On March 3, 2021 Herantis Pharma Plc ("Herantis"), an innovative clinical stage biotech company pioneering new disease modifying and regenerative biologic and gene therapies, reported its Full Year Report for January – December 2020. It is available on Herantis’ website (Financial information) (Press release, Herantis Pharma, MAR 3, 2021, View Source,c3300578 [SID1234577483]).
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"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."