On September 29, 2025 Soligenix, Inc. (Nasdaq: SNGX) ("Soligenix" or the "Company"), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported the closing of its previously announced "reasonable best efforts" public offering with participation from existing and certain healthcare focused institutional investors for the purchase and sale of 5,555,560 shares of common stock of the Company (or common stock equivalents in lieu thereof) and warrants to purchase up to 5,555,560 shares of common stock at a combined purchase price of $1.35 per share and accompanying warrant (the "Offering") (Press release, Soligenix, SEP 29, 2025, View Source [SID1234656324]). The warrants have an exercise price of $1.35 per share, are exercisable immediately and will expire five years from the issuance date. The Company received aggregate gross proceeds of approximately $7.5 million, before deducting placement agent fees and other Offering expenses.

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The Company agreed that certain existing May 2023, April 2024 and July 2024 warrants (together, the "Existing Warrants") to purchase an aggregate of 1,162,064 shares of common stock will be amended such that the Existing Warrants will have a reduced exercise price of $1.35 per share and shall expire commensurate with the warrants sold in the Offering.

This funding extends the Company’s cash runway through the end of 2026, providing sufficient funds for anticipated key inflection points. The Company intends to use the net proceeds of this Offering to fund research and development and commercialization activities, working capital and general corporate purposes.

A.G.P./Alliance Global Partners acted as the sole placement agent in connection with the Offering.

The securities described above were offered pursuant to a registration statement on Form S-1 (File No. 333-290413), previously filed with the Securities and Exchange Commission ("SEC") on September 19, 2025, which became effective on September 25, 2025. This Offering was made only by means of a prospectus forming part of the effective registration statement. Copies of the final prospectus relating to the Offering may be obtained on the SEC’s website located at View Source Electronic copies of the final prospectus relating to the Offering may be obtained from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at [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 the registration or qualification under the securities laws of any such state or other jurisdiction.

On September 29, 2025 ReCode Therapeutics, a clinical-stage genetic medicines company using tissue-specific delivery to power the next wave of mRNA and gene correction therapeutics, reported the close of over $29 million in additional financing (Press release, ReCode Therapeutics, SEP 29, 2025, View Source;utm_medium=rss&utm_campaign=recode-therapeutics-announces-over-29-million-in-additional-financing-to-advance-genetic-medicines-pipeline-and-provides-corporate-update [SID1234656323]). The company also reported expanded support from the Cystic Fibrosis Foundation (CF Foundation) and a new research collaboration with Praxis Precision Medicines, Inc. (NASDAQ: PRAX).

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"With continued support from organizations like the CF Foundation and our collaboration with Praxis, we are building on our momentum to deliver on the promise of genetic medicines for people living with genetic diseases who currently have limited or no effective treatments," said Shehnaaz Suliman, M.D., MBA, M.Phil., chief executive officer of ReCode Therapeutics.

Key Updates

Over $29 Million Raised in New Financing: ReCode has raised more than $29 million to advance its pipeline of genetic medicines, including investigational therapies for cystic fibrosis (CF). The funding strengthens the company’s financial foundation as it progresses its clinical and preclinical programs.
Expanded Support from the CF Foundation: The CF Foundation, which previously invested $15 million to support the development of and early-stage clinical trials for RCT2100, an inhaled mRNA therapy, is committing an additional $3 million to support the company’s ongoing Phase 2 clinical trial of RCT2100. RCT2100 is designed to provide functional CFTR protein by delivering a correct copy of CFTR mRNA to lung cells, offering potential benefits to all people with CF, including those with rare and nonsense mutations who do not benefit from existing modulator therapies. In total, the Foundation has agreed to invest up to $33 million in ReCode’s mRNA and gene editing research programs. For more information, please visit www.CF-Clinical-Studies.com.
Partnership with Praxis Precision Medicines for ASO Delivery: ReCode has entered into a research collaboration with Praxis Precision Medicines, Inc., a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal excitation-inhibition imbalance, to identify a well-tolerated lipid nanoparticle (LNP) formulation that enhances the delivery of antisense oligonucleotides (ASOs) to underexposed brain regions.
ERS and NACFC Attendance: ReCode leadership will attend the European Respiratory Society (ERS) Congress in Amsterdam, the Netherlands, from September 27 to October 1, and the North American Cystic Fibrosis Conference (NACFC) in Seattle from October 22 to 25.

On September 29, 2025 Oncolytics Biotech Inc. (Nasdaq: ONCY) ("Oncolytics" or the "Company"), a clinical-stage immunotherapy company developing pelareorep, reported an update on the proposed design of its planned registration-directed clinical trial in first-line pancreatic ductal adenocarcinoma (PDAC) (Press release, Oncolytics Biotech, SEP 29, 2025, View Source [SID1234656322]). The Company is currently scheduled to meet with the U.S. Food and Drug Administration (FDA) in mid-November 2025 to advance study details.

