Egle Therapeutics and Consortium Partners Awarded €8 Million Grant from Horizon Europe to Advance Clinical Development of EGL-001 in Neoadjuvant Head and Neck Cancer

On March 2, 2026 Egle Therapeutics SAS (Egle), a clinical-stage biotechnology company pioneering precision medicines that modulate regulatory T cells (Tregs) to rebalance immune function in patients with autoimmune diseases and cancer, reported it was awarded approximately €8 million in grant funding by Horizon Europe, the European Commission’s key funding program for research and innovation. This funding from the European Union will support an Egle-led initiative in partnership with a consortium of four leading European scientific institutions to advance the clinical development of EGL-001, a novel anti-CTLA-4 x IL-2m fusion protein, and to facilitate a comprehensive translational research program to de-risk later-stage clinical development.

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"This Horizon Europe funding strengthens our ability to advance EGL-001’s clinical development and significantly expand the translational research needed to guide patient selection alongside several leading European partners. The grant enables the evaluation of EGL-001 by studying therapy-naïve patients in the neoadjuvant setting and focusing on head and neck squamous cell carcinoma as a single, well-defined indication," said John Celebi, CEO of Egle Therapeutics. "In parallel, we are advancing our ongoing Phase 1/2 study of EGL-001, where it has been well tolerated with early signs of single-agent activity in PD-(L)1-resistant disease. We remain on track to report top-line data from this study in the second half of this year and look forward to bringing our Treg-focused product candidates closer to patients in need."

As part of this initiative, Egle will collaborate with University College London (United Kingdom), Vall d’Hebron Institute of Oncology (VHIO) (Spain), Gustave Roussy (France), and Technical University of Dresden (Germany) to conduct a multicenter, randomized, open-label Phase 1/2 neoadjuvant clinical trial in patients with head and neck squamous cell carcinoma (HNSCC), a high-incidence, high-mortality cancer with limited benefit from current immunotherapies. This trial will evaluate the safety, tolerability, and early efficacy of EGL-001 in combination with pembrolizumab in these patients.

This initiative also integrates a comprehensive translational research program, including multi-omics profiling, immune monitoring, and AI-driven pathomics modeling, to deliver predictive biomarkers for patient stratification, ultimately supporting regulatory alignment and de-risking later-stage development. The consortium also provides cutting-edge expertise in immunology, genomics, pathology, and computational biology, alongside established clinical trial capacity across EU member states.

"EGL-001 represents a highly differentiated, Treg-based approach to cancer treatment that is designed to selectively disarm and remove regulatory T cells inside tumors, making tumor types with prominent Treg-driven immune suppression, including HNSCC, compelling settings for clinical evaluation," said Prof. Aurélien Marabelle, M.D., Ph.D., Gustave Roussy Cancer Center. "In addition, this project incorporates a rigorous, clinically actionable framework to evaluate a novel approach to tumor-driven immune suppression and to rapidly generate translational insights that can inform future development and patient selection. On behalf of the consortium partners, we are excited to partner with Egle to advance this work and generate the clinical and translational evidence needed to bring new options like EGL-001 to patients."

About EGL-001
EGL-001 is an investigational anti-CTLA-4-IL-2m fusion protein designed to selectively disarm and remove regulatory T cells (Tregs) in the tumor microenvironment and to block CTLA-4 to help restore effector T-cell priming and function. This dual-target approach is intended to induce tumor-selective Treg apoptosis through an Fc receptor-independent mechanism, with the goal of strengthening anti-tumor immunity while supporting tolerability and use in combination regimens, including with PD-(L)1 inhibitors. EGL-001 is currently being evaluated in an ongoing multicenter, open-label, first-in-human Phase 1/2 clinical trial (NCT06622486) in patients with selected advanced and/or metastatic solid tumors, with dose escalation underway both as a single agent and in combination with an anti-PD-(L)1 therapy to assess safety, tolerability, and preliminary anti-tumor activity and to identify recommended doses for expansion.

