Tillkännagivande • May 31
Better Therapeutics Files Form 15 Better Therapeutics, Inc. has announced that it has filed a Form 15 with the Securities and Exchange Commission to voluntarily deregister its common stock under the Securities Exchange Act of 1934, as amended. The par value of the company's common stock was $0.0001 per share. Tillkännagivande • Mar 18
Better Therapeutics Receives Notice from Nasdaq Regarding Non-Compliance with the Minimum Bid Price and Market Value of Listed Securities Requirements for Continued Listing on The Nasdaq Capital Market As previously reported, on December 14, 2023, Better Therapeutics, Inc. (the ‘Company’) received notice from the Listing Qualifications Staff (the ‘Staff’) of The Nasdaq Stock Market LLC (‘Nasdaq’) indicating that, based upon the Company’s non-compliance with the minimum bid price and market value of listed securities requirements for continued listing on The Nasdaq Capital Market, the Company’s securities were subject to delisting unless the Company timely requested a hearing before the Nasdaq Hearings Panel (the ‘Panel’). On December 21, 2023, the Company requested a hearing before the Panel, which temporarily stayed the suspension of trading and delisting of the Company’s common stock. The hearing occurred on March 14, 2024, and the Company voluntarily requested a delisting of its securities at the hearing. As a result, Nasdaq issued a notice to the Company that its shares will be suspended from trading at the open of business on March 18, 2024, and Nasdaq will file a Form 25 Notification of Delisting with the Securities and Exchange Commission after applicable appeal periods have lapsed. The Company further intends to file a Form 15 with the Securities and Exchange Commission to suspend its reporting obligations under the Securities Exchange Act of 1934, as amended. Tillkännagivande • Mar 17
Better Therapeutics Voluntarily Requests a Delisting of its Securities and Expects its Securities to Be Delisted in the Near Term As previously reported, on December 14, 2023, Better Therapeutics, Inc. (the Company) received notice from the Listing Qualifications Staff of The Nasdaq Stock Market LLC indicating that, based upon the Company’s non-compliance with the minimum bid price and market value of listed securities requirements for continued listing on The Nasdaq Capital Market, the Company’s securities were subject to delisting unless the Company timely requested a hearing before the Nasdaq Hearings Panel. On December 21, 2023, the Company requested a hearing before the Panel, which temporarily stayed the suspension of trading and delisting of the Company’s common stock. The hearing was scheduled for March 14, 2024. On March 14, 2024, the Company has voluntarily requested a delisting of its securities and expects its securities to be delisted in the near term. The Company further intends to file a Form 15 with the Securities and Exchange Commission to suspend its reporting obligations under the Securities Exchange Act of 1934, as amended. Tillkännagivande • Mar 01
Better Therapeutics, Inc. has withdrawn its Follow-on Equity Offering. Better Therapeutics, Inc. has withdrawn its Follow-on Equity Offering.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 52,493,438
Security Name: Warrants
Security Type: Equity Warrant
Securities Offered: 52,493,438
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 52,493,438 Tillkännagivande • Feb 21
Better Therapeutics, Inc. Receives FDA Breakthrough Device Designation for Digital Therapeutic Platform Targeting Advanced Liver Disease Better Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its novel Cognitive Behavioral Therapy (CBT) platform intended to treat adults with metabolic dysfunction-associated steatohepatitis (MASH), formerly known as NASH. Breakthrough status is reserved for technologies that demonstrate the potential to be more effective than current standard of care in patients with serious or life-threatening conditions. Better Therapeutics earned breakthrough status based on the outcomes of its LivVita clinical study, which successfully met its primary endpoint by reducing liver fat within 90 days, while also achieving key secondary endpoints related to improved liver health without any device-related adverse events. Results of the study were published in Gastro Hep Advances. Better Therapeutics' novel form of CBT works by targeting the lifestyle behaviors that are known to cause and/or contribute to the progression of metabolic diseases. The platform was developed to address the current gap in broadly accessible and standardized intensive behavioral therapies that effectively enable the implementation of existing treatment guidelines that call for behavior change as the foundation of treatment. The Company's CBT platform has already demonstrated clinically meaningful outcomes in type 2 diabetes (T2D), leading to the FDA authorization of AspyreRx tm in 2023 as the first prescription digital therapy to deliver CBT as a treatment for T2D. Tillkännagivande • Jan 24
Better Therapeutics, Inc. announced that it has received $0.25 million in funding On January 23, 2024, Better Therapeutics, Inc. closed the transaction. The company issued 1,471,453 shares at an issue price of $0.1699 per share for the gross proceeds of $249,999.8647 pursuant to Regulation D and included participation from single investor. Tillkännagivande • Jan 18
