Exhibit
No.
|
Description
|
|
Unaudited Condensed Consolidated Interim Financial Statements for the Three Months Ended March 31, 2021.
|
||
Management’s Discussion and Analysis of Financial Condition and Results of Operations for the Three Months Ended March 31, 2021.
|
||
Press Release dated May 12, 2021.
|
IMMUNOCORE HOLDINGS PLC
|
||||
Date:
|
May 12, 2021
|
By:
|
/s/ Bahija Jallal, Ph.D.
|
|
Name
|
Bahija Jallal, Ph.D.
|
|||
Title:
|
Chief Executive Officer
|
Page
|
|
2
|
|
3
|
|
4 | |
5 | |
6 |
Notes
|
2021
£’000
|
2020
£’000
|
||||||||
Revenue
|
3
|
8,270
|
8,255
|
|||||||
Total revenue
|
8,270
|
8,255
|
||||||||
|
||||||||||
Net other operating (expense) / income
|
(82
|
)
|
10
|
|||||||
Research and development costs
|
(19,885
|
)
|
(20,779
|
)
|
||||||
Administrative expenses
|
(20,184
|
)
|
(9,605
|
)
|
||||||
Operating loss
|
(31,881
|
)
|
(22,119
|
)
|
||||||
|
||||||||||
Finance income
|
4
|
22
|
1,383
|
|||||||
Finance costs
|
5
|
(1,860
|
)
|
(1,067
|
)
|
|||||
Non-operating (expense) / income
|
(1,838
|
)
|
316
|
|||||||
|
||||||||||
Loss before taxation
|
(33,719
|
)
|
(21,803
|
)
|
||||||
Income tax credit
|
6
|
4,681
|
3,164
|
|||||||
Loss for the period
|
(29,038
|
)
|
(18,639
|
)
|
||||||
|
||||||||||
Other comprehensive income
|
|
|||||||||
Other comprehensive income that are or may be reclassified to profit or loss in subsequent periods (net of tax):
|
|
|||||||||
Exchange differences on translation of foreign operations
|
(92
|
)
|
367
|
|||||||
Total other comprehensive (loss) / income for the period, net of tax
|
(92
|
)
|
367
|
|||||||
|
||||||||||
Total comprehensive loss for the period, net of tax
|
(29,130
|
)
|
(18,272
|
)
|
||||||
Basic and diluted loss per share - £
|
7
|
(0.76
|
)
|
(0.74
|
)
|
Notes
|
March 31,
2021
£’000
|
December 31,
2020
£’000
|
|||||||||
Non-current assets
|
|||||||||||
Property, plant and equipment
|
8
|
12,321
|
13,754
|
||||||||
Right of use assets
|
9
|
22,742
|
23,093
|
||||||||
Investment in sub-lease
|
540
|
776
|
|||||||||
Other non-current financial assets
|
3,812
|
4,410
|
|||||||||
Deferred tax asset
|
2,213
|
2,230
|
|||||||||
Total non-current assets
|
41,628
|
44,263
|
|||||||||
Current assets
|
|||||||||||
Trade and other receivables
|
10
|
8,821
|
10,280
|
||||||||
Tax receivable
|
17,615
|
12,935
|
|||||||||
Cash and cash equivalents
|
313,083
|
129,716
|
|||||||||
Total current assets
|
339,519
|
152,931
|
|||||||||
Total assets
|
381,147
|
197,194
|
|||||||||
Equity
|
|||||||||||
Share capital
|
12
|
88
|
64
|
||||||||
Share premium
|
12
|
211,286
|
-
|
||||||||
Foreign currency translation reserve
|
12
|
71
|
163
|
||||||||
Other reserves
|
12
|
386,167
|
386,167
|
||||||||
Share-based payment reserve
|
12, 13
|
27,092
|
18,821
|
||||||||
