Invivyd Announces Proposed Public Offering of Common Stock

Invivyd Announces Proposed Public Offering of Common Stock




Invivyd Announces Proposed Public Offering of Common Stock

NEW HAVEN, Conn., Nov. 17, 2025 (GLOBE NEWSWIRE) — Invivyd, Inc. (Invivyd) (Nasdaq: IVVD) today announced that it has commenced an underwritten public offering of shares of its common stock. In addition, Invivyd intends to grant the underwriters an option for a period of 30 days to purchase up to an additional 15% of the shares of Invivyd common stock sold in the public offering at the public offering price, less underwriting discounts and commissions. All of the shares are being offered by Invivyd. 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.

Cantor is acting as sole book-running manager for the offering.

Invivyd intends to use the net proceeds that it will receive from the offering, together with its existing cash and cash equivalents, for commercial preparedness for the potential launch of VYD2311, continued research and development related to its pipeline programs such as respiratory syncytial virus (RSV) and measles, continued advancement of the Spike Protein Elimination and Recovery (SPEAR) Study Group efforts related to assessing the effects of monoclonal antibody therapy for Long COVID and COVID-19 Post-Vaccination Syndrome, and for working capital and other general corporate purposes.

The securities described above are being offered by Invivyd pursuant to a shelf registration statement on Form S-3 (File No. 333-267643) filed with the U.S. Securities and Exchange Commission (SEC) on September 28, 2022 and declared effective by the SEC on October 5, 2022.

The offering will be made only by means of a prospectus supplement and accompanying prospectus that form a part of the registration statement. A preliminary prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and accompanying prospectus relating to the offering, when available, may be obtained from Cantor Fitzgerald & Co., Attention: Equity Capital Markets, 110 East 59th Street, 6th Floor, New York, New York 10022; or by e-mail at prospectus@cantor.com. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

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 registration or qualification under the securities laws of any such state or jurisdiction.

About Invivyd

Invivyd, Inc. (Nasdaq: IVVD) is a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2. Invivyd deploys a proprietary integrated technology platform unique in the industry designed to assess, monitor, develop, and adapt to create best in class antibodies. In March 2024, Invivyd received emergency use authorization (EUA) from the U.S. FDA for a monoclonal antibody (mAb) in its pipeline of innovative antibody candidates.

Trademarks are the property of their respective owners.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipates,” “believes,” “could,” “expects,” “intends,” “potential,” “projects,” and “future” or similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements include, but are not limited to, statements regarding the timing, anticipated terms and success of the proposed offering, as well as the anticipated use of the net proceeds from the proposed offering. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause Invivyd’s actual results to be materially different than those expressed in or implied by Invivyd’s forward-looking statements. For Invivyd, this includes satisfaction of the customary closing conditions of the offering, delays in obtaining required stock exchange or other regulatory approvals, political uncertainties, stock price volatility and uncertainties relating to the financial markets, the medical community and the global economy, and the impact of instability in general business and economic conditions, including changes in inflation, interest rates and the labor market. Other factors that may cause Invivyd’s actual results to differ materially from those expressed or implied in the forward-looking statements in this press release are described under the heading “Risk Factors” in the preliminary prospectus supplement relating to the offering to be filed with the SEC, in Invivyd’s Annual Report on Form 10-K for the year ended December 31, 2024 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2025 filed with the SEC, and in Invivyd’s other filings with the SEC, and in its future reports to be filed with the SEC and available at www.sec.gov. Forward-looking statements contained in this press release are made as of this date, and Invivyd undertakes no duty to update such information whether as a result of new information, future events or otherwise, except as required under applicable law.

Contacts:

Media Relations
(781) 208-0160
media@invivyd.com

Investor Relations
(781) 208-1747
investors@invivyd.com

Kraig Biocraft Laboratories Fulfilling Order for Customized Spider Silk Application from Leading Performance Sports Brand

Kraig Biocraft Laboratories Fulfilling Order for Customized Spider Silk Application from Leading Performance Sports Brand




Kraig Biocraft Laboratories Fulfilling Order for Customized Spider Silk Application from Leading Performance Sports Brand

Company to deliver spider silk yarns for elite-tier athletic application

ANN ARBOR, Mich., Nov. 17, 2025 (GLOBE NEWSWIRE) — Kraig Biocraft Laboratories, Inc. (OTCQB: KBLB) (“Company” or “Kraig Labs”), a world leader in spider silk technology*, today announced that it is fulfilling an order for spider silk from a globally recognized performance sports apparel brand as part of a confidential pilot development program.

This project will incorporate the Company’s next-generation recombinant spider silk into a cutting-edge application targeted at the highest tier of performance apparel. While specific project details remain protected, Kraig Labs can confirm that the program is designed for one of the most demanding and innovation-focused segments of the athletic market.

This customer’s market leadership, engineering sophistication, and reputation for excellence in performance apparel made them the ideal choice for this initial pilot engagement. Their market leadership and commitment to innovation is the reason Kraig Labs selected to fulfill this request from among the numerous recent inbound inquiries it received.

The Company is now processing a portion of its recombinant spider silk inventory into yarns tailored to the precise specifications provided by the customer’s development team. Delivery of these specialized materials is expected before the end of the first quarter.

As a focused pilot program, this order calls for a small, purpose-built quantity of spider silk designed explicitly for this highly specialized application. Even at this limited scale, the project provides a powerful platform for demonstrating the performance capabilities and commercial potential of the Company’s specialized spider silk technology within a premier performance environment.

