GUERBET : Adjustment of 2025 financial targets.




GUERBET : Adjustment of 2025 financial targets.

Adjustment of 2025 financial targets

Villepinte, 2 December 2025, 5.45 p.m.: Guerbet (FR0000032526 GBT), a global specialist in contrast agents and solutions for medical imaging, is announcing a downward revision to its financial targets for full-year 2025.

Following an inspection by the U.S. Food and Drug Administration (FDA) during the first half of the year, the Guerbet Group developed and initiated the implementation of a compliance plan at its Raleigh site in the United States. This plan has been reinforced over the past weeks in response to FDA’s observations¹.

Guerbet always puts the patient front and centre of its commitments and affirm its determination to ensure production meets the highest regulatory and quality standards.

Guerbet mobilised human, financial and technical internal resources and hired external experts to conduct comprehensive assessments and take other interim measures under the compliance plan, in alignment with FDA guidance to industry. The implementation of the compliance plan has delayed the release of batches manufactured at the site, and this is expected to result in a loss of revenue for the Group in the 2025 financial year. The implementation of compliance plan activities will also give rise to exceptional costs.

Under these conditions, Guerbet will not be able to meet its 2025 targets and now anticipates:

• A decrease in revenue of between -4 % and -5 % at constant exchange rates and on a like-for-like basis, compared with a slight decrease of -1% previously announced;
• A restated EBITDA margin of between 10,5% and 12% of revenue, compared with between 12% and 13% previously announced;
• Free cash flow of between -5M€ and -15M€, versus slightly negative previously announced

The operational consequences and financial impact for the 2026 financial year are currently being analysed. The company will inform the market as soon as it has additional information.

About Guerbet

At Guerbet, we build lasting relationships so that we enable people to live better. That is our purpose. We are a global leader in medical imaging, offering a comprehensive range of pharmaceutical products, medical devices, and digital and AI solutions for diagnostic and interventional imaging. As pioneers in contrast products for 99 years, with more than 2,905 employees worldwide, we continuously innovate and devote 9% of our revenue to Research and Development in four centers in France and the United States. Guerbet (GBT) is listed in compartment B of Euronext Paris and generated revenue of €841m in 2024. For more information, please visit www.guerbet.com.

Forward-looking statements

Certain information contained in this press release is not historical data but constitutes forward-looking statements. These forward-looking statements are based on estimates, forecasts and assumptions including, without limitation, assumptions regarding the Group’s current and future strategy and the economic environment in which the Group operates. They involve known and unknown risks, uncertainties and other factors, which may result in a significant difference between the Group’s actual performance and results and those presented explicitly or implicitly in these forward-looking statements.

These forward-looking statements are only valid as of the date of this press release and the Group expressly disclaims any obligation or commitment to issue an update or revision of the forward-looking statements contained in this press release to reflect changes in the assumptions, events, conditions or circumstances on which such forward-looking statements are based. Forward-looking statements contained in this press release are for illustrative purposes only. Forward-looking statements and information are not guarantees of future performance and are subject to risks and uncertainties that are difficult to predict and generally beyond the control of the Group.

These risks and uncertainties include, but are not limited to, uncertainties inherent in research and development, future clinical data and analyses, including post-marketing analyses, decisions by regulatory authorities, such as the Food and Drug Administration or the European Medicines Agency, whether or not to approve, and when, the application for a drug, process or biological product for one of these candidate products, as well as their labeling decisions and other factors that may affect the availability or commercial potential of these candidate products. A detailed description of the risks and uncertainties related to the Group’s activities can be found in chapter 4.8 “Risk factors” of the Group’s Universal Registration Document registered by the AMF under number D.25-0220 on April 3, 2025, available on the Group’s website (www.guerbet.com).

1 Warning Letter dated 17 October 2025

Contacts:

Guerbet    
Christine Allard, SVP Public Affairs and Corporate Communications +33 6 30 11 57 82 / christine.allard@guerbet.com

Seitosei.Actifin                                                                               
Marianne Py, Financial Communication + 33 6 85 52 76 93 / marianne.py@seitosei-actifin.com
Jennifer Jullia, Press +33 6 02 08 45 49   / jennifer.jullia@seitosei-actifin.com

Attachment

• 2025 12 02 CP GBT_Ajustement Guidance 2025_UK Vdef

GUERBET : Adjustment of 2025 financial targets.




GUERBET : Adjustment of 2025 financial targets.

Adjustment of 2025 financial targets

Villepinte, 2 December 2025, 5.45 p.m.: Guerbet (FR0000032526 GBT), a global specialist in contrast agents and solutions for medical imaging, is announcing a downward revision to its financial targets for full-year 2025.

Following an inspection by the U.S. Food and Drug Administration (FDA) during the first half of the year, the Guerbet Group developed and initiated the implementation of a compliance plan at its Raleigh site in the United States. This plan has been reinforced over the past weeks in response to FDA’s observations¹.

