24/7 Market News- Kraig Labs Breakthrough Science is Pivoting to Scalable Business




24/7 Market News- Kraig Labs Breakthrough Science is Pivoting to Scalable Business

How Decades of Innovation Are Converging for Commercial Spider Silk Success

DENVER, Dec. 10, 2025 (GLOBE NEWSWIRE) — 247marketnews.com, a pioneer in digital media dedicated to the swift distribution of financial market news and information, reports that Kraig Biocraft Laboratories (OTCQB: KBLB)(“the Company”, “Kraig”, “Kraig Labs”), the undisputed global leader in the development and commercialization of spider silk, is entering a defining phase in its corporate and scientific evolution.

What began as a bold idea by Kim Thompson, Kraig’s founder and CEO, more than a decade ago, is now maturing into a viable business model blending genetic engineering, biotechnology, and commercial textile manufacturing. Kraig Labs’ journey, from acquiring key patent rights abandoned by a failed predecessor to developing proprietary gene-insertion protocols and delivering advanced materials for the U.S. Army, highlights how persistence and innovation can transform a visionary concept into a tangible, scalable technology.

From Nexia’s Collapse to Kraig’s Breakthrough

In the early 2000s, Nexia Biotechnologies spent more than $110 million attempting to mass-produce spider silk proteins using goats and bacterial systems. The idea was compelling, but the results were not. When Nexia’s model collapsed, Thompson strategically acquired the license to key patents from the University of Wyoming after Nexia Biotechnologies, the Canadian firm burned through its funding without achieving commercial viability. This acquisition provided KBLB with foundational spider silk gene sequences, but the real breakthrough came through Thompson’s vision to combine them with cutting-edge genetic engineering, establishing the Company as the world’s first to viable solution to produce recombinant spider silk at industrial scale in a $200 billion technical textiles market (5.2% CAGR to 2030, Grand View Research).

Rather than using mammals or fermentation vats, Thompson envisioned leveraging one of nature’s most efficient silk producers: the silkworm. His insight was simple but revolutionary, insert spider silk DNA into silkworms so that they could spin the protein naturally, at industrial scale.

Collaboration with the University of Notre Dame: PiggyBac Technology and the Birth of a Platform

To execute that vision, Kraig Labs entered into a pivotal collaboration with the University of Notre Dame, where scientists utilized PiggyBac transposon gene-insertion technology, a tool that allows integration of foreign genes into host organisms. Using PiggyBac, Kraig and Notre Dame successfully created the world’s first transgenic silkworms capable of spinning recombinant spider silk in 2010.

That collaboration led to the creation of the Dragon Silk™ line, a hybrid fiber blending the elasticity and strength of spider silk with the processability of silkworm silk. Building on these early successes, Kraig Labs then developed its own proprietary genetic protocols, expanding beyond PiggyBac into advanced editing systems tailored specifically for its production needs.

Scientific Milestones and Military Collaboration

Kraig Labs’ spider silk has since evolved through multiple generations of material advancements, including:

• Monster Silk® – the company’s first commercially viable hybrid fiber.
• Dragon Silk™ – developed for enhanced toughness and durability.
• BAM-1 and Next-Generation Hybrids – the latest fibers optimized for strength, flexibility, and yield in production environments.

From Lab to Market: Building the Business Model

After years of R&D validation, Kraig Labs shifted its focus toward commercial scalability, establishing rearing and production operations in Asia to leverage existing sericulture infrastructure. The Company now operates multiple production centers, each capable of sustaining overlapping rearing cycles to ensure continuous fiber output.

With these facilities running concurrently, Kraig Labs has entered a new phase, moving from prototype to production.

A Long Road to a New Industry

Unlike the efforts that rode on its coattails, Kraig Labs’ efforts to bring spider silk to market was never about chasing hype, it was always about solving one of nature’s hardest engineering challenges and then about bringing the resulting technological breakthroughs to market.

So many competitors walked away, after burning through eight and nine-figure budgets and realizing creating usable spider silk is nearly impossible, as Kraig Labs developed new genetics and new production methods that turned decades of failed theory into a scalable reality.

Key Milestones in Kraig Labs’ Evolution

• 2006–2008: Kraig Biocraft Laboratories founded; acquisition of spider silk-related patents from Nexia Biotechnologies.
• 2009–2012: Collaboration with the University of Notre Dame yields first transgenic silkworms using PiggyBac technology.
• 2016: U.S. Army awards Kraig Labs a contract to develop ballistic “shoot packs” using Dragon Silk.
• 2018–2022: Monster Silk® and Dragon Silk™ commercial validation efforts expand; production trials begin in Vietnam.
• 2023–2025: Kraig Labs opens new hybrid breeding facilities; achieves largest production runs in company history; expands to dual-facility operations.

Looking Ahead: Commercialization and Global Opportunity

With advanced genetics, and a growing production base, Kraig Labs is positioning itself at the forefront of the bio-materials revolution. The Company’s recombinant spider silk platform is designed for applications across performance textiles, defense, luxury goods, and industrial composites; potential multi-billion-dollar market opportunities.

As 2025 draws to a close, Kraig Biocraft Laboratories stands as a rare biotech success story, a company that not only persisted through two decades of scientific and economic challenges but now appears poised to redefine the materials industry itself.

For more information about Kraig Labs’ spider silk technology and partnership opportunities, visit www.kraiglabs.com

Please click here to read the full Kraig Labs analyst report on 247marketnews.com.

About Kraig Biocraft Laboratories, Inc.

Kraig Biocraft Laboratories, Inc. (OTCQB: KBLB) is a biotechnology company focused on the development and commercialization of spider silk-based fiber technologies. Through its proprietary silkworm-based genetic engineering platform, Kraig Labs produces high-performance, cost-effective, and scalable spider silk materials for use in defense, performance apparel, technical textiles, and medical applications.

For more information, please visit: www.kraiglabs.com

Contact sales@247marketnews.com for Analyst Report coverage and other investor/public relations services.

About 24/7 Market News

24/7 Market News (247) is a leading market news platform for public companies. As a pioneer in digital media, 247 is dedicated to the swift distribution of financial market news and information. 247 takes great pride in creating innovative public relations campaigns that help clients reach the target audience.

PAID EDITORIAL DISCLOSURE: This is a paid editorial communication intended for informational purposes only. 247 is a third-party media provider and has been compensated for providing ongoing KBLB market outreach and other services. This press release may include technical analysis and should not be construed as financial or investment advice. Trading stocks involves risks, and readers should consult with their financial advisor before making investment decisions. Please review 247’s Full Disclaimer https://www.247marketnews.com/disclaimer/. Please go to https://247marketnews.com/kblb-disclosure/ for further KBLB and 247marketnews.com disclosure information.

CONTACT:
24/7 Market News
Editor@247marketnews.com

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements that are subject to various risks and uncertainties. Such statements include statements regarding the Company’s ability to grow its business and other statements that are not historical facts, including statements which may be accompanied by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Actual results could differ materially from those described in these forward-looking statements due to a number of factors, including without limitation, the Company’s ability to continue as a going concern, general economic conditions, and other risk factors detailed in the Company’s filings with the SEC. The forward-looking statements contained in this press release are made as of the date of this press release, and the Company does not undertake any responsibility to update such forward-looking statements except in accordance with applicable law.

