Valneva and Serum Institute of India Announce Discontinuation of Chikungunya Vaccine License Agreement




Valneva and Serum Institute of India Announce Discontinuation of Chikungunya Vaccine License Agreement

Saint-Herblain (France), Pune, (India), December 31, 2025 – Valneva SE (“Valneva” or “the Company”), a specialty vaccine company, and Serum Institute of India (SII), a Cyrus Poonawalla Group company today announced that they have mutually agreed to discontinue their license agreement for Valneva’s single-shot chikungunya vaccine.

Valneva´s strategic intent in regaining full rights is to assume direct control over its supply chain and commercialization for endemic high-risk countries, thereby accelerating access for regions most affected by the disease. 

Supporting access to the vaccine in low-and-middle-income countries (LMICs) falls within the framework of the funding agreement Valneva signed with the Coalition for Epidemic Preparedness Innovations (CEPI) in July 2024 with co-funding from the European Union¹.  

About Chikungunya
Chikungunya virus (CHIKV) is a mosquito-borne viral disease spread by the bites of infected Aedes mosquitoes which causes fever, severe joint and muscle pain, headache, nausea, fatigue and rash. Joint pain is often debilitating and can persist for weeks to years¹.
In 2004, the disease began to spread quickly, causing large-scale outbreaks around the world. Since the re-emergence of the virus, CHIKV has now been identified in over 110 countries in Asia, Africa, Europe and the Americas². Between 2013 and 2023, more than 3.7 million cases were reported in the Americas³ and the economic impact is considered to be significant. The medical and economic burden is expected to grow with climate change as the mosquito vectors that transmit the disease continue to spread geographically. As such, the World Health Organization (WHO) has highlighted chikungunya as a major public health problem.⁴

About Valneva SE
We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly specialized and targeted approach, applying our deep expertise across multiple vaccine modalities, focused on providing either first-, best- or only-in-class vaccine solutions.
We have a strong track record, having advanced multiple vaccines from early R&D to approvals, and currently market three proprietary travel vaccines.
Revenues from our growing commercial business help fuel the continued advancement of our vaccine pipeline. This includes the only Lyme disease vaccine candidate in advanced clinical development, which is partnered with Pfizer, the world’s most clinically advanced Shigella vaccine candidate, as well as vaccine candidates against other global public health threats. More information is available at www.valneva.com.

About CEPI
CEPI was launched in 2017 as an innovative partnership between public, private, philanthropic and civil organisations. Its mission is to accelerate the development of vaccines and other biologic countermeasures against epidemic and pandemic disease threats and enable equitable access to them. CEPI has supported the development of more than 70 vaccine candidates or platform technologies against multiple known high-risk pathogens and is advancing the development of rapid response platforms for vaccines against a future Disease X. Central to CEPI’s pandemic-beating five-year plan for 2022-2026 is the ‘100 Days Mission’ to compress the time taken to develop safe, effective, globally accessible vaccines against new threats to just 100 days.

About Horizon Europe
Horizon Europe — #HorizonEU — is the European Union’s flagship Research and Innovation programme, part of the EU-long-term Multiannual Financial Framework (MFF) with a budget of €95,5 billion to spend over a seven-year period (2021-2027).  Under Horizon Europe, health research will be supported with the aim to find new ways to keep people healthy, prevent diseases, develop better diagnostics and more effective therapies, use personalised medicine approaches to improve healthcare and wellbeing, and take up innovative health technologies, such as digital ones.

About Serum Institute of India Private Limited 
Serum Institute of India Pvt. Ltd, part of Cyrus Poonawalla Group is a global leader in vaccine manufacturing, dedicated to providing affordable vaccines worldwide. Present across 170+ countries, including the US, UK, and Europe, SIIPL holds the distinction of being the world’s largest vaccine manufacturer. SIIPL’s multifunctional production and one-of-the-largest facilities in Hadapsar & Manjari, Pune, with an annual capacity of 4 billion doses, has saved over 30 million lives over the years.  
Founded in 1966, SIIPL’s primary mission is to produce life-saving immunobiological drugs, with a particular emphasis on affordability and accessibility. Guided by a strong commitment to improving global health, the company has played a pivotal role in reducing the prices of essential vaccines, such as Diphtheria, Tetanus, Pertussis, HIB, BCG, r-Hepatitis B, Measles, Mumps, and Rubella. Notably, they are the manufacturers of ‘Pneumosiil,’ the world’s most affordable PCV, ‘Cervavac’ the first indigenous qHPV vaccine in India, and R21/Matrix-M™, the second Malaria vaccine to be authorized for use in children in malaria-endemic regions, ‘MenFive’, the first in the world Pentavalent (ACYWX) Meningococcal Polysaccharide Conjugate Vaccine, approved and WHO-prequalified for use in the pediatric population. Moreover, SIIPL has been at the forefront of the global fight against COVID-19, delivering over 2 billion doses of the COVID-19 vaccine worldwide. 
To further expand its global presence and ensure widespread vaccine availability, SIIPL has established Serum Life Sciences Ltd, a subsidiary in the UK and Serum Inc., a subsidiary in the US. Through relentless pursuit of innovation, SII continues to champion the cause of affordable vaccines, making a positive impact on the lives of millions worldwide. www.seruminstitute.com 

Forward-Looking Statements
This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to use and regulatory review of existing products. In addition, even if the actual results or development of Valneva are consistent with the forward-looking statements contained in this press release, those results or developments of Valneva may not be sustained in the future. In some cases, you can identify forward-looking statements by words such as “could,” “should,” “may,” “expects,” “anticipates,” “believes,” “intends,” “estimates,” “aims,” “targets,” or similar words. These forward-looking statements are based largely on the current expectations of Valneva as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, the expectations of Valneva could be affected by, among other things, uncertainties and delays involved in the development and manufacture of vaccines, unexpected clinical trial results or new adverse events, unexpected regulatory actions or delays, competition in general, currency fluctuations, the impact of the global and European credit crisis, and the ability to obtain or maintain patent or other proprietary intellectual property protection. Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made in this press release will in fact be realized. Valneva is providing this information as of the date of this press release and disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

1 https://jvi.asm.org/content/jvi/88/20/11644.full.pdf
2 https://cmr.asm.org/content/31/1/e00104-16
3 PAHO/WHO data: Number of reported cases of chikungunya fever in the Americas (Cumulative Cases 2018-2023 and Cases per year 2013-2017). https://www.paho.org/data/index.php/en/mnu-topics/chikv-en/550-chikv-weekly-en.html. Last accessed 01 Aug 2023.
4 Geographical expansion of cases of dengue and chikungunya beyond the historical areas of transmission in the Region of the Americas (who.int)

Attachment

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Total number of shares and voting rights in Zealand Pharma as of December 31, 2025




Total number of shares and voting rights in Zealand Pharma as of December 31, 2025

Company announcement – No. 27 / 2025

Total number of shares and voting rights in Zealand Pharma as of December 31, 2025

Copenhagen, Denmark, December 31, 2025 – Zealand Pharma A/S (“the Company” or “Zealand Pharma”) (Nasdaq: ZEAL) (CVR-no. 20045078), a biotechnology company transforming the future of metabolic health, today announces, in accordance with section 32 of the Danish Capital Markets Act, the total number of shares and voting rights in the Company at the end of a calendar month during which changes to its share capital have occurred.

In Company Announcement No. 25 / 2025 dated December 11, 2025, Zealand Pharma announced a share capital increase due to the exercise of employee warrants. Following this announcement, the table below details the total number of shares and voting rights in Zealand Pharma as of December 31, 2025.

The Company’s Articles of Association are available on the Company’s website https://www.zealandpharma.com.

# # #

About Zealand Pharma A/S
Zealand Pharma A/S (Nasdaq: ZEAL) is a biotechnology company focused on advancing medicines for obesity and metabolic health. Combining more than 25 years of peptide R&D expertise with a proprietary data platform that leverages advanced data‑driven and AI/ML approaches, Zealand Pharma aims to lead a new era in obesity and metabolic health.

To date, more than ten Zealand Pharma‑invented drug candidates have entered clinical development, of which two products have reached the market and three candidates are in late-stage development. The Company has collaborations with global pharmaceutical and biotechnology partners for research, development, and commercialization.

