Prenetics Enters Into Warrant Exchange Agreements With Warrant Holders, Strengthening Capital Structure

Prenetics Enters Into Warrant Exchange Agreements With Warrant Holders, Strengthening Capital Structure




Prenetics Enters Into Warrant Exchange Agreements With Warrant Holders, Strengthening Capital Structure

CHARLOTTE, N.C., Dec. 23, 2025 (GLOBE NEWSWIRE) — Prenetics Global Limited (NASDAQ: PRE) (“Prenetics” or the “Company”), a leading health sciences company and parent of the IM8 premium health and longevity brand, today announced that it has entered into warrant exchange agreements, subject to customary closing conditions, with holders representing approximately 83.4% of its outstanding Class A and Class B warrants, pursuant to a voluntary warrant exchange program designed to simplify the Company’s capital structure and materially reduce potential future dilution.

The warrant exchange program was developed based on investor feedback and following discussions with several of the Company’s largest institutional shareholders, who expressed strong support for consolidating legacy warrant instruments into a cleaner capital structure.

Background and Participation

In connection with the Company’s prior financing in October 2025, 2,722,642 Class A ordinary shares were issued, with one Class A warrant and one Class B warrant issued for each such Class A ordinary share, for a total of 5,445,284 warrants.

As of the date of this announcement, the Company has entered into exchange agreements covering 4,539,722 of the 5,445,284 aggregate Class A and Class B warrants, representing approximately 83.4% participation.

Summary of the Warrant Exchange

Under the exchange agreements:

  • One (1) Class A warrant and one (1) Class B warrant with exercise prices of $24.12 and $32.16, respectively, each with a five-year term have been exchanged for
  • One (1) new Class C warrant with:
    • an exercise price of $18.00 per Class A ordinary share,
    • a two-year term commencing upon the effectiveness of a registration statement on Form F-3 registering the resale of the shares issuable upon exercise of the Class C warrants, and
    • a standard forced-redemption (call) feature.

The Company may exercise its forced-redemption right only after the registration statement on Form F-3 registering the resale of the shares issuable upon exercise of the Class C warrants is declared effective and only if the Company’s Class A ordinary shares trade at or above 120% of the exercise price (i.e., $21.60) for ten (10) consecutive trading days.

Warrant holders participated in the exchange on a voluntary basis, and identical terms were offered to all eligible warrant holders.

Impact on Capital Structure

Based on the exchange agreements, a total of approximately 4.54 million in aggregate of the Company’s outstanding Class A warrants and Class B warrants is expected to be exchanged for approximately 2.27 million Class C warrants.

After such exchange, the total number of outstanding Class A warrants, Class B warrants and Class C warrants is expected to be approximately 3.18 million in aggregate, representing a reduction of approximately 42.0% from the number of Class A and Class B warrants issued in the October 2025 financing round, and further up to 50% assuming participation in full by all holders of Class A warrants and Class B warrants.

The Company believes this reduction materially improves its long-term dilution profile, reduces warrant overhang, and enhances the investability of its ordinary shares. The Company is not undertaking this warrant exchange in connection with any financing transaction and has no plans to conduct any equity or equity-linked capital raise in the foreseeable future.

Strategic Rationale and Benefits

The Company believes this warrant exchange delivers several meaningful benefits to the Company and its shareholders, including:

  • Up to 50% reduction from the number of outstanding Class A warrants and Class B warrants, materially lowering long-term dilution risk
  • Substantial elimination of two deep out-of-the-money legacy classes of warrants, reducing up to 50% of the overhang on the Company’s shares that resulted from the Class A warrants and Class B warrants
  • Simplification in favor of a single, unified class of warrants, improving transparency and institutional investability
  • Improved alignment with shareholders, by providing a more realistic and attainable path to warrant redemption

The Company noted that its largest institutional investors, each with significant long-term investments, have participated in the exchange, reflecting strong confidence in the revised structure and its long-term benefits.

About Prenetics
Prenetics (NASDAQ: PRE) is a leading health sciences company redefining the future of health and longevity through IM8 — its flagship consumer brand co-founded with David Beckham and championed by World No. 1 tennis player Aryna Sabalenka. IM8 has achieved the fastest growth trajectory in supplement industry history, reaching $100 million+ in ARR within 11 months of launch, outpacing even leading AI startups.

About IM8
IM8 is the pinnacle of premium core nutrition, born from a collaboration between David Beckham as a co-founding partner, and an elite team of scientists spanning medical professionals, academia and space science. Combining cutting-edge science with nature’s most potent ingredients, IM8 delivers a holistic, science-backed approach to health, empowering you to live your most vibrant life. IM8’s flagship product, Daily Ultimate Essentials is an all-in-one powder supplement engineered to replace 16 different supplements in a delicious drink and is NSF Certified for Sport, non-GMO, vegan, free from common allergens, and contains no artificial flavors, colors or sweeteners. IM8 is a subsidiary of Prenetics (NASDAQ: PRE), a leading global health sciences company dedicated to advancing consumer health. To learn more about IM8, please visit www.IM8health.com.

Investor Relations Contact:
investors@prenetics.com
PRE@mzgroup.us

Angela Cheung
Investor Relations / Corporate Finance
angela.hm.cheung@prenetics.com

Forward-Looking Statements
This press release contains forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. Statements that are not historical facts, including statements about the Company’s goals, targets, projections, outlooks, beliefs, expectations, strategy, plans, objectives of management for future operations of the Company, and growth opportunities are forward-looking statements. Our guidance (including warrant structure, numbers and timeline) reflects management’s current estimates and assumptions as of the date of this release, is subject to significant risks and uncertainties, and is not a guarantee of future performance. Actual results may differ materially. In some cases, forward-looking statements can be identified by words or phrases such as “may,” “will,” “expect,” “anticipate,” “target,” “aim,” “estimate,” “intend,” “plan,” “believe,” “potential,” “continue,” “is/are likely to,” “guidance,” “outlook,” “forecast,” or other similar expressions. Forward-looking statements are based upon estimates and forecasts and reflect the views, assumptions, expectations, and opinions of the Company, which involve inherent risks and uncertainties, and therefore they should not be relied upon as being necessarily indicative of future results. A number of factors could cause actual results to differ materially from those contained in any forward-looking statement, including but not limited to factors beyond the Company’s control that prevent the closing and final consummation of the exchange agreements. In addition to the foregoing factors, you should also carefully consider the other risks and uncertainties described in the “Risk Factors” section of the Company’s most recent registration statement and the prospectus therein, and the other documents filed by the Company from time to time with the U.S. Securities and Exchange Commission. Unless otherwise specified, all information provided in this press release is as of the date of this press release, and the Company does not undertake any duty to update such information, except as required under applicable law.

Prenetics Enters Into Warrant Exchange Agreements With Warrant Holders, Strengthening Capital Structure

Prenetics Enters Into Warrant Exchange Agreements With Warrant Holders, Strengthening Capital Structure




Prenetics Enters Into Warrant Exchange Agreements With Warrant Holders, Strengthening Capital Structure

CHARLOTTE, N.C., Dec. 23, 2025 (GLOBE NEWSWIRE) — Prenetics Global Limited (NASDAQ: PRE) (“Prenetics” or the “Company”), a leading health sciences company and parent of the IM8 premium health and longevity brand, today announced that it has entered into warrant exchange agreements, subject to customary closing conditions, with holders representing approximately 83.4% of its outstanding Class A and Class B warrants, pursuant to a voluntary warrant exchange program designed to simplify the Company’s capital structure and materially reduce potential future dilution.

