Release Date: August 14, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Secured a written SPA agreement from the FDA, derisking the NurOwn asset.
- Reached alignment with the FDA on CMC aspects of the Phase 3 trial.
- Actively pursuing non-dilutive funding, including a promising grant application for up to $15 million.
- Selected a leading CRO and building a network of over 12 clinical centers for broad patient access.
- Reduced net loss significantly from $5.3 million in Q2 2023 to $2.5 million in Q2 2024.
Negative Points
- NASDAQ notification to maintain a $1 share price for 10 consecutive trading days by October 28 or risk delisting.
- Need to achieve a $35 million market cap to avoid delisting.
- Potential shareholder dilution with the proposed increase in authorized shares from 100 million to 250 million.
- Uncertainty around the exact costs of the upcoming Phase 3b trial and production costs.
- Dependence on securing non-dilutive funding and strategic partnerships to bolster financial position.
Q & A Highlights
Q: Can you please elaborate on the key milestones that investors should be looking forward to in the near term?
A: (Chaim Lebovits, President, CEO) We are focused on securing trial site agreements, pursuing non-dilutive funding through grants and strategic partnerships, and initiating the trial and enrolling the first patient. These milestones are crucial for driving shareholder value.
Q: With the proposed increase in authorized shares, what is your plan for equity raises over the next several quarters?
A: (Chaim Lebovits, President, CEO) Increasing authorized shares provides flexibility for strategic opportunities without immediate dilution. Our focus is on non-dilutive funding sources such as grants and strategic collaborations. We have a history of efficient capital management and aim to minimize dilution.
Q: What non-equity funding sources currently have a good probability of transacting before the Phase 3b trial initiation?
A: (Chaim Lebovits, President, CEO) We are pursuing multiple non-equity funding avenues, including grants from organizations like CIRM and partnerships with pharmaceutical companies. Outsourcing intellectual property is not currently considered, but strategic partnerships are possible.
Q: Is there a provision for interim analysis of early signs of efficacy in the planned clinical trial?
A: (Chaim Lebovits, President, CEO) An independent Data Safety Monitoring Board will be established for periodic safety evaluations during the Phase 3b trial.
Q: Is the ALS FRS score at enrollment higher than in the prior Phase 3 study?
A: (Bob Dagher, Chief Medical Officer) Based on simulations, the ALS FRS score is expected to be higher than in the previous trial, which should enhance the trial's execution.
Q: Will there be more trial sites than in the prior Phase 3, thus allowing the trial slots to be filled more quickly?
A: (Bob Dagher, Chief Medical Officer) Yes, we plan to add more sites for the Phase 3b trial, which will increase the rate of enrollment and speed up the trial timelines.
Q: Has a commercial manufacturing partner been secured?
A: (Hartoun Hartounian, Chief Operating Officer) We are in advanced discussions with potential commercial manufacturing partners and are confident in securing a suitable partner in a timely manner.
Q: Is the Phase 3b inclusion criteria more stringent than the prior Phase 3 study?
A: (Bob Dagher, Chief Medical Officer) Yes, the criteria are more refined to focus on patients earlier in the disease course, which should increase the likelihood of showing benefits from our treatment.
Q: Does the company need to implement any new actions or adjustments on the CMC front to reach alignment with the FDA?
A: (Chaim Lebovits, President, CEO) We have reached alignment with the FDA to initiate the trial, which was crucial for moving forward.
Q: Could you provide a mechanistic rationale for why an effect might be more easily identifiable under the new ALS FRS criteria?
A: (Bob Dagher, Chief Medical Officer) The new criteria ensure that patients are earlier in their disease course and have a higher likelihood of showing benefits from NurOwn, which should result in more robust data.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
