Herantis Pharma (HRNTS) H1 2024 earnings summary

Executive summary

• HER-096, a peptide mimicking CDNF, is the lead asset targeting Parkinson's disease, with demonstrated brain penetration and safety in phase Ia clinical trials and a Clinical Trial Application for phase Ib submitted, targeting initiation in 2H 2024.

• Preclinical and early clinical data show HER-096's potential to modify disease progression, addressing a high unmet need in Parkinson's and possibly other neurodegenerative diseases.

• The company has secured significant non-dilutive funding and external validation from leading Parkinson's research charities, the European Innovation Council, and received EUR 3.6 million from MJFF and Parkinson's Virtual Biotech for phase Ib and biomarker projects.

• HER-096's phase Ib trial will focus on safety, tolerability, and biomarkers in patients, with top-line data anticipated before the second half of 2025.

Financial highlights

• Operating expenses and R&D spending increased in line with clinical and manufacturing activities for phase Ib and II preparations, with R&D expenses at EUR 2.1 million.

• Loss for the first half was EUR 2.6 million to EUR 2.8 million, reflecting ramped-up R&D and operational costs.

• Cash and securities at period end were EUR 3.4–3.5 million, including funds in a short-term fixed income fund.

• No revenue reported; other operating income EUR 987,000, mainly from grants.

Outlook and guidance

• Phase Ib clinical trial approval and first patient dosing targeted for 2H 2024, with top-line data anticipated before the second half of 2025.

• Current funding is sufficient to complete phase Ib and support activities into 2H 2025, but additional capital will be required for phase II.

• Strategy includes seeking partners for late-stage development and commercialization.