On February 23, 2026 Aptose Biosciences Inc. ("Aptose" or the "Company") (TSX: APS; OTC: APTOF) reported that it has entered into an amended and restated arrangement agreement (the "Amended and Restated Arrangement Agreement") amending and restating the arrangement agreement dated November 18, 2025 (the "Original Arrangement Agreement"), pursuant to which Aptose will continue from the Canada Business Corporations Act to the Business Corporations Act (Alberta) ("ABCA") (the "Continuance") and subsequently be acquired by HS North America Ltd. (the "Purchaser"), a wholly owned subsidiary of Hanmi Pharmaceutical Co. Ltd. ("Hanmi" and together with the Purchaser, the "Hanmi Purchasers"), by way of a statutory plan of arrangement under the ABCA (the "Arrangement" and, together with the Continuance, the "Transaction").

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The Amended and Restated Arrangement Agreement amends and restates the Original Arrangement Agreement to, among other things, schedule a new date for the special meeting of shareholders to seek approval of the Transaction (the "Meeting"), originally scheduled to be held on January 16, 2026 (the "Original Meeting") which has been reconvened to March 31, 2026 at 11:00 a.m. (EST) (the "Reconvened Meeting"). The Original Meeting was postponed to address comments raised by the United States Securities and Exchange Commission ("SEC") on the Company’s transaction statement on Schedule 13E-3, as amended.

Aptose has prepared and filed with the SEC a definitive proxy statement for the Reconvened Meeting (the "Proxy Statement"). A copy of the Proxy Statement will be mailed to all shareholders of the Company as soon as practicable. The Proxy Statement, form of proxy, letter of transmittal, as well as Schedule 13E-3, as amended, will also be available for download under Aptose’s profile on SEDAR+ at www.sedarplus.ca and EDGAR at www.sec.gov.

On December 12, 2025, Aptose obtained an interim order from the Court of King’s Bench of Alberta (the "Court") authorizing the holding of the Meeting and matters relating to the conduct of the Meeting.

Aptose also announced a revised record date for the Meeting, now set for the close of business on February 24, 2026.

The Reconvened Meeting will be held virtually via live audio webcast at https://meetings.lumiconnect.com/400-581-122-608. All shareholders who wish to attend the Reconvened Meeting must follow the procedures set out in the Proxy Statement. Shareholders who are unable to attend the Reconvened Meeting are strongly encouraged to complete, date, sign and return the form of proxy (in the case of registered shareholders) or voting instruction form (in the case of non-registered shareholders) provided with the meeting materials so that as many shareholders as possible are represented and vote at the Reconvened Meeting.

Aptose’s board of directors unanimously recommends that the shareholders vote FOR the special resolutions approving the Continuance and the Arrangement at the Reconvened Meeting.

Aptose also announced today that it has entered into a US$11.1 million second amended and restated 2025 facility agreement with Hanmi (the "Second A&R 2025 Facility Agreement").

The Second A&R 2025 Facility Agreement is uncommitted and administered through multiple advances until May 31, 2026, and will be used to fund Aptose’s business and clinical operations expenses reasonably related to the advancement of Tuspetinib ("TUS"). Aptose has not yet received funds from the Second A&R 2025 Facility Agreement but expects the first advance soon. This Second A&R 2025 Facility Agreement has been amended and restated from the prior December 2025 amended and restated facility agreement between Hanmi and Aptose, which was amended and restated from the prior September 2025 facility agreement between Hanmi and Aptose. No single advance shall be for an amount in excess of US$2,000,000, and any unpaid principal amount with respect to each advance shall accrue interest at six percent (6%) per annum. The Second A&R 2025 Facility Agreement contains customary affirmative and negative covenants and securities that are subject to a number of limitations and exceptions.

