Herantis Publishes Year-End Report for 2021

Herantis Pharma Plc, Company Release, inside information, 3 March 2022 at 08:00 EET

“An important milestone for Herantis in 2021 was the selection of HER-096, a synthetic, small peptidomimetic, as the lead preclinical development candidate for the treatment of Parkinson’s disease. This was done by a rigorous process based on extensive preclinical and CMC-data. During 2021 we also validated HER-096’s unique mechanism of action, its passage into the brain in therapeutic concentrations upon simple subcutaneous administration and the efficacy of a convenient three times per week dosing regimen in preclinical studies. In addition, we have identified biomarkers in the Phase 1b CDNF study in patients that can support our clinical development programme. Furthermore, a cost-effective manufacturing process of HER-096 has been established. Due to the rapid progress in development and encouraging data, we shall now prioritize the development of HER-096 within the Herantis portfolio and concentrate our efforts on getting it into clinic as soon as possible.

Our focus in 2022 is to generate a data package required for the Clinical Trial Application (CTA) of the Phase 1 study to demonstrate the safety and brain penetration of HER-096 in man.”

Commented Interim CEO, Frans Wuite, MD.

Herantis Pharma Plc (“Herantis”), developing disease modifying therapies for Parkinson’s disease, announced today the company’s Year-end report for 2021.

A live webinar (in English) will be held today, at 10:00 EET / 9:00 CET.

Link to Registration: Herantis’ FY 2021 Report Webinar

Highlights January-December 2021

Significant progress has been made with HER-096:

  • Selection of HER-096 as the lead candidate for development based on efficacy, safety, pharmacokinetic, pharmacodynamic and stability criteria.
  • Demonstration of HER-096 penetrating the blood brain barrier and entering the brain in therapeutic concentrations after a single subcutaneous administration in a rat model.
  • Confirmation of a unique mechanism of action, similar to CDNF, resulting in a significant reduction of alpha-synuclein deposition, neuroinflammation, and remarkable restoration of dopaminergic neurons in preclinical disease models
  • Identification of novel biomarker candidates in the Phase 1b Cerebral Dopamine Neurotrophic Factor (CDNF) study aimed at supporting future clinical development of HER-096

Other operational highlights:

  • A collaboration with Nanoform Finland Plc. was formed to investigate the feasibility of applying the nanoforming process to rhCDNF.  In 2021, we established that nanoformed rhCDNF nanoparticles retain their stability and activity.
  • Formation of Herantis Scientific Advisory Board (SAB), consisting of leading experts in the development of therapies for Parkinson’s disease from industry and academia: Dr.Anders Gersel Pedersen M.D. (chair), Dr. Daniele Bravi M.D., Prof. David Dexter, PhD, and Prof. Alberto Espay M.D. MSc
  • Hilde Furberg, MSc, an experienced biopharma executive, was elected to the Board of Directors
  • Completion of a private placement exceeding EUR 4.0 million
  • Herantis published several papers and scientific posters in scientific media and conferences during 2021

Events after year end 2021

On January 20th, 2022, Herantis Pharma’s Board of Directors appointed Frans Wuite, MD, MBA, as the interim CEO, effective immediately. Wuite is also the Vice Chairman of Herantis’ Board of Directors and will continue in this role. Herantis’ CEO until January 20th, 2022, Dr. Craig Cook, left the company following the Board of Directors’ decision. A search for a permanent CEO will be launched. In connection with the CEO transition and following strong preclinical data in 2021, Herantis’ Board of Directors has decided to focus a significant majority of the company’s development efforts to advance HER-096, a small, synthetic peptidomimetic molecule derived from the active site of CDNF. HER-096 combines the unique mode of action of the CDNF protein to target Parkinson’s disease with the ease of subcutaneous administration.

Group’s Key Figures:

Year-end 2021 Report Webinar Details

Interim CEO, Frans Wuite, MD will present Herantis and comment on the Year-end 2021 report followed by a live Q&A session. Please join the webinar a few minutes in advance.

Date: March 3, 2022, at 10:00 EET /9:00 CET.

Link to Registration: Herantis’ FY 2021 Report Webinar

After registering, you will receive a confirmation email containing information about joining the webinar.

The full report is attached this release and is available in the company’s website www.herantis.com

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For more information, please contact:

Julie Silber/Gabriela Urquilla

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

Email: ir@herantis.com

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 focuses on disease modifying, CDNF-based therapies for Parkinson’s disease that aim to restore proteostasis, body’s natural neuronal protective mechanism. A failure in proteostasis results in pathological accumulation of protein aggregates, neuroinflammation and various forms of cellular stress that is widely implicated in the development of neurodegenerative diseases such as Parkinson’s and Alzheimer’s disease. CDNF is a protein that occurs naturally in the body. Its role is to protect neurons by balancing proteostasis, thereby preventing and counteracting disease generating mechanisms.

Herantis’ development focus is on the CDNF-based; HER-096 (a synthetic peptide). HER-096 has demonstrated to have a multimodal mechanism of action mimicking CDNF and to improve functional recovery of damaged neurons in preclinical models. Importantly, in an initial animal model, HER-096 has been shown to readily penetrate the blood brain barrier allowing for convenient subcutaneous dosing. Thanks to their multimodal mechanism of action, Herantis’ molecules have the potential to stop the progression of Parkinson’s disease and significantly improve patients’ quality of life.

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 visit https://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.