Geron Corporation Announces Strategic Restructuring Plan to Position the Company for Long-Term Value Creation




Geron Corporation Announces Strategic Restructuring Plan to Position the Company for Long-Term Value Creation

Restructuring Supports RYTELO^® U.S. Commercial Strategy and Investment in Clinical Development

Expected to Reduce 2026 Projected Operating Expenses

FOSTER CITY, Calif., Dec. 11, 2025 (GLOBE NEWSWIRE) — Geron Corporation (Nasdaq: GERN), a commercial-stage biopharmaceutical company aiming to change lives by changing the course of blood cancer, today announced a strategic restructuring plan intended to position the Company for long-term value creation for patients and shareholders and improve its financial discipline.

“After my first four months at Geron, the leadership team and I have assessed the business with the goal of streamlining our organizational structure to advance our strategy and create long-term value. We are implementing these changes from a position of strength and in the spirit of prudent fiscal management,” said Harout Semerjian, President and Chief Executive Officer of Geron. “Our key objectives remain unchanged. We are focused on driving RYTELO commercial growth in the U.S., exploring opportunities for making RYTELO available outside the U.S., and continuing to advance our Phase 3 IMpactMF trial. We expect this restructuring will have a meaningful impact on our 2026 operating expenses and position Geron to meet the needs of patients. I want to express my gratitude to the employees that will be impacted in this restructuring. Your contributions over the years have made a positive difference in the lives of the people we endeavor each day to assist.”

The Company’s strategic restructuring plan is expected to result in an approximately one-third reduction in Geron’s current workforce of approximately 260 employees. As a result of the restructuring plan, which is expected to be substantially complete in the first quarter of 2026, initial projected full year 2026 operating expenses are expected to be less than the Company’s projected full year 2025 operating expenses, with savings expected to be realized beginning in the first quarter of 2026. Geron will incur restructuring charges consisting primarily of cash-based expenses in connection with the restructuring plan, with additional information to be provided in a Current Report on Form 8-K to be filed with the Securities and Exchange Commission. Geron thanks all employees who will be impacted by today’s announcement for their contributions to the Company.

About Geron
Geron is a commercial-stage biopharmaceutical company aiming to change lives by changing the course of blood cancer. Our first-in-class telomerase inhibitor RYTELO (imetelstat) is approved in the United States and the European Union for the treatment of certain adult patients with LR-MDS with transfusion-dependent anemia. We are also conducting a pivotal Phase 3 clinical trial of imetelstat in JAK-inhibitor R/R MF, as well as studies in other hematologic malignancies. Inhibiting telomerase activity, which is increased in malignant stem and progenitor cells in the bone marrow, aims to potentially reduce proliferation and induce death of malignant cells. To learn more, visit www.geron.com or LinkedIn.

Use of Forward-Looking Statements
Except for the historical information contained herein, this press release contains forward-looking statements made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that such statements, include, without limitation, those regarding: (i) the Company’s belief that the restructuring plan will streamline the Company’s organizational structure, advance its strategy, position the Company for long-term value creation for patients and shareholders, support RYTELO commercial strategy and investment in clinical development, and improve financial discipline; (ii) the Company’s focus on driving RYTELO commercial growth in the U.S., exploring opportunities for making RYTELO available outside the U.S., and continuing to advance its Phase 3 IMpactMF trial; (iii) the Company’s expectation that the restructuring will have a meaningful impact on its 2026 operating expenses and position the Company to meet the needs of patients; (iv) the expected size of the reduction in workforce and the Company’s expectations that initial projected full year 2026 operating expenses will be lower than projected full year 2025 operating expenses, with savings expected to be realized beginning in the first quarter of 2026; (v) the expected costs and timing for completion of the restructuring; and (vi) other statements that are not historical facts, constitute forward-looking statements. These forward-looking statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. These risks and uncertainties, include, without limitation, risks and uncertainties related to: (a) whether Geron is successful in commercializing RYTELO (imetelstat) for the treatment of certain patients with lower-risk MDS with transfusion dependent anemia and achieves market acceptance across the breadth of the eligible patient segments in RYTELO’s approved indication; (b) whether the FDA and European Commission will approve imetelstat for other indications on the timelines expected, or at all; (c) Geron’s plans to commercialize RYTELO in the European Union, or EU, and risks related to operating outside of the U.S.; (d) whether Geron overcomes potential delays and other adverse impacts that may be caused by enrollment, clinical, safety, efficacy, technical, scientific, intellectual property, manufacturing and regulatory challenges in order to have the financial resources for and meet expected timelines and planned milestones; (e) whether regulatory authorities permit the further development of imetelstat on a timely basis, or at all, without any clinical holds; (f) whether any future safety or efficacy results of RYTELO treatment cause its benefit-risk profile to become unacceptable; (g) whether imetelstat actually demonstrates disease-modifying activity in patients and the ability to target the malignant stem and progenitor cells of the underlying disease; (h) whether Geron meets its post-marketing requirements and commitments for RYTELO; (i) whether there are failures or delays in manufacturing or supplying sufficient quantities of RYTELO (imetelstat) or other clinical trial materials that impact commercialization of RYTELO or the continuation of clinical trials; (j) that the projected timing for the interim and final analyses of the Phase 3 IMpactMF trial in R/R MF may vary depending on actual death rates in the trial; (k) whether Geron stays in compliance with and satisfies its obligations under its debt and synthetic royalty financing agreements; and (l) whether Geron successfully completes its restructuring plan, manages the changes in its workforce, and realizes expected operating expense savings. Additional information on the above risks and uncertainties and additional risks, uncertainties and factors that could cause actual results to differ materially from those in the forward-looking statements are contained in Geron’s filings and periodic reports filed with the Securities and Exchange Commission under the heading “Risk Factors” and elsewhere in such filings and reports, including Geron’s quarterly report on Form 10-Q for the quarter ended September 30, 2025, and subsequent filings and reports by Geron. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made, and the facts and assumptions underlying the forward-looking statements may change. Except as required by law, Geron disclaims any obligation to update these forward-looking statements to reflect future information, events, or circumstances.

