Announcement • Jun 04
Herantis Pharma Finalizes Phase 2a Study Design For HER-096 And Reports Positive FDA Feedback Herantis Pharma recently completed a pre-IND meeting with the U.S. Food and Drug Administration (FDA) to discuss the planned clinical development of HER-096. The FDA raised no concerns regarding the Company's chemistry, manufacturing and controls (CMC) information or preclinical data package and confirmed that, based on the current data package, Herantis would be in a position to activate U.S. clinical sites should an Investigational New Drug (IND) application be submitted. The FDA considered the Phase 2a trial design appropriate for the current stage of development and discussions also included the endpoint strategy for future clinical studies. The Phase 2a study is designed to evaluate the efficacy, safety and tolerability of HER-096 in patients with early-stage Parkinson's disease and is expected to provide the first evidence of its potential to deliver meaningful clinical benefit in patients. The randomized, double-blind, placebo-controlled study is expected to enroll approximately 100 newly diagnosed Parkinson’s disease patients who are not receiving symptomatic medication across multiple sites in Europe. Patients will receive twice-weekly subcutaneous dosing of HER-096 or placebo for six months, followed by a six-month open-label extension. The study will use a Digital Motor Score (DMS) as its primary endpoint, complemented by established clinical assessments, imaging and biomarker analyses. The integration of Indivi's digital biomarker platform is intended to provide objective and continuous assessments of disease progression and treatment response. Herantis has appointed CTC Clinical Trial Consultants AB (CTC) as the clinical CRO to support the execution of the Phase 2a study. CTC brings extensive experience in Parkinson's disease clinical trials and will support study start-up, site management and operational execution across participating study centers. Herantis has already secured significant support for the program through the previously announced EUR 8 million Horizon Europe grant and the potential for further investment from the European Innovation Council (EIC) Fund. Over 50% of the funding required to execute the Phase 2 study has been secured or identified. The Company continues to evaluate financing alternatives to support advancement into Phase 2, including strategic partnerships, equity financing and non-dilutive funding. HER-096 is a first-in-class small peptide that combines the neuroprotective mechanism of cerebral dopamine neurotrophic factor (CDNF), with the convenience of subcutaneous administration. In a Phase 1b clinical trial, HER-096 was shown to be generally safe and well tolerated in Parkinson’s disease patients. Price Target Changed • Mar 26
Price target increased by 50% to €2.40 Up from €1.60, the current price target is provided by 1 analyst. New target price is 44% above last closing price of €1.67. Stock is up 19% over the past year. The company is forecast to post a net loss per share of €0.13 next year compared to a net loss per share of €0.28 last year. New Risk • Mar 08
New major risk - Negative shareholders equity The company has negative equity. Total equity: -€1.7m This is considered a major risk. Being in negative equity means that the company's liabilities exceed its assets, meaning it owes more to creditors than it has in owned assets. While this doesn't mean the company is about to collapse, in the long-term, this is unsustainable. The company may have issues meeting financial obligations, is at risk of becoming insolvent and may have difficulty raising capital, especially more debt, if needed. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (9.1% average weekly change). Negative equity (-€1.7m). Earnings are forecast to decline by an average of 24% per year for the foreseeable future. Revenue is less than US$1m (€178k revenue, or US$207k). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (€8.7m net loss in 3 years). Market cap is less than US$100m (€52.7m market cap, or US$61.2m). 