Better Therapeutics Inc. Announces Publication of Cost-Effectiveness Analysis Demonstrating AspyreRx Is More Effective and Less Costly Than Standard of Care Alone Better Therapeutics Inc. announced the publication of health economic data for its prescription-only digital behavioral treatment for type 2 diabetes (T2D), AspyreRx. The study, titled "Cost-Effectiveness Analysis of a Prescription Digital Therapeutic in Type 2 Diabetes'' has been published in Advances in Therapy, a prominent peer-reviewed medical journal. The study's authors conclude that, from a healthcare payer perspective, AspyreRx plus standard of care (SoC) was estimated to be both economically and clinically superior to SoC alone over the lifetime horizon. According to the American Diabetes Association, the estimated national cost of diabetes in 2022 was $412.9 billion, of which $306.6 billion (74%) represents direct health care expenditures attributable to diabetes and $106.3 billion (26%) represents lost productivity from work-related absenteeism, reduced productivity at work and at home, unemployment from chronic disability, and premature mortality. AspyreRx delivers a novel form of personalized cognitive behavioral therapy, backed by robust data demonstrating clinically meaningful and durable hemoglobin A1c reductions in patients with T2D. This latest study modeled the cost-effectiveness of AspyreRx plus SoC versus SoC alone in T2D over a lifetime horizon. The analysis followed the modeling precedent established by the Institute for Clinical and Economic Review (ICER) for the appraisals of T2D medications. From a healthcare payer perspective, AspyreRx plus SoC versus SoC alone was dominant because AspyreRx was associated both with gains in quality-adjusted life years (QALYs) and cost savings of $7,343 per patient over the lifetime horizon (i.e., adding AspyreRx to SoC is more effective and less costly). AspyreRx plus SoC was cost-effective at a willingness-to-pay of $100,000 per QALY over SoC alone, with an incremental net monetary benefit (INMB) of $17,443. At other commonly applied thresholds of $50,000 and $150,000 per QALY, the study yielded INMBs of $12,393 and $22,493, respectively. Savings were primarily driven by a reduction in drug costs, followed by reductions in adverse event costs. Tillkännagivande • Jan 02
Better Therapeutics, Inc. Announces Submission for FDA Breakthrough Device Designation for Digital Therapeutic Platform to Treat Liver Disease Better Therapeutics, Inc. announced it has submitted a request to the U.S. Food and Drug Administration (FDA) for Breakthrough Device Designation for its novel PDT designed to treat metabolic dysfunction-associated steatotic liver disease (MASLD) and metabolic dysfunction-associated steatohepatitis (MASH), formerly known as NAFLD and NASH. This regulatory step for Better Therapeutics follows the completion of the Company’s LivVita Liver Study and the subsequent publication of its results in Gastro Hep Advances. The study successfully met its primary endpoint by reducing liver fat within 90 days, while also achieving key secondary endpoints related to improved liver health without any device related adverse events. The study’s authors concluded the totality of positive efficacy, safety and usability data indicates the potential of Better Therapeutics’ digitally delivered CBT to help address the significant unmet clinical needs observed in MASLD and MASH. The FDA’s Breakthrough Device Designation is designed to expedite the development, assessment, and review of devices that demonstrate the potential to address life-threatening or irreversibly debilitating conditions where no approved or cleared alternative treatment options exist. The expected response timeline from the FDA is 60 days after receipt of a Breakthrough Device Designation application. Tillkännagivande • Dec 18
Better Therapeutics Provides Non-Compliance Update As previously disclosed by Better Therapeutics, Inc. (the “Company”), on June 16, 2023, the Listing Qualifications Department (the “Staff”) of the Nasdaq Stock Market (“Nasdaq”) notified the Company that it was not in compliance with the minimum bid price requirement and the market value of listed securities requirement for continued listing on the Nasdaq Capital Market. Nasdaq Listing Rule 5550(a)(2) requires companies listed on the Nasdaq Capital Market to maintain a minimum bid price of at least $1 per share (the “Minimum Bid Price Requirement”). Nasdaq Listing Rule 5550(b)(2) requires companies listed on the Nasdaq Capital Market to maintain a minimum market value of listed securities of at least $35 million (the “MVLS Requirement”). The letters noted that, as of their date, the bid price of the Company’s common stock, par value $0.0001 per share, was below $1.00 per share and the Company’s market value of listed securities was below $35 million, in each case for 30 consecutive business days. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company was provided 180 calendar days, or until December 13, 2023, to regain compliance. On December 14, 2023, the Company received written notification (the “December Notice”) from the Staff indicating that, based upon (i) the Company’s continued non-compliance with the Minimum Bid Price Requirement and (ii) the Company’s continued non-compliance with the MVLS Requirement, the Staff determined that the Company was not eligible for an additional 180 day extension to meet the continued listing requirements. As a result, the Staff determined to delist the Company’s securities from Nasdaq, effective December 26, 2023, unless the Company timely requests an appeal to a Nasdaq Hearings Panel (the “Panel”) on or before December 21, 2023. The Company intends to request an appeal of this determination prior to the December 21st deadline. The request for an appeal will stay the suspension and delisting of the Company’s common stock pending the decision of the Panel. There can be no assurance that the Company’s appeal of the delisting determination will be successful or that the Company will be successful in maintaining the listing of its common stock on The Nasdaq Capital Market. New Risk • Nov 29
