• |
KIMMTRAK (tebentafusp-tebn), our ImmTAC molecule targeting an HLA-A*02:01 gp100 antigen, is our first
approved product. The FDA and the EC have approved KIMMTRAK (tebentafusp-tebn and tebentafusp, respectively) for the treatment of HLA-A*02:01-positive adult patients with unresectable or mUM. The UK’s MHRA, Health Canada, and the
Australian Government Department of Health’s TGA have each approved KIMMTRAK for the treatment of HLA-A*02:01-positive adult patients with mUM. KIMMTRAK is now approved in over 30 countries and we have commercially launched in the United
States, Germany and France, among other territories. The Company launched commercial KIMMTRAK in Austria and Israel in the first quarter and expects the commercial transition in Italy in the second quarter of 2023. The Company expects to
launch commercial KIMMTRAK in four additional European countries by the end of 2023.
|
• |
Tebentafusp is also being developed for the treatment of previously treated, advanced melanoma. In June 2022, we presented updated clinical data from our Phase 1b clinical trial
of tebentafusp in metastatic cutaneous melanoma (mCM) at the 2022 ASCO Annual Meeting. In mCM patients who progressed on prior anti-PD(L)1, tebentafusp with durvalumab continues to demonstrate promising overall survival (OS) (1-yr ~75%)
compared to recent benchmarks (1-yr ~55%). The Company has started randomization in the Phase 2/3 clinical trial. This trial is randomizing patients with previously treated, advanced melanoma, excluding only uveal melanoma, that have
progressed on an anti-PD1, received prior ipilimumab and, if applicable, received a BRAF kinase inhibitor. Patients will be randomized to one of three arms including tebentafusp, as monotherapy or in combination with an anti-PD1, and a
control arm. The Phase 2 portion of the trial will include 40 patients per arm and has a dual primary endpoint of overall survival (OS) and ctDNA reduction.
|
• |
IMC-F106C, our ImmTAC molecule targeting an optimal HLA-A*02 PRAME antigen is currently being evaluated in a first-in-human, Phase 1/2 dose
escalation clinical trial in patients with multiple solid tumor cancers. The initial Phase 1 data from the dose escalation study of IMC-F106C, the first PRAME x CD3 ImmTAC bispecific protein, was presented at the 2022 European Society for
Medical Oncology (ESMO) Congress. Durable RECIST responses and reduction in circulating tumor DNA (ctNDA) were observed across multiple solid tumors. The Company is continuing to expand the clinical trial footprint for PRAME-A02 trials,
enrolling patinets into the Phase 1/2 monotherapy and combination arms across multiple tumor types, including the four expansion arms for patients with advanced ovarian, non-small cell lung, endometrial cancers, and melanoma. The Company
expects to report data from the monotherapy and combination arms by the first half of 2024.
|
• |
IMC-T119C, our ImmTAC molecule targeting an optimal HLA-A*24 PRAME antigen was announced as part of our pipeline in January 2023 with
planned IND or CTA submission in 2024. In order to expand the potential of TCR therapy targeting PRAME, the Company is developing IMC-T119C, a first-in-class ImmTAC product candidate targeting a PRAME peptide presented by HLA-A24. HLA-24
is an HLA-type that is estimated to be present in 60% of people in Japan and 15-20% in Western populations.
|
• |
IMC-P115C, our half-life extended ImmTAC molecule targeting an optimal HLA-A*02 PRAME antigen was announced as part of our pipeline in
January 2023 with planned IND or CTA submission in 2024. This ImmTAC candidate was designed with the aim of improving patient convenience. IMC-P115C targets the same PRAME-A02 peptide and uses the same CD3 end and TCR specificity as
IMC-F106C.
|
• |
IMC-R117C, our ImmTAC molecule targeting an optimal HLA-A*02 PIWIL1 antigen was announced as part of our pipeline in January 2023 with
planned IND or CTA submission in the fourth quarter of 2023. PIWIL1 is believed to play a role in tumor progression and is expressed across a range of tumors including colorectal, which is historically insensitive to immune checkpoints,
as well as gastro-esophageal, and pancreatic cancer. PIWIL1 is also reported to be a negative prognostic marker. The Company believes IMC-R117C is the first PIWIL1 targeted immunotherapy.
