Exhibit
No.
|
Description
|
|
Unaudited Condensed Consolidated Interim Financial Statements for the Three and Nine Months Ended September 30, 2021.
|
||
Management’s Discussion and Analysis of Financial Condition and Results of Operations for the Three and Nine Months Ended September 30, 2021.
|
||
Press Release dated November 10, 2021.
|
IMMUNOCORE HOLDINGS PLC
|
||||
Date:
|
November 10, 2021
|
By:
|
/s/ Bahija Jallal, Ph.D.
|
|
Name
|
Bahija Jallal, Ph.D.
|
|||
Title:
|
Chief Executive Officer
|
Page
|
|
Unaudited Condensed Consolidated Statements of Loss and Other Comprehensive Income for the Three and Nine Months Ended September 30, 2021 and 2020
|
2
|
Unaudited Condensed Consolidated Statements of Financial Position as at September 30, 2021 and December 31, 2020
|
3
|
Unaudited Condensed Consolidated Statements of Changes in Equity for the Nine Months Ended September 30, 2021 and 2020
|
4 |
Unaudited Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2021 and 2020
|
5
|
Unaudited Condensed Consolidated Notes to the Financial Statements
|
6
|
Three months ended
September 30,
|
Nine months ended
September 30,
|
|||||||||||||||||||
Notes |
2021
£’000
|
2020
£’000
|
2021
£’000
|
2020
£’000
|
||||||||||||||||
Revenue
|
3
|
5,924
|
6,652
|
19,927
|
22,694
|
|||||||||||||||
Total revenue
|
5,924
|
6,652
|
19,927
|
22,694
|
||||||||||||||||
Net other operating (expense) / income
|
(28
|
)
|
52
|
(70
|
)
|
408
|
||||||||||||||
Research and development costs
|
(16,798
|
)
|
(20,409
|
)
|
(53,154
|
)
|
(57,566
|
)
|
||||||||||||
Administrative expenses
|
4
|
(20,048
|
)
|
(9,714
|
)
|
(64,033
|
)
|
(31,569
|
)
|
|||||||||||
Operating loss
|
(30,950
|
)
|
(23,419
|
)
|
(97,330
|
)
|
(66,033
|
)
|
||||||||||||
Finance income
|
5
|
8
|
367
|
42
|
1,972
|
|||||||||||||||
Finance costs
|
6
|
(1,317
|
)
|
(570
|
)
|
(4,465
|
)
|
(2,272
|
)
|
|||||||||||
Non-operating expense
|
(1,309
|
)
|
(203
|
)
|
(4,423
|
)
|
(300
|
)
|
||||||||||||
Loss before taxation
|
(32,259
|
)
|
(23,622
|
)
|
(101,753
|
)
|
(66,333
|
)
|
||||||||||||
Income tax credit
|
7
|
2,125
|
4,265
|
9,619
|
11,120
|
|||||||||||||||
Loss for the period
|
(30,134
|
)
|
(19,357
|
)
|
(92,134
|
)
|
(55,213
|
)
|
||||||||||||
Other comprehensive (loss) / income
|
||||||||||||||||||||
Other comprehensive (loss) / income that is or may be reclassified to profit or loss in subsequent
periods:
|
||||||||||||||||||||
Exchange differences on translation of foreign operations
|
(38
|
)
|
16
|
(92
|
)
|
338
|
||||||||||||||
Total other comprehensive (loss) / income for the period
|
(38
|
)
|
16
|
(92
|
)
|
338
|
||||||||||||||
Total comprehensive loss for the period
|
(30,172
|
)
|
(19,341
|
)
|
(92,226
|
)
|
(54,875
|
)
|
||||||||||||
Basic and diluted loss per share - £
|
8
|
(0.69
|
)
|
(0.72
|
)
|
(2.19
|
)
|
(2.02
|
)
|
Notes
|
September 30,
2021
£’000
|
December 31,
2020
£’000
|
||||||||||
Non-current assets
|
||||||||||||
Property, plant and equipment
|
9
|
10,043
|
13,754
|
|||||||||
Right of use assets
|
22,772
|
23,093
|
||||||||||
Investment in sub-lease
|
188
|
776
|
||||||||||
Other non-current financial assets
|
5,609
|
4,410
|
||||||||||
Deferred tax asset
|
2,257
|
2,230
|
||||||||||
Total non-current assets
|
40,869
|
44,263
|
||||||||||
Current assets
|
||||||||||||
Trade and other receivables
|
10
|
10,765
|
10,280
|
|||||||||
Tax receivable
|
22,555
|
12,935
|
||||||||||
Cash and cash equivalents
|
256,551
|
129,716
|
||||||||||
Total current assets
|
289,871
|
152,931
|
||||||||||
Total assets
|
330,740
|
197,194
|
||||||||||
Equity
|
||||||||||||
Share capital
|
12
|
88
|
64
|
|||||||||
Share premium
|
12
|
211,930
|
—
|
|||||||||
Foreign currency translation reserve
|
12
|
71
|
163
|
|||||||||
