Herantis Pharma Announces Poster and Presentation at MDS Virtual Congress 2021

Herantis Pharma Plc, Press Release, 17 September 2021 at 9:00 EEST

First-in-Man Clinical Trial of Intraputamenal CDNF in Parkinson’s disease Finds a Consorted Biomarker Response in a Subgroup of Subjects.

Herantis Pharma Plc (“Herantis”), focusing on disease modifying therapies for debilitating neurodegenerative diseases, today announced that data highlighting biomarker response in Herantis’ First-in-Man clinical trial of intraputamenal CDNF in Parkinson’s disease will be presented at the International Parkinson and Movement Disorder Society annual congress (MDS Virtual Congress 2021) from 17 Sept  – 22 Sept 2021. The presentation includes results from the completed Phase I First-in-Human clinical study in advanced Parkinson’s disease (PD) patients with monthly intraputamenal infusions of recombinant human CDNF (rhCDNF) protein  at three (3) study centers in Sweden and Finland.

The data includes that the primary endpoint of the Phase I trial showing intraputamenal CDNF is safe and well-tolerated. Please reference the Company’s press release published on August 27, 2020 (link to press release). Additionally, as an Exploratory endpoint, Herantis conducted two proteomics studies to explore potential changes in cerebrospinal fluid (CSF) biomarkers.

In the targeted CSF proteomics study:

• Several CSF biomarkers changed in response to CDNF treatment in a subset of 36% of patients who enrolled to this study.

• The CSF biomarker changes correlated with improved motor function in several patients and dopamine transporter PET signal.

• Furthermore, the CSF biomarker profiling indicates that there was a biological response to intraputamenal CDNF treatment in a subset of PD patients that may be associated with modulation of proteostasis, neuroinflammation and synaptic remodeling.

“We’re excited to share this data evaluating intraputamenal CDNF First-in-Man study at this year’s virtual MDS Congress,” said Dr. Henri Huttunen, Co-Founder & Chief Scientific Office. “This data further strengthens our understanding of not only the safety and tolerability of CDNF as a treatment option for patients with Parkinson’s disease, but also the impact that CDNF has on CSF biomarkers changes & biological response."

After the conclusion of the conference, the poster can be found on our website here: (Link to website)

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 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 (a biological protein) is Herantis’ lead program and a clinical stage asset; and xCDNF (a synthetic peptide version of CDNF) is Herantis’ follow-on program. CDNF is a natural protein that occurs naturally in the body whose natural 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. Both CDNF and xCDNF, via their multimodal mechanism of action, have the potential to improve neuronal survival and stop the progression of Parkinson’s and other neurodegenerative diseases with a significant therapeutic impact on the quality of patients’ lives.

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

About The International Parkinson and Movement Disorder Society

The International Parkinson and Movement Disorder Society (MDS) is a professional society of more than 11,000 clinicians, scientists and other healthcare professionals dedicated to improving the care of patients with movement disorders through education and research.