SCIENTURE and BlinkRx Announce Strategic Collaboration to Expand Patient Access to Arbli™, the First FDA-Approved Ready-to-Use Oral Suspension of Losartan Potassium




SCIENTURE and BlinkRx Announce Strategic Collaboration to Expand Patient Access to Arbli™, the First FDA-Approved Ready-to-Use Oral Suspension of Losartan Potassium

U.S. Losartan market totals $245M annually with 71M prescriptions 

COMMACK, NY, Dec. 10, 2025 (GLOBE NEWSWIRE) — SCIENTURE HOLDINGS, INC. (NASDAQ: SCNX), a holding company for existing and planned pharmaceutical operating companies focused on providing enhanced value to patients, physicians and caregivers through the development, commercialization, and distribution of novel specialty products that address unmet market needs, and Blink Rx LLC (“BlinkRx”), one of the most advanced patient access platforms for branded medications, today announced a strategic collaboration to expand national access to Arbli^™, the first FDA-approved, ready-to-use oral suspension formulation of losartan potassium. Arbli^™ is expected to be available on the BlinkRx platform in Q1 2026.

BlinkRx holistically orchestrates and automates patient access, support, and delivery across the entire prescription journey. Its platform not only improves accessibility but also elevates the patient experience and drives meaningful health outcomes. With BlinkRx, 52% more patients start therapy and remain on their medication 40% longer as prescribed.

According to IQVIA data (MAT September 2025), the U.S. losartan market totals approximately $245 million in annual sales, with over 71 million prescriptions written each year. With Arbli^™, Scienture is positioned to address this significant commercial opportunity while fulfilling an unmet need for millions of patients requiring alternative dosage formats.

“Arbli^™ represents a meaningful advancement for patients who need a ready-to-use oral suspension of losartan potassium,” commented Narasimhan Mani, President and co-CEO of Scienture. “BlinkRx removes friction in the patient journey, from reducing administrative barriers and accelerating therapy initiation to improving adherence, which translates into greater prescription volume, longer duration on therapy, lower access costs, and broader patient affordability and reach.”

“This collaboration reflects our shared commitment to affordability, access, and sustained therapeutic benefit,” stated Shankar Hariharan, Executive Chairman and co-CEO of Scienture. “Our goal has always been to deliver accessible, patient-centric therapies. Partnering with BlinkRx ensures that more people can start treatment without unnecessary delays or barriers.”

Geoffrey Chaiken, CEO of Blink Health, Inc., the parent company of BlinkRx, added, “We are proud to support Scienture in expanding access to Arbli^™. Losartan is widely prescribed across the U.S. and offering a ready-to-use oral suspension helps meet an important medical need. BlinkRx’s platform will ensure patients can start therapy sooner, stay supported throughout treatment, and experience improved outcomes.”

About Arbli^™

Arbli^™ is a novel proprietary formulation of losartan, a widely prescribed angiotensin receptor blocker (ARB) for hypertension. It is the first and only liquid formulation of losartan on the market that does not require compounding and has reduced dosing volume and long-term shelf life at room temperature storage. Arbli^™ is FDA-approved for the treatment of hypertension in patients greater than six years old, for reducing the risk of stroke in patients with hypertension and left ventricular hypertrophy, and for treating diabetic nephropathy in certain patients with type 2 diabetes. By offering a safe, effective, and convenient liquid alternative, Arbli^™ provides a tailored solution for patients who require or prefer a liquid formulation. As an FDA-approved product, Arbli^™ provides consistent quality and dosing accuracy, addressing the risks and inconsistencies often associated with extemporaneously compounded losartan prescriptions. Arbli^™ has two issued patents from the USPTO, which are also listed in the FDA Orangebook.

Arbli^™ is the first and only oral liquid formulation of losartan approved by the U.S. FDA. Arbli^™ comes in a 165 mL bottle as a peppermint flavored suspension that does not require refrigeration, and has been approved for a shelf life of 24 months from the date of manufacture when stored at room temperature.

INDICATION

Arbli^™ is an angiotensin II receptor blocker (ARB) indicated for:

• Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
• Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy.
• Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension.

IMPORTANT SAFETY INFORMATION

• Do not take Arbli^™ when pregnant. When pregnancy is detected, discontinue Arbli^™ as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. Arbli^™ can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death.
• Do not co-administer Arbli^™ with aliskiren in patients with diabetes. Avoid use of aliskiren with Arbli^™ in patients with renal impairment (GFR <60 mL/min).
• Do not administer Arbli^™ in patients with severe hepatic impairment. Arbli^™ has not been studied in patients with severe hepatic impairment.
• The most common adverse reactions are (incidence ≥2% and greater than placebo): dizziness, upper respiratory infection, nasal congestion, and back pain.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. You may also contact Scienture at 1-833-754-4917.

Please see the full Prescribing Information for complete product information. For more information, talk to your healthcare provider.

About Hypertension

Hypertension (high blood pressure) is a cardiovascular condition, when the pressure in the blood vessels is too high (140/90 mmHg or higher). According to the CDC, hypertension, or high blood pressure, affects nearly half of adults in the United States, or 119.9 million people. Hypertension is defined as a systolic blood pressure of 140 mmHg or higher, and diastolic blood pressure of 90 mmHg or higher. Hypertension is a risk factor for stroke and heart disease, which are leading causes of death in the U.S. Factors that increase the risk of having high blood pressure include: older age, genetics, being overweight or obese, not being physically active, high-salt diet and drinking too much alcohol. Hypertension is clinically diagnosed if, when blood pressure is measured on two different days, the systolic blood pressure readings on both days is ≥140 mmHg and/or the diastolic blood pressure readings on both days is ≥ 90 mmHg.

About Scienture Holdings, Inc.

SCIENTURE HOLDINGS, INC. (NASDAQ: “SCNX”), through its wholly owned subsidiary, Scienture, LLC, is a comprehensive pharmaceutical product company focused on providing enhanced value to patients, physicians and caregivers by offering novel specialty products to satisfy unmet market needs. Scienture, LLC is a branded, specialty pharmaceutical company consisting of a highly experienced team of industry professionals who are passionate about developing and bringing to market unique specialty products that provide enhanced value to patients and healthcare systems. The assets in development at Scienture are across therapeutics areas, indications and cater to different market segments and channels. For more information please visit: www.scientureholdings.com and www.scienture.com.

About BlinkRx

BlinkRx is revolutionizing the pharmacy experience, using cutting-edge technology to dramatically improve patient access for branded medications. Health care providers benefit from dedicated access teams and streamlined prior authorization support for patients. Patients enjoy affordable, transparent pricing, co-pay assistance, free home delivery, and personalized support.

Learn more at www.blinkrx.com.

