• |
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. The U.S. Food and Drug Administration (FDA) will review the Biologics License application (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. We anticipate completing submission of a Marketing Authorization Application, or MAA, to the European Medicines Agency, or
EMA, and the United Kingdom’s Medicines and Healthcare Regulatory Agency, or MHRA, in the third quarter of 2021. The EMA granted tebentafusp accelerated assessment procedure for this MAA.
|
• |
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, the Company has 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 anticipate reporting Phase 1 initial data from this trial in the fourth quarter of 2021.
|
• |
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, the Company has 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 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
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 during the second half of 2021 in support of our Phase 1 trial.
|
• |
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 June 30,
|
||||||||||||
2021
|
2020
|
|||||||||||
$’000
|
£’000
|
£’000
|
||||||||||
Revenue
|
7,915 |
5,733
|
7,787
|
|||||||||
Research and development expenses
|
(22,740
|
)
|
(16,471
|
)
|
(16,378
|
)
|
||||||
Administrative expenses
|
(32,860
|
)
|
(23,801
|
)
|
(12,250
|
)
|
||||||
Net other operating income
|
55
|
40
|
346
|
|||||||||
Operating loss
|
(47,630
|
)
|
(34,499
|
)
|
(20,495
|
)
|
||||||
Finance income
|
17
|
12
|
222
|
|||||||||
Finance costs
|
(1,778
|
)
|
(1,288
|
)
|
(635
|
)
|
||||||
Non-operating expense
|
(1,761
|
)
|
(1,276
|
)
|
(413
|
)
|
||||||
Loss before taxes
|
(49,391
|
)
|
(35,775
|
)
|
(20,908
|
)
|
||||||
Income tax credit
|
3,884
|
2,813
|
3,691
|
|||||||||
Loss for the period
|
(45,507
|
)
|
(32,962
|
)
|
(17,217
|
)
|
Three Months Ended June 30,
|
||||||||||||
2021
|
2020
|
|||||||||||
$’000
|
£’000
|
£’000
|
||||||||||
GlaxoSmithKline
|
1,775
|
1,286
|
1,705
|
|||||||||
Eli Lilly
|
-
|
-
|
424
|
|||||||||
Genentech
|
6,140
|
4,447
|
5,658
|
|||||||||
Total
|
7,915
|
5,733
|
7,787
|
Three Months Ended June 30,
|
|||||||||||||
2021
|
2020
|
||||||||||||
$’000
|
|
£’000
|
£’000
|
||||||||||
External research and development expenses:
|
|||||||||||||
Tebentafusp
|
7,582
|
5,492
|
8,131
|
||||||||||
IMC-F106C (PRAME)
|
1,291
|
935
|
364
|
||||||||||
IMC-C103C (MAGE-A4)
|
1,207
|
873
|
491
|
||||||||||
IMC-I109V(HBV)
|
804
|
582
|
409
|
||||||||||
Other programs
|
2,258
|
1,637
|
1,440
|
||||||||||
Research expenses
|
178
|
129
|
157
|
||||||||||
Total external research and development expenses
|
13,320
|
9,648
|
10,992
|
||||||||||
Internal research and development expenses:
|
|||||||||||||
Headcount related expenses
|
7,262
|
5,260
|
4,655
|
||||||||||
Laboratory consumables
|
1,541
|
1,116
|
701
|
||||||||||
Laboratory equipment expenses
|
614
|
445
|
27
|
||||||||||
Other
|
3
|
2
|
3
|
||||||||||
Total internal research and development expenses
|
9,420
|
|
6,823
|
5,386
|
|||||||||
Total research and development expenses
|
22,740
|
16,471
|
16,378
|
Six Months Ended June 30,
|
||||||||||||
2021
|
2020
|
|||||||||||
$’000
|
£’000 |
£’000
|
||||||||||
Revenue
|
19,333
|
14,003
|
16,042
|
|||||||||
Research and development expenses
|
(50,193
|
)
|
(36,356
|
)
|
(37,157
|
)
|
||||||
Administrative expenses
|
(60,726
|
)
|
(43,985
|
)
|
(21,855
|
)
|
||||||
Net other operating (expense) / income
|
(58
|
)
|
(42
|
)
|
356
|
|||||||
Operating loss
|
(91,644
|
)
|
(66,380
|
)
|
(42,614
|
)
|
||||||
Finance income
|
47
|
34 |
1,605
|
|||||||||
Finance costs
|
(4,346
|
)
|
(3,148
|
)
|
(1,702
|
)
|
||||||
Non-operating expense
|
(4,299
|
)
|
(3,114 | ) |
(97
|
)
|
||||||
Loss before taxes
|
(95,943
|
)
|
(69,494
|
)
|
(42,711
|
)
|
||||||
Income tax credit
|
10,346
|
7,494 |
6,855
|
|||||||||
Loss for the period
|
(85,597
|
)
|
(62,000
|
)
|
(35,856
|
)
|
Six Months Ended June 30,
|
||||||||||||
2021
|
2020
|
|||||||||||
$’000
|
£’000
|
£’000
|
||||||||||
GlaxoSmithKline
|
6,428
|
4,656
|
2,400
|
|||||||||
Eli Lilly
|
-
|
-
|
3,098
|
|||||||||
Genentech
|
12,905
|
9,347
|
10,544
|
|||||||||
Total
|
19,333
|
14,003
|
16,042
|
Six Months Ended June 30,
|
|||||||||||||
2021
|
|
2020
|
|||||||||||
$’000
|
£’000
|
|
£’000
|
||||||||||
External research and development expenses:
|
|||||||||||||
Tebentafusp
|
18,714
|
13,555
|
17,595
|
||||||||||
IMC-F106C (PRAME)
|
3,012
|
2,182
|
904
|
||||||||||
IMC-C103C (MAGE-A4)
|
2,688
|
1,947
|
1,892
|
||||||||||
IMC-I109V(HBV)
|
1,818
|
1,317
|
847
|
||||||||||
Other programs
|
5,282
|
3,826
|
2,475
|
||||||||||
Research expenses
|
278
|
201
|
299
|
||||||||||
Total external research and development expenses
|
31,792
|
23,028
|
24,012
|
||||||||||
Internal research and development expenses:
|
|||||||||||||
Headcount related expenses
|
14,493
|
10,498
|
10,318
|
||||||||||
Laboratory consumables
|
2,767
|
2,004
|
|
2,023
|
|||||||||
Laboratory equipment expenses
|
1,131
|
819
|
753
|
||||||||||
Other
|
10
|
7
|
51
|
||||||||||
Total internal research and development expenses
|
18,401
|
13,328
|
13,145
|
||||||||||
Total research and development expenses
|
50,193
|
36,356
|
37,157
|
Six Months Ended June 30,
|
||||||||||||
2021
|
2021
|
2020
|
||||||||||
$’000
|
£’000
|
£’000
|
||||||||||
(unaudited)
|
||||||||||||
Cash and cash equivalents at beginning of year
|
179,085
|
129,716
|
73,966
|
|||||||||
Net cash flows used in operating activities
|
(80,867
|
)
|
(58,575
|
)
|
(40,645
|
)
|
||||||
Net cash flows from / (used in) investing activities
|
61
|
44
|
(1,684
|
)
|
||||||||
Net cash flows from financing activities
|
286,834
|
207,761
|
25,054
|
|||||||||
Net foreign exchange difference on cash held
|
(105
|
)
|
(76
|
)
|
118
|
|||||||
Cash and cash equivalents at end of period
|
385,008
|
278,870
|
56,809
|
• |
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.
|