Investors and Media
Dawn Schottlandt
Senior Vice President, Investor Relations and Corporate Affairs
dschottlandt@geron.com

Matisse Pharmaceuticals receives INN isupartob sodium recognizing first-in-class drug status for M6229




Matisse Pharmaceuticals receives INN isupartob sodium recognizing first-in-class drug status for M6229

Geleen, December 11, 2025

Matisse Pharmaceuticals B.V., a clinical stage company developing a medicinal product for the treatment of sepsis, today announced that Matisse’s lead compound M6229, has received the International Non-proprietary Name (INN) isupartob sodium from the World Health Organization. The new class of products ending on the extension –partob, was established by the WHO to define a class of heparin derivatives for histone binders, giving isupartob sodium the recognition as first-in-class product. The INN is a globally recognized, public-domain name that is distinct from a drug’s brand name (trademark) and is crucial for clear and safe communication in medicine and pharmacy.

“We are delighted that isupartob sodium has been recognized as a first-in-class therapy through the award of its International Nonproprietary Name (INN), which includes a new and distinctive suffix. This designation reflects Matisse’s leadership in advancing extracellular histone neutralization as a novel therapeutic approach designed to treat sepsis and other histone induced inflammatory indications”, says Marcel Jacobs, CEO of Matisse Pharmaceuticals.

Matisse will adapt this new name in future communication about the lead compound of Matisse.

About Matisse Pharmaceuticals
Matisse Pharmaceuticals B.V. was founded in 2014 in Geleen, the Netherlands. Matisse is dedicated to develop a product portfolio of safe and innovative therapies for disease indications characterized by elevated levels of circulating cytotoxic histones, such as in sepsis.

Matisse’s lead compound isupartob sodium is based on the discovery that in patients suffering from sepsis, proteins called histones are released into the blood stream by the innate immune system which are toxic to cell membranes leading to cell death and release of additional histones. Due to this self-enforcing cascade, sepsis patients are at risk of death from organ failure. The highly negatively charged isupartob sodium binds to the positively charged extracellular histones and inhibits the self-enforcing cascade of increasing histone levels, thereby preventing further organ damage and death.

After two successful clinical trials in healthy volunteers and sepsis patients, isupartob sodium is now entering clinical phase 2 development.  

About sepsis

According to the WHO, sepsis is one of the leading causes of death worldwide. Currently, there is no effective treatment against sepsis approved by regulatory authorities. From the 49 million patients globally suffering from sepsis every year, more than 20% die. Approximately 40% of the sepsis cases are children under the age of 5, with close to 3 million children not surviving sepsis. According to a study by Buchman et al. (2020), published in Critical Care Medicine, sepsis is the most common cause of in-hospital deaths, costing over $62 billion annually in the USA alone.

For more information, please contact:

Marcel Jacobs, CEO
(T) +31 6 575 27 541
(E) info@matissepharmaceuticals.com
(W) www.matissepharmaceuticals.com

Attachments

• 20251211 (NL) Matisse ontvang INN isupartob sodium (final)
• isupartob sodium product picture

Geron Corporation Announces Strategic Restructuring Plan to Position the Company for Long-Term Value Creation




Geron Corporation Announces Strategic Restructuring Plan to Position the Company for Long-Term Value Creation

Restructuring Supports RYTELO^® U.S. Commercial Strategy and Investment in Clinical Development

Expected to Reduce 2026 Projected Operating Expenses

FOSTER CITY, Calif., Dec. 11, 2025 (GLOBE NEWSWIRE) — Geron Corporation (Nasdaq: GERN), a commercial-stage biopharmaceutical company aiming to change lives by changing the course of blood cancer, today announced a strategic restructuring plan intended to position the Company for long-term value creation for patients and shareholders and improve its financial discipline.

“After my first four months at Geron, the leadership team and I have assessed the business with the goal of streamlining our organizational structure to advance our strategy and create long-term value. We are implementing these changes from a position of strength and in the spirit of prudent fiscal management,” said Harout Semerjian, President and Chief Executive Officer of Geron. “Our key objectives remain unchanged. We are focused on driving RYTELO commercial growth in the U.S., exploring opportunities for making RYTELO available outside the U.S., and continuing to advance our Phase 3 IMpactMF trial. We expect this restructuring will have a meaningful impact on our 2026 operating expenses and position Geron to meet the needs of patients. I want to express my gratitude to the employees that will be impacted in this restructuring. Your contributions over the years have made a positive difference in the lives of the people we endeavor each day to assist.”

The Company’s strategic restructuring plan is expected to result in an approximately one-third reduction in Geron’s current workforce of approximately 260 employees. As a result of the restructuring plan, which is expected to be substantially complete in the first quarter of 2026, initial projected full year 2026 operating expenses are expected to be less than the Company’s projected full year 2025 operating expenses, with savings expected to be realized beginning in the first quarter of 2026. Geron will incur restructuring charges consisting primarily of cash-based expenses in connection with the restructuring plan, with additional information to be provided in a Current Report on Form 8-K to be filed with the Securities and Exchange Commission. Geron thanks all employees who will be impacted by today’s announcement for their contributions to the Company.

