On April 30, 2026 Pliant Therapeutics (Nasdaq: PLRX) reported the dosing of the first participant in the FORTIFY Phase 1b open-label indication expansion clinical trial of PLN-101095 in combination with pembrolizumab, in patients with immune checkpoint inhibitor (ICI)-refractory advanced or metastatic solid tumors. PLN-101095 is an oral, small molecule, dual selective inhibitor of the integrins αvβ8 and αvβ1.

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"We are pleased to announce this milestone for the FORTIFY trial and the expansion into solid tumor cohorts that we believe are supported by PLN-101095’s mechanism of action," said Bernard Coulie, M.D., Ph.D.., Chief Executive Officer of Pliant. "As a leader in integrin drug development, we look forward to exploring the full potential of this novel drug candidate."

FORTIFY – Phase 1b Clinical Trial Design

The primary objective of this trial is to evaluate the safety, tolerability, pharmacokinetics and preliminary evidence of anti-tumor activity of PLN-101095 when administered orally in combination with pembrolizumab in adult participants with advanced or metastatic solid tumors. The expansion trial is enrolling three cohorts of patients with NSCLC, clear cell renal cell carcinoma, or one of a subset of tumors with high tumor mutational burden. Patients will be treated for 14 days with PLN-101095 as monotherapy dosed at 1,000 mg twice daily, after which pembrolizumab will be added as combination therapy. Enrollment is underway with interim data expected in 2027.

PLN-101095 for the Treatment of Checkpoint Resistant Tumors

PLN-101095 is an oral, small molecule inhibitor of integrins αvβ8 and αvβ1. Activated transforming growth factor-β (TGF-β) has been shown to foster an immuno-suppressive tumor microenvironment (TME) that contributes to immune-checkpoint inhibitor (ICI) resistance and treatment failure in cancer.1 Blocking integrins αvβ8 and αvβ1 has been shown to prevent the activation of TGF-β and is expected to stimulate immune activation by increasing immune cell infiltration into the tumor microenvironment.2,3 PLN-101095 is currently being evaluated in Phase 1a/1b open-label, dose-escalation and indication expansion trial (NCT 06270706) to evaluate the safety, tolerability, pharmacokinetics, and preliminary evidence of antitumor activity of PLN-101095 in combination with pembrolizumab, in patients with immune checkpoint inhibitor (ICI)-refractory advanced or metastatic solid tumors. PLN-101095 in combination with an anti-PD-1 monoclonal antibody (mAb) elicited a dose-dependent reduction in tumor volume and increased CD8+ T cell tumor infiltration in the tumor microenvironment compared with anti-PD-1 mAb therapy alone.4 In preclinical studies, PLN-101095 demonstrated monotherapy activity in reduction of tumor volume and increased cluster of differentiation (CD)8+ T cell infiltration.

(Press release, Pliant Therapeutics, APR 30, 2026, View Source [SID1234664996])

On April 30, 2026 EnGeneIC Limited reported that the first patient has been dosed in its clinical trial evaluating EnGeneIC’s investigational EGFR-targeted EDV (EnGeneIC Dream Vector) therapy in patients with recurrent glioblastoma multiforme (GBM), an aggressive and currently incurable form of brain cancer.The trial is being led by Principal Investigator Dr. Mark Wong, Medical Oncologist at Westmead Hospital, one of Australia’s leading comprehensive cancer centres. Additional Australian recruitment sites will include the Kinghorn Cancer Centre, with further expansion planned to clinical sites in Singapore.

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"This first patient dosed milestone is a critical step forward for patients with recurrent glioblastoma, who typically have very limited treatment options once standard therapies have failed," said Dr. Mark Wong. "We look forward to assessing the safety and potential clinical benefit of this investigational therapy in a patient population with significant unmet medical need."

The investigational treatment consists of EGFR-targeted EnGeneIC Dream Vectors (EDVs) — bacterially derived, nanocell-based particles engineered to selectively bind to epidermal growth factor receptor (EGFR), which is frequently over-expressed in glioblastoma. The EDVs are loaded with the chemotherapeutic agent doxorubicin and the immune-modulating adjuvant α-galactosyl ceramide (α-GalCer).