The warrant exchange program was developed based on investor feedback and following discussions with several of the Company’s largest institutional shareholders, who expressed strong support for consolidating legacy warrant instruments into a cleaner capital structure.

Background and Participation

In connection with the Company’s prior financing in October 2025, 2,722,642 Class A ordinary shares were issued, with one Class A warrant and one Class B warrant issued for each such Class A ordinary share, for a total of 5,445,284 warrants.

As of the date of this announcement, the Company has entered into exchange agreements covering 4,539,722 of the 5,445,284 aggregate Class A and Class B warrants, representing approximately 83.4% participation.

Summary of the Warrant Exchange

Under the exchange agreements:

  • One (1) Class A warrant and one (1) Class B warrant with exercise prices of $24.12 and $32.16, respectively, each with a five-year term have been exchanged for
  • One (1) new Class C warrant with:
    • an exercise price of $18.00 per Class A ordinary share,
    • a two-year term commencing upon the effectiveness of a registration statement on Form F-3 registering the resale of the shares issuable upon exercise of the Class C warrants, and
    • a standard forced-redemption (call) feature.

The Company may exercise its forced-redemption right only after the registration statement on Form F-3 registering the resale of the shares issuable upon exercise of the Class C warrants is declared effective and only if the Company’s Class A ordinary shares trade at or above 120% of the exercise price (i.e., $21.60) for ten (10) consecutive trading days.

Warrant holders participated in the exchange on a voluntary basis, and identical terms were offered to all eligible warrant holders.

Impact on Capital Structure

Based on the exchange agreements, a total of approximately 4.54 million in aggregate of the Company’s outstanding Class A warrants and Class B warrants is expected to be exchanged for approximately 2.27 million Class C warrants.

After such exchange, the total number of outstanding Class A warrants, Class B warrants and Class C warrants is expected to be approximately 3.18 million in aggregate, representing a reduction of approximately 42.0% from the number of Class A and Class B warrants issued in the October 2025 financing round, and further up to 50% assuming participation in full by all holders of Class A warrants and Class B warrants.

The Company believes this reduction materially improves its long-term dilution profile, reduces warrant overhang, and enhances the investability of its ordinary shares. The Company is not undertaking this warrant exchange in connection with any financing transaction and has no plans to conduct any equity or equity-linked capital raise in the foreseeable future.

Strategic Rationale and Benefits

The Company believes this warrant exchange delivers several meaningful benefits to the Company and its shareholders, including:

  • Up to 50% reduction from the number of outstanding Class A warrants and Class B warrants, materially lowering long-term dilution risk
  • Substantial elimination of two deep out-of-the-money legacy classes of warrants, reducing up to 50% of the overhang on the Company’s shares that resulted from the Class A warrants and Class B warrants
  • Simplification in favor of a single, unified class of warrants, improving transparency and institutional investability
  • Improved alignment with shareholders, by providing a more realistic and attainable path to warrant redemption

The Company noted that its largest institutional investors, each with significant long-term investments, have participated in the exchange, reflecting strong confidence in the revised structure and its long-term benefits.

About Prenetics
Prenetics (NASDAQ: PRE) is a leading health sciences company redefining the future of health and longevity through IM8 — its flagship consumer brand co-founded with David Beckham and championed by World No. 1 tennis player Aryna Sabalenka. IM8 has achieved the fastest growth trajectory in supplement industry history, reaching $100 million+ in ARR within 11 months of launch, outpacing even leading AI startups.

About IM8
IM8 is the pinnacle of premium core nutrition, born from a collaboration between David Beckham as a co-founding partner, and an elite team of scientists spanning medical professionals, academia and space science. Combining cutting-edge science with nature’s most potent ingredients, IM8 delivers a holistic, science-backed approach to health, empowering you to live your most vibrant life. IM8’s flagship product, Daily Ultimate Essentials is an all-in-one powder supplement engineered to replace 16 different supplements in a delicious drink and is NSF Certified for Sport, non-GMO, vegan, free from common allergens, and contains no artificial flavors, colors or sweeteners. IM8 is a subsidiary of Prenetics (NASDAQ: PRE), a leading global health sciences company dedicated to advancing consumer health. To learn more about IM8, please visit www.IM8health.com.

Investor Relations Contact:
investors@prenetics.com
PRE@mzgroup.us

Angela Cheung
Investor Relations / Corporate Finance
angela.hm.cheung@prenetics.com

Forward-Looking Statements
This press release contains forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. Statements that are not historical facts, including statements about the Company’s goals, targets, projections, outlooks, beliefs, expectations, strategy, plans, objectives of management for future operations of the Company, and growth opportunities are forward-looking statements. Our guidance (including warrant structure, numbers and timeline) reflects management’s current estimates and assumptions as of the date of this release, is subject to significant risks and uncertainties, and is not a guarantee of future performance. Actual results may differ materially. In some cases, forward-looking statements can be identified by words or phrases such as “may,” “will,” “expect,” “anticipate,” “target,” “aim,” “estimate,” “intend,” “plan,” “believe,” “potential,” “continue,” “is/are likely to,” “guidance,” “outlook,” “forecast,” or other similar expressions. Forward-looking statements are based upon estimates and forecasts and reflect the views, assumptions, expectations, and opinions of the Company, which involve inherent risks and uncertainties, and therefore they should not be relied upon as being necessarily indicative of future results. A number of factors could cause actual results to differ materially from those contained in any forward-looking statement, including but not limited to factors beyond the Company’s control that prevent the closing and final consummation of the exchange agreements. In addition to the foregoing factors, you should also carefully consider the other risks and uncertainties described in the “Risk Factors” section of the Company’s most recent registration statement and the prospectus therein, and the other documents filed by the Company from time to time with the U.S. Securities and Exchange Commission. Unless otherwise specified, all information provided in this press release is as of the date of this press release, and the Company does not undertake any duty to update such information, except as required under applicable law.

Press Release: Sanofi’s Wayrilz approved in the EU as the first BTK inhibitor to treat immune thrombocytopenia

Press Release: Sanofi’s Wayrilz approved in the EU as the first BTK inhibitor to treat immune thrombocytopenia




Press Release: Sanofi’s Wayrilz approved in the EU as the first BTK inhibitor to treat immune thrombocytopenia

Sanofi’s Wayrilz approved in the EU as the first BTK inhibitor to treat immune thrombocytopenia

  • Novel treatment targets BTK through multi-immune modulation to help address the underlying causes of ITP
  • Approval based on the LUNA 3 phase 3 study that demonstrated rapid and durable platelet response and improvements in other ITP symptoms
  • ITP is a rare disease of complex immune dysregulation leading to lower platelet counts, bleeding, and reduced quality of life

Paris, December 23, 2025 – The European Commission has approved Wayrilz (rilzabrutinib), a novel, oral, reversible, Bruton’s tyrosine kinase (BTK) inhibitor, as a new treatment for immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments. This follows the positive opinion by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

Wayrilz can help address the underlying causes of ITP through multi-immune modulation, targeting different pathways across the immune system.

“ITP is caused by complex immune system dysregulation leading to low platelet counts, bleeding and other often overlooked symptoms that can affect both physical and mental health, significantly impacting quality of life,” said Waleed Ghanima, MD, Head of Research and a Consultant Hematologist at Østfold Hospital, Norway. “The traditional approach to disease management focuses on restoring platelet counts and reducing bleeding risk, but patients may still experience other symptoms. Wayrilz offers a new approach, targeting the underlying cause of ITP through multi-immune modulation to help address the multi-faceted burden of this disease.”

