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WORK Medical Technology Group LTD Subsidiary Obtains Manufacturing Approval for Its AI-Automated Blood Cell Morphology Analyzer

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WORK Medical Technology Group LTD Subsidiary Obtains Manufacturing Approval for Its AI-Automated Blood Cell Morphology Analyzer




WORK Medical Technology Group LTD Subsidiary Obtains Manufacturing Approval for Its AI-Automated Blood Cell Morphology Analyzer

Hangzhou, China, Dec. 29, 2025 (GLOBE NEWSWIRE) — WORK Medical Technology Group LTD (Nasdaq: WOK) (“WORK Medical” or the “Company”), a supplier of medical devices in China, through its subsidiary, Work (Hangzhou) Medical Treatment Equipment Co., Ltd. and its subsidiaries in China, today announced that its subsidiary, Hunan Saitumofei Co., Ltd., has received manufacturing approval from the Hunan Provincial Medical Products Administration for its Class II medical device, the Artificial Intelligence (“AI”)-Automated Human Blood Cell Morphology Analyzer. This regulatory approval represents a milestone in WORK Medical’s research and development strategy and is expected to position the Company’s new AI-driven device as a key growth catalyst.

The analyzer consists of a main unit and embedded analysis software. The main unit integrates an optical imaging system, sample-handling module, barcode scanner, automatic oil-immersion unit, control board, and protective housing. It performs white blood cell differential counts on human blood smears and quantifies morphological parameters of red blood cells and platelets, supporting clinicians in cell morphology screening. Powered by advanced AI automation, the analyzer combines high-speed digital imaging, deep-learning algorithms, and a fully automated workflow to identify, pre-classify, and describe the morphology of white blood cells, red blood cells, and platelets in peripheral blood smears. The analyzer, scheduled to begin manufacturing in the first half of 2026, is designed to enhance efficiency, consistency, and accuracy in microscopic examinations while reducing manual workload and operational costs.

Mr. Shuang Wu, the Chief Executive Officer and Chairman of the Board of Directors of WORK Medical, commented: “This new analyzer integrates cutting-edge AI technology into traditional medical testing, improving consistency, efficiency, and accuracy while minimizing manual intervention and associated costs. The device has progressed from an auxiliary image-reading tool into a fully automated, standardized, and remotely accessible core testing platform. With continuous AI-algorithm iteration and pipeline integration, it is expected to become standard equipment in hematology and oncology departments at tertiary hospitals and primary-care laboratories, and is aimed to provide support for early screening of blood disorders, quality-control enhancement, and labor-cost optimization. We are optimistic about this product line’s growth and its revenue potential for the Company.”

About WORK Medical Technology Group LTD

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

Forward-Looking Statements

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

For more information, please contact:

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

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

SELLAS Life Sciences Provides Update on Pivotal Phase 3 REGAL Trial of Galinpepimut-S (GPS) in Acute Myeloid Leukemia (AML)

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SELLAS Life Sciences Provides Update on Pivotal Phase 3 REGAL Trial of Galinpepimut-S (GPS) in Acute Myeloid Leukemia (AML)




SELLAS Life Sciences Provides Update on Pivotal Phase 3 REGAL Trial of Galinpepimut-S (GPS) in Acute Myeloid Leukemia (AML)

  • Contract Research Organization for the REGAL trial has informed the Company that 72 events have occurred in the trial as of December 26, 2025; SELLAS remains blinded to trial outcomes
  • Timing of the final analysis is event-driven, and SELLAS will announce the occurrence of the 80th event

NEW YORK, Dec. 29, 2025 (GLOBE NEWSWIRE) — SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today provided an update on the ongoing Phase 3 REGAL trial evaluating GPS as a potential maintenance therapy in patients with AML after second complete remission (CR2).

Following the Independent Data Monitoring Committee (IDMC) recommendation in August 2025 that the Phase 3 REGAL trial continue without modification, it was expected that the 80th event (death) required to trigger the final analysis would occur before year-end. The REGAL trial is an overall survival study, and per the statistical analysis plan, the final analysis will be triggered once 80 events (deaths) have occurred.

SELLAS was informed by its contract research organization managing the REGAL trial that the pooled number of events was 72 as of December 26, 2025. SELLAS remains blinded to all efficacy and survival data outcomes and, as no outcomes analyses were performed and no statistical penalty has been incurred, this one-time update on the aggregate number of events does not impact future statistical analyses. Because the final analysis is event-driven, and the timing of studies with overall survival as an endpoint can vary, SELLAS will announce the 80th event when it occurs.

“We appreciate the continued dedication of the patients, families, and investigators participating in the pivotal Phase 3 REGAL trial where survival times, fortunately for patients and caregivers, appear longer than expected,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. “While the 80th event has not yet occurred, and we remain fully blinded, every passing month may increase the probability of a successful study as highlighted by key opinion leaders in our recent R&D event. Conclusive data will follow the unblinding and analyses of the study results. We remain steadfast in our commitment to advancing breakthrough therapies, such as GPS, that possess the potential to significantly improve the lives of patients with AML.”

“The REGAL study represents a meaningful effort to evaluate GPS as a novel therapeutic approach in an AML population with significant unmet need,” said Dr. Yair Levy, Director of Hematologic Malignancies Research at Texas Oncology Baylor University Medical Center, and a member of the REGAL Steering Committee. “For patients who are unable to undergo transplant, as in the REGAL study, their treatment usually consists of a combination of hypomethylating agents and/or a BCL-2 inhibitor, with an expected median overall survival of around eight months. We hope to see an extended survival benefit, with a tolerable safety profile, as observed in previous GPS studies.”

SELLAS Life Sciences Virtual R&D Day – October 29, 2025: Advancing Novel Therapies in Acute Myeloid Leukemia (AML): An Overview of the Ongoing Phase 3 REGAL Trial of Galinpepimut-S (GPS) and SLS009 Program Update. To access a replay of the R&D Day, please click here.

About Phase 3 REGAL Trial

REGAL (NCT04229979) is a Phase 3 randomized registrational clinical trial for GPS in AML patients who have achieved complete remission following second-line salvage therapy (CR2 patients). The primary endpoint is overall survival. The IDMC is an independent group of medical, scientific, and biostatistics experts who are responsible for reviewing and evaluating patient safety and efficacy data for REGAL, and for monitoring quality and overall conduct to ensure the validity, scientific and clinical merits of the study. The IDMC charter provides for periodic reviews of safety, efficacy, and futility in addition to the interim and final analyses.

About SELLAS Life Sciences Group, Inc.