Each of the September 2025 facility agreement and December 2025 amended and restated facility agreement constitutes a "related-party transaction" within the meaning of Multilateral Instrument 61-101 – Protection of Minority Security Holders in Special Transactions ("MI 61-101") as Hanmi is a related party of the Company under Canadian securities laws. However, the Company is relying on the exemption from the formal valuation and minority shareholder approval requirements contained in MI 61-101 on the basis of the "financial hardship" exemption therein. In its consideration and approval of the September 2025 facility agreement and December 2025 amended and restated facility agreement, the board of directors of the Company, acting in good faith and having taken into account the liquidity, financial position and cash needs of the Company, the alternatives available to the Company, relevant benefits, risks and other factors, including the relative impacts on applicable stakeholders, and such matters they considered relevant or appropriate, unanimously determined that entering into the September 2025 facility agreement and December 2025 amended and restated facility agreement will result in an improvement of the Company’s financial position, and that the terms of the September 2025 facility agreement and December 2025 amended and restated facility agreement are reasonable in the circumstances of Aptose.

(Press release, Hanmi, FEB 23, 2026, View Source [SID1234662914])

On February 23, 2026 Galapagos NV (Euronext & NASDAQ: GLPG) reported its financial results for the full year 2025 and provided an update on the fourth quarter 2025 and its year-to-date performance.

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"2025 was a pivotal year for Galapagos, during which our Board of Directors took decisive action to chart a new strategic course for the Company," said Henry Gosebruch, CEO of Galapagos. "Since assuming the role of Chief Executive Officer in May, our new senior leadership team and I have focused on the Company’s transformation to better position Galapagos for long-term value creation."

"The wind-down of our cell therapy activities is underway, and we have strengthened our leadership team with the capabilities required for our next phase. Our focus is on building sustainable long-term growth through transformative business development, leveraging our unique position and strengths as well as our collaboration with Gilead. We are pleased with the momentum we have built to date and will continue to apply a selective approach in pursuing the right opportunities and the right transactions. Through disciplined capital allocation, we aim to build a pipeline of novel therapeutics that can deliver meaningful benefits for patients and create long-term value for shareholders. We are off to a strong start, and I am excited about what lies ahead," concluded Gosebruch.

Aaron Cox, CFO of Galapagos, added, "At year-end, Galapagos remained robustly capitalized, with approximately €3.0 billion in cash and financial investments as of December 31, 2025. This strong financial position underpins our ability to act decisively and allocate capital in a disciplined manner as we evaluate business development opportunities. Following completion of the wind-down of the cell therapy activities, we continue to expect to be cash flow neutral to positive by the end of 2026 excluding any business development activities and currency fluctuations, and anticipate a 2026 year-end cash position in the range of €2.775 billion to €2.850 billion."

Post-period events

The Board of Directors appointed Paulo Fontoura as Non-Executive Independent Director by way of cooptation, replacing Dr. Susanne Schaffert, who stepped down effective November 1, 2025.
On January 5, 2026, Galapagos announced that the works council consultation process regarding the wind-down of cell therapy activities had been completed and that its Board of Directors decided to initiate the wind-down of the Company’s cell therapy activities. The wind-down remains on schedule and is expected to be substantially completed by the end of the third quarter of 2026.
The remaining Galapagos organization expects to be a lean organization of approximately 35-40 employees by the end of 2026, repositioned for long-term growth through transformational business development, while maintaining a dedicated presence at its headquarters in Mechelen, Belgium and its U.S. hubs in Chicago, IL and San Francisco, CA.
With the wind-down progressing on schedule, Galapagos is now fully focused on pursuing transformative business development opportunities aligned with areas of high unmet medical need.
Fourth Quarter 2025 Business Update
CORPORATE

Continued to strengthen and enhance the management team to drive implementation of Galapagos strategy by appointing Fred Blakeslee as Executive Vice President and General Counsel, effective October 16, 2025, succeeding Ms. Valeria Cnossen. Additionally, Ms. Missotten, Chief Human Resource officer, ceased to be a member of the Executive Committee as of December 31, 2025. To ensure continuity, she will continue to serve the Company until June 30, 2026.
Enhanced governance by appointing Dr. Neil Johnston and Devang Bhuva by way of co-optation as Non-Executive Independent Director and Non-Executive Non-Independent Director, respectively, effective November 1, 2025. In connection with these co-optations, Non-Executive Independent Directors Dr. Elisabeth Svanberg, and Non-Executive Non-Independent Director and current CFO of Gilead, Andrew Dickinson, stepped down.
IMMUNOLOGY SMALL MOLECULE PIPELINE