(Press release, Egle Therapeutics, MAR 2, 2026, View Source [SID1234663202])

Zymeworks Provides Corporate Update and Reports Fourth Quarter and Full Year 2025 Financial Results

On March 2, 2026 Zymeworks Inc. (Nasdaq: ZYME), a biotechnology company managing a portfolio of licensed healthcare assets, while developing a diverse pipeline of novel, multifunctional biotherapeutics, reported financial results for the fourth quarter and year ended December 31, 2025 and provided a summary of recent business highlights.

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"Over the past year, we have redefined our approach to what success can look like at Zymeworks. We have put in place a focused strategy, a refreshed leadership team, and a Board of Directors aligned around thoughtful capital allocation and long-term value creation for shareholders," said Kenneth Galbraith, Chair, Chief Executive Officer and interim Chief Financial Officer of Zymeworks. "Our objective is to combine a portfolio of predictable, recurring revenues driven by growing royalties with disciplined deployment of capital to deliver sustainable total shareholder returns over time. The additional capital from our recently announced non-recourse royalty-backed note provides non-dilutive capital to support the continued execution of our stock repurchase program and any potential strategic acquisitions aligned with our new business approach."

Galbraith continued, "We believe that our growing royalty portfolio positions us to generate durable and growing cash flows, while our R&D capabilities allow us to identify and advance internal or externally generated assets in ways that create incremental value. In 2026, we remain focused on timely execution of each element of our novel strategy. This means delivering clinical progress on our R&D portfolio, continued progress on development and commercialization of Ziihera and pasritamig by our partners, expanding partnerships and collaborations, and demonstrating tangible outcomes from our corporate strategy. The unique structured financing with Royalty Pharma illustrates our desire and capabilities to utilize creative financings and partnerships to drive long-term value for our shareholders."

Recent Developments

In March 2026, we entered into a $250.0 million royalty-backed note financing arrangement with Royalty Pharma. The structure of the loan facility was tailored to reflect the long-term potential of the underlying royalty of zanidatamab. This customized approach provides for only 30% of royalty interests related to Ziihera to be pledged as collateral and creates a longer-term duration than a traditional royalty loan, with any duration risk shared by us and Royalty Pharma. Compared to a traditional royalty-backed loan, we believe this structure enables us to preserve greater near-term royalty cash flows, which can be strategically deployed toward share repurchases or value-accretive acquisitions on an accelerated timeframe. In addition, we believe the transaction enhances strategic flexibility, with 70% of the Ziihera royalty remaining unencumbered through the duration of the loan, with full royalty rights reverting to us once the loan has been repaid in full. Importantly, the financing achieves these financial and strategic benefits with limited impact to our long-term economic participation in the Ziihera royalty stream compared to a traditional royalty-backed loan.

Wholly-Owned Programs

In January 2026, we announced our R&D priorities for 2026 and beyond, including our intention to continue conducting Phase 1 clinical studies for ZW191 and ZW251 in 2026. In addition, we announced that beyond 2026, we expect to focus our ADVANCE research efforts on multispecific antibody and engineered-cytokine platforms, funded partially with early-stage partnerships and collaborations. Investigational New Drug applications (IND) for multispecific programs, ZW209 and ZW1528, remain on track for submission in 2026. We anticipate that development of wholly-owned preclinical candidates from our multispecific antibody portfolio should provide for one planned IND filing per annum commencing in 2028. We intend to continue actively sharing peer-reviewed publications and data across preclinical and clinical programs, while we continue evaluating partnership opportunities.

"Results from the HERIZON-GEA-01 study point to the potential of this practice-changing, HER2-targeted therapy for patients with gastroesophageal cancer, a population with significant unmet need, and, if confirmed over time, across other HER2-expressing tumors," stated Paul Moore, Ph.D., Chief Scientific Officer at Zymeworks. "Designed and developed in-house, zanidatamab reflects the strength of our proprietary Azymetric platform, with our teams now applying our capabilities to advance our next-generation assets with increasing innovation and biological insight. We look forward to presenting continued progress in our R&D portfolio during 2026, including at the AACR (Free AACR Whitepaper) Annual Meeting in April in San Diego, CA."