“The approval of Wayrilz in the EU for the treatment of ITP underscores Sanofi’s commitment to leveraging our knowledge of the immune system to develop innovative treatments that make a meaningful impact on people living with rare and inflammatory diseases,” said Brian Foard, Executive Vice President, Head of Specialty Care at Sanofi. “Wayrilz has a differentiated mechanism of action, enabling multi-immune modulation to address the underlying pathology of ITP, allowing patients to benefit from an advanced treatment to help manage their disease.”

The EU approval of Wayrilz is based on the pivotal LUNA 3 phase 3 study (clinical study identifier: NCT04562766), in which Wayrilz met the primary and secondary endpoints, demonstrating a positive impact on sustained platelet counts as well as other ITP symptoms.

The LUNA 3 phase 3 study, presented at the 66th American Society of Hematology Annual Meeting and Exposition, and also published in Blood, evaluated the efficacy and safety of Wayrilz compared to placebo in adults (n=202) with persistent or chronic ITP. Patients who achieved platelet count response at 12 weeks were eligible to continue the full 24-week double-blind period (64% of patients in the Wayrilz arm and 32% of patients in the placebo arm). Patients receiving Wayrilz experienced the following compared to patients receiving placebo:

  • Statistically significant durable platelet response at week 25 (23% of patients in Wayrilz arm vs. 0% in placebo arm; p<0.0001) 
  • Faster time to first platelet response (36 days in Wayrilz arm vs. not reached in placebo arm; p<0.0001)
  • Longer duration of platelet response (least square mean of 7 weeks in Wayrilz arm vs. 0.7 weeks in placebo arm)

Patients receiving Wayrilz reported an overall 10.6-point improvement in the overall quality of life domain compared to a 2.3-point increase in the placebo arm, based on The Immune Thrombocytopenia Patient Assessment Questionnaire, a clinical tool designed to measure ITP symptoms and impacts. The results of this analysis are descriptive and were not powered for statistical significance.

The most common adverse reactions (incidence ≥10%) are diarrhea, nausea, headache, abdominal pain, and COVID-19.

Wayrilz has already been approved in the US and the United Arab Emirates (UAE), and it is currently under regulatory review for ITP in Japan and China. It received fast track and orphan drug designations (ODD) in the US for ITP, with similar orphan designations in the EU and Japan. In other indications under investigation, the US Food and Drug Administration (FDA) granted Wayrilz ODD for three additional rare diseases, including warm autoimmune hemolytic anemia (wAIHA), IgG4-related disease (IgG4-RD), and sickle cell disease (SCD). Wayrilz also received FDA fast track designation and EU orphan designation in IgG4-RD.

About the LUNA 3 study
LUNA 3 (clinical study identifier: NCT04562766) was a randomized, multicenter, phase 3 study evaluating the efficacy and safety of Wayrilz vs. placebo in adult and adolescent patients with persistent or chronic ITP. Patients received either oral Wayrilz 400 mg twice a day or placebo through a 12- to 24-week double-blind treatment period, followed by a 28-week open-label treatment period, and then a four-week safety follow-up or long-term extension period. The adolescent part of the study is ongoing. The primary endpoint for the EU is the proportion of adult participants able to achieve platelet counts at or above 50,000/μL for at least eight out of the last 12 weeks of the 24-week blinded treatment period in the absence of rescue therapy. Secondary endpoints included time to platelet response (platelet count ≥50 x 109/L or between 30 x 109/L and <50 x 109/L and at least doubled from baseline in absence of rescue therapy), number of weeks maintaining a specific platelet response (i.e., doubled or within range), rescue therapy use, physical fatigue score, and bleeding score as assessed by change from baseline in Idiopathic Thrombocytopenic Purpura Bleeding Scale (IBLS) assessment at Week 25.

About Wayrilz
Wayrilz (rilzabrutinib) is the first BTK inhibitor for ITP that helps address the root cause of disease through multi-immune modulation. BTK, expressed in B cells, macrophages, and other innate immune cells, plays a critical role in multiple immune-mediated disease processes and inflammatory pathways. With the application of Sanofi’s TAILORED COVALENCY® technology, Wayrilz can selectively inhibit the BTK target. This innovative therapy is now approved for ITP in the US, in the EU, and in the UAE. Regulatory review for use in ITP is currently ongoing in China and Japan.

Wayrilz is being studied across a variety of rare diseases, including wAIHA, IgG4-RD, and SCD. These additional indications are currently under investigation and have not been approved by regulatory authorities.

About ITP
ITP is a disease of complex immune dysregulation that causes low platelet counts (<100,000/μL), resulting in a variety of bleeding symptoms and high risk of thromboembolism risk. Beyond bruising and bleeding, which can include potentially life-threatening episodes like intracranial hemorrhage, people living with ITP may experience reduced quality of life, including physical fatigue and cognitive impairment.

About Sanofi
Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time.
Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY

Media Relations
Sandrine Guendoul | +33 6 25 09 14 25 | sandrine.guendoul@sanofi.com
Evan Berland | +1 215 432 0234 | evan.berland@sanofi.com
Léo Le Bourhis | +33 6 75 06 43 81 | leo.lebourhis@sanofi.com
Victor Rouault | +33 6 70 93 71 40 | victor.rouault@sanofi.com
Timothy Gilbert | +1 516 521 2929 | timothy.gilbert@sanofi.com
Léa Ubaldi | +33 6 30 19 66 46 | lea.ubaldi@sanofi.com

Investor Relations
Thomas Kudsk Larsen | +44 7545 513 693 | thomas.larsen@sanofi.com
Alizé Kaisserian | +33 6 47 04 12 11 | alize.kaisserian@sanofi.com
Keita Browne | +1 781 249 1766 | keita.browne@sanofi.com
Nathalie Pham | +33 7 85 93 30 17 | nathalie.pham@sanofi.com
Thibaud Châtelet | +33 6 80 80 89 90 | thibaud.chatelet@sanofi.com
Yun Li | +33 6 84 00 90 72 | yun.li3@sanofi.com

Sanofi forward-looking statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans”, and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2024. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

All trademarks mentioned in this press release are the property of the Sanofi group.

 

Attachment

Press Release: Sanofi’s Wayrilz approved in the EU as the first BTK inhibitor to treat immune thrombocytopenia

Press Release: Sanofi’s Wayrilz approved in the EU as the first BTK inhibitor to treat immune thrombocytopenia




Press Release: Sanofi’s Wayrilz approved in the EU as the first BTK inhibitor to treat immune thrombocytopenia

Sanofi’s Wayrilz approved in the EU as the first BTK inhibitor to treat immune thrombocytopenia

  • Novel treatment targets BTK through multi-immune modulation to help address the underlying causes of ITP
  • Approval based on the LUNA 3 phase 3 study that demonstrated rapid and durable platelet response and improvements in other ITP symptoms
  • ITP is a rare disease of complex immune dysregulation leading to lower platelet counts, bleeding, and reduced quality of life

Paris, December 23, 2025 – The European Commission has approved Wayrilz (rilzabrutinib), a novel, oral, reversible, Bruton’s tyrosine kinase (BTK) inhibitor, as a new treatment for immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments. This follows the positive opinion by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

Wayrilz can help address the underlying causes of ITP through multi-immune modulation, targeting different pathways across the immune system.

“ITP is caused by complex immune system dysregulation leading to low platelet counts, bleeding and other often overlooked symptoms that can affect both physical and mental health, significantly impacting quality of life,” said Waleed Ghanima, MD, Head of Research and a Consultant Hematologist at Østfold Hospital, Norway. “The traditional approach to disease management focuses on restoring platelet counts and reducing bleeding risk, but patients may still experience other symptoms. Wayrilz offers a new approach, targeting the underlying cause of ITP through multi-immune modulation to help address the multi-faceted burden of this disease.”