SELLAS is a late-stage clinical biopharmaceutical company focused on the development of novel therapeutics for a broad range of cancer indications. SELLAS’ lead product candidate, GPS, is licensed from Memorial Sloan Kettering Cancer Center and targets the WT1 protein, which is present in an array of tumor types. GPS has the potential as a monotherapy and combination with other therapies to address a broad spectrum of hematologic malignancies and solid tumor indications. The Company is also developing SLS009 (tambiciclib) – potentially the first and best-in-class differentiated small molecule CDK9 inhibitor with reduced toxicity and increased potency compared to other CDK9 inhibitors. Data suggests that SLS009 demonstrated a high response rate in AML patients with unfavorable prognostic factors including ASXL1 mutation, commonly associated with poor prognosis in various myeloid diseases. For more information on SELLAS, please visit www.sellaslifesciences.com.

Forward-Looking Statements

This press release contains forward-looking statements. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, forward-looking statements can be identified by terminology such as “plan,” “expect,” “anticipate,” “may,” “might,” “will,” “should,” “project,” “believe,” “estimate,” “predict,” “potential,” “intend,” or “continue” and other words or terms of similar meaning. These statements include, without limitation, statements related to the GPS clinical development program, including the REGAL study and the timing of future milestones related thereto. These forward-looking statements are based on current plans, objectives, estimates, expectations, and intentions, and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties with oncology product development and clinical success thereof, the uncertainty of regulatory approval, and other risks and uncertainties affecting SELLAS and its development programs as set forth under the caption “Risk Factors” in SELLAS’ Annual Report on Form 10-K filed on March 20, 2025 and in its other SEC filings. Other risks and uncertainties of which SELLAS is not currently aware may also affect SELLAS’ forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. The forward-looking statements herein are made only as of the date hereof. SELLAS undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations, or other circumstances that exist after the date as of which the forward-looking statements were made.

Investor Contact

John Fraunces

Managing Director

LifeSci Advisors, LLC

jfraunces@lifesciadvisors.com

Advanced Pharmacovigilance Training Course: Performing Successful Due Diligence to Benefit-Risk Assessments and What to Consider (Online Event: Mar 23rd – Mar 25th, 2026) – ResearchAndMarkets.com

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Advanced Pharmacovigilance Training Course: Performing Successful Due Diligence to Benefit-Risk Assessments and What to Consider (Online Event: Mar 23rd – Mar 25th, 2026) – ResearchAndMarkets.com




Advanced Pharmacovigilance Training Course: Performing Successful Due Diligence to Benefit-Risk Assessments and What to Consider (Online Event: Mar 23rd – Mar 25th, 2026) – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Advanced Pharmacovigilance: From Performing Successful Due Diligence to Benefit-Risk Assessments – What to Consider Training Course (Mar 23rd – Mar 25th, 2026)” training has been added to ResearchAndMarkets.com’s offering.


This course is designed for those with at least two years’ knowledge in drug safety and will provide a comprehensive, yet practical assessment of the main regulations required to produce a compliant reporting company. Pharmacovigilance has undergone rapid regulatory change in recent years, which has resulted in a complex range of safety and risk assessment activities to perform.

Who Should Attend:

This course would be of maximum benefit to those safety professionals who are working both in the clinical and post-marketing safety arena including QA for auditing. The course covers very diverse activities within the safety department and would be advantageous to those who have either multifunction responsibilities or medical directors who manage teams in the various disciplines.

Key topics to be addressed:

  • Audits and expectations – risk-based inspections
  • Compliance and drug safety
  • Overview of the PSMF in the EU
  • Product safety reviews – purpose and function (incorporating the latest EU signal analysis requirements)
  • Safety reporting in licensing agreements
  • Developing company core safety information (CCSI) – CIOMS III
  • PSURs – timing, content and the DSUR and the latest ICH E2C (2nd revision requirements)
  • Implications for safety reporting in global clinical trials
  • Risk-benefit determinations
  • Risk management plans (RMPs)

Benefits of attending

  • Expand your global safety knowledge
  • Enhance your team’s capabilities and compliance in both the regulations and your company’s expectations
  • Help ensure you build and maintain a quality pharmacovigilance department ready for any pharmacovigilance inspection
  • Participate in group workshop sessions and discuss how to apply the legislation to ensure compliance, especially to satisfy regulatory inspections

Certifications:

  • CPD: 18 hours for your records
  • Certificate of completion

Key Topics Covered:

Due diligence

  • Due diligence on products/companies (partners and acquisitions)
  • Due diligence involvement – team composition
  • Safety information requirements for due diligence
  • Review of safety data (clinical and post-marketing)
  • Defining risk in due diligence appraisals

Training for drug safety reporting duties

  • Regulations concerning safety training
  • Who trains whom and when?
  • Training versus job description
  • Training records, maintenance and updates
  • Role of QA and HR in training

Audits and expectations

  • Regulatory expectations in pharmacovigilance audits (risk-based inspections)
  • Preparation for the audit
  • Records to be available at the audit
  • Audit findings/recommendations

Compliance and drug safety

  • Basic principles – what will the regulators want to see?
  • Measuring compliance
  • Quality versus quantity in safety reports
  • Future aspects in ensuring efficient compliance
  • Quality management under the new EU legislation

The PSMF

  • The PSMF – purpose and maintenance
  • The PSMF annexes
  • The PSMF and audits

Interactive exercise: The requirements for a safety department

Product safety reviews – purpose and function

  • The Safety Review Committee (SRC)
  • What to look for in signal evaluation under latest EU guidance
  • Timings for safety review in clinical and post-marketed products
  • Record keeping for safety review meetings
  • Serious safety findings – crisis management following new safety findings

Interactive exercise: designing the requirements for a safety review group

Safety reporting in licensing agreements

  • What types of licensing agreements exist?
  • What are the EU and FDA regulations concerning licensing agreements?
  • Audits of pharmacovigilance capabilities in licensing partners
  • What agreements need to be in place for safety reporting?
  • Safety reporting agreements – what needs to be covered?
  • Monitoring safety agreements – what happens if it goes wrong?

Developing CCSI – CIOMS III

  • CIOMS III and CCSI
  • Developmental core safety information (DCSI)
  • How to determine what to include and what to exclude in DCSI/CCSI
  • Are there differences in EU and FDA?
  • Maintenance and development of CCSI

Interactive exercise: should new safety data from a clinical trial be put into core safety information?

