WORK Medical Technology Group LTD Partners with Wuxi Branch of Ruijin Hospital-Shanghai Jiao Tong University School of Medicine to Develop AI-Applications in Healthcare

WORK Medical Technology Group LTD Partners with Wuxi Branch of Ruijin Hospital-Shanghai Jiao Tong University School of Medicine to Develop AI-Applications in Healthcare




WORK Medical Technology Group LTD Partners with Wuxi Branch of Ruijin Hospital-Shanghai Jiao Tong University School of Medicine to Develop AI-Applications in Healthcare

Hangzhou, China, Sept. 22, 2025 (GLOBE NEWSWIRE) — WORK Medical Technology Group LTD (Nasdaq: WOK) (“WORK Medical” or the “Company”), a supplier of medical devices in China, through its subsidiary, Work (Hangzhou) Medical Treatment Equipment Co., Ltd. (“Work Hangzhou”) and its subsidiaries in China, today announced the signing of a strategic cooperation agreement (the “Agreement”) between Work Hangzhou and the Wuxi Branch of Ruijin Hospital-Shanghai Jiao Tong University School of Medicine (“Xin Rui Hospital”) to jointly develop medical products utilizing artificial intelligence (the “AI”). This collaboration represents an initiative in advancing WORK Medical’s AI strategy, with the goal of accelerating the development of a next-generation, AI-driven smart clinical ecosystem.

Pursuant to the Agreement, Work Hangzhou agrees to support Xin Rui Hospital in advancing hospital informatization and the application of AI-powered medical products. Both parties aim to integrate AI technology with Xin Rui Hospital’s multimodal medical resources, including text, imaging, and laboratory data, to build a digital knowledge base for intelligent healthcare. With Xin Rui Hospital’s clinical diagnostic, treatment and expert resources, Work Hangzhou also plans to enhance its multimodal universal medical AI solution, expanding from single-image data to complex multimodal data. The collaboration is expected to drive the development, training and clinical application of AI models across multiple healthcare scenarios, as both parties endeavor to create a comprehensive framework covering data governance, model training and the translation of research into clinical practice.

Xin Rui Hospital, located in Wuxi, Jiangsu Province, China, is a Grade 3-Class B tertiary hospital affiliated with Ruijin Hospital–Shanghai Jiao Tong University School of Medicine, one of China’s premier Grade 3-Class A tertiary hospitals and a National Clinical Research Center designated by the National Health Commission.

Mr. Wu Shuang, chief executive officer and chairman of WORK Medical, commented: “We are delighted to partner with Xin Rui Hospital. By combining our expertise with Xin Rui Hospital’s clinical data and practical environment, we aim to establish a model for hospital digitalization and intelligent healthcare applications. We expect this collaboration to accelerate the AI transformation of domestic hospitals, broaden the adoption of our technology solutions, promote the development of AI-driven healthcare, and unlock new opportunities and long-term value for WORK Medical.”

About WORK Medical Technology Group LTD

WORK Medical Technology Group LTD, through its subsidiary, Work (Hangzhou) Medical Treatment Equipment Co., Ltd. and its subsidiaries in China, is a supplier of medical devices that develops and manufactures Class I and II medical devices and sells Class I and II disposable medical devices through operating subsidiaries in China. The Company has a diverse product portfolio comprising 21 products, including customized and multifunctional masks and other medical consumables. All the products have been sold in 34 provincial-level administrative regions in China, with 15 of them sold in more than 30 countries worldwide. The Company has received a number of quality-related manufacturing designations and has registered 17 products with the U.S. Food and Drug Administration allowing their products to enter the U.S. market. For more information, please visit the Company’s website: https://www.workmedtech.com/corporate.

Forward-Looking Statements

This press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will,” and variations of these words or similar expressions that are intended to identify forward-looking statements. Any such statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Any forward-looking statements in this press release are based on the Company’s current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. 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, and the Company cautions investors that actual results may differ materially from the anticipated results and encourages investors to review other factors that may affect its future results set forth in the Company’s annual report on Form 20-F and other documents filed by the Company with the U.S. Securities and Exchange Commission. The Company explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.

For more information, please contact:

WORK Medical Technology Group LTD
Investor Relations Department
Email: ir@workmedtech.com

Ascent Investor Relations LLC
Tina Xiao
Phone: +1-646-932-7242
Email: investors@ascent-ir.com

WORK Medical Technology Group LTD Partners with Wuxi Branch of Ruijin Hospital-Shanghai Jiao Tong University School of Medicine to Develop AI-Applications in Healthcare

WORK Medical Technology Group LTD Partners with Wuxi Branch of Ruijin Hospital-Shanghai Jiao Tong University School of Medicine to Develop AI-Applications in Healthcare




WORK Medical Technology Group LTD Partners with Wuxi Branch of Ruijin Hospital-Shanghai Jiao Tong University School of Medicine to Develop AI-Applications in Healthcare

Hangzhou, China, Sept. 22, 2025 (GLOBE NEWSWIRE) — WORK Medical Technology Group LTD (Nasdaq: WOK) (“WORK Medical” or the “Company”), a supplier of medical devices in China, through its subsidiary, Work (Hangzhou) Medical Treatment Equipment Co., Ltd. (“Work Hangzhou”) and its subsidiaries in China, today announced the signing of a strategic cooperation agreement (the “Agreement”) between Work Hangzhou and the Wuxi Branch of Ruijin Hospital-Shanghai Jiao Tong University School of Medicine (“Xin Rui Hospital”) to jointly develop medical products utilizing artificial intelligence (the “AI”). This collaboration represents an initiative in advancing WORK Medical’s AI strategy, with the goal of accelerating the development of a next-generation, AI-driven smart clinical ecosystem.

Pursuant to the Agreement, Work Hangzhou agrees to support Xin Rui Hospital in advancing hospital informatization and the application of AI-powered medical products. Both parties aim to integrate AI technology with Xin Rui Hospital’s multimodal medical resources, including text, imaging, and laboratory data, to build a digital knowledge base for intelligent healthcare. With Xin Rui Hospital’s clinical diagnostic, treatment and expert resources, Work Hangzhou also plans to enhance its multimodal universal medical AI solution, expanding from single-image data to complex multimodal data. The collaboration is expected to drive the development, training and clinical application of AI models across multiple healthcare scenarios, as both parties endeavor to create a comprehensive framework covering data governance, model training and the translation of research into clinical practice.