“The approval of Wayrilz in the EU for the treatment of ITP underscores Sanofi’s commitment to leveraging our knowledge of the immune system to develop innovative treatments that make a meaningful impact on people living with rare and inflammatory diseases,” said Brian Foard, Executive Vice President, Head of Specialty Care at Sanofi. “Wayrilz has a differentiated mechanism of action, enabling multi-immune modulation to address the underlying pathology of ITP, allowing patients to benefit from an advanced treatment to help manage their disease.”

The EU approval of Wayrilz is based on the pivotal LUNA 3 phase 3 study (clinical study identifier: NCT04562766), in which Wayrilz met the primary and secondary endpoints, demonstrating a positive impact on sustained platelet counts as well as other ITP symptoms.

The LUNA 3 phase 3 study, presented at the 66th American Society of Hematology Annual Meeting and Exposition, and also published in Blood, evaluated the efficacy and safety of Wayrilz compared to placebo in adults (n=202) with persistent or chronic ITP. Patients who achieved platelet count response at 12 weeks were eligible to continue the full 24-week double-blind period (64% of patients in the Wayrilz arm and 32% of patients in the placebo arm). Patients receiving Wayrilz experienced the following compared to patients receiving placebo:

  • Statistically significant durable platelet response at week 25 (23% of patients in Wayrilz arm vs. 0% in placebo arm; p<0.0001) 
  • Faster time to first platelet response (36 days in Wayrilz arm vs. not reached in placebo arm; p<0.0001)
  • Longer duration of platelet response (least square mean of 7 weeks in Wayrilz arm vs. 0.7 weeks in placebo arm)

Patients receiving Wayrilz reported an overall 10.6-point improvement in the overall quality of life domain compared to a 2.3-point increase in the placebo arm, based on The Immune Thrombocytopenia Patient Assessment Questionnaire, a clinical tool designed to measure ITP symptoms and impacts. The results of this analysis are descriptive and were not powered for statistical significance.

The most common adverse reactions (incidence ≥10%) are diarrhea, nausea, headache, abdominal pain, and COVID-19.

Wayrilz has already been approved in the US and the United Arab Emirates (UAE), and it is currently under regulatory review for ITP in Japan and China. It received fast track and orphan drug designations (ODD) in the US for ITP, with similar orphan designations in the EU and Japan. In other indications under investigation, the US Food and Drug Administration (FDA) granted Wayrilz ODD for three additional rare diseases, including warm autoimmune hemolytic anemia (wAIHA), IgG4-related disease (IgG4-RD), and sickle cell disease (SCD). Wayrilz also received FDA fast track designation and EU orphan designation in IgG4-RD.

About the LUNA 3 study
LUNA 3 (clinical study identifier: NCT04562766) was a randomized, multicenter, phase 3 study evaluating the efficacy and safety of Wayrilz vs. placebo in adult and adolescent patients with persistent or chronic ITP. Patients received either oral Wayrilz 400 mg twice a day or placebo through a 12- to 24-week double-blind treatment period, followed by a 28-week open-label treatment period, and then a four-week safety follow-up or long-term extension period. The adolescent part of the study is ongoing. The primary endpoint for the EU is the proportion of adult participants able to achieve platelet counts at or above 50,000/μL for at least eight out of the last 12 weeks of the 24-week blinded treatment period in the absence of rescue therapy. Secondary endpoints included time to platelet response (platelet count ≥50 x 109/L or between 30 x 109/L and <50 x 109/L and at least doubled from baseline in absence of rescue therapy), number of weeks maintaining a specific platelet response (i.e., doubled or within range), rescue therapy use, physical fatigue score, and bleeding score as assessed by change from baseline in Idiopathic Thrombocytopenic Purpura Bleeding Scale (IBLS) assessment at Week 25.

About Wayrilz
Wayrilz (rilzabrutinib) is the first BTK inhibitor for ITP that helps address the root cause of disease through multi-immune modulation. BTK, expressed in B cells, macrophages, and other innate immune cells, plays a critical role in multiple immune-mediated disease processes and inflammatory pathways. With the application of Sanofi’s TAILORED COVALENCY® technology, Wayrilz can selectively inhibit the BTK target. This innovative therapy is now approved for ITP in the US, in the EU, and in the UAE. Regulatory review for use in ITP is currently ongoing in China and Japan.

Wayrilz is being studied across a variety of rare diseases, including wAIHA, IgG4-RD, and SCD. These additional indications are currently under investigation and have not been approved by regulatory authorities.

About ITP
ITP is a disease of complex immune dysregulation that causes low platelet counts (<100,000/μL), resulting in a variety of bleeding symptoms and high risk of thromboembolism risk. Beyond bruising and bleeding, which can include potentially life-threatening episodes like intracranial hemorrhage, people living with ITP may experience reduced quality of life, including physical fatigue and cognitive impairment.

About Sanofi
Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time.
Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY

Media Relations
Sandrine Guendoul | +33 6 25 09 14 25 | sandrine.guendoul@sanofi.com
Evan Berland | +1 215 432 0234 | evan.berland@sanofi.com
Léo Le Bourhis | +33 6 75 06 43 81 | leo.lebourhis@sanofi.com
Victor Rouault | +33 6 70 93 71 40 | victor.rouault@sanofi.com
Timothy Gilbert | +1 516 521 2929 | timothy.gilbert@sanofi.com
Léa Ubaldi | +33 6 30 19 66 46 | lea.ubaldi@sanofi.com

Investor Relations
Thomas Kudsk Larsen | +44 7545 513 693 | thomas.larsen@sanofi.com
Alizé Kaisserian | +33 6 47 04 12 11 | alize.kaisserian@sanofi.com
Keita Browne | +1 781 249 1766 | keita.browne@sanofi.com
Nathalie Pham | +33 7 85 93 30 17 | nathalie.pham@sanofi.com
Thibaud Châtelet | +33 6 80 80 89 90 | thibaud.chatelet@sanofi.com
Yun Li | +33 6 84 00 90 72 | yun.li3@sanofi.com

Sanofi forward-looking statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans”, and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2024. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

All trademarks mentioned in this press release are the property of the Sanofi group.

 

Attachment

FDA approves another interchangeable Ranibizumab Biosimilar, Nufymco® – Strengthening US Presence with Zydus as Commercialization Partner

Formycon AG

/ Key word(s): Regulatory Approval/Alliance

FDA approves another interchangeable Ranibizumab Biosimilar, Nufymco® – Strengthening US Presence with Zydus as Commercialization Partner

23.12.2025 / 14:02 CET/CEST

The issuer is solely responsible for the content of this announcement.


 

Press Release // December 23, 2025

FDA approves another interchangeable Ranibizumab Biosimilar, Nufymco® Strengthening US Presence with Zydus as Commercialization Partner 

  • FDA approves Biologics License Application (BLA) for additional ranibizumab biosimilar under the trade name Nufymco®
  • Zydus becomes commercialization partner for Nufymco® in the US
  • Targeted strategy to maximize market penetration for ranibizumab biosimilars by building further on existing partnerships
     

Planegg-Martinsried, Germany – Formycon AG (FWB: FYB, Prime Standard, “Formycon”) and Bioeq AG (“Bioeq”) announce that the U.S. Food and Drug Administration (FDA) has approved Nufymco®1 (ranibizumab-leyk), an interchangeable biosimilar to Lucentis®2. With its second FDA-approved ranibizumab biosimilar in the US, the companies are further underscoring their pioneering position in high-quality biosimilar development.