PSURs and the revisions in ICH E2C

  • Timing for PSURs
  • PSUR content and latest format
  • Late breaking information and PSUR extensions
  • The DSUR

The EU Clinical Trials Directive

  • The principles of the Directive
  • Implications for safety reporting in global clinical trials
  • The SUSAR database
  • The EUDRACT database
  • The new EU clinical trial regulation

Risk-benefit determinations

  • Definitions of risk-benefit – FDA and EU perspective
  • Risk-benefit assessments – who does this and where does the information go?
  • Safety assessments and risk-benefit – frequency and reporting
  • Changes in risk-benefit – how to manage and review existing profiles

Risk-benefit determinations

  • Definitions of risk-benefit – FDA and EU perspective
  • Risk-benefit assessments – who does this and where does the information go?
  • Safety assessments and risk-benefit – frequency and reporting
  • Changes in risk-benefit – how to manage and review existing profiles

Interactive exercise: reviewing the safety and risk-benefit of a product

RMPs

  • Purpose
  • Content
  • Monitoring and updating the RMP
  • Reporting the RMP

Crisis management within drug safety

  • Regulations and guidelines in connection with serious safety issues
  • What determines a crisis?
  • Communications to regulators – what is required?
  • Communications within the company
  • What happens next?

Interactive exercise: deciding how to handle a major crisis within the company

  • Delegates will be split into groups and present what they need to have in place in order to effectively manage the crisis and look to its resolution.

Speakers:

Graeme Ladds

Director

PharSafer Associates Ltd.

Graeme Ladds, Director of PharSafer, has over 30 years’ experience working in the pharmaceutical industry. Having started his career at Ashbourne Pharmaceuticals in 1989 as Head of Drug Safety & Medical Information, he went on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals.

He then set up his consultancy and specialist CRO company, PharSafer Associates Ltd, where he has been involved in establishing pharmacovigilance in companies, performing audits across Europe and the USA, SOP writing, acting as QP for companies, and helping with regulatory inspections.

For more information about this training visit https://www.researchandmarkets.com/r/v06j3e

About ResearchAndMarkets.com

ResearchAndMarkets.com is the world’s leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Contacts

ResearchAndMarkets.com

Laura Wood, Senior Press Manager

press@researchandmarkets.com

For E.S.T Office Hours Call 1-917-300-0470

For U.S./ CAN Toll Free Call 1-800-526-8630

For GMT Office Hours Call +353-1-416-8900

European Union Pharmaceutical Regulations & Strategy Training Course: Legal Frameworks, Pre-Submission Strategy, Data Presentation, and Post-Approval Obligations (Online Event: Mar 2nd – 3rd, 2026) – ResearchAndMarkets.com

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European Union Pharmaceutical Regulations & Strategy Training Course: Legal Frameworks, Pre-Submission Strategy, Data Presentation, and Post-Approval Obligations (Online Event: Mar 2nd – 3rd, 2026) – ResearchAndMarkets.com




European Union Pharmaceutical Regulations & Strategy Training Course: Legal Frameworks, Pre-Submission Strategy, Data Presentation, and Post-Approval Obligations (Online Event: Mar 2nd – 3rd, 2026) – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “EU (European Union) Pharmaceutical Regulations & Strategy Training Course (Mar 2nd – Mar 3rd, 2026)” training has been added to ResearchAndMarkets.com’s offering.


This interactive course will provide an overview of the current European pharmaceutical regulatory environment, procedures and obligations and discuss how to interpret and apply the legislation. The proposed EU pharmaceuticals legislation changes will be discussed in the relevant sections.

In the highly regulated field of pharmaceuticals, staying abreast of regulatory affairs is crucial for ensuring compliance, maintaining market authorisations, and effectively managing drug development and post-approval obligations. Navigating the complexities of regulatory processes, particularly in the context of evolving legislation, can be challenging. This is where a comprehensive understanding of pharmaceutical regulatory affairs becomes indispensable.

Creating and coordinating an effective regulatory strategy is an essential part of the work of a regulatory affairs department and can save valuable time and money. It is therefore important to be aware of potential changes which may impact on strategy.

The programme will cover the legal basis of regulation, development strategies and the importance of pre-submission activities as well a brief overview of the format for presentation of data, the registration procedures for obtaining marketing authorisations and post-authorisation obligations and strategic considerations.

The UK is no longer part of the EU but knowledge of interactions and collaboration with the EU and other regulatory agencies are important for obtaining and maintaining marketing authorisations in the UK. Case study sessions will explore options and strategies for key regulatory activities and provide an opportunity for discussion and the sharing of experiences with our expert trainer and other delegates.

Benefits of attending

  • Understand the legal basis of the current EU regulatory environment
  • Outline the background to and the proposed EU pharmaceutical legislation changes
  • Discuss development strategy and pre-submission activities
  • Review procedures for applying for a marketing authorisation in the EU/EEA and in the UK
  • Discuss post-authorisation strategic considerations and obligations

Who Should Attend:

The course is designed primarily for regulatory affairs personnel, however it will also be of value to those who interact with the regulatory affairs function and would benefit from an understanding of action timelines and information requirements. It will be particularly relevant to all those working in:

  • Regulatory affairs
  • Project management
  • Business planning
  • Commercial management
  • Manufacturing and QA
  • Labelling and artwork
  • Medical information
  • Clinical
  • Pharmacovigilance

Certifications:

  • CPD: 12 hours for your records
  • Certificate of completion

Key Topics Covered:

Day 1

EU regulatory environment: legal basis

  • Key regulations, directives and guidelines
  • Proposed EU pharmaceuticals legislation changes Information sources

Information sources

Case Study One

Development and Strategy

  • Drug discovery
  • Scientific advice

Development process

  • Pharmaceutical R&D
  • Non-clinical tests
  • Clinical studies – Phase I to III

EU Clinical Trials Regulation

Types and categories of marketing Authorisations

Adaptive marketing authorisation procedures

The Common Technical Document (CTD)

  • Overview of Structure and content of a CTD

Procedures for obtaining a marketing authorisation in the EU and EMA

  • The EU centralised procedure

Other EU centralised procedures

  • Referral and arbitration

Day 2

Other procedures for obtaining a marketing authorisation in the EU

  • Coordination group
  • Decentralised procedure (DCP)
  • Mutual recognition procedure (MRP)
  • National procedures

Managing product labelling

Case Study Two

Abridged applications and Generics

  • Types and Requirements

Product Life Cycle; Post approval

Patents and SPCs

Parallel trade

Post-authorisation obligations; pharmacovigilance, variations and renewals

Pharmacovigilance

Licence variations

  • Type I and Type II variations and timelines
  • Procedures and timelines

Extensions

Case Study Three

Renewals

Sunset clause

Phase IV Trials

Classification change

Generic development

Strategic factors

Criteria for successful products

Speakers:

Norah Lightowler

Lightowler Associates

Norah Lightowler is a partner in Lightowler Associates, an independent consultancy offering regulatory advice and support to pharmaceutical companies in or proposing to enter the European market for human pharmaceuticals. They are in their twentieth year of successful business. Norah has wide experience in the pharmaceutical and related neutraceutical, herbal and devices industries as a pharmaceutical assessor with the UK regulatory authority and as associate director of European regulatory affairs with an international pharmaceutical company. She is experienced in organising and presenting courses on European regulatory control systems, including requirements, procedures and strategy.

