BT-001 (AspyreRx™) prescription digital therapy, a form of personalized cognitive behavioral therapy, has demonstrated clinically meaningful and durable hemoglobin A1c reductions in patients with type 2 diabetes (T2D). The current study examined the cost-effectiveness of BT-001 plus standard of care (SoC) versus SoC alone in T2D over a lifetime horizon from a healthcare payer perspective.

METHODS:

We modeled the T2D pathway using an individual patient-level simulation; clinical data were sourced from the intention-to-treat subset of the BT-001 randomized clinical trial (RCT). SoC across both arms included the composition of oral and injectable treatments for T2D. Events were simulated using the United Kingdom Prospective Diabetes Study Outcomes Model 2 risk equation. A 3-month model cycle length was used in the first year, then annual model cycles were used in line with the original risk engine specifications. Patient characteristics informed event equations and Monte Carlo random sampling was used to assess the occurrence of events within each model cycle. Incidence of hypoglycemic events, drug discontinuation, costs, and health utilities and disutility values were sourced from the literature.

RESULTS:

From a payer perspective, BT-001 plus SoC versus SoC alone was dominant with a gain in quality-adjusted life years (QALYs) of 0.101 and cost savings of $7343 per patient over the lifetime horizon (i.e., more effective and less costly). BT-001 plus SoC was cost-effective at a willingness-to-pay of $100,000 per QALY (incremental net monetary benefit was $17,443). Savings with BT-001 were primarily driven by a reduction in drug acquisition costs. The reduction in hemoglobin A1c with BT-001 was associated with fewer T2D complications.

CONCLUSIONS:

BT-001 plus SoC was estimated to dominate SoC alone over the lifetime horizon from a payer perspective, suggesting that using BT-001 can empower patients to better manage their diabetes with the potential for lifelong advantages.

01 Dec 2022·Diabetes care

Randomized, Controlled Trial of a Digital Behavioral Therapeutic Application to Improve Glycemic Control in Adults With Type 2 Diabetes

Article

Author: Lupinacci, Paul ; Gubbi, Ananda ; Hsia, Judith ; Denham, Douglas ; Guthrie, Nicole L. ; Bonaca, Marc P. ; Berman, Mark A.

OBJECTIVE:

To evaluate the efficacy and safety of a digital therapeutic application (app) delivering cognitive behavioral therapy (CBT) designed to improve glycemic control in patients with type 2 diabetes.

RESEARCH DESIGN AND METHODS:

Adults with type 2 diabetes and an HbA1c of 7 to <11% were randomly assigned to receive access to a digital therapeutic app delivering CBT (BT-001) or a control app, both on top of standard of care management. CBT is an established form of psychological treatment that endeavors to identify and change unhelpful thinking patterns. The primary study end point was treatment group difference in mean HbA1c change from baseline to 90 days.

RESULTS:

Among 669 randomly assigned subjects who completed app onboarding, the mean age was 58 years, BMI 35 kg/m2, 54% were female, 28% Black, and 16% Latino. Baseline HbA1c was 8.2 and 8.1% in the BT-001 and control groups, respectively. After 90 days of app access, change in HbA1c was −0.28% (95% CI −0.41, −0.15) in the BT-001 group and +0.11% (95% CI −0.02, 0.23) in the control group (treatment group difference 0.39%; P < 0.0001). HbA1c reduction paralleled exposure to the therapeutic intervention, assessed as the number of modules completed on the app (P for trend <0.0001). No adverse events in either group were attributed to app use and no adverse device effects reported.

CONCLUSIONS:

Patients randomly assigned to the BT-001 arm relative to the control arm had significantly lower HbA1c at 90 days. The digital therapeutic may provide a scalable treatment option for patients with type 2 diabetes.

01 Aug 2022·Clinical cardiology

Cognitive behavioral therapy delivered via digital mobile application for the treatment of type 2 diabetes: Rationale, design, and baseline characteristics of a randomized, controlled trial

Article

Author: Hsia, Judith ; Edwards, Kate ; Mosesso, Kara ; Lupinacci, Paul ; Simmons, Martha ; Guthrie, Nicole L. ; Mehta, Prapti ; Berman, Mark A. ; Skuban, Aleksandar ; Gearhart, Michelle ; Canonico, Mario Enrico ; Bonaca, Marc P.