Founded in 1998, Zealand Pharma is headquartered in Copenhagen, Denmark, with a U.S. presence in Boston, Massachusetts. Learn more at www.zealandpharma.com.

Contacts
Adam Lange (Investors)
Vice President, Investor Relations
Zealand Pharma
alange@zealandpharma.com

Neshat Ahmadi (Investors)
Investor Relations Manager
Zealand Pharma
neahmadi@zealandpharma.com

Rachel James-Owens (Media)
Vice President, Corporate Communications & Media Relations
Zealand Pharma
RJamesOwens@zealandpharma.com

BioNTX Marks the Close of the First Quarter of the 21st Century with Growth, Workforce Momentum, and Innovation Leadership




BioNTX Marks the Close of the First Quarter of the 21st Century with Growth, Workforce Momentum, and Innovation Leadership

IRVING, Texas, Dec. 31, 2025 (GLOBE NEWSWIRE) — As 2025 ends, BioNTX reflects on a year—and the close of the first quarter of the 21st century—defined by accelerated growth, expanded engagement, and strategic collaboration across North Texas’s life science and healthcare innovation ecosystem. From major biomanufacturing investments and workforce development gains to record-setting convenings, the region continued to build momentum. As the community bids farewell to 2025, it looks ahead with renewed commitment to strengthening North Texas’s position as a nationally competitive bioscience hub.

A full list of 2025 regional growth highlights are available here.

Member Engagement & Programming
With nearly 200 member organizations, BioNTX delivered its most active year of programming to date, hosting more than 30 events focused on connection, talent, and industry insight. Signature events included Legal, CFO and Investor Forums, Women Driving Innovation, HR Forum & Career Symposium, Talent Network Meet & Greets, and the expansion of BIO BREAK into Frisco—reflecting strong regional demand. These efforts reinforce BioNTX’s role as the connective tissue of the regional ecosystem.

Workforce Development Momentum Through BHIANT
2025 marked a breakthrough year for BHIANT, BioNTX’s workforce development initiative, as industry, education, and community partners aligned to strengthen talent pipelines into life sciences and biomanufacturing careers. Through expanded collaborations with partners like regional ISD’s, Dallas College, and Panthera BioSolutions, BHIANT engaged employers, delivered industry led curriculum, and advanced a regional workforce model that connects education directly to employer demand—positioning North Texas as a leader in scalable, industry-informed workforce development.

Innovation Storytelling & Thought Leadership
BioNTX launched BioNTX Presents: Inside Innovation, a new podcast spotlighting founders, researchers, executives, and investors shaping the region’s future. The series has quickly become a cornerstone of BioNTX’s public engagement and storytelling strategy.

A Record-Setting iC³ Summit
The 2025 iC³ Life Science & Healthcare Innovation Summit, held at the Hilton Anatole in Dallas, convened the largest and most diverse audience in the event’s history. The two-day summit featured national dialogue on AI, biomanufacturing, translational medicine, policy, and venture growth, alongside record levels of participation from healthcare systems and industry leaders.

Looking Ahead to 2026
With major capital investments, expanding federal and state support, a rapidly growing biomanufacturing base, and deepening regional partnerships, North Texas enters 2026 with historic momentum. BioNTX will continue expanding workforce pipelines, strengthening education and employer partnerships, enhancing Inside Innovation, and advancing programs that support R&D, early-stage companies, and clinical innovation.

“The story of 2025 is only the beginning,” added Kathleen Otto-Rosenblum, CEO of BioNTX. “North Texas is building a future defined by discovery, opportunity, and shared prosperity.”

About BioNTX
BioNTX is the bioscience and healthcare innovation trade organization serving the North Texas region. The organization fosters innovation and community through collaborative networking events, educational programming, professional development, market visibility, a purchasing consortium, and by being the voice for the North Texas biosciences and healthcare innovation community.

Media Contact:
Eric Moore
BioNTX
972.679.6056
emoore@biontx.org

Clearmind Medicine Regains Compliance with Nasdaq Minimum Bid Price Requirement




Clearmind Medicine Regains Compliance with Nasdaq Minimum Bid Price Requirement

Vancouver, Canada, Dec. 31, 2025 (GLOBE NEWSWIRE) — Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) (“Clearmind” or the “Company”), a clinical-stage biotech company focused on the discovery and development of novel neuroplastogen-derived therapeutics to solve major under-treated health problems, announced that it has received a notification letter from the Listing Qualifications Department of the Nasdaq Stock Market (“Nasdaq”), informing the Company that it has regained compliance with the minimum bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2).

The Company had previously announced that it was notified by Nasdaq on December 4, 2025, that it was not in compliance with the minimum bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2), as the closing bid price of the Company’s common shares had been below $1.00 for more than 30 consecutive business days.

On December 30, 2025, Nasdaq provided confirmation to the Company that for the last 10 consecutive business days, from December 15 through December 29, 2025, the closing bid price of the Company’s common shares was $1.00 per share or greater, that the Company has hence regained compliance with Listing Rule 5550(a)(2) and that the matter is now closed.

About Clearmind Medicine Inc.

Clearmind is a clinical-stage psychedelic pharmaceutical biotech company focused on the discovery and development of novel psychedelic-derived therapeutics to solve widespread and underserved health problems, including alcohol use disorder. Its primary objective is to research and develop psychedelic-based compounds and attempt to commercialize them as regulated medicines, foods, or supplements.

The Company’s intellectual portfolio currently consists of nineteen patent families, including 31 granted patents. The Company intends to seek additional patents for its compounds whenever warranted and will remain opportunistic regarding the acquisition of additional intellectual property to build its portfolio.

Shares of Clearmind are listed for trading on Nasdaq under the symbol “CMND” and the Frankfurt Stock Exchange under the symbol “CWY0.”

For further information, visit: https://www.clearmindmedicine.com or contact:

Investor Relations
invest@clearmindmedicine.com

Telephone: (604) 260-1566
US: CMND@crescendo-ir.com

General Inquiries
Info@Clearmindmedicine.com
www.Clearmindmedicine.com

Forward-Looking Statements:

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses advancing innovative treatments for AUD, the high level of interest from both patients and leading clinical sites in CMND-100, CMND-100’s potential to transform AUD treatment and its belief that that this rapid progress positions it to generate additional valuable data, bringing it closer to delivering a breakthrough therapy that addresses the root causes of addiction with an improved safety profile. Forward-looking statements are not historical facts, and are based upon management’s current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management’s expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company’s reports filed from time to time with the Securities and Exchange Commission (“SEC”), including, but not limited to, the risks detailed in the Company’s annual report on Form 20-F for the fiscal year ended October 31, 2024 and subsequent filings with the SEC. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Clearmind is not responsible for the contents of third-party websites.

Intelligent Bio Solutions Announces New Manufacturing Partnership to Strengthen Global Production Capability and Increase Margins




Intelligent Bio Solutions Announces New Manufacturing Partnership to Strengthen Global Production Capability and Increase Margins

Partnership with Syrma Johari Medtech, a globally recognized medical device engineering and manufacturing organization, expands INBS’ global manufacturing capacity, strengthens supply-chain resilience, and supports an expected improvement of approximately 20 percentage points in gross margin ahead of planned U.S. market entry

NEW YORK, Dec. 31, 2025 (GLOBE NEWSWIRE) — Intelligent Bio Solutions Inc. (Nasdaq: INBS) (“INBS” or the “Company”), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today announced a new strategic manufacturing partnership with Syrma Johari MedTech Ltd. (“Syrma Johari”), a globally recognized medical device engineering and manufacturing organization with over 45 years of experience, to support and scale the production of its Intelligent Fingerprinting Drug Screening Reader. The collaboration is also expected to support long-term margin improvement.

The partnership is expected to deliver significant operational and financial benefits for the Company. INBS anticipates annual production cost savings of more than 40%, translating to an expected improvement of approximately 20 percentage points in gross margin compared with its previous manufacturing arrangement. Additionally, Syrma Johari’s manufacturing capacity is approximately four times INBS’ current capacity, positioning the Company to efficiently support anticipated demand as it scales commercial operations.

The partnership strengthens INBS’ global manufacturing strategy, reducing reliance on a single supplier and building greater resilience into its supply chain. It further broadens capacity, ensures continuity, and creates flexibility as the Company prepares for anticipated future demand across multiple regions and planned U.S. market entry in 2026.

