TG Therapeutics to Participate in the 8th Annual Evercore Healthcare Conference




TG Therapeutics to Participate in the 8th Annual Evercore Healthcare Conference

Fireside chat scheduled for Tuesday, December 2, 2025 at 12:30 PM ET

NEW YORK, Nov. 28, 2025 (GLOBE NEWSWIRE) — TG Therapeutics, Inc. (NASDAQ: TGTX) today announced that Michael S. Weiss, the Company’s Chairman and Chief Executive Officer, will participate in the 8^th Annual Evercore Healthcare Conference, which is taking place from December 2 – 4, 2025. The fireside chat is scheduled to take place on Tuesday, December 2, 2025, at 12:30 PM ET.

A live webcast of the fireside chat will be available on the Events page, located within the Investors & Media section, of the Company’s website at http://ir.tgtherapeutics.com/events.

ABOUT TG THERAPEUTICS
TG Therapeutics is a fully integrated, commercial stage, biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline including several investigational medicines, TG Therapeutics has received approval from the U.S. Food and Drug Administration (FDA) for BRIUMVI^® (ublituximab-xiiy) for the treatment of adult patients with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, as well as approval from several regulatory agencies outside of the U.S. for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features. For more information, visit www.tgtherapeutics.com, and follow us on X (formerly Twitter) @TGTherapeutics and on LinkedIn.

BRIUMVI^® is a registered trademark of TG Therapeutics, Inc.

CONTACT:
Investor Relations
Email: ir@tgtxinc.com
Telephone: 1.877.575.TGTX (8489), Option 4

Media Relations 
Email: media@tgtxinc.com
Telephone: 1.877.575.TGTX (8489), Option 6

Results of the Votes of the Combined Shareholders’ General Meeting of November 27, 2025




Results of the Votes of the Combined Shareholders’ General Meeting of November 27, 2025

Daix (France), New York City (New York, United States), November 28, 2025 – Inventiva (Euronext Paris and Nasdaq: IVA) (the “Company”), a clinical-stage biopharmaceutical company focused on the development of oral therapies for the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”), today announced the results of the votes of its Combined Shareholders’ Meeting.  

The Combined Shareholders’ Meeting was held on Thursday November 27, 2025, at 9 a.m. at Hôtel Villa M, 24-30 Bd Pasteur, 75015 Paris (France), under the chairmanship of Mr. Pierre Broqua.

Mr. Pierre Broqua proceeded to the usual formalities of the opening of the meeting, in particular to the constitution of the Bureau by appointing Mr. Eric Duranson, as secretary of the general meeting.

All the resolutions submitted to vote have been adopted by the shareholders, with the exception of the 5^th resolution, which had been the subject of a negative recommendation by the Board of Directors. The 5^th resolution would have empowered the Board of Directors to decide on share capital increases reserved for members of a company savings plan to be set up by the Company.

Pursuant to Article R. 22-10-14 IV. of the French Commercial Code, the Combined Shareholders’ Meeting approved, without modification, the compensation policy for the Chief Executive Officer as described in the Combined Shareholders’ Meeting notice brochure available on the Company’s website under the heading “Shareholders’ Meeting”.

• Total number of shares composing the share capital: 191 077 498
• Total number of shares with voting rights: 191 027 885

About Inventiva

Inventiva is a clinical-stage biopharmaceutical company focused on the research and development of oral small molecule therapies for the treatment of patients with MASH and other diseases with significant unmet medical need. The Company is currently evaluating lanifibranor, a novel pan-PPAR agonist, in the NATiV3 pivotal Phase 3 clinical trial for the treatment of adult patients with MASH, a common and progressive chronic liver disease.

Inventiva is a public company listed on compartment B of the regulated market of Euronext Paris (ticker: IVA, ISIN: FR0013233012) and on the Nasdaq Global Market in the United States (ticker: IVA). http://www.inventivapharma.com

Contacts
  

Important Notice

This press release contains certain “forward-looking statements” within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release are forward-looking statements. These statements include, but are not limited to, forecasts and estimates with respect to Inventiva’s cash resources, forecasts and estimates with respect to Inventiva’s NATiV3 Phase 3 clinical trial of lanifibranor in MASH , including duration, timing and costs, and the results and timing thereof and regulatory matters with respect thereto, clinical trial data releases and publications, the potential therapeutic benefits of lanifibranor, and future activities, expectations, plans, growth and prospects of Inventiva, and the absence of material adverse events. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will”, “would”, “could”, “might”, “should”, “designed”, “hopefully”, “target”, “potential”, “opportunity”, “possible”, “aim”, and “continue” and similar expressions. Such statements are not historical facts but rather are statements of future expectations and other forward-looking statements that are based on management’s beliefs. These statements reflect such views and assumptions prevailing as of the date of the statements and involve known and unknown risks and uncertainties that could cause future results, performance, or future events to differ materially from those expressed or implied in such statements. Actual events are difficult to predict and may depend upon factors that are beyond Inventiva’s control. There can be no guarantees with respect to pipeline product candidates that the clinical trial results will be available on their anticipated timeline, that future clinical trials will be initiated as anticipated, that product candidates will receive the necessary regulatory approvals, or that any of the anticipated milestones by Inventiva or its partners will be reached on their expected timeline, or at all. Future results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates due to a number of factors, including that the recommendation of the DMC may not be indicative of a potential marketing approval, Inventiva cannot provide assurance on the impacts of the Suspected Unexpected Serious Adverse Reaction on the results or timing of the NATiV3 trial or regulatory matters with respect thereto, that Inventiva is a clinical-stage company with no approved products and no historical product revenues, Inventiva has incurred significant losses since inception and has never generated any revenue from product sales, Inventiva will require additional capital to finance its operations, in the absence of which, Inventiva may be required to significantly curtail, delay or discontinue one or more of its research or development programs or be unable to expand its operations or otherwise capitalize on its business opportunities and may be unable to continue as a going concern, Inventiva’s ability to obtain financing and to enter into potential transactions, Inventiva’s future success is dependent on the successful clinical development, regulatory approval and subsequent commercialization of its lanifibranor, preclinical studies or earlier clinical trials are not necessarily predictive of future results and the results of Inventiva’s and its partners’ clinical trials may not support Inventiva’s and its partners’ product candidate claims, Inventiva’s expectations with respect to its clinical trials may prove to be wrong and regulatory authorities may require additional holds and/or additional amendments to Inventiva’s clinical trials, Inventiva’s expectations with respect to the clinical development plan for lanifibranor for the treatment of MASH may not be realized and may not support the approval of a New Drug Application, Inventiva’s ability to identify additional products or product candidates with significant commercial potential, Inventiva’s expectations with respect to its pipeline prioritization plan and related workforce reduction, including whether the plan will be implemented and the timing, potential benefits, expenses and consequences relating thereto, Inventiva’s ability to execute on its commercialization, marketing and manufacturing capabilities and strategy, Inventiva’s ability to successfully cooperate with existing partners or enter into new partnerships, and to fulfill its obligations under any agreements entered into in connection with such partnerships, the benefits of its existing and future partnerships on the clinical development, regulatory approvals and, if approved, commercialization of its product candidates, and the achievement of milestones thereunder and the timing thereof, Inventiva and its partners may encounter substantial delays beyond expectations in their clinical trials or fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities, the ability of Inventiva and its partners to recruit and retain patients in clinical studies, enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside Inventiva’s and its partners’ control, Inventiva’s product candidates may cause adverse drug reactions or have other properties that could delay or prevent their regulatory approval, or limit their commercial potential, Inventiva faces substantial competition and Inventiva’s business, and pre-clinical studies and clinical development programs and timelines, its financial condition and results of operations could be materially and adversely affected by changes in laws and regulations, unfavorable conditions in its industry, geopolitical events, such as the conflict between Russia and Ukraine and related sanctions, the conflict in the Middle East and the related risk of a larger conflict, health epidemics, and macroeconomic conditions, including developments in international trade policies, global inflation, financial and credit market fluctuations, tariffs and other trade barriers, international trade relations, political turmoil, and natural catastrophes, uncertain financial markets and disruptions in banking systems. Given these risks and uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts, and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. Readers are cautioned not to place undue reliance on any of these forward-looking statements.

