Herantis Pharma Plc, Press release, 19 January 2023 at 1:00 pm EST
Antti Vuolanto, CEO of Herantis Pharma said, “We made good progress in 2022 achieving encouraging preclinical results and submitting clinical trial application (CTA) for HER-096. Pending CTA approval, we plan 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.”
Herantis Pharma Plc (“Herantis”), an innovative biotech company developing new disease-modifying therapies for Parkinson’s disease, are hosting an R&D update webinar today.
Link to the webinar (14:00-15:00 EET/13:00-14:00 CET): Click Here to Register
HER-096 is a peptidomimetic molecule designed to retain the biological activity of the neuroprotective CDNF protein. Thanks to its multimodal mechanism of action, Herantis’ HER-096 has the potential to stop the progression of Parkinson’s disease and significantly improve patients’ quality of life.
The management team will give an update on preclinical results for HER-096 and explain why it is a perfect drug candidate for Parkinson’s disease. The update will also cover exploratory biomarker data findings from the CDNF phase 1 study, next steps for the clinical development of HER-096 and milestones for 2023.
Conclusions from HER-096 preclinical pharmacology and toxicology studies:
- Pharmacokinetic and distribution studies consistently showed brain exposure at therapeutic levels (=penetration of blood-brain barrier) in multiple animal species
- Subcutaneous dosing for five weeks in an alpha-synuclein mouse model showed:
- Target pathway modulation in the target brain area
- Improvement of motor symptoms
- 28-day repeated dose toxicology studies with subcutaneous administration successfully completed in rat and dog
- No systemic toxicities observed
- Some local adverse effects at the injection sites, as expected
- No anti-drug antibodies in rat
Exploratory biomarker data findings from the CDNF phase 1 study:
- Cerebrospinal fluid (CSF) analysis identified 3 biomarkers that responded to CDNF infusion into the brain
- Information obtained from this analysis will be used in further development of HER-096
2023 development milestones for HER-096:
- Phase 1a clinical trial application (CTA) regulatory approval
- First HER-096 human dose in Phase 1a study
- First HER-096 preclinical publication
- Phase 1a read-out: Evidence of HER-096 safety and blood-brain barrier penetration in humans
Interested parties unable to watch the live webcast will be able to view and listen to an archived copy of the webcast, which will be available on www.herantis.com/investors/ following the conclusion of the event.
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, Sweden: +358 40 5161400
Company website: www.herantis.com
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 and Nasdaq First North Growth Market Sweden. As previously announced by Herantis, Nasdaq Stockholm AB has approved Herantis' application to delist the shares of Herantis from Nasdaq First North Growth Market Sweden, and the last day of trading in the shares of Herantis on Nasdaq First North Growth Market Sweden shall be January 31, 2023.
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.