J-Star Announces Interim Financial Results for the First Six Months of 2025




J-Star Announces Interim Financial Results for the First Six Months of 2025

TAICHUNG CITY, Taiwan, Dec. 18, 2025 (GLOBE NEWSWIRE) — J-Star Holding Co., Ltd. (Nasdaq: YMAT) (“J-Star” or the “Company”), a leading provider of innovative carbon fiber and composite solutions across a wide range of applications including personal sports equipment, healthcare products, automobile parts, resin systems, and research and development services, today announced its unaudited financial results for the six months ended June 30, 2025 (“First Half 2025”).

Financial and Business Highlights

• Revenue increased 30.7% to $10.6 million compared to $8.1 million for the same period last year
• Gross margin of 26.9% compared to 30.2% for the same period last year
• Delivered net operating profit of $154,000 and profit after income tax of $5,000 as the Company focused on launching its branded products and preparation for its Nasdaq Initial Public Offering
• Significantly expanded in rackets, including launching YMA’s first company-owned pickleball brand
• Successfully completed Initial Public Offering in July 2025, raising $5.0 million in gross proceeds

Comments from Sam Van, Chief Executive Officer of J-Star

“We are proud to have become a leading provider of innovative carbon fiber and composite solutions with products that have been endorsed by major brands and embraced by champions for over six decades. Our strong first half 2025 results are indicative of our ability to innovate toward high growth markets such as rackets, adapt to evolving market conditions in bikes, and execute with discipline. As a public company, we believe we are still in the early stages of a compelling growth journey.”

“Revenue of $10.6 million grew more than 30% in 1H 2025, including approximately 500% growth in both our rackets and technical services businesses. This performance reflects successful evolution of our business model toward becoming a solutions provider rather than a traditional OEM. Notably, we were able to more than offset the deliberate reduction in bicycle volumes to focus on maintaining margins, as well as a decline in crank revenue following the acquisition of our customer by a third party.”

“In the first half of 2025 we prepared for YMA’s launch of a line of in-house pickleball paddles as part of our direct-to-consumer strategy as we seek to capture our share of the world’s fastest growing sport, and we have since introduced the first two paddles – Horizon and Supernova. We also partnered up with cycling industry veterans to create a new premium carbon fiber components brand – QO Bikes. We are encouraged by the initial market response to both offerings. We are focusing on preparing the automation production line setup ahead of the planned facility in Texas over the coming months.”

“Looking ahead, we are focused on establishing our U.S.-based manufacturing capabilities, as part of our stated OEM strategy to develop capacity closer to our customers, particularly for the pickleball market. This strategy will enable us to improve inventory management, reduce transportation time, and lower our costs relative to competitors, as well as adding value to our customers through a ‘made in America’ approach.”

First Half 2025 Results

Total revenue for 1H 2025 was $10.6 million, an increase of 30.7% compared to $8.1 million for the first six months of 2024 (“1H 2024”). The growth was driven by a substantial increase in rackets and technical services sales, which more than offset lower sales of bicycle frames and components, reflecting a deliberate focus on maintaining margins rather than pursuing volumes in the bikes business.

Gross profit was $2.8 million, or 26.9% gross margin, compared to gross profit of $2.4 million, or 30.2% gross margin, for 1H 2024. The decrease in gross margin was concentrated in rackets as the Company reoriented business models to provide RD/Design/Raw Material supply services and acting as trading agent in preparation for exiting the China OEM business and expanding to the U.S.

Total operating expenses were $2.7 million, an increase of 47.6% compared to $1.8 million for 1H 2024. The increase was driven by higher administrative expenses, including non-recurring IPO-related expenses and costs associated with the launch of QO Bikes in Spain, as well as higher R&D expenses as we focus on preparing the automation factory setup in Houston, Texas.

Operating income was $154,000, a decrease of 75.3% compared to operating income of $623,000 in 1H 2024. Non-operating expenses, including finance costs, interest income and foreign exchange gains, were $139,000 in 1H 2025 compared to $230,000 in 1H 2024.

Profit after income tax was $5,000 ($0.00 per share) compared to $479,000 ($0.03 per share) in 1H 2024.

Cash and cash equivalents were $909,995 as of June 30, 2025, compared to $649,106 at December 31, 2024.

About J-Star Holding Co., Ltd.

J-Star (NASDAQ: YMAT) is a holding company with operations conducted through subsidiaries in Taiwan, Hong Kong, and Samoa with its headquarters in Taiwan. J-Star’s predecessor group was established in 1970, and has accumulated over 50 years of know-how in material composites industry. J-Star develops and commercializes the technology on carbon reinforcement and resin systems. With decades of experience and knowledge in composites and materials, J-Star is able to apply its expertise and technology to design and manufacture a great variety of lightweight, high-performance carbon composite products, ranging from key structural parts of electric bicycles and sports bicycles, rackets, automobile parts to healthcare products. Visit j-starholding.com and ymaunivers.com to learn more.

