On September 29, 2026 Peptomyc reported the final closing of its equity financing round at €5.7 million, with a €0.7 million investment from the Institut Català de Finances (ICF). This is the first investment made through the Lidera Transferència en Salut fund, managed by the Government of Catalonia’s public development bank.

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The closing completes the round opened in February 2026 with a €5 million first closing led by Alta Life Sciences Spain I F.C.R. – a fund advised by Asabys Partners – and Aurora Science, with participation from the EIC Fund, part of the European Innovation Council, Laudecum, and CDTI Innovación through its SICC Innvierte.

With the ICF’s entry, Peptomyc’s investor base combines specialist life sciences funds with public co-investors at Catalan (ICF), Spanish (CDTI) and European (EIC Fund) level.

The proceeds fund the completion of Peptomyc’s three ongoing clinical studies of OMO-103, manufacturing readiness for later-stage development, and the company’s discussions with potential pharmaceutical partners. Since the first closing, Peptomyc has appointed Stephan Braun, MD, PhD, as Chief Medical Officer and expects to report data from its Phase 1b study of OMO-103 in first-line metastatic pancreatic cancer before the end of 2026.

"Closing this round with public co investment from the ICF, alongside investors who have backed MYC inhibition from the laboratory into the clinic, is a meaningful endorsement of the science and of the team," said Jesús Martín García, CEO of Peptomyc. "We now have the resources to complete our ongoing studies and to build the clinical and translational evidence that will guide the next stage of development for OMO-103."

Vanessa Servera, CEO of the ICF, added: "Peptomyc is a clear example of how science developed in Catalonia can reach patients worldwide. We are pleased to back the company at a decisive point in its growth, and to do so with the first investment from the Lidera Transferència en Salut fund."

The Lidera Transferència en Salut fund, managed by the ICF, invests in health and life sciences companies spun out of Catalan universities and research centers. The fund has €60 million, with €50 million from the Government of Catalonia and €10 million from the ICF, and supports advanced therapies at an early stage of development, to make them viable and help create companies that private investors will want to back.

"MYC was considered undruggable for decades. Peptomyc has shown that it can be targeted safely in patients and has taken OMO-103 into three further trials, and this round positions the company to define where the drug can make the biggest difference for patients and to take it there," said Montserrat Vendrell, Partner at Asabys Partners and Board Member at Peptomyc. "Seeing the ICF join investors who have supported the company for years says a lot about the quality of the science and the team, and about the strength of the Catalan life sciences ecosystem."

Direct MYC inhibition represents one of the most pursued goals in oncology. OMO-103 is the first successful direct pan-MYC inhibitor in the clinic, reported in Nature Medicine in 2024. Its three ongoing studies are designed to identify where OMO-103 adds the most for patients and to build the clinical, translational and manufacturing base for its later-stage development.

About OMO-103

OMO-103 is a cell-penetrating mini-protein derived from Omomyc that directly inhibits MYC, an oncogenic driver deregulated in approximately 70% of human cancers and long considered undruggable. In its first-in-human Phase 1 study, published in Nature Medicine in 2024, OMO-103 showed a favorable safety profile, target engagement and early signs of clinical activity. It is currently being evaluated in three studies: a Phase 1b trial in combination with standard chemotherapy in first-line metastatic pancreatic cancer, a Phase 2 trial in relapsed osteosarcoma, and a window-of-opportunity study in pancreatic cancer in the United States.

(Press release, Peptomyc, SEP 29, 2026, View Source [SID1234671139])

On September 28, 2026 NeOnc Technologies Holdings (NASDAQ: NTHI) reported another major date on the biotech calendar: November 17, 2026, when the company is scheduled to meet with the U.S. Food and Drug Administration for an in-person End-of-Phase 1 Type B meeting covering its experimental brain-cancer drug NEO212.

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The meeting could become an important inflection point for a company that has rapidly assembled a string of clinical, regulatory and Wall Street catalysts.

NeOnc says it plans to seek FDA feedback on NEO212’s proposed patient population, trial design, endpoints, dose selection and the evidence that could ultimately support a marketing application. The company also intends to discuss a potential registrational strategy and whether a proposed Phase 2 design could potentially support an accelerated-approval pathway; marking a meaningful transition from dose-finding toward the next stage of clinical development.