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Key Elements of the Proposed Registration Study
•Three-arm design – patients will be randomized to receive:
1.Gemcitabine + nab-paclitaxel (GnP) control arm.
2.GnP + pelareorep.
3.GnP + pelareorep + checkpoint inhibitor (CPI).
•Primary endpoint: Overall Survival (OS).
•Statistical rigor: The trial will be powered to detect statistical significance between the investigational arms and the control arm.
•Planned interim analysis: An interim efficacy analysis will be incorporated to enable early assessment of potential clinical benefit.

This proposed design builds on a post-hoc, pooled clinical analysis, which found that the addition of pelareorep to chemotherapy achieved an approximate 22% two-year survival rate, compared to just 9% for patients treated with chemotherapy alone, as in historical, third-party benchmarks (link to the PR).

"We are excited to advance this potential registration-directed study in first-line pancreatic cancer with a well-powered, three-arm design," said Jared Kelly, Chief Executive Officer of Oncolytics. "By evaluating pelareorep with chemotherapy and in combination with checkpoint inhibition, we expect to position this program to deliver meaningful data for patients and regulators alike. We believe that potential partners will recognize the possibility this trial design presents to establish pelareorep as the first approved immunotherapy in first-line pancreatic cancer – a transformative milestone in oncology."

On September 29, 2025 Kura Oncology, Inc. (Nasdaq: KURA) and Kyowa Kirin Co., Ltd. (TSE: 4151, "Kyowa Kirin") reported that the first patient has been dosed under the KOMET-017 clinical trial protocol (NCT07007312), comprising two independent, global, randomized double-blind, placebo-controlled Phase 3 trials to evaluate ziftomenib, Kura Oncology’s investigational menin inhibitor, in combination with both intensive and non-intensive combination regimens in patients with newly diagnosed NPM1-mutated (NPM1-m) or KMT2A-rearranged (KMT2A-r) acute myeloid leukemia (AML) (Press release, Kura Oncology, SEP 29, 2025, View Source [SID1234656319]).

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"The dosing of the first patient under the KOMET-017 protocol is a major milestone in the pursuit of improved treatments for patients with newly diagnosed AML," said Amer Zeidan, M.B.B.S., M.H.S., Chief of the Division of Hematologic Malignancies, Director of Hematology Early Therapeutics Research at Yale Cancer Center and lead investigator of KOMET-017. "AML remains one of the most aggressive and difficult-to-treat blood cancers, with many patients relapsing despite currently available therapies. Ziftomenib, which in my opinion has the potential to be the best-in-class menin inhibitor, has demonstrated promising safety and activity in early phase clinical trials of NPM1-m and KMT2A-r AML both as monotherapy and in combination with multiple standards of care. These two randomized Phase 3 trials offer the potential to confirm benefit across frontline populations that account for nearly half of newly diagnosed AML patients and where safe, tolerable and effective options are urgently needed."

"This is a pivotal moment for Kura, Kyowa Kirin, and patients with AML," said Mollie Leoni, M.D., Chief Medical Officer of Kura Oncology. "To our knowledge, KOMET-017 is the only menin inhibitor program actively pursuing registrational trials across both intensive and non-intensive chemotherapy settings, underscoring the potential to address a broad spectrum of patients with AML. The opportunity to advance to the frontline AML setting offers the potential to reach patients earlier in their disease course, when the possibility to meaningfully change the trajectory of the disease is greatest. The willingness of the FDA to allow the trials to use MRD negative CR and CR as primary endpoints for accelerated approval is groundbreaking and could potentially enable us to deliver ziftomenib more quickly to patients in need. We are committed to driving the KOMET-017 program forward with the goal of transforming care for patients who continue to face a devastating prognosis."

"The initiation of the KOMET-017 trial represents a significant step forward in expanding treatment options for newly diagnosed AML patients with NPM1-m and KMT2A-r," said Takeyoshi Yamashita, Ph.D., Executive Vice President and Chief Medical Officer of Kyowa Kirin. "AML remains a disease with poor prognosis, and developing safe and effective therapies is an urgent need. Ziftomenib’s innovative mechanism of action, combined with its potential efficacy alongside both intensive and non-intensive therapies, holds promise to improve patients’ quality of life and extend survival. Kyowa Kirin is committed to collaborating closely with Kura Oncology to bring life-changing value to patients living with AML."