Partnered Programs

Zanidatamab Demonstrated its Potential as HER2-Targeted Agent-of-Choice

In November 2025, together with our partners Jazz and BeOne, we announced positive topline results from the Phase 3 HERIZON-GEA-01 trial supporting Ziihera as the potential HER2-targeted agent-of-choice and new standard of care in first-line HER2+ locally advanced or metastatic GEA regardless of PD-L1 status. Based on these data, our partner Jazz expects to complete the supplemental Biologics License Application submission for zanidatamab in the first quarter of 2026 for the treatment of first-line HER2+ locally advanced or metastatic GEA under the real-time oncology review program in the U.S., where zanidatamab has been granted Breakthrough Therapy Designation. Jazz has also submitted these data for inclusion in the National Comprehensive Cancer Network Guidelines (NCCN Guidelines). Upon regulatory review, Jazz expects a potential commercial launch for zanidatamab in first-line HER2+ locally advanced or metastatic GEA to take place in the second half of 2026.

In January 2026, Jazz updated enrollment guidance for EmpowHER-303 in which they expect to complete enrollment in the first half of 2027, with a top-line data readout later in 2027 or in early 2028. The EmpowHER-BC-303 study is a randomized clinical trial comparing zanidatamab plus physician’s choice of chemotherapy against trastuzumab plus physician’s choice of chemotherapy for the treatment of patients with metastatic HER2+ breast cancer. Jazz is also pursuing collaborations with partners to combine zanidatamab with novel therapies. For example, the Phase 1 Beamion-BCGC1 trial (NCT06324357) in combination with Boehringer Ingelheim’s zongertinib was recently initiated to explore the combination in metastatic HER2+ breast cancer, along with other potential tumor types.

In January 2026, the New Drug Submission for Ziihera was approved by Health Canada for the treatment of adults with previously treated, unresectable locally advanced or metastatic HER2+ (IHC 3+) biliary tract cancer, as monotherapy. Ziihera’s market authorization has been issued with conditions, pending the results of trials to verify its clinical benefit. Subsequently, in February 2026 Ziihera was approved by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of biliary tract cancer.

In addition to the $53.0 million in milestone payments already received for Ziihera in biliary tract cancer, Zymeworks is entitled to receive up to $440.0 million in milestone payments from Jazz and BeOne related to approvals of Ziihera in GEA in the U.S., Europe, Japan, and China. Zymeworks also has the potential to receive milestone payments related to future regulatory approvals in further indications, beyond biliary tract cancer and GEA, totaling $89.0 million, collectively, from Jazz and BeOne. For Jazz this includes a $50.0 million milestone payment upon regulatory approval of zanidatamab from the U.S. Food and Drug Administration in a third indication and a $25.0 million milestone payment upon regulatory approval of zanidatamab from the European Commission in a third indication. For BeOne this includes a $4.0 million payment upon first patient dosed with zanidatamab in a third registrational study in the territory and a $10.0 million payment upon approval of zanidatamab by a regulatory authority for the third indication in the territory.

Under the collaboration agreement with Jazz, Zymeworks is eligible to receive tiered royalties of 10% to high teens on global annual sales of Ziihera up to $2.0 billion and 20% on annual net sales above $2.0 billion. Jazz holds global marketing rights to Ziihera, excluding Asia, and holds marketing rights in Japan.

Under the collaboration agreement with BeOne, Zymeworks is eligible to receive tiered royalties of mid-single to mid-double digits on global annual net sales of Ziihera up to $1.0 billion and 19.5% on annual net sales above $1.0 billion. BeOne holds marketing rights to Ziihera in Asia (excluding Japan).

Zymeworks expects that royalty revenue from Ziihera sales will increase as potential regulatory approvals are obtained in global markets for GEA. In addition, Zymeworks could be eligible to receive future commercial milestones totaling $977.5 million and increased royalties as additional indications of Ziihera are developed, approved and commercialized by Jazz and BeOne.

Pasritamig

In 2025, J&J initiated two Phase 3 trials studying pasritamig as monotherapy in late-line metastatic castration-resistant prostate cancer (mCRPC) and pasritamig in combination with docetaxel in participants with metastatic castration-resistant prostate cancer (KLK2-PASenger).

In February 2026, J&J presented new clinical data on pasritamig at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary (ASCO-GU) annual meeting as follows:

Poster – 171: Safety and efficacy of pasritamig + docetaxel in participants with metastatic castration-resistant prostate cancer: Initial results of a phase 1b study.
Poster – 172: Phase 1 safety, efficacy, pharmacokinetics and pharmacodynamics of pasritamig in Asian population with mCRPC.

