Analyst Comment

Herantis H2'24 earnings preview: Towards Phase Ib studies

Hera Pre

Translation: Original comment published in Finnish on 8/20/2024 at 7:27 am EEST.

Herantis will publish its H1 report on Thursday, August 22 at 8.00 am EEST. The webcast starting at 10 am can be viewed here. Herantis has completed a Phase Ia study with HER-096, a candidate in development for the treatment of Parkinson's disease. We anticipate that the next phase, starting in H2'24, will provide further information on the properties, dosing and safety of Ib prior to larger efficacy trials. The financial situation has developed positively, and cash should be sufficient for the execution of Phase Ib. In the medium term, Herantis aims to enter into a development and commercialization agreement to fund Phase II.

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 patients with Parkinson's disease. We expect the study to start in H2'24. 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. Herantis said it is seeking a development and commercialization agreement to fund a larger Phase II study.

In figures, we expect H1 revenue of EUR -2.4 MEUR and EPS of EUR -0.12.

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 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.

Key Estimate Figures2024-06-19

	2023	24e	25e
Revenue	0.0	0.0	0.0
growth-%		150.0 %
EBIT (adj.)	0.2	-4.9	-5.2
EBIT-% (adj.)	3,850.0 %	-48,550.5 %	-51,916.5 %
EPS (adj.)	0.01	-0.24	-0.22
Dividend	0.00	0.00	0.00
Dividend %
P/E (adj.)	114.2	neg.	neg.
EV/EBITDA	165.2	neg.	neg.