AUGUST 09, 2023 THERAPEUTICS Better Therapeutics Team Frank Karbe Diane Gomez-Thinnes Chief Commercial Officer Disclaimer Certain statements in this Presentation may be considered 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," " ...

Financial Data and Key Metrics Changes - The net loss for Q2 2023 was $7.6 million, an improvement from $9.9 million in Q2 2022, resulting in a loss per share of $0.24 compared to $0.41 last year [16][17] - Cash and cash equivalents decreased to $6.2 million as of June 30, 2023, down from $15.7 million at the end of 2022, but pro forma cash after recent financings was $12.9 million [40][128] - Operating expenses were reduced significantly, with R&D expenses at $2.2 million compared to $4.2 million in the same period last year [37] Business Line Data and Key Metrics Changes - AspyreRx is positioned to treat the majority of the 29 million adults diagnosed with Type 2 diabetes in the U.S. [5] - The company is focusing on a cash pay option for patients with insurance claim rejections, aiming to keep out-of-pocket costs low [4] Market Data and Key Metrics Changes - Over 72% of payers find AspyreRx valuable, with 64% anticipating coverage, indicating strong market interest [2] - The company is targeting five to six priority geographies for initial market penetration based on data analysis [118] Company Strategy and Development Direction - The company aims to commercialize AspyreRx in Q4 2023, with plans to broaden payer coverage and secure federal supply schedule access [21][128] - The strategy includes obtaining breakthrough device designation for NAFLD and NASH by the end of 2023 [22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving commercial traction through provider, payer, and patient adoption of AspyreRx [18] - The FDA authorization has resolved regulatory risks and is expected to facilitate broader payer discussions [18][59] Other Important Information - The wholesale acquisition cost for AspyreRx is set at $750 for a 90-day treatment, with a total expected cost of $1,500 for a six-month treatment [112][113] - The company has completed approximately 90% enrollment in its real-world evidence studies, on track for completion by the end of Q3 2023 [108] Q&A Session Summary Question: What will operating expenses look like post-commercialization? - Management indicated that operating expenses are expected to remain flat initially, with potential increases depending on commercial traction [70] Question: How many patients will be enrolled in the real-world evidence study? - Approximately 1,000 patients are expected to be enrolled, with interim data anticipated by the end of the year [51] Question: What is the expected cash pay price for AspyreRx? - The cash pay price is not finalized, but providers suggest a reasonable range of $25 to $50 per month for out-of-pocket costs [53][75] Question: How are early discussions with payers going post-authorization? - Management reported encouraging feedback from payers regarding the trial design and clinical data, with ongoing discussions about value-based agreements [82][84]

[PART I. FINANCIAL INFORMATION](index=4&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed financial statements for Better Therapeutics, Inc., including the Balance Sheets, Statements of Operations and Comprehensive Loss, Statements of Stockholders' (Deficit)/Equity, and Statements of Cash Flows, along with detailed notes explaining the company's business, significant accounting policies, debt, equity, and recent financial events [Condensed Balance Sheets](index=4&type=section&id=Condensed%20Balance%20Sheets) This table provides a snapshot of the company's financial position, detailing assets, liabilities, and stockholders' deficit at specific dates | ASSETS / LIABILITIES (in thousands) | June 30, 2023 (unaudited) | December 31, 2022 (audited) | | :---------------------------------- | :------------------------ | :-------------------------- | | Cash and cash equivalents | $6,196 | $15,740 | | Total current assets | $7,422 | $18,446 | | Total Assets | $11,604 | $22,943 | | Total current liabilities | $13,873 | $13,494 | | Long-term debt, net | $8,519 | $10,348 | | Total liabilities | $22,392 | $23,842 | | Accumulated deficit | $(128,449) | $(111,503) | | Total Stockholders' Deficit | $(10,788) | $(899) | [Condensed Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This table summarizes the company's financial performance over specific periods, showing revenues, expenses, and net loss | (in thousands, except per share data) | Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :------------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $2,240 | $4,241 | $5,629 | $7,914 | | Sales and marketing | $1,704 | $1,683 | $3,808 | $3,727 | | General and administrative | $3,081 | $3,675 | $6,513 | $7,303 | | Total operating expenses | $7,025 | $9,599 | $15,950 | $18,944 | | Loss from operations | $(7,025) | $(9,599) | $(15,950) | $(18,944) | | Interest expense, net | $(563) | $(329) | $(994) | $(646) | | Net loss | $(7,589) | $(9,928) | $(16,946) | $(19,590) | | Net loss per share, basic and diluted | $(0.24) | $(0.42) | $(0.62) | $(0.83) | [Condensed Statements of Stockholders' (Deficit)/Equity](index=6&type=section&id=Condensed%20Statements%20of%20Stockholders'%20(Deficit)%2FEquity) This table details changes in the company's equity or deficit over time, including net loss, stock issuances, and share-based compensation | (in thousands, except share data) | Common Shares | Stock Amount | Additional Paid-in Capital | Accumulated Deficit | Total Stockholders' Deficit | | :-------------------------------- | :------------ | :----------- | :------------------------- | :------------------ | :-------------------------- | | Balance as of December 31, 2022 | 23,851,022 | $2 | $110,602 | $(111,503) | $(899) | | Net loss (Q1 2023) | — | — | — | $(9,357) | $(9,357) | | Issuance of common stock, net | 7,878,786 | $1 | $6,099 | — | $6,100 | | Share-based compensation | — | — | $493 | — | $493 | | Balance as of June 30, 2023 | 31,797,101 | $3 | $117,658 | $(128,449) | $(10,788) | [Condensed Statements of Cash Flows](index=7&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) This table outlines the cash inflows and outflows from operating, investing, and financing activities over specific periods | CASH FLOWS (in thousands) | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :------------------------ | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(13,803) | $(15,581) | | Net cash used in investing activities | $(1,024) | $(446) | | Net cash provided by financing activities | $5,283 | $5,146 | | Net change in cash and cash equivalents | $(9,544) | $(10,881) | | Cash and cash equivalents, end of period | $6,196 | $29,685 | [Notes to Condensed Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) This section provides detailed explanations and additional information supporting the condensed financial statements [Note 1. Description of Business and Summary of Significant Accounting Policies](index=9&type=section&id=Note%201.%20Description%20of%20Business%20and%20Summary%20of%20Significant%20Accounting%20Policies) This note describes the company's core business, product development, recent financing activities, and significant accounting policies - Better Therapeutics, Inc. is a prescription digital therapeutics company developing software-based cognitive behavioral therapy (CBT) for cardiometabolic diseases (CMDx), with initial focus on Type 2 Diabetes (T2D), hypertension, hyperlipidemia, NAFLD, NASH, and CKD[44](index=44&type=chunk)[129](index=129&type=chunk) - In July 2023, the FDA authorized AspyreRx (formerly BT-001), a prescription-only PDT for T2D, which is expected to launch commercially in **Q4 2023**[18](index=18&type=chunk)[101](index=101&type=chunk) - The company is conducting real-world evidence studies for AspyreRx, with interim results expected in **Q4 2023**, to provide long-term data on usage and outcomes[19](index=19&type=chunk)[105](index=105&type=chunk) - The company completed a private placement in April 2023, raising approximately **$6.5 million**, and further capital raises in July 2023 totaling **$4.5 million**, to support the commercial launch of AspyreRx[20](index=20&type=chunk)[25](index=25&type=chunk)[127](index=127&type=chunk)[128](index=128&type=chunk) - As of June 30, 2023, the company had **$6.2 million** in cash and an accumulated deficit of **$(128.4) million**, raising substantial doubt about its ability to continue as a going concern beyond **Q4 2023** without additional funding[25](index=25&type=chunk)[51](index=51&type=chunk)[117](index=117&type=chunk)[205](index=205&type=chunk)[230](index=230&type=chunk)[540](index=540&type=chunk) - The company received Nasdaq deficiency letters in June 2023 for not meeting minimum bid price and market value of listed securities requirements, with a deadline of **December 13, 2023**, to regain compliance[50](index=50&type=chunk)[575](index=575&type=chunk) [Note 2. Debt](index=13&type=section&id=Note%202.%20Debt) This note details the company's secured term loan agreement, including its maturity, interest rates, and recent amendments - The company's secured term loan agreement with Hercules Capital (up to **$50 million**) has a maturity date of **August 1, 2025**, with interest-only payments until **March 1, 2023**, after which principal became payable[58](index=58&type=chunk)[149](index=149&type=chunk) - An amendment in April 2023 ceased amortization payments until **November 1, 2023**, upon achieving certain benchmarks, including FDA authorization of AspyreRx[31](index=31&type=chunk)[175](index=175&type=chunk) - As of June 30, 2023, the outstanding debt balance was **$14.2 million**, with an interest rate of **13.95%**[58](index=58&type=chunk)[149](index=149&type=chunk) [Note 3. Accrued Liabilities](index=14&type=section&id=Note%203.