||
Net cash used in operating activities
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||||
Cash flows from investing activities
|
||||||||||||||||
Bank interest received on cash and cash equivalents |
||||||||||||||||
Proceeds from sale of property, plant and equipment
|
|
|
|
|
||||||||||||
Purchase of property, plant and equipment
|
11
|
(
|
)
|
(
|
)
|
(
|
)
|
|||||||||
Purchase of intangible assets
|
|
|
|
(
|
)
|
|||||||||||
Proceeds from investment in sub-leases
|
|
|
|
|
||||||||||||
Leasehold incentive
|
|
|
|
|
||||||||||||
Net cash flows (used in) from investing activities
|
(
|
)
|
|
(
|
)
|
|||||||||||
Cash flows from financing activities
|
||||||||||||||||
Gross proceeds from issue of share capital
|
15
|
|
|
|
||||||||||||
Costs from issue of share capital
|
15
|
(
|
)
|
(
|
)
|
(
|
)
|
|||||||||
Proceeds from exercise of share options | 15 | |||||||||||||||
Non-current interest-bearing loan received
|
|
|
|
|
||||||||||||
Interest paid on non-current interest-bearing loan
|
|
(
|
)
|
(
|
)
|
|
||||||||||
Repayment of lease liabilities
|
12
|
(
|
)
|
(
|
)
|
(
|
)
|
|||||||||
|
|
|
|
|||||||||||||
Increase / (decrease) in net cash and cash equivalents
|
|
|
(
|
)
|
||||||||||||
Net foreign exchange difference on cash held
|
|
(
|
)
|
(
|
)
|
|||||||||||
Cash and cash equivalents at beginning of the year
|
|
|
|
|||||||||||||
Cash and cash equivalents at end of the year
|
|
|
|
1. |
Accounting policies
|
• |
determine whether promises contained within the collaboration agreements are distinct from the other promises in the contract;
|
• |
assess whether milestones or other variable consideration should be included in the transaction price;
|
• |
determine whether performance obligations are satisfied at a point in time or over time, and
|
• |
identify and consistently apply an appropriate method of measuring progress for performance obligations satisfied over time for the purposes of revenue recognition.
|
• |
whether achievement of a development milestone is highly susceptible to factors outside the entity’s influence, such as milestones involving the judgment or actions of third parties, including regulatory bodies or the customer;
|
• |
whether the uncertainty about the achievement of the milestone is not expected to be resolved for a long period of time;
|
• |
whether the Company can reasonably predict that a milestone will be achieved based on previous experience; and.
|
• |
the complexity and inherent uncertainty underlying the achievement of the milestone.
|
• |
adjustments arising from a change in the estimate of when the performance obligation will have been completed.
|
• |
a change in the estimate of the transaction price due to changes in the assessment of whether variable consideration is constrained because it is not considered probable of being received; and
|
• |
the recognition of revenue.
|
• |
past history and experience with similar contracts.
|
• |
unexpected fluctuations in planned spend.
|
• |
changes to project timelines
|
•
|
Leasehold improvements
|
-
|
over the expected lease term.
|
•
|
Plant and equipment
|
-
|
|
•
|
Right-of-use assets
|
-
|
over the expected lease term
|
• |
Level 1: quoted prices (unadjusted) in active markets for identical assets or liabilities.
|
• |
Level 2: inputs other than quoted prices included in Level 1 that are observable for the asset or liability, either directly (i.e., as prices) or indirectly (i.e., derived from prices).
|
• |
Level 3: inputs for the asset or liability that are not based on observable market data (unobservable inputs).
|
2. |
Revenue & segmental reporting
|
2021 |
2020 |
2019 |
||||||||||
Collaboration revenue
|
|
£’000
|
|
£’000
|
|
£’000
|
||||||
GlaxoSmithKline
|
|
|
|
|||||||||
Eli Lilly
|
|
|
|
|||||||||
Genentech
|
|
|
|
|||||||||
Total collaboration revenue
|
|
|
|
|||||||||
Pre-product revenue
|
|
|
|
|||||||||
Total revenue
|
|
|
|
United Kingdom
|
|
|
|
|||||||||
United States
|
|
|
|
|||||||||
Europe
|
|
|
|
|||||||||
Total revenue
|
|
|
|
2021
|
2020
|
|||||||
£’000
|
£’000
|
|||||||
Current deferred revenue
|
|
|
||||||
Non-current deferred revenue
|
|
|
||||||
|
|
3. |
Operating loss is stated after charging (crediting)
|
2021
|
2020 |
2019
|
||||||||||
|
£’000
|
|
£’000
|
|
£’000
|
|||||||
Loss on disposal of property, plant and equipment
|
|
|
|
|||||||||
Profit on derecognition of leases
|
|
(
|
)
|
|
||||||||
Remeasurement of leases
|
(
|
)
|
(
|
)
|
|
|||||||
Loss on write-offs of intangible fixed assets
|
|
|
|
|||||||||
Depreciation of property, plant and equipment (Note 11)
|
|
|
|
|||||||||
Depreciation of right-of-use assets (Note 12) |
||||||||||||
Amortization of intangible assets
|
|
|
|
|||||||||
Short-term lease expense
|
|
|
|
|||||||||
Sub-lease income (Note 5)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||
Foreign exchange (gains)/losses
|
(
|
)
|
|
|
4. |
Staff numbers and costs
|
2021
No. of employees
|
2020
No. of employees
|
2019
No. of employees
|
||||||||||
Research
|
|
|
|
|||||||||
Development
|
|
|
|
|||||||||
Corporate
|
|
|
|
|||||||||
Total
|
|
|
|
The aggregate staff costs of these persons were as follows:
|
2021
|
2020
|
2019
|
|||||||||
£’000
|
£’000
|
£’000
|
||||||||||
Wages and salaries
|
|
|
|
|||||||||
Social security costs
|
|
|
|
|||||||||
Share-based payments (Note 19)
|
|
|
|
|||||||||
Contributions to defined contribution plans (Note 21)
|
|
|
|
|||||||||
|
|
|
5. |
Net other operating (loss) / income
|
2021
|
2020
|
2019
|
||||||||||
|
£’000
|
|
£’000
|
|
£’000
|
|||||||
Profit on derecognition of leases
|
|
|
||||||||||
Loss on disposal of property, plant and equipment
|
(
|
)
|
(
|
)
|
||||||||
Settlement agreement
|
|
|
||||||||||
Sub-lease income
|
|
|
|
|||||||||
Remeasurement of leases
|
|
|||||||||||
Other
|
|
|
||||||||||
(
|
)
|
|
|
6. |
Finance income
|
2021
|
2020
|
2019
|
||||||||||
£’000
|
£’000
|
£’000
|
||||||||||
Interest on cash and cash equivalents and other receivables
|
|
|
|
|||||||||
Gain on entering into sub-leases on leasehold properties
|
|
|
|
|||||||||
Interest on investment in sub-lease
|
|
|
|
|||||||||
Gain from change in fair value of derivative liability
|
|
|
|
|||||||||
|
|
|
7. |
Finance costs
|
2021
|
2020
|
2019
|
||||||||||
|
£’000
|
|
£’000
|
|
£’000
|
|||||||
Interest on lease liabilities (see Note 12)
|
|
|
|
|||||||||
Interest expenses on financial liabilities measured at amortized cost
|
|
|
|
|||||||||
Loss from change in fair value of embedded derivative asset
|
|
|
|
|||||||||
Loss from change in fair value of derivative liability
|
|
|
|
|||||||||
Other finance costs
|
|
|
|
|||||||||
|
|
|
8. |
Income tax
|
2021
|
2020
|
2019
|
||||||||||
|
£’000
|
|
£’000
|
|
£’000
|
|||||||
Profit or loss
|
||||||||||||
Current tax:
|
||||||||||||
R&D tax credit for the year
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||
Tax related to share-based compensation plans
|
|
|
|
|||||||||
Foreign corporation tax on profits for the year
|
|
|
|
|||||||||
Adjustments in respect of prior years
|
|
(
|
)
|
|
||||||||
Total current tax
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||
Deferred tax:
|
||||||||||||
Current year
|
(
|
)
|
(
|
)
|
|
|||||||
Effect of changes in tax rates
|
|
(
|
)
|
|
||||||||
Movement in overseas unrecognized deferred tax asset
|
|
|
|
|||||||||
Originating and reversal of timing differences, including adjustments in respect of prior years
|
|
(
|
)
|
(
|
)
|
|||||||
Total deferred tax
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||
Total income tax credit
|
(
|
)
|
(
|
)
|
(
|
)
|
Reconciliation of tax expense and accounting profit for 2021, 2020 and 2019:
|
2021
|
2020
|
2019
|
|||||||||
|
£’000
|
|
£’000
|
|
£’000
|
|||||||
Loss before tax
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||
Tax credit using the UK Corporation tax rate of
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||
Effect of:
|
||||||||||||
Non-deductible expenses
|
|
|
|
|||||||||
Other permanent differences
|
|
|
(
|
)
|
||||||||
Additional deduction for R&D expenditure
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||
Surrender of tax losses for R&D tax credit refund
|
|
|
|
|||||||||
R&D expenditure credits
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||
Movement in deferred tax not recognized
|
|
|
|
|||||||||
Adjustments to tax charge in respect of previous periods - deferred tax
|
|
(
|
)
|
(
|
)
|
|||||||
Adjustments to tax charge in respect of previous periods
|
|
(
|
)
|
|
||||||||
State taxes
|
|
|
|
|||||||||
Effects of overseas tax rates
|
|
|
|
|||||||||
Effects of tax rates in foreign jurisdictions
|
|
(
|
)
|
|
||||||||
Total tax credit included in loss for the year
|
(
|
)
|
(
|
)
|
(
|
)
|
2021
|
2020
|
2019
|
||||||||||
£’000
|
|
£’000
|
|
£’000
|
||||||||
Current tax:
|
||||||||||||
United States:
|
||||||||||||
Federal
|
|
(
|
)
|
|
||||||||
State
|
|
|
||||||||||
United Kingdom
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||
Total current tax
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||
Deferred tax:
|
||||||||||||
United States:
|
||||||||||||
Federal
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||
State
|
|
|
(
|
)
|
||||||||
United Kingdom
|
|
|
|
|||||||||
Total deferred tax
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||
Total income tax credit
|
(
|
)
|
(
|
)
|
(
|
)
|
9. |
Basic and diluted loss per share
|
2021
|
2020
|
2019
|
||||||||||
Loss for the year (£000’s)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||
Basic and diluted weighted average number of shares
|
|
|
|
|||||||||
Basic and diluted loss per share (£) (1)
|
(
|
)
|
(
|
)
|
(
|
)
|
(1) |
|
10. |
Intangible assets
|
11. |
Property, plant and equipment
|
Leasehold
properties and improvements
|
Plant and
equipment
|
Assets under
construction
|
Total
|
|||||||||||||
|
£’000
|
|
£’000
|
|
£’000
|
|
£’000
|
|||||||||
Cost:
|
||||||||||||||||
At January 1, 2020
|
|
|
|
|
||||||||||||
Additions
|
|
|
|
|
||||||||||||
Transfers
|
|
|
(
|
)
|
|
|||||||||||
Effect of foreign currency translation
|
(
|
)
|
(
|
)
|
|
(
|
)
|
|||||||||
Disposals
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||
At December 31, 2020
|
|
|
|
|
||||||||||||
Additions
|
|
|
|
|
||||||||||||
Transfers
|
|
|
(
|
)
|
|
|||||||||||
Effect of foreign currency translation
|
|
(
|
)
|
|
(
|
)
|
||||||||||
Disposals
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||
At December 31, 2021
|
|
|
|
|
||||||||||||
Depreciation and impairment:
|
||||||||||||||||
At January 1, 2020
|
|
|
|
|
||||||||||||
Depreciation charge for the year
|
|
|
|
|
||||||||||||
Effect of foreign currency translation
|
(
|
)
|
(
|
)
|
|
(
|
)
|
|||||||||
Disposals
|
(
|
)
|
(
|
)
|
|
(
|
)
|
|||||||||
At December 31, 2020
|
|
|
|
|
||||||||||||
Depreciation charge for the year
|
|
|
|
|
||||||||||||
Effect of foreign currency translation
|
|
(
|
)
|
|
(
|
)
|
||||||||||
Disposals
|
(
|
)
|
(
|
)
|
|
(
|
)
|
|||||||||
At December 31, 2021
|
|
|
|
|
||||||||||||
Carrying value:
|
||||||||||||||||
At December 31, 2021
|
|
|
|
|
||||||||||||
At December 31, 2020
|
|
|
|
|
||||||||||||
At January 1, 2020
|
|
|
|
|
12. |
Leases
|
• |
Options to terminate the lease early at the right of the tenant
|
• |
