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Watchlist
Account
Immunocore
IMCR
#5385
Rank
$1.57 B
Marketcap
๐ฌ๐ง
United Kingdom
Country
$30.48
Share price
-3.71%
Change (1 day)
-13.64%
Change (1 year)
๐ Pharmaceuticals
๐งฌ Biotech
Categories
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Annual Reports
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Annual Reports (20-F)
Immunocore
Quarterly Reports (10-Q)
Financial Year FY2026 Q3
Immunocore - 10-Q quarterly report FY2026 Q3
Text size:
Small
Medium
Large
0001671927
December 31
2026
Q3
FALSE
P10Y
John Goll
472
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
10-Q
x
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended
September 30, 2026
or
o
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from ____________ to ____________
Commission File Number:
001-39992
Immunocore Holdings plc
(Exact name of registrant as specified in its charter)
England and Wales
Not Applicable
(State or other jurisdiction of incorporation or organization)
(I.R.S. Employer Identification No.)
92 Park Drive
Milton Park
Abingdon, Oxfordshire,
United Kingdom
OX14 4RY
(Address of principal executive offices)
(Zip Code)
+44
1235
438600
(Registrant’s telephone number, including area code)
(Former name, former address and former fiscal year, if changed since last report)
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading Symbol(s)
Name of each exchange on which registered
American Depositary Shares, each representing one ordinary share, nominal value £0.002 per share
IMCR
The
Nasdaq
Stock Market LLC
Ordinary Share, nominal value £0.002 per share*
*
The
Nasdaq
Stock Market LLC*
*Not for trading, but only in connection with the listing of the American Depositary Shares on The Nasdaq Stock Market LLC
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
x
Yes
o
No
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
x
Yes
o
No
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer
x
Accelerated filer
o
Non-accelerated filer
o
Smaller reporting company
o
Emerging growth company
o
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
o
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
o
Yes
x
No
Indicate the number of shares outstanding of each of the issuer’s classes of shares, as of the latest practicable date.
As of October 31, 2026, the registrant had
51,681,376
ordinary shares (including ordinary shares in the form of American Depositary Shares) outstanding, par value £0.002.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q (the "Quarterly Report") contains forward-looking statements that involve substantial risks and uncertainties. In some cases, you can identify forward-looking statements by the words “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “objective,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and “ongoing,” or the negative of these terms, or other comparable terminology intended to identify statements about the future. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. The forward-looking statements and opinions contained in this Quarterly Report are based upon information available to us as of the date of this Quarterly Report and, while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. Forward-looking statements include, but are not limited to, statements about:
•
the therapeutic potential and expected clinical benefits of KIMMTRAK®;
•
the planned geographic expansion and expansion of patient reach for KIMMTRAK;
•
the plans for expansion and growth into new melanoma indications, beyond melanoma into other tumor types, and beyond oncology;
•
the safety, efficacy and clinical progress of our various ongoing clinical programs and any planned clinical programs, including those for tebentafusp, brenetafusp, IMC-P115C, IMC-R117C, IMC-M113V, IMC-S118AI, and IMC-U120AI;
•
our ability to continue to generate revenues, which is dependent upon maintaining significant market acceptance among physicians, patients and healthcare payors;
•
our ability to maintain regulatory approval of KIMMTRAK for metastatic uveal melanoma ("mUM") in the United States, European Union and other territories, as well as our ability to obtain and maintain regulatory approval in additional indications, jurisdictions, and the timing thereof;
•
our expectations regarding the continued commercialization and marketing of KIMMTRAK for mUM, including expanding into and the related timing of reaching patients in additional indications and territories;
•
our ability to build a sustainable pipeline of new product candidates, including but not limited to future generations of KIMMTRAK and additional product candidates identified and developed using our ImmTAX® platform;
•
our ability to continue successfully executing our sales and marketing strategy of KIMMTRAK in the United States, Europe and elsewhere, including continuing to successfully recruit and retain sales and marketing personnel and to successfully build the market for our medicines;
•
the rate and degree of market acceptance of our product candidates among physicians, patients, patient advocacy groups, third-party payors and the medical community and our ability and our distribution and marketing partners’ ability to obtain coverage and adequate reimbursement and pricing for our medicines from government and third-party payors and risks relating to the success of our patient assistance programs;
•
the initiation, timing, progress and results of our ongoing and planned clinical trials, including the expansion arms of such trials, for tebentafusp in advanced melanoma and adjuvant uveal (or ocular) melanoma, brenetafusp,
IMC-P115C, IMC-R117C, IMC-M113V,
IMC-S118AI, and IMC-U120AI, and our research and development programs, including delays or disruptions in clinical trials, non-clinical experiments and investigational new drug application-enabling studies;
•
our estimates regarding the period of time for which our current capital resources will be sufficient to fund our continued operations, our future expenses, including the impact thereon of changes in interest rates and inflation, fluctuating exchange rates and other macroeconomic factors, and our future revenues and our need for and ability to obtain additional financing;
•
our expectations regarding timing of regulatory filings for, or our ability to obtain regulatory approval of, our product candidates;
•
our ability to obtain accelerated approval for current and future product candidates from the U.S. Food and Drug Administration ("FDA"), the European Commission, or other comparable regulatory authorities in other jurisdictions;
•
our expectations regarding business disruptions affecting the initiation, patient enrollment, clinical trial site monitoring, development and operation of our current and proposed clinical trials, including as a result of a public health emergency or other global and macroeconomic factors, such as the war in Ukraine, the conflict in the Middle East, global geopolitical tensions, supply chain disruptions, and changes in interest rates and inflation;
•
our business strategies and goals, including our 2026 strategic priorities;
•
our plans to collaborate, or statements regarding our current collaborations, and our ability to find future partners and collaborators;
•
the performance of our third-party suppliers and manufacturers;
•
our expectations regarding our ability to obtain, maintain and enforce intellectual property protection for our products and product candidates and our ability to operate our business without infringing, misappropriating or otherwise violating the intellectual property rights of others;
•
our expectations regarding competition with respect to KIMMTRAK or any of our current or future product candidates, as well as innovations by current and future competitors in our industry;
•
our expectations regarding regulatory developments in the United States and other countries, including potential changes in healthcare laws and regulations;
•
our financial performance and our ability to effectively manage our anticipated growth;
•
our ability to identify, recruit and retain qualified employees, including key commercial or management personnel; and
•
whether we are classified as a Passive Foreign Investment Company ("PFIC") for current and future periods.
Any forward-looking statements in this Quarterly Report reflect our current views with respect to future events or to our future financial performance and involve known and unknown risks, uncertainties and assumptions that could cause our actual results and the timing of certain events to differ materially from future results expressed or implied by the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those identified herein, and those discussed in the section titled “Risk Factors,” set forth in Part II, Item 1A of this Quarterly Report, if any, our Annual Report on Form 10-K filed with the Securities and Exchange Commission ("SEC") on February 25, 2026, and in our other SEC filings. As a result of these factors, we cannot assure you that the forward-looking statements in this Quarterly Report will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this Quarterly Report.
TABLE OF CONTENTS
PART I – FINANCIAL INFORMATION
Page
ITEM 1.
Financial Statements (unaudited)
2
Condensed Consolidated Balance Sheets as of
September 30, 2026
and
December 31, 2025
2
Condensed Consolidated Statements of Operations and Comprehensive
Loss
for the
three and nine months ended September 30, 2026 and 2025
3
Condensed Consolidated Statements of Shareholders’ Equity for the
three and nine months ended September 30, 2026
and
2025
4
Condensed Consolidated Statements of Cash Flows for the
nine months ended September 30, 2026 and 2025
6
Notes to the Condensed Consolidated Financial Statements
7
ITEM 2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
15
ITEM 3.
Quantitative and Qualitative Disclosures about Market Risk
28
ITEM 4.
Controls and Procedures
30
PART II – OTHER INFORMATION
ITEM 1.
Legal Proceedings
31
ITEM 1A.
Risk Factors
31
ITEM 2.
Unregistered Sales of Equity Securities and Use of Proceeds
31
ITEM 3.
Defaults Upon Senior Securities
31
ITEM 4.
Mine Safety Disclosures
31
ITEM 5.
Other Information
31
ITEM 6.
Exhibits
32
Signatures
33
1
Table of Contents
PART I - FINANCIAL INFORMATION
Item 1. Financial Statements
Immunocore Holdings plc
Condensed Consolidated Balance Sheets
(Unaudited) (In thousands, except share and per share data)
September 30,
2026
December 31,
2025
Assets
Current assets
Cash and cash equivalents
$
512,245
$
467,709
Marketable securities
389,053
396,444
Accounts receivable, net
88,032
73,977
Prepaid expenses and other current assets
63,636
51,870
Inventory, net
7,467
6,742
Total current assets
1,060,433
996,742
Property and equipment, net
14,053
11,462
Operating lease right of use assets, net
36,272
38,783
Other non-current assets
18,481
20,282
Total assets
$
1,129,239
$
1,067,269
Liabilities and shareholders’ equity
Current liabilities
Accounts payable
$
21,385
$
24,364
Accrued expenses and other current liabilities
205,894
219,744
Deferred revenue, current
573
583
Operating lease liabilities, current
1,767
2,006
Total current liabilities
229,619
246,697
Accrued expenses, non-current
41,600
—
Deferred revenue, non-current
4,344
4,858
Operating lease liabilities, non-current
39,220
41,556
Interest-bearing loans and borrowings
394,750
393,125
Total liabilities
709,533
686,236
Commitments and contingencies (Note 10)
Shareholders’ equity
Ordinary shares (voting and non-voting), £
0.002
par value, authority to allot up to a maximum nominal value of £
149,303
and £
149,633
shares as of September 30, 2026 and December 31, 2025, respectively, and
51,635,820
and
50,689,271
shares issued and outstanding as of September 30, 2026 and December 31, 2025, respectively.
139
136
Deferred shares, £
0.0001
par value,
5,793,501
shares authorized, issued and outstanding as of September 30, 2026 and December 31, 2025.
1
1
Additional paid-in capital
1,286,584
1,240,255
Accumulated deficit
(
833,334
)
(
831,275
)
Accumulated other comprehensive loss
(
33,684
)
(
28,084
)
Total shareholders' equity
419,706
381,033
Total liabilities and shareholders' equity
$
1,129,239
$
1,067,269
The accompanying notes form an integral part of these condensed consolidated financial statements.