Zydus Lifesciences Limited (including its subsidiaries and affiliates; “Zydus”) has been secured as another strong commercialization partner for the US market. The company has proven expertise with medically administered drugs (known as Medical Part B), a category that includes Nufymco®. Recently, Zydus also obtained exclusive rights to Formycon’s Keytruda®3 biosimilar FYB206 for the US and Canada – a strong testament to the attractiveness of and confidence in Formycon’s development platform.

Nufymco® is an interchangeable biosimilar to Lucentis®, developed by Formycon, and will be available in the US for all approved indications, expanding access to essential retinal therapies by offering a more affordable treatment option for patients.

“Our FDA approval for Nufymco® marks an important milestone for Formycon and reaffirms our role as an innovative leader in biosimilar development. With two strong and internationally established partners, we are ideally positioned to expand access to high-quality and affordable ranibizumab biosimilars for ophthalmic patients in the US. This expanded market coverage opens new growth opportunities by enabling a differentiated approach within the complex US healthcare and reimbursement landscape, supporting sustainable market penetration,” comments Dr. Stefan Glombitza, CEO of Formycon AG.

Nufymco® is FDA approved for the treatment of patients with age-related neovascular (wet) macular degeneration (AMD) and other serious eye diseases such as diabetic macular edema (DME), diabetic retinopathy (DR), macular edema due to retinal vein occlusion (RVO), and myopic choroidal neovascularization (mCNV).

1) Nufymco® is a registered trademark of Formycon AG
2) Lucentis® is a registered trademark of Genentech, Inc.
3) Keytruda
® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, (NYSE: MRK) Rahway, NJ/USA.

About Formycon:
Formycon AG (FSE: FYB) is a leading, independent developer of high-quality biosimilars, follow-on products of biopharmaceutical medicines. The company focuses on therapies in ophthalmology, immunology, immuno-oncology and other key disease areas, covering almost the entire value chain from technical development through clinical trials to approval by the regulatory authorities. For commercialization of its biosimilars, Formycon relies on strong, well-trusted and long-term partnerships worldwide. With FYB201/ranibizumab and FYB202/ustekinumab, Formycon already has two biosimilars on the market. Another biosimilar, FYB203/aflibercept, has been approved by the FDA, EMA, and MHRA. Four pipeline candidates – including FYB208/dupilumab – are currently in development. With its biosimilars, Formycon is making an important contribution to providing as many patients as possible with access to highly effective and affordable medicines.

Formycon AG is headquartered in Munich, listed in the Prime Standard of the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY. Further information can be found at: https://www.formycon.com/

About Bioeq:
Bioeq is a Swiss biopharmaceutical joint venture between the Polpharma Biologics Group and Formycon AG. Bioeq develops, licenses, and markets biosimilars. www.bioeq.ch

About Zydus Lifesciences Limited:
Zydus Lifesciences Limited is an innovation-led life-sciences company with leadership positions across pharmaceuticals and consumer wellness, supported by an emerging MedTech franchise and a global footprint across the United States, India and other international markets. As of September 30, 2025, the group employs 27,000 people worldwide, including 1,500 scientists engaged in R&D, and is driven by its mission to unlock new possibilities in lifesciences through quality healthcare solutions that impact lives. The group aspires to transform lives through path-breaking discoveries. For more details visit www.zyduslife.com

About Biosimilars:
Since their introduction in the 1980s, biopharmaceutical drugs have revolutionized the treatment of serious and chronic diseases. By 2032, many of these drugs will lose their patent protection – including 45 blockbusters with an estimated total annual global turnover of more than 200 billion US dollars. Biosimilars are successor products to biopharmaceutical drugs for which market exclusivity has expired. They are approved in highly regulated markets such as the EU, the USA, Canada, Japan and Australia in accordance with strict regulatory procedures. Biosimilars create competition and thus give more patients access to biopharmaceutical therapies. At the same time, they reduce costs for healthcare systems. Global sales of biosimilars currently amount to around 21 billion US dollars. Analysts assume that sales could rise to over 74 billion US dollars by 2030.

 
Contact:

Sabrina Müller,
Director Investor Relations & Corporate Communications,
Formycon AG
Fraunhoferstr. 15
82152 Planegg-Martinsried
Germany

Tel.: +49 (0) 89 – 86 46 67 149
Fax: + 49 (0) 89 – 86 46 67 110

Sabrina.Mueller@formycon.com

 

Disclaimer:
This press release may contain forward-looking statements and information which are based on Formycon’s current expectations and certain assumptions. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, performance of the company, development of the products and the estimates given here. Such known and unknown risks and uncertainties comprise, among others, the research and development, the regulatory approval process, the timing of the actions of regulatory bodies and other governmental authorities, clinical results, changes in laws and regulations, product quality, patient safety, patent litigation, contractual risks and dependencies from third parties. With respect to pipeline products, Formycon AG does not provide any representation, warranties or any other guarantees that the products will receive the necessary regulatory approvals or that they will prove to be commercially exploitable and/or successful. Formycon AG assumes no obligation to update these forward-looking statements or to correct them in case of developments which differ from those anticipated. This document neither constitutes an offer to sell nor a solicitation of an offer to buy or subscribe for securities of Formycon AG. No public offering of securities of Formycon AG will be made nor is a public offering intended. This document and the information contained therein may not be distributed in or into the United States of America, Canada, Australia, Japan or any other jurisdictions, in which such offer or such solicitation would be prohibited. This document does not constitute an offer for the sale of securities in the United States.


23.12.2025 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
The issuer is solely responsible for the content of this announcement.

The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.


Language: English
Company: Formycon AG
Fraunhoferstraße 15
82152 Planegg-Martinsried
Germany
Phone: +49 89 864667 100
Fax: +49 89 864667 110
E-mail: ir@formycon.com
Internet: www.formycon.com
ISIN: DE000A1EWVY8, NO0013586024
WKN: A1EWVY, A4DFJH
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart, Tradegate Exchange; Oslo
EQS News ID: 2250924

 
End of News EQS News Service

2250924  23.12.2025 CET/CEST

MannKind Shares FUROSCIX® Business Updates

MannKind Shares FUROSCIX® Business Updates




MannKind Shares FUROSCIX® Business Updates

  • FDA approves FUROSCIX® for use in pediatric patients weighing 43kg or above
  • USPTO issues five patents for FUROSCIX ReadyFlow Autoinjector

WESTLAKE VILLAGE, Calif. and BURLINGTON, Mass., Dec. 23, 2025 (GLOBE NEWSWIRE) — MannKind Corporation (Nasdaq: MNKD) today announced two business updates—approval of the FUROSCIX® (furosemide) On-body Infusor for pediatric patients and issuance of additional intellectual property protection for the investigational-stage FUROSCIX ReadyFlow Autoinjector, which is currently under review by the U.S. FDA.

FUROSCIX Expanded Treatment Options for Appropriate Pediatric Patients
The U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for FUROSCIX® (furosemide) On-body Infusor, expanding the indication of this product to include pediatric patients weighing 43 kg or more. FUROSCIX was previously approved for the treatment of edema associated with chronic heart failure (CHF) and chronic kidney disease (CKD) in adults. This additional approval fulfills all post-marketing requirements outlined in the original approval letter under the Pediatric Research Equity Act.