Accumulated deficit
|
(378,907
|
)
|
(349,869
|
)
|
|||||||
Total equity
|
245,797
|
55,346
|
|||||||||
Non-current liabilities
|
|||||||||||
Interest-bearing loans and borrowings
|
11
|
36,437
|
36,654
|
||||||||
Deferred liabilities
|
19,225
|
24,868
|
|||||||||
Lease liabilities
|
9
|
25,035
|
25,190
|
||||||||
Provisions
|
160
|
138
|
|||||||||
Total non-current liabilities
|
80,857
|
86,850
|
|||||||||
Current liabilities
|
|||||||||||
Interest-bearing loans and borrowings
|
11
|
546
|
---
|
||||||||
Trade and other payables
|
14
|
26,359
|
25,728
|
||||||||
Deferred liabilities
|
25,710
|
27,118
|
|||||||||
Lease liabilities
|
9
|
1,764
|
2,043
|
||||||||
Provisions
|
114
|
109
|
|||||||||
Total current liabilities
|
54,493
|
54,998
|
|||||||||
Total liabilities
|
135,350
|
141,848
|
|||||||||
Total equity and liabilities
|
381,147
|
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 December 31, 2019
|
—
|
283,250
|
(32
|
)
|
10,659
|
-
|
(279,106
|
)
|
14,771
|
|||||||||||||||||||||||
Effects of the corporate reorganization
|
12
|
49
|
(283,250
|
)
|
-
|
-
|
283,201
|
-
|
-
|
|||||||||||||||||||||||
At January 1, 2020
|
49
|
-
|
(32
|
)
|
10,659
|
283,201
|
(279,106
|
)
|
14,771
|
|||||||||||||||||||||||
Loss for the period
|
-
|
-
|
-
|
-
|
-
|
(18,639
|
)
|
(18,639
|
)
|
|||||||||||||||||||||||
Other comprehensive income
|
-
|
-
|
367
|
-
|
-
|
-
|
367
|
|||||||||||||||||||||||||
Total comprehensive income / (loss) for the period
|
-
|
-
|
367
|
-
|
-
|
(18,639
|
)
|
(18,272
|
)
|
|||||||||||||||||||||||
Conversion of interest-bearing loan
|
-
|
-
|
-
|
-
|
-
|
(510
|
)
|
(510
|
)
|
|||||||||||||||||||||||
Derecognition of derivative liability
|
-
|
-
|
-
|
-
|
-
|
3,840
|
3,840
|
|||||||||||||||||||||||||
Issue of share capital
|
12
|
6
|
- |
-
|
-
|
47,095
|
-
|
47,101
|
||||||||||||||||||||||||
Equity-settled share-based payment transactions
|
12, 13
|
-
|
-
|
-
|
205
|
-
|
-
|
205
|
||||||||||||||||||||||||
At March 31, 2020
|
55
|
-
|
335
|
10,864
|
330,296
|
(294,415
|
)
|
47,135
|
||||||||||||||||||||||||
As at January 1, 2021
|
64
|
-
|
163
|
18,821
|
386,167
|
(349,869
|
)
|
55,346
|
||||||||||||||||||||||||
Loss for the period
|
-
|
-
|
-
|
-
|
-
|
(29,038
|
)
|
(29,038
|
)
|
|||||||||||||||||||||||
Other comprehensive loss
|
-
|
-
|
(92
|
)
|
-
|
-
|
-
|
(92
|
)
|
|||||||||||||||||||||||
Total comprehensive loss for the period
|
-
|
-
|
(92
|
)
|
-
|
-
|
(29,038
|
)
|
(29,130
|
)
|
||||||||||||||||||||||
Issue of share capital
|
12
|
24
|
210,961
|
-
|
- | - | - |
210,985
|
||||||||||||||||||||||||
Equity-settled share-based payment transactions
|
12, 13
|
-
|
325
|
-
|
8,271
|
-
|
-
|
8,596
|
||||||||||||||||||||||||
At March 31, 2021
|
88
|
211,286
|
71
|
27,092
|
386,167
|
(378,907
|
)
|
245,797
|
2021
£’000
