Universitat Autònoma de Barcelona

Theriva Biologics and the Universitat Autònoma de Barcelona to receive a total of €2.28 Million to support the THERICEL project, a suspension cell platform for manufacturing viral-based therapiesROCKVILLE, Md., Sept. 16, 2024 (GLOBE NEWSWIRE) -- Theriva™ Biologics (NYSE American: TOVX), (“Theriva” or the “Company”) a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced that the THERICEL project has been awarded funding of €2.28 million from the National Knowledge Transfer Program of the Spanish government’s Ministry of Science, Innovation & Universities to support a collaboration between the Company and the Universitat Autònoma de Barcelona (UAB) to advance the Company’s suspension cell platform for the clinical manufacture of adenovirus- and adeno-associated virus (AAV) therapies. Under the award, Theriva will receive a loan of €1.33 million as a lump sum payment in Q4 2024 which shall be repaid over 7 years commencing three years from the date of award and UAB will receive a grant of €0.95 million dedicated to the THERICEL project and paid in annual installments over the next 3 years. The THERICEL project is intended to establish the viability of using proprietary Theriva’s A549 suspension cell platform for the clinical manufacture of adenoviral and AAV therapies. Suspension cell manufacture is expected to dramatically increase efficiency and decrease the cost of manufacturing compared to currently used adherent cell platforms. Theriva efforts under the award will focus on scaling-up the manufacture of VCN-01, the Company’s lead oncolytic virus product candidate currently undergoing Phase 2b clinical evaluation in patients with newly diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC). UAB researchers will evaluate the potential utility of the suspension cell line for the manufacture of AAV products for use in gene therapy. “We are honored to receive this funding award, which provides additional capital and external validation of our therapeutic approach,” said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. “This award will accelerate the start-up for our innovative suspension cell platform, which we believe will further position Theriva at the forefront of oncolytic virus development and may provide collaborative opportunities in product manufacture. Together with our collaborators at the Universitat Autònoma de Barcelona, we look forward to working towards our shared mission of addressing the high unmet needs of patients.” The Ministry of Science, Innovation & Universities funding was obtained through a competitive review process under a State scientific and technical innovation plan to support public-private collaborative projects (Proyectos en colaboración público-privada 2023). Funding for Theriva is awarded in the form of an unsecured loan at an interest rate of 4.015%, with a fixed 3-year grace period before the first repayment is due along with accrued interest. After the grace period, the maximum repayment period is 7 years. About Theriva™ Biologics, Inc. Theriva™ Biologics (NYSE American: TOVX), is a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need. The Company is advancing a new oncolytic adenovirus platform designed for intravenous (IV), intravitreal and antitumoral delivery to trigger tumor cell death, improve access of co-administered cancer therapies to the tumor, and promote a robust and sustained anti-tumor response by the patient’s immune system. The Company’s lead candidates are: (1) VCN-01, an oncolytic adenovirus designed to replicate selectively and aggressively within tumor cells, and to degrade the tumor stroma barrier that serves as a significant physical and immunosuppressive barrier to cancer treatment; (2) SYN-004 (ribaxamase) which is designed to degrade certain commonly used IV beta-lactam antibiotics within the gastrointestinal (GI) tract to prevent microbiome damage, thereby limiting overgrowth of pathogenic organisms such as VRE (vancomycin resistant Enterococci) and reducing the incidence and severity of acute graft-versus-host-disease (aGVHD) in allogeneic hematopoietic cell transplant (HCT) recipients; and (3) SYN-020, a recombinant oral formulation of the enzyme intestinal alkaline phosphatase (IAP) produced under cGMP conditions and intended to treat both local GI and systemic diseases. For more information, please visit Theriva Biologics’ website at www.therivabio.com. Forward-Looking Statement This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases forward-looking statements can be identified by terminology such as “may,” “should,” “potential,” “continue,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” and similar expressions, and include statements regarding the potential of Theriva’s suspension cell platform to dramatically increase efficiency and decrease the cost of manufacturing of virus and AAV therapies, Theriva receiving a loan of €1.33 million as a lump sum payment in Q4 2024 and UAB receiving a total of €0.95 million paid in annual installments over the next 3 years; the THERICEL project establishing the viability of using proprietary Theriva’s A549 suspension cell platform for the clinical manufacture of adenoviral and AAV therapies; suspension cell manufacture dramatically increasing efficiency and decreasing the cost of manufacturing compared to currently used adherent cell platforms; the award accelerating the start-up for the Company’s innovative suspension cell platform; the award further positioning Theriva at the forefront of oncolytic virus development and providing collaborative opportunities in product manufacture; and working with collaborators at UAB towards the shared mission of addressing the high unmet needs of patients. Important factors that could cause actual results to differ materially from current expectations include, among others, the Company’s ability to accelerate the start-up for its innovative suspension cell platform; the Company’s ability to utilize the