Corporate presentation

On August 18, 2025 Moleculin presented its corporate presentation (Presentation, Moleculin, AUG 18, 2025, View Source [SID1234655353]).

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Philochem AG Announces Completion of Antitrust Clearance and Closing of the OncoACP3 Licensing Agreement with RayzeBio, a Bristol Myers Squibb Company, With a Potential Value of up to $1.35 Billion Plus Royalties

On August 18, 2025 Philochem AG ("Philochem"), a wholly-owned subsidiary of Philogen company (MIL: PHIL), and RayzeBio, Inc. ("RayzeBio"), a wholly-owned subsidiary of Bristol-Myers Squibb company (NYSE: BMY), reported the successful completion of U.S. antitrust review and the closing of the global licensing agreement for OncoACP3, a clinical-stage therapeutic and diagnostic agent targeting prostate cancer (Press release, Philogen, AUG 18, 2025, View Source [SID1234655354]).

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The transaction, initially announced on June 10, 2025, has now been finalized following clearance under the Hart–Scott–Rodino Antitrust Improvements Act of 1976 by the U.S. Federal Trade Commission (FTC). As part of the agreement, Philochem will receive an upfront payment of $350 million.

RayzeBio will be responsible for the development and any subsequent commercialization of OncoACP3. The license agreement also includes up to $1.0 billion in development, regulatory and commercial milestone payments, as well as mid-single to low double-digit royalties on global net sales.

"I am very pleased that we have received clearance, allowing us to proceed with this agreement with RayzeBio," said Dario Neri, CEO and CSO of Philogen. "They share our vision for revolutionizing the diagnosis and treatment of prostate cancer. We believe that OncoACP3 has all the credentials to become a breakthrough treatment for patients, translating scientific innovation into an important medical advance".

Ben Hickey, President, RayzeBio commented: "The closing of this agreement marks an important milestone for RayzeBio as we expand our leadership in the radiopharmaceuticals space. We look forward to advancing OncoACP3 for the benefit of patients, consistent with our strategy to bring forward best-in-class RPT candidates."

LIXTE Biotechnology Holdings Provides Corporate Update

On August 18, 2025 LIXTE Biotechnology Holdings, Inc. ("LIXTE" or the "Company") (Nasdaq: LIXT and LIXTW), a clinical-stage pharmaceutical company developing a new class of cancer therapy to enhance chemotherapy and immunotherapy, reported an update on its recent activities (Press release, Lixte Biotechnology, AUG 18, 2025, View Source [SID1234655373]).

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"This has been a transformative period for our company," said Geordan Pursglove, who became LIXTE’s new Chairman and Chief Executive Officer in June. "Momentum has been energized on several fronts, including securing essential funding to support our ongoing clinical trials, and to pursue long-term growth opportunities to enhance shareholder value."

Added Bas van der Baan, President and Chief Scientific Officer, "We are especially proud of the recent publication in a leading medical journal, Nature, further validating the promise of our proprietary compound, LB-100, to treat ovarian and colorectal cancer. The recent formation of our medical advisory committee marks yet another strategic step toward our mission of developing and delivering effective solutions to patients battling cancer."

LIXTE’s clinical trials are underway for ovarian cancer at the M.D. Anderson Cancer Center and at Northwestern University, supported by GSK. The Company’s colorectal trial, supported by F. Hoffmann-La Roche, is being conducted at the Netherlands Cancer Institute.

Summary of Recent Corporate Activities:

● Completion of two financings: a private placement with accredited investors, raising aggregate gross proceeds to the Company of approximately $5 million, and a registered direct offering with accredited investors, raising aggregate gross proceeds to the Company of approximately $1.5 million. Proceeds will be used for general corporate purposes and working capital and allowed the Company to regain compliance for continued listing on the Nasdaq Capital Market.

● Management and Board changes: Geordan Pursglove was appointed Chairman and Chief Executive officer in June 2025, succeeding Bas van der Baan, who became President and Chief Scientific Officer. Jason Sawyer and Michael Holloway, MD, joined LIXTE’s Board as independent directors in July 2025, succeeding Stephen Forman, MD, and Yun Yen, MD, who were appointed to serve as members of a newly established Scientific Advisory Committee. Other committee members include Bas van der Baan and Board member René Bernards, PhD.

● Validation of LB-100: The medical journal Nature has published findings that validate LIXTE’s ongoing clinical trials with LB-100. A team led by principal investigator Amir Jazaeri, MD, professor of Gynecologic Oncology and Reproductive Medicine at The University of Texas MD Anderson Cancer Center, studied survival outcomes of patients treated with immune checkpoint blockade therapy. The study showed that patients having tumors with inactivating mutations in PPP2R1A – the major scaffold subunit of protein phosphatase 2A (PP2A) – had significantly better overall survival, compared with patients who did not have this mutation in their tumors. (View Source

● New Pre-Clinical trial: LIXTE has initiated a new pre-clinical study in collaboration with Netherlands Cancer Institute (NKI) to test whether "initiated" cells that carry mutations found in cancer cells can be eliminated by treatment with LB-100. The study represents a new opportunity in cancer prevention.

