Bio-Path(BPTH) - 2025 Q3 - Quarterly Report

Drug Development - The company has four drug candidates in development targeting at least five different cancer indications and one obesity indication [67]. - The lead drug candidate, BP1001 (prexigebersen), is in a Phase 2 clinical trial for untreated acute myeloid leukemia (AML) patients, with a preliminary review showing 75% of newly diagnosed patients achieving complete remission or related outcomes [71]. - The Phase 2 trial includes three cohorts, with approximately 98 evaluable patients in the first cohort and 54 evaluable patients in each of the second and third cohorts [69]. - The second drug candidate, BP1002, targeting Bcl-2, has discontinued enrollment in its Phase 1 trial due to challenges in a crowded development landscape [72]. - BP1003, targeting the STAT3 protein, is in IND enabling studies for pancreatic cancer, with a focus on its potential as a treatment due to the severity of the disease [74]. - BP1001-A, a modified version of prexigebersen, is undergoing a Phase 1/1b trial, with the first cohort completed and no dose-limiting toxicities reported [75]. - The company is developing a molecular biomarker package to identify patients likely to respond to prexigebersen treatment, enhancing the probability of success [80]. - The company plans to expand its drug development programs to include new disease-causing protein targets and develop new liposomal antisense drug candidates [79]. Financial Performance - As of September 30, 2025, the company had an accumulated deficit of $126.0 million and a net loss of $1.0 million for the three months ended September 30, 2025, compared to a net loss of $2.1 million for the same period in 2024 [84]. - Research and development expenses for the three months ended September 30, 2025, were $0.3 million, a decrease of $1.0 million compared to the same period in 2024, primarily due to cash flow constraints and pausing clinical trials [97]. - General and administrative expenses for the three months ended September 30, 2025, were $0.2 million, a decrease of $1.1 million compared to the same period in 2024, mainly due to reduced salaries and benefits expenses [97]. - The company's net loss for the nine months ended September 30, 2025, was $8.4 million, a decrease of $1.3 million compared to the same period in 2024 [105]. - The company had a cash balance of $0.0 million as of September 30, 2025, a decrease of $1.2 million compared to December 31, 2024, indicating insufficient cash to meet obligations for the next 12 months [108]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $1.6 million, with a net loss for the period of $8.4 million [109]. - Net cash provided by financing activities for the nine months ended September 30, 2025, was $0.4 million, compared to $7.2 million for the same period in 2024 [112]. - The company expects to continue incurring significant operating losses as it expands drug development programs and commercialization efforts [84]. - The company currently has no lines of credit or arranged access to debt financing, relying on cash on hand and potential equity offerings for funding [107]. - The company anticipates that any revenue generated in the future will fluctuate based on the timing and success of drug candidate commercialization [89]. Financing Activities - The 2022 Shelf Registration Statement allows for the offering of up to $110.0 million in various securities, including common stock and warrants [113]. - On March 25, 2024, the company completed a registered direct offering of 75,000 shares for gross proceeds of approximately $0.3 million, with net proceeds of about $0.2 million after expenses [114]. - The At The Market Offering Agreement executed on April 4, 2024, resulted in the sale of 436,511 shares for gross proceeds of approximately $2.0 million, yielding net proceeds of around $1.8 million [115]. - As of June 30, 2025, the company sold 334,929 shares under the Subsequent ATM Prospectus Supplement for gross proceeds of approximately $1.1 million, with net proceeds of about $1.0 million [116]. - The April 2024 Registered Direct Offering raised approximately $1.2 million from the sale of 375,000 shares, with net proceeds of about $0.9 million after expenses [117]. - The June 2024 PIPE generated gross proceeds of approximately $4.0 million, with net proceeds of around $3.3 million after deducting fees and expenses [118]. - The October 2024 Private Placement raised approximately $4.0 million, resulting in net proceeds of about $3.5 million after expenses [119]. - In February 2025, investors exercised pre-funded warrants for 2,540,000 shares at a weighted average exercise price of approximately $0.001 per share [120]. - The company anticipates significant operating expenses related to clinical trials and regulatory approvals, necessitating substantial additional capital [127]. Compliance and Risk - As of September 30, 2025, the March 2025 Promissory Notes were in default and became convertible under the default provisions [126]. - As of September 30, 2025, the company reported no material off-balance sheet arrangements [128]. - There have been no significant changes to the company's critical accounting policies since the last annual report [129]. - The company did not disclose any quantitative or qualitative market risk information [130].