Bio-Path Holdings (NASDAQ:BPTH), Incorporated (NASDAQ: BPTH) discussed third-quarter financial results and provided updates on its pipeline and corporate developments during its latest earnings call. The company reported a net loss of $2.1 million, or $0.70 per share, for the quarter, marking an improvement from the $3.2 million loss in the same period last year. Research and development expenses decreased due to lower manufacturing and clinical trial costs, while general and administrative expenses increased slightly.
The company's cash position stood at $0.6 million as of September 30, 2024. During the call, CEO Peter Nielsen highlighted the expansion of the DNAbilize platform into obesity and metabolic diseases and provided updates on ongoing clinical trials for various cancer treatments.
Key Takeaways
- Bio-Path Holdings reported a net loss of $2.1 million for Q3 2024, an improvement from the previous year.
- The company's DNAbilize platform is expanding beyond oncology, with a new program for obesity and metabolic diseases.
- Clinical trials for cancer treatments, including BP1001-A for solid tumors and prexigebersen for AML, are progressing.
- Research and development expenses decreased, while general and administrative expenses increased.
- The company's cash position was $0.6 million as of September 30, 2024.
Company Outlook
- Bio-Path looks forward to the next data readout from the solid tumor study, potentially early next year.
- The company is excited about entering the obesity and metabolic disease space with BP1001-A.
- Bio-Path continues to advance its pipeline with a focus on delivering new medicines and creating value for stakeholders.
Bearish Highlights
- The company experienced a net loss, although less than the previous year.
- The cash position decreased from $1.1 million at the end of 2023 to $0.6 million as of September 30, 2024.
Bullish Highlights
- BP1001-A's potential to treat obesity and Type 2 diabetes could represent a significant expansion of the DNAbilize platform.
- Clinical trials for BP1001-A and prexigebersen are ongoing, with the latter showing promise in treating AML.
- BP1002, targeting Bcl-2 mRNA, could provide an alternative for Venetoclax-resistant patients.
Misses
- There was no mention of meeting or exceeding revenue or earnings expectations.
Q&A Highlights
- The call concluded without a Q&A session, and no additional remarks were provided.
InvestingPro Insights
Bio-Path Holdings' financial situation and market performance reflect the challenges faced by early-stage biopharmaceutical companies. According to InvestingPro data, the company's market capitalization stands at a modest $3.23 million, underscoring its current position as a small-cap biotech firm. This aligns with the company's reported cash position of $0.6 million as of September 30, 2024, highlighting the need for careful financial management.
InvestingPro Tips reveal that Bio-Path Holdings holds more cash than debt on its balance sheet, which is a positive sign for a company in the development stage of novel therapies. This financial prudence could provide some runway as the company advances its clinical trials and expands its DNAbilize platform into new therapeutic areas like obesity and metabolic diseases.
However, the company faces significant challenges. An InvestingPro Tip indicates that Bio-Path is not profitable over the last twelve months, which is reflected in the negative operating income of -$13.04 million for the same period. This is consistent with the company's reported net loss and the ongoing expenses associated with research and development of its pipeline candidates.
The stock's performance has been particularly concerning, with InvestingPro data showing a year-to-date price total return of -90.28% as of the latest available data. This substantial decline aligns with the InvestingPro Tip noting that the stock has fared poorly over the last month and has fallen significantly over the last year.
Despite these challenges, analysts have set a fair value target of $20 per share, significantly above the current trading price. This suggests potential upside if Bio-Path can successfully advance its clinical programs and realize the value of its expanded pipeline.
For investors considering Bio-Path Holdings, it's worth noting that InvestingPro offers 11 additional tips that could provide further insights into the company's financial health and market position. These additional tips could be particularly valuable for understanding the full picture of Bio-Path's investment potential in the context of its ongoing clinical developments and financial challenges.
Full transcript - Bio Path Holdings Inc (BPTH) Q3 2024:
Operator: Good morning and welcome to the Bio-Path Holdings, Incorporated Third Quarter 2024 Conference Call. All participants will be in listen-only mode. [Operator Instructions] Please note this event is being recorded. I would now like to turn the conference over to Will O'Connor of Stern (AS:PBHP) Investor Relations. Please go ahead.