Forward Looking-Statements

Certain statements contained in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to the expected trading commencement and closing dates. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors discussed in the “Risk Factors” section of the final prospectus filed with the SEC. For these reasons, among others, investors are cautioned not to place undue reliance upon any forward-looking statements in this press release. Any forward-looking statements contained in this press release speak only as of the date hereof, and J-Star specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

Contact:
Matt Chesler, CFA
FNK IR
646-809-2183
investor@j-starholding.com

Femasys Secures U.S. FDA Clearance for Next-Generation FemVue Diagnostic Device




Femasys Secures U.S. FDA Clearance for Next-Generation FemVue Diagnostic Device

— Innovative single-device solution integrates proven FemVue and FemChec^® technologies to support fallopian tube evaluation and improve workflow efficiency–

ATLANTA, Dec. 18, 2025 (GLOBE NEWSWIRE) — Femasys Inc. (NASDAQ: FEMY), a leading biomedical innovator making fertility and non-surgical permanent birth control more accessible and cost-effective to women worldwide, announced today it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its FemVue Controlled device, an innovative diagnostic solution designed for controlled contrast delivery to evaluate fallopian tube status. The next-generation FemVue Controlled device integrates features of the Company’s original FemVue and FemChec technologies into a single FDA-cleared product, enabling multiple clinical uses while streamlining manufacturing and practice workflows.

“This FDA clearance represents an important milestone for Femasys as we continue to advance practical, clinician-focused innovations,” said Kathy Lee-Sepsick, Chief Executive Officer and Founder of Femasys Inc. “FemVue Controlled reflects our commitment to simplifying care delivery while strengthening the scalability and efficiency of our product portfolio.”

About FemVue Controlled
FemVue^® Controlled is an FDA-cleared diagnostic device designed for controlled delivery of a consistent alternating pattern of saline and air as contrast media during ultrasound imaging to evaluate fallopian tube status. The next-generation device integrates features of the Company’s FemVue and FemChec^® technologies into a single platform, enabling multiple clinical uses within one solution, including confirmation of tubal patency prior to use with FemaSeed^®. Learn more at www.FemVue.com.

About Femasys
Femasys is a leading biomedical innovator focused on making fertility and non-surgical permanent birth control more accessible and cost-effective for women worldwide through its broad, patent-protected portfolio of novel, in-office therapeutic and diagnostic products. As a U.S. manufacturer with global regulatory approvals, Femasys is actively commercializing its lead product innovations in the U.S. and key international markets. Femasys’ fertility portfolio includes FemaSeed^® Intratubal Insemination, a groundbreaking first-step infertility treatment and FemVue^®, a companion diagnostic for fallopian tube assessment. Published clinical trial data demonstrates FemaSeed is over twice as effective as traditional IUI, with a comparable safety profile, and high patient and practitioner satisfaction.¹

FemBloc^® permanent birth control is the first and only non-surgical, in-office alternative to centuries-old surgical sterilization that received full regulatory approval in Europe in June of 2025, the UK in August 2025, and New Zealand in September 2025. Commercialization of this highly cost-effective, convenient and significantly safer approach will be completed through strategic partnerships in select European countries. Alongside FemBloc, the FemChec^®, diagnostic product provides an ultrasound-based test to confirm procedural success. Published data from initial clinical trials demonstrated compelling effectiveness, five-year safety, and high patient and practitioner satisfaction.² For U.S. FDA approval, enrollment in the FINALE pivotal trial (NCT05977751) is on-going.

Learn more at www.femasys.com, or follow us on X, Facebook and LinkedIn.

References
¹Liu, J. H., Glassner, M., Gracia, C. R., Johnstone, E. B., Schnell, V. L., Thomas, M. A., L. Morrison, Lee-Sepsick, K. (2024). FemaSeed Directional Intratubal Artificial Insemination for Couples with Male-Factor or Unexplained Infertility Associated with Low Male Sperm Count. J Gynecol Reprod Med, 8(2), 01-12. doi: 10.33140/JGRM.08.02.08.

²Liu, J. H., Blumenthal, P. D., Castaño, P. M., Chudnoff, S. C., Gawron, L. M., Johnstone, E. B., Lee-Sepsick, K. (2025). FemBloc Non-Surgical Permanent Contraception for Occlusion of the Fallopian Tubes. J Gynecol Reprod Med, 9(1), 01-12. doi: 10.33140/JGRM.09.01.05.

Forward-Looking Statements 
This press release contains forward-looking statements that are subject to substantial risks and uncertainties. Forward-looking statements can be identified by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “pending,” “intend,” “believe,” “suggests,” “potential,” “hope,” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on our current expectations and are subject to inherent uncertainties, risks and assumptions, many of which are beyond our control, difficult to predict and could cause actual results to differ materially from what we expect. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, among others: our ability to obtain regulatory approvals for our FemBloc product candidate; develop and advance our current FemBloc product candidate and successfully enroll and complete the clinical trial; the ability of our clinical trial to demonstrate safety and effectiveness of our product candidate and other positive results; estimates regarding the total addressable market for our products and product candidate; our ability to commercialize our products and product candidate, our ability to establish, maintain, grow or increase sales and revenues, or the effect of delays in commercializing our products, including FemaSeed; our business model and strategic plans for our products, technologies and business, including our implementation thereof; and those other risks and uncertainties described in the section titled “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024, and other reports as filed with the SEC. Forward-looking statements contained in this press release are made as of this date, and Femasys undertakes no duty to update such information except as required under applicable law.

Contacts: 
David Gutierrez, Dresner Corporate Services, (312) 780-7204, dgutierrez@dresnerco.com
Nathan Abler, Dresner Corporate Services, (714) 742-4180, nabler@dresnerco.com

Sienna Announces Completion of $250 Million Offering of 3.524% Series F Senior Unsecured Debentures




Sienna Announces Completion of $250 Million Offering of 3.524% Series F Senior Unsecured Debentures

NOT FOR DISSEMINATION TO U.S. NEWS WIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES

This news release constitutes a “designated news release” for the purposes of Sienna’s amended and restated prospectus supplement dated November 14, 2025 to its short form base shelf prospectus dated November 29, 2024.