Xin Rui Hospital, located in Wuxi, Jiangsu Province, China, is a Grade 3-Class B tertiary hospital affiliated with Ruijin Hospital–Shanghai Jiao Tong University School of Medicine, one of China’s premier Grade 3-Class A tertiary hospitals and a National Clinical Research Center designated by the National Health Commission.

Mr. Wu Shuang, chief executive officer and chairman of WORK Medical, commented: “We are delighted to partner with Xin Rui Hospital. By combining our expertise with Xin Rui Hospital’s clinical data and practical environment, we aim to establish a model for hospital digitalization and intelligent healthcare applications. We expect this collaboration to accelerate the AI transformation of domestic hospitals, broaden the adoption of our technology solutions, promote the development of AI-driven healthcare, and unlock new opportunities and long-term value for WORK Medical.”

About WORK Medical Technology Group LTD

WORK Medical Technology Group LTD, through its subsidiary, Work (Hangzhou) Medical Treatment Equipment Co., Ltd. and its subsidiaries in China, is a supplier of medical devices that develops and manufactures Class I and II medical devices and sells Class I and II disposable medical devices through operating subsidiaries in China. The Company has a diverse product portfolio comprising 21 products, including customized and multifunctional masks and other medical consumables. All the products have been sold in 34 provincial-level administrative regions in China, with 15 of them sold in more than 30 countries worldwide. The Company has received a number of quality-related manufacturing designations and has registered 17 products with the U.S. Food and Drug Administration allowing their products to enter the U.S. market. For more information, please visit the Company’s website: https://www.workmedtech.com/corporate.

Forward-Looking Statements

This press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will,” and variations of these words or similar expressions that are intended to identify forward-looking statements. Any such statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Any forward-looking statements in this press release are based on the Company’s current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. 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, and the Company cautions investors that actual results may differ materially from the anticipated results and encourages investors to review other factors that may affect its future results set forth in the Company’s annual report on Form 20-F and other documents filed by the Company with the U.S. Securities and Exchange Commission. The Company explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.

For more information, please contact:

WORK Medical Technology Group LTD
Investor Relations Department
Email: ir@workmedtech.com

Ascent Investor Relations LLC
Tina Xiao
Phone: +1-646-932-7242
Email: investors@ascent-ir.com

Fierce Biotech names Incyclix Bio a “Fierce 15” Biotech Company of 2025

Fierce Biotech names Incyclix Bio a “Fierce 15” Biotech Company of 2025




Fierce Biotech names Incyclix Bio a “Fierce 15” Biotech Company of 2025

RESEARCH TRIANGLE PARK, N.C., Sept. 22, 2025 (GLOBE NEWSWIRE) — Incyclix Bio, LLC, today announced that Fierce Biotech has named it as one of 2025’s Fierce 15 biotechnology companies, designating it as one of the most innovative and promising private biotechnology companies in the industry.

“We’re honored to be named one of 2025’s Fierce 15 biotechnology companies,” said Patrick Roberts, Pharm.D., Ph.D., Chief Executive Officer and Co-Founder of Incyclix Bio. “We have made great strides in our research and clinical development of a potential best-in-class CDK2 inhibitor, never losing sight of our ultimate goal to get treatments to patients. This recognition comes at a pivotal moment at Incyclix as we work to complete our critical study of INX-315 for the treatment of patients with treatment-resistant breast and ovarian cancers who are in critical need of new options.”

Incyclix Bio aims to advance precision treatments that target the aberrant proliferation driving many cancers. The Company’s lead compound, INX-315, is a potent and selective cyclin-dependent kinase 2 (CDK2) inhibitor in clinical development. At the 2024 San Antonio Breast Cancer Symposium, the Company announced interim clinical data demonstrating the safety and efficacy of INX-315 from the ongoing Phase 1/2 clinical trial, INX-315-01, in patients with CDK4/6 inhibitor (CDK4/6i) resistant estrogen receptor positive/human epidermal growth factor receptor 2 negative (ER+/HER2-) breast cancer or CCNE1-amplified solid tumors. In April 2025, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for INX-315 for the treatment of CCNE1-amplified platinum-resistant/refractory ovarian cancer. With additional financing from a recent series B extension, the Company is on track to complete INX-315-01 (NCT05735080) in mid-2026.

The Fierce 15 celebrates the spirit of being “fierce” – championing innovation and creativity, even in the face of intense competition. This is Fierce Biotech’s 23rd annual Fierce 15 selection.

“Over the past 23 years, our Fierce 15 special report has spotlighted the private biotechs pushing science into uncharted territory, whose approaches and discoveries represent genuine leaps forward,” said Ayla Ellison, Editor-in-Chief, Fierce Life Sciences and Healthcare, “This year we’ve selected 15 pre-commercial biotechs that are advancing transformative science in an unrelenting industry landscape. These companies exemplify the innovation and determination driving the next generation of therapies that will hopefully benefit patients worldwide.”  

An internationally recognized daily report reaching a network of over 300,000 biotech and pharma industry professionals, Fierce Biotech provides subscribers with an authoritative analysis of the day’s top stories. Every year Fierce Biotech evaluates hundreds of early-stage companies from around the world for its annual Fierce 15 list, which is based on a variety of factors such as the strength of its technology, partnerships, venture backers and a competitive market position.

About Fierce Biotech
Fierce Biotech covers the biopharma waterfront, from drug development through the entire lifecycle—tracking regulatory approvals, payer negotiations, manufacturing, marketing, patent fights, government investigations and regulation, M&A deals and beyond. Our aim is to analyze the day’s news, showing readers not only what they need to know, but why they need to know it. Beyond the daily, the Fierce Biotech team produces special reports that take stock of the industry’s products and finances and shed new light on industry trends.
www.fiercebiotech.com

About Incyclix Bio
Incyclix Bio is a next-generation cell cycle control company advancing precision treatments that target the aberrant proliferation driving many cancers. The company’s lead compound, INX-315, is a potent and selective cyclin-dependent kinase 2 (CDK2) inhibitor in clinical development. Incyclix Bio is a scientific leader in understanding cyclin-dependent kinases (CDKs) and their role in the cell cycle as attractive therapeutic targets across many tumor types, including ovarian, breast and lung cancers. Headquartered in Research Triangle Park, NC, Incyclix Bio is founded by pioneers in CDK inhibitor discovery, research and development. For more information, visit incyclixbio.com.