Cautionary Statements Regarding Forward-Looking Statements

This press release contains certain statements that may be deemed to be “forward-looking statements” within the federal securities laws, including the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Statements that are not historical are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements relate to future events or our future performance or future financial condition. These forward-looking statements are not historical facts, but rather are based on current expectations, estimates and projections about our company, our industry, our beliefs and our assumptions. Such forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future, including for the products we may launch, the success those products may have in the marketplace, and our strategies related to those products. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. In some cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” or the negative of these terms or other similar expressions, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements are subject to a number of risks and uncertainties (some of which are beyond our control) that may cause actual results or performance to be materially different from those expressed or implied by such forward-looking statements. Accordingly, readers should not place undue reliance on any forward-looking statements. These risks include risks relating to agreements with third parties; our ability to raise funding in the future, as needed, and the terms of such funding, including potential dilution caused thereby; our ability to continue as a going concern; security interests under certain of our credit arrangements; our ability to maintain the listing of our common stock on the Nasdaq Capital Market; claims relating to alleged violations of intellectual property rights of others; the outcome of any current legal proceedings or future legal proceedings that may be instituted against us; unanticipated difficulties or expenditures relating to our business plan; and those risks detailed in our most recent Annual Report on Form 10-K and subsequent reports filed with the SEC.

Forward-looking statements speak only as of the date they are made. Scienture Holdings, Inc. undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise that occur after that date, except as otherwise provided by law.

Contact:

SCIENTURE HOLDINGS, INC.
20 Austin Blvd
Commack, NY 11725
Phone: (866) 468-6535
Email: IR@Scienture.com

BlinkRx Contacts
BlinkRx Media Contact:
Dan Dantus
dan.dantus@blinkrx.com
www.blinkrx.com
Blink Health LinkedIn

Ajax Therapeutics Receives Orphan Drug Designation from the U.S. FDA for AJ1-11095 for the Treatment of Myelofibrosis




Ajax Therapeutics Receives Orphan Drug Designation from the U.S. FDA for AJ1-11095 for the Treatment of Myelofibrosis

AJ1-11095 is a first-in-class Type II JAK2 inhibitor currently in a Phase 1 study for the treatment of patients with myelofibrosis, previously treated with a Type I JAK2 inhibitor

NEW YORK and CAMBRIDGE, Mass., Dec. 10, 2025 (GLOBE NEWSWIRE) — Ajax Therapeutics, Inc., a biopharmaceutical company developing next generation JAK inhibitors for patients with myeloproliferative neoplasms (MPNs), today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to AJ1-11095 for the treatment of myelofibrosis, a debilitating blood cancer that affects approximately 20,000 patients in the U.S. AJ1-11095 is the first JAK2 inhibitor to enter the clinic that binds the Type II conformation of the JAK2 kinase, in contrast to all currently approved JAK2 inhibitors that bind the Type I conformation. AJ1-11095 is in an ongoing Phase 1 trial in patients with myelofibrosis who have been previously treated with a Type I JAK2 inhibitor and have either not responded or have lost response (NCT identifier: NCT06343805).

“Orphan Drug Designation is an important milestone in our clinical development of AJ1-11095 for the treatment of myelofibrosis,” said David Steensma, MD, FACP, Chief Medical Officer of Ajax. “This designation reinforces the compelling need for effective new treatment options for patients suffering from myelofibrosis, and supports our continued efforts to advance AJ1-11095 to address the unmet need for patients who would benefit from improved treatment efficacy, or who have not responded to existing therapies.”

About AJ1-11095
AJ1-11095 was designed by Ajax Therapeutics using structure-based drug design and computational methods at scale to selectively bind the Type II conformation of the JAK2 kinase in order to provide greater efficacy with disease modification compared to all currently approved JAK2 inhibitors, including ruxolitinib, which bind the Type I conformation of JAK2. AJ1-11095 has been shown in preclinical studies to reverse marrow fibrosis, reduce mutant allele burden, and maintain efficacy against MPN cells that become resistant to chronic Type I JAK2 inhibition. 

About Myelofibrosis
Myelofibrosis (MF) is a rare blood cancer that affects approximately 20,000 patients in the United States and approximately 26,000 patients in Europe. The disease is characterized by spleen enlargement, scarring (fibrosis) in the bone marrow, progressive anemia, and debilitating symptoms such as fatigue, night sweats, itching, and abdominal discomfort, which can impair a patient’s quality of life. The most widely used treatment for MF patients are Type I JAK2 inhibitors, which can reduce spleen size and provide symptomatic improvement but have little effect on the underlying cause of disease. Over time, most MF patients stop Type I JAK2 inhibitor therapy; the most common causes for treatment discontinuation include a lack of benefit or loss of response, adverse events such as anemia, and disease progression. 

About Ajax Therapeutics
Ajax Therapeutics, Inc. is pursuing uniquely selective approaches to develop novel next generation therapies for myeloproliferative neoplasms (MPNs), including myelofibrosis. By combining the deep cancer and structural biology insights of our founding scientists with the industry’s most advanced computational drug discovery and protein structure platforms, we aim to discover and develop more precisely designed therapies to address the significant unmet needs for patients with MPNs.

Please find more information at www.ajaxtherapeutics.com.

CONTACT: Media Contact:
Kathryn Morris
The Yates Network
914-204-6412
kathryn@theyatesnetwork.com

PetMeds Announces Holiday Collection: Wellness-Focused Gifts for Pets and the People Who Love Them




PetMeds Announces Holiday Collection: Wellness-Focused Gifts for Pets and the People Who Love Them

DELRAY BEACH, Fla., Dec. 10, 2025 (GLOBE NEWSWIRE) — PetMed Express, Inc., d/b/a PetMeds and parent company of PetCareRx, (Nasdaq: PETS) (the “Company”), today unveiled its new Holiday Collection, a curated selection of health, wellness, and lifestyle products designed for pet parents who want to give purposeful, practical gifts this season. Unlike traditional pet gifts such as toys or beds, PetMeds’ giftable assortment focuses on products that improve pets’ everyday health, comfort, safety, and happiness, making them ideal for the pet owner who has everything.

“With more pet parents treating their furry friends like true members of the family, holiday gifting has shifted toward smart, wellness-oriented products,” said Leslie Campbell, CEO at PetMeds. “This collection offers gifts that actually make a difference, offering everything from emergency kits and grooming essentials to DNA tests designed to help pets live longer, healthier lives.”

PetMeds’ 2025 Holiday Collection

Grooming & Pampering Gifts

Give pets the gift of comfort, cleanliness, and spa-day bliss:

• Dr. Cuddles Dry Shampoo – A no-rinse cleaning solution perfect for winter or travel.
• TropiClean Perfect Fur Thick Double Coat Shampoo for Dogs – Specially formulated for breeds with a short undercoat and longer overcoat, like German Shepherds, Siberian Huskies, and Pomeranians.
• Moko Beauty & Grooming Collection – Premium grooming and coat-care essentials for dogs. Powered with medical grade Manuka honey which soothes, hydrates and softens skin leaving the coat smooth.
• Curry on a Stik – A unique grooming tool that pets love being brushed with.

Health, First Aid & Peace-of-Mind Gifts

For pet parents who prefer gifts that keep their pets healthy.

• Dr. Cuddles ReadyRESCUE™ First Response Detoxifier – A fast-acting emergency detoxifier that offers peace of mind in accidental ingestion cases.
• Operation Good Boy Dog First Aid + Medical Kit – A must-have home safety kit for dogs and cats.
• Oncotect At-Home Cancer Screening Test – A groundbreaking urine test for early cancer detection in dogs.
• DNA My Dog Allergy Test – Helps identify sensitivities and improve pets’ long-term wellness.
• AlphaDog DNA: The Essential Canine DNA Test – Breed, traits, and health insights all in one.
• Etalon Equine Genetics Pro Package + Ancestry Bundle – An advanced genetics test designed for horse owners, breeders, and competitive riders.