|
• |
IMC-M113V, our ImmTAV molecule targeting a human immunosuppression virus, or HIV, gag antigen bispecific TCR molecule, expected to be
evaluated in a Phase 1 clinical trial for which we are currently enrolling patients. Our goal is to develop a functional cure for HIV. Initial Phase 1 safety and pharmacodynamic activity data from the single ascending dose portion of the
study was presented at the Conference on Retroviruses and Opportunistic Infections (CROI) in 2023. IMC-M113V was well tolerated at doses where the Company observed biomarkers of T cell engagement. The Company has started enrolling people
living with HIV in the multiple ascending dose (MAD) part of the trial, to identify a safe and tolerable dosing schedule. This study will also test whether IMC-M113V could lead to reduction in the viral reservoir and control of HIV after
stopping all therapies (antiretroviral therapies and ImmTAV), or functional cure. The MAD trial will enroll up to 28 patients.
|
• |
IMC-I109V, our ImmTAV molecule targeting a conserved hepatitis B virus, or HBV, envelope antigen, is
currently being evaluated in a Phase 1 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. We reported initial data from our trial in June 2022, observing a transient decrease in the HBV surface antigen, as well as transient elevations in alanine transaminase (“ALT”) and cytokines. The Company is
enrolling patients in the single ascending dose (SAD) portion of the study.
|
• |
we may face disruptions affecting the site initiation, patient enrollment, clinical trial site monitoring, development and operation of our clinical trials, including public health emergencies such as the
COVID-19 pandemic or other pandemics or epidemics;
|
• |
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, including as a result of supply
chain disruptions caused by the COVID-19 pandemic or other pandemics or epidemics, the war in Ukraine or global geopolitical tensions;
|
• |
we may be unable to obtain additional funding necessary to continue our operations on favorable terms or at all, including as a result of global and macroeconomic factors as described elsewhere herein;
|
• |
we have faced and expect to face further increased costs as a result of rising global inflation including significant increases in commodity prices, energy and fuel prices, and employee costs;
|
• |
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,
|
||||||||||||
2023
|
2022
|
|||||||||||
$’000
|
£’000
|
£’000
|
||||||||||
Product revenue, net
|
52,014
|
42,052
|
7,682
|
|||||||||
Pre-product revenue, net
|
—
|
—
|
2,829
|
|||||||||
Total revenue from sale of therapies
|
52,014
|
42,052
|
10,511
|
|||||||||
Collaboration revenue
|
3,079
|
2,489
|
11,963
|
|||||||||
Total revenue
|
55,093
|
44,541
|
22,474
|
|||||||||
Cost of product revenue
|
(220
|
)
|
(178
|
)
|
(248
|
)
|
||||||
Research and development expenses
|
(35,189
|
)
|
(28,449
|
)
|
(18,581
|
)
|
||||||
Selling and administrative expenses
|
(41,190
|
)
|
(33,301
|
)
|
(20,105
|
)
|
||||||
Operating income / (loss)
|
(21,506
|
)
|
(17,387
|
)
|
(16,460
|
)
|
||||||
Finance income
|
3,149
|
2,546
|
10
|
|||||||||
Finance costs
|
(2,004
|
)
|
(1,620
|
)
|
(1,333
|
)
|
||||||
Net finance income (costs)
|
1,145
|
926
|
(1,323
|
)
|
||||||||
Loss before taxes
|
(20,361
|
)
|
(16,461
|
)
|
(17,783
|
)
|
||||||
Income tax (charge) / credit
|
(292
|
)
|
(236
|
)
|
1,655
|
|||||||
Loss for the period
|
(20,653
|
)
|
(16,697
|
)
|
(16,128
|
)
|
Three Months Ended March 31, 2023
|
||||||||||||
2023
|
2022
|
|||||||||||
$’000
|
£’000
|
£’000
|
||||||||||
United States
|
36,529
|
29,533
|
7,682
|
|||||||||
Europe
|
15,249
|
12,328
|
2,829
|
|||||||||
Rest of World
|
236
|
191
|
—
|
|||||||||
Total revenue from sale of therapies
|
52,014
|
42,052
|
10,511
|
Three Months Ended March 31,
|
||||||||||||
2023