CONTACTS:

Media Contact
Tony Plohoros
908-591-2839
tplohoros@6degreespr.com

Linda Lam
Director of Marketing
Fierce Life Sciences Events
llam@questex.com

Fierce Biotech names Incyclix Bio a “Fierce 15” Biotech Company of 2025

Fierce Biotech names Incyclix Bio a “Fierce 15” Biotech Company of 2025




Fierce Biotech names Incyclix Bio a “Fierce 15” Biotech Company of 2025

RESEARCH TRIANGLE PARK, N.C., Sept. 22, 2025 (GLOBE NEWSWIRE) — Incyclix Bio, LLC, today announced that Fierce Biotech has named it as one of 2025’s Fierce 15 biotechnology companies, designating it as one of the most innovative and promising private biotechnology companies in the industry.

“We’re honored to be named one of 2025’s Fierce 15 biotechnology companies,” said Patrick Roberts, Pharm.D., Ph.D., Chief Executive Officer and Co-Founder of Incyclix Bio. “We have made great strides in our research and clinical development of a potential best-in-class CDK2 inhibitor, never losing sight of our ultimate goal to get treatments to patients. This recognition comes at a pivotal moment at Incyclix as we work to complete our critical study of INX-315 for the treatment of patients with treatment-resistant breast and ovarian cancers who are in critical need of new options.”

Incyclix Bio aims to advance precision treatments that target the aberrant proliferation driving many cancers. The Company’s lead compound, INX-315, is a potent and selective cyclin-dependent kinase 2 (CDK2) inhibitor in clinical development. At the 2024 San Antonio Breast Cancer Symposium, the Company announced interim clinical data demonstrating the safety and efficacy of INX-315 from the ongoing Phase 1/2 clinical trial, INX-315-01, in patients with CDK4/6 inhibitor (CDK4/6i) resistant estrogen receptor positive/human epidermal growth factor receptor 2 negative (ER+/HER2-) breast cancer or CCNE1-amplified solid tumors. In April 2025, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for INX-315 for the treatment of CCNE1-amplified platinum-resistant/refractory ovarian cancer. With additional financing from a recent series B extension, the Company is on track to complete INX-315-01 (NCT05735080) in mid-2026.

The Fierce 15 celebrates the spirit of being “fierce” – championing innovation and creativity, even in the face of intense competition. This is Fierce Biotech’s 23rd annual Fierce 15 selection.

“Over the past 23 years, our Fierce 15 special report has spotlighted the private biotechs pushing science into uncharted territory, whose approaches and discoveries represent genuine leaps forward,” said Ayla Ellison, Editor-in-Chief, Fierce Life Sciences and Healthcare, “This year we’ve selected 15 pre-commercial biotechs that are advancing transformative science in an unrelenting industry landscape. These companies exemplify the innovation and determination driving the next generation of therapies that will hopefully benefit patients worldwide.”  

An internationally recognized daily report reaching a network of over 300,000 biotech and pharma industry professionals, Fierce Biotech provides subscribers with an authoritative analysis of the day’s top stories. Every year Fierce Biotech evaluates hundreds of early-stage companies from around the world for its annual Fierce 15 list, which is based on a variety of factors such as the strength of its technology, partnerships, venture backers and a competitive market position.

About Fierce Biotech
Fierce Biotech covers the biopharma waterfront, from drug development through the entire lifecycle—tracking regulatory approvals, payer negotiations, manufacturing, marketing, patent fights, government investigations and regulation, M&A deals and beyond. Our aim is to analyze the day’s news, showing readers not only what they need to know, but why they need to know it. Beyond the daily, the Fierce Biotech team produces special reports that take stock of the industry’s products and finances and shed new light on industry trends.
www.fiercebiotech.com

About Incyclix Bio
Incyclix Bio is a next-generation cell cycle control company advancing precision treatments that target the aberrant proliferation driving many cancers. The company’s lead compound, INX-315, is a potent and selective cyclin-dependent kinase 2 (CDK2) inhibitor in clinical development. Incyclix Bio is a scientific leader in understanding cyclin-dependent kinases (CDKs) and their role in the cell cycle as attractive therapeutic targets across many tumor types, including ovarian, breast and lung cancers. Headquartered in Research Triangle Park, NC, Incyclix Bio is founded by pioneers in CDK inhibitor discovery, research and development. For more information, visit incyclixbio.com.

CONTACTS:

Media Contact
Tony Plohoros
908-591-2839
tplohoros@6degreespr.com

Linda Lam
Director of Marketing
Fierce Life Sciences Events
llam@questex.com

Femasys Partners with Medical Electronic Systems to Launch FemSperm™ Analysis Kit for use with FemaSeed

Femasys Partners with Medical Electronic Systems to Launch FemSperm™ Analysis Kit for use with FemaSeed




Femasys Partners with Medical Electronic Systems to Launch FemSperm™ Analysis Kit for use with FemaSeed

Addition strengthens FemSperm family of products and enables gynecologists to offer complete in-office sperm handling for FemaSeed Intratubal Insemination

ATLANTA, Sept. 22, 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 a partnership with Medical Electronic Systems LLC (MES) to provide advanced sperm analysis technology. The FemSperm Analysis Kit completes the FemSperm product family, joining the Setup Kit and Insemination Prep Kit. Together, they expand Femasys’ infertility portfolio and, for the first time, enables gynecologists to perform in-office sperm preparation and analysis for use with its first-step infertility treatment, FemaSeed Intratubal Insemination.

“The launch of the FemSperm Analysis Kit advances our mission to deliver innovative reproductive care that is more accessible and affordable for the millions of women facing infertility,” said Kathy Lee-Sepsick, Chief Executive Officer and Founder of Femasys Inc. “By partnering with MES, a recognized leader in sperm analysis technology, and branding their advanced solution under our FemSperm product line, we have created a complete, turnkey offering that empowers gynecologists to provide FemaSeed in-office infertility treatment previously available only in fertility clinics.”