Other reserves
|
12
|
386,167
|
386,167
|
|||||||||
Share-based payment reserve
|
12, 13
|
45,634
|
18,821
|
|||||||||
Accumulated deficit
|
(442,003
|
)
|
(349,869
|
)
|
||||||||
Total equity
|
201,887
|
55,346
|
||||||||||
Non-current liabilities
|
||||||||||||
Interest-bearing loans and borrowings
|
11
|
37,280
|
36,654
|
|||||||||
Deferred revenue
|
3
|
10,681
|
24,868
|
|||||||||
Lease liabilities
|
25,486
|
25,190
|
||||||||||
Provisions
|
81
|
138
|
||||||||||
Total non-current liabilities
|
73,528
|
86,850
|
||||||||||
Current liabilities
|
||||||||||||
Interest-bearing loans and borrowings
|
11
|
546
|
—
|
|||||||||
Trade and other payables
|
14
|
28,815
|
25,728
|
|||||||||
Deferred revenue
|
3
|
24,450
|
27,118
|
|||||||||
Lease liabilities
|
1,369
|
2,043
|
||||||||||
Provisions
|
145
|
109
|
||||||||||
Total current liabilities
|
55,325
|
54,998
|
||||||||||
Total liabilities
|
128,853
|
141,848
|
||||||||||
Total equity and liabilities
|
330,740
|
197,194
|
|
Notes
|
Share
capital
£’000
|
Share
premium
£’000
|
Foreign
currency
translation
reserve
£’000
|
Share-
based
payment
reserve
£’000
|
Other
reserve
£’000
|
Accumulated
deficit
£’000
|
Total
equity
£’000
|
|||||||||||||||||||||||
At January 1, 2021 - adjusted
|
12
|
64
|
—
|
163
|
18,821
|
386,167
|
(349,869
|
)
|
55,346
|
||||||||||||||||||||||
Loss for the period
|
—
|
—
|
—
|
—
|
—
|
(92,134
|
)
|
(92,134
|
)
|
||||||||||||||||||||||
Other comprehensive loss
|
—
|
—
|
(92
|
)
|
—
|
—
|
—
|
(92
|
)
|
||||||||||||||||||||||
Total comprehensive loss for the period
|
—
|
—
|
(92
|
)
|
—
|
—
|
(92,134
|
)
|
(92,226
|
)
|
|||||||||||||||||||||
Issue of share capital
|
12
|
24
|
210,961
|
—
|
—
|
—
|
—
|
210,985
|
|||||||||||||||||||||||
Exercise of share options
|
12
|
—
|
644
|
—
|
—
|
—
|
—
|
644
|
|||||||||||||||||||||||
Equity-settled share-based payment transactions
|
12, 13
|
—
|
325
|
—
|
26,813
|
—
|
—
|
27,138
|
|||||||||||||||||||||||
At September 30, 2021
|
88
|
211,930
|
71
|
45,634
|
386,167
|
(442,003
|
)
|
201,887
|
|
Notes
|
Share
capital
£’000
|
Share
premium
£’000
|
Foreign
currency
translation
reserve
£’000
|
Share-
based
payment
reserve
£’000
|
Other
reserve
£’000
|
Accumulated
deficit
£’000
|
Total
equity
£’000
|
|||||||||||||||||||||||
At January 1, 2020 - adjusted
|
12
|
49
|
—
|
(32
|
)
|
10,659
|
283,201
|
(279,106
|
)
|
14,771
|
|||||||||||||||||||||
Loss for the period
|
—
|
—
|
—
|
—
|
(55,213
|
)
|
(55,213
|
)
|
|||||||||||||||||||||||
Other comprehensive income
|
—
|
—
|
338
|
—
|
—
|
—
|
338
|
||||||||||||||||||||||||
Total comprehensive income / (loss) for the period
|
—
|
—
|
338
|
—
|
—
|
(55,213
|
)
|
(54,875
|
)
|
||||||||||||||||||||||
Conversion of interest-bearing loan
|
—
|
—
|
—
|
—
|
—
|
(510
|
)
|
(510
|
)
|
||||||||||||||||||||||
Derecognition of derivative liability
|
—
|
—
|
—
|
—
|
—
|
3,840
|
3,840
|
||||||||||||||||||||||||
Issue of share capital
|
12
|
6
|
—
|
—
|
—
|
47,135
|
—
|
47,141
|
|||||||||||||||||||||||
Equity-settled share-based payment transactions
|
12, 13
|
—
|
—
|
—
|
5,181
|
—
|
—
|
5,181
|
|||||||||||||||||||||||
At September 30, 2020
|
55
|
—
|
306
|
15,840
|
330,336
|
(330,989
|
)
|
15,548
|
Nine months ended
September 30,
|
||||||||
2021
£’000
|
2020
£’000
|
|||||||
Cash flows from operating activities
|
||||||||
Loss for the period
|
(92,134
|
)
|
(55,213
|
)
|
||||
Adjustments for:
|
||||||||
Depreciation of property, plant and equipment
|
4,194
|
4,527
|
||||||
Depreciation of right of use assets
|
1,100
|
1,926
|
||||||
Remeasurement of right of use assets
|
91
|
199
|
||||||
Loss / (gain) on disposal of property, plant and equipment
|
182
|
(148
|
)
|
|||||
Net finance costs
|
4,423
|
300
|
||||||
Foreign exchange loss
|
320
