Release Date: May 15, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Bio-Path Holdings Inc (BPTH, Financial) reported positive interim results from Stage 2 of the Phase 2 clinical trial of prexigebersen for treating acute myeloid leukemia, showing better efficacy than current therapies.
- The company expanded its intellectual property portfolio with newly issued patents in Mexico, Australia, and Japan, enhancing protection in 21 countries.
- Bio-Path Holdings Inc (BPTH) plans to pursue FDA expedited programs for fast-track designation for prexigebersen, addressing a clear and serious unmet need in elderly patients.
- Completion of the second dose cohort in the Phase 1/1B clinical trial of BP1002 for treating refractory relapsed AML, including venetoclax-resistant patients, showing no dose-limiting toxicity.
- Strengthened financial position with a $1.2 million registered direct offering and $2.3 million through an at-the-market offering, supporting ongoing clinical development.
Negative Points
- Bio-Path Holdings Inc (BPTH) reported a net loss of $3.2 million for the first quarter of 2024, although this was an improvement from the previous year's loss of $5.3 million.
- The company's cash position was very low at $0.2 million as of March 31, 2024, down from $1.1 million at the end of 2023, indicating a potential need for further financing.
- General and administrative expenses increased to $1.4 million in the first quarter of 2024, driven by higher legal fees.
- Net cash used in operating activities was $1.0 million for the first quarter of 2024, necessitating the recent fundraising activities to maintain operations.
- The ongoing need for additional clinical trials and safety testing for new drug candidates like BP1003, which could delay market entry and increase costs.
Q & A Highlights
Q: Can you provide an update on the progress of your lead product candidate, prexigebersen, for the treatment of acute myeloid leukemia (AML)?
A: Peter Nielsen, CEO, reported positive interim results from Stage 2 of the Phase 2 clinical trial of prexigebersen for AML, showing that the drug was safely administered and demonstrated efficacy signals better than current therapies. The company plans to pursue FDA expedited programs for fast-track designation for this treatment.
Q: What are the latest developments in your BP1002 program targeting Bcl-2?
A: Peter Nielsen, CEO, shared that the second dose cohort of the Phase 1/1B clinical trial of BP1002 for refractory relapsed AML, including venetoclax-resistant patients, has been completed. BP1002 targets Bcl-2 mRNA, offering a potential alternative for patients who have relapsed on venetoclax.
Q: How is the BP1003 program, which targets the STAT3 protein, progressing?
A: Peter Nielsen, CEO, mentioned that BP1003 has shown promise in reducing STAT3 expression and enhancing the sensitivity of cancer cells to chemotherapy in preclinical studies. The company is finalizing safety testing to submit an IND application to the FDA.
Q: What financial results did Bio-Path Holdings report for the first quarter of 2024?
A: Anthony Price, SVP of Finance, reported a net loss of $3.2 million or $4.88 per share, with a decrease in research and development expenses and a slight increase in general and administrative expenses. The company ended the quarter with $0.2 million in cash.
Q: What steps has Bio-Path Holdings taken to strengthen its financial position recently?
A: Anthony Price, SVP of Finance, highlighted that the company secured $3.5 million through an at-the-market offering agreement and a registered direct offering, which will support ongoing clinical development.
Q: What are the future plans for Bio-Path Holdings in advancing its clinical programs?
A: Peter Nielsen, CEO, expressed optimism about the year ahead, emphasizing the company's commitment to reporting updates on their clinical programs and managing resources effectively to develop new treatments for cancer patients.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