Variable lease payments with a guaranteed minimum increase and capped maximum increase
|
2021
|
2020
|
|||||||
|
£’000
|
|
£’000
|
|||||
Balance at 1 January
|
|
|
||||||
Effect of adopting new accounting standards
|
|
(
|
)
|
|||||
Additions
|
|
|
||||||
Remeasurements
|
|
(
|
)
|
|||||
Derecognition
|
|
(
|
)
|
|||||
Depreciation charge for the year
|
(
|
)
|
(
|
)
|
||||
|
|
2021
|
2020
|
|||||||
|
£’000
|
|
£’000
|
|||||
Less than one year
|
|
|
||||||
One to five years
|
|
|
||||||
More than five years
|
|
|
||||||
Total undiscounted lease liabilities
|
|
|
2021
|
2020
|
|||||||
|
£’000
|
|
£’000
|
|||||
Current
|
|
|
||||||
Non-current
|
|
|
||||||
Total lease liabilities
|
|
|
2021
|
2020
|
|||||||
Amounts recognized in the Consolidated Statements of Loss
|
|
£’000
|
|
£’000
|
||||
Interest on lease liabilities
|
|
|
||||||
Expenses relating to short-term leases
|
|
|
||||||
Expenses relating to leases of low-value assets
|
|
|
||||||
Interest on investment in sub-lease
|
|
(
|
)
|
Amounts recognized in the Consolidated Statement of Cash Flows
|
2021
|
2020
|
||||||
|
£’000
|
|
£’000
|
|||||
Total cash outflow for leases
|
|
|
Lease income
|
2021
|
2020
|
||||||
|
£’000
|
|
£’000
|
|||||
Sub-lease income
|
|
|
||||||
Finance lease income on the net investment in the lease
|
|
|
Maturity analysis – undiscounted finance lease income
|
2021
|
2020
|
||||||
|
£’000
|
|
£’000
|
|||||
Less than one year
|
|
|
||||||
One to two years
|
|
|
||||||
Two to three years
|
|
|
||||||
Three to four years
|
|
|
||||||
Four to five years
|
|
|
||||||
More than five years
|
|
|
||||||
Total undiscounted finance lease income
|
|
|
||||||
Unearned finance income
|
|
(
|
)
|
|||||
Net investment in the lease
|
|
|
13. |
Other non-current financial assets
|
2021
|
2020
|
|||||||
|
£’000
|
|
£’000
|
|||||
Long-term security deposits
|
|
|
||||||
Prepayments
|
|
|
||||||
Other
|
|
|
||||||
|
|
14. |
Trade and other receivables
|
2021
|
2020
|
|||||||
|
£’000
|
|
£’000
|
|||||
Trade receivables
|
|
|
||||||
Other receivables
|
|
|
||||||
Prepayments and accrued income
|
|
|
||||||
|
|
15. |
Capital and reserves
|
Growth
shares
|
Series A
shares
|
Series B
shares
|
Series C
shares
|
Ordinary
shares
|
Deferred
shares
|
|||||||||||||||||||
Issued and fully paid share capital
(0.2p per share, except deferred shares which are 0.01p per share)
|
||||||||||||||||||||||||
At January 1, 2019 - adjusted
|
|
|
|
|
|
|||||||||||||||||||
Repurchased and cancelled | ( |
) | ||||||||||||||||||||||
New shares issued for cash
|
|
|
|
|||||||||||||||||||||
Exercise of share options
|
|
|
|
|
|
|||||||||||||||||||
At December 31, 2019
|
|
|
|
|
|
|||||||||||||||||||
Repurchased and cancelled | ( |
) | ||||||||||||||||||||||
New shares issued for cash
|
|
|
|
|
|
|||||||||||||||||||
New shares issued for non-cash consideration |
||||||||||||||||||||||||
Exercise of share options
|
|
|
|
|
|
|||||||||||||||||||
At December 31, 2020
|
|
|
|
|
|
|||||||||||||||||||
Repurchased and cancelled | ( |
) | ||||||||||||||||||||||
New shares issued for cash
|
|
|
|
|
|
|||||||||||||||||||
Exercise of share options
|
|
|
|
|
|
|||||||||||||||||||
At December 31, 2021
|
|
|
|
|
|
2021
£
|
2020
(Adjusted)
£
|
|||||||
Allotted, called up and fully paid
|
||||||||
Ordinary shares
|
|
|
||||||
Series A shares
|
|
|
||||||
Series B shares
|
|
|
||||||
Series C shares
|
|
|
||||||
Growth shares
|
|
|
||||||
Deferred shares |
||||||||
|
|
Share premium
|
||||
|
£’000
|
|||
At January 1, 2019 – adjusted
|
|
|||
At December 31, 2019
|
|
|||
At December 31, 2020
|
|
|||
New shares issued for cash
|
|
|||
Exercise of share options
|
|
|||
Equity-settled share-based payment transaction |
||||
At December 31, 2021
|
|
• |
managing the budgeting process;
|
• |
managing funding and liquidity risk; and
|
• |
maintaining strong investor relations.
|
16. |
Non-current interest-bearing loans and borrowings
|
2021
|
2020
|
|||||||
|
£’000
|
|
£’000
|
|||||
Long-term borrowings
|
|
|
||||||
|
|
17. |
Provisions
|
Total
|
||||
|
£’000
|
|||
At January 1, 2020
|
|
|||
Arising during the year
|
|
|||
Utilized
|
(
|
)
|
||
At December 31, 2020
|
|
|||
Arising during the year
|
|
|||
Utilized
|
(
|
)
|
||
At December 31, 2021
|
|
|||
Current
|
|
|||
Non-current
|
|
18. |
Trade and other payables
|
2021
|
2020
|
|||||||
|
£’000
|
|
£’000
|
|||||
Trade payables
|
|
|
||||||
Other taxation and social security
|
|
|
||||||
Pension Liability
|
|
|
||||||
Accruals
|
|
|
||||||
|
|
19. |
Share-based payments
|
Number of shares issuable
|
Number of
share options (#)
|
Weighted average
exercise price ($)
|
||||||
Outstanding at 1 January 2019 - adjusted
|
|
|
||||||
Awards granted
|
|
|
||||||
Awards exercised
|
(
|
)
|
|
|||||
Awards forfeited
|
(
|
)
|
|
|||||
Outstanding at 31 December 2019
|
|
|
||||||
Awards granted
|
|
|
||||||
Awards exercised
|
(
|
)
|
|
|||||
Awards forfeited
|
(
|
)
|
|
|||||
Outstanding at 31 December 2020
|
|
|
||||||
Awards granted
|
|
|
||||||
Awards exercised
|
(
|
)
|
|
|||||
Awards forfeited
|
(
|
)
|
|
|||||
Awards replacing Growth Shares |
||||||||
Outstanding at December 31, 2021
|
|
|
||||||
Exercisable at December 31, 2021
|
|
|
Number of shares issuable
|
Number of
growth shares
|
Weighted average
hurdle rate $
|
||||||
Outstanding at January 1, 2019
|
|
|
||||||
Awards forfeited
|
(
|
)
|
|
|||||
Awards replaced with options
|
|
|||||||
Outstanding at December 31, 2019
|
|
|
||||||
Awards granted
|
|
|
||||||
Awards forfeited
|
(
|
)
|
|
|||||
Awards replaced with options
|
|
|||||||
Outstanding at December 31, 2020
|
|
|
||||||
Awards forfeited
|
(
|
)
|
|
|||||
Awards replaced with options
|
(
|
)
|
|
|||||
Outstanding at December 31, 2021
|
|
|
||||||
Exercisable at December 31, 2021
|
|
|
Share options | ||||||
Exercise
price £
|
Number of
options
|
Weighted average
remaining
contractual life
|
||||
|
||||||
|
||||||
|
||||||
|
||||||
|
||||||
|
||||||
|
||||||
|
||||||
|
|
February 2021
|
April 2021
|
July 2021
|
October 2021
|
||||||||||||
Share price at grant date
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||
Exercise price
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||
Expected volatility
|
|
%
|
|
%
|
|
%
|
|
%
|
||||||||
Expected life (years)
|
|
|
|
|
||||||||||||
Risk free rate
|
(
|
)%
|
|
%
|
|
%
|
|
%
|
||||||||
Fair value
|
$
|
|
$
|
|
$
|
|
$
|
|
Growth shares
|
Share options
|
|||||||||||||||||||||||
Apr-20
|
Jun-20
|
Apr- 20
|
Jun- 20
|
Oct-20
|
Nov- 20
|
|||||||||||||||||||
Share price at grant date
|
$
|
|
$
|
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||||||
Exercise price
|
|
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||||||||
Hurdle rate
|
$ |
|
$
|
|
|
|
|
|
||||||||||||||||
Expected volatility
|
|
%
|
|
%
|
|
%
|
|
%
|
|
%
|
|
%
|
||||||||||||
Expected life (years)
|
|
|
|
|
|
|
||||||||||||||||||
Risk free rate
|
|
%
|
(
|
)%
|
|
%
|
(
|
%
|
(
|
%
|
(
|
)%
|
||||||||||||
Fair value
|
$ |
|
$
|
|
$
|
|
$
|
|
$ |
|
$
|
|
Growth shares
|
Share options
|
Share options
|
Share options
|
|||||||||||||
|
Apr-17
|
May-19
|
Apr-17
|
2016
|
||||||||||||
Share price at grant date
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||
Exercise price
|
|
$
|
|
$
|
|
$ |
|
|||||||||
Hurdle rate
|
$
|
|
|
|
|
|||||||||||
Expected volatility
|
|
%
|
|
%
|
|
%
|
|
%
|
||||||||
Expected life (years)
|
|
|
|
|
||||||||||||
Risk free rate
|
|
%
|
|
%
|
|
%
|
|
%
|
||||||||
Fair value
|
$
|
|
$
|
|
$
|
|
$ |
|
20. |
Financial instruments
|
At December 31, 2021
|
Carrying
amount
£’000
|
Contractual
cash flows
£’000
|
One year
or less
£’000
|
|||||||||
Financial assets
|
||||||||||||
Trade receivables
|
|
|
|
|||||||||
Non-current financial assets
|
|
|
|
|||||||||
Cash and cash equivalents
|
|
|
|
|||||||||
Total financial assets
|
|
|
|
|||||||||
Financial liabilities
|
||||||||||||
Trade payables and accruals
|
|
|
|
|||||||||
Interest-bearing loans and borrowings (Note 16)
|
|
|
|
|||||||||
Total financial liabilities
|
|
|
|
At December 31, 2020
|
Carrying
amount
£’000
|
Contractual
cash flows
£’000
|
One year
or less
£’000
|
|||||||||
Financial assets
|
||||||||||||
Trade receivables
|
|
|
|
|||||||||
Prepayments and accrued income
|
|
|
|
|||||||||
Long-term security deposit
|
|
|
|
|||||||||
Cash and cash equivalents
|
|
|
|
|||||||||
Total financial assets
|
|
|
|
|||||||||
Financial liabilities
|
||||||||||||
Trade payables
|
|
|
|
|||||||||
Interest-bearing loans and borrowings (Note 16)
|
|
|
|
|||||||||
Total financial liabilities
|
|
|
|
2021
Carrying
amount
£’000
|
2020
Carrying
amount
£’000
|
|||||||
Cash and cash equivalents
|
|
|
||||||
|
|
2021
Carrying amount
£’000
|
2020
Carrying amount
£’000
|
|||||||
Interest-bearing loans and borrowings
|
|
|
||||||
|
|
2021
Carrying
amount
£’000
|
2020
Carrying
amount
£’000
|
|||||||
Financial assets at amortized cost:
|
||||||||
Deposits and non-current assets
|
|
|
||||||
Cash and cash equivalents
|
|
|
||||||
Trade and other receivables |
||||||||
|
|
|||||||
Financial liabilities at amortized cost:
|
||||||||
Trade payables
|
|
|
||||||
Accruals |
||||||||
Interest-bearing loans and borrowings (Note 16)
|
|
|
||||||
|
|
2021
|
2020
|
|||||||||||||||
Carrying
amount
£’000
|
Fair value
£’000
|
Carrying
amount
£’000
|
Fair value
£’000
|
|||||||||||||
Financial assets at amortized cost:
|
||||||||||||||||
Trade receivables
|
|
|
|
|
||||||||||||
Current deposits and accrued income
|
|
|
|
|
||||||||||||
Non-current financial assets and other receivables
|
|
|
|
|
||||||||||||
Cash and cash equivalents
|
|
|
|
|
||||||||||||
Total financial assets at amortized cost
|
|
|
|
|
Fair value of financial liabilities
|
2021
|
2020
|
||||||||||||||
Carrying
amount
|
Fair value
|
Carrying
amount
|
Fair value
|
|||||||||||||
£’000 | £’000 | £’000 | £’000 | |||||||||||||
Financial liabilities at amortized cost | ||||||||||||||||
Trade payables and accruals
|
|
|
|
|
||||||||||||
Interest-bearing loans and borrowings (Note 16)
|
|
|
|
|
||||||||||||
Total financial liabilities
|
|
|
|
|
21. |
Post-employment benefit plans
|
22. |
Commitments and contingencies
|
As at December 31, 2021
|
Less than 1
year
|
1-3
years
|
3-5
years
|
More than 5
years
|
Total
|
|||||||||||||||
Lease liabilities – existing
|
|
|
|
|
|
|||||||||||||||
Lease liabilities – contingent
|
|
|
|
|
|
|||||||||||||||
Manufacturing
|
|
|
|
|
|
|||||||||||||||
Capital commitments
|
|
|
|
|
|
|||||||||||||||
Total contractual obligations
|
|
|
|
|
|
As at December 31, 2020
|
Less than 1
year
|
1-3
years
|
3-5
years
|
More than 5
years
|
Total
|
|||||||||||||||
Lease liabilities – existing
|
|
|
|
|
|
|||||||||||||||
Lease liabilities – contingent
|
|
|
|
|
|
|||||||||||||||
Manufacturing
|
|
|
|
|
|
|||||||||||||||
Capital commitments
|
|
|
|
|
|
|||||||||||||||
Total contractual obligations
|
|
|
|
|
|
23. |
Related party disclosures
|
2021
|
2020
|
2019
|
||||||||||
|
£’000
|
|
£’000
|
|
£’000
|
|||||||
Short-term employee benefits
|
|
|
|
|||||||||
Share-based payment
|
|
|
|
|||||||||
|
|
|
24. |
Events after the reporting period
|
|
Sincerely,
|
|
|
|
GlaxoSmithKline Intellectual Property Development Limited
|
1. |
Definitions. Capitalized terms used herein but not otherwise defined shall have the respective meanings given to them in the Loan Agreement.
