AIM ImmunoTech Announces Expiration and Preliminary Results of its Rights Offering for Aggregate Gross Proceeds of $1.8 Million

AIM ImmunoTech Announces Expiration and Preliminary Results of its Rights Offering for Aggregate Gross Proceeds of $1.8 Million




AIM ImmunoTech Announces Expiration and Preliminary Results of its Rights Offering for Aggregate Gross Proceeds of $1.8 Million

OCALA, Fla., March 04, 2026 (GLOBE NEWSWIRE) — AIM ImmunoTech Inc. (NYSE American: AIM) – AIM ImmunoTech Inc. (“AIM” or the “Company”), an immuno-pharma company focused on the research and development of its lead product, Ampligen® (rintatolimod), for the treatment of late-stage pancreatic cancer – a lethal and unmet global health problem – today announced the preliminary results of its previously announced rights offering (the “Rights Offering”) which expired at 5:00 p.m., Eastern Time, on March 3, 2026. The Company estimates that the Rights Offering will result in total subscriptions of approximately $1.8 million. The results of the Rights Offering are preliminary and subject to change pending finalization and verification by the Company and its subscription agent, Broadridge Corporate Issuer Solutions, LLC.

Each right entitled the holder to purchase one unit (“Unit”), at a subscription price of $1,000 per Unit, consisting of one share of the Company’s Series G Convertible Preferred Stock (the “Preferred Stock”), and 2,000 Class G Common Stock Purchase Warrants to purchase the Company’s Common Stock (the “Warrants”).

The Company anticipates the closing of the Rights Offering will occur on or about March 6, 2026, subject to satisfaction or waiver of all conditions to closing. Upon the closing, the subscription agent will distribute, by way of direct registration in book-entry form or through the facilities of DTC, as applicable, shares of the Preferred Stock and Warrants to holders of rights who have validly exercised their rights and paid the subscription price in full. No physical stock or warrant certificates will be issued to such holders.

Maxim Group LLC acted as dealer-manager for the Rights Offering. Questions about the Rights Offering or requests for copies of the final prospectus may be directed to Maxim Group LLC at 300 Park Avenue, New York, NY 10022, Attention: Syndicate Department, or via email at syndicate@maximgrp.com or telephone at (212) 895-3745.

The Company’s registration statement on Form S-1 (Registration No. 333-292085) was declared effective by the Securities and Exchange Commission (“SEC”) on February 10, 2026. The prospectus relating to and describing the terms of the Rights Offering has been filed with the SEC as a part of the registration statement and is available on the SEC’s website at http://www.sec.gov.

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

About AIM ImmunoTech

AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of its lead product, Ampligen® (rintatolimod), for the treatment of late-stage pancreatic cancer, a lethal and unmet global health problem. Ampligen is a dsRNA and highly selective TLR3 agonist immuno-modulator that has shown broad-spectrum activity in clinical trials.

Forward Looking Statements

Some of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties. Among other things, for those statements, the Company claims the protection of safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements set forth in the press release speak only as of the date of the press release. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. The Company is in various stages of seeking to determine whether Ampligen® will be effective in the treatment of multiple types of viral diseases, cancers, and immune-deficiency disorders and disclosures in the Company’s reports filed with the SEC on its website and in its press releases set forth its current and anticipated future activities. These activities are subject to change for a number of reasons. Significant additional testing and trials will be required to determine whether Ampligen® will be effective in the treatment of these conditions. Results obtained in animal models do not necessarily predict results in humans. Human clinical trials will be necessary to prove whether or not Ampligen® will be efficacious in humans. No assurance can be given as to whether current or planned clinical trials will be successful or yield favorable data and the trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. Even if these clinical trials are initiated, the Company cannot assure that the clinical studies will be successful or yield any useful data or require additional funding. Among the studies are clinical trials that provide only preliminary data with a small number of subjects, and no assurance can be given that the findings in these studies will prove true or that the study or studies will yield favorable results. No assurance can be given that future studies will not result in findings that are different from those reported in the studies referenced in the Company’s reports filed with the SEC, on the Company’s website and in its press releases. Operating in foreign countries carries with it a number of risks, including potential difficulties in enforcing intellectual property rights. The Company cannot assure that its potential foreign operations will not be adversely affected by these risks.

Please review the “Risk Factors” section in the Company’s latest annual report on Form 10-K and subsequent quarterly reports on Form 10-Q and the registration statement. Its filings are available at www.aimimmuno.com. The information found on the Company’s website is not incorporated by reference herein and is included for reference purposes only.

