Herantis Pharma (HRNTS) H1 2024 earnings summary

Executive summary

• HER-096, a peptide mimicking CDNF, is the lead asset targeting Parkinson's disease and CNS disorders, with demonstrated brain penetration and safety in Phase 1a clinical trials and preparations underway for Phase 1b and II.

• 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.

• Significant unmet need in Parkinson's disease, with over 328,000 new diagnoses yearly in target geographies and no current disease-modifying therapies.

• The company has secured significant non-dilutive funding and external validation from leading Parkinson's research charities and the European Innovation Council.

• Highly experienced leadership and advisory board with proven track record in clinical development.

Financial highlights

• Operating expenses increased in 1H 2024 due to clinical and manufacturing activities for Phase 1b and II preparations, totaling €2.7M compared to €1.8M in 1H 2023.

• Net loss for the first half was EUR 2.7 million, reflecting ramped-up R&D and operational costs.

• Cash and securities at period end were EUR 3.5 million as of June 30, 2024.

• Equity position strengthened to EUR 4.9 million as of June 30, 2024, up from EUR 2.0 million a year earlier.

• Cash flow from operating activities was negative EUR 3 million for the first half.

Outlook and guidance

• Phase 1b clinical trial is expected to start in 2H 2024, pending regulatory approval, with top-line data anticipated before the second half of 2025.

• Current funding is sufficient to complete Phase 1b and support activities into 2H 2025, but additional capital will be required for Phase II.

• Preparation for Phase II trials is ongoing, with a focus on safety, biomarkers, and optimal dosing.

• Strategy includes partnering for late-stage development and commercialization.