“Our industry-leading semen analysis technology powers the FemSperm Analysis Kit, delivering accurate, efficient, and standardized assessment of key sperm parameters,” said Eric Carver, President of Medical Electronic Systems LLC. “We are thrilled to partner with Femasys to bring our technology to gynecologists as part of a complete, integrated solution that expands access to high-quality infertility care.”

With the availability of the FemSperm product family, gynecologists can now perform sperm preparation and analysis, enabling them to offer FemaSeed Intratubal Insemination directly within their practices. FemaSeed is a next-generation artificial insemination solution that enhances natural fertilization by delivering sperm precisely to the fallopian tube, the site of conception. Positioned as a true first step in the fertility journey, FemaSeed offers a safe, accessible, and cost-effective alternative to intrauterine insemination (IUI). In its pivotal trial, FemaSeed achieved more than double the pregnancy rates of IUI in cases of low male sperm count.1 As an affordable, less invasive, lower-risk option before IVF, FemaSeed is authorized for use in the U.S., Europe, UK, Canada, Israel, Australia and New Zealand. Learn more at www.femaseed.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, United Kingdom 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.

About Medical Electronic Systems LLC (MES)
Medical Electronic Systems (MES) is a global leader in automated semen analysis solutions, providing advanced equipment to fertility clinics, hospitals, and laboratories worldwide. MES technologies are designed to deliver accurate, efficient, and standardized results in sperm analysis. MES is recognized for introducing the first FDA- and CE-cleared, at-home semen analysis solution, the smartphone-based YO® Home Sperm Test, bringing laboratory-grade accuracy to consumers and expanding access to male fertility testing. More information on MES can be found at www.mes-global.com.

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

Femasys Partners with Medical Electronic Systems to Launch FemSperm™ Analysis Kit for use with FemaSeed

Femasys Partners with Medical Electronic Systems to Launch FemSperm™ Analysis Kit for use with FemaSeed




Femasys Partners with Medical Electronic Systems to Launch FemSperm™ Analysis Kit for use with FemaSeed

Addition strengthens FemSperm family of products and enables gynecologists to offer complete in-office sperm handling for FemaSeed Intratubal Insemination

ATLANTA, Sept. 22, 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 a partnership with Medical Electronic Systems LLC (MES) to provide advanced sperm analysis technology. The FemSperm Analysis Kit completes the FemSperm product family, joining the Setup Kit and Insemination Prep Kit. Together, they expand Femasys’ infertility portfolio and, for the first time, enables gynecologists to perform in-office sperm preparation and analysis for use with its first-step infertility treatment, FemaSeed Intratubal Insemination.

“The launch of the FemSperm Analysis Kit advances our mission to deliver innovative reproductive care that is more accessible and affordable for the millions of women facing infertility,” said Kathy Lee-Sepsick, Chief Executive Officer and Founder of Femasys Inc. “By partnering with MES, a recognized leader in sperm analysis technology, and branding their advanced solution under our FemSperm product line, we have created a complete, turnkey offering that empowers gynecologists to provide FemaSeed in-office infertility treatment previously available only in fertility clinics.”

“Our industry-leading semen analysis technology powers the FemSperm Analysis Kit, delivering accurate, efficient, and standardized assessment of key sperm parameters,” said Eric Carver, President of Medical Electronic Systems LLC. “We are thrilled to partner with Femasys to bring our technology to gynecologists as part of a complete, integrated solution that expands access to high-quality infertility care.”

With the availability of the FemSperm product family, gynecologists can now perform sperm preparation and analysis, enabling them to offer FemaSeed Intratubal Insemination directly within their practices. FemaSeed is a next-generation artificial insemination solution that enhances natural fertilization by delivering sperm precisely to the fallopian tube, the site of conception. Positioned as a true first step in the fertility journey, FemaSeed offers a safe, accessible, and cost-effective alternative to intrauterine insemination (IUI). In its pivotal trial, FemaSeed achieved more than double the pregnancy rates of IUI in cases of low male sperm count.1 As an affordable, less invasive, lower-risk option before IVF, FemaSeed is authorized for use in the U.S., Europe, UK, Canada, Israel, Australia and New Zealand. Learn more at www.femaseed.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, United Kingdom 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.

About Medical Electronic Systems LLC (MES)
Medical Electronic Systems (MES) is a global leader in automated semen analysis solutions, providing advanced equipment to fertility clinics, hospitals, and laboratories worldwide. MES technologies are designed to deliver accurate, efficient, and standardized results in sperm analysis. MES is recognized for introducing the first FDA- and CE-cleared, at-home semen analysis solution, the smartphone-based YO® Home Sperm Test, bringing laboratory-grade accuracy to consumers and expanding access to male fertility testing. More information on MES can be found at www.mes-global.com.

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

Yatiri Bio Receives Grant to Advance Proteomics Interoperability in Cancer Research

Yatiri Bio Receives Grant to Advance Proteomics Interoperability in Cancer Research




Yatiri Bio Receives Grant to Advance Proteomics Interoperability in Cancer Research

SAN DIEGO, Sept. 22, 2025 (GLOBE NEWSWIRE) — Yatiri Bio Inc. today announced it has received a grant from the Gates Foundation to launch a one-year project, Proteomics Interoperability, aimed at improving how large-scale proteomics data can be integrated and applied to global health challenges.

Proteomics, the large-scale study of proteins, has emerged as a cornerstone of modern drug discovery, driving the search for new drug targets, early detection biomarkers, and measures of treatment efficacy. However, the field faces a critical challenge: data is generated using multiple, distinct technologies, each with strengths and limitations. Yatiri Bio aims to overcome this challenge with this project, which will develop advanced machine learning models to bridge these technologies, enabling the combination of diverse data types into a unified, interpretable framework.