|
2. |
Joinder.
|
a. |
New Loan Party. New Loan Party hereby is added as a “Loan Party” and a “Guarantor” under the Loan Agreement. All
references in the Agreement to a “Loan Party” shall hereafter mean and include the Existing Loan Parties and New Loan Party, individually and collectively, jointly and severally; and New Loan Party shall hereafter have all rights,
duties and obligations of a “Loan Party” thereunder. All references in the Agreement to a “Guarantor” shall respectively hereafter mean and include the Commercial Sub, Core Sub and New Loan Party, individually and collectively, jointly
and severally; and New Loan Party shall hereafter have all rights, duties and obligations of a “Guarantor” thereunder.
|
b. |
Joinder to Loan Agreement. New Loan Party
hereby joins the Loan Agreement, and agrees to comply with and be bound by all of the terms, conditions and covenants of the Loan Agreement and the Loan Documents to which it is a party, as if it were originally named a “Loan Party”
therein (effective as of the date of this Amendment).
|
c. |
Grant of Security Interest. To secure the
prompt payment and performance of all of the Obligations, New Loan Party hereby grants to Collateral Agent, for the ratable benefit of Lenders, a continuing lien upon and security interest in all of New Loan Party’s now existing or
hereafter arising rights and interest in the Collateral, whether now owned or existing or hereafter created, acquired, or arising, and wherever located. New Loan Party further covenants and agrees that by its execution hereof it shall
provide all such information, complete all such forms, and take all such actions, and enter into all such agreements, in form and substance reasonably satisfactory to Collateral Agent and each Lender that are reasonably deemed necessary
by Collateral Agent or any Lender in order to grant a valid, perfected first priority security interest to Collateral Agent, for the ratable benefit of Lenders, in the Collateral. New Loan Party hereby authorizes Collateral Agent to
file financing statements or take any other action required to perfect Collateral Agent’s security interests in the Collateral, without notice to the New Loan Party, with all appropriate jurisdictions to perfect or protect Collateral
Agent’s interest or rights under the Loan Documents, including a notice that any disposition of the Collateral, except to the extent permitted by the terms of the Loan Agreement, by the New Loan Party, or any other Person, shall be
deemed to violate the rights of Collateral Agent under the Code. Notwithstanding the foregoing, or anything to the contrary herein, no filing or registration of the Loan Agreement shall be made with Companies House in the United
Kingdom. Without limiting the generality of the foregoing, New Loan Party hereby grants and pledges to Collateral Agent, for the ratable benefit of the Lenders, to secure the prompt payment and performance of all of the Obligations, a
perfected security interest in all of the issued and outstanding shares of capital stock of Parent and shall deliver to Collateral Agent one or more original stock certificates, if certificated, representing such shares together with
duly executed instruments of transfer or assignment in blank, all in form and substance satisfactory to Collateral Agent, within seven (7) Business Days of receipt by the relevant member of New Loan Party of the duly stamped STFs.
|
d. |
Representations and Warranties. New Loan
Party hereby represents and warrants to Collateral Agent and each Lender that all representations and warranties in the Loan Agreement and the Loan Documents to which New Loan Party is a party made on the part of Existing Loan Parties
are true and correct on the date hereof (as updated by the Perfection Certificate delivered to Oxford on or around the date of this Amendment) with respect to Existing Loan Parties and New Loan Party, with the same force and effect as
if New Loan Party were named as “Loan Party” in the Loan Agreement and the Loan Documents to which it is a party in addition to Existing Loan Parties.
|
3. |
Consent.
|
a. |
Collateral Agent and Oxford, which constitute the Required Lenders, hereby consent to the Exchange Transaction on the date hereof, strictly in accordance with the terms of the Exchange Agreement and, to the
extent that any waivers under the Loan Agreement or any other Loan Document, including, without limitations, Section 7.3 of the Loan Agreement, are required for Borrower to enter into the Exchange Agreement and consummate the Exchange
Transaction, Collateral Agent and Required Lenders hereby provide such waivers.
|
4. |
Section 6.2(a)(i) of the Loan Agreement is hereby amended and restated in its entirety as follows:
|
5. |
Section 6.2(a)(vi) of the Loan Agreement is hereby amended and restated as follows:
|
6. |
Section 6.2(a)(viii) of the Loan Agreement is hereby amended and restated as follows:
|
7. |
The Loan Agreement is hereby amended by adding the following Section 6.14 thereto:
|
8. |
Section 7.2 of the Loan Agreement is hereby amended and restated as follows:
|
9. |
The Loan Agreement is hereby amended by deleting therefrom Sections 7.3(b) and 7.3(c).
|
10. |
The following Section 7.12 is hereby added to the Loan Agreement:
|
11. |
Section 8.2(a) of the Loan Agreement is hereby amended and restated in its entirety as follows:
|
12. |
Section 8.12 of the Loan Agreement is hereby amended and restated in its entirety as follows:
|
13. |
Section 10 of the Loan Agreement is hereby amended by amending and restating the address for Borrower and Guarantors therein as follows:
|
If to Borrower and/or |
IMMUNOCORE HOLDINGS LIMITED | ||
Guarantors: | IMMUNOCORE LIMITED | ||
IMMUNOCORE LLC
|
|||
IMMUNOCORE COMMERCIAL LLC
|
|||
92 Park Drive, Milton Park | |||
Abingdon
|
|||
Oxon | |||
OX14 4RY
|
|||
United Kingdom
|
|||
Attn: Brian Di Donato, Chief Financial Officer | |||
and Lily Hepworth, Chief Legal Counsel
|
|||
Fax: +1 (610) 828-5918
|
|||
Email: brian.didonato@immunocore and | |||
lily.hepworth@immunocore.com
|
With a copy to: |
IMMUNOCORE HOLDINGS LIMITED
|
||
IMMUNOCORE LLC | |||
IMMUNOCORE COMMERCIAL LLC
|
|||
Six Tower Bridge, Suite 540
|
|||
181 Washington Street | |||
Conshohocken, PA 19422
|
|||
Attn: Brian Di Donato, Chief Financial Officer | |||
and Lily Hepworth, Chief Legal Counsel | |||
Fax: +1 (610) 828-5918
|
|||
Email: brian.didonato@immunocore and | |||
lily.hepworth@immunocore.com
|
14. |
Section 13.1 of the Loan Agreement is hereby amended by adding the following definitions thereto in alphabetical order:
|
15. |
Section 13.1 of the Loan Agreement is hereby amended by amending and restating the following definitions therein as follows:
|
16. |
Parts (g) and (h) of the defined term “Permitted Indebtedness” in Section 13.1 of the Loan Agreement are hereby amended and restated in their entirety to read as follows:
|
17. |
Parts (i) and (j) of the defined term “Permitted Liens” in Section 13.1 of the Loan Agreement are hereby amended and restated in their entirety to read as follows:
|
18. |
Section 13.1 of the Loan Agreement is hereby amended by deleting therefrom definitions of “HoldCo Loan Agreement,” “HoldCo Transaction,” and “SPAC.”
|
19. |
Waiver and Extension. With reference to that certain Post Closing
Letter, dated as of November 6, 2020, and Exhibit A attached thereto, the Loan Parties, Collateral Agent and Lenders hereby agree as follows:
|
a. |
The bailee waiver from DHL referenced in Section 5 on Exhibit A is hereby waived, and any Event of Default that shall have occurred with respect to non-delivery of such bailee waiver is hereby waived;
|
b. |
The due date of the assignment separate from certificate, and share certificate (if not previously delivered to Collateral Agent) of Immunocore Ireland referenced in Section 2 of Exhibit A is hereby extended to February 18, 2021, and any
Event of Default that shall have occurred with respect to non-delivery of such items is hereby waived;
|
20. |
Limitation of Amendment and Waivers.
|
a. |
The amendments, waivers and consents set above are effective for the purposes set forth herein and shall be limited precisely as written and shall not be deemed to (a) be a consent to any amendment, waiver or
modification of any other term or condition of any Loan Document, or (b) otherwise prejudice any right, remedy or obligation which Lenders or Loan Parties may now have or may have in the future under or in connection with any Loan Document,
as amended hereby.
|
b. |
This Amendment shall be construed in connection with and as part of the Loan Documents and all terms, conditions, representations, warranties, covenants and agreements set forth in the Loan Documents, except
as herein amended, are hereby ratified and confirmed and shall remain in full force and effect. For the avoidance of doubt, this Amendment shall be considered part of the Loan Documents.
|
21. |
To induce Collateral Agent and Lenders to enter into this Amendment, Loan Parties hereby represents and warrants to Collateral Agent and Lenders as follows:
|
a. |
Holdco has no liabilities, Indebtedness or outstanding litigation immediately prior to the consummation of the Exchange Transaction and the HoldCo has no material liabilities, Indebtedness or outstanding
litigation immediately prior to the consummation of the Exchange Transaction (this does not take away from any other representation or warranty previously made or being made herein by Borrower).
|
b. |
Immediately after giving effect to this Amendment (a) the representations and warranties contained in the Loan Documents are true, accurate and complete in all respects as of the date hereof (except to the
extent such representations and warranties relate to an earlier date, in which case they are true and correct as of such date), and (b) no Event of Default has occurred and is continuing;
|
c. |
Each of the Loan Parties has the power and due authority to execute and deliver this Amendment and to perform its obligations under the Loan Agreement, as amended by this Amendment;
|
d. |
The organizational documents of Loan Parties delivered to Collateral Agent on the Effective Date, and updated pursuant to subsequent deliveries by the Loan Parties to the Collateral Agent, and including
following and in connection with the Exchange Transactions, remain true, accurate and complete and have not been amended, supplemented or restated and are and continue to be in full force and effect;
|
e. |
The execution and delivery by Loan Parties of this Amendment and the performance by each of them of its obligations under the Loan Agreement, as amended by this Amendment, have been duly authorized;
|
f. |
The execution and delivery by Loan Parties of this Amendment and the performance by each Loan Party of its obligations under the Loan Agreement, as amended by this Amendment, do not and will not contravene
(i) any law or regulation binding on or affecting Borrower, (ii) any contractual restriction with a Person binding on such Loan Party, (iii) any order, judgment or decree of any court or other governmental or public body or authority, or
subdivision thereof, binding on such Loan Party, or (iv) the organizational documents of such Loan Party;
|
g. |
The execution and delivery by Loan Parties of this Amendment and the performance by each Loan Party of its obligations under the Loan Agreement, as amended by this Amendment, do not require any order,
consent, approval, license, authorization or validation of, or filing, recording or registration with, or exemption by any governmental or public body or authority, or subdivision thereof, binding on such Loan Party, except as already has
been obtained or made; and
|
h. |
This Amendment has been duly executed and delivered by each of Loan Party and is the binding obligation of such Loan Party, enforceable against Loan Party in accordance with its terms, except as such
enforceability may be limited by bankruptcy, insolvency, reorganization, liquidation, moratorium or other similar laws of general application and equitable principles relating to or affecting creditors’ rights.
|
22. |
Except as expressly set forth herein, the Loan Agreement shall continue in full force and effect without alteration or amendment. This Amendment and the Loan Documents represent the entire agreement about
this subject matter and supersede prior negotiations or agreements.
|
23. |
This Amendment shall be deemed effective as of the First Amendment Date upon (a) the due execution and delivery to Collateral Agent of this Amendment by each party hereto, (b) Borrower’s payment of all
Lenders’ Expenses incurred through the date hereof, which may be debited (or ACH’d) from the Designated Deposit Account in accordance with Section 2.3(d) of the Loan Agreement, (c) delivery by HoldCo to Collateral Agent of a separate
Guaranty (in such form and substance as acceptable to Collateral Agent) entered into by HoldCo, (d) delivery by HoldCo to Collateral Agent of the HoldCo Security Agreement entered into by HoldCo and (e) delivery by Parent of fully executed
Success Fee Letter to Oxford.
|
24. |
Borrower hereby covenants to the following:
|
a. |
On the date hereof, deliver to Collateral Agent, evidence of consummation of the Exchange Transaction, subject to the post closing portions of such transactions.
|
b. |
On or before the due date set forth in Section 2(c) of this Amendment, deliver to Collateral Agent, original stock certificate(s) for all outstanding Shares of Parent along with assignment separate(s).
|
c. |
On or before February 22, 2021, deliver to Collateral Agent evidence satisfactory to Collateral Agent that the property insurance policies required by Section 6.5 of the Loan Agreement are in full force and
effect, together with appropriate evidence showing loss payable and/or additional insured clauses or endorsements in favor of Collateral Agent.