“We are pleased to make FUROSCIX available to the pediatric population, a highly specific patient group, offering a convenient option outside the hospital setting for those who meet the weight criteria,” said Dr. Ajay Ahuja, Chief Medical Officer of MannKind Corporation.

Five New U.S. Patents Provide Protection to FUROSCIX ReadyFlow Autoinjector
The U.S. Patent and Trademark Office (USPTO) issued five patents with claims that protect the FUROSCIX ReadyFlow Autoinjector. These patents cover the high-concentration liquid compositions of furosemide and associated methods of treatment potentially through 2040, further reinforcing MannKind’s intellectual property position around this innovative drug-device combination. The patents would be listed in the FDA’s Orange Book, if the FUROSCIX ReadyFlow Autoinjector is approved by the FDA.

The newly issued patents complement previously issued patents supporting FUROSCIX and the FUROSCIX ReadyFlow Autoinjector, creating a robust IP portfolio that is designed to protect the formulation and delivery approach for years to come.

FUROSCIX ReadyFlow Autoinjector Could Transform Care from Hours to Seconds
MannKind recently announced that the FDA accepted for review its sNDA for the FUROSCIX ReadyFlow Autoinjector for the treatment of edema in adults with CHF or CKD. The application has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of July 26, 2026.

If approved, the FUROSCIX ReadyFlow Autoinjector would deliver an IV-equivalent diuretic dose (subcutaneous furosemide injection 80 mg/mL) in under 10 seconds, providing a new option for patients with CHF or CKD to manage fluid buildup episodes from the convenience of their home rather than in a hospital setting. The FDA-approved FUROSCIX On-body Infusor was approved in 2022 for the treatment of edema in adult patients with chronic heart failure and, in 2025, for adult patients with chronic kidney disease in 2025.

“FUROSCIX ReadyFlow Autoinjector has the potential to redefine how patients manage fluid overload episodes,” said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. “By delivering an IV-equivalent diuretic dose in seconds from the comfort of home, this innovation, if approved, could significantly reduce hospital visits, improve quality of life, and lower healthcare costs—creating meaningful value for patients, providers, and payers alike.”

About FUROSCIX
FUROSCIX® (furosemide injection), 80 mg/10 mL for subcutaneous use is indicated for the treatment of edema (i.e., congestion, fluid overload, or hypervolemia) in pediatric patients who weigh at least 43 kg and adult patients with chronic heart failure or chronic kidney disease, including the nephrotic syndrome.

IMPORTANT SAFETY INFORMATION
FUROSCIX is contraindicated in patients with anuria and in patients with a history of hypersensitivity to furosemide, any component of the FUROSCIX formulation, or medical adhesives. 

Furosemide may cause fluid, electrolyte, and metabolic abnormalities, particularly in patients receiving higher doses, patients with inadequate oral electrolyte intake, and in elderly patients. Serum electrolytes, CO2, BUN, creatinine, glucose, and uric acid should be monitored frequently during furosemide therapy.

Excessive diuresis may cause dehydration and blood volume reduction with circulatory collapse and possibly vascular thrombosis and embolism, particularly in elderly patients.

Furosemide can cause dehydration and azotemia. If increasing azotemia and oliguria occur during treatment of severe progressive renal disease, discontinue furosemide.

Cases of tinnitus and reversible or irreversible hearing impairment and deafness have been reported with furosemide. Reports usually indicate that furosemide ototoxicity is associated with rapid injection, severe renal impairment, the use of higher than recommended doses, hypoproteinemia or concomitant therapy with aminoglycoside antibiotics, ethacrynic acid, or other ototoxic drugs.

In patients with severe symptoms of urinary retention (because of bladder emptying disorders, prostatic hyperplasia, urethral narrowing), the administration of furosemide can cause acute urinary retention related to increased production and retention of urine. These patients require careful monitoring, especially during the initial stages of treatment.

Contact with water or other fluids and certain patient movements during treatment may cause the On-body Infusor to prematurely terminate infusion. Ensure patients can detect and respond to alarms.

The most common adverse reactions with FUROSCIX administration in clinical trials were site and skin reactions including erythema, bruising, edema, and injection site pain.

Please see the full Prescribing Information (https://www.furoscix.com/wp-content/uploads/prescribing-information.pdf) and Instructions for Use (https://www.furoscix.com/wp-content/uploads/instructions-for-use.pdf).

About MannKind
MannKind Corporation (Nasdaq: MNKD) is a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient-centric solutions. Focused on cardiometabolic and orphan lung diseases, we develop and commercialize treatments that address serious unmet medical needs, including diabetes, pulmonary hypertension, and fluid overload in heart failure and chronic kidney disease.

With deep expertise in drug-device combinations, MannKind aims to deliver therapies designed to fit seamlessly into daily life.

Learn more at mannkindcorp.com.

Forward-Looking Statements
This press release contains forward-looking statements that involve risks and uncertainties, including statements about a potential regulatory action date, statements regarding the potential duration of patent protection and statements regarding the potential benefits of the administration of furosemide via an autoinjector for providers, patients and payors. Words such as “believes”, “anticipates”, “plans”, “expects”, “intends”, “will”, “goal”, “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon MannKind’s current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the risk that issues that develop in the review by the FDA may subject us to unanticipated delays or prevent us from obtaining marketing approval, the risk that we may be unable to protect our proprietary rights as well as other risks detailed in MannKind’s filings with the Securities and Exchange Commission, including under the “Risk Factors” heading of its Annual Report on Form 10-K for the year ended December 31, 2024, and subsequent periodic reports on Form 10-Q and current reports on Form 8-K. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.

FUROSCIX is a registered trademark of scPharmaceuticals, a wholly owned subsidiary of MannKind Corporation.

MANNKIND is a registered trademark of MannKind Corporation.

CONTACT: MannKind Contacts:

Media Relations:
Christie Iacangelo
(818) 292-3500
media@mnkd.com

Investor Relations:
Kate Miranda
(781) 301-6869
ir@mnkd.com

BillionToOne to Participate in the 44th Annual J.P. Morgan Healthcare Conference

BillionToOne to Participate in the 44th Annual J.P. Morgan Healthcare Conference




BillionToOne to Participate in the 44th Annual J.P. Morgan Healthcare Conference

MENLO PARK, Calif., Dec. 23, 2025 (GLOBE NEWSWIRE) — BillionToOne, Inc. (NASDAQ: BLLN), a next-generation molecular diagnostics company with a mission to create powerful and accurate tests that are accessible to all, today announced that Company management will participate in the 44th Annual J.P. Morgan Healthcare Conference.

Management will present from 9:45am to 10:25am Pacific Time on Monday, January 12th, 2026.

A live and archived webcast will be available on the “Events & Presentations” page of BillionToOne’s investor relations website at https://investors.billiontoone.com/news-events/events-presentations.

About BillionToOne

Headquartered in Menlo Park, California, BillionToOne is a molecular diagnostics company with a mission to create powerful and accurate tests that are accessible to all. The company’s patented Quantitative Counting Templates™ (QCT™) molecular counting platform is the only multiplex technology that can accurately count DNA molecules at the single-molecule level. For more information, visit www.billiontoone.com.

