Correction to release sent on March 2nd, 2023, at 8:00 a.m. EET: the release category has been updated by removal of “insider information” and the Key Figures table is now included in the release. Nothing else differs from the previous release.
Herantis Pharma Plc
Company Release, March 7, 2023, at 19:40 EET/ 18:40 CET
“We made good progress in 2022 achieving encouraging preclinical results and submitting clinical trial application (CTA) for HER-096. The compelling preclinical data supports the potential of HER-096 to be a disease-modifying therapy for Parkinson’s disease with a unique mechanism of action. We look forward to the first HER-096 human dose in 1H 2023 and to create additional value in 2023 through early clinical development and to pursue partnering opportunities for HER-096. In December 2022, Herantis was selected to receive financing from European Innovation Council Accelerator program: a grant of €2.5 with the option to receive additional funding through an equity investment. Qualifying for this highly competitive funding scheme is a great recognition of our HER-096 development,” commented CEO Antti Vuolanto.
Herantis Pharma Plc (“Herantis”), a company developing disease-modifying therapies for Parkinson’s disease, released today the company’s 2H & FY report for 2022. The full report is attached to this release and is available in the company’s websitewww.herantis.com.
A webinar (in English) will be held today, March 2, 2023 at 10:00 EET / 9:00 CET
Please join the webinar a few minutes in advance. Registration is required for this event. To register for this event, you need a Zoom account. After registering, you will receive a confirmation email containing information about joining the webinar.
Business highlights January – December 2022
- Submission of clinical trial application (CTA) for a Phase 1a study of HER-096 in December.
- Selected for European Innovation Council (EIC) grant in December, of €2.5 million through their prestigious EIC Accelerator, with the option to receive additional funding through an equity investment, pending negotiation.
- In December, Nasdaq Stockholm AB approved Herantis’ delisting application regarding the secondary listing on the Nasdaq First North Growth Market Sweden.
- Antti Vuolanto appointed as the CEO in July. He has acted as the Chief Operating Officer of Herantis Pharma since 2018.
- 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
- Data from preclinical pharmacology and toxicology studies strengthens the preclinical dataset of HER-096.
Events after the reporting period
- February 20, 2023, Finnish Medicines Agency, Fimea and the ethics committee approved the Clinical Trial Application (CTA). Herantis will initiate the Phase 1 study with the aim to demonstrate evidence of HER-096 safety and blood-brain penetration in humans. The Phase 1 study will be conducted in Finland.
Summary and outlook for 2023
Herantis submitted a Clinical Trial Application (CTA) end of 2022 to the Finnish Medicines Agency Fimea, the national competent authority for regulating pharmaceuticals. The Phase 1a study, which includes assessment of safety, tolerability, and blood-brain barrier penetration in healthy volunteers, will be carried out in Finland. Successful completion of the study would represent a significant milestone for Herantis.
Near-term milestones for HER-096 are:
- Phase 1a clinical trial application (CTA) regulatory approval (targeted 1H/2023) – achieved February 20, 2023
- First HER-096 human dose in Phase 1a study (targeted 1H/2023)
- Phase 1a read-out: Evidence of HER-096 safety and blood-brain barrier penetration in humans (targeted 2H/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
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 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.
For more information, please visit www.herantis.com.
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.