“This collaboration underscores the growing recognition of our material’s potential in high-value, high-performance applications,” said Kim Thompson, Kraig Labs’ Founder and CEO. “We are excited to support this project and a customer whose commitment to innovation aligns with our own. We look forward to showcasing what our spider silk can deliver at the elite level of apparel design and performance.”

Kraig Labs will share additional updates as appropriate and consistent with the confidentiality terms of the agreement.

For the latest updates on Kraig Labs and its pioneering spider silk technologies, visit www.kraiglabs.com.

For details about other recent Kraig Labs advancements, please watch the Company’s investor conference at www.kraiglabs.com/videos or on the Company’s YouTube Channel https://www.youtube.com/@kraigbiocraftlaboratories2270.

To view the most recent news from Kraig Labs and/or to sign up for Company alerts, please go to www.KraigLabs.com/news   

* For a description of our historical leadership in this technology, please follow this link https://www.kraiglabs.com/world-leader/

About Kraig Biocraft Laboratories, Inc.

Kraig Biocraft Laboratories, Inc. (www.KraigLabs.com), a reporting biotechnology company is the leading developer of genetically engineered spider silk-based fiber technologies.

The Company has achieved a series of scientific breakthroughs in the area of spider silk technology with implications for the global textile industry.

Cautionary Statement Regarding Forward Looking Information

Statements in this press release about the Company’s future and expectations other than historical facts are “forward-looking statements.” These statements are made on the basis of management’s current views and assumptions. As a result, there can be no assurance that management’s expectations will necessarily come to pass. These forward-looking statements generally can be identified by phrases such as “believes,” “plans,” “expects,” “anticipates,” “foresees,” “estimated,” “hopes,” “if,” “develops,” “researching,” “research,” “pilot,” “potential,” “could” or other words or phrases of similar import. Forward looking statements include descriptions of the Company’s business strategy, outlook, objectives, plans, intentions and goals. All such forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from those in forward-looking statements. This press release does not constitute an offer to sell or the solicitation of an offer to buy any security.

Ben Hansel, Hansel Capital, Inc.

(720) 288-8495

ir@KraigLabs.com

Protext Mobility, Inc. (OTC: TXTM) Announces Strategic TruLeaf Partnership & Next-Level Innovation

Protext Mobility, Inc. (OTC: TXTM) Announces Strategic TruLeaf Partnership & Next-Level Innovation




Protext Mobility, Inc. (OTC: TXTM) Announces Strategic TruLeaf Partnership & Next-Level Innovation

FORT LAUDERDALE, Fla., Nov. 17, 2025 (GLOBE NEWSWIRE) — Protext Mobility, Inc. (OTC: TXTM) (“Protext” or the “Company”) is proud to announce a strategic Letter of Intent (LOI) with TruLeaf, marking a pivotal moment in the company’s growth and mission. This partnership not only accelerates technology adoption and market expansion but also opens the door to innovative financial applications leveraging CBD-based assets.

Highlights:

  • TruLeaf provides strategic support, including product samples, initial inventory shipments, infrastructure support, and operational resources.
  • Perfect synergy: TruLeaf’s nanotechnology enhances TXTM’s kettle technology, significantly increasing bioavailability. Products are cheaper, faster-acting, and more effective, benefiting patients worldwide.
  • TruLeaf’s natural CBD FECO without THC, combined with Farm Bill compliance, provides a regulatory and competitive advantage.
  • The resulting API (active pharmaceutical ingredient) and mg quantities of CBD can be treated as real-world assets (RWA) on the company’s balance sheet, recognized under IFRS/GAAP as income/gain, strengthening net profit without cash outflow.
  • These assets could potentially support the creation of a stablecoin, enabling future staking, investment, or liquidity applications — a true financial innovation benefiting all shareholders.
  • This partnership is aligned with TXTM Tribe Mission: raising all boats by improving patient outcomes, advancing global healing, and creating shareholder value.

Strategic Rationale

  1. Technological Synergy & Bioavailability
    • TruLeaf’s nanotechnology complements TXTM’s kettle technology.
    • Dramatically increases bioavailability, improving effectiveness and speed of action for patients.
    • Reduces production costs, enhancing shareholder value.
    • Supports the mission of global healing and patient wellbeing.
  2. Regulatory & Competitive Advantage
    • THC-free CBD FECO aligns with Farm Bill compliance.
    • Provides a clear market differentiation and competitive edge.
  3. Financial Strengthening & Asset Potential
    • CBD API is a real-world asset (RWA) recognized under IFRS/GAAP as income/gain.
    • Strengthens balance sheet, net profit, and potential share price.
    • RWA could support innovative stablecoin creation or staking mechanisms, creating new financial opportunities for the company and shareholders.
  4. Market Validation & Mission Impact
    • TruLeaf’s support is a vote of confidence from a successful, established partner.
    • Accelerates growth, operational scaling, and market entry.
    • Delivers meaningful impact for patients and the TXTM Tribe Mission: “raising all boats.”

Dylon Du Plooy, CEO, mentioned:

“This is a landmark moment for TXTM. TruLeaf’s nanotechnology enhances our kettle technology, dramatically increasing bioavailability, making our products more effective, faster, and more affordable for patients. The resulting API is a real-world asset on our balance sheet, recognized as income/gain, and has the potential to support stablecoin creation for staking or investment — a transformative financial innovation. Combined with THC-free CBD FECO and Farm Bill compliance, we now have a regulatory and competitive advantage. This partnership accelerates growth, strengthens our market position, and aligns perfectly with the TXTM Tribe Mission: raising all boats, for shareholders, patients, and global healing.”