In December 2025, we announced topline Phase 2 results for TYK2 inhibitor, GLPG3667, in patients with dermatomyositis (DM) and systemic lupus erythematosus (SLE), which are summarized as follows:
The GALARISSO DM study met its primary endpoint, showing that GLPG3667, administered once daily at 150 mg (N=21) in addition to standard-of-care therapy, achieved a statistically significant clinical benefit in the Total Improvement Score (TIS)1 at Week 24 (p=0.0848; Δ: 14.26), compared to placebo (N=19). The pre-specified threshold of statistical significance was set at 10% (α=0.1). GLPG3667 also showed meaningful clinical improvements compared to placebo on several secondary endpoints of disease activity, including TIS20, TIS40, TIS60 and m-CDASI-A2. GLPG3667 demonstrated a favorable safety and tolerability profile throughout the 24-week treatment period.
In the GALACELA SLE study, GLPG3667, administered once daily at 75 mg (N=59) and 150 mg (N= 64) in addition to standard-of-care therapy, the primary endpoint analysis of dose-response on SLE responder index (SRI)-4 at Week 32 did not meet statistical significance. However, GLPG3667 showed numerical improvements over placebo (N=63) on several secondary endpoints, particularly on skin-related outcomes. The safety profile was consistent with previous studies with GLPG3667. The GALACELA study is currently ongoing, and the final Week 48 data, expected in the second quarter of 2026, will be essential to assess the totality of the evidence and determine potential next steps for the SLE program.
As part of our ongoing efforts to maximize the value of this program for both patients and Galapagos, we are evaluating all strategic options. These include potential partnership and business development opportunities to accelerate development of GLPG3667 in DM. Additionally, we continue to explore opportunities to expand into other severe autoimmune diseases with significant unmet medical need.
ONCOLOGY CAR-T CELL THERAPY UPDATE

As noted above, the Company announced in January 2026 the start of the wind-down of its cell therapy activities to pursue new transformational business development transactions using its available cash resources. In connection with the wind-down, we notified study investigators of the early termination of the Phase 1/2 ATALANTA-1 (CD19 CAR-T candidate GLPG5101) and Phase 1/2 PAPILIO-1 (BCMA CAR-T candidate GLPG5301) studies. Patients from both studies will roll over into the long-term HESPERIA study (NCT06652633) to monitor long-term safety and efficacy. Residual spending associated with these long-term follow-up studies is expected to be minimal.
Financial performance
Full year 2025 key figures (consolidated)
(€ millions, except basic & diluted earnings per share)

December 31, 2025 December 31, 2024 % Change
Supply revenues 29.9 34.8 -14%
Collaboration revenues 1,082.3 240.8 +349%
Total net revenues 1,112.2 275.6 +304%
Cost of sales (29.7) (34.8) -15%
R&D expenses (459.4) (335.5) +37%
G&Ai and S&Mii expenses (153.4) (134.4) +14%
Impairment of the cell therapy activities (228.1) - +100%
Other operating income 53.5 40.8 +31%
Operating profit/loss (-) 295.1 (188.3)
Fair value adjustments and net exchange differences (39.4) 95.8
Net other financial result 45.2 89.4 -49%
Income taxes 18.6 1.8
Net profit /loss (-) from continuing operations 319.5 (1.3)
Net profit from discontinued operations, net of tax 1.4 75.4
Net profit of the year 320.9 74.1
Basic and diluted earnings per share (€) 4.87 1.12