|
25. |
Each Loan Party hereby remises, releases, acquits, satisfies and forever discharges the Lenders and Collateral Agent, their agents, employees, officers, directors, predecessors, attorneys and all others
acting or purporting to act on behalf of or at the direction of the Lenders and Collateral Agent (“Releasees”), of and from any and all manner of actions, causes of action, suit, debts, accounts,
covenants, contracts, controversies, agreements, variances, damages, judgments, claims and demands whatsoever, in law or in equity, which any of such parties ever had, now has or, to the extent arising from or in connection with any act,
omission or state of facts taken or existing on or prior to the date hereof, may have after the date hereof against the Releasees, for, upon or by reason of any matter, cause or thing whatsoever relating to or arising out of the Loan
Agreement or the other Loan Documents on or prior to the date hereof through the date hereof. Without limiting the generality of the foregoing, such Loan Party waives and affirmatively agrees not to allege or otherwise pursue any defenses,
affirmative defenses, counterclaims, claims, causes of action, setoffs or other rights they do, shall or may have as of the date hereof, including the rights to contest relative to the Loan Documents: (a) the right of Collateral Agent and
each Lender to exercise its rights and remedies described in the Loan Documents; (b) any provision of this Amendment or the Loan Documents; or (c) any conduct of the Lenders or other Releasees relating to or arising out of the Loan
Agreement or the other Loan Documents on or prior to the date hereof.
|
26. |
This Amendment may be executed in any number of counterparts, each of which shall be deemed an original, and all of which, taken together, shall constitute one and the same instrument.
|
27. |
This Amendment and the rights and obligations of the parties hereto shall be governed by and construed in accordance with the laws of the State of New York.
|
BORROWER:
|
||
IMMUNOCORE LIMITED
|
||
By
|
/s/ Bahija Jallal | |
Name: Bahija Jallal
|
||
Title: Director and Chief Executive Officer
|
||
GUARANTORS:
|
||
IMMUNOCORE LLC
|
||
By
|
/s/ Bahija Jallal | |
Name: Bahija Jallal
|
||
Title: Chief Executive Officer
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IMMUNOCORE COMMERCIAL LLC
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By
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/s/ Bahija Jallal | |
Name: Bahija Jallal
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||
Title: Chief Executive Officer
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IMMUNOCORE HOLDINGS LIMITED
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||
By
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/s/ Bahija Jallal | |
Name: Bahija Jallal
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||
Title: Director and Chief Executive Officer
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||
COLLATERAL AGENT AND LENDER:
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||
OXFORD FINANCE LUXEMBOURG S.À R.L.
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By
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Name:
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||
Title:
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BORROWER: |
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IMMUNOCORE LIMITED
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By |
Name: |
||
Title: |
GUARANTORS:
|
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IMMUNOCORE LLC
|
|
By |
Name: |
||
Title: |
IMMUNOCORE COMMERCIAL LLC
|
|
By |
Name: |
||
Title: |
IMMUNOCORE HOLDINGS LIMITED
|
|
By |
Name: |
||
Title: |
COLLATERAL AGENT A.ND LENDER:
|
|
OXFORD FINANCE LUXEl\1BOURG S.A R.L.
|
|
By |
/s/ Laurent Belik |
Name: |
Laurent Belik | |
Title: |
Manager |
By |
/s/ Caroline Kinyua |
Name: |
Caroline Kinyua | |
Title: |
Manager |
DATED |
|
2021
|
1.
|
Interpretation
|
4
|
2.
|
Waiver of pre-emption rights
|
6
|
3.
|
Share Exchange
|
7
|
4.
|
Consideration
|
7
|
5.
|
Completion
|
8
|
6.
|
Warranties
|
10
|
7.
|
United States tax matters
|
13
|
8.
|
Provisions relating to this Agreement
|
14
|
9.
|
Notices
|
15
|
10.
|
Law and jurisdiction
|
17
|
11.
|
Agency
|
17
|
12.
|
Nominee arrangements
|
19
|
SCHEDULE 1
|
20
|
(1) |
THE PERSONS whose names and addresses are set out in column (A) of
the table in Part A of Schedule 1, save for those persons whose names are marked with an asterix next to their names in such table (each a “Seller” and together the “Sellers”);
|
(2) |
THE PERSONS whose names and addresses are set out in column (A) of
the table in Part B of Schedule 1 (each a “Beneficial Owner” and together the “Beneficial Owners”);
|
(3) |
IMMUNOCORE LIMITED, a private limited company incorporated under
the laws of England and Wales (company number: 06456207) whose registered office is at 92 Park Drive, Milton Park, Abingdon,
Oxfordshire, United Kingdom OX14 4RY (the “Company”); and
|
(4) |
IMMUNOCORE HOLDINGS LIMITED, a private limited company incorporated
under the laws of England and Wales (company number: 13119746) whose registered office is at 92 Park Drive, Milton Park, Abingdon, Oxfordshire, United Kingdom OX14 4RY (the “Buyer”).
|
(A) |
(i) The Sellers; and (ii) the persons whose names and addresses are set out in column (B) of the table in Part B of Schedule 1 (each a “Nominee Shareholder” and together the “Nominee Shareholders”) are the legal owners of the entire issued share capital of the Company comprising 2,679,764 Ordinary Shares, 1,699,576 Series A Shares, 1,148,703 Series B Shares, 823,719 Series C
Shares, 43,490 G1 Shares and 19,260 G2 Shares (together, the “Sale Shares”).
|
(B) |
Each of the Nominee Shareholders holds the legal title to the Sale Shares set out against such Nominee Shareholder’s name in columns (B), (C), (D), (E), (F) and/or (G) of the table in Part A of Schedule 1 on behalf of the Beneficial
Owner set out next to such Nominee Shareholder’s name in column (A) of the table in Part B of Schedule 1.
|
(C) |
The Buyer wishes to acquire from the Sellers and, as regards the Sale Shares referred to in recital (B), the Beneficial Owners and the Nominee Shareholders the Sale Shares on the terms of this Agreement in consideration of the issue by
the Buyer of such proportions and classes of its shares to the Sellers and the Nominee Shareholders so that the issued share capital of the Buyer following Completion is (ignoring the subscriber share which will be held (in addition) by the
initial shareholder of the Buyer) identical to the issued share capital of the Company immediately prior to Completion and is held by the Sellers and the Nominee Shareholders in the same proportions, save that the number of shares in the
capital of the Buyer is proportionately higher (the “Share Exchange”). The parties agree that the Share Exchange constitutes a Holding Company Reorganisation within the meaning of the Company
Articles.
|
(D) |
Immediately prior to the allotment and issue of the Consideration Shares by the Buyer pursuant to this Agreement, the entire issued share capital of the Buyer comprises one ordinary share of £0.0001 in the capital of the Buyer (such
share being fully paid up and held by Sir John Irving Bell (as the initial shareholder of the Buyer)).
|
(E) |
The Share Exchange is intended to qualify as an exchange under section 351 of the U.S. Internal Revenue Code of 1986, as amended (the “Code”) and may also qualify as a “reorganization” under
section 368(a) of the Code. The parties intend for this Agreement to constitute a “plan of reorganization” under the provisions of section 368(a) of the Code and U.S. Treasury Regulations 1.368-2(g) and 1.368-3, if applicable.
|
1.
|
Interpretation
|
1.1
|
In this Agreement where the context admits:
|
1.2 |
References to clauses and schedules are references to clauses of, and Schedules to, this Agreement and references to this Agreement include the Schedules.
|
1.3 |
The headings and sub-headings are inserted for convenience only and shall not affect the construction of this Agreement.
|
1.4 |
Unless the context does not so admit, references to the singular include a reference to the plural and references to the masculine include a reference to the feminine and the neuter.
|
1.5 |
In this Agreement, the interpretation of general words shall not be restricted by words indicating a particular class or particular examples and “including” means “including
without limitation”.
|
2. |
Waiver of pre-emption rights
|
2.1 |
Each Seller, in his, her or its capacity as holder of the Sale Shares set out beside such Seller’s name in columns (B), (C), (D), (E), (F) and/or (G) of the table in Part A of Schedule 1, hereby waives all rights of pre-emption whether
conferred upon such Seller by the Companies Act, the Company Articles, the Shareholders’ Agreement or otherwise in respect of the sale and transfer of the Sale Shares held by such Seller subject to the terms of, and as set forth in, this
Agreement.
|
2.2 |
Each Beneficial Owner hereby waives and agrees to procure, and acknowledges and confirms that such Beneficial Owner has procured, the waiver by its Nominee Shareholder (as holder of the Sale Shares set out beside such Nominee
Shareholder’s name in columns (B), (C), (D), (E), (F) and/or (G) of the table in Part A of Schedule 1) of all rights of pre-emption whether conferred upon such Nominee Shareholder by the Companies Act, the Company Articles, the
Shareholders’ Agreement or otherwise in respect of the sale and transfer of the Sale Shares held by such Nominee Shareholder subject to the terms of, and as set forth in, this Agreement.
|
3. |
Share Exchange
|
3.1 |
Terms of Sale
|
3.2 |
No sale of part only
|
4. |
Consideration
|
4.1 |
Consideration Shares
|
4.2 |
Rights
|
4.3 |
Registration
|
5. |
Completion
|
5.1 |
Completion
|
5.2 |
Sellers’ and Beneficial Owners’ Obligations at Completion
|
(A) |
each Seller shall deliver to the Buyer stock transfer form(s) in respect of the Sale Shares registered in the name of such Seller duly executed by such Seller in favour of the Buyer together with the share certificates for such Sale
Shares or duly executed indemnities in respect of such share certificates;
|
(B) |
each Beneficial Owner shall procure the delivery by its relevant Nominee Shareholder to the Buyer of the stock transfer form(s) in respect of the Sale Shares registered in the name of such Nominee Shareholder duly executed by such
Nominee Shareholder in favour of the Buyer together with the share certificates for such Sale Shares or duly executed indemnities in respect of such share certificates; and
|
(C) |
each Seller and Beneficial Owner who is a party to the Shareholders’ Agreement shall deliver to the Buyer the New Shareholders’ Agreement, duly executed by such Seller and Beneficial Owner.
|
5.3 |
Buyer’s Obligations at Completion and post Completion
|
(A) |
On Completion, the Buyer shall:
|
(1) |
allot and issue to the Sellers and the Nominee Shareholders, free from all Encumbrances and fully paid, the number of Consideration Shares set out beside their respective names in column (H) of the table in Part A of Schedule 1;
|
(2) |
procure that the names of the Sellers and the Nominee Shareholders are entered in the register of members of the Buyer in respect of the Consideration Shares allotted to them pursuant to clause 3 (and the register of applications and
allotments and the register of persons with significant control of the Buyer be updated accordingly);
|
(3) |
execute and deliver to the Sellers and the Nominee Shareholders share certificate(s) in respect of the number and classes of Consideration Shares allotted to them as set out beside their respective names in column (H) of the table in
Part A of Schedule 1; and
|
(4) |
deliver to all signatories thereto the New Shareholders’ Agreement, duly executed by the Buyer.
|
(B) |
Within 30 days of Completion, the Buyer shall file Companies House form SH01 (return of allotment of shares) in respect of the allotment of the Consideration Shares pursuant to this Agreement.
|
5.4 |
Company’s Obligations at Completion
|
5.5 |
Further Assurance
|
6. |
Warranties
|
6.1 |
Seller and Beneficial Owner Warranties
|
(A) |
Each Seller hereby severally warrants to and for the benefit of the Buyer as follows:
|
(1) |
Capacity. Such Seller has full power and authority to
enter into and perform this Agreement, and may execute and deliver this Agreement and perform such Seller’s obligations hereunder without requiring or obtaining the consent of any third party and this Agreement constitutes
(or will when executed constitute) valid and binding obligations of such Seller in accordance with its terms.
|
(2) |
Title. Such Seller is the registered owner of the
number of Sale Shares set out against such Seller’s name in columns (B), (C), (D), (E), (F) and/or (G) of the table in Part A of Schedule 1 and has the right to transfer the entire legal and beneficial title to such Sale
Shares free from any Encumbrances (save for those which arise pursuant to the Company Articles and/or the Shareholders’ Agreement).
|
(B) |
Each Beneficial Owner hereby severally warrants to and for the benefit of the Buyer as follows:
|
(1) |
Capacity. Such Beneficial Owner has full power and
authority to enter into and perform this Agreement, and may execute and deliver this Agreement and perform such Beneficial Owner’s obligations hereunder without requiring or obtaining the consent of any third party and this
Agreement constitutes (or will when executed constitute) valid and binding obligations of such Beneficial Owner in accordance with its terms.
|
(2) |
Title. Such Beneficial Owner’s Nominee Shareholder is
the registered owner of the number of Sale Shares set out against such Nominee Shareholder’s name in columns (B), (C), (D), (E), (F) and/or (G) of the table in Part A of Schedule 1 and has the right to transfer the Sale
Shares (and the Beneficial Owner has directed its Nominee Shareholder to transfer such Sale Shares to the Buyer (including the entire legal title)) free from any Encumbrances (save for those which arise pursuant to the
Company Articles and/or the Shareholders’ Agreement).
|
(3) |
Beneficial ownership. Such Beneficial Owner is the
holder of the entire beneficial title to the number of Sale Shares set out against such Beneficial Owner’s Nominee Shareholder’s name in columns (B), (C), (D), (E), (F) and/or (G) of the table in Part A of Schedule 1 and
such Beneficial Owner has the right to transfer (or procure the transfer) of the entire legal and beneficial title to such Sale Shares to the Buyer free from any Encumbrances (save for those which arise pursuant to the
Company Articles and/or the Shareholders’ Agreement).