CONTACT: IR Contact:

JTC Team, LLC

Jenene Thomas

908.824.0775

AIM@jtcir.com

ICAN Poll: Overwhelming Majority of Respondents Oppose Glyphosate Stockpiling, Reject Manufacturer Immunity

ICAN Poll: Overwhelming Majority of Respondents Oppose Glyphosate Stockpiling, Reject Manufacturer Immunity




ICAN Poll: Overwhelming Majority of Respondents Oppose Glyphosate Stockpiling, Reject Manufacturer Immunity

New public opinion data from 2,569 respondents reveals near-unanimous opposition to key provisions of the administration’s glyphosate executive order

AUSTIN, Texas, March 04, 2026 (GLOBE NEWSWIRE) — The Informed Consent Action Network (ICAN) released the results of a public opinion poll conducted in response to the Trump Administration’s executive order directing federal agencies to stockpile glyphosate-based herbicides. The poll, which drew 2,569 respondents, found sweeping opposition to federal stockpiling of glyphosate, near-total rejection of legal immunity for manufacturers, and widespread concern about the integrity of safety research used to justify current policies.

Key Findings

97.8     respondents oppose legal immunity for manufacturers of glyphosate-based herbicides — the strongest consensus in the poll.
       
89.0     oppose the federal stockpiling of glyphosate-based herbicides as part of national preparedness planning.
       
95.6     are aware that glyphosate-based herbicides have been linked to more than $10 billion in cancer-related jury verdicts and settlements.
       
95.6     say the November 2025 retraction of a foundational safety study has affected their trust in current glyphosate safety claims.
       


Context and Background
The poll was launched in February 2026 following the administration’s executive order directing federal agencies to ensure an adequate domestic supply of glyphosate and related chemical herbicides as part of national preparedness planning. The order came amid heightened public scrutiny of glyphosate’s safety profile, driven by several converging developments:

Bayer AG, which acquired Monsanto in 2018, has paid more than $10 billion in verdicts and settlements related to claims that its glyphosate-based Roundup herbicide causes cancer — particularly non-Hodgkin’s lymphoma — and continues to face approximately 67,000 active lawsuits. In February 2026, Bayer proposed a $7.25 billion class settlement to resolve current and future claims. (Source: Bloomberg / Insurance Journal, February 17, 2026)

On November 28, 2025, a study published in Regulatory Toxicology and Pharmacology — long cited as a foundational piece of evidence supporting glyphosate’s safety — was formally retracted, raising further questions about the scientific basis for current regulatory positions.

“These results speak for themselves,” said Del Bigtree, founder and CEO of ICAN. “The American public is paying attention. They know about the billions in legal judgments. They know the key safety study has been retracted. They are sending a clear message: they do not support policies that result in stockpiling products with unresolved safety questions or shield corporations from accountability.”

About the Poll
The ICAN Glyphosate Public Opinion Poll was conducted online in February 2026 and distributed through ICAN’s email list, website, and social media channels. A total of 2,569 respondents answered four multiple-choice questions covering awareness of glyphosate litigation, federal stockpiling policy, manufacturer legal immunity, and the impact of a recent study retraction on public trust. Each question offered three response options: Yes, No, or Unsure.

The full results report, including detailed data visualizations and analysis for each question, is available HERE.

Note: This poll reflects the views of ICAN’s engaged audience and is not presented as a statistically representative sample of the broader U.S. population. Results should be interpreted within the context of the respondent base. A complete methodology note is included in the full report.

About ICAN
The Informed Consent Action Network (ICAN) is a 501(c)(3) nonprofit organization focused on scientific integrity within the vaccine and pharmaceutical industries. Through investigations, legal actions, public education, and Freedom of Information campaigns, ICAN works to ensure that government health agencies and corporations are held to the highest standards of transparency and accountability. ICAN is the producer of The HighWire, a weekly investigative news program. Learn more at icandecide.org.

Media Contact: Catharine Layton | press@icandecide.org | 512-522-8739

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/59926f6d-1466-4426-bb25-c75c2697a7c7

CytomX Therapeutics to Report Fourth Quarter and Full Year 2025 Financial Results on March 16, 2026

CytomX Therapeutics to Report Fourth Quarter and Full Year 2025 Financial Results on March 16, 2026




CytomX Therapeutics to Report Fourth Quarter and Full Year 2025 Financial Results on March 16, 2026

SOUTH SAN FRANCISCO, Calif., March 04, 2026 (GLOBE NEWSWIRE) — CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologics, today announced that it will report full year 2025 financial results on Monday, March 16, 2026, before the open of U.S. markets. Following the announcement, the Company will host a conference call and webcast at 8:00 a.m. ET / 5:00 a.m. PT.

Participants may access the live webcast of the conference call from the Events and Presentations page of CytomX’s website at https://ir.cytomx.com/events-and-presentations. Participants may register for the conference call here and are advised to do so at least 10 minutes prior to joining the call. An archived replay of the webcast will be available on the Company’s website.

About CytomX Therapeutics, Inc.