Syrma Johari brings a deep and proven track record in the design, engineering, and production of regulated medical technology devices. It operates 14 manufacturing locations and four design and innovation centres across India, Europe, and the United States, with a combined plant area of over 1.1 million sq. ft. Syrma Johari is fully certified to ISO 13485, MDSAP, FDA, TUV SUD, and GMP standards, ensuring world-class compliance and quality in medical device manufacturing.

Syrma Johari’s scale, vertical integration, and export-oriented operating model enable high-quality production while creating efficiencies in sourcing, tooling, testing, and logistics. Its expertise in electronics, mechanical assembly, PCB manufacturing, functional testing, and clean-room processes positions them to produce INBS’ fingerprint drug-screening reader to a consistently high standard, while delivering cost advantages over time. As Syrma Johari prepares to open its new medical-grade plastics manufacturing facility in India in January 2026, it is further expanding its capabilities to meet growing global demand and provide international clients with a strategically located, reliable manufacturing alternative in Asia.

Syrma Johari’s extensive regulatory and quality-assurance capabilities further align with INBS’ global expansion plans. It provides end-to-end quality systems, regulatory documentation support, and compliance processes designed to meet the requirements of major jurisdictions, including the U.S., Europe, Canada, the UK, and key Asia-Pacific markets. This depth of experience will support INBS as it continues advancing its regulatory pathways and prepares for increased commercial activity worldwide.

“Partnering with Syrma Johari is a strategically significant milestone for our business,” said Callistus Sequeira, Vice President of Global Quality and Operations at Intelligent Bio Solutions. “Its global footprint, manufacturing excellence, and proven track record in regulated medical devices make it an outstanding partner as we scale production of our Drug Screening Reader. This collaboration strengthens our supply chain, supports future growth, and enhances our ability to deliver reliable, high-quality products to customers around the world.”

Syrma Johari’s leadership shared a similar sentiment, noting that the partnership reflects a strong alignment in innovation, quality, and long-term vision, and that it is pleased to support INBS in scaling a disruptive drug-screening technology with global potential.

“Partnering with Intelligent Bio Solutions is an exciting opportunity to apply our engineering strength, manufacturing scale, and quality systems to a breakthrough technology with global potential,” said Pankaj Wadke, Head International Sales & Business Development at Syrma Johari MedTech Ltd. “At Syrma Johari MedTech, we are committed to enabling innovative solutions that make a meaningful impact, and we look forward to supporting INBS as they expand access to this disruptive, non-invasive drug-screening platform.”

About Intelligent Bio Solutions Inc. 

Intelligent Bio Solutions Inc. (NASDAQ: INBS) is a medical technology company delivering intelligent, rapid, non-invasive testing solutions. The Company believes that its Intelligent Fingerprinting Drug Screening System will revolutionize portable testing through fingerprint sweat analysis, which has the potential for broader applications in additional fields. Designed as a hygienic and cost-effective system, the test screens for the recent use of drugs commonly found in the workplace, including opiates, cocaine, methamphetamine, and cannabis. With sample collection in seconds and results in under ten minutes, this technology would be a valuable tool for employers in safety-critical industries. The Company’s current customer segments outside the U.S. include construction, manufacturing and engineering, transport and logistics firms, mining, drug treatment organizations, and coroners.

For more information, visit: https://ibs.inc/

About Syrma Johari MedTech

Syrma Johari MedTech is a global medical device engineering and manufacturing company with over 45 years of experience delivering advanced electronics, medical devices, and life-science equipment. Operating 14 manufacturing facilities and multiple R&D centres across India, the U.S., and Europe, the company provides end-to-end services spanning design, engineering, prototyping, PCBA, assembly, supply chain, and QARA support. Syrma Johari holds ISO 13485:2016, MDSAP, FDA, GMP, and TUV SUD certifications and has commercialised 245+ medical products worldwide.

For more information, visit: https://syrmajoharimedtech.com/

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, statements regarding Intelligent Bio Solutions Inc.’s ability to successfully develop and commercialize its drug and diagnostic tests, realize commercial benefits from its partnerships and collaborations, and secure regulatory clearance or approvals, among others. Although Intelligent Bio Solutions Inc. believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, actual results may differ materially from those expressed or implied by such statements. Intelligent Bio Solutions Inc. has attempted to identify forward-looking statements by terminology, including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “projects,” “intends,” “potential,” “may,” “could,” “might,” “will,” “should,” and “approximately,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those described in Intelligent Bio Solutions’ public filings with the U.S. Securities and Exchange Commission. Any forward-looking statements contained in this release speak only as of the date of this release. Intelligent Bio Solutions undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Company Contact

Intelligent Bio Solutions Inc.  
info@ibs.inc  

Investor & Media Contact

Valter Pinto, Managing Director  
KCSA Strategic Communications  
PH: (212) 896-1254  
INBS@kcsa.com

Allarity Therapeutics Issues 2025 End of Year CEO Letter to Shareholders




Allarity Therapeutics Issues 2025 End of Year CEO Letter to Shareholders

TARPON SPRINGS, Fla., December 31, 2025 – Allarity Therapeutics, Inc. (“Allarity” or the “Company”) (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing stenoparib (2X-121)—a differentiated, dual PARP and WNT pathway inhibitor—today issued the following letter to shareholders from the Company’s Chief Executive Officer.

Dear Shareholders,

As we close out 2025, I write to you with both optimism and gratitude. Your continued support has helped steer Allarity Therapeutics through a period of meaningful transformation and disciplined execution. This December marks two years since I assumed the role of Chief Executive Officer. Since that time, our efforts have been anchored by a clear and focused strategy centered on advancing stenoparib, our novel dual inhibitor of PARP and the WNT pathway- for advanced ovarian cancers as well as other advanced, difficult-to-treat cancers such as recurrent Small Cell Lung Cancer. The progress we have made has been remarkable- we have strengthened our financial future while simultaneously accelerating stenoparib toward FDA approval. In the season of reflection, I wanted to take a few moments to review these past two years and build on that momentum for 2026 and beyond.

2024 – A Strategic Reset and Foundation for Progress
Looking back, the first full calendar year of my tenure, 2024, was a year of strategic reset for Allarity. We undertook a comprehensive realignment, shedding legacy programs that had limited value in order to focus exclusively on stenoparib and its incredible potential as a game changing therapy for advanced ovarian and other cancers. That focused approach has allowed us to realize and now deepen our understanding of stenoparib’s unique therapeutic mechanism of action, to separate this molecule from the first-generation PARP inhibitors. It has also allowed us to expand the possibilities for stenoparib beyond ovarian cancer. Solidifying this unique mechanism, deepening our clinical experience showing durable clinical benefit with a uniquely attractive safety profile has opened up the future for this molecule and for the enterprise value creation it affords Allarity as a company. That we have now placed stenoparib squarely on a path toward clinical and regulatory success is highlighted by the FDA’s recent decision to grant stenoparib Fast Track Designation.

At the same time, we took critical steps to strengthen the company’s corporate and financial foundations. Our capital structure was simplified, resulting in a single class of common stock, and the company regained full compliance with Nasdaq listing standards. These developments ensured continued access to the public markets and removed longstanding structural overhangs that had weighed on the investment case for our company. Equally important, we resolved outstanding legacy matters with the SEC inherited from the Company’s prior period, allowing us to move forward with a full focus on execution and long-term value creation.

Operationally, we streamlined the organization, recruited experienced oncology leadership, and implemented cost-efficiency measures designed to extend our financial runway without compromising clinical development priorities. As a result, we ended 2024 as a more focused organization, supported by a strengthened balance sheet and a clear strategic direction.

2025 – Executing with Focus and Expanding Potential
In 2025, we remained focused on accelerating stenoparib toward FDA approval in ovarian cancer. Importantly, we have now also extended stenoparib’s clinical potential to additional high value cancer indications, most notably recurrent Small Cell Lung Cancer- a devastating disease without clear therapeutic options. All of this was accomplished while further strengthening our company’s financial health.