NEO212 enters that meeting with some intriguing, though still preliminary, human data.

During Phase 1, dose escalation reached the protocol-defined maximum tolerated dose at 810 mg, after which the recommended Phase 2 dose was established at 610 mg. The company has highlighted a patient with recurrent IDH1 wild-type, MGMT-methylated glioblastoma who experienced an approximately 60% tumor reduction and 21 months of disease control. Another heavily pretreated patient with lung cancer metastatic to the brain experienced stable disease for approximately 16 months. These are individual patient observations, not proof of efficacy, and larger trials will have to determine whether the results can be replicated.

NeOnc CEO Amir Heshmatpour put the immediate objective plainly: "This meeting will help us understand FDA’s feedback on the population, study design and endpoints for the next stage of development."

The NEO212 catalyst arrives as the broader NeOnc story is also attracting Wall Street attention. Roth Capital recently initiated coverage of NeOnc with a $20 price target, with analyst Jonathan Aschoff reportedly anticipating potential pivotal-trial starts by the end of 2026.

NeOnc is now advancing two potential therapies in its CNS cancer pipeline, giving investors more than one clinical catalyst to watch. Its lead program, NEO100, recently generated topline Phase 2a data in recurrent IDH1-mutant high-grade glioma, with the company reporting six-month progression-free survival of 48.9% versus a prespecified 20% benchmark and median overall survival of 26.09 months. NeOnc said it plans to engage with the FDA regarding a potential registrational pathway.

The parallel development tracks could give NeOnc multiple potential catalysts heading into 2027. Roth Capital’s research indicates Aschoff expects an FDA Type B End-of-Phase 2 meeting for NEO100 in October and sees potential pivotal-trial starts before the end of 2026.

Meanwhile, NeOnc has raised capital from institutional investors, including a September registered direct offering priced at $4.20 per share and accompanying warrants. Company insiders have also been active buyers: SEC filings show recent open-market purchases by executives including Heshmatpour and Thomas C. Chen.

That backdrop makes November 17 particularly interesting. NTHI is approaching the FDA with a defined Phase 2 dose, early signals of clinical activity and a stated ambition to develop NEO212 across difficult-to-treat CNS cancers.

If the agency provides a workable path forward on population, endpoints and study design, NEO212 could emerge from the meeting with a substantially clearer development roadmap.

For NTHI shareholders, November 17 is therefore less about expecting an approval and more about watching whether the FDA conversation turns NEO212 from an intriguing clinical program into a more clearly defined late-stage development story.

(Press release, Neonc, SEP 28, 2026, View Source [SID1234671159])

On September 28, 2026 Defence Therapeutics Inc. ("Defence" or the "Company") (CSE: DTC, OTCQB: DTCFF, FSE: DTC), a publicly traded biotechnology company developing next-generation precision oncology therapeutics using its proprietary Accum platform, reported a corporate update as the Company continues to execute on the strategic priorities outlined in its recent letter to shareholders.

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Since assuming the role of President and Chief Executive Officer in August, Dr. Amie Phinney and the Defence leadership team have focused on translating the Company’s strategy into execution across its scientific programs, leadership and operations. Defence is prioritizing Accum-enhanced antibody-drug conjugate ("ADC") partnerships, the in-house development of Accum-enabled radiotherapeutics, and the evaluation of strategic development options for AccuTOX.

"Our recent shareholder letter set out a focused strategy for Defence and, importantly, a commitment to demonstrate progress against it," said Dr. Phinney. "We are now moving forward with that execution, strengthening the expertise supporting our priority programs, aligning leadership incentives with long-term shareholder value creation, and deploying the capital and resources needed to advance our strategy."

To this end, Dr. Svetlana Selivanova has resigned from Defence’s Board of Directors to transition to the Company’s Scientific Advisory Board ("SAB"), where she will deepen her scientific engagement with the Company and contribute her expertise in radiopharmacology. Her appointment strengthens the scientific expertise supporting Defence’s growing radiopharmaceutical program as the Company advances its strategy to evaluate the potential of Accum to improve the intracellular delivery and retention of radioisotopes in tumour cells. The transition builds on Defence’s strategic priority, including the appointment of Dr. Ryan Simms as Chief Operating Officer and Head of Radiopharmaceutical Programs and the expansion of the Company’s development strategy to evaluate both alpha- and beta-emitting radioisotopes.