CytomX is a clinical-stage, oncology-focused biopharmaceutical company focused on developing novel conditionally activated, masked PROBODY® therapeutics designed to be localized to the tumor microenvironment. By pioneering a novel pipeline of localized biologics, powered by its PROBODY therapeutic platform, CytomX’s vision is to create safer, more effective therapies for the treatment of cancer. CytomX’s robust and differentiated pipeline comprises therapeutic candidates across multiple treatment modalities including antibody-drug conjugates (“ADCs”), cytokines and T-cell engagers. CytomX’s clinical-stage pipeline includes varsetatug masetecan (Varseta-M; CX-2051) and CX-801. Varseta-M is a masked, conditionally activated ADC armed with a topoisomerase-1 inhibitor payload and directed toward epithelial cell adhesion molecule (EpCAM). EpCAM is a highly expressed tumor antigen that has previously been undruggable due to expression on normal tissues. Varseta-M is designed to open a therapeutic window for this high potential target and is initially being developed for the treatment of metastatic colorectal cancer. Varseta-M was discovered in collaboration with ImmunoGen, now part of AbbVie. CX-801 is a masked interferon alpha-2b PROBODY® cytokine with broad potential applicability in traditionally immuno-oncology sensitive as well as insensitive (cold) tumors. CX-801 is initially being developed for the treatment of metastatic melanoma. CytomX has established strategic collaborations with multiple leaders in oncology, including Amgen, Astellas, Bristol Myers Squibb, Regeneron and Moderna. For more information about CytomX and how it is working to make conditionally activated treatments the new standard-of-care in the fight against cancer, visit www.cytomx.com and follow us on LinkedIn and X (formerly Twitter).

Company Contact:
Chris Ogden
SVP, Chief Financial Officer
cogden@cytomx.com

Investor Contact:
Precision AQ (formerly Stern Investor Relations)
Stephanie Ascher
stephanie.ascher@precisionaq.com

Media Contact:
Precision AQ
Colleen Ketchum
colleen.ketchum@precisionaq.com

Galecto Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Galecto Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)




Galecto Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

BOSTON, March 04, 2026 (GLOBE NEWSWIRE) — Galecto, Inc. (NASDAQ: GLTO), a biotechnology company working to redefine care for people with hematologic disorders, today announced that it granted equity awards on March 2, 2026, to four newly-hired, non-executive employees. The inducement grants were approved by Galecto’s independent Compensation Committee and were made as material inducements to such individuals’ acceptance of employment with Galecto in accordance with Nasdaq Listing Rule 5635(c)(4).

The inducement grants consist of non-qualified stock options to purchase an aggregate of 153,700 shares of the Galecto’s common stock with a 10-year term and an exercise price of $29.58 per share. The options vest as to 25% on the first anniversary of the applicable grant date and in equal monthly installments for the following 36 months. The inducement grants are subject to the terms and conditions of the 2022 Galecto, Inc. Inducement Plan, and the terms and conditions of a stock option agreement.

About Galecto, Inc.

Galecto, Inc. is a clinical-stage biotechnology company advancing a pipeline of antibody therapeutics to transform treatment of a broad spectrum of hematological cancers. Galecto’s pipeline includes a highly differentiated mutant calreticulin (mut-CALR)-driven myeloproliferative neoplasm portfolio targeting essential thrombocythemia and myelofibrosis. Galecto’s pipeline also includes GB3226, a first-in-class preclinical dual inhibitor of ENL-YEATS and FLT3 for the treatment of multiple genetic subsets of acute myeloid leukemia.

Media Contact:
Lia Dangelico
Deerfield Group
lia.dangelico@deerfieldgroup.com

Investor Contact:
Brian Ritchie
LifeSci Advisors
britchie@lifesciadvisors.com

Genvor Announces Strategic Expansion into Health and Wellness Market, Leveraging Proprietary AI-Accelerated BioCypher Platform to Develop Consumer Peptide Solutions

Genvor Announces Strategic Expansion into Health and Wellness Market, Leveraging Proprietary AI-Accelerated BioCypher Platform to Develop Consumer Peptide Solutions




Genvor Announces Strategic Expansion into Health and Wellness Market, Leveraging Proprietary AI-Accelerated BioCypher Platform to Develop Consumer Peptide Solutions

Company’s proprietary peptide platform expands beyond agriculture into human recovery, performance, and wellness

Woodland, CA, March 04, 2026 (GLOBE NEWSWIRE) — Genvor, Inc. (OTCQB: GNVR), a biotechnology company harnessing AI to generate novel peptides that deliver high-performance solutions across agriculture and human health, today announced its formal entry into the human health and wellness sector, marking a significant expansion of its corporate strategy into consumer-focused biological innovation.

The expansion is powered by Genvor’s proprietary BioCypher™ platform, an AI-driven peptide generation engine backed by a library of millions of designed peptides that has already produced dozens of researched lead agricultural candidates across more than a dozen pathogens and multiple areas of crop protection. With health and wellness peptides already engineered within this library, Genvor is now leveraging the BioCypher platform to identify and advance the most promising candidates into safe, effective, and commercially viable consumer health and wellness products.

With global peptide therapeutics and supplements markets experiencing strong growth and projected to reach multi-billion-dollar valuations in the coming decade, Genvor is positioned to apply its deep scientific expertise and proven peptide design capabilities to meet surging consumer demand for science-backed recovery, performance, and wellness solutions. Industry analysts forecast the global peptide supplements market alone to grow from approximately USD $4.1 billion in 2025 to USD $11.2 billion by 2035, driven by rising consumer interest in muscle recovery, immune support, and bioavailable health products.