%20Accrued%20Liabilities) This note provides a breakdown of the company's accrued liabilities, including amounts due to service providers and professionals | Accrued Liabilities (in thousands) | June 30, 2023 | December 31, 2022 | | :--------------------------------- | :------------ | :---------------- | | Due to service providers | $1,656 | $1,335 | | Due to professionals | $158 | $506 | | Financed insurance | $460 | $963 | | Accrued interest | $164 | $168 | | Other | $10 | $654 | | Total Other accrued liabilities | $2,448 | $3,626 | [Note 4. Fair Value Measurements](index=14&type=section&id=Note%204.%20Fair%20Value%20Measurements) This note explains the valuation methods for financial instruments and their classification within the fair value hierarchy - The carrying value of financial instruments (cash equivalents, accounts payable, accrued liabilities, notes payable) approximates fair value due to their short-term nature. Money market funds are classified as **Level 1 financial instruments**[80](index=80&type=chunk)[184](index=184&type=chunk) [Note 5. Net Loss Per Share Attributable to Common Stockholders](index=14&type=section&id=Note%205.%20Net%20Loss%20Per%20Share%20Attributable%20to%20Common%20Stockholders) This note details the calculation of net loss per share, considering common stock outstanding and potentially dilutive securities | (in thousands, except per share amounts) | Three Months Ended June 30, 2023 | Six Months Ended June 30, 2023 | | :--------------------------------------- | :------------------------------- | :----------------------------- | | Net loss | $(7,589) | $(16,946) | | Weighted-average common stock outstanding | 31,232,684 | 27,562,525 | | Loss per share, basic and diluted | $(0.24) | $(0.62) | - All potentially dilutive securities were anti-dilutive for the periods presented due to net losses, resulting in basic net loss per share equaling diluted net loss per share[55](index=55&type=chunk)[62](index=62&type=chunk)[190](index=190&type=chunk) [Note 6. Share-Based Compensation](index=14&type=section&id=Note%206.%20Share-Based%20Compensation) This note outlines the company's stock option and incentive plans, including activity, unrecognized expense, and compensation expense - The 2021 Stock Option and Incentive Plan initially reserved **3.6 million shares**, with an automatic annual increase. As of June 30, 2023, **1.5 million shares** were reserved[64](index=64&type=chunk) - The 2022 Inducement Plan reserved **600 thousand shares** for prospective officers and employees, with **400 thousand shares** remaining reserved as of June 30, 2023[65](index=65&type=chunk) | Stock Options Activity (in thousands, except per share data) | Shares Subject to Options Outstanding | Weighted-Average Exercise Price | | :--------------------------------------------------------- | :------------------------------------ | :------------------------------ | | Balance as of December 31, 2022 | 3,999,223 | $3.95 | | Granted | 984,560 | $1.07 | | Exercised | (1,544) | $0.50 | | Forfeited | (366,903) | $4.01 | | Balance as of June 30, 2023 | 4,615,336 | $3.49 | - Total unrecognized compensation expense for unvested stock options was **$2.7 million** as of June 30, 2023, to be recognized over a weighted-average period of **4.75 years**[84](index=84&type=chunk) | Equity-Based Compensation Expense (in thousands) | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :----------------------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $300 | $316 | | Sales and marketing | $48 | $31 | | General and administrative | $540 | $420 | | Total equity-based compensation expense | $888 | $767 | [Note 7. Income Taxes](index=17&type=section&id=Note%207.%20Income%20Taxes) This note explains the company's income tax position, including the effective tax rate and factors influencing it - The effective tax rate was **zero** for the six months ended June 30, 2023 and 2022, primarily due to a change in valuation allowance[94](index=94&type=chunk) [Note 8. Commitments and Contingencies](index=17&type=section&id=Note%208.%20Commitments%20and%20Contingencies) This note describes the company's involvement in legal matters and its estimated accrued liabilities related to disputes - The company is involved in claims and legal matters in the ordinary course of business, with an estimated accrued liability of **$1.1 million** as of June 30, 2023, related to a disputed change order with a vendor[95](index=95&type=chunk) [Note 9. Restructuring](index=17&type=section&id=Note%209.