|
326
|
||||||
Equity settled share-based payment expenses
|
27,138
|
5,181
|
||||||
Income tax credit
|
(9,619
|
)
|
(11,120
|
)
|
||||
Working capital adjustments:
|
||||||||
Increase in trade and other receivables
|
(1,684
|
)
|
(612
|
)
|
||||
Increase / (decrease) in trade and other payables
|
3,085
|
(6,224
|
)
|
|||||
Movement in provisions and other charges
|
(21
|
)
|
(50
|
)
|
||||
Decrease in deferred liabilities
|
(16,853
|
)
|
(18,670
|
)
|
||||
Cash used in operations
|
(79,778
|
)
|
(79,578
|
)
|
||||
Net income tax credit received
|
—
|
38,904
|
||||||
Net cash used in operating activities
|
(79,778
|
)
|
(40,674
|
)
|
||||
Cash flows from investing activities
|
||||||||
Bank interest received on cash and cash equivalents
|
15
|
676
|
||||||
Proceeds from sale of property, plant and equipment
|
64
|
52
|
||||||
Purchase of property, plant and equipment
|
(730
|
)
|
(2,727
|
)
|
||||
Lease capital contribution
|
—
|
1,088
|
||||||
Proceeds from investment in sub-leases
|
549
|
241
|
||||||
Net cash flows used in investing activities
|
(102
|
)
|
(670
|
)
|
||||
Cash flows from financing activities
|
||||||||
Gross proceeds from issue of share capital
|
226,528
|
27,288
|
||||||
Costs from issue of share capital
|
(15,543
|
)
|
(58
|
)
|
||||
Exercise of share options
|
644
|
45
|
||||||
Interest paid on non-current interest-bearing loan
|
(2,473
|
)
|
—
|
|||||
Repayment of lease liabilities
|
(2,465
|
)
|
(3,297
|
)
|
||||
Net cash flows from financing activities
|
206,691
|
23,978
|
||||||
Increase/(decrease) in cash and cash equivalents
|
126,811
|
(17,366
|
)
|
|||||
Net foreign exchange difference on cash held
|
24
|
87
|
||||||
Cash and cash equivalents at beginning of the year
|
129,716
|
73,966
|
||||||
Cash and cash equivalents at end of the period
|
256,551
|
56,687
|
For the three months ended
September 30,
|
For the nine months ended
September 30,
|
|||||||||||||||
2021
£’000
|
2020
£’000
|
2021
£’000
|
2020
£’000
|
|||||||||||||
GSK
|
1,263
|
1,944
|
5,919
|
4,344
|
||||||||||||
Eli Lilly
|
—
|
424
|
—
|
3,522
|
||||||||||||
Genentech
|
4,187
|
4,284
|
13,534
|
14,828
|
||||||||||||
Total collaboration revenue
|
5,450
|
6,652
|
19,453
|
22,694
|
||||||||||||
Pre-product revenue
|
474
|
—
|
474
|
—
|
||||||||||||
Total revenue
|
5,924
|
6,652
|
19,927
|
22,694
|
||||||||||||
|
||||||||||||||||
United Kingdom
|
1,263
|
1,944
|
5,919
|
4,344
|
||||||||||||
United States
|
4,187
|
4,708
|
13,534
|
18,350
|
||||||||||||
European Union
|
474
|
—
|
474
|
—
|
||||||||||||
Total revenue
|
5,924
|
6,652
|
19,927
|
22,694
|
|
At
September 30,
2021
£’000
|
At
December 31,
2020
£’000
|
||||||
Current deferred revenue:
|
||||||||
GSK
|
—
|
2,668
|
||||||
Eli Lilly
|
7,361
|
7,361
|
||||||
Genentech
|
17,089
|
17,089
|
||||||
Current deferred revenue
|
24,450
|
27,118
|
||||||
Non-current deferred revenue:
|
||||||||
GSK
|
—
|
1,371
|
||||||
Genentech
|
10,681
|
23,497
|
||||||
Non-current deferred revenue
|
10,681
|
24,868
|
||||||
Total deferred revenue
|
35,131
|
51,986
|
For the three months ended
September 30,
|
For the nine months ended
September 30,
|
|||||||||||||||
|
2021
£’000
|
2020
£’000
|
2021
£’000
|
2020
£’000
|
||||||||||||
Bank and other interest on cash and cash equivalents
|
2
|
360
|
17
|
660
|
||||||||||||
Interest on investment in sub-lease
|
6
|
7
|
25
|
25
|
||||||||||||
Gain on change in fair value of derivative liability
|
—
|
—
|
—
|
1,287
|
||||||||||||
8
|
367
|
42
|
1,972
|
For the three months ended
September 30,
|
For the nine months ended
September 30,
|
|||||||||||||||
|
2021
£’000
|
2020
£’000
|
2021
£’000
|
2020
£’000
|
||||||||||||
Interest expense on lease liabilities
|
428
|
570
|
1,301
|
1,847
|
||||||||||||