About Geron
Geron is a commercial-stage biopharmaceutical company aiming to change lives by changing the course of blood cancer. Our first-in-class telomerase inhibitor RYTELO (imetelstat) is approved in the United States and the European Union for the treatment of certain adult patients with LR-MDS with transfusion-dependent anemia. We are also conducting a pivotal Phase 3 clinical trial of imetelstat in JAK-inhibitor R/R MF, as well as studies in other hematologic malignancies. Inhibiting telomerase activity, which is increased in malignant stem and progenitor cells in the bone marrow, aims to potentially reduce proliferation and induce death of malignant cells. To learn more, visit www.geron.com or LinkedIn.

Use of Forward-Looking Statements
Except for the historical information contained herein, this press release contains forward-looking statements made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that such statements, include, without limitation, those regarding: (i) the Company’s belief that the restructuring plan will streamline the Company’s organizational structure, advance its strategy, position the Company for long-term value creation for patients and shareholders, support RYTELO commercial strategy and investment in clinical development, and improve financial discipline; (ii) the Company’s focus on driving RYTELO commercial growth in the U.S., exploring opportunities for making RYTELO available outside the U.S., and continuing to advance its Phase 3 IMpactMF trial; (iii) the Company’s expectation that the restructuring will have a meaningful impact on its 2026 operating expenses and position the Company to meet the needs of patients; (iv) the expected size of the reduction in workforce and the Company’s expectations that initial projected full year 2026 operating expenses will be lower than projected full year 2025 operating expenses, with savings expected to be realized beginning in the first quarter of 2026; (v) the expected costs and timing for completion of the restructuring; and (vi) other statements that are not historical facts, constitute forward-looking statements. These forward-looking statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. These risks and uncertainties, include, without limitation, risks and uncertainties related to: (a) whether Geron is successful in commercializing RYTELO (imetelstat) for the treatment of certain patients with lower-risk MDS with transfusion dependent anemia and achieves market acceptance across the breadth of the eligible patient segments in RYTELO’s approved indication; (b) whether the FDA and European Commission will approve imetelstat for other indications on the timelines expected, or at all; (c) Geron’s plans to commercialize RYTELO in the European Union, or EU, and risks related to operating outside of the U.S.; (d) whether Geron overcomes potential delays and other adverse impacts that may be caused by enrollment, clinical, safety, efficacy, technical, scientific, intellectual property, manufacturing and regulatory challenges in order to have the financial resources for and meet expected timelines and planned milestones; (e) whether regulatory authorities permit the further development of imetelstat on a timely basis, or at all, without any clinical holds; (f) whether any future safety or efficacy results of RYTELO treatment cause its benefit-risk profile to become unacceptable; (g) whether imetelstat actually demonstrates disease-modifying activity in patients and the ability to target the malignant stem and progenitor cells of the underlying disease; (h) whether Geron meets its post-marketing requirements and commitments for RYTELO; (i) whether there are failures or delays in manufacturing or supplying sufficient quantities of RYTELO (imetelstat) or other clinical trial materials that impact commercialization of RYTELO or the continuation of clinical trials; (j) that the projected timing for the interim and final analyses of the Phase 3 IMpactMF trial in R/R MF may vary depending on actual death rates in the trial; (k) whether Geron stays in compliance with and satisfies its obligations under its debt and synthetic royalty financing agreements; and (l) whether Geron successfully completes its restructuring plan, manages the changes in its workforce, and realizes expected operating expense savings. Additional information on the above risks and uncertainties and additional risks, uncertainties and factors that could cause actual results to differ materially from those in the forward-looking statements are contained in Geron’s filings and periodic reports filed with the Securities and Exchange Commission under the heading “Risk Factors” and elsewhere in such filings and reports, including Geron’s quarterly report on Form 10-Q for the quarter ended September 30, 2025, and subsequent filings and reports by Geron. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made, and the facts and assumptions underlying the forward-looking statements may change. Except as required by law, Geron disclaims any obligation to update these forward-looking statements to reflect future information, events, or circumstances.

Investors and Media
Dawn Schottlandt
Senior Vice President, Investor Relations and Corporate Affairs
dschottlandt@geron.com

Praxis Precision Medicines Announces Plans to File an NDA for Relutrigine in SCN2A and SCN8A Developmental and Epileptic Encephalopathies in Early 2026




Praxis Precision Medicines Announces Plans to File an NDA for Relutrigine in SCN2A and SCN8A Developmental and Epileptic Encephalopathies in Early 2026

EMBOLD data to serve as basis of efficacy and safety following discussion with the FDA

BOSTON, Dec. 11, 2025 (GLOBE NEWSWIRE) — Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system (CNS) disorders characterized by neuronal excitation-inhibition imbalance, today announced the successful completion of the planned discussion with the FDA leading to the confirmation to file a New Drug Application (NDA) for relutrigine in early 2026.

“We are very pleased with the collaborative discussions we’ve had with the FDA, which support our path toward an NDA submission in early 2026,” said Marcio Souza, president and chief executive officer. “Building on the unprecedented and compelling results from the EMBOLD study, where relutrigine demonstrated statistically significant and clinically meaningful improvements, we are advancing toward delivering a much-needed therapy for children living with these devastating diseases.”