Cash and Financial investments 2,998.0 3,317.8

DETAILS OF THE FULL YEAR 2025 FINANCIAL RESULTS

Total operating profit from continuing operations amounted to €295.1 million in 2025, compared to an operating loss of €188.3 million in 2024. This operating profit was primarily due to the release in revenue of the remaining deferred income balance allocated to the drug discovery platform for an amount of €1,069.0 million. The operating expenses were negatively impacted for a total of €399.8 million, by 1) the decision to wind down the cell therapy activities with an impact of €275.0 million, consisting of an impairment of the cell therapy activities of €228.1 million (on goodwill and fixed assets), severance costs of €33.3 million, costs for early termination of collaborations of €16.3 million, deal costs of €10.1 million, €1.5 million additional accelerated non-cash cost recognition for subscription right plans and €7.5 million other costs, partly offset by a positive fair value adjustment of the contingent consideration payable of €21.8 million; and by 2) the strategic reorganization related to the small molecules business announced in January 2025, for €124.8 million. The latter was reflected in severance costs of €47.7 million, costs for early termination of collaborations of €46.1 million, impairment on fixed assets related to small molecules activities of €9.5 million, deal costs of €14.8 million, €4.6 million additional accelerated non-cash cost recognition for subscription right plans and €2.1 million other operating expenses.

Total net revenues amounted to €1,112.2 million in 2025, compared to €275.6 million last year. The revenue recognition related to the exclusive access rights granted to Gilead under the OLCA3 for the Galapagos’ drug discovery platform amounted to €1,069.0 million in 2025, compared to €230.2 million in 2024. It was assessed based on the intention to wind down and on the facts and circumstances on December 31, 2025, that the deferred income balance allocated to the Company’s drug discovery platform is no longer justified in the 2025 IFRS financial statements, leading to full recognition of the deferred income at December 31, 2024, as revenue. For the avoidance of doubt, the OLCA remains in effect. Royalty income from Gilead for Jyseleca amounted to €12.2 million in 2025 (€10.6 million in 2024).
Cost of sales amounted to €29.7 million in 2025 as compared to €34.8 million in 2024 and related to the supply of Jyseleca to Alfasigma under the transition agreement. The related revenues are reported in total net revenues.
R&D expenses in 2025 amounted to €459.4 million, compared to €335.5 million in 2024. Subcontracting costs increased by €72.8 million from €160.1 million in 2024 to €232.9 million in 2025 primarily driven by costs for the early termination of collaboration programs and costs for the cell therapy programs in oncology. Depreciation and impairment costs in 2025 increased to €42.4 million, compared to €35.4 million in 2024, due to impairments on fixed assets related to small molecules programs. Personnel costs increased from €87.7 million in 2024 to €147.2 million in 2025 primarily due to severance costs.
S&M and G&A expenses amounted to €153.4 million in 2025, compared to €134.4 million in 2024. The increase in S&M and G&A expenses was mainly due to higher personnel costs, which increased from €59.2 million in 2024 to €81.0 million in 2025 due to increased severance costs.
Impairment of the cell therapy activities is a result of the Company’s previously announced strategic alternatives process for the cell therapy activities whereby the Company assessed the cell therapy activities associated assets’ recoverable amount in accordance with IAS 36. The recoverable amount was estimated lower than the assets’ carrying value. As a result, the Company recognized an impairment loss of €228.1 million, thereby aligning the cell therapy assets’ book value with the Company’s strategic decision to wind down the cell therapy activities, which resulted in a full impairment of both the associated goodwill and intangible assets and a partial impairment of property, plant and equipment.
Other operating income of €40.8 million in 2024 increased to €53.5 million in 2025, mainly driven by the fair value adjustment of the contingent consideration payable of €21.8 million, partly offset by lower grant and R&D incentives income.
Net financial income in 2025 amounted to €5.8 million, compared to net financial income of €185.2 million in 2024.

Fair value adjustments and net currency exchange results amounted to a negative amount of €39.4 million in 2025, compared to fair value adjustments and net currency exchange gains in 2024 of €95.8 million. They were primarily attributable to €18.3 million of negative changes in fair value of current financial investments, and to €44.8 million of unrealized currency exchange losses on cash and cash equivalents and current financial investments at amortized cost in U.S. dollars, partly offset by a positive effect of €22.7 million as consequence of the settlement of a hedging instrument.
Net other financial income in 2025 amounted to €45.2 million, compared to net other financial income of €89.4 million in 2024. Net interest income amounted to €45.3 million in 2025 compared to €88.5 million of net interest income in 2024, due to a decrease in the interest rates and a shift from investments in term deposits generating financial income to investments in money market funds generating fair value changes. Fair value gains and interest income derived from cash, cash equivalents and financial investments excluding any currency exchange results amounted to €103.0 million in 2025 (compared to €140.4 million in 2024).
Galapagos had €18.6 million of tax income in 2025, compared to €1.8 million of tax income in 2024. The increase is mainly explained by the reversal of the deferred tax liabilities linked to capitalized intangible assets related to the cell therapy activities, as the Company recorded an impairment on these intangible assets. Galapagos did not incur a current tax liability in 2025 because the profit of the year is fully absorbed by current year tax deductions.