We remain eligible to receive up to $18.0 million in development milestone payments and up to $186.5 million in commercial milestone payments relating to pasritamig, as well as royalties on product sales.

Share Repurchase Program Update

In November 2025, the Board of Directors authorized a new share repurchase program providing the ability to repurchase up to $125.0 million in common stock. This followed the completion of a $60.0 million share repurchase program originally announced in August 2024. The share repurchase program underscores our confidence in Zymeworks’ long-term growth prospects and helps enhance shareholder value by reducing share count, while maintaining cash resources for operations and growth investments and preserving financial flexibility for strategic opportunities.

As of March 2, 2026, the Company has utilized approximately $62.5 million of this approved repurchase program to acquire 2,580,415 shares at an average price of $24.22 per share (exclusive of commission expense and estimated excise tax). As of March 2, 2026, the Company had approximately 73,749,607 million common shares outstanding (unaudited).

Financial Outlook

Operating Expense Discipline: In January 2026, the Company provided guidance on adjusted gross operating expense (non-GAAP), which combines adjusted research and development (R&D) expense (non-GAAP) and adjusted general and administrative (G&A) expense (non-GAAP) (excluding stock compensation expense), outlining a disciplined framework of approximately $300.0 million in aggregate adjusted gross operating expenditures (non-GAAP) over a three-year period ending December 31, 2028. The Company also announced that it expects a greater proportion of adjusted gross operating expense (non-GAAP) to be incurred in 2026 and decline in 2027 and 2028, reflecting a deliberate and measured investment across R&D and G&A aligned with clearly defined strategic priorities. This outlook reflects current expectations, underscores the Company’s continued focus on cost discipline and capital allocation rigor, and does not include any potential acquisition-related expenses or new partnerships and collaborations. The Company’s GAAP gross operating expenses in 2025 were $198.5 million and the Company currently expects adjusted gross operating expenses (non-GAAP) in 2026 to be approximately 20% lower than adjusted gross operating expenses (non-GAAP) in 2025 of $170.5 million, excluding the impact of any acquisition-related expenses or new partnerships and collaborations.

Financial Results for the Quarter and Year Ended December 31, 2025

The key financial highlights for our 2025 results are as follows:

Revenue – Total revenue was $2.5 million in 4Q-2025, and $106.0 million for 2025, compared to $31.0 million and $76.3 million for the same periods in 2024, respectively. The increase for the year was driven mainly by achievement of significant clinical and regulatory milestones and exercise of an option under our collaborations with J&J, BeOne, GSK, Daiichi Sankyo, and BMS, which collectively contributed to the majority of the year‑over‑year growth. This growth was partially offset by a decline in development‑support and drug‑supply revenue from Jazz, reflecting the transition of responsibility for certain zanidatamab clinical activities to Jazz under our amended agreements. As Jazz continues to assume these activities, we expect development‑support revenue from Jazz to continue decreasing, while royalty revenue from Jazz is expected to grow over time as commercial sales of Ziihera increase.

Research and Development (R&D) Expenses – R&D expenses were $31.2 million in 4Q-2025, and $137.0 million for 2025, compared to $37.1 million and $134.6 million for the same periods in 2024, respectively. The increase for the year was primarily due to an increase in preclinical and research expenses for ZW209 and ZW1528 and higher costs from the progression of clinical studies for ZW251, ZW191 and ZW171 until ZW171 was discontinued. The increase was also driven by non-cash stock-based compensation expense and an increase in consulting and rent expense. These impacts were partially offset by reduced spending on ZW220 (paused), zanidatamab (transitioned to Jazz), and zanidatamab zovodotin (discontinued in 2023).

General and Administrative (G&A) Expenses – G&A expenses were $15.4 million in 4Q-2025, and $61.5 million for 2025, compared to $16.2 million and $61.5 million for the same periods in 2024, respectively. Year-over-year changes were driven by an increase in non-cash stock-based compensation, offset by a decrease in salaries and benefits due to reduced headcount, consulting, rent, and information technology expenses.

