Summit Therapeutics (NASDAQ: SMMT) posts 2025 loss but ends year with $713M cash
Filing Impact
Filing Sentiment
Form Type
8-K
Rhea-AI Filing Summary
Summit Therapeutics Inc. reported its fourth quarter and full-year 2025 results and outlined clinical progress centered on ivonescimab, its investigational bispecific PD‑1/VEGF antibody. For 2025, GAAP operating expenses rose to $1,094.4 million, driving a GAAP net loss of $1,079.6 million or $(1.44) per share, largely influenced by $732.4 million of stock-based compensation. On a Non-GAAP basis, operating expenses were $362.0 million and net loss was $347.2 million or $(0.46) per share. Cash, cash equivalents and short-term investments increased to $713.4 million as of December 31, 2025, supported by $617.5 million of financing cash inflows in 2025.
Clinically, the FDA accepted Summit’s Biologics License Application for ivonescimab plus chemotherapy in EGFR-mutated non-squamous NSCLC, assigning a PDUFA goal action date of November 14, 2026. Key Phase III milestones include an interim progression-free survival analysis for the HARMONi‑3 squamous cohort expected in Q2 2026, with final PFS and interim overall survival in the second half of 2026, and final PFS for the non‑squamous cohort expected in the first half of 2027. Summit also highlighted the planned Phase III ILLUMINE study in PD‑L1 positive head and neck cancer and multiple collaborations and investigator-sponsored trials expanding ivonescimab’s development footprint.
Positive
- FDA accepted the Biologics License Application for ivonescimab plus chemotherapy in EGFR-mutated non-squamous NSCLC, with a November 14, 2026 PDUFA goal date, creating a clear potential regulatory pathway for the company’s lead asset.
Negative
- None.
Insights
Large 2025 loss is stock-comp heavy, while cash and late-stage pipeline strengthened.
Summit Therapeutics reported a 2025 GAAP net loss of
Cash, cash equivalents and short-term investments reached
On the pipeline side, the FDA’s acceptance of the ivonescimab BLA with a
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported): February 23, 2026
| (Exact Name of Registrant as Specified in Its Charter) | ||||||||
| (State or Other Jurisdiction of Incorporation) | (Commission File Number) | (IRS Employer Identification No.) | ||||||
| (Address of Principal Executive Offices) | (Zip Code) | |||||||
Registrant’s Telephone Number, Including Area Code: (305) 203-2034
| Not applicable | ||
| (Former Name or Former Address, If Changed Since Last Report) | ||
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
Securities registered pursuant to Section 12(b) of the Act:
| Title of Each Class | Trading Symbol(s) | Name of Each Exchange on Which Registered | ||||||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
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. ☐
| Item 2.02 | Results of Operations and Financial Condition. | ||||
On February 23, 2026, Summit Therapeutics Inc. (the “Company”) issued a press release announcing its financial results and operational progress for the fourth quarter and full year ended December 31, 2025. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference into this Item 2.02 as if fully set forth herein.
In accordance with General Instruction B.2 of Form 8-K, the information set forth under Item 2.02 and in Exhibit 99.1 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 7.01 | Regulation FD Disclosure. | ||||
The Company will utilize slides during its earnings call scheduled for 4:30pm ET on February 23, 2026 to announce its fourth quarter and full year 2025 financial results and provide an operational update for the Company. A copy of the slides is furnished as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated by reference into this Item 7.01 as if fully set forth herein.
In accordance with General Instruction B.2 of Form 8-K, the information set forth under Items 2.02 and 7.01 and in Exhibits 99.1 and 99.2 shall not be deemed “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
| Item 9.01 | Financial Statements and Exhibits. | ||||
(d) Exhibits
Exhibit Number | Description | ||||
| 99.1 | Press Release, dated February 23, 2026 | ||||
| 99.2 | Presentation Slides for February 23, 2026 Earnings Call | ||||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | ||||
SIGNATURE
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, hereunto duly authorized.
| SUMMIT THERAPEUTICS INC. | ||||||||
Date: February 23, 2026 | By: | /s/ Manmeet S. Soni | ||||||
Chief Operating Officer, Chief Financial Officer and Director | ||||||||
| (Principal Financial Officer) | ||||||||
1 Summit Therapeutics Reports Financial Results and Operational Progress for the Fourth Quarter and Year Ended December 31, 2025 HARMONi-3 Squamous Cohort of Global Phase III 1L NSCLC Study: Interim PFS Analysis Planned in Q2 2026; Final PFS and Interim OS Data Planned in Second Half of 2026 HARMONi-3 Squamous Cohort Enrollment Screening Has Been Completed Phase III ILLUMINE Study in 1L PD-L1 Positive R/M HNSCC Sponsored by Cooperative Group, GORTEC, to Initiate; First Patient Expected in Early Q2 2026 US FDA Accepts BLA Filing Based on HARMONi Study; PDUFA Goal Action Date of November 14, 2026 First Patient Dosed in Revolution Medicines Clinical Trial Collaboration Evaluating Ivonescimab in Combination with RAS(ON) Inhibitors in RAS Mutant Tumors GSK Collaboration Clinical Trials Evaluating Ivonescimab in Combination with GSK’s Novel B7-H3, Risvutatug Rezetecan, Expected to Start Mid-2026 Miami, Florida, February 23, 2026 - Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") today reports its financial results and provides an update on clinical and operational progress for the fourth quarter and year ended December 31, 2025. Clinical & Operational Updates Operational progress continues with ivonescimab (SMT112), an investigational, potentially first-in-class bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule: • Since in-licensing ivonescimab (SMT112), from Akeso Inc. (Akeso, HKEX Code: 9926.HK) in January 2023, over 4,000 patients have been treated with ivonescimab in clinical studies globally, and over 60,000 patients have been treated in a commercial setting with ivonescimab in China, as noted by Akeso. Summit has rights to develop and commercialize ivonescimab in North America, South America, Europe, the Middle East, Africa, and Japan, while Akeso retains development and commercialization rights for remaining territories, including China. • Summit is developing ivonescimab in non-small cell lung cancer (NSCLC) and colorectal cancer (CRC), specifically conducting multiregional Phase III clinical trials in the following proposed indications: o HARMONi: Ivonescimab combined with chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a third-generation EGFR tyrosine kinase inhibitor (TKI) o HARMONi-3: Ivonescimab combined with chemotherapy in patients with first-line metastatic NSCLC, with two distinct cohorts to be analyzed separately for squamous tumors and non- squamous tumors
