“Herantis achieved significant milestones in 2023; a successful first-in-human trial with HER-096 and strengthening of the financial position. We are excited that Phase 1a trial met its primary and secondary endpoints: good safety profile, favourable pharmacokinetic profile, and efficient penetration to central nervous system after subcutaneous administration. This provides a solid basis for further clinical development of the highly promising HER-096 as disease-modifying therapy for Parkinson’s disease. We also signed a term sheet with EIC Fund, the investment arm of the EIC, for up to EUR 15 million in direct equity investments. In December, despite of the very challenging environment for biotech companies, we were delighted to close a financing round and welcome EIC Fund as a new investor. After a successful 2023, we are enthusiastic to advance HER-096 into the next stage of development,” said Antti Vuolanto, CEO of Herantis.

Herantis Pharma Plc (“Herantis”), a clinical-stage biotechnology company developing disease modifying therapies for Parkinson’s disease, released today the company’s 2H and FY 2023 report. The full report is attached to this release and is also available at the company’s website: www.herantis.com.

A webinar (in English) will be held today at 9:30 EET / 8:30 CET.

Please use the following link to register for this event:
https://herantis.videosync.fi/fy-2023-report

After registering, you will receive a confirmation email containing information about joining the webcast. Questions can be submitted throughout the webcast event.

Business highlights January – December 2023:

• HER-096 Phase 1a clinical trial met all primary and secondary endpoints:
  • Clinical Trial Application (CTA) for a Phase 1a trial for HER-096 was approved in February.
  • The first healthy volunteer was dosed in April.
  • In October, the read-out from the clinical trial demonstrated favorable safety and tolerability profile, fast uptake of HER-096, and significant HER-096 concentration in the cerebrospinal fluid (CSF) after a single subcutaneous injection.

• In April, Herantis signed the European Innovation Council (EIC) Accelerator grant agreement. Herantis will receive EUR 2.5 million grant funding from the EIC Accelerator program over the next two years.

• Term sheet signed in July with EIC Fund, the investment arm of the EIC. Herantis’ is eligible for up to EUR 15 million in direct equity investments, subject to certain customary terms and conditions.

• Business Finland reached the positive decision in September of waiving off EUR 4,495,649 of the loans granted by it to Herantis for the development of CDNF (Cerebral Dopamine Neurotrophic Factor). This decreased the long-term debt and increased the equity by corresponding amount.

• Herantis successfully completed a directed share issue raising EUR 4.5 million in gross proceeds December.
  • 3,219,139 new shares were issued with a subscription price of EUR 1.40 per new share.
  • This share issue attracted several new shareholders in addition to continued support from existing shareholders.
  • EIC Fund became a new shareholder with an investment of 1/3 of the total share issue.

Events after the reporting period:

• March 4th, Herantis announced two poster presentations at the AD/PD 2024 conference.
  • Phase 1a first-in-human trial results of HER-096 to be presented to the scientific audience for the first time.
  • Preclinical data shows that HER-096 promotes functional recovery and regeneration of stressed neurons.

Key figures:

Formulas used to calculate key figures:
Equity ratio = Equity/balance sheet total, Earnings per share = Profit for the period/average number of shares
Average number of shares = Weighted average number of shares.
The number of shares weighted by the number of days each share has been outstanding during the review period

Summary of 2023 and outlook for 2024

2023 milestones for HER-096 were:

• Phase 1a clinical trial application (CTA) regulatory approval (targeted 1H/2023)
  • achieved February 20, 2023

• First HER-096 human dose in Phase 1a study (targeted 1H/2023)
  • achieved April 19, 2023

• Phase 1a read-out: Evidence of HER-096 safety and blood-brain barrier penetration in humans (targeted in Q4/2023)
  • achieved October 25, 2023

2024 milestones for HER-096:

• Phase 1b clinical trial application submitted (targeted 1H/2024)

• Phase 1b clinical trial application approved (targeted 2H/2024)

• First Parkinson’s patient dosed with HER-096 in a Phase 1b trial (targeted 2H/2024)

For more information, please contact:
Tone Kvåle, CFO
Tel: +47 915 19576
Email: ir@herantis.com

Certified Advisor: UB Corporate Finance Oy, Finland: +358 9 25 380 225

About Herantis Pharma Plc
Herantis Pharma Plc is a clinical-stage biotechnology company developing disease modifying therapies for Parkinson’s disease. Herantis’ lead product HER-096, is an advanced small synthetic chemical peptidomimetic molecule developed based on the active site of the CDNF protein. It combines the compelling mechanism of action of CDNF with the convenience of subcutaneous administration. The Phase 1a clinical trial demonstrated a good safety and tolerability profile, and efficient blood-brain barrier penetration of subcutaneously administered HER-096 in humans. The shares of Herantis are listed on the Nasdaq First North Growth Market Finland.

Company website: www.herantis.com

Forward-looking statements
This company release includes forward-looking statements which are not historical facts but statements regarding future expectations instead. These forward-looking statements include without limitation, those regarding Herantis’ future financial position and results of operations, the Company’s strategy, objectives, future developments in the markets in which the Company participates or is seeking to participate or anticipated regulatory changes in the markets in which the Company operates or intends to operate. In some cases, forward-looking statements can be identified by terminology such as “aim,” “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “forecast,” “guidance,” “intend,” “may,” “plan,” “potential,” “predict,” “projected,” “should” or “will” or the negative of such terms or other comparable terminology. By their nature, forward-looking statements involve known and unknown risks, uncertainties and other factors because they relate to events and depend on circumstances that may or may not occur in the future. Forward-looking statements are not guarantees of future performance and are based on numerous assumptions. The Company’s actual results of operations, including the Company’s financial condition and liquidity and the development of the industry in which the Company operates, may differ materially from (and be more negative than) those made in, or suggested by, the forward-looking statements contained in this company release. Factors, including risks and uncertainties that could cause these differences include, but are not limited to risks associated with implementation of Herantis’ strategy, risks and uncertainties associated with the development and/or approval of Herantis’ drug candidates, ongoing and future clinical trials and expected trial results, the ability to commercialize drug candidates, technology changes and new products in Herantis’ potential market and industry, Herantis’ freedom to operate in respect of the products it develops (which freedom may be limited, e.g., by competitors’ patents), the ability to develop new products and enhance existing products, the impact of competition, changes in general economy and industry conditions, and legislative, regulatory and political factors. In addition, even if Herantis’ historical results of operations, including the Company’s financial condition and liquidity and the development of the industry in which the Company operates, are consistent with the forward-looking statements contained in this company release, those results or developments may not be indicative of results or developments in subsequent periods.