On October 6, 2025 Atossa Therapeutics, Inc. (Nasdaq: ATOS; "Atossa" or the "Company), a clinical-stage biopharmaceutical company developing new approaches in breast cancer treatment and prevention, reported an amendment to its Phase 2 EVANGELINE study of (Z)-endoxifen in premenopausal women with newly diagnosed early-stage ER+/HER2- breast cancer (Press release, Atossa Therapeutics, OCT 6, 2025, View Source [SID1234656469]). The amended, non-registrational design is expected to accelerate objective readouts while reducing projected future study costs, consistent with Atossa’s focus on extending operating runway and deploying capital where it is most impactful. In 2026, Atossa is concentrating its resources on near-term, NDA-enabling activities for investigational (Z)-endoxifen.

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"This amendment is about efficiency, focus, and financial discipline," said Steven Quay, M.D., Ph.D., Atossa’s Chairman and Chief Executive Officer. "By streamlining EVANGELINE, we are rationalizing study spending and concentrating our strong balance sheet on the NDA-enabling package we plan to advance in 2026, without changing our safety oversight or commitment to rigorous data."

Capital Allocation Highlights

Prioritizing runway and catalysts: The amended design is expected to reduce future EVANGELINE study costs and further focus on NDA-enabling work under Atossa’s 2025-2026 operating plan
Faster, objective decision points: Cohort A patients with an initial Ki-67 of > 10% employ a pre-specified two-stage futility rule using short-interval, objective endpoints (e.g., Week-4 Ki-67 ≤10%) to enable earlier go/no-go decisions. Cohort B will be for patients with initial Ki-67 of < 10%
Safety unchanged: There is no change to patient-safety data collection or Data Safety Monitoring Committee (DSMC) oversight with this amendment
Operational focus: A single-arm, open-label structure concentrates efforts on one regimen and the data elements most relevant to a future NDA
EVANGELINE Design Snapshot (As Amended)

Study type: Single-arm, open-label, non-registrational Phase 2 in premenopausal women with ER+/HER2– breast cancer in the pre-surgical setting
Cohort A (signal-seeking): Two-stage futility design assessing the Week-4 Ki-67 ≤10% rate to allow early stop if not promising
Cohort B (estimation): Week-24 objective response (RECIST 1.1, central review)
Rationale: Focus on objective, short-interval endpoints to inform development decisions efficiently while preserving patient safeguards
Study size change: The original EVANGELINE study design included 214 patients. This amendment reduces the patient total to 40-65 patients
Clinical context

EVANGELINE run-in data previously presented at the 2024 San Antonio Breast Cancer Symposium showed a Week-4 Ki-67 ≤10% rate of 86% across evaluated (Z)-endoxifen dose levels with/without Ovarian Function Suppression (OFS). In 2021, Atossa reported an 86% response rate of Ki-67 < 10% for women on low dose (4 mg/day) endoxifen in the same pre-surgery neoadjuvant setting. Published comparators in similar settings report a 41% response rate with tamoxifen and a 78% response rate with an aromatase inhibitor and OFS (Nitz UA, et al., J Clin Oncol. 2022 Aug 10;40(23):2557-2567). However, no efficacy conclusions can be drawn from the ongoing study at this point. There is no change to patient safety data collection or Data Safety Monitoring Committee oversight by this amendment.

ABOUT EVANGELINE

EVANGELINE is a single-arm, open-label, non-registrational Phase 2 study evaluating investigational (Z)-endoxifen in premenopausal women with ER+/HER2– breast cancer in the pre-surgical setting. The trial uses short-interval, objective endpoints with a pre-specified two-stage futility rule to enable faster, data-driven decisions.

Participating U.S. centers include: Mayo Clinic Rochester; Mayo Clinic Arizona; Mayo Clinic Florida; Washington University School of Medicine; St. Elizabeth Healthcare; Bon Secours Cancer Institute; Vanderbilt-Ingram Cancer Center; Henry Ford Cancer Institute; Fred Hutch; Dana-Farber Cancer Institute; Baylor University; University of Arizona; Northwestern University; Avera Cancer Institute; and California Research Institute. For current site activation status and updates, see ClinicalTrials.gov (NCT05607004).

ABOUT (Z)-ENDOXIFEN

(Z)-endoxifen is an investigational, active metabolite of tamoxifen being developed by Atossa for hormone receptor–positive breast-cancer settings. Its safety and efficacy have not been established.

On October 6, 2025 MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ: MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875) (the "Company"), reported that Yuichi Iwaki, M.D., Ph.D., President and CEO, and David H. Crean, Ph.D., Chief Business Officer, will present a corporate overview at the LD Micro Main Event XIX Investor Conference (Press release, MediciNova, OCT 6, 2025, View Source [SID1234656468]). The conference is being held on October 19 – 22, 2025 at the Hotel Del Coronado in San Diego, CA.