2 o HARMONi-7: Ivonescimab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression o HARMONi-GI3: Ivonescimab combined with chemotherapy in patients with first-line unresectable metastatic CRC • Today, we provide the following updates for the global Phase III HARMONi-3 clinical trial: o For the HARMONi-3 squamous cohort: • Screening by investigators for patient enrollment in the squamous cohort of HARMONi-3 has been completed in the first quarter of 2026. • We amended the study’s statistical analysis plan and expect to conduct an interim analysis for progression free survival (PFS) in the second quarter of 2026. Overall survival (OS) is expected to be immature at the time of the interim PFS analysis. • We continue to expect to reach the prespecified number of events for the final PFS analysis, if applicable, in the second half of 2026. o For the HARMONi-3 non-squamous cohort: • Enrollment is currently expected to complete in the second half of 2026. • We expect to reach the prespecified number of events for the final PFS analysis in the first half of 2027. Interim analyses for overall survival are planned to be conducted based upon reaching prespecified numbers of events. . • Today, we announce that GORTEC, a European Head and Neck Oncology and Radiotherapy Group based in France, will begin to activate clinical trial sites in the Phase III clinical study, GORTEC 2024-04 ILLUMINE (NCT07264075). This study will evaluate ivonescimab monotherapy and ivonescimab in combination with ligufalimab, Akeso’s proprietary anti-CD47 monoclonal antibody, against monotherapy pembrolizumab in a randomized three-arm study. The study is intended to be conducted in multiple countries in Europe and in China; Summit may consider the expansion of this study into the United States. The primary endpoint for the study is overall survival. The study, with approximately 780 patients with PD- L1 positive, recurrent and/or metastatic head and neck squamous cell carcinoma (R/M HNSCC), is expected to begin enrollment early in the second quarter of 2026. o Phase II data supporting this study was previously presented at ESMO 2024, whereby ivonescimab in combination with ligufalimab demonstrated an objective response rate of 60% in 20 patients with a median PFS of 7.1 months after a median follow-up time of 4.1 months; overall survival was not mature at the time of this analysis. At the time of data cut-off for this presentation, no patients receiving ivonescimab plus ligufalimab permanently discontinued drug treatment due to treatment-related adverse events. • In January 2026, we announced that the U.S. Food & Drug Administration (FDA) has accepted for filing Summit's Biologics License Application (BLA) seeking approval for ivonescimab in combination with chemotherapy in patients with EGFR-mutated locally advanced or metastatic non-squamous NSCLC who have received prior EGFR TKI therapy. The FDA provided a Prescription Drug User Fee Act (PDUFA) goal action date of November 14, 2026. The BLA was submitted based on the overall results of the Phase III HARMONi trial.
3 • In June 2025, we announced a clinical collaboration with Revolution Medicines, Inc. (RevMed) to evaluate ivonescimab in combination with three RAS(ON) inhibitors, including the multi-selective inhibitor daraxonrasib (RMC-6236), G12D-selective inhibitor zoldonrasib (RMC-9805), and G12C-selective inhibitor elironrasib (RMC-6291), in solid tumor settings with RAS mutations. The initial study under this collaboration, sponsored by RevMed, began enrolling patients in the first quarter of 2026. • In January 2026, we announced a clinical collaboration with GSK plc (“GSK”) to evaluate ivonescimab in combination with GSK’s novel B7-H3, risvutatug rezetecan, in multiple solid tumors. The initial study under this collaboration agreement is expected to begin dosing patients in mid-2026. • In Summit's global Phase III trials, the non-squamous cohort of HARMONi-3, HARMONi-7, and HARMONi- GI3, continue to enroll. In addition to the multiregional studies conducted and sponsored by Summit, our partners at Akeso are enrolling several single-region Phase III studies exclusively in China in multiple indications, including biliary-tract cancer, triple-negative breast cancer, head and neck squamous cell carcinoma, small cell lung cancer, colorectal cancer, and pancreatic cancer. • We plan to continue further expansion of the global Phase III clinical development program for ivonescimab in additional settings and tumor types. Today, we announced the ILLUMINE study; we intend to continue to provide more details in the coming months with respect to additional Phase III studies evaluating ivonescimab beyond the announcement of the ILLUMINE study. • Clinical trial collaborations and investigator sponsored trials (ISTs) with leading academic organizations, including MD Anderson, the Memorial Sloan Kettering Cancer Center, and the Dana Farber Cancer Institute, among others, continue to progress and expand evaluating ivonescimab in solid tumors. Summit is supporting more than 60 ISTs, of which 15 are actively enrolling. Financial Highlights Cash and Cash Equivalents and Short-term Investments • Aggregate cash and cash equivalents and short-term investments were $713.4 million and $412.3 million at December 31, 2025 and December 31, 2024, respectively. GAAP and Non-GAAP Operating Expenses • GAAP operating expenses were $1,094.4 million for the full year of 2025, compared to $226.0 million for the full year of 2024. The increase in GAAP operating expenses was due to the increase in stock-based compensation expense of $681.4 million primarily related to modification to our performance-based stock option awards which occurred earlier during the current fiscal year. • Non-GAAP operating expenses were $362.0 million for the full year of 2025, compared to $175.0 million for the full year of 2024. The increase in Non-GAAP operating expenses was due to expansion of clinical studies and development costs related to ivonescimab.
4 GAAP and Non-GAAP Research and Development (R&D) Expenses • GAAP R&D expenses were $537.7 million for the full year of 2025, compared to $150.8 million for the full year of 2024. The increase was due to the increase in stock-based compensation expense of $202.5 million primarily related to modification to our performance-based stock option awards which occurred earlier during the current fiscal year. • Non-GAAP R&D expenses were $319.2 million for the full year of 2025, compared to $134.8 million for the full year of 2024. The increase is primarily due to initiating new clinical trials and expanding current clinical trials from last year. GAAP and Non-GAAP General and Administrative (G&A) Expenses • GAAP G&A expenses were $556.7 million for the full year of 2025, compared to $60.2 million for the full year of 2024. The increase was due to the increase in stock-based compensation expense of $478.9 million primarily related to modification to our performance-based stock option awards which occurred earlier during the current fiscal year. • Non-GAAP G&A expenses were $42.8 million for the full year of 2025, compared to $25.2 million for the full year of 2024. The increase is related to building our infrastructure to support the development of ivonescimab. GAAP and Non-GAAP Net Loss • GAAP net loss for the full year of 2025 and 2024 was $1,079.6 million or $(1.44) per basic and diluted share, and $221.3 million or $(0.31) per basic and diluted share, respectively. • Non-GAAP net loss for the full year of 2025 and 2024 was $347.2 million or $(0.46) per basic and diluted share, and $170.3 million or $(0.24) per basic and diluted share, respectively.