Iovance’s Amtagvi® (lifileucel) Receives Health Canada Approval for Advanced Melanoma

On August 18, 2025 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, reported Health Canada has issued a Notice of Compliance with Conditions (NOC/c) for Amtagvi (lifileucel), a tumor-derived autologous T cell immunotherapy (Press release, Iovance Biotherapeutics, AUG 18, 2025, View Source [SID1234655338]). Amtagvi is indicated for the treatment of adult patients with unresectable or metastatic melanoma that has progressed on or after at least one prior systemic therapy including a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor, and who have no satisfactory alternative treatment options.

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"This approval in Canada is our first marketing authorization outside the U.S. and marks a significant step forward for Iovance as we prepare to introduce Amtagvi in countries with a high prevalence of advanced melanoma and address substantial unmet needs in solid tumor cancers," said Frederick Vogt, Ph.D., J.D., Interim Chief Executive Officer and President of Iovance. "We expect to authorize our first Canadian treatment center within the next few months, and we continue to advance our ex-U.S. strategy for Amtagvi in additional markets."

Market authorization in Canada under the NOC/c guidance was granted based on safety and efficacy results from the global, multicenter C-144-01 trial investigating Amtagvi in patients with advanced melanoma previously treated with anti-PD-1 therapy and targeted therapy, where applicable. The market authorization is conditional, pending the results of trials to confirm its clinical benefit.

About the C-144-01 Clinical Trial
C-144-01 is a global, multicenter Phase 2 study in which patients received treatment with lifileucel monotherapy. The study enrolled patients with metastatic melanoma who were previously treated with at least one systemic therapy, including a PD-1 blocking antibody, and if BRAF V600 mutation‑positive, a BRAF inhibitor or BRAF inhibitor with MEK inhibitor. Efficacy was established on the basis of objective response rate (ORR), and duration of response (DOR) by Independent Review Committee (IRC) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The detailed results of C-144-01 were published in the Journal for ImmunoTherapy of Cancer in 2022. A five-year analysis of C-144-01 was published in the Journal of Clinical Oncology in 2025.

Iovance is investigating Amtagvi in frontline advanced melanoma in the Phase 3 trial, TILVANCE-301 (NCT05727904), as well as in additional solid tumor types.

Skyhawk Therapeutics Announces Strategic Collaboration with Merck KGaA, Darmstadt, Germany to Discover Novel RNA-Targeting Small Molecules for Neurological Disorders

On August 18, 2025 Skyhawk Therapeutics, Inc., a leader in the discovery and development of small molecules that modulate RNA expression, reported a strategic research collaboration with Merck KGaA, Darmstadt, Germany, a leading science and technology company (Press release, Skyhawk Therapeutics, AUG 18, 2025, View Source [SID1234655356]). The collaboration will focus on the discovery of novel RNA-targeting small molecules in select neurological indications with high unmet medical need.

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Under the terms of the agreement, Skyhawk will use its proprietary SkySTAR (Skyhawk Small molecule Therapeutics for Alternative splicing of RNA) platform to identify small molecule candidates directed at specific RNA targets designated by Merck KGaA, Darmstadt, Germany. The collaboration aims to expand the potential of RNA modulation in diseases where traditional approaches have proven challenging, leveraging Skyhawk’s industry-leading capabilities in RNA splicing modulation and Merck KGaA, Darmstadt, Germany’s expertise in drug development and commercialization.

"Our collaboration with Skyhawk aligns with our strategic focus on innovative science and next-generation technologies that have the potential to deliver impactful medicines to patients with neurological conditions," said Amy Kao, Senior Vice President and Global Head of Neuroscience & Immunology Research Unit, Merck KGaA, Darmstadt, Germany. "We believe RNA splicing modulation represents an exciting frontier in drug discovery, and Skyhawk’s expertise positions them as an ideal partner in this space. It is also in line with our mission in bringing more medicines to more patients, faster."

"We are proud to partner with Merck KGaA, Darmstadt, Germany a company with a strong heritage of innovation and a commitment to advancing transformative science," said Bill Haney, Chief Executive Officer of Skyhawk Therapeutics. "This collaboration underscores the power of our SkySTAR platform to address challenging disease biology through precise RNA targeting, and we look forward to working closely with Merck KGaA, Darmstadt, Germany to bring potential first-in-class medicines forward."

Skyhawk will lead discovery and preclinical development efforts, after which Merck KGaA, Darmstadt, Germany will assume responsibility for further development and commercialization upon option exercise. The overall deal is valued at over $2 billion, with Skyhawk being eligible for milestone payments, as well as tiered royalties on commercial sales.