|
2020
£’000
|
|||||||
Cash flows from operating activities
|
||||||||
Loss for the period
|
(29,038
|
)
|
(18,639
|
)
|
||||
Adjustments for:
|
||||||||
Depreciation of property, plant and equipment
|
1,460
|
1,592
|
||||||
Depreciation of right of use assets
|
347
|
649
|
||||||
Loss on disposal of property, plant and equipment
|
191
|
23
|
||||||
Net finance costs/(income)
|
1,838
|
(316
|
)
|
|||||
Movement in provisions and other charges
|
28
|
1,878
|
||||||
Foreign exchange translation differences
|
(368
|
)
|
245
|
|||||
Equity settled share-based payment expenses
|
8,596
|
205
|
||||||
Income tax credit
|
(4,681
|
)
|
(3,164
|
)
|
||||
Working capital adjustments:
|
||||||||
(Increase)/decrease in trade and other receivables
|
2,068
|
(279
|
)
|
|||||
(Decrease)/increase in trade and other payables
|
631
|
(5,049
|
)
|
|||||
(Decrease)/increase in deferred liabilities
|
(7,051
|
)
|
(7,663
|
)
|
||||
Net cash used in operating activities
|
(25,979
|
)
|
(30,518
|
)
|
||||
Cash flows from investing activities
|
||||||||
Proceeds from sale of property, plant and equipment
|
-
|
14
|
||||||
Purchase of property, plant and equipment
|
(220
|
)
|
(1,426
|
)
|
||||
Proceeds from investment in sub-leases
|
245
|
78
|
||||||
Net cash flows used in investing activities
|
25
|
(1,334
|
)
|
|||||
Cash flows from financing activities
|
||||||||
Proceeds from exercise of share options
|
-
|
4
|
||||||
Gross proceeds from issue of share capital
|
226,528
|
27,288
|
||||||
Costs from issue of share capital
|
(15,543
|
)
|
(58
|
)
|
||||
Interest paid on non-current interest-bearing loan
|
(810
|
)
|
-
|
|||||
Repayment of lease liabilities
|
(802
|
)
|
(1,085
|
)
|
||||
Net cash flows from financing activities
|
209,373
|
26,149
|
||||||
Increase/(decrease) in net cash and cash equivalents
|
183,419
|
(5,703
|
)
|
|||||
Net foreign exchange difference on cash held
|
(52
|
)
|
114
|
|||||
Cash and cash equivalents at beginning of the period
|
129,716
|
73,966
|
||||||
Cash and cash equivalents at end of the period
|
313,083
|
68,377
|
For the three
months ended
March 31,
2021
£’000
|
For the three
months ended
March 31,
2020
£’000
|
|||||||
GlaxoSmithKline
|
3,370
|
695
|
||||||
Eli Lilly
|
-
|
2,674
|
||||||
Genentech
|
4,900
|
4,886
|
||||||
8,270
|
8,255
|
|||||||
United Kingdom
|
3,370
|
695
|
||||||
United States
|
4,900
|
7,560
|
||||||
8,270
|
8,255
|
At
March 31,
2021
£’000
|
At
December 31,
2020
£’000
|
|||||||
Current deferred revenue:
|
||||||||
GlaxoSmithKline
|
1,260
|
2,668
|
||||||
Eli Lilly
|
7,361
|
7,361
|
||||||
Genentech
|
17,089
|
17,089
|
||||||
Current deferred revenue
|
25,710
|
27,118
|
||||||
Non-current deferred revenue:
|
||||||||
GlaxoSmithKline
|
-
|
1,371
|
||||||
Eli Lilly
|
-
|
-
|
||||||
Genentech