Please refer to the Universal Registration Document for the year ended December 31, 2024 filed with the Autorité des Marchés Financiers on April 15, 2025 and the Annual Report on Form 20-F for the year ended December 31, 2024 filed with the Securities and Exchange Commission (the “SEC”) on April 15, 2025 for other risks and uncertainties affecting Inventiva, including those described under the caption “Risk Factors”, and in future filings with the SEC. Other risks and uncertainties of which Inventiva is not currently aware may also affect its forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. All information in this press release is as of the date of the release. Except as required by law, Inventiva has no intention and is under no obligation to update or review the forward-looking statements referred to above. Consequently, Inventiva accepts no liability for any consequences arising from the use of any of the above statements.

Attachment

• Inventiva – PR – Results General Meeting November 2025 – EN – 11 28 2025

Zelluna ASA Announces Appointment of Geir Christian Melen as New Chief Financial Officer




Zelluna ASA Announces Appointment of Geir Christian Melen as New Chief Financial Officer

Oslo, Norway, 28 November 2025 – Zelluna (OSE: ZLNA), a company pioneering allogeneic “off-the-shelf” T Cell Receptor-based Natural Killer (TCR-NK) cell therapies for the treatment of cancer, today announced the appointment of Geir Christian Melen as new Chief Financial Officer, effective 01 January 2026. Hans Vassgård Eid will be stepping down as CFO of Zelluna ASA from the end of December 2025 and supporting the transition thereafter.

“I am very pleased to appoint Geir Christian as our new Chief Financial Officer at such a pivotal time for Zelluna. After seven years with the company, Geir brings a deep understanding of our TCR-NK platform and a strong financial skill set that will support our transition into clinical development. I would also like to express my sincere appreciation to Hans for his significant contributions to Zelluna. He has been CFO of Ultimovacs since 2015 and played a key role in securing a successful business combination between Zelluna and Ultimovacs. I am grateful for his strong contributions successfully integrating the two businesses, and creating a sound basis for taking Zelluna into the clinical development phase. We wish him every success in his future endeavours.” said Namir Hassan, CEO of Zelluna

Geir Christian brings extensive senior leadership experience across the Norwegian biotech and life sciences sector, including multiple CFO and CEO roles in both publicly listed and privately held companies including in Algeta and Photocure. Over his career, he has led financial operations, corporate strategy, and capital market engagement for several life science organisations, giving him a deep understanding of the financial, regulatory, and operational demands of the industry.

Geir Christian has also been part of Zelluna as Finance Director for over seven years, holding a key leadership role across finance and operations. He brings strong familiarity with Zelluna’s TCR-NK platform, financial strategy, and organisational priorities.

“I am excited to take on the CFO role as Zelluna advances toward its first-in-human study. Having been part of the company for several years, I have seen the potential of the TCR-NK platform and the dedication and strong competence of the team. I look forward to contributing to this next phase as we enter clinical development with our lead program ZI-MA4-1.” said Geir Christian Melen, incoming CFO of Zelluna

About Zelluna ASA

Zelluna ASA (OSE: ZLNA) is a biotechnology company pioneering the development of allogeneic ‘off-the-shelf’ T Cell Receptor-based Natural Killer (TCR-NK) cells for the treatment of cancer. The company’s platform combines the innate killing power of NK cells with the precision targeting of TCRs, designed to address the limitations of current cell therapies, particularly in solid tumours. Zelluna’s proprietary manufacturing process enables scalable, cost-effective production of TCR-NK cell therapies, with potential for broad patient accessibility. The company’s lead program, ZI-MA4-1, targets the MAGE-A4 tumour antigen and is expected to enter clinical trials in 2026. Zelluna is headquartered in Oslo, Norway.

Namir Hassan, CEO, Zelluna ASA

Email: namir.hassan@zelluna.com

Phone: +44 7720 687608

This information is considered to be inside information pursuant to the EU Market Abuse Regulation and is subject to the disclosure requirements pursuant to Section 5-12 in the Norwegian Securities Trading Act.

This stock exchange announcement was published by Joachim Midttun, Finance manager of Zelluna ASA, on 28 November 2025 at 07.50 CET.

InnoCare Announces First Patient Dosed in the Global Phase II Clinical Trial of TYK2 Inhibitor Soficitinib for Treatment of Prurigo Nodularis




InnoCare Announces First Patient Dosed in the Global Phase II Clinical Trial of TYK2 Inhibitor Soficitinib for Treatment of Prurigo Nodularis

BEIJING, Nov. 27, 2025 (GLOBE NEWSWIRE) — InnoCare Pharma (HKEX: 9969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today that the first patient has been dosed in the global Phase II clinical trial of its novel TYK2 inhibitor, Soficitinib (ICP-332), for the treatment of patients with prurigo nodularis in China.

Soficitinib is a potent and selective TYK2 inhibitor that is being developed for the treatment of various T-cell related autoimmune disorders. The Current indications under development are strategically positioned within the vast dermatology market, including atopic dermatitis, vitiligo, prurigo nodularis, urticaria, and more. TYK2 plays a key role in the JAK-STAT signaling pathway and is critical in the pathogenesis of inflammatory diseases.

Prurigo nodularis is a chronic inflammatory skin disease characterized by severe itching and skin nodules, which significantly impairs patients’ quality of life. Soficitinib alleviates symptoms by blocking the signaling pathways of cytokines related to itching and inflammation, such as IL-4, IL-13, and IL-31, thereby reducing neurogenic itch responses and inhibiting skin inflammation.

There are about 10 million patients with prurigo nodularis worldwide¹. The global prurigo nodularis market was valued at US$2 billion in 2024 and is expected to grow to US$3 billion in 2034².