2
Table of Contents
Immunocore Holdings plc
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited) (In thousands, except share and per share data)
Three Months Ended September 30,
Nine Months Ended September 30,
2026
2025
2026
2025
Revenue:
Revenue from sale of therapies, net
$
102,222
$
103,693
$
324,826
$
295,538
Total revenue
102,222
103,693
324,826
295,538
Cost and operating expenses:
Cost of revenue from sale of therapies
(
676
)
(
513
)
(
2,198
)
(
2,384
)
Research and development expense
(
74,703
)
(
70,572
)
(
209,761
)
(
196,048
)
Selling, general and administrative expense
(
40,452
)
(
39,779
)
(
122,192
)
(
122,768
)
Loss from operations
(
13,609
)
(
7,171
)
(
9,325
)
(
25,662
)
Other income (expense):
Interest income
3,606
4,123
10,606
12,570
Interest expense
(
3,059
)
(
3,043
)
(
9,172
)
(
9,113
)
Foreign currency gain (loss)
(
1,770
)
1,333
971
3,675
Other income, net
763
5,062
5,609
15,224
Net (loss) income before income taxes
(
14,069
)
304
(
1,311
)
(
3,306
)
Income tax expense
(
153
)
(
481
)
(
748
)
(
2,148
)
Net loss
$
(
14,222
)
$
(
177
)
$
(
2,059
)
$
(
5,454
)
Other comprehensive income (loss)
Exchange differences on translation of foreign operations
646
(
3,392
)
(
5,600
)
3,757
Total comprehensive loss
$
(
13,576
)
$
(
3,569
)
$
(
7,659
)
$
(
1,697
)
Basic and diluted net loss per share
$
(
0.28
)
$
(
0.00
)
$
(
0.04
)
$
(
0.11
)
Basic and diluted weighted-average number of shares outstanding
51,559,315
50,403,717
51,105,338
50,262,697
The accompanying notes form an integral part of these condensed consolidated financial statements.
3
Table of Contents
Immunocore Holdings plc
Condensed Consolidated Statements of Shareholders’ Equity
(Unaudited) (In thousands, except share data)
Ordinary Shares
Deferred Shares
Additional Paid-in Capital
Accumulated
Deficit
Accumulated Other Comprehensive (Loss) Income
Total Shareholders' Equity
Shares
Amount
Shares
Amount
As of December 31, 2025
50,689,271
$
136
5,793,501
$
1
$
1,240,255
$
(
831,275
)
$
(
28,084
)
$
381,033
Net income
—
—
—
—
—
12,971
—
12,971
Other comprehensive loss
—
—
—
—
—
—
(
7,289
)
(
7,289
)
Equity plan options exercised and units
assigned
142,657
1
—
—
655
—
—
656
Share-based compensation expense
—
—
—
—
6,302
—
—
6,302
As of March 31, 2026
50,831,928
$
137
5,793,501
$
1
$
1,247,212
$
(
818,304
)
$
(
35,373
)
$
393,673
Net loss
—
—
—
—
—
(
808
)
—
(
808
)
Other comprehensive income
—
—
—
—
—
—
1,043
1,043
Equity plan options exercised and units
assigned
648,231
1
—
—
16,485
—
—
16,486
Share-based compensation expense
—
—
—
—
9,404
—
—
9,404
As of June 30, 2026
51,480,159
$
138
5,793,501
$
1
$
1,273,101
$
(
819,112
)
$
(
34,330
)
$
419,798
Net loss
—
—
—
—
—
(
14,222
)
—
(
14,222
)
Other comprehensive income
—
—
—
—
—
—
646
646
Equity plan options exercised and units
assigned
155,661
1
—
—
3,753
—
—
3,754
Share-based compensation expense
—
—
—
—
9,730
—
—
9,730
As of September 30, 2026
51,635,820
$
139
5,793,501
$
1
$
1,286,584
$
(
833,334
)
$
(
33,684
)
$
419,706
The accompanying notes form an integral part of these condensed consolidated financial statements.
4
Table of Contents
Immunocore Holdings plc
Condensed Consolidated Statements of Shareholders’ Equity
(Unaudited) (In thousands, except share data)
Ordinary Shares
Deferred Shares
Additional Paid-in Capital
Accumulated
Deficit
Accumulated Other Comprehensive (Loss) Income
Total Shareholders' Equity
Shares
Amount
Shares
Amount
As of December 31, 2024
50,064,860
$
135
5,793,501
$
1
$
1,190,104
$
(
795,761
)
$
(
33,763
)
$
360,716
Net income
—
—
—
—
—
5,023
—
5,023
Other comprehensive income
—
—
—
—
—
—
673
673
Exercise of share options
119,749
—
—
—
2,551
—
—
2,551
Share-based compensation expense
—
—
—
—
9,516
—
—
9,516
As of March 31, 2025
50,184,609
$
135
5,793,501
$
1
$
1,202,171
$
(
790,738
)
$
(
33,090
)
$
378,479
Net loss
—
—
—
—
—
(
10,300
)
—
(
10,300
)
Other comprehensive income
—
—
—
—
—
—
6,476
6,476
Exercise of share options
187,459
—
—
—
3,670
—
—
3,670
Share-based compensation expense
—
—
—
—
10,156
—
—
10,156
As of June 30, 2025
50,372,068
$
135
5,793,501
$
1
$
1,215,997
$
(
801,038
)
$
(
26,614
)
$
388,481
Net loss
—
—
—
—
—
(
177
)
—
(
177
)
Other comprehensive loss
—
—
—
—
—
—
(
3,392
)
(
3,392
)
Exercise of share options
95,886
—
—
—
1,866
—
—
1,866
Share-based compensation expense
—
—
—
—
9,786
—
—
9,786
As of September 30, 2025
50,467,954
$
135
5,793,501
$
1
$
1,227,649
$
(
801,215
)
$
(
30,006
)
$
396,564
The accompanying notes form an integral part of these condensed consolidated financial statements.
5
Table of Contents
Immunocore Holdings plc
Condensed Consolidated Statements of Cash Flows
(Unaudited) (In thousands)
Nine Months Ended September 30,
2026
2025
Cash flows from operating activities
Net loss
$
(
2,059
)
$
(
5,454
)
Adjustments for:
Share-based compensation expense
25,436
29,359
Depreciation
3,080
2,432
Unrealized foreign exchange gains, net
(
1,423
)
(
10,229
)
Unrealized gains on marketable securities
(
5,609
)
(
15,224
)
Non-cash lease expense
1,895
1,681
Other
1,620
1,576
Changes in assets and liabilities:
Increase in accounts receivable
(
15,803
)
(
9,330
)
Increase in prepayments and other current assets
(
12,791
)
(
5,724
)
Decrease in accounts payable
(
3,980
)
(
3,874
)
Increase in accrued expenses
34,259
37,920
Decrease in deferred revenue
(
436
)
(
243
)
(Decrease) increase in operating lease liabilities
(
1,978
)
524
Decrease (increase) in other operating assets
32
(
1,471
)
Net cash provided by operating activities
22,243
21,943
Cash flows from investing activities
Purchase of marketable securities
—
(
30,000
)
Proceeds from sale of marketable securities
13,000
16,000
Purchase of property and equipment
(
4,913
)
(
1,460
)
Net cash provided by (used in) investing activities
8,087
(
15,460
)
Cash flows from financing activities
Proceeds from exercise of share options
20,896
8,087
Net cash provided by financing activities
20,896
8,087
Increase in cash and cash equivalents
51,226
14,570
Net foreign exchange difference on cash held
(
6,690
)
28,112
Cash and cash equivalents at beginning of period
467,709
455,731
Cash and cash equivalents at end of period
$
512,245
$
498,413
Supplemental disclosure of cash flow and noncash information
Cash paid for interest
$
(
10,063
)
$
(
10,063
)
Cash paid for income taxes, net of refunds
$
(
727
)
$
(
3,585
)
Purchases of property and equipment in accounts payable
$
887
$
216
The accompanying notes form an integral part of these condensed consolidated financial statements.
6
Table of Contents
Immunocore Holdings plc
Notes to the Condensed Consolidated Financial Statements
(Unaudited)
1.
Description of business
Immunocore Holdings plc (collectively with its subsidiaries, the “Company”) is a public limited company incorporated in England and Wales and has the following wholly owned subsidiaries: Immunocore Limited, Immunocore LLC, Immunocore Commercial LLC, Immunocore Ireland Limited, Immunocore GmbH, and Immunocore Nominees Limited with operations based primarily in the United Kingdom and United States. The Company is pioneering and delivering transformative immunomodulating medicines to radically improve outcomes for patients with cancer, infectious diseases, and autoimmune diseases. Leveraging its proprietary, flexible, off-the-shelf ImmTAX platform, the Company’s pipeline includes clinical and preclinical programs in oncology, infectious diseases, and autoimmune diseases.
In January and April 2022, the Company received approval from the U.S. Food and Drug Administration ("FDA") and European Commission ("EC"), respectively, for its lead product, KIMMTRAK, for the treatment of unresectable or metastatic uveal melanoma. The Company has subsequently received approvals in further territories, and the Company continues to launch and seek approvals in additional territories. KIMMTRAK is now approved in
39
countries and the Company has commercially launched the product in over
30
countries, including the United States, Germany and France, among other territories.
2.
Summary of significant accounting policies
Basis of presentation
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States ("U.S. GAAP") for interim financial reporting and pursuant to the requirements for reporting on Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information required for the full annual financial statements and should be read in conjunction with the annual consolidated financial statements of the Company for the year ended December 31, 2025, included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (the "SEC") on February 25, 2026 (the "Annual Report").
The accompanying condensed consolidated financial statements contain all normal recurring adjustments necessary to present a fair statement of the financial position, results of operations, and cash flows for the interim periods reported. In the opinion of management, all adjustments considered necessary to present fairly the results of the interim periods have been included and consist only of normal and recurring adjustments. Certain information and footnote disclosures have been condensed or omitted as permitted under U.S. GAAP. The results for the three and nine months ended September 30, 2026 are not necessarily indicative of the results to be expected for the year ending December 31, 2026, or any future year or period.
Use of estimates
The preparation of the condensed consolidated financial statements in conformity with U.S. GAAP requires management to make judgments, estimates and assumptions. These judgments, estimates and assumptions affect the reported assets and liabilities as well as income and expenses in the financial period.
The estimates and associated assumptions are based on information available when the condensed consolidated financial statements are prepared, historical experience and various other factors which are believed to be reasonable under the circumstances, the results of which form the basis of making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources.
Existing circumstances and assumptions about future developments, however, may change due to market changes or circumstances arising that are beyond the Company’s control. Actual results could differ from those estimates. Estimates are primarily made in relation to revenue recognition, operating lease incremental borrowing rates, share-based compensation expense, clinical accruals, and deferred tax asset valuation allowances.
7
Table of Contents
Fair value measurements
Where financial and non-financial assets and liabilities are measured at fair value, the Company uses appropriate valuation techniques for which sufficient data are available, maximizing the use of relevant observable inputs and minimizing the use of unobservable inputs.
As of September 30, 2026 and December 31, 2025, the Company held $
455.0
million and $
366.8
million, respectively, of money market funds required to be measured at fair value on a recurring basis within cash and cash equivalents. In addition, as of September 30, 2026 and December 31, 2025, the Company held $
389.1
million and $
396.4
million of marketable securities, respectively. The Company recorded unrealized gains of $
5.6
million and $
15.2
million for the nine months ended September 30, 2026 and September 30, 2025, respectively, on these marketable securities. The fair value of these cash equivalents and marketable securities is based on quoted prices from active markets (Level 1 inputs). Other financial instruments, although not recorded at fair value on a recurring basis, include cash, accounts receivable, accounts payable and debt obligations.
The fair value of borrowings under the convertible senior notes (the “Notes”, disclosed in Note 5. “Interest-bearing loans and borrowings”) were based on Level 2 inputs, which include observable inputs estimated using discounted cash flows and market-based expectations for interest rates, credit risk, and the contractual terms of debt instruments. After initial recognition, borrowings are measured at amortized cost using the effective interest method.