%20Restructuring) This note details the company's workforce reduction initiative and the associated restructuring charges and payments - In March 2023, the company announced a workforce reduction of approximately **35%** of its employees as part of a cost reduction initiative[96](index=96&type=chunk)[212](index=212&type=chunk) | Restructuring Activity (in thousands) | Employee Severance and Related Benefits | | :------------------------------------ | :-------------------------------------- | | Balance at December 31, 2022 | - | | Charges | $430 | | Payments | $(393) | | Balance at June 30, 2023 | $37 | [Note 10. Subsequent Events](index=18&type=section&id=Note%2010.%20Subsequent%20Events) This note reports significant events occurring after the balance sheet date, including additional capital raises - In July 2023, the company completed a private placement of **2,897,657 shares** for **$2.1 million** and a registered direct offering of **3,859,649 shares** for **$2.2 million**, with net proceeds intended to support the commercial launch of AspyreRx[98](index=98&type=chunk)[128](index=128&type=chunk)[137](index=137&type=chunk)[545](index=545&type=chunk) - The company also issued and sold **2,023,583 shares** for **$2.4 million** in 'at-the-market' offerings in July 2023 but suspended and terminated the related prospectus[127](index=127&type=chunk)[136](index=136&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=18&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial performance and condition, highlighting key operational developments, financial results for the three and six months ended June 30, 2023, and an analysis of liquidity, capital resources, and critical accounting policies [Overview](index=19&type=section&id=Overview) This section introduces Better Therapeutics as a prescription digital therapeutics company, its product AspyreRx, and its clinical trial successes - Better Therapeutics is a prescription digital therapeutics company focused on cardiometabolic diseases, with AspyreRx (formerly BT-001) for T2D recently authorized by the FDA and expected to launch in **Q4 2023**[101](index=101&type=chunk)[129](index=129&type=chunk) - The company's PDTs deliver a novel form of CBT to address root causes of diseases, aiming for broad reimbursement coverage and significant health economic benefits[103](index=103&type=chunk)[131](index=131&type=chunk) - BT-001 clinical trial met primary and secondary endpoints, showing statistically significant and clinically meaningful **A1c improvements**, with positive patient engagement and safety data[133](index=133&type=chunk) - Positive top-line results were achieved in the LivVita study for NAFLD and NASH, showing a **16% average relative reduction in liver fat (MRI-PDFF)** and significant improvements in ALT and FAST Score[45](index=45&type=chunk)[520](index=520&type=chunk) [Recent Events](index=21&type=section&id=Recent%20Events) This section summarizes recent financing activities, including private placements and 'at-the-market' offerings - The company completed an April Private Placement of **7,878,786 common shares** for **$6.5 million**[107](index=107&type=chunk) - In July 2023, the company issued **2,023,583 common shares** for **$2.4 million** via an 'at-the-market' offering, but subsequently suspended and terminated the related prospectus[136](index=136&type=chunk)[108](index=108&type=chunk) - Also in July 2023, the company completed a private placement of **2,897,657 shares** for **$2.1 million** and a registered direct offering of **3,859,649 shares** for **$2.2 million**, with proceeds for AspyreRx commercial launch[137](index=137&type=chunk)[545](index=545&type=chunk) [Impact of Macroeconomic Events](index=21&type=section&id=Impact%20of%20Macroeconomic%20Events) This section discusses how global economic uncertainty, including inflation and rising interest rates, could affect the company's operations - Global economic uncertainty, including political instability, conflict (Ukraine), rising interest rates, and high inflation, could materially and adversely affect the company's business, financial condition, and results of operations[138](index=138&type=chunk) [Components of Results of Operations](index=22&type=section&id=Components%20of%20Results%20of%20Operations) This section explains the primary revenue sources and categorizes operating expenses, detailing their components and expected trends - Primary revenue sources are expected from reimbursement coverage for treatments by commercial insurers, Medicare, Medicaid, and Veterans Administration[111](index=111&type=chunk) - Operating expenses are categorized into research and development, sales and marketing, and general and administrative[112](index=112&type=chunk) - R&D expenses include external costs (CROs, consultants, software development) and internal personnel costs, with capitalized internal-use software costs presented separately[113](index=113&type=chunk)[141](index=141&type=chunk) - Sales and marketing expenses are expected to increase as the company prepares for the commercial launch of AspyreRx, focusing on payers, patients, and healthcare providers[142](index=142&type=chunk) - General and administrative expenses are expected to increase due to