|
19,225
|
23,497
|
||||||
Non-current deferred revenue
|
19,225
|
24,868
|
||||||
Total deferred revenue
|
44,935
|
51,986
|
For the three
months ended
March 31, 2021
£’000
|
For the three
months ended
March 31, 2020
£’000
|
|||||||
Bank interest on cash and cash equivalents
|
11
|
86
|
||||||
Interest on investment in sub-lease
|
11
|
10
|
||||||
Gain on change in fair value of derivative liability
|
-
|
1,287
|
||||||
22
|
1,383
|
For the three
months ended
March 31, 2021
£’000
|
For the three
months ended
March 31, 2020
£’000
|
|||||||
Interest on lease liabilities
|
439
|
642
|
||||||
Interest expenses on financial liabilities measured at amortized cost
|
1,421
|
159
|
||||||
Loss from change in fair value of embedded derivative asset
|
-
|
266
|
||||||
1,860
|
1,067
|
For the three
months ended
March 31,
2021
|
For the three
months ended
March 31,
2020
|
|||||||
Loss for the period (£000’s)
|
(29,038
|
)
|
(18,639
|
)
|
||||
Basic and diluted weighted average number of shares
|
38,451,332
|
25,263,027
|
||||||
Basic and diluted loss per share (£) (1)
|
(0.76
|
)
|
(0.74
|
)
|
March 31,
2021
£’000
|
December 31,
2020
£’000
|
|||||||
Current
|
1,764
|
2,043
|
||||||
Non-current
|
25,035
|
25,190
|
||||||
Total lease liabilities
|
26,799
|
27,233
|
March 31,
2021
£’000
|
December 31,
2020
£’000
|
|||||||
Trade receivables
|
687
|
2,051
|
||||||
Other receivables
|
1,121
|
1,722
|
||||||
Prepayments and accrued income
|
7,013
|
6,507
|
||||||
8,821
|
10,280
|
March 31,
2021
£’000
|
December 31,
2020
£’000
|
|||||||
Current interest-bearing loans and borrowings
|
546
|
-
|
||||||
Non-current interest-bearing loans and borrowings
|
36,437
|
36,654
|
||||||
36,983
|
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
|
62,891
|
1,699,576
|
1,148,703
|
823,719
|
2,679,764
|
-
|
||||||||||||||||||
Impact of corporate reorganization
|
(62,500
|
)
|
(1,699,576
|
)
|
(1,148,703
|
)
|
(823,719
|
)
|
29,103,121
|
5,793,501
|
||||||||||||||
At January 1, 2021 – adjusted
|
391
|
-
|
-
|
-
|
31,782,885
|
5,793,501
|
||||||||||||||||||
Repurchased and cancelled
|
(391
|
)
|
-
|
-
|
-
|
-
|
-
|
|||||||||||||||||
New shares issued for cash
|
-
|
-
|
-
|
-
|
12,003,203
|
-
|
||||||||||||||||||
At March 31, 2021
|
- | - | - | - |
43,786,088
|
5,793,501
|
Shares at Par Value
|
March 31, 2021
£
|
December 31, 2020
£
|
||||||
Allotted, called up and fully paid
|
||||||||
Ordinary shares
|
87,572
|
268
|
||||||
Series A shares
|
- |
170
|
||||||
Series B shares
|
- |
115
|
||||||
Series C shares
|
- |
82
|
||||||
Growth shares
|
- |
6
|
||||||
Deferred shares
|
579
|
-
|
||||||
88,151
|
641
|
|
£’000
|
|||
At January 1, 2021 – adjusted
|
-
|
|||
New shares issued for cash
|
210,961
|
|||
Equity-settled share-based payment transactions
|
325