The project will focus on HPV-related cervical cancer, a significant health priority for the Foundation given its disproportionate impact on women in low- and middle-income countries. Yatiri Bio will analyze matched tumor and adjacent non-cancerous tissues using three complementary approaches: unbiased proteomics (Yatiri Bio), aptamer-based proteomics (Somalogic), and antibody-based proteomics (Olink). By integrating these datasets, the company aims to demonstrate how proteomics interoperability can reveal more reliable disease signatures and accelerate the development of precision medicine.

“Our mission is to make advanced proteomics insights broadly accessible and clinically meaningful,” said Pilgrim Jackson, CEO of Yatiri Bio. “With the support from the Foundation, we can facilitate the integration of proteomics datasets across modalities to inform drug discovery and early detection strategies for diseases like HPV-related cervical cancer, while also creating a scalable model that can be applied globally.”

Yatiri Bio will develop and optimize a deep neural network architecture to integrate proteomics data across platforms. In addition to addressing the technical challenge of data harmonization, Yatiri Bio will generate a reference dataset and methods that can be shared with the scientific community, strengthening the field’s ability to apply proteomics at scale.

About Yatiri Bio

Yatiri Bio is a biotechnology company at the forefront of quantitative proteomics and AI-driven translational medicine. By combining rigorous mass spectrometry with advanced machine learning, Yatiri Bio is developing scalable tools to uncover actionable biomarkers and accelerate precision medicine. The company’s mission is to put patients first by translating complex biological data into meaningful health insights.

Note to editors: This announcement does not imply endorsement by the Gates Foundation. Please do not attribute quotes to foundation staff without prior approval.

Media Contact
info@yatiribio.com

Pfizer to Acquire Metsera and its Next-Generation Obesity Portfolio

Pfizer to Acquire Metsera and its Next-Generation Obesity Portfolio




Pfizer to Acquire Metsera and its Next-Generation Obesity Portfolio

  • Proposed acquisition to add four highly differentiated clinical-stage incretin and amylin programs to Pfizer’s pipeline
  • Transaction valued at $47.50 per Metsera share in cash upon closing, for an initial enterprise value of $4.9 billion with a CVR of up to $22.50 per share in additional payments
  • Pfizer to host a public webcast at 8 am EDT today

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) and Metsera, Inc. (NASDAQ: MTSR) today announced the companies have entered into a definitive agreement under which Pfizer will acquire Metsera, a clinical-stage biopharmaceutical company accelerating the next generation of medicines for obesity and cardiometabolic diseases. The acquisition brings deep expertise and a portfolio of differentiated oral and injectable incretin, non-incretin and combination therapy candidates with potential best-in-class efficacy and safety profiles. The Boards of Directors of both Metsera and Pfizer have unanimously approved the transaction.


“Obesity is a large and growing space with over 200 health conditions associated with it. The proposed acquisition of Metsera aligns with our focus on directing our investments to the most impactful opportunities and propels Pfizer into this key therapeutic area,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “We are excited to apply our deep cardiometabolic experience and manufacturing and commercial infrastructure to accelerate a portfolio that includes potential best-in-class injectables, with clinical data differentiated by efficacy, tolerability and durability supporting monthly dosing, with the aim to address the ongoing unmet needs associated with obesity and related diseases.”

Metsera has a portfolio of promising therapeutic candidates and combinations with four programs in clinical development and several next-generation programs with IND-enabling studies ongoing, aimed at addressing key unmet needs via fewer injections while achieving improved efficacy and tolerability. This includes MET-097i, a weekly and monthly injectable GLP-1 receptor agonist (RA), both in Phase 2 development; MET-233i, a monthly amylin analog candidate being evaluated as monotherapy and in combination with MET-097i in Phase 1 development; two oral GLP-1 RA candidates expected to begin clinical trials imminently; and additional preclinical nutrient-stimulated hormone therapeutics. Initial Phase 1 clinical results for MET-233i showcasing a potential best-in-class profile were presented on September 17 as a late-breaker at the 61st Annual Meeting of the European Association for the Study of Diabetes (EASD).

Under the terms of the agreement, Pfizer will acquire all outstanding shares of Metsera common stock for $47.50 per share in cash at closing, representing an enterprise value of approximately $4.9 billion. Additionally, the agreement includes a non-transferable contingent value right (CVR) entitling holders to potential additional payments of up to $22.50 per share in cash tied to three specific clinical and regulatory milestones: $5 per share following the Phase 3 clinical trial start of Metsera’s MET-097i+MET-233i combination, $7 per share following U.S. Food and Drug Administration (FDA) approval of Metsera’s monthly MET-097i monotherapy, and $10.50 per share following FDA approval of Metsera’s monthly MET-097i+MET-233i combination, if achieved. The transaction is expected to close in the fourth quarter of 2025, subject to the satisfaction of customary closing conditions, including receipt of required regulatory approvals and approval by Metsera’s shareholders. Pfizer will provide any updates to its financial outlook in conjunction with its upcoming quarterly earnings.

“Since our founding in 2022, Metsera has worked tirelessly to reduce the physical, emotional, and economic burdens of obesity with a portfolio of next generation nutrient-stimulated hormone therapeutic candidates. Our team has invented and developed multiple injectable and oral candidate medicines and a category-leading peptide engineering platform, which together promise class-leading performance in a major sector of population health,” said Whit Bernard, Co-Founder and Chief Executive Officer of Metsera. “Today’s announcement sets a path for our portfolio to potentially transform the lives of hundreds of millions of people and represents an excellent outcome for our shareholders. We look forward to joining forces with Pfizer to leverage their global clinical, regulatory, manufacturing and commercial capabilities to realize the promise of improved human health at scale.”

Citi is acting as Pfizer’s financial advisor for the transaction with Wachtell, Lipton, Rosen & Katz acting as legal advisor. Metsera’s financial advisors for the transaction are Goldman Sachs & Co. LLC, Guggenheim Securities, LLC, BofA Securities, Inc., and Allen & Company LLC with Paul, Weiss, Rifkind, Wharton & Garrison LLP acting as legal advisor.

Investor Call Details

Pfizer Inc. invites Pfizer investors and the general public to view and listen to a webcast of a live conference call with investment analysts at 8 a.m. EDT on Monday, September 22, 2025.