anticipated headcount increases and costs associated with operating as a public company[538](index=538&type=chunk) [Results of Operations](index=23&type=section&id=Results%20of%20Operations) This section analyzes the company's financial performance, detailing changes in R&D, sales and marketing, G&A expenses, and net loss | (in thousands) | Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | Change ($) | Change (%) | | :------------- | :------------------------------- | :------------------------------- | :--------- | :--------- | | R&D Expenses | $2,240 | $4,241 | $(2,001) | (47)% | | S&M Expenses | $1,704 | $1,683 | $21 | 1% | | G&A Expenses | $3,081 | $3,675 | $(594) | (16)% | | Net Loss | $(7,589) | $(9,928) | $2,339 | (24)% | | (in thousands) | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | Change ($) | Change (%) | | :------------- | :----------------------------- | :----------------------------- | :--------- | :--------- | | R&D Expenses | $5,629 | $7,914 | $(2,285) | (29)% | | S&M Expenses | $3,808 | $3,727 | $81 | 2% | | G&A Expenses | $6,513 | $7,303 | $(790) | (11)% | | Net Loss | $(16,946) | $(19,590) | $2,644 | (13)% | - R&D expenses decreased primarily due to completion of the BT-001 pivotal trial, personnel cost reductions from restructuring, and increased capitalized software development costs[116](index=116&type=chunk)[145](index=145&type=chunk) - Sales and marketing expenses remained relatively flat for the three months, but increased slightly for the six months due to higher personnel costs for AspyreRx commercial launch preparation, offset by severance costs[146](index=146&type=chunk)[539](index=539&type=chunk) - General and administrative expenses decreased due to lower business insurance costs, partially offset by a write-off of capitalized costs related to unpursued financing strategies[118](index=118&type=chunk)[524](index=524&type=chunk) - Net interest expense increased due to higher interest rates and an additional **$5.0 million** borrowed under the secured term loan agreement in Q2 2022[119](index=119&type=chunk)[148](index=148&type=chunk) [Liquidity and Capital Resources](index=24&type=section&id=Liquidity%20and%20Capital%20Resources) This section assesses the company's cash position, funding needs, and cash flow activities, addressing its ability to continue as a going concern - As of June 30, 2023, the company had **$6.2 million** in cash and an accumulated deficit of **$(128.4) million**, with current capital expected to fund operations through **Q4 2023**, raising substantial doubt about its going concern ability[151](index=151&type=chunk)[540](index=540&type=chunk) - The company will require substantial additional funding for product development, regulatory authorization, and commercialization infrastructure[540](index=540&type=chunk) | Cash Flows (in thousands) | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :------------------------ | :----------------------------- | :----------------------------- | | Operating Activities | $(13,803) | $(15,581) | | Investing Activities | $(1,024) | $(446) | | Financing Activities | $5,283 | $5,146 | - Net cash used in operating activities decreased to **$13.8 million** in H1 2023 from **$15.6 million** in H1 2022, primarily due to a lower net loss and changes in operating assets and liabilities[178](index=178&type=chunk)[153](index=153&type=chunk) - Cash used in investing activities increased to **$1.0 million** in H1 2023 from **$0.4 million** in H1 2022, mainly due to capitalized internal-use software costs and capital expenditures[179](index=179&type=chunk)[549](index=549&type=chunk) - Cash provided by financing activities was **$5.3 million** in H1 2023, primarily from common stock issuance and employee stock purchase plan, offset by debt payments[180](index=180&type=chunk) - The company has no contractual obligations or off-balance sheet arrangements as of June 30, 2023[181](index=181&type=chunk)[541](index=541&type=chunk) [Critical Accounting Policies and Estimates](index=26&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) This section highlights key accounting policies and estimates that require significant management judgment, such as software capitalization and tax valuation allowances - Management's financial statements rely on estimates and assumptions for capitalized internal-use software costs, fair values of stock-based awards, and valuation allowance for deferred tax assets[526](index=526&type=chunk) - Capitalized internal-use software costs are amortized over an estimated useful life of **3 years**[156](index=156&type=chunk) - Long-lived assets are reviewed for impairment when circumstances indicate that the carrying amount may not be recoverable[157](index=157&type=chunk) - Equity-based compensation for employees is recognized over the service period, while non-employee awards are measured at grant date fair value[186](index=186&type=chunk)[158](index=158&type=chunk) - Net