Interest expense on financial liabilities measured at amortized cost
|
889
|
—
|
3,164
|
159
|
||||||||||||
Loss from change in fair value of embedded derivative asset
|
—
|
—
|
—
|
266
|
||||||||||||
1,317
|
570
|
4,465
|
2,272
|
For the three months ended
September 30,
|
For the nine months ended
September 30,
|
|||||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||||
Loss for the period (£’000s)
|
(30,134
|
)
|
(19,357
|
)
|
(92,134
|
)
|
(55,213
|
)
|
||||||||
Basic and diluted weighted average number of shares
|
43,796,084
|
27,024,168
|
42,030,746
|
27,306,935
|
||||||||||||
Basic and diluted loss per share (£) (1)
|
(0.69
|
)
|
(0.72
|
)
|
(2.19
|
)
|
(2.02
|
)
|
|
September 30,
2021
£’000
|
December 31,
2020
£’000
|
||||||
Trade receivables
|
1,674
|
2,051
|
||||||
Other receivables
|
1,112
|
1,722
|
||||||
Prepayments and accrued income
|
7,979
|
6,507
|
||||||
|
10,765
|
10,280
|
|
September 30,
2021
£’000
|
December 31,
2020
£’000
|
||||||
Current interest-bearing loans and borrowings
|
546
|
—
|
||||||
Non-current interest-bearing loans and borrowings
|
37,280
|
36,654
|
||||||
|
37,826
|
36,654
|
Issued share capital (0.2p
per share, except deferred
shares which are 0.01p per
share)
|
Growth
Shares
|
Series A
Shares
|
Series B
Shares
|
Series C Shares
|
Ordinary
Shares
|
Deferred
Shares
|
||||||||||||||||||
At January 1, 2021 – adjusted
|
391
|
—
|
—
|
—
|
31,782,885
|
5,793,501
|
||||||||||||||||||
Repurchased and cancelled
|
(391
|
)
|
—
|
—
|
—
|
—
|
—
|
|||||||||||||||||
New shares issued for cash
|
—
|
—
|
—
|
—
|
12,003,203
|
—
|
||||||||||||||||||
Exercise of share options
|
—
|
—
|
—
|
—
|
55,843
|
—
|
||||||||||||||||||
At September 30, 2021
|
—
|
—
|
—
|
—
|
43,841,931
|
5,793,501
|
Shares at Par Value
|
September 30, 2021
£
|
December 31, 2020
£
|
||||||
Allotted, called up and fully paid
|
||||||||
Ordinary shares
|
87,684
|
268
|
||||||
Series A shares
|
—
|
170
|
||||||
Series B shares
|
—
|
115
|
||||||
Series C shares
|
—
|
82
|
||||||
Growth Shares
|
—
|
6
|
||||||
Deferred shares
|
579
|
—
|
||||||
|
88,263
|
641
|
|
£’000
|
|||
At January 1, 2021 – adjusted
|
—
|
|||
New shares issued for cash
|
210,961
|
|||
Exercise of share options
|
644
|
|||
Equity-settled share-based payment transactions
|
325
|
|||
At September 30, 2021
|
211,930
|
Number of shares issuable
|
Number of share
options (#)
|
Weighted average
exercise price ($)
|
||||||
Outstanding at January 1, 2021
|
4,551,359
|
17.16
|
||||||
Awards granted
|
4,538,527
|
26.19
|
||||||
Awards exercised
|
(55,843
|
)
|
15.88
|
|||||
Awards forfeited
|
(146,801
|
)
|
26.46
|
|||||
Awards replacing Growth Shares
|
312,500
|
38.72
|
||||||
Outstanding at September 30, 2021
|
9,199,742
|
22.28
|
||||||
Exercisable at September 30, 2021
|
2,506,791
|
19.14
|
Number of shares issuable
|
Number of growth
Shares
|
Weighted average
hurdle rate $
|
||||||
Outstanding at January 1, 2021
|
314,456
|
37.53
|
||||||
Awards forfeited
|
(1,956
|
)
|
40.95
|
|||||
Awards replaced with options
|
(312,500
|
)
|
37.48
|
|||||
Outstanding at September 30, 2021
|
—
|
—
|
||||||
Exercisable at September 30, 2021
|
—
|
—
|
Share options
|
||||||||||||
Exercise price $
|
Number of
Options
|
Weighted average
remaining
contractual life
|
||||||||||
11.83
|
444,220
|
3.4
|
||||||||||
17.46
|
3,934,055
|
8.7
|
||||||||||
26.00
|
4,487,795
|
9.3
|
||||||||||
32.98
|
16,545
|
4.3
|
||||||||||
39.02
|
4,000
|
9.8
|
||||||||||
40.93
|
123,850
|
7.4
|
||||||||||
41.74
|
52,432
|
9.5
|
||||||||||
46.38
|
136,845
|
4.3
|
|
February
2021
|
April
2021
|
July
2021
|
|||||||||
Share price at grant date
|
$
|
26.00
|
$
|
41.74
|
$
|
39.02
|
||||||
Exercise price
|
$
|
26.00
|
$
|
41.74
|
$
|
39.02
|
||||||