About Relutrigine (PRAX-562)
Relutrigine is a first-in-class small molecule in development for the treatment of developmental and epileptic encephalopathies (DEEs) as a preferential inhibitor of persistent sodium current, shown to be a key driver of seizure symptoms in severe DEEs. Relutrigine’s mechanism of precision sodium channel (NaV) modulation is consistent with superior selectivity for disease-state NaV channel hyperexcitability. In vivo studies of relutrigine have demonstrated dose-dependent inhibition of seizures up to complete control of seizure activity in SCN2A, SCN8A and other DEE mouse models. Relutrigine has been generally well-tolerated in three Phase 1 studies and has demonstrated biomarker changes indicative of NaV channel modulation. Data from the Phase 2 EMBOLD study demonstrated a well-tolerated safety profile with robust, short- and long-term improvement in motor seizures in a heavily pre-treated population, alongside maintained seizure freedom in some patients with SCN2A- and SCN8A-DEE. Relutrigine has received Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation from the FDA for the treatment of SCN2A-DEE, SCN8A-DEE and Dravet syndrome; as well as Breakthrough Therapy Designation (BTD), and ODD from the European Medicines Agency for the treatment of SCN2A-DEE and SCN8A-DEE. To learn more about the EMERALD and EMBOLD studies, please visit ResilienceStudies.com.

About Praxis
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating insights from genetic epilepsies into the development of therapies for CNS disorders characterized by neuronal excitation-inhibition imbalance. Praxis is applying genetic insights to the discovery and development of therapies for rare and more prevalent neurological disorders through our proprietary small molecule platform, Cerebrum™, and antisense oligonucleotide (ASO) platform, Solidus™, using our understanding of shared biological targets and circuits in the brain. Praxis has established a diversified, multimodal CNS portfolio including multiple programs across movement disorders and epilepsy, with four clinical-stage product candidates. For more information, please visit www.praxismedicines.com and follow us on Facebook, Instagram, LinkedIn and Twitter/X.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995 and other federal securities laws, including express or implied statements regarding Praxis’ future expectations, plans and prospects, including, without limitation, statements regarding the development of Praxis’ product candidates and the anticipated timing of regulatory submissions and interactions, as well as other statements containing the words “anticipate,” “believe,” “continue,” “could,” “endeavor,” “estimate,” “expect,” “anticipate,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” “target,” “will” or “would” and similar expressions that constitute forward-looking statements under the Private Securities Litigation Reform Act of 1995.

The express or implied forward-looking statements included in this press release are only predictions and are subject to a number of risks, uncertainties and assumptions, including, without limitation: uncertainties inherent in clinical trials; the expected timing of clinical trials, data readouts and the results thereof, and submissions for regulatory approval or review by governmental authorities; regulatory approvals to conduct trials; and other risks concerning Praxis’ programs and operations as described in its Annual Report on Form 10-K for the year ended December 31, 2024 and as updated in its Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, as well as other filings made with the Securities and Exchange Commission. Although Praxis’ forward-looking statements reflect the good faith judgment of its management, these statements are based only on information and factors currently known by Praxis. As a result, you are cautioned not to rely on these forward-looking statements. Any forward-looking statement made in this press release speaks only as of the date on which it is made. Praxis undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.

CONTACT: Investor Contact:
Praxis Precision Medicines
investors@praxismedicines.com
857-702-9452


Media Contact:
Dan Ferry
Life Science Advisors
Daniel@lifesciadvisors.com
617-430-7576

Praxis Precision Medicines Announces Plans to File an NDA for Relutrigine in SCN2A and SCN8A Developmental and Epileptic Encephalopathies in Early 2026




Praxis Precision Medicines Announces Plans to File an NDA for Relutrigine in SCN2A and SCN8A Developmental and Epileptic Encephalopathies in Early 2026

EMBOLD data to serve as basis of efficacy and safety following discussion with the FDA

BOSTON, Dec. 11, 2025 (GLOBE NEWSWIRE) — Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system (CNS) disorders characterized by neuronal excitation-inhibition imbalance, today announced the successful completion of the planned discussion with the FDA leading to the confirmation to file a New Drug Application (NDA) for relutrigine in early 2026.

“We are very pleased with the collaborative discussions we’ve had with the FDA, which support our path toward an NDA submission in early 2026,” said Marcio Souza, president and chief executive officer. “Building on the unprecedented and compelling results from the EMBOLD study, where relutrigine demonstrated statistically significant and clinically meaningful improvements, we are advancing toward delivering a much-needed therapy for children living with these devastating diseases.”

About Relutrigine (PRAX-562)
Relutrigine is a first-in-class small molecule in development for the treatment of developmental and epileptic encephalopathies (DEEs) as a preferential inhibitor of persistent sodium current, shown to be a key driver of seizure symptoms in severe DEEs. Relutrigine’s mechanism of precision sodium channel (NaV) modulation is consistent with superior selectivity for disease-state NaV channel hyperexcitability. In vivo studies of relutrigine have demonstrated dose-dependent inhibition of seizures up to complete control of seizure activity in SCN2A, SCN8A and other DEE mouse models. Relutrigine has been generally well-tolerated in three Phase 1 studies and has demonstrated biomarker changes indicative of NaV channel modulation. Data from the Phase 2 EMBOLD study demonstrated a well-tolerated safety profile with robust, short- and long-term improvement in motor seizures in a heavily pre-treated population, alongside maintained seizure freedom in some patients with SCN2A- and SCN8A-DEE. Relutrigine has received Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation from the FDA for the treatment of SCN2A-DEE, SCN8A-DEE and Dravet syndrome; as well as Breakthrough Therapy Designation (BTD), and ODD from the European Medicines Agency for the treatment of SCN2A-DEE and SCN8A-DEE. To learn more about the EMERALD and EMBOLD studies, please visit ResilienceStudies.com.