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 15% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$27m free cash flow). Share price has been highly volatile over the past 3 months (15% average weekly change). Negative equity (-US$9.9m). Earnings are forecast to decline by an average of 41% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (100% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$9.81m market cap). Minor Risk Currently unprofitable and not forecast to become profitable next year (US$43m net loss next year). Tillkännagivande • Nov 23
Better Therapeutics, Inc. Announces CFO Changes, Effective November 27, 2023 On November 14, 2023, Mark Heinen notified Better Therapeutics, Inc. of his resignation as the chief financial officer of the Company, effective November 27, 2023. Frank Karbe, the Company's chief executive officer ("CEO"), will assume the duties of principal financial officer and Leslie Miller, the Company's controller, will assume the duties of principal accounting officer. Mr. Heinens resignation supports a series of expense reduction measures, including voluntary salary reductions by the CEO and other executives, to extend the cash runway sufficiently to demonstrate commercial traction for AspyreRx, and did not result from any disagreement with the Company or any person affiliated with the Company. New Risk • Nov 10
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$27m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$27m free cash flow). Negative equity (-US$9.9m). Earnings are forecast to decline by an average of 41% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (71% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$6.21m market cap). Minor Risks Currently unprofitable and not forecast to become profitable next year (US$43m net loss next year). Share price has been volatile over the past 3 months (13% average weekly change). Tillkännagivande • Nov 09
Better Therapeutics, Inc. to Report Q3, 2023 Results on Nov 09, 2023 Better Therapeutics, Inc. announced that they will report Q3, 2023 results Pre-Market on Nov 09, 2023 New Risk • Nov 05
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 35% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Negative equity (-US$11m). Earnings are forecast to decline by an average of 35% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (71% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$6.49m market cap). Minor Risks Currently unprofitable and not forecast to become profitable next year (US$44m net loss next year). Share price has been volatile over the past 3 months (13% average weekly change). New Risk • Oct 19
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: US$8.89m This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Negative equity (-US$11m). Shareholders have been substantially diluted in the past year (71% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$8.89m market cap). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$28m net loss in 3 years). Share price has been volatile over the past 3 months (13% average weekly change). Tillkännagivande • Oct 12
Better Therapeutics, Inc. Announces New Data Highlighting Concurrent Use of AspyreRx and GLP-1 Receptor Agonists to Treat Type 2 Diabetes Better Therapeutics, Inc. announced top-line findings from a recent subgroup analysis of AspyreRx (formerly BT-001) in its pivotal trial for type 2 diabetes (T2D). The analysis reveals that adjunctive use of AspyreRx with standard of care, including GLP-1 receptor agonists (GLP-1), leads to a substantially greater clinical improvement compared to control participants who did not incorporate AspyreRx into their regimen. A cost effectiveness analysis, which was part of a broader Health Economics and Outcomes Research (HEOR) conducted by Better Therapeutics, indicates that the utilization of AspyreRx may not only be more effective than standard of care alone but may also be less costly for payers. The new subgroup analysis data may be particularly relevant in the context of recent draft guidance from the FDA, titled 'Regulatory Considerations for Prescription Drug Use-Related Software, released in September, which provides clarity about the agency's views and intent to consider the combined effectiveness of pharmaceuticals and digital therapeutic solutions when making drug labeling decisions. "The FDA's draft guidance opens up the possibility of expanding drug labeling to include the increased benefits patients may experience while also using PDTs. Strengthened drug labeling then has the potential to raise awareness about the concurrent benefits of drugs and PDTs, which enables providers to improve clinical outcomes. This included using a "Standard of Care" comparison, as well as not constraining patients to a specific medication profile and not incentivizing patients to use the BT-001 therapy. The clinical trial included a diverse, nationally representative patient population including participants from minority groups often underrepresented in diabetes studies. 