Guerbet always puts the patient front and centre of its commitments and affirm its determination to ensure production meets the highest regulatory and quality standards.

Guerbet mobilised human, financial and technical internal resources and hired external experts to conduct comprehensive assessments and take other interim measures under the compliance plan, in alignment with FDA guidance to industry. The implementation of the compliance plan has delayed the release of batches manufactured at the site, and this is expected to result in a loss of revenue for the Group in the 2025 financial year. The implementation of compliance plan activities will also give rise to exceptional costs.

Under these conditions, Guerbet will not be able to meet its 2025 targets and now anticipates:

• A decrease in revenue of between -4 % and -5 % at constant exchange rates and on a like-for-like basis, compared with a slight decrease of -1% previously announced;
• A restated EBITDA margin of between 10,5% and 12% of revenue, compared with between 12% and 13% previously announced;
• Free cash flow of between -5M€ and -15M€, versus slightly negative previously announced

The operational consequences and financial impact for the 2026 financial year are currently being analysed. The company will inform the market as soon as it has additional information.

About Guerbet

At Guerbet, we build lasting relationships so that we enable people to live better. That is our purpose. We are a global leader in medical imaging, offering a comprehensive range of pharmaceutical products, medical devices, and digital and AI solutions for diagnostic and interventional imaging. As pioneers in contrast products for 99 years, with more than 2,905 employees worldwide, we continuously innovate and devote 9% of our revenue to Research and Development in four centers in France and the United States. Guerbet (GBT) is listed in compartment B of Euronext Paris and generated revenue of €841m in 2024. For more information, please visit www.guerbet.com.

Forward-looking statements

Certain information contained in this press release is not historical data but constitutes forward-looking statements. These forward-looking statements are based on estimates, forecasts and assumptions including, without limitation, assumptions regarding the Group’s current and future strategy and the economic environment in which the Group operates. They involve known and unknown risks, uncertainties and other factors, which may result in a significant difference between the Group’s actual performance and results and those presented explicitly or implicitly in these forward-looking statements.

These forward-looking statements are only valid as of the date of this press release and the Group expressly disclaims any obligation or commitment to issue an update or revision of the forward-looking statements contained in this press release to reflect changes in the assumptions, events, conditions or circumstances on which such forward-looking statements are based. Forward-looking statements contained in this press release are for illustrative purposes only. Forward-looking statements and information are not guarantees of future performance and are subject to risks and uncertainties that are difficult to predict and generally beyond the control of the Group.

These risks and uncertainties include, but are not limited to, uncertainties inherent in research and development, future clinical data and analyses, including post-marketing analyses, decisions by regulatory authorities, such as the Food and Drug Administration or the European Medicines Agency, whether or not to approve, and when, the application for a drug, process or biological product for one of these candidate products, as well as their labeling decisions and other factors that may affect the availability or commercial potential of these candidate products. A detailed description of the risks and uncertainties related to the Group’s activities can be found in chapter 4.8 “Risk factors” of the Group’s Universal Registration Document registered by the AMF under number D.25-0220 on April 3, 2025, available on the Group’s website (www.guerbet.com).

1 Warning Letter dated 17 October 2025

Contacts:

Guerbet    
Christine Allard, SVP Public Affairs and Corporate Communications +33 6 30 11 57 82 / christine.allard@guerbet.com

Seitosei.Actifin                                                                               
Marianne Py, Financial Communication + 33 6 85 52 76 93 / marianne.py@seitosei-actifin.com
Jennifer Jullia, Press +33 6 02 08 45 49   / jennifer.jullia@seitosei-actifin.com

Attachment

• 2025 12 02 CP GBT_Ajustement Guidance 2025_UK Vdef

Health-ISAC® Announces results of 2026 Board of Directors Election




Health-ISAC® Announces results of 2026 Board of Directors Election

ORLANDO, Fla., Dec. 02, 2025 (GLOBE NEWSWIRE) — Health Information Sharing and Analysis Center (Health-ISAC), the non-profit world-class, industry-led sharing organization that provides the global health sector with a trusted community for sharing cyber and physical security threats, released the results of its recent Board elections.

The Board of Directors reflects a diverse mix of stakeholders in various subsectors of the health industry. Board members serve in a voluntary capacity to provide strategic governance and direction for Health-ISAC’s community based upon their experience and expertise as security leaders in organizations within the health sector.

“We welcome our new Board members and are pleased to have our returning incumbent members,” says Denise Anderson, Health-ISAC President and CEO. “I look forward to working with the Board to continue the success and growth of our vital global community.”