About Protext Mobility, Inc. (OTC: TXTM)

Protext Mobility is focused on the research, testing, and development of highly bioavailable, nanotechnology-based botanical formulations for nutraceutical and pharmaceutical applications. Through proprietary live plant extraction technologies, the company aims to advance plant-based therapeutics that address wellness and health needs globally.

Investor & Media Contact:
Dylon Du Plooy – dylon@rsammd.co.za
Dr. J – exportintl@aol.com

Follow Us:
X (Twitter): https://x.com/ProtextP

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of applicable securities laws. Actual results may differ materially due to market conditions, foreign exchange fluctuations, operational execution, regulatory requirements, and other risks detailed in the Company’s filings with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements.

Neocis Unveils Next-Generation AI-Powered Robotic System for Dental Implants

Neocis Unveils Next-Generation AI-Powered Robotic System for Dental Implants




Neocis Unveils Next-Generation AI-Powered Robotic System for Dental Implants

Yomi® S and YomiPlan® AI Platform Now FDA-Cleared, Offering Unprecedented Precision, Efficiency, and Access for Dentists and Patients

MIAMI, Nov. 17, 2025 (GLOBE NEWSWIRE) — Neocis®, the pioneer behind the first and only U.S. FDA-cleared robotic system for dental implant surgery, today announced the launch and FDA approval of its next-generation robotic platform: Yomi S. The new system, powered by advanced AI software YomiPlan, redefines what’s possible in dental surgery—delivering surgical precision, streamlined workflows, and high-quality patient outcomes.

Designed for maximum efficiency and minimal invasiveness, Yomi S can now be operated by a single practitioner via foot pedal and touchscreen—freeing up staff resources and making robotic-assisted implant surgery more accessible to general dentists. The system features a smaller footprint, enhanced dexterity, better visibility, and a new AI-powered planning suite that automates complex preoperative tasks.

Unlocking Growth for Dentists, Better Outcomes for Patients
Nearly 200 million Americans are missing at least one tooth, and one-third of adults over 65 need full-arch replacement. Traditional implant surgery is often time-consuming and costly, limiting patient access. Yomi S changes that.

For dentists, the Yomi S platform creates new opportunities to expand practice offerings and drive revenue:

  • Single-Operator Workflow: Enhanced automation allows one clinician to manage the procedure, reducing operational overhead.
  • YomiPlan AI: Proprietary machine learning algorithms automate segmentation of critical anatomy (e.g., nerves, sinuses) from CBCT scans, dramatically speeding up the planning phase.
  • Versatile Use Cases: In addition to implants, Yomi S unlocks new applications that will vastly expand the market opportunity beyond dental implants.
  • Compliant and Secure: YomiPlan meets the latest FDA standards for cybersecurity and medical software, ensuring safety in connected clinical environments.

“Yomi S simplifies procedures thanks to excellent robotic range of motion, extended reach, touchscreen, and voice commands, while maintaining superior accuracy,” says Dr. Jay Neugarten, DDS, MD, FACS. “I approach each patient with the same care I would give my mother. With the capabilities of Yomi S, I am committed to providing exceptional quality treatment that every patient deserves.”

Making Minimally Invasive, Same-Day Implants a Reality

Patients benefit significantly from Yomi S’s minimally invasive, flapless approach. By reducing incisions and surgical time, the system helps shorten recovery periods and reduce discomfort.

With real-time AI-guided navigation through the entire implant planning, imaging and surgical process, Yomi S supports safer implant procedures—automatically highlighting dental nerves and other vital structures, much like lane-assist features in modern vehicles.

“Yomi was totally painless and it’s more precise than a human being would be. I’ve had an implant before on the other side with a different doctor and without this technology – and this one was so much easier,” said Yomi patient Anders Brag. “The results were terrific and I really didn’t feel anything afterwards – and in my prior experience I had pain.”

“Yomi S isn’t just groundbreaking for dental robotics; it sets a new standard for robotic surgery in general. With ease of use as the primary focus, Yomi S enables every dental practice to integrate robotics into their workflow” said Alon Mozes, founder and CEO of Neocis. “We’ve combined robotic precision with an intuitive, surgeon-friendly design to make implant surgery faster and more accessible than ever before. Yomi has nearly completed 100,000 osteotomies, and we’re excited to accelerate growth with Yomi S to deliver the best care to patients everywhere.”

About Yomi
The Yomi robotic system is a computerized robotic navigational system intended to provide assistance in both the planning (preoperative) and the surgical (intraoperative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides robotic navigational guidance of the surgical instruments. The system can also be used for planning and performing guided bone reduction (also known as alveoloplasty) of the mandible and/or maxilla. Yomi is intended for use in partially edentulous and fully edentulous adult patients who qualify for dental implants.

Since 2016, Yomi has been helping clinicians around the country plan and place dental implants with a high level of precision and efficiency, so they can operate with confidence, expand their practices, and deliver an excellent patient experience. The platform has assisted in the placement of nearly 100,000 implants.

About Neocis
Neocis is transforming dental surgery with robotics. The company collaborates closely with leading clinicians to develop innovative technologies that help advance patient care and improve quality of life. Based in Miami, Neocis is venture-backed with funding from Mirae Asset Financial Group, NVentures, Intuitive Ventures, DFJ Growth, Mithril Capital Management, Norwest Venture Partners, Vivo Capital, Section 32, and surgical robotics pioneer Fred Moll. For more information, visit neocis.com.

Contact
For more information, please contact the Neocis media relations team at info@neocis.com.

