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.

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 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 10, 2025 BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, reported that the European Commission has approved TEVIMBRA (tislelizumab), in combination with gemcitabine and cisplatin, for the first-line treatment of adult patients with metastatic or recurrent nasopharyngeal carcinoma (NPC), not amenable to curative surgery or radiotherapy (Press release, BeOne Medicines, JUL 10, 2025, View Source [SID1234654331]). Nasopharyngeal carcinoma is a rare cancer in which malignant cells form in the nasopharynx, the upper part of the throat located behind the nose.1

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"The approval of TEVIMBRA combined with chemotherapy in Europe marks an important advancement for people with recurrent or metastatic nasopharyngeal carcinoma—a rare and challenging disease," said Prof. Lisa Licitra, Chief of the Head and Neck Cancer Medical Oncology Department at Fondazione IRCCS Istituto Nazionale dei Tumori in Milan, Italy. "Thanks to the compelling results from the RATIONALE-309 study, we now have a powerful new treatment that not only delays disease progression but also helps patients live longer. This approval brings new hope and a clinically proven option to patients who urgently need better care."

The approval in NPC is based on results of RATIONALE-309 (NCT03924986), a double-blind, placebo-controlled, multicenter, Phase 3 study, which randomized 263 treatment-naïve patients who received either TEVIMBRA in combination with gemcitabine plus cisplatin or placebo in combination with gemcitabine plus cisplatin. The primary endpoint was met at the first prespecified interim analysis in which TEVIMBRA significantly prolonged progression-free survival (PFS) in the intent-to-treat (ITT) population (HR 0.52 [95% CI:0.38, 0.73] p<0.0001), showing a 48% reduction in the risk of disease progression or death. The median PFS in the TEVIMBRA plus chemotherapy arm was 9.2 months compared to 7.4 months in the placebo plus chemotherapy arm.

An updated analysis with an additional 12 months of follow-up showed efficacy results consistent with the interim analysis. Clinically meaningful and sustained improvement in overall survival (OS) was observed, with a median OS of 45.3 months for TEVIMBRA plus chemotherapy compared to 31.8 months for placebo plus chemotherapy.

TEVIMBRA plus chemotherapy was generally well tolerated, and no new safety signals were identified. Pooled safety data included over 3,900 patients who received TEVIMBRA, either as monotherapy (n=1,952) or in combination with chemotherapy (n=1,950), at the approved dosing regimen. The most common Grade 3 or 4 adverse reactions (≥ 10%) associated with TEVIMBRA given in combination with chemotherapy were neutropenia, anemia, and thrombocytopenia.

"Following our recent EU approval of TEVIMBRA for extensive-stage small cell lung cancer, this new authorization in nasopharyngeal carcinoma reflects strong momentum in broadening access to our immunotherapy across solid tumors," said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeOne. "With a comprehensive EU label spanning lung and gastrointestinal cancers, and more than 100 regulatory approvals globally, we are delivering on our ambition to bring innovative therapies to more patients around the world."

TEVIMBRA was previously approved in the EU as a first-line treatment for eligible patients with gastric or gastroesophageal junction (G/GEJ) adenocarcinoma, as a first-line treatment for unresectable esophageal squamous cell carcinoma (ESCC), as a second-line treatment in ESCC after prior platinum-based chemotherapy, as a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC), and for three non-small cell lung cancer (NSCLC) indications covering both the first- and second-line settings.

About Nasopharyngeal Cancer (NPC)

Nasopharyngeal cancer, also known as nasopharyngeal carcinoma, is a type of head and neck cancer that starts in the nasopharynx, the upper throat passage that connects the nose to the lungs.2 NPC, which can be categorized into different pathological subtypes (keratinizing squamous, non-keratinizing, and basaloid squamous)3, is often diagnosed at advanced stages due to its deep anatomical location and mild early symptoms, making early detection challenging.4 In 2020, NPC accounted for approximately 133,000 new cancer cases and 80,000 deaths per year globally and exhibits a unique geographical pattern, with its prevalence notably concentrated in Asia.5 While the overall 5-year survival rate for NPC is approximately 63%, in advanced disease the survival rate decreases to 49%.6

About TEVIMBRA (tislelizumab)

TEVIMBRA is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody with high affinity and binding specificity against PD-1. It is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors.

TEVIMBRA is the foundational asset of BeOne’s solid tumor portfolio and has shown potential across multiple tumor types and disease settings. The global TEVIMBRA clinical development program includes almost 14,000 patients enrolled to date in 35 countries and regions across 70 trials, including 21 registration-enabling studies. TEVIMBRA is approved in 46 countries, and more than 1.5 million patients have been treated globally.

Important Safety Information

The current European Summary of Product Characteristics (SmPC) for TEVIMBRA is available from the European Medicines Agency.

This information is intended for a global audience. Product availability and approved indications vary by country. Please refer to local prescribing information for complete details.

On July 10, 2025 Amplia Therapeutics Limited (ASX: ATX), ("Amplia" or the "Company"), reported that an additional confirmed partial response (PR) has been recorded in the Company’s ongoing ACCENT clinical trial in pancreatic cancer (Press release, Amplia Therapeutics, JUL 10, 2025, View Source;v=4a466cc3f899e00730cfbfcd5ab8940c41f474b6 [SID1234654332]). The trial is investigating the Company’s best-in-class FAK inhibitor narmafotinib in combination with standard-of-care chemotherapies gemcitabine and Abraxane.

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The additional partial response brings the objective response rate to 31%, namely 17 out of 55 patients enrolled in the trial. This compares very favourably to chemotherapy alone where a 23% response rate was reported in the benchmark MPACT study1.

A confirmed partial response is a formal designation of response where tumour shrinkage >30% is recorded and sustained for two (2) or more months and where no new cancerous lesions have been detected.

Amplia CEO and MD Dr Chris Burns commented: "We are excited to announce another confirmed partial response in the ongoing ACCENT trial. This latest PR brings the response rate for the ACCENT trial to 31%, considerably better than the 23% reported for the benchmark study of chemotherapy alone. Importantly, our study is still ongoing with 20 patients currently on study."

This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics.

About Narmafotinib

Narmafotinib (AMP945) is the company’s best-in-class inhibitor of the protein FAK, a protein over- expressed in pancreatic cancer and a drug target gaining increasing attention for its role in solid tumours. The drug, which is a highly potent and selective inhibitor of FAK, has shown promising data in a range of preclinical cancer studies.