Significant accounting policies
The significant accounting policies used in the preparation of these condensed consolidated financial statements as of and for the three and nine months ended September 30, 2026 are consistent with those disclosed in No
te 2. "Summary of Significant Accounting Policies"
in the audited consolidated financial statements for the year ended December 31, 2025, included in the Company’s Annual Report.
Recently issued and recently adopted accounting pronouncements
In November 2024, the FASB issued ASU 2024-03, Income Statement – Reporting Comprehensive Income – Expense Disaggregation Disclosures (Subtopic 220-40). This ASU requires disclosure in the notes to the financial statements, at each interim and annual reporting period, of specified information about certain costs and expenses including purchases of inventory, employee compensation, depreciation and intangible asset amortization included in each relevant expense caption. Also required is a qualitative description of the amounts remaining in relevant expense captions that are not separately disaggregated. This ASU is effective for all public entities for annual reporting periods beginning after December 15, 2026, and interim periods within annual reporting periods beginning after December 15, 2027, and early adoption is permitted. This ASU should be applied either prospectively to financial statements issued after the effective date of this update or retrospectively to any or all prior periods presented in the financial statements. The Company is currently evaluating these new disclosure requirements and the impact of adoption on its financial statements.
3.
Revenue
During the three and nine months ended September 30, 2026, the Company recognized $
102.2
million and $
324.8
million, respectively (2025: $
103.7
million and $
295.5
million, respectively), of net revenue from sale of therapies relating to the sale of KIMMTRAK primarily in the United States and Europe after estimated deductions for rebates, chargebacks and returns, which are recognized in Accrued expenses and other current liabilities and Accrued expenses, non-current, as set out in the Company’s accounting policies included in the Annual Report.
Revenue from sale of therapies, net is presented by country / region based on the location of the end customer below (in thousands):
Three Months Ended September 30,
Nine Months Ended September 30,
2026
2025
2026
2025
United States
$
62,224
$
67,300
$
204,599
$
187,994
Europe
34,923
33,526
103,460
99,372
International
5,075
2,867
16,767
8,172
Revenue from sale of therapies, net
$
102,222
$
103,693
$
324,826
$
295,538
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Revenue from sale of therapies, net for the three and nine months ended September 30, 2026 included $
9.9
million and $
30.9
million, respectively (2025: $
6.2
million and $
18.8
million, respectively), of partnered revenue pursuant to the Company's separate agreements with Medison Pharma Ltd. ("Medison") and Er-Kim Pharmaceuticals Bulgaria EOOD. Revenue from these agreements is allocated between the Company's European and International markets.
Accounts receivable from contracts with customers
Accounts receivable as of September 30, 2026 and December 31, 2025 were $
88.0
million and $
74.0
million, respectively. An allowance for lifetime expected credit losses on accounts receivable is measured using historical credit loss experience, conditions at the end of each reporting period, and reasonable and supportable forecasts that affect collectability. Expected credit losses as of September 30, 2026 and December 31, 2025 were immaterial.
Accruals for rebates, chargebacks and returns
Current and non-current accruals for rebates, chargebacks and returns as of September 30, 2026 were as follows (in thousands):
Rebates
Chargebacks
Returns
Total
As of December 31, 2025
$
129,531
$
2,682
$
567
$
132,780
Provisions recorded in the period
77,891
33,020
1,600
112,511
Credits and payments made
(
34,566
)
(
32,940
)
(
1,159
)
(
68,665
)
As of September 30, 2026
$
172,856
$
2,762
$
1,008
$
176,626
Included in the above are non-current accruals for rebates, chargebacks and returns of $
41.6
million and $
0.0
million as of September 30, 2026 and December 31, 2025, respectively, as these amounts are not required to be paid in the twelve months from the balance sheet date.
Deferred revenue
Current and non-current deferred revenue as of September 30, 2026 and December 31, 2025 relates to a revised distribution agreement with Medison entered into in November 2022. Under the revised agreement, the Company received a non-refundable payment of $
5.0
million in exchange for granting Medison exclusive distribution rights in South America. The Company has determined that the deferred revenue relates to the Company’s single, combined performance obligation to supply KIMMTRAK to Medison and to grant Medison the exclusive right to distribute KIMMTRAK in South America. The revenue will be recognized on a straight-line basis over the term of the contract of
10
years from the date of the first commercial sale in the territory. Following the first commercial sale in the territory during the three months ended June 30, 2025, the Company began recognizing this revenue within net revenue from sale of therapies and consequently the Company classifies the portion of deferred revenue expected to be recognized over the next twelve months as current.
4.
Accrued expenses and other current liabilities
Accrued expenses and other current liabilities consisted of the following (in thousands):
September 30,
2026
December 31,
2025
Rebates, chargebacks and returns
$
135,026
$
132,780
Clinical accruals
38,494
40,945
Employee related expenses
12,523
16,542
Contract manufacturing
8,170
17,143
Interest accruals
1,677
4,193
Commercial services
2,705
2,349
Other accruals
7,299
5,792
$
205,894
$
219,744
See Note 3. “Revenue” for a breakdown of rebates, chargebacks and returns.
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Clinical accruals primarily represent unbilled work undertaken by contract research organizations as part of the advancement of the Company's clinical programs.
5.
Interest-bearing loans and borrowings
Interest-bearing loans and borrowings consisted of the following as of September 30, 2026 (in thousands):
Fair Value
Principal Amount
Unamortized Debt Issuance Costs
Net Carrying Amount
Amount
Level
Convertible senior notes
$
402,500
$
(
7,750
)
$
394,750
$
363,578
Level 2
Interest-bearing loans and borrowings consisted of the following as of December 31, 2025 (in thousands):
Fair Value
Principal Amount
Unamortized Debt Issuance Costs
Net Carrying Amount
Amount
Level
Convertible senior notes
$
402,500
$
(
9,375
)
$
393,125
$
363,538
Level 2
See Note 7 to our financial statements in our Annual Report on Form 10-K for the year ended December 31, 2025 for a complete description of the terms of the Notes. No material changes have occurred since that date.
Interest expense consisted of the following (in thousands):
Three Months Ended September 30,
Nine Months Ended September 30,
2026
2025
2026
2025
Convertible senior notes
Coupon interest
$
2,516
$
2,516
$
7,547
$
7,547
Amortization of debt issuance costs
543
527
1,625
1,566
Total interest expense
$
3,059
$
3,043
$
9,172
$
9,113
Issuance costs incurred with the notes were $
13.4
million and are being amortized as interest expense on an effective interest rate method over the expected life of the notes, through February 2030, at an effective interest rate of
3.06
%.
6.
Share-based compensation
The following table shows the total share-based compensation expense recorded in the Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands):
Three Months Ended September 30,
Nine Months Ended September 30,
2026
2025
2026
2025
Research and development
$
2,916
$
2,168
$
8,303
$
6,667
Selling, general and administrative
$
6,814
$
7,669
$
17,133
$
22,692
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Equity Incentive Plan
Under the Company’s Equity Incentive Plan ("EIP"), the Company may grant market value options, share appreciation rights or restricted shares, restricted share units ("RSUs"), performance share units and other share-based awards to the Company’s employees. The Company’s board members and consultants are eligible to receive awards under the Company’s non-employee sub-plan to the EIP. Awards may be granted at such times as the Company may determine, but will generally be granted annually following the end of the financial year. Awards vest at such times and as specified in the award agreement, typically being over a
four-year
period, although the Company retains the discretion to provide for other vesting schedules. If the participant violates the non-competition, non-solicitation, confidentiality or other similar restrictive covenant provisions of any employment contract, the right of the participant to receive these shares on vesting shall terminate immediately. The Company maintains discretion over the type and terms of equity awards granted. Share options lapse on the
ten
th anniversary from the date of grant, and they are not subject to performance conditions or entitled to dividends. As of September 30, 2026, the Company has reserved
6,967,770
authorized shares for future issuance under the EIP.
Share option activity
The number and weighted average exercise prices of share options were as follows:
Number of Share Options
Weighted Average Exercise Price
Weighted Average Remaining Contractual Term
Aggregate Intrinsic Value (in thousands)
Outstanding as of December 31, 2025
10,374,316
$
31.34
5.9
years
$
87,338
Awards granted
1,729,075
31.97
Awards exercised
(
827,511
)
25.21
Awards forfeited
(
353,822
)
42.33
Awards expired
(
209,004
)
59.72
Outstanding as of September 30, 2026
10,713,054
$
30.99
5.7
years
$
46,340
Exercisable as of September 30, 2026
7,858,731
$
29.40
4.6
years
$
45,452
As of September 30, 2026, total unrecognized compensation expense related to share options granted but not vested was $
23.4
million, which the Company expects to recognize over a remaining weighted-average period of
1.6
years.
Awards granted in the three and nine months ended September 30, 2026 and 2025 have been valued using the Black-Scholes option pricing model. The assumptions used in the models for share options granted were as follows:
Three Months Ended September 30,
Nine Months Ended September 30,
2026
2025
2026
2025
Share price at grant date
$
31.65
$
33.28
$
28.52
- $
34.71
$
28.63
- $
33.28
Exercise price
$
31.65
$
33.28
$
28.52
- $
34.71
$
28.63
- $
33.28
Expected volatility
50.07
%
52.82
%
50.07
% -
53.52
%
52.82
% -
55.78
%
Expected life
5.5
years
5.5
years
5.5
years
5.5
years
Risk free rate
4.27
%
4.04
%
3.68
% -
4.27
%
3.94
% -
4.41
%
Fair value
$
16.08
$
17.42
$
14.55
- $
17.62
$
15.11
- $
17.42
Restricted share unit activity
In February 2025, the Company introduced RSU awards that vest over a
four-year
service period with
25
% on each anniversary of the grant date. An RSU award represents the right to receive
one
of the Company’s American Depositary Shares ("ADSs") upon vesting of the RSU. The fair value of each RSU award is based on the closing price of the ADSs on Nasdaq on the date of grant.
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Table of Contents
The number and weighted average fair value of RSU awards were as follows:
Number of RSUs
Weighted Average Grant Date Fair Value
Unvested and outstanding as of December 31, 2025
496,156
$
29.88
Awards granted
638,799
32.33
Awards vested
(
119,038
)
29.70
Awards forfeited
(
102,160
)
30.66
Unvested and outstanding as of September 30, 2026
913,757
$
31.53
As of September 30, 2026, total unrecognized compensation expense related to RSU awards granted but not vested was $
15.8
million, which the Company expects to recognize over a remaining weighted-average period of
2.0
years.
7.
Basic and diluted net (loss) income per share
Basic and diluted net (loss) income per share is calculated as follows (in thousands, except share and per share amounts):
Three Months Ended September 30,
Nine Months Ended September 30,
2026
2025
2026
2025
Net loss
$
(
14,222
)
$
(
177
)
$
(
2,059
)
$
(
5,454
)
Basic and diluted weighted-average number of shares outstanding
51,559,315
50,403,717
51,105,338
50,262,697
Basic and diluted net loss per share
$
(
0.28
)
$
(
0.00
)
$
(
0.04
)
$
(
0.11
)
The potential shares from outstanding share options and RSUs of
11,626,811
as of September 30, 2026 (September 30, 2025:
11,064,752
), have been excluded from the calculation of diluted net loss per share due to their anti-dilutive effect.