|
|||
At March 31, 2021
|
211,286
|
Number of shares issuable
|
Number of share
options (#)
|
Weighted average
exercise price ($)
|
||||||
Outstanding at January 1, 2021
|
4,551,359
|
17.16
|
||||||
Awards granted
|
4,482,045
|
26.00
|
||||||
Awards exercised
|
-
|
-
|
||||||
Awards forfeited
|
(30,175
|
)
|
21.34
|
|||||
Awards replacing growth shares
|
312,500
|
38.72
|
||||||
Outstanding at March 31, 2021
|
9,315,729
|
22.14
|
||||||
Exercisable at March 31, 2021
|
2,012,001
|
19.40
|
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
|
)
|
37.489
|
|||||
Outstanding at March 31, 2021
|
-
|
-
|
||||||
Exercisable at March 31, 2021
|
-
|
-
|
Share options |
||||||||
Exercise price $
|
Number of
Options
|
Weighted average
remaining
contractual life
|
||||||
11.8348
|
459,970
|
3.9
|
||||||
17.4643
|
4,001,580
|
9.2
|
||||||
26.00
|
4,576,939
|
9.9
|
||||||
32.983
|
16,545
|
4.8
|
||||||
40.932
|
123,850
|
8.5
|
||||||
46.3896
|
136,845
|
9.9
|
|
Share options
|
|||
Share price at grant date
|
$
|
26.00
|
||
Exercise price
|
$
|
26.00
|
||
Expected volatility
|
88
|
%
|
||
Expected life
|
4 years
|
|||
Risk-free rate
|
(0.05
|
%)
|
||
Fair value
|
$
|
16.16
|
March 31,
2021
£’000
|
December 31,
2020
£’000
|
|||||||
Trade payables
|
5,165
|
5,783
|
||||||
Other taxation and social security
|
623
|
620
|
||||||
Accruals
|
20,571
|
19,325
|
||||||
26,359
|
25,728
|
£’000s
|
|
Less than
1 year
|
|
1-3
years
|
|
3-5
years
|
|
More than
5 years
|
|
Total
|
|||||
Lease liabilities – existing
|
3,490
|
5,247
|
4,249
|
31,979
|
44,965
|
||||||||||
Lease liabilities – contingent
|
282
|
2,308
|
2,418
|
1,558
|
6,566
|
||||||||||
Manufacturing
|
2,172
|
74
|
-
|
-
|
2,246
|
||||||||||
Capital commitments
|
72
|
-
|
-
|
-
|
72
|
||||||||||
Total contractual obligations
|
6,016
|
7,629
|
6,667
|
33,537
|
53,849
|
£’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). We anticipate completing submission of a
Biologics License Application, or BLA, to the U.S. Food and Drug Administration, or FDA, in the third quarter of 2021, followed by a Marketing Authorization Application, or MAA, submission to the European Medicines Agency, or EMA.
|
• |
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. We anticipate reporting Phase 1 initial data from this trial in the fourth quater of 2021.
|
• |
IMC-F106C, our ImmTAC molecule targeting an
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, and breast cancers. We anticipate reporting Phase 1 initial data from this 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 anticipate commencing dosing in our Phase 1 single ascending dose, or SAD, trial in mid-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 March 31,
|
||||||||||||
2021
|
2020
|
|||||||||||
|
$'000
|
|
£'000
|
|
£'000
|