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Presentation Date: Monday, October 20, 2025
Time: 1:30pm Pacific Time
Register to view presentation: Webcast Link

A live webcast of the presentation can be accessed on the investor relations section of the MediciNova website. A replay of the webcast will be archived and available following the event for 90 days.

Drs. Iwaki and Crean will be available for one-on-one meetings throughout the conference.

On October 6, 2025 Theriva Biologics (NYSE American: TOVX), ("Theriva" or the "Company"), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, reported an upcoming presentation at the 32nd Annual Congress of the European Society of Gene & Cell Therapy (ESGCT), to be held in Seville, Spain from 7-10 October 2025 (Press release, Theriva Biologics, OCT 6, 2025, View Source [SID1234656466]).

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Co-founder of VCN Biosciences S.L. (now Theriva Biologics S.L.) Dr. Ramón Alemany – Head of the Immunotherapy and Virotherapy Group at the ProCURE Program of the Catalan Institute of Oncology (ICO) and the Oncobell Program of the Biomedical Research Institute of Bellvitge (IDIBELL) in Barcelona – will present new mechanistic and preclinical data for VCN-12, a next generation oncolytic adenovirus selected from Theriva’s VCN-X discovery program. VCN-12 is derived from lead clinical product VCN-01 (zabilugene almadenorepvec) and is armed with additional transgenes designed to improve tumor cell lysis, enhance stroma degradation, and augment the antitumor immune response.

Title: "Cancer Virotherapy with Armed Oncolytic Adenoviruses"
Presentation #: INV16
Date and time: Wednesday 08 October 2025, 08:30 am CEST
Session: 3b Virotherapy and Cancer Gene Therapy
Location: Room Parallel B, Seville Exhibition and Conference Centre (Fibes), Seville, Spain
In addition to the scheduled presentation on VCN-12, a recently-published pre-ESGCT meeting monograph details the results of a preclinical study conducted by investigators at the University of Navarra evaluating the intracranial administration of VCN-01 for the potential treatment of brain tumors. The authors highlight the urgent need to develop new and improved therapies for brain cancers and conclude that their findings "provide a strong rationale for its [VCN-01] further development as a therapeutic option for patients with brain tumors" (Palacios-Alonso D et al. (2025) Toxicity and Biodistribution of the Oncolytic Virus VCN-01 Following Intracranial Injection in Syrian Hamsters.

On October 6, 2025 Vivoryon Therapeutics N.V. (Euronext Amsterdam: VVY; NL00150002Q7) ("Vivoryon" or the"Company"), a clinical stage company developing small molecule medicines for inflammatory and fibrotic disorders, with a primary focus on kidney diseases, reported that it has completed a private placement of new shares to selected investors ("Offering") with gross proceeds in the amount of EUR 5.1 million (Press release, Vivoryon Therapeutics, OCT 6, 2025, View Source [SID1234656465]).

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Pursuant to the results of the Offering, the Company will issue 3,380,500new ordinary shares at an offering price of EUR 1.50 per share, amounting to gross proceeds of EUR 5.1 million. The new shares issued pursuant to the Offering represent 12.9 % of Vivoryon’s existing issued share capital and will be issued from the Company’s authorized capital under exclusion of the existing shareholders’ pre-emptive rights. As a consequence, the Company’s number of shares outstanding will increase to 29,614,337 and the Company’s share capital will increase from EUR 262,338.37 by EUR 33,805.00 to EUR 296,143.37 on completion of the Offering.

The private placement was supported by existing and new shareholders.

"This successful financing demonstrates the trust and confidence of both our longstanding and our new investors in our program and company strategy" said Frank Weber, MD, CEO of Vivoryon. "This is the first time Vivoryon has raised capital for the development of varoglutamstat in chronic kidney disease and it is an important step in moving the project forward including securing a strategic partnership. We are currently in discussions with several pharmaceutical companies, and this additional support provides us with the financial runway and financial flexibility to realize the right collaboration."

The Company intends to use the proceeds from the private placement towards realizing the immediate next steps in ongoing clinical development of its lead candidate varoglutamstat, namely securing a partnership and, if required, additional funding to enable initiation of the planned Phase 2 study in diabetic kidney disease, as well as for general corporate purposes.

The Company now expects, based on its most recent financial and business plan, that its existing cash and cash equivalents including the proceeds from the private placement will be sufficient to fund its operating plans well into Q3 2026.