This dual-payload design is intended to directly kill EGFR-expressing tumour cells while simultaneously activating a broad anti-tumour immune response, potentially converting an immunologically "cold" tumour into one capable of sustained immune recognition and attack.

In the clinical context, recurrent GBM remains highly resistant to conventional chemotherapy and immunotherapy, and EGFR-targeted EDVs offer a novel approach by combining targeted intracellular drug delivery with immune activation in a disease where both effective tumour penetration and immune engagement have historically been major challenges.

Dr. Jennifer MacDiarmid, Joint CEO and Director of EnGeneIC, commented "This clinical trial builds on spectacular overall survival outcomes currently observed in Compassionate Case Study patients with recurrent glioblastoma who had exhausted all available treatment options. Those results provided the strong clinical rationale to advance this EGFR-targeted EDV therapy into a formal clinical trial, allowing us to rigorously evaluate both its anti-cancer and immune-stimulating potential."

Patient recruitment is expected to continue across Australian and Singaporean sites in accordance with the trial protocol and applicable regulatory approvals.

About Glioblastoma

Glioblastoma multiforme is the most common and aggressive primary brain cancer in adults. Despite treatment with surgery, radiation and chemotherapy, recurrence is common and survival outcomes remain poor, highlighting the urgent need for new therapeutic approaches.

(Press release, EnGeneIC, APR 30, 2026, View Source [SID1234664995])

On April 30, 2026 OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) (the "Company"), reported its full year 2025 unaudited consolidated financial results, as approved by the Board of Directors on April 29, 2026. Audit procedures by the Company’s statutory auditors on the Company’s 2025 consolidated financial statements are still ongoing.

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Full Year 2025 Consolidated Financial Results (IFRS, unaudited)

In million euros 2024 2025
Revenues 69.9 2.6
Other income 13.6 0.1
Operating income 83.4 2.7
Research and development expenses (30.4) (33.9)
General and administrative expenses (6.5) (8.8)
Share-based payments non-cash expenses (2.7) (1.9)
Other operating items - 4.4
Operating profit (loss) 43.7 (37.5)
Financial income (loss) (3.9) 0.1
Net income (loss) 37.4 (37.7)
EPS (in € per share) 1.71 (1.69)
Net cash flows from operating activities 48.4 (34.0)
Net cash flows from investment activities (46.9) 41.4
Net cash flows from financing activities (3.5) (6.5)
Net cash flows (1.9) 0.8
Cash and cash equivalents at closing 16.7 17.6
Total Cash Position at closing (incl. long-term deposits) 64.2 22.7

Operating income in 2025 amounted to €2.7 million, primarily reflecting revenues generated by Tedopi’s supply of early access program in France for €1.4 million, and the deferred recognition of a portion of the $48 million upfront payment from the AbbVie licensing agreement on OSE-230 signed in April 2024 for €0.8 million. In comparison, operating income in 2024 totaled €83.4 million, mainly driven by the immediate booking of the majority of the AbbVie upfront payment for €42.2 million, €25.3 million from the amendment to the agreement with Boehringer Ingelheim on BI 765063 (OSE-172), and €13.5 million from the asset purchase by Boehringer Ingelheim related to the "cis-targeting" anti-PD1/cytokine platform.

Research and development expenses increased by 11.5% over the period, amounting to €33.9 million in 2025, compared to €30.4 million the prior year. This increase reflects our development programs moving forward, notably the ongoing Phase 3 pivotal trial of Tedopi – Artemia – actively recruiting, as well as a lower amount of Research Tax Credit (CIR) amounting to €4.6 million in 2025, compared to €5.3 million in 2024.