For the three and nine months ended September 30, 2026, shares issuable upon the potential conversion of all of the Notes were excluded from the calculation of diluted net (loss) income per share due to their anti-dilutive effect.
8.
Income taxes
Income tax expense is recognized at an amount determined by multiplying the net income (loss) before income taxes for the interim reporting period by the Company’s estimated annual effective tax rate, adjusted for the tax effect of certain items recognized in full in the interim period. As such, the effective tax rate in the condensed consolidated financial statements may differ from the Company’s estimate of the effective tax rate for the Company’s consolidated financial statements for the year ending
December 31, 2026
.
The Company’s co
nsolidated estimated effective tax rate for the three and nine months ended September 30, 2026, was (
1.1
)% and (
57.1
)%, respectively. The change in effective tax rate for the three months ended September 30, 2026, as compared to the nine months ended September 30, 2026, is driven by a loss before tax of $
14.1
million for the three months ended September 30, 2026, in contrast to a loss before tax of $
1.3
million for the nine months ended September 30, 2026. During the three and nine months ended September 30, 2026, the Company recorded a tax expense of $
0.2
million and $
0.7
million, respectively (September 30, 2025: tax expense of $
0.5
million and $
2.1
million, respectively). For the
three and nine
months ended
September 30, 2026
, the Company excluded the United Kingdom and the United States from the calculation of the annual estimated tax rate as the Company anticipates an ordinary loss in these jurisdictions for which the tax benefit cannot be recognized.
The Company benefits from the U.K. large company Research & Development Expenditure Credit ("RDEC") regime which can generate a cash rebate of up t
o
15
%
of qualifying research and development expenditures incurred after April 1, 2023. Tax credits receivable under the RDEC regime are recorded "above the line" as a reduction from research and development expenses.
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Table of Contents
No
deferred tax assets have been recognized as of
September 30, 2026
and
December 31, 2025. The majority of the Company’s deferred tax assets relate to net operating loss and R&D carryforwards that can only be realized if the Company is profitable in future periods. Accordingly, the Company has provided a valuation allowance against the full amount of the net deferred tax assets due to uncertainties as to their ultimate realization
.
9.
Segment information
The Company operates in
one
operating segment: immunotherapies, which is focused on pioneering and delivering transformative immunomodulating medicines in the areas of cancer, infectious diseases and autoimmune diseases.
The Company primarily generates revenue from
one
stream, revenue from the sale of therapies, which consists of sales of KIMMTRAK. The Company manages its business activities on a consolidated basis. Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker ("CODM"), the Chief Executive Officer, in making decisions regarding resource allocation and assessing performance. The measure of the segment profit or loss used is consolidated net loss, and the measure of segment assets is reported on the condensed consolidated balance sheet as total assets. The accounting policies of the immunotherapies segment are the same as those described in Note 2. "Summary of significant accounting policies".
The following table summarizes the reportable segment's financial information (in thousands):
Three Months Ended September 30,
Nine Months Ended September 30,
2026
2025
2026
2025
Revenue
$
102,222
$
103,693
$
324,826
$
295,538
Less:
Cost of revenue from sale of therapies
(
676
)
(
513
)
(
2,198
)
(
2,384
)
External research and development (R&D) expenses:
PRAME programs
(
24,159
)
(
21,967
)
(
65,464
)
(
59,950
)
Tebentafusp programs
(
10,306
)
(
11,789
)
(
30,408
)
(
30,196
)
Infectious disease programs
(
1,965
)
(
1,347
)
(
3,336
)
(
4,077
)
All other external clinical and preclinical costs
(
11,599
)
(
15,551
)
(
36,444
)
(
42,035
)
Total external R&D expenses
(
48,029
)
(
50,654
)
(
135,652
)
(
136,258
)
R&D salaries and other employee-related costs
(
13,824
)
(
11,932
)
(
42,222
)
(
35,882
)
Selling, general and administrative (SG&A) salaries and other employee-related costs
(
13,410
)
(
14,038
)
(
40,406
)
(
39,083
)
Other SG&A expenses
(
20,280
)
(
18,071
)
(
64,692
)
(
60,992
)
Other segment expense, net (a)
(
20,225
)
(
8,662
)
(
41,715
)
(
26,393
)
Segment and consolidated net loss
$
(
14,222
)
$
(
177
)
$
(
2,059
)
$
(
5,454
)
(a) Other segment expenses, net includes other internal R&D expenses, share-based compensation expense, R&D tax credits, interest income, interest expense, foreign currency gain, other income, net and income tax expense (benefit).
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10.
Commitments and contingencies
Lease commitments
The maturities of operating lease liabilities as of September 30, 2026 were as follows (in thousands):
Remainder of 2026
$
1,925
2027
5,810
2028
5,537
2029
5,282
2030 and thereafter
49,686
Total lease payments
68,240
Less imputed interest
(
27,253
)
Present value of operating lease liabilities
$
40,987
Future lease commitments - leases not yet commenced
$
4,898
Future lease commitments - leases not yet commenced
The Company has entered into a non-cancellable lease agreement for premises that will commence in 2028 and end in 2031, with total future minimum lease payments of $
3.0
million. During October 2026, the Company entered into an additional non-cancellable lease agreement for premises that commenced on October 1, 2026 and will end in 2036, with total future minimum lease payments of $
1.9
million. These amounts are not included in the present value of operating lease liabilities above as the leases had not commenced as of September 30, 2026.
Manufacturing commitments
The Company enters into a number of manufacturing commitments for the future purchase of materials and contract manufacturing services. While the majority of such contracts can be cancelled on reasonable notice, due to the significant ongoing expenditure associated with the Company’s programs, the Company estimates it has non-cancellable commitments in relation to the development and supply of product candidates totaling $
25.1
million, the majority of which are estimated to be paid within twelve months from the balance sheet date.
Gates collaboration
Under the terms of the Company’s agreement with the Gates Foundation, the Company is required to develop, manufacture and commercialize soluble TCR bispecific therapeutic candidates targeted to mutually agreed neglected diseases, currently HIV, with the potential to treat people at an affordable price in developing countries. In the event of certain defaults by the Company under the agreement, which the Company considers to be within its control, the Gates Foundation has the right to sell, or require the Company to buy back, any of the shareholdings in the Company held by the Gates Foundation. In such an event, if within 12 months after such redemption or sale, the Company experiences a change in control at a valuation of more than
150
% of the valuation used for the redemption or the sale of the shares, the Company has agreed to pay the Gates Foundation compensation equal to the excess of what it would have received in such transaction if it still held its shares at the time of such change of control over what it received in the sale or redemption of its shares.
Other agreements
The Company has also entered into
collaboration and license agreements which provide for various future milestone payments upon the achievement of specified development, regulatory, commercial and sales-based milestones, as well as potential future royalty and other payments. These future milestone payments are contingent upon future events that are not considered probable of achievement as of September 30, 2026. As of September 30, 2026, the Company was unable to estimate the timing or likelihood of achieving these milestones, due to the early stage of development.
Legal proceedings
The Company is not currently a party to any material legal proceedings.
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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
You should read the following discussion and analysis of our financial condition and results of operations together with our condensed consolidated financial statements and the related notes thereto appearing elsewhere in this Quarterly Report. The accompanying MD&A, including all periods presented, has been prepared under U.S. GAAP. Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties. We also recommend that you read our discussion and analysis of financial condition and results of operations together with our audited financial statements and notes thereto, and the section titled “Risk Factors” each of which appear in our Annual Report on Form 10-K for the year ended December 31, 2025 as filed with the SEC on February 25, 2026 (the "Annual Report") as well as the section titled “Special Note Regarding Forward-Looking Statements".
Overview
We are a commercial stage biotechnology company pioneering and delivering transformative immunomodulating medicines to radically improve outcomes for patients with cancer, infectious diseases, and autoimmune diseases. Leveraging our proprietary, flexible, off-the-shelf ImmTAX
platform, we are developing a deep pipeline in multiple therapeutic areas, including clinical stage programs in oncology, infectious disease, and autoimmune diseases, an advanced preclinical program in autoimmune disease and earlier preclinical programs across three therapeutic areas.
In 2022, we received approval for our lead product, KIMMTRAK (tebentafusp), for the treatment of unresectable or metastatic uveal melanoma ("mUM") from the FDA, the European Commission, and other health authorities. KIMMTRAK is now approved in 39 countries and we have commercially launched KIMMTRAK in over
30
countries, including the United States, Germany and France, among other territories.
KIMMTRAK is the lead product from our ImmTAX platform and was the first approved therapy in mUM. To date, we have treated over 5,000 cancer patients with KIMMTRAK, and our other ImmTAX product candidates, which we believe is the largest clinical data set of any T cell engager bispecific in solid tumors and any TCR therapeutic. Our clinical programs are being conducted with patients with a broad range of cancers including melanoma, ovarian, lung, and colorectal, among others. We believe that these tumor types have large addressable patient populations and significant unmet need. We are progressing three late-stage clinical programs within our ImmTAC® portfolio, including KIMMTRAK and PRAME-targeted brenetafusp.
Since our inception, we have focused on organizing and staffing our company, raising capital, performing research and development activities to advance our research, development and technology, and commercialization of KIMMTRAK. While we have successfully generated revenue from KIMMTRAK, which is our first marketed product, our ability to generate higher levels of revenue from other marketed products, which may never be fully developed or commercialized, depends on the successful development and regulatory approval of one or more of our product candidates and our ability to finance operations. We have raised funds through our initial public offering, private placements of our ordinary and preferred shares, debt financings, revenue and historical payments from our collaboration partners. These funds have been and are being used to fund operations and invest in activities for technology creation, drug discovery and clinical development programs, infrastructure, creation of portfolio of intellectual property and commercial and administrative support.
We have incurred significant operating losses and expect to continue to incur significant expenses and operating losses for the near future. We had net losses of $2.1 million and $5.5 million for the nine months ended September 30, 2026 and 2025, respectively. As of September 30, 2026, our accumulated deficit was $833.3 million. We expect to continue to incur significant and increasing expenses and to incur operating losses for the foreseeable future, as we advance our product candidates through preclinical and clinical development and seek regulatory approvals, manufacture drug supplies, maintain and expand our intellectual property portfolio, as well as hire additional personnel, pay for further accounting, audit, legal, regulatory and consulting services, and pay costs associated with director and officer liability insurance, investor and public relations activities and other expenses associated with operating as a public company.
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Table of Contents
We do not expect to generate revenue from the sale of our other product candidates unless and until we successfully complete clinical development of and obtain regulatory approval for such product candidates. As a result, we may need additional funding to support our continued operations and pursue our clinical development and growth strategy. Until we can generate sufficient revenue from product sales, if ever, we expect to finance our operations through a combination of public or private equity offerings, debt financings, government funding arrangements, collaborations and marketing and distribution and licensing arrangements. We may be unable to raise additional funds or enter into such other arrangements on favorable terms, or at all, particularly in light of recently worsening macroeconomic conditions, such as supply chain disruptions, fluctuations in interest rates and volatility in the capital markets. If we fail to raise capital or enter into such arrangements as, and when, needed, we may have to significantly delay, scale back or discontinue the development and commercialization of one or more of our programs.