Newly elected Board Member:
• Michael Brewer – CISO, Neurocrine Biosciences

Re-elected Board Members:
• Anthony Soules – VP and CISO, Amgen
• Scott T. Nichols – Global Product Security Leader, Danaher
• Rishi Tripathi – SVP, CISO and CTO, Mount Sinai Health System
• Sahan Fernando – CISO, Rady Children’s Hospital and Health Center
• Dr. Hans-Martin von Stockhausen, Principal Key Expert Cybersecurity, Siemens Healthineers

The Board of Directors is as follows:
• Tarik Rahmanovic – Director, Research & Active Measures and Emerging Technologies, AbbVie
• Anthony Soules – VP and CISO, Amgen
• Anahi Santiago – CISO, ChristianaCare
• Scott T. Nichols – Global Product Security Leader, Danaher
• Brad Carvellas – SVP and Chief Digital Officer, The Guthrie Clinic
• TJ Bean – CISO, HCA Healthcare
• Gregory Barnes – VP and CISO, Regeneron 
• Roisin Suver – AVP, Cyber Threat Intelligence, Humana
• Nancy Brainerd – Senior Director, Product Security, Medtronic
• Rishi Tripathi – SVP, CISO and CTO, Mount Sinai Health System
• Michael Brewer – CISO, Neurocrine Biosciences
• Dirk de Wit – Head of Product Security, Phillips
• Sahan Fernando – CISO, Rady Children’s Hospital and Health Center
• Dr. Hans-Martin von Stockhausen, Principal Key Expert Cybersecurity, Siemens Healthineers
• Colleen McMahon – CISO and VP of Global Security, Viatris Pharmaceuticals

The newly elected board will be installed at Health-ISAC’s 2025 Fall Americas Summit in Carlsbad, California, December 1-5, 2025. Health-ISAC extends thanks and deep appreciation to outgoing Board member Terry Rice, former CISO, Merck for his dedicated service to Health-ISAC.

About Health-ISAC

Health-ISAC^® (Health Information Sharing and Analysis Center) is a non-profit, member-driven organization dedicated to protecting the global health sector from cyber and physical threats. Through real-time alerts, collaboration, and usable intelligence, Health-ISAC helps health organizations improve security and resilience.

Health-ISAC
12249 Science Drive, Suite 370
Orlando, FL 32826
+1 321-593-1470
www.health-isac.org
LinkedIn: https://www.linkedin.com/company/health-isac/
X: https://x.com/HealthISAC

Please direct media inquiries to:
Mary Stratton
AVP of Marketing
marketing@h-isac.org

LAMY Completes Strategic Acquisition of Cancer Therapy Innovator Exousia AI, Inc.




LAMY Completes Strategic Acquisition of Cancer Therapy Innovator Exousia AI, Inc.

EXOUSIA AI SECURES HIGH-VALUE ORPHAN DRUG DESIGNATION

ORLANDO, Fla., Dec. 02, 2025 (GLOBE NEWSWIRE) — LAMY, to become Exousia Bio, Inc. (OTCPINK: LMMY) (the “Company” or “Exo Bio”), operating as a leading U.S. biotechnology company focused on exosome-based cancer therapy, today announced the completion of the acquisition of 100% of Exousia AI, Inc. in an all-stock transaction. LAMY issued 62,223,000 restricted shares of its Common stock to finalize the deal, consolidating ownership of a highly promising preclinical oncology platform.

Foundation Built on Exclusive, Worldwide Licensing

The strategic acquisition reinforces Exousia Bio’s position as an innovator in the exosome space. The Company has secured two exclusive worldwide licenses for Exosome technology. These patented and patent-pending intellectual property rights are foundational, covering the critical areas of exosome use in cancer therapy and the proprietary loading of exosomes for targeted drug delivery. The versatility of the loading process, applicable to both human-derived and plant-based exosomes, establishes a robust and scalable platform for future drug development.

Orphan Drug Designation (ODD): A Transformative Preclinical Achievement

A cornerstone of this acquisition is the immediate benefit of the recently received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for its Glioblastoma (GBM) therapy.

Achieving ODD at this preclinical stage is a highly significant corporate and regulatory milestone. This designation not only acknowledges the therapy’s potential to address a rare disease with profound unmet medical needs but also confers substantial, immediate, and long-term financial and strategic advantages.

The ODD’s significant value proposition includes:

• 7 Years of Market Exclusivity: Post-approval, the designation provides a guaranteed seven years of market exclusivity, securing a competitive advantage and protecting future revenue streams.
• Tax and Fee Benefits: The Company will benefit from significant tax credits for qualified clinical research costs and a waiver of the New Drug Application (NDA) user fees.
• Expedited Regulatory Pathway: ODD status facilitates close consultation with the FDA, offering assistance with study design and providing a clearer, potentially accelerated path toward regulatory approval.

While the Company plans to retain a specialized firm to conduct an independent valuation of the ODD, initial estimates place its potential value in the tens of millions of dollars, underscoring the foresight of the acquisition strategy.

Preclinical Success and Corporate Expansion

The transaction includes a completed in-vivo mouse study demonstrating extremely positive results using Exosomes to treat Glioblastoma multiforme (GBM). The findings from this study are currently being compiled into a comprehensive research paper for peer-reviewed publication.

To support the rapid progression of this pipeline, LAMY will expand its executive leadership and Board of Directors, with plans to announce a Chief Science Officer and Chief Medical Officer, and form a Scientific Advisory Board in the near future.

