Faron Pharma Regulatory News (FARN)

Faron Pharmaceuticals Oy

("Faron" or the "Company")

Harmful association of glucocorticoids in interferon beta-1a treated patients published in Intensive Care Medicine

- Detailed analyses following INTEREST trial conclude glucocorticoids block the upregulation of CD73 in the lung capillaries and inhibit interferon signalling

Company announcement, 20 May 2020 at 9.00 AM (EET)

TURKU - FINLAND - Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), the clinical stage biopharmaceutical company, announces today that the results of its detailed analyses into the effects of glucocorticoids on intravenous (IV) interferon (IFN) beta-1a activity, which arose following the INTEREST trial in 2018, have been published in Intensive Care Medicine, a world leading journal in the field of critical care.

The results showed that the desired mechanism of action of IV IFN beta-1a in the lung vasculature - the upregulation of CD73 - is blocked by the administration of glucocorticoids. In addition, the administration of glucocorticoids with IV IFN beta-1a increases mortality in patients with acute respiratory distress syndrome (ARDS) compared to patients administered with IV IFN beta-1a alone. As previously announced, analysis from the INTEREST trial showed Day-28 mortality for patients receiving concomitant glucocorticoids with IV IFN beta-1a was 39.7% compared to 10.6% for patients receiving IV IFN beta-1a alone (p < 0.001).

Dr. Markku Jalkanen, Faron's CEO, said: "This is a crucial publication for the critical care community, detailing the important scientific detective work that has been undertaken since the unexpected readout from the INTEREST trial. It is especially important in these times when ICUs are filled with COVID-19 patients, many of whom may be receiving treatment with glucocorticoids. Prior clinical data have shown that glucocorticoids are harmful in viral-induced ARDS and the World Health Organization has already recommended not to use glucocorticoids in severely ill COVID-19 patients. These published and peer-reviewed data give us the mechanistic reason why and the results are without dispute. The potential lung protective effects of interferon beta through upregulation of CD73, should it be endogenous or exogenous, are lost with the administration of glucocorticoids."

In recent weeks Faron has announced that its investigational IV IFN beta-1a (Traumakine) is being trialled in two global studies investigating potential COVID-19 treatments - the World Health Organization (WHO) Solidarity study, involving over 90 countries, and the global REMAP-CAP trial (Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community-Acquired Pneumonia) underway across close to 200 sites in 14 countries. The Company continues to develop Traumakine as a treatment for ARDS patients. As previously announced, in March the U.S. Food and Drug Administration (FDA) accepted the Company's proposed protocol design for the next Traumakine study, which will exclude the use of concomitant glucocorticoids.

"Glucocorticoids inhibit type I IFN beta signaling and the upregulation of CD73 in human lung" in Intensive Care Medicine can be found here.

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

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.