"We are very pleased that Svetlana will continue her work with Defence in a role that allows us to more directly leverage her scientific expertise," said Dr. Phinney.

The Company also announces that its Board of Directors has approved the grant of an aggregate number of 7,000,000 incentive restricted stock units ("RSUs") to Dr. Amie Phinney, President and Chief Executive Officer, and Mr. Sébastien Plouffe, Executive Chairman. The RSUs are structured as performance-based incentives tied to defined share-price milestones, aligning a significant component of leadership compensation with long-term shareholder value creation.

The RSUs will be issued in five equal installments upon the common shares of the Company achieving closing prices on the Canadian Securities Exchange at or above $0.75, $1.00, $1.25, $1.50 and $1.75, respectively. Each RSU entitles the holder to receive one common share of the Company. The RSUs expire on September 24, 2029, and remain subject to the terms of the Company’s Omnibus Incentive Plan and applicable securities laws.

The Company is also pleased to provide another update on its sharing agreement dated March 6, 2026 (the "Sharing Agreement") with Sorbie Bornholm LP ("SBLP") previously described in the Company’s news releases of March 9 and February 27, 2026. Further to the first settlement dated August 14, 2026, the Company has received the second Settlement in the amount of $249,696.72 as of the settlement date of September 15, 2026, against 606,060 Placement Shares released to SBLP. As of today, 9,696,971 Placement Shares are held in escrow in connection with the Sharing Agreement and there are 16 Settlement payments remaining.

Defence remains focused on the priorities communicated to shareholders: expanding opportunities to evaluate Accum with partnered ADCs, generating foundational data and advancing its Accum-enabled radiotherapeutics programs, and determining the optimal path forward for AccuTOX. The Company expects to provide further updates as these initiatives progress.

(Press release, Defence Therapeutics, SEP 28, 2026, View Source;utm_medium=rss&utm_campaign=defence-therapeutics-provides-updates-on-sharing-agreement-2 [SID1234671146])

On September 28, 2026 OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE), a clinical-stage biotech company dedicated to developing first-in-class therapies in immuno-oncology and immuno-inflammation, reported its cash position as of June 30, 2026, updated its financial calendar and provided a business update.

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"On the operational front, enrolment of Tedopi’s Phase 3 trial ARTEMIA in non-small cell lung cancer is on track. The interim futility analysis for ARTEMIA is event-driven. Deaths across the study have accrued more slowly than originally projected, and the analysis is now expected in early-2027, which is definitely interesting. In parallel, the subcutaneous formulation of lusvertikimab is moving as planned and results should be available by mid-2027 to support pursuing clinical development in ulcerative colitis. We are also very encouraged by our conversations with key opinion leaders to move rapidly into a Phase 2 trial with the current formulation in Chronic Pouchitis, a significant unmet need", commented Marc Le Bozec, Chief Executive Officer of OSE Immunotherapeutics. "We have been actively engaging with institutional investors in the United States and in Europe for the past few months, helped by a flexible bridge financing in May, and are confident that the strength of our pipeline provides a solid foundation as we work to secure the financing needed to reach key value inflection points."

Cash Position as of June 30, 2026

As of June 30, 2026, OSE Immunotherapeutics’ cash position totalled €11.1 million, compared to €17.0 million as of March 31, 2026.

The Company implemented a flexible bridge equity financing in May 2026 which, in addition to available cash, and based on its current plans, is estimated to be sufficient to fund its operations through December 2026. This cash runway does not include any potential future milestone payments from existing partnerships.

This bridge financing was the first step of a global financing strategy aiming at securing OSE’s 3-year Strategic Plan and the Company continues to actively engage with institutional investors in the United States and in Europe in view to further extend its runway beyond 2026.

In addition, the Company continues to evaluate several complementary options, including a potential new strategic partnership involving one of its proprietary assets, restructuring of its existing debt, and potential milestone payments from current partnerships.

In the context of its ongoing financing efforts, the Company has deferred the publication of its half-year financial statements for 2026 and its Interim Financial Report to a later date.

