On July 13, 2025 CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, reported a favorable outcome in opposition proceedings before the European Patent Office (EPO) concerning its European patent EP3445407, which covers its GPC3-targeted CAR-T cell therapy (Press release, Carsgen Therapeutics, JUL 13, 2025, View Source [SID1234654362]).

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On July 3, 2025, a U.S.-based biotechnology — the sole appellant among the original two opponents — formally withdrew its appeal against the EPO Opposition Division’s earlier decision to maintain the patent. This withdrawal renders the EPO’s decision final and binding for the opponents, effectively concluding their part in the opposition process.

The patent was granted by the EPO in 2022 and opposed by two parties in 2023. Following oral proceedings, the EPO Opposition Division issued a decision to maintain the patent in amended form, upholding key claims related to the use of GPC3 CAR-T cell therapy following cyclophosphamide and fludarabine lymphodepletion pretreatment, in the treatment of liver cancer, lung cancer, ovarian cancer, breast cancer, gastric cancer, and thyroid cancer. Following the decision, only one opponent filed an appeal within the allowable period. That appeal has now been withdrawn.

Under EPO procedures, the opponents or any other third party can no longer challenge the patent at the EPO. This development further reinforces CARsgen’s intellectual property position in the field of GPC3-targeted CAR-T therapies, a promising and innovative approach for the treatment of solid tumors.

On July 11, 2025 Xspray Pharma reported the company has now completed the population pharmacokinetic (PopPK) modeling that constitutes key regulatory documentation ahead of submitting a New Drug Application (NDA) for the product candidate XS003 (Press release, Xspray, JUL 11, 2025, View Source [SID1234655400]). The analysis confirms bioequivalence with the reference drug Tasigna, at less than half the dose – a strong indication marking a potential paradigm shift in the treatment of CML with nilotinib.

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The analysis is based on modeling and simulation of data from a comparative study in healthy volunteers. The developed PopPK model, which simulates repeated dosing until steady state is reached, shows a strong correlation with observed concentrations – supporting its regulatory relevance.

The results confirm formal bioequivalence between XS003 and Tasigna in terms of systemic exposure (AUC and Cmax) – despite the XS003 dose being less than half that of the reference drug. In addition, a clinical study has shown that XS003 has significantly improved food interaction and a more predictable dose response, which can facilitate precise dose adjustments in clinical practice. Previously communicated data showed that bioavailability increased by only 28% with food intake – compared to up to 82% for Tasigna. This absorption stability with food intake may reduce the risk of concentration-dependent side effects, such as abnormal heart rhythm (QTc prolongation), particularly in real-world settings where strict fasting can be difficult to maintain

"The data announced today form the pivotal foundation for our regulatory submission with XS003, this confirms our HyNap platform which can create bioequivalent improved formulations with significantly lower dosing and stable absorption even with food intake. This represents a crucial step forward in our strategy to expand the commercialization of our products," says Per Andersson, CEO of Xspray Pharma.

With these results, Xspray Pharma plans to submit a NDA application in the near future. XS003 will be the company’s second product candidate submitted for FDA approval following Dasynoc, both based on the HyNap technology: An innovative amorphous formulation technique that has shown potential to improve absorption for a range of products including protein kinase inhibitors.

For further information, please contact:

Jacob Nyberg, IR
Xspray Pharma AB (publ)
Tel: + 46 (0) 70 767 08 83
E-mail: [email protected]

On July 11, 2025 Milestone Pharmaceuticals Inc. ("Milestone") (Nasdaq: MIST) reported that it has commenced an underwritten public offering (the "Offering") of its common shares, accompanying Series A warrants to purchase common shares (the "Series A Warrants") and accompanying Series B warrants to purchase common shares (the "Series B Warrants"), and, in lieu of common shares to certain investors that so choose, pre-funded warrants to purchase common shares, accompanying Series A Warrants and accompanying Series B warrants (Press release, Milestone Pharmaceuticals, JUL 11, 2025, View Source [SID1234654369]). All securities to be sold in the Offering will be sold by Milestone. The Offering is subject to market and other conditions and there can be no assurance as to whether or when the Offering may be completed, or as to the actual size or terms of the Offering.

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Milestone intends to use the net proceeds from the Offering, together with existing cash and cash equivalents, to fund the clinical development and commercial launch of etripamil in its lead indication of paroxysmal supraventricular tachycardia (PSVT), as well as for working capital and other general corporate purposes.

TD Cowen, Piper Sandler & Co. and Wells Fargo Securities are acting as joint book-running managers for the Offering. H.C. Wainwright & Co. is acting as lead manager for the Offering.

The securities described above are being offered by Milestone pursuant to a shelf registration statement on Form S-3 (File No. 333-283162), including a base prospectus, that was declared effective by the U.S. Securities and Exchange Commission (the "SEC") on November 22, 2024. The Offering is being made only by means of a prospectus supplement and accompanying prospectus that form a part of the registration statement. A preliminary prospectus supplement related to the Offering will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. A copy of the preliminary prospectus supplement and the accompanying prospectus relating to the Offering may also be obtained, when available, from: TD Securities (USA) LLC, 1 Vanderbilt Avenue, New York, NY 10017, by telephone at 855-495-9846, or by email at [email protected]; Piper Sandler, Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, or by telephone at (800) 747-3924, or by email at [email protected]; and Wells Fargo Securities, LLC, 90 South 7th Street, 5th Floor, Minneapolis, MN 55402, or by telephone at 800-645-3751 (option #5), or by email at [email protected].