Clever, Unexpected Gifts for Pet Lovers

Thoughtful and unique items that every pet parent needs.

• Multipet Toys – playtime favorites for both dogs and cats.
• Woof Collection – A curated set of long-lasting enriching toys with options for hip and joint or skin and coat supplements.
• Bark Treats – Dental chews perfect as a tasty stocking stuffer for dogs of all sizes.
• Shameless Pets Party Mix Crunchy Bites Dog Treats Variety Pack – oven-baked with all natural, limited ingredients.

For the Cat Who Has Everything

• CA Pixi Smart Mouse Camera 13034 – the best way cat parents can easily monitor and communicate with their feline friends when they aren’t at home.
• Vetality Harmony Pet Calming Litter Box Diffuser – Portable diffuser cartridges that emit the P.E.T. pheromone which mimics the calming maternal pheromone cats recognize their entire life.
• Alamo Nature HQS Complete Variety Pack Wet Cat Food – 4 flavorful recipes to help your cat live its best life.
• Wellness Complete Healthy Indulgence Shreds Variety Pack Wet Cat Food – slices of meat in a light gravy to satisfy the most refined feline palettes.

Gift a Cleaner Home

• Boxie Glo Crystal Non-Clumping Litter – less dust, superior clumping, and better odor control makes daily litter box maintenance easier and more pleasant.

Equine

• Curry on a Stik – Avoid tired hands and ensure a beautifully groomed pet– plus, it’s designed for acupressure and massage!
• Nutramax Cosequin ASU Joint Health Supplement – A nutritional supplement powder with Glucosamine, Chondroitin, ASU, and MSM to help horses maintain healthy joints.
• Cavalor Energy Boost Paste – Provides important nutrients and an extra dose of quick energy to help horses give their best performance and aid in recovery.
• Nutramax Cosequin® ASU Plus – Hyaluronic Acid & Green Tea extract provides joint health support for equine athletes regardless of discipline or performance level.
• Alzoo Plant-Based Herbal Collar – repel flies, fleas, and ticks with this collar made of natural plant-based ingredients.

The Holiday Giftable Essentials Collection is available now at PetMeds.com, with fast shipping and subscription options for select items.

About PetMeds

Founded in 1996, PetMeds is a pioneer in the direct-to-consumer pet healthcare sector. As a trusted national online pharmacy, PetMeds is licensed across all 50 states and staffed with expert pharmacists dedicated to supporting pet wellness, pets and pet parents, and the veterinarians who serve them. Through its PETS family of brands and through its PetCareRx subsidiary, the Company offers a comprehensive range of pet health solutions – including top-brand and generic pharmaceuticals, compounded medications, and better-for-your-pet OTC supplements and nutrition. Focused on value, convenience, and care, PetMeds and PetCareRx empower pet parents to help their dogs, cats, and horses live longer, healthier lives. To learn more, visit www.PetMeds.com and www.PetCareRx.com.

Media Contact for PetMeds:

Berns Communications Group
Danielle Poggi
dpoggi@bcg-pr.com

Investor Contact:

ICR, LLC
Reed Anderson
investor@petmeds.com

DARE to PLAY™ Sildenafil Cream Now Available for Pre-Order by Prescription: First Evidence-Based Topical Arousal Cream for Women Begins Commercial Rollout in Select States via 503B Outsourcing Facility




DARE to PLAY™ Sildenafil Cream Now Available for Pre-Order by Prescription: First Evidence-Based Topical Arousal Cream for Women Begins Commercial Rollout in Select States via 503B Outsourcing Facility

Developed and evaluated specifically for women, DARE to PLAY™ Sildenafil Cream is a first-of-its-kind female arousal cream, a non-hormonal topical cream shown in clinical studies to increase genital blood flow in 10–15 minutes, and improve arousal sensations based on clinically-validated endpoints. Market introduction of DARE to PLAY™ is expected to mark a breakthrough in women’s sexual health and represents important progress toward closing one of medicine’s most persistent gender gaps.

SAN DIEGO, Dec. 10, 2025 (GLOBE NEWSWIRE) — Daré Bioscience, Inc. (NASDAQ: DARE), a purpose-driven health biotech company solely focused on closing the gap in women’s health between promising science and real-world solutions, today announced that providers in select states can now begin prescribing DARE to PLAY™ Sildenafil Cream, a proprietary topical arousal cream designed specifically for women to enhance genital blood flow and arousal response.

DARE to PLAY™ represents the first and only evidence-backed sildenafil cream formulation for women. Its commercial availability through a 503B outsourcing facility will mark the first time a topical sildenafil formulation manufactured in accordance with cGMP requirements and supported by clinical data will be accessible to women.

DARE to PLAY™ uses sildenafil, the same active ingredient found in Viagra®, to improve genital blood flow. Applied topically, it’s designed for use as needed, to enhance the body’s natural arousal response without systemic effects, providing women with a new, evidence-based tool to take charge of their sexual health.

“When Viagra was approved in 1998, it revolutionized sexual medicine for men. But for women, comparable progress on enhancing the natural arousal sensations has stalled for nearly three decades,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “We believe DARE to PLAY™ represents a long overdue correction, giving women an option to reconnect with their own bodies, their pleasure, and their confidence, using science that finally recognizes their needs.”

Existing products promoted for arousal lean heavily on marketing language, consumer reviews, and lifestyle branding without real evidence. DARE to PLAY™ is the first and only topical formulation of sildenafil developed specifically for women and backed by:

• Toxicology studies covering oral, anal, vaginal, and reproductive health;
• Multiple clinical trials in women, including a randomized placebo-controlled study with 200 women and their sexual partners; and
• Published, peer-reviewed research in medical journals such as The Green Journal, the official publication of the American College of Obstetrics and Gynecology (ACOG) and the Journal of Sexual Medicine, the official publication of the International Society for the Study of Women’s Sexual Health (ISSWSH).

“As more women speak openly about their sexual health, the need for research-backed solutions has never been greater,” said Dr. Irwin Goldstein, Director of San Diego Sexual Medicine and a founder of ISSWSH. “Daré’s commitment to both clinical integrity and timely access ensures women who need it don’t have to wait to benefit from this innovation.”

While continuing activities necessary to seek U.S. Food and Drug Administration (FDA) approval of its proprietary sildenafil cream formulation in the future, Daré Bioscience is making DARE to PLAY™ available as a Section 503B compounded product, manufactured in an outsourcing facility subject to FDA inspection and under current Good Manufacturing Practice (cGMP) regulations to ensure quality, strength and consistency. Compounded drug products are not FDA approved. The FDA does not evaluate compounded drug products for safety, effectiveness, or quality.

DARE to PLAY™ can now be prescribed for pre-order by licensed healthcare providers for prescription fulfillment in these states: CT, FL, IN, MO, NH, NJ, OR, PA, RI, and UT, and will ship within 45 days of order placement during the pre-order phase. DARE to PLAY™ prescriptions are being accepted through the DARE Health Hub, managed by Medvantx. DARE to PLAY™ will be available in other states throughout December and early 2026. Visit https://daretoplaybio.com/ for more information on DARE to PLAY™, including how to access a prescription and to sign up for an alert on when it is available in your state.

