Release Date: May 15, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- ASPIRE trial enrollment has surpassed 50% and is proceeding faster than anticipated, with full enrollment expected by Q1 2025.
- Lower-than-expected event rate in the ASPIRE trial suggests prolonged survival for patients, indicating potential efficacy of ivospemin.
- Successful divestiture of assets from the eflornithine pediatric neuroblastoma program to US WorldMeds, securing upfront and milestone payments.
- Completed enrollment in the PACES trial for colorectal cancer prevention, with data expected in the second half of 2026.
- Received a new patent in the US and Canada for a fixed dose combination of eflornithine and sulindac, strengthening the company's intellectual property portfolio.
Negative Points
- Net loss for Q1 2024 increased to $7.1 million from $5.1 million in Q1 2023, reflecting higher research and development expenses.
- Total cash as of March 31, 2024, was relatively low at approximately $260,000, raising concerns about short-term financial stability.
- Panbela's common stock was suspended from trading on Nasdaq and is now quoted on the OTCQB, potentially affecting investor confidence and capital raising capabilities.
- The company is facing a high burn rate, with significant cash used in operations, necessitating further fundraising to sustain activities.
- Delay in the interim analysis of the ASPIRE trial to Q1 2025, which may impact the timeline for potential regulatory approval and commercialization.
Q & A Highlights
Q: Can you tell us the stopping criteria for the, hopefully, 1Q '25 ASPIRE interim for both for efficacy and for futility? Can you just quote that?
A: Jennifer Simpson, President and CEO of Panbela Therapeutics, explained that the interim analysis is based on approximately 33% of the total events, which amounts to about 170 events. She mentioned that it is a superiority analysis and stopping for futility is unlikely. She also noted that enrollment was faster than anticipated and patients are living longer than expected, which might align the completion of enrollment with the interim analysis.
Q: Anything about [alpha spend], just some specific hurdles we can think about?
A: Jennifer Simpson detailed that the alpha spend for the interim analysis is minimal, designed to be de minimis. The study is powered at 90% with a hazard ratio of 0.75 overall and an alpha of 0.025, one-sided, indicating a small alpha spend for the interim.
Q: Do you think that the 1Q '25 timing, is there risk of the events occurring -- that are occurring still strongly tracking to 1Q '25?
A: Jennifer Simpson affirmed that they are still tracking to 1Q '25 for the interim analysis. She mentioned that they would update the public if there appears to be a delay, but as of now, they are on track.
Q: I was just wondering if we could get a little bit more insight into the current cash position. I was wondering if there's any steps that you may be taking to help strengthen the cash position.
A: Susan Horvath, CFO of Panbela Therapeutics, acknowledged the need for additional funds beyond what was raised in January. She mentioned the filing of an S-1 in April aimed at raising capital and finding a national exchange to uplift the company’s stock. She also noted an incremental upfront payment received from US WorldMeds in April as a bridge to further fundraising.
Q: The $262,000 cash, that does include the net proceeds from the January rates?
A: Susan Horvath confirmed that the $262,000 includes net proceeds from the January offering. She explained that the company had a loss of $7 million in the quarter, which was offset by the proceeds, and did not include the additional payment from US WorldMeds received in April.
Q: Thank you very much for the update.
A: Jennifer Simpson responded affirmatively, indicating readiness to provide further updates as necessary.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