Expected volatility
|
88
|
%
|
89
|
%
|
85
|
%
|
||||||
Expected life
|
4 years
|
4 years
|
4 years
|
|||||||||
Risk-free rate
|
(0.05
|
%)
|
0.25
|
%
|
0.26
|
%
|
||||||
Fair value
|
$
|
16.16
|
$
|
26.18
|
$
|
23.69
|
September 30,
2021
£’000
|
December 31,
2020
£’000
|
|||||||
Trade payables
|
4,458
|
5,783
|
||||||
Other taxation and social security
|
778
|
620
|
||||||
Accruals
|
23,579
|
19,325
|
||||||
28,815
|
25,728
|
£’000s
|
Less than
1 year
|
1-3
years
|
3-5
Years
|
More than
5 years
|
Total | |||||||||||||||
Lease liabilities – existing
|
2,955
|
5,454
|
4,621
|
30,740
|
43,770
|
|||||||||||||||
Lease liabilities – contingent
|
564
|
2,362
|
2,365
|
1,275
|
6,566
|
|||||||||||||||
Manufacturing
|
2,615
|
589
|
—
|
—
|
3,204
|
|||||||||||||||
Capital commitments
|
229
|
—
|
—
|
—
|
229
|
|||||||||||||||
Total contractual obligations
|
6,363
|
8,405
|
6,986
|
32,015
|
53,769
|
£’000s
|
Less than
1 year
|
1-3
years
|
3-5
Years
|
More than
5 years
|
Total | |||||||||||||||
Lease liabilities – existing
|
3,529
|
5,322
|
4,286
|
32,600
|
45,737
|
|||||||||||||||
Lease liabilities – contingent
|
—
|
2,254
|
2,471
|
1,841
|
6,566
|
|||||||||||||||
Manufacturing
|
2,824
|
500
|
—
|
—
|
3,324
|
|||||||||||||||
Capital commitments
|
77
|
—
|
—
|
—
|
77
|
|||||||||||||||
Total contractual obligations
|
6,430
|
8,076
|
6,757
|
34,441
|
55,704
|
• |
Tebentafusp, our ImmTAC molecule targeting an HLA-A*02:01 gp100 antigen, demonstrated monotherapy
activity and achieved the primary endpoint of superior overall survival in a randomized Phase 3 clinical trial in patients with previously untreated metastatic uveal melanoma. The OS Hazard Ratio (HR) 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; 12% ipilimumab; 6% dacarbazine). The FDA accepted the submission of the BLA, in the third quarter of 2021. The FDA will review
the BLA for tebentafusp (IMCgp100) under the Real-Time Oncology Review (RTOR) 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.
Tebentafusp is also being reviewed under the FDA’s Project Orbis initiative, which enables concurrent review by the health authorities in partner countries that have requested participation. The EMA, the United
Kingdom’s Medicines and Healthcare Regulatory Agency, or MHRA, and the Australian Government of Health have accepted the submission of the MAA. Over 150 patients have accessed tebentafusp through the global early access program
across 14 countries.
|
• |
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. As of June 30, 2021, we have enrolled 39 patients in the Phase 1
study. Early pharmacodynamic data indicate that IMC-C103C monotherapy is demonstrating biological activity at the doses currently under evaluation. We will report Phase 1 initial data from the trial at the onsite and online European Society
of Medical Oncology Immuno-Oncology (ESMO IO) Congress in December 2021. The company will host an investor call on December 6th that will be accessible via the ‘Investor Relations’ section of the Company’s website.
|
• |
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. PRAME is overexpressed in many solid tumors including NSCLC, SCLC, endometrial, ovarian, melanoma, and breast cancers. As of June 30, 2021, we have enrolled 23
patients in the Phase 1 study. 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
mid-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 in our Phase 1 single ascending dose, or SAD, trial in the second quarter of 2021.
|
• |
IMC-M113V, our ImmTAV molecule targeting a human immunosuppression virus, or HIV, gag antigen bispecific TCR molecule, is
currently in pre-clinical development. We anticipate regulatory submission to enable clinical testing during the second half of 2021.