Raphael Pharmaceutical Announces Filing of Provisional Patent Application for the Treatment of Neutrophil-Dominant Autoimmune Diseases, Including Rheumatoid Arthritis (RA)

Raphael Pharmaceutical Announces Filing of Provisional Patent Application for the Treatment of Neutrophil-Dominant Autoimmune Diseases, Including Rheumatoid Arthritis (RA)




Raphael Pharmaceutical Announces Filing of Provisional Patent Application for the Treatment of Neutrophil-Dominant Autoimmune Diseases, Including Rheumatoid Arthritis (RA)

NEW YORK, Nov. 17, 2025 (GLOBE NEWSWIRE) — Raphael Pharmaceutical Inc. (“Raphael Pharmaceutical” or the “Company”) (OTCQB: RAPH), a clinical-stage biotechnology company developing an innovative research platform based on cannabinoids free of THC and CBD, today announced the filing of a provisional patent application with the United States Patent and Trademark Office.

The application covers the use of the Company’s highly purified cannabinoid-based technology platform in the treatment of neutrophil-dominant autoimmune diseases, including its lead product candidate for rheumatoid arthritis (RA), as well as psoriatic arthritis, inflammatory bowel disease, systemic lupus erythematosus with neutrophil involvement, and gout.

Raphael previously announced positive proof-of-concept clinical study results for its cannabinoid-based formula for the management of RA. The study was successfully completed in the United States under Institutional Review Board (“IRB”) approval and in compliance with U.S. Food and Drug Administration (“FDA”) regulations. No adverse effects were reported throughout the trial.

The provisional patent application, titled, “Raphael Pharmaceutical, Inc. / Rambam MedTech Formula for Treating Neutrophil-Dominant Autoimmune Diseases (including RA)” (No. 63/911,729), was filed jointly with the Medical Cannabis Research and Innovation Center (MCRIC) at Rambam Health Care Campus – one of the world’s leading university hospitals.

Raphael and Rambam have collaborated under a sponsored research agreement signed in 2019, granting Raphael exclusive access to Rambam’s world-class cannabinoid research and development program, led by Dr. Igal Louria-Hayon, who serves as both Chief Technology Officer (CTO) of Raphael and Head of the Medical Cannabis Research and Innovation Center at Rambam Health Care Campus.

Dr. Louria-Hayon is a global expert in cannabinoid research and cell-to-cell communication.  

“The filing of this provisional patent application represents a major milestone for Raphael and our partner Rambam,” said Shlomi Pilo, President and CEO of Raphael Pharmaceutical. “It is a critical step forward in protecting our innovative cannabinoid-based technology platform and moving toward the initial launch of our commercial product “RaphaWell,” which is designed for targeted, orally accessible delivery to patients within the RA community in the U.S.”

Dr. Louria-Hayon added, “Based on our research to date, we believe Raphael Pharmaceutical’s proprietary formula has the potential to offer a safe and cost-effective option that significantly reduces inflammation, and severe symptoms for millions of people suffering from rheumatoid arthritis.   As reflected in the scope of the provisional patent, we also believe this highly purified cannabinoid platform may have broader applications in other chronic inflammatory conditions.”

Key Findings from the Proof-of-Concept Clinical Study

Raphael Pharmaceutical utilizes a highly purified cannabinoid formulation derived from the hemp plant, entirely free of psychoactive cannabis components, with exceptional anti-inflammatory potential.

The formulation is administered orally and demonstrated no side effects.

It is designed to interact with the human endocannabinoid system by activating cannabinoid receptors expressed on immune cells.

In 2025, the Company announced positive Proof-of-Concept clinical results for the use of its cannabinoid-based formula in the treatment of RA.

The eight-week IRB-approved study conducted in the United States showed significant improvements in pain, sleep quality, and overall well-being, which became evident as early as week four and persisted through the end of the trial.

This included a reduction in DAS28 scores from high disease activity to moderate disease severity.

About Raphael Pharmaceutical Inc.

Raphael Pharmaceutical Inc. (“Raphael”) (OTCQB: RAPH) is a clinical-stage biotechnology company focused on developing an innovative research platform based on THC-free and CBD-free cannabinoids for the treatment of inflammatory diseases.   The Company’s lead product candidate, RaphaWell, is a highly purified non-psychoactive cannabinoid formulation developed for targeted, orally accessible delivery to patients, designed specifically for the treatment of rheumatoid arthritis, with no reported side effects.

For more information, please visit: https://www.raphaelpharmaceutical.com/

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.   These statements are based on current expectations, assumptions, and projections about the Company’s business and are not guarantees of future performance.   Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond the Company’s control, that could cause actual results to differ materially from those expressed or implied herein.   Additional information about the risks facing the Company’s business is available in its most recent Annual Report on Form 10-K and subsequent filings on Forms 10-Q and 8-K with the U.S. Securities and Exchange Commission (SEC).   Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. The Company undertakes no obligation to update or revise any forward-looking statements, except as required by applicable law.

Investor Contact:

The Equity Group        
Devin Sullivan
Managing Director                
T: (212) 836-9608        
dsullivan@theequitygroup.com

Conor Rodriguez
Associate        
T: (212) 836-9628        
crodriguez@theequitygroup.com

OSE Immunotherapeutics Announces Positive Recommendation from Independent Data Monitoring Committee (IDMC) to Continue Pivotal Phase 3 ARTEMIA Trial Evaluating Tedopi® in Non-Small Cell Lung Cancer

OSE Immunotherapeutics Announces Positive Recommendation from Independent Data Monitoring Committee (IDMC) to Continue Pivotal Phase 3 ARTEMIA Trial Evaluating Tedopi® in Non-Small Cell Lung Cancer




OSE Immunotherapeutics Announces Positive Recommendation from Independent Data Monitoring Committee (IDMC) to Continue Pivotal Phase 3 ARTEMIA Trial Evaluating Tedopi® in Non-Small Cell Lung Cancer

OSE Immunotherapeutics Announces Positive Recommendation from Independent Data Monitoring Committee (IDMC) to Continue Pivotal Phase 3 ARTEMIA Trial Evaluating Tedopi® in Non-Small Cell Lung Cancer

NANTES, France, November 17, 2025 – 6:00pm CET – OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE), a clinical-stage biotechnology company developing immunotherapies for cancer and autoimmune diseases, today announced that the Independent Data Monitoring Committee (IDMC) overseeing the Company’s international pivotal Phase 3 clinical trial, ARTEMIA, evaluating Tedopi® in non-small cell lung cancer (NSCLC), has issued a positive recommendation to continue the study without modifications.