Will O’Connor: Thank you, operator. Welcome to the Bio-Path Holdings Conference Call and Webcast to review the company's third quarter 2024 financial results and to provide an update on recent pipeline and corporate developments. Earlier, we issued a press release, which outlines the topics we plan to discuss on today's call, and that press release is available at biopathholdings.com. With me today from Bio-Path are President and CEO, Peter Nielsen; and Senior Vice President of Finance, Accounting, and Administration, Anthony Price. Before we begin the call, I'd like to remind you that today's discussion will contain forward-looking statements that involve risks and uncertainties. These risks and uncertainties are outlined in today's press release and in the company's recent filings with the Securities and Exchange Commission, which we urge you to read. Our actual results may differ materially from what is discussed on today's call. With that, I'll now turn the call over to Bio-Path’s CEO, Peter Nielsen.
Peter Nielsen: Thanks, Will. Good morning, everyone and thank you for joining us. As we approach the end of 2024, I look back with pride on all we have achieved. Importantly, we continue to deliver on our promise to usher in a new era of DNA-powered medicine. I'll begin this morning with an exciting development that expands the utility of our DNAbilize platform beyond oncology. Last month we announced the initiation of our clinical development program for BP1001-A, as a treatment for obesity and related metabolic diseases. This marks the first application of our DNAbilize platform for development of a non-cancer application, which highlights the broad therapeutic potential of this technology. BP1001-A is a modified product from prexigebersen sharing the same drug substance with enhanced nanoparticle properties. The disease pathology leading to obesity suggests that BP1001-A which suppresses the adaptor protein Grb2, has the potential to treat insulin resistant, a major contributor to obesity, Type 2 diabetes and other related metabolic diseases. Based on our review of published research, we expect down-regulating GRB2 expression with BP1001-A will enhance insulin sensitivity. Preclinical studies to confirm these assumptions will kick-off this quarter and we expect these findings will provide crucial insights into the mechanism and efficacy of BP1001-A in enhancing insulin sensitivity and reveal its therapeutic potential for obesity and Type 2 diabetes. Beyond obesity, we also continue to advance a Phase 1/1b clinical trial of BP1001-A in patients with solid tumors, including ovarian, endometrial, pancreatic, and triple negative breast cancer, some of the most challenging cancers to treat with today's therapeutic toolkit. This trial is being conducted at several leading cancer centers and will initially evaluate the safety in solid tumor patients. Patients diagnosed with recurrent ovarian and endometrial cancer, often have poor outcomes and it is our hope that we may provide clinical benefit for such patients. We look forward to the next dose cohort completion and data readout from this study, potentially early next year. Turning now to the progress we have made with our lead product candidate, prexigebersen. We continue to advance the amended Stage 2 of our Phase 2 trial in AML. It is an open-label two-stage multi-center study of Prexigibiricin in combination with decitabine and venetoclax in two cohorts of patients with previously untreated AML and refractory relapsed AML. A third cohort includes the treatment of refractory relapsed AML patients who are venetoclax resistant or intolerant with the two drug combination of prexigebersen and decitabine. The primary endpoint for this study will be the number of patients who achieve complete remission, which includes complete remission with incomplete hematologic recovery and complete remission with partial hematologic recovery. We also made considerable progress advancing our Phase 1/1b clinical trial of BP1002 in refractory relapse AML patients. BP1002 targets the Bcl-2 protein. However, BP1002 activity is based on blocking the Bcl-2 messenger RNA and not the BH3 domain, which is the mechanism of treatment for the frontline drug, Venetoclax. Bcl-2 is responsible for driving cell survival in up to 60% of all cancers. High expression of Bcl-2 has been correlated with poor prognosis for patients diagnosed with AML. As a result, we believe that BP1002 could provide an alternative for Venetoclax patients who have relapsed, including AML patients who previously received Venetoclax treatments. By targeting the key protein involved in the Venetoclax treatment at the messenger RNA level, BP1002 may overcome and prevent some of the mechanisms of resistance that affect Venetoclax treatment. Venetoclax has shown activity against the anti-apoptotic protein, Bcl-2, and works by neutralizing the protein's BH3 domain. It is an approved treatment for chronic lymphocytic leukemia, or CLL patients, and untreated AML patients. However, with the exception of some patients treated with allogeneic hematopoietic cell transplantation, relapse invariably incurs, oftentimes due to BH3 domain mutation over time. A total of three evaluable patients