This press release shall not constitute an offer to sell or a 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 registration or qualification under the securities laws of any such state or jurisdiction.

On July 11, 2025 Elegen, a global leader in next-generation DNA manufacturing, and Nutcracker Therapeutics, a global leader in next-generation RNA design and manufacturing, reported the launch of a pilot program to demonstrate the industry’s first fully synthetic, cell-free manufacturing platform for RNA-based personalized cancer therapeutics (PCTs). The pilot marks another step toward making PCTs more accessible, timely, and scalable (Press release, Nutcracker Therapeutics, JUL 11, 2025, View Source [SID1234654354]).

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As late-stage PCT clinical trials progress and therapy developers work to create the next generation of PCTs, the speed, reliability, scaling and cost of traditional production methods pose a major challenge. Specifically, the first step of DNA template production is hindered by the use of bacterial cells in the process, which can be unreliable and introduce contamination that must be removed. The second step of GMP-grade RNA production from the template is impeded by a slow, unreliable, and inefficient process in which only one therapy can be made per GMP suite. Consequently, PCT production is slow, very costly, and does not scale for individualized therapies — a new manufacturing paradigm is needed.

Nutcracker Therapeutic’s NMU-Symphony system, the second generation of its Nutcracker Manufacturing Unit (NMU), brings the fastest, most scalable, and cost-efficient GMP RNA manufacturing platform available today. Fully enclosed and built for speed, it reliably delivers clinical-grade PCTs consistent with just a three-week overall turnaround time, from RNA sequence design to released nanoparticle formulated drug product — cutting traditional timelines in half. By incorporating Elegen’s cell-free GMP-ready DNA template production, the combination of the two platforms will enable an even faster and more scalable synthesis of longer, more complex neo-antigen sequences, while eliminating risks of bioburden and endotoxin contamination.

With a faster, more reliable and lower-cost solution, Elegen and Nutcracker Therapeutics aim to democratize PCTs, making them accessible to more developers and saving critical time for cancer patients, where even days can make a meaningful impact.

"Integrating cell-free DNA with cell-free biochip-based RNA production gives researchers and partners worldwide access to a more reliable, streamlined, and cost-effective platform to rapidly test and advance new therapies," said Matthew Hill, founder and CEO of Elegen. "By eliminating cells from the process, we can accelerate the development and evaluation of new therapeutic modalities, helping patients receive treatment as quickly as possible."

"We’re not just improving our manufacturing process, we’re laying the foundation to democratize PCTs with truly scalable solutions," added Benjamin Eldridge, co-founder and chief technology officer of Nutcracker Therapeutics. "Achieving that vision means giving developers the ability to produce clinical-grade RNA without investing hundreds of millions in infrastructure. This is a key step toward our mission of delivering scalable, low-cost, and rapid formulated RNA manufacturing for individualized therapies."

Elegen’s cell-free ENFINIA DNA with an unparalleled combination of speed, length, accuracy and complexity integrates seamlessly with Nutcracker Therapeutics’ existing RNA-based PCT development process, which leverages artificial intelligence and machine learning technologies through its CodonCracker RNA design software, the NMU-Symphony microfluidics biochip-based system, and ProcessVision technology for real-time performance and quality monitoring. Combined, Elegen and Nutcracker Therapeutic’s technologies enable the efficient, flexible, and GMP-ready production of individualized nanoparticle-formulated RNA therapeutics.

On July 11, 2025 CEL-SCI Corporation ("CEL-SCI" or the "Company") (NYSE American: CVM), a clinical stage cancer immunotherapy company, reported the pricing of a best-efforts offering of 1,500,000 shares of its common stock (Press release, Cel-Sci, JUL 11, 2025, View Source [SID1234654353]). Each share of common stock is being sold at an offering price of $3.82 per share, priced at-the-market under NYSE American rules. Total gross proceeds from the offering, before deducting the placement agent’s fees and other offering expenses, are expected to be approximately $5.7 million. The offering is expected to close on July 14, 2025, subject to satisfaction of customary closing conditions.

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The Company intends to use the net proceeds from the offering to fund the continued development of Multikine, general corporate purposes, and working capital.

ThinkEquity is acting as the sole placement agent for the offering.

The securities will be offered and sold pursuant to a shelf registration statement on Form S-3 (File No. 333-265995), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the "SEC") on July 1, 2022, and declared effective on July 15, 2022. The offering will be made only by means of a written prospectus. A final prospectus supplement and accompanying prospectus describing the terms of the offering will be filed with the SEC on its website at www.sec.gov. Copies of the prospectus supplement and the accompanying prospectus relating to the offering may also be obtained, when available, from the offices of ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.