General and administrative expenses increased by 34.0% over the period, amounting to €8.8 million in 2025, compared to €6.5 million in 2024. This significant increase primarily reflects legal fees incurred in connection with the exceptional context surrounding the Annual General Meeting held on September 30, 2025, which led to a complete renewal of the Company’s governance, as well as legal proceedings initiated against certain minority shareholders. These non-recurring expenses were partially offset by a reduction in personnel costs, following the partial deferral of compensation from 2023 to 2024 for certain key executives. Excluding these non-recurring expenses, general and administrative expenses represented €7.8m, increasing by 19.5% year-on-year.

Share-based payments non-cash expenses amounted to €1.9 million in 2025, compared to €2.7 million a year earlier. These expenses are mainly comprised of calculated non-cash expenses in application of IFRS2, amounting to €1.5 million and €2.1 million in 2025 and 2024, respectively. The decrease in 2025 notably reflects a reversal of expenses due to the cancellation of 219,970 free shares granted in 2024 to former CEO Nicolas Poirier, following a negative vote by shareholders on the "Say-on-Pay" ex post provision at the Annual General Meeting held on September 30, 2025.

Other operating items amounted to €4.4 million in 2025, representing a partial waiver of debt related to conditional advances paid by Bpifrance for the EFFICLIN project after it was terminated by the Company.

Operating loss amounted to €(37.5) million in 2025, compared to a profit of €43.7 million a year earlier, essentially reflecting an exceptional income in 2024 related to the AbbVie licensing agreement on OSE-230 and the amendment on the BI 765063 (OSE-172) agreement as well as the asset purchase agreement from the "cis-targeting" anti-PD1/cytokine platform by Boehringer Ingelheim.

Financial income amounted to €0.1 million in 2025, compared to a loss of €(3.9) million a year earlier. This variation is mainly related to calculated non-cash expenses reflecting the change in fair value of the warrant passive derivative in the European Investment Bank (EIB) finance contract.

Net loss amounted to €(37.7) million in 2025, compared to a profit of €37.4 million a year earlier, essentially reflecting non-recurring income in 2024.

Net cash flows from operating activities amounted to €(34.0) million in 2025, reflecting our development programs moving forward, notably the ongoing Phase 3 trial of Tedopi – Artemia – actively recruiting, compared to €48.4 million a year earlier, essentially reflecting non-recurring income in 2024.

Net cash flows from investment activities amounted to €41.4 million in 2025, compared to €(46.9) million a year earlier, essentially reflecting cash management in various term deposit instruments.

Net cash flows from financing activities amounted to €(6.5) million in 2025, compared to €(3.5) million a year earlier. This variation mainly reflects an early repayment of the EIB loan for €3.0 million in January 2025.

Cash and cash equivalents totaled €17.6 million as of December 31, 2025, compared to €16.7 million a year earlier. Including fixed-term deposits classified as current and non-current financial assets, total cash position amounted to €22.7 million and €64.2 million as of December 31, 2025 and 2024, respectively.

Cash Runway and Financing

The Company’s cash and cash equivalents totaled €17.0 million as of March 31, 2026, compared to €22.7 million as of December 31, 2025.

Based on its current plans, assumptions and available financial resources, the Company estimates that its cash and cash equivalents will be sufficient to fund its operations until the beginning of fourth quarter 2026, as previously guided. This cash runway does not include any potential exercise of warrants issued to the benefit of Vester Finance, as the contract was fully terminated in April 2026, nor any potential future milestone payments from existing partnerships.

To extend its runway beyond the beginning of the fourth quarter of 2026, the Company continues to evaluate several complementary options, including a potential new strategic partnership involving one of its proprietary assets, equity financing, restructuring of its existing debt, and potential milestone payments from current partnerships.

Although the Company is confident in its ability to meet its short-term financing objectives, there is no guarantee that it will be able to obtain the necessary financing to meet its needs or to obtain funds at attractive terms and conditions to finance all of its activities on a 12-month horizon.

Pending the potential completion of such above-mentioned transactions, the Company has deferred the publication of its audited consolidated financial statements and its Universal Registration Document for the fiscal year 2025 to May 28, 2026, at the latest. Certification of the 2025 consolidated financial statements by the Company’s auditors will take place before the filing of the Universal Registration Document with the French financial markets authority (Autorité des Marchés Financiers) (the "AMF"), no later than May 28, 2026. Should no sufficient financing transaction be completed in due time, the statutory auditors are expected to include a going concern qualification in their certification report.