loss per share calculations are based on weighted-average common shares outstanding, with all potentially dilutive securities considered anti-dilutive due to net losses[190](index=190&type=chunk) - Income taxes are accounted for using the asset and liability method, with a valuation allowance established for deferred tax assets when recovery is not more likely than not[189](index=189&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=28&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Better Therapeutics, Inc. is not required to provide the information typically required by this item - The company qualifies as a 'smaller reporting company' and is therefore not required to provide quantitative and qualitative disclosures about market risk[193](index=193&type=chunk) [Item 4. Controls and Procedures](index=28&type=section&id=Item%204.%20Controls%20and%20Procedures) Management evaluated the effectiveness of the company's disclosure controls and procedures as of June 30, 2023, concluding they were effective at a reasonable assurance level. There were no material changes in internal control over financial reporting during the quarter - Management concluded that disclosure controls and procedures were **effective** at a reasonable assurance level as of June 30, 2023[165](index=165&type=chunk) - No material changes in internal control over financial reporting occurred during the three months ended June 30, 2023[544](index=544&type=chunk) [PART II. OTHER INFORMATION](index=29&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=29&type=section&id=Item%201.%20Legal%20Proceedings) The company reported no material legal proceedings - There are no material legal proceedings to report[167](index=167&type=chunk)[196](index=196&type=chunk) [Item 1A. Risk Factors](index=29&type=section&id=Item%201A.%20Risk%20Factors) This section outlines significant risks and uncertainties that could materially affect the company's business, financial condition, and operating results. Key risks include the company's limited operating history, substantial doubt about its ability to continue as a going concern, dependence on AspyreRx commercialization, intense competition, extensive government regulation, and potential stock price volatility - The company has a limited operating history and has incurred significant financial losses since inception, with substantial doubt about its ability to continue as a going concern[173](index=173&type=chunk)[205](index=205&type=chunk)[225](index=225&type=chunk)[230](index=230&type=chunk)[233](index=233&type=chunk) - The business is highly dependent on the successful commercialization of AspyreRx, and failure to achieve market acceptance or delays would materially harm the business[225](index=225&type=chunk)[246](index=246&type=chunk)[247](index=247&type=chunk) - The company will need substantial additional funding and may be forced to delay, reduce, or terminate product development or commercialization efforts if unable to raise capital[225](index=225&type=chunk)[235](index=235&type=chunk)[237](index=237&type=chunk) - The clinical and commercial landscapes for cardiometabolic diseases are highly competitive, with risks from competitors developing more effective or safer technologies[225](index=225&type=chunk)[249](index=249&type=chunk)[278](index=278&type=chunk) - The company's products and operations are subject to extensive government regulation, and failure to comply or delays in obtaining regulatory authorizations could harm the business[199](index=199&type=chunk)[338](index=338&type=chunk)[392](index=392&type=chunk)[393](index=393&type=chunk) - The insurance coverage and reimbursement status of newly-authorized products is uncertain, and failure to obtain adequate coverage could limit marketability and revenue generation[227](index=227&type=chunk)[381](index=381&type=chunk)[411](index=411&type=chunk)[412](index=412&type=chunk) - The company's Loan Agreement with Hercules Capital contains restrictions and subjective acceleration clauses that limit operational flexibility and could lead to immediate repayment demands[225](index=225&type=chunk)[299](index=299&type=chunk)[331](index=331&type=chunk) - The price of the common stock may be volatile due to various factors, including operating performance, macroeconomic conditions, and analyst reports[228](index=228&type=chunk)[435](index=435&type=chunk)[465](index=465&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=69&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section details the unregistered sales of equity securities, specifically the April and July private placements, and the intended use of proceeds to support the commercial launch of AspyreRx - In April 2023, the company issued **7,878,786 common shares** for approximately **$6.5 million** in a private placement, with proceeds intended for AspyreRx commercial launch and strategic initiatives[512](index=512&type=chunk) - In July 2023, the company issued **2,897,654 common shares** for approximately **$2.1 million** in a private placement, with net proceeds also supporting the launch of AspyreRx[485](index=485&type=chunk) [Item 3. Defaults Upon Senior Securities](index=70&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities - There are no defaults upon senior securities to report[530](index=530&type=chunk) [Item 4. Mine Safety Disclosures](index=70&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) The company reported no mine safety disclosures - There are no mine safety disclosures to report[487](index=487&type=chunk) [Item 5. Other Information](index=70&type=section&id=Item%205.