award funding successfully; the Company’s and VCN’s ability to reach clinical milestones when anticipated, including the ability of the suspension cell platform to manufacture virus and AAV products at appropriate the required quality and scale for clinical use, generating clinical data that establishes VCN-01 may lead to improved clinical outcomes for patients with PDAC and other solid cancers; the Company’s and VCN’s product candidates demonstrating safety and effectiveness, as well as results that are consistent with prior results; the ability to complete clinical trials on time and achieve the desired results and benefits; the ability to obtain regulatory approval for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to the Company’s and VCN’s ability to promote or commercialize their product candidates for the specific indications, acceptance of product candidates in the marketplace and the successful development, marketing or sale of the Company’s and VCN’s products, developments by competitors that render such products obsolete or non-competitive, the Company’s and VCN’s ability to maintain license agreements, the continued maintenance and growth of the Company’s and VCN’s patent estate, the ability to continue to remain well financed, and other factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 and its other filings with the SEC, including subsequent periodic reports on Forms 10-Q and current reports on Form 8-K. The information in this release is provided only as of the date of this release, and Theriva Biologics undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law. For further information, please contact:Investor Relations: Chris CalabreseLifeSci Advisors, LLCccalabrese@lifesciadvisors.com917-680-5608 Source: Theriva Biologics, Inc.

Issuance of the Klotho gene-therapy patent will be instrumental in protecting ANEW’s IP for development and commercialization in the U.S.NEW YORK, Aug. 15, 2024 (GLOBE NEWSWIRE) -- ANEW MEDICAL, INC. (“ANEW” or “the Company”) (NASDAQ: WENA) a U.S. -based biotechnology company focused on developing cell and gene-based treatments for aging, and age-related diseases, today announced the grant and issuance of U.S. Patent No. 12,036,268 (“the 268 patent”) covering the secreted RNA splice variant of the human Klotho gene, referred to as “s-KL”, for the treatment of cognitive and neurodegenerative diseases. The human Klotho gene, sometimes referred to as the “anti-aging” gene, also controls many normal brain and neurologic functions. The Klotho gene-therapy patent in the U.S. is instrumental new intellectual property (“IP”) protecting its development and commercialization in the U.S. ANEW previously announced that patents have already been granted and issued in Europe, China, and other Asian markets. ANEW’s IP portfolio has been licensed on an exclusive worldwide basis from the Universitat Autònoma de Barcelona (UAB) and Institució Catalana De Recerca Estudis Avançats (ICREA) in Barcelona, Spain, and provides ANEW with rights to develop and commercialize novel genetic approaches for the treatment of neurodegenerative diseases, including Alzheimer’s, amyotrophic lateral sclerosis (ALS or “Lou Gehrig’s disease”), Parkinson’s disease, and other age-related disorders. Replacing or augmenting the production of the gene product, s-KL, may also be used to support longevity. “This is a major win for ANEW and our shareholders,” commented Dr. Joseph Sinkule, the Founder, Chairman and CEO of ANEW. “It provides us with the protection we need to successfully move forward with the development of our innovative protein, cell and gene therapies using our patented sequence and use of s-KL secreted Klotho RNA splice variant sequence and delivery systems to treat these devastating neurodegenerative diseases. With the issuance of this important patent in the USA, ANEW has secured an enviable global IP position with patents already issued in Europe, China, Hong Kong, and Japan.” About ANEW MEDICAL, INC.ANEW MEDICAL, INC. (NASDAQ: WENA) is a biopharmaceutical company specializing in the development of patented, novel disease-modifying technologies targeting the brain and central nervous system (CNS) that are seen as key developments in treating neurodegenerative and age-related disorders. The Company obtained exclusive worldwide rights to platform technologies and knowhow to develop cutting edge protein, gene and cell therapies to treat age-related pathologies such as Alzheimer’s and Parkinson’s Disease, ALS, multiple sclerosis and rare neurodegenerative diseases. The company is managed by a team of individuals and advisors who are highly experienced in biopharmaceutical product development and commercialization. For more information, contact:Eric BoydInvestor RelationsEmail: IR@anewmeds.com Forward-Looking Statements:This press release contains forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions. Without limiting the generality of the foregoing, the forward-looking statements in this press release include descriptions of the Company’s future commercial operations. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, such as the Company’s inability to implement its business plans, identify and realize additional opportunities, or meet or exceed its financial projections and changes in the regulatory or competitive environment in which the Company operates. You should carefully consider the foregoing factors and the other risks and uncertainties described in the documents filed or to be filed by the Company with the U.S. Securities and Exchange Commission (the “SEC”) from time to time, which could cause actual events and results to differ materially from those contained in the forward-looking statements. Copies of these documents are available on the SEC’s website, www.sec.gov. All information provided herein is as of the date of this press release, and the Company undertakes no obligation to update any forward-looking statement, except as required under applicable law.