Dr. Jasmine Cui, Co-founder, Chairwoman, and CEO of InnoCare, said, “InnoCare’s pipeline under development now covers ten major autoimmune diseases, with a particular focus on dermatological conditions. The Phase II clinical study of Soficitinib for moderate-to-severe atopic dermatitis demonstrated outstanding efficacy and a strong safety profile. The data has been released as a late-breaking oral presentation at the American Academy of Dermatology (AAD) Annual Meeting. We are accelerating global clinical development to bring innovative therapies to more autoimmune patients as early as possible.”

About InnoCare

InnoCare is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancers and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States.

InnoCare Forward-looking Statements

This report contains the disclosure of some forward-looking statements. Except for statements of facts, all other statements can be regarded as forward-looking statements, that is, about our or our management’s intentions, plans, beliefs, or expectations that will or may occur in the future. Such statements are assumptions and estimates made by our management based on its experience and knowledge of historical trends, current conditions, expected future development and other related factors. This forward-looking statement does not guarantee future performance, and actual results, development and business decisions may not match the expectations of the forward-looking statement. Our forward-looking statements are also subject to a large number of risks and uncertainties, which may affect our short-term and long-term performance.

___________________________
¹ https://doi.org/10.1111/jdv.20585
² Global Market Insights

Eisai Submits New Drug Application for Subcutaneous Formulation of “LEQEMBI®” for the Treatment of Early Alzheimer’s Disease in Japan




Eisai Submits New Drug Application for Subcutaneous Formulation of “LEQEMBI®” for the Treatment of Early Alzheimer’s Disease in Japan

If approved, lecanemab would be the first and only anti-amyloid treatment in Japan to offer an at-home injection from the initiation of treatment for this progressive, relentless disease

TOKYO and CAMBRIDGE, Mass., Nov. 27, 2025 (GLOBE NEWSWIRE) — Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that Eisai has filed a new drug application for “LEQEMBI^®” (brand name, generic name: lecanemab) seeking approval for a subcutaneous formulation (subcutaneous autoinjector: SC-AI) as a new route of administration to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).

The application is based on data from multiple subcutaneous (SC) administration sub-studies of lecanemab conducted as part of the Phase 3 Clarity AD open-label extension (OLE), following the 18-month core study in individuals with Mild Cognitive Impairment (MCI) due to Alzheimer‘s disease (AD) or mild stage of AD dementia (collectively referred to as early AD). It was confirmed that the once-weekly administration of SC-AI 500mg resulted in equivalent exposure to once every two weeks intravenous (IV) administration and similar clinical and biomarker benefits. Subcutaneous administration demonstrated a safety profile similar to IV administration, with less than 2% incidence of systemic injection/infusion-related reactions.

If approved, the SC-AI of 500 mg (two 250 mg injections) could be used to administer a once-weekly dose at home from the initiation of treatment, as an alternative to the current IV administration every two weeks dose in the hospital setting. The potential approval of SC-AI would expand the option for patients and care partners to receive LEQEMBI treatment at home. The injection time for each autoinjector (250mg injection) is approximately 15 seconds. The SC formulation also has the potential to reduce healthcare resources associated with IV dosing, such as preparation for infusion and nurse monitoring, while streamlining the overall AD treatment care pathway.

AD is a progressive, relentless disease with amyloid beta (Aβ) and tau as hallmarks that is caused by a continuous underlying neurotoxic process driven by protofibrils* that begins before amyloid plaque accumulation and continues after plaque removal.^1,2,3 Only LEQEMBI fights AD in two ways – targeting both protofibrils and amyloid plaque, which can impact tau downstream.

LEQEMBI is currently approved in 51 countries and regions and is under regulatory review in 9 countries.

Eisai serves as the lead for lecanemab’s development and regulatory submissions globally with Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.

*Protofibrils are believed to contribute to the brain injury that occurs with AD and are considered to be the most toxic form of Aβ, having a primary role in the cognitive decline associated with this progressive, debilitating condition.¹ Protofibrils cause injury to neurons in the brain, which in turn, can negatively impact cognitive function via multiple mechanisms, not only increasing the development of insoluble Aβ plaques but also increasing direct damage to brain cell membranes and the connections that transmit signals between nerve cells or nerve cells and other cells. It is believed the reduction of protofibrils may prevent the progression of AD by reducing damage to neurons in the brain and cognitive dysfunction.²

Notes to Editors

1. About lecanemab (generic name, brand name: LEQEMBI^®)
   Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ).

   Lecanemab has been approved in 51 countries and regions including Japan, the United States, Europe, China, South Korea, Taiwan, and Saudi Arabia, and is under regulatory review in 9 countries. Leqembi received manufacturing and marketing approval in Japan on September, 2023 for the indication of a treatment for slowing progression of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease (AD). Following the initial phase with treatment every two weeks for 18 months, intravenous (IV) maintenance dosing with treatment every four weeks was approved in the U.S., China, he United Kingdom, and others, and applications have been filed in 4 countries and regions. The U.S. FDA approved Eisai’s Biologics License Application (BLA) for subcutaneous maintenance dosing with LEQEMBI IQLIK in August 2025. A rolling Supplemental Biologics License Application (sBLA) for initiation treatment was initiated under Fast Track status in September 2025, and completed in November 2025.

   Since July 2020 the Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer’s Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S, funded by the National Institute on Aging, part of the National Institutes of Health, Eisai and Biogen. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing and includes lecanemab as the backbone anti-amyloid therapy.

2. About the Collaboration between Eisai and Biogen for AD
   Eisai and Biogen have been collaborating on the joint development and commercialization of AD treatments since 2014. Eisai serves as the lead of lecanemab development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority.
3. About the Collaboration between Eisai and BioArctic for AD
   Since 2005, Eisai and BioArctic have had a long-term collaboration regarding the development and commercialization of AD treatments. Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement with BioArctic in December 2007. The development and commercialization agreement on the antibody lecanemab back-up was signed in May 2015.
4. About Eisai Co., Ltd. 
   Eisai’s Corporate Concept is “to give first thought to patients and people in the daily living domain, and to increase the benefits that health care provides.” Under this Concept (also known as human health care (hhc) Concept), we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to create and deliver innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.

   In addition, we demonstrate our commitment to the elimination of neglected tropical diseases (NTDs), which is a target (3.3) of the United Nations Sustainable Development Goals (SDGs), by working on various activities together with global partners.

   For more information about Eisai, please visit www.eisai.com (for global headquarters: Eisai Co., Ltd.), and connect with us on X, LinkedIn and Facebook. The website and social media channels are intended for audiences outside of the UK and Europe. For audiences based in the UK and Europe, please visit www.eisai.eu and Eisai EMEA LinkedIn.

5. About Biogen
   Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patient’s lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth.

The company routinely posts information that may be important to investors on its website at www.biogen.com. Follow Biogen on social media – Facebook, LinkedIn, X, YouTube.