Each frontline trial design includes dual-primary endpoints to support potential U.S. accelerated approval and full approval. The intensive chemotherapy Phase 3 trial of ziftomenib in combination with standard induction cytarabine / daunorubicin (7+3) will assess minimal residual disease (MRD) negative complete response (CR) and event-free survival (EFS) as dual-primary endpoints. The non-intensive chemotherapy Phase 3 trial of ziftomenib in combination with venetoclax / azacitidine will assess CR and overall survival (OS) as dual-primary endpoints. The trial is intended to serve as a registrational study and builds on encouraging clinical data previously reported with ziftomenib in genetically defined subsets of AML. The trial is expected to enroll patients at up to 200 sites worldwide, reflecting strong global interest in advancing ziftomenib for patients in need. More information regarding the KOMET-017 trial is available at www.clinicaltrials.gov (identifier: NCT07007312).

On September 29, 2025 IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulatory, off-the-shelf therapeutic cancer vaccines, reported an update on the regulatory pathway for Cylembio (imsapepimut and etimupepimut, adjuvanted) following a pre-BLA meeting with the U.S. Food and Drug Administration (FDA) (Press release, IO Biotech, SEP 29, 2025, View Source [SID1234656318]). The FDA has recommended that IO Biotech not submit a BLA based on the data from the IOB-013 clinical trial. As previously announced, in the IOB-013 trial, treatment with Cylembio plus pembrolizumab improved progression free survival (PFS), however the results narrowly missed statistical significance. The company plans to continue the dialogue with FDA to align on the design of a potential new registrational study for Cylembio.

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"We had a productive meeting with the FDA; while this is not the outcome we had hoped for, we respect the FDA’s feedback and remain confident in the therapeutic potential of Cylembio," said Mai-Britt Zocca, PhD, president and chief executive officer of IO Biotech. "We look forward to continuing the dialogue with the FDA to align on the design for a potential new registrational study. Additionally, we plan to discuss the data from our IOB-013 study with European regulators and determine a path to submission in the EU." 

The company is implementing a plan to conserve capital while it pursues a pathway to regulatory approval for Cylembio and works to complete ongoing studies. The company currently has capital to run its operations into the first quarter of 2026 and is restructuring to reduce the company’s ongoing expense structure. The company expects to incur a non-recurring charge of between $1.0 – $1.5 million in the third quarter of 2025 related to the restructuring, which includes an approximate 50 percent reduction in full-time employees.

About Cylembio

Cylembio (imsapepimut and etimupepimut, adjuvanted) is an investigational, immune-modulatory, off-the-shelf therapeutic cancer vaccine candidate designed to kill both tumor cells and immune-suppressive cells in the tumor microenvironment (TME) by stimulating activation and expansion of T cells against indoleamine 2,3-dioxygenase 1 (IDO1) positive and/or programmed death-ligand 1 (PD-L1) positive cells. The company is currently conducting a pivotal Phase 3 trial (IOB-013/KN-D18; NCT05155254) investigating Cylembio in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) versus pembrolizumab alone in patients with advanced melanoma, a Phase 2 basket trial (IOB-022/KN-D38; NCT05077709) investigating Cylembio in combination with pembrolizumab as first line treatment in patients with advanced solid tumors, and a Phase 2 basket trial (IOB-032/PN-E40; NCT05280314) investigating Cylembio in combination with pembrolizumab as neo-adjuvant/adjuvant treatment of patients with solid tumors. Enrollment in the Phase 3 trial was completed rapidly by December 2023 with topline results from this trial reported in the third quarter of 2025. Enrollment in the two ongoing company-sponsored Phase 2 clinical trials is complete.

The clinical trials are sponsored by IO Biotech and conducted in collaboration with Merck, which is supplying pembrolizumab. IO Biotech maintains global commercial rights to Cylembio.

Cylembio is a registered trademark of IO Biotech ApS, a subsidiary of IO Biotech.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside of the US and Canada).

About the IOB-013/KN-D18 Phase 3 Clinical Trial

IOB-013/KN-D18 (ClinicalTrials.gov: NCT05155254) is an open label, randomized Phase 3 pivotal clinical trial evaluating Cylembio in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) versus pembrolizumab alone in patients with previously untreated, unresectable or metastatic (advanced) melanoma. Enrollment in the trial was completed by December 2023 with a total of 407 patients enrolled from more than 100 centers across the United States, Europe, Australia, Turkey, Israel and South Africa. The primary endpoint of the study was progression free survival. Secondary endpoints include overall response rate, overall survival, durable objective response rate, complete response rate, duration of response, time to complete response, disease control rate, and incidence of adverse events and serious adverse events (safety and tolerability). Biomarkers in the blood and tumor tissue will also be assessed as exploratory endpoints. The company reported topline results from this trial in the third quarter of 2025. IO Biotech is sponsoring the Phase 3 trial and Merck is supplying pembrolizumab.