(Press release, OSE Immunotherapeutics, APR 30, 2026, View Source [SID1234664994])

On April 30, 2026 TME Pharma N.V. (Euronext Growth Paris: ALTME), a clinical-stage biotechnology company specializing in the development of novel therapies for brain cancer and eye diseases, reported its financial results for the fiscal year ending December 31, 2025. The Annual Report 2025, as approved by the management and supervisory boards on April 30, 2025, is available on TME Pharma’s website (www.tmepharma.com).

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In June 2025, TME Pharma changed its organizational structure to a virtual company structure to allow it to continue pursuing the goals of financing, licensing or M&A transactions focused on its clinical stage assets, NOX-A12 and NOX-E36 while minimizing costs by outsourcing essentially all functions to maintain the programs and conduct industrial partner and investor outreach.

2025 Financial Summary
On December 31, 2025, TME Pharma and its subsidiaries had cash resources of €2 million. In March 2026, TME announced that it had agreed with certain lenders, involved in the May 2025 and August 2025 financing, to extend the maturity of their loans by a further 12 months, extending the cash runway into Q2 2027 taking into consideration the current level of business operations.
As in prior years, TME Pharma has not generated any revenues. The Group – TME Pharma N.V.,TME Pharma AG – does not expect to generate any revenues from any product candidates that it develops until the Group either signs a licensing agreement or obtains regulatory approval and commercializes its products or enters into collaborative agreements with third parties.

The Net loss in 2025 amounted €3.3M (2024: €5.7M). Total equity as of December 31, 2025 is now €1.6M negative (December 31, 2024: €1.6M positive).

Outlook for 2026
At this time, TME Pharma is focusing on securing licensing agreements or partnerships for NOX-A12 and NOX-E36.
As announced in 2025, the company is also exploring alternative sources of revenue and activities as well as financing and partnering solutions for NOX-A12 and NOX-E36. TME Pharma will seek shareholder approval as required for any potential transactions which emerge as part of the new strategy and issue press releases on all material developments.

Diede van den Ouden, CEO of TME Pharma, said: "As a shareholder and as a director, I remain optimistic about the future of TME Pharma. Publications, like in *Nature Communications* on triple therapy for NOX-A12, demonstrates that TME assets could hold significant potential value. It is up to us to realize that value."

(Press release, TME Pharma, APR 30, 2026, View Source [SID1234664993])

On April 30, 2026 Totus Medicines, a clinical stage, precision medicines company leveraging AI-powered small molecule drug discovery to advance a differentiated pipeline of therapeutics against high-value, historically difficult to drug targets in multiple therapeutic areas, reported that interim Phase 1b clinical data from its ongoing study of TOS-358, a next-generation pan-mutant, covalent, alpha-specific PI3K inhibitor, in combination with Fulvestrant, in heavily pre-treated metastatic HR+/HER- breast cancer patients, will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Breast Cancer Annual Congress, taking place in Berlin, Germany, May 5-8, 2026.

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Presentation Details:
Conference: ESMO (Free ESMO Whitepaper) Breast Cancer 2026
Session: Poster Presentation
Date / Time: 13:15, Thursday, May 7, 2026

TOS-358 is an oral, highly selective, pan-mutant, covalent PI3Ka inhibitor that achieves >95% continuous target engagement at clinically relevant doses for deep and durable inhibition of PI3K-AKT signaling. PI3Ka driver mutations are present in approximately 40% of ER-positive/HER2-negative breast cancer, 50% of endometrial adenocarcinoma, and a meaningful subset of head and neck squamous cell carcinoma (HNSCC) patients. Totus Medicines is advancing TOS-358 as a potential best-in-class PI3Ka inhibitor into Ph1b clinical development across selected solid tumor indications.

(Press release, Totus Medicines, APR 30, 2026, View Source [SID1234664992])