Our confidence in stenoparib was further reinforced by the continued clinical benefit evident from our first trial dosing patients twice daily. Specifically, we presented updated data at the AACR Special Conference on Ovarian Cancer showing median Overall Survival had not been reached even though the median time to follow up exceeded 22 months. For context, the most exciting recent advances approved or submitted for the treatment of advanced ovarian cancer patients have shown median overall survival of approximately 16 months. Notably, two patients have now remained on therapy for over 30 months—a rare outcome for such advanced patients- underscoring both the durability of clinical benefit and the favorable safety profile of stenoparib. These data continue to support our belief that stenoparib’s unique, dual inhibition of PARP and WNT pathways offers distinct, practical advantages compared to first-generation PARP inhibitors. Indeed, we have now begun a new Phase 2 trial protocol to confirm and extend these results and to accelerate stenoparib toward FDA approval. We have also begun to explore clinical opportunities for stenoparib beyond ovarian cancer, signing an agreement to explore stenoparib in a recurrent small cell lung cancer trial fully funded by the US Veteran’s administration. This is the first trial to explore the activity of stenoparib in combination with other cancer agents and ideally allows us to show that stenoparib can be the combination therapy of choice for numerous cancer indications. Moreover, we have been collaborating with the Indiana Biosciences Research Institute (IBRI) to more fully appreciate stenoparib’s role in blocking the WNT pathway- a key pathway activated in many advanced cancer, most notably colorectal cancers. These preclinical studies will provide the foundation for further expanding the enterprise value of stenoparib.

We also advanced our DRP® companion diagnostic platform, entering into a new licensing and laboratory services agreement that validated the platform’s utility beyond our internal pipeline. These activities reinforce the value of our proprietary tools while offsetting costs and supporting broader industry adoption.

Financially, we maintained a disciplined operating model. Our cash runway remains aligned with our development objectives, and we continue to manage operating expenses and liabilities with rigor. During the year, we made selective and tactical use of our share repurchase capacity as part of our broader approach to shareholder stewardship, while preserving financial stability.

Taken together, the progress made in 2025 reflects an organization executing with focus and intent. We advanced stenoparib toward FDA approval in ovarian cancer, broadened its potential into new indications, and further reinforced the scientific and financial foundations that will support continued clinical development. This combination of clinical momentum and financial discipline positions Allarity well for the next stage of progress.

2026 – From Foundation to Continued Progress
Looking ahead, 2026 represents an inflection point for Allarity. Our focus is on expanding the enterprise value of Allarity—by first looking to deepen and accelerate the advanced of stenoparib toward approval, by expanding the indications for stenoparib and by being opportunistic in finding additional avenues to enhance and expand the Allarity enterprise.

In Closing
The past two years have required decisive change, hard choices, and persistent focus. The decisions we have made throughout the last two years have positioned Allarity to continue to move forward as a more capable and credible company, focused on bringing better cancer therapies to patients. As we enter 2026, I am confident that the foundation we have laid will support meaningful progress across clinical, regulatory, and strategic dimensions. Thank you for your continued belief in our mission and for joining us on this journey.

Sincerely,
Thomas H. Jensen
Chief Executive Officer

About Stenoparib/2X-121
Stenoparib is an orally available, small-molecule dual-targeted inhibitor of PARP1/2 and tankyrase 1/2. At present, tankyrases are attracting significant attention as emerging therapeutic targets for cancer, principally due to their role in regulating the WNT signaling pathway. Aberrant WNT/β-catenin signaling has been implicated in the development and progression of numerous cancers. By inhibiting PARP and blocking WNT pathway activation, stenoparib’s unique therapeutic action shows potential as a promising therapeutic for many cancer types, including ovarian cancer, Small Cell Lung Cancer and colorectal cancer. Allarity has secured exclusive global rights for the development and commercialization of stenoparib, which was originally developed by Eisai Co. Ltd. and was formerly known under the names E7449 and 2X-121. Allarity has two ongoing Phase 2 trial protocols for stenoparib in Ovarian Cancer patients. In the first, patients who had had 2+ lines of therapy were enrolled on stenoparib and given drug twice daily. This protocol has been closed to further enrollment but continues for the enrolled patients who are still receiving benefit from stenoparib administration. The updated data from this study were presented at this AACR special conference on advances in Ovarian Cancer. Note that, as these data are from an ongoing trial, analyses may change as the study fully matures. An amended protocol designed expressly to capitalize on the emerging clinical experience with stenoparib in platinum resistant patients began enrolling patients this summer. This amended protocol enrolls only platinum resistant or platinum-ineligible patients and is designed to accelerate the clinical development of stenoparib toward FDA approval.

About the Drug Response Predictor – DRP^® Companion Diagnostic
Allarity uses its drug-specific DRP^® to select those patients who, by the gene expression signature of their cancer, may have a high likelihood of benefiting from a specific drug. By screening patients before treatment, and only treating those patients with a sufficiently high, drug-specific DRP score, the therapeutic benefit rate may be enhanced. The DRP method builds on the comparison of sensitive vs. resistant human cancer cell lines, including transcriptomic information from cell lines, combined with clinical tumor biology filters and prior clinical trial outcomes. DRP is based on messenger RNA expression profiles from patient biopsies. The DRP^® platform has shown an ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients across dozens of clinical studies (both retrospective and prospective). The DRP platform, which may be useful in all cancer types and is patented for dozens of anti-cancer drugs, has been extensively published in the peer-reviewed literature.

About Allarity Therapeutics
Allarity Therapeutics, Inc. (NASDAQ: ALLR) is a clinical-stage biopharmaceutical company dedicated to developing personalized cancer treatments. The Company is focused on development of stenoparib, a novel PARP/tankyrase inhibitor for advanced ovarian cancer patients, using its DRP^® technology to develop a companion diagnostic that can be used to select those patients expected to derive the greatest clinical benefit from stenoparib. Allarity is headquartered in the U.S., with a research facility in Denmark, and is committed to addressing significant unmet medical needs in cancer treatment. For more information, visit www.allarity.com.

Follow Allarity on Social Media
LinkedIn: https://www.linkedin.com/company/allaritytx/

Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements provide the Company’s current expectations or forecasts of future events. The words “anticipates,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predicts,” “project,” “should,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements include, but are not limited to, statements regarding the Company’s strategy, plans, and objectives; the clinical development, potential regulatory approval, and commercial prospects of stenoparib; expectations regarding ongoing and future clinical trials, including enrollment, data generation, and study outcomes; potential expansion of stenoparib into additional cancer indications; anticipated regulatory interactions; the development and potential commercialization of stenoparib; the utility and adoption of the Company’s DRP® companion diagnostic platform; and the Company’s ability to maintain financial discipline, preserve financial stability, and pursue strategic or development opportunities. Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject to multiple risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, risksrisks related to the Company’s ability to successfully advance the clinical development of stenoparib; uncertainties inherent in clinical trials, including patient enrollment, timing, data interpretation, and outcomes; the timing and outcome of regulatory interactions and approval processes; the potential for delays or changes in development plans; reliance on third parties for clinical, manufacturing, or research activities; competition from other therapies; manufacturing, supply chain, and scale-up risks; the Company’s ability to maintain financial discipline and obtain additional financing if needed; and general market, economic, and industry conditions. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in our Form 10-K annual report filed with the Securities and Exchange Commission (the “SEC”) on March 31, 2025, and our Form 10-Q quarterly reports filed with the SEC on May 9, 2025, August 15, 2025 and November 14, 2025, available at the SEC’s website at www.sec.gov, and as well as discussions of potential risks, uncertainties and other important factors in the Company’s subsequent filings with the SEC. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information unless required by law.

###

Company Contact:         
        investorrelations@allarity.com

        
Media Contact:
        Thomas Pedersen
        Carrotize PR & Communications
        +45 6062 9390
        tsp@carrotize.com

Attachment

• Allarity Therapeutics Issues 2025 End of Year CEO Letter to Shareholders

Hydreight Technologies Enters the At-Home STI Testing Market With Exclusive Distribution and 50,000 Pre-Orders




Hydreight Technologies Enters the At-Home STI Testing Market With Exclusive Distribution and 50,000 Pre-Orders

VANCOUVER, British Columbia, Dec. 31, 2025 (GLOBE NEWSWIRE) — Hydreight Technologies Inc. (“Hydreight” or the “Company”), a digital health platform enabling on-demand care, pharmacy fulfillment, and enterprise healthcare services across the United States, today announced its entry into the rapidly expanding at-home sexually transmitted infection (“STI”) pre-screening market through an exclusive distribution agreement with Health Screen Collective (“HSC”).

