Herantis Pharma Full Year Report 2020

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Herantis Pharma Plc
Company Release 3 March 2021 at 8:00 a.m. EET
Press Release

Herantis Pharma Plc (“Herantis”), an innovative clinical stage biotech company pioneering new disease modifying and regenerative biologic and gene therapies, today published its Full Year Report for January – December 2020. It is available on Herantis’ website (Financial information).

“2020 was a fast-paced, purpose-driven, and transitional year for Herantis as we enter the next chapter of development for our fascinating science and innovative disease modifying treatments for patients suffering from debilitating neurological and lymphatic diseases. The year was notable for favorable data in our key programs, a new strategy for our Parkinson’s program, and significant funds raised. 

For CDNF, a natural biological molecule, we were very pleased to announce data in August confirming the drug successfully achieved its primary endpoint of safety and tolerability in a First-in-Human Phase I-II study in Parkinson’s disease patients. This was a momentous achievement successfully taking the drug into human subjects. Going forward, we will focus on new routes of administration including nose-to-brain (nasal spray) and skin injection (subcutaneous). This strategy is expected to expand the target population to earlier stage patients, accelerate clinical development, and increase the attractiveness of our CDNF asset to partners. 

For xCDNF, an engineered peptide using only the smallest most potent fragments of CDNF, we generated impressive data confirming the potency of the compound plus its ability to cross the blood brain barrier to reach the brain tissue, both of which are critical elements for the success for this therapy. Importantly, as with the new CDNF administration routes above, xCDNF is administered via a simple skin injection without the need for surgery.

It is exciting to have two such compelling assets in our portfolio, and we very much look forward to developing these two programs with their respective merits.

For Lymfactin®, our gene therapy product, we were very pleased to announce in November favorable 24-month follow-up review from Phase I Lymfactin® trial in Breast Cancer Related Lymphedema (BCRL). Post the FY 2020 financial reporting period, results from Phase II study with Lymfactin® in BCRL have been announced separately 2nd March.

We raised a total of approximately EUR 15 million during 2020 with two direct share issues in May and December. 2020 has been a year of considerable progress for Herantis, and we enter 2021 with an optimised foundation, solid business fundamentals, and exciting milestones planned for the year ahead. I am very proud of the accomplishments and the significant advancements Herantis has made this past year to shape its future.”

-  Excerpt from CEO Craig Cook’s comments in the full-year report

Formulas used to calculate key figures:

Equity ratio = Equity/balance sheet total
Earnings per share = Profit for 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.

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 Pharma Plc is an innovative clinical stage biotech company with a diverse pipeline of pioneering investigational therapeutics looking to modify the course of debilitating nervous system and lymphatic diseases and break the boundaries of standard therapeutic approaches. Leveraging deep scientific brilliance in protein dysregulation for neurodegenerative diseases, and growth stimulation in lymphatic diseases, Herantis is advancing a rich pipeline of regenerative biological and gene therapies for high impact diseases.  These include i. CDNF biological therapy that acts on the proteostatic mechanisms of disease for the treatment of Parkinson’s disease and other neurodegenerative diseases, and ii. Lymfactin® VEGF-C gene therapy for restoring lymphatic structure and function for the treatment of oncology related secondary Lymphedema and other lymphatic based diseases.  Herantis is pursuing disease modifying treatments that slow, stop, or even reverse the course of diseases, and bring much needed innovation to these underserved diseases.  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.