“Our BioCypher platform has already demonstrated its power across more than a dozen agricultural pathogens and multiple meaningful areas of crop protection,” said Chad Pawlak, Chief Executive Officer of Genvor. “Expanding into consumer health and wellness reflects our ability to unlock what has been in our library since the company’s founding. Advancing these product candidates into consumer markets is a natural evolution that creates multiple revenue pathways from a single platform. This expansion positions us to innovate responsibly while delivering meaningful value to customers, commercial partners and investors.”

Genvor’s BioCypher platform combines computational biology with machine learning to generate novel peptides faster than traditional R&D approaches, designing candidates optimized for both agricultural performance and human bioavailability. The company’s dual-market commercialization model pairs a licensing-first approach in agriculture with a direct-to-consumer model in human health, bringing targeted peptide-based recovery and performance solutions to market through strategic partnerships and retail channels.

Genvor is in discussions with strategic partners who bring authentic credibility, market access, and deep expertise in recovery and performance optimization. The company’s consumer health pipeline also includes applications in anti-aging, daily wellness, and targeted recovery formulations, all leveraging the same BioCypher-designed peptide sequences that underpin its agricultural programs.

As part of this strategic expansion, Genvor also announced a realignment of senior leadership responsibilities. George Stavrides, Executive Vice President of Business Development and Commercialization, will assume expanded oversight of the company’s agricultural commercialization initiatives, focusing on building revenue-producing collaborations and advancing licensing partnerships with Tier-1 agricultural companies. This ensures continuity and growth across Genvor’s established agricultural programs, which span eight crop targets across anti-pathogen and enhanced nutrition applications.

Pawlak will devote increased focus to capital markets strategy and the expansion of Genvor’s consumer peptide platform, including partnership development, research collaborations, and the coordination of regulatory, commercial, and investor interests as the company builds its presence in the health and wellness market.

Genvor welcomes new commercial partners, investors, financial institutions, and strategic collaborators to engage in this dynamic phase of growth as the company advances innovative peptide solutions across agriculture and human health and wellness.

About Genvor

Genvor, Inc. (OTCQB: GNVR) is a biotechnology company harnessing AI to generate novel peptides that deliver high-performance solutions across agriculture and human health. Genvor’s proprietary BioCypher platform designs peptides that enhance crop performance, reduce chemical inputs, and support human recovery and wellness. Through strategic partnerships and a dual-market commercialization model, Genvor is advancing peptide science from field to finish line. For more information, visit www.genvor.com.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are based on current expectations and projections about future events and are not guarantees of future performance. Forward-looking statements include, among others, statements regarding the potential benefits, outcomes, and scope of Genvor’s expansion into the health and wellness market, the development and commercialization of consumer peptide products, the growth of the peptide supplements market, the company’s partnership strategy, and the expected roles and responsibilities of the company’s leadership team. Actual results may differ materially from those expressed or implied. Factors that could cause such differences include, but are not limited to, research results, product development outcomes, regulatory developments, funding availability, market conditions, market adoption, competitive dynamics, and the ability to attract and retain strategic partners. Genvor undertakes no obligation to update or revise forward-looking statements, except as required by law.

Contact:
Carly Scaduto
carly@carlyscadutoconsulting.com


Pacira BioSciences to Participate in Fireside Chat at the Barclays 28th Annual Global Healthcare Conference

Pacira BioSciences to Participate in Fireside Chat at the Barclays 28th Annual Global Healthcare Conference




Pacira BioSciences to Participate in Fireside Chat at the Barclays 28th Annual Global Healthcare Conference

BRISBANE, Calif., March 04, 2026 (GLOBE NEWSWIRE) — Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to deliver innovative, non-opioid pain therapies to transform the lives of patients, today announced that it will participate in an analyst-led fireside chat at the Barclays 28th Annual Global Healthcare Conference at 2:30 PM ET on Wednesday, March 11, 2026 in Miami. Live audio of the event can be accessed by visiting the “Events” page of the company’s website at investor.pacira.com. A replay of the webcast will also be available for two weeks following the event.

About Pacira
Pacira delivers innovative, non-opioid pain therapies to transform the lives of patients. Pacira has three commercial-stage non-opioid treatments: EXPAREL® (bupivacaine liposome injectable suspension), a long-acting local analgesic currently approved for infiltration, fascial plane block, and as an interscalene brachial plexus nerve block, an adductor canal nerve block, and a sciatic nerve block in the popliteal fossa for postsurgical pain management; ZILRETTA® (triamcinolone acetonide extended-release injectable suspension), an extended-release, intra-articular injection indicated for the management of osteoarthritis knee pain; and iovera®º, a novel, handheld device for delivering immediate, long-acting, drug-free pain control using precise, controlled doses of cold temperature to a targeted nerve. The company is also advancing a pipeline of clinical-stage assets for musculoskeletal pain and adjacencies, its most advanced product candidate, PCRX-201 (enekinragene inzadenovec), a novel locally administered gene therapy in Phase 2 clinical development for osteoarthritis of the knee. To learn more about Pacira, visit www.pacira.com.