Pivotal Phase 3 clinical trial ARTEMIA of Tedopi in second-line non-small cell lung cancer (NSCLC)

Enrolment in the international pivotal Phase 3 clinical trial ARTEMIA evaluating Tedopi in 363 HLA-A2 positive patients with metastatic NSCLC who have developed secondary resistance to immune checkpoint inhibitors is on track for completion by end of December 2026, as planned.

As per protocol, a futility analysis will be conducted independently by the statisticians of the Independent Data Monitoring Committee (IDMC). This analysis, performed when the trial reaches a predefined number of events, is based on an interim survival analysis and will remain blinded to the Sponsor, Regulatory Authorities, and all Investigators.

Initial assumptions anticipated reaching the required and predefined number of deaths by Q3 2026. While enrolment of the study has progressed according to plan, the trial is showing a lower number of deaths than initially expected, and the Company now anticipates reaching the predefined number of death events by the end of 2026. Consequently, the futility analysis is now expected to take place early 2027.

Other clinical trials evaluating Tedopi in multiple indications

TEDOVA in ovarian cancer

In May 2026, the Company reported positive topline results from the TEDOVA/GINECO-OV244b/ENGOT-ov58 academic, international, Phase 2 trial sponsored by ARCAGY-GINECO and evaluating Tedopi, with or without pembrolizumab, as a maintenance treatment in 185 patients with platinum-sensitive recurrent ovarian cancer (PSOC).

The primary endpoint was progression-free survival (PFS) comparing Tedopi combined with pembrolizumab and the best supportive care. It was met and results showed a statistically significant improvement in PFS for the combination of Tedopi and pembrolizumab compared to best supportive care (median PFS: 4.1 months vs 2.8 months; HR=0.53; p<0.001). When comparing the two investigational arms, the addition of pembrolizumab to Tedopi resulted in a 28% reduction in the risk of progression or death (HR=0.72, p=0.074).

These results were presented by principal investigator Alexandra Leary, MD, PhD, at the ASCO (Free ASCO Whitepaper) 2026 Annual Meeting in May 2026 in Chicago, United States.

Combi-TED in NSCLC

Topline results from the Combi-TED Phase 2 international clinical trial sponsored by FoRT and evaluating Tedopi in second-line treatment in combination with anti-PD1 or chemotherapy in 105 patients with metastatic NSCLC will be presented by principal investigator Federico Cappuzzo, MD, PhD, at the ESMO (Free ESMO Whitepaper) 2026 Annual Meeting on October 25, 2026, in Madrid, Spain.

Subcutaneous formulation of lusvertikimab (IL-7R) in inflammatory bowel diseases (IBD)

The subcutaneous formulation of lusvertikimab to be advanced in clinical development was selected and characterized earlier this year. The achieved concentration at 225mg per mL, based on previously evaluated intravenous efficacious doses in Phase 2 of 450mg and 850mg, is potentially compatible with the use of an autoinjector device.

The application for authorization of a Phase I study in healthy volunteers is currently being prepared with a submission scheduled by the end of 2026, with results expected by mid-2027.

(Press release, OSE Immunotherapeutics, SEP 28, 2026, View Source [SID1234671137])

On September 28, 2026 Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs" or the "Company," Stock Code: 9887.HK) reported that opamtistomig (LBL-024), the Company’s proprietary PD‑L1/4‑1BB bispecific antibody, has been granted Orphan Drug Designation (ODD) by Japan’s Ministry of Health, Labour and Welfare (MHLW) for the treatment of extrapulmonary neuroendocrine carcinoma (EP-NEC). This is the third Orphan Drug Designation for opamtistomig, following designations in the U.S. Food and Drug Administration (FDA) and the European Commission (EC), marking a further expansion of its global regulatory recognition into a strategically important Asian market.

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The designation provides opamtistomig with access to a range of regulatory and development incentives in Japan, which may include:

Financial support and subsidies for clinical development.
Regulatory consultation and advice from Japan’s Ministry of Health, Labour and Welfare (MHLW) and other relevant authorities.
Potential access to priority consultation and expedited review pathways, as applicable.
Reduction or exemption of certain application and examination fees, and
An extended re‑examination period following marketing authorization.

These incentives are expected to facilitate and potentially accelerate the clinical development, regulatory submission, and commercialization of opamtistomig in Japan, particularly for EP-NEC and other high-potential indications.