MARKHAM, Ontario, Dec. 18, 2025 (GLOBE NEWSWIRE) — Sienna Senior Living Inc. (“Sienna” or the “Company”) (TSX: SIA) announced today that it has completed its previously announced offering (the “Offering”) of $250 million aggregate principal amount of series F senior unsecured debentures (the “Debentures”). The Offering was led by BMO Capital Markets, TD Securities Inc. and CIBC Capital Markets, as joint lead agents and bookrunners. The Debentures were issued at par, bear interest at a rate of 3.524% per annum and will mature on December 18, 2028.

The Debentures are rated “BBB (Stable)” by Morningstar DBRS.

Sienna intends to use the net proceeds from the Offering to fund the early redemption of all of its $175 million aggregate principal amount of 3.450% Series B Senior Unsecured Debentures (the “Series B Debentures”), due February 27, 2026, on December 22, 2025 and/or for general corporate purposes.

The Debentures were sold by way of a private placement in each of the provinces of Canada.

The Debentures have not been registered under the U.S. Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the Debentures in any jurisdiction in which such offer, solicitation or sale would be unlawful.

About Sienna Senior Living

Sienna Senior Living Inc. (TSX:SIA) offers a full range of senior living options, including independent living, assisted living and memory care under its Aspira retirement brand, long-term care, and specialized programs and services. Sienna’s approximately 15,000 employees are passionate about cultivating happiness in daily life. For more information, please visit www.siennaliving.ca.

Forward-Looking Statements

Certain of the statements contained in this news release are forward-looking statements and are provided for the purpose of presenting information about management’s current expectations and plans relating to the future. Readers are cautioned that such statements may not be appropriate for other purposes. These statements generally use forward-looking words, such as “anticipate”, “continue”, “could”, “expect”, “may”, “will”, “estimate”, “believe”, “goals” or other similar words and include, without limitation, statements with respect to the intended use of proceeds and the redemption of the Series B Debentures.

These statements are subject to significant known and unknown risks and uncertainties that may cause actual results or events to differ materially from those expressed or implied by such statements and, accordingly, should not be read as guarantees of future performance or results and will not necessarily be accurate indications of whether or not such results will be achieved. The forward-looking statements in this news release are based on information currently available and what management currently believes are reasonable assumptions. The Company does not undertake any obligation to publicly update or revise any forward-looking statements except as may be required by applicable law.

FOR FURTHER INFORMATION, PLEASE CONTACT:

David Hung
Chief Financial Officer and Executive Vice President, Investments
(905) 489-0258
david.hung@siennaliving.ca

Sangamo Therapeutics Initiates Rolling Submission of BLA to U.S. FDA for ST-920 in Fabry Disease




Sangamo Therapeutics Initiates Rolling Submission of BLA to U.S. FDA for ST-920 in Fabry Disease

STAAR study demonstrated positive mean annualized estimated glomerular filtration rate (eGFR) slope at 52-weeks across all dosed patients in the study, which U.S. Food and Drug Administration (FDA) has agreed will serve as an endpoint to support accelerated approval pathway 

Isaralgagene civaparvovec continues to show favorable safety and tolerability profile

Sangamo expects to complete Biological License Application (BLA) submission under accelerated approval pathway in second quarter of 2026

RICHMOND, Calif., Dec. 18, 2025 (GLOBE NEWSWIRE) — Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, has initiated a rolling submission of a BLA to the FDA seeking accelerated approval of isaralgagene civaparvovec, or ST-920, a wholly owned investigational gene therapy for the treatment of adults with Fabry disease.

Rolling submission allows for completed modules of the BLA to be submitted and reviewed by the FDA on an ongoing basis rather than waiting for the entire BLA to be submitted at once. 

“The initiation of our BLA submission marks an important milestone for Sangamo and for Fabry patients in need,” said Nathalie Dubois-Stringfellow, Ph.D., Sangamo’s Chief Development Officer. “The compelling data from our STAAR study shows the potential of ST-920 to provide safe and long-lasting clinical benefits to a wide range of Fabry disease patients. We look forward to working with the FDA as we continue to advance the regulatory process.”

The totality of data from the registrational STAAR study demonstrated the potential for isaralgagene civaparvovec as a one-time, durable treatment of the underlying pathology of Fabry disease to provide meaningful, multi-organ, clinical benefits above current standards of care. Furthermore, the STAAR study demonstrated a positive mean annualized eGFR slope at 52-weeks across all dosed patients in the study, which the FDA has agreed will serve as endpoint to support accelerated approval.

Isaralgagene civaparvovec has been granted Orphan Drug, Fast Track and RMAT designations from the FDA, Orphan Medicinal Product designation and PRIME eligibility from the European Medicines Agency and Innovative Licensing and Access Pathway from U.K. Medicines and Healthcare products Regulatory Agency.

Sangamo expects to complete submission of the BLA to the FDA under the accelerated approval pathway in the second quarter of 2026.

About the STAAR Study
The Phase 1/2 STAAR study is a global open-label, single-dose, dose-ranging, multicenter clinical study designed to evaluate isaralgagene civaparvovec, or ST-920, a gene therapy product candidate in patients with Fabry disease. Isaralgagene civaparvovec requires a one-time infusion without preconditioning.