CONTACT: Company Contact:
Pacira BioSciences, Inc.
Christian Pedetti
(973) 254-4387
Christian.pedetti@pacira.com

Vasomune Therapeutics, Inc., and AnGes, Inc., Announce US FDA Clearance of Investigational New Drug (IND) Application For Pegevongitide (AV-001) Treatment in Resuscitation of Severely Burned Patients

Vasomune Therapeutics, Inc., and AnGes, Inc., Announce US FDA Clearance of Investigational New Drug (IND) Application For Pegevongitide (AV-001) Treatment in Resuscitation of Severely Burned Patients




Vasomune Therapeutics, Inc., and AnGes, Inc., Announce US FDA Clearance of Investigational New Drug (IND) Application For Pegevongitide (AV-001) Treatment in Resuscitation of Severely Burned Patients

TORONTO–(BUSINESS WIRE)–#ARDS–Vasomune Therapeutics, Inc., (“Vasomune”), a clinical-stage biopharmaceutical company, today announced U.S. Food and Drug Administration (FDA) clearance of the Investigational New Drug (IND) application to develop Pegevongitide (AV-001) for use in the acute resuscitation of severely burned patients. Pegevongitide, an injectable Tie2 agonist that blocks vascular leak, is currently being researched for the prevention and treatment of acute respiratory distress syndrome (ARDS) (NCT05123755).


“Vascular leak reflects a loss of endothelial barrier integrity, thereby allowing fluid and proteins to escape the intravascular space into surrounding tissues. This disrupts oxygen delivery, organ perfusion, and destabilizes hemodynamics. By activating the pivotal target Tie2, Pegevongitide targets a root mechanism of endothelial instability and leakage,” said Harold Kim, Ph.D., Vice-President of Research at Vasomune.

“In severely burned patients, vascular leak allows large volumes of fluid, proteins, and inflammatory mediators to shift from the bloodstream into injured and uninjured tissues,” said Dr. John C Kubasiak, Chief of Burn Surgery at Loyola University Medical Center in Chicago. “As a burn surgeon, I witness the impact of vascular leak driving profound edema, shock, impaired oxygen delivery, and multi-organ dysfunction.”

This new IND clearance allows Vasomune to initiate a clinical program evaluating Pegevongitide safety and efficacy in the resuscitation of severely burned patients. Pegevongitide offers a promising new approach by targeting the Tie2/Angiopoietin-1 signaling pathway to stabilize blood vessels, prevent vascular leakage and reduce vascular inflammation. Published preclinical data using Pegevongitide supports that this mechanism can reduce vascular leak and improve hemodynamic function.

Dr. Ei Yamada, President & CEO of AnGes, said that “We are encouraged by the FDA decision to allow the expansion of our AV-001 development program. Our commitment to developing AV-001 will allow us to take a step forward in the treatment of serious pathologies driven by vascular leak.”

About Vasomune Therapeutics, Inc.

Vasomune Therapeutics, Inc. is a private clinical-stage biopharmaceutical company developing the next generation of medicines to boost the body’s ability to defend against vascular leak. Founded in 2014, Vasomune has focused on vascular normalization strategies, and has progressed the lead candidate Pegevongitide (AV-001) from bench to bedside. Vascular dysfunction and vascular leak are associated with the pathology of several disease states, including bacterial and viral pneumonia and acute respiratory distress syndrome, sepsis, hemorrhagic shock, acute kidney injury, stroke, and vascular dementia. Vasomune’s corporate headquarters and laboratories are in Toronto, Canada with US offices in Raleigh, NC. For more information about the company please visit http://www.vasomune.com.

About AnGes, Inc.

AnGes, Inc., a biopharmaceutical company founded in December 1999, focuses on the development of gene-based medicines. The company’s flagship development product and genetic drug, HGF gene therapy products, received Breakthrough Therapy designation from the FDA in 2024. AnGes is currently working on the development of a Tie2 tyrosine kinase receptor agonist (AV-001) for viral and bacterial-associated pneumonia and an NF-κB decoy oligonucleotide for chronic discogenic lumbar back pain. Furthermore, AnGes acquired EmendoBio in December 2020 to expand its capabilities in genome-editing technologies. For more information, visit https://www.anges.co.jp/en/.

Contacts

Shahid Ahmad, Vice-President Operations and Planning

Vasomune Media Relations

sahmad@vasomune.com

Affinia Therapeutics Granted FDA Fast Track Designation for AFTX-201 as a Treatment for People Living with BAG3-Associated Dilated Cardiomyopathy (DCM)

Affinia Therapeutics Granted FDA Fast Track Designation for AFTX-201 as a Treatment for People Living with BAG3-Associated Dilated Cardiomyopathy (DCM)




Affinia Therapeutics Granted FDA Fast Track Designation for AFTX-201 as a Treatment for People Living with BAG3-Associated Dilated Cardiomyopathy (DCM)

An investigational medicine that addresses the genetic root cause of BAG3 DCM, AFTX-201 is being evaluated in the UPBEAT© clinical trial

AFTX-201 is designed using Affinia’s proprietary capsid engineered for efficient cardiac transduction at doses that are 5-10-fold lower than doses of gene therapies using conventional capsids

WALTHAM, Mass.–(BUSINESS WIRE)–Affinia Therapeutics (“Affinia”), an innovative gene therapy company with a pipeline of first-in-class and/or best-in-class adeno-associated virus (AAV) gene therapies initially for devastating cardiovascular diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation (FTD) for AFTX-201, a potential best-in-class investigational genetic medicine for the treatment of BAG3-associated dilated cardiomyopathy (DCM).