40.2% of participants were non-white; Participants had long-standing type 2 diabetes, high cardiovascular risk, multiple comorbidities with use of multiple medications. AspyreRx (fka BT-001) was granted marketing authorization by the U.S. Food and Drug Administration (FDA) in July 2023 as the first prescription-only digital behavioral therapeutic device delivering a novel form of cognitive behavioral therapy (CBT) via smartphone to treat adults with type 2 diabetes (T 2D). AspyreRx is backed by robust data demonstrating clinically meaningful and sustained reduction in HbA1c as well as improvements in other markers of cardiometabolic health when used up to 180 days. The Company has developed a proprietary platform for the development of FDA-regulated, software-based solutions for T2D, heart disease and other conditions. The forward-looking statements in this press release include, but are not limited to, statements regarding 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, beliefs regarding the importance of behavior modification and comprehensive management approaches in diabetes treatment, statements related to recent draft guidance from the FDA and the potential of labeling to drive improved awareness of PDTs, among others. 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 As pyreRx, 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' business. Tillkännagivande • Sep 29
Better Therapeutics, Inc. Completes Enrollment in Real-World Evidence Program Evaluating Long-term Effectiveness of AspyreRx in Type 2 Diabetes Better Therapeutics, Inc. announced it has completed the enrollment of 1,000 participants across two studies as part of its ongoing clinical program to evaluate the long-term effectiveness of AspyreRxTM (formerly BT-001). AspyreRx received FDA authorization in July 2023 as the first PDT to deliver Cognitive Behavioral Therapy (CBT) to treat adults with type 2 diabetes (T2D). Better Therapeutics' ongoing clinical studies are designed to assess the long-term effectiveness of AspyreRx in diverse populations, as measured by change in HbA1c, and safety, as measured by severity and frequency of adverse events. The impact on medication use and healthcare utilization one year after beginning treatment with AspyreRx will also be evaluated, along with an advanced understanding of patient engagement patterns in a real-world setting. In addition, these studies intend to inform the durability of this digital therapeutic intervention. Participants have been enrolled across Colorado Prevention Center (CPC), affiliated with the University of Colorado Anschutz Medical Campus, the Durham Veterans Association (VA) Health Care System, Ascension DePaul, and Mass General Brigham (MGB). All enrolled participants have been randomized and on-boarded onto AspyreRx or a control app. Depending on adequate power, Better Therapeutics plans to share initial 6-month data by the end of 2023. This initial readout is expected to be followed by additional data releases in 2024. Tillkännagivande • Aug 12
Better Therapeutics, Inc. announced that it has received $2.115287 million in funding On August 11, 2023, Better Therapeutics, Inc. closed the transaction. The transaction included participation from 10 investors. The company has paid sales commissions of $126,900 in the transaction. Price Target Changed • Aug 10
Price target decreased by 20% to US$6.00 Down from US$7.50, the current price target is an average from 2 analysts. New target price is 724% above last closing price of US$0.73. Stock is down 59% over the past year. The company is forecast to post a net loss per share of US$0.96 next year compared to a net loss per share of US$1.69 last year. Tillkännagivande • Aug 03
Better Therapeutics, Inc. to Report Q2, 2023 Results on Aug 09, 2023 Better Therapeutics, Inc. announced that they will report Q2, 2023 results After-Market on Aug 09, 2023 New Risk • Jul 29
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 72% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Negative equity (-US$9.8m). Shareholders have been substantially diluted in the past year (72% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$22m net loss in 3 years). Share price has been volatile over the past 3 months (15% average weekly change). Market cap is less than US$100m (US$25.1m market cap). Tillkännagivande • Jul 27
Better Therapeutics, Inc. announced that it expects to receive $2.115287 million in funding Better Therapeutics, Inc. announced that it has entered into a definitive purchase agreement for the purchase of 2,897,654 shares of its common stock in a private placement at a price per share of $0.73 for the gross proceeds of $2,115,287.42 on July 25, 2023. The transaction will include participation from officers and directors of the Company. The transaction is expected to close on July 27, 2023 subject to the satisfaction of customary closing conditions. The PIPE shares issued to the Purchasers under the PIPE Purchase Agreement were issued pursuant to an exemption from registration provided for under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”) and Regulation D promulgated thereunder. Tillkännagivande • Jul 12
Better Therapeutics, Inc. Receives Fda Authorization for Aspyrerx to Treat Adults with Type 2 Diabetes Better Therapeutics, Inc. announced that the Food and Drug Administration (FDA) authorized AspyreRx™? (formerly BT-001), a prescription-only digital therapeutic (PDT) treatment indicated to provide cognitive behavioral therapy to patients 18 years or older with type 2 diabetes (T2D). AspyreRx was reviewed through the FDA's De Novo pathway and its authorization creates a new class of diabetes digital behavioral therapeutic devices. AspyreRx is expected to launch commercially in Fourth Quarter 2023. AspyreRx was granted marketing authorization based on efficacy and safety data from a randomized controlled trial involving 668 participants, demonstrating clinically meaningful results, which were published in Diabetes Care. Summary of Clinical Trial Results: The trial met its primary (p; 1 in 2 people achieved a mean A1c reduction of 1.3% after 180 days of use. Tillkännagivande • Jun 25
