Faron Pharma Regulatory News (FARN)

Faron Pharmaceuticals Oy

("Faron" or the "Company")

Faron hosts virtual R&D Day today

Company announcement, 16 June 2020 at 9.01 AM (EET)

TURKU - FINLAND - Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), the clinical stage biopharmaceutical company, will today host a virtual R&D Day via webcast to present its R&D strategy and provide insight into Faron's two clinical stage programmes, Clevegen and Traumakine. The event will take place today at 3.00 p.m. EEST, 1.00 p.m. BST, 8.00 a.m. EDT. Further to the announcement earlier today, no new price sensitive information will be disclosed.

Markku Jalkanen, Chief Executive Officer, will host the event together with members of the Executive Leadership and senior management teams. In addition, the following external experts will provide additional perspectives on both Clevegen and Traumakine:

· Prof. Alberto Mantovani, Humanitas University, Milan, Italy

· Ass. Prof. Maija Hollmén, MediCity, Turku University, Finland

· Dr. Petri Bono, Terveystalo, Helsinki, Finland

Clevegen

Clevegen is Faron's wholly-owned novel precision cancer immunotherapy, targeting Clever-1 positive tumour associated macrophages (TAMs) in selected metastatic or inoperable solid tumours, currently under development in the ongoing phase I/II MATINS clinical trial. As announced this morning, the World Health Organization (WHO) has now accepted the proposed INN name of bexmarilimab for Clevegen.

Presentations will include:

· A comprehensive review of myeloid cell plasticity in cancer formation

· Clevegen (bexmarilimab) induced immune activation in patients from the MATINS trial

· A review of the safety and efficacy results from Part I of the MATINS study

· An update on Part II cohorts and the bexmarilimab clincial expansion plans

Traumakine

Traumakine is currently under development for the treatment of patients with Acute Respiratory Distress Syndrome (ARDS). Faron will provide an overview of data generated to date (including insights into the detrimental effect of corticosteroids on ARDS patients), the next steps in Traumakine's clincial development and an overview of the ongoing clinical trials including:

· The REMAP-CAP trial

· The WHO's Solidarity trial in COVID-19 patients

· A new US based study called HIBISCUS, which is focusing on ICU entered patients with acute respiratory failure caused by viral infection (e.g. COVID-19, influenza). Details of this new study were announced earlier today and are also summarised below

· An update on manufacturing

About HIBISCUS

Human Interferon Beta In Severe CoronavirUS (HIBISCUS) study is a phase II/III pivotal, randomized, placebo controlled Traumakine study in severely ill COVID-19 patients. The study aims to recruit 350 patients with 1:1 randomization and patients will be followed for ventilation free days (VFD) and mortality over the 28 day period post first dosing. No corticosteroid use will be accepted in this study which is expected to enroll patients over 6-8 months throughout the US with many significant hospitals participating. The study's principal investigator will be Prof. Daniel Talmor from Harvard University's Beth Israel Deaconess Medical Center (BIDMC). Further details will be provided in due course.

Agenda and presentations

To register for the event and receive the webcast details please contact Consilium Strategic Communications at faron@consilium-comms.com 

A replay will be made available on the investor section of Faron's website shortly after the event.

For more information please contact:

Faron Pharmaceuticals Oy

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com 

Panmure Gordon (UK) Limited, Nomad and Broker

Emma Earl, Freddy Crossley (Corporate Finance)

James Stearns (Corporate Broking)

Phone: +44 207 886 2500

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen, Jussi Majamaa

Phone: +358 (0)40 555 4727

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

Stern Investor Relations, Inc.

Julie Seidel

Phone: +(1)212 362 1200

Email: Julie.Seidel@sternir.com 

About Faron Pharmaceuticals Ltd

Faron (AIM: FARN, First North: FARON) is a clinical stage biopharmaceutical company developing novel treatments for medical conditions with significant unmet needs. The Company currently has a pipeline based on the receptors involved in regulation of immune response in oncology and organ damage. Clevegen, its precision immunotherapy, is a novel anti-Clever-1 antibody with the ability to switch immune suppression to immune activation in various conditions, with potential across oncology, infectious disease and vaccine development. Currently in phase I/II clinical development as a novel macrophage checkpoint immunotherapy for patients with untreatable solid tumours, Clevegen has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules. Traumakine, the Company's pipeline candidate to prevent vascular leakage and organ failures, has completed a phase III clinical trial in Acute Respiratory Distress Syndrome (ARDS). Plans for its future development are being finalised to avoid interfering steroid use together with Traumakine. Faron is based in Turku, Finland. Further information is available at www.faron.com