AFTX-201 is designed to deliver a fully human, full-length BAG3 transgene using Affinia’s proprietary capsid engineered for efficient cardiac transduction at doses that are 5-10-fold lower than those associated with gene therapies using conventional capsids such as AAV9 or AAVrh74. The safety and efficacy of AFTX-201 as a treatment for people living with BAG3 DCM is being investigated in the UPBEAT© clinical trial. AFTX-201 is given as a simple one-time intravenous administration. Preclinical studies in an animal disease model demonstrated that AFTX-201 increased BAG3 protein levels in the heart and completely restored cardiac function.

“We are grateful to the FDA for granting the Fast Track designation to AFTX-201 as a treatment for BAG3 DCM and to the patient and physician communities for their support of our UPBEAT clinical trial,” said Hideo Makimura, M.D., Ph.D., Chief Medical Officer at Affinia. “This Fast Track designation, together with the FDA’s recent approval of our IND application for AFTX-201 and the European Medicines Agency’s designation of AFTX-201 as an Orphan Drug, strengthens our conviction that AFTX-201 has the potential to significantly improve the lives of those affected by BAG3 DCM.”

“DCM is the leading cause of heart failure in young people and the most frequent indication for heart transplantation despite current treatments,” said Greg Ruf, Founder and Executive Director of the DCM Foundation. “People whose DCM is caused by a genetic mutation such as BAG3 may benefit from a gene therapy approach.”

Fast Track designation is designed to help drugs reach patients faster based on the drug’s potential to fill an unmet medical need and treat serious conditions. Programs receiving FTD benefit from early and frequent interactions with the FDA during the clinical development process and review of the marketing application on a rolling basis before the sponsor submits the complete application. If relevant criteria are met, the FDA may also consider an accelerated approval and priority review of the marketing application. These benefits could decrease the development time of the drug to approval.

About the UPBEAT© clinical trial

The UPBEAT clinical trial (NCT07426419 on clinicaltrials.gov) is a multicenter, single-arm, open-label Phase 1/2 clinical trial designed to evaluate the safety, tolerability, pharmacodynamics, and preliminary efficacy of AFTX-201 in adults with genetically confirmed BAG3-associated dilated cardiomyopathy. The trial includes a dose-exploration phase followed by a dose-expansion phase. All participants will receive a single intravenous infusion of AFTX-201 at a dose that has been deemed safe and efficacious based on preclinical studies. The primary objective of the trial is to evaluate safety and tolerability through 52 weeks following administration. Secondary and exploratory objectives include pharmacodynamic and preliminary efficacy assessments, which will be evaluated as changes from baseline. Study design, dose selection, and monitoring plans are informed by input from patients, clinicians, and regulators and by completed nonclinical proof-of-concept, biodistribution, and safety studies, which demonstrated complete correction of heart ejection fraction to normal (wild-type) level and adequate safety margin for the doses being explored in the clinical trial. Protocol-defined stopping rules, centralized safety data review, and oversight by an independent Data Safety Monitoring Board are implemented to ensure the safety of participants. Interested participants are encouraged to reach out to Affinia via clinicaltrials@affiniatx.com and to their medical care provider.

About Affinia Therapeutics

Affinia Therapeutics is a clinical-stage biotech company pioneering a shift to a new class of rationally designed gene therapies that treat rare and prevalent diseases. Affinia Therapeutics’ pipeline of first-in-class or best-in-class product candidates, initially in cardiovascular diseases, leverages its proprietary next-generation capsids, payloads, or manufacturing approaches and have shown efficacy, safety, and differentiation in relevant animal models. For more information, visit https://www.affiniatx.com.

Contacts

Media contact:
Kathy Vincent

kathy@kathyvincent.com
310-403-8951

Guardant Health Launches Coast-to-Coast Screening Tour, Bringing Shield Colon Cancer Blood Test to Over 100 Communities Across America

Guardant Health Launches Coast-to-Coast Screening Tour, Bringing Shield Colon Cancer Blood Test to Over 100 Communities Across America




Guardant Health Launches Coast-to-Coast Screening Tour, Bringing Shield Colon Cancer Blood Test to Over 100 Communities Across America

  • Shield Across America mobile screening tour launches during Colorectal Cancer Awareness Month to address nation’s dangerously low screening rates by bringing Shield blood test directly to Americans
  • Route will focus on rural communities across the country with the lowest screening rates and highest CRC incidence and mortality
  • Shield is proven to increase screening rates with a 93% adherence

PALO ALTO, Calif.–(BUSINESS WIRE)–Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced the launch of Shield Across America, a historic coast-to-coast mobile screening tour bringing Shield, the first and only FDA-approved blood test as a primary colorectal cancer (CRC) screening option and recommended in national guidelines, directly to over 100 communities across the country from Las Vegas to Hartford, Atlanta and more.