About LAMY (to become) Exousia Bio, Inc.

Exousia Bio, Inc., a leader in exosome-based biotechnology, develops and manufactures mammalian and plant-derived exosomes using proprietary technologies for nucleic acid loading and targeted delivery to tissues and cells. The platform enables the custom production of exosomes with enhanced genetic functionality, capable of selectively targeting specific cells to address diseases with significant unmet medical needs. These engineered exosomes have demonstrated the potential to target cancer stem cells, the primary drivers of recurrence and metastasis in various cancers, including glioblastoma and pancreatic cancer. The same platform technology also holds promise for treating a broad spectrum of viral infections.

SAFE HARBOR

Forward-looking statements in this release are made under the “safe harbor” provision of the Private Securities Litigation Reform Act of 1995. LAMY’s forward-looking statements do not guarantee future performance. This news release includes forward-looking statements concerning the parties’ future level of business. These statements are necessarily subject to risk and uncertainty. Actual results could differ materially from those projected in these forward-looking statements due to certain risk factors that could cause results to differ materially from estimated results. Management cautions that all statements as to future results of operations are necessarily subject to risks, uncertainties, and events that may be beyond the control of LAMY, and no assurance can be given that such results will be achieved. Potential risks and uncertainties include, but are not limited to, the ability to procure, appropriately price, retain, and complete projects, as well as changes in products and competition.

CONTACT:

Exousia Bio, Inc.
www.exousiabio.com
X: @ExousiaBio

Investor Relations
ir@exousiabio.com

Health-ISAC® Announces results of 2026 Board of Directors Election




Health-ISAC® Announces results of 2026 Board of Directors Election

ORLANDO, Fla., Dec. 02, 2025 (GLOBE NEWSWIRE) — Health Information Sharing and Analysis Center (Health-ISAC), the non-profit world-class, industry-led sharing organization that provides the global health sector with a trusted community for sharing cyber and physical security threats, released the results of its recent Board elections.

The Board of Directors reflects a diverse mix of stakeholders in various subsectors of the health industry. Board members serve in a voluntary capacity to provide strategic governance and direction for Health-ISAC’s community based upon their experience and expertise as security leaders in organizations within the health sector.

“We welcome our new Board members and are pleased to have our returning incumbent members,” says Denise Anderson, Health-ISAC President and CEO. “I look forward to working with the Board to continue the success and growth of our vital global community.”

Newly elected Board Member:
• Michael Brewer – CISO, Neurocrine Biosciences

Re-elected Board Members:
• Anthony Soules – VP and CISO, Amgen
• Scott T. Nichols – Global Product Security Leader, Danaher
• Rishi Tripathi – SVP, CISO and CTO, Mount Sinai Health System
• Sahan Fernando – CISO, Rady Children’s Hospital and Health Center
• Dr. Hans-Martin von Stockhausen, Principal Key Expert Cybersecurity, Siemens Healthineers

The Board of Directors is as follows:
• Tarik Rahmanovic – Director, Research & Active Measures and Emerging Technologies, AbbVie
• Anthony Soules – VP and CISO, Amgen
• Anahi Santiago – CISO, ChristianaCare
• Scott T. Nichols – Global Product Security Leader, Danaher
• Brad Carvellas – SVP and Chief Digital Officer, The Guthrie Clinic
• TJ Bean – CISO, HCA Healthcare
• Gregory Barnes – VP and CISO, Regeneron 
• Roisin Suver – AVP, Cyber Threat Intelligence, Humana
• Nancy Brainerd – Senior Director, Product Security, Medtronic
• Rishi Tripathi – SVP, CISO and CTO, Mount Sinai Health System
• Michael Brewer – CISO, Neurocrine Biosciences
• Dirk de Wit – Head of Product Security, Phillips
• Sahan Fernando – CISO, Rady Children’s Hospital and Health Center
• Dr. Hans-Martin von Stockhausen, Principal Key Expert Cybersecurity, Siemens Healthineers
• Colleen McMahon – CISO and VP of Global Security, Viatris Pharmaceuticals

The newly elected board will be installed at Health-ISAC’s 2025 Fall Americas Summit in Carlsbad, California, December 1-5, 2025. Health-ISAC extends thanks and deep appreciation to outgoing Board member Terry Rice, former CISO, Merck for his dedicated service to Health-ISAC.

About Health-ISAC

Health-ISAC^® (Health Information Sharing and Analysis Center) is a non-profit, member-driven organization dedicated to protecting the global health sector from cyber and physical threats. Through real-time alerts, collaboration, and usable intelligence, Health-ISAC helps health organizations improve security and resilience.

Health-ISAC
12249 Science Drive, Suite 370
Orlando, FL 32826
+1 321-593-1470
www.health-isac.org
LinkedIn: https://www.linkedin.com/company/health-isac/
X: https://x.com/HealthISAC

Please direct media inquiries to:
Mary Stratton
AVP of Marketing
marketing@h-isac.org

LAMY Completes Strategic Acquisition of Cancer Therapy Innovator Exousia AI, Inc.