Market Opportunity

An estimated 20 million women in the United States experience challenges related to genital arousal, yet there are no FDA-approved therapeutics to address this need. The availability of DARE to PLAY™ through a cGMP 503B facility provides this large, underserved community of women access to a product uniquely supported by clinical evidence and scientific rigor.

Section 503B

References to Section 503B, 503B, 503B compounding, 503B compounded product, and similar terms refer to Section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA) and the production and supply of compounded drugs by Section 503B-registered outsourcing facilities without patient-specific prescriptions in accordance with Section 503B.

About Daré Bioscience

Daré Bioscience is a purpose-driven health biotech company solely focused on closing the gap in women’s health between promising science and real-world solutions. Every innovation Daré advances is based in advanced science and backed by rigorous, peer-reviewed research. From contraception to menopause, pelvic pain to fertility, vaginal health to infectious disease, Daré is working to close critical gaps in care using science that serves her needs.

For decades, women have been told to “wait it out” or “live with it,” while innovations that could improve their quality of life languish in the regulatory or funding pipeline. With growing awareness around menopause, sexual health, and vaginal health, the conversation is shifting. However, access to real, evidence-based solutions continues to lag. Daré was founded to change that. As a female-led health biotech company, Daré is accelerating the development of credible, science-based solutions that meet the high standards of clinical rigor – randomized, controlled trials; validated endpoints; peer-reviewed publications; and current Good Manufacturing Practice (cGMP) requirements.

To learn more about Daré’s mission to deliver differentiated therapies for women and its innovation pipeline, please visit www.darebioscience.com.

Daré Bioscience leadership has been named on the Medicine Maker’s Power List and Endpoints News’ Women in Biopharma and Daré’s CEO has been honored as one of Fierce Pharma’s Most Influential People in Biopharma for Daré’s contributions to innovation and advocacy in the women’s health space.

Daré may announce material information about its finances, products and product candidates, clinical trials and other matters using the Investors section of its website (http://ir.darebioscience.com), SEC filings, press releases, public conference calls and webcasts. Daré will use these channels to distribute material information about the company and may also use social media to communicate important information about the company, its finances, products and product candidates, clinical trials and other matters. The information Daré posts on its investor relations website or through social media channels may be deemed to be material information. Daré encourages investors, the media, and others interested in the company to review the information Daré posts in the Investors section of its website and to follow these X (formerly Twitter) accounts: @SabrinaDareCEO and @DareBioscience. Any updates to the list of social media channels the company may use to communicate information will be posted in the Investors section of Daré’s website.

Forward-Looking Statements

Daré cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “plan,” “potential,” “seek,” “should,” “would,” “project,” “target,” “explore” “objective,” “on track,” or the negative version of these words and similar expressions. In this press release, forward-looking statements include, but are not limited to, statements relating to plans and timing for commercial availability of DARE to PLAY™ Sildenafil Cream in states in the U.S., production of the compounded drug product in accordance with cGMP requirements, the ability of the product to enhance genital arousal response in women without systemic effects, the market opportunity for the product, its market position, its impact in women’s sexual health, and its ability to gain market acceptance, and Daré’s plans to seek FDA approval of its sildenafil cream formulation, pending additional development activities. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Daré’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, without limitation, risks and uncertainties related to: Daré’s reliance on a Section 503B-registered outsourcing facility, a licensed dispensing pharmacy with an online platform, and other third parties to bring DARE to PLAY™ Sildenafil Cream to market and facilitate access to the product and the risk that those third parties do not perform as expected; difficulties in establishing and sustaining relationships with third-party collaborators; the risk that FDA could stop permitting Section 503B-registered outsourcing facilities to manufacture and fulfill orders for compounded sildenafil products or change the conditions under which sildenafil may be used in compounding or compounded sildenafil products may be distributed; the ability of Daré’s outsourcing facility partner to maintain its registration with the FDA under Section 503B of the Federal Food, Drug, and Cosmetic Act; the timing of establishing, and ability to maintain, state-required licensure or registration to enable fulfillment of prescriptions for DARE to PLAY™ Sildenafil Cream; Daré’s inexperience, as a company, in and lack of infrastructure for commercializing products; the degree of market demand and acceptance for DARE to PLAY™ Sildenafil Cream; competitive product launches; greater than expected costs to bring compounded drug products to market and marketing costs; shifts in consumer spending or behavior; Daré’s ability to raise additional capital when and as needed to execute its business strategy and continue as a going concern; Daré’s dependence on grants and other financial awards from governmental entities and a private foundation; limitations on Daré’s ability to raise additional capital through sales of its common stock or other equity securities due to restrictions under SEC and Nasdaq rules and regulations or contractual limitation; Daré’s ability to retain its licensed rights to develop and commercialize a product or product candidate; Daré’s ability to satisfy the monetary obligations and other requirements in connection with its exclusive, in-license agreements covering the critical patents and related intellectual property related to its products and product candidates; Daré’s ability to adequately protect or enforce its, or its licensor’s, intellectual property rights; disputes or other developments concerning Daré’s intellectual property rights; product liability claims; governmental investigations or actions relating to Daré’s products or product candidates or the business activities of Daré, its commercial collaborators or other third parties on which Daré relies; changes in healthcare, pharmaceutical, consumer protection or privacy laws and regulatory policies; increased scrutiny from regulators; Daré’s ability to develop, obtain FDA or foreign regulatory approval for, and commercialize its product candidates and to do so on communicated timelines; failure or delay in starting, completing or conducting clinical trials of a product candidate and the inherent uncertainty of outcomes of clinical trials; the risks that positive findings in early clinical and/or nonclinical studies of a product candidate may not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate and that interim data or results from a particular clinical study do not necessarily predict the final results for that study; the risk that the FDA, other regulatory authorities, members of the scientific or medical communities or investors may not accept or agree with Daré’s interpretation of or conclusions regarding data from clinical studies of its product candidates; the effects of macroeconomic conditions, geopolitical events, and major changes and disruptions in U.S. government policies and operations on Daré’s ability to raise additional capital or on Daré’s operations, financial results and condition, and ability to achieve current plans and objectives; Daré’s ability to maintain compliance with Nasdaq’s continued listing requirements and continue to have its common stock listed on The Nasdaq Capital Market; and cybersecurity incidents or similar events that compromise Daré’s technology systems and/or significantly disrupt Daré’s business or those of third parties on which Daré relies. Daré’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of Daré’s risks and uncertainties, you are encouraged to review its documents filed with the U.S. Securities and Exchange Commission, including Daré’s recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Daré undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

Contacts:

Daré Bioscience Investor Relations
innovations@darebioscience.com

Source: Daré Bioscience, Inc.