About Fabry Disease
Fabry disease is a lysosomal storage disorder caused by mutations in the galactosidase alpha gene (GLA), which leads to deficient alpha-galactosidase A (α-Gal A) enzyme activity, which is necessary for metabolizing globotriaosylceramide (Gb3). The buildup of Gb3 in the cells can cause serious damage to vital organs, including the kidney, heart, nerves, eyes, gut and skin. Symptoms of Fabry disease can include decreased or absent sweat production, heat intolerance, angiokeratoma (skin blemishes), vision problems, kidney disease, heart failure, gastrointestinal disturbance, mood disorders, neuropathic pain and tingling in the extremities.

About Sangamo Therapeutics

Sangamo Therapeutics is a genomic medicine company dedicated to translating ground-breaking science into medicines that transform the lives of patients and families afflicted with serious neurological diseases who do not have adequate or any treatment options. Sangamo believes that its zinc finger epigenetic regulators are ideally suited to potentially address devastating neurological disorders and that its capsid discovery platform can expand delivery beyond currently available intrathecal delivery capsids, including in the central nervous system. Sangamo’s pipeline also includes multiple partnered programs and programs with opportunities for partnership and investment. To learn more, visit www.sangamo.com and connect with us on LinkedIn and X.

Forward-Looking Statements

This press release contains forward-looking statements regarding Sangamo’s current expectations. These forward-looking statements include, without limitation, statements relating to: the safety and efficacy and therapeutic potential of isaralgagene civaparvovec, including the potential for it to be a one-time, durable treatment option for Fabry disease to provide meaningful, multi-organ clinical benefits above current standards of care; the potential for isaralgagene civaparvovec to qualify for the FDA’s accelerated approval program, including the adequacy of data generated in the Phase 1/2 STAAR study to support any such approval; expectations concerning the availability of additional data to support a potential BLA submission for isaralgagene civaparvovec, and the timing of such submission; and other statements that are not historical fact. These statements are not guarantees of future performance and are subject to certain risks and uncertainties that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties related to Sangamo’s lack of capital resources to obtain regulatory approval for and commercialize its product candidates in a timely manner or at all, including the ability to secure a commercialization partner for ST-920; the uncertain timing and unpredictable nature of clinical trial results, including the risk that preliminary or topline data is not indicative of final results, that the therapeutic effects observed in the latest clinical data from the Phase 1/2 STAAR study will not be durable in patients and that final clinical trial data from the study will not validate the safety and efficacy of isaralgagene civaparvovec, including that the 52-week data from the Phase 1/2 STAAR study will not support a BLA submission and/or that the 104-week data from such study will not verify the clinical benefit of isaralgagene civaparvovec or support FDA approval, and that the patients withdrawn from ERT will remain off ERT; Sangamo’s need for substantial additional funding to execute its operating plan and to continue to operate as a going concern; the effects of macroeconomic factors or financial challenges on the global business environment, healthcare systems and Sangamo’s business and operations; the research and development process; the unpredictable regulatory approval process for product candidates across multiple regulatory authorities; the potential for technological developments that obviate technologies used by Sangamo; Sangamo’s reliance on collaborators and the potential inability to secure additional collaborations; and Sangamo’s ability to achieve expected future financial performance.

All forward-looking statements about Sangamo’s future plans and expectations, including Sangamo’s development plans for its product candidates, are subject to Sangamo’s ability to secure adequate additional funding. There can be no assurance that Sangamo and its current or potential future partners will be able to develop commercially viable products. Actual results may differ materially from those projected in these forward-looking statements due to the risks and uncertainties described above and other risks and uncertainties that exist in the operations and business environments of Sangamo and its collaborators. These risks and uncertainties are described more fully in Sangamo’s Securities and Exchange Commission, or SEC, filings and reports, including in Sangamo’s Annual Report on Form 10-K for the year ended December 31, 2024, as supplemented by its Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, each filed with the SEC, and future filings and reports that Sangamo makes from time to time with the SEC. Forward-looking statements contained in this announcement are made as of this date, and Sangamo undertakes no duty to update such information except as required under applicable law.

Contacts

Investor Relations
Louise Wilkie
ir@sangamo.com

Media Inquiries
Melinda Hutcheon
media@sangamo.com

Numab Therapeutics Achieves Milestone in Second Collaboration Project with Boehringer Ingelheim




Numab Therapeutics Achieves Milestone in Second Collaboration Project with Boehringer Ingelheim

Numab to receive milestone payment

Boehringer Ingelheim has advanced its novel multi-specific antibody for retinal diseases resulting from a collaboration with Numab into preclinical development

HORGEN, Switzerland, Dec. 18, 2025 (GLOBE NEWSWIRE) — Numab Therapeutics AG (“Numab”), a biotechnology company advancing a proprietary pipeline of multi-specific antibodies in immunology and oncology, announced today that Boehringer Ingelheim has advanced its novel multi-specific antibody for the treatment of wet age-related macular degeneration (AMD) resulting from a collaboration with Numab into preclinical development. The milestone achievement triggers a payment to Numab as part of the agreement.