5 Use of Non-GAAP Financial Measures This release includes measures that are not in accordance with U.S. generally accepted accounting principles (“Non-GAAP measures”). These Non-GAAP measures should be viewed in addition to, and not as a substitute for, Summit's reported GAAP results, and may be different from Non-GAAP measures used by other companies. In addition, these Non-GAAP measures are not based on any comprehensive set of accounting rules or principles. Summit management uses these Non-GAAP measures for internal budgeting and forecasting purposes and to evaluate Summit’s financial performance. Summit management believes the presentation of these Non-GAAP measures is useful to investors for comparing prior periods and analyzing ongoing business trends and operating results. For further information regarding these Non-GAAP measures, please refer to the tables presenting reconciliations of our Non-GAAP results to our U.S. GAAP results and the “Notes on our Non-GAAP Financial Information” that accompany this press release. Fourth Quarter 2025 Earnings Call Summit will host an earnings call this afternoon, Monday, February 23, 2026, at 4:30pm ET. The conference call will be accessible by dialing (800) 715-9871 (toll-free domestic) or (646) 307-1963 (international) using conference code 9472421. We encourage you to join the live webcast, which is accessible through Summit’s website www.smmttx.com, as we intend to display slides simultaneously. An archived edition of the webcast will be available on our website after the call. About Ivonescimab Ivonescimab, known as SMT112 in Summit’s license territories, North America, South America, Europe, the Middle East, Africa, and Japan, and as AK112 outside of Summit’s license territories, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti- angiogenesis effects associated with blocking VEGF into a single molecule. By design, ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity to PD-1 when in the presence of VEGF. This is intended to differentiate ivonescimab as there is potentially higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal tissue in the body. We believe ivonescimab’s specifically engineered tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the TME (Zhong, et al, iScience, 2025). This tetravalent structure, the intentional novel design of the molecule, and bringing these two targets into a single bispecific antibody with cooperative binding qualities have the potential to direct ivonescimab to the tumor tissue versus healthy tissue. The intent of this design, together with a half-life of 6 to 7 days after the first dose (Zhong, et al, iScience, 2025) increasing to approximately 10 days at steady state dosing, is to improve upon previously established efficacy thresholds, side effects, and safety profiles associated with prior approved drugs to these targets. Ivonescimab was engineered by Akeso Inc. (HKEX Code: 9926.HK) and is currently utilized in multiple Phase III clinical trials. Over 4,000 patients have been treated with ivonescimab in clinical studies globally, and over 60,000 patients when considering those treated in a commercial setting in China, as noted by Akeso. There are currently 15 Phase III clinical studies that are either announced, ongoing, or have been completed studying ivonescimab, four of which are Summit-sponsored global studies, one of which is a multiregional study
6 sponsored by a cooperative group, and ten of which are being or have been conducted in China by Akeso. Summit began its clinical development of ivonescimab in NSCLC, commencing enrollment in 2023 in two multiregional Phase III clinical trials, HARMONi and HARMONi-3. In 2025, the Company began enrolling patients in HARMONi- 7. Summit expanded its Phase III clinical development program into CRC in the fourth quarter of 2025 by initiating enrollment in HARMONi-GI3. HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non- squamous NSCLC who were previously treated with a 3rd generation EGFR TKI (e.g., osimertinib). Detailed results of the study were provided in September 2025, and a Biologics License Application (BLA) was submitted to the United States Food and Drug Administration (FDA) for marketing authorization, which the FDA accepted for filing in January 2026; the goal Prescription Drug User Fee Act (PDUFA) date is November 14, 2026. HARMONi-3 is a Phase III clinical trial, which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic, squamous or non- squamous NSCLC, irrespective of PD-L1 expression. HARMONi-7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression. HARMONi-GI3 is a Phase III clinical trial evaluating ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy in patients with first-line unresectable metastatic CRC. Also including Summit’s license territories, a Phase III study is planned to be conducted by GORTEC, a cooperative group dedicated to Head and Neck Oncology, in recurrent / metastatic head and neck squamous cell carcinoma (r/m HNSCC). ILLUMINE is a three-arm Phase III clinical trial which is intended to evaluate ivonescimab monotherapy, as well as ivonescimab in combination with ligufalimab, Akeso’s proprietary anti-CD47 monoclonal antibody, compared to monotherapy pembrolizumab in patients with PD-L1 positive r/m HNSCC. In addition, Akeso has recently had positive read-outs in three single-region (China), randomized Phase III clinical trials, HARMONi-A, HARMONi-2, and HARMONi-6, for ivonescimab in NSCLC, including a statistically significant overall survival benefit in HARMONi-A with a manageable safety profile in each study. HARMONi-A was a Phase III clinical trial which evaluated ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with an EGFR TKI. HARMONi-2 is a Phase III clinical trial evaluating monotherapy ivonescimab against monotherapy pembrolizumab in patients with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression. HARMONi-6 is a Phase III clinical trial evaluating ivonescimab in combination with platinum-based chemotherapy compared with tislelizumab, an anti-PD-1 antibody, in combination with platinum-based chemotherapy in patients with locally advanced or metastatic squamous NSCLC, irrespective of PD-L1 expression.