Biogen Safe Harbor
This news release contains forward-looking statements, including about the potential clinical effects of lecanemab; the potential benefits, safety and efficacy of lecanemab; potential regulatory discussions, submissions and approvals and the timing thereof including for LEQEMBI (lecanemab) subcutaneous autoinjector (SC-AI); the potential to streamline the Alzheimer’s disease treatment pathway; the anticipated benefits and potential of Biogen’s collaboration arrangements with Eisai; the potential of Biogen’s commercial business and pipeline programs, including lecanemab; and risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by such words as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “forecast,” “goal,” “guidance,” “hope,” “intend,” “may,” “objective,” “outlook,” “plan,” “possible,” “potential,” “predict,” “project,” “prospect,” “should,” “target,” “will,” “would” or the negative of these words or other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements. Given their forward-looking nature, these statements involve substantial risks and uncertainties that may be based on inaccurate assumptions and could cause actual results to differ materially from those reflected in such statements.

These forward-looking statements are based on management’s current beliefs and assumptions and on information currently available to management. Given their nature, we cannot assure that any outcome expressed in these forward-looking statements will be realized in whole or in part. We caution that these statements are subject to risks and uncertainties, many of which are outside of our control and could cause future events or results to differ materially from those stated or implied in this document, including, among others, uncertainty of our long-term success in developing, licensing, or acquiring other product candidates or additional indications for existing products; expectations, plans, prospects and timing of actions relating to product approvals, approvals of additional indications for our existing products, sales, pricing, growth, reimbursement and launch of our marketed and pipeline products; the potential impact of increased product competition in the biopharmaceutical and healthcare industry, as well as any other markets in which we compete, including increased competition from new originator therapies, generics, prodrugs and biosimilars of existing products and products approved under abbreviated regulatory pathways; our ability to effectively implement our corporate strategy; difficulties in obtaining and maintaining adequate coverage, pricing, and reimbursement for our products; the drivers for growing our business, including our dependence on collaborators and other third parties for the development, regulatory approval, and commercialization of products and other aspects of our business, which are outside of our full control; risks related to commercialization of biosimilars, which is subject to such risks related to our reliance on third-parties, intellectual property, competitive and market challenges and regulatory compliance; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials or success in early stage clinical trials may not be predictive of results in later stage or large scale clinical trials or trials in other potential indications; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; and the occurrence of adverse safety events, restrictions on use with our products, or product liability claims; and any other risks and uncertainties that are described in other reports we have filed with the U.S. Securities and Exchange Commission, which are available on the SEC’s website at www.sec.gov.

These statements speak only as of the date of this press release and are based on information and estimates available to us at this time. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and in our subsequent reports on Form 10-Q. Except as required by law, we do not undertake any obligation to publicly update any forward-looking statements whether as a result of any new information, future events, changed circumstances or otherwise.

Digital Media Disclosure
From time to time, we have used, or expect in the future to use, our investor relations website (investors.biogen.com), the Biogen LinkedIn account (linkedin.com/company/biogen-) and the Biogen X account (https://x.com/biogen) as a means of disclosing information to the public in a broad, non-exclusionary manner, including for purposes of the SEC’s Regulation Fair Disclosure (Reg FD). Accordingly, investors should monitor our investor relations website and these social media channels in addition to our press releases, SEC filings, public conference calls and websites, as the information posted on them could be material to investors.

References

1. Amin L, Harris DA. Aβ receptors specifically recognize molecular features displayed by fibril ends and neurotoxic oligomers. Nat Commun. 2021;12:3451. doi:10.1038/s41467-021-23507-z
2. Ono K, Tsuji M. Protofibrils of Amyloid-β are Important Targets of a Disease-Modifying Approach for Alzheimer’s Disease. Int J Mol Sci. 2020;21(3):952. doi: 10.3390/ijms21030952. PMID: 32023927; PMCID: PMC7037706.
3. Hampel H, Hardy J, Blennow K, et al. The amyloid pathway in Alzheimer’s disease.
   Mol Psychiatry. 2021;26(10):5481-5503.

Eisai Submits New Drug Application for Subcutaneous Formulation of “LEQEMBI®” for the Treatment of Early Alzheimer’s Disease in Japan




Eisai Submits New Drug Application for Subcutaneous Formulation of “LEQEMBI®” for the Treatment of Early Alzheimer’s Disease in Japan

If approved, lecanemab would be the first and only anti-amyloid treatment in Japan to offer an at-home injection from the initiation of treatment for this progressive, relentless disease

TOKYO and CAMBRIDGE, Mass., Nov. 27, 2025 (GLOBE NEWSWIRE) — Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that Eisai has filed a new drug application for “LEQEMBI^®” (brand name, generic name: lecanemab) seeking approval for a subcutaneous formulation (subcutaneous autoinjector: SC-AI) as a new route of administration to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).

The application is based on data from multiple subcutaneous (SC) administration sub-studies of lecanemab conducted as part of the Phase 3 Clarity AD open-label extension (OLE), following the 18-month core study in individuals with Mild Cognitive Impairment (MCI) due to Alzheimer‘s disease (AD) or mild stage of AD dementia (collectively referred to as early AD). It was confirmed that the once-weekly administration of SC-AI 500mg resulted in equivalent exposure to once every two weeks intravenous (IV) administration and similar clinical and biomarker benefits. Subcutaneous administration demonstrated a safety profile similar to IV administration, with less than 2% incidence of systemic injection/infusion-related reactions.

If approved, the SC-AI of 500 mg (two 250 mg injections) could be used to administer a once-weekly dose at home from the initiation of treatment, as an alternative to the current IV administration every two weeks dose in the hospital setting. The potential approval of SC-AI would expand the option for patients and care partners to receive LEQEMBI treatment at home. The injection time for each autoinjector (250mg injection) is approximately 15 seconds. The SC formulation also has the potential to reduce healthcare resources associated with IV dosing, such as preparation for infusion and nurse monitoring, while streamlining the overall AD treatment care pathway.

AD is a progressive, relentless disease with amyloid beta (Aβ) and tau as hallmarks that is caused by a continuous underlying neurotoxic process driven by protofibrils* that begins before amyloid plaque accumulation and continues after plaque removal.^1,2,3 Only LEQEMBI fights AD in two ways – targeting both protofibrils and amyloid plaque, which can impact tau downstream.

LEQEMBI is currently approved in 51 countries and regions and is under regulatory review in 9 countries.

Eisai serves as the lead for lecanemab’s development and regulatory submissions globally with Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.

*Protofibrils are believed to contribute to the brain injury that occurs with AD and are considered to be the most toxic form of Aβ, having a primary role in the cognitive decline associated with this progressive, debilitating condition.¹ Protofibrils cause injury to neurons in the brain, which in turn, can negatively impact cognitive function via multiple mechanisms, not only increasing the development of insoluble Aβ plaques but also increasing direct damage to brain cell membranes and the connections that transmit signals between nerve cells or nerve cells and other cells. It is believed the reduction of protofibrils may prevent the progression of AD by reducing damage to neurons in the brain and cognitive dysfunction.²

Notes to Editors

1. About lecanemab (generic name, brand name: LEQEMBI^®)
   Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ).

   Lecanemab has been approved in 51 countries and regions including Japan, the United States, Europe, China, South Korea, Taiwan, and Saudi Arabia, and is under regulatory review in 9 countries. Leqembi received manufacturing and marketing approval in Japan on September, 2023 for the indication of a treatment for slowing progression of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease (AD). Following the initial phase with treatment every two weeks for 18 months, intravenous (IV) maintenance dosing with treatment every four weeks was approved in the U.S., China, he United Kingdom, and others, and applications have been filed in 4 countries and regions. The U.S. FDA approved Eisai’s Biologics License Application (BLA) for subcutaneous maintenance dosing with LEQEMBI IQLIK in August 2025. A rolling Supplemental Biologics License Application (sBLA) for initiation treatment was initiated under Fast Track status in September 2025, and completed in November 2025.