About Praxis
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating insights from genetic epilepsies into the development of therapies for CNS disorders characterized by neuronal excitation-inhibition imbalance. Praxis is applying genetic insights to the discovery and development of therapies for rare and more prevalent neurological disorders through our proprietary small molecule platform, Cerebrum™, and antisense oligonucleotide (ASO) platform, Solidus™, using our understanding of shared biological targets and circuits in the brain. Praxis has established a diversified, multimodal CNS portfolio including multiple programs across movement disorders and epilepsy, with four clinical-stage product candidates. For more information, please visit www.praxismedicines.com and follow us on Facebook, Instagram, LinkedIn and Twitter/X.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995 and other federal securities laws, including express or implied statements regarding Praxis’ future expectations, plans and prospects, including, without limitation, statements regarding the development of Praxis’ product candidates and the anticipated timing of regulatory submissions and interactions, as well as other statements containing the words “anticipate,” “believe,” “continue,” “could,” “endeavor,” “estimate,” “expect,” “anticipate,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” “target,” “will” or “would” and similar expressions that constitute forward-looking statements under the Private Securities Litigation Reform Act of 1995.

The express or implied forward-looking statements included in this press release are only predictions and are subject to a number of risks, uncertainties and assumptions, including, without limitation: uncertainties inherent in clinical trials; the expected timing of clinical trials, data readouts and the results thereof, and submissions for regulatory approval or review by governmental authorities; regulatory approvals to conduct trials; and other risks concerning Praxis’ programs and operations as described in its Annual Report on Form 10-K for the year ended December 31, 2024 and as updated in its Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, as well as other filings made with the Securities and Exchange Commission. Although Praxis’ forward-looking statements reflect the good faith judgment of its management, these statements are based only on information and factors currently known by Praxis. As a result, you are cautioned not to rely on these forward-looking statements. Any forward-looking statement made in this press release speaks only as of the date on which it is made. Praxis undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.

CONTACT: Investor Contact:
Praxis Precision Medicines
investors@praxismedicines.com
857-702-9452


Media Contact:
Dan Ferry
Life Science Advisors
Daniel@lifesciadvisors.com
617-430-7576

Bio Usawa Welcomes Global Health Strategist, Professor Prashant Yadav, as Chair of Its Global Access and Health Equity Advisory Board




Bio Usawa Welcomes Global Health Strategist, Professor Prashant Yadav, as Chair of Its Global Access and Health Equity Advisory Board

Strategic Appointment Aligns Business Growth with Mission to Deliver Equitable, Affordable Medicines

SAN FRANCISCO and KIGALI, Rwanda, Dec. 11, 2025 (GLOBE NEWSWIRE) — Bio Usawa Inc., a biotechnology company dedicated to developing and delivering high-quality, affordable medicines, today announced the appointment of Professor Prashant Yadav as Director and Chair of its newly formed Global Access and Health Equity Advisory Board. This pivotal appointment underscores Bio Usawa’s foundational commitment to integrating health equity and sustainable access into the core of its business strategy.

In this dual role, Professor Yadav will provide strategic oversight and guidance to ensure Bio Usawa fulfills its mission on a global scale. As Chair, he will lead the Advisory Board’s efforts to design and advance innovative access models, foster transformative partnerships to strengthen health systems, and embed equity across all aspects of the company’s operations—from R&D to delivery.

“We are thrilled and honored to welcome Professor Yadav to Bio Usawa’s leadership,” said Dr. Menghis Bairu, CEO and President of Bio Usawa. “His unique combination of unparalleled vision, on-the-ground practical advice and commitment to equitable global healthcare has been an invaluable contribution to our Company since inception. He continues to inspire us as we navigate the complex journey from breakthrough science to patient impact. Professor Yadav’s appointment signals our unwavering resolve to grow as a business that measures success not just in milestones, but in lives improved equitably.”

Professor Yadav is a globally recognized researcher, educator, and policy advisor in healthcare delivery. A Senior Fellow at the Council on Foreign Relations, his insights have shaped discourse and policy worldwide. His analysis has been featured in leading publications including the Financial Times, The New York Times, The Economist, and Nature, and he is a frequent expert commentator on networks such as BBC, CNN, and NPR.

His distinguished career spans academia and on-the-ground impact. He has held faculty and lecturer positions at INSEAD, MIT, the University of Michigan, and Harvard Medical School. Previously, he served as the Strategy Leader for Supply Chains at the Bill & Melinda Gates Foundation and as Vice President of Healthcare Research at the William Davidson Institute, University of Michigan.

“I am inspired by Bio Usawa’s mission-led approach and its deep commitment to aligning commercial objectives with social impact,” said Professor Yadav. “As well, the Bio Usawa leadership team consists of seasoned and highly respected drug development, manufacturing, and commercialization leaders who have run and led multiple global biotech companies and pharma divisions. Joining the Board and chairing this critical advisory body presents a powerful opportunity to translate promising biotech innovations into tangible, equitable health solutions. I look forward to working with the team to build resilient access pathways that leave no community behind.”

Grounded in the principle of “Usawa” (Swahili for equity/fairness), Bio Usawa believes that business growth and lasting social impact are mutually reinforcing. The establishment of the Global Access and Health Equity Advisory Board, under Professor Yadav’s leadership, institutionalizes this belief, ensuring it remains central to the company’s strategic decisions.

