Herantis Pharma to focus on CDNF and xCDNF programs

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Herantis Pharma Plc

Company release, Inside Information  

29 March 2021 at 9:00 PM EET

Herantis Pharma Plc (“Herantis or the Company”), an innovative clinical stage biotech company pioneering new disease modifying and regenerative therapies, today announced that the Board of Directors has decided to focus all company resources on Herantis’ CDNF and xCDNF assets and to commence seeking out-licensing partners for the Lymfactin® program in the treatment of Breast Cancer Related Lymphedema (BCRL). 

As previously announced in a press release on March 2, 2021 that while a favourable safety profile for Lymfactin® has been established, and important observations on the potential activity of Lymfactin® were made, the efficacy data from the Phase II Lymfactin® program was inconclusive.

This prompted a full evaluation of the overall program and the company resources required to move the program forward. The review focused on learnings from this pioneering study and how best to address them to accurately capture treatment effect, implications for the overall program, resourcing requirements for the Lymfactin® program moving forward, and strategic considerations together with Herantis’ central nervous system (CNS) assets. As a result of this comprehensive evaluation, Herantis’ Board of Directors have concluded that the best course of action for the Company is firstly to focus all activities, strategy and resources solely on the exciting CNS portfolio, and secondly to seek a suitable partner to take over further development of the innovative Lymfactin® program.

Craig Cook CEO commented "We are at an inflection point and this is an important strategic decision. It is the right time to separate the Company assets and move forward as a pure play Neuroscience company focusing on our CDNF and xCDNF portfolios. We are very grateful to the patients, investigators and medical professionals involved in the Lymfactin® program, without their contributions, we would not have been able to advance this ground-breaking research into the treatment of BCRL with Lymfactin®.”

In-line with this decision, Herantis will structure all its research and operations on neurodegenerative diseases, accelerating its programs in Parkinson’s Disease and other neurodegenerative diseases. 

Herantis will host a live session 30th March at 10am CET/11am EET with Craig Cook, CEO and Antti Vuolanto, COO, to further discuss the company’s new strategic focus.

Call Details:

Herantis Pharma Strategic Update Webinar

Date:   30th March

Time:  10:00 am – 10:30 CET

11.00 am – 11.30 EET

Please register for Herantis Pharma Company Update: Focus on CDNF and xCDNF Programs by clicking this link:

https://attendee.gotowebinar.com/register/317179831752146192

After registering, you will receive a confirmation email containing information about joining the webinar.

About Cerebral Dopamine Neurotrophic Factor - CNDF and xCDNF

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 Parkinsons Disease, Alzheimers and other diseases. 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. 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. Both CDNF and xCDNF have, via their multimodal mechanism of action, the potential improves neuronal survival and to stop the progression of Parkinson’s and other neurodegenerative disease and have a significant therapeutic impact on the lives of patients.

About Lymfactin®                                   

Lymfactin® is the world’s first and only clinical stage gene therapy that repairs damages of the lymphatic system. It expresses the human growth factor VEGF-C, which is naturally associated with the development of lymphatic vessels. Based on preclinical studies, Lymfactin® triggers the growth of new functional lymphatic vasculature in the injured area and thus repairs the underlying cause of secondary lymphedema. The first target indication for Lymfactin® is Breast Cancer Associated Lymphedema; Herantis believes that Lymfactin® may also be suitable for the treatment of other forms of secondary lymphedema if its safety and efficacy are established in the first indication.

Lymfactin®, patented by Herantis, is based on the internationally renowned scientific research of academy professor Kari Alitalo and his research group, a national center of excellence at the University of Helsinki.

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 drug development company looking to break the boundaries of standard therapeutic approaches. Our regenerative medicine drug candidates 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. The Herantis programs are potentially disease modifying that treat the cause as well as symptoms of disease and bring the innovation necessary to provide further treatment options in underserved diseases. The shares of Herantis are listed on the Nasdaq First North Growth Market Finland and Nasdaq First North Growth Market Sweden.

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