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Better Therapeutics Enrolls First Patient in Real World Evidence Study with Colorado Prevention Center Clinical Research

Open-label, randomized, controlled study will evaluate BT-001, a prescription digital therapeutic (PDT) delivering cognitive behavioral therapy to address behavioral root cause of type 2 diabetes

Multi-year study will evaluate effectiveness, durability, healthcare utilization and medication changes associated with use of BT-001 in a diverse patient population and real-world clinical setting

Better Therapeutics, Inc. (“Better Therapeutics”, NASDAQ: BTTX), a prescription digital therapeutics company developing cognitive behavioral therapy to address the root causes of cardiometabolic diseases, in partnership with Colorado Prevention Center (CPC) Clinical Research, today announced the first patient has been enrolled in a real-world evidence study to evaluate the long-term effectiveness and healthcare utilization changes associated with the use of BT-001 for the treatment of type 2 diabetes. The open-label, randomized, controlled study is actively recruiting patients with type 2 diabetes from the University of Colorado Health System.

“CPC is excited to commence enrollment within the University of Colorado Health System to understand how BT-001 impacts cardiometabolic risk and healthcare utilization in our diverse, type 2 diabetes population by addressing the behavioral root causes of this complex and prevalent condition,” said Marc Bonaca, MD, MPH, executive director of CPC Clinical Research and CPC Community Health. “We look forward to providing regular updates on progress and outcomes to evaluate the long-term durability of effectiveness and cost of care impact.”

“Today’s announcement marks the second real-world study collaborator initiating enrollment within the last six months and an important milestone for Better Therapeutics,” said Mark Berman, MD, chief medical officer of Better Therapeutics. “CPC’s contribution to our multi-year real world evidence study will generate robust data demonstrating the potential to improve and maintain glycemic control and reduce ongoing healthcare costs and medications that payers can use to assess for coverage reimbursement.”

About Colorado Prevention Center (CPC) Clinical Research

CPC Clinical Research, an academic research organization and an affiliate of the University of Colorado Anschutz Medical Campus, is a mission-driven non-profit organization that exists to improve health through innovative science and community engagement. For over 30 years, CPC has been a leader in research and implementation, experienced in clinical trial design, oversight, and management, including registration trials (Phase I-IV), real-world data, and pragmatic trials. Members of CPC’s leadership team are experienced faculty of the university and have chaired and/or served on FDA advisory committees, including the Cardiovascular and Renal, Endocrine and Metabolism, and Reproductive Health committees. Through our Community Health Programs, we develop innovative and evidence-based health promotion programs, interactive health technology, and community partnerships to help win the fight against cardiovascular disease in Colorado. As a result of these efforts, CPC Community Health has provided health education and/or coaching to over 82,000 individuals and made significant improvements in the lives of those at risk for cardiovascular disease.

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About Better Therapeutics

Better Therapeutics is a prescription digital therapeutics (PDT) company developing a novel form of cognitive behavioral therapy to address the root causes of cardiometabolic diseases. The company has developed a proprietary platform for the development of FDA-regulated, software-based solutions for type 2 diabetes, heart disease and other conditions. The cognitive behavioral therapy delivered by Better Therapeutics’ PDT is designed to enable changes in neural pathways of the brain so lasting changes in behavior become possible. Addressing the underlying causes of these diseases has the potential to dramatically improve patient health while lowering healthcare costs. Better Therapeutics clinically validated mobile applications are intended to be prescribed by physicians and reimbursed like traditional medicines.

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Forward-Looking Statements

Certain statements made in this press release are "forward-looking statements" within the meaning of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are typically identified by words such as “plan,” “believe,” “expect,” “anticipate,” “intend,” “outlook,” “estimate,” “forecast,” “project,” “continue,” “could,” “may,” “might,” “possible,” “potential,” “predict,” “should,” “would” and other similar words and expressions, but the absence of these words does not mean that a statement is not forward-looking. The forward-looking statements are based on the current expectations of the management of Better Therapeutics and are inherently subject to uncertainties and changes in circumstances and their potential effects and speak only as of the date of such statement. There can be no assurance that future developments will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements including: risks related to Better Therapeutics’ business, such as the willingness of the FDA to approve PDTs and insurance companies to reimburse their use; and other risks and uncertainties included under the header “Risk Factors” in the definitive proxy statement/prospectus filed by us on October 12, 2021.


Better Therapeutics and Colorado Prevention Center Clinical Research enroll the first patient in a real-world evidence study to evaluate BT-001, a prescription digital therapeutic (PDT) BT-001 for type 2 diabetes.


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