Because of the numerous risks and uncertainties associated with pharmaceutical development, we are unable to predict the timing or amount of future revenues, increased expenses or when or if we will be able to achieve or maintain profitability. If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and may be forced to reduce our operations.
Recent Developments
We have achieved target enrollment of 540 patients in the registrational Phase 3 TEBE-AM trial, evaluating tebentafusp as monotherapy, and in combination with pembrolizumab, versus a control arm in patients with previously treated advanced cutaneous melanoma. The trial is event-driven and topline overall survival data is expected in the second quarter of 2027.
The five-year overall survival data from the Phase 3 trial of KIMMTRAK in patients with unresectable or mUM, which were presented at the AACR 2026 meeting, have been accepted by the European Medicines Agency for inclusion in the European SmPC (Summary of Product Characteristics). This addition to the SmPC will allow us to engage more broadly with healthcare professionals in the region about the data.
We will present data from our Phase 1/2 trial evaluating brenetafusp alone and in combination with KIMMTRAK in HLA-A*02:01-positive patients with mUM, in a poster session, on Friday, November 6, at 12:00 p.m. ET, at the 2026 Society for Immunotherapy of Cancer (SITC) Annual Meeting. The data will also be presented in an oral session on Saturday, November 7, at 3:45 p.m. ET. The data from the abstract include:
•
As of June 2026, 22 HLA-A*02:01 positive patients with mUM received brenetafusp monotherapy at clinically active doses and 26 received the combination of tebentafusp and brenetafusp in the Phase 1/2 trial.
•
We believe that these are the first data showing clinical activity and a manageable safety profile for a combination of two T cell engagers in a solid tumor.
•
The most common brenetafusp monotherapy treatment-related adverse events (TRAEs) were reversible and manageable cytokine release syndrome (CRS) (73%) and rash (50%) consistent with the molecule’s mechanism of action. Grade 3/4 TRAEs were primarily transient lymphocyte decrease, consistent with mechanism and which resolved without intervention. Combination regimens were generally well-tolerated, with Grade 1/2 CRS and rash (77% each). The most common TRAEs were Grade 1/2 CRS and rash (77% each). These attenuated over time with no Grade ≥3 CRS reported. No TRAE led to discontinuation or death.
•
Among the 16 evaluable patients who received brenetafusp monotherapy in the second-line or later setting, overall response rate (ORR) was 19%, median duration of response (mDoR) was 14.5 months, median progression-free survival (mPFS) was 4.2 months, and median overall survival (OS) was 20.3 months.
•
Across the 17 evaluable first-line patients who received the combination, ORR was 29%, mDoR was 24.1 months, mPFS was 8.1 months, and median OS was not yet reached with 29 months of follow-up and 10 patients still on study. The two-year OS rate was 70%.
•
Based on these data, we are planning to start DUET-UVEAL, a randomized Phase 2/3 trial, to evaluate the combination for the treatment of HLA-A*02:01-positive adults with unresectable or metastatic uveal melanoma.
We expect to present clinical data for brenetafusp from the ovarian and lung cohorts in the Phase 1/2 trial at a medical conference later this year.
In October 2026, we announced that the first person with type 1 diabetes has been dosed in the Phase 1 trial of IMC-S118AI, our first tissue-specific autoimmune candidate.
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Components of Results of Operations
Revenue
Revenue from sale of therapies, net
Revenue from sale of therapies, net relates to the sale of KIMMTRAK following marketing approval. We recognize net revenue from sale of therapies at the point in time that control transfers to a customer, which is typically on delivery to our distributors and healthcare providers. We also operate under consignment arrangements where control passes when our distributors take KIMMTRAK out of consignment inventory. The amount of revenue recognized reflects the consideration to which we expect to be entitled, net of estimated deductions for rebates, chargebacks and product returns. These estimates consider contractual and statutory requirements, the expected payor and patient mix, sell-through data, our customers’ inventory levels, anticipated demand and the volume of customer purchase orders, internal data, and other information provided by our customers and third-party logistics providers, and in certain countries, pricing negotiations. Further information on estimates is provided under the section below headed, “Critical Accounting Estimates”.
Operating Expenses
Cost of revenue from sale of therapies
Cost of revenue from sale of therapies represents production costs including raw materials, external manufacturing costs, and other costs incurred in bringing inventories to their location and condition prior to sale. Cost of revenue from sale of therapies may also include costs related to manufacturing losses and excess or obsolete inventory costs. Overheads and internal costs of revenue from sale of therapies are minimal under our manufacturing arrangements.
Research and development expenses
Research and development ("R&D") expenses consist primarily of costs incurred for current or planned investigations undertaken with the prospect of gaining new scientific or technical knowledge and understanding. R&D expenses consist primarily of employee-related costs, including salaries and share-based compensation expense, costs associated with clinical trial activities undertaken by contract research organizations, and external manufacturing costs associated with R&D undertaken by contract manufacturing organizations ("CMOs"), laboratory consumables, internal clinical trial expenses, payments for purchased rights and milestones in connection with third-party in-process R&D agreements, costs associated with maintaining laboratory equipment, costs associated with our R&D facilities, including a reasonable allocation of overhead costs, and reductions from expenses for R&D tax credits. R&D expenses are expensed as incurred, although the timing of expense recognition can vary with contractual and payment terms in order to determine when services are received.
R&D expenses incurred with external organizations to undertake R&D activities on our behalf typically relate to clinical programs and are assigned to the individual programs in tables further below. However, for certain preclinical programs and other research spend incurred externally, such spend is not assigned to individual programs. Internal R&D expenses primarily relate to employee-related costs, facilities, information technology used in R&D activities and laboratory consumables. Due to the cross functional expertise of our people, it is not possible to provide a breakdown of internal costs by program.
We expect our R&D expenses to increase in the future as we advance existing and future product candidates into and through clinical studies and pursue further regulatory approval. The process of conducting the necessary clinical studies to obtain regulatory approval is costly and time-consuming. We maintain our headcount at a level required to support our continued research activities and development of our product candidates. Clinical trials generally become larger and more costly to conduct as they advance into later stages. We cannot determine with certainty the timing of initiation, the duration or the completion costs of current or future preclinical studies and clinical trials of our product candidates due to the inherently unpredictable nature of preclinical and clinical development. Clinical and preclinical development timelines, the probability of success and development costs can differ materially from expectations. At this time, we cannot reasonably estimate or know the nature, timing and estimated costs of the efforts that will be necessary to complete the development of any product candidates that we develop from our programs. As a result, our R&D expenses may vary substantially from period to period based on the timing of our R&D activities.
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Research and development tax credits
As a company that carries out extensive R&D activities, we benefit from the U.K. R&D tax regime. For the periods ended September 30, 2026 and 2025, we claimed credits under the Research and Development Expenditure Credit ("RDEC") program and these credits are presented as a reduction to R&D expenses.
Under the RDEC program, tax credits for qualifying R&D expenses are granted at a headline rate of 20% and can generate cash rebates of up to 15% of qualifying R&D expenses.
Recent amendments to the U.K. R&D tax credit regime introduced restrictions on the tax relief that can be claimed for expenses incurred on subcontracted R&D activities or externally provided workers for accounting periods beginning on or after April 1, 2024. Under these rules, relief is generally not available where such subcontracted activities are not carried out in the United Kingdom or such workers are not subject to U.K. payroll taxes, subject to limited exceptions.
Selling, general and administrative expenses
Selling, general and administrative ("SG&A") expenses consist primarily of employee-related costs, including salaries and share-based compensation expense, for selling, corporate and other administrative and operational functions including finance, legal, human resources, commercial-related expenses, information technology, as well as a proportion of facility-related costs.
In order to support our continued commercialization and global expansion of KIMMTRAK, R&D activities, and our operations as a public company, we expect that we will continue to incur selling, distribution, commercial, accounting, audit, legal, regulatory, compliance, director and officer insurance costs, as well as investor and public relations expenses. Additionally, if and as we receive further regulatory approvals of product candidates, we anticipate an increase in employee-related costs and expenses in connection with our commercial operations. We have experienced, and may continue to experience, increased employee-related costs attributable to offering and maintaining competitive salaries and other impacts due to global inflation.
Interest income
Interest income arises on cash balances and short-term money market funds. Our interest income may fluctuate depending on the movement of interest rates and our total amount of cash and cash equivalents.
Interest expense
Interest expense represents costs under our interest-bearing loans and borrowings under the effective interest method.
Foreign currency (losses) gains
Foreign currency (losses) gains arise on a variety of items, including on U.S. dollar monetary assets and liabilities held by our main operating subsidiary in the United Kingdom, including cash and cash equivalents.
Other income, net
Other income, net consists primarily of unrealized gains (losses) resulting from the change in fair value of our marketable securities and also includes loan and borrowing costs and other items.
Income tax (expense) benefit
We are subject to corporate taxation in the United Kingdom and our wholly-owned subsidiaries are subject to corporate taxation in the United States, Ireland and Switzerland. Due to the nature of our business and on a consolidated basis, we have generated cumulative losses since inception. Our income tax expense represents the sum of income taxes payable in Ireland and Switzerland, offset by movements in our deferred tax assets.
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Unsurrendered tax losses are carried forward to be offset against future taxable profits. After accounting for tax credits receivable, there were accumulated tax losses available for carry forward in the United Kingdom and United States of $773.7 million and $113.6 million, respectively, as of September 30, 2026. A full valuation allowance is recognized in respect of accumulated tax losses and other temporary differences in the United Kingdom and United States because future profits are not sufficiently certain.
As we generate significant net revenue from sale of therapies, we are able to benefit from the U.K.’s “patent box” regime, which allows profits attributable to revenues from patents or patented products to be taxed at a lower rate than other revenue. We have filed the patent box election for the 2023 and 2024 tax years and intend to file the patent box election for 2025 and subsequent years, if applicable. The effective rate of tax for relevant streams of revenue for companies receiving this relief is 10%.
Comparison of the Three Months Ended September 30, 2026 and 2025
Revenue
The following table summarizes our total revenue (in thousands):
Three Months Ended September 30,
2026
2025
Increase /
(decrease)
% Increase /
(decrease)
Revenue from sale of therapies, net
$
102,222
$
103,693
$
(1,471)
(1.4)
%
Total revenue
$
102,222
$
103,693
$
(1,471)
(1.4)
%
Revenue from sale of therapies, net
Revenue from sale of therapies, net is presented by country / region based on location of the end customer in the table below (in thousands):
Three Months Ended September 30,
2026
2025
Increase /
(decrease)
% Increase /
(decrease)
United States
$
62,224
$
67,300
$
(5,076)
(7.5)
%
Europe
34,923
33,526
1,397
4.2
%
International
5,075
2,867
2,208
77.0
%
Revenue from sale of therapies, net
$
102,222
$
103,693
$
(1,471)
(1.4)
%
For the three months ended September 30, 2026, we generated net revenue from sale of therapies of $102.2 million due to the sale of KIMMTRAK, of which $62.2 million was in the United States, $34.9 million in Europe and $5.1 million in International regions. Revenue from sale of therapies, net decreased in the three months ended September 30, 2026 compared to the three months ended September 30, 2025, primarily due to an impact on US net sales in the third quarter of 2026 from (i) wholesaler stocking that occurred in the second quarter of 2026 and (ii) one additional week of sales in the third quarter of 2025.