Other Income, net – Other income was $2.7 million in 4Q-2025, and $12.8 million for 2025, compared to $4.4 million and $20.5 million for the same periods in 2024, respectively. The change for the year was driven primarily by lower interest income due to a reduction in cash, cash equivalents and marketable securities as well as by a net foreign exchange loss.

Net Loss – Net loss was $41.2 million in 4Q-2025, and $81.1 million for 2025, compared to a net loss of $23.5 million and $122.7 million for the same periods in 2024, respectively. The change for the year was primarily due to an increase in revenue and decreases in total operating expenses and in income tax expense, partially offset by a decrease in interest income.

Liquidity – As of December 31, 2025, we had $270.6 million of cash resources consisting of cash, cash equivalents and marketable securities, comprised of $41.2 million in cash and cash equivalents and $229.4 million in marketable securities. Based on current operating plans, and assuming full execution of the $125.0 million share repurchase plan, we expect our existing cash resources as of December 31, 2025, when combined with anticipated regulatory milestone payments of $440.0 million related to the potential approvals of Ziihera in GEA in the U.S., Europe, Japan, and China, as well as the net proceeds from our royalty-backed note financing with Royalty Pharma, to fund our planned operations beyond 2028. This anticipated cash runway does not take into account any contribution from additional future milestone payments or royalties related to Ziihera, other current licensed product candidates or contributions from future partnerships and collaborations.

(Press release, Zymeworks, MAR 2, 2026, View Source [SID1234663201])

GT Biopharma Reports Full Year 2025 Financial Results

On March 2, 2026 GT Biopharma, Inc. (the "Company") (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary natural killer (NK) cell engager TriKE platform, reported full year 2025 financial results for the period ended December 31, 2025.

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"2026 looks to bring more significant milestones for the company, as we plan to initiate the first clinical trial with GTB-5550," said Michael Breen, Executive Chairman and Chief Executive Officer. "Advancing our third TriKE candidate into the clinic underscores the continued momentum of our pipeline. GTB-3650 has shown an excellent safety profile thus far, and the higher dose cohorts will be more reflective of surpassing a potential efficacy threshold. With sufficient cash runway through Q4 2026, we look forward to providing the next update in the third quarter of 2026."

GTB-3650 TriKE for CD33 positive leukemias

The ongoing Phase 1 dose escalation study is evaluating GTB-3650 for relapsed or refractory (r/r) CD33 expressing hematologic malignancies, including refractory acute myeloid leukemia and high-risk myelodysplastic syndrome. Enrollment in Cohort 4 (10 µg/kg/day) is ongoing, and the Company expects to initiate dosing in Cohort 5 (25 µg/kg/day) in Q2 2026. The Company anticipates providing the next update in the third quarter of 2026, which would include longer term follow-up on the six patients in Cohort 1 through 3 as well as initial observations from patients in Cohort 4 and Cohort 5. Dose escalation may continue up to Cohort 7 as necessary with the potential to evaluate GTB-3650 in a total of 14 patients (two patients per cohort). GTB-3650 is dosed in two-week blocks, two weeks on and two weeks off, for up to four months based on clinical benefit. The trial aims to assess the safety, pharmacokinetics, pharmacodynamics, in vivo expansion of endogenous patient NK cells and clinical activity.

GTB-5550 TriKE for B7H3 positive solid tumor cancers

The Phase 1 basket trial with GTB-5550 will be the first dual nanobody TriKE tested with more patient-friendly subcutaneous dosing. The Phase 1a dose escalation portion of the trial will test up to 6 dose levels to identify the maximum tolerated dose (MTD). After the dose escalation phase, the Phase 2 expansion component of the trial will then confirm the MTD identified in the Phase 1a trial in up to seven different possible metastatic disease cohorts (castration-resistant prostate cancer, ovarian cancer, breast cancer, head and neck cancer, non-small cell lung cancer, pancreatic cancer, and bladder cancer) and further evaluate its safety, tolerability and preliminary anti-tumor activity. The Company remains well on track to initiate the trial in mid-2026.

