Release Date: November 15, 2024

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Bio-Path Holdings Inc (NASDAQ:BPTH) has initiated a clinical development program for BP 101 A, targeting obesity and related metabolic diseases, marking the first non-cancer application of their DNAbilize platform.
• The company is advancing a Phase 11 B clinical trial of BP 1,001 in patients with challenging solid tumors, including ovarian, endometrial, pancreatic, and triple-negative breast cancer.
• Enrollment for the third higher dosing cohort of BP 1,002 in refractory relapsed AML patients was completed faster than projected, indicating strong demand for new treatment options.
• BP 103, targeting the STAT3 protein, has shown broad anti-tumor effects in preclinical models, and the company is preparing for an IND application submission to the FDA.
• The company reported a reduced net loss of $2.1 million for Q3 2024 compared to $3.2 million in Q3 2023, indicating improved financial management.

Negative Points

• Bio-Path Holdings Inc (NASDAQ:BPTH) reported a decrease in cash reserves, with $0.6 million as of September 30, 2024, compared to $1.1 million at the end of 2023.
• Research and development expenses decreased, which may indicate a slowdown in certain areas of clinical development.
• General and administrative expenses increased due to higher legal fees and salaries, which could impact overall profitability.
• The company is still in early stages of clinical trials for many of its products, meaning potential revenue generation is still uncertain and far off.
• The success of BP 1,002 and BP 103 is contingent on overcoming significant scientific and regulatory hurdles, which poses a risk to future progress.

Q & A Highlights

• Warning! GuruFocus has detected 1 Warning Sign with BPTH.

Q: Can you provide more details on the new clinical development program for BP 101 A targeting obesity and metabolic diseases? A: Peter Nielsen, CEO, explained that BP 101 A is a modified product from their existing platform, aimed at treating insulin resistance, a major contributor to obesity and type 2 diabetes. Preclinical studies are set to begin this quarter to assess its potential in enhancing insulin sensitivity.

Q: What progress has been made in the phase 11 B clinical trial of BP 1,001 for solid tumors? A: Peter Nielsen, CEO, stated that the trial is advancing at several leading cancer centers, focusing on ovarian, endometrial, pancreatic, and triple-negative breast cancer. The next dose cohort completion and data readout are expected early next year.

Q: How is the phase two trial of Kreij in AML progressing? A: Peter Nielsen, CEO, reported that the trial is ongoing with a focus on patients with previously untreated AML and refractory relapsed AML. The primary endpoint is the number of patients achieving complete remission.

Q: Can you elaborate on the financial results for the third quarter of 2024? A: Anthony Price, SVP of Finance, noted a net loss of $2.1 million, a decrease from the previous year. R&D expenses decreased due to reduced manufacturing costs, while general and administrative expenses increased due to higher legal fees and salaries.

Q: What are the future plans for BP 103 targeting the stat three protein? A: Peter Nielsen, CEO, highlighted that BP 103 has shown potential in preclinical models for various cancers. They have identified a method for oligo detection in plasma, which will aid in completing the IND application for FDA submission.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.