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R&D Expenses
The following table summarizes our R&D expenses (in thousands):
Three Months Ended September 30,
2026
2025
Increase /
(decrease)
% Increase /
(decrease)
External R&D expenses:
PRAME programs
$
24,159
$
21,967
$
2,192
10.0
%
Tebentafusp programs
10,306
11,789
(1,483)
(12.6)
%
Infectious disease programs
1,965
1,347
618
45.9
%
All other external clinical and preclinical costs
11,599
15,551
(3,952)
(25.4)
%
Total external R&D expenses
48,029
50,654
(2,625)
(5.2)
%
Internal R&D expenses:
Salaries and other employee-related costs
13,824
11,932
1,892
15.9
%
Share-based compensation expense
2,916
2,168
748
34.5
%
All other internal R&D costs
11,287
8,055
3,232
40.1
%
U.K. R&D tax credits
(1,353)
(2,237)
884
(39.5)
%
Total internal R&D expenses
26,674
19,918
6,756
33.9
%
Total R&D expenses
$
74,703
$
70,572
$
4,131
5.9
%
For the three months ended September 30, 2026, our R&D expenses were $74.7 million, compared to $70.6 million for the three months ended September 30, 2025.
For the three months ended September 30, 2026, our external R&D expenses decreased by $2.6 million primarily due to a net decrease in all other external clinical and preclinical costs of $4.0 million related to timing of manufacturing activities in the pipeline, primarily for our autoimmune programs, and a decrease of $1.5 million in expenses incurred for our tebentafusp programs as a result of the timing of costs associated with the ATOM clinical trial. These decreases were partially offset by an increase of $2.2 million in expenses incurred for our PRAME programs, primarily driven by higher costs associated with enrollment in our PRISM-MEL-301 Phase 3 clinical trial, partially offset by lower costs following decreased patient enrollment in the PRAME-101 Phase 1/2 clinical trial.
For the three months ended September 30, 2026, our internal R&D expenses increased by $6.8 million primarily due to increases in all other internal R&D costs and salaries and other employee-related costs in connection with the advancement of our clinical and preclinical programs.
SG&A Expenses
For the three months ended September 30, 2026, our SG&A expenses were $40.5 million, compared to $39.8 million for the three months ended September 30, 2025, reflecting an increase of $0.7 million. This increase was primarily due to costs related to business support functions to support our growing pipeline and global commercial expansion.
Interest Income and Interest Expense
For the three months ended September 30, 2026, interest income was $3.6 million, compared to $4.1 million for the three months ended September 30, 2025. This decrease of $0.5 million was due to lower interest rates earned on our money market funds. For the three months ended September 30, 2026, interest expense on our convertible senior notes was $3.1 million, compared to $3.0 million for the three months ended September 30, 2025.
Foreign Currency (Loss) Gain
For the three months ended September 30, 2026, foreign currency loss was $1.8 million, compared to a gain of $1.3 million for the three months ended September 30, 2025. This movement of $3.1 million reflects adverse exchange rate movements of the U.S. dollar against the pound sterling and the euro when comparing the three months ended September 30, 2026 with the three months ended September 30, 2025.
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Other Income, Net
For the three months ended September 30, 2026, other income, net was $0.8 million, compared to $5.1 million for the three months ended September 30, 2025. This decrease was due to lower unrealized gains due to less favorable interest rates impacting our marketable securities in the three months ended September 30, 2026 compared to the three months ended September 30, 2025.
Income Tax Expense
For the three months ended September 30, 2026, the income tax expense was $0.2 million, compared to $0.5 million for the three months ended September 30, 2025. This change was primarily the result of lower forecasted taxable income in the United States and Ireland for 2026 compared to 2025.
Comparison of the Nine Months Ended September 30, 2026 and 2025
Revenue
The following table summarizes our total revenue (in thousands):
Nine Months Ended September 30,
2026
2025
Increase /
(decrease)
% Increase /
(decrease)
Revenue from sale of therapies, net
$
324,826
$
295,538
$
29,288
9.9
%
Total revenue
$
324,826
$
295,538
$
29,288
9.9
%
Revenue from sale of therapies, net
Revenue from sale of therapies, net is presented by country / region based on location of the end customer below (in thousands).
Nine Months Ended September 30,
2026
2025
Increase /
(decrease)
% Increase /
(decrease)
United States
$
204,599
$
187,994
$
16,605
8.8
%
Europe
103,460
99,372
4,088
4.1
%
International
16,767
8,172
8,595
105.2
%
Revenue from sale of therapies, net
$
324,826
$
295,538
$
29,288
9.9
%
For the nine months ended September 30, 2026, we generated revenue from sale of therapies, net of $324.8 million, due to the sale of KIMMTRAK, of which $204.6 million was in the United States, $103.5 million in Europe and $16.7 million in International. Revenue from sale of therapies, net increased in the nine months ended September 30, 2026 compared to the nine months ended September 30, 2025, due to continued growth in the United States, Europe and international regions.
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R&D Expenses
The following table summarizes our R&D expenses (in thousands):
Nine Months Ended September 30,
2026
2025
Increase /
(decrease)
% Increase /
(decrease)
External R&D expenses:
PRAME programs
$
65,464
$
59,950
$
5,514
9.2
%
Tebentafusp programs
30,408
30,196
212
0.7
%
Infectious disease programs
3,336
4,077
(741)
(18.2)
%
All other external clinical and preclinical costs
36,444
42,035
(5,591)
(13.3)
%
Total external R&D expenses
135,652
136,258
(606)
(0.4)
%
Internal R&D expenses:
Salaries and other employee-related costs
42,222
35,882
6,340
17.7
%
Share-based compensation expense
8,303
6,667
1,636
24.5
%
All other internal R&D costs
28,896
23,780
5,116
21.5
%
U.K. R&D tax credits
(5,312)
(6,539)
1,227
(18.8)
%
Total internal R&D expenses
74,109
59,790
14,319
23.9
%
Total R&D expenses
$
209,761
$
196,048
$
13,713
7.0
%
For the nine months ended September 30, 2026, our R&D expenses were $209.8 million, compared to $196.0 million for the nine months ended September 30, 2025.
For the nine months ended September 30, 2026, our external R&D expenses decreased by $0.6 million primarily due to a net decrease of $5.6 million in all other external clinical and preclinical costs related to the timing of third-party costs associated with our earlier stage programs, including our autoimmune programs. This decrease was partially offset by a net increase of $5.5 million in expenses incurred for our PRAME programs associated with continued enrollment in our PRISM-MEL-301 Phase 3 clinical trial, partially offset by lower costs following decreased patient enrollment in the PRAME-101 Phase 1/2 clinical trial.
For the nine months ended September 30, 2026, our internal R&D expenses increased by $14.3 million primarily due to an increase in salaries and other employee-related costs and all other internal R&D costs in accordance with the advancement of our clinical and preclinical programs.
SG&A Expenses
For the nine months ended September 30, 2026, our SG&A expenses were $122.2 million, compared to $122.8 million for the nine months ended September 30, 2025, reflecting a decrease of $0.6 million. The decrease was primarily due to lower internal costs following increases in share-based compensation forfeitures, partially offset by increased costs related to business support functions to support our growing pipeline and global commercial expansion.
Interest Income and Interest Expense
For the nine months ended September 30, 2026, interest income was $10.6 million compared to $12.6 million for the nine months ended September 30, 2025. This decrease of $2.0 million was due to lower interest rates earned on our money market funds in the nine months ended September 30, 2026. For the nine months ended September 30, 2026, interest expense on our convertible senior notes was $9.2 million compared to $9.1 million for the nine months ended September 30, 2025.
Foreign Currency Gain
For the nine months ended September 30, 2026, foreign currency gain was $1.0 million compared to $3.7 million for the nine months ended September 30, 2025. This decrease of $2.7 million reflects more adverse exchange rate movements mainly of the U.S. dollar against the pound sterling and the euro in the nine months ended September 30, 2026 compared to the nine months ended September 30, 2025.
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Other Income, Net
For the nine months ended September 30, 2026, other income, net was $5.6 million compared to $15.2 million for the nine months ended September 30, 2025. This decrease was due to lower unrealized gains due to less favorable interest rates impacting our marketable securities in the nine months ended September 30, 2026 compared to the nine months ended September 30, 2025.
Income Tax (Expense) Benefit
For the nine months ended September 30, 2026, the income tax expense was $0.7 million compared to $2.1 million for the nine months ended September 30, 2025. This change was primarily the result of lower forecasted taxable income in the United States and Ireland for 2026 compared to 2025.
Liquidity and Capital Resources
Sources of Liquidity
Although we have recorded revenue from the sale of therapies for the nine months ended September 30, 2026, we expect to continue to incur significant and increasing expenses, cumulative negative cash flows from our operations and operating losses for the foreseeable future. We have an accumulated deficit of $833.3 million as of September 30, 2026.
Since our inception, we have funded our operations primarily with proceeds from sales of equity securities, revenue from sale of therapies, debt financings and historical payments from collaboration partners. As of September 30, 2026 and December 31, 2025, we had cash and cash equivalents of $512.2 million and $467.7 million, respectively, and marketable securities of $389.1 million and $396.4 million, respectively. Our working capital was $830.8 million as of September 30, 2026, compared to $750.0 million as of December 31, 2025.
In September 2022, we entered into an Open Market Sale Agreement (the "Sales Agreement") with Jefferies LLC ("Jefferies"), pursuant to which we may issue and sell ADSs, each representing one ordinary share, having an aggregate offering price of up to $250 million, from time to time, in one or more at-the-market offerings, for which Jefferies will act as sales agent and/or principal. The at-the-market facility has been registered under the Securities Act of 1933, as amended, pursuant to our Registration Statement on Form S-3ASR (File No. 333-278120). As of September 30, 2026, no issuances or sales have been made pursuant to the Sales Agreement.
In February 2024, we completed a private offering of $402.5 million aggregate principal amount of the Notes. Our net proceeds from the offering of the Notes were $389.1 million, after deducting the initial purchasers’ discounts and commissions and the offering expenses. The Notes are senior, unsecured obligations of the Company and will mature on February 1, 2030, unless earlier converted, redeemed or repurchased. The Notes will accrue interest payable semiannually in arrears on February 1 and August 1 of each year, beginning on August 1, 2024, at a rate of 2.50% per year. Part of the proceeds were used to repay in full loans outstanding under our previous loan agreement with Pharmakon.
Other than the above mentioned indebtedness, our lease obligations and supplier purchase commitments in the normal course of business, we currently have no other ongoing material financing commitments, such as lines of credit or guarantees, that are expected to affect our liquidity over the next five years.