For more information about this training visit https://www.researchandmarkets.com/r/teu577

About ResearchAndMarkets.com
ResearchAndMarkets.com is the world’s leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Contacts

ResearchAndMarkets.com

Laura Wood, Senior Press Manager

press@researchandmarkets.com

For E.S.T Office Hours Call 1-917-300-0470

For U.S./ CAN Toll Free Call 1-800-526-8630

For GMT Office Hours Call +353-1-416-8900

Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union Training Course (Online Event: Mar 5th – Mar 6th, 2026) – ResearchAndMarkets.com

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Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union Training Course (Online Event: Mar 5th – Mar 6th, 2026) – ResearchAndMarkets.com




Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union Training Course (Online Event: Mar 5th – Mar 6th, 2026) – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union Training Course (Mar 5th – Mar 6th, 2026)” training has been added to ResearchAndMarkets.com’s offering.


This interactive course will guide you through national procedures as well as explore the implications of and updates on the Eurasian Union regulation.

The pharmaceutical markets in Russia, the Eurasian Union and the CIS are of growing commercial importance and companies looking to take advantage of the opportunities available need to be fully up to date with the evolving regulatory landscape for human pharmaceuticals, including the potential for market access offered by the latest legislation.

The focus of the programme is to offer practical advice in developing your regulatory strategy for product approval in these countries and you will get the full benefit of our trainer’s experience and expertise in the region.

Benefits of attending:

  • Understand the competitive landscape of the growing markets in the CIS region
  • Discover the essential information on the latest regulations and registration procedures in the Eurasian Customs Union
  • Discuss national requirements and guidance for drug approval in the core CIS markets of Russia, Kazakhstan, Belarus, Ukraine and Azerbaijan
  • Develop your CIS regional submission plan and place it within your global regulatory strategy
  • Gain practical advice from an industry expert working in the CIS region

Why you should attend

Attending this programme will:

  • Give you the full background to the CIS pharmaceutical market
  • Ensure that you understand all the implications of the latest regulations which will affect how you do business in the Eurasian Economic Union (EAEU)
  • Help clarify the document requirements and timelines of national procedures and EAEU registration procedures
  • Update you on the national regulations in Russia, Belarus, Kazakhstan, Ukraine and other CIS countries

Who Should Attend:

This seminar will be of particular interest to all those who need to learn about successful marketing authorisation applications and regulatory compliance in this region. The seminar will be useful either as an introductory or refresher course.

Certifications:

  • CPD: 12 hours for your records
  • Certificate of completion

Key Topics Covered:

Day 1

CIS – regional regulatory overview

  • CIS and Russia Market Overview
  • Market protection policies
  • CIS and Russia in regional and international Regulatory Harmonisation

Common regional requirements in CIS

  • Administrative data, translations, normative documents, samples, labelling, etc

Eurasian economic area

  • Countries current members of EAEU and EAEU Official bodies
  • History of EUAE, scope of products, available experience
  • Terms of transition period for medicines

Eurasian Regulations for Medicines

  • Overview of EAEU regulatory framework
  • Registration Procedures and Application Process
  • EAEU submission documents and data requirements
  • GMP inspections
  • PhV requirements

Day 2

Registration of Medicine in Russia

  • Regulatory authorities in Russia
  • Key regulations governing the registration process
  • Clinical trials

National Regulatory Procedures in Russia

  • Application dossier and data requirements
  • Post approval life cycle maintenance applications
  • Safety reporting and market surveillance
  • Price and reimbursement
  • Patent data protection

Registration in other EAEU countries

  • Kazakhstan, Belarus, Armenia, Kirgizstan

Registration in other CIS countries

  • EU sphere of influence: Ukraine, Moldova, Georgia
  • National procedures: Azerbaijan, Uzbekistan, Tajikistan, Turkmenistan

Workshop – CIS Regional Regulatory Strategy

Speakers:

Anna Harrington-Morozova

Scientific and Regulatory Director

Regem Consulting Ltd

Anna Harrington-Morozova is a regulatory, drug development and external relations professional with over 20 years’ experience gained in regulatory authority, academia, clinical and industry environment. Anna graduated in Russia as a pharmacist. After working in the Russian Ministry of Health and the Clinical Pharmacology Department of Moscow Medical University Anna held regulatory and external relation positions in the pharmaceutical industry and CROs in Russia and the UK, including senior regulatory affairs posts in GSK, EISAI, ICON and PRA. Anna currently acts as a Scientific and Regulatory Director at Regem Consulting Ltd – a regulatory and drug development consultancy with a focus on global regulatory and drug development strategies, advocacy and registrations in emerging markets.

For more information about this training visit https://www.researchandmarkets.com/r/rthrb0

About ResearchAndMarkets.com

ResearchAndMarkets.com is the world’s leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Contacts

ResearchAndMarkets.com

Laura Wood, Senior Press Manager

press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470

For U.S./ CAN Toll Free Call 1-800-526-8630

For GMT Office Hours Call +353-1-416-8900

Biosimilars Training Course: Prepare for the Biosimilar Market Growth As Some of the World’s Best-known Biologics Face Patent Expiration in the Coming Years (Online Event: Mar 16th – Mar 17th, 2026) – ResearchAndMarkets.com

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Biosimilars Training Course: Prepare for the Biosimilar Market Growth As Some of the World’s Best-known Biologics Face Patent Expiration in the Coming Years (Online Event: Mar 16th – Mar 17th, 2026) – ResearchAndMarkets.com




Biosimilars Training Course: Prepare for the Biosimilar Market Growth As Some of the World’s Best-known Biologics Face Patent Expiration in the Coming Years (Online Event: Mar 16th – Mar 17th, 2026) – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Biosimilars Training Course (Mar 16th – Mar 17th, 2026)” training has been added to ResearchAndMarkets.com’s offering.


In today’s pharmaceutical landscape, the rise of biosimilars presents a pivotal shift in therapeutic options, offering more affordable alternatives to biologics whose patents are expiring. With major biologics facing patent expiration in the near future, the biosimilars market is poised for substantial growth, driving increased interest and investment in this sector.