Barinthus Bio Announces Update on Phase 1 AVALON Clinical Trial of VTP-1000 for the Treatment of Celiac Disease




Barinthus Bio Announces Update on Phase 1 AVALON Clinical Trial of VTP-1000 for the Treatment of Celiac Disease

• VTP-1000, an antigen-specific immunotherapy to treat celiac disease, showed a dose-dependent pharmacological effect in the SAD portion of the trial
• VTP-1000 was well-tolerated with no treatment-related SAEs
• The MAD portion of the trial, which includes a gluten challenge, is ongoing

GERMANTOWN, Md., Dec. 10, 2025 (GLOBE NEWSWIRE) — Barinthus Biotherapeutics plc (NASDAQ: BRNS) (“Barinthus Bio,” or the “Company”), an immunology and inflammation (“I&I”) company focused on developing immune tolerance therapies with curative potential, today announced an update on its first-in-human Phase 1 trial of VTP-1000 in adults with celiac disease. In the single ascending dose (“SAD”) portion of the trial, VTP-1000 was well tolerated with no treatment-related serious adverse events (“SAEs”) and a dose-dependent pharmacological effect observed. The multiple ascending dose (“MAD”) portion of the trial, which includes a gluten challenge, is ongoing with data expected in the second half of 2026.

The SAD portion of the Phase 1 AVALON trial (NCT06310291) enrolled 18 patients in three placebo-controlled cohorts of ascending doses. VTP-1000 was well tolerated at all dose levels with no treatment-related SAEs. Pharmacological data collected showed a dose-dependent effect.

“I’m encouraged by the results from VTP-1000, the first antigen-specific immune tolerance therapy for celiac disease to utilize an immunomodulator,” said Dr. Leon Hooftman, Chief Medical Officer of Barinthus Bio. “The treatment was well-tolerated across all dose levels, with no therapy related serious adverse events. Importantly, the IL-2 response observed at all doses together with the safety data demonstrates immune recognition without serious inflammation. These dose-dependent pharmacological effects are promising, and upcoming results from multiple dosing and further immunological analysis will be critical in refining the optimal regimen and understanding the therapy’s potential for true disease modification and patient benefit.”

VTP-1000 is an investigational, injectable antigen-specific tolerance immunotherapy that utilizes Barinthus Bio’s proprietary SNAP-TI platform to co-deliver multiple gluten-derived peptide antigens (from wheat, barley and rye proteins) and the immunomodulator rapamycin in nanoparticles designed to promote immune tolerance to gluten.

“These data from the SAD portion of the AVALON trial demonstrate the ability of a single dose of VTP-1000 to stimulate a robust targeted immune response that may minimize adverse effects associated with gluten antigen exposure in patients with celiac disease,” said Bill Enright, Chief Executive Officer of Barinthus Bio. “We look forward to providing details of the data, including pharmacological responses, at a scientific conference in 2026.”

About Celiac Disease

Celiac disease is caused by an autoimmune response to dietary gluten. It is relatively common, impacting an estimated one in 100 people of all ages (approximately 80 million people globally) and increasing in incidence. When people with celiac disease eat even small amounts of gluten-containing foods, their body mounts an autoimmune response consisting of T effector cells that cause inflammation. This can lead to rapid onset of symptoms (vomiting, diarrhea, etc.), as well as damage to the mucosal lining of the small intestine that can cause long-term consequences (e.g., malnutrition and vitamin deficiencies). Celiac disease is an area of high unmet need with no currently approved treatments; instead, people with celiac disease are advised to strictly avoid consuming gluten, which can be difficult due to the presence of gluten in many foods and cross-contamination of food production surfaces.

About Barinthus Bio

Barinthus Biotherapeutics (NASDAQ: BRNS) is a clinical-stage biopharmaceutical company developing novel immunotherapeutic candidates for treating autoimmune and inflammatory diseases with curative potential. Barinthus Bio’s pipeline for I&I indications is enabled by our proprietary and highly differentiated platform for promoting immune tolerance, SNAP-TI, that is designed to guide a patient’s T cells to reduce inflammation and restore the natural state of immune non-responsiveness to healthy tissue. Our lead candidate, VTP-1000, is designed to restore immune non-responsiveness to gluten in patients with celiac disease and is currently in a Phase 1 clinical trial. Barinthus Bio’s differentiated technology platform and therapeutic approach, coupled with deep scientific expertise and focus on clinical development, uniquely positions the company to navigate towards delivering treatments that improve the lives of people with autoimmune and inflammatory diseases. For more information, visit www.barinthusbio.com.

Forward Looking Statements

This press release contains forward-looking statements regarding Barinthus Bio within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, which can generally be identified as such by use of the words “may,” “will,” “plan,” “forward,” “encouraging,” “believe,” “potential,” “expect,” and similar expressions, although not all forward-looking statements contain these identifying words. These forward-looking statements include, without limitation, express or implied statements regarding our future expectations, plans and prospects, including our product development activities and clinical trials, including timing for readouts of any preliminary, interim or final data for any of our programs, the timing for initiation of any clinical trials, our anticipated regulatory filings and approvals, our cash runway, our ability to develop and advance our current and future product candidates and programs, and the terms and timing of the restructuring and related activities. Any forward-looking statements in this press release are based on our management’s current expectations and beliefs and are subject to numerous risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks and uncertainties related to the success, cost and timing of our pipeline development activities and planned and ongoing clinical trials, including the risk that the timing for preliminary, interim or final data or initiation of our clinical trials may be delayed, the risk that interim or topline data may not reflect final data or results, our ability to execute on our strategy, regulatory developments, the risk that we may not achieve the anticipated benefits of our pipeline prioritization and corporate restructuring, our ability to fund our operations and access capital, our cash runway, including the risk that our estimate of our cash runway may be incorrect, global economic uncertainty, including disruptions in the banking industry, the conflicts in Ukraine, Israel and Gaza, and other risks identified in our filings with the Securities and Exchange Commission (the “SEC”), including our most recent annual report on Form 10-K and subsequent filings we may make with the SEC. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We expressly disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.

Media contacts:
Alexis Feinberg
Vice President
ICR Healthcare
Barinthus@icrinc.com

Jonathan Edwards
Associate Partner
ICR Healthcare
Barinthus@icrinc.com

Company contact:
ir@barinthusbio.com

Accrete Health Partners Launches Partnership with Atalan to Co-develop Groundbreaking Patient Experience Intelligence Module




Accrete Health Partners Launches Partnership with Atalan to Co-develop Groundbreaking Patient Experience Intelligence Module

Strategic Co-Development Partnership Expands Relationship between Bon Secours Mercy Health and Atalan to Unify Workforce and Patient Experience Analytics

PHILADELPHIA, Dec. 10, 2025 (GLOBE NEWSWIRE) — Atalan, the world’s first Clinical Retention Intelligence (CRI) platform, today announced a strategic partnership with Accrete Health Partners, the venture arm of Bon Secours Mercy Health (BSMH), one of the top 20 largest health systems in the U.S. The partnership will focus on accelerating the development of Atalan PX, a new module designed to bridge clinician retention and patient experience, helping health system leaders improve both workforce stability and patient outcomes.

”Accrete Health Partners was created to identify, test, and invest in emerging technologies that advance operational and clinical innovation across the system and beyond,” said Cyril Philip, Vice President of Digital Ventures at BSMH and Accrete Health Partners. “Our Acceleration Funds allow us to move quickly with high-performing startup partners and co-develop solutions alongside our clinical and operational leaders. This funding helps launch an expanded partnership with Atalan, whose PX platform offers new ways to enhance its core product with new data and insights.”