Investor Contact
ir@billiontoone.com

Media Contact
billiontoone@moxiegrouppr.com

Vaccinex, Inc. Announces $60 million Agreement to Finance a Phase 2b clinical trial of pepinemab to treat Alzheimer’s Disease

Vaccinex, Inc. Announces $60 million Agreement to Finance a Phase 2b clinical trial of pepinemab to treat Alzheimer’s Disease




Vaccinex, Inc. Announces $60 million Agreement to Finance a Phase 2b clinical trial of pepinemab to treat Alzheimer’s Disease

ROCHESTER, N.Y., Dec. 23, 2025 (GLOBE NEWSWIRE) — Vaccinex, Inc. (VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating Alzheimer’s disease (AD) by inhibiting semaphorin 4D (SEMA4D) induced pathology in brain, today announced that it has entered into a $60 million revenue sharing agreement with Pepinemab Development Venture, LP (PDV) to continue advancing development of its pepinemab anti-SEMA4D antibody in an enlarged phase 2b clinical trial for treatment of AD. PDV LP is an investment entity established by FCMI, an existing Vaccinex investor. Albert Friedberg is Chairman of FCMI and of the Vaccinex Board. The agreements provide that, in exchange for the commitment of funding, PDV will receive 50% of future economic proceeds received by Vaccinex from a development partner or licensee of pepinemab related to neurological indications and 25% related to other indications.

This agreement follows on promising data previously reported from studies in animal disease models and in the early stage SIGNAL-AD phase 1/2a clinical trial indicating that treatment with pepinemab antibody (1) blocks crosstalk between reactive astrocytes and microglia that amplifies glial reactivity leading to inflammation and glial scars; (2) preserves vascular integrity in brain; and (3) downregulates expression of AD disease-related proteins in cerebral spinal fluid (CSF) including SNAP25 associated with synaptic loss and GAP-43 that promotes tau spreading and accumulation. In addition, data from a randomized Phase 2 study in Huntington’s disease (HD, n=179) as well as the completed SIGNAL-AD phase 1/2a study in Mild Cognitive Impairment (MCI) and mild AD (n=50) suggest that pepinemab was well-tolerated and that treatment early in disease has favorable effects on biomarkers related to disease progression and appears to slow cognitive decline.

More recently, a large group of investigators led by Dr. Philip De Jager, Professor of Neurology and Chief, Division of Neuroimmunology at Columbia University Medical Center, identified a genetic signature associated with a unique subset of astrocytes termed Ast10 whose representation in brain correlates with cognitive decline in Alzheimer’s. Importantly, the SEMA4D-PLXNB1 signaling pathway was identified as a top ligand-receptor pair that strongly regulates Ast10 representation in brain. Based on information shared by Dr. De Jager and colleagues, we were able to determine that pepinemab treatment (1) reduced representation of Ast10 cells in brain, and (2) that this appears to be associated with slowing of cognitive decline relative to the placebo controls. Results were reported at the Clinical Trials on Alzheimer’s Disease (CTAD) Conference in San Diego, December 3, 2025. We believe that the combination of biological, clinical and genetic evidence for the important role of the SEMA4D-PLXNB1 signaling pathway in AD progression is a compelling reason to continue development of pepinemab as a potentially novel and effective therapeutic for AD.

About Vaccinex Inc. 

Vaccinex, Inc. is pioneering a differentiated approach to treating slowly progressive neurodegenerative diseases including Alzheimer’s and Huntington’s disease through the inhibition of semaphorin 4D (SEMA4D). The Company’s lead drug candidate, pepinemab, blocks SEMA4D, a potent biological effector that it believes triggers a chain of pathogenic events downstream of astrocyte reactivity that drive disease progression in both AD and HD.

Forward Looking Statements

To the extent that statements contained in this presentation are not descriptions of historical facts regarding Vaccinex, Inc. (“Vaccinex,” “we,” “us,” or “our”), they are forward-looking statements reflecting management’s current beliefs and expectations. Such statements include, but are not limited to, statements about the Company’s plans, expectations and objectives with respect to the results and timing of clinical trials of pepinemab in various indications, the use and potential benefits of pepinemab in Huntington’s and Alzheimer’s disease and other indications, the expected timeline for publication and disclosure of trial results, and other statements identified by words such as “may,” “will,” “appears,” “expect,” “planned,” “anticipate,” “estimate,” “intend,” “hypothesis,” “potential,” “suggest,” “advance,” and similar expressions or their negatives (as well as other words and expressions referencing future events, conditions, or circumstances). Forward-looking statements involve substantial risks and uncertainties that could cause the outcome of the Company’s research and pre-clinical development programs, clinical development programs, future results, performance, or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, uncertainties inherent in the execution, cost and completion of preclinical and clinical trials, uncertainties related to regulatory approval, the risks related to the Company’s dependence on its lead product candidate pepinemab, the ability to leverage its ActivMAb® platform, the impact of the COVID-19 pandemic, and other matters that could affect the Company’s development plans or the commercial potential of its product candidates. Except as required by law, the Company assumes no obligation to update these forward-looking statements. For a further discussion of these and other factors that could cause future results to differ materially from any forward-looking statement, see the section titled “Risk Factors” in the Company’s periodic reports and its most recent year end Annual Report on Form 10-K.

Investor Contact
Elizabeth Evans, PhD
Chief Operating Officer, Vaccinex, Inc.
(585) 271-2700
eevans@vaccinex.com

Join Jupiter Neurosciences’ Exclusive Live Investor Webinar and Q&A Session on January 6

Join Jupiter Neurosciences’ Exclusive Live Investor Webinar and Q&A Session on January 6




Join Jupiter Neurosciences’ Exclusive Live Investor Webinar and Q&A Session on January 6

Jupiter, Florida, Dec. 23, 2025 (GLOBE NEWSWIRE) — Jupiter Neurosciences, Inc. (NASDAQ: JUNS) (“Jupiter” or the “Company”), a clinical-stage pharmaceutical company developing JOTROL, a patented resveratrol-based platform, is pleased to invite investors to a webinar on January 6, 2026, at 4:15 p.m. ET.

The exclusive event, hosted by RedChip Companies, will feature Jupiter Neuroscience Chairman and CEO Chister Rosén who will provide investors with an overview of Jupiter Neurosciences’ scientific platform, clinical development plans, and commercial strategy heading into 2026. Rosén will discuss the Company’s lead asset, JOTROL, including its differentiated bioavailability profile and upcoming Phase 2a clinical trial in Parkinson’s disease, as well as the broader therapeutic potential across neuroinflammatory and rare disease indications. The presentation will also outline Jupiter’s dual-path approach, highlighting the launch and early commercialization of its Nugevia longevity product line, the rationale for leveraging the same clinically validated technology across pharmaceutical and consumer markets, and how recent financing initiatives support disciplined execution across both pathways.

A live Q&A session will follow the presentation.

To register for the free webinar, please visit: https://www.redchip.com/webinar/JUNS/86401333631

Questions can be pre-submitted to JUNS@redchip.com or online during the live event.

About Jupiter Neurosciences, Inc.

Jupiter Neurosciences is a clinical-stage pharmaceutical company pursuing a dual-path strategy to address neuroinflammation and promote healthy aging. The Company is advancing a therapeutic pipeline targeting central nervous system (CNS) disorders and rare diseases, while also expanding into the consumer longevity market with its Nugevia product line. Both efforts are powered by JOTROL, Jupiter’s proprietary, enhanced resveratrol formulation that has demonstrated significantly improved bioavailability. Nugevia brings clinical-grade science to the supplement space, supporting mental clarity, skin health, and mitochondrial function. The Company’s prescription pipeline is focused broadly on CNS disorders, presently with a Phase IIa in Parkinson’s disease, including indications such as Alzheimer’s Disease, Mucopolysaccharidoses Type I, Friedreich’s Ataxia, and MELAS. More information may be found on the Company’s website www.jupiterneurosciences.com.