   Since July 2020 the Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer’s Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S, funded by the National Institute on Aging, part of the National Institutes of Health, Eisai and Biogen. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing and includes lecanemab as the backbone anti-amyloid therapy.

2. About the Collaboration between Eisai and Biogen for AD
   Eisai and Biogen have been collaborating on the joint development and commercialization of AD treatments since 2014. Eisai serves as the lead of lecanemab development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority.
3. About the Collaboration between Eisai and BioArctic for AD
   Since 2005, Eisai and BioArctic have had a long-term collaboration regarding the development and commercialization of AD treatments. Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement with BioArctic in December 2007. The development and commercialization agreement on the antibody lecanemab back-up was signed in May 2015.
4. About Eisai Co., Ltd. 
   Eisai’s Corporate Concept is “to give first thought to patients and people in the daily living domain, and to increase the benefits that health care provides.” Under this Concept (also known as human health care (hhc) Concept), we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to create and deliver innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.

   In addition, we demonstrate our commitment to the elimination of neglected tropical diseases (NTDs), which is a target (3.3) of the United Nations Sustainable Development Goals (SDGs), by working on various activities together with global partners.

   For more information about Eisai, please visit www.eisai.com (for global headquarters: Eisai Co., Ltd.), and connect with us on X, LinkedIn and Facebook. The website and social media channels are intended for audiences outside of the UK and Europe. For audiences based in the UK and Europe, please visit www.eisai.eu and Eisai EMEA LinkedIn.

5. About Biogen
   Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patient’s lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth.

The company routinely posts information that may be important to investors on its website at www.biogen.com. Follow Biogen on social media – Facebook, LinkedIn, X, YouTube.

Biogen Safe Harbor
This news release contains forward-looking statements, including about the potential clinical effects of lecanemab; the potential benefits, safety and efficacy of lecanemab; potential regulatory discussions, submissions and approvals and the timing thereof including for LEQEMBI (lecanemab) subcutaneous autoinjector (SC-AI); the potential to streamline the Alzheimer’s disease treatment pathway; the anticipated benefits and potential of Biogen’s collaboration arrangements with Eisai; the potential of Biogen’s commercial business and pipeline programs, including lecanemab; and risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by such words as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “forecast,” “goal,” “guidance,” “hope,” “intend,” “may,” “objective,” “outlook,” “plan,” “possible,” “potential,” “predict,” “project,” “prospect,” “should,” “target,” “will,” “would” or the negative of these words or other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements. Given their forward-looking nature, these statements involve substantial risks and uncertainties that may be based on inaccurate assumptions and could cause actual results to differ materially from those reflected in such statements.

These forward-looking statements are based on management’s current beliefs and assumptions and on information currently available to management. Given their nature, we cannot assure that any outcome expressed in these forward-looking statements will be realized in whole or in part. We caution that these statements are subject to risks and uncertainties, many of which are outside of our control and could cause future events or results to differ materially from those stated or implied in this document, including, among others, uncertainty of our long-term success in developing, licensing, or acquiring other product candidates or additional indications for existing products; expectations, plans, prospects and timing of actions relating to product approvals, approvals of additional indications for our existing products, sales, pricing, growth, reimbursement and launch of our marketed and pipeline products; the potential impact of increased product competition in the biopharmaceutical and healthcare industry, as well as any other markets in which we compete, including increased competition from new originator therapies, generics, prodrugs and biosimilars of existing products and products approved under abbreviated regulatory pathways; our ability to effectively implement our corporate strategy; difficulties in obtaining and maintaining adequate coverage, pricing, and reimbursement for our products; the drivers for growing our business, including our dependence on collaborators and other third parties for the development, regulatory approval, and commercialization of products and other aspects of our business, which are outside of our full control; risks related to commercialization of biosimilars, which is subject to such risks related to our reliance on third-parties, intellectual property, competitive and market challenges and regulatory compliance; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials or success in early stage clinical trials may not be predictive of results in later stage or large scale clinical trials or trials in other potential indications; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; and the occurrence of adverse safety events, restrictions on use with our products, or product liability claims; and any other risks and uncertainties that are described in other reports we have filed with the U.S. Securities and Exchange Commission, which are available on the SEC’s website at www.sec.gov.

These statements speak only as of the date of this press release and are based on information and estimates available to us at this time. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and in our subsequent reports on Form 10-Q. Except as required by law, we do not undertake any obligation to publicly update any forward-looking statements whether as a result of any new information, future events, changed circumstances or otherwise.

Digital Media Disclosure
From time to time, we have used, or expect in the future to use, our investor relations website (investors.biogen.com), the Biogen LinkedIn account (linkedin.com/company/biogen-) and the Biogen X account (https://x.com/biogen) as a means of disclosing information to the public in a broad, non-exclusionary manner, including for purposes of the SEC’s Regulation Fair Disclosure (Reg FD). Accordingly, investors should monitor our investor relations website and these social media channels in addition to our press releases, SEC filings, public conference calls and websites, as the information posted on them could be material to investors.

References

1. Amin L, Harris DA. Aβ receptors specifically recognize molecular features displayed by fibril ends and neurotoxic oligomers. Nat Commun. 2021;12:3451. doi:10.1038/s41467-021-23507-z
2. Ono K, Tsuji M. Protofibrils of Amyloid-β are Important Targets of a Disease-Modifying Approach for Alzheimer’s Disease. Int J Mol Sci. 2020;21(3):952. doi: 10.3390/ijms21030952. PMID: 32023927; PMCID: PMC7037706.
3. Hampel H, Hardy J, Blennow K, et al. The amyloid pathway in Alzheimer’s disease.
   Mol Psychiatry. 2021;26(10):5481-5503.

HealthTab™ to Power NHS Pilot




HealthTab™ to Power NHS Pilot

Bringing Cholesterol-Lowering Injections to U.K. Community Pharmacies

VANCOUVER, British Columbia, Nov. 27, 2025 (GLOBE NEWSWIRE) — AVRICORE HEALTH INC. (TSXV: AVCR) (the “Company” or “Avricore”) is pleased to announce HealthTab™ is being deployed in a new pilot launched by Barts Health NHS Trust, in collaboration with UCL Partners and the British Heart Foundation (BHF), to deliver inclisiran cholesterol-lowering injections through community pharmacies.