Under the agreement, Hydreight will serve as the exclusive distributor of HSC’s at-home STI pre-screen testing kits across its national platform. The Company has already secured approximately 50,000 pre-orders, with deliveries expected to begin in early 2026.

A Widespread, Under-Diagnosed Public Health Reality

Sexually transmitted infections represent one of the most prevalent and under-diagnosed healthcare challenges in the United States. According to the Centers for Disease Control and Prevention (CDC), approximately one in five people in the U.S. is living with an STI at any given time, with tens of millions of new infections occurring annually. Despite this prevalence, a significant portion of infections remain undiagnosed due to stigma, inconvenience, cost, and long wait times associated with traditional clinic-based testing.

Globally, the World Health Organization (WHO) estimates that more than one million curable STIs are acquired every day, underscoring the scale of the issue and the growing need for accessible, private screening solutions.

Testing in Minutes, Not Days

HSC’s at-home STI pre-screen testing kits are designed to deliver results in minutes rather than days, enabling faster awareness and earlier engagement with care. Using validated lateral-flow immunoassay technology, the kits allow individuals to collect samples privately at home through clear, step-by-step instructions, eliminating the need for clinic visits or laboratory processing delays at the initial screening stage.

Depending on the selected panel, the kits provide pre-screening for multiple common infections, including:

• Chlamydia trachomatis
• Neisseria gonorrhoeae
• Trichomonas vaginalis
• Mycoplasma genitalium
• Candida albicans
• Gardnerella vaginalis

This approach addresses one of the most critical gaps in STI care today: speed matters. Faster screening enables earlier clinical decisions, reduces transmission risk, and improves patient follow-through.

Accuracy & Sensitivity Highlights

According to product validation data and Instructions for Use provided by Health Screen Collective, the at-home STI pre-screen testing kits demonstrate high levels of sensitivity, specificity, and overall accuracy across multiple screened pathogens. The tests utilize validated lateral-flow immunoassay technology and are designed to detect clinically relevant infection markers with performance characteristics comparable to commonly used laboratory-based screening methods for initial detection. These accuracy metrics support the kits’ role as reliable pre-screening tools, enabling faster identification of potential infections and earlier clinical follow-up when integrated into licensed care pathways.

From Pre-Screening to End-to-End Care

The kits are positioned as pre-screening tools, designed to help individuals identify potential infections earlier and take appropriate next steps. When integrated into Hydreight’s platform, users can move seamlessly from pre-screening to licensed medical review, confirmatory testing, clinical consultation, and treatment coordination, where clinically appropriate.

This integrated workflow transforms at-home testing from a standalone product into a connected digital healthcare experience, addressing both access and continuity of care.

Why This Matters for Hydreight

STI screening is a high-frequency, repeat-use healthcare category, driven by public health guidelines and ongoing patient behavior. The combination of recurring screening needs, rapid results, and integrated clinical follow-up aligns directly with Hydreight’s platform-first strategy.

The initial 50,000 pre-orders reflect early demand from enterprise partners, healthcare operators, and distribution channels seeking scalable, at-home pre-screening solutions that can be deployed nationally and embedded into broader digital care workflows.

“This category highlights exactly why our platform exists,” said Shane Madden, Chief Executive Officer of Hydreight. “When you combine fast, at-home screening with licensed providers and national fulfillment, you remove friction from a category that desperately needs it. That’s where real healthcare transformation happens.”

Platform Leverage, Not a One-Off Product

Hydreight views at-home STI pre-screening as another example of how its infrastructure can be leveraged to rapidly launch and scale healthcare services across large, fragmented markets. Rather than operating as a single product, the Company expects this offering to drive repeat engagement, downstream clinical services, pharmacy fulfillment, and long-term platform utilization.

On behalf of the Board of Directors

Shane Madden
Director and Chief Executive Officer
Hydreight Technologies Inc.

Contact
Email: ir@hydreight.com; Telephone: (702) 970-8112

Hydreight Technologies Inc Ranked Number 56 Fastest-Growing Company in North America on the 2024 Deloitte Technology Fast 500™

Hydreight Technologies Recognized as a Top 50 TSX Venture Exchange Company

About Hydreight Technologies Inc.
Hydreight Technologies Inc is building one of the largest mobile clinic networks in the United States. Its proprietary, fully integrated platform has hosted a network of over 3000 nurses, over 300 doctors and a pharmacy network through its Doctor networks across 50 states. The platform includes a built-in, easy-to-use suite of fully integrated tools for accounting, documentation, sales, inventory, booking, and managing patient data, which enables licensed healthcare professionals to provide services directly to patients at home, office or hotel. Hydreight is bridging the gap between provider compliance and patient convenience, empowering nurses, med spa technicians, and other licensed healthcare professionals. The Hydreight platform allows healthcare professionals to deliver services independently, on their own terms, or to add mobile services to existing location-based operations. Hydreight has a 503B pharmacy network servicing all 50 states and is closely affiliated with a U.S. certified e-script and telemedicine provider network.

About VSDHOne – Direct to Consumer Platform
Developed in partnership with Victory Square Technologies (CSE: VST) (OTC: VSQTF) (FWB: 6F6), Hydreight Technologies launched the VSDHOne (Read as VSDH-One) platform. VSDHOne simplifies the entry challenges for companies and medi-spa businesses to enter the online healthcare space compliantly. This platform will help all businesses to launch a direct-to-consumer healthcare brand in a matter of days in all 50 states. Compliant offerings include: GLP-1s, peptides, personalized healthcare treatments, sermorelin, testosterone replacement therapy (“TRT”), hair loss, skincare, sexual health and more. Hydreight invested in technology, legal and infrastructure to launch this platform. The VSDHOne platform offers a complete, and modular end-to-end solution for businesses looking to launch direct-to-consumer healthcare brands. From compliance and telemedicine technology to nationwide doctor and pharmacy networks, VSDHOne provides all the tools needed for a seamless entry into the online healthcare space. The platform is designed to significantly reduce the time and costs associated with launching such services, making it possible for businesses to go live in days instead of months.

Neither TSXV nor its Regulation Services Provider (as that term is defined in policies of the TSXV) accepts responsibility for the adequacy or accuracy of this release. This press release does not constitute an offer of securities for sale in the United States. The securities being offered have not been, nor will they be, registered under the United States Securities Act of 1933, as amended, and such securities may not be offered or sold within the United States absent U.S. registration or an applicable exemption from U.S. registration requirements.

Cautionary Note Regarding Forward-Looking Information
This press release contains statements which constitute “forward-looking information” within the meaning of applicable securities laws, including statements regarding the plans, intentions, beliefs and current expectations of the Company with respect to future business activities and operating performance. Forward-looking information is often identified by the words “may”, “would”, “could”, “should”, “will”, “intend”, “plan”, “anticipate”, “believe”, “estimate”, “expect” or similar expressions and includes information regarding expectations for the 2025 and 2026 strategic outlook, the Company’s growth, margins, and VSDHOne’s and Hydreight’s anticipated performance and related operational metrics. This also includes information regarding Product Orders, which are defined as follows: Product Orders Placed reflect demand initiated by licensees and partners; Product Orders Fulfilled refer to orders processed by pharmacy partners and prepared for delivery; and Product Orders Delivered refer to orders that have reached the patient. Orders may be cancelled or returned, which can affect the relationship between orders placed, fulfilled, delivered, and recognized revenue. Hydreight uses Product Orders Placed as its primary operational KPI because it reflects real-time platform activity and partner demand. All operational and accounting measures reconcile at period end.