About Bio Usawa
Bio Usawa develops, licenses, and manufactures high quality, affordable monoclonal antibodies and biosimilars targeting cancer, diabetes complications, infectious diseases, and autoimmune conditions. The Company integrates access and fairness into its business model from the outset to create a future where advanced therapies are within reach for all who need them. For more information, visit www.biousawa.com.

Media Contact:

Daniel Levine
Levine Media Group
+1 510-280-5405
danny@levinemediagroup.com

Heartflow FFRCT Analysis Delivers Prognostic Power and Significant Cost Savings in New Analyses of Over 90,000 Patients with Coronary Artery Disease




Heartflow FFRCT Analysis Delivers Prognostic Power and Significant Cost Savings in New Analyses of Over 90,000 Patients with Coronary Artery Disease

Lesion-specific FFRCT predicts individual cardiovascular outcomes and delivers greater-than-modeled cost savings for real-world population in FISH&CHIPS analyses from England’s National Health Service

MOUNTAIN VIEW, Calif., Dec. 11, 2025 (GLOBE NEWSWIRE) — Heartflow, Inc. (Heartflow) (Nasdaq: HTFL), the leader in AI technology for coronary artery disease (CAD), announced two new analyses from FISH&CHIPS, a real-world, multicenter, retrospective study of more than 90,000 patients conducted by the National Health Service (NHS) in England, representing the largest fractional flow reserve (FFR_CT) study ever conducted. The data, presented today at the European Society of Cardiology’s European Association of Cardiovascular Imaging (EACVI) conference in Vienna, provide the strongest real-world evidence to date that Heartflow FFR_CT Analysis derived from coronary computed tomography angiography (CTA) improves diagnostic decision-making, predicts future cardiovascular events, and delivers substantial, system-wide cost savings.

“These real-world data show that coronary CTA plus Heartflow FFR_CT Analysis brings both clinical and economic value when utilized in a large health system,” said Timothy Fairbairn, Ph.D., principal investigator for the FISH&CHIPS study, Liverpool Heart and Chest Hospital, and Associate Professor at the University of Liverpool, UK. “The introduction of Heartflow FFR_CT Analysis into the NHS resulted in fewer avoidable tests, lower inpatient and outpatient costs, and substantial overall savings for both the hospitals and patients. It’s a compelling example of how noninvasive AI-powered technology can reshape care pathways at scale.”

Lesion-Specific Heartflow FFR_CT Analysis Predicts Individual Cardiovascular Outcomes
In a nationwide analysis of 7,836 patients who underwent FFR_CT in the FISH&CHIPS study, investigators evaluated the prognostic value of Heartflow FFR_CT Analysis across individual outcomes, including myocardial infarction (MI), cardiovascular mortality, all-cause mortality, and revascularization. Key findings include:¹

• The lower the FFR_CT values, the higher the risk of MI, revascularization, cardiovascular death, and all-cause death, independent of traditional cardiovascular risk factors.
• Patients with the lowest FFR_CT values faced a four-fold increased risk of heart attack and a three-fold increased risk of cardiovascular death.
• Lesion-specific FFR_CT (measured just beyond a specific stenosis) was the strongest predictor in the study of MI and revascularization, compared to distal vessel FFR_CT (measured at the end of the artery).

Heartflow FFR_CT Analysis Delivers Greater-Than-Expected Cost Savings
A separate analysis of FISH&CHIPS data evaluated the cost-effectiveness of incorporating Heartflow FFR_CT Analysis into the diagnostic pathway for stable CAD. The findings showed that the national program:²

• Reduced downstream cardiovascular testing, including invasive coronary angiography.
• Increased appropriate revascularization and improved revascularization ratios.
• Produced £1,042 GBP ($1,394 USD) in per-patient cost savings at two years, substantially exceeding the cost savings modeled by NHS and the National Institute for Health and Care Excellence (NICE) during initial assessment and adoption. This suggests a potential £25 million GBP ($33.45 million USD) cost savings per year for the health system.
• Demonstrated cost savings beginning in the first year, with benefits persisting in lifetime modeling.

“These data provide compelling real-world evidence underscoring the clinical value of lesion-specific Heartflow FFR_CT Analysis to provide precise, localized physiological assessments,” said Campbell Rogers, M.D., F.A.C.C., Chief Medical Officer at Heartflow. “We now see that lesion-specific FFR_CT insights can also help predict which patients are most likely to experience future events, enabling clinicians to tailor care earlier with greater precision and reduce costs.”

These analyses are the latest to demonstrate the prognostic power of the Heartflow One platform, the most accurate noninvasive AI-enabled CAD assessment technology, including RoadMap™ Analysis, FFR_CT Analysis and Plaque Analysis. Insights from FISH&CHIPS add to a growing body of evidence demonstrating the clinical and economic value of the Heartflow One platform providing superior patient outcomes in patients with confirmed CAD.^3,4 A retrospective analysis of symptomatic patients from a cohort of the FISH&CHIPS Study presented at the American Heart Association (AHA) Scientific Sessions 2025 provided strong validation of total plaque volume-based staging measured with Heartflow Plaque Analysis as a predictor of future heart attacks or cardiovascular death.⁵ Heartflow One provides an integrated workflow that empowers physicians to improve care by enabling a faster, more optimal diagnosis to avoid unnecessary tests.