From national sporting events to rural senior centers and beyond, the tour will educate patients on the importance of CRC screening and provide patients of screening-eligible age the opportunity to screen with Shield via the mobile screening lab. The Shield Across America tour will focus on rural areas that face the biggest barriers to colorectal cancer screening and the highest incidence and mortality rates.

The tour launch coincides with National CRC Awareness Month, underscoring Guardant Health’s commitment to close America’s colorectal cancer screening gap and help more Americans get screened.

CRC remains the second leading cause of cancer-related deaths in the U.S., and recently the leading cancer death for those under 50. Despite being highly treatable when caught early, more than 54 million eligible Americans – 1 in 3 – do not complete their CRC screening because they find current options unpleasant or inconvenient. Shield Across America aims to eliminate the barriers that have kept many Americans from getting screened by expanding access to Shield through mobile screening lab stops nationwide.

“Shield Across America seeks to address a fundamental challenge in colorectal cancer screening in our country: access,” said AmirAli Talasaz, Guardant Health co-CEO. “By bringing screening directly to where Americans live, work and enjoy with a focus on our rural communities who face some of the biggest barriers to screening, we aim to encourage more people to get their lifesaving screening and close our nation’s screening gap.”

Shield is proven to increase screening rates in the real world, with 93% of patients completing the test in the first 100,000 Shield tests ordered – a significant improvement in screening adherence rates over other types of tests.1 Recently, the National Comprehensive Cancer Network included the Shield blood test in its updated CRC screening guidelines, paving the way for improved patient access and additional major clinical guideline inclusions.

Built on Guardant’s proprietary technology pioneered more than a decade ago, Shield is covered by Medicare, the Veterans Affairs Community Care Network and TRICARE, for active-duty service members, and is commercially available across the U.S.

Shield is available by prescription only and can be completed during a routine doctor’s visit. To find a screening event near you or find more details on the Shield test to discuss with your local provider, visit ShieldAcrossAmerica.com.

About Shield

Shield is a methylation partitioning cell-free DNA (mp-cfDNA) non-invasive, blood-based screening test that detects alterations associated with colorectal cancer in the blood. It is intended as a screening test for individuals at average risk for the disease, age 45 or older, and is not intended for individuals at high risk for colorectal cancer. The Shield test can be considered in a manner similar to guideline-recommended non-invasive CRC screening options and can be completed during any healthcare visit. A positive Shield result raises concern for the presence of colorectal cancer or advanced adenoma and the patient should be referred for colonoscopy evaluation.

About Guardant Health

Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer and treatment selection for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook.

Guardant Health Forward-Looking Statements

This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential utilities, values, benefits and advantages of Guardant Health’s liquid biopsy tests or assays, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect Guardant Health’s financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” and elsewhere in its Annual Report on Form 10-K for the year ended December 31, 2025 and in its other reports filed with or furnished to the Securities and Exchange Commission. The forward-looking statements in this press release are based on information available to Guardant Health as of the date hereof, and Guardant Health disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Guardant Health’s views as of any date subsequent to the date of this press release.

 

1 Inadomi JM, Vijan S, Janz NK, et al. Adherence to colorectal cancer screening: a randomized clinical trial of competing strategies. Arch Intern Med. 2012;172(7):575-582.

Contacts

Investor Contact:
Zarak Khurshid

investors@guardanthealth.com

Media Contact:
Meaghan Smith

press@guardanthealth.com

Theolytics Awarded €8 million in Horizon Europe 2025 Grant Funding to Advance Phase 2 Study of THEO-260 in Ovarian Cancer

Theolytics Awarded €8 million in Horizon Europe 2025 Grant Funding to Advance Phase 2 Study of THEO-260 in Ovarian Cancer




Theolytics Awarded €8 million in Horizon Europe 2025 Grant Funding to Advance Phase 2 Study of THEO-260 in Ovarian Cancer

  • Pending final negotiation, grant will fund up to 20 patients in the OCTOPOD-IV Phase 2a expansion study of THEO-260 in platinum-resistant ovarian cancer
  • Competitive funding award highlights Theolytics’ innovative science and strong clinical development plan
  • Application coordinated with several major international clinical centres and world-class partners

Oxford UK, March 4, 2026. Theolytics, a clinical-stage biotechnology company developing next-generation oncolytic immunotherapies, has been awarded, pending final negotiation, €8 million in non-dilutive grant funding from Horizon Europe 2025, the European Union’s flagship research and innovation funding programme. Horizon Europe 2025 is supporting high-impact clinical-stage projects aimed at improving patient outcomes and strengthening Europe’s scientific leadership. The grant to Theolytics will provide significant financial support to advance the company’s Phase 2 OCTOPOD-IV clinical trial evaluating THEO-260, its novel therapeutic candidate designed to address unmet needs in patients with advanced ovarian cancer.

