MATINS Update - Safety and efficacy results from Part I of MATINS study presented in poster at ASCO20 Virtual - Patient recruitment for Part II in multiple cohorts progressing well

TURKU – FINLAND – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), the clinical stage biopharmaceutical company, today announces that the safety and efficacy results from Part I of the MATINS trial have been presented in a poster at the virtual ASCO20 (American Society of Clinical Oncology) Annual Meeting.  Separately, the Company is also pleased to announce below an update on Part II of the MATINS trial.

ASCO Poster Presentation

The ongoing phase I/II MATINS clinical trial is investigating the tolerability, safety and efficacy of Clevegen (FP-1305), Faron's wholly-owned novel precision cancer immunotherapy targeting Clever-1 positive tumour associated macrophages (TAM), in selected metastatic or inoperable solid tumours.

Data were presented on all 30 patients in Part I of the trial, who had advanced solid tumours and had exhausted all standard therapeutic options. The poster included previously announced data, reporting that

• Clevegen was well tolerated without dose-limiting toxicities;
• CLEVER-1 inhibition led to immune cell activation and downregulation of several checkpoint molecules;
• Interferon gamma and chemokine CXCL10 responses were associated with clinical responses observed in target or non-target lesions.

The poster, Immune activation in fi­rst-in-human anti-macrophage antibody (anti-Clever-1 mAb; FP-1305) phase I/II MATINS trial: Part 1 dose-escalation, safety and efficacy results, is available at the ASCO meeting library (https://meetinglibrary.asco.org) with identification code 3097.

MATINS Trial Part II update

Part II of the MATINS study has begun and the Company is pleased that patient recruitment continues to be strong, despite the COVID-19 pandemic. This Part II now contains cohorts of nine different cancers at 1.0 mg/kg dosing and three colorectal cancer (CRC) cohorts at 0.3, 1.0 and 3.0 mg/kg. Of these, the 0.3 mg/kg cohort has already recruited, with the additional two CRC cohorts expected to be recruited by mid-summer 2020. The Company intends to present data from these test cohorts (10 patients at each dosing levels) to the FDA at the end-of-phase II meeting to obtain advice ahead of expansion into the pivotal Part III stage of the trial.

Dr. Petri Bono, the Principle Investigator of the MATINS study, said:  “The MATINS trial’s Part I results have shown a  tolerable safety profile for Clevegen, as well as exciting clinical activity in the target lesions of several terminal cancer patients. Clevegen represents a novel mechanism of action and this macrophage checkpoint inhibition has already, in Part I of the trial, shown clinical response in immunologically ‘cold’ tumours traditionally not responsive to currently available checkpoint inhibitors. I very much look forward to continuing patient enrolment for Part II of the trial, which is progressing well for the selected tumour types.”

Dr. Markku Jalkanen, Faron's CEO, said: “Despite the study patients’ very advanced stage of disease and several lines of previous therapies, including PD-1 and CTLA-4 inhibitors, the early results from this dose finding stage of the MATINS study are very encouraging for single agent efficacy.”

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

About the MATINS study

The MATINS study is the first-in-human open label Phase I/II clinical trial with an adaptive design to investigate the safety and efficacy of Clevegen in selected metastatic or inoperable solid tumours. The selected tumours under investigation are cutaneous melanoma, hepatobiliary/hepatocellular, pancreatic, ovarian and colorectal cancer, all known to host a significant number of Clever-1 positive tumour associated macrophages (TAM). All together these five target groups consist of approximately 2 million annual cases worldwide. Cancer patients with high Clever-1 expression are identified with a simple blood myeloid cell staining with Clevegen ("liquid biopsy").

Part I of the trial deals with tolerability, safety and dose escalation to optimize dosing. As the trial is an open label study, the Company expects to report findings as the dosing progresses. The cohort expansion during Part II will focus on identification of patients who show an increased number of Clever-1 positive circulating monocytes and the safety and efficacy of the treatment. Colorectal cancer and ovarian cancer have been selected as the first and second expansion cohorts in Part II. During Part III, the main focus will be on assessing the efficacy of Clevegen on study subjects who show an increased number of Clever-1 positive circulating monocytes, making the treatment precisely targeted and maximizing the chances of success for efficacy. The treatment, if successful, may ultimately be used as a standalone therapy or in combination with other immunotherapies like PD-1 inhibitors.

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