Release Date: August 22, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- HER-096 has demonstrated brain penetration and a good safety profile in Phase 1a clinical study.
- The company has secured significant non-dilutive research funding, including EUR6.1 million from charities and the European Innovation Council.
- Herantis Pharma PLC (OHEL:HRTIS, Financial) has a strong team and advisory board with senior industry experts.
- The company received a milestone payment of EUR750,000 from the EIC accelerator grant.
- HER-096 shows potential not only for Parkinson's disease but also for other neurodegenerative diseases.
Negative Points
- The company reported a loss of EUR2.6 million for the first half of the year.
- Operating expenses have increased due to heightened activities, including preparations for Phase 1b and Phase 2 trials.
- The company will need to raise additional funds to start Phase 2 clinical trials.
- The research funding of EUR3.6 million is not yet fully in the bank and will be paid in installments upon reaching certain milestones.
- The Phase 1b clinical study is not designed to provide efficacy data, which may delay concrete proof of HER-096's effectiveness.
Q & A Highlights
Highlights of Herantis Pharma PLC (OHEL:HRTIS) Earnings Call
Q: Can you explain the financial terms of the research funding agreement that you obtained from Michael J. Fox and Parkinson's UK?
A: The EUR3.6 million research funding is a loan that must be repaid if HER-096 generates sales revenue or other value, such as licensing agreements. The repayment is 10% of the gain until four times the capital provided (EUR14.4 million) is paid back. This funding is a significant external validation for Herantis Pharma.
Q: What is the aim for the upcoming Phase 1b clinical trial? Do you expect to see any efficacy data from that?
A: The aim is to bridge the Phase 1a clinical study in healthy individuals towards Phase 2, focusing on safety and tolerability in Parkinson's patients. Biomarker-related endpoints will also be studied, but the trial is not designed to provide efficacy data.
Q: Since you now have secured EUR3.6 million in funding, are you fully funded until the start of the Phase 2 clinical trial?
A: With the current funding, we have cash into the second half of 2025, allowing us to deliver top-line data from Phase 1b. However, additional funds will be needed to start the Phase 2 trial due to preparation requirements, especially on the CMC side.
Q: What is the state of biomarkers in the clinical study context?
A: The Phase 1b trial is crucial for testing our biomarker hypotheses. The biomarker program has advanced well, supported by funding from the EIC and Michael J. Fox Foundation, and will help design Phase 2 clinical studies.
Q: Which clinical study results are needed before potential partners would agree to make a big deal?
A: There is no clear-cut answer as different companies have varying objectives. The Phase 1b trial is a significant milestone, but partnering deals could potentially happen earlier. We are in continuous discussions with multiple pharma partners.
Q: Which drugs currently in clinical trials for Parkinson's disease are you most worried about as competitors?
A: We are not worried about competitors as HER-096 has a unique mechanism of action. Success in other Parkinson's disease drug developments would benefit us by paving the way in regulatory and commercial aspects.
Q: In the upcoming study, is twice a week optimal dosing, not more frequently?
A: Based on Phase 1a pharmacokinetics, we selected twice a week dosing for Phase 1b, believing it to be optimal. Further pharmacokinetic studies will inform the administration plan for Phase 2 clinical studies.
Q: When do you expect to get approval for the Phase 1b application? How predictable is the application process?
A: The clinical trial application process in Europe is now quite predictable. We expect to receive approval during Q3 and start the clinical study in Q4 this year.
Q: What are the main side effects of HER-096?
A: Most safety-related events are due to subcutaneous administration, not specific to HER-096. No systemic side effects have been observed so far, but Phase 1b will provide more information on potential side effects in Parkinson's patients.
Q: How can early onset Parkinson's patients participate voluntarily in the Phase 2 trial? What qualifications must these patients have?
A: Details about the Phase 2 study have not been disclosed yet. For the Phase 1b study, patients can participate through the clinical site in Finland, CRSD, which recruits patients for the study.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