Atalan PX expands Atalan’s platform to address a persistent industry challenge: the disconnect between patient experience data and workforce engagement. Frontline leaders often struggle to translate fragmented data into coordinated, meaningful action. Atalan PX unifies patient experience and workforce-related data in a single platform and applies AI to help leaders surface patterns, identify emerging operational challenges, and guide targeted action to support team engagement and the care experience.

“BSMH has been an invaluable partner to our team,” said Tiffany Chan, CEO & Founder of Atalan. “Our collaboration with BSMH and Accrete reflects a shared vision: workforce stability and patient experience are inseparable. Together, we’re building a new model for connected performance intelligence in healthcare.”

The partnership builds on a collaboration between Atalan and BSMH, which successfully piloted Atalan’s CRI platform within a regional market. Within six months, BSMH saw positive early results that supported expanding its use of Atalan across additional markets to support broader clinical teams.

“Investing in our workforce is a core part of our strategy,” said Tim Watson, Vice President of Physician Recruitment at BSMH. “Atalan helps us better understand what strengthens the clinician experience so we can build programs that support their long-term success.”

Healthcare operations are entering an era where data drives progress – across every aspect. With advances in AI, health systems have the power to turn the massive data they already hold into actionable foresight. The organizations that harness that potential will lead the next wave of innovation, using connected intelligence to elevate experiences and enhance financial and operational performance.

About Atalan

Atalan is the first Clinician Retention Intelligence (CRI) platform, helping health systems predict and prevent surprise clinician resignations up to 12 months in advance to improve workforce stability. Using real-time, objective data that health systems already have, Atalan’s machine learning models pinpoint at-risk clinicians, uncover the causes, and tailor proactive interventions. The outcome: protected revenue, stronger margins, and uninterrupted, high-quality patient care.

To learn more, visit www.atalantech.com.

About Accrete Health Partners

Accrete Health Partners is a strategic digital holding company that aligns and unifies leading digital health products, services, and technologies through strategic development, investments, and partnerships. With a goal to grow through strategic accumulation, Accrete is led by professionals who have the experience and proven understanding of what it takes to use technology, data, and digital tools to make health care easier for patients, as well as for health care systems and hospitals. Together, we are unlocking talent and technology synergies to innovate and scale solutions that make a difference in health care. Learn more at Accretedigital.com.

Media Contact:
Sharon Golubchik
RAYNZ
sharon@raynzhealth.com

Rakovina Therapeutics Announces Upcoming Webinar with Variational AI




Rakovina Therapeutics Announces Upcoming Webinar with Variational AI

From Handshake to Breakthrough: How Rakovina & Variational AI Are Cracking the Code on CNS-Penetrant Cancer Therapies

VANCOUVER, British Columbia, Dec. 10, 2025 (GLOBE NEWSWIRE) — Rakovina Therapeutics Inc. (TSX-V: RKV) (FSE: 7JO0) (“Rakovina” or the “Company”), a biopharmaceutical company advancing innovative cancer therapies through artificial intelligence (AI)-powered drug discovery, is pleased to announce that the Company will host a 60-minute webinar on December 17, 2025 at 10:00 AM PST.

The session, titled From Handshake to Breakthrough will bring together leaders from Rakovina Therapeutics and Variational AI for a fireside discussion on how the two companies are tackling one of oncology’s toughest design challenges: creating CNS-penetrant, multi-target cancer therapeutics. Using the AI-designed ATR/mTOR inhibitor program as a case study, the teams will outline how the partnership began, the biological hurdles they set out to overcome, and what the latest preclinical data mean for future development.

The webinar will conclude with an open Q&A, allowing participants to engage directly with both organizations.

Please RSVP for this event with the zoom link below:

https://us02web.zoom.us/meeting/register/qP7xfiVlT2mC7GNS5_177A#/registration

About Rakovina Therapeutics Inc.
Rakovina Therapeutics is a biopharmaceutical research company focused on the development of innovative cancer treatments. Our work is based on unique technologies for targeting the DNA-damage response powered by Artificial Intelligence (AI) using the proprietary Deep-Docking™ and Enki™ platforms. By using AI, we can review and optimize drug candidates at a much greater pace than ever before.

The Company has established a pipeline of distinctive DNA-damage response inhibitors with the goal of advancing one or more drug candidates into human clinical trials in collaboration with pharmaceutical partners. Further information may be found at www.rakovinatherapeutics.com.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this release.

Notice Regarding Rakovina Therapeutics Forward-Looking Statements:
This release includes forward-looking statements regarding the company and its respective business, which may include, but is not limited to, statements with respect to the proposed business plan of the company and other statements. Often, but not always, forward-looking statements can be identified by the use of words such as “plans,” “is expected,” “expects,” “scheduled,” “intends,” “contemplates,” “anticipates,” “believes,” “proposes” or variations (including negative variations) of such words and phrases, or state that certain actions, events, or results “may,” “could,” “would,” “might,” or “will” be taken, occur, or be achieved. Such statements are based on the current expectations of the management of the company. The forward-looking events and circumstances discussed in this release may not occur by certain specified dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting the company, including risks regarding the biopharmaceutical industry, economic factors, regulatory factors, the equity markets generally, and risks associated with growth and competition.

Although the company has attempted to identify important factors that could cause actual actions, events, or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events, or results to differ from those anticipated, estimated, or intended. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made, and the company undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise. The reader is referred to the company’s most recent filings on SEDAR+ for a more complete discussion of all applicable risk factors and their potential effects, copies of which may be accessed through the company’s profile page at www.sedar.com.

For Further Information Contact:
Michelle Seltenrich, BSc MBA
Director, Corporate Development
IR@rakovinatherapeutics.com
778-773-5432

Igyxos Biotherapeutics Announces Positive Results from Phase 1 Trial of IGX12, its First-in-Class Monoclonal Antibody for the Treatment of Male and Female Infertility




Igyxos Biotherapeutics Announces Positive Results from Phase 1 Trial of IGX12, its First-in-Class Monoclonal Antibody for the Treatment of Male and Female Infertility

TOURS, France, Dec. 10, 2025 (GLOBE NEWSWIRE) — Igyxos Biotherapeutics, a biotechnology company dedicated to developing innovative monoclonal antibodies for infertility treatment, today announced the successful completion of its Phase 1 clinical trial evaluation of IGX12.

The recent Multiple Ascending Dose (MAD) Phase 1 trial of IGX12 was a randomised, placebo-controlled study in 14 healthy male volunteers at two doses (20 & 40 μg/kg) given every other week as 4 subcutaneous injections over 6 weeks.

These results demonstrated an excellent safety profile at both doses, with no serious adverse events reported. The pharmacokinetic (PK) profile showed a gradual absorption phase and a slow elimination half-life which could be supportive of monthly dosing, important for fertility treatment. These results are supported by the preceding Single Ascending Dose (SAD) study in 32 healthy volunteers (16 men & 16 women), reported in March 2025. The company is now planning Phase 2 trials, due to start in leading fertility centres in Europe in 2026.

IGX12 is a first-in-class potentiating monoclonal antibody developed by Igyxos to enhance the potency and efficacy of follicle-stimulating hormone (FSH), a critical hormone involved in female and male gametogenesis. IGX12 has been designed to improve ovarian stimulation in women undergoing medically assisted reproductive technologies and enhance spermatogenesis in men with oligozoospermia, the medical term for a low sperm count.