|||||||
(unaudited)
|
||||||||||||
Revenue
|
11,408
|
8,270
|
8,255
|
|||||||||
Research and development expenses
|
(27,431
|
)
|
(19,885
|
)
|
(20,779
|
)
|
||||||
Administrative expenses
|
(27,844
|
)
|
(20,184
|
)
|
(9,605
|
)
|
||||||
Net other operating (expense) / income
|
(113
|
)
|
(82
|
)
|
10
|
|||||||
Operating loss
|
(43,980
|
)
|
(31,881
|
)
|
(22,119
|
)
|
||||||
Finance income
|
30
|
22
|
1,383
|
|||||||||
Finance costs
|
(2,565
|
)
|
(1,860
|
)
|
(1,067
|
)
|
||||||
Non-operating (expense) / income
|
(2,535
|
)
|
(1,838
|
)
|
316
|
|||||||
Loss before taxes
|
(46,515
|
)
|
(33,719
|
)
|
(21,803
|
)
|
||||||
Income tax credit
|
6,457
|
4,681
|
3,164
|
|||||||||
Loss for the period
|
(40,058
|
)
|
(29,038
|
)
|
(18,639
|
)
|
|
Three Months Ended March 31,
|
|||||||||||
|
2021
|
2020
|
||||||||||
|
|
$'000
|
|
£'000
|
|
£'000
|
||||||
|
(unaudited)
|
|||||||||||
GlaxoSmithKline
|
4,649
|
3,370
|
695
|
|||||||||
Eli Lilly
|
-
|
-
|
2,674
|
|||||||||
Genentech
|
6,759
|
4,900
|
4,886
|
|||||||||
Total
|
11,408
|
8,270
|
8,255
|
|
Three Months Ended March 31,
|
|||||||||||
|
2021
|
2020
|
||||||||||
|
|
$'000
|
|
£'000
|
|
£'000
|
||||||
|
(unaudited)
|
|||||||||||
External research and development expenses:
|
||||||||||||
Tebentafusp
|
11,133
|
8,069
|
9,464
|
|||||||||
IMC-F106C (PRAME)
|
1,717
|
1,245
|
540
|
|||||||||
IMC-C103C (MAGE-A4)
|
1,481
|
1,074
|
1,401
|
|||||||||
IMC-I109V(HBV)
|
1,012
|
734
|
438
|
|||||||||
Other programs
|
3,021
|
2,190
|
1,035
|
|||||||||
Research expenses
|
99
|
72
|
142
|
|||||||||
Total external research and development expenses
|
18,463
|
13,384
|
13,020
|
|||||||||
Internal research and development expenses:
|
||||||||||||
Headcount related expenses
|
7,228
|
5,238
|
5,663
|
|||||||||
Laboratory consumables
|
1,224
|
888
|
1,322
|
|||||||||
Laboratory equipment expenses
|
515
|
374
|
716
|
|||||||||
Other
|
1
|
1
|
58
|
|||||||||
Total internal research and development expenses
|
8,968
|
6,501
|
7,759
|
|||||||||
Total research and development expenses
|
27,431
|
19,885
|
20,779
|
Three Months Ended March 31,
|
||||||||||||
2021
|
2021
|
2020
|
||||||||||
|
$'000
|
|
£'000
|
|
£'000
|
|||||||
(unaudited)
|
||||||||||||
Cash and cash equivalents at beginning of year
|
178,943
|
129,716
|
73,966
|
|||||||||
Net cash flows used in operating activities
|
(35,838
|
)
|
(25,979
|
)
|
(30,518
|
)
|
||||||
Net cash flows from / (used in) investing activities
|
34
|
25
|
(1,334
|
)
|
||||||||
Net cash flows from financing activities
|
288,830
|
209,373
|
26,149
|
|||||||||
Net foreign exchange difference on cash held
|
(72
|
)
|
(52
|
)
|
114
|
|||||||
Cash and cash equivalents at end of period
|
431,897
|
313,083
|
68,377
|
• |
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.