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Cash Flows
The following table summarizes the primary sources and uses of cash and cash equivalents for each period presented (in thousands):
Nine Months Ended September 30,
2026
2025
Cash and cash equivalents at beginning of period
$
467,709
$
455,731
Net cash provided by operating activities
22,243
21,943
Net cash provided by (used in) investing activities
8,087
(15,460)
Net cash provided by financing activities
20,896
8,087
Net foreign exchange difference on cash held
(6,690)
28,112
Cash and cash equivalents at end of period
$
512,245
$
498,413
Net cash provided by operating activities was $22.2 million for the nine months ended September 30, 2026, compared to net cash provided by operating activities of $21.9 million for the nine months ended September 30, 2025. This change of $0.3 million was primarily driven by a decrease in loss from operations, partially offset by working capital movements, including increases in accounts receivable and prepaid expenses.
Net cash provided by investing activities was $8.1 million for the nine months ended September 30, 2026, compared to net cash used in investing activities of $15.5 million for the nine months ended September 30, 2025. The increase of $23.6 million is predominantly due to the purchase of marketable securities in 2025, partially offset by lower proceeds from the sale of marketable securities and higher purchases of property and equipment in the nine months ended September 30, 2026 compared to the same period in 2025.
Net cash provided by our financing activities during the nine months ended September 30, 2026 was $20.9 million compared to $8.1 million for the nine months ended September 30, 2025. The net cash provided by financing activities in both periods was related to the exercise of share options.
Future Capital Requirements
We expect to continue to incur significant operating losses in the foreseeable future and expect our expenses to increase in connection with our ongoing activities, particularly as we continue to commercialize KIMMTRAK in additional territories, continue our research and development programs and the advancement of our product candidates through preclinical and clinical development, and seek regulatory approval and pursue commercialization of any approved product candidates.
The amounts and timing of our actual expenditure may vary significantly depending on numerous factors. Our expenses will continue to increase if, and as, we:
•
pursue further approval and commercialization of KIMMTRAK in additional indications and territories;
•
continue to advance the development of our clinical trials and preclinical 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, IT and other groups to support our operations and initiatives as we progress product candidates toward commercialization;
•
seek to attract and retain skilled personnel;
•
create additional infrastructure to further 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 other product candidates;
•
further develop a sales, marketing and distribution infrastructure to further 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
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•
experience any delays, interruptions or encounter issues with any of the above, including any delays or other impacts as a result of the war in Ukraine, the conflict in the Middle East, global geopolitical tension, worsening macroeconomic conditions, including supply chain disruptions, fluctuations in interest rates, rising inflation, tariffs and other trade barriers, or health epidemics or pandemics.
Since our inception, we have raised funds from sales of equity securities, debt financing, revenue from sale of therapies and collaboration agreements. In order to maintain such levels of expenditure and our anticipated expenditure, we may raise further funds by exploring debt or equity financing, or potentially further collaborations, in the future. The amount we are able to raise from these options can vary with market conditions, including the impacts of macroeconomic conditions such as supply chain disruptions, fluctuations in interest rates and volatility in the capital markets, and our longer term strategy as a company is dependent on our ability to successfully raise such funding. Moreover, we have based our estimates on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect.
We held cash and cash equivalents of $512.2 million and marketable securities of $389.1 million as of September 30, 2026. Based on our current operating plans, we expect that our existing cash and cash equivalents and marketable securities balances, along with anticipated revenue from KIMMTRAK, will enable us to fund our operating expenses and capital expenditure requirements for at least twelve months from the date of filing of this Quarterly Report. Given our need for additional financing to support the long-term clinical development of our programs, we intend to consider additional financing opportunities when market terms are favorable to us.
Because of the numerous risks and uncertainties associated with research, development and commercialization of pharmaceutical product candidates, we are unable to estimate the exact amount of our working capital requirements. Our future funding requirements will depend on and could increase significantly as a result of many factors, including:
•
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 R&D 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;
•
the amount of sales and other revenues from KIMMTRAK in the United States, Europe, and other regions, if approved;
•
our ability to successfully commercialize our other product candidates;
•
our ability to have clinical and commercial products successfully manufactured consistent with FDA, regulations of the EU 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 continued 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 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.
A change in the outcome of any of these or other variables with respect to the development of any of our current and future product candidates could significantly change the costs and timing associated with the development and commercialization of that product candidate. Furthermore, our operating plans may change in the future, and we may need additional funds to meet operational needs and capital requirements associated with such operating plans.
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Until we can generate sufficient revenue to finance our cash requirements, which we may never do, we expect to finance our future cash needs through a combination of public or private equity offerings, debt financings, collaborations, strategic alliances, licensing arrangements and other marketing or distribution arrangements as well as grant funding. If we raise additional capital through marketing and distribution arrangements or other collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish certain valuable rights to our product candidates, technologies, future revenue streams or research programs or grant licenses on terms that may not be favorable to us. If we raise additional capital through public or private equity offerings, the terms of these securities may include liquidation or other preferences that adversely affect our shareholders’ rights. Further, to the extent that we raise additional capital through the sale of ordinary shares or securities convertible or exchangeable into ordinary shares, our shareholders’ ownership interest will be diluted. If we raise additional capital through debt financing, it would be subject to fixed payment obligations and may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we are unable to obtain additional funding on favorable terms when needed, we may have to delay, reduce the scope of or terminate one or more of our R&D programs or clinical trials.
Our ability to raise additional capital may also be adversely impacted by potential worsening global economic conditions and disruptions to, and volatility in, financial markets in the United States and worldwide. We are also mindful that conditions in the current macroeconomic environment could affect our ability to achieve our goals. We sell our products in countries that face economic volatility and weakness. Although we have historically collected receivables from customers in such countries, sustained weakness or further deterioration of the local economies and currencies may cause customers in those countries to be unable to pay for our products. We will continue to monitor these conditions and will attempt to adjust our business processes, as appropriate, to mitigate macroeconomic risks to our business.
Contractual Obligations
Leases and manufacturing
As part of our ongoing operations, we have material contractual lease obligations over expected lease terms of several years and expiry dates extending to 2043 primarily for our most significant facilities in the United Kingdom. These obligations and potential obligations could result in payments of up to $73.1 million. The majority of such payments represent longer-term commitments as outlined in the notes to our condensed consolidated financial statements. The lease agreements are cancellable assuming certain conditions are met prior to expiry. We expect to continue to incur expenses for such leases for the foreseeable future. As we continue to grow, launch further products or expand our operations in other countries, we may determine that it is necessary to enter into further lease agreements, which would increase our cash outflows. Further obligations or commitments in the near term relate to our capital expenditure requirements for the purpose of improving our leased facilities. If we continue to grow, such commitments may become significant in value.
We have a number of existing manufacturing obligations, some of which relate to the manufacture of KIMMTRAK. We have similar obligations related to our earlier stage programs. These obligations and potential obligations could result in payments of up to $25.1 million, and are expected to increase as we continue to advance our pipeline in 2026 and beyond. While we have already incurred costs for commercial launches of KIMMTRAK in the United States, Europe and other territories, additional manufacturing obligations may arise in future in relation to product sales in these territories. We have also entered into third-party agreements relating to marketing and distribution of KIMMTRAK. The majority of such obligations have standard payment terms, and our level of non-cancellable commitments with such parties is not considered material. To meet demand, we may amend or enter into further agreements with CMOs or other parties which could cause our cash requirements to increase. While receipts from the sale of KIMMTRAK or other future products may fund our ongoing manufacturing and sales efforts, there can be no assurance that we will earn such revenues. In the longer term, if we receive regulatory approval for our other product candidates, we would expect to incur significant commercialization expenses related to product manufacturing, sales, marketing and distribution, depending on where we choose to commercialize. We may also require additional capital to pursue in-licenses or acquisitions of other product candidates.
In addition to the above obligations, commitments and potential future cash outflows, we enter into a variety of agreements and financial commitments in the normal course of business. The terms generally provide us the option to cancel, reschedule and adjust our requirements based on our business needs, prior to the delivery of goods or performance of services. However, it is not possible to predict the amount of future payments under these agreements due to the conditional nature of our obligations and the unique facts and circumstances involved in each particular agreement.
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Financing obligations
Under the terms of our agreement with the Gates Foundation, we are required to develop, manufacture and commercialize soluble TCR bispecific therapeutic candidates targeted to mutually agreed neglected diseases, currently HIV, with the potential to treat people at an affordable price in developing countries. In the event of certain defaults by us under the agreement, the Gates Foundation has the right to sell, or require us to buy-back, any of our shareholdings held by the Gates Foundation. In such an event, if within 12 months after such redemption or sale, we experience a change in control at a valuation of more than 150% of the valuation used for the redemption or the sale of the shares, we have agreed to pay the Gates Foundation compensation equal to the excess of what it would have received in such transaction if it still held its shares at the time of such change of control over what it received in the sale or redemption of its shares.
In February 2024, we completed a private offering of $402.5 million aggregate principal amount of the Notes, including the exercise in full of the initial purchasers’ option to purchase up to an additional $52.5 million principal amount of Notes. Our net proceeds from the offering of the Notes were $389.1 million, after deducting the initial purchasers’ discounts and commissions and the offering expenses. The Notes are senior, unsecured obligations of the Company and will mature on February 1, 2030, unless earlier converted, redeemed or repurchased. The Notes will accrue interest payable semiannually in arrears on February 1 and August 1 of each year, beginning on August 1, 2024, at a rate of 2.50% per year. See Note 5. “Interest-bearing loans and borrowings” of the notes to our condensed consolidated financial statements in Part I of this Quarterly Report for further information.
Our Key Collaboration Agreements
Bristol-Myers Squibb ("BMS") Collaboration
In February 2024, we entered into a clinical trial collaboration and supply agreement with BMS (the "BMS Agreement") to investigate our ImmTAC bispecific TCR candidate targeting PRAME HLA-A*02:01, brenetafusp, in combination with BMS’s nivolumab, in first-line advanced cutaneous melanoma. Under the terms of the BMS Agreement, we are sponsoring and funding the registrational Phase 3 clinical trial of brenetafusp in combination with nivolumab in first-line advanced cutaneous melanoma (PRISM-MEL-301), and BMS is providing nivolumab. No monetary consideration is transferred as a result of the BMS Agreement.
Critical Accounting Estimates
Our condensed consolidated financial statements as of
September 30, 2026
and for the
three and nine
months ended
September 30, 2026
and
2025
, respectively, have been prepared in accordance with U.S. GAAP. The preparation of the condensed consolidated financial statements requires us to make judgments, estimates and assumptions that affect the value of assets and liabilities—as well as contingent assets and liabilities—as reported on the balance sheet date, and revenues and expenses arising during the fiscal period.
The estimates and associated assumptions are based on information available when the condensed consolidated financial statements are prepared, historical experience and various other factors which are believed to be reasonable under the circumstances, the results of which form the basis of making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Existing circumstances and assumptions about future developments, however, may change due to market changes or circumstances arising that are beyond our control. Hence, estimates may vary from the actual values.
The estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognized in the period in which they become known and are applied prospectively.
Those judgments and estimates made, together with our significant accounting policies, are set out in our Annual Report.