Investors are cautioned that forward-looking information is not based on historical facts but instead reflects the Company’s management’s expectations, estimates or projections concerning future results or events based on the opinions, assumptions and estimates of management considered reasonable at the date the statements are made. Although the Company believes that the expectations reflected in such forward-looking information are reasonable, such information involves risks and uncertainties, and undue reliance should not be placed on such information, as unknown or unpredictable factors could have material adverse effects on future results, performance or achievements of the Company. Among the key factors that could cause actual results to differ materially from those projected in the forward-looking information are the following: the ability to obtain requisite regulatory and other approvals with respect to the business operated by the Company and/or the potential impact of the listing of the Company’s shares on the TSXV on relationships, including with regulatory bodies, employees, suppliers, customers and competitors; changes in general economic, business and political conditions, including changes in the financial markets; changes in applicable laws; compliance with extensive government regulation; and the diversion of management time as a result of being a publicly listed entity. This forward-looking information may be affected by risks and uncertainties in the business of the Company and market conditions.

Should one or more of these risks or uncertainties materialize, or should assumptions underlying the forward-looking information prove incorrect, actual results may vary materially from those described herein as intended, planned, anticipated, believed, estimated or expected. Although the Company has attempted to identify important risks, uncertainties and factors which could cause actual results to differ materially, there may be others that cause results not to be as anticipated, estimated or intended. The Company does not intend, and does not assume any obligation, to update this forward-looking information except as otherwise required by applicable law.

Regulatory Statements
Neither the TSX Venture Exchange nor its Regulation Services Provider (as defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this communication. This communication does not constitute an offer to sell, or a solicitation of an offer to buy, securities in the United States. The securities referenced herein have not been and will not be registered under the United States Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an applicable exemption.

Profusa Bolsters European Commercial Network with New French Distributor, MedSell




Profusa Bolsters European Commercial Network with New French Distributor, MedSell

MedSell commercializes Lumee™ Oxygen tissue monitoring in France, building upon distributor partnerships in Spain, Germany, the Benelux countries, Austria, the United Kingdom, and Scandinavia, to now reach approximately 200,000 annual CLI cases in the European Union

Agreement complements KOL collaboration with Vascular Center at Groupe Hospitalier Paris Saint Joseph, Paris that accounts for approximately 8% of all CLTI cases in France

BERKELEY, Calif, Dec. 31, 2025 (GLOBE NEWSWIRE) — Profusa, Inc. (“Profusa” or the “Company”) (Nasdaq: PFSA), a commercial stage digital health company pioneering the next generation of technology platform enabling the continuous monitoring of an individual’s biochemistry, announces a new distributor partnership in France with MedSell.  MedSell is a French company that specializes in the commercialization and distribution of innovative medical devices within the French healthcare market by leveraging tailored commercial, marketing, and market-entry support services.  As part of its portfolio, Profusa’s new partner will commercialize Lumee Oxygen tissue monitoring in France in both hospital settings and outpatient care, especially in wound care and healing clinics addressing patients with complex and chronic wounds.

Benoit Salaün, Pharm.D., Ph.D., MedSell General Manager, said, “Our collaboration with Profusa stems from our particular interest in Lumee Oxygen tissue monitoring for the large population of patients in France with Critical Limb Threatening Ischemia (CLTI). The device enables the measurement of tissue oxygen perfusion before revascularization, during endovascular or open surgical procedures, and throughout follow-up in hospitals or wound care clinics. We believe Lumee Oxygen tissue monitoring meets a critical unmet clinical need and can bring significant added value to clinicians by supporting decision-making and patient monitoring across the entire treatment pathway.”

With MedSell, Profusa builds upon previously announced distributor partnerships in Spain, Germany, the Benelux countries, Austria, the United Kingdom, and Scandinavia, to now represent more than 200,000 CLI cases annually in the European Union.  Further, the distribution partnership with MedSell complements Profusa’s previously announced collaboration with Yann Gouëffic, M.D., Ph.D., professor of vascular surgery in the Vascular Center at Groupe Hospitalier Paris Saint Joseph, Paris, France and a leading surgeon in the field of critical limb threatening ischemia (CLTI). Under the agreement, Pr. Gouëffic adopts Lumee™ oxygen monitoring technology in his practice and in clinical studies that advance application of Lumee for home monitoring. Pr. Gouëffic and his associated practices account for approximately 8% of all CLTI cases in France.

“We are focused on executing on our commercial strategies, including plans to potentially achieve $200 to $250 million in revenue by 2030; capitalize on the near-term as we begin to commercialize in Europe in 2Q 2026  with the goal of addressing the US Lumee oxygen opportunity in 2027.  We expect to deliver 2026 potential revenue of $0.5 to $2 million and $9 to $13 million potential revenue in 2027,” said Ben Hwang, Ph.D., Profusa’s Chairman and CEO.  “The European clinical community continues to validate our Lumee Oxygen tissue monitoring, including recent presentations of US-based clinical trial data at Paris Vascular Insights and Leipzig Interventional Course.  We are committed to making our oxygen tissue monitoring platform easily accessible both at the clinic and at home to improve overall patient outcomes and reduce healthcare costs.”

About Profusa

Based in Berkeley, Calif., Profusa is a commercial stage digital health company led by visionary scientific founders, an experienced management team and a world-class board of directors in the development of a new generation of tissue-integrated sensors to detect and continuously transmit actionable, medical-grade data for personal and medical use. With its long-lasting, injectable and affordable biosensors and its intelligent data platform, Profusa aims to provide people with a personalized biochemical signature rooted in data that clinicians can trust and rely on.

“LUMEE”, “PROFUSA” and the PROFUSA logo are registered trademarks of Profusa Inc. in the United States, Canada, European Union, China, Japan, South Korea and Australia.

For more information, visit https://profusa.com.

Special Note Regarding Forward-Looking Statements

Certain statements in this press release (this “Press Release”) may be considered “forward-looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally relate to future events or future financial or operating performance of Profusa. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “forecast,” “future,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “propose,” “seek,” “should,” “strive,” “will,” or “would” or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which may be beyond the control of Profusa and could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Profusa and its management are inherently uncertain. Profusa cautions you that these statements are based on a combination of facts and factors currently known and projections of the future, which are inherently uncertain. There are risks and uncertainties described in the definitive proxy/final prospectus relating to the business combination, which has been filed with the SEC, and in other documents filed by Profusa from time to time with the SEC. These filings may identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Profusa cannot assure you that the forward-looking statements in this communication will prove to be accurate.

Contacts
Investor and Media Contacts
email:  info@coreir.com
phone:  1 (212) 655-0924

Best Wegovy Pricing for 2026: Industry Analysis of FDA-Approved Oral and Injectable Cost Pathways as Telehealth Access Expands




Best Wegovy Pricing for 2026: Industry Analysis of FDA-Approved Oral and Injectable Cost Pathways as Telehealth Access Expands

Complete Pricing Comparison Shows FDA-Approved Wegovy Access From $149 Oral to Ro’s $199 Injectable Through Telehealth as 1 in 8 Americans Now Use GLP-1 Medications

NEW YORK, Dec. 30, 2025 (GLOBE NEWSWIRE) — Disclaimer: This article is for informational purposes only and does not constitute medical advice. GLP-1 medications require evaluation by a licensed clinician. Consult a qualified healthcare professional before starting any prescription treatment. This article contains affiliate links; a commission may be earned at no additional cost to the reader.

If you have searched for Wegovy pricing recently and felt like every source gives a different number, you are not alone. The landscape has shifted significantly in the final weeks of 2025, with FDA approvals, manufacturer pricing updates, and evolving telehealth access structures creating both opportunity and confusion for consumers evaluating their options.

View the current Ro Wegovy offer (official Ro page)

In this context, “best” refers to the most current, clearly published, and regulatorily approved pricing information available to consumers at the time of publication—not a value judgment, endorsement, or comparison of superiority.

This article examines publicly available pricing disclosures, FDA approvals, and telehealth access structures to help consumers independently evaluate Wegovy cost pathways in 2026.

According to Gallup data from October 2025, approximately 12.4% of U.S. adults report taking GLP-1 medications for weight loss—more than double the rate measured in early 2024. For consumers researching pricing as the new year begins, understanding what platforms have published and what regulatory changes have occurred provides essential context for informed evaluation.

December 2025 Regulatory and Pricing Timeline

The Wegovy pricing and access landscape changed substantially in the final weeks of 2025. According to published announcements and regulatory filings:

December 22, 2025: According to Novo Nordisk and independent reporting from ABC News, the FDA approved an oral Wegovy formulation—the first oral GLP-1 medication indicated for weight management in adults.

