• Cash: $2 million as of September 30, 2024.
• Strategic Financing: $19.5 million, with $16.5 million received and an additional $3 million expected in February 2025.
• Working Capital: Approximately $23 million, including combined cash of the entities at the time of the business combination.
• Phase Two Study - Cancer Related Pain: Statistically significant pain reduction in a study with 165 patients.
• Phase Two Study - Chemotherapy Induced Neuropathic Pain: 125 patients, higher doses of Hal Neuron showed greater pain reduction.
• Long COVID Proof of Concept Study: 22 patients treated, significant improvement in fatigue and other symptoms compared to 17 matched controls.
• Long COVID Phase Two Study: 45 patients enrolled, results expected shortly.

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

Release Date: November 07, 2024

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

Positive Points

• Dogwood Therapeutics Inc (NASDAQ:DWTX) announced a strategic business combination with Pharmagest Holding Incorporated, resulting in a significant expansion of their pipeline.
• The company secured a $19.5 million strategic financing, with $16.5 million already received and an additional $3 million expected in February 2025, providing approximately $23 million in working capital.
• The expanded pipeline includes Hal Neuron, a NAV 1.7 modulator, which has shown promising results in reducing cancer-related pain and chemotherapy-induced neuropathic pain.
• Dogwood Therapeutics Inc (NASDAQ:DWTX) has a strong management team with extensive experience in developing and commercializing blockbuster drugs.
• The company is poised to release top-line results from their long COVID phase two study and has a clear path for future development milestones.

Negative Points

• Dogwood Therapeutics Inc (NASDAQ:DWTX) reported a cash balance of only $2 million as of September 30, 2024, prior to the strategic financing.
• The company is reliant on future financing and successful milestone achievements to sustain operations beyond 2025.
• There are no FDA-approved treatments for chemotherapy-induced neuropathic pain, indicating a challenging regulatory pathway.
• The long COVID study results are still pending, and the company faces uncertainty regarding the efficacy of their treatment in this area.
• The company has yet to finalize the design and regulatory approval for the phase two B trial of Hal Neuron, which could delay progress.

Q & A Highlights

Q: Can you discuss the durability of response for Hal Neuron and any dose-response relationship observed? A: (R. Michael Gendreau, Chief Medical Officer) In the cancer-related pain study, the average response duration was 57 days for Hal Neuron compared to 10.5 days for placebo among responders. This was from a single cycle of four days of injections. We observed a dose-response relationship in the chemotherapy-induced neuropathic pain study, with the best results at the highest dose, which we are taking forward into the phase two B study.

Q: Are there any respiratory-related tolerability issues with Hal Neuron, and how does once-a-day dosing compare to twice-a-day? A: (R. Michael Gendreau, Chief Medical Officer) We did not observe any respiratory adverse events. Once-a-day dosing showed a better tolerability profile compared to twice-a-day, with no meaningful change in efficacy, making it the preferred choice.

Q: What are the details and steps required for the phase two B trial for Hal Neuron? A: (R. Michael Gendreau, Chief Medical Officer) The phase two B trial will use a high dose once-a-day regimen over eight days, with a primary endpoint at week four. It will be a 1:1 randomization against placebo, with an interim analysis planned for the second half of 2025. The trial design is consistent with FDA expectations, focusing on pain reduction over time.

Q: Are there any conditions to receive the second tranche of funding in February 2025? A: (Gregory Duncan, CEO) There are no material obligations to meet for the additional $3 million, as long as we maintain consistent listing standards and other public entity requirements. CKLS is committed to the asset and its development.

Q: Will the FDA require data on opioid reduction in your trials? A: (R. Michael Gendreau, Chief Medical Officer) While the FDA may be interested in rescue medication reduction, we do not plan to pursue an opioid-sparing claim. The trial will aim to keep ancillary medications constant, using non-opioid rescue options to avoid complicating the results.

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