LAMY Completes Strategic Acquisition of Cancer Therapy Innovator Exousia AI, Inc.

EXOUSIA AI SECURES HIGH-VALUE ORPHAN DRUG DESIGNATION

ORLANDO, Fla., Dec. 02, 2025 (GLOBE NEWSWIRE) — LAMY, to become Exousia Bio, Inc. (OTCPINK: LMMY) (the “Company” or “Exo Bio”), operating as a leading U.S. biotechnology company focused on exosome-based cancer therapy, today announced the completion of the acquisition of 100% of Exousia AI, Inc. in an all-stock transaction. LAMY issued 62,223,000 restricted shares of its Common stock to finalize the deal, consolidating ownership of a highly promising preclinical oncology platform.

Foundation Built on Exclusive, Worldwide Licensing

The strategic acquisition reinforces Exousia Bio’s position as an innovator in the exosome space. The Company has secured two exclusive worldwide licenses for Exosome technology. These patented and patent-pending intellectual property rights are foundational, covering the critical areas of exosome use in cancer therapy and the proprietary loading of exosomes for targeted drug delivery. The versatility of the loading process, applicable to both human-derived and plant-based exosomes, establishes a robust and scalable platform for future drug development.

Orphan Drug Designation (ODD): A Transformative Preclinical Achievement

A cornerstone of this acquisition is the immediate benefit of the recently received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for its Glioblastoma (GBM) therapy.

Achieving ODD at this preclinical stage is a highly significant corporate and regulatory milestone. This designation not only acknowledges the therapy’s potential to address a rare disease with profound unmet medical needs but also confers substantial, immediate, and long-term financial and strategic advantages.

The ODD’s significant value proposition includes:

• 7 Years of Market Exclusivity: Post-approval, the designation provides a guaranteed seven years of market exclusivity, securing a competitive advantage and protecting future revenue streams.
• Tax and Fee Benefits: The Company will benefit from significant tax credits for qualified clinical research costs and a waiver of the New Drug Application (NDA) user fees.
• Expedited Regulatory Pathway: ODD status facilitates close consultation with the FDA, offering assistance with study design and providing a clearer, potentially accelerated path toward regulatory approval.

While the Company plans to retain a specialized firm to conduct an independent valuation of the ODD, initial estimates place its potential value in the tens of millions of dollars, underscoring the foresight of the acquisition strategy.

Preclinical Success and Corporate Expansion

The transaction includes a completed in-vivo mouse study demonstrating extremely positive results using Exosomes to treat Glioblastoma multiforme (GBM). The findings from this study are currently being compiled into a comprehensive research paper for peer-reviewed publication.

To support the rapid progression of this pipeline, LAMY will expand its executive leadership and Board of Directors, with plans to announce a Chief Science Officer and Chief Medical Officer, and form a Scientific Advisory Board in the near future.

About LAMY (to become) Exousia Bio, Inc.

Exousia Bio, Inc., a leader in exosome-based biotechnology, develops and manufactures mammalian and plant-derived exosomes using proprietary technologies for nucleic acid loading and targeted delivery to tissues and cells. The platform enables the custom production of exosomes with enhanced genetic functionality, capable of selectively targeting specific cells to address diseases with significant unmet medical needs. These engineered exosomes have demonstrated the potential to target cancer stem cells, the primary drivers of recurrence and metastasis in various cancers, including glioblastoma and pancreatic cancer. The same platform technology also holds promise for treating a broad spectrum of viral infections.

SAFE HARBOR

Forward-looking statements in this release are made under the “safe harbor” provision of the Private Securities Litigation Reform Act of 1995. LAMY’s forward-looking statements do not guarantee future performance. This news release includes forward-looking statements concerning the parties’ future level of business. These statements are necessarily subject to risk and uncertainty. Actual results could differ materially from those projected in these forward-looking statements due to certain risk factors that could cause results to differ materially from estimated results. Management cautions that all statements as to future results of operations are necessarily subject to risks, uncertainties, and events that may be beyond the control of LAMY, and no assurance can be given that such results will be achieved. Potential risks and uncertainties include, but are not limited to, the ability to procure, appropriately price, retain, and complete projects, as well as changes in products and competition.

CONTACT:

Exousia Bio, Inc.
www.exousiabio.com
X: @ExousiaBio

Investor Relations
ir@exousiabio.com

Sangamo Therapeutics Receives U.S. FDA Fast Track Designation for ST-503 for the Treatment of Small Fiber Neuropathy




Sangamo Therapeutics Receives U.S. FDA Fast Track Designation for ST-503 for the Treatment of Small Fiber Neuropathy

RICHMOND, Calif., Dec. 02, 2025 (GLOBE NEWSWIRE) — Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to ST-503, an investigational epigenetic regulator for the treatment of intractable pain due to small fiber neuropathy (SFN), a type of chronic neuropathic pain.