Expected rebate and chargeback percentage for revenue deductions
Since approval of KIMMTRAK in 2022, we have a short history of actual rebate claims or chargebacks, and such information may have limited predictive value. We use the expected value method to estimate expected rebate and chargeback percentages for revenue deductions, which considers the likelihood of a rebate or chargeback being applicable to sales. The proportion of sales subject to a rebate or chargeback is inherently uncertain and estimates are based on internal assumptions, which may change as we develop more product experience, and third-party data, which we assess for reliability and relevance.
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We are subject to state government Medicaid programs and other qualifying federal and state programs in the United States requiring rebates to be paid to participating state and local government entities, depending on the eligibility and circumstances of patients treated with KIMMTRAK after we have sold vials to specialty distributors. We are also subject to chargebacks from its specialty distributors under the 340B program in the United States, whereby qualifying hospitals are entitled to purchase KIMMTRAK at a lower price. For such sales, our specialty distributors charge back the difference between the wholesale acquisition cost and this lower price. Estimating expected rebate and chargeback percentages for revenue deductions is judgmental due to the time delay between the date of the sale to specialty distributors and the subsequent dates on which we are able to determine actual amounts of chargebacks and rebates. We form estimates of 340B chargeback deductions by analyzing sell-through data relating to the hospital mix of onward sales made by specialty distributors. For Medicaid and other rebates, we form estimates based on information obtained from claims received and other industry data, and external health coverage statistics. Judgment is applied to consider the relevance and reliability of information used to make these estimates.
Judgment has historically been made in determining expected rebate percentages for the amount of net revenue from sale of therapies in France. Rebates payable were subject to a high degree of estimation uncertainty. Our estimate of these rebates represented the difference between the expected agreed price for the commercial sale of KIMMTRAK in France, which has historically been subject to negotiation, and the initial price of tebentafusp and KIMMTRAK until we completed price negotiations in France in the year ended December 31, 2025. Analysis of further legislative requirements, sales volumes and the expected benefit of KIMMTRAK to patients in France was also required in the assessment of rebates payable. We applied judgment to assess internal targets, pricing information of other therapies approved for sale in France, information obtained from price negotiations of KIMMTRAK in other countries, and information connected with KIMMTRAK’s safety profile when forming our estimated rebate deduction from revenue. For other European markets where the price is open to negotiation, judgments are made in line with expected pricing outcomes.
Our total accrued revenue deductions as of September 30, 2026 were $176.6 million, including amounts of $28.3 million for the critical estimates subject to greater estimation uncertainty and judgments described above. These amounts are included within Accrued expenses and other current liabilities and Accrued expenses, non-current in the Condensed Consolidated Balance Sheets as of September 30, 2026. In the three months ending December 31, 2026, we expect to pay approximately $120.0 million related to accrued revenue deductions.
A 20% increase or decrease in estimates of expected rebate and chargeback percentages for amounts payable to governments or government agencies for the critical estimates described above would have resulted in a $5.7 million reduction or increase in Revenue from sale of therapies, net reported in the Condensed Consolidated Statements of Operations and Comprehensive Loss for the nine months ended September 30, 2026. We believe our expected values of accruals reported in the Condensed Consolidated Balance Sheets are materially appropriate; however, due to the uncertainties and judgments outlined above, it is possible eventual amounts could significantly differ to these estimates.
Recently Issued and Adopted Accounting Pronouncements
We discuss the effect of recently issued and adopted pronouncements in Note 2. ''Summary of Significant Accounting Policies'' to the condensed consolidated financial statements.
Item 3.
Quantitative and Qualitative Disclosures About Market Risk.
We are exposed to interest rate, currency, credit and liquidity risks. Our executive board oversees the management of these risks supported by a financial risk committee that advises on financial risks and the appropriate financial risk governance framework for us. The financial risk committee provides assurance to our executive board that our financial risk activities are governed by appropriate policies and procedures and that financial risks are identified, measured and managed in accordance with our policies and risk objectives. The most significant financial risks to which we are exposed include the risks discussed below.
Interest Rate Risk
Our exposure to changes in interest rates relates to investments in deposits and to changes in the interest for overnight deposits and marketable securities. Changes in the general level of interest rates may lead to an increase or decrease in the fair value of these investments.
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In February 2024, we completed a private offering of $402.5 million aggregate principal amount of Notes, which mature on February 1, 2030, unless earlier converted, redeemed, or repurchased. The Notes accrue interest payable semiannually at a fixed rate of 2.50% per annum, commencing August 1, 2024. Issuance costs totaling $13.4 million are being amortized as interest expense at an effective rate of 3.06% over the life of the Notes. Given the fixed interest rate, we are not subject to interest rate risk with respect to these Notes. However, changes in market interest rates could affect the fair value of the Notes and the price of our ADSs, influencing the decision of noteholders to convert their Notes.
We are currently not subject to interest rate risks related to any other liabilities shown in the Condensed Consolidated Balance Sheets.
Currency Risk
Foreign currency risk is the risk that the fair value or future cash flows of a financial instrument will fluctuate because of changes in foreign exchange rates. Our exposure to the risk of changes in foreign exchange rates relates primarily to fluctuations in value of foreign currency cash and cash equivalents balances held by our main operating subsidiary in the United Kingdom, our operating activities in foreign subsidiaries, and outsourced supplier agreements denominated in currencies other than functional currency. We minimize foreign currency risk by maintaining cash and cash equivalents of each currency at levels sufficient to meet foreseeable expenditure to the extent practical.
Our cash and cash equivalents were $512.2 million and $467.7 million as of September 30, 2026 and December 31, 2025, respectively. As of September 30, 2026, 69% of our cash and cash equivalents were held by our U.K. operating subsidiary, of which 47% were denominated in U.S. dollars, 39% were denominated in pounds sterling and 14% were denominated in euros. All of our marketable securities were held by our U.K. parent company and were denominated in U.S. dollars. The remainder of our cash and cash equivalents are held across our other subsidiaries and denominated in a mix of operating currencies. Changes in exchange rates had an impact on U.S. dollar cash and cash equivalents balances held by our main operating subsidiary in the United Kingdom, which resulted in foreign exchange gains in the nine months ended September 30, 2026 and 2025. These gains were partially offset by foreign exchange losses primarily on intercompany loans in the nine months ended September 30, 2026. Further movements in exchange rates or returns to previous exchange rate levels have caused, and may continue to cause, material fluctuations or equivalent losses in the Condensed Consolidated Statements of Operations and Comprehensive Loss.
A five percentage point increase in exchange rates would reduce the carrying value of net financial assets and liabilities held in foreign currencies as of September 30, 2026 by $8.5 million and as of December 31, 2025 by $6.5 million. A five percentage point decrease in exchange rates would increase the carrying value of net financial assets and liabilities held in foreign currencies as of September 30, 2026 by $8.5 million and as of December 31, 2025 by $6.5 million.
Credit Risk
We are exposed to credit risk from our operating activities, primarily accounts receivable, and cash and cash equivalents and marketable securities held with banks and financial institutions. Cash and cash equivalents and marketable securities are maintained with high-quality financial institutions in the United Kingdom and United States. We are also potentially subject to concentrations of credit risk in our accounts receivable with respect to amounts owed by a limited number of entities comprising our customer base. Our exposure to credit losses is low, however, owing largely to the credit quality of our distributors and other customers, the significant majority of which are considerably larger than us.
We continually monitor our positions with, and the credit quality of, the financial institutions and corporations which are counterparts to our financial instruments and do not anticipate non-performance. The maximum default risk corresponds to the carrying amount of the financial assets shown in the Condensed Consolidated Balance Sheets. We monitor the risk of a liquidity shortage. The main factors we consider are the maturities of financial assets as well as expected cash flows from equity measures.
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Item 4.
Controls and Procedures
Disclosure Controls and Procedures
We maintain “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the "Exchange Act"), that are designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms, and is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosure.
Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of our disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) as of September 30, 2026. Based on such evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that, as of September 30, 2026, our disclosure controls and procedures were effective.
Changes in Internal Control Over Financial Reporting
There has been no change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the fiscal quarter ended
September 30, 2026
that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
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PART II – OTHER INFORMATION
Item 1.
Legal Proceedings
From time to time, we may become subject to arbitration, litigation or claims arising in the ordinary course of business. We are not currently a party to any arbitration or legal proceeding that, if determined adversely to us, would have a material adverse effect on our business, operating results or financial condition. The results of any future claims or proceedings cannot be predicted with certainty, and regardless of the outcome, litigation can have an adverse impact on us because of defense and litigation costs, diversion of management resources, and other factors.
Item 1A. Risk Factors
Our business has significant risks. In addition to the other information set forth in this Quarterly Report on Form 10-Q, you should carefully consider the risks described in Part I, Item 1A. “Risk Factors” in our Annual Report. These are not the only risks facing our business. Other risks and uncertainties that we are not currently aware of or that we currently consider immaterial also may materially adversely affect our business, financial condition and future results if our assumptions about those risks are incorrect or if circumstances change.
There were no material changes during the period covered in this Quarterly Report to the risk factors previously disclosed in
Item 1A. Risk Factors
in our Annual Report.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
Insider Trading Arrangements
During our last fiscal quarter, our directors and officers (as defined in Rule 16a-1(f) under the Exchange Act) adopted or terminated the contracts, instructions or written plans for the purchase or sale of our securities as set forth in the table below.
Type of Trading Arrangement
Name and Position
Action
Adoption/ Termination
Date
Rule 10b5-1
(1)
Non-
Rule 10b5-1
(2)
Total Ordinary Shares to be Sold
(3)
Expiration Date
John Goll
SVP, Finance & Chief Accounting Officer
Adoption
September 15, 2026
X
42,044
December 31, 2027
(1)
Contract, instruction or written plan intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) under the Exchange Act.
(2)
“Non-Rule 10b5-1 trading arrangement” as defined in Item 408(c) of Regulation S-K under the Exchange Act.
(3)
Represents ordinary shares in the form of American Depositary Shares.
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Item 6. Exhibits
Exhibit Number
Incorporation by Reference
Description
Schedule / Form
File Number
Exhibit
Filing Date
3.1
Articles of Association of Immunocore Holdings plc
10-Q
001-39992
3.1
August 8, 2024
31.1*
Certification by the Principal Executive Officer pursuant to Securities Exchange Act Rules 13a-14(a) and 15d-14(a) as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
31.2*
Certification by the Principal Financial Officer pursuant to Securities Exchange Act Rules 13a-14(a) and 15d-14(a) as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
32.1**
Certification by the Principal Executive Officer and the Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
101.INS*
Inline XBRL Instance Document (the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document).
101.SCH*
Inline XBRL Taxonomy Extension with Embedded Linkbase Schema Documents.
104*
Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101).
*
Filed herewith.
**
This certification is deemed furnished, not "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
IMMUNOCORE HOLDINGS PLC
Date:
November 6, 2026
By:
/s/ Bahija Jallal
Name:
Bahija Jallal, Ph.D.
Title:
Chief Executive Officer
(On Behalf of the Registrant and as Principal Executive Officer)
Date:
November 6, 2026
By:
/s/ Travis Coy
Name:
Travis Coy
Title:
Chief Financial Officer
(
Principal Financial Officer)
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