Researchers have developed -- and shared -- a process for creating brain cortical organoids -- essentially miniature artificial brains with functioning neural networks. Researchers worldwide can now create highly realistic brain cortical organoids -- essentially miniature artificial brains with functioning neural networks -- thanks to a proprietary protocol released this month by researchers at the University of California San Diego. The new technique, published in Nature Protocols, paves the way for scientists to perform more advanced research regarding autism, schizophrenia and other neurological disorders in which the brain's structure is usually typical, but electrical activity is altered. That's according to Alysson Muotri, Ph.D., corresponding author and director of the UC San Diego Sanford Stem Cell Institute (SSCI) Integrated Space Stem Cell Orbital Research Center. The SSCI is directed by Dr. Catriona Jamieson, a leading physician-scientist in cancer stem cell biology whose research explores the fundamental question of how space alters cancer progression. The newly detailed method allows for the creation of tiny replicas of the human brain so realistic that they rival "the complexity of the fetal brain's neural network," according to Muotri, who is also a professor in the UC San Diego School of Medicine's Departments of Pediatrics and Cellular and Molecular Medicine. His brain replicas have already traveled to the International Space Station (ISS), where their activity was studied under conditions of microgravity. Two other protocols for creating brain organoids are publicly accessible, but neither allow researchers to study the brain's electrical activity. Muotri's method, however, allows researchers to study neural networks created from the stem cells of patients with various neurodevelopmental conditions. "You no longer need to create different regions and assemble them together," said Muotri, adding that his protocol allows different brain areas -- like the cortex and midbrain -- "to co-develop, as naturally observed in human development." "I believe we will see many derivations of this protocol in the future for the study of different brain circuits," he added. Such "mini brains" can be used to test potentially therapeutic drugs and even gene therapies before patient use, as well as to screen for efficacy and side effects, according to Muotri. A plan to do so is already in the works. Muotri and researchers at the Federal University of Amazonas in Manaus, Amazonas, Brazil, are teaming up to record and investigate Amazonian tribal remedies for Alzheimer's disease -- not on Earth-based mouse models, but on diseased human brain organoids in space. A recent Humans in Space grant -- awarded by Boryung, a leading health care investment company based in South Korea -- will help fuel the research project, which spans multiple continents and habitats, from the depths of the Amazon rainforest to Muotri's lab on the coast of California -- and, eventually, to the International Space Station. Other research possibilities for the brain organoids include disease modeling, understanding human consciousness and additional space-based experiments. In March, Muotri -- in partnership with NASA -- sent to space a number of brain organoids made from the stem cells of patients with Alzheimer's disease and ALS (amyotrophic lateral sclerosis, also known as Lou Gehrig's disease). The payload returned in May and results, which will eventually be published, are being reviewed. Because microgravity mimics an accelerated version of Earth-based aging, Muotri should be able to witness the effects of several years of disease progression while studying the month-long mission's payload, including potential changes in protein production, signaling pathways, oxidative stress and epigenetics. "We're hoping for novel findings -- things researchers haven't discovered before," he said. "Nobody has sent such a model into space, until now." Co-authors of the study include Michael Q. Fitzgerald, Tiffany Chu, Francesca Puppo, Rebeca Blanch and Shankar Subramaniam, all of UC San Diego, and Miguel Chillón, of the Universitat Autònoma de Barcelona and the Institució Catalana de Recerca i Estudis Avançats, both in Barcelona, Spain. Blanch is also affiliated with the Universitat Autònoma de Barcelona. This work was supported by the National Institutes of Health R01MH100175, R01NS105969, MH123828, R01NS123642, R01MH127077, R01ES033636, R21MH128827, R01AG078959, R01DA056908, R01HD107788, R01HG012351, R21HD109616, R01MH107367, California Institute for Regenerative Medicine (CIRM) DISC2-13515 and a grant from the Department of Defense W81XWH2110306.