Fast Track Designation aims to facilitate the development and expedite the review of new therapeutics that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Companies granted this designation are given the opportunity for more frequent interactions with the FDA. These clinical programs may also be eligible to apply for Accelerated Approval and Priority Review if relevant criteria are met.

“We are very pleased to receive FDA Fast Track Designation for ST-503. SFN is a debilitating chronic pain disorder, with limited effective treatment options currently available,” said Nathalie Dubois-Stringfellow, Ph.D., Sangamo’s Chief Development Officer. “This designation underscores the high unmet patient need in SFN and the urgency to develop safe and effective nonopioid treatment alternatives. We are preparing to dose the first patient in our Phase 1/2 study and look forward to sharing data once available.”

ST-503 is currently being evaluated in the Phase 1/2 STAND study, where patient recruitment and enrollment are in progress. In September 2025, Sangamo presented updated nonclinical data highlighting the pharmacology and safety of ST-503 in chronic neuropathic pain at the 9th International Congress on Neuropathic Pain. The data demonstrated the durability, potency and selectivity of ST-503 in nonhuman primates, alongside a favorable safety profile, supporting its development for the treatment of chronic neuropathic pain. A copy of the presentation is available in the Presentations section of the Sangamo website. Sangamo expects to dose the first Phase 1/2 STAND study patient in the coming months.

About the STAND Study
Sangamo is preparing for the Phase 1/2 STAND study, a multicenter, double-blind, randomized, sham-controlled dose escalation study to assess the safety, tolerability and preliminary efficacy of a one-time dose of ST-503, administered intrathecally to patients with SFN. The STAND study is enrolling adult patients with a confirmed diagnosis of SFN who have pain that has been refractory to first line medical therapies for at least 6 months.

About Small Fiber Neuropathy
Small Fiber Neuropathy (SFN) is a condition that damages small nerve fibers, leading to burning, prickling, stabbing or “lightning-like” intractable pain, numbness, as well as autonomic issues like heart rate changes, digestion problems and orthostatic intolerance. SFN can be caused by a broad array of pathologies impacting the central or peripheral nervous systems, such as surgical trauma, spinal cord injury, nerve compression, neurological and infectious diseases, or metabolic and hereditary syndromes. SFN has an estimated prevalence of 53 people out of every 100,000 in the U.S., and more broadly, peripheral neuropathies are estimated to affect nearly 40 million Americans. Antidepressants, anticonvulsants, opioids and topical therapies are potential treatment options, although no long-lasting or curative therapies are currently available for SFN patients, leading to a high unmet medical need for this patient population.

About Sangamo Therapeutics

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

Forward-Looking Statements

This press release contains forward-looking statements regarding Sangamo’s current expectations. These forward-looking statements include, without limitation, statements relating to the ability of the Fast Track designation to facilitate the development and expedite the review of ST-503, the ability of ST-503 to meet relevant criteria in order to be eligible to apply for Accelerated Approval and Priority Review, the therapeutic potential of ST-503, including its potential to improve the lives of patients and to have a favorable effect on small fiber neuropathy, Sangamo’s expectation for, and timelines related to, dosing patients in the Phase 1/2 STAND study and other statements that are not historical fact. These statements are not guarantees of future performance and are subject to risks and uncertainties that are difficult to predict. Sangamo’s actual results may differ materially and adversely from those expressed. Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties related to: reliance on results of early clinical trials, such as the Phase 1/2 STAND study, which results are not necessarily predictive of future clinical trial results; the research and development process, including the enrollment, operation and results of clinical trials and the presentation of clinical data; the unpredictable regulatory approval process for product candidates across multiple regulatory authorities; the manufacturing of products and product candidates; the commercialization of approved products; the potential for technological developments that obviate technologies used by Sangamo; Sangamo’s need for substantial additional funding to execute its operating plan and to continue to operate as a going concern; the effects of macroeconomic factors or financial challenges on the global business environment, healthcare systems and Sangamo’s business and operations; Sangamo’s reliance on collaborators and the potential inability to secure additional collaborations; and Sangamo’s ability to achieve expected future financial performance.

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

Contacts

Investor Relations
Louise Wilkie
ir@sangamo.com

Media Inquiries
Melinda Hutcheon
media@sangamo.com

SCIENTURE to Participate in the iAccess Alpha Virtual Best Ideas Winter Investment Conference 2025 on December 9–10, 2025




SCIENTURE to Participate in the iAccess Alpha Virtual Best Ideas Winter Investment Conference 2025 on December 9–10, 2025

COMMACK, NY, Dec. 02, 2025 (GLOBE NEWSWIRE) — SCIENTURE HOLDINGS, INC. (NASDAQ: SCNX), a holding company for existing and planned pharmaceutical operating companies focused on providing enhanced value to patients, physicians and caregivers through the development, commercialization, and distribution of novel specialty products that address unmet market needs, today announced that management will be participating in the iAccess Alpha Virtual Best Ideas Winter Investment Conference 2025 on December 9^th – 10^th, 2025.