Better Therapeutics, Inc. Receives Non-Compliance Notice From Nasdaq On June 16, 2023, Better Therapeutics, Inc. (Company) received deficiency letters from the Listing Qualifications Department (the “Staff”) of the Nasdaq Stock Market (“Nasdaq”) notifying the Company that it is not in compliance with the minimum bid price requirement and the market value of listed securities requirement for continued listing on the Nasdaq Capital Market. Nasdaq Listing Rule 5550(a)(2) requires companies listed on the Nasdaq Capital Market to maintain a minimum bid price of at least $1 per share (the “Minimum Bid Price Requirement”). Nasdaq Listing Rule 5550(b)(2) requires companies listed on the Nasdaq Capital Market to maintain a minimum market value of listed securities of at least $35 million (the “MVLS Requirement”). The letters noted that, as of their date, the bid price of the Company's common stock, par value $0.0001 per share ("Common Stock") was below $1 per share and the Company's market value of listed securities was below $35 million, in each case for 30 consecutive business days. The notifications received have no immediate effect on the Company’s continued listing on the Nasdaq Capital Market, subject to the Company’s compliance with the other continued listing requirements. In accordance with Nasdaq rules, the Company has been provided 180 calendar days, or until December 13, 2023, to regain compliance with the Minimum Bid Price Requirement and the MVLS Requirement. To regain compliance with the Minimum Bid Price Requirement, the closing bid price of the Common Stock must meet or exceed $1.00 per share for a minimum of ten consecutive business days during the 180 day compliance period. If the Company is not in compliance with the Minimum Bid Price Requirement by December 13, 2023, the Company may qualify for a second 180 calendar day compliance period. To regain compliance with the MVLS Requirement, the Company's market value of listed securities must close at $35 million or more for a minimum of ten consecutive business days during the 180 day compliance period. If the Company does not qualify for, or fails to regain compliance with the Minimum Bid Price Requirement during the second 180 day compliance period, or if the Company is not in compliance with the MVLS Requirement by December 13, 2023, then the Staff will provide written notice to the Company that its securities are subject to delisting, at which point the Company would have an option to appeal the delisting determination to a Nasdaq hearings panel. The Company intends to actively monitor the closing bid price of its Commons Stock and its market value of listed securities and may, if appropriate, consider implementing available options to regain compliance with the Minimum Bid Price Requirement and the MVLS Requirement under the Nasdaq Listing Rules. Major Estimate Revision • May 18
Consensus revenue estimates increase by 33%, EPS downgraded The consensus outlook for fiscal year 2023 has been updated. 2023 revenue forecast increased from US$150.0k to US$200.0k. EPS estimate fell from -US$1.28 to -US$1.49 per share. Healthcare Services industry in the US expected to see average net income growth of 3.8% next year. Consensus price target of US$7.00 unchanged from last update. Share price fell 8.7% to US$0.79 over the past week. Tillkännagivande • May 05
Better Therapeutics, Inc. to Report Q1, 2023 Results on May 11, 2023 Better Therapeutics, Inc. announced that they will report Q1, 2023 results at 9:30 AM, US Eastern Standard Time on May 11, 2023 Price Target Changed • Mar 31
Price target decreased by 34% to US$11.67 Down from US$17.67, the current price target is an average from 3 analysts. New target price is 1,569% above last closing price of US$0.70. Stock is down 65% over the past year. Tillkännagivande • Dec 09
Better Therapeutics, Inc. Completes Exploratory Trial for Fatty Liver Disease and Announces Positive Topline Results Better Therapeutics, Inc. announced positive topline results of the first-ever study evaluating the feasibility of using a prescription digital therapeutic to reduce liver fat and improve liver disease biomarkers in Nonalcoholic Fatty Liver Disease (NAFLD) and Nonalcoholic Steatohepatitis (NASH). The study included a cohort of 22 patients with NAFLD and NASH and used Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) scans, a validated proxy for liver biopsies, to monitor changes in liver fat. Changes in a range of exploratory liver biomarkers were also assessed. Currently, there is no FDA approved treatment for these conditions, which affect approximately one in four Americans and cause approximately $100 billion in direct medical cost annually. And while some drug candidates are in various phases of research and development, they often present side effects that could limit their utility in patients, if approved. The LivVita Study met its primary endpoint, showing a statistically significant positive signal with an average relative reduction in MRI-PDFF of 16% (p=0.01) in the intent-to-treat population (N=19). Additional highlights include: A statistically significant mean reduction in Alanine transaminase (ALT) of -17 IU/L (p=0.002); A statistically significant mean change in FAST Score of 20% (p=0.01); No severe adverse events or device related adverse events; and High engagement and patient satisfaction with treatment, with Net Promoter Score of +75 and 94% of subjects still using the app after 90 days. The study relied on Better Therapeutics’ CBT platform, which has been developed with the intention of helping patients with cardiometabolic diseases – including NASH and NAFLD – access a tailored treatment that leverages CBT techniques to address underlying causes of these diseases and help them make sustainable behavioral changes. This platform has already shown progress elsewhere, leading to the submission of a de novo classification request for BT-001, Better Therapeutics’ prescription digital therapy for type 2 diabetes, currently under review by the FDA. Better Therapeutics intends to publish these data in a peer-reviewed journal, apply for breakthrough device designation with the FDA, and potentially seek a partner to accelerate development of a NAFLD/NASH specific PDT. Board Change • Nov 16
