Faron Pharma Regulatory News (FARN)

Faron Pharmaceuticals Oy

("Faron" or the "Company")

Faron provides update on pipeline progress ahead of R&D Day

Company announcement, 16 June 2020 at 9.00 AM (EET)

Inside information

TURKU - FINLAND - Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), the clinical stage biopharmaceutical company, today provides an update on the progress of its two clinical stage programmes, Clevegen and Traumakine, ahead of the Company's virtual R&D Day.

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. Faron today announces that:

· The World Health Organization (WHO) has approved bexmarilimab as the International Nonproprietary Name (INN) for Clevegen.

· An additional cohort has been added to Part II of the ongoing MATINS trial, exploring the potential of bexmarilimab in patients with anaplastic thyroid cancer, currently without effective treatment. This follows announcement by the Company on 30 March 2020 of the cancer types to be included in Part II of the trial.

· Clinical expansion plans for bexmarilimab will include the investigation of alternative dosing cycles, as pharmacodynamics markers may indicate a need for shorter frequencies, as well as further studies in additional clinical settings.

· Clinical studies are being planned to investigate bexmarilimab in combination with standard of care (SOC) as a first-line therapy in selected advanced solid tumours, and as a standalone neoadjuvant therapy for patients with early stage colon cancer. The Company currently expects patient recruitment for a small number of cohorts to complete around late Q3 with discussions with the FDA to follow in Q4.

Traumakine

Traumakine, Faron's investigational intravenous (IV) interferon (IFN) beta-1a, is currently under development for the treatment of patients with Acute Respiratory Distress Syndrome (ARDS) and is being used in two global, adaptive trials investigating potential COVID-19 treatments - REMAP-CAP, the Randomized, Embedded, Multifactorial Adaptive Platform rial for Community-Acquired Pneumonia, and the WHO Solidarity trial.

Today the Company announces that a third trial will investigate the potential of Faron's IV IFN beta-1a to treat COVID-19. HIBISCUS (Human Interferon Beta In Severe CoronavirUS), will be an investigator initiated study at Harvard Medical School's Beth Israel Deaconess Medical Center (BIDMC), focused on ICU patients with ARDS caused by viral infection (e.g. COVID-19, influenza). The phase II/III pivotal, randomized, placebo controlled study aims to recruit 350 patients with 1:1 randomization who will be followed for ventilation free dats (VFD) and mortality over the 28 day period post first dosing. No corticosteroid use will be accepted in the study which is expected to enroll patients over 6-8 months throughout the US with many significant hospitals participating. Commencement of the trial remains subject to finalisation of funding arrangements and regulatory approval. Further announcements will be made in due course.

Dr. Markku Jalkanen, Faron's CEO, said: "We are pleased today to be reporting the continued progress of our two development programmes. Confirming the generic name, bexmarilimab, for our lead immunotherapy is an important milestone for this programme which is rapidly advancing and has shown exciting clinical activity. The positive data seen so far for bexmarilimab gives us the confidence to pursue ambitious future clinical expansion plans for this potential therapy.

"The scientific community is currently focused on discovering new therapeutics to treat COVID-19 and we are very pleased to be supporting these efforts, now with three trials investigating the potential of Traumakine in severely ill patients. We continue to believe in the potential of Traumakine as a future treatment for ARDS and one that could have significant impact on the intensive-care burden from COVID-19. We look forward to providing updates on both development programmes as they progress."

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 ("MAR").

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 

Caution regarding forward looking statements

Certain statements in this announcement, are, or may be deemed to be, forward looking statements. Forward looking statements are identified by their use of terms and phrases such as ''believe'', ''could'', "should", "expect", "hope", "seek", ''envisage'', ''estimate'', ''intend'', ''may'', ''plan'', ''potentially'', ''will'' or the negative of those, variations or comparable expressions, including references to assumptions. These forward-looking statements are not based on historical facts but rather on the Directors' current expectations and assumptions regarding the Company's future growth, results of operations, performance, future capital and other expenditures (including the amount, nature and sources of funding thereof), competitive advantages, business prospects and opportunities. Such forward looking statements reflect the Directors' current beliefs and assumptions and are based on information currently available to the Directors.

A number of factors could cause actual results to differ materially from the results and expectations discussed in the forward-looking statements, many of which are beyond the control of the Company. In particular, the early data from initial patients in the MATINS trial may not be replicated in larger patient numbers and the outcome of clinical trials may not be favourable or clinical trials over and above those currently planned may be required before the Company is able to apply for marketing approval for a product. In addition, other factors which could cause actual results to differ materially include the ability of the Company to successfully licence its programmes within the anticipated timeframe or at all, risks associated with vulnerability to general economic and business conditions, competition, environmental and other regulatory changes, actions by governmental authorities, the availability of capital markets or other sources of funding, reliance on key personnel, uninsured and underinsured losses and other factors. Although any forward-looking statements contained in this announcement are based upon what the Directors believe to be reasonable assumptions, the Company cannot assure investors that actual results will be consistent with such forward looking statements. Accordingly, readers are cautioned not to place undue reliance on forward looking statements. Subject to any continuing obligations under applicable law or any relevant AIM Rule requirements, in providing this information the Company does not undertake any obligation to publicly update or revise any of the forward-looking statements or to advise of any change in events, conditions or circumstances on which any such statement is based.