Cassava Sciences Appoints Dr. Joseph Hulihan as Chief Medical Officer

By: Cassava Sciences, Inc. via GlobeNewswire

August 07, 2025 at 07:30 AM EDT

Joseph Hulihan, MD, MSHP, brings substantial clinical development experience advancing novel therapies for TSC-related epilepsy and other neurological disorders
Clinical study for simufilam in TSC-related epilepsy expected to begin in H1 2026

AUSTIN, Texas, Aug. 07, 2025 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (NASDAQ: SAVA, “Cassava”, the “Company”), a clinical-stage biotechnology company focused on developing novel, investigational treatments for central nervous system (CNS) disorders, today announced the appointment of Dr. Joseph Hulihan as Chief Medical Officer (CMO). Dr. Hulihan will devote approximately half of his professional time to Cassava, advising on the clinical development of simufilam, Cassava’s investigational candidate for the treatment of Tuberous Sclerosis Complex (TSC)-related epilepsy.

Dr. Hulihan is an accomplished clinician with over 25 years of experience in industry, specializing in the development of therapeutics for epilepsy and other neurological disorders. Dr. Hulihan previously served as Chief Medical Officer at Marinus Pharmaceuticals and as a senior Global Medical Affairs Leader at the Janssen Pharmaceutical Companies of Johnson & Johnson. Dr. Hulihan is board certified in Neurology and Electroencephalography (EEG).

“We are pleased to welcome Dr. Hulihan to Cassava. He brings a keen understanding of clinical drug development strategies for TSC-related epilepsy, with strong connections to the TSC community. As we prepare to initiate the clinical program for simufilam as a potential treatment for TSC-related epilepsy, we believe Joe’s experience will play a vital role in the program’s success,” said Rick Barry, President and Chief Executive Officer of Cassava.

“Advancing innovative neurotherapeutics has been the focus of my career, and I look forward to doing so again here at Cassava with simufilam as a potential first-in-class treatment for TSC-related epilepsy,” commented Dr. Hulihan. “I am excited about simufilam’s novel mechanism of action and about initiating a proof-of-concept study in the first half of 2026.”

Prior to joining Cassava, Dr. Hulihan focused on the development of ganaxolone for seizure disorders including TSC-related epilepsy as CMO at Marinus, which was acquired by Immedica Pharma in March 2025. At the Janssen and Ortho-McNeil Pharmaceutical groups of Johnson & Johnson, Dr. Hulihan held senior leadership roles in Medical Affairs in Neuroscience and CNS Research. Dr. Hulihan has served as a principal investigator, member of clinical development teams, group supervisor, and study physician on more than 25 late-stage neurology-focused clinical trials and authored more than 70 published papers. Dr. Hulihan received his medical degree from Drexel University School of Medicine, with Honors in Neurology. He also earned a Master of Science in Health Policy from the Jefferson School of Population Health.

About Cassava Sciences, Inc.

Cassava Sciences, Inc. (NASDAQ: SAVA), is a clinical-stage biotechnology company focused on developing novel, investigational treatments, including simufilam, for central nervous system disorders, such as tuberous sclerosis complex (TSC)-related epilepsy, and potentially other indications. Simufilam is a proprietary, investigational oral small molecule believed to modulate activity of the filamin A protein, which regulates diverse aspects of neuronal development. The Company is based in Austin, Texas.

For more information, please visit: https://www.CassavaSciences.com.

For More Information Contact:

Investors
Sandya von der Weid
svonderweid@lifesciadvisors.com

Company
Eric Schoen, Chief Financial Officer
(512) 501-2450
ESchoen@CassavaSciences.com
IR@cassavasciences.com

Cautionary Note Regarding Forward-Looking Statements:

This news release contains forward-looking statements that may include but are not limited to statements regarding: the clinical development of simufilam as a potential treatment for TSC-related epilepsy, our plans to conduct a clinical study with simufilam in H1 2026, and the potential for simufilam as a treatment for TSC-related epilepsy and other potential indications. These statements may be identified by words such as “anticipate”, “before”, “believe”, “could”, “expect”, “forecast”, “intend”, “may”, ”pending”, “plan”, “possible”, “potential”, “prepares for”, “will”, and other words and terms of similar meaning.

Such statements are based on our current expectations and projections about future events. Such statements speak only as of the date of this news release and are subject to a number of risks, uncertainties and assumptions, including, but not limited to, those risks relating to the ability to advance studies related to TSC-related epilepsy and other potential indications, and other risks inherent in drug discovery and development or specific to Cassava Sciences, Inc., as described in the section entitled “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024, and subsequent reports to be filed with the SEC. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from expectations in any forward-looking statement. In light of these risks, uncertainties, and assumptions, the forward-looking statements and events discussed in this news release are inherently uncertain and may not occur, and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Accordingly, you should not rely upon forward-looking statements as predictions of future events. Except as required by law, we disclaim any intention or responsibility for updating or revising any forward-looking statements. For further information regarding these and other risks related to our business, investors should consult our filings with the SEC, which are available on the SEC's website at www.sec.gov.

All of our pharmaceutical assets under development are investigational product candidates. These have not been approved for use in any medical indication by any regulatory authority in any jurisdiction and their safety, efficacy or other desirable attributes, if any, have not been established in any patient population. Consequently, none of our product candidates is approved or available for sale anywhere in the world.

Our clinical results from earlier-stage clinical trials or preclinical studies may not be indicative of future results from later-stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements or any scientific data we present or publish.

We are in the business of new drug discovery and development. Our research and development activities are long, complex, and costly and involve a high degree of risk. Holders of our common stock should carefully read our Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q in their entirety, including the risk factors therein. Because risk is fundamental to the process of drug discovery and development, you are cautioned not to invest in our publicly traded securities unless you are prepared to sustain a total loss of the money you have invested.