%20Other%20Information) The company reported no other information - There is no other information to report[514](index=514&type=chunk) [Item 6. Exhibits](index=71&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Quarterly Report on Form 10-Q, including organizational documents, purchase agreements, and certifications - Key exhibits include the Second Amended and Restated Certificate of Incorporation, Amended and Restated Bylaws, Securities Purchase Agreements from April and July 2023, the First Amendment to the Loan and Security Agreement, and ATM Sales Agreement[488](index=488&type=chunk) - Certifications from the Principal Executive Officer and Principal Financial Officer pursuant to the Sarbanes-Oxley Act are also filed[488](index=488&type=chunk)[532](index=532&type=chunk) [Signatures](index=72&type=section&id=Signatures) The report is duly signed on behalf of Better Therapeutics, Inc. by its Chief Executive Officer and Chief Financial Officer - The report is signed by Frank Karbe, Chief Executive Officer, and Mark Heinen, Chief Financial Officer, on **August 9, 2023**[517](index=517&type=chunk)[533](index=533&type=chunk)

And finally, a decrease in HbA1C and outpatient visits were cited most in terms of measures for a successful diabetes treatment. We look forward to taking these valuable insights as we move into meetings with key supporters at the national level while developing our VISN-level coverage approach. As we refine our plans for market entry, the first phase in our launch will be focused on continuing efforts to expand coverage amongst payers. Covered lives will be a key metric and determinant of success for us. W ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 For the transition period from ____________ to ______________ Page Item 1. Legal Proceedings 26 Item 1A. Risk Factors 26 Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 67 Item 3. Defaults Upon Senior Securities 68 Item 4. Mine Safety Disclosures 68 Item 5. Other Information 68 Item 6. Exhibits 69 Signatures 70 | --- | --- | |-------|-------------------------------------------------------------------------------------- ...

Company Participants Conference Call Participants Operator I would now like to turn the call over to Mark Heinen, Chief Financial Officer. Please begin. Thank you, operator. Good morning, everyone, and welcome to the Better Therapeutics Conference Call. Our press release was issued this morning and can be found in the Investors section of corporate website bettertx.com. During today's call, we will provide a business update a financial overview of the fourth quarter and fiscal year 2022 and provide our outl ...

Coverage and Reimbursement 31 To optimize payer reimbursement coverage following a potential commercial launch, we are generating evidence to substantiate the value of BT-001 with longer-term data related to usage and outcomes in a real world setting. This is additive to the evidence generated from our six-month randomized controlled pivotal trial. We are conducting such real world evidence studies in partnerships with Mass General Brigham, Colorado Prevention Center Clinical Research, University of Colorad ...

Better Therapeutics, Inc. (OTC:BTTX) Q3 2022 Earnings Conference Call November 14, 2022 4:30 PM ET Company Participants Mark Heinen - Chief Financial Officer Frank Karbe - President and Chief Executive Officer Mark Berman - Chief Medical Officer Diane Gómez-Thinnes - Chief Commercial Officer Conference Call Participants Thomas Flaten - Lake Street Capital Markets Rahul Rakhit - LifeSci Capital Keay Nakae - Chardan Operator Good afternoon, and welcome to the Better Therapeutics Third Quarter 2022 Financial R ...

n | www.bookmark.com/art/an/and/au/mat/multion/arma Pioneering Prescription Digital Therapeutics for Cardiometabolic Diseases THIRD QUARTER 2022 EARNINGS CONFERENCE CALL NOVEMBER 14, 2022 THERAPEUTICS Disclaimer This presentation ("Presentation") is for informational purposes only. The information contained herein does not purport to be all-inclusive and neither Better Therapeutics, Inc. ("BetterTX" or the "Company") nor any of its respective affiliates nor any of its or their control persons, officers, dir ...