|
• |
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.
|
Three Months Ended September 30, | ||||||||||||
2021 |
2020 | |||||||||||
|
$’000
|
£’000
|
£’000
|
|||||||||
Revenue
|
7,980
|
5,924
|
6,652
|
|||||||||
Research and development expenses
|
(22,627
|
)
|
(16,798
|
)
|
(20,409
|
)
|
||||||
Administrative expenses
|
(27,005
|
)
|
(20,048
|
)
|
(9,714
|
)
|
||||||
Net other operating (loss) income
|
(38
|
)
|
(28
|
)
|
52
|
|||||||
Operating loss
|
(41,690
|
)
|
(30,950
|
)
|
(23,419
|
)
|
||||||
Finance income
|
11
|
8
|
367
|
|||||||||
Finance costs
|
(1,774
|
)
|
(1,317
|
)
|
(570
|
)
|
||||||
Non-operating expense
|
(1,763
|
)
|
(1,309
|
)
|
(203
|
)
|
||||||
Loss before taxes
|
(43,453
|
)
|
(32,259
|
)
|
(23,622
|
)
|
||||||
Income tax credit
|
2,862
|
2,125
|
4,265
|
|||||||||
Loss for the period
|
(40,591
|
)
|
(30,134
|
)
|
(19,357
|
)
|
Three Months Ended September 30, | ||||||||||||
2021 | 2020 | |||||||||||
$’000 | £’000 | £’000 | ||||||||||
GSK
|
1,701
|
1,263
|
1,944
|
|||||||||
Eli Lilly
|
—
|
—
|
424
|
|||||||||
Genentech
|
5,640
|
4,187
|
4,284
|
|||||||||
Total collaboration revenue
|
7,341
|
5,450
|
6,652
|
|||||||||
Pre-product revenue
|
639
|
474
|
—
|
|||||||||
Total revenue
|
7,980
|
5,924
|
6,652
|
Three Months Ended September 30,
|
||||||||||||
2021 | 2020 | |||||||||||
$’000 | £’000 | £’000 | ||||||||||
External research and development expenses:
|
||||||||||||
Tebentafusp
|
6,262
|
4,649
|
9,306
|
|||||||||
IMC-F106C (PRAME)
|
2,311
|
1,715
|
350
|
|||||||||
IMC-C103C (MAGE-A4)
|
2,185
|
1,622
|
1,710
|
|||||||||
IMC-I109V(HBV)
|
101
|
75
|
1,549
|
|||||||||
Other programs
|
2,458
|
1,825
|
1,685
|
|||||||||
Research expenses
|
125
|
93
|
116
|
|||||||||
Total external research and development expenses
|
13,442
|
9,979
|
14,716
|
|||||||||
Internal research and development expenses:
|
||||||||||||
Headcount related expenses
|
7,070
|
5,249
|
4,007
|
|||||||||
Laboratory consumables
|
1,340
|
995
|
1,227
|
|||||||||
Laboratory equipment expenses
|
753
|
559
|
448
|
|||||||||
Other
|
22
|
16
|
11
|
|||||||||
Total internal research and development expenses
|
9,185
|
6,819
|
5,693
|
|||||||||
Total research and development expenses
|
22,627
|
16,798
|
20,409
|
• |
a share based payment charge of £8.2 million, an increase of £6.4 million as a result of share option arrangements in connection with our IPO;
|
• |
other staff related expenses of £3.9 million, an increase of £0.9 million;
|
• |
pre-commercial expenditure related to tebentafusp of £5.1 million, an increase of £4.8 million;
|
• |
legal and professional fees of £2.5 million, an increase of £1.3 million primarily attributable to additional costs incurred as a result of being a public company;
|
• |
depreciation of property, plant and equipment of £1.7 million, an increase of £0.5 million;
|
• |
other corporate costs of £1.9 million, an increase of £0.3 million due to higher internal infrastructure expenditure; and
|
• |
favourable foreign exchange movements of £3.3 million in the three months ended September 30, 2021, compared with unfavorable movements of £0.6 million for the same period in the prior year, a decrease of £3.9
million.