As outlined in the study protocol of ARTEMIA, the IDMC meets on a regular basis to review data from the ongoing trial. The IDMC is a group of independent experts including one US and one European lung cancer expert and an independent statistician who are external to the study. Their role is to assess the progress, safety data and critical efficacy endpoints of the clinical trial for safeguarding the interest of study participants. The IDMC provides the sponsor and the Steering committee with recommendations regarding study modification, continuation or termination. IDMCs are customary for large, randomized, multi-site studies, such as ARTEMIA.

Dr. Silvia Comis, Chief Clinical and Medical Research Officer at OSE Immunotherapeutic, said. “We are very pleased with the IDMC’s recommendation to continue our Phase 3 trial without changes. As of early October, date of the IDMC meeting, 102 patients had been randomized in the trial. We are now approaching 120, fully aligned with our enrollment projections for 2025.”

The ARTEMIA trial was launched in September 2024 and is designed to compare Tedopi® monotherapy to standard-of-care docetaxel in HLA-A2 positive patients with metastatic NSCLC who have developed secondary resistance to immune checkpoint inhibitors. The study is being conducted across multiple international sites in Europe, UK, USA and Canada and aims to provide confirmatory data to support regulatory submission.

A second IDMC review is anticipated in Q1 2026. Completion of recruitment in the ARTEMIA trial is foreseen for end of 2026, with readout for primary endpoint of overall survival in Q1 2028.

ABOUT OSE IMMUNOTHERAPEUTICS
OSE Immunotherapeutics is a biotech company dedicated to developing first-in-class assets in immuno-oncology (IO) and immuno-inflammation (I&I) that address the unmet patient needs of today and tomorrow. We partner with leading academic institutions and biopharmaceutical companies in our efforts to develop and bring to the market transformative medicines for people with serious diseases. OSE Immunotherapeutics is based between Nantes and Paris and is quoted on Euronext.
Additional information about OSE Immunotherapeutics assets is available on the Company’s website: www.ose-immuno.com. Follow us on LinkedIn.

Contacts

Fiona Olivier
fiona.olivier@ose-immuno.com

Sylvie Détry
sylvie.detry@ose-immuno.com

French Media Contact
FP2COM
Florence Portejoie
fportejoie@fp2com.fr
+33 6 07 768 283
U.S. Media Contact
Rooney Partners LLC
Kate Barrette
kbarrette@rooneypartners.com
+1 212 223 0561

Forward-looking statements
This press release contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics’ management considering its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate.

These forward-looking statements include statements typically using conditional and containing verbs such as “expect”, “anticipate”, “believe”, “target”, “plan”, or “estimate”, their declensions and conjugations and words of similar import. Although the OSE Immunotherapeutics management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics’ shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which are difficult to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed in or implied or projected by the forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with the AMF. Such forward-looking statements are not guarantees of future performance. This press release includes only summary information and should be read with the OSE Immunotherapeutics Universal Registration Document filed with the AMF on April 30, 2025, including the annual financial report for the fiscal year 2024, available on the OSE Immunotherapeutics’ website. Other than as required by applicable law, OSE Immunotherapeutics issues this press release at the date hereof and does not undertake any obligation to update or revise the forward-looking information or statements.

Attachment

Raphael Pharmaceutical Announces Filing of Provisional Patent Application for the Treatment of Neutrophil-Dominant Autoimmune Diseases, Including Rheumatoid Arthritis (RA)

Raphael Pharmaceutical Announces Filing of Provisional Patent Application for the Treatment of Neutrophil-Dominant Autoimmune Diseases, Including Rheumatoid Arthritis (RA)




Raphael Pharmaceutical Announces Filing of Provisional Patent Application for the Treatment of Neutrophil-Dominant Autoimmune Diseases, Including Rheumatoid Arthritis (RA)

NEW YORK, Nov. 17, 2025 (GLOBE NEWSWIRE) — Raphael Pharmaceutical Inc. (“Raphael Pharmaceutical” or the “Company”) (OTCQB: RAPH), a clinical-stage biotechnology company developing an innovative research platform based on cannabinoids free of THC and CBD, today announced the filing of a provisional patent application with the United States Patent and Trademark Office.

The application covers the use of the Company’s highly purified cannabinoid-based technology platform in the treatment of neutrophil-dominant autoimmune diseases, including its lead product candidate for rheumatoid arthritis (RA), as well as psoriatic arthritis, inflammatory bowel disease, systemic lupus erythematosus with neutrophil involvement, and gout.

Raphael previously announced positive proof-of-concept clinical study results for its cannabinoid-based formula for the management of RA. The study was successfully completed in the United States under Institutional Review Board (“IRB”) approval and in compliance with U.S. Food and Drug Administration (“FDA”) regulations. No adverse effects were reported throughout the trial.