|
(C) |
The warranties given by each Seller or Beneficial Owner in clause 6.1(A) and/or clause 6.1(B) are given in respect of that Seller or Beneficial Owner only and no other person and each Seller and Beneficial Owner
acknowledges and accepts that the Buyer is entering into this Agreement in reliance upon such warranties, each of which is given on the basis that it will remain true and accurate at all times up to and including Completion.
|
6.2 |
Company Warranties
|
(A) |
The Company has full power and authority to enter into and perform this Agreement and all agreements to be entered into by it pursuant to this Agreement.
|
(B) |
The Company has been duly incorporated and is validly existing under the laws of England and Wales.
|
(C) |
This Agreement constitutes (or will when executed constitute) binding and enforceable obligations on the Company in accordance with its terms.
|
(D) |
The entering into and performance by the Company of its obligations under this Agreement:
|
(1) |
will not result in a breach of any provision of the constitution of the Company;
|
(2) |
will not result in a breach of, or constitute a default under, any agreement under which the Company enjoys rights or by which it is bound;
|
(3) |
will not breach or constitute a default under any existing statutes or regulations having the force of law in England applicable to companies generally; and
|
(4) |
will not result in a breach of any order, judgment or decree of any court or governmental, administrative or regulatory body or agency to which the Company is party or by which it is bound; and
|
(5) |
does not require the consent of any third party that has not already been obtained as of the date hereof.
|
6.3 |
Buyer Warranties
|
(A) |
Capacity
|
(1) |
The Buyer has full power and authority to enter into and perform this Agreement and all agreements to be entered into by it pursuant to this Agreement.
|
(2) |
The Buyer has been duly incorporated and is validly existing under the laws of England and Wales.
|
(3) |
This Agreement constitutes (or will when executed constitute) binding and enforceable obligations on the Buyer in accordance with its terms.
|
(4) |
The entering into and performance by the Buyer of its obligations under this Agreement:
|
(a) |
will not result in a breach of any provision of the constitution of the Buyer;
|
(b) |
will not result in a breach of, or constitute a default under, any agreement under which the Buyer enjoys rights or by which it is bound;
|
(c) |
will not breach or constitute a default under any existing statutes or regulations having the force of law in England applicable to companies generally;
|
(d) |
will not result in a breach of any order, judgment or decree of any court or governmental, administrative or regulatory body or agency to which the Buyer is party or by which it is bound; and
|
(e) |
does not require the consent of any third party.
|
(B) |
Share Capital
|
(1) |
Immediately prior to the allotment and issue of the Consideration Shares by the Buyer, the entire issued share capital of the Buyer comprises one ordinary share of £0.0001 in the capital of the Buyer.
|
(2) |
No person has the right or has claimed to have a right (whether exercisable now or at a future date and whether contingent or not) to subscribe for, convert any security into or otherwise acquire any shares, debentures or
other securities of the Buyer, including pursuant to an option or warrant.
|
(3) |
The Consideration Shares to be allotted and issued pursuant to the terms of this Agreement, when so allotted and issued in accordance with the terms and for the consideration set forth in this Agreement, will be validly
allotted and issued, fully paid and free of any Encumbrances (other than restrictions on transfer under the New Articles or set out in the New Shareholders’ Agreement). The Consideration Shares to be issued pursuant to the
terms of this Agreement will be issued in compliance with all applicable laws.
|
(C) |
Subsidiaries
|
(D) |
Insolvency
|
(1) |
Insolvency Proceedings have not commenced in relation to the Buyer or (if applicable) any part of its assets or undertaking.
|
(2) |
There are no circumstances which entitle or may entitle any person to commence any Insolvency Proceedings in relation to the Buyer or (if applicable) any part of its assets or undertaking.
|
6.4 |
Warranties to be independent
|
7. |
United States tax matters
|
7.2 |
The Share Exchange is intended to qualify as an exchange under section 351 of the Code and may also qualify as a “reorganization” under section 368(a) of the Code. The parties intend for this Agreement to constitute a “plan
of reorganization” under the provisions of section 368(a) of the Code and U.S. Treasury Regulations 1.368-2(g) and 1.368-3, if applicable. Solely for United States tax purposes, the Buyer, the Sellers and the Beneficial Owners
shall treat, and shall not take any United States tax reporting position inconsistent with the treatment of, the Share Exchange as a transaction pursuant to which no gain or loss is recognised under section 351 of the Code or
as a reorganisation within the meaning of section 368(a) of the Code for U.S. tax purposes, unless otherwise required by Law. The Buyer, the Sellers and the Beneficial Owners shall, and shall cause their affiliates to (if
required for United States tax purposes), prepare all United States tax filings, including any applicable statements required by Treasury Regulations §1.351-3(a), §1.351-3(b), §1.368-3(a), and/or §1.368- 3(b) as applicable
(together, the “U.S. Tax Statements”) and, in a manner consistent with the treatment of the Share Exchange as a transaction pursuant to which no gain or loss is recognised under section
351 of the Code or as a reorganization within the meaning of section 368(a) of the Code unless otherwise required by applicable Law. Nothing herein shall require a Seller, a Beneficial Owner or its or their direct or indirect
members to enter into a gain recognition agreement under section 367(a) of the Code or the Treasury Regulations thereunder. The Buyer, the Sellers and the Beneficial Owners (in each case, if applicable) shall report the Share
Exchange as an exchange under section 351 of the Code unless otherwise notified in writing by the Buyer or unless otherwise required by law.
|
7.3 |
The Buyer, the Sellers and the Beneficial Owners and their affiliates shall reasonably cooperate with each other, including the sharing of relevant information, filings, and working papers (such as those related to the
calculation of tax basis) necessary to complete the U.S. Tax Statements in a timely manner.
|
7.4 |
No consideration other than stock will be issued by the Buyer as part of the Share Exchange.
|
7.5 |
Each party to the Share Exchange will pay their respective expenses, if any, incurred in connection with the Share Exchange.
|
7.6 |
The Buyer will remain in existence following the Share Exchange.
|
8. |
Provisions relating to this Agreement
|
8.1 |
Whole agreement and variations
|
(B) |
No variation of this Agreement shall be effective unless made in writing and signed by each of the parties.
|
8.2 |
Agreement survives Completion
|
8.3 |
Rights and other matters
|
(A) |
The rights, powers, privileges and remedies provided in this Agreement are cumulative and are not exclusive of any rights, powers, privileges or remedies provided by law or otherwise.
|
(B) |
No failure to exercise nor any delay in exercising any right, power, privilege or remedy under this Agreement shall in any way impair or affect the exercise thereof or operate as a waiver thereof in whole or in part.
|
(C) |
No single or partial exercise of any right, power, privilege or remedy under this Agreement shall prevent any further or other exercise thereof or the exercise of any other right, power, privilege or remedy.
|
8.4 |
Invalidity
|
8.5 |
Counterparts
|
9. |
Notices
|
9.1 |
Language
|
9.2 |
Service
|
(A) |
Any communication and/or information to be given to a party in connection with this Agreement shall be in writing in English and shall either be:
|
(1) |
delivered by hand or sent by pre-paid first-class post or a reputable international courier using overnight service (as applicable) at its registered office or: (i) in the case of a Seller, to the address of such Seller
specified in the table in Part A of Schedule 1; or (ii) in the case of a Beneficial Owner, to the address of such Beneficial Owner’s Nominee Shareholder specified in column (B) of the table in Part B of Schedule 1; or
|
(2) |
sent by email to the email addresses as may be notified by the parties from time to time,
|
(B) |
A communication sent according to clause 9.2 shall be deemed to have been received:
|
(1) |
if delivered by hand, at the time of delivery at the proper address;
|
(2) |
if sent by pre-paid first-class post or a reputable international courier using overnight service, on the business day after posting; or
|
(3) |
if sent by email, at the time of completion of transmission by the sender, unless the sender receives a notification that the email has not been successfully delivered,
|
9.3 |
This clause 9 does not apply to the service of any proceedings or other documents in any legal action or, where applicable, any arbitration or other method of dispute resolution which shall be governed by the applicable
law, rule or regulation.
|
9.4 |
Change of address
|
9.5 |
Electronic and website communications
|
10. |
Law and jurisdiction
|
10.1 |
English Law
|
10.2 |
Jurisdiction
|
10.3 |
Contracts (Rights of Third Parties) Act 1999
|
11. |
Agency
|
(A) |
exercise all voting rights (including class rights) attaching to such Seller’s Sale Shares or such Nominee Shareholder’s Sale Shares (whether in writing or at a meeting of the shareholders of the Company or a class of any
shareholders of the Company) to signify agreement on behalf of that Seller or that Nominee Shareholder to any resolution and/or class consent to be passed by the shareholders of the Company under Part 13 of the Companies Act
or otherwise; and
|
(B) |
approve, execute or sign and deliver all deeds, documents, resolutions (whether ordinary or special), consents, certificates, instruments, forms and/or agreements,
|
11.2 |
Without prejudice to the generality of clause 11.1, each Seller shall take such actions as required by clause 11.1 in connection with:
|
(A) |
any re-organisation of the issued or unissued share capital of the Company (including, but not limited to, any conversion, re-designation, sub-division or consolidation of the issued share capital of the Company);
|
(B) |
any reduction of capital of the Company (by way of any reduction in the nominal value, or number, of any of the shares of the Company and/or any reduction of any undistributable reserves); and/or
|
(C) |
the adoption of new articles of association of the Company and any change of name of the Company,
|
(A) |
exercise all voting rights (including class rights) attaching to such Seller’s Consideration Shares or such Nominee Shareholder’s Consideration Shares (whether in writing or at a meeting or the shareholders of the Buyer or
a class of any shareholders of the Buyer); and
|
(B) |
approve, execute or sign and deliver all deeds, documents, resolutions (whether ordinary or special), consents, certificates, instruments, forms and/or agreements,
|
11.4 |
Without prejudice to the generality of clause 11.3, each Seller and each Beneficial Owner shall take such actions as required by clause 11.3 in connection with:
|
(A) |
the execution of the New Shareholders’ Agreement;
|
(B) |
any reduction of capital of the Buyer (by way of any reduction in the nominal value of any of the shares of the Buyer and/or any reduction of any undistributable reserves);
|
(C) |
the re-registration of the Buyer as a public limited company in accordance with the procedure set out in sections 90 – 96 (inclusive) of the Companies Act and the associated change of name of the Buyer and adoption of new
articles of association of the Buyer appropriate for a public limited company (or equivalent in any jurisdiction);
|
(D) |
consenting to a general meeting of the Buyer being held on short notice in accordance with section 307(4) of the Companies Act and providing a proxy in favour of any director of the Buyer to vote such Seller’s Consideration
Shares or a Nominee Shareholder’s Consideration Shares in favour of any resolution and/or class consent proposed at such general meeting in connection with a Prospective Qualifying IPO; and
|
(E) |
the authorisation of the board of directors of the Buyer to issue new shares in the Buyer pursuant to section 551 of the Companies Act and disapply any rights of pre-emption of the shareholders of the Buyer whether under
section 561 of the Companies Act or set out in the New Articles.
|
11.5 |
If any Seller or Beneficial Owner fails to comply with the provisions of clauses 11.1 to 11.4, the Buyer shall be constituted as the agent of each defaulting Seller or defaulting Beneficial Owner (or its Nominee
Shareholder, as applicable) for taking such actions as are necessary to enforce the provisions of clauses 11.1, 11.2, 11.3 and/or 11.4 and any director of the Buyer shall be empowered to execute and deliver on behalf of such
defaulting Seller or defaulting Beneficial Owner (or its Nominee Shareholder, as applicable) any document that such director considers reasonably necessary in connection with any of the matters set out in clauses 11.1, 11.2,
11.3 and/or 11.4.