About JOTROL

Resveratrol is one of the world’s most extensively researched molecules. Thorough evaluation has shown that for the compound to be effective, it requires a high C-Max (~300 ng/ml of resveratrol in plasma), achievable only with doses exceeding 3 grams using earlier resveratrol products. Poor bioavailability has been a well-documented issue with resveratrol. Doses over 2 grams have been associated with severe gastrointestinal (GI) side effects, which have prevented the compound from receiving regulatory approval for any indication.

Jupiter Neurosciences (JUNS) conducted a Phase I study demonstrating that JOTROL achieves over nine times higher bioavailability compared to resveratrol used in earlier clinical trials (e.g., Turner et al., MCI/Early Alzheimer’s Disease trial, and Yui et al., Friedreich’s Ataxia trial). The results of this Phase I study, which will be cross-referenced in all upcoming JOTROL trials, were published in the Journal of Alzheimer’s Disease and AAPS Open in February 2022. JUNS is now advancing JOTROL toward a Phase IIa trial in Parkinson’s Disease.

In addition to its therapeutic applications, JOTROL serves as the foundation for Jupiter’s Nugevia consumer supplement line. By leveraging the same clinically validated delivery technology, Nugevia introduces pharmaceutical-grade bioavailability into the wellness space, offering targeted support for cognitive health, skin vitality, and cellular energy.

About Nugevia

Nugevia is Jupiter Neurosciences’ premium longevity and performance supplement line powered by the same patented JOTROL micellar delivery technology advancing through clinical trials for CNS disorders. Built on pharmaceutical-grade science, each formulation features synergistic, highly bioavailable active ingredients designed to target key pillars of healthy aging, including cognitive resilience (MND), mitochondrial energy and recovery (PWR), and cellular skin vitality (GLO).

Unlike conventional supplements that often struggle with poor absorption and inconsistent results, Nugevia products are rooted in peer-reviewed clinical data, developed under pharmaceutical standards, and informed by strategic research collaborations with leading institutions including Harvard, Georgetown, MIT’s Picower Institute, and the University of Miami. More information is available at www.nugevia.com.

FORWARD-LOOKING STATEMENTS

Certain statements in this announcement are forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties and are based on the Company’s current expectations, including the Company’s ability to generate revenues from the sale of JOTROL products to consumers through the DTC model. Investors can find many (but not all) of these statements by the use of words such as “approximates,” “believes,” “hopes,” “expects,” “anticipates,” “estimates,” “projects,” “intends,” “plans,” “will,” “would,” “should,” “could,” “may” or other similar expressions. Although the Company believes that the expectations expressed in these forward-looking statements are reasonable, it cannot assure you that such expectations will turn out to be correct. The Company cautions investors that actual results may differ materially from the anticipated results and encourages investors to read the risk factors contained in the Company’s final prospectus and other reports it files with the SEC before making any investment decisions regarding the Company’s securities. The Company undertakes no obligation to update or revise publicly any forward-looking statements to reflect subsequent occurring events or circumstances, or changes in its expectations, except as may be required by law.

Contact:

IR@jupiterneurosciences.com

JUNS@redchip.com

CooperCompanies Appoints Walter M Rosebrough, Jr. to its Board of Directors

CooperCompanies Appoints Walter M Rosebrough, Jr. to its Board of Directors




CooperCompanies Appoints Walter M Rosebrough, Jr. to its Board of Directors

Enters into Cooperation Agreement with Browning West

SAN RAMON, Calif., Dec. 23, 2025 (GLOBE NEWSWIRE) — CooperCompanies (Nasdaq: COO), a leading medical device company, announced today that the Company’s Board of Directors (the “Board”) has appointed Walter (Walt) M Rosebrough, Jr. as an independent director, effective as of January 3, 2026. In connection with this appointment, the Company also has entered into a cooperation agreement (the “Cooperation Agreement”) with Browning West, LP. (“Browning West”). Mr. Rosebrough will join the Board’s Corporate Governance & Nominating Committee. The Board has also agreed that, by the end of 2026, it shall provide due and serious consideration for Mr. Rosebrough to be appointed Chair of the Board. In addition, the Board will identify and appoint a new independent director with medical technology experience, with the mutual agreement of Browning West.

Mr. Rosebrough currently serves as CEO Emeritus and Senior Advisor of STERIS plc (NYSE: STE), a global medical device business focused on infection prevention products and services. During his tenure as CEO of STERIS from 2007 to 2021, STERIS’s stock generated a 10-fold total return or an 18% annualized return compared with a 10% annualized return for the S&P 500, and the company’s market capitalization increased by over $20 billion. His career also includes nearly two decades at Hill-Rom Holdings, Inc., where he held senior executive positions, including President and CEO of Support Systems International and President and CEO of Hill-Rom. Mr. Rosebrough currently serves as Independent Chair on the Board of Varex Imaging (NASDAQ: VREX).

“We are pleased to welcome Walt to our Board,” said Colleen Jay, Incoming Chair of the Board of CooperCompanies. “He brings decades of leadership experience in the medical device manufacturing and healthcare industries, and his proven track record delivering sustainable growth will support our strategic vision and ongoing focus of delivering long-term value for shareholders.”

“Cooper has significant long-term potential, and we are pleased to have aligned on a constructive path forward with the Cooper Board,” said Usman S. Nabi, Co-Founder and Chief Investment Officer of Browning West. “We believe Walt’s appointment along with the Company’s commitment to additional Board refreshment position Cooper to drive the critical initiatives required to unlock sustained long-term value for all shareholders.”

Browning West has agreed to certain customary standstill and voting commitments in connection with the Cooperation Agreement and will support the Board’s full slate of directors at the 2026 Annual Meeting of Stockholders. The Cooperation Agreement will be filed by the Company with the U.S. Securities and Exchange Commission (“SEC”) as an exhibit to the Current Report on Form 8-K.

About CooperCompanies
CooperCompanies (Nasdaq: COO) is a leading global medical device company focused on helping people experience life’s beautiful moments through its two business units, CooperVision and CooperSurgical. CooperVision is a trusted leader in the contact lens industry, helping to improve the way people see each day. CooperSurgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most. Headquartered in San Ramon, CA, CooperCompanies has a workforce of more than 15,000, sells products in over 130 countries, and positively impacts over fifty million lives each year. For more information, please visit www.coopercos.com.

About Browning West, LP
Browning West is an independent investment partnership based in Los Angeles, California. The partnership employs a concentrated, long-term and fundamental approach to investing and focuses primarily on investments in North America and Western Europe. Founded in 2019, Browning West seeks to identify and invest in a limited number of high-quality businesses and to hold these investments for multiple years. Backed by a select group of leading foundations, family offices, and university endowments, our unique capital base allows us to focus on long-term value creation at our portfolio companies.

Forward-Looking Statements
This press release contains “forward-looking statements” as defined by the Private Securities Litigation Reform Act of 1995. Statements relating to the Company’s potential transactions, capital allocation priorities, share repurchase program, efforts to enhance long-term shareholder value, plans, strategies, future actions, and other statements of which are other than statements of historical fact, are forward-looking. Forward-looking statements necessarily depend on assumptions, data, or methods that may be incorrect or imprecise and are subject to risks and uncertainties. Statements regarding future events and performance and contain words such as “expects” and similar words or phrases. A wide range of factors could materially affect future developments, including, but not limited to, uncertainties related to market conditions and other factors set forth in our other filings with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K. These risks and uncertainties may cause actual future results or actions to be materially different than those expressed in such forward-looking statements. We do not intend, or undertake any duty, to update any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law.

Contact:
Kim Duncan
Vice President, Investor Relations and Risk Management
925-460-3663
ir@cooperco.com