Dr. Elke Bestel, Chief Medical Officer of Igyxos Biotherapeutics, said, “There has been little innovation in the field of infertility over the last 40 years. Unlike current IVF treatment regimens, our innovative monoclonal antibody-based approach addresses both female and male infertility. Male infertility accounts for nearly half of all infertility cases and currently has no approved treatment. We are excited by these promising results, this time in exclusively male cohorts. Our goal is to bring a new treatment option for infertility to everyone that needs it.”

Florent Ferré, Chief Executive Officer of Igyxos Biotherapeutics, said, “Following the results of our Single Ascending Dose study in March, these MAD study results are another important new milestone in the clinical development of our innovative approach to treating infertility. We are extremely encouraged by these positive Phase 1 results in both male and female cohorts.”

About Igyxos Biotherapeutics

Igyxos Biotherapeutics is dedicated to developing innovative treatments for infertility in both men and women. Its lead asset, IGX12, is a first-in-class potentiating monoclonal antibody designed to enhance the potency and efficacy of follicle-stimulating hormone (FSH), an essential hormone for reproduction both in men and women.

Since its foundation in France in 2017, the company has raised over EUR 27 million in funding, including EUR 19 million in equity from business angels and investors including Bpifrance via its Biotechnology Health Acceleration Fund, GO Capital, UI Investissement, and approximately EUR 8 million in grants, loans and repayable advances from Bpifrance and regional funding bodies.

For more information, visit our website, and follow us on LinkedIn.

Media contacts

Igyxos Biotherapeutics
Florent Ferré, CEO
Florent.ferre@igyxos.com

Scius Communications 
Katja Stout
+44 778 943 5990
katja@sciuscommunications.com
Daniel Gooch
+44 7747 875479
daniel@sciuscommunications.com

Bioxodes raises €5.5 million Series A extension to continue preparations for pivotal trial of breakthrough stroke candidate




Bioxodes raises €5.5 million Series A extension to continue preparations for pivotal trial of breakthrough stroke candidate

• Newton Biocapital enters as new investor, strong participation of existing investors
• Pivotal Phase 2b trial initiation in 2027 of BIOX-101 to treat intracerebral hemorrhage
• BIOX-101 may be commercialized as early as H2 2030  

Gosselies, Belgium, 10 December 2025 (08:30 am CET) – Bioxodes SA, a clinical stage biopharmaceutical company developing novel therapies for the prevention and treatment of thrombotic and inflammatory diseases, has raised €5.5 million in a Series A extension funding round, enabling the company to continue preparations to launch a potentially registrational Phase 2b trial of its lead candidate BIOX-101 to treat intracerebral hemorrhage (ICH) in 2027. Newton Biocapital, a specialist life science venture capital firm focusing on early-stage companies in Europe and Japan, entered as a new investor, together with other new and existing shareholders, bringing the total Series A financing to about €17.5 million.

“Bioxodes is grateful for the renewed trust in the company’s ability to develop our groundbreaking treatment for hemorrhagic stroke. Our Phase 2a data clinical results in ICH patients are very promising and the principal investigator is encouraging us to push forward rapidly with registrational studies. I am particularly excited to see the respected specialist fund, Newton Biocapital, join our group of shareholders. The funding advances preparations for the pivotal Phase 2b trial and may enable us to bring BIOX-101 to patients as early as the second half of 2030,” said Marc Dechamps, CEO at Bioxodes.

Bioxodes in September announced strong interim results for its BIRCH Phase 2a trial in ICH, meeting the safety endpoint, and achieving highly encouraging efficacy signals across clinical and biomarker measures. The unanimous recommendation of the DMC at that time was to launch a larger Phase 2b trial. Starting the study in 2027 could allow Bioxodes to submit BIOX-101 for conditional marketing authorizations for a Go-to-Market in the U.S. by late 2030 and in Europe by early 2031. The company also plans to develop BIOX-101 to treat ischemic stroke. To fund these future clinical trials, Bioxodes has launched a €80 million Series B fundraising. The company is also in active discussions with potential partners.

“Bioxodes looks to be a rare example of a success story in stroke. The BIOX-101 Phase 2a trial yielded very convincing data in intracerebral hemorrhage, an often deadly disease that presents an important unmet medical need.  While the company is breaking new ground in this indication, we believe the path to registration is clear, with objective endpoints that look achievable based on the data at hand. BIOX-101 is exactly the kind of innovative drug that we at Newton like to have in our portfolio, also given our previous experience supporting companies in neurological and neurovascular diseases, including stroke,” said Alain Parthoens, Chief Executive Officer at Newton Biocapital.

Intracerebral hemorrhage (ICH) is a devastating condition with no approved therapies, accounting for up to 40% of all stroke-related deaths, despite making up just 15% of cases. Mortality approaches 50% at 30 days, and approximately half of all ICH-related deaths happen within the first 24 hours. Fewer than 20% of survivors achieve functional independence after six months, often due to secondary damage resulting from the untreatable bleeding and associated inflammation, which causes secondary ischemia, neuroinflammation and neuronal damage, amongst others.

Marketed anticoagulants cannot be used to prevent secondary ischemic lesions after ICH because they invariably carry a risk of exacerbating bleeding. BIOX-101 is the first-in-class therapeutic candidate with an anticoagulant effect that has been shown not to increase bleeding. Separately, the drug candidate also has been shown to exert potent anti-inflammatory effects through its impact on the neutrophils, which can worsen the damage of the initial stroke by triggering inflammation and swelling. This dual anticoagulant and anti-inflammatory mode of action is expected to improve survival and contribute to faster and better outcomes for patients with ICH.

BIOX-101 is a proprietary recombinant version of a small protein found in the saliva of the tick (Ixodes ricinus). It is designed to inhibit the harmful secondary effects of hemorrhagic stroke such as secondary ischemia, neuroinflammation and neuronal damage. Unlike currently marketed anticoagulants, BIOX-101 is an investigational anticoagulant that reduces clotting without increasing bleeding. It does this by targeting Factors XIa and XIIa of the intrinsic coagulation pathway. The candidate product also exerts anti-inflammatory effects through a second mechanism, inhibiting activation of neutrophils and their release of extracellular DNA filaments (also called neutrophil extracellular traps or NETs), which can cause excessive inflammation, contributing to edema expansion and exacerbating brain damage and disrupting the blood-brain barrier. Bioxodes reported positive BIOX-101 Phase 2a clinical proof of concept data in ICH patients and is currently preparing to initiate a Phase 2b trial in ICH and as well as Phase 2 trials of BIOX-101 to treat acute ischemic stroke and an undisclosed indication.

Bioxodes SA (www.bioxodes.com) is a clinical stage biopharmaceutical company developing novel therapies for the prevention and treatment of thrombotic and inflammatory diseases. The company’s lead asset, BIOX-101, is a first-in-class drug candidate being developed to treat stroke. BIOX-101’s unique dual mechanism of action is the foundation of an innovative pipeline of drug candidates for treatment and prevention of thromboinflammatory diseases. Worldwide, Bioxodes holds both granted and pending patents associated with BIOX-101. Bioxodes research is supported by the Walloon Region (SPW Recherche), and the company is registered in Belgium under number 825.151.779.

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• 20251210 Bioxodes PR serie A extension (final, clean)