Company release

Interim report

Herantis Pharma Plc | Company Release | August 22, 2024 at 08:00:00 EEST

Herantis Pharma publishes 1H 2024 report today

"We have successfully continued the development of HER-096 by submitting a phase 1b clinical trial application to regulatory authorities. In the trial, HER-096 will be administered for the first time to Parkinson's patients. The study provides significant new information about repeated subcutaneous administrations of HER-096 and will be essential for planning of future phase 2 studies. We expect to receive the phase 1b regulatory approval and start the study in the second half of 2024. Phase 1b trial funding has been secured from the two leading Parkinson's patient organisations: the Michael J Fox Foundation and Parkinson UK through their Virtual Biotech program. We negotiated the agreement during the first half of 2024 and signed it right after the review period on July 1, 2024. This is a significant achievement, as these highly respected organizations consider that HER-096 is one of the most promising new drug candidates for treatment of Parkinson's disease. This external validation is also very significant for the partnering discussions," 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 1H 2024 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 10:00 EEST / 9:00 CEST.

Please use the following link to register for this event:
https://herantis.videosync.fi/2024-h1-results

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 – June 2024:

• Herantis submitted a Clinical Trial Application (CTA) for a Phase 1b clinical trial of HER-096 in May, with the aim of initiating the trial in 2H 2024.
  • The primary aim of the Phase 1b clinical trial is to show that repeated subcutaneous doses of HER-096 are safe and well-tolerated in patients with Parkinson’s disease, building on the results from the Phase 1a clinical trial which demonstrated efficient brain penetration and favorable safety profile in healthy volunteers.
• Herantis received milestone payment of EUR 750 thousand from European Innovation Council in June.
  • Herantis obtained an EUR 2.5 million European Innovation Council (EIC) Accelerator grant in 2023. Herantis received the first EUR 1.4 million payment tranche in May 2023.

Events after the reporting period:

• July 1^th, Herantis announced that The Michael J. Fox Foundation for Parkinson’s Research (MJFF) and The Parkinson’s Virtual Biotech will together finance Herantis’ Phase 1b clinical trial of HER-096 in Parkinson’s disease and the on-going biomarker project with research funding of EUR 3.6 million.
  • “MJFF is proud to support a wide range of treatment approaches across the globe,” said Katharina Klapper, director of clinical research, MJFF. “We are constantly seeking to support new disease-modifying therapies for people with Parkinson’s and we look forward to seeing the outcomes of this clinical trial.”
  • Dr Arthur Roach, Director of Parkinson’s Virtual Biotech, said: “Disease-modifying treatments that can meaningfully slow the progression of Parkinson’s are a desperate unmet need for the millions living with this devastating condition across the world. We’re delighted to be working with Herantis Pharma to fund an early-stage trial of this pioneering new therapy as part of the Parkinson’s Virtual Biotech program led by Parkinson’s UK.”
• On July 2^nd, the Board of Directors decided on a new option rights program. Under the new option rights program 2024 I, in aggregate up to 400,000 option rights entitling to shares may be issued to the CEO of Herantis, management team members, and other key personnel.

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:

Herantis’ plan for 2024 is to start the Phase 1b trial of HER-096 for Parkinson’s disease.

2024 milestones for HER-096:

• Phase 1b clinical trial application submitted (targeted 1H/2024)
  • achieved May 20, 2024
• Phase 1b clinical trial application approved (targeted 2H/2024)
• First subject dosed in the HER-096 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 Ltd

Tel: +358 9 25 380 225

Email: ubcf@unitedbankers.fi

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.