Herantis H1'24 flash comment: Phase Ib starts at the end of the year
Translation: Original comment published in Finnish on 8/22/2024 at 9:06 am EEST.
As expected, Herantis confirmed in its H1 report that it will initiate a Phase Ib study with HER-096 in Parkinson's disease. The new funding announced in H1 will be sufficient to cover the next phase of research. The result was slightly weaker than expected due to higher costs.
Good cash situation for Phase Ib
Late last year, Herantis completed a Phase Ia study showing that HER-096, a drug candidate for Parkinson's disease, crossed the blood-brain barrier. There were also no tolerability concerns, which helped reduce the risk associated with development and paved the way for further development of the candidate. Earlier this year, Herantis announced that it had filed for a Phase Ib study authorization, the primary objective of which is to evaluate the safety and tolerability of subcutaneously administered HER-096 in both healthy volunteers and Parkinson's disease patients at repeated doses. Herantis now says it expects to administer the dosage to the first patient in H2'24, which is in line with our expectations. During H1, Herantis' financial position was strengthened by a 750 TEUR grant from the European Innovation Council (EIC) At the beginning of July, the Company announced EUR 3.6 MEUR of research funding, which will provide sufficient funds for the execution of Phase Ib.
EBIT was -2.76 MEUR, below our forecast of -2.38 MEUR due to higher-than-expected operating expenses. Cash flow for the period was -3.0 MEUR and cash and cash equivalents were 3.5 MEUR. The cash position will be reinforced by the above-mentioned research funding of 3.6 MEUR to be paid in three installments upon achievement of research milestones. We estimate the company's cash runway to last until H2'25.
High-potential, high-risk drug development company
Herantis is developing HER-096 as a disease-modifying treatment for Parkinson's disease. The development is at an early clinical stage, so there is a high risk of market entry and it will take time to conduct the necessary studies. There are currently no drugs on the market that affect the progression of the disease, so the commercial opportunity to offset the risk is significant. We have described the company's situation in more detail in our recent Initiation of coverage report.
Herantis Pharma
Herantis Pharma Plc is a clinical-stage biotechnology company developing disease modifying therapies for Parkinson’s disease. Herantis’ lead product HER-096 is a small synthetic chemical peptidomimetic molecule developed based on the active site of the CDNF protein. HER-096 combines the mechanism of action of CDNF with subcutaneous administration. The Phase 1a clinical trial demonstrated a good safety and tolerability profile as well as blood-brain barrier penetration of subcutaneously administered HER-096. The shares of Herantis are listed on the Nasdaq First North Growth Market Finland.
Read more on company pageKey Estimate Figures19/06
2023 | 24e | 25e | |
---|---|---|---|
Revenue | 0.0 | 0.0 | 0.0 |
growth-% | 150.00 % | ||
EBIT (adj.) | 0.2 | -4.9 | -5.2 |
EBIT-% (adj.) | 3,850.00 % | -48,550.50 % | -51,916.50 % |
EPS (adj.) | 0.01 | -0.24 | -0.22 |
Dividend | 0.00 | 0.00 | 0.00 |
Dividend % | |||
P/E (adj.) | 114.17 | - | - |
EV/EBITDA | 165.20 | - | - |