About FISH&CHIPS
FISH&CHIPS, the largest FFR_CT study conducted to date, is a real-world, multicenter, quasi-experimental observational clinical study designed to assess the incremental impact of adding FFR_CT to a coronary CTA-first diagnostic paradigm for CAD at a national level. The study analyzed data from 27 NHS hospital sites in England, including 90,553 patients followed for at least two years. The primary objective was to determine whether introducing a coronary CTA+FFR_CT diagnostic pathway was clinically useful and safe compared to a standard-of-care diagnostic chest pain pathway using coronary CTA alone. Two-year data were published in May 2025 in Nature Medicine, showing improved care efficiency with a reduction in unnecessary invasive and noninvasive cardiac tests using coronary CTA and Heartflow FFR_CT versus coronary CTA alone. The study was funded by the UK Medical Research Council (MRC) and supported by the National Institute for Health and Care Research (NIHR) Research Delivery Network.

About Heartflow’s Technology and Research
Heartflow’s technology is redefining precision cardiovascular care through clinically-proven AI and the world’s largest coronary imaging dataset. Heartflow has been adopted by more than 1,400 institutions globally and continues to strengthen its commercial presence to make this cutting-edge solution more widely available to an increasingly diverse patient population. Backed by ACC/AHA guidelines and supported by more than 600 peer-reviewed publications, Heartflow has redefined how clinicians manage care for over 500,000 patients worldwide. Key benefits include:

• Proprietary data pipeline: Built from more than 110 million annotated CTA images, Heartflow’s data foundation powers advanced AI models that deliver highly accurate, reproducible insights across diverse patient populations.
• Extensive clinical and real-world validation: Heartflow’s AI-driven solutions have been validated through clinical evidence in over 100 studies assessing over 365,000 patients. Proven in real-world practice with reproducibility and accuracy, Heartflow’s coronary CTA image acceptance rates exceed 97%.
• Seamless clinical integration via upgraded workflow: Heartflow delivers final quality-reviewed analyses instantly upon order, enabling clinicians to move from diagnosis to decision without delay.
• Quality system, global security and patient-data integrity compliance: Heartflow meets or exceeds leading international standards, including HITRUST, SOC 2 Type 2, ISO 13485, and ISO 27001.

About Heartflow, Inc.
Heartflow is transforming coronary artery disease from the world’s leading cause of death into a condition that can be detected early, diagnosed accurately, and managed for life. The Heartflow One platform uses AI to turn coronary CTA images into personalized 3D models of the heart, providing clinically meaningful, actionable insights into plaque location, volume, and composition and its effect on blood flow — all without invasive procedures. Discover how we’re shaping the future of cardiovascular care at heartflow.com.

Media Contact
Elliot Levy
elevy@heartflow.com

Investor Contact
Nick Laudico
nlaudico@heartflow.com

‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾‾
¹ Bell et al. AHA 2025.
² Fairbairn et al. EACVI 2025.
³ Madsen KT, et al. ADVANCE-DK 7-year. Presented at TCT Scientific Sessions 2024
⁴ Douglas PS, et al. The PRECISE Randomized Clinical Trial. JAMA Cardiol. 2023;8(10):904–914. doi:10.1001/jamacardio.2023.2595
⁵ Fairbairn et al. AHA 2025.

Genmab to Hold 2025 R&D Update and ASH Data Review Meeting




Genmab to Hold 2025 R&D Update and ASH Data Review Meeting

Media Release

• Event to be held virtually via live webcast and archived on www.genmab.com

Copenhagen, Denmark; December 11, 2025 – Genmab A/S (Nasdaq: GMAB) will hold its 2025 R&D Update and ASH Data Review Meeting today, December 11, 2025 at 11:00 AM Eastern Time (5:00 PM CET / 4:00 PM GMT). The event will take place virtually and can be attended via live webcast. To register for the webcast, click https://genmab-post-ash-2025.open-exchange.net/registration. An archive of the webcast will be available on Genmab’s website.

This meeting is not an official program of the ASH Annual Meeting.

About Genmab 
Genmab is an international biotechnology company with a core purpose of guiding its unstoppable team to strive toward improving the lives of patients with innovative and differentiated antibody therapeutics. For more than 25 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with knock-your-socks-off (KYSO) antibody medicines^®. 

Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X.

Contact:        
Marisol Peron, Senior Vice President, Global Communications & Corporate Affairs
T: +1 609 524 0065; E: mmp@genmab.com

Andrew Carlsen, Vice President, Head of Investor Relations
T: +45 3377 9558; E: acn@genmab.com

This Media Release contains forward looking statements. The words “believe,” “expect,” “anticipate,” “intend” and “plan” and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with preclinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on www.genmab.com and the risk factors included in Genmab’s most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Media Release nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law.

Genmab A/S and/or its subsidiaries own the following trademarks: Genmab^®; the Y-shaped Genmab logo^®; Genmab in combination with the Y-shaped Genmab logo^®; HuMax^®; DuoBody^®; HexaBody^®; DuoHexaBody^®, HexElect^® and KYSO^®.

Media Release no. i27
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122

Genmab A/S
Carl Jacobsens Vej 30
2500 Valby
Denmark

Attachment

• 111225_i27_Post ASH Event

Aukera Therapeutics Comes Out of Stealth




Aukera Therapeutics Comes Out of Stealth

David Urech to join the board

BASEL, Switzerland, Dec. 11, 2025 (GLOBE NEWSWIRE) — Aukera Therapeutics, a preclinical-stage biotech spin-off from the University of Basel is officially coming out of stealth as it enters preclinical efficacy studies. It announced today that it has raised some CHF 4.5M to date and attracted new board member and investor David Urech. Other current investors include Kickfund and Zürcher Kantonalbank.

Aukera is focused on the therapy of neurological conditions associated with RAPTOR activity (regulatory-associated protein of mTOR). The company screened billions of compounds using AI-supported technology to discover a highly selective RAPTOR inhibitor modulating the mTORC1 signaling network – a new approach to selectively tackling a proven target with the potential for greater efficacy and favorable safety.