In 2020, Numab and Boehringer Ingelheim entered into a research collaboration and worldwide licensing agreement on two projects, one aiming at novel therapies for patients with wet age-related macular degeneration (AMD), a progressive, irreversible retinal disease, and the second aimed at difficult-to-treat lung and gastrointestinal (GI) cancers. The advancement of both programs into development by Boehringer Ingelheim represents meaningful progress across the collaboration, which brings together Boehringer Ingelheim’s leading expertise in the research and development of life changing breakthrough therapies with Numab’s multi-specific antibody platform.

“Reaching this milestone in the second project highlights the continued success of our collaboration with Boehringer Ingelheim and further validates the potential of Numab’s antibody platform to discover and advance novel molecules for multiple disease targets,” said Angehrn Pavik, CEO of Numab. “We are proud of the progress achieved so far and our strong track record executing development collaborations with global Pharma partners. I look forward to continuing our work together towards impactful new therapies for patients”.

About Numab Therapeutics AG
Numab Therapeutics AG is developing multi-specific antibody-based immunotherapies for inflammation and cancer. Reproducible plug-and-play therapeutic design process using proprietary platforms λ-CapTM and MATCHTM, and state-of-the-art Fc engineering puts Numab in a unique position to overcome historical drug discovery barriers and build a pipeline of new and important medicines aimed to maximize patient benefits. Numab’s diverse research pipeline spans multiple therapeutic areas and creates the opportunity for the next generation of first-in-class and best-in-class medicines. For further information, visit https://www.numab.com.

For further details, please contact:

Numab Therapeutics
Barbara Angehrn Pavik
Chief Executive Officer
b.angehrn@numab.com

Numab Investor Contact:
Victoria Igumnova
Meru Advisors
vigumnova@meruadvisors.com

Cocrystal Pharma Receives IRB Approval from Emory University School of Medicine for Phase 1b Human Challenge Study with CDI-988 for Prevention and Treatment of Norovirus




Cocrystal Pharma Receives IRB Approval from Emory University School of Medicine for Phase 1b Human Challenge Study with CDI-988 for Prevention and Treatment of Norovirus

• Subject enrollment expected to begin in Q1 2026
• CDI-988 is the first oral broad-spectrum antiviral drug candidate for potential prevention of norovirus outbreaks and treatment of acute viral gastroenteritis caused by norovirus infection
• There are no approved treatments or vaccines currently available for norovirus infection

BOTHELL, Wash., Dec. 18, 2025 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces the approval from the Institutional Review Board (IRB) at Emory University School of Medicine to initiate a Phase 1b human challenge study with CDI-988. This study aims to evaluate CDI-988 as both a preventive and treatment for norovirus infections. Initial screening of study subjects is currently underway, with enrollment expected to begin in the first quarter of 2026. The IRB approval from Emory University School of Medicine follows Cocrystal’s prior regulatory milestones, including U.S. Food and Drug Administration (FDA) clearance of its investigational New Drug (IND) application.

CDI-988 is the first oral antiviral drug candidate developed for the prevention and treatment of norovirus acute gastroenteritis. It was specifically designed as a broad-spectrum inhibitor by targeting a highly conserved region of the viral 3CL protease of all noroviruses, including GII.4 and recently re-emerging GII.17.

The randomized, double-blind, placebo-controlled Phase 1b study will be conducted at Emory University and involve up to 40 healthy subjects ages 18-49. Participants will be screened and infected with the norovirus GII.2 (Snow Mountain Virus). The study’s primary efficacy endpoint is to assess the reduction in incidence of clinical symptoms, while the secondary efficacy endpoint focuses on the reduction in viral shedding and disease severity. The study will also assess the safety and pharmacokinetic profile of CDI-988. Additional information is available on clinicaltrials.gov.

“This approval from the Emory IRB marks a significant milestone in advancing our Phase 1b norovirus challenge study,” said Sam Lee, Ph.D., Cocrystal’s President and co-CEO. “We are very excited about collaborating with the Emory team, given their exceptional expertise in norovirus and experience in human challenge studies.

“Cocrystal’s norovirus challenge study is a critical step in addressing the global burden of norovirus outbreaks, which account for an estimated 700 million cases each year worldwide. We are committed to delivering innovative medicine for norovirus outbreaks and chronic norovirus infection among immunocompromised patients,” added Dr. Lee.

“CDI-988 may revolutionize the management of the highly contagious norovirus, which is known for quickly spreading in hospitals, nursing homes, cruise ships, schools, disaster relief sites, military settings and other semi-closed environments,” said James Martin, CFO and co-CEO. “Used as a prophylaxis, oral CDI-988 could offer a potential solution and add a new layer of defense.”

CDI-988 was designed with Cocrystal’s proprietary structure-based drug discovery platform technology. In August 2025 Cocrystal announced favorable Phase 1 safety and tolerability data from all CDI-988 dose cohorts including the highest dose of 1200 mg. In September 2025 the Company received a Study May Proceed Letter from the FDA for the Phase 1b challenge study.

About Norovirus

Norovirus is a common and highly contagious virus that afflicts people of all ages and causes symptoms of acute gastroenteritis including nausea, vomiting, stomach pain and diarrhea, as well as fatigue, fever and dehydration. This debilitating illness causes an estimated 200,000 deaths worldwide each year, with a societal cost of approximately $60 billion. In the U.S., norovirus is responsible for about 21 million cases of acute gastroenteritis annually, including 109,000 hospitalizations, 465,000 emergency department visits and nearly 900 deaths, with an estimated annual economic burden of $10.6 billion.