The provisional patent application, titled, “Raphael Pharmaceutical, Inc. / Rambam MedTech Formula for Treating Neutrophil-Dominant Autoimmune Diseases (including RA)” (No. 63/911,729), was filed jointly with the Medical Cannabis Research and Innovation Center (MCRIC) at Rambam Health Care Campus – one of the world’s leading university hospitals.

Raphael and Rambam have collaborated under a sponsored research agreement signed in 2019, granting Raphael exclusive access to Rambam’s world-class cannabinoid research and development program, led by Dr. Igal Louria-Hayon, who serves as both Chief Technology Officer (CTO) of Raphael and Head of the Medical Cannabis Research and Innovation Center at Rambam Health Care Campus.

Dr. Louria-Hayon is a global expert in cannabinoid research and cell-to-cell communication.  

“The filing of this provisional patent application represents a major milestone for Raphael and our partner Rambam,” said Shlomi Pilo, President and CEO of Raphael Pharmaceutical. “It is a critical step forward in protecting our innovative cannabinoid-based technology platform and moving toward the initial launch of our commercial product “RaphaWell,” which is designed for targeted, orally accessible delivery to patients within the RA community in the U.S.”

Dr. Louria-Hayon added, “Based on our research to date, we believe Raphael Pharmaceutical’s proprietary formula has the potential to offer a safe and cost-effective option that significantly reduces inflammation, and severe symptoms for millions of people suffering from rheumatoid arthritis.   As reflected in the scope of the provisional patent, we also believe this highly purified cannabinoid platform may have broader applications in other chronic inflammatory conditions.”

Key Findings from the Proof-of-Concept Clinical Study

Raphael Pharmaceutical utilizes a highly purified cannabinoid formulation derived from the hemp plant, entirely free of psychoactive cannabis components, with exceptional anti-inflammatory potential.

The formulation is administered orally and demonstrated no side effects.

It is designed to interact with the human endocannabinoid system by activating cannabinoid receptors expressed on immune cells.

In 2025, the Company announced positive Proof-of-Concept clinical results for the use of its cannabinoid-based formula in the treatment of RA.

The eight-week IRB-approved study conducted in the United States showed significant improvements in pain, sleep quality, and overall well-being, which became evident as early as week four and persisted through the end of the trial.

This included a reduction in DAS28 scores from high disease activity to moderate disease severity.

About Raphael Pharmaceutical Inc.

Raphael Pharmaceutical Inc. (“Raphael”) (OTCQB: RAPH) is a clinical-stage biotechnology company focused on developing an innovative research platform based on THC-free and CBD-free cannabinoids for the treatment of inflammatory diseases.   The Company’s lead product candidate, RaphaWell, is a highly purified non-psychoactive cannabinoid formulation developed for targeted, orally accessible delivery to patients, designed specifically for the treatment of rheumatoid arthritis, with no reported side effects.

For more information, please visit: https://www.raphaelpharmaceutical.com/

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.   These statements are based on current expectations, assumptions, and projections about the Company’s business and are not guarantees of future performance.   Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond the Company’s control, that could cause actual results to differ materially from those expressed or implied herein.   Additional information about the risks facing the Company’s business is available in its most recent Annual Report on Form 10-K and subsequent filings on Forms 10-Q and 8-K with the U.S. Securities and Exchange Commission (SEC).   Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. The Company undertakes no obligation to update or revise any forward-looking statements, except as required by applicable law.

Investor Contact:

The Equity Group        
Devin Sullivan
Managing Director                
T: (212) 836-9608        
dsullivan@theequitygroup.com

Conor Rodriguez
Associate        
T: (212) 836-9628        
crodriguez@theequitygroup.com

OSE Immunotherapeutics Announces Positive Recommendation from Independent Data Monitoring Committee (IDMC) to Continue Pivotal Phase 3 ARTEMIA Trial Evaluating Tedopi® in Non-Small Cell Lung Cancer

OSE Immunotherapeutics Announces Positive Recommendation from Independent Data Monitoring Committee (IDMC) to Continue Pivotal Phase 3 ARTEMIA Trial Evaluating Tedopi® in Non-Small Cell Lung Cancer




OSE Immunotherapeutics Announces Positive Recommendation from Independent Data Monitoring Committee (IDMC) to Continue Pivotal Phase 3 ARTEMIA Trial Evaluating Tedopi® in Non-Small Cell Lung Cancer

OSE Immunotherapeutics Announces Positive Recommendation from Independent Data Monitoring Committee (IDMC) to Continue Pivotal Phase 3 ARTEMIA Trial Evaluating Tedopi® in Non-Small Cell Lung Cancer

NANTES, France, November 17, 2025 – 6:00pm CET – OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE), a clinical-stage biotechnology company developing immunotherapies for cancer and autoimmune diseases, today announced that the Independent Data Monitoring Committee (IDMC) overseeing the Company’s international pivotal Phase 3 clinical trial, ARTEMIA, evaluating Tedopi® in non-small cell lung cancer (NSCLC), has issued a positive recommendation to continue the study without modifications.

As outlined in the study protocol of ARTEMIA, the IDMC meets on a regular basis to review data from the ongoing trial. The IDMC is a group of independent experts including one US and one European lung cancer expert and an independent statistician who are external to the study. Their role is to assess the progress, safety data and critical efficacy endpoints of the clinical trial for safeguarding the interest of study participants. The IDMC provides the sponsor and the Steering committee with recommendations regarding study modification, continuation or termination. IDMCs are customary for large, randomized, multi-site studies, such as ARTEMIA.

Dr. Silvia Comis, Chief Clinical and Medical Research Officer at OSE Immunotherapeutic, said. “We are very pleased with the IDMC’s recommendation to continue our Phase 3 trial without changes. As of early October, date of the IDMC meeting, 102 patients had been randomized in the trial. We are now approaching 120, fully aligned with our enrollment projections for 2025.”

