Genomics data suggests having an active Klotho gene sequence may help people live longer, healthier lives

The Company was granted patents in Europe, China, and Hong Kong and awaits issuance of patents in the U.S. and Canada

NEW YORK, July 9, 2024 — ANEW MEDICAL, INC. (NASDAQ: WENA) (“ANEW”), a biopharmaceutical company specializing in the advancement of novel disease-modifying therapies for neurological and age-related disorders, announces plans to advance its recently patented Klotho gene therapy program for neurodegenerative disorders.

ANEW has compelling initial data suggesting that maintaining elevated levels of Klotho in the body significantly contributes to longer, healthier lifespans. Conversely, the data reveals that individuals with depleted or lower-than-normal levels of Klotho are more susceptible to neurodegenerative disorders such as ALS, Alzheimer’s, and Parkinson’s Disease. ANEW will also investigate other age-related disorders associated with depleted Klotho levels, such as memory loss, osteoporosis, sarcopenia (muscle wasting), diabetes mellitus, and certain cardiovascular conditions.

Dr. Joseph Sinkule, CEO and Founder of ANEW MEDICAL, commented: “Administering a medication based on the Klotho isoform of interest, secreted Klotho (s-KL), may contribute to longer, healthier lives. Research by our strategic partner, the Okinawa Research Center for Longevity Science (ORCLS) in Japan, suggests that the Klotho gene is a key factor in age-related longevity. Klotho emerged as one of the two most significant genes from their studies, and we look forward to continuing our research with ORCLS as we advance ANEW’s clinical development programs for Neurodegenerative Disorders.”

ANEW has development plans to advance its program in three distinct areas:

• FDA Clinical Trials: The development of therapeutics to treat neurodegenerative diseases and age-related disorders involves using an adenovirus (AAV) vector to deliver the secreted Klotho gene DNA sequence to neurons in the central nervous system (CNS). This approach aims to correct deficiencies in the levels of s-KL.

• Klotho Diagnostics: The development and commercialization of a diagnostic that will enable healthcare providers to accurately quantify levels of Klotho gene and protein isoforms in blood samples. This tool will also provide ANEW with the necessary diagnostic to screen patients for its clinical trials.

• Age-Related Disorders: ANEW plans to develop exploratory approaches to promote longevity in healthy populations using gene or cell-based Klotho therapies, as well as other genes of interest that are directly related to longevity.

Dr. Shalom Hirshman, M.D., Chief Medical Advisor and Board member, stated: “ANEW is in a strong position to significantly influence the treatment of ALS, Alzheimer’s, and other neurodegenerative disorders. With our patent-protected gene therapy platform technology, we have the potential to improve health and extend life expectancy.”

About ANEW MEDICAL, INC.:

ANEW MEDICAL is a biopharmaceutical company specializing in the advancement of novel disease-modifying therapies for neurological and age-related disorders. The company’s focus on central nervous systems (CNS) diseases utilizing cell and gene therapies to mitigate age-related pathologies such as Alzheimer’s disease, dementia symptoms and neuromuscular diseases. The Company has exclusive worldwide rights to develop and commercialize proprietary product platforms based on its proprietary isoform transcribed from the human Klotho gene referred to as secreted Klotho or “s-KL”. This s-KL protein or gene therapy has been recognized for its potential to mitigate age-related pathologies such as ALS, Alzheimer’s and Parkinson’s Disease. The Company is also evaluating other core technology platforms to acquire for development and commercialization by the Company. For more information, please visit: www.anewmeds.com.

About Klotho:

Klotho is a gene that is integral to aging and cognitive function. The gene encodes two main protein variants: the full-length Klotho which is produced in the kidneys to regulate phosphate and calcium, and the secreted Klotho (s-KL) which is an RNA splice variant primarily synthesized in the brain. The s-KL variant is essential for maintaining normal brain and neurological functions. ANEW’s gene therapy program targeting klotho shows significant potential in treating age-related diseases like Amyotrophic Lateral Sclerosis (ALS), Alzheimer’s Disease, and Parkinson’s Disease. ANEW’s s-KL programs are advancing the use of Klotho as a target for gene and cell therapies, as well as in diagnostics for neurological and age-related disorders.

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.

For more information, contact:

Investor Relations and Public Relations

Eric Boyd eric@anewmeds.com

or

PCG Advisory LLC.

Jeff Ramson or Adam Holdsworth
Email: ir@anewmeds.com
Website: www.anewmeds.com

Source: ANEW MEDICAL, Inc.