Release Date: August 28, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Faron Pharmaceuticals Oy (FRA:4FR, Financial) successfully raised EUR 35.5 million in the first half of 2024, resulting in a cash balance of over EUR 30 million by the end of June.
- The company has sufficient funds to support operations until the first quarter of 2025.
- Faron Pharmaceuticals Oy (FRA:4FR) has shown excellent results in Phase II trials for relapsed refractory MDS with bexmarilimab, leading to positive feedback from the FDA.
- The FDA granted fast track designation for bexmarilimab for the treatment of relapsed refractory myelodysplastic syndrome, which includes benefits like more frequent meetings with the FDA and eligibility for accelerated approval.
- The company has increased its shareholder base and liquidity, becoming one of the largest market caps in Helsinki First North.
Negative Points
- Despite the successful fundraising, the current cash runway will not be sufficient to complete the full readout of the Phase II trial, requiring additional funding or partnerships.
- The company had to make significant cuts in headcount and operational costs to manage financial constraints.
- There was a CEO and CFO change during the first half of 2024, which can be disruptive for the company.
- The biotech sector's challenging capital market conditions have impacted Faron Pharmaceuticals Oy (FRA:4FR), necessitating small bridging rounds to maintain operations.
- The company cannot provide specific timelines or details about ongoing partnership discussions due to confidentiality, which may create uncertainty for investors.
Q & A Highlights
Q: Can you say anything more about your discussions with partners? Have you started those with relevant companies? And if so, can you give an indication of how many and what's your target to complete those discussions?
A: (Juho Jalkanen, Chief Operating Officer) These discussions are ongoing but are under discrete confidentiality. We cannot speculate or provide guidance and timelines for that. It's industry standard to keep such discussions confidential.
Q: Will the cash runway into Q1 2025 cover finishing the Phase II trial as well as beginning the Phase III?
A: (Erik Ostrowski, Non-Executive Director) We will finish recruitment by the end of 2024, but the current cash runway will not be sufficient to complete the full readout of the Phase II trial. We will need additional funding to proceed into Phase III.
Q: Regarding the potential for an accelerated approval in the relapsed setting, what magnitude of response rate do you believe you would require?
A: (Juho Jalkanen, Chief Operating Officer) The FDA and leading KOLs are focusing on CR and PR rates. Currently, existing treatments have a 0% to 5% response rate, while we are targeting 15% to 20% for approval.
Q: Could you provide more color on the patient populations in the Phase II trial? Are you including frontline high-risk MDS patients? Are you no longer recruiting refractory MDS patients?
A: (Petri Bono, Chief Medical Officer) We are enrolling both frontline and relapsed patients. (Juho Jalkanen, Chief Operating Officer) The market for relapsed refractory MDS is significant, and the frontline setting is even larger. Our safety profile and survival rates are expected to be better than current treatments.
Q: What is the optimal plan for getting to the pivotal trial? Is it licensing after the BEXMAB data or another capital raise to finance that trial?
A: (Juho Jalkanen, Chief Operating Officer) We aim to optimize this. The best deal would come after the Phase II readout, but we may need a capital raise to maximize deal value. Partnering is in motion, and we are likely to partner before that.
Q: How will the fast-track designation benefit the company going forward?
A: (Petri Bono, Chief Medical Officer) It signifies the regulatory authorities' recognition of the asset's potential. It allows for more frequent meetings with the FDA and eligibility for accelerated approval and priority review if relevant criteria are met.
Q: What are the potential markets for frontline high-risk MDS? Is there any upside in targeting both populations?
A: (Juho Jalkanen, Chief Operating Officer) The relapsed refractory market is significant, and the frontline setting is even larger. Our safety profile and survival rates are expected to be better than current treatments, providing ample market opportunities.
Q: How does the FDA's fast-track designation impact external validation of your drug?
A: (Juho Jalkanen, Chief Operating Officer) The fast-track designation is a significant external validation from the FDA, indicating their belief in our technology and its potential. This validation is crucial for attracting future partnerships and investments.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