High number of new and inexperienced directors There are 9 new directors who have joined the board in the last 3 years. The company's board is composed of: 9 new directors. No experienced directors. No highly experienced directors. Director Suying Liu is the most experienced director on the board, commencing their role in 2020. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Tillkännagivande • Nov 08
Better Therapeutics, Inc. to Report Q3, 2022 Results on Nov 14, 2022 Better Therapeutics, Inc. announced that they will report Q3, 2022 results After-Market on Nov 14, 2022 Tillkännagivande • Oct 28
Better Therapeutics Appoints Diane Gomez-Thinnes as Chief Commercial Officer Better Therapeutics, Inc. announced that Diane Gomez-Thinnes joined the company as Chief Commercial Officer starting October 26, 2022. Gomez-Thinnes brings more than two decades of experience in the healthcare industry, leading the commercialization and launch of products spanning the medical device, prescription medicines and consumer health sectors for companies including Johnson & Johnson and Galderma, where she served as President of U.S. Operations. At Galderma, Gomez-Thinnes led the company’s largest U.S. business in which she delivered double digit growth while playing a leadership role during a transformative period for the company. During her tenure, she directed the launch of more than 20 products including innovative drug delivery technology, a refreshed consumer product line, and new aesthetics products with a focus on data-informed treatments. Prior to Galderma, Gomez-Thinnes spent 17 years at Johnson & Johnson, ultimately serving as Worldwide President for Mentor, where she led the return of that business to a #1 global leadership position through a refreshed product pipeline, a new digital customer experience solution, and in-market commercial partnerships. Gomez-Thinnes joins Better Therapeutics following the FDA’s acceptance of the company’s de novo classification request of its BT-001 prescription digital therapy for type 2 diabetes (T2D) in adults for review. This comes on the heels of completion of an encouraging pivotal clinical trial generating positive results for the company’s lead prescription digital therapeutic. The Better Therapeutics CBT platform is designed to deliver a novel form of CBT via a smartphone application to help individuals tackle the underlying causes of cardiometabolic diseases. In its pivotal trial for BT-001, T2D patients using the Better Therapeutics platform with the current standard of care showed improved A1C control compared to patients only receiving the current standard of care and were less likely to need additional – and often more costly – medications to control their disease progression. Tillkännagivande • Sep 23
Better Therapeutics, Inc. Submits De Novo Request to U.S. FDA for BT-001 Investigational Prescription Digital Therapy for Type 2 Diabetes Better Therapeutics, Inc. announced that it has submitted a de novo classification request to the U.S. Food and Drug Administration (FDA) seeking marketing authorization for BT-001, its potentially first-in-class digital therapeutic designed to use CBT to treat Type 2 Diabetes (T2D) in patients 18 years and older. This submission follows positive results from the BT-001 pivotal trial, the largest randomized control study ever conducted of a digital therapeutic to evaluate glycemic response in T2D. The trial met both its primary and secondary endpoints demonstrating statistically and clinically meaningful reductions in A1c over the current standard of care, even as control group patients increased use of blood sugar lowering medications. The results achieved were sustainable and improved between day 90 and day 180 of the trial, demonstrating that BT-001 has the potential to deliver meaningful, durable improvements in blood sugar control for a complex range of patients with T2D already on standard of care blood sugar lowering medications. In addition, exploratory data revealed a host of cardiometabolic improvements as well as lower medication utilization compared to the control group, supporting the potential for BT-001 to improve the overall health of patients with T2D and potentially reduce the usage of increasingly costly T2D medications associated with the progression of the disease. If authorized by the FDA, BT-001 would be the first validated, prescription solution for delivering CBT to T2D patients at scale, from their digital devices. In addition to treating T2D with BT-001, if authorized, Better Therapeutics is exploring the potential to use CBT for other cardiometabolic conditions, including nonalcoholic fatty liver disease, nonalcoholic steatohepatitis, hypertension, and hyperlipidemia. Recent Insider Transactions • Sep 15
Head of Finance & Interim CFO recently bought US$97k worth of stock On the 13th of September, Mark Heinen bought around 50k shares on-market at roughly US$1.94 per share. This transaction increased Mark's direct individual holding by 2x at the time of the trade. This was the largest purchase by an insider in the last 3 months. Mark has been a buyer over the last 12 months, purchasing a net total of US$135k worth in shares. Tillkännagivande • Aug 05