Positioned to tackle the complex, immune-suppressed nature of advanced solid tumours, THEO-260 is an oncolytic immunotherapy designed for effective killing of both cancer cells and cancer-associated fibroblasts (CAFs), while inducing immune activation. Platinum-resistant ovarian cancer represents a prototype of a broader category of stroma-rich solid tumours for which THEO-260 is being developed.

Margaret Duffy, CSO and Co-founder of Theolytics, said, “Our collective success with this grant award reflects the extraordinary work being done by the team at Theolytics, and the calibre of our clinical and translational partner centres. The Horizon Europe award validates both the scientific rationale behind our THEO-260 programme and the huge potential of its novel oncolytic and ‘CAF-lytic’ mechanism to address a significant unmet need in stroma-rich solid cancers. By integrating advanced translational analyses into our clinical trial design, we will clinically demonstrate the differentiated mechanism of action of THEO-260 and provide key data to advance this programme and deliver true impact for cancer patients.”

This highly competitive Horizon Europe 2025 award follows a rigorous grant review process and highlights the company’s innovative science, strong technical area expertise, clear clinical development plan and the opportunity for THEO-260 to address a clear unmet patient need.

The grant application was coordinated with several major partners, expert clinical and translational centres involved in the OCTOPOD-IV study and includes the University of Navarra, Catalan Institute of Oncology in Spain; the Princess Margaret Hospital in Toronto, Canada; and The Institute of Cancer Research (ICR) in London, UK. Two thirds of the funds will be received directly by Theolytics to advance the OCTOPOD-IV Phase 2a expansion trial, and the other third will be deployed directly to the partners in support of their work on the trial.

OCTOPOD-IV (NCT06618235) is a first-in-human, multi-centre trial to assess safety, tolerability and preliminary efficacy of THEO-260 in patients with high-grade serous ovarian or endometrioid cancer. In addition, the trial is designed to determine the recommended Phase 2 dose and demonstrate THEO-260’s differentiated cancer/cancer-associated fibroblast-lytic mechanism of action in patients through comprehensive biomarker analysis.

Prof Alan Melcher, Professor of Translational Immunotherapy at The Institute of Cancer Research, London, said, “The differentiated mechanism of action – targeting the stroma and inducing immune activity in the suppressed tumour microenvironment (TME) – of this oncolytic immunotherapy THEO-260 offers the potential to provide an important new treatment option for patients with advanced solid tumours. We are pleased to support the OCTOPOD-IV study, for which the ICR will provide important translational data to assess this novel and promising approach.”

Dr Antonio González, Director of the Department of Medical Oncology and Cancer Center at the Clínica Universidad de Navarra, and President of the Spanish Cooperative Group for Gynaecological Cancer Research, added, “We see many women with advanced platinum-resistant ovarian cancer, whose life expectancy is typically only a year or less. There remains a serious lack of effective treatment options for these women, and so we are hopeful that THEO-260 may bring an advance in therapy that will improve and extend the lives of our patients.”

Recruitment at UK and Spanish clinical sites for OCTOPOD-IV is ongoing and will now expand into further international centres (including additional sites in Spain and Canada). A second clinical trial (OCTOPOD-IP) in the US, which will investigate intraperitoneal (IP) delivery of THEO-260 to advanced ovarian cancer patients, has also been initiated in collaboration with The University of Texas MD Anderson Cancer Center (NCT07211659).

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About Theolytics

Theolytics is working to develop best-in-class oncolytic immunotherapies. The company has pioneered a new approach to develop efficacious, targeted adenoviral candidates suitable for direct and systemic intravenous delivery.

The company is focused on the advancement of its lead programme THEO-260 in clinical trials with the ambition of providing better outcomes for patients with stroma-rich solid cancers, for whom current treatment options are limited. Additional pipeline programmes in preclinical development include novel candidates developed for colorectal cancer and haematological malignancies where there remains significant unmet need.

Theolytics was founded in 2017, is headquartered in Oxford UK, and is backed by international life sciences investors Taiho Ventures, M Ventures, Oxford Science Enterprises, Epidarex Capital, Sound Bioventures, BGF and Oxford University Innovation.

For more information, please see our website www.theolytics.com

About Horizon Europe 2025 Programme

The ‘Boosting the translation of biotech research into innovative health therapies’ topic, which forms part of the wider Horizon Europe 2025 Health initiative, is designed to accelerate the translation of promising biotech research into clinical development and aims to deliver the following outcomes:

  • Faster access to innovative therapies for healthcare providers, researchers and patients
  • Increased number of clinical trials evaluating novel biotech therapeutic approaches conducted within the European Union
  • Strengthened competitiveness of small and medium-size enterprises (SMEs) in the EU and Associated Countries within the health biotech sector

More information on the Horizon Europe Health initiative can be found here.

Contact

Theolytics

David Apelian, CEO

enquiries@theolytics.com

MEDiSTRAVA

Frazer Hall, Mark Swallow

Theolytics@medistrava.com