The Company reported a net profit from continuing operations in 2025 of €319.5 million, compared to a net loss from its continuing operations of €1.3 million in 2024.

Net profit from discontinued operations related to Jyseleca amounted to €1.4 million, compared to net profit amounting to €75.4 million in 2024. The net result for discontinued operations included €11.7 million of R&D expenses primarily related to the final settlement of disputed expenses with Alfasigma, and €11.9 million of other operating income related to a fair value adjustment of the contingent consideration receivable from Alfasigma as a consequence of an adjusted sales forecast. The operating profit from discontinued operations in 2024, was mainly related to the gain on the sale of the Jyseleca business to Alfasigma of €52.3 million.

Galapagos reported a net profit in 2025 of €320.9 million, compared to a net profit of €74.1 million in 2024.

Cash and financial investments
Cash and financial investments totaled €2,998.0 million on December 31, 2025, as compared to €3,317.8 million on December 31, 2024. At December 31, 2025, cash and financial investments included $2,159.0 million held in U.S. dollars ($726.9 million on December 31, 2024) which could generate foreign exchange gains or losses in the financial results in accordance with the fluctuation of the EUR/U.S. dollar exchange rate as the Company’s functional currency is EUR (translated at a rate of 1.175 €/$ at December 31, 2025).

Total net decrease in cash and financial investments amounted to €319.8 million in 2025, compared to a net decrease of €366.7 million in 2024. This net decrease was composed of (i) €189.1 million of operational cash burn (*) including cash in of €111.7 million related to the return on financial investments, (ii) €128.3 million of negative exchange rate differences, positive changes in fair value of current financial investments and variation in accrued interest income, (iii) €20.0 million convertible loan issued to a third party, and (iv) €17.6 million of net cash in related to the sale/acquisition of subsidiaries.

Financial Guidance
In connection with the wind-down of the cell therapy activities, the Company expects an operating cash outflow of up to €50 million in Q1 2026, as well as one-time restructuring cash impact of €125 to €175 million in 2026, a reduction of €25 million compared to the prior guidance of €150 million to €200 million. In addition, Galapagos anticipates cash costs of approximately €35 million to €40 million for final implementation of the restructuring announced in January 2025. Costs related to the ongoing TYK2 program, including completion of the Phase 2 clinical trials in DM and SLE, as well as ongoing support to advance the program toward Phase 3 development, are expected to be up to €40 million in 2026.

Galapagos expects to be cash flow neutral to positive by the end of 2026, excluding any business development activities or currency fluctuations. Galapagos anticipates it will have approximately €2.775 billion to €2.850 billion in cash and financial investments, at December 31, 2026, based on a constant EUR/U.S. dollar exchange rate of 1.175 €/$ at December 31, 2025.

Annual Report 2025

Galapagos is currently finalizing the financial statements for the year ended December 31, 2025. The Company’s independent auditor has confirmed that its audit procedures in relation to the financial information for the year ended December 31, 2025, in accordance with the International Standards on Auditing are substantially completed and have not revealed any material corrections required to be made to the financial information included in this press release. Should any material changes arise during the audit’s finalization, an additional press release will be issued. The assurance work in relation to the sustainability information is ongoing at this moment and not completed yet. Galapagos aims to publish the fully audited full year 2025 annual report on, or around, March 26, 2026.