Better Therapeutics, Inc. to Report Q2, 2022 Results on Aug 11, 2022 Better Therapeutics, Inc. announced that they will report Q2, 2022 results Pre-Market on Aug 11, 2022 Tillkännagivande • Jul 29
Better Therapeutics, Inc. Completes Pivotal Trial of BT-001 for Type 2 Diabetes and Announces Positive Secondary Endpoint Results Better Therapeutics, Inc. announced the completion of the pivotal clinical trial for BT-001, an investigational first-in-class prescription digital therapeutic that is designed to use nCBT to treat type 2 diabetes (T2D). With the positive data reported by this pivotal clinical trial, Better Therapeutics intends to submit a de novo classification request to the U.S. Food and Drug Administration (FDA) in the third quarter of 2022, seeking marketing authorization for BT-001 for the treatment of patients with T2D. If granted, BT-001 would become the first prescription digital therapeutic for the treatment of T2D. This data follows the announcement in March that the trial had met its primary endpoint at day 90 with a p-value of < 0.0001. The secondary endpoint data assessed at day 180 continued this trend, showing statistically significant decreases in A1c levels when compared to a control group receiving standard of care (p-value = 0.01). The results achieved were sustainable and improved between day 90 and day 180 of the trial, demonstrating that BT-001 has the potential to deliver meaningful, durable improvements in blood sugar control for a complex range of patients with T2D already on standard of care blood sugar lowering medications. In addition, exploratory data revealed a host of cardiometabolic improvements as well as lower medication utilization compared to the control group, supporting the potential for BT-001 to improve the overall health of patients with T2D and potentially reduce the usage of increasingly costly T2D medications associated with the progression of the disease. Among the encouraging results shown were: Sustained and improved A1c levels in patients using BT-001, with average absolute A1c reduction improving from 0.3% at day 90 to 0.4% at day 180, supporting that the treatment effects of BT-001 were durable. The difference in A1c levels after 180 days of treatment between BT-001 treated patients and Standard of Care (SOC) control group patients receiving standard of care remained statistically significant (p=0.01) even as more SOC patients increased blood sugar lowering medications. Half of patients using BT-001 experienced clinically meaningful A1c reductions with a mean reduction of 1.3% in this subgroup at 180 days (SD 0.8%). Results indicated that patients who did not use BT-001 were more likely to be placed on additional medications to improve A1c control. After the day 180 A1c draw, 1.7 times more SOC control patients increased their medications compared to BT-001 patients. BT-001 demonstrated reassuring safety, with significantly fewer adverse (p<0.001) and serious adverse events (p=0.01) as compared to the SOC control group. A clear dose-response between greater engagement in nCBT and greater reductions in A1c was found, supporting nCBT as a mechanism of action. The open label, randomized, controlled, parallel group trial enrolled a nationally representative group of 668 adults with T2D and mean baseline A1c of 8.1%. Participants in the trial had long standing T2D (mean 11 years), multiple comorbidities, and were already on multiple diabetes medications, representing a difficult to treat patient population. Participants were randomized to receive standard of care with or without BT-001 and the primary efficacy endpoint was the difference in mean change from baseline in A1c after 90 days of treatment between the two groups. The trial was designed with a high bar to pass and to avoid artificial designs that could produce large outcomes that do not apply to all patients. This includes not constraining patients to a specific medication profile and not incentivizing patients to use the BT-001 therapy. Tillkännagivande • Jul 12
Better Therapeutics, Inc. Announces Publication of the Rationale, Design and Baseline Characteristics Manuscript for Type 2 Diabetes Pivotal Trial of BT-001 Better Therapeutics, Inc. announced the publication of a manuscript detailing the study design and methodology for its pivotal clinical trial of BT-001 in adult patients with type 2 diabetes (T2D) in the medical journal, Clinical Cardiology. The study represents a first-in-class randomized, controlled clinical trial of a prescription digital therapeutic (PDT) for the treatment of T2D and is expected to support the filing of a de novo classification request with the U.S. Food and Drug Administration (FDA) in the third quarter of 2022. The company announced positive primary endpoint data for this trial in March of this year and expects to release secondary data in the third quarter of this year. The manuscript, titled, 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, includes a detailed description of study design, efficacy and safety endpoints, the nCBT protocols embedded in BT-001, statistical considerations and baseline characteristics of the study population. BT-001 is an investigational digital therapeutic designed to provide nCBT via a T2D patient’s smartphone to support dietary change, physical activity and medication adherence for the reduction of A1c. The open-label, randomized, controlled, parallel group trial evaluated the efficacy and safety of BT-001 and its