To view and listen to the webcast visit Pfizer’s web site at www.pfizer.com/investors or directly at https://onlinexperiences.com/Launch/QReg/ShowUUID=7F348066-0A7A-4167-A63D-F43BA26B6867&LangLocaleID=1033&GroupID=Onyx. Information on accessing and pre-registering for the webcast will be available at www.pfizer.com/investors beginning today. Participants are advised to pre-register in advance of the conference call.

You can listen to the conference call by dialing either 800-456-4352 in the United States or Canada or 785-424-1086 outside of the United States and Canada. The password is “73086.” Please join the call five minutes prior to the start time to avoid operator hold times.

The transcript and webcast replay of the call will be made available on Pfizer’s web site at www.pfizer.com/investors within 24 hours after the end of the live conference call and will be accessible for at least 90 days.

About Metsera

Metsera is a clinical-stage biopharmaceutical company accelerating the next generation of medicines for obesity and metabolic diseases. Metsera is advancing a broad portfolio of oral and injectable incretin, non-incretin and combination therapies with potential best-in-class profiles to address multiple therapeutic targets and meet the future needs of a rapidly evolving weight loss treatment landscape. Metsera was founded in 2022 and is based in New York City. For more information, please visit us at www.metsera.com.

About Pfizer: Breakthroughs That Change Patients’ Lives

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on X at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

Disclosure Notice: The information contained in this release is as of September 22, 2025.

This release contains forward-looking information about, among other topics, Pfizer’s proposed acquisition of Metsera, Pfizer’s and Metsera’s pipeline products, including their potential benefits, potential best-in-class status, differentiation, profile and dosing, potential clinical trials, and the anticipated timing of completion of the proposed acquisition, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, risks related to the satisfaction or waiver of the conditions to closing the proposed acquisition (including the failure to obtain necessary regulatory approvals and failure to obtain the requisite vote by Metsera stockholders) in the anticipated timeframe or at all, including the possibility that the proposed acquisition does not close; the possibility that competing offers may be made; risks related to the ability to realize the anticipated benefits of the proposed acquisition, including the possibility that the expected benefits from the acquisition will not be realized or will not be realized within the expected time period; the risk that the businesses will not be integrated successfully; disruption from the transaction making it more difficult to maintain business and operational relationships, including Metsera’s ability to attract and retain highly qualified management and other clinical and scientific personals; negative effects of this announcement or the consummation of the proposed acquisition on the market price of Pfizer’s or Metsera’s common stock and/or operating results; significant transaction costs; unknown liabilities; the risk of litigation and/or regulatory actions related to the proposed acquisition or Metsera’s business; other business effects and uncertainties, including the effects of industry, market, business, economic, political or regulatory conditions; future exchange and interest rates; risks and uncertainties related to issued or future executive orders or other new, or changes in, laws, regulations or policy; changes in tax and other laws, regulations, rates and policies; the uncertainties inherent in business and financial planning, including, without limitation, risks related to Pfizer’s business and prospects, adverse developments in Pfizer’s markets, or adverse developments in the U.S. or global capital markets, credit markets, regulatory environment, tariffs and other trade policies or economies generally; future business combinations or disposals; uncertainties regarding the commercial success of Metsera’s pipeline products or Pfizer’s commercialized and/or pipeline products; risks associated with Metsera conducting clinical trials and preclinical studies outside of the United States; Metsera’s reliance on third parties to conduct clinical trials and preclinical studies and for the manufacture and shipping of its product candidates; the risk that Metsera’s product candidates are associated with side effects, adverse events or other properties or safety risks; risks associated with Metsera’s license and collaboration agreements and future strategic alliances; Metsera’s ability to obtain, maintain, defend and enforce patent or other intellectual property protection for current or future product candidates or technology; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; risks associated with initial, preliminary or interim data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; whether and when drug applications may be filed in any jurisdictions for Pfizer’s or Metsera’s pipeline products for any potential indications; whether and when any such applications may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether any such products will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of such products; uncertainties regarding the impact of COVID-19; and competitive developments.

You should carefully consider the foregoing factors and the other risks and uncertainties that affect the businesses of Pfizer and Metsera described in the “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results” (in the case of Pfizer) and “Special Note regarding Forward Looking Statements” (in the case of Metsera) sections of their respective Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other documents filed by either of them from time to time with the U.S. Securities and Exchange Commission (the “SEC”), all of which are available at www.sec.gov. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and Pfizer and Metsera assume no obligation to, and do not intend to, update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise, unless required by law. Neither Pfizer nor Metsera gives any assurance that it will achieve its expectations.

Additional Information and Where to Find It

In connection with the proposed transaction, Metsera will be filing documents with the SEC, including preliminary and definitive proxy statements relating to the proposed transaction. The definitive proxy statement will be mailed to Metsera’s stockholders in connection with the proposed transaction. This communication is not a substitute for the proxy statement or any other document that may be filed by Metsera with the SEC. BEFORE MAKING ANY VOTING DECISION, INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE PRELIMINARY AND DEFINITIVE PROXY STATEMENTS AND ANY OTHER DOCUMENTS TO BE FILED WITH THE SEC IN CONNECTION WITH THE PROPOSED TRANSACTION OR INCORPORATED BY REFERENCE IN THE PROXY STATEMENT WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION. Any vote in respect of resolutions to be proposed at Metsera’s stockholder meeting to approve the proposed transaction or other responses in relation to the proposed transaction should be made only on the basis of the information contained in Metsera’s proxy statement. Investors and security holders may obtain free copies of these documents (when they are available) and other related documents filed with the SEC at the SEC’s web site at www.sec.gov, or at www.metsera.com.

No Offer or Solicitation

This communication is for information purposes only and is not intended to and does not constitute, or form part of, an offer, invitation or the solicitation of an offer or invitation to purchase, otherwise acquire, subscribe for, sell or otherwise dispose of any securities, or the solicitation of any vote or approval in any jurisdiction, pursuant to the proposed transaction or otherwise, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law.

Participants in the Solicitation

Metsera and its directors, executive officers and other members of management and employees, under SEC rules, may be deemed to be “participants” in the solicitation of proxies from stockholders of Metsera in favor of the proposed transaction. Information about Metsera’s directors and executive officers is set forth in Part III of Metsera’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024, which was filed with the SEC on March 26, 2025. Additional information concerning the interests of Metsera’s participants in the solicitation, which may, in some cases, be different than those of Metsera’s stockholders generally, will be set forth in Metsera’s proxy statement relating to the proposed transaction when it becomes available. These documents are available free of charge at the SEC’s web site at www.sec.gov and at www.metsera.com.