|
Nine Months Ended September 30, | ||||||||||||
2021 | 2020 | |||||||||||
$’000 | £’000 | £’000 | ||||||||||
Revenue
|
26,842 | 19,927 |
22,694
|
|||||||||
Research and development expenses
|
(71,598
|
)
|
(53,154
|
)
|
(57,566
|
)
|
||||||
Administrative expenses
|
(86,252
|
)
|
(64,033
|
)
|
(31,569
|
)
|
||||||
Net other operating (expense) / income
|
(94
|
)
|
(70
|
)
|
408
|
|||||||
Operating loss
|
(131,102
|
)
|
(97,330
|
)
|
(66,033
|
)
|
||||||
Finance income
|
57
|
42 |
1,972
|
|||||||||
Finance costs
|
(6,014
|
)
|
(4,465
|
)
|
(2,272
|
)
|
||||||
Non-operating expense
|
(5,957
|
)
|
(4,423 | ) |
(300
|
)
|
||||||
Loss before taxes
|
(137,059
|
)
|
(101,753
|
)
|
(66,333
|
)
|
||||||
Income tax credit
|
12,957
|
9,619 |
11,120
|
|||||||||
Loss for the period
|
(124,102
|
)
|
(92,134
|
)
|
(55,213
|
)
|
Nine Months Ended September 30, | ||||||||||||
2021 | 2020 | |||||||||||
$’000 |
£’000
|
£’000
|
||||||||||
GSK
|
7,973
|
5,919
|
4,344
|
|||||||||
Eli Lilly
|
—
|
—
|
3,522
|
|||||||||
Genentech
|
18,230
|
13,534
|
14,828
|
|||||||||
Total collaboration revenue
|
26,203
|
19,453
|
22,694
|
|||||||||
Pre-product revenue
|
639
|
474
|
—
|
|||||||||
Total
|
26,842
|
19,927
|
22,694
|
Nine Months Ended September 30, | ||||||||||||
2021 | 2020 | |||||||||||
$’000 | £’000 | £’000 | ||||||||||
External research and development expenses:
|
||||||||||||
Tebentafusp
|
24,521
|
18,204
|
26,901
|
|||||||||
IMC-F106C (PRAME)
|
5,249
|
3,897
|
1,254
|
|||||||||
IMC-C103C (MAGE-A4)
|
4,807
|
3,569
|
3,602
|
|||||||||
IMC-I109V(HBV)
|
1,875
|
1,392
|
2,396
|
|||||||||
Other programs
|
7,612
|
5,651
|
4,160
|
|||||||||
Research expenses
|
396
|
294
|
415
|
|||||||||
Total external research and development expenses
|
44,460
|
33,007
|
38,728
|
|||||||||
Internal research and development expenses:
|
||||||||||||
Headcount related expenses
|
21,211
|
15,747
|
14,325
|
|||||||||
Laboratory consumables
|
4,040
|
2,999
|
3,250
|
|||||||||
Laboratory equipment expenses
|
1,856
|
1,378
|
1,201
|
|||||||||
Other
|
31
|
23
|
62
|
|||||||||
Total internal research and development expenses
|
27,138
|
20,147
|
18,838
|
|||||||||
Total research and development expenses
|
71,598
|
53,154
|
57,566
|
• |
a share based payment charge of £24.4 million which has increased by £19.3 million compared to the comparative period;
|
• |
other employee related expenses of £10.9 million, a decrease of £1.7 million;
|
• |
pre-commercial expenditure related to tebentafusp of £11.2 million, an increase of £10.4 million;
|
• |
legal and professional fees of £7.6 million, an increase of £4.7 million primarily attributable to the IPO and additional costs incurred as a result of being a public company;
|
• |
depreciation of property, plant and equipment of £5.3 million, a decrease of £0.5 million;
|
• |
other corporate costs of £5.7 million, an increase of £0.6 million reflecting higher infrastructure costs; and
|
• |
favourable foreign exchange movements of £1.1 million, compared to £0.7 million in the comparative period, a decrease of £0.4 million
|
Nine Months Ended September 30, | ||||||||||||
2021 | 2021 | 2020 | ||||||||||
$’000 | £’000 | £’000 | ||||||||||
(unaudited)
|
||||||||||||
Cash and cash equivalents at beginning of year
|
174,727
|
129,716
|
73,966
|
|||||||||
Net cash flows used in operating activities
|
(107,461
|
)
|
(79,778
|
)
|
(40,674
|
)
|
||||||
Net cash flows used in investing activities
|
(137
|
)
|
(102
|
)
|
(670
|
)
|
||||||
Net cash flows from financing activities
|
278,413
|
206,691
|
23,978
|
|||||||||
Net foreign exchange difference on cash held
|
32
|
24
|
87
|
|||||||||
Cash and cash equivalents at end of period
|
345,574
|
256,551
|
56,687
|
• |
continue to advance our clinical trials and the development of our 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 product candidates;
|
• |
establish a sales, marketing and distribution infrastructure to 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 our product candidates, if approved;
|
• |
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.
