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CymaBay Therapeutics Hosting Virtual Analyst Day on September 22

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CymaBay Therapeutics (NASDAQ: CBAY) announced a virtual analyst day on September 22, 2022, focusing on seladelpar, its leading asset for treating primary biliary cholangitis (PBC). The event will feature insights from hepatology expert Kris Kowdley, alongside presentations from CymaBay's leadership about the clinical development progress of seladelpar. PBC is a chronic liver disease primarily affecting women, characterized by impaired bile flow and potential serious health risks. Seladelpar, a first-in-class oral PPARδ agonist, aims to address unmet medical needs in PBC treatment.

Positive
  • Seladelpar is in late-stage development for treating PBC, which is a significant medical need.
  • CymaBay has received breakthrough therapy designation and orphan drug status, enhancing seladelpar's approval prospects.
Negative
  • Forward-looking statements entail risks related to product development success and regulatory approvals.
  • Potential delays or inability to secure financing could hinder the commercialization of seladelpar.

Redefining Expectations for PBC Patients

September 22, 2022 at 10:30 AM ET

NEWARK, Calif., Sept. 14, 2022 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, today announced that management will host a virtual analyst day on seladelpar, the company’s lead asset in development for patients with the autoimmune liver disease, primary biliary cholangitis (PBC) on Thursday, September 22, 2022 at 10:30 am Eastern Time.

The Analyst Day will feature a presentation from a hepatology key opinion leader, Kris Kowdley, MD, FACP, FACG, AGAF, FAASLD, Director of Liver Institute Northwest and Professor of Medicine at Washington State University, who will discuss the current treatment landscape and future goals for treating patients with PBC.

CymaBay’s seladelpar is a potent, selective, orally active delpar or PPARδ agonist, in late-stage development for patients with PBC. Members of CymaBay’s leadership team will discuss updates on the seladelpar clinical development program, recently presented data, and potential patient impact in the U.S. and globally.

A live question and answer session will follow the formal presentations. To register for the event, please click here or visit https://lifesci.rampard.com/WebcastingAppv5/Events/eventsDispatcher.jsp?Y2lk=MTk5NA==.

About PBC
PBC is a rare, chronic inflammatory liver disease primarily affecting women (1 in 1,000) over the age of 40. PBC is characterized by impaired bile flow (known as cholestasis) and the accumulation of toxic bile acids in the liver, leading to inflammation and destruction of the bile ducts within the liver and causing increased levels of alkaline phosphatase (ALP) and total bilirubin. The most common early symptoms of PBC are itching (pruritus) and fatigue, which can be very debilitating for some patients. Progression of PBC is associated with an increased risk of liver cancer and liver-related mortality.

About Seladelpar
Seladelpar is a first-in-class oral, selective PPARδ agonist shown to regulate critical metabolic and liver disease pathways in indications with high unmet medical need. Preclinical and clinical data support its ability to regulate genes involved in bile acids synthesis, inflammation, fibrosis and lipid metabolism, storage and transport.

About CymaBay
CymaBay Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on improving the lives of people with liver and other chronic diseases that have high unmet medical need through a pipeline of innovative therapies. Our deep understanding of the underlying mechanisms of liver inflammation and fibrosis, and the unique targets that play a role in their progression, have helped us receive breakthrough therapy designation (U.S. Food and Drug Administration), PRIority MEdicines status (European Medicines Agency) and orphan drug status (U.S. and Europe) for seladelpar, a first-in-class treatment for people with primary biliary cholangitis (PBC). Our evidence-based decision-making and commitment to the highest quality standards reflect our relentless dedication to the people, families and communities we serve. To learn more, visit www.cymabay.com and follow us on Twitter and Linkedin.

Cautionary Statements
Any statements made in this press release and at the symposium referenced above regarding the potential for seladelpar to treat PBC and potentially improve clinical symptoms of the disease, the potential benefits to patients, the timing of the release of seladelpar clinical data, the future adoption and utilization of currently approved therapies, the anticipated evolution of the PBC treatment paradigm, future therapeutics, surrogate endpoints, potential target product profiles and potential quality of life benefits are forward-looking statements that are subject to risks and uncertainties. Actual outcomes and results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of risks and uncertainties, which include, without limitation, risks related to: the success, cost and timing of product development activities; effects observed in trials to date that may not be repeated in the future; any delays or inability to obtain or maintain regulatory approval of product candidates; and the ability to obtain sufficient financing to complete development, regulatory approval and commercialization of product candidates. Additional risks relating to CymaBay are contained in CymaBay's filings with the Securities and Exchange Commission, including without limitation its most recent Annual Report on Form 10-K and other documents subsequently filed with or furnished to the Securities and Exchange Commission. CymaBay disclaims any obligation to update these forward-looking statements except as required by law.

For additional information about CymaBay visit www.cymabay.com.

Public Relations Contact:

Glenn Silver
Lazar-FINN Partners
(973) 818-8198
Glenn.silver@finnpartners.com

Investor Relations Contact:

Hans Vitzthum
LifeSci Advisors, LLC
(617) 430-7578
Hans@LifeSciAdvisors.com


FAQ

What is the purpose of CymaBay's virtual analyst day on September 22, 2022?

The virtual analyst day aims to provide updates on seladelpar, CymaBay's lead asset for treating primary biliary cholangitis (PBC).

Who will present at CymaBay's analyst day?

Kris Kowdley, a hepatology key opinion leader, will present alongside CymaBay's leadership team.

What is seladelpar and what disease does it target?

Seladelpar is a first-in-class oral PPARδ agonist developed for primary biliary cholangitis (PBC), a chronic liver disease.

What is primary biliary cholangitis (PBC)?

PBC is a rare chronic liver disease primarily affecting women, characterized by impaired bile flow and potential liver damage.

What regulatory designations has seladelpar received?

Seladelpar has been granted breakthrough therapy designation and orphan drug status by regulatory agencies.

CymaBay Therapeutics, Inc.

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