Narasimhan Mani, President and co-CEO of Scienture is scheduled to present at 2:00 PM EST on December 9^th. Shankar Hariharan, Executive Chairman and co-CEO of Scienture, will join him for one-on-one meetings with investors on December 10^th.

The live webcast of Scienture’s presentation will be available at https://www.webcaster5.com/Webcast/Page/3148/53307, and a replay will be accessible afterward. The presentation will also be available on the Company’s website at https://scientureholdings.com/investors/ under the “Events and Presentations” tab.

iAccess Alpha hosts virtual investor conferences featuring high-potential small and micro-cap companies as investment opportunities. These two-day events include webcast presentations on Day 1, followed by one-on-one meetings between company management teams and pre-qualified investors on Day 2.

For more information about the iAccess Alpha Virtual Best Ideas Winter Investment Conference 2025, or to register and schedule a one-on-one meeting with Scienture, please visit the conference website at: https://www.iaccessalpha.com.

About Scienture Holdings, Inc.

SCIENTURE HOLDINGS, INC. (NASDAQ: “SCNX”), through its wholly owned subsidiary, Scienture, LLC, is a comprehensive pharmaceutical product company focused on providing enhanced value to patients, physicians and caregivers by offering novel specialty products to satisfy unmet market needs. Scienture, LLC is a branded, specialty pharmaceutical company consisting of a highly experienced team of industry professionals who are passionate about developing and bringing to market unique specialty products that provide enhanced value to patients and healthcare systems. The assets in development at Scienture are across therapeutics areas, indications and cater to different market segments and channels. For more information please visit: www.scientureholdings.com and www.scienture.com.

Cautionary Statements Regarding Forward-Looking Statements

This press release contains certain statements that may be deemed to be “forward-looking statements” within the federal securities laws, including the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Statements that are not historical are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements relate to future events or our future performance or future financial condition. These forward-looking statements are not historical facts, but rather are based on current expectations, estimates and projections about our company, our industry, our beliefs and our assumptions. Such forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future, including for the products we may launch, the success those products may have in the marketplace, and our strategies related to those products. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. In some cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” or the negative of these terms or other similar expressions, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements are subject to a number of risks and uncertainties (some of which are beyond our control) that may cause actual results or performance to be materially different from those expressed or implied by such forward-looking statements. Accordingly, readers should not place undue reliance on any forward-looking statements. These risks include risks relating to agreements with third parties; our ability to raise funding in the future, as needed, and the terms of such funding, including potential dilution caused thereby; our ability to continue as a going concern; security interests under certain of our credit arrangements; our ability to maintain the listing of our common stock on the Nasdaq Capital Market; claims relating to alleged violations of intellectual property rights of others; the outcome of any current legal proceedings or future legal proceedings that may be instituted against us; unanticipated difficulties or expenditures relating to our business plan; and those risks detailed in our most recent Annual Report on Form 10-K and subsequent reports filed with the SEC.

Forward-looking statements speak only as of the date they are made. Scienture Holdings, Inc. undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise that occur after that date, except as otherwise provided by law.

Contact:

SCIENTURE HOLDINGS, INC.
20 Austin Blvd
Commack, NY 11725
Phone: (866) 468-6535
Email: IR@Scienture.com

BillionToOne to Report Third Quarter 2025 Financial Results on December 9, 2025




BillionToOne to Report Third Quarter 2025 Financial Results on December 9, 2025

MENLO PARK, Calif., Dec. 02, 2025 (GLOBE NEWSWIRE) — BillionToOne, Inc. (NASDAQ: BLLN), a molecular diagnostics company with a mission to create powerful and accurate tests that are accessible to all, today announced that the Company plans to release its financial results for third quarter ended September 30, 2025 after the market close on Tuesday, December 9, 2025. BillionToOne will host a conference call to discuss its financial results at 1:30pm Pacific Time / 4:30pm Eastern Time the same day.

To participate in the conference call, please register here before the 1:30pm Pacific Time / 4:30pm Eastern Time start. A live and archived webcast will be available on the “Events” page of BillionToOne’s investor relations website at https://investors.billiontoone.com/.

About BillionToOne

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

Investor Contact
ir@billiontoone.com

Media Contact
billiontoone@moxiegrouppr.com

BioNexus Gene Lab Corp. (Nasdaq: BGLC) Secures $500 Million Equity Facility From ARC Group International to Support Expansion of Precision Diagnostics, CDMO Operations, and Therapeutic Commercialization




BioNexus Gene Lab Corp. (Nasdaq: BGLC) Secures $500 Million Equity Facility From ARC Group International to Support Expansion of Precision Diagnostics, CDMO Operations, and Therapeutic Commercialization

SHERIDAN, Wyo., Dec. 02, 2025 (GLOBE NEWSWIRE) — BioNexus Gene Lab Corp. (“BGLC” or the “Company”), an emerging provider of precision oncology diagnostics with expanding operations across Southeast Asia, today announced it has entered into a $500,000,000 Equity Purchase Agreement (the “Facility”) with ARC Group International Ltd. (“ARC”), a global investment bank and the parent of ARC Group Securities, a FINRA registered broker dealer. The Company believes this facility will provide it with long-term, discretionary access to capital to advance its strategic initiatives, including the commercialization of the VitaGuard™ minimal residual disease (MRD) platform, the addition of contract development and manufacturing organization (“CDMO”) services to its business regionally, and building the Company’s therapeutic development and commercialization programs.