This seminar delves into the critical distinctions between biosimilars and their reference biologics, addressing the complex regulatory pathways and challenges in both the EU and US markets.

Participants will gain insights into essential dossier requirements specific to biotech products compared to pharma products, alongside strategies for successful biosimilar development. Moreover, the course emphasises key biological considerations and the concept of totality in biological reviews, discussing unique aspects of biosimilars compared to small molecule generics.

This course will equip attendees with comprehensive knowledge essential for navigating the evolving biosimilar landscape.

Benefits of attending

  • Discuss global considerations and definitions of biotech/biosimilar products
  • Gain an invaluable overview of the regulatory pathways for biosimilars in the EU and US
  • Understand the key Module 3 dossier requirements for biotech products versus pharmaceutical products
  • Learn how to develop effective strategies for development of biosimilar products

Who Should Attend:

This course is perfect for pharmaceutical professionals working in regulation, quality assurance, pharmaceutical development, and R&D, including:

  • Regulatory affairs professionals
  • Medical affairs professionals
  • Clinical development managers
  • Quality assurance personnel
  • Legal and compliance officers

Certifications:

  • CPD: 12 hours for your records
  • Certificate of completion

Key Topics Covered:

Day 1

Biologics introduction

  • Technical and legal definitions
  • Examples of biologics
  • The complexity of biologicals
  • The challenges with the development of biologics

Biosimilars vs generics

  • How the process is the product
  • A simple excursive to be reminded of the difference between biosimilars and generics
  • Creating a copy with limited and imperfect tools

The (e)CTD

  • International Council of harmonization (ICH)
  • The common technical document
  • CMC explained (incl. quality by design, specifications)
  • Why the CMC section for biologics is more extensive (as compared to small molecules)

The (e)CTD continued

Day 2

The registration process

  • A review of EMA and FDA biosimilar guidelines
  • Biosimilar development as a step-wise approach

    • Quality
    • Non-clinical
    • Clinical
  • Non-comparable biologics
  • Other regulatory topics

    • Interchangeability
    • Naming
    • Labelling
    • Pharmacovigilance

Module 3 for biosimilars – section by section

  • In-depth review of module 3 documentation with special remarks regarding biologics and biosimilars specifically

Challenges for biosimilar sponsors

  • Global development
  • Costs
  • Uncertainty

Main players in the biosimilar field

  • A review of the current situation

Strategic considerations

  • A summary of key points to consider when (starting to) develop biosimilars

Case study

Speakers:

Andrew Willis

Consultant

Independent

Andrew Willis is an independent consultant providing expert advice and training on global regulatory solutions and pharmaceutical development. Previously, he worked for Catalent Pharma Solutions as VP Regulatory Affairs & Consulting Services. Catalent is the world’s leading contract manufacturer and distributor of pharmaceuticals, and he was head of a team of internal and external regulatory affairs consultants. He qualified as a Chemist from the University of Glamorgan, after which he furthered his understanding of pharmaceutical development, working as a research chemist with Parke Davis. He has 10 years manufacturing and analytical experience prior to entering regulatory affairs as a Senior Executive Officer with responsibility for submission of European MAAs and project management of development programs.

He currently has a total of 28 years pharmaceutical experience with extensive knowledge in the development and manufacture of sterile, solid oral, inhalation, topical and biotech pharmaceutical products. These experiences have allowed knowledge of many Biotech products requirements with experiences of growth hormones and multiple cancer treatments, including development and clinical registration of the first genetically modified live bacterium for such treatment.

He has extensive experience of major European and US regulatory projects, in the clinical and marketing authorisation stages, and has significant experience in coordinating and managing meetings with European and US Health Authorities. Specific experience includes the project management of a large MAA requiring full clinical data, followed by Mutual Recognition of the application in all of the European Concerned Member States. The project recorded successful outcomes in all major markets (26 countries) and was viewed as highly successful by the client, meeting very stringent project timings.

For more information about this training visit https://www.researchandmarkets.com/r/kvxsfr

About ResearchAndMarkets.com

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ImmunityBio Founder Dr. Patrick Soon-Shiong Recognized as One of “100 Most Influential People in Oncology in 2025”

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ImmunityBio Founder Dr. Patrick Soon-Shiong Recognized as One of “100 Most Influential People in Oncology in 2025”




ImmunityBio Founder Dr. Patrick Soon-Shiong Recognized as One of “100 Most Influential People in Oncology in 2025”

CULVER CITY, Calif.–(BUSINESS WIRE)–ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, today announced that OncoDaily has recognized Dr. Patrick Soon-Shiong as being one of “The 100 Most Influential People in Oncology in 2025.” Soon-Shiong is the company’s Founder, Executive Chairman and Global Chief Scientific and Medical Officer, and is a global thought leader in advancing the goal of a cancer-free society.


On its website announcing the honor, OncoDaily highlighted Soon-Shiong’s extensive scientific and research accomplishments, noting that The 100 Most Influential People in Oncology in 2025 recognizes changemakers in cancer care who have helped shape current oncology practice and continue to drive innovation across research, patient outcomes, advocacy, philanthropy, leadership, and education.

OncoDaily, the “Voice of Oncology,” is a respected global source of news and information about developments in oncology, whose editorial staff and advisory board is comprised of leading academics, researchers and physicians specializing in cancer. Its annual Influential People list highlights individuals whose work is shaping oncology through clinical leadership, scientific innovation, education, advocacy, and philanthropy.

“Dr. Soon-Shiong has earned this honor in recognition of his lifelong commitment to science, medicine, and patient care, a commitment that inspires our team and our partners every day,” said Richard Adcock, President and CEO of ImmunityBio. “His ideas and leadership are a driving force powering our mission to bring transformative therapies to people living with cancer and other serious diseases.”

About ImmunityBio

ImmunityBio is a vertically-integrated commercial stage biotechnology company developing next-generation therapies that bolster the natural immune system to defeat cancers and infectious diseases. The Company’s range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. Designated an FDA Breakthrough Therapy, ANKTIVA is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS that activates NK cells, T cells, and memory T cells for a long-duration response. The Company is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases. For more information, visit ImmunityBio.com (Founder’s Vision) and connect with us on X (Twitter), Facebook, LinkedIn, and Instagram.