Cocrystal Pharma’s Structure-Based Drug Discovery Platform Technology

Cocrystal’s proprietary structural biology, along with its expertise in enzymology and medicinal chemistry, enable its development of novel antiviral agents. The Company’s platform provides a three-dimensional structure of inhibitor complexes at near-atomic resolution, providing immediate insight to guide Structure Activity Relationships. This helps identify novel binding sites and enables a rapid turnaround of structural information through highly automated X-ray data processing and refinement. The goal of this technology is to facilitate the development of novel broad-spectrum antivirals for the treatment of acute, chronic and potentially pandemic viral diseases.

About Cocrystal Pharma, Inc.

Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), noroviruses and hepatitis C viruses. Cocrystal employs unique structure-based technologies to create viable antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding our initiation of the norovirus study in the first quarter of 2026 and the potential of CDI-988 for norovirus infections. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks and uncertainties arising from inflation, affordability, the possibility of a recession, the impact of future interest rate changes on the economy, tariffs and the resulting litigation, and geopolitical conflicts including those in Ukraine and Middle East on our Company, our collaboration partners, and on the U.S. and global economies, including manufacturing and research delays arising from raw materials and labor shortages, supply chain disruptions and other business interruptions including any adverse impacts on our ability to obtain raw materials for and otherwise proceed with the planned norovirus study or subsequent studies as well as similar problems with our vendors and our current and any future clinical research organizations (CROs) and contract manufacturing organizations (CMOs), the progress and results of the studies including any adverse findings or delays, the ability of us and our CROs to recruit volunteers for, and to otherwise proceed with, clinical studies, our and our collaboration partners’ technology and software performing as expected, financial difficulties experienced by certain partners, the results of any current and future preclinical and clinical studies, general risks arising from clinical studies, receipt of regulatory approvals, regulatory changes and any adverse developments which may arise therefrom, potential mutations in a virus we are targeting that may result in variants that are resistant to a product candidate we develop, the potential for the development of effective treatments by competitors which could reduce or eliminate a prospective future market share commercializing any product candidates we may develop in the future, and our ability to meet our future liquidity needs. Further information on our risk factors is contained in our filings with the SEC, including the “Risk Factors” in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2024 and the Prospectus dated September 25, 2025. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Contact:

Alliance Advisors IR
Jody Cain
310-691-7100
jcain@allianceadvisors.com

# # #

Replimune to Present at the 44th Annual J.P. Morgan Healthcare Conference




Replimune to Present at the 44th Annual J.P. Morgan Healthcare Conference

WOBURN, Mass., Dec. 18, 2025 (GLOBE NEWSWIRE) — Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that members of the Replimune management team will present at the 44^th Annual J.P. Morgan Healthcare Conference on Wednesday, January 14, 2025 at 1:30 PM PT.

A simultaneous webcast will be available in the Investors section of Replimune’s website at replimune.com. A replay will be available for 30 days following the conference.

About Replimune
Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of novel oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is intended to ignite local activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to then activate a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit www.replimune.com.

Investor Inquiries
Chris Brinzey
ICR Healthcare
339.970.2843
chris.brinzey@icrhealthcare.com

Media Inquiries
Arleen Goldenberg
Replimune
917.548.1582
media@replimune.com

Beacon Therapeutics to Present at the 44th Annual JP Morgan Healthcare Conference




Beacon Therapeutics to Present at the 44th Annual JP Morgan Healthcare Conference

LONDON and CAMBRIDGE, Mass., Dec. 18, 2025 (GLOBE NEWSWIRE) — Beacon Therapeutics Holdings Limited (‘Beacon Therapeutics’ or ‘the Company’), a leading clinical-stage biotechnology company with a mission to save and restore vision in people with rare and prevalent ocular diseases, today announced that Lance Baldo, M.D., Chief Executive Officer of Beacon Therapeutics, will present a company overview at the 44^th Annual JP Morgan Healthcare Conference being held January 12-15, 2025 in San Francisco, US.

The presentation is scheduled for Tuesday, 13^th January at 2:30 PM PT.

The Company completed enrollment in its pivotal VISTA trial evaluating lead ocular gene therapy candidate, laru-zova, for the treatment of X-linked retinitis pigmentosa (XLRP) in July 2025 and expects twelve-month topline data in the second half of 2026.

Most recently, Beacon announced that it had treated the first patient in its LANDSCAPE clinical trial of laru-zova for patients with XLRP, evaluating the safety of bilateral administration.

About Beacon Therapeutics
Beacon Therapeutics is a clinical-stage biotechnology company dedicated to saving and restoring sight for people living with rare and prevalent ocular diseases. The Company is harnessing the transformative power of gene therapy to deliver the most meaningful outcomes for severe ocular diseases. Beacon’s pipeline currently targets devastating blinding retinal diseases such as X-linked retinitis pigmentosa (XLRP) and geographic atrophy.

Beacon Therapeutics’ investors include Forbion, Syncona Limited, Oxford Science Enterprises, TCGX and Advent Life Sciences, among others. Learn more about Beacon Therapeutics at beacontx.com and follow on LinkedIn for more updates.