|
2022
|
|||||||||||
$’000
|
£’000
|
£’000
|
||||||||||
Eli Lilly
|
—
|
—
|
7,361
|
|||||||||
Genentech
|
3,079
|
2,489
|
4,602
|
|||||||||
Total collaboration revenue
|
3,079
|
2,489
|
11,963
|
Three Months Ended March 31,
|
||||||||||||
2023
|
2022
|
|||||||||||
$’000
|
£’000
|
£’000
|
||||||||||
External research and development expenses:
|
||||||||||||
Tebentafusp
|
4,196
|
3,392
|
4,616
|
|||||||||
IMC-F106C (PRAME)
|
8,954
|
7,239
|
1,984
|
|||||||||
IMC-C103C (MAGE-A4)
|
849
|
686
|
1,510
|
|||||||||
IMC-I109V(HBV)
|
980
|
792
|
466
|
|||||||||
IMC-M113V (HIV)
|
800
|
647
|
8
|
|||||||||
Other programs
|
3,549
|
2,869
|
1,004
|
|||||||||
Research expenses
|
210
|
170
|
111
|
|||||||||
Total external research and development expenses
|
19,538
|
15,795
|
9,699
|
|||||||||
Internal research and development expenses:
|
||||||||||||
Salaries and other employee related costs
|
9,346
|
7,556
|
5,593
|
|||||||||
Share based payments
|
1,692
|
1,368
|
934
|
|||||||||
Laboratory consumables
|
3,232
|
2,613
|
1,214
|
|||||||||
Laboratory equipment expenses
|
1,149
|
929
|
1,061
|
|||||||||
Other
|
232
|
188
|
80
|
|||||||||
Total internal research and development expenses
|
15,651
|
12,654
|
8,882
|
|||||||||
Total research and development expenses
|
35,189
|
28,449
|
18,581
|
Three Months Ended March 31,
|
||||||||||||
2023
|
2022
|
|||||||||||
$’000
|
£’000
|
£’000
|
||||||||||
Share-based payment charge
|
6,547
|
5,293
|
6,479
|
|||||||||
Other employee related expenses
|
9,412
|
7,609
|
4,096
|
|||||||||
Selling and commercial costs
|
10,430
|
8,432
|
6,624
|
|||||||||
Legal and professional fees
|
3,648
|
2,949
|
1,740
|
|||||||||
Depreciation
|
1,180
|
954
|
1,073
|
|||||||||
Other expenses
|
4,094
|
3,311
|
2,474
|
|||||||||
Foreign exchange losses / (gains)
|
5,879
|
4,753
|
(2,381
|
)
|
||||||||
Total selling and administrative expenses
|
41,190
|
33,301
|
20,105
|
Three Months Ended March 31,
|
||||||||||||
2023
|
2023
|
2022
|
||||||||||
$’000
|
£’000
|
£’000
|
||||||||||
Cash and cash equivalents at beginning of year
|
411,317
|
332,539
|
237,886
|
|||||||||
Net cash flows from / (used in) operating activities
|
10,875
|
8,792
|
(30,833
|
)
|
||||||||
Net cash flows used in investing activities
|
(487
|
)
|
(394
|
)
|
(133
|
)
|
||||||
Net cash flows from / (used in) financing activities
|
3,074
|
2,485
|
(1,332
|
)
|
||||||||
Net foreign exchange difference on cash held
|
(7,374
|
)
|
(5,961
|
)
|
265
|
|||||||
Cash and cash equivalents at end of period
|
417,405
|
337,461
|
205,853
|
• |
execute our sales and marketing strategy of KIMMTRAK in the United States, Europe and elsewhere;
|
• |
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;
|
• |
continue to advance our ongoing and potential additional 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;
|
• |
seek marketing approvals and reimbursement for our product candidates, including as a result of the timing and outcome of regulatory filings and actions;
|
• |
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;
|
• |
seek additional collaborations with third parties;
|
• |
acquire or in-license other product candidates and technologies;
|
• |
maintain, protect, defend, enforce and expand our intellectual property portfolio; and encounter increased costs, difficulties collecting receivables from our customers, supply chain or other disruptions,
or delays or other issues with any of the above, including as a result of global or worsening macroeconomic conditions, including increased interest rates and rising global inflation, increases in commodity, energy and fuel prices,
heightened interest rates and inflation, exchange rate fluctuations, liquidity concerns at or failures of banks and financial institutions, the war in Ukraine, global geopolitical tension and health epidemics or pandemics such as
COVID-19.
|