Forward Looking Statements

This communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements, if any, regarding the potential implications of the recognition of Dr. Patrick Soon-Shiong, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio, Inc. by OncoDaily as one of the most influential people in oncology in 2025. Forward-looking statements are based on management’s current expectations and assumptions and are subject to a number of risks and uncertainties, many of which are beyond the Company’s control, that could cause actual outcomes or results to differ materially from those expressed or implied by these statements. These risks and uncertainties include, but are not limited to, changes in business, regulatory, scientific, or market conditions. More details about these and other risks that may impact ImmunityBio’s business are described under the heading “Risk Factors” in the Company’s Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on March 3, 2025, and the Company’s Form 10-Q filed with the SEC on November 5, 2025 and in subsequent filings made by ImmunityBio with the SEC, which are available on the SEC’s website at www.sec.gov. ImmunityBio cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date hereof. ImmunityBio does not undertake any duty to update any forward-looking statement or other information in this press release, except to the extent required by law.

Contacts

Investors

Hemanth Ramaprakash, PhD, MBA

ImmunityBio, Inc.

+1 858-746-9289

Hemanth.Ramaprakash@ImmunityBio.com

Media

Sarah Singleton

ImmunityBio, Inc.

+1 415-290-8045

Sarah.Singleton@ImmunityBio.com

CEL-SCI Reports Fiscal 2025 Results

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CEL-SCI Reports Fiscal 2025 Results




CEL-SCI Reports Fiscal 2025 Results

  • Filed for Breakthrough Designation for Multikine in Saudi Arabia
  • A 212-patient Confirmatory Registration Study for Multikine in PD-L1 low newly diagnosed head and neck cancer patients is currently in final stage of preparations – enrollment expected to begin Spring 2026
  • Plans to seek early approval in U.S. based on pre-surgical response rate upon full enrollment

VIENNA, Va.–(BUSINESS WIRE)–$CVM #Multikine–CEL-SCI Corporation (NYSE American: CVM) reported financial results for the fiscal year ended September 30, 2025, as well as key clinical and corporate developments.


“During fiscal 2025, our regulatory advancements accelerated driven by new opportunities for Multikine in Saudi Arabia and the green light we have received for our Confirmatory Registration trial in the U.S.,” stated CEL-SCI CEO, Geert Kersten. “The Confirmatory Registration study required by the FDA is designed to confirm data from our prior Phase 3 study by evaluating Multikine in only those patients who showed the best type of tumor responses and survival in that study in a highly statistically significant manner. The long-term survival with our drug of 73% vs. only 45% without our drug, a huge improvement demonstrated in our prior Phase 3 study, significantly decreases risk associated with the development of Multikine as a cancer therapy. Preparations for this final registration study are ongoing, and we expect to commence enrollment in Spring 2026.”

Clinical and Corporate Developments:

  • CEL-SCI is in final preparations to start enrollment of its 212-patient U.S. Confirmatory Registration Study for Multikine in newly diagnosed locally advanced head and neck cancer patients. The U.S. Food and Drug Administration (FDA) has given CEL-SCI the go-ahead for the study. Enrollment is expected to begin in Spring 2026. CEL-SCI plans to seek early approval based on early tumor response data which is expected by 2028.
  • An application was submitted for Breakthrough Medicine Designation for Multikine in the treatment of head and neck cancer in Saudi Arabia as recommended by the Saudi Food and Drug Authority (SFDA). This was done in combination with a Saudi company, also as recommended by the SFDA. CEL-SCI believes it has addressed all of the scientific questions posed by the SFDA. In response to an additional request, CEL-SCI also submitted a blueprint for its strategy to support and become a part of the Saudi Arabia’s ambitious Vision 2030 goals to further advance the Kingdom’s global leadership in biotechnology.
  • CEL-SCI’s cGMP state-of-the-art dedicated manufacturing facility commissioning was validated and manufacturing of Multikine for the confirmatory Registration Study was completed, a significant milestone towards starting enrollment. Should Multikine receive regulatory clearance for patient access and sales in Saudi Arabia based on the Breakthrough Medicine Designation, CEL-SCI is ready to manufacture and ship doses to Saudi Arabia from its U.S. facility while diversifying its geographic manufacturing base with support from Saudi counterparts.
  • CEL-SCI is working closely with Ergomed, a clinical research organization (CRO) with a strong track record of fast enrolment and high-quality study delivery, to complete the final preparations for its confirmatory Registration Study. Ergomed has been a strategic partner and collaborator for over 10 years and was instrumental in successfully completing the Phase 3 study.
  • A new study supports CEL-SCI’s strategy to seek early approval in the U.S. The third-party study recently published in Cancer Cell titled “Distinct CD8+ T cell dynamics associate with response to neoadjuvant cancer immunotherapies” provides support for CEL-SCI’s approach. The concept that tumor responses predict survival has been acknowledged for many cancer types and has led to accelerated approval of many cancer drugs. The data give further support that this is also true in the neoadjuvant pre-surgical immunotherapy treatment of head and neck cancer.
  • More data on PD-L1 as a predictive biomarker signals a clear regulatory pathway for Multikine in PD-L1 negative patients. There is a growing body of data on PD-L1 as a predictive biomarker and diagnostic for cancer. In June 2025, the FDA approved Merck’s KEYTRUDA® (pembrolizumab), an anti-PD-L1 therapy, for the treatment of adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1. Of note, the FDA granted Merck priority review in February 2025 and approval in June 2025 based on interim results. This sets a positive precedent for Multikine. Importantly, while Keytruda confers benefit in patients with a high levels of PD-L1, Multikine has been shown to significantly extend life in patients with low to zero levels of PD-L1. Multikine reduced the risk of death by 66% compared to standard of care in the target population of patients with low and zero PD-L1, while Keytruda reduced the risk of recurrence and progression (EFS) by 30% compared with standard of care in patients whose tumors expressed higher PD-L1 without demonstrating improvement in overall survival.

Financial Results

During the fiscal year ended September 30, 2025, research and development expenses were $15.9 million, which decreased by approximately $2.3 million, or 13%, compared to the year ended September 30, 2024. General and administrative expenses in fiscal 2025 were $8.9 million, which increased by approximately $0.7 million, or 9%, compared to the year ended September 30, 2024. Net loss available to common shareholders decreased by $2.2 million to approximately $25.4 million for the twelve months ended September 30, 2025 from $27.6 million in fiscal 2024. The operating cash expenditures for the year were approximately $17.1 million. CEL-SCI’s audited financial statements contained an audit opinion from its independent registered public accounting firm that included an explanatory paragraph related to CEL-SCI’s ability to continue as a going concern. CEL-SCI raised gross proceeds of approximately $28.3 million in fiscal 2025 through the sale of common stock.