Abstract:

Background:

The prevalence of type 2 diabetes (T2D) continues to rise in the United States and worldwide. Cognitive behavioral therapy (CBT) has been shown to improve glycemic control in patients with T2D, but broad implementation has been limited by inherent access and resource constraints. Digital therapeutics have the potential to overcome these obstacles.

Hypothesis:

To describe the rationale and design of a trial evaluating the efficacy and safety of a digital therapeutic providing CBT to improve glycemic control in adults with T2D.

Methods:

This randomized, controlled, multicenter, Phase 3 trial evaluates the hypothesis that BT‐001, an investigational digital therapeutic intended to help patients with T2D improve their glycemic control, on top of standard of care therapy, will lower hemoglobin A1c (HbA1c) compared to a control app across a broad range of patients in a real‐world setting. The study is designed to provide evidence to support FDA review of this device as a digital therapeutic. The intervention is provided within the digital application (app) and includes no person‐to‐person coaching. The primary endpoint is the difference in HbA1c change from baseline to 90 days for BT‐001‐allocated subjects compared with those assigned to the control app. Safety assessment includes adverse events and adverse device effects. The study incorporates pragmatic features including entirely remote conduct with at‐home visits for physical measures and blood sample collection.

Conclusions:

This randomized, controlled trial evaluates a cognitive behavioral intervention delivered via smartphone app which has the potential to provide a scalable treatment option for patients with T2D.

News (Medical) associated with Adalimumab biosimilar(Biora)

16 Sep 2024

·pipelinereview.com

BioInvent and Transgene’s Oncolytic Virus BT-001 Shows Promising Antitumor Activity in Ongoing Phase 1/2a Trial in Solid Tumors that Failed Previous Treatments