November 17, 2025: According to Novo Nordisk’s announcement, the company introduced updated cash-pay pricing structures for injectable Wegovy, with promotional pricing available through participating platforms and pharmacies.

November 2025: According to published reporting, the Trump administration announced pricing arrangements for certain GLP-1 medications through a direct-to-consumer program expected to launch in early 2026.

Early January 2026: According to Novo Nordisk, the oral Wegovy formulation is expected to become available through pharmacies and select telehealth providers, with additional pricing details to be confirmed at launch.

This timeline provides context for consumers evaluating which access pathways may align with their circumstances as 2026 begins.

View the current Ro Wegovy offer (official Ro page)

Published Wegovy Pricing Disclosures: What Platforms and Manufacturers Have Stated

Consumers encounter varying price points because multiple pricing structures exist simultaneously across different access pathways. The following reflects publicly available disclosures from manufacturers, platforms, and regulatory sources as of December 2025.

Manufacturer and Platform Disclosures:

According to Novo Nordisk’s published information, the wholesale acquisition cost for Wegovy is approximately $1,349 per month. However, various programs, partnerships, and access pathways publish substantially different consumer-facing prices.

According to Ro’s official website, the platform publishes cash-pay Wegovy pricing beginning at $199 per month for certain starter doses during a limited promotional period, with membership fees and higher dose pricing listed separately in their disclosures.

Manufacturer and platform disclosures indicate oral Wegovy cash-pay pricing beginning at published introductory levels, depending on dose and access pathway, with broader availability expected in early 2026. Higher dose pricing has not been fully disclosed at the time of this publication.

Telehealth GLP-1 Evaluation Criteria Consumers Review in 2026

Based on publicly available company disclosures at time of publication.

According to published platform information, consumers evaluating telehealth access pathways typically review medication sourcing, membership requirements, insurance compatibility, and provider access structures as part of their evaluation process.

View the current Ro Wegovy offer (official Ro page)

Understanding Oral and Injectable Wegovy: Published Information

The FDA’s December 22, 2025 approval of oral Wegovy creates a new consideration for consumers evaluating access pathways. According to manufacturer announcements, published clinical data, and platform disclosures:

Oral Wegovy (Approved December 2025):

According to Novo Nordisk’s announcement, oral Wegovy contains the same active ingredient (semaglutide) as injectable Wegovy and demonstrated weight loss outcomes in clinical trials. The company states that the oral formulation requires specific administration protocols, including being taken on an empty stomach with a small amount of water, with a 30-minute wait before eating, drinking, or taking other oral medications.

According to the OASIS 4 trial data published in The New England Journal of Medicine, participants who adhered to the oral semaglutide treatment protocol experienced average weight loss of approximately 16.6% over 64 weeks, while the overall trial population (regardless of adherence) experienced average weight loss of approximately 13.6%.

Injectable Wegovy:

According to published clinical trial data from the STEP 1 trial, participants taking injectable Wegovy 2.4 mg weekly experienced average weight loss of approximately 14.9% over 68 weeks alongside lifestyle modifications.

Format Considerations:

According to published information, both formulations require evaluation by a licensed clinician and are indicated for the same patient populations. Consumers typically discuss format preferences and individual circumstances with their healthcare provider.

Ro Wegovy Access: Published Pricing and Program Structure

For consumers specifically evaluating Ro, the following reflects the company’s published disclosures as of December 2025.

Medication Pricing (Cash-Pay):

According to Ro’s official website:

• Ro lists cash-pay Wegovy pricing beginning at $199 per month for certain starter doses for a limited promotional period, with higher doses priced differently, according to its published disclosures
• The promotional pricing is noted as available through March 31, 2026
• Higher doses (including 2.4 mg) are listed at different price points

Membership Structure:

According to Ro’s published information, the Ro Body membership is required for weight loss program access:

• First month membership listed at $45
• Ongoing monthly membership listed at $145

Published Membership Inclusions:

According to Ro’s website, the membership includes licensed provider access, messaging availability, health coaching, monitoring tools, and periodic check-ins. Consumers typically review the full scope of included services on the platform’s official website.

Medication Sourcing:

According to Ro’s disclosures, Wegovy accessed through their platform is sourced through NovoCare Pharmacy, which is operated by Novo Nordisk. The company states this provides authentic, FDA-approved Wegovy.

Insurance Pathway:

According to Ro’s published information, the platform offers an insurance concierge service to assist with prior authorization processes. The company notes certain limitations regarding government insurance programs.

Ro states on its official website that the platform cannot coordinate coverage for Medicare, Medicaid, or VA plans for GLP-1 medications used for weight loss. Consumers with government insurance are advised to review their specific plan details and explore options independently.

View the current Ro Wegovy offer (official Ro page)

FDA Eligibility Criteria: Who Wegovy Is Indicated For

According to FDA prescribing information, Wegovy is indicated for specific patient populations. Consumers typically review eligibility criteria, insurance compatibility, and ongoing program requirements directly with the platform and a licensed clinician.

FDA-Approved Indications:

According to FDA prescribing information, Wegovy is indicated for:

Chronic Weight Management: Adults with obesity (BMI of 30 or greater) OR adults with overweight (BMI of 27 or greater) who also have at least one weight-related medical condition such as high blood pressure, type 2 diabetes, or high cholesterol. According to prescribing information, treatment should be used alongside a reduced-calorie diet and increased physical activity.

Cardiovascular Risk Reduction: Adults with established cardiovascular disease and either obesity or overweight, to reduce the risk of major adverse cardiovascular events.

BMI Reference Points:

Contraindications:

According to FDA prescribing information, Wegovy should NOT be used by individuals who:

• Have a personal or family history of medullary thyroid carcinoma (MTC)
• Have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
• Have known hypersensitivity to semaglutide or any product components
• Are pregnant or planning to become pregnant (discontinuation is recommended at least 2 months before planned pregnancy)
• Are breastfeeding

Consumers with questions about eligibility or contraindications should consult directly with a licensed healthcare provider.

Understanding the Regulatory Landscape: FDA-Approved vs. Compounded Medications

Consumers researching weight loss medication options may encounter both FDA-approved branded medications and compounded formulations. Understanding the regulatory distinction provides important context for evaluation.

FDA-Approved Medications:

According to FDA communications, approved medications have undergone review for safety, efficacy, and manufacturing quality. Examples include Wegovy, Ozempic, Zepbound, and Mounjaro, which carry specific FDA-approved indications and labeling.

Compounded Medications:

The FDA has stated that compounded versions of semaglutide are not reviewed or approved as finished products for safety, effectiveness, or quality.

According to FDA communications, compounded medications are prepared by licensed pharmacies based on individual prescriptions. While the active pharmaceutical ingredients may be the same, compounded products have not undergone FDA review as finished formulations.

Regulatory Context:

According to published FDA communications, the agency declared the semaglutide shortage resolved in February 2025, which affected compounding permissions. According to regulatory analysis, litigation challenging these determinations continues.

According to FDA safety communications, patients considering compounded options should ask their provider or compounder how to measure and administer the intended dose and which ingredient form is being used.

Consumers evaluating different access pathways should discuss regulatory considerations with their healthcare provider as part of their decision-making process.

Clinical Trial Context: Published Weight Loss Data

For consumers researching effectiveness, understanding what clinical trials demonstrated provides context—while recognizing that individual outcomes vary significantly.

Injectable Wegovy (STEP 1 Trial):

According to the STEP 1 clinical trial published in The New England Journal of Medicine:

• Participants taking Wegovy 2.4 mg weekly experienced average weight loss of approximately 14.9% over 68 weeks
• According to the published data, 86% of participants lost at least 5% of body weight
• The trial included lifestyle modifications alongside medication

Oral Wegovy (OASIS 4 Trial):

According to the OASIS 4 trial published in The New England Journal of Medicine:

• Participants who adhered to the oral treatment protocol experienced average weight loss of approximately 16.6% over 64 weeks
• The overall trial population (regardless of adherence) experienced average weight loss of approximately 13.6%
• According to the manufacturer, results were considered comparable to injectable formulation trials, though the studies were conducted separately

Important Clinical Trial Context:

According to standard clinical research principles, trial results represent population averages from controlled conditions with specific patient populations, lifestyle interventions, and medical supervision. Individual outcomes vary significantly based on adherence, lifestyle factors, medical history, and biological response. Clinical trial results should not be interpreted as guarantees of individual outcomes.