Koch Wertpapierhandels GmbH supported the private placement, Girolist AG acted as Transfer Agent.

The new shares are expected to be admitted to trading on Euronext Amsterdam on October 7, 2025 with delivery to the investors on or around October 9, 2025. The new shares will rank pari passu in all respects with the existing ordinary shares in the Company.

On October 6, 2025 Trogenix Ltd ("Trogenix"), a pioneering biotech company dedicated to developing innovative cancer therapies, reported the completion of its Series A financing, raising £70 million / $95 million (Press release, Trogenix, OCT 6, 2025, View Source;utm_medium=rss&utm_campaign=trogenix-announces-95-million-series-a-financing [SID1234656464]). The funding will enable the rapid advancement of its robust pipeline of potentially curative cancer therapies across multiple aggressive solid tumours into the clinic.

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Ken Macnamara, Chief Executive Officer at Trogenix, said:

"This significant investment accelerates our lead programme in glioblastoma and follow-on programme in colorectal cancer liver metastases through the clinic, advances our pipeline in liver and lung cancers, and further enhances our Odysseus platform. We are honoured to have the support of existing and new investors who share our mission to deliver breakthrough treatments and pursue cures for the thousands of patients and families facing devastating diagnoses each year."

The Series A financing was led by IQ Capital with participation from founding investor 4BIO Capital, returning investors Cancer Research Horizons, the Brain Tumor Investment Fund, and new investors Eli Lilly and Company, Meltwind, LongeVC, and Calculus Capital, as well as undisclosed private investors. The investment underscores the transformative, curative potential of Trogenix’s precision genetic medicines driven by the Company’s Odysseus platform that identifies and targets the universal vulnerabilities of solid tumours. Trogenix’s revolutionary technology delivers highly potent combination payloads that kill cancerous cells and stimulate the immune system whilst leaving surrounding healthy tissue untouched, thereby changing the treatment paradigm for cancer patients.

Max Bautin, Co-founder and Managing Partner at lead investor, IQ Capital, said:

"Our outsized investment in Trogenix in today’s selective funding landscape reflects our confidence in the company’s world-leading science, exceptional management team and a clear roadmap for delivery both in the clinic and commercially. We are particularly excited by the potential opportunities ahead across Trogenix’s pipeline and look forward to our future collaboration."

This investment in Trogenix also represents Cancer Research Horizons’ largest investment to-date, highlighting the transformational potential of Trogenix’s breakthrough technology in cancer treatment.

Iain Foulkes, Chief Executive Officer at Cancer Research Horizons, commented:

"Trogenix’s platform technology is a powerful example of the innovation we seek to accelerate. Representing our largest investment to date, this partnership reflects our commitment to advancing science with the potential to transform cancer treatment. As they advance into clinical trials for glioblastoma, one of the hardest to treat cancers, we’re pleased to support a team whose work could reshape therapeutic approaches and improve outcomes for patients facing the greatest need."

Dima Kuzmin, Co-founder and Managing Partner at founding investor, 4BIO Capital, and Chairman of Trogenix, added:

"We are proud to have supported Trogenix through the initial incubation stage and spin-out from the University of Edinburgh, and are very happy to continue our support alongside this strong syndicate. It is exciting to see the company forge ahead with its clinical development to deliver a pioneering portfolio of cancer therapies to patients in need."

Trogenix is revolutionising cancer treatment by combining the dual power of cancer cell killing and immune stimulation, delivered via a Trojan Horse approach that reawakens the immune system to provide long-term protection against tumour recurrence. Playing a central role to Trogenix’s precision cancer treatments are its proprietary Synthetic Super Enhancers (SSEs) which are activated by targeting the unique identity of diseased cell states, rather than individual genes, to control two key payloads: a cytotoxic prodrug converting enzyme and an immune stimulating cytokine. SSEs are exquisitely designed using Trogenix’s proprietary technology platform, Odysseus, which rigorously identifies and optimises targets in cancer cells to rapidly generate candidates with manufacturable profiles for preclinical development.

Trogenix’s lead programme, in glioblastoma (GBM), one of the most aggressive and treatment-resistant brain cancers, is advancing toward clinical trials with first patient dosing anticipated in Q1 2026. Only 25% of GBM patients survive beyond one year[1] and despite decades of research and significant investment, treatment options remain severely limited. The Company’s follow-on programme is in colorectal cancer liver metastases (CRCLM). Colorectal cancer is the third most common cancer worldwide[2], with at least 25% of patients developing CRCLM[3].

In addition to its lead and follow-on programmes, Trogenix will be developing its pipeline focused on other aggressive solid cancers including hepatocellular carcinoma and non-small cell lung carcinoma.