Financial Performance - Interest expense for the nine months ended September 30, 2023, was $1.5 million, up from $1.1 million in the same period of 2022, due to higher interest rates and an additional $5.0 million borrowed [189]. - Cash used in operating activities for the nine months ended September 30, 2023, was $19.7 million, a decrease from $22.6 million in the same period of 2022 [194][196]. - Cash provided by financing activities for the nine months ended September 30, 2023, was $11.6 million, compared to $5.2 million in the same period of 2022 [194][198]. - The company incurred a net loss of $22.8 million for the nine months ended September 30, 2023, compared to a net loss of $31.0 million for the same period in 2022, with an accumulated deficit of $134.3 million as of September 30, 2023 [229]. - As of September 30, 2023, the company had $6.6 million in cash and an accumulated deficit of $134.3 million [193]. - The existing cash and cash equivalents of $6.6 million as of September 30, 2023, are expected to fund operations into the first quarter of 2024, raising substantial doubt about the company's ability to continue as a going concern [229]. Debt and Financing - As of September 30, 2023, the outstanding debt balance was $14.3 million, with an interest rate of 14.2%, compared to $14.9 million and 13.2% as of December 31, 2022 [190]. - The company incurred $518 thousand in debt issuance costs related to the Loan Agreement, which are being amortized through the maturity date [190]. - The company drew down $10 million from the Term Loan Facility in October 2021 and an additional $5 million in May 2022, with remaining borrowing contingent on compliance with covenants [285]. - Amortization payments under the Term Loan Facility are set to begin on November 1, 2023 [352]. - The company is required to maintain a minimum aggregate balance of $2.5 million in cash in controlled accounts as collateral under the Loan Agreement [372]. Product Development and Commercialization - The company has never generated revenue from product sales and does not expect to do so until the fourth quarter of 2023 following the commercial launch of AspyreRx in October 2023 [251]. - The company is highly dependent on the successful commercialization of AspyreRx, and failure to do so would materially harm its business [240]. - The clinical trial process for obtaining marketing authorizations is lengthy and expensive, with uncertain outcomes that could adversely affect the company's ability to commercialize its products [220]. - The company anticipates that expenses will increase substantially as it advances its product candidates into clinical development, which entails significant risks [227]. - The company plans to advance its lead product, AspyreRx, through commercialization and expand its operational and management systems to support clinical operations [252]. - The company received FDA authorization for AspyreRx in July 2023, following the completion of its pivotal clinical trial in July 2022 [295]. - Future revenue generation is dependent on the widespread adoption of AspyreRx by physicians, which may be influenced by various factors including reimbursement and perceived efficacy [310]. - The company does not expect to generate significant revenue until it obtains regulatory authorization for its product candidates, which is uncertain [255]. Market and Competitive Landscape - The market acceptance of AspyreRx in the United States is crucial, and failure to gain such acceptance would negatively impact the company's business [220]. - The clinical and commercial landscapes for cardiometabolic diseases are highly competitive, with major pharmaceutical companies as significant competitors [268]. - The company may face legal proceedings and litigation, including intellectual property disputes, which could materially harm its business and results of operations [220]. - The company may enter into collaborations or strategic alliances to develop products and pursue new markets [278]. - The company may face challenges in securing collaborations or partnerships due to competition from larger firms with more resources [343]. Operational Challenges - The company has experienced disruptions and performance issues with its platform, which could negatively impact business operations and financial results [313]. - The company may face difficulties in recruiting and retaining effective sales and marketing personnel, impacting its ability to commercialize products [275]. - Increased patient demand for support could raise costs and adversely affect the company's financial condition [277]. - The company may encounter difficulties in enrolling sufficient patients for clinical trials, which could delay development timelines [341]. - The company may experience increased costs and program delays due to challenges in patient enrollment and retention in clinical trials [364]. - The company must enhance its product AspyreRx with additional functionalities and indications to remain competitive in the market [333]. Regulatory and Compliance Risks - The company may require additional FDA marketing authorizations for modifications to its devices, and failure to obtain these could adversely affect its financial condition [324]. - The FDA may lack experience in evaluating the safety and effectiveness of product candidates based on cognitive behavioral therapy (CBT), potentially leading to longer regulatory review processes [342]. - The de novo classification process requires extensive data to demonstrate safety and efficacy, which may delay or prevent marketing authorization for other product candidates [374]. - The company must comply with stringent privacy and data security requirements, which may exceed legal obligations [378]. - Maintaining effective disclosure controls and internal control over financial reporting is crucial for timely and accurate financial statements [381]. Future Outlook and Strategic Plans - The company intends to seek Breakthrough Device Designation from the FDA for its investigational CBT-based treatment platform by the end of 2023 [369]. - The company expects expenses to increase in connection with planned operations and may seek additional capital through various financing methods [292]. - The company believes it can fund its operating expenses into the first quarter of 2024, but changing circumstances may require seeking additional funds sooner [258]. - Future acquisitions may be pursued to add complementary companies or technologies, but integration challenges could arise [272]. - The company faces risks related to potential changes in U.S. tax laws that could adversely affect cash flow and tax liabilities [288]. - Unfavorable global economic conditions could adversely affect the company's business and financial condition [349]. - The company has approximately $77.6 million in net operating losses (NOLs) for U.S. federal and state income tax purposes as of September 30, 2023 [287].
Better Therapeutics(BTTX) - 2023 Q3 - Quarterly Report