Category: Corporate, Research and Pipeline

Contacts

Media Contact: PfizerMediaRelations@Pfizer.com
Investor Contact: IR@Pfizer.com

Bayer First Company to Advance Cell Therapy as Well as Gene Therapy Against Parkinson’s Disease

Bayer First Company to Advance Cell Therapy as Well as Gene Therapy Against Parkinson’s Disease




Bayer First Company to Advance Cell Therapy as Well as Gene Therapy Against Parkinson’s Disease

  • First investigational allogeneic pluripotent stem cell derived therapy pivotal Phase III clinical trial exPDite-2 with bemdaneprocel started
  • Phase II gene therapy trial REGENERATE-PD with AB-1005 initiated randomizing participants in United Kingdom and Poland, with Germany following shortly and ongoing in the USA
  • Parkinson’s disease second most common and fastest growing neurodegenerative disease affecting more than 10 million people worldwide

BERLIN–(BUSINESS WIRE)–Bayer announced today progress for two potential therapies against Parkinson’s disease (PD). A first participant received randomized treatment in the pivotal Phase III clinical trial, exPDite-2, of bemdaneprocel, an investigational cell therapy for PD. At the same time, first European participants have been randomized in REGENERATE-PD, a Phase II clinical trial of AB-1005, an investigational gene therapy. Both therapies are focused on treating moderate-stage PD and are being developed in collaboration with Bayer’s wholly owned, independently operated subsidiary companies, BlueRock Therapeutics LP (bemdaneprocel) and AskBio Inc. (AB-1005) respectively.

“Our dual approach in addressing Parkinson’s disease through both cell and gene therapies exemplifies our strategic vision and maximizes our chances of offering renewed hope for Parkinson’s patients who have been waiting for new therapies for too long,” said Christian Rommel, Global Head of Research and Development of Bayer’s Pharmaceutical Division. “We are energized by being at the forefront of the development of disease modifying therapies that have the potential to make a meaningful impact on Parkinson’s patients lives.”

Bayer is setting a global benchmark in the development, manufacturing, and commercialization of cell and gene therapies based on the establishment of a comprehensive end-to-end approach that covers the entire spectrum from research to production and includes state-of-the-art production facilities worldwide.

“Parkinson’s disease is characterized by the loss of dopamine producing cells in the brain resulting in motor impairments,” said Gabi Belfort, MD, PhD, Senior Vice President and Bemdaneprocel Product Lead at BlueRock Therapeutics. “Bemdaneprocel aims to replace these lost cells with new dopamine producing neurons and we are excited that the pivotal Phase III exPDite-2 clinical trial to explore this approach is now underway.”

“We believe there is a significant need for neurorestorative therapies in Parkinson’s, and AskBio is committed to exploring the potential of investigational gene therapy AB-1005 in the treatment of this severe, progressive chronic disease,” said Adrian Kells, PhD, Senior Vice President, Integrated Product Team Lead, Parkinsons and MSA, at AskBio. “We are excited to share the news of the advancement of our REGENERATE-PD clinical trial in Europe, which we believe is an important update for patients and the medical community.”

Bemdaneprocel and AB-1005 are investigational therapies which have not been approved by any regulatory authority, and their efficacy and safety have not been established or fully evaluated.

About Parkinson’s Disease

Parkinson’s disease (PD) is a progressive neurodegenerative disease. It has a significant impact on a person’s daily life. In PD, the death of dopamine producing nerve cells in the brain leads to the continuous loss of motor function. Symptoms include tremors, muscle rigidity, and slowness of movement. Additionally, people with PD experience non-motor symptoms, including fatigue and lack of energy, cognitive issues, and depression. Symptoms typically intensify over time and make everyday tasks demanding. The prevalence of PD has doubled over the past 25 years. Today, more than 10 million people worldwide are estimated to be living with PD. This makes it the world’s second most prevalent neurodegenerative disease. It is also the most frequent movement disorder. At present there is no cure, and current treatment options are inadequate and lack the holistic management of symptoms so there is an urgent need for new therapies.

About Bemdaneprocel (BRT-DA01)

Bemdaneprocel (BRT-DA01) is an investigational cell therapy designed to replace the dopamine producing neurons that are lost in Parkinson’s disease. These dopaminergic neuron precursors are derived from human embryonic pluripotent stem cells that continue developing into mature dopamine neurons after implantation. In a surgical procedure, these neuron precursors are implanted into the brain of a person with Parkinson’s disease. When transplanted, they have the potential to re-form neural networks that have been severely affected by Parkinson’s disease and to potentially restore motor and non-motor function to patients. In 2021 bemdaneprocel received Fast Track Designation and in 2024 a Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA. Data from the Phase I trial’s 12 participants presented at the 2024 International Congress of Parkinson’s Disease and Movement Disorders (MDS) demonstrated good tolerability, with no serious adverse events related to drug product at 24 months post-surgery. Further, encouraging trends were observed in secondary endpoints related to motor impairments at 24 months post-surgery. These participants continue in the long term Continued Evaluation Study. Bemdaneprocel has not been approved for treatment of any disease or medical condition by any health authority.

About exPDite-2

exPDite-2 is the first Phase III pivotal clinical trial for an investigational allogeneic pluripotent stem cell derived therapy to treat Parkinson’s disease. In a Phase I study with 12 participants, bemdaneprocel was well tolerated, with no serious adverse events related to drug product at 24 months post-surgery. In addition, encouraging trends were observed in secondary endpoints related to motor impairments at 24 months post-surgery. Building on these results, exPDite-2 is a multicenter, double-blind trial that will assess the efficacy, safety and overall impact of bemdaneprocel compared to a sham surgery control. The trial is designed to enroll approximately 102 participants with Parkinson’s disease. The primary endpoint of the study is change from baseline to week 78 in PD diary measure of ON-time without troublesome dyskinesia, adjusted for a 16-hour waking day. In addition, the trial will incorporate secondary endpoints designed to assess objective measures of movement, non-motor symptoms, safety and tolerability, and instruments that capture activities of daily living and quality of life. For more information about the exPDite-2 clinical trial, visit clinicaltrials.gov (NCT06944522), or visit bluerocktx.com.