|
12. |
Nominee arrangements
|
(A)
Name and address of Seller
|
(B)
Ordinary Shares
|
(C)
Series A Shares
|
(D)
Series B Shares
|
(E)
Series C Shares
|
(F)
G1 Shares
|
(G)
G2 Shares
|
(H)
Number and class of
Consideration Shares to be
issued by the Buyer
|
667, L.P. of 860 Washington Street, 3rd Floor, New York, NY 10014, United States
|
366
|
3,931
|
0
|
20,538
|
0
|
0
|
36,600 Ordinary Consideration Shares
393,100 Series A Consideration Shares
2,053,800 Series C Consideration Shares
|
Attridge, Penelope of Angeston Court, Fop Street, Uley, Dursley, GL11 5AL
|
661
|
0
|
0
|
0
|
0
|
0
|
66,100 Ordinary Consideration Shares
|
Avego Bioscience IMCR, LLC of c/o Avego Management, LLC, 1055B Powers Place, 2nd Floor, Alpharetta, GA 30009, United States
|
0
|
0
|
0
|
46,677
|
0
|
0
|
4,667,700 Series C Consideration Shares
|
Baker Brothers Life Sciences, L.P. of 860 Washington Street, 3rd Floor, New York, NY 10014, United States
|
4,599
|
49,181
|
0
|
254,036
|
0
|
0
|
459,900 Ordinary Consideration Shares
4,918,100 Series A Consideration Shares
25,403,600 Series C
|
(A)
Name and address of Seller
|
(B)
Ordinary Shares
|
(C)
Series A Shares
|
(D)
Series B Shares
|
(E)
Series C Shares
|
(F)
G1 Shares
|
(G)
G2 Shares
|
(H)
Number and class of
Consideration Shares to be
issued by the Buyer
|
Consideration Shares
|
|||||||
* The Bank of New York (Nominees) Limited of One Piccadilly Gardens, Manchester, M1 1RN
|
6,296
|
67,323
|
0
|
0
|
0
|
0
|
629,600 Ordinary Consideration Shares
6,732,300 Series A Consideration Shares
|
* BBHISL Nominees Ltd, Acct 122514 of c/o HSBC Bank Plc, 8 Canada Square, London, E14 5HQ, United Kingdom
|
6,857
|
73,318
|
0
|
0
|
0
|
0
|
685,700 Ordinary Consideration Shares
7,331,800 Series A Consideration Shares
|
* BBHISL Nominees Ltd, Acct 130646 of c/o HSBC Bank Plc, 8 Canada Square, London, E14 5HQ, United Kingdom
|
1,892
|
20,244
|
0
|
0
|
0
|
0
|
189,200 Ordinary Consideration Shares
2,024,400 Series A Consideration Shares
|
* BBHISL Nominees Ltd, Acct 131418 of c/o HSBC Bank Plc, 8 Canada Square, London, E14 5HQ, United Kingdom
|
5
|
75
|
0
|
0
|
0
|
0
|
500 Ordinary Consideration Shares
7,500 Series A Consideration Shares
|
Bell, John Irving of Riverholme, Thames Street, Wallingford, OX10 0HD, United
|
1,152
|
0
|
0
|
0
|
0
|
0
|
115,200 Ordinary Consideration Shares
|
(A)
Name and address of Seller
|
(B)
Ordinary Shares
|
(C)
Series A Shares
|
(D)
Series B Shares
|
(E)
Series C Shares
|
(F)
G1 Shares
|
(G)
G2 Shares
|
(H)
Number and class of
Consideration Shares to be
issued by the Buyer
|
Kingdom
|
|||||||
Betton, Andrew of 21 Old Farm Avenue, London, N14 5QR
|
776
|
0
|
0
|
0
|
0
|
0
|
77,600 Ordinary Consideration Shares
|
Bill & Melinda Gates Foundation of PO Box 23350, Seattle MD, United States
|
6,948
|
0
|
203,697
|
0
|
0
|
0
|
694,800 Ordinary Consideration Shares
20,369,700 Series B
Consideration Shares
|
BlackRock Health Sciences Trust II of 100 Bellevue Parkway, Wilmington, Delaware 19809
|
0
|
0
|
0
|
64,380
|
0
|
0
|
6,438,000 Series C Consideration Shares
|
BlackRock Health Sciences Master Unit Trust of 190 Elgin Avenue, George Town, Grand Cayman, KY1-9005 Cayman Islands
|
0
|
0
|
0
|
1,517
|
0
|
0
|
151,700 Series C Consideration Shares
|
Blackwell, Christina Jane of Flat 3, 14 Cheyne Gardens, London SW3 5QT
|
74,673
|
800
|
0
|
0
|
0
|
0
|
7,467,300 Ordinary Consideration Shares
80,000 Series A Consideration Shares
|
Blackwell, Nigel Stirling of The Ham, Ickleton Road, Wantage, Oxfordshire,
|
164,428
|
1,350
|
2
|
0
|
0
|
0
|
16,442,800 Ordinary
|
(A)
Name and address of Seller
|
(B)
Ordinary Shares
|
(C)
Series A Shares
|
(D)
Series B Shares
|
(E)
Series C Shares
|
(F)
G1 Shares
|
(G)
G2 Shares
|
(H)
Number and class of
Consideration Shares to be
issued by the Buyer
|
OX12 9JA, United Kingdom
|
Consideration Shares
135,000 Series A Consideration Shares
200 Series B Consideration Shares
|
||||||
Blackwell, Nigel and Roots, Nigel, the Trustees of The Ham Trust of The Ham, Ickleton Road, Wantage, Oxfordshire, OX12 9JA, United Kingdom
|
6,329
|
0
|
0
|
0
|
0
|
0
|
632,900 Ordinary Consideration Shares
|
Blackwell, Nigel, Roots, Nigel and Maitland, Jane, the Trustees of the Nigel Blackwell Family Trust of The Ham, Ickleton Road, Wantage, Oxfordshire, OX12 9JA, United Kingdom
|
170,730
|
1,062
|
0
|
0
|
0
|
0
|
17,073,000 Ordinary Consideration Shares
106,200 Series A Consideration Shares
|
Canuto, Corin of 23 High Street, Potterne, Wiltshire, SN10 5NA, United Kingdom
|
815
|
0
|
0
|
0
|
0
|
0
|
81,500 Ordinary Consideration Shares
|
CCB International Overseas Limited of 12/F, CCB Tower, 3 Connaught Road Central, Central, Hong Kong
|
2,179
|
0
|
63,905
|
0
|
0
|
0
|
217,900 Ordinary Consideration Shares
6,390,500 Series B Consideration
|
(A)
Name and address of Seller
|
(B)
Ordinary Shares
|
(C)
Series A Shares
|
(D)
Series B Shares
|
(E)
Series C Shares
|
(F)
G1 Shares
|
(G)
G2 Shares
|
(H)
Number and class of
Consideration Shares to be
issued by the Buyer
|
Shares
|
|||||||
The Chancellor, Masters and Scholars of the University of Oxford of c/o Oxford University Innovation, Buxton Court, 3 West Way, Oxford OX2 0JB, United Kingdom
|
29,886
|
404
|
0
|
0
|
0
|
0
|
2,988,600 Ordinary Consideration Shares
40,400 Series A Consideration Shares
|
* Chase Nominees Limited A/C Fidlend of PO Box 7732, 1 Chaseside, Bournemouth, BH1 9XA, United Kingdom
|
1,053
|
11,275
|
0
|
0
|
0
|
0
|
105,300 Ordinary Consideration Shares
1,127,500 Series A Consideration Shares
|
Cross, Nicholas John of Lashford House, Dry Sandford, Abingdon, Oxfordshire, OX13 6JP, United Kingdom
|
467,458
|
6,462
|
2
|
0
|
0
|
0
|
46,745,800 Ordinary Consideration Shares
646,200 Series A Consideration Shares
200 Series B Consideration Shares
|
The Dean and Chapter of the Cathedral Church of Christ in Oxford of the Foundation of King Henry the Eighth of The Treasury, St Aldates, Oxford, OX1 1DP
|
2,419
|
41
|
0
|
0
|
0
|
0
|
241,900 Ordinary Consideration Shares
4,100 Series A Consideration Shares
|
(A)
Name and address of Seller
|
(B)
Ordinary Shares
|
(C)
Series A Shares
|
(D)
Series B Shares
|
(E)
Series C Shares
|
(F)
G1 Shares
|
(G)
G2 Shares
|
(H)
Number and class of
Consideration Shares to be
issued by the Buyer
|
Duffy, Anthony of 20 Burnbury Road, London, SW12 0EJ
|
1,034
|
0
|
0
|
0
|
0
|
0
|
103,400 Ordinary Consideration Shares
|
Eli Lilly SA of Chemin des Coquelicots 16, 1214, Vernier, Switzerland
|
39,703
|
398,338
|
71,588
|
0
|
0
|
0
|
3,970,300 Ordinary Consideration Shares
39,833,800 Series A
Consideration Shares
7,158,800 Series B Consideration Shares
|
Financial Consultants (Jersey) Limited a/c 91 of Centenary House, La Grande Route de St Pierre, St Peter, JE3 7AY, Jersey
|
35,186
|
416
|
0
|
0
|
0
|
0
|
3,518,600 Ordinary Consideration Shares
41,600 Series A Consideration Shares
|
Four Pines Master Fund LP of 650 South Exeter Street, Suite 1070, Baltimore MD 21202, United States
|
0
|
0
|
0
|
27,457
|
0
|
0
|
2,745,700 Series C Consideration Shares
|
GA IMC Holding, L.P. of Clarendon House, 2 Church Street, Hamilton, HM 11, Bermuda
|
18,963
|
0
|
555,893
|
219,659
|
0
|
0
|
1,896,300 Ordinary Consideration Shares
55,589,300 Series B
Consideration Shares
21,965,900 Series C
|
(A)
Name and address of Seller
|
(B)
Ordinary Shares
|
(C)
Series A Shares
|
(D)
Series B Shares
|
(E)
Series C Shares
|
(F)
G1 Shares
|
(G)
G2 Shares
|
(H)
Number and class of
Consideration Shares to be
issued by the Buyer
|
Consideration Shares
|
|||||||
Gee, Jonathan of 3 Hornbeam Close, Podington, Wellingborough, NN29 7HZ
|
1,322
|
0
|
0
|
0
|
0
|
0
|
132,200 Ordinary Consideration Shares
|
GT Healthcare Fund 1 LP of c/o Walkers Corporate Limited, Cayman Corporate Centre, 27 Hospital Road, George Town, Grand Cayman KY1- 9008, Cayman Islands
|
116,599
|
0
|
0
|
0
|
0
|
0
|
11,659,900 Ordinary Consideration Shares
|
HC IC Holdings LLC of 1177 Avenue of the Americas, 40th floor, New York, NY 10036, United States
|
0
|
0
|
0
|
8,237
|
0
|
0
|
823,700 Series C Consideration Shares
|
Hietanen, Satu of 297a Green Lanes, London N4 2ES
|
287
|
0
|
0
|
0
|
0
|
0
|
28,700 Ordinary Consideration Shares
|
Holmes, Andrew of 51 Doneraile Street, London, SW6 6EW
|
130
|
300
|
0
|
0
|
0
|
0
|
13,000 Ordinary Consideration Shares
30,000 Series A Consideration Shares
|
Immunocore Nominees Limited of 92 Park Drive, Milton Park, Abingdon, Oxfordshire, OX14 4RY, United
|
22,300
|
0
|
0
|
0
|
43,490
|
19,260
|
2,230,000 Ordinary Consideration Shares
4,349,000 G1 Consideration
|
(A)
Name and address of Seller
|
(B)
Ordinary Shares
|
(C)
Series A Shares
|
(D)
Series B Shares
|
(E)
Series C Shares
|
(F)
G1 Shares
|
(G)
G2 Shares
|
(H)
Number and class of
Consideration Shares to be
issued by the Buyer
|
Kingdom
|
Shares
1,926,000 G2 Consideration Shares
|
||||||
Jakobsen, Bent Karsten of Flat 7, Lincombe Lodge, Fox Lane, Boars Hill, Oxford OX1 5DN, United Kingdom
|
39,973
|
0
|
0
|
0
|
0
|
0
|
3,997,300 Ordinary Consideration Shares
|
JDRF T1D Fund, LLC of 200 Vesey Street, 28th Floor, New York, NY 10281, United States
|
1,090
|
0
|
31,953
|
0
|
0
|
0
|
109,000 Ordinary Consideration Shares
3,195,300 Series B Consideration Shares
|
Moore Kingston Smith Trust Corporation Limited and Tilly Vivien Lesley Chown as Trustees of the William Thomas Chown Discretionary Will Trust of Devonshire House, 60 Goswell Road, London EC1M
7AD, United Kingdom
|
24,676
|
0
|
0
|
0
|
0
|
0
|
2,467,600 Ordinary Consideration Shares
|
Knowles, Jonathan Kenneth Charles of Paradiesstrasse 73, CH4102, Binningen, Baselland, Switzerland
|
49,775
|
664
|
832
|
0
|
0
|
0
|
4,977,500 Ordinary Consideration Shares
66,400 Series A Consideration Shares
|
(A)
Name and address of Seller
|
(B)
Ordinary Shares
|
(C)
Series A Shares
|
(D)
Series B Shares
|
(E)
Series C Shares
|
(F)
G1 Shares
|
(G)
G2 Shares
|
(H)
Number and class of
Consideration Shares to be
issued by the Buyer
|
83,200 Series B Consideration Shares
|
|||||||
Laing, Caroline Elizabeth of 4 Charlbury Road, Oxford, OX2 6UT, United Kingdom
|
88,628
|
1,228
|
0
|
0
|
0
|
0
|
8,862,800 Ordinary Consideration Shares
122,800 Series A Consideration Shares
|
Laing, Ian Michael of 4 Charlbury Road, Oxford, OX2 6UT, United Kingdom
|
377,792
|
5,234
|
2
|
0
|
0
|
0
|
37,779,200 Ordinary Consideration Shares
523,400 Series A Consideration Shares
200 Series B Consideration Shares
|
Lammer, Peter of Newton House, Faringdon, SN7 8PY, United Kingdom
|
96,589
|
0
|
8,595
|
0
|
0
|
0
|
9,658,900 Ordinary Consideration Shares
859,500 Series B Consideration Shares
|
Levi, Sergio of 29 Milliner House, Hortensia Road, London SW10 0QB
|
374
|
0
|
0
|
0
|
0
|
0
|
37,400 Ordinary Consideration Shares
|
Lincoln College Oxford of Turl Street,
|
2,419
|
41
|
0
|
0
|
0
|
0
|
241,900 Ordinary Consideration
|
(A)
Name and address of Seller
|
(B)
Ordinary Shares
|
(C)
Series A Shares
|
(D)
Series B Shares
|
(E)
Series C Shares
|
(F)
G1 Shares
|
(G)
G2 Shares
|
(H)
Number and class of
Consideration Shares to be
issued by the Buyer
|
Oxford, OX1 3DR
|
Shares
4,100 Series A Consideration Shares
|
||||||
* Mag & Co. FBO Fidelity Series Growth Company Fund of 140 Broadway, New York NY 10005, United States
|
1,730
|
18,504
|
0
|
0
|
0
|
0
|
173,000 Ordinary Consideration Shares
1,850,400 Series A Consideration Shares
|
Malin Life Sciences Holdings Limited of 2 Harbour Square, Crofton Road, Dun Laoghaire, County Dublin, A96 D6R0 Ireland