for dosing cohort are scheduled to be treated with BP1002 monotherapy in a standard 3+3 design, unless there is a dose limiting toxicity, which would require an additional three patients tested. The first dose cohort consisted of a starting dose of 20 milligrams per square meter, and there were no dose-limiting toxicity. The approved treatment cycle is two doses per week over four weeks, with a total of eight doses administered over 28 days. The Phase 1/1b portion of the study is expected to commence after completion of BP1002 monotherapy cohorts and will assess the safety and efficacy of BP1002 in combination with decitabine and refractory relapse AML patients. After the FDA completed its review of data from the first dosing cohorts, we initiated enrollment for the third higher dosing cohort of 60 milligrams per square meter. Enrollment was completed within six weeks, faster than projected, which underscores the continued need for new treatment options in this vulnerable patient population. Finally, let's review the progress we've made with BP1003, which targets the STAT3 protein. STAT3 is a transcription factor that regulates various tumorigenic processes, such as tumor proliferation, metastasis, and drug resistance. Its overexpression and aberrant activation characterize many cancers, including breast, lung, ovarian, liver, and colon cancer. Activation of STAT3, the pathway in breast and ovarian cancer cells, promotes tumor initiation, migration, and taxol resistance. STAT3 also promotes 5-FU resistance in colorectal cancer cells. Its role in numerous malignancies made STAT3 a potential cancer therapeutic target. BP1003 is a novel liposome incorporated STAT3 antisense oligodeoxynucleotide that efficiently reduces STAT3 expression and enhances the sensitivity of breast and ovarian cancer cells to taxol and 5-FU. In September, we announced a publication highlighting the therapeutic potential of BP1003 in a variety of cancer types in the peer-reviewed journal Biomedicines. The article describes the broad antitumor effect of BP1003 in numerous pre-clinical solid tumor models, including breast, ovarian, and pancreatic cancer. After an extended period of testing, we have identified a method for oligo detection in trace quantities in plasma that we expect will enable us to complete final safety needed to finalize an investigational new drug, or IND application, for submission to the FDA. We are particularly excited to launch our first in-human validation of this cutting-edge therapy in an especially challenging cancer indication that has limited treatment options. With that, I'll now hand over the program to Anthony Price for a brief review of our financials along with balance sheet highlights. Anthony?
Anthony Price: Thanks, Peter. The company reported a net loss of $2.1 million, or $0.70 per share, for the three months ended September 30, 2024, compared to a net loss of $3.2 million, or $6.36 per share, for the three months ended September 30, 2023. Research and development expense for the three months ended September 30, 2024, decreased to $1.3 million compared to $2.3 million, for the three months ended September 30th, 2023, primarily due to decreased manufacturing expenses related to drug product releases, as well as a decrease in expense related to our clinical trial for BP1001 in AML due to timing of patient enrollment during the quarter. General and administrative expense for the three months ended September 30, 2024 increased to $1.3 million compared to $1.0 million for the three months ended September 30th, 2023 primarily due to increased legal fees and salaries and benefits expense. As of September 30th, 2024, the company had cash of $0.6 million compared to $1.1 million as of December 31, 2023. Net cash used in operating activities for the nine months ended September 30, 2024 was $7.7 million compared to $9.7 million for the comparable period in 2023. Net cash provided by financing activities for the nine months ended September 30th, 2024 was $7.2 million. With that, I'll now turn the call back over to Peter.
Peter Nielsen: Thanks, Anthony. As you can see, we continue to make meaningful progress, both advancing and expanding our DNAbilize platform. Our oncology programs continue to enroll, moving us one step closer towards our mission to deliver a better path for cancer patients. We are excited by our expansion into the obesity and metabolic space and look forward to keeping you apprised of our plans as they unfold. Collectively, the progress we are making across our pipeline is setting the stage for a strong finish to the year, as we work to bring new medicine to patients in need of while creating value for our stakeholders. With that, operator, we are ready to open the call for questions.
Operator: We will now begin the question-and-answer session. [Operator Instructions] This concludes our question and answer session. I would like to turn the conference back over to Peter Nielsen for any closing remarks.
Peter Nielsen: Thank you. Thank you again, everyone, for joining us and for your continued support of Bio-Path. Have a great day.
Operator: The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.
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