About CEL-SCI Corporation

CEL-SCI believes that boosting a patient’s immune system while it is still intact should provide the greatest possible impact on survival. Multikine is designed to help the immune system “target” the tumor before surgery, radiation and chemotherapy because that is the time when the immune system is still relatively intact and thereby thought to be better able to mount an attack on the tumor.

Multikine (Leukocyte Interleukin, Injection), a true first-line cancer therapy, has been dosed in over 740 patients and received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck. Based on the data from the completed randomized controlled Phase 3 study of 928 patients, the FDA concurred with CEL-SCI’s target patient selection criteria and gave the go-ahead to conduct a confirmatory Registration Study which will enroll 212 patients. CEL-SCI will enroll newly diagnosed locally advanced not yet treated resectable head and neck cancer patients with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expression (determined via biopsy), representing about 100,000 patients annually.

The Company has operations in Vienna, Virginia, and near/in Baltimore, Maryland.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this press release, the words “intends,” “believes,” “anticipated,” “plans” and “expects,” and similar expressions, are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Factors that could cause or contribute to such differences include an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company’s potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI’s filings with the Securities and Exchange Commission, including but not limited to its report on Form 10-K for the year ended September 30, 2025. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

* Multikine (Leukocyte Interleukin, Injection) is the trademark that CEL-SCI has registered for this investigational therapy. This proprietary name is subject to FDA review in connection with the Company’s future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use.

Contacts

COMPANY CONTACT:

Gavin de Windt

CEL-SCI Corporation

(703) 506-9460

60 Degrees Pharmaceuticals Announces Detection of Babesia Infection in 24 Percent of Patients Presenting with Chronic Fatigue in Peer-Reviewed, Sponsored Study at NC State

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60 Degrees Pharmaceuticals Announces Detection of Babesia Infection in 24 Percent of Patients Presenting with Chronic Fatigue in Peer-Reviewed, Sponsored Study at NC State




60 Degrees Pharmaceuticals Announces Detection of Babesia Infection in 24 Percent of Patients Presenting with Chronic Fatigue in Peer-Reviewed, Sponsored Study at NC State

  • Further validates continuation of the B-FREE Study to evaluate the efficacy and safety of ARAKODA® (tafenoquine) for treatment of chronic babesiosis
  • Data support theory among specialists that Babesia infection may prolong recovery times in patients with chronic fatigue

WASHINGTON, Dec. 29, 2025 (GLOBE NEWSWIRE) — 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (“60 Degrees Pharma” or the “Company”), a pharmaceutical company focused on developing new medicines for vector-borne disease, today announced that infection with Babesia, a parasite that causes the emerging tick-borne illness called babesiosis, was found in 24 percent of a cohort of 50 patients with chronic fatigue in a study conducted by researchers at North Carolina State University, and published in Pathogens.

Results announced today contribute to efforts to confirm a long-held theory within the U.S. vector-borne disease community that Babesia and chronic disease may be linked – specifically, that Babesia infection may prolong recovery times in patients with chronic fatigue.

The results also reinforce the importance of the B-Free Chronic Babesiosis Study (NCT06656351), which is evaluating efficacy and safety of the ARAKODA regimen of tafenoquine over 90 days for resolution of severe fatigue in patients with chronic babesiosis. The Company’s B-Free Study is now enrolling at the Icahn School of Medicine at Mount Sinai in New York.

“Healthcare providers who treat tick-borne illness may not be surprised by the results of this study,” said 60 Degrees Pharma Chief Executive Officer, Geoffrey Dow. “While the results don’t prove that Babesia infection causes chronic disease, they are consistent with that hypothesis and highlight the need for prospective controlled studies which the Company is now undertaking.”

Tafenoquine is approved for malaria prophylaxis in the United States under the product name ARAKODA®. Tafenoquine has not been proven to be effective for treatment or prevention of babesiosis and is not approved by the United States Food and Drug Administration for such an indication.

About the North Carolina State University Chronic Fatigue Study

The study involved a cohort of 50 participants selected from a group of 173 individuals who self-reported a history of chronic diseases and potential exposure to arthropod vectors. Participants had all experienced fatigue for at least six months with concurrent neurological symptoms. Participants provided three blood samples over a week, which were archived and later cultured and tested for Babesia DNA using PCR assays.

The study was conducted under an Institutional Review Board (IRB)-approved protocol and was funded in part by 60 Degrees Pharma.

About Babesiosis
Babesiosis is a tick-borne illness caused by Babesia parasites that develop and multiply in red blood cells. Its symptoms include fevers, chills, sweats, and fatigue, and in severe cases, can be life-threatening in elderly and immunosuppressed patients. Incidence of the disease is rapidly rising, particularly in the Northeast. Transmitted through the bite of the black-legged (deer) tick, the vector that spreads Lyme disease, babesiosis is an orphan disease. Insurance claims research commissioned by the Company suggest that the minimum annual incidence of babesiosis is at least 25,000 cases per year, although the true number may be much larger than this. Currently no U.S. Food and Drug Administration (FDA)-approved treatment exists specifically for babesiosis.

Babesia infection persists for months, and potentially for several years, following a tick bite. In patients with risk factors (e.g., immunosuppression, age, asplenia), persistent infection may result in recurring clinical relapses of the disease, each with the potential for hospitalization. In individuals without such known risk factors, it has been generally assumed that persistent infection is not clinically meaningful. However, the potential clinical significance of persistent infection in individuals with dysregulated immune systems (e.g., chronic tick-borne diseases, long Covid and other long syndromes) has not been studied, but is hypothesized to complicate recovery from other chronic symptoms. The lack of sufficiently sensitive, FDA-approved diagnostics has stymied efforts to study this problem.

About 60 Degrees Pharmaceuticals, Inc.
60 Degrees Pharmaceuticals, Inc., founded in 2010, specializes in developing and commercializing new medicines for the treatment and prevention of vector-borne disease. The Company achieved U.S. Food and Drug Administration approval of Its lead product, ARAKODA® (tafenoquine), for malaria prevention in 2018. ARAKODA is commercially available in the U.S. and Australia. 60 Degrees Pharmaceuticals, Inc. also collaborates with prominent research and academic organizations in the U.S. and Australia. 60 Degrees Pharmaceuticals, Inc. is headquartered in Washington, D.C., with a subsidiary in Australia. Learn more at www.60degreespharma.com.

The statements contained herein may include prospects, statements of future expectations and other forward-looking statements that are based on management’s current views and assumptions and involve known and unknown risks and uncertainties. Actual results, performance or events may differ materially from those expressed or implied in such forward-looking statements.