|
46,991
|
424,894
|
0
|
0
|
0
|
0
|
4,699,100 Ordinary Consideration Shares
42,489,400 Series A
Consideration Shares
|
Master and Scholars of Balliol College in the University of Oxford of Broad Street, Oxford, OX1 3BJ
|
2,419
|
41
|
0
|
0
|
0
|
0
|
241,900 Ordinary Consideration Shares
4,100 Series A Consideration Shares
|
MediGene AG of Lochhamer Strasse 11, 82152, Planegg/Martinsried, Germany
|
32,407
|
0
|
0
|
0
|
0
|
0
|
3,240,700 Ordinary Consideration Shares
|
Mellon, James of Viking House, Nelson
|
3,571
|
0
|
0
|
0
|
0
|
0
|
357,100 Ordinary Consideration
|
(A)
Name and address of Seller
|
(B)
Ordinary Shares
|
(C)
Series A Shares
|
(D)
Series B Shares
|
(E)
Series C Shares
|
(F)
G1 Shares
|
(G)
G2 Shares
|
(H)
Number and class of
Consideration Shares to be
issued by the Buyer
|
Street, Douglas, Isle Of Man, IM1 2AH
|
Shares
|
||||||
Merton Acquisition HoldCo LLC of 4 Park Plaza, Suite 550, Irvine CA 92614, USA
|
47,093
|
239,003
|
0
|
0
|
0
|
0
|
4,709,300 Ordinary Consideration Shares
23,900,300 Series A
Consideration Shares
|
Molloy, Peter Eamon of 193 Great Knollys Street, Reading, Berkshire, RG1 7HA
|
405
|
0
|
0
|
0
|
0
|
0
|
40,500 Ordinary Consideration Shares
|
N5 Investments AS of Parkveien 55, Oslo, 0256, Norway
|
1,613
|
0
|
0
|
0
|
0
|
0
|
161,300 Ordinary Consideration Shares
|
Neomed Innovation V L.P. of 13 Castle Street, St. Helier, Jersey JE4 5UT, Channel Islands
|
24,807
|
0
|
0
|
0
|
0
|
0
|
2,480,700 Ordinary Consideration Shares
|
* Nortrust Nominees Limited a/c WIZ02 of 50 Bank Street, London, E14 5NT, United Kingdom
|
27,303
|
291,814
|
0
|
0
|
0
|
0
|
2,730,300 Ordinary Consideration Shares
29,181,400 Series A
Consideration Shares
|
Nuframe Limited of Centenary House, La Grande Route de St Pierre, St Peter,
|
35,185
|
416
|
0
|
0
|
0
|
0
|
3,518,500 Ordinary Consideration Shares
|
(A)
Name and address of Seller
|
(B)
Ordinary Shares
|
(C)
Series A Shares
|
(D)
Series B Shares
|
(E)
Series C Shares
|
(F)
G1 Shares
|
(G)
G2 Shares
|
(H)
Number and class of
Consideration Shares to be
issued by the Buyer
|
JE3 7AY, Jersey
|
41,600 Series A Consideration Shares
|
||||||
Pointer, David James of 38 Pearce Avenue, Poole, BH14 8EH, United Kingdom
|
100,431
|
1,391
|
0
|
0
|
0
|
0
|
10,043,100 Ordinary Consideration Shares
139,100 Series A Consideration Shares
|
The President Fellows and Scholars of the College of the Holy and Undivided Trinity in the University of Oxford of Broad Street, Oxford, OX1 3BH
|
1,210
|
21
|
0
|
0
|
0
|
0
|
121,000 Ordinary Consideration Shares
2,100 Series A Consideration Shares
|
President and Scholars of the College of Corpus Christi in the University of Oxford of Merton Street, Oxford, OX1 4JF
|
1,210
|
21
|
0
|
0
|
0
|
0
|
121,000 Ordinary Consideration Shares
2,100 Series A Consideration Shares
|
President and Scholars of the College of Saint Mary Magdalen in the University of Oxford of High Street, Oxford, OX1 4AU
|
1,935
|
33
|
0
|
0
|
0
|
0
|
193,500 Ordinary Consideration Shares
3,300 Series A Consideration Shares
|
The Principal and Fellows of the College of the Lady Margaret in the
|
1,210
|
21
|
0
|
0
|
0
|
0
|
121,000 Ordinary Consideration
|
(A)
Name and address of Seller
|
(B)
Ordinary Shares
|
(C)
Series A Shares
|
(D)
Series B Shares
|
(E)
Series C Shares
|
(F)
G1 Shares
|
(G)
G2 Shares
|
(H)
Number and class of
Consideration Shares to be
issued by the Buyer
|
University of Oxford of Lady Margaret Hall, Norham Gardens, Oxford OX2 6QA
|
Shares
2,100 Series A Consideration Shares
|
||||||
The Principal and Fellows of Somerville College in the University of Oxford of Woodstock Road, Oxford, OX2 6HD
|
1,210
|
21
|
0
|
0
|
0
|
0
|
121,000 Ordinary Consideration Shares
2,100 Series A Consideration Shares
|
Robinson, George Edward Silvanus of 20 Campden Hill Square, London, W8 7JY, United Kingdom
|
424,255
|
6,447
|
2
|
0
|
0
|
0
|
42,425,500 Ordinary Consideration Shares
644,700 Series A Consideration Shares
200 Series B Consideration Shares
|
Rock Springs Capital Master Fund LP of 650 South Exeter Street, Suite 1070, Baltimore MD 21202, United States
|
2,724
|
0
|
79,881
|
104,338
|
0
|
0
|
272,400 Ordinary Consideration Shares
7,988,100 Series B Consideration Shares
10,433,800 Series C
Consideration Shares
|
(A)
Name and address of Seller
|
(B)
Ordinary Shares
|
(C)
Series A Shares
|
(D)
Series B Shares
|
(E)
Series C Shares
|
(F)
G1 Shares
|
(G)
G2 Shares
|
(H)
Number and class of
Consideration Shares to be
issued by the Buyer
|
RTW Innovation Master Fund, Ltd of c/o RTW Investments, LP, 40 10th Avenue, Floor 7, New York, NY 10014
|
0
|
0
|
0
|
14,744
|
0
|
0
|
1,474,400 Series C Consideration Shares
|
RTW Master Fund, Ltd of c/o RTW Investments, LP, 40 10th Avenue, Floor 7, New York, NY 10014
|
4,967
|
53,112
|
0
|
45,530
|
0
|
0
|
496,700 Ordinary Consideration Shares
5,311,200 Series A Consideration Shares
4,553,000 Series C Consideration Shares
|
RTW Venture Fund Limited of c/o RTW Investments, LP, 40 10th Avenue, Floor 7, New York, NY 10014
|
1,580
|
0
|
46,324
|
16,606
|
0
|
0
|
158,000 Ordinary Consideration Shares
4,632,400 Series B Consideration Shares
1,660,600 Series C Consideration Shares
|
Spark Venture Management Limited of 62 Dean Street, London, W1D 4QF
|
725
|
12
|
0
|
0
|
0
|
0
|
72,500 Ordinary Consideration Shares
1,200 Series A Consideration Shares
|
(A)
Name and address of Seller
|
(B)
Ordinary Shares
|
(C)
Series A Shares
|
(D)
Series B Shares
|
(E)
Series C Shares
|
(F)
G1 Shares
|
(G)
G2 Shares
|
(H)
Number and class of
Consideration Shares to be
issued by the Buyer
|
Spooner, John of Glebe Farm, Great Rissington, Cheltenham, GL54 2LH
|
115
|
0
|
0
|
0
|
0
|
0
|
11,500 Ordinary Consideration Shares
|
* State Street Nominees Limited a/c 24F3 of Quartermile 3, 10 Nightingale Way, Edinburgh EH3 9EG, United Kingdom
|
1,603
|
17,149
|
0
|
0
|
0
|
0
|
160,300 Ordinary Consideration Shares
1,714,900 Series A Consideration Shares
|
* State Street Nominees Limited a/c 24JA of Quartermile 3, 10 Nightingale Way, Edinburgh EH3 9EG, United Kingdom
|
375
|
4,035
|
0
|
0
|
0
|
0
|
37,500 Ordinary Consideration Shares
403,500 Series A Consideration Shares
|
* State Street Nominees Limited a/c IM86 of Quartermile 3, 10 Nightingale Way, Edinburgh EH3 9EG, United Kingdom
|
48
|
524
|
0
|
0
|
0
|
0
|
4,800 Ordinary Consideration Shares
52,400 Series A Consideration Shares
|
St Catherine’s College in the University of Oxford of Manor Road, Oxford, OX1 3UJ
|
13,516
|
166
|
0
|
0
|
0
|
0
|
1,351,600 Ordinary Consideration Shares
16,600 Series A Consideration Shares
|
Teichman, Thomas of 4 Ralston Street,
|
776
|
0
|
0
|
0
|
0
|
0
|
77,600 Ordinary Consideration
|
(A)
Name and address of Seller
|
(B)
Ordinary Shares
|
(C)
Series A Shares
|
(D)
Series B Shares
|
(E)
Series C Shares
|
(F)
G1 Shares
|
(G)
G2 Shares
|
(H)
Number and class of
Consideration Shares to be
issued by the Buyer
|
London, SW3 4DS
|
Shares
|
||||||
Terra Magnum LLC of 4701 Sangmore Road, Suite 100N-1018, Bethesda MD 20816, United States
|
136
|
0
|
3,995
|
0
|
0
|
0
|
13,600 Ordinary Consideration Shares
399,500 Series B Consideration Shares
|
Tran, Nghi of 8 Elm Close, Amersham, HP6 5DD
|
287
|
0
|
0
|
0
|
0
|
0
|
28,700 Ordinary Consideration Shares
|
Treves, Angela Veronica of 4 Alwyne Place, London, N1 2NL, United Kingdom
|
15,381
|
206
|
0
|
0
|
0
|
0
|
1,538,100 Ordinary Consideration Shares
20,600 Series A Consideration Shares
|
The Warden and Fellows of All Souls College of High Street, Oxford, OX1 4AL
|
967
|
16
|
0
|
0
|
0
|
0
|
96,700 Ordinary Consideration Shares
1,600 Series A Consideration Shares
|
The Warden and Fellows of St Antony’s College of 62 Woodstock Rd, Oxford, OX2 6JF
|
1,210
|
21
|
0
|
0
|
0
|
0
|
121,000 Ordinary Consideration Shares
2,100 Series A Consideration Shares
|
(A)
Name and address of Seller
|
(B)
Ordinary Shares
|
(C)
Series A Shares
|
(D)
Series B Shares
|
(E)
Series C Shares
|
(F)
G1 Shares
|
(G)
G2 Shares
|
(H)
Number and class of
Consideration Shares to be
issued by the Buyer
|
The Warden and Scholars of the House or College of Scholars of Merton in the University of Oxford of Merton Street, Oxford, OX1 4JD
|
1,210
|
21
|
0
|
0
|
0
|
0
|
121,000 Ordinary Consideration Shares
2,100 Series A Consideration Shares
|
Wanganui Pty Limited of c/o Intralink Wealth Management, Level 14, 470 Collins Street, Melbourne VIC, 3000, Australia
|
10,073
|
0
|
2,151
|
0
|
0
|
0
|
1,007,300 Ordinary Consideration Shares
215,100 Series B Consideration Shares
|
WuXi PharmaTech Healthcare Fund I
L.P. of 288 Fute Zhong Road, Waigaoqiao Free Trade Zone,
Shanghai, 200131, China
|
2,724
|
0
|
79,881
|
0
|
0
|
0
|
272,400 Ordinary Consideration Shares
7,988,100 Series B Consideration Shares
|
TOTAL
|
2,679,764
Ordinary Shares
|
1,699,576
Series A Shares
|
1,148,703
Series B Shares
|
823,719
Series C Shares
|
43,490 G1
Shares
|
19,260 G2
Shares
|
267,976,400 Ordinary
Consideration Shares
169,957,600 Series A
Consideration Shares
114,870,300 Series B
Consideration Shares
82,371,900 Series C
Consideration Shares
|
(A)
Name and address of Seller
|
(B)
Ordinary Shares
|
(C)
Series A Shares
|
(D)
Series B Shares
|
(E)
Series C Shares
|
(F)
G1 Shares
|
(G)
G2 Shares
|
(H)
Number and class of
Consideration Shares to be
issued by the Buyer
|
4,349,000 G1 Consideration Shares
1,926,000 G2 Consideration Shares
|
(A)
Beneficial Owner
|
(B)
Name and address of Nominee Shareholders
|
Fidelity Mt. Vernon Street Trust: Fidelity Growth Company Fund
|
The Bank of New York (Nominees) Limited of One Piccadilly Gardens, Manchester, M1 1RN
|
Fidelity Select Portfolios: Biotechnology Portfolio
|
BBHISL Nominees Ltd, Acct 122514 of c/o HSBC Bank Plc, 8 Canada Square, London, E14 5HQ, United Kingdom
|
Fidelity Growth Company Commingled Pool
|
BBHISL Nominees Ltd, Acct 130646 of c/o HSBC Bank Plc, 8 Canada Square, London, E14 5HQ, United Kingdom
|
Fidelity Blue Chip Growth Commingled Pool
|
BBHISL Nominees Ltd, Acct 131418 of c/o HSBC Bank Plc, 8 Canada Square, London, E14 5HQ, United Kingdom
|
Fidelity Securities Fund: Fidelity Blue Chip Growth Fund
|
Chase Nominees Limited A/C Fidlend of PO Box 7732, 1 Chaseside, Bournemouth, BH1 9XA, United Kingdom
|
Fidelity Mt. Vernon Street Trust: Fidelity Series Growth Company Fund
|
Mag & Co. FBO Fidelity Series Growth Company Fund of 140 Broadway, New York NY 10005, United States
|
Schroder UK Public Private Trust Plc
|
Nortrust Nominees Limited a/c WIZ02 of 50 Bank Street, London, E14 5NT, United Kingdom
|
Fidelity Advisor Series VII: Fidelity Advisor Biotechnology Fund
|
State Street Nominees Limited a/c 24F3 of Quartermile 3, 10 Nightingale Way, Edinburgh EH3 9EG, United Kingdom
|
Fidelity Securities Fund: Fidelity Series Blue Chip Growth Fund
|
State Street Nominees Limited a/c 24JA of Quartermile 3, 10 Nightingale Way,
|
(A)
Beneficial Owner
|
(B)
Name and address of Nominee Shareholders
|
Edinburgh EH3 9EG, United Kingdom
|
|
Fiam Target Date Blue Chip Growth Commingled Pool
|
State Street Nominees Limited a/c IM86 of Quartermile 3, 10 Nightingale Way, Edinburgh EH3 9EG, United Kingdom
|
EXECUTED for and on behalf of
|
)
|
IMMUNOCORE HOLDINGS LIMITED
|
)
|
acting by a director:
|
)
|
EXECUTED for and on behalf of
|
) |
IMMUNOCORE LIMITED | ) |
acting by a director: | ) |
I. |
Capitalized terms
used herein but not otherwise defined shall have the respective meanings given to them in the Loan Agreement.
