• |
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.
|