LUND, Sweden, and STRASBOURG, France I September 14, 2024 I BioInvent International AB (“BioInvent”) (Nasdaq Stockholm: BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, and Transgene (Euronext Paris: TNG) , a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, today announce new initial data from their ongoing Phase 2/2a study on the multifunctional oncolytic virus BT-001, demonstrating antitumor activity in patients with refractory solid tumors . The data presented today at the2024European Society for Medical Oncology (ESMO) Annual Meeting, showed that BT-001 induced tumor regression in patients unresponsive to prior anti PD(L)-1 treatment, both as a monotherapy and in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA® (pembrolizumab). Preliminary translational data suggest that BT-001 replicates in the tumor where the payloads are expressed with undetectable systemic exposure . BT-001 alone or in combination with pembrolizumab was well tolerated and showed first signs of efficacy with clinical responses in 2 of 6 refractory patients when given in combination with pembrolizumab. BT-001 treatment turned “cold” tumors to “hot” inducing T cell infiltration , a higher M1/M2 ratio , and a shift toPD(L)-1 positivity in the tumor microenvironment . Dr. S. Champiat, Medical Oncologist, Head of the Inpatient Unit, Drug Development Department (DITEP) at Institut Gustave Roussy , commented:”The immunological data generated by BT-001 suggest that, as hoped, BT-001 is replicating in the tumor and its payload of transgenes is expressed, with very limited exposure outside of the tumor thereby limiting systemic toxicity. I look forward to additional results from this ongoing study which will provide further evidence of the safety and clinical activity of BT-001 and its potential role as a new therapy for cancer patients with solid tumors. “ Transgene and BioInvent are co-developing BT-001, an oncolytic virus developed using Transgene’s Invir.IO® platform armed to express GM-CSF and BioInvent’s full-length anti-CTLA-4 monoclonal antibody, to elicit a strong and effective anti-tumoral response in solid tumors. Alessandro Riva, Chairman and CEO of Transgene , said: “We are pleased to present the first promising clinical data on BT-001 at ESMO 2024 which confirm its mechanism of action as a single agent injected intratumorally and importantly demonstrate first signs of anti-tumor activity. Added to its good safety profile alone and in combination with pembrolizumab, BT-001 has the potential to shrink lesions and induce stable disease in refractory patients who may have few other treatment options. We will further explore the safety and efficacy of BT-001 in this development program with our partner BioInvent and report additional data when it becomes available.” Andres McAllister, MD, PhD, Chief Medical Officer at BioInvent International AB, concluded: “We are encouraged by the early clinical results presented at ESMO for BT-001, which encodes a potent Treg-depleting recombinant human anti-CTLA-4 antibody generated by our proprietary n-CoDeR® and F.I.R.S.T™ platforms,. This clinical proof of concept confirms our ability to identify antibodies that bind to a selected target but exhibit a differentiated activity, allowing the development of promising new drug candidates such as BT-001.” The abstract and Poster titled: “Initial clinical results of BT-001, an oncolytic virus expressing an anti-CTLA4 mAb, administered as single agent and in combination with pembrolizumab in patients with advanced solid tumors.” . The poster can be accessed at the company’s website https://www.bioinvent.com/en/our-science/scientific-publications . KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. About the trial The ongoing Phase 1/2a ( NCT: 04725331 ) study is a multicenter, open label, dose-escalation trial evaluating BT-001 as a single agent and in combination with