|
2. |
Section 6.10 of the Loan Agreement is hereby amended and restated as follows:
|
6.10 |
Non-Borrower Entities. The aggregate value of assets held by Immunocore Ireland shall not at any time exceed the lesser of (i) Ten Million Dollars ($10,000,000.00 ) or
( ii) 10% of Loan Parties' total consolidated assets at such time, and the aggregate assets
held by lmmunocore Nominees shall not at any given time exceed One Million Dollars($1,000,000.00). lmmunocore LLC may not hold assets with an aggregate value in excess of Ten Million Dollars($10,000,000.00 ) a nd lmmunocore Commercial LLC may not hold assets with an aggregate value in excess of Twenty Five Million Dollars($25,000,000.00). Furthermore, none of lmmunocore Ireland. Immunocore Nominees, ImmunocoreLLC, or Immunocore Commercial LLC shall maintain any Intellectual Property.
|
3. |
Parts (k) of the defined term " Permitted Investments" in Section 13.1 of the Loan Agreement arc hereby amended and restated in their entirety to read as follows:
|
"(k) |
(i) Investments by any Borrower in any other in co-borrowers or other Loan Parties that are direct Foreign Subsidiaries of Borrower, (ii) Investments by Subsidiaries in Borrower, (iii)
Investments by Borrower
or the Loan Parties in Immunocore Ireland in an aggregate annual amount not to exceed $10,000,000, (iv) Investments by Borrower or the Loan Parties in Immunocore
Nominees in an aggregate annual amount not to exceed $10,000,000, (v) Investments by Borrower or the Loan Parties in Immunocore LLC and Immunocore Commercial LLC in any given year in an amount sufficient to fund their respective operations in accordance with the then applicable Board approved Annual Projections, and (vi) Investments by any Guarantor that is a parent entity of Borrower or any other Loan Party (a "Parent Guarantor"), in Borrower."
|
4. |
Limitation of Amendments.
|
a. |
The amendments set above are effective for the purposes set forth
herein and shall be limited precisely as written and shall not be deemed to (a) be a consent to
any amendment, waiver or modification
of any other term or condition of any Loan Document, or (b) otherwise prejudice any right, remedy
or obligation which Lenders or Loan Parties may now have or may have in the future under or in connection with any Loan Document, as amended hereby.
|
b. |
This Amendment shall be construed in connection with and as part of the Loan Documents and all terms, conditions, representations, warranties, covenants and agreements set forth in the Loan Documents, except as herein amended, are hereby ratified
and confirmed and shall remain in full force and effect. For the avoidance of doubt, this
Amendment shall be considered part of the Loan Documents.
|
5. |
To induce Collateral Agent and Lenders to enter into this Amendment, Loan Parties hereby represents and warrants to Collateral Agent and Lenders as follows:
|
a. |
Immediately after
giving effect to this Amendment (a) the representations and warranties contained in the Loan Documents are true, accurate and complete in all respects as of the date hereof
(except to the extent such representations and warranties relate to an earlier date, in which case they are true and correct as of such date), and (b) no Event of Default has occurred and is continuing;
|
b. |
Each of the Loan Parties has the power and due authority to execute and deliver
this Amendment and to perform its obligations under the Loan Agreement, as amended by this Amendment;
|
c. |
The organizational documents of Loan Parties delivered to Collateral Agent on the Effective Date, and updated
pursuant to subsequent deliveries by the Loan Parties to the Collateral Agent, and including following and in connection
with the Exchange Transactions, remain true, accurate and complete and have not been amended, supplemented or restated and are and continue to be in full force and effect;
|
d. |
The execution and delivery by Loan
Parties of this Amendment and the performance by each of them of its obligations
under the Loan Agreement, as amended by this Amendment, have been duly authorized;
|
e. |
The execution and delivery by Loan Parties of this Amendment and the performance by each Loan Party of its obligations
under the Loan Agreement, as amended by this Amendment, do not and will not contravene (i) any law or regulation binding on or affecting Borrower,
(ii) any contractual restriction with a
Person binding on such Loan Party, (iii) any order, judgment or decree of any court or other
governmental or public body or authority, or subdivision thereof, binding on
such Loan Party, or
(iv) the organizational documents of such Loan Party;
|
f. |
The execution and delivery by Loan Parties of this Amendment and the performance by each Loan Party of its obligations
under the Loan Agreement, as amended by this Amendment, do not
require any order, consent, approval, license , authorization or validation of, or filing, recording or registration with, or exemption by any governmental or
public body or authority, or subdivision thereof, binding on such Loan Party, except as already has been obtained or made; and
|
g. |
This Amendment has been duly executed and delivered
by each of Loan Party and is the binding obligation of such Loan Party, enforceable against Loan Party in accordance with its terms, except as such enforceability may be limited by
bankruptcy, insolvency, reorganization, liquidation , moratorium or other similar laws of general application and equitable principles relating to or affecting creditors' rights.
|
6. |
Except as expressly
set forth herein, the Loan Agreement shall continue in full force and effect without alteration or amendment. This Amendment
and the Loan Documents represent the entire agreement about this subject matter and supersede prior negotiations or agreements.
|
7. |
This Amendment shall be deemed effective
as of the Second Amendment Date upon (a) the due execution and delivery to Collateral Agent of this Amendment by
each party hereto and (b) Borrower's payment of all Lenders' Expenses
incurred through the date hereof, which may be debited (or ACH'd) from the Designated Deposit Account in accordance with Section 2.3(d) of the Loan Agreement.
|
8. |
Each Loan Party hereby remises, releases,
acquits, satisfies and forever discharges the Lenders and Collateral Agent, their agents, employees, officers, directors, predecessors, attorneys
and all others acting or purporting to act on behalf of or at the direction of the Lenders and Collateral Agent ("Releasees"), of and from any and all manner of actions, causes of action, suit, debts,
accounts, covenants, contracts,
controversies, agreements, variances, damages, judgments, claims and demands whatsoever, in law or in equity, which any of such parties ever
had, now has or, to the extent arising from or in connection with any act,
omission or state of facts taken or existing on or prior to the
date hereof, may have after the date hereof against the Releasees, for, upon or by reason of any matter, cause or thing whatsoever relating to or arising out of the Loan Agreement or the other Loan Documents on or prior to the date hereof through the date hereof. Without limiting the generality of the foregoing,
such Loan Party waives and affirmatively agrees not to allege or otherwise pursue any defenses, affirmative
defenses, counterclaims, claims, causes of action, setoffs or other rights they do, shall or may have as of the date hereof, including the rights to contest relative to the Loan Documents: (a) the right of Collateral Agent and each Lender to exercise its rights and remedies described in the Loan Documents; (b) any provision of this Amendment or the Loan Documents; or (c) any conduct of the Lenders or other Releasees relating to or arising
out of the Loan Agreement or the other Loan Documents on or prior to the date hereof.
|
9. |
This Amendment may be executed in any number of counterparts, each of which shall be deemed an original, and all of which, taken together, shall constitute one and the same instrument.
|
10.
|
This
Amendment and the rights and obligations of the parties hereto shall be governed by and construed in accordance with the laws of the State of New York.
|
By |
/s/ Brian Di Donato |
|
Name: |
Brian Di Donato |
|
Title: |
CEO |
By | /s/ Bahija Jallal |
|
Name: | Bahija Jallal | |
Title: | Dr |
By | /s/ Bahija Jallal |
|
Name: | Bahija Jallal | |
Title: | Dr |
By | /s/ Bahija Jallal |
|
Name: | Bahija Jallal | |
Title: | Dr |
By | ||
Name: | ||
Title: |
By | ||
Name: | ||
Title: |
By | ||
Name: | ||
Title: |
By | ||
Name: | ||
Title: |
By | ||
Name: | ||
Title: |
By | /s/ Laurent BÉLIK /s/ Mélanie FLORSCH | |
Name: | Laurent BÉLIK Mélanie FLORSCH | |
Title: | Manager Manager |
/s/ John Sadler
|
/s/ Claire MacLeod
|
||
Mr J Sadler
|
Mrs C MacLeod
|
||
Authorised Signatory
For and on behalf of
Glaxo Group Limited
Corporate Director
|
Authorised Signatory
For and on behalf of
Edinburgh Pharmaceutical Industries Limited
Corporate Director
|
1. |
I have reviewed this annual report on Form 20-F of Immunocore Holdings plc (the “Company”);
|
2. |
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in
light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3. |
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial
condition, results of operations and cash flows of the Company as of, and for, the periods presented in this report;
|
4. |
The Company’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules
13a-15(e) and 15d-15(e)) for the Company and have:
|
(a) |
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that
material information relating to the Company, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
(b) |
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision,
to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
(c) |
Evaluated the effectiveness of the Company’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of
the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
|
(d) |
Disclosed in this report any change in the Company’s internal control over financial reporting that occurred during the period covered by the annual
report that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting; and
|
5. |
The Company’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the Company’s auditors
and the audit committee of the Company’s board of directors (or persons performing the equivalent functions):
|
(a) |
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely
affect the Company’s ability to record, process, summarize and report financial information; and
|
(b) |
Any fraud, whether or not material, that involves management or other employees who have a significant role in the Company’s internal control over financial reporting.
|
By:
|
/s/ Bahija Jallal, Ph.D.
|
|
Bahija Jallal, Ph.D.
|
||
Chief Executive Officer
|
||
(Principal Executive Officer)
|
1. |
I have reviewed this annual report on Form 20-F of Immunocore Holdings plc (the “Company”);
|
2. |
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3. |
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the
financial condition, results of operations and cash flows of the Company as of, and for, the periods presented in this report;
|
4. |
The Company’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange
Act Rules 13a-15(e) and 15d-15(e)) for the Company and have:
|
(a) |
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material
information relating to the Company, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
(b) |
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide
reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
(c) |
Evaluated the effectiveness of the Company’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure
controls and procedures, as of the end of the period covered by this report based on such evaluation;
|
(d) |
Disclosed in this report any change in the Company’s internal control over financial reporting that occurred during the period covered by the annual report that has
materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting; and
|
5. |
The Company’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the
Company’s auditors and the audit committee of the Company’s board of directors (or persons performing the equivalent functions):
|
(a) |
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely
to adversely affect the Company’s ability to record, process, summarize and report financial information; and
|
(b) |
Any fraud, whether or not material, that involves management or other employees who have a significant role in the Company’s internal control over
financial reporting.
|
By:
|
/s/ Brian Di Donato
|
|
Brian Di Donato
|
||
Chief Financial Officer
|
||
(Principal Financial Officer)
|
(1) |
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and
|
(2) |
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
/s/ Bahija Jallal, Ph.D.
|
||
Chief Executive Officer
|
||
(Principal Executive Officer)
|
/s/ Brian Di Donato
|
||
Chief Financial Officer
|
||
(Principal Financial Officer)
|