Safety Information: What Consumers Should Know

According to FDA prescribing information and published clinical trial data, Wegovy carries specific safety considerations that consumers should review with their healthcare provider.

Boxed Warning:

According to FDA prescribing information, Wegovy carries a boxed warning regarding thyroid C-cell tumors:

In rodent studies, semaglutide caused thyroid tumors, including thyroid cancer. According to the FDA, it is unknown whether Wegovy causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans. Wegovy is contraindicated in patients with personal or family history of MTC or MEN 2.

Commonly Reported Side Effects:

According to clinical trial data, commonly reported side effects include:

• Nausea
• Diarrhea
• Vomiting
• Constipation
• Abdominal pain
• Headache and fatigue

According to prescribing information, gastrointestinal side effects are most commonly reported when starting treatment or increasing doses and may improve as the body adjusts.

Serious Side Effects:

According to prescribing information, serious side effects may include pancreatitis, gallbladder problems, kidney problems, serious allergic reactions, increased heart rate, and depression or suicidal thoughts. Consumers should seek medical attention for severe symptoms.

Medical Supervision Requirement:

According to FDA prescribing information, Wegovy requires ongoing medical supervision. Consumers should discuss the full scope of potential benefits and risks with a licensed healthcare provider before and during treatment.

Consumer Self-Assessment Framework

Rather than product recommendations, this framework helps consumers evaluate whether further exploration of GLP-1 medication pathways may be appropriate for their circumstances.

Consumers May Consider Further Evaluation If They:

• Meet FDA eligibility criteria (BMI 30+ or BMI 27+ with weight-related medical condition)
• Have discussed weight management options with a healthcare provider
• Understand that GLP-1 medications work alongside lifestyle modifications
• Can evaluate the financial commitment involved in ongoing treatment
• Are comfortable with telehealth-based or in-person medical care models

Consumers Should Consult Healthcare Providers If They Have:

• Any contraindications listed in prescribing information
• Uncertainty about eligibility or appropriateness
• Questions about interactions with current medications
• Concerns about side effects or monitoring requirements
• Government insurance and need guidance on coverage options

Questions Consumers Typically Discuss With Providers:

• Am I a candidate based on BMI and health factors?
• What are the potential benefits and risks for my specific situation?
• What monitoring and follow-up would be required?
• How do different access pathways compare for my circumstances?
• What is the expected timeline and financial commitment?

Consumers typically review eligibility criteria, insurance compatibility, and ongoing program requirements directly with the platform and a licensed clinician.

View the current Ro Wegovy offer (official Ro page)

Frequently Asked Questions

What has Ro published regarding Wegovy pricing?

According to Ro’s official website, the platform lists cash-pay Wegovy pricing beginning at $199 per month for certain starter doses during a limited promotional period. The Ro Body membership is listed at $45 for the first month and $145 monthly thereafter. Higher doses and ongoing pricing are listed separately in their disclosures.

What is the source of Wegovy through Ro?

According to Ro’s published disclosures, Wegovy accessed through their platform is sourced through NovoCare Pharmacy, which is operated by Novo Nordisk.

Is Ro a licensed telehealth platform?

According to publicly available information, Ro is a telehealth company that has operated since 2017 and partners with licensed healthcare providers across all 50 U.S. states.

What has been published regarding oral Wegovy availability?

According to Novo Nordisk’s announcement, the oral Wegovy formulation is expected to become available through pharmacies and select telehealth providers in early January 2026. Consumers should verify availability directly with platforms.

What are the insurance limitations through Ro?

According to Ro’s website, the platform cannot coordinate coverage for Medicare, Medicaid, or VA plans for GLP-1 medications used for weight loss. The company offers an insurance concierge service for consumers with commercial insurance.

How do clinical trial results relate to individual outcomes?

According to standard clinical research principles, trial results represent population averages and do not guarantee individual outcomes. Results vary based on adherence, lifestyle factors, medical history, and biological response.

Summary: Evaluating Wegovy Access Pathways in 2026

The weight loss medication landscape has evolved substantially as 2026 begins. For consumers evaluating Wegovy access pathways, this analysis has examined:

What Has Been Published:

• Manufacturer and platform pricing disclosures
• FDA approval updates including oral formulation
• Telehealth access structures and membership requirements
• Clinical trial data and safety information

What Consumers Typically Evaluate:

• Eligibility based on FDA indications
• Access pathway alignment with individual circumstances
• Financial commitment and insurance considerations
• Format preferences (oral vs. injectable)
• Provider access and support structures

Regulatory Context:

• FDA-approved medications have undergone safety and efficacy review
• Compounded formulations have different regulatory status
• The landscape continues to evolve with new approvals and pricing structures

For consumers interested in exploring Ro’s published Wegovy pricing and access structure, view the current Ro Wegovy offer (official Ro page) to review current disclosures and evaluate whether further exploration aligns with individual circumstances.

Contact Information

According to Ro’s website, consumers can access platform information and support through:

Website: ro.co/weight-loss

Emai: care@ro.co

Support: Available through the Ro platform

Disclaimers

Content and Medical Disclaimer: This article is for informational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. The descriptions of potential benefits are based on published clinical research and do not guarantee individual outcomes. GLP-1 medications require evaluation by a licensed clinician. The information provided here does not replace the professional judgment of your healthcare provider.

Professional Medical Disclaimer: This article is educational and does not constitute medical advice. If you are currently taking medications, have existing health conditions, are pregnant or nursing, or are considering any major changes to your health regimen, consult your physician before starting any prescription treatment. Do not change, adjust, or discontinue any medications or prescribed treatments without your physician’s guidance and approval.

Safety Information: Wegovy (semaglutide) carries a boxed warning regarding thyroid C-cell tumors observed in rodent studies. Wegovy is contraindicated in patients with personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Common side effects include nausea, diarrhea, vomiting, constipation, and abdominal pain. Serious side effects may include pancreatitis, gallbladder problems, kidney problems, and serious allergic reactions. For complete safety information, review the full prescribing information and consult your healthcare provider.

Results Disclaimer: Individual results will vary based on factors including age, starting weight, baseline health condition, lifestyle factors, consistency of use, adherence to diet and exercise recommendations, genetic factors, current medications, and other individual variables. Clinical trial results represent averages and are not guarantees of individual outcomes. Results are not guaranteed. Prescription approval is not guaranteed; licensed medical providers make final determinations based on individual medical appropriateness.

FTC Affiliate Disclosure: This article contains affiliate links. If you purchase through these links, a commission may be earned at no additional cost to you. This compensation does not influence the accuracy, neutrality, or integrity of the information presented. All descriptions are based on published research, manufacturer announcements, clinical trial data, and publicly available platform information.

Pricing Disclaimer: All prices, promotional offers, and terms mentioned were accurate based on published information at the time of publication (December 2025) but are subject to change without notice. Always verify current pricing and terms on official websites before making decisions.

Publisher Responsibility: The publisher of this article has made every effort to ensure accuracy at the time of publication based on publicly available information, manufacturer announcements, clinical trial publications, and platform disclosures. We do not accept responsibility for errors, omissions, or outcomes resulting from the use of the information provided. Readers are encouraged to verify all details directly with Ro, Novo Nordisk, their insurance provider, and their healthcare provider before making decisions.

Insurance Coverage Note: Insurance coverage for GLP-1 medications varies significantly by plan. Many commercial insurance plans require prior authorization for weight loss medications. Medicare Part D plans generally do not cover GLP-1 medications when prescribed for weight loss. Coverage may apply for cardiovascular risk reduction in patients with established heart disease. Medicaid coverage varies by state. Always confirm benefits directly with your insurer before beginning treatment.

Telehealth Platform Disclosure: According to standard telehealth industry structure, Ro operates as a technology platform that coordinates care. Licensed medical providers affiliated with Ro make independent prescribing decisions. NovoCare Pharmacy, operated by Novo Nordisk, dispenses medications. These are separate entities with distinct roles in the care process.

Analysis based on information available as of December 30, 2025. Verify current information directly with Ro, manufacturers, insurance providers, and healthcare professionals.

CONTACT: Email: care@ro.co