pembrolizumab (anti-PD-1 treatment). Patient inclusions are ongoing in Europe (France, Belgium) and the trial has been authorized in the US. Phase 1 is divided into two parts. In part A, patients with metastatic/advanced tumors receive single agent, intra-tumoral administrations of BT-001. Part B explores the combination of intra-tumoral injections of BT-001 with pembrolizumab. In this part, KEYTRUDA® (pembrolizumab) is provided to the trial by MSD (Merck & Co). Phase 2a will evaluate the combination regimen in several patient cohorts with selected tumor types. These expansion cohorts will offer the possibility of exploring the activity of this approach to treat other malignancies not traditionally addressed with this type of treatment. About BT-001 BT-001 is an oncolytic virus generated using Transgene’s Invir.IO® platform and its patented large-capacity VVcopTK-RR- oncolytic virus, which has been engineered to encode both a Treg-depleting human recombinant anti-CTLA-4 antibody generated by BioInvent’s proprietary n-CoDeR®/F.I.R.S.T™ platforms, and the human GM-CSF cytokine. By selectively targeting the tumor microenvironment, BT-001 is expected to elicit a much stronger and more effective antitumoral response. As a consequence, by reducing systemic exposure, the safety and tolerability profile of the anti-CTLA-4 antibody may be greatly improved. BT-001 is being co-developed as part of a 50/50 collaboration on oncolytic viruses between Transgene and BioInvent. To know more on BT-001, watch our video here . About BioInvent BioInvent International AB (Nasdaq Stockholm: BINV) is a clinical-stage biotech company that discovers and develops novel and first-in-class immuno-modulatory antibodies for cancer therapy, with currently four drug candidates in five ongoing clinical programs in Phase 1/2 trials for the treatment of hematological cancer and solid tumors, respectively. The Company’s validated, proprietary F.I.R.S.T™ technology platform identifies both targets and the antibodies that bind to them, generating many promising new drug candidates to fuel the Company’s own clinical development pipeline and providing licensing and partnering opportunities. The Company generates revenues from research collaborations and license agreements with multiple top-tier pharmaceutical companies, as well as from producing antibodies for third parties in the Company’s fully integrated manufacturing unit. More information is available at www.bioinvent.com . Follow on Twitter: @BioInvent. More information is available at www.bioinvent.com . Follow us on Twitter: @BioInvent About Transgene Transgene (Euronext: TNG) is a biotechnology company focused on designing and developing targeted immunotherapies for the treatment of cancer. Transgene’s programs utilize viral vector technology with the goal of indirectly or directly killing cancer cells. The Company’s clinical-stage programs consist of a portfolio of therapeutic vaccines and oncolytic viruses: TG4050, the first individualized therapeutic vaccine based on the myvac ® platform, TG4001 for the treatment of HPV-positive cancers, as well as BT-001 and TG6050, two oncolytic viruses based on the Invir.IO® viral backbone. With Transgene’s myvac ® platform, therapeutic vaccination enters the field of precision medicine with a novel immunotherapy that is fully tailored to each individual. The myvac ® approach allows the generation of a virus-based immunotherapy that encodes patient-specific mutations identified and selected by Artificial Intelligence capabilities provided by its partner NEC. With its proprietary platform Invir.IO®, Transgene is building on its viral vector engineering expertise to design a new generation of multifunctional oncolytic viruses.Additional information about Transgene is available at: www.transgene.fr Follow us on social media: X (formerly Twitter): @TransgeneSA – LinkedIn: @Transgene SOURCE: BioInvent