Key Highlights

• HealthTab™ enters secondary-prevention care inside the NHS — a major expansion from screening into therapy-linked workflows.
• Integration with Ortus-iHealth connects HealthTab directly into hospital clinical systems, positioning the platform as core infrastructure for NHS pharmacy-based care.
• Inclisiran pilot validates HealthTab as a trusted technology partner inside a high-profile cardiovascular program.
• Significantly expands HealthTab’s addressable market by enabling participation in long-term lipid management pathways.
• Strengthens Avricore’s position in U.K. community pharmacy networks, aligning perfectly with NHS policy to shift chronic-condition management into pharmacies.

Supported by a £198,000 BHF grant, the pilot reflects growing momentum toward decentralizing cardiovascular therapy delivery and reducing hospital burden by shifting appropriate services into community pharmacies, while better supporting people with long-term conditions closer to home. The initiative builds on the ELoPE-CVD programme, which aims to expand access to preventive heart care in local communities and optimise lipid management for patients at highest cardiovascular risk.

HealthTab Integration with Ortus-Health Platform

A major advancement enabling this new pathway is the integration of HealthTab™ with the Ortus-iHealth platform, which allows pharmacy-generated results to flow directly into hospital clinical systems. This connectivity complements HealthTab’s existing integration with the NHS App (via Patient Knows Best), ensuring data is instantly available to both specialist clinicians and patients within established NHS digital pathways.

From Primary to Secondary Prevention – HealthTab’s Expanding Role

HealthTab has transformed primary prevention by making early cardiometabolic testing fast, reliable and accessible in pharmacies. This pilot now brings HealthTab into secondary prevention, enabling community pharmacies to safely deliver and monitor advanced lipid-lowering therapy for patients already living with cardiovascular disease. This is a major expansion of the platform’s role, placing HealthTab at the heart of pharmacy-based treatment delivery (initiation, administration, monitoring).

“Bringing inclisiran injections into community pharmacies is an important milestone for cardiovascular care, and we’re proud that HealthTab is helping make it possible,” said Rodger Seccombe, CEO of Avricore Health. “We started by empowering pharmacies to identify risk through point-of-care testing. Now, by integrating with the Ortus platform and linking into specialist teams, HealthTab is enabling those same pharmacies to play a meaningful role in secondary prevention and long-term condition management.”

HealthTab™ Supporting Pharmacy-Led Delivery of Inclisiran

The pilot will evaluate how community pharmacies can:

• Administer inclisiran injections traditionally delivered in hospital lipid clinics
• Initiate therapy sooner for patients awaiting specialist care
• Identify at-risk patients through pharmacy-based cholesterol testing powered by HealthTab™
• Provide structured follow-up and monitoring as part of an integrated, long-term lipid management pathway

The NHS has set out a clear ambition to prevent up to 150,000 heart attacks, strokes and cases of dementia over the next decade by improving detection and management of high-risk conditions including high cholesterol. They also commit to increasing the role of community pharmacies in the management of long-term conditions and linking them more tightly into shared digital records.

A Major Step Forward in Platform Expansion

  Strengthens HealthTab’s Position Inside NHS Clinical Pathways

• Being deployed within a major cardiovascular programme highlights HealthTab’s role as a trusted platform for community-based diagnostics and workflow support, spanning both primary and secondary prevention.

  Integration With Ortus Enhances Platform Value

• Connecting HealthTab™ to hospital clinical systems through Ortus moves the platform beyond diagnostics into fully integrated care-team support, helping to create the kind of interoperable, shared record infrastructure envisioned in the NHS’ 10-year agenda.

  Supports Expansion Into Treatment-Linked Workflows

• The ability to support therapy initiation, administration and monitoring, in addition to screening and testing, expands HealthTab’s relevance and value for each deployed site and positions community pharmacies as key partners in long-term cardiovascular condition management.

HealthTab™ at the Core of Scalable, Integrated POCT

HealthTab™ is a complete, turnkey solution for community-based POCT networks, combining best-in-class instruments, cloud software, standardized workflows, and comprehensive training and support. At its center is a secure, cloud-based platform that seamlessly connects point-of-care analyzers, patient results, and QC data into a unified digital infrastructure for distributed testing environments.

This fully integrated approach ensures quality-assured testing, consistent data capture across all locations, and real-time analytics for public-health reporting and performance monitoring, while dramatically reducing implementation complexity for participating sites.

Commitment to Quality and Accuracy

HealthTab™ is designed to meet the highest standards of analytical performance and reliability. Through its partnership with CEQAL Inc., a world-leading reference method laboratory and member of the CDC Cholesterol Reference Method Laboratory Network (CRMLN), HealthTab operates a comprehensive quality management program that mirrors the rigour of accredited clinical laboratories.

The program includes centralized lot monitoring of reagents, internal quality-control procedures, regular external quality-assessment (EQA) events, and expert oversight services to support the accuracy, consistency, and traceability of results to internationally recognized reference standards across participating sites.

About Avricore Health Inc.

Avricore Health Inc. (TSXV: AVCR) is a pharmacy service innovator focused on acquiring and developing early-stage technologies aimed at advancing pharmacy practice and patient care. Through its flagship offering HealthTab™, a wholly owned subsidiary, the Company’s mission is to make actionable health information more accessible to everyone by creating the world’s largest network of rapid testing devices in community pharmacies.

Contact:

Avricore Health Inc.                                        
info@avricorehealth.com                                          
avricore.com                                 

Cautionary Note Regarding Forward-Looking Statements

Information in this press release that involves Avricore Health’s expectations, plans, intentions, or strategies regarding the future are forward-looking statements that are not facts and involve a number of risks and uncertainties. Avricore Health generally uses words such as “outlook,” “will,” “could,” “would,” “might,” “remains,” “to be,” “plans,” “believes,” “may,” “expects,” “intends,” “anticipates,” “estimate,” “future,” “positioned,” “potential,” “project,” “remain,” “scheduled,” “set to,” “subject to,” “upcoming,” and similar expressions to help identify forward-looking statements. In this press release, forward-looking statements include statements regarding: the completion of the placement and the expected timing thereof and the Company’s expected use of proceeds from the placement; the unique features that the HealthTab™ platform offers to pharmacists and patients. Forward-looking statements reflect the then-current expectations, beliefs, assumptions, estimates and forecasts of Avricore Health’s management. The forward-looking statements in this press release are based upon information available to Avricore Health as of the date of this press release. Forward-looking statements believed to be true when made may ultimately prove to be incorrect. These statements are not guarantees of the future performance of Avricore Health and are subject to a few risks, uncertainties, and other factors, some of which are beyond its control and may cause actual results to differ materially from current expectations, including without limitation: failure to meet regulatory requirements; changes in the market; potential downturns in economic conditions; and other risk factors described in Avricore’s public filings. These forward-looking statements speak only as of the date on which they are made, and the Company undertakes no obligation to update them publicly to reflect new information or the occurrence of future events or circumstances, unless otherwise required to do so by law.