Depending upon the outcome, the results from this trial are intended to be part of a data package to support regulatory submissions for marketing authorization.

About AB1005

AB-1005 is an investigational gene therapy based on adeno-associated viral vector serotype 2 (AAV2) containing the human glial cell line-derived neurotrophic factor (GDNF) transgene, which allows for stable and continuous expression of GDNF in localized regions of the brain after direct neurosurgical injection with MRI-monitored convection enhanced delivery. In nonclinical studies, GDNF has been shown to promote the survival and morphological differentiation of dopaminergic neurons. Recombinant GDNF has long been evaluated as a potential treatment for diseases, such as PD, marked by progressive degeneration of midbrain dopaminergic neurons. Through a combination of an investigational gene therapy and innovative neurosurgical delivery approach, one can now test the GDNF hypothesis in PD by getting this neurotrophic factor to these degenerating nigrostriatal neurons in a potentially more clinically relevant fashion.

About REGENERATE-PD

REGENERATE-PD is a Phase II, randomized, double-blind, surgery controlled trial of the efficacy and safety of intraputaminally administered investigational gene therapy AB-1005 in the treatment of adults (45–75 years) with moderate-stage Parkinson’s disease. The trial will include an estimated 87 participants with trial sites located in Germany, Poland, the United Kingdom, and the United States. For more information about the REGENERATE-PD clinical trial, visit clinicaltrials.gov (NCT06285643), or visit askbio.com.

About Bayer

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to www.bayer.com.

Find more information at www.bayer.com.

Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Contacts

Contact for media inquiries:
Elaine Colón

Ph: +1-732-236-1587

Email: elaine.colon@bayer.com

Helio Diagnostics: A European CDMO dedicated to In Vitro Diagnostics

Helio Diagnostics: A European CDMO dedicated to In Vitro Diagnostics




Helio Diagnostics: A European CDMO dedicated to In Vitro Diagnostics

Helio Diagnostics:

A European CDMO dedicated to In Vitro Diagnostics

Helio Diagnostics is backed by a team with 25+ years of experience in the development and manufacturing of complex diagnostic devices.

Marseille, France – September 22, 2025 – Helio Diagnostics, a European leader in end-to-end Contract Development and Manufacturing (CDMO) services for In Vitro Diagnostics (IVD), was founded by seasoned entrepreneurs. Under the leadership of CEO Stéphane Debono, the company is supported by a Board of Directors bringing together Corinne Danan, Philippe Dhamelincourt, Vincent Fert, and Fabienne Hermitte.

“Our goal is to become a reference European CDMO in IVD outsourcing, making innovation operational” said Stéphane Debono, CEO. “The diagnostic industry is expanding rapidly, and clients need partners who combine technical depth with operational agility. With our experience and pure focus on IVD, Helio Diagnostics is ideally positioned to become a trusted partner to the world’s leading diagnostic companies.”

Trusted by Industry Leaders

Helio Diagnostics has already established long-term partnerships with global diagnostic companies:

“Helio Diagnostics provides reliable manufacturing and technical support for our Ipsogen RUO and IVD products – a partner we trust for long-term collaboration. Their team has ensured seamless technology transfer and lifecycle management for some of our IVD-R product registrations. With their ongoing technical support, customer focus, agility and flexibility, they are a partner of choice.” – Thierry Bernard, CEO at QIAGEN.

“Veracyte has selected Helio Diagnostics to maintain continuity of supply for our Prosigna IVD nCounter test. Having worked with this team before, we are confident that Helio Diagnostics is a partner we can count on to serve our customers outside the US.”Marc Stapley, Veracyte’s CEO.

A Strategic Market Opportunity

The $13 billion global IVD outsourcing market is growing at 7.5% annually but remains fragmented, with few specialized end-to-end CDMOs.

Helio Diagnostics was created to fill this gap: a dedicated European partner focused solely on In Vitro Diagnostics. With a seasoned team and seamless “plug-and-play” integration, Helio Diagnostics delivers flexible, customized solutions already trusted by leading diagnostic companies.

From concept to commercialization, Helio Diagnostics covers the full IVD lifecycle with a 360° perspective:

  • Feasibility & development – assay design, development studies and pilot production
  • Performance Verification, Analytical and Clinical Validation
  • Industrialization and Tech Transfer – scale-up, process verification and validation
  • Quality Assurance & Regulatory Affairs – ISO 13485 and 21 CFR Part 820 compliance, CE – marking, FDA and global submissions
  • Manufacturing & Logistics – kit production, cold chain management and worldwide shipping
  • Lifecycle Management – post launch monitoring, real-time stability studies and continuous improvement

Helio Diagnostics combines flexibility, integration, and operational excellence to support diagnostic innovators from concept to market across multiple fields: oncology, infectious diseases, and more. Our team leverages decades of combined expertise to help partners overcome technical, regulatory, and operational challenges with agility, accelerating time to market while delivering reliable, compliant solutions at scale.

At Helio Diagnostics, our mission is to be the trusted European partner for diagnostics companies looking to accelerate innovation, scale efficiently and succeed globally.

***

About Helio Diagnostics

Helio Diagnostics is a European CDMO dedicated to In Vitro Diagnostics (IVD) — helping companies bring tests from concept to market with speed, compliance, and reliability.

With 25+ years of proven manufacturing expertise in Marseille, Helio Diagnostics’ team combines technical depth, regulatory know-how, and operational excellence to support diagnostic innovators worldwide with:

●       Development & Validation
●       Regulatory support
●       Scalable manufacturing
●       Global logistics
●       Lifecycle management

The mission: make innovation operational with customized and flexible solutions.

Helio Diagnostics already serves a global client base and maintains trusted partnerships with leading diagnostic companies worldwide.

Contacts

Stephane Debono, President and CEO

stephane.debono@heliodiag.com

Marie Puvieux, press officer, ATCG Partners

+33 6 10 54 36 72

heliodiag@atcg-partners.com

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