The ARTEMIA trial was launched in September 2024 and is designed to compare Tedopi® monotherapy to standard-of-care docetaxel in HLA-A2 positive patients with metastatic NSCLC who have developed secondary resistance to immune checkpoint inhibitors. The study is being conducted across multiple international sites in Europe, UK, USA and Canada and aims to provide confirmatory data to support regulatory submission.

A second IDMC review is anticipated in Q1 2026. Completion of recruitment in the ARTEMIA trial is foreseen for end of 2026, with readout for primary endpoint of overall survival in Q1 2028.

ABOUT OSE IMMUNOTHERAPEUTICS
OSE Immunotherapeutics is a biotech company dedicated to developing first-in-class assets in immuno-oncology (IO) and immuno-inflammation (I&I) that address the unmet patient needs of today and tomorrow. We partner with leading academic institutions and biopharmaceutical companies in our efforts to develop and bring to the market transformative medicines for people with serious diseases. OSE Immunotherapeutics is based between Nantes and Paris and is quoted on Euronext.
Additional information about OSE Immunotherapeutics assets is available on the Company’s website: www.ose-immuno.com. Follow us on LinkedIn.

Contacts

Fiona Olivier
fiona.olivier@ose-immuno.com

Sylvie Détry
sylvie.detry@ose-immuno.com

French Media Contact
FP2COM
Florence Portejoie
fportejoie@fp2com.fr
+33 6 07 768 283
U.S. Media Contact
Rooney Partners LLC
Kate Barrette
kbarrette@rooneypartners.com
+1 212 223 0561

Forward-looking statements
This press release contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics’ management considering its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate.

These forward-looking statements include statements typically using conditional and containing verbs such as “expect”, “anticipate”, “believe”, “target”, “plan”, or “estimate”, their declensions and conjugations and words of similar import. Although the OSE Immunotherapeutics management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics’ shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which are difficult to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed in or implied or projected by the forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with the AMF. Such forward-looking statements are not guarantees of future performance. This press release includes only summary information and should be read with the OSE Immunotherapeutics Universal Registration Document filed with the AMF on April 30, 2025, including the annual financial report for the fiscal year 2024, available on the OSE Immunotherapeutics’ website. Other than as required by applicable law, OSE Immunotherapeutics issues this press release at the date hereof and does not undertake any obligation to update or revise the forward-looking information or statements.

Attachment

New therapeutic approach to facilitate healing of bed sores

New therapeutic approach to facilitate healing of bed sores




New therapeutic approach to facilitate healing of bed sores

Researchers from UBC and Vancouver Coastal Health are developing natural plant compounds into a healing gel that could speed up recovery and prevent wounds from returning

VANCOUVER, British Columbia, Nov. 17, 2025 (GLOBE NEWSWIRE) — Every day in hospitals and long-term care homes, people with limited mobility develop painful pressure injuries, commonly known as bed sores. These wounds heal slowly and often reoccur in the same spot. Researchers from the University of British Columbia (UBC) and Vancouver Coastal Health are now creating a topical, plant-based gel that could help these chronic wounds heal faster with improved strength to prevent recurrence.

Led by Dr. David Granville (Professor, UBC Faculty of Medicine) and Heather Mak (Executive Director, Vancouver Coastal Health), the project is funded through Genome British Columbia’s (Genome BC) Genesolve program with support from viDA Therapeutics Inc. The team is working to develop natural compounds already approved by Health Canada into a clinically ready treatment that could move more quickly from the lab to the bedside.

Tackling a Growing Health Challenge

“Non-healing wounds are a silent epidemic,” said Dr. Granville. “Patients may suffer for many months with sores that never fully heal. And if they do heal, the healed wound is usually much weaker leaving it prone to tearing or further injury. By using safe, plant-derived compounds that block the enzyme responsible for this damage, we hope to restore the skin’s ability to repair itself and help people heal permanently.”

Pressure injuries are among the most common wounds encountered in healthcare. They develop when prolonged pressure on the skin, such as lying or sitting in one position for too long, disrupts blood flow and damages tissue. The resulting ulcers can result in significant pain, infection and a loss of independence, especially among older adults and those with limited mobility. British Columbia’s aging population means these injuries are becoming an even greater challenge for hospitals and care homes.

The Science Behind the Solution

Dr. Granville’s lab found that a protein called Granzyme B, an enzyme that cuts other proteins like scissors, accumulates in aging skin and slow-healing wounds. As its levels rise, the enzyme eats away at key structural proteins in the skin and hinders healing. By blocking Granzyme B with natural, plant-based compounds, the researchers believe that wounds will heal quicker and more completely, lowering the risk of reopening.

The team will test three Health Canada-approved compounds in topical gels using a standard model of pressure injury. Their results will form the basis for clinical trials and future healthcare use.

“Chronic wounds take a huge toll on patients, caregivers and the healthcare system,” said Dr. Heather Mak, Executive Director, Professional Practice and Education, Nursing, Vancouver Coastal Health. “By combining clinical insight with discovery research, we’re moving toward practical solutions that can improve recovery and quality of life.”

A Made-in-BC Collaboration

The project combines academic research, clinical expertise and biotech innovation. ViDA Therapeutics, a Vancouver-based company co-founded by Dr. Granville and Alistair Duncan, brings its experience developing granzyme inhibitors for age related and inflammatory conditions. The partners aim to translate these findings into a scalable, manufacturable gel that could be ready for clinician-sponsored trials as early as 2027.