Aukera CEO and co-founder, Stefan Imseng, Ph.D., is pledging to pursue a therapy in Tuberous Sclerosis Complex (TSC), a rare multisystem genetic disorder.

“TSC typically starts in infancy and leads to seizures and a plethora of neuropsychiatric symptoms,” said Stefan, adding that mutations in TSC genes overactivate mTORC1 and lead to hyperexcitability of neurons in the brain. “Aukera’s RAPTOR inhibitors dampen mTORC1 activity, which is expected to result in reduced frequency and severity of seizures, offering relief for TSC patients, families and caregivers.”

The company plans to expand later to other indications with mTORC1 dysregulation, such as neurodegeneration, metabolic disorders, age-related diseases.

“The promise to change the lives of more than one million TSC patients, and the scientific excellence of the Aukera team, is why I decided to invest and join the board,” said David Urech, founder and former CEO of Numab Therapeutics whose subsidiary Yellow Jersey sold to J&J for $1.25 B in 2024.

About Aukera Therapeutics
Aukera Therapeutics is developing the first RAPTOR inhibitors for the treatment of mTORC1-related pathologies. The company is a spin-off from the Biozentrum of the University of Basel, founded on seminal academic research from the laboratories of Professors Michael N. Hall and Timm Maier. Aukera pairs mTOR expertise with an AI-driven drug discovery engine built for complex and hard-to-drug targets. The company’s lead program focuses on rare neurological disorders such as TSC. Future use of RAPTOR inhibitors include neurodegenerative, metabolic and age-related diseases. Aukera has received funding and support from Venture Kick, BaseLaunch, the Innovation Office of the University of Basel and Innosuisse.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/0fa1d97a-8a6a-459d-8754-fc61e33c284f

Immunovant Announces Pricing of $550 Million Common Stock Financing




Immunovant Announces Pricing of $550 Million Common Stock Financing

• Funding to provide runway through potential Graves’ Disease commercial launch

NEW YORK, Dec. 11, 2025 (GLOBE NEWSWIRE) — Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases, today announced the pricing of an underwritten offering of its common stock, with anticipated gross proceeds to Immunovant of approximately $550 million, before deducting underwriting discounts and commissions and other expenses payable by Immunovant in connection with the transaction. Roivant Sciences Ltd., the Company’s controlling stockholder, has agreed to purchase shares in the offering. All of the shares are to be sold by Immunovant.

Immunovant currently expects that its existing cash and cash equivalents, together with the proceeds from the transaction, will be sufficient to fund its operating expenses and capital expenditures through the potential commercial launch of IMVT-1402 in the Graves’ Disease indication.

Immunovant offered 26.2 million shares of its common stock in the offering at an offering price of $21.00 per share. The offering is expected to close on or about December 12, 2025, subject to satisfaction of customary closing conditions.

Leerink Partners is acting as the sole underwriter for the offering.

The shares in the offering are being offered by Immunovant pursuant to an automatic registration statement on Form S-3 previously filed with the SEC.

When available, a copy of the final prospectus supplement and the accompanying prospectus relating to the offering may also be obtained from: Leerink Partners LLC, Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, or by telephone at (800) 808-7525 ext. 6105, or by email at syndicate@leerink.com.

This press release does not constitute an offer to sell or a solicitation of an offer to buy, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful before registration or qualification under the securities laws of that state or jurisdiction.

Forward-Looking Statements

This press release contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as “can,” “may,” “might,” “will,” “would,” “should,” “expect,” “believe,” “estimate,” “design,” “plan,” “intend,” and other similar expressions are intended to identify forward-looking statements. Such forward-looking statements include, but are not limited to, the uncertainties related to the completion of the offering. All forward-looking statements are based on estimates and assumptions by Immunovant’s management that, although Immunovant believes to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Immunovant expected. Such risks and uncertainties include, among others: Immunovant may not be able to protect or enforce its intellectual property rights; initial results or other preliminary analyses or results of early clinical trials may not be predictive final trial results or of the results of later clinical trials; the timing and availability of data from clinical trials; the timing of discussions with regulatory agencies, as well as regulatory submissions and potential approvals; the continued development of Immunovant’s product candidates, including the number and timing of the commencement of additional clinical trials; Immunovant’s scientific approach, clinical trial design, indication selection, and general development progress; future clinical trials may not confirm any safety, potency, or other product characteristics described or assumed in this press release; any product candidate that Immunovant develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; Immunovant’s product candidates may not be beneficial to patients, or even if approved by regulatory authorities, successfully commercialized; the potential impact of global factors, such as international trade tariffs, geopolitical tensions, and adverse macroeconomic conditions on Immunovant’s business operations and supply chain, including its clinical development plans and timelines; Immunovant’s business is heavily dependent on the successful development, regulatory approval, and commercialization of IMVT-1402; Immunovant is at various stages of clinical development for IMVT-1402 and batoclimab; and Immunovant will require additional capital to fund its operations and advance IMVT-1402 and batoclimab through clinical development. These and other risks and uncertainties are more fully described in Immunovant’s periodic and other reports filed with the Securities and Exchange Commission (SEC), including in the section titled “Risk Factors” in Immunovant’s Annual Report on Form 10-K filed with the SEC on May 29, 2025, and Immunovant’s subsequent filings with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Immunovant undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Contact:
Investors
Keyur Parekh
keyur.parekh@roivant.com

Media
Stephanie Lee
stephanie.lee@roivant.com