ImmunotherapyVaccineClinical StudyPhase 2

04 Mar 2024

·www.businesswire.com

Better Therapeutics Announces Acceptance of Late Breaking Abstract for Its AspyreRx Pivotal Trial 180 Day Outcomes and Participation at the 17th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD)

SAN FRANCISCO--( BUSINESS WIRE )-- Better Therapeutics, Inc. (NASDAQ: BTTX), a pioneer in developing prescription digital therapeutics (PDTs) for treating cardiometabolic diseases, today announced the acceptance of a late-breaking abstract presenting 180-day outcomes data and its participation at the 17th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD), to be held from March 6 to 9, 2024, in Florence, Italy. ATTD serves as a premier international forum showcasing cutting-edge advancements in diabetes care, bringing together clinicians, researchers, industry leaders, and policymakers from around the world to exchange knowledge and foster collaboration in the pursuit of innovative solutions for diabetes management. Key highlights of Better Therapeutics’ participation at ATTD include: Accepted 2024 ATTD Peer-Reviewed Abstract The late-breaking abstract findings further validate the use of AspyreRx ™ as a safe and effective treatment for patients with type 2 diabetes (T2D). The abstract highlights statistically significant improvements in HbA1c, blood pressure, weight, mood, and quality of life in patients treated with AspyreRx compared to a Standard of Care control group at 180 days. AspyreRx patients also experienced significantly fewer adverse events and medication increases, thereby indicating meaningful reductions in overall healthcare utilization. Abstract Submission Number: 1282 Presentation Session: E-Poster Viewing Abstract Title: Randomized, Controlled Trial Of A Novel Digital Therapeutic In Patients With Type 2 Diabetes: BT-001 Pivotal Trial 180 Day Outcomes Abstracts will be published in the peer-reviewed Journal of Diabetes Technology & Therapeutics. Industry Symposium Additionally, Better Therapeutics will host a sponsored industry symposium on Saturday, March 09, 2024, at 8:30 a.m. local time (CET). Speaker Kara Mosesso , ANP-BC, CDCES, Medical Director at Better Therapeutics, will be joined by moderator David Rodbard , MD, Chief Scientific Officer at Biomedical Informatics Consultants. They will discuss the unmet treatment need in T2D, present AspyreRx’s mechanism of action and pivotal data, and highlight the meaningfully enhanced efficacy of AspyreRx plus glucagon-like peptide 1 (GLP-1) agonist use compared to GLP-1 use without AspyreRx. Exhibition Booth Attendees will have the opportunity to experience AspyreRx firsthand and learn more about its clinical benefits at the Better Therapeutics exhibition booth. AspyreRx is the first and only U.S. Food and Drug Administration (FDA)-authorized fully digital lifestyle intervention designed to treat T2D. “We are thrilled to participate in the prestigious ATTD Conference and share our latest research and insights with the global diabetes community,” said Mark Berman , MD, Chief Medical Officer at Better Therapeutics. “We look forward to engaging with fellow experts, exchanging knowledge, and advancing the field of digital therapeutics to improve diabetes outcomes.” For more information about ATTD 2024, visit: https://attd.kenes.com/ About Better Therapeutics Better Therapeutics is a prescription digital therapeutics company developing a novel form of cognitive behavioral therapy to address underlying factors that sustain or worsen cardiometabolic diseases. The Company has developed a proprietary platform for the development of FDA-regulated, software-based solutions for T2D, heart disease and other conditions. The CBT delivered by Better Therapeutics’ PDTs 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. For more information visit: bettertx.com About AspyreRx AspyreRx (formerly BT-001) was granted marketing authorization by the FDA in July 2023 as the first prescription-only digital therapeutic to treat adults with type 2 diabetes (T2D). AspyreRx is backed by robust data demonstrating clinically meaningful and sustained reduction in A1c as well as improvements in other markers of cardiometabolic health when used up to 180 days. Using proven techniques that target the underlying psychological, behavioral, and cognitive factors that sustain or worsen T2D, AspyreRx is a self-paced, engaging experience that patients can access from their smartphone. It is prescribed by a healthcare provider in 90-day increments, with proprietary CBT delivered digitally in a weekly step-by-step process. Through interactive therapy lessons, skill-building modules, weekly goal setting and tracking, patients connect changes in behavior to improvements in blood sugar and other biometrics. Each step in the experience builds on the prior to enable and reinforce cognitive restructuring, building the emotional resilience and acceptance needed to make enduring changes. Indications for Use AspyreRx is a prescription-only digital therapeutic device intended to provide cognitive behavioral therapy to patients 18 years or older with type 2 diabetes. The device targets behavior to aid in the management of type 2 diabetes in patients who are under the care of a healthcare provider. AspyreRx provides cognitive behavioral therapy as a treatment that should be used adjunctively with standard of care. 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 in this press release include, but are not limited to, statements regarding Better Therapeutics’ expectations related to the efficacy and potential benefits of PDTs, including AspyreRx, and CBT, and their potential treatment applications and their ability to improve clinical outcomes, expectations regarding the rebate agreement and the potential for the rebate agreement to increase accessibility and coverage of Better Therapeutics’ products, and expectations regarding the commercial traction of AspyreRx and partnering and coverage discussions, among others. These 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 authorize PDTs for commercial distribution and insurance companies to reimburse their use, market acceptance of PDTs, including AspyreRx, the risk that the results of previously conducted studies will not be interpreted favorably by the FDA or repeated or observed in ongoing or future studies involving Better Therapeutics’ product candidates and other risks and uncertainties included under the header “Risk Factors” in Better Therapeutics’ quarterly report on Form-10-Q for the fiscal quarter ended September 30, 2023 filed with the Securities and Exchange Commission (“SEC”) on November 09, 2023, and those that are included in any of the Company’s subsequent filings with the SEC.