Japan is one of the world’s major pharmaceutical markets, with a market size of over $73 billion in 2025, of which the immuno‑oncology segment accounted for over $8 billion, ranking behind only the United States, China, and Europe. By securing orphan drug designation in this strategic market, opamtistomig not only represents a breakthrough for the EP‑NEC indication but also establishes priority consultation and accelerated review pathways within Japan’s regulatory framework, paving the way for the subsequent development and registration of opamtistomig for other tumor indications in Japan.

Since October 2024, opamtistomig has received Breakthrough Therapy Designation from the National Medical Products Administration (NMPA) of China, Orphan Drug Designation and Fast Track designation from the U.S. FDA, and Orphan Drug Designation from the European Commission. In July 2026, its New Drug Application (NDA) was granted Priority Review by the NMPA. In August 2026, NDA submitted to NMPA and now under technical review. To date, opamtistomig has demonstrated promising and durable efficacy signals across seven tumor types, including EP‑NEC (first‑line and post‑line), non‑small cell lung cancer (NSCLC), small cell lung cancer (SCLC), biliary tract cancer (BTC), hepatocellular carcinoma (HCC), esophageal squamous cell carcinoma (ESCC), and ovarian cancer (OC).

Clinical results from multiple studies of opamtistomig in EP‑NEC, NSCLC, and BTC have been presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, the World Conference on Lung Cancer (WCLC), and the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Congress. The clinical data and innovative value of opamtistomig have been widely recognized, further validating opamtistomig as an "IO 2.0" backbone therapy with survival benefit across immunologically ‘cold tumors’ and a broad range of indications.

Executive Commentary
Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, commented: "The orphan drug designation in Japan represents an important milestone in the global development of opamtistomig and further strengthens its regulatory recognition across the four key markets of China, the United States, Europe, and Japan. It underscores the innovative value and global development potential of opamtistomig, particularly in EP-NEC, a tumor type with substantial unmet medical needs. We look forward to leveraging the regulatory incentives associated with this designation to accelerate the development and registration of opamtistomig in Japan, while advancing additional high-potential indications and bringing this innovative therapy to more patients in Japan and around the world."

About Opamtistomig
Opamtistomig (LBL-024) is emerging as a next-generation pan-cancer backbone therapy with potential overall survival (OS) benefit that simultaneously targets PD-L1 and the co-stimulatory receptor 4-1BB. Currently, opamtistomig is being evaluated in 14 indications, including one pivotal single-arm registrational study, one confirmatory Phase III study, and nine proof-of-concept studies, covering major indications such as NSCLC and multiple cold tumors. To date, opamtistomig has demonstrated robust antitumor activity across seven tumor types—extrapulmonary neuroendocrine carcinoma (EP-NEC), non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), biliary tract cancer (BTC), hepatocellular carcinoma (HCC), esophageal squamous cell carcinoma (ESCC), and ovarian cancer (OC)—highlighting its clinical value and broad therapeutic promise.

Developed using Leads Biolabs’ proprietary X-Body bispecific platform, opamtistomig is designed to simultaneously block PD-1/PD-L1 immune suppression and conditionally activate 4-1BB, an agonist pathway, resulting in a potent and synergistic anti-tumor immune response. It has a safety profile comparable to PD-1/PD-L1 inhibitors and demonstrates broader-spectrum anti-cancer potential. Mechanistically, 4-1BB agonism can reactivate exhausted T cells and promote robust T-cell proliferation, offering significant promise for PD-1/PD-L1–resistant or immunologically "cold" tumors and potentially offering durable survival benefits.

Recognizing its clinical potential, opamtistomig received Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA) in October 2024, and Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) in November 2024. Additionally, in January 2026, opamtistomig was granted Fast Track Designation (FTD) by the FDA and ODD by the European Commission, further underscoring its potential to address unmet medical needs in this patient population. In July 2026, its New Drug Application (NDA) was granted priority review designation by the NMPA, followed by NDA acceptance in August 2026, positioning opamtistomig as a potential world’s first approved 4-1BB-targeting antibody, the first approved agonist antibody, and the first approved treatment for EP-NEC.

(Press release, Nanjing Leads Biolabs, SEP 28, 2026, View Source [SID1234671136])