7 Akeso is actively conducting multiple Phase III clinical studies in settings outside of NSCLC, including biliary-tract cancer, triple-negative breast cancer, head and neck squamous cell carcinoma, small cell lung cancer, colorectal cancer, and pancreatic cancer. Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was initially approved for marketing authorization in China in May 2024. Ivonescimab was granted Fast Track designation by the US FDA for the HARMONi clinical trial setting. About Summit Therapeutics Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on the discovery, development, and commercialization of patient-, physician-, caregiver- and societal-friendly medicinal therapies intended to improve quality of life, increase potential duration of life, and resolve serious unmet medical needs. Summit was founded in 2003 and our shares are listed on the Nasdaq Global Market (symbol "SMMT"). We are headquartered in Miami, Florida, and we have additional offices in Palo Alto, California, Princeton, New Jersey, Dublin, Ireland, and Oxford, UK. For more information, please visit https://www.smmttx.com and follow us on X @SMMT_TX. Contact Summit Investor Relations: Dave Gancarz Chief Business & Strategy Officer Nathan LiaBraaten Senior Director, Investor Relations investors@smmttx.com media@smmttx.com Summit Forward-looking Statements Any statements in this press release about the Company’s future expectations, plans and prospects, including but not limited to, statements about the clinical and preclinical development of the Company’s product candidates, entry into and actions related to the Company’s partnership with Akeso Inc., the intended use of the net proceeds from the private placements, the Company's anticipated spending and cash runway, the therapeutic potential of the Company’s product candidates, the potential commercialization of the Company’s product candidates, the timing of initiation, completion and availability of data from clinical trials, the potential submission of applications for marketing approvals, the expected timing of BLA submissions or FDA decisions, potential acquisitions, statements about the previously disclosed At-The-Market equity offering program (“ATM Program”), the expected proceeds and uses thereof, the Company’s estimates regarding stock-based compensation, and other statements containing the words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "would," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the Company’s ability to sell shares of our common stock under the ATM Program, the conditions affecting
8 the capital markets, general economic, industry, or political conditions, including the effects of geopolitical developments, domestic and foreign trade policies, and monetary policies, the results of our evaluation of the underlying data in connection with the development and commercialization activities for ivonescimab, the outcome of discussions with regulatory authorities, including the Food and Drug Administration, the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future clinical trials, the results of such trials, and their success, global public health crises, that may affect timing and status of our clinical trials and operations, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials or preclinical studies will be indicative of the results of later clinical trials, whether business development opportunities to expand the Company’s pipeline of drug candidates, including without limitation, through potential acquisitions of, and/or collaborations with, other entities occur, expectations for regulatory approvals, laws and regulations affecting government contracts and funding awards, availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the "Risk Factors" and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of filings that the Company makes with the Securities and Exchange Commission. Summit defines a “positive study” as a clinical study that with one or more prespecified primary endpoints in which one of those endpoints achieves a statistically significant benefit according to the protocol or statistical analysis plan. Any change to our ongoing trials could cause delays, affect our future expenses, and add uncertainty to our commercialization efforts, as well as to affect the likelihood of the successful completion of clinical development of ivonescimab. Accordingly, readers should not place undue reliance on forward-looking statements or information. In addition, any forward-looking statements included in this press release represent the Company’s views only as of the date of this release and should not be relied upon as representing the Company’s views as of any subsequent date. The Company specifically disclaims any obligation to update any forward-looking statements included in this press release. Summit Therapeutics and the Summit Therapeutics logo are trademarks of Summit Therapeutics Inc. and/or its affiliates. Copyright 2026, Summit Therapeutics Inc. All Rights Reserved.
9 Summit Therapeutics Inc. GAAP Consolidated Statements of Operations (in millions, except per share data) Three Months Ended December 31, Year Ended December 31, 2025 2024 2025 2024 Operating expenses: Research and development $ 147.3 $ 51.4 $ 537.7 $ 150.8 Acquired in-process research and development — — — 15.0 General and administrative 77.7 14.2 556.7 60.2 Total operating expenses 225.0 65.6 1,094.4 226.0 Other income, net 5.8 4.4 14.8 13.4 Interest expense — — — (8.7) Net loss $ (219.2) $ (61.2) $ (1,079.6) $ (221.3) Net loss per share attributable to common shareholders per share, basic and diluted $ (0.29) $ (0.08) $ (1.44) $ (0.31) Summit Therapeutics Inc. GAAP Consolidated Balance Sheet Information (in millions) December 31, 2025 December 31, 2024 Cash and cash equivalents and short-term investments $ 713.4 $ 412.3 Total assets $ 751.2 $ 435.6 Total liabilities $ 92.3 $ 46.8 Total stockholders' equity $ 658.9 $ 388.8
10 Summit Therapeutics Inc. GAAP Consolidated Statement of Cash Flows Information (in millions) Year Ended December 31, 2025 2024 Net cash used in operating activities $ (322.9) $ (142.1) Net cash used in investing activities (174.3) (205.3) Net cash provided by financing activities 617.5 381.2 Effect of exchange rates on cash and cash equivalents 0.1 — Increase in cash, cash equivalents and restricted cash $ 120.4 $ 33.8
11 Summit Therapeutics Inc. Schedule Reconciling Selected Non-GAAP Financial Measures (in millions, except per share data) Three Months Ended December 31, Year Ended December 31, 2025 2024 2025 2024 Reconciliation of GAAP to Non-GAAP Research and Development Expense GAAP Research and Development $ 147.3 $ 51.4 $ 537.7 $ 150.8 Stock-based compensation (Note 1) (45.3) (4.3) (218.5) (16.0) Non-GAAP Research and Development $ 102.0 $ 47.1 $ 319.2 $ 134.8 Reconciliation of GAAP to Non-GAAP General and Administrative Expenses GAAP General and Administrative $ 77.7 $ 14.2 $ 556.7 $ 60.2 Stock-based compensation (Note 1) (66.4) (6.7) (513.9) (35.0) Non-GAAP General and Administrative $ 11.3 $ 7.5 $ 42.8 $ 25.2 Reconciliation of GAAP to Non-GAAP Operating Expenses GAAP Operating Expenses $ 225.0 $ 65.6 $ 1,094.4 $ 226.0 Stock-based compensation (Note 1) (111.7) (11.0) (732.4) (51.0) Non-GAAP Operating Expense $ 113.3 $ 54.6 $ 362.0 $ 175.0 Reconciliation of GAAP Net Loss to Non-GAAP Net Loss GAAP Net Loss $ (219.2) $ (61.2) $ (1,079.6) $ (221.3) Stock-based compensation (Note 1) 111.7 11.0 732.4 51.0 Non-GAAP Net Loss $ (107.5) $ (50.2) $ (347.2) $ (170.3) Reconciliation of GAAP Net Loss to Non-GAAP Net Loss Per Common Share GAAP Net Loss Per Basic and Diluted Common Share $ (0.29) $ (0.08) $ (1.44) $ (0.31) Stock-based compensation (Note 1) 0.15 0.01 0.98 0.07 Non-GAAP Net loss Per Basic and Diluted Common Share $ (0.14) $ (0.07) $ (0.46) $ (0.24) Basic and Diluted Common Shares 766.4 737.5 747.7 718.5
12 Summit Therapeutics Inc. Schedule Reconciling Selected Non-GAAP Financial Measures (in millions) Unaudited Three Months Ended December 31, 2025 September 30, 2025 June 30, 2025 March 31, 2025 December 31, 2024 Reconciliation of GAAP to Non-GAAP Operating Expenses GAAP Operating Expenses $ 225.0 $ 234.2 — $ 568.4 $ 66.8 $ 65.6 Stock-based compensation (Note 1) (111.7) (130.8) (478.8) (11.1) — (11.0) Non-GAAP Operating Expense $ 113.3 $ 103.4 $ 89.6 $ 55.7 $ 54.6 Reconciliation of GAAP Net Loss to Non-GAAP Net Loss GAAP Net Loss $ (219.2) $ (231.8) $ (565.7) $ (62.9) $ (61.2) Stock-based compensation (Note 1) 111.7 130.8 478.8 11.1 11.0 Non-GAAP Net Loss $ (107.5) $ (101.0) $ (86.9) $ (51.8) $ (50.2) Summit Therapeutics Inc. Notes on our Non-GAAP Financial Information Non-GAAP financial measures adjust GAAP financial measures for the items listed below. These Non-GAAP measures should be viewed in addition to, and not as a substitute for Summit's reported GAAP results, and may be different from Non-GAAP measures used by other companies. In addition, these Non-GAAP measures are not based on any comprehensive set of accounting rules or principles. Summit management uses these Non-GAAP measures for internal budgeting and forecasting purposes and to evaluate Summit’s financial performance. Summit management believes the presentation of these Non-GAAP measures is useful to investors for comparing prior periods and analyzing ongoing business trends and operating results. Each of Non-GAAP Research and Development Expense, Non-GAAP General and Administrative Expenses, Non-GAAP Operating Expenses, Non-GAAP Net Loss and Non-GAAP EPS differ from GAAP in that such measures exclude the non-cash charges and costs associated with stock-based compensation. Note 1: Stock-based compensation is a non-cash charge and costs calculated for this expense can vary year-over-year depending on the stock price of awards on the date of grant as well as the timing of compensation award arrangement.