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

HealthTab™ to Power NHS Pilot




HealthTab™ to Power NHS Pilot

Bringing Cholesterol-Lowering Injections to U.K. Community Pharmacies

VANCOUVER, British Columbia, Nov. 27, 2025 (GLOBE NEWSWIRE) — AVRICORE HEALTH INC. (TSXV: AVCR) (the “Company” or “Avricore”) is pleased to announce HealthTab™ is being deployed in a new pilot launched by Barts Health NHS Trust, in collaboration with UCL Partners and the British Heart Foundation (BHF), to deliver inclisiran cholesterol-lowering injections through community pharmacies.

Key Highlights

• HealthTab™ enters secondary-prevention care inside the NHS — a major expansion from screening into therapy-linked workflows.
• Integration with Ortus-iHealth connects HealthTab directly into hospital clinical systems, positioning the platform as core infrastructure for NHS pharmacy-based care.
• Inclisiran pilot validates HealthTab as a trusted technology partner inside a high-profile cardiovascular program.
• Significantly expands HealthTab’s addressable market by enabling participation in long-term lipid management pathways.
• Strengthens Avricore’s position in U.K. community pharmacy networks, aligning perfectly with NHS policy to shift chronic-condition management into pharmacies.

Supported by a £198,000 BHF grant, the pilot reflects growing momentum toward decentralizing cardiovascular therapy delivery and reducing hospital burden by shifting appropriate services into community pharmacies, while better supporting people with long-term conditions closer to home. The initiative builds on the ELoPE-CVD programme, which aims to expand access to preventive heart care in local communities and optimise lipid management for patients at highest cardiovascular risk.

HealthTab Integration with Ortus-Health Platform

A major advancement enabling this new pathway is the integration of HealthTab™ with the Ortus-iHealth platform, which allows pharmacy-generated results to flow directly into hospital clinical systems. This connectivity complements HealthTab’s existing integration with the NHS App (via Patient Knows Best), ensuring data is instantly available to both specialist clinicians and patients within established NHS digital pathways.

From Primary to Secondary Prevention – HealthTab’s Expanding Role

HealthTab has transformed primary prevention by making early cardiometabolic testing fast, reliable and accessible in pharmacies. This pilot now brings HealthTab into secondary prevention, enabling community pharmacies to safely deliver and monitor advanced lipid-lowering therapy for patients already living with cardiovascular disease. This is a major expansion of the platform’s role, placing HealthTab at the heart of pharmacy-based treatment delivery (initiation, administration, monitoring).

“Bringing inclisiran injections into community pharmacies is an important milestone for cardiovascular care, and we’re proud that HealthTab is helping make it possible,” said Rodger Seccombe, CEO of Avricore Health. “We started by empowering pharmacies to identify risk through point-of-care testing. Now, by integrating with the Ortus platform and linking into specialist teams, HealthTab is enabling those same pharmacies to play a meaningful role in secondary prevention and long-term condition management.”

HealthTab™ Supporting Pharmacy-Led Delivery of Inclisiran

The pilot will evaluate how community pharmacies can:

• Administer inclisiran injections traditionally delivered in hospital lipid clinics
• Initiate therapy sooner for patients awaiting specialist care
• Identify at-risk patients through pharmacy-based cholesterol testing powered by HealthTab™
• Provide structured follow-up and monitoring as part of an integrated, long-term lipid management pathway

The NHS has set out a clear ambition to prevent up to 150,000 heart attacks, strokes and cases of dementia over the next decade by improving detection and management of high-risk conditions including high cholesterol. They also commit to increasing the role of community pharmacies in the management of long-term conditions and linking them more tightly into shared digital records.

A Major Step Forward in Platform Expansion

  Strengthens HealthTab’s Position Inside NHS Clinical Pathways

• Being deployed within a major cardiovascular programme highlights HealthTab’s role as a trusted platform for community-based diagnostics and workflow support, spanning both primary and secondary prevention.

  Integration With Ortus Enhances Platform Value

• Connecting HealthTab™ to hospital clinical systems through Ortus moves the platform beyond diagnostics into fully integrated care-team support, helping to create the kind of interoperable, shared record infrastructure envisioned in the NHS’ 10-year agenda.

  Supports Expansion Into Treatment-Linked Workflows

• The ability to support therapy initiation, administration and monitoring, in addition to screening and testing, expands HealthTab’s relevance and value for each deployed site and positions community pharmacies as key partners in long-term cardiovascular condition management.

HealthTab™ at the Core of Scalable, Integrated POCT

HealthTab™ is a complete, turnkey solution for community-based POCT networks, combining best-in-class instruments, cloud software, standardized workflows, and comprehensive training and support. At its center is a secure, cloud-based platform that seamlessly connects point-of-care analyzers, patient results, and QC data into a unified digital infrastructure for distributed testing environments.

This fully integrated approach ensures quality-assured testing, consistent data capture across all locations, and real-time analytics for public-health reporting and performance monitoring, while dramatically reducing implementation complexity for participating sites.

Commitment to Quality and Accuracy

HealthTab™ is designed to meet the highest standards of analytical performance and reliability. Through its partnership with CEQAL Inc., a world-leading reference method laboratory and member of the CDC Cholesterol Reference Method Laboratory Network (CRMLN), HealthTab operates a comprehensive quality management program that mirrors the rigour of accredited clinical laboratories.

The program includes centralized lot monitoring of reagents, internal quality-control procedures, regular external quality-assessment (EQA) events, and expert oversight services to support the accuracy, consistency, and traceability of results to internationally recognized reference standards across participating sites.

About Avricore Health Inc.

Avricore Health Inc. (TSXV: AVCR) is a pharmacy service innovator focused on acquiring and developing early-stage technologies aimed at advancing pharmacy practice and patient care. Through its flagship offering HealthTab™, a wholly owned subsidiary, the Company’s mission is to make actionable health information more accessible to everyone by creating the world’s largest network of rapid testing devices in community pharmacies.

Contact:

Avricore Health Inc.                                        
info@avricorehealth.com                                          
avricore.com                                 

Cautionary Note Regarding Forward-Looking Statements

Information in this press release that involves Avricore Health’s expectations, plans, intentions, or strategies regarding the future are forward-looking statements that are not facts and involve a number of risks and uncertainties. Avricore Health generally uses words such as “outlook,” “will,” “could,” “would,” “might,” “remains,” “to be,” “plans,” “believes,” “may,” “expects,” “intends,” “anticipates,” “estimate,” “future,” “positioned,” “potential,” “project,” “remain,” “scheduled,” “set to,” “subject to,” “upcoming,” and similar expressions to help identify forward-looking statements. In this press release, forward-looking statements include statements regarding: the completion of the placement and the expected timing thereof and the Company’s expected use of proceeds from the placement; the unique features that the HealthTab™ platform offers to pharmacists and patients. Forward-looking statements reflect the then-current expectations, beliefs, assumptions, estimates and forecasts of Avricore Health’s management. The forward-looking statements in this press release are based upon information available to Avricore Health as of the date of this press release. Forward-looking statements believed to be true when made may ultimately prove to be incorrect. These statements are not guarantees of the future performance of Avricore Health and are subject to a few risks, uncertainties, and other factors, some of which are beyond its control and may cause actual results to differ materially from current expectations, including without limitation: failure to meet regulatory requirements; changes in the market; potential downturns in economic conditions; and other risk factors described in Avricore’s public filings. These forward-looking statements speak only as of the date on which they are made, and the Company undertakes no obligation to update them publicly to reflect new information or the occurrence of future events or circumstances, unless otherwise required to do so by law.