|
March 31,
2021
£’000
|
December 31,
2020
£’000
|
|||||||
Non-current assets
|
||||||||
Property, plant and equipment
|
12,321
|
13,754
|
||||||
Right of use assets
|
22,742
|
23,093
|
||||||
Investment in sub-lease
|
540
|
776
|
||||||
Other non-current financial assets
|
3,812
|
4,410
|
||||||
Deferred tax asset
|
2,213
|
2,230
|
||||||
Total non-current assets
|
41,628
|
44,263
|
||||||
Current assets
|
||||||||
Trade and other receivables
|
8,821
|
10,280
|
||||||
Tax receivable
|
17,615
|
12,935
|
||||||
Cash and cash equivalents
|
313,083
|
129,716
|
||||||
Total current assets
|
339,519
|
152,931
|
||||||
Total assets
|
381,147
|
197,194
|
||||||
Equity
|
||||||||
Share capital
|
88
|
64
|
||||||
Share premium
|
211,286
|
-
|
||||||
Foreign currency translation reserve
|
71
|
163
|
||||||
Other reserves
|
386,167
|
386,167
|
||||||
Share-based payment reserve
|
27,092
|
18,821
|
||||||
Accumulated deficit
|
(378,907
|
)
|
(349,869
|
)
|
||||
Total equity
|
245,797
|
55,346
|
||||||
Non-current liabilities
|
||||||||
Interest-bearing loans and borrowings
|
36,437
|
36,654
|
||||||
Deferred liabilities
|
19,225
|
24,868
|
||||||
Lease liabilities
|
25,035
|
25,190
|
||||||
Provisions
|
160
|
138
|
||||||
Total non-current liabilities
|
80,857
|
86,850
|
||||||
Current liabilities
|
||||||||
Interest-bearing loans and borrowings
|
546
|
---
|
||||||
Trade and other payables
|
26,359
|
25,728
|
||||||
Deferred liabilities
|
25,710
|
27,118
|
||||||
Lease liabilities
|
1,764
|
2,043
|
||||||
Provisions
|
114
|
109
|
||||||
Total current liabilities
|
54,493
|
54,998
|
||||||
Total liabilities
|
135,350
|
141,848
|
||||||
Total equity and liabilities
|
381,147
|
197,194
|
|
|
Three Months Ended March 31,
|
||||||||||
|
|
2021
|
|
2020
|
||||||||
|
$000
|
£’000
|
|
£’000
|
||||||||
|
|
(unaudited)
|
||||||||||
Revenue
|
|
11,408
|
8,270
|
8,255
|
||||||||
Research and development expenses
|
|
(27,431
|
)
|
(19,885
|
)
|
(20,779
|
)
|
|||||
Administrative expenses
|
|
(27,844
|
)
|
(20,184
|
)
|
(9,605
|
)
|
|||||
Net other operating (expense) / income
|
|
(113
|
)
|
(82
|
)
|
10
|
||||||
Operating loss
|
|
(43,980
|
)
|
(31,881
|
)
|
(22,119
|
)
|
|||||
Finance income
|
|
30
|
22
|
1,383
|
||||||||
Finance costs
|
|
(2,565
|
)
|
(1,860
|
)
|
(1,067
|
)
|
|||||
Non-operating (expense) / income
|
|
(2,535
|
)
|
(1,838
|
)
|
316
|
||||||
Loss before taxes
|
|
(46,515
|
)
|
(33,719
|
)
|
(21,803
|
)
|
|||||
Income tax credit
|
|
6,457
|
4,681
|
3,164
|
||||||||
Loss for the period
|
|
(40,058
|
)
|
(29,038
|
)
|
(18,639
|
)
|
|
For the three
months ended
March 31
2021
|
For the three
months ended
March 31,
2020
|
||||||
Loss for the period (£000’s)
|
(29,038
|
)
|
(18,639
|
)
|
||||
Basic and diluted weighted average number of shares
|
38,451,332
|
25,263,027
|
||||||
Basic and diluted loss per share (£) (1)
|
(0.76
|
)
|
(0.74
|
)
|
|
Three Months Ended March 31,
|
|||||||||||
|
2021
|
2021
|
2020
|
|||||||||
|
$000
|
£’000
|
£’000
|
|||||||||
|
(unaudited)
|
|||||||||||
Cash and cash equivalents at beginning of year
|
178,943
|
129,716
|
73,966
|
|||||||||
Net cash flows used in operating activities
|
(35,838
|
)
|
(25,979
|
)
|
(30,518
|
)
|
||||||
Net cash flows from / (used in) investing activities
|
34
|
25
|
(1,334
|
)
|
||||||||
Net cash flows from financing activities
|
288,830
|
209,373
|
26,149
|
|||||||||
Net foreign exchange difference on cash held
|
(72
|
)
|
(52
|
)
|
114
|
|||||||
Cash and cash equivalents at end of period
|
431,897
|
313,083
|
68,377
|