GTB-5550 will be administered by subcutaneous (SQ) injection in the abdominal area for 5 consecutive days during Week 1 and Week 2 followed by 2 weeks of no treatment. One treatment cycle is 4 weeks in duration. A minimum of 2 cycles is planned, and patient-appropriate disease reassessment is performed after 2 cycles and every 8-12 weeks thereafter. Treatment may continue until disease progression, unacceptable toxicity, patient refusal, or treatment is no longer in the best interest of the patient. Patients are followed for 12 months to determine progression free survival (PFS) and overall survival (OS).

Year Ended December 31, 2025 Financial Summary

Cash Position: The Company had cash and cash equivalents of approximately $7 million as of December 31, 2025, and an unaudited proforma cash balance as of January 31, 2026 of approximately $9 million, which is anticipated to be sufficient to fund the Company’s operations through the fourth quarter of 2026.

Research and Development (R&D) Expenses: R&D expenses for the year ended December 31, 2025 were approximately $3.5 million compared to $5.8 million for the prior year. The $2.3 million decrease was primarily due to a reduction in production and material costs. R&D expenses primarily relate to the Company’s continued licensing, development and production of its most advanced TriKE product candidates GTB-3650 and GTB-5550 along with the progression on other promising product candidates. In late June 2024, the Company received clearance from the Food and Drug Administration with respect to its Investigational New Drug ("IND") application in relation to its next generation GTB-3650 camelid nanobody product. Study enrollment began in early 2025 and the Company has advanced into the clinic, enrolling patients, and performing tests for data collection throughout the year. In late January 2026, the Company received clearance from the FDA with respect to its IND Application in relation to GTB-5550, with a Phase 1 dose escalation basket trial expected to initiate mid-2026.

Selling, General and Administrative (SG&A) Expenses (Excluding Stock Compensation): SG&A expenses for the year ended December 31, 2025 were relatively flat compared to the prior year, amounting to approximately $8.5 million compared to $8.3 million, respectively.

Loss from Operations: The Company reported a loss from operations of approximately $12.4 million for the year ended December 31, 2025, compared to $14.4 million for the prior year. The $2 million decrease consisted primarily of significant decreases in R&D expenses (as described above).

Net Loss: The Company reported a net loss of approximately $28.4 million for the year ended December 31, 2025, compared to $13.2 million for the prior year. The $15.2 million increase consisted almost entirely of a non-cash expense resulting from the change in fair value of additional investment rights connected to the Company’s Series L Preferred Stock during the year.

(Press release, GT Biopharma, MAR 2, 2026, View Source [SID1234663200])

OSE Immunotherapeutics Accelerates Strategic Refocusing to Advance Late Stage Value Drivers Lusvertikimab and Tedopi®

On March 2, 2026 OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE), reported a targeted realignment of its R&D portfolio to reinforce execution of its previously announced 2026-2028 strategic plan. The Company will pause development of OSE‑230, allowing OSE to focus its resources on late‑stage, high‑potential assets lusvertikimab (OSE‑127) and Tedopi. These two assets are expected to generate multiple clinical catalysts over the next three years.

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At the same time, Boehringer Ingelheim has decided to discontinue BI 770371 in MASH following completion of an exploratory Phase 2 study that did not demonstrate efficacy in this indication. The treatment was well tolerated with a manageable safety profile, and this indication‑specific decision does not affect the molecule’s ongoing oncology development, where multiple Phase 1 studies continue as planned.

Marc Le Bozec, Chief Executive Officer of OSE Immunotherapeutics, commented: "These decisions mark a disciplined evolution of our portfolio. By stepping away from selected early‑stage programs which were not expected to generate meaningful value inflection points over our three-year strategic program, we are concentrating our resources where OSE can create the greatest value in the near term. This strengthened focus enhances our ability to deliver late‑stage clinical progress, secure meaningful partnerships, and accelerate Tedopi and lusvertikimab, the cornerstone assets of our 2026–2028 roadmap. In parallel, the Company continues to actively assess financing options to fully support the progression of its late‑stage clinical portfolio."

OSE‑230: Strategic Focus on Near‑Term Value

OSE Immunotherapeutics has decided to pause OSE‑230 as part of its ongoing portfolio prioritization and disciplined capital allocation strategy. This decision, following an amendment to the collaboration agreement with the development partner in December 2025, reflects the Company’s focus on advancing its most mature clinical programs and near‑term value drivers. OSE Immunotherapeutics will continue to assess opportunities to maximize value across its broader pipeline.