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

Nyxoah to Participate in the Piper Sandler 37th Annual Healthcare Conference




Nyxoah to Participate in the Piper Sandler 37th Annual Healthcare Conference

Nyxoah to Participate in the Piper Sandler 37^th Annual Healthcare Conference

Mont-Saint-Guibert, Belgium – 27 November, 2025, 10:05pm CET / 4:05pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today announced that the management team will participate in a fireside chat at the Piper Sandler 37^th Annual Healthcare Conference on Thursday, Dec. 4, 2025. The fireside chat is scheduled at 1:30 p.m. (ET) the same day via webcast.

A live audio webcast of the presentation will be available online at the investor relations page of the Company’s website at investors.nyxoah.com.

About Nyxoah
Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat OSA. Nyxoah’s lead solution is the Genio system, a patient-centered, leadless and battery-free hypoglossal neurostimulation therapy for OSA, the world’s most common sleep disordered breathing condition that is associated with increased mortality risk and cardiovascular comorbidities. Nyxoah is driven by the vision that OSA patients should enjoy restful nights and feel enabled to live their life to its fullest.

Following the successful completion of the BLAST OSA study, the Genio system received its European CE Mark in 2019. Nyxoah completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, currently contraindicated in competitors’ therapy. Additionally, the Company announced positive outcomes from the DREAM IDE pivotal study and receipt of approval from the FDA for a subset of adult patients with moderate to severe OSA with an AHI of greater than or equal to 15 and less than or equal to 65.

For more information, please visit http://www.nyxoah.com/.

Caution – CE marked since 2019. FDA approved in August 2025 as prescription-only device.

Contact:

Nyxoah
John Landry
Chief Financial Officer
IR@nyxoah.com

Rémi Renard
Chief Investor Relations & Corporate Communication Officer
IR@nyxoah.com

Attachment

• ENGLISH_NYXH Piper Conf Advisory PR_2025

Dipharma publishes a peer-reviewed study in Organic Process Research & Development: a novel approach to detect and characterize nitrosamine formation in APIs




Dipharma publishes a peer-reviewed study in Organic Process Research & Development: a novel approach to detect and characterize nitrosamine formation in APIs

The pioneer method combines the nitrosation assay procedure (NAP) with 15N-enriched nitrosating reagents and 15N NMR spectroscopy for a safer Active Pharmaceutical Ingredients manufacturing process

MILAN, Nov. 27, 2025 (GLOBE NEWSWIRE) — Dipharma Francis S.r.l. (Dipharma), a leading Contract Development and Manufacturing Organization (CDMO) and a global manufacturer of Active Pharmaceutical Ingredients (APIs) and advanced intermediates, proudly announces the publication of the open-access article titled: “Hunt for NDSRIs: Unveiling Hidden Threats with the Novel ¹⁵N-Enriched NAP Test” in the scientific journal Organic Process Research & Development (OPR&D).

The work outlines a novel and insightful approach developed by Dipharma to detect nitrosamine impurities, particularly nitrosamine drug-substance-related impurities (NDSRIs). Nitrosamines are small nitrogen-based compounds that may form through unintended nitrosation pathways during synthesis, storage or degradation, and are closely monitored because many nitrosamines are potent mutagens and probable human carcinogens. Their control is therefore essential for patient safety, regulatory compliance and the integrity of the pharmaceutical supply chain.

The publication is freely accessible to scientists and industry stakeholders worldwide at:
https://pubs.acs.org/doi/10.1021/acs.oprd.5c00223
It appears in Organic Process Research & Development (OPR&D), a leading peer-reviewed journal focused on chemical process development and scale-up for industrial applications, issued by the American Chemical Society (ACS).

In the article, authored by Anna Simonetto, R&D Researcher, Gabriele Razzetti, Global Director of R&D, and Simone Mantegazza, Research Laboratory Manager, at Dipharma Francis, together with Prof. Enrico Monzani at the University of Pavia (Italy), the research team presents an innovative method that overcomes the limitations of traditional mass-based techniques. By integrating the nitrosation assay procedure (NAP) with ¹⁵N-enriched nitrosating reagents and ¹⁵N-NMR spectroscopy, the authors provide a selective and sensitive technique to detect and characterize nitrosamines, including challenging NDSRIs, even in complex matrices or when dealing with isomeric or degradation-derived species.

This strategy offers a robust and early-stage tool for assessing nitrosamine formation during API development and manufacturing, supporting impurity profiling, process understanding, and alignment with evolving regulatory expectations.
For both innovator and generic pharmaceutical companies, this research represents a significant step forward in proactively identifying and addressing nitrosamine-related challenges and ensuring long-term product reliability.
Dipharma congratulates the authors for this achievement, which reinforces the Company’s commitment to science-driven solutions and to enabling customers to make informed, sustainable decisions throughout the API development lifecycle.

“This publication strengthens Dipharma’s long-term strategy for nitrosamine control, which is grounded in multidisciplinary scientific investigation and combines advanced analytical solutions, a robust Risk Assessment Protocol, and proactive measures designed to safeguard compliance and product safety,” said Gabriele Razzetti, Global Director of R&D at Dipharma Francis S.r.l. “Thanks to our innovative approach, we can confirm or exclude nitrosamine formation with exceptional clarity, even in the most complex scenarios. For our partners, this means having a reliable foundation for risk assessment, regulatory justification, and mitigation planning. It also gives them the confidence that Dipharma is fully aligned with their objectives for safe, robust and future-proof API manufacturing, supported by continuous collaboration and a strong commitment to supply continuity. This study further demonstrates the excellence of our R&D team, whose scientific rigor and problem-solving capabilities continue to drive our success.”

About the Dipharma Francis group
The Dipharma Group is a global CDMO and a leading manufacturer of APIs and Intermediates, with about 600 skilled and highly committed employees, 4 cGMP plants, located in the U.S.A. and Italy, plus sales offices in Italy, the U.S.A. and China. The fully equipped R&D Centers develop innovative chemical processes and crystalline forms for the most prominent pharmaceutical companies worldwide. As a third-generation family-owned company, Dipharma has a long history of stability, commitment, and financial solidity. Dipharma has the right size and variety of scale-up capabilities to act as a global player and manage processes efficiently, while offering flexibility and agility to promptly solve any challenge. Experience you can trust.

For more information:
Paola Clerici         
Communication Manager         
Dipharma Francis S.r.l.
paola.clerici@dipharma.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/a1724d65-6a65-4938-b0ab-a023fec14ef4