Company Overview - Better Therapeutics, Inc. is focused on developing prescription digital therapeutics to address cardiometabolic diseases, with the U.S. spending approximately $4.0 trillion annually on healthcare, 90% of which is for chronic diseases[88]. Clinical Trials and Product Development - The clinical trial for BT-001 involved 668 patients with type 2 diabetes, achieving a statistically significant A1c reduction of -0.4% at 90 days (p < 0.001) and -0.3% at 180 days (p <= 0.01) compared to the control group[91]. - The mean A1c reduction for BT-001 patients was 1.3%, with half of the patients achieving clinically meaningful improvements[91]. - The FDA accepted the de novo classification request for BT-001 in October 2022, which could lead to marketing authorization for treating type 2 diabetes[91]. - The company initiated real-world evidence studies to evaluate the long-term effectiveness of BT-001, with interim results expected in 2023[93]. - A clinical study for digitally delivered CBT to reduce liver fat and improve liver disease biomarkers is underway, with 22 patients enrolled[94]. Financial Performance - Research and development expenses for Q3 2022 were $5.5 million, down from $6.7 million in Q3 2021, primarily due to decreased clinical trial costs[111]. - Total operating expenses for Q3 2022 were $10.996 million, a 22% increase from $8.995 million in Q3 2021[110]. - The net loss for Q3 2022 was $11.405 million, an 8% decrease from $12.461 million in Q3 2021[110]. - Research and development expenses increased to $13.4 million for the nine months ended September 30, 2022, compared to $13.1 million for the same period in 2021, primarily due to a $4.9 million rise in personnel and consulting costs[112]. - Sales and marketing expenses rose to $5.3 million for the nine months ended September 30, 2022, from $1.2 million in the same period of 2021, driven by increased personnel, marketing, and consulting expenses for BT-001's potential launch[114]. - General and administrative expenses were $11.3 million for the nine months ended September 30, 2022, compared to $4.2 million for the same period in 2021, largely due to a $3.4 million increase in personnel and consulting costs[116]. - Interest expense, net was $1.1 million for the nine months ended September 30, 2022, compared to $3,000 for the same period in 2021, reflecting interest on a secured term loan with Hercules Capital[119]. - The company reported a net cash used in operating activities of $22.6 million for the nine months ended September 30, 2022, compared to $15.0 million for the same period in 2021[129]. - Cash provided by financing activities was $5.2 million for the nine months ended September 30, 2022, down from $18.7 million in the same period of 2021, primarily due to proceeds from long-term debt and stock options[132]. - As of September 30, 2022, the company had $22.3 million in cash and an accumulated deficit of $102.7 million, indicating significant cash burn and reliance on external funding[125]. - The company expects to incur substantial expenses for the development and potential commercialization of its product candidates, indicating a need for additional funding in the future[127]. Funding and Capital Structure - The company completed a merger with Mountain Crest Acquisition Corp. II, raising $59.0 million in funding upon completion[123]. - The secured term loan agreement with Hercules Capital allows for borrowing in tranches based on clinical milestones, with $10.0 million borrowed in October 2021 and $5.0 million in May 2022[124]. Accounting and Reporting - No impairment of long-lived assets was indicated during the nine months ended September 30, 2022[145]. - Equity-based compensation expense is recognized over the service period, with performance conditions only recognized if probable[146]. - The fair value of common stock is determined based on the closing price on the grant date[149]. - The expected term for equity-based awards is calculated using the simplified method, averaging the time-to-vesting and contractual life[150]. - Expected volatility for options was estimated using the average historic price volatility of industry peers due to limited trading history[151]. - The company is classified as an "emerging growth company" and intends to take advantage of certain exemptions from reporting requirements[159]. - The company will remain an emerging growth company until it meets specific revenue or market value thresholds[160]. - The company is also classified as a "smaller reporting company," allowing for reduced disclosure obligations[163]. - Deferred tax assets are assessed for recoverability based on future taxable income, with a valuation allowance established when necessary[156]. - Basic and diluted net loss per share attributable to common stock is equal due to all potentially dilutive securities being antidilutive[158].