ability to improve glycemic control among patients with T2D. Participants were randomized to receive standard of care with or without BT-001 and the primary efficacy endpoint was the difference in mean change from baseline in A1c after 90 days of treatment between the two groups. The secondary efficacy endpoint is the change from baseline to Day 180. Exploratory endpoints include physical measures, biomarkers, healthcare utilization, and patient-reported outcomes (PRO). Patients receiving standard of care were on multiple anti-hyperglycemic meds at baseline and free to adjust meds as needed. In this way, the design parallels cardiovascular outcome trials of other medications. The clinical trial enrolled 669 adults with T2D and supported inclusion and exclusion criteria chosen to enroll a representative population of adult outpatients with T2D across population groups often underrepresented in biotech research, including women, minority groups and patients in low socioeconomic status neighborhoods. The manuscript highlights key potential advantages of the digital therapeutic over in-person nCBT, which include its scalability, standardization of the intervention, and ease of access. The latter is particularly important for rural residents and patients with time, mobility or transportation limitations. In-clinic CBT is a long-standing and well-studied therapeutic approach, but broad utilization has been limited by inherent access and resource constraints. Prescription digital therapeutics that digitally deliver nCBT have the potential to overcome these obstacles by making behavioral therapy accessible and affordable to millions of patients in need. Tillkännagivande • May 06
Better Therapeutics, Inc. to Report Q1, 2022 Results on May 13, 2022 Better Therapeutics, Inc. announced that they will report Q1, 2022 results Pre-Market on May 13, 2022 Board Change • Apr 30
High number of new and inexperienced directors There are 8 new directors who have joined the board in the last 3 years. The company's board is composed of: 8 new directors. No experienced directors. No highly experienced directors. Director Suying Liu is the most experienced director on the board, commencing their role in 2020. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Recent Insider Transactions • Apr 02
Independent Director recently bought US$86k worth of stock On the 29th of March, Andrew Armanino bought around 40k shares on-market at roughly US$2.14 per share. This was the largest purchase by an insider in the last 3 months. Insiders have collectively bought US$540k more in shares than they have sold in the last 12 months. Tillkännagivande • Mar 29
Better Therapeutics, Inc. Announces Positive Primary Endpoint Data from the Pivotal Clinical Trial for the company's BT-001 Prescription Digital Therapeutic Better Therapeutics, Inc. announced positive primary endpoint data from the pivotal clinical trial for the company's BT-001 prescription digital therapeutic. The data released by Better Therapeutics demonstrated the safety and efficacy of BT-001 in an open label, randomized, controlled, parallel group trial enrolled 669 adults with type 2 diabetes and mean baseline A1c of 8.1%. Participants were randomized to receive standard of care with or without BT-001 and the primary efficacy endpoint was the difference in mean change from baseline in A1c after 90 days of treatment between the two groups. The six-month trial is ongoing and is expected to be completed in second quarter of 2022. The findings included data showing: A highly statistically significant primary efficacy endpoint (n=602) improvement in A1c between the intervention and control groups (-0.4%, p <0.001). Clinically meaningful changes (A1c reductions of 0.4% or more) in 42.7% of the group receiving standard of care and BT-001 vs. 25.4% in the group receiving standard of care alone (difference of 17.3%, p <0.0010). A clear dose-response between greater engagement in nCBT and greater reductions in A1c, supporting nCBT as a mechanism of action. Measures of patient engagement, adherence, persistence, and satisfaction were all positive. Tillkännagivande • Mar 01
Better Therapeutics, Inc. Announces New CMS HCPCS Code for Prescription Digital Behavioral Therapies Better Therapeutics, Inc. announced a new code from the Center for Medicare and Medicaid Services (CMS) that paves the way for reimbursement of these therapies. CMS recently created new, Level II Healthcare Common Procedure Coding Systems (HCPCS) codes for prescription digital behavioral therapy that will be effective in April 2022. BT-001 is Better Therapeutics’ PDT delivering cognitive behavioral therapy to address behavioral root cause of type 2 diabetes. It is currently being studied in a potentially pivotal study involving 669 patients recruited from six geographic regions in the U.S. Primary endpoint data will readout in first quarter 2022, and the study is expected to conclude in second quarter 2022. The company anticipates filing a de novo submission with the FDA soon thereafter. Tillkännagivande • Feb 17
Better Therapeutics, Inc. Enrolls First Patient in Real World Evidence Study with Colorado Prevention Center Clinical Research Better Therapeutics, Inc. 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. Board Change • Nov 03
Less than half of directors are independent Following the recent departure of a director, there is only 1 independent director on the board. The company's board is composed of: 1 independent director. 5 non-independent directors. Director Risa Lavizzo-Mourey was the last director to join the board, commencing their role in 2021. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model.