Clinical Study

04 Mar 2024

·www.biospace.com

Better Therapeutics Announces Acceptance of Late Breaking Abstract for Its AspyreRx Pivotal Trial 180 Day Outcomes and Participation at the 17th International Conference on Advanced Technologies

Company to host sponsored education session on Saturday, March 09, 2024; Expanding access to a high quality and effective lifestyle modification intervention SAN FRANCISCO--(BUSINESS WIRE)-- Better Therapeutics, Inc. (NASDAQ: BTTX), a pioneer in developing prescription digital therapeutics (PDTs) for treating cardiometabolic diseases, today announced the acceptance of a late-breaking abstract presenting 180-day outcomes data and its participation at the 17th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD), to be held from March 6 to 9, 2024, in Florence, Italy. ATTD serves as a premier international forum showcasing cutting-edge advancements in diabetes care, bringing together clinicians, researchers, industry leaders, and policymakers from around the world to exchange knowledge and foster collaboration in the pursuit of innovative solutions for diabetes management. Key highlights of Better Therapeutics’ participation at ATTD include: Accepted 2024 ATTD Peer-Reviewed Abstract The late-breaking abstract findings further validate the use of AspyreRx™ as a safe and effective treatment for patients with type 2 diabetes (T2D). The abstract highlights statistically significant improvements in HbA1c, blood pressure, weight, mood, and quality of life in patients treated with AspyreRx compared to a Standard of Care control group at 180 days. AspyreRx patients also experienced significantly fewer adverse events and medication increases, thereby indicating meaningful reductions in overall healthcare utilization. Abstract Submission Number: 1282 Presentation Session: E-Poster Viewing Abstract Title: Randomized, Controlled Trial Of A Novel Digital Therapeutic In Patients With Type 2 Diabetes: BT-001 Pivotal Trial 180 Day Outcomes Abstracts will be published in the peer-reviewed Journal of Diabetes Technology & Therapeutics. Industry Symposium Additionally, Better Therapeutics will host a sponsored industry symposium on Saturday, March 09, 2024, at 8:30 a.m. local time (CET). Speaker Kara Mosesso, ANP-BC, CDCES, Medical Director at Better Therapeutics, will be joined by moderator David Rodbard, MD, Chief Scientific Officer at Biomedical Informatics Consultants. They will discuss the unmet treatment need in T2D, present AspyreRx’s mechanism of action and pivotal data, and highlight the meaningfully enhanced efficacy of AspyreRx plus glucagon-like peptide 1 (GLP-1) agonist use compared to GLP-1 use without AspyreRx. Exhibition Booth Attendees will have the opportunity to experience AspyreRx firsthand and learn more about its clinical benefits at the Better Therapeutics exhibition booth. AspyreRx is the first and only U.S. Food and Drug Administration (FDA)-authorized fully digital lifestyle intervention designed to treat T2D. “We are thrilled to participate in the prestigious ATTD Conference and share our latest research and insights with the global diabetes community,” said Mark Berman, MD, Chief Medical Officer at Better Therapeutics. “We look forward to engaging with fellow experts, exchanging knowledge, and advancing the field of digital therapeutics to improve diabetes outcomes.” For more information about ATTD 2024, visit: About Better Therapeutics Better Therapeutics is a prescription digital therapeutics company developing a novel form of cognitive behavioral therapy to address underlying factors that sustain or worsen cardiometabolic diseases. The Company has developed a proprietary platform for the development of FDA-regulated, software-based solutions for T2D, heart disease and other conditions. The CBT delivered by Better Therapeutics’ PDTs 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. For more information visit: bettertx.com About AspyreRx AspyreRx (formerly BT-001) was granted marketing authorization by the FDA in July 2023 as the first prescription-only digital therapeutic to treat adults with type 2 diabetes (T2D). AspyreRx is backed by robust data demonstrating clinically meaningful and sustained reduction in A1c as well as improvements in other markers of cardiometabolic health when used up to 180 days. Using proven techniques that target the underlying psychological, behavioral, and cognitive factors that sustain or worsen T2D, AspyreRx is a self-paced, engaging experience that patients can access from their smartphone. It is prescribed by a healthcare provider in 90-day increments, with proprietary CBT delivered digitally in a weekly step-by-step process. Through interactive therapy lessons, skill-building modules, weekly goal setting and tracking, patients connect changes in behavior to improvements in blood sugar and other biometrics. Each step in the experience builds on the prior to enable and reinforce cognitive restructuring, building the emotional resilience and acceptance needed to make enduring changes. Indications for Use AspyreRx is a prescription-only digital therapeutic device intended to provide cognitive behavioral therapy to patients 18 years or older with type 2 diabetes. The device targets behavior to aid in the management of type 2 diabetes in patients who are under the care of a healthcare provider. AspyreRx provides cognitive behavioral therapy as a treatment that should be used adjunctively with standard of care. 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 in this press release include, but are not limited to, statements regarding Better Therapeutics’ expectations related to the efficacy and potential benefits of PDTs, including AspyreRx, and CBT, and their potential treatment applications and their ability to improve clinical outcomes, expectations regarding the rebate agreement and the potential for the rebate agreement to increase accessibility and coverage of Better Therapeutics’ products, and expectations regarding the commercial traction of AspyreRx and partnering and coverage discussions, among others. These 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 authorize PDTs for commercial distribution and insurance companies to reimburse their use, market acceptance of PDTs, including AspyreRx, the risk that the results of previously conducted studies will not be interpreted favorably by the FDA or repeated or observed in ongoing or future studies involving Better Therapeutics’ product candidates and other risks and uncertainties included under the header “Risk Factors” in Better Therapeutics’ quarterly report on Form-10-Q for the fiscal quarter ended September 30, 2023 filed with the Securities and Exchange Commission (“SEC”) on November 09, 2023, and those that are included in any of the Company’s subsequent filings with the SEC.

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