Summit Therapeutics Q4 & FY 2025 Earnings Call February 23, 2026 4:30pm ET
Forward Looking Statement Any statements in this presentation about the Company’s future expectations, plans and prospects, including but not limited to, statements about the clinical and preclinical development of the Company’s product candidates, entry into and actions related to the Company’s partnership with Akeso Inc., the Company's anticipated spending and cash runway, the therapeutic potential of the Company’s product candidates, the potential commercialization of the Company’s product candidates, the timing of initiation, completion and availability of data from clinical trials, the potential submission of applications for marketing approvals, the expected timing of BLA submissions or FDA decisions, potential acquisitions, statements about the previously disclosed At-The-Market equity offering program (“ATM Program”), the expected proceeds and uses thereof, the Company’s estimates regarding stock-based compensation, and other statements containing the words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "would," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the Company’s ability to sell shares of our common stock under the ATM Program, the conditions affecting the capital markets, general economic, industry, or political conditions, including the effects of geopolitical developments, domestic and foreign trade policies, and monetary policies, the results of our evaluation of the underlying data in connection with the development and commercialization activities for ivonescimab, the outcome of discussions with regulatory authorities, including the Food and Drug Administration, the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future clinical trials, the results of such trials, and their success, global public health crises, that may affect timing and status of our clinical trials and operations, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials or preclinical studies will be indicative of the results of later clinical trials, whether business development opportunities to expand the Company’s pipeline of drug candidates, including without limitation, through potential acquisitions of, and/or collaborations with, other entities occur, expectations for regulatory approvals, laws and regulations affecting government contracts and funding awards, availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the "Risk Factors" and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of filings that the Company makes with the Securities and Exchange Commission. Summit defines a “positive study” as a clinical study that with one or more prespecified primary endpoints in which one of those endpoints achieves a statistically significant benefit according to the protocol or statistical analysis plan. Any change to our ongoing trials could cause delays, affect our future expenses, and add uncertainty to our commercialization efforts, as well as to affect the likelihood of the successful completion of clinical development of ivonescimab. Accordingly, readers should not place undue reliance on forward- looking statements or information. In addition, any forward-looking statements included in this presentation represent the Company’s views only as of the date of this release and should not be relied upon as representing the Company’s views as of any subsequent date. The Company specifically disclaims any obligation to update any forward-looking statements included in this presentation. Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit Therapeutics and the Summit Therapeutics logo are trademarks of Summit Therapeutics Inc. Copyright 2026, Summit Therapeutics Inc. All Rights Reserved.2 Summit Proprietary Information - Do Not Copy or Distribute Q4 & YE 2025 Earnings Presentation | 2/2026
Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). HARMONi-3 Clinical Trial Update ⚫ HARMONi-3: ◼ Phase III multi-regional clinical study in 1L NSCLC comparing ivonescimab + chemo vs. pembrolizumab + chemo ◼ For two separate cohorts, squamous and non-squamous histologies, statistical analyses for PFS and OS will be conducted separately (two separate ITT populations) ⚫ February 2026 HARMONi-3 Updates: ◼ HARMONi-3 squamous cohort: patient screening completed Q1 2026 ◼ Statistical plan amended to include interim PFS analysis of HARMONi-3 squamous cohort ◼ Note: OS is expected to be immature at time of this interim PFS analysis ⚫ Timing Expectations: ◼ Q2 2026: interim PFS analysis expected for HARMONi-3 squamous cohort ◼ H2 2026: final PFS & interim OS data for HARMONi-3 squamous cohort expected ◼ H2 2026: expected completion of enrollment for HARMONi-3 non-squamous cohort ◼ H1 2027: final PFS in HARMONi-3 non-squamous cohort Summit Sponsored Trial 3 Summit Proprietary Information Do Not Copy or Distribute Q4 & YE 2025 Earnings Presentation | 2/2026 Abbreviations: 1L=first-line; chemo=chemotherapy; vs.=versus; PFS=progression-free survival; OS=overall survival; ITT=intention-to-treat; Q[X]=quarter number of a fiscal year; H[X}=half number of a fiscal year;
Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Data generated and analyzed by Akeso. z 4 1 Q4 2025 & Current Highlights BLA Filed; PDUFA Nov 14, 2026 Enrollment progressing Squam. Interim PFS Q21 Squam. Final PFS, Int. OS H2 20261 Non-Squam. Final PFS H1 20271 Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Studies starting mid-2026 GSK: GORTEC: Groupe d'Oncologie Radiothérapie Tête Et Cou or Head and Neck Oncology and Radiotherapy Group; RevMed: Revolution Medicines PDUFA: Prescription Drug User Fee Act; OS: overall survival; PFS: progression-free survival; HR: hazard ratio; PD-1=programmed cell death protein 1; References: 1. Summit Therapeutics Press Release February 23, 2026; Studies conducted by Akeso are single-region studies conducted in China. Summit Collaborations: First patient dosed Q1 2026 RevMed: Enrollment initiated 2L+ EGFRm NSCLC ivonescimab + chemo stat sig OS vs. chemo OS HR 0.74 (p=0.19) 1L Squamous NSCLC ivonescimab + chemo stat sig PFS vs. PD-1 + chemo PFS HR 0.60 (p<0.0001) Phase III ILLUMINE study in HNSCC, expect FPI Q2 2026 GORTEC: Summit Proprietary Information - Do Not Copy or Distribute Q4 & YE 2025 Earnings Presentation | 2/2026
Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit Proprietary Information - Do Not Copy or Distribute Q4 & YE 2025 Earnings Presentation | 2/20265 Ivonescimab Anti-VEGF Anti-PD-1 Includes both Summit and Akeso trials Total Ivonescimab Trials Sponsored by Summit or Akeso2 Patients Dosed in All Clinical Trials3 Patients Dosed Commercially in China3 Phase III Trials in Multiple Tumor Types1 Positive Phase III Readouts to Date The only in-class Phase III Readouts Leadership in global oncology with a proven track record with high-speed and quality execution. Proven Track Record 4 Global Phase III Trials Mission: Patients First To improve quality of life, increase potential duration of life, by resolving serious unmet medical needs Indications Approved in China by the NMPA 4 Phase III Trials with Positive Results PD-1 x VEGF Class Frontrunner with Multi-Year Lead 15 Phase III Trials1 >4K Trial Patients 2 Chinese Approvals >60K Commercial Patients in China 44 Sponsored Trials Abbreviations: PD-1=programmed cell death protein 1; VEGF=vascular endothelial growth factor; NMPA = National Medical Products Administration (China); References: 1. Total Phase III clinical trials announced, enrolling, or completed as of February 20, 2026, via clinicaltrials.gov or public announcement; 2. Ivonescimab trials via clinicaltrials.gov; 3. Akeso public announcements Total Trials Involving Ivonescimab on clinicaltrials.gov2 142 Total Trials
Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit Proprietary Information - Do Not Copy or Distribute Q4 & YE 2025 Earnings Presentation | 2/20266 Abbreviations: 1L=first-line; 2L=second-line; AG=albumin-bound paclitaxel plus gemcitabine; BTC=biliary tract cancer; Chemo=chemotherapy; CPS=combined positive score; CRC=colorectal cancer; EGFRm+=epidermal growth factor receptor mutant positive; GEJ=gastroesophageal junction; HCC=hepatocellular carcinoma; HNSCC=head and neck squamous cell carcinoma; mAb=monoclonal antibody; NSCLC=non-small-cell lung cancer; OC=ovarian cancer; PD-L1=programmed cell death-ligand 1; PDAC=pancreatic ductal adenocarcinoma; SCLC=Small Cell Lung Cancer; TIGIT=T cell immunoreceptor with Ig and ITIM domains; TNBC=triple negative breast cancer; vs.=versus. Reference: ClinicalTrials.gov These ivonescimab clinical trials are being conducted in China and/or Australia and are fully sponsored and managed by Akeso. TUMOR TYPE STUDY LINE & INDICATION REGIMEN STATUS Approved PHASE 1/1b 2 3 Lung 2L advanced EGFRm+ NSCLC ivonescimab + chemo vs. placebo + chemo Active, Recruiting Complete 1L metastatic NSCLC (all PD-L1 levels) ivonescimab vs. pembrolizumab Active, Recruiting Complete 1L advanced or metastatic NSCLC ivonescimab + chemo vs. tislelizumab + chemo Active, Recruiting Complete 2L advanced or metastatic NSCLC progressed on or after PD-L1 therapy ivonescimab + docetaxel vs. placebo + docetaxel Not Yet Recruiting Consolidation treatment SCLC not progressed after chemoradiation ivonescimab vs. placebo Recruiting AK112-208 1L advanced or metastatic NSCLC ivonescimab + cadonilimab ± chemo Recruiting Breast 1L inoperable locally advanced/ metastatic TNBC ivonescimab + nab-paclitaxel vs. placebo + nab-paclitaxel Recruiting AK117-203 1L metastatic TNBC ivonescimab + chemo Recruiting Gynecologic AK104-221 2L OC ivonescimab ± chemo ± cadonilimab Recruiting AK112-211 1L platinum-sensitive OC ivonescimab ± chemo ± olaparib Recruiting Head and Neck 1L recurrent or metastatic HNSCC with PD-L1 positive (CPS ≥1) ivonescimab + AK117 vs. placebo + pembrolizumab Recruiting Gastrointestinal 1L unresectable locally advanced or metastatic BTC ivonescimab + chemo vs. durvalumab + chemo Active, Recruiting Complete 1L metastatic PDAC ivonescimab + chemo ± AK117 vs. placebo + chemo Recruiting 1L metastatic CRC ivonescimab + chemo vs. bevacizumab + chemo Recruiting AK112-209 1L advanced HCC ivonescimab ± anti-TIGIT antibody ± cadonilimab ± anti-TIGIT/TGF-β vs. sintilimab + bevacizumab Recruiting AK112-210 1L metastatic PDAC ivonescimab ± cadonilimab ± AG vs. AG Recruiting AK119-202 1L or 2L microsatellite stable CRC ivonescimab + anti-CD73 mAb ± chemo Recruiting AK130-201 2L advanced BTC ivonescimab ± anti-TIGIT/TGF-β or ivonescimab Not yet recruiting Various Cancers AK117-202 1L or 2L advanced or metastatic NSCLC, GEJ, BTC, PDAC ivonescimab + ligufalimab ± chemo Active, Not Recruiting AK127-104 1L advanced malignant tumors ivonescimab + anti-TIGIT antibody Not yet recruiting Lung 2L advanced EGFRm+ NSCLC ivonescimab + chemo vs. placebo + chemo Active, Recruiting Complete 1L metastatic NSCLC ivonescimab + chemo vs. pembrolizumab + chemo Recruiting 1L metastatic PD-L1 high (≥50%) NSCLC ivonescimab vs. pembrolizumab Recruiting Gastrointestinal 1L metastatic CRC ivonescimab + chemo vs. bevacizumab + chemo Recruiting Ivonescimab Development: Summit + Akeso Pipelines Phase I and II trials completed by Akeso.
Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit Proprietary Information - Do Not Copy or Distribute Q4 & YE 2025 Earnings Presentation | 2/20267 Ivonescimab Development Plan Ivo esci ab evelop e t: Summit Pipeline References: 1. In Summit license territories, Data on File 55. Summit Therapeutics Inc. Supported = at a minimum, a notification of support communicated to PI; 2. Publications available at smmttx.com, Accessed on Jan 6, 2026. Abbreviations: 1L=first-line; 2L=second-line; ADC=antibody drug conjugate; Chemo=chemotherapy; CRC=colorectal cancer; EGFRm+=epidermal growth factor receptor mutant positive; ISTs=Investigator Sponsored Trials; NSCLC=non-small-cell lung cancer; PDAC=pancreatic ductal adenocarcinoma; HNSCC=head and neck squamous cell carcinoma; PD-L1=programmed cell death-ligand 1; RAS=renin-angiotensin system; RASi=RAS inhibitor; RAS(ON)i=RAS inhibitor to RAS proteins in ON state (revmed.com/science, Accessed Jan 10, 2026); SCLC=small cell lung cancer; incl.=including; vs.=versus. Reference: ClinicalTrials.gov Present-time biopharma confidence in ivonescimab is a significant governor in our go-forward clinical development expense Collaborations GORTEC: Ph3 ILLUMINE Study: HNSCC RevMed: Novel RAS(ON)i: NSCLC, PDAC, CRC GSK: Novel B7-H3: multi-tumor incl. SCLC More Planned in 2026 >60 ISTs1 15 Currently Enrolling 5 via MD Anderson Collaboration 46 Ivonescimab Posters, Publications & Presentations2 RASi ADC llaborations >60 ISTs Supported1 >46 Phase I and II trials completed by Akeso. Summit planning to initiate additional set of Phase III studies with continuous details coming throughout 2026
Ivonescimab 1L NSCLC Ivonescimab vs. Anti-PD-1 +/- chemo Presented at WCLC 2024 Presidential Symposium1 The Lancet2 Approved indication in China Awaiting data maturation for OS Squamous, PD-L1 All-Comers Ivonescimab + chemo vs. tislelizumab (PD-1) + chemo Presented at ESMO 2025 Presidential Symposium3 The Lancet4 sNDA pending in China Awaiting data maturation for OS EGFRm NSCLC Post-TKI Ivonescimab + Chemo vs. Placebo + Chemo EGFRm after a TKI Ivonescimab + chemo vs. placebo + chemo Presented at ASCO 20245 OS Update: SITC Nov. 20257 JAMA6 Approved indication in China EGFRm after a 3rd-gen TKI Ivonescimab + chemo vs. placebo + chemo Presented at WCLC 2025 Presidential Symposium8 US BLA submitted Q4 2025 Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). 8 PD-L1 Positive, Monotherapy Ivonescimab vs. pembrolizumab References: 1. Wang C, et al. HARMONi-2. Presented at WCLC 2024.; 2. Xiong A, et al. Lancet. 2025;405(10481):839-849; 3. Lu S, et al. HARMONi-6. Presented at ESMO 2025.; 4. Chen Z, et al. Lancet. 2025;406(10515):2078-2088.; 5. Zhang L, et al. HARMONi-A study. Presented at ASCO 2024.; 6. Fang W, et al. JAMA. 2024;332(7):561-570.; 7. Zhang L, et al. Final OS Analysis: HARMONi-A. Presented at SITC 2025.; 8. Goldman J, et al. HARMONi. Presented at WCLC 2025. Abbreviations: 1L=first-line; 2L=second-line; ASCO=American Society of Clinical Oncology; chemo=chemotherapy; EGFRm=epidermal growth factor receptor mutation; ESMO=European Society for Medical Oncology; gen=generation; JAMA=The Journal of the American Medical Association; NSCLC=non-small cell lung cancer; OS=overall survival; PD-1=programmed cell death protein 1; PD-L1=programmed cell death-ligand 1; SITC=The Society for Immunotherapy of Cancer; sNDA=Supplemental New Drug Application (for marketing authorization); TKI=tyrosine kinase inhibitor; VEGF=vascular endothelial growth factor; vs.=versus; WCLC=World Conference on Lung Cancer. Four Phase III Clinical Studies with Positive Results Summit Proprietary Information - Do Not Copy or Distribute Q4 & YE 2025 Earnings Presentation | 2/2026
Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit Proprietary Information - Do Not Copy or Distribute Q4 & YE 2025 Earnings Presentation | 2/2026 Potential growth beyond current PD-(L)1 & VEGF indications Examples of opportunities include: PD-L1 low TNBC, EGFRm NSCLC Platform Opportunity 9 for PD-(L)1 Inhibitors + VEGF Inhibitors >50 approved indications1 + Checkpoint Inhibitor Global Market >$90B in 20282 >$20B NSCLC PD-(L)1: >$50B in 20243 $30B pembrolizumab in 20244 >$20B in 20285 >$110B VEGF Inhibitor Global Market 1. KEYTRUDA® USPI, OPDIVO® USPI, LIBTAYO® USPI, IMFINZI® USPI, BAVENCIO® USPI, JEMPERLI® USPI, TECENTRIQ® USPI, ZYNYZ® USPI, AVASTIN® USPI, CYRAMZA® USPI, LENVIMA® USPI, INLYTA® USPI, SUTENT® USPI. 2. TD Cowen and IQVIA, estimates. 3. Stifel report, estimate; compilation of Form 10-K and 20-F as filed with the US SEC. 4. MRK 2024 Form 10-K, as filed with the US SEC. 5. TD Cowen and IQVIA, estimate. Abbreviations: EGFRm=epidermal growth factor receptor mutation; NSCLC=non-small-cell lung cancer; PD-1=programmed cell death protein 1; PD-L1=programmed cell death-ligand 1; TNBC=triple-negative breast cancer; VEGF=vascular endothelial growth factor
Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit Proprietary Information - Do Not Copy or Distribute Q4 & YE 2025 Earnings Presentation | 2/202610 Upcoming Catalysts: Shaping the Path Forward FY26 Further details to continue for new global Phase IIIs 1H26 HARMONi-3 SQ: Interim PFS analysis expected ILLUMINE: Coop group Phase III HNSCC study FPI expected 2H26 HARMONi-3 SQ: Final PFS, interim OS data readout expected HARMONi-3 nSQ: Completion of enrollment expected HARMONi: BLA PDUFA Date: EGFRm NSCLC post-TKI 1H27 HARMONi-3 nSQ: Final PFS data readout expected Anti-VEGF Anti-PD-1 Abbreviations: Coop=cooperative; HNSCC=head and neck squamous cell carcinoma; TKI=tyrosine kinase inhibitor; BLA=Biologics License Application; EGFRm=epidermal growth factor receptor mutant; NSCLC=non-small-cell lung cancer; nSQ=non-squamous; OS=overall survival; PD-1=programmed cell death protein 1; PFS=progression-free survival; SQ=squamous; VEGF=vascular endothelial growth factor; PDUFA=Prescription Drug User Fee Act; PDUFA Date: Targeted action date by the health authority (US Food & Drug Administration) for BLA application; FY=fiscal year; 1H=first half; 2H=second half.
Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit Proprietary Information - Do Not Copy or Distribute Q4 & YE 2025 Earnings Presentation | 2/2026 Strong Balance Sheet to Kick Off 2026 11 $713.4M Cash as of December 31, 2025 $0 No Debt as of December 31, 2025
Financial Summary Q4’25 vs. Q3’25 (1) Excludes stock-based compensation December 31, 2025 September 30, 2025 Total GAAP Operating Expenses $ 225.0 $ 234.2 Research and development 147.3 131.1 General and administrative 77.7 103.1 Non-GAAP Operating Expenses $ 113.3 $ 103.4 Non-GAAP Research and Development (1) 102.0 90.5 Non-GAAP General and Administrative (1) 11.3 12.9 GAAP Net Loss $ (219.2) $ (231.8) Non-GAAP Net Loss $ (107.5) $ (101.0) Three Months Ended (in millions) Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). 12 Summit Proprietary Information - Do Not Copy or Distribute Q4 & YE 2025 Earnings Presentation | 2/2026 (1) Excludes stock-based compensation Refer to the next slides for reconciliations between Generally Accepted Accounting Principles (GAAP) and Non-GAAP financial measures.
Schedule Reconciling Selected Non-GAAP Financial Measures Note 1: Stock-based compensation is a non-cash charge and costs calculated for this expense can vary year-over-year depending on the stock price of awards on the date of grant as well as the timing of compensation award arrangements. December 31, 2025 September 30, 2025 Reconciliation of GAAP to Non-GAAP Research and Development Expense GAAP Research and development $ 147.3 $ 131.1 Stock-based compensation (Note 1) (45.3) (40.6) Non-GAAP Research and Development $ 102.0 $ 90.5 Reconciliation of GAAP to Non-GAAP General and Administrative Expenses GAAP General and administrative $ 77.7 $ 103.1 Stock-based compensation (Note 1) (66.4) (90.2) Non-GAAP General and Administrative $ 11.3 $ 12.9 Reconciliation of GAAP to Non-GAAP Operating Expenses GAAP Operating expenses $ 225.0 $ 234.2 Stock-based compensation (Note 1) (111.7) (130.8) Non-GAAP Operating Expense $ 113.3 $ 103.4 Three Months Ended (in millions) Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). 13 Summit Proprietary Information - Do Not Copy or Distribute Q4 & YE 2025 Earnings Presentation | 2/2026
Schedule Reconciling Selected Non-GAAP Financial Measures Note 1: Stock-based compensation is a non-cash charge and costs calculated for this expense can vary year-over-year depending on the stock price of awards on the date of grant as well as the timing of compensation award arrangements. December 31, 2025 September 30, 2025 Reconciliation of GAAP Net Loss to Non-GAAP Net Loss GAAP Net Loss $ (219.2) $ (231.8) Stock-based compensation (Note 1) 111.7 130.8 Non-GAAP Net Loss $ (107.5) $ (101.0) Reconciliation of GAAP EPS to Non-GAAP EPS GAAP Loss Per Share $ (0.29) $ (0.31) Stock-based compensation (Note 1) 0.15 0.18 Non-GAAP Loss Per Share $ (0.14) $ (0.13) Basic and Diluted Weighted Average Shares Outstanding 766.4 743.4 Three Months Ended (in millions) Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). 14 Summit Proprietary Information - Do Not Copy or Distribute Q4 & YE 2025 Earnings Presentation | 2/2026
Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit Proprietary Information - Do Not Copy or Distribute Q4 & YE 2025 Earnings Presentation | 2/202615 Bob Duggan Chairman & Co-Chief Executive Officer Dave Gancarz Chief Business & Strategy Officer Manmeet Soni Chief Operating Officer & Chief Financial Officer Dr. Maky Zanganeh President & Co-Chief Executive Officer Dr. Allen Yang Chief R&D Officer
FAQ
What were Summit Therapeutics (SMMT) key financial results for full-year 2025?
Summit Therapeutics reported a 2025 GAAP net loss of $1,079.6 million, or $(1.44) per share. Non-GAAP net loss was $347.2 million, or $(0.46) per share, reflecting adjustments that primarily remove $732.4 million of stock-based compensation expense.
How much cash did Summit Therapeutics (SMMT) have at December 31, 2025?
Summit ended 2025 with $713.4 million in cash, cash equivalents and short-term investments. This compares to $412.3 million a year earlier and was supported by $617.5 million of net cash provided by financing activities during the year.
Why did Summit Therapeutics’ (SMMT) operating expenses increase so sharply in 2025?
GAAP operating expenses rose to $1,094.4 million in 2025 mainly due to $681.4 million higher stock-based compensation from modifications to performance-based option awards. Non-GAAP operating expenses, excluding stock-based compensation, were $362.0 million, reflecting expanded clinical development of ivonescimab.
What is the status of Summit Therapeutics’ ivonescimab BLA and PDUFA date?
The US FDA accepted Summit’s Biologics License Application for ivonescimab plus chemotherapy in EGFR-mutated non-squamous NSCLC. The agency assigned a Prescription Drug User Fee Act (PDUFA) goal action date of November 14, 2026 for its regulatory decision.
What upcoming Phase III milestones did Summit Therapeutics (SMMT) highlight for ivonescimab?
Summit expects an interim progression-free survival analysis for the HARMONi‑3 squamous cohort in Q2 2026, with final PFS and interim overall survival in the second half of 2026. Final PFS for the HARMONi‑3 non-squamous cohort is expected in the first half of 2027.
How large were Summit Therapeutics’ (SMMT) 2025 R&D and G&A expenses?
In 2025, GAAP research and development expense was $537.7 million and GAAP general and administrative expense was $556.7 million. On a Non-GAAP basis, excluding stock-based compensation, R&D expense was $319.2 million and G&A expense was $42.8 million.
Filing Exhibits & Attachments
5 documents
Summit Therapeutics Inc
NASDAQ:SMMT
SMMT Rankings
SMMT Latest News
SMMT Latest SEC Filings
Feb 23, 2026
[10-K] Summit Therapeutics Inc. Files Annual Report