Herantis Pharma: Results for the First Half Year January 1 – June 30, 2021

Herantis Pharma Plc

Company Release August 26, 2021, at 9:00 a.m. EEST/8:00 a.m. CEST

Dr. Craig Cook CEO of Herantis commented: “In 2021, Herantis continued to optimize its assets and shape the company for future success as we transformed into a pure play CNS biotech company. The continued generation of strong data prompted our strategic decision to focus on our CNS assets, CDNF and xCDNF (HER-096). Following more than a decade of extensive R&D for CDNF and xCDNF, we are now reaping the fruits of those efforts.”

Herantis Pharma Plc (“Herantis”), focusing on disease modifying therapies for debilitating neurodegenerative diseases, today announces its half yearly financial report for the period January 1 – June 30, 2021. It is available on Herantis’ website (Financial information). Investors, analysts and media are invited to a webcasted live call today at 10:30 EEST / 9:30 CEST.

To register for Herantis’ 1H 2021 Financial Report live call

Register Here: Herantis’ 1H 2021 Financial Report Live Call

Webinar ID: 235-655-763

Questions can be submitted throughout the webcast event.

Following the webcast of the live call, a recording will be available on Herantis Pharma’s website (www.herantis.com).

Herantis transformed into a pure play CNS biotech company

Highlights January – June 2021:

  • Strategic data drive decision taken to fully focus all company resources on Herantis’ CDNF and xCDNF assets, thus becoming a pure play CNS (central nervous system) biotech company.
  • Selected HER-096 as the xCDNF candidate to take forward into further development for the treatment of Parkinson’s Disease (PD) and other neurodegenerative diseases, an important milestone for the company. HER-096 was selected based on clear and compelling preclinical data including that it:
  • Effectively penetrates the Blood-Brain-Barrier (BBB)
  • Potently protects neurons and restores their functional phenotype
  • Significantly reduces aggregation of the toxic protein alpha-synuclein and the associated neuroinflammation
  • Restores proteostasis
  • A study showing CDNF’s therapeutic effects in alpha-synuclein-based animal models was published in Molecular Therapy, a leading scientific journal. This study provides new insight in how CDNF affects alpha-synuclein pathology on the molecular and cellular level.
  • Entered into an agreement with Nanoform Finland Plc. The collaboration provides for formulation proof-of- concept studies to combine Herantis’ CDNF therapy for Parkinson’s disease, with Nanoform nanoparticle technology.
  • Two presentations summarizing the results from the Phase I-II First-In-Man Clinical Trial of CDNF in PD were presented at the 15th International Conference on Alzheimer’s and Parkinson’s Diseases, AD/PD™ 2021.
  • The clinical trial results from Phase II study investigating Herantis’ patented gene therapy Lymfactin®, for the treatment of Breast Cancer Related Lymphedema (BCRL), were inconclusive. The primary purpose of the trial was to determine whether there was an additional benefit of Lymfactin® treatment in combination with lymph node transfer surgery, compared to surgery alone. While both treatment groups experienced clear clinical benefits, the trial did not establish additional treatment benefit for Lymfactin® in combination with surgery, compared to surgery alone. Strategic decision taken to seek out-licensing partners for the Lymfactin® program.
  • Hilde Furberg was elected to the Board of Directors  
  • Hilde brings 35+ years of global leadership experience both as a Board member and through her years in global sales, marketing, strategy and management in the international Pharma/Biotech industries
  • Former European Head of Rare Disease Europe/GM and Senior VP Rare Diseases EMEA at Genzyme/Sanofi Genzyme
  • Presented novel evidence of biological and biomarker impact in humans from the CDNF Phase 1 clinical study

Group’s key figures:

Summary and outlook for 2021:

The new Herantis is a pure play CNS company, and the programs are fully focused on disease modifying therapeutics to address the unmet need in Parkinson’s disease and other neurological illnesses. During the remainder of 2021 we will continue executing our roadmap as we aim to complete formulation activities for the new CDNF administrations routes, and continue strengthening the preclinical proof of concept data for HER-096 (xCDNF).

For more information, please contact:

Julie Silber/Gabriela Urquilla

Tel: +46 (0)79-348 62 77 / +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 therapies for debilitating neurodegenerative diseases by restoring the neuronal protective mechanism of proteostasis, a key system in neurodegenerative disease. Proteostasis regulates proteins within the body and influences the fate of every protein from synthesis to degradation. Its failure results in a vicious cycle of pathological accumulation of protein aggregates, neuroinflammation and various forms of cellular stress that is widely implicated with the development of many neurodegenerative diseases including Parkinson’s Disease, Alzheimer’s and other diseases. CDNF is a protein that occurs naturally in the body whose normal role is to protect neurons by balancing and supporting proteostasis, thereby preventing and counteracting disease generating mechanisms. Herantis is taking this natural ability and harnessing it as a treatment for neurodegenerative disease. CDNF – a biological protein – is Herantis’ lead program and a clinical stage asset; and HER-096 – a synthetic peptidomimetic version of CDNF – is Herantis’ follow-on program. Both CDNF and HER-096 have, via their multimodal mechanism of action, the potential to improve neuronal survival and function, and to stop the progression of Parkinson’s and other neurodegenerative disease and have a significant therapeutic impact on the lives of patients.

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 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.