Contact:
info@beacontx.com

Media & Investors:
beacon@icrhealthcare.com

First Patient Dosed in SAB BIO’s SAFEGUARD Clinical Trial of SAB-142 for the Treatment of Stage 3 T1D




First Patient Dosed in SAB BIO’s SAFEGUARD Clinical Trial of SAB-142 for the Treatment of Stage 3 T1D

• Enrollment in the SAFEGUARD trial is ongoing at multiple centers globally
• Company on-track to share Phase 2b data in 2H 2027

MIAMI, Dec. 18, 2025 (GLOBE NEWSWIRE) — SAB Biotherapeutics, Inc. (Nasdaq: SABS), a clinical-stage biopharmaceutical company developing human anti-thymocyte immunoglobulin (hATG) for type 1 diabetes (T1D) and other autoimmune diseases, today announced the dosing of the first patient with SAB-142 in the Phase 2b registrational SAFety and Efficacy of human anti-thymocyte immunoGlobUlin SAB-142 ARresting progression of type 1 Diabetes (SAFEGUARD) clinical trial. SAB-142 is in development as a novel, potentially best-in-class, disease-modifying immunotherapeutic approach to treat stage 3 T1D by delaying the progression of disease.

“The first patient treated in the SAFEGUARD study marks a significant milestone for SAB BIO as we are one step closer to advancing our ‘Beyond Insulin’ vision to bring a potentially safe and effective disease modifying therapy, SAB-142, to approval. SAB-142 is a fully human biologic that targets multiple immune cells implicated in T1D without necessarily killing them. SAB-142 is emerging as a potentially best-in-class treatment for people living with T1D,” said Alexandra Kropotova, M.D., MBA, Chief Medical Officer, SAB BIO. “We are focused on the rapid enrollment of our trial with multiple sites activated around the world. The successful initiation of our global Phase 2b trial, combined with robust Phase 1 safety, immunogenicity, and pharmacodynamic data presented earlier this year at major diabetes conferences, provides strong clinical momentum heading into the new year.”

Dr. Kropotova added, “I would like to thank the clinical trial participants, their families, the clinicians, and our colleagues at collaborating institutions, including the Australasian Type 1 Diabetes Immunotherapy Collaborative (ATIC), AK Clinical Research, and SAB BIO’s global CRO partner, for their invaluable contributions to our clinical trials. We look forward to sharing more updates from our Phase 2b SAFEGUARD trial in 2026.”

The SAFEGUARD trial is currently enrolling additional study participants at multiple centers around the globe, including the U.S., Australia, and New Zealand, with European sites joining soon. The first patient in SAFEGUARD was dosed at The Royal Melbourne Hospital (RMH) in Australia by Professor John Wentworth and team.

About the SAFEGUARD Trial
SAFety and Efficacy of human anti-thymocyte immunoGlobUlin SAB-142 ARresting progression of type 1 Diabetes (SAFEGUARD) trial is a double-arm, multi-center Phase 2b study designed to assess the safety, efficacy, and tolerability of SAB-142 in patients with stage 3 new onset T1D. SAB-142 is in development as a novel, potentially best-in-class, disease-modifying immunotherapeutic approach to treat T1D by delaying the progression of disease. SAFEGUARD Part A is a dose-ranging study in adult patients. SAFEGUARD Part B is a randomized double-blind, placebo-controlled, dose-ranging study. Enrolled patients will receive two SAB-142 infusions six months apart. All patients, including the placebo-control group, are eligible for the 12-month long-term extension study upon study completion. Additional details are available on www.clinicaltrials.gov (NCT07187531).

About SAB-142
SAB-142 is a potentially disease-modifying, redosable immunotherapy in clinical development for the treatment of autoimmune type 1 diabetes (T1D). SAB-142 is a multi-specific, fully human anti-thymocyte globulin (hATG) with a mechanism of action analogous to that of rabbit ATG (rATG). rATG has demonstrated in multiple clinical trials the ability to slow disease progression in patients with new- or recent-onset of Stage 3 T1D. SAB-142, like rATG, directly targets multiple immune cells involved in destroying pancreatic beta cells, including modulation of “bad acting” T-lymphocytes like cytotoxic T-cells. By stopping immune cells from attacking beta cells, this treatment has the potential to preserve insulin-producing beta cells.

About SAB BIO
SAB BIO is a clinical-stage biopharmaceutical company focused on developing multi-specific, high-potency, human immunoglobulin G (hIgG) to treat and prevent immune and autoimmune disorders. The Company’s lead candidate, SAB-142, targets autoimmune T1D with a disease-modifying therapeutic approach that aims to change the T1D treatment paradigm by delaying onset and potentially preventing disease progression of Stage 3 T1D patients. Using advanced genetic engineering and antibody science, SAB BIO developed a proprietary technology which holds the potential to generate additional novel therapeutic candidates utilizing the human immune response, without the need for human donors or convalescent plasma. SAB BIO has optimized genetic engineering in the development of transchromosomic cattle, or Tc-Bovine™, to produce hIgG. SAB BIO’s drug development production system is able to generate a diverse repertoire of specifically targeted, high-potency, hIgGs that can address a wide range of serious unmet needs in human diseases. For more information, visit www.sab.bio.

Forward-Looking Statements
Certain statements made in this current report that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “to be,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook,” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding future events, including statements about the development and clinical trial results of the Company’s T1D program and other discovery programs.

