| • |
KIMMTRAK net product sales were $106.7 million for the first quarter ended March 31, 2026, representing an increase of 13.6%, as compared to the same period in 2025.
|
| • |
19.1% year-over-year sales growth in the United States with mean duration of treatment of 14 months.
|
| • |
4.9% year-over-year sales growth in Europe, driven by increased demand and launches in European markets.
|
| • |
Five-year overall survival (OS) data from the landmark Phase 3 trial of KIMMTRAK in patients with unresectable or mUM were presented in an oral session at the American Association for Cancer
Research (AACR) 2026 meeting, representing the longest follow-up reported for any T cell engager in a solid tumor. In this study of 378 patients, KIMMTRAK doubled the likelihood of being alive at five years with an OS rate of 16% versus 8%
in the control arm (HR 0.67), while demonstrating a median OS of 21.6 months compared to 16.9 months for investigator’s choice.
|
| • |
The OS benefit with KIMMTRAK was observed regardless of known poor prognostic factors at baseline (high tumor burden [≥10cm]; elevated lactate dehydrogenase [LDH]) or tumor location (hepatic only;
hepatic and extra-hepatic). OS benefit was also observed in patients with a best response of progressive disease, including those with >20% tumor growth as best change on treatment.
|
| • |
The data also confirmed that the OS benefit was primarily driven by KIMMTRAK rather than subsequent therapies. Among patients treated with KIMMTRAK who were alive at five years, nearly half (44%)
received only KIMMTRAK, while among patients in the control arm alive at the same time point, 86% subsequently received KIMMTRAK.
|
| • |
The Company is currently enrolling patients in the TEBE-AM registrational Phase 3 trial and expects to complete enrollment in the first half of 2026 with topline data expected as early as the
second half of 2026.
|
| • |
The Phase 3 trial is enrolling three arms: tebentafusp monotherapy, tebentafusp in combination with pembrolizumab, and a control (investigator's choice of therapy including clinical trials,
chemotherapy, or retreatment with anti-PD1 or BRAF therapy). The primary endpoint of the randomized Phase 3 trial is Overall Survival (OS).
|
| • |
There is great unmet need in second- and later-line cutaneous melanoma, with no therapy having shown, to date, an OS improvement post checkpoint inhibitors in a randomized clinical trial. The
Company estimates that there is a potential to address up to 4,000 previously treated advanced HLA-A*02:01 positive CM patients.
|
| • |
The European Organisation for Research and Treatment of Cancer (EORTC) continues to expand the site footprint of the Phase 3 Adjuvant Trial in Ocular Melanoma (ATOM).
|
| • |
The Company estimates that the HLA-A*02:01 positive, high-risk adjuvant uveal melanoma patient population could be up to 1,200 patients in the US and Europe.
|
| • |
Despite approved therapies, there remains a need for improved progression-free survival and OS, and there is the potential to address an estimated 10,000 HLA-A*02:01 positive patients in the US and
Europe.
|
| • |
The Company continues to evaluate brenetafusp in a Phase 1/2 trial in combination in platinum-resistant ovarian cancer (PROC) and in earlier lines of platinum-sensitive ovarian cancer (PSOC). In
the same trial, the Company continues signal detection in metastatic NSCLC cohorts, including combination in earlier-line NSCLC.
|
| • |
The Company is enrolling patients in the Phase 1 dose escalation trial evaluating IMC-P115C in patients with multiple solid tumors.
|
| • |
The Company expects to present Phase 1/2 data from both trials in the second half of 2026.
|
| • |
The Company is enrolling patients in the Phase 1/2 dose escalation trial evaluating IMC-R117C in HLA-A*02:01 positive patients with advanced solid tumors, including colorectal cancer, as a single
agent and in combination with standards of care.
|
| • |
The Company expects to present initial data in 2027.
|
| • |
Patient enrollment continues at higher doses in the multiple ascending dose (MAD) part of the Phase 1/2 clinical trial to identify a safe and tolerable dose.
|
| • |
Additional Phase 1 MAD data is expected to be presented in the second half of 2026.
|
| • |
The Company filed a clinical trial application (CTA) for IMC-S118AI (PPI x PD1) in December 2025 and expects to begin the Phase 1 trial in the first half of 2026.
|
| • |
The Company plans to file a CTA or investigational new drug (IND) application for IMC-U120AI (CD1a x PD1) in the second half of 2026.