Conference call and webcast presentation

Galapagos will host a conference call on February 24, 2026, at 14:00 CET / 8:00 am ET. To participate in the conference call, please register using this link. Dial-in numbers will be provided upon registration. The conference call can be accessed 10 minutes prior to the start of the call using the access information provided in the e-mail received upon registration or by using the "call me" feature. The live webcast is available on glpg.com or via the following link. The archived webcast will be available for replay shortly after the close of the call on the investor section of the website.

(Press release, Galapagos, FEB 23, 2026, View Source [SID1234662912])

On February 23, 2026 Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a fully integrated, late-stage biotechnology company advancing a sustainable pipeline of genetic therapies for rare disorders with high unmet need, reported that the Company will participate in the TD Cowen 46th Annual Health Care Conference and Leerink Partners Global Healthcare Conference in Boston and Miami, respectively.

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Gaurav Shah, M.D., Chief Executive Officer, will take part in a fireside chat and management will host investor meetings at each conference. Participation details are as follows:

TD Cowen 46th Annual Health Care Conference
Date: March 2, 2026
Time: 11:10 AM ET

Leerink Partners Global Healthcare Conference
Date: March 10, 2026
Time: 9:20 AM ET

Webcasts of the presentations will be available here on the Investors section of the Company’s website.

(Press release, Rocket Pharmaceuticals, FEB 23, 2026, View Source [SID1234662882])

On February 23, 2026 Blackstone Life Sciences ("BXLS") reported a research and development funding agreement to advance the clinical development of bleximenib (JNJ-75276617), an investigational oral menin inhibitor, for acute myeloid leukemia ("AML"). AML is the most common type of acute leukemia in adults, yet continues to be extremely challenging to treat, with the lowest survival of all leukemia types.

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Johnson & Johnson and funds managed by BXLS will jointly finance a portion of the ongoing and future clinical trials of bleximenib in AML. This is the first time that BXLS and Johnson & Johnson have entered into a co-funding agreement.

"We believe that bleximenib’s promising clinical data, combined with Johnson & Johnson’s deep expertise in hematologic malignancies, create a strong foundation to address critical gaps in patient care," said Dr. Nicholas Galakatos, Global Head of BXLS. "We are excited by this agreement with Johnson & Johnson, furthering our network of global leaders to accelerate innovation across the life sciences sector."

"As an aggressive, fast-progressing blood cancer with high relapse rates, there is an urgent need for better, more tolerable treatment options for patients living with AML. Our mission is to help leaders like Johnson & Johnson advance the promise of innovative medicines like bleximenib and bring them to patients across the globe," added Dr. Ari Brettman, Senior Managing Director, BXLS.

About Bleximenib (JNJ-75276617)
Bleximenib is an investigational oral menin inhibitor being evaluated for the treatment of patients with newly diagnosed and relapsed or refractory AML. It targets a key oncogenic interaction between menin and KMT2A proteins, disrupting a pathway that drives leukemic cell growth in patients with KMT2A gene rearrangements or NPM1 gene mutations.

Bleximenib is currently being investigated in Phase 1, 2, and 3 clinical trials, either as a monotherapy or in combination with AML-directed therapies to further explore its potential in both relapsed or refractory and newly diagnosed AML settings.

About Acute Myeloid Leukemia (AML)
Acute Myeloid Leukemia (AML) is an aggressive, fast-progressing blood cancer with high relapse rates and especially poor outcomes for older patients or those with high-risk genetic profiles with KMT2A gene rearrangements – highlighting the urgent need for better, more tolerable treatment options. The disease is the most common acute leukemia in adults yet continues to be an extremely challenging blood cancer to treat with the lowest survival rate of all leukemias. AML progresses rapidly and without prompt treatment patients can die within months.

(Press release, Blackstone Life Sciences, FEB 23, 2026, View Source [SID1234662881])

On February 23, 2026 Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") reported its financial results and provides an update on clinical and operational progress for the fourth quarter and year ended December 31, 2025.

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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:
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)
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
HARMONi-7: Ivonescimab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression
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:
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.
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.
Phase II data supporting this study was previously presented at ESMO (Free ESMO Whitepaper) 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.
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.
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.
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 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.

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.

(Press release, Summit Therapeutics, FEB 23, 2026, View Source [SID1234662880])