|
Three Months Ended September 30, | ||||||||||||
2021 | 2020 | |||||||||||
$’000 | £’000 | £’000 | ||||||||||
Revenue
|
7,980 | 5,924 |
6,652
|
|||||||||
Research and development expenses
|
(22,627
|
)
|
(16,798
|
)
|
(20,409
|
)
|
||||||
Administrative expenses
|
(27,005
|
)
|
(20,048
|
)
|
(9,714
|
)
|
||||||
Net other operating (loss) income
|
(38
|
)
|
(28
|
)
|
52
|
|||||||
Operating loss
|
(41,690
|
)
|
(30,950
|
)
|
(23,419
|
)
|
||||||
Finance income
|
11
|
8
|
367
|
|||||||||
Finance costs
|
(1,774
|
)
|
(1,317
|
)
|
(570
|
)
|
||||||
Non-operating expense
|
(1,763
|
)
|
(1,309
|
)
|
(203
|
)
|
||||||
Loss before taxes
|
(43,453
|
)
|
(32,259
|
)
|
(23,622
|
)
|
||||||
Income tax credit
|
2,862
|
2,125
|
4,265
|
|||||||||
Loss for the period
|
(40,591
|
)
|
(30,134
|
)
|
(19,357
|
)
|
Nine Months Ended September 30,
|
||||||||||||
2021 |
2020
|
|||||||||||
$’000
|
£’000
|
£’000
|
||||||||||
Revenue
|
26,842 | 19,927 |
22,694
|
|||||||||
Research and development expenses
|
(71,598
|
)
|
(53,154
|
)
|
(57,566
|
)
|
||||||
Administrative expenses
|
(86,252
|
)
|
(64,033
|
)
|
(31,569
|
)
|
||||||
Net other operating (expense) / income
|
(94
|
)
|
(70
|
)
|
408
|
|||||||
Operating loss
|
(131,102
|
)
|
(97,330
|
)
|
(66,033
|
)
|
||||||
Finance income
|
57
|
42
|
1,972
|
|||||||||
Finance costs
|
(6,014
|
)
|
(4,465
|
)
|
(2,272
|
)
|
||||||
Non-operating expense
|
(5,957
|
)
|
(4,423
|
)
|
(300
|
)
|
||||||
Loss before taxes
|
(137,059
|
)
|
(101,753
|
)
|
(66,333
|
)
|
||||||
Income tax credit
|
12,957
|
9,619
|
11,120
|
|||||||||
Loss for the period
|
(124,102
|
)
|
(92,134
|
)
|
(55,213
|
)
|
Nine Months Ended September 30,
|
||||||||||||
2021 |
2021
|
2020
|
||||||||||
$’000
|
£’000
|
£’000
|
||||||||||
|
(unaudited)
|
|||||||||||
Cash and cash equivalents at beginning of year
|
174,727
|
129,716
|
73,966
|
|||||||||
Net cash flows used in operating activities
|
(107,461
|
)
|
(79,778
|
)
|
(40,674
|
)
|
||||||
Net cash flows used in investing activities
|
(137
|
)
|
(102
|
)
|
(670
|
)
|
||||||
Net cash flows from financing activities
|
278,413
|
206,691
|
23,978
|
|||||||||
Net foreign exchange difference on cash held
|
32
|
24
|
87
|
|||||||||
Cash and cash equivalents at end of period
|
345,574
|
256,551
|
56,687
|
|
September 30,
2021
£’000
|
December 31,
2020
£’000
|
||||||
Non-current assets
|
||||||||
Property, plant and equipment
|
10,043
|
13,754
|
||||||
Right of use assets
|
22,772
|
23,093
|
||||||
Investment in sub-lease
|
188
|
776
|
||||||
Other non-current financial assets
|
5,609
|
4,410
|
||||||
Deferred tax asset
|
2,257
|
2,230
|
||||||
Total non-current assets
|
40,869
|
44,263
|
||||||
Current assets
|
||||||||
Trade and other receivables
|
10,765
|
10,280
|
||||||
Tax receivable
|
22,555
|
12,935
|
||||||
Cash and cash equivalents
|
256,551
|
129,716
|
||||||
Total current assets
|
289,871
|
152,931
|
||||||
Total assets
|
330,740
|
197,194
|
||||||
Equity
|
||||||||
Share capital
|
88
|
64
|
||||||
Share premium
|
211,930
|
—
|
||||||
Foreign currency translation reserve
|
71
|
163
|
||||||
Other reserves
|
386,167
|
386,167
|
||||||
Share-based payment reserve
|
45,634
|
18,821
|
||||||
Accumulated deficit
|
(442,003
|
)
|
(349,869
|
)
|
||||
Total equity
|
201,887
|
55,346
|
||||||
Non-current liabilities
|
||||||||
Interest-bearing loans and borrowings
|
37,280
|
36,654
|
||||||
Deferred revenue
|
10,681
|
24,868
|
||||||
Lease liabilities
|
25,486
|
25,190
|
||||||
Provisions
|
81
|
138
|
||||||
Total non-current liabilities
|
73,528
|
86,850
|
||||||
Current liabilities
|
||||||||
Interest-bearing loans and borrowings
|
546
|
—
|
||||||
Trade and other payables
|
28,815
|
25,728
|
||||||
Deferred revenue
|
24,450
|
27,118
|
||||||
Lease liabilities
|
1,369
|
2,043
|
||||||
Provisions
|
145
|
109
|
||||||
Total current liabilities
|
55,325
|
54,998
|
||||||
Total liabilities
|
128,853
|
141,848
|
||||||
Total equity and liabilities
|
330,740
|
197,194
|