BI 770371: Partner‑Led Realignment, Focus on Oncology

Although BI 770371 was well tolerated with a manageable safety profile, Boehringer Ingelheim has decided to discontinue development of BI 770371 for people with liver cirrhosis caused by MASH after an exploratory Phase 2 study (NCT06675929) did not demonstrate efficacy to support further development in this indication.

This MASH decision does not impact BI 770371’s ongoing oncology development, which was the initial and lead program of the OSE and Boehringer Ingelheim collaboration, where the mechanism of action is distinct and multiple Phase 1 programs remain active and progressing as planned.

Additional Pipeline Prioritization

As part of the Company’s ongoing portfolio streamlining, OSE will also discontinue exploratory research activities related to the CLEC‑1 programme in oncology, an early myeloid checkpoint target still at preclinical stage. While scientifically promising, CLEC‑1 in oncology does not fall within the Company’s immediate clinical or partnership priorities. This decision further aligns OSE’s portfolio with its late‑stage value creation strategy.

Expected Value Inflection Points over OSE’s three-year strategic plan (2026-2028)

On January 29, 20261, OSE announced the selection of chronic pouchitis and hidradenitis suppurativa (HS) as the next potential targeted indications for lusvertikimab (OSE‑127), based on strong IL‑7R‑driven biological rationale. In parallel, the Company is developing a subcutaneous formulation to advance lusvertikimab in ulcerative colitis (UC) and completing the Tedopi Phase 3 in NSCLC.

This 2026-2028 strategic plan comes with significant expected value inflection points, including2:

Q2 2026: Tedopi Ovarian Cancer Investigator Sponsored Trial Phase 2 read-out
Q3 2026: Tedopi NSCLC Pivotal Phase 3 interim futility analysis
H2 2026: Tedopi 2L NSCLC combo Investigator Sponsored Trial Phase 2 read-out
H1 2027: Lusvertikimab sub-cutaneous formulation readiness
H2 2027: Possible start of Ulcerative Colitis Phase 2b/3
Q1 2028: Tedopi NSCLC Pivotal Phase 3 read-out
2028: Lusvertikimab 1st Phase 2 read-out in pouchitis or hidradenitis suppurativa.

(Press release, OSE Immunotherapeutics, MAR 2, 2026, View Source [SID1234663199])

MAIA Biotechnology Announces Pricing of $30 Million Underwritten Public Offering of Common Stock

On March 2, 2026 MAIA Biotechnology, Inc., (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, reported the pricing of its underwritten public offering of 20,000,000 shares of its common stock at a public offering price of $1.50 per share for aggregate gross proceeds of $30 million, prior to deducting underwriting discounts and other offering expenses. In addition, the Company has granted the underwriters a 45-day option to purchase up to an additional 3,000,000 shares of common stock at the public offering price per share, less the underwriting discounts to cover over-allotments, if any. The offering is expected to close on March 4, 2026, subject to satisfaction of customary closing conditions.

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The offering was structured as a straightforward common stock only investment with no warrant coverage and was led by healthcare-dedicated investors alongside existing shareholders.

Konik Capital Partners, LLC, a division of T.R. Winston & Company is acting as the sole book-running manager for the offering.

MAIA intends to use the net proceeds from the offering to conduct clinical trials and for working capital and general corporate purposes.

The securities described above are being offered and sold pursuant to a "shelf" registration statement on Form S-3 (File No. 333-273984), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the "SEC") on August 15, 2023, and declared effective on August 23, 2023.

The offering is being made only by means of a prospectus supplement and accompanying prospectus that form a part of the registration statement.. A prospectus supplement describing the terms of the public offering will be filed with the SEC and will form a part of the effective registration statement. A preliminary prospectus supplement and accompanying prospectus relating to this offering have been filed with the SEC.

Copies of the prospectus supplement and the accompanying prospectus relating to this offering may be obtained, when available, on the SEC’s website at View Source or by contacting Konik Capital Partners LLC, a division of T.R. Winston & Company, at 7 World Trade Center, 46th Floor, New York, NY 10007, Attention: Capital Markets Team, Email: [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

(Press release, MAIA Biotechnology, MAR 2, 2026, View Source [SID1234663198])