Release Date: March 06, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Herantis Pharma PLC (OHEL:HRTIS, Financial) has shown promising clinical data from phase 1A and ongoing phase 1B studies for their lead compound HER-096, which is designed to modify Parkinson's disease.
- The company has secured significant external funding, including EUR 3.6 million from the Michael J. Fox Foundation and Parkinson's UK, validating their research and covering the costs of the phase 1B trial.
- HER-096 has demonstrated efficient brain penetration and a good safety profile, which are crucial for its potential success in treating Parkinson's disease.
- Herantis Pharma PLC (OHEL:HRTIS) has raised EUR 5.2 million in a challenging funding market, ensuring a cash runway into Q2 2026, which extends beyond the phase 1B clinical trial data readout.
- The company is actively seeking partnerships with big pharma companies, having already signed confidentiality agreements with 10 companies, indicating strong interest in their research.
Negative Points
- The company's financial position showed a negative equity at the end of 2024, although this was improved by a recent cash injection.
- There is uncertainty regarding the exact timeline and outcomes of the phase 1B trial, as the first Parkinson's patient dose was administered in January 2025, but the specific results are pending.
- The market for disease-modifying therapies in Parkinson's disease is highly competitive, and Herantis Pharma PLC (OHEL:HRTIS) faces challenges in differentiating its product from others.
- The company's future plans for expanding HER-096's application to other neurodegenerative diseases like Alzheimer's or ALS are still speculative and dependent on further data and partnerships.
- Regulatory challenges remain, particularly concerning the use of biomarkers in late-stage clinical trials, which could impact the design and approval of future studies.
Q & A Highlights
Q: What was the significance of the pharmacokinetic data from the part one of the phase 1B clinical trial?
A: The pharmacokinetic data is crucial for designing a phase 2 study that addresses clinical efficacy. It helps determine the appropriate dose level and frequency of administration for HER-096. The data confirmed that preclinical assumptions translate well into clinical settings, providing insights for phase 2 study design. - Antti Vuolanto, CEO
Q: What is the main objective of part two of the phase 1B clinical trial, and are you on track to report top-line data in Q3 2025?
A: The main objective is to assess safety and establish biomarker studies in Parkinson's patients. While symptom observation is part of the study, the one-month treatment duration is short for the target indication. We are on track to report top-line data in Q3 2025. - Antti Vuolanto, CEO
Q: How long is Herantis Pharma's cash runway following the recent EUR5.2 million funding?
A: The recent funding extends our cash runway into Q2 2026, which is well beyond the phase 1B clinical trial data readout. - Tone Kvåle, CFO
Q: Are the phase 1 results translatable to other indications beyond Parkinson's, and is there a plan to partner for phase 2 trials in other neurodegenerative diseases?
A: The safety data from phase 1A and 1B is applicable to other indications. While it's premature to discuss partnerships, the potential for licensing or partnering will depend on phase 1B data and subsequent negotiations. - Antti Vuolanto, CEO
Q: What support do Michael J. Fox Foundation and Parkinson's UK provide beyond funding?
A: They offer regular follow-up calls, insights into data, and guidance on regulatory processes. Their ambition is to support HER-096 in becoming a true treatment, providing valuable expertise in Parkinson's disease. - Antti Vuolanto, CEO
Q: How do regulators view biomarkers in Parkinson's disease, and will phase 2 plans involve a partner?
A: Biomarkers are primarily used to demonstrate HER-096's biological response. While regulatory endpoints for approval may not require biomarkers, this will be addressed with a partner in phase 2 and 3, depending on phase 1B results. - Antti Vuolanto, CEO
Q: Why should investors consider investing in Herantis Pharma?
A: Herantis is approaching a major value inflection point with significant market potential and unmet clinical need in Parkinson's disease. The company is well-positioned in the disease modification space, offering a unique opportunity in the next 6 to 12 months. - Antti Vuolanto, CEO
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