“This project embodies what our Genesolve program was created to do: turn cutting edge discoveries into tangible health benefits,” said Dr. Federica Di Palma, Chief Scientific Officer and Vice President, Research and Innovation at Genome BC. “In this case, delivering real benefits to the healthcare system and patients.”

About the Genesolve Program

Genome BC’s Genesolve program supports translational research that bridges discovery and application in British Columbia’s life sciences sector. By connecting researchers, healthcare providers and industry partners, Genesolve accelerates the development of genomic innovations with real-world impact.

About Genome British Columbia:

Genome BC is a not-for-profit organization that has advanced genomics research and innovation for 25 years, growing a world-class life sciences sector in BC and delivering sustainable benefits for British Columbia, Canada and beyond. Genome BC has attracted over $1.1 billion in direct co-investment to the province, which has contributed to funding more than 600 genomics research and innovation projects. These initiatives enhance healthcare and address environmental and natural resource challenges, improving the lives of British Columbians. Genome BC also integrates genomics into society by supporting responsible research and innovation and fostering an understanding and appreciation of the life sciences among educators, students and the public. www.genomebc.ca

Contact:

Brad Lyle, Communications Manager, Genome BC
blyle@genomebc.ca
778.999.8195

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/3df4012c-3ac5-43c2-aae5-3c2daa35451f

New therapeutic approach to facilitate healing of bed sores

New therapeutic approach to facilitate healing of bed sores




New therapeutic approach to facilitate healing of bed sores

Researchers from UBC and Vancouver Coastal Health are developing natural plant compounds into a healing gel that could speed up recovery and prevent wounds from returning

VANCOUVER, British Columbia, Nov. 17, 2025 (GLOBE NEWSWIRE) — Every day in hospitals and long-term care homes, people with limited mobility develop painful pressure injuries, commonly known as bed sores. These wounds heal slowly and often reoccur in the same spot. Researchers from the University of British Columbia (UBC) and Vancouver Coastal Health are now creating a topical, plant-based gel that could help these chronic wounds heal faster with improved strength to prevent recurrence.

Led by Dr. David Granville (Professor, UBC Faculty of Medicine) and Heather Mak (Executive Director, Vancouver Coastal Health), the project is funded through Genome British Columbia’s (Genome BC) Genesolve program with support from viDA Therapeutics Inc. The team is working to develop natural compounds already approved by Health Canada into a clinically ready treatment that could move more quickly from the lab to the bedside.

Tackling a Growing Health Challenge

“Non-healing wounds are a silent epidemic,” said Dr. Granville. “Patients may suffer for many months with sores that never fully heal. And if they do heal, the healed wound is usually much weaker leaving it prone to tearing or further injury. By using safe, plant-derived compounds that block the enzyme responsible for this damage, we hope to restore the skin’s ability to repair itself and help people heal permanently.”

Pressure injuries are among the most common wounds encountered in healthcare. They develop when prolonged pressure on the skin, such as lying or sitting in one position for too long, disrupts blood flow and damages tissue. The resulting ulcers can result in significant pain, infection and a loss of independence, especially among older adults and those with limited mobility. British Columbia’s aging population means these injuries are becoming an even greater challenge for hospitals and care homes.

The Science Behind the Solution

Dr. Granville’s lab found that a protein called Granzyme B, an enzyme that cuts other proteins like scissors, accumulates in aging skin and slow-healing wounds. As its levels rise, the enzyme eats away at key structural proteins in the skin and hinders healing. By blocking Granzyme B with natural, plant-based compounds, the researchers believe that wounds will heal quicker and more completely, lowering the risk of reopening.

The team will test three Health Canada-approved compounds in topical gels using a standard model of pressure injury. Their results will form the basis for clinical trials and future healthcare use.

“Chronic wounds take a huge toll on patients, caregivers and the healthcare system,” said Dr. Heather Mak, Executive Director, Professional Practice and Education, Nursing, Vancouver Coastal Health. “By combining clinical insight with discovery research, we’re moving toward practical solutions that can improve recovery and quality of life.”

A Made-in-BC Collaboration

The project combines academic research, clinical expertise and biotech innovation. ViDA Therapeutics, a Vancouver-based company co-founded by Dr. Granville and Alistair Duncan, brings its experience developing granzyme inhibitors for age related and inflammatory conditions. The partners aim to translate these findings into a scalable, manufacturable gel that could be ready for clinician-sponsored trials as early as 2027.

“This project embodies what our Genesolve program was created to do: turn cutting edge discoveries into tangible health benefits,” said Dr. Federica Di Palma, Chief Scientific Officer and Vice President, Research and Innovation at Genome BC. “In this case, delivering real benefits to the healthcare system and patients.”

About the Genesolve Program

Genome BC’s Genesolve program supports translational research that bridges discovery and application in British Columbia’s life sciences sector. By connecting researchers, healthcare providers and industry partners, Genesolve accelerates the development of genomic innovations with real-world impact.

About Genome British Columbia:

Genome BC is a not-for-profit organization that has advanced genomics research and innovation for 25 years, growing a world-class life sciences sector in BC and delivering sustainable benefits for British Columbia, Canada and beyond. Genome BC has attracted over $1.1 billion in direct co-investment to the province, which has contributed to funding more than 600 genomics research and innovation projects. These initiatives enhance healthcare and address environmental and natural resource challenges, improving the lives of British Columbians. Genome BC also integrates genomics into society by supporting responsible research and innovation and fostering an understanding and appreciation of the life sciences among educators, students and the public. www.genomebc.ca

Contact:

Brad Lyle, Communications Manager, Genome BC
blyle@genomebc.ca
778.999.8195

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/3df4012c-3ac5-43c2-aae5-3c2daa35451f