Herantis publishes 1H Report for 2022

Herantis Pharma Plc

Company Release August 25, 2022, at 8:00 a.m. EEST/7:00 a.m. CEST

“During 1H 2022, Herantis' focus was on HER-096’s related projects in preparation of the first-in-human study. We are pleased by the amount of investor interest in Herantis, especially under the difficult market conditions, that lead to our successful capital raises in April and May of 2022. In April, we reported encouraging blood-brain barrier penetration data in large animals which is an important milestone towards HER-096 clinical studies. These data strengthen the preclinical dataset of HER-096 as a promising new drug candidate for the treatment of neurodegenerative diseases like Parkinson’s disease.”

Herantis Pharma Plc ("Herantis") an innovative biotech company developing new disease modifying therapies for Parkinson's disease, released today the company’s 1H report for 2022. The full report is attached to this release and is available in the company’s websitewww.herantis.com.

A live webinar (in English) will be held today, 25 Aug 2022.

  • CEO, Antti Vuolanto, CSO Henri Huttunen and CFO Tone Kvåle will present Herantis and comment on the 1H 2022 report followed by a live Q&A session
  • Time:10:00 EEST / 9:00 CEST
  • Link to Registration:Herantis’ 1H 2022 Report Webinar
  • Please join the webinar a few minutes in advance.

Business highlights for the period January 1 – June 30, 2022

Successful Fundraising

  • Directed issue, raised gross proceeds of 1.46 MEUR in April
  • Fully subscribed rights issue, raised gross proceeds of 7.25 MEUR in May

Initial results of blood-brain barrier (BBB) penetration in dogs for HER-096 announced in April

  • The results demonstrated that following a single subcutaneous administration of HER-096, our lead product candidate, the concentration of HER-096 measured from the cerebrospinal fluid (CSF) reaches a pharmacologically active level.
  • This result is aligned with previous data obtained from rats and mice.

Dr. Charlotte Videbæk was appointed Vice President of Clinical Development in April

  • Dr. Videbæk is a neurologist with a strong track record from clinical development at international pharmaceutical companies (Novartis, Roche and Lundbeck) developing therapies for neurodegenerative diseases, including Parkinson’s disease.

Nanoform Collaboration

  • Results of proof-of-concept study demonstrating successful preparation of HER-096 nanoparticles were reported in March.

CEO Transition

  • In January, Herantis Pharma’s Board of Directors appointed board member Frans Wuite, MD, MBA, as the interim CEO. Dr. Craig Cook left the company following the Board of Directors’ decision.

Events after the reporting period

Antti Vuolanto was appointed as the CEO by the Board of Directors of Herantis Pharma Plc effective on July 22. Antti Vuolanto has acted as the Chief Operating Officer of Herantis Pharma Plc since 2018.Frans Wuite will continue in his role as board member of Herantis’ Board of Directors.

Group’s key figures:



2022 Outlook

In 2022, Herantis' focus is on submission of a Clinical Trial Application (CTA) by the end of the year to obtain regulatory approval for the first in-human study with HER-096 that is planned to start in 2023 in Finland.

Our near-term milestones for HER-096 are:

  • Final results of the preclinical Blood-Brain-Barrier (BBB) penetration studies in several animal species (targeted H2/2022)
  • Preclinical safety data (GLP studies) (targeted H2/2022)
  • Submission of CTA (targeted H2/2022)
  • Approval of the CTA (targeted H1/2023)
  • First HER-096 human dose in Phase 1 study (targeted H1/2023); and
  • Demonstration of HER-096 BBB penetration and safety in human (targeted H2/2023).

For more information, please contact:

Julie Silber/Gabriela Urquilla

Tel: +46 (0)7 93 486 277/+46 (0)72-396 72 19


Certified Advisor: UB Securities Ltd, Finland: +358 9 25 380 225, Sweden: +358 40 5161400

Company website:www.herantis.com

About Herantis Pharma Plc

Herantis Pharma Plc is an innovative biotech company developing disease modifying therapies for Parkinson’s disease. Herantis lead product HER-096, is an advanced small and synthetic chemical peptidomimetic molecule developed based on the active site of the parent CDNF protein. It combines the compelling mechanism of action of the CDNF protein with the convenience of subcutaneous administration.

The shares of Herantis are listed on the Nasdaq First North Growth Market Finland and Nasdaq First North Growth Market Sweden.

For more information, please visithttps://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.