Bio-Path(BPTH) - 2024 Q4 - Annual Report

Drug Development - The company has four drug candidates in development targeting at least five different cancer indications, with the lead candidate BP1001 (prexigebersen) currently in a Phase 2 clinical trial for untreated AML patients[305]. - In the Phase 2 trial, 75% of newly diagnosed AML patients achieved complete remission or complete remission with incomplete blood count recovery (CR/CRi/CRh) after treatment with prexigebersen, decitabine, and venetoclax[309]. - The company plans to complete enrollment for the first two cohorts of the Phase 2 trial by 2026, with a total of approximately 98 evaluable patients in Cohort 1 and 54 in Cohort 2[309]. - The second drug candidate, BP1002, targeting the Bcl-2 protein, has discontinued enrollment in its Phase 1 trial due to challenges in recruiting patients in a competitive landscape[311]. - BP1003, targeting the STAT3 protein, is in IND enabling studies, with plans to file an IND application and initiate a Phase 1 study for pancreatic cancer and NSCLC[314]. - BP1001-A, a modified version of prexigebersen, is undergoing a Phase 1/1b trial, with the first dose cohort completed and no dose limiting toxicities reported[315]. - The company is exploring BP1001-A as a potential treatment for obesity and Type 2 diabetes, with preclinical studies showing it may enhance insulin sensitivity[316][317]. - The company is developing a molecular biomarker package to accompany prexigebersen treatment to identify patients more likely to respond to the investigational treatment[319]. - The company intends to apply its DNAbilize® technology to new disease-causing protein targets and develop new liposomal antisense drug candidates[318]. - The company holds intellectual property for its drug products in clinical development, including composition of matter and method of use patents for RNAi antisense nanoparticle drug products[320]. Financial Performance - As of December 31, 2024, the company had an accumulated deficit of $117.5 million and a net loss of$9.9 million, a decrease from $16.1 million in 2023[321]. - The company reported no revenue for the years ended December 31, 2024 and 2023, indicating a reliance on future drug candidate commercialization for revenue generation[322][329]. - Research and development expenses for 2024 were$7.3 million, down from $11.6 million in 2023, primarily due to decreased manufacturing expenses[330]. - General and administrative expenses increased to$4.7 million in 2024 from $4.2 million in 2023, attributed to higher salaries and expenses related to a special shareholder meeting[332]. - The net operating loss for 2024 was$12.0 million, a decrease of $3.8 million compared to 2023[332]. - The company had a cash balance of$1.2 million at December 31, 2024, which is insufficient to cover current liabilities and capital expenditures[336]. - Net cash used in operating activities for 2024 was $10.6 million, with the net loss contributing significantly to this figure[337]. - The net loss per share for 2024 was$4.12, a significant improvement from $33.63 per share in 2023[334]. - The company anticipates continued significant operating losses as it expands drug development and commercialization efforts[321]. Financing Activities - The company raised approximately$10.7 million through various financing activities in 2024, including registered direct offerings and private placements[339]. - The company entered into an At The Market Offering Agreement on April 4, 2024, allowing the sale of up to $2.0 million in common stock, resulting in the sale of 436,511 shares for gross proceeds of approximately$2.0 million and net proceeds of about $1.8 million after expenses[345]. - On April 19, 2024, the company increased the offering under the At The Market Offering Agreement by an additional$1.1 million, selling 334,929 shares for gross proceeds of approximately $1.1 million and net proceeds of about$1.0 million[346]. - The company completed a registered direct offering on April 19, 2024, selling 375,000 shares for gross proceeds of approximately $1.2 million, with net proceeds of around$0.9 million after fees[347]. - In June 2024, the company raised approximately $4.0 million through a private placement, selling 180,000 shares and various warrants, with net proceeds of about$3.3 million after expenses[350]. - The October 2024 private placement generated approximately $4.0 million in gross proceeds, with net proceeds of about$3.5 million after deducting fees, while canceling certain previously issued warrants[351]. - The company issued a promissory note for $161,000 on March 6, 2025, with a purchase price of$140,000 after a discount, requiring five payments totaling $161,000[352]. - The company expects to incur significant operating expenses for ongoing activities, including clinical trials and regulatory approvals, necessitating substantial additional capital[353]. - As of December 31, 2024, the company reported no material off-balance sheet arrangements[354].