|
|
Quarter Ended
|
||||||||
|
March 31,
2026
|
March 31,
2025
|
|||||||
|
Revenue from sale of therapies, net
|
$
|
106,677
|
$
|
93,881
|
||||
|
Total revenue
|
106,677
|
93,881
|
||||||
|
Cost of revenue from sale of therapies
|
(434
|
)
|
(831
|
)
|
||||
|
Research and development expense
|
(61,113
|
)
|
(56,468
|
)
|
||||
|
Selling, general, & administrative expense
|
(37,850
|
)
|
(40,198
|
)
|
||||
|
Income (Loss) from operations
|
7,280
|
(3,616
|
)
|
|||||
|
Interest income
|
3,418
|
4,176
|
||||||
|
Interest expense
|
(3,051
|
)
|
(3,025
|
)
|
||||
|
Foreign currency gain
|
3,849
|
3,080
|
||||||
|
Other income, net
|
1,776
|
5,469
|
||||||
|
Net income before income taxes
|
13,272
|
6,084
|
||||||
|
Income tax expense
|
(301
|
)
|
(1,061
|
)
|
||||
|
Net income
|
$
|
12,971
|
$
|
5,023
|
||||
|
Basic net income per share
|
$
|
0.26
|
$
|
0.10
|
||||
|
Basic weighted-average number of shares outstanding
|
50,754,763
|
50,086,684
|
||||||
|
Diluted net income per share
|
$
|
0.25
|
$
|
0.10
|
||||
|
Diluted weighted-average number of shares outstanding
|
52,934,787
|
51,949,798
|
||||||
|
March 31,
2026
|
December 31, 2025
|
|||||||
|
ASSETS
|
||||||||
|
Current assets
|
||||||||
|
Cash and cash equivalents
|
$
|
452,675
|
$
|
467,709
|
||||
|
Marketable securities
|
392,221
|
396,444
|
||||||
|
Accounts receivable, net
|
81,068
|
73,977
|
||||||
|
Prepaid expenses and other current assets
|
69,590
|
51,870
|
||||||
|
Inventory, net
|
8,253
|
6,742
|
||||||
|
Total current assets
|
1,003,807
|
996,742
|
||||||
|
Property and equipment, net
|
12,128
|
11,462
|
||||||
|
Operating lease right of use assets, net
|
37,546
|
38,783
|
||||||
|
Other non-current assets
|
18,614
|
20,282
|
||||||
|
Total assets
|
$
|
1,072,095
|
$
|
1,067,269
|
||||
|
Liabilities and shareholders’ equity
|
||||||||
|
Current liabilities
|
||||||||
|
Accounts payable
|
$
|
30,157
|
$
|
24,364
|
||||
|
Accrued expenses and other current liabilities
|
207,388
|
219,744
|
||||||
|
Deferred revenue, current
|
572
|
583
|
||||||
|
Operating lease liabilities, current
|
1,996
|
2,006
|
||||||
|
Total current liabilities
|
240,113
|
246,697
|
||||||
|
Deferred revenue, non-current
|
4,622
|
4,858
|
||||||
|
Operating lease liabilities, non-current
|
40,027
|
41,556
|
||||||
|
Interest-bearing loans and borrowings
|
393,660
|
393,125
|
||||||
|
Total liabilities
|
$
|
678,422
|
$
|
686,236
|
||||
|
Shareholders' equity
|
||||||||
|
Ordinary shares
|
137
|
136
|
||||||
|
Deferred shares
|
1
|
1
|
||||||
|
Additional paid-in capital
|
1,247,212
|
1,240,255
|
||||||
|
Accumulated deficit
|
(818,304
|
)
|
(831,275
|
)
|
||||
|
Accumulated other comprehensive loss
|
(35,373
|
)
|
(28,084
|
)
|
||||
|
Total shareholders' equity
|
393,673
|
381,033
|
||||||
|
Total liabilities and shareholders' equity
|
$
|
1,072,095
|
$
|
1,067,269
|
||||
|
2026
|
2025
|
|||||||
|
Cash and cash equivalents at beginning of period
|
$
|
467,709
|
$
|
455,731
|
||||
|
Net cash (used in) provided by operating activities
|
(13,775
|
)
|
435
|
|||||
|
Net cash provided by investing activities
|
4,219
|
9,702
|
||||||
|
Net cash provided by financing activities
|
656
|
2,551
|
||||||
|
Net foreign exchange difference on cash held
|
(6,134
|
)
|
8,426
|
|||||
|
Cash and cash equivalents at end of period
|
$
|
452,675
|
$
|
476,845
|
||||