Under the terms of the Agreement, BGLC, at its sole discretion, may issue and sell registered shares of its common stock to ARC over the commitment period of 36 months.   In consideration for ARC’s commitment, BGLC issued 175,000 shares of common stock as a one-time fee, priced at the closing price on Nov 26, 2025 – $4.32. ARC is prohibited from owning more than 9.99% of BGLC’s outstanding shares at any time and is restricted from short-selling or hedging the Company’s securities.   The Company will file a registration statement to register the resale of shares issued under the Facility, and no shares may be sold prior to registration.

The Facility complements BGLC’s previously announced $20 million At-The-Market program, enhancing the Company’s financial flexibility while preserving strategic control over the timing and scale of capital deployment.

“This commitment from ARC strengthens our capital position at a pivotal time for BGLC,” said Sam Tan, Chief Executive Officer of BioNexus Gene Lab Corp. “Following our recently executed exclusive licensing agreement for the VitaGuard MRD platform in Southeast Asia, and with the ongoing transformation of our business into a CDMO capable of supporting high-value bioprocessing and manufacturing, we are building a diversified biotechnology platform with multiple growth pathways.”

“Importantly, this Facility is entirely at our discretion and is intended to support milestone-driven initiatives rather than routine financing,” Tan added. “We intend to draw from this resource selectively and responsibly as we advance our diagnostics, CDMO, and therapeutic commercialization programs.”

Please refer to the Company’s Form 8-K filed on December 2, 2025 regarding this transaction for more pertinent details concerning the Facility.

Advancing Precision Oncology in Southeast Asia

On November 28, 2025, BGLC executed a definitive licensing agreement with Fidelion Diagnostics Pte. Ltd. to commercialize the VitaGuard™ MRD assay, a next-generation liquid biopsy platform for early cancer detection, recurrence monitoring, and precision-treatment decision making. The ARC Facility enhances BGLC’s ability to support clinical adoption, regulatory pathways, and infrastructure development necessary to bring MRD testing to broader populations across Malaysia, Singapore, Indonesia, and Thailand.

Supporting BGLC’s CDMO Transformation

BGLC continues to expand its business to include contract development and manufacturing organization services, enabling the Company to participate in biologics production, assay manufacturing, and high-performance diagnostic supply chains. The Facility strengthens BGLC’s ability to invest in quality-systems upgrades, manufacturing capacity, technical capabilities, and strategic partnerships aligned with global CDMO standards.

Advancing Therapeutic Opportunities

The Company also continues to progress the strategic partnership initiative with BirchBioMed Inc., the subject of a recently announced non-binding term sheet, including regional regulatory planning for FS2, a topical therapeutic candidate targeting fibrosis, hypertrophic scarring, and skin regeneration. The Facility provides capital optionality to support clinical, regulatory, and commercial preparations as the term sheet potentially moves into a definitive partnership. For more information, visit www.birchbiomed.com.

About BioNexus Gene Lab Corp.

BioNexus Gene Lab Corp. (Nasdaq: BGLC) is an emerging provider of precision medical diagnostics solutions, expanding into contract development and manufacturing services. Through its subsidiaries, the Company is expanding its capabilities in oncology diagnostics, biologics development, specialty manufacturing, and integrated laboratory services across Southeast Asia. BioNexus Gene Lab Corp. is headquartered in Kuala Lumpur, Malaysia.

For more information, visit www.bionexusgenelab.com.

About ARC Group International Ltd.

ARC Group is a global investment bank, asset manager and management consultancy firm established in 2015. The firm specializes in capital markets, mergers & acquisitions, strategic advisory, and asset management, supporting clients through complex cross-border transactions and offering tailored financing solutions. ARC Group operates across twelve countries and three continents, providing expertise in sectors ranging from technology and digital assets to consumer goods and advanced industries. For more information, visit www.arc-group.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the Company’s growth strategy, expansion plans, expected use of proceeds, commercialization of the VitaGuard MRD platform, development of CDMO capabilities, therapeutic initiatives, and the anticipated benefits of the Equity Purchase Agreement and ATM program. Forward-looking statements are based on current expectations, estimates, forecasts, and projections and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in the statements. These risks and uncertainties are described in the Company’s filings with the U.S. Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Forward-looking statements speak only as of the date hereof, and the Company undertakes no obligation to update any forward-looking statements except as required by law.

Contact

Investor Relations
BioNexus Gene Lab Corp.
Email: ir@bionexusgenelab.com