These statements are based on the current expectations of SAB BIO and are not predictions of actual performance, and are not intended to serve as, and must not be relied on, by any investor as a guarantee, prediction, definitive statement, or an assurance, of fact or probability. These statements are only current predictions or expectations, and are subject to known and unknown risks, uncertainties and other factors which may be beyond our control. Actual events and circumstances are difficult or impossible to predict, and these risks and uncertainties may cause our or our industry’s results, performance, or achievements to be materially different from those anticipated by these forward-looking statements. A further description of risks and uncertainties can be found in the sections captioned “Risk Factors” in our most recent annual report on Form 10-K, subsequent quarterly reports on Form 10-Q, as may be amended or supplemented from time to time, and other filings with or submissions to, the U.S. Securities and Exchange Commission, which are available at https://www.sec.gov/. Except as otherwise required by law, SAB BIO disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events, or circumstances or otherwise.

CONTACTS

Investor Relations:
Cristi Barnett
ir@sab.bio

Media:
Sheila Carlson
media@sab.bio

MUVON Therapeutics Appoints Dr. Christine Günther as Chief Technology Officer




MUVON Therapeutics Appoints Dr. Christine Günther as Chief Technology Officer

Zurich, Switzerland, December 18, 2025 – MUVON Therapeutics, a clinical-stage biotechnology company focused on developing a novel platform for the regeneration of skeletal muscle tissue, announces the appointment of cell therapy pioneer Christine Günther, MD, PhD, as Chief Technology Officer (CTO), effective December 1, 2025. Dr. Günther brings more than 30 years of experience translating regenerative medicine innovations from development to clinical application. 

Dr. Günther combines a rare blend of medical innovation and technology leadership and a proven track record as a biotech entrepreneur, scaling sustainable cell therapy businesses from startup to exit. Her expertise spans iPSC (stem cell) technology, cell and gene therapy development, CMC, GMP manufacturing, regulatory affairs, and clinical translation—capabilities that will be instrumental in advancing MUVON’s personalized tissue engineered treatment for muscle regeneration.

“We warmly welcome Christine to our team. Her broad-based experience, energy, and leadership of MUVON’s technology development strategy will help propel us through the next stage of our journey,” said Dr. Deana Mohr, Chief Executive Officer of MUVON Therapeutics. “Her demonstrated ability to translate regenerative medicine from bench to bedside, combined with her deep expertise in clinical development and manufacturing, makes her the ideal leader to advance our technology platform to patients in need.”

“I’m excited to become a member of the MUVON organization at this pivotal moment, when the company just announced groundbreaking Phase 2 results with its first-in-class muscle precursor cell-based therapy in restoring bladder health,” said Dr. Christine Günther, newly appointed CTO of MUVON Therapeutics. “The company’s innovative approach to regenerative medicine has tremendous potential to address serious unmet medical needs. I look forward to working with the team to accelerate development and bring transformative treatments to patients.”

Dr. Günther has built an exceptional track record over 30+ years in cell therapy, including over 12 years as CEO and Medical Director of Munich-based biotech apceth (now Minaris Regenerative Medicine), which she grew into one of Europe’s leading contract development and manufacturing organization (CDMO) in cell and gene therapy before its acquisition by Hitachi Chemical in 2019. Previously, she served as Medical Director at the Bavarian Stem Cell and Cord Blood Bank, where she led GMP-compliant stem cell programs and helped establish a major public cord blood bank. From 2021 to 2025, she served as Entrepreneur-in-Residence at Evotec, advancing key initiatives to develop the company’s cell therapy strategy with a particular focus on the iPSC-based platform. She subsequently became Managing Director of the GMP Cell Factory in Italy, leading its transition to clinical-stage readiness.

By training, Dr. Günther is an M.D., board-certified in Internal Medicine and Hematology/Oncology, and has served as a Qualified Person for cell and gene therapy (including pharmacovigilance) since 2002, as well as a Manager for Regulatory Affairs. Since 2022, she acted as a member of the Advisory Board of MUVON.

For more information, please contact:

Dr. Deana Mohr, CEO        
info@muvon-therapeutics.ch

About the SUISSE-MPC2 Phase 2 Study

SUISSE-MPC2 (NCT05534269) is a single-center, randomized, blinded Phase 2 clinical trial evaluating MUVON’s investigational, tissue-engineered autologous muscle precursor cell (MPC)-based therapy (MPCCOL) in women with stress urinary incontinence (SUI) who had failed prior conservative treatments. Thirty patients received one of two dose levels of MPCCOL, prepared from a small calf-muscle biopsy and injected via a proprietary ultrasound-guided device into the external urethral sphincter to regenerate muscle and restore function. The study’s primary endpoint was the change from baseline to 6 months in stress incontinence episode frequency (IEF), with 24-hour pad weight as the key secondary endpoint, and treatment response defined as a ≥50% reduction in either measure. SUISSE-MPC2 met both endpoints with high statistical significance (p<0.0001), demonstrated an 87% responder rate and a favorable safety and tolerability profile. Stress urinary incontinence (SUI) is the involuntary loss of urine during effort, physical exertion or increased abdominal pressure and is highly prevalent, affecting over 150 million women worldwide.

About MUVON Therapeutics AG

MUVON Therapeutics is dedicated to the discovery and development of personalized regenerative treatments with the goal of establishing them as an affordable standard of care, with an initial focus on the treatment of stress urinary incontinence in women. Our mission is to help the millions of patients suffering from serious debilitating diseases regain control of their lives by offering them minimally invasive treatment for regeneration of skeletal muscle tissue. Founded in 2020 as a clinical-stage life science spin-off from the University of Zurich, MUVON Therapeutics was accelerated by the Wyss Zurich Translational Center from 2021-2025. For more information about MUVON Therapeutics, please visit: www.muvon-therapeutics.ch

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