Cautionary Note Regarding Forward-Looking Statements

This press release may contain “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward‐looking statements reflect the current view about future events. When used in this press release, the words “anticipate,” “believe,” “estimate,” “expect,” “future,” “intend,” “plan,” or the negative of these terms and similar expressions, as they relate to us or our management, identify forward‐looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy, activities of regulators and future regulations and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following: there is substantial doubt as to our ability to continue on a going-concern basis; we might not be eligible for Australian government research and development tax rebates; if we are not able to successfully develop, obtain FDA approval for, and provide for the commercialization of non-malaria prevention indications for tafenoquine (ARAKODA® or other regimen) or Celgosivir in a timely manner, we may not be able to expand our business operations; we may not be able to successfully conduct planned clinical trials or patient recruitment in our trials might be slow or negligible; and we have no manufacturing capacity which puts us at risk of lengthy and costly delays of bringing our products to market. More detailed information about the Company and the risk factors that may affect the realization of forward- looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (“SEC”), including the information contained in our Annual Report on Form 10-K filed with the SEC on April 1, 2024, and our subsequent SEC filings. Investors and security holders are urged to read these documents free of charge on the SEC’s website at www.sec.gov. As a result of these matters, changes in facts, assumptions not being realized or other circumstances, the Company’s actual results may differ materially from the expected results discussed in the forward-looking statements contained in this press release. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Media Contact:
Sheila A. Burke
SheilaBurke-consultant@60degreespharma.com
(484) 667-6330

Investor Contact:
Patrick Gaynes
patrickgaynes@60degreespharma.com

BiomX Announces $3.0 Million Private Placement

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BiomX Announces $3.0 Million Private Placement




BiomX Announces $3.0 Million Private Placement

Proceeds to Support the Company’s Assessment of Opportunities to Advance BX011 and Ongoing Evaluation of Strategic Alternatives

NESS ZIONA, Israel, Dec. 29, 2025 (GLOBE NEWSWIRE) — BiomX Inc. (NYSE American: PHGE) (“BiomX” or the “Company”), a clinical-stage company advancing novel natural and engineered phage therapies targeting specific pathogenic bacteria, today announced that it has entered into definitive agreements in connection with a private investment in public equity (“Private Placement”) financing for expected gross proceeds of approximately $3.0 million, before deducting placement agent fees and other offering expenses.

H.C. Wainwright & Co. acted as the exclusive placement agent for the private placement.

About the Private Placement
In the Private Placement, the Company agreed to issue and sell shares of its Series Y Convertible Preferred Stock, with a stated value of $1,000 per share, together with warrants (collectively, the “Securities”) with an aggregate stated value of up to $3.3 million, for an aggregate purchase price of $3.0 million.

Each share of Series Y Convertible Preferred Stock will accrue dividends at a rate of 15% per annum, payable quarterly, and will have a maturity of one year from the closing date. The Series Y Convertible Preferred Stock will be convertible into shares of the Company’s common stock, subject to the limitations set forth in the definitive agreements, including the receipt of stockholder approval to the extent required under NYSE American rules.

In connection with the Private Placement, the Company will also issue warrants to acquire up to 3,300,000 shares of the Company’s common stock. The warrants will have a five-year term and an exercise price initially equal to $2.00, the applicable conversion price of the Series Y Convertible Preferred Stock, subject to certain adjustments if stockholder approval is obtained.

The Private Placement is expected to close on or about December 30, 2025, subject to the satisfaction of customary closing conditions.

The Securities sold in the Private Placement have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), or applicable state securities laws, and were offered and sold in reliance on exemptions from the registration requirements of the Securities Act. The Company has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the shares of common stock issuable upon conversion of the Series Y Convertible Preferred Stock and exercise of the warrants.

The Company intends to use the net proceeds from the private placement to support its assessment of opportunities across its bacteriophage programs, including BX011 for Staphylococcus aureus infections associated with diabetic foot infections, and for general corporate purposes, including providing operational flexibility while the Company continues to evaluate strategic alternatives.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any Securities, nor shall there be any sale of Securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.

About BiomX
BiomX is a clinical-stage company leading the development of natural and engineered phage cocktails and personalized phage treatments designed to target and destroy harmful bacteria for the treatment of chronic diseases with substantial unmet needs. BiomX discovers and validates proprietary bacterial targets and applies its BOLT (“BacteriOphage Lead to Treatment”) platform to customize phage compositions against these targets. For more information, please visit www.biomx.com, the content of which does not form a part of this press release.

Safe Harbor
This press release contains express or implied “forward-looking statements” within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “target,” “believe,” “expect,” “will,” “may,” “anticipate,” “estimate,” “would,” “positioned,” “future,” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters.  For example, when BiomX refers to the anticipated closing of the Private Placement and timing thereof, the intended use of the net proceeds, the receipt of stockholder approval, the evaluation of opportunities related to its clinical programs, including BX011, the timing and design of potential future development activities, and its ongoing assessment of strategic alternatives, it is using forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on BiomX management’s current beliefs, expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of BiomX’s control. These risks and uncertainties include, but are not limited to, market and other conditions, BiomX’s ability to obtain all necessary regulatory approvals on a timely basis, or at all; BiomX’s ability to obtain stockholder approval on a timely basis, or at all; the closing of the private placement on a timely basis on the terms described herein, or at all; changes in applicable laws or regulations; the possibility that BiomX may be adversely affected by other economic, business, and/or competitive factors, including risks inherent in pharmaceutical research and development, such as: adverse results in BiomX’s drug discovery, preclinical and clinical development activities, the risk that the results of preclinical studies and early clinical trials may not be replicated in later clinical trials, BiomX’s ability to enroll patients in its clinical trials, and the risk that any of its clinical trials may not commence, continue or be completed on time, or at all; decisions made by the FDA and other regulatory authorities; investigational review boards at clinical trial sites and publication review bodies with respect to our development candidates; BiomX’s ability to obtain, maintain and enforce intellectual property rights for its platform and development candidates; its potential dependence on collaboration partners; competition; uncertainties as to the sufficiency of BiomX’s cash resources to fund its planned activities for the periods anticipated and BiomX’s ability to manage unplanned cash requirements; and general economic and market conditions. Therefore, investors should not rely on any of these forward-looking statements and should review the risks and uncertainties described under the caption “Risk Factors” in BiomX’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on March 25, 2025, and additional disclosures BiomX makes in its other filings with the SEC, which are available on the SEC’s website at www.sec.gov. Forward-looking statements are made as of the date of this press release, and except as provided by law BiomX expressly disclaims any obligation or undertaking to update forward-looking statements.

Contacts:

BiomX, Inc.
Ben Cohen
Head Corporate Communications
benc@biomx.com