Faron, etusivu

Registration of Placing Shares

THIS ANNOUNCEMENT AND THE INFORMATION CONTAINED HEREIN IS RESTRICTED AND IS NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN, INTO OR FROM THE UNITED STATES, AUSTRALIA, CANADA, JAPAN, THE REPUBLIC OF SOUTH AFRICA, SINGAPORE, HONG KONG OR ANY OTHER JURISDICTION IN WHICH SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL.

THIS ANNOUNCEMENT IS ONLY DIRECTED AT PERSONS IN THE UNITED KINGDOM THAT ARE QUALIFIED INVESTORS WITHIN THE MEANING OF ARTICLE 2(E) OF REGULATION 2017/1129/EU AS INCORPORATED INTO UK DOMESTIC LAW BY VIRTUE OF THE EUROPEAN UNION (WITHDRAWAL) ACT 2018 THAT ARE ALSO (I) INVESTMENT PROFESSIONALS FALLING WITHIN ARTICLE 19(5) OF THE FINANCIAL SERVICES AND MARKETS ACT 2000 (FINANCIAL PROMOTION) ORDER 2005 (THE “ORDER”) AND/OR (II) HIGH NET WORTH ENTITIES, AND OTHER PERSONS TO WHOM IT MAY LAWFULLY BE COMMUNICATED, FALLING WITHIN ARTICLE 49(2)(A) TO (E) OF THE ORDER (EACH SUCH PERSON BEING REFERRED TO AS A “RELEVANT PERSON”). ACCORDINGLY, THIS ANNOUNCEMENT AND ITS CONTENTS MUST NOT BE ACTED ON OR RELIED ON BY PERSONS WHO ARE NOT RELEVANT PERSONS. ANY INVESTMENT OR INVESTMENT ACTIVITY TO WHICH THIS ANNOUNCEMENT RELATES IS AVAILABLE ONLY TO RELEVANT PERSONS AND WILL BE ENGAGED IN ONLY WITH RELEVANT PERSONS. PERSONS INTO WHOSE POSSESSION THIS ANNOUNCEMENT COMES ARE REQUIRED TO INFORM THEMSELVES ABOUT AND TO OBSERVE ANY SUCH RESTRICTIONS.

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

Registration of Placing Shares with the Trade Register

Capitalised terms used in this announcement have the meanings given to them in the announcement made on 11 February 2021 regarding the proposed issue and placing of new ordinary shares in the Company (the “Launch Announcement“) and the subsequent announcement released at 7.00 a.m. GMT / 9.00 a.m. EET on 12 February 2021 (the “Pricing and Results Announcement”), unless the context provides otherwise.

Company announcement, 12 February 2021 at 3:00 p.m. GMT / 5:00 p.m. EET

TURKU – FINLAND – Faron Pharmaceuticals Oy (First North: FARON, AIM: FARN), the clinical stage biopharmaceutical company, has as previously announced completed the Placing. The Company announced the results of the Placing on 12 February 2021.

A total of 3,521,127 Placing Shares subscribed for in the Placing have been issued and registered in the Trade Register today on 12 February 2021. The Placing Shares confer a right to dividends and other shareholder rights from their registration with the Trade Register. Following the Placing, the aggregate number of ordinary shares in the Company is 50,417,874. One ordinary share entitles to one vote in the general meeting of the Company. The Company holds no treasury shares.

Trading in the Placing Shares is expected to commence on First North and AIM latest on or around 16 February 2021.

For more information please contact:

Faron Pharmaceuticals Oy

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com

Swedbank AB (publ), Finnish Branch, Financial Adviser

Mika Karikoski (Corporate Finance)

Phone: +358 (0)40 741 6959

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner, Mark Rogers

Phone: + 44 207 213 0880

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 40 555 4727

Jukka Järvelä

Phone: +358 50 553 8990

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

Julie Seidel, Naina Zaman

Phone: +1 (212) 362-1200

E-mail: 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. Bexmarilimab is its investigative precision immunotherapy with the potential to provide permanent immune stimulation for difficult-to-treat cancers through targeting myeloid function. A novel anti-Clever-1 humanised antibody, bexmarilimab targets Clever-1 positive (Common Lymphatic Endothelial and Vascular Endothelial Receptor 1) tumour associated macrophages (TAMs) in the tumour microenvironment, converting these highly immunosuppressive M2 macrophages to immune stimulating M1 macrophages. With the ability to switch immune suppression to immune activation in various conditions, bexmarilimab has potential across oncology, infectious diseases and vaccine development. Currently in phase I/II clinical development as a potential therapy for patients with untreatable solid tumours, bexmarilimab has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules. Traumakine is an investigational intravenous (IV) interferon beta-1a therapy for the treatment of acute respiratory distress syndrome (ARDS) and other ischemic or hyperinflammatory conditions. In addition to its profound antiviral effect, Traumakine upregulates the cell surface protein Cluster of Differentiation 73 (CD73), an enzyme that suppresses pro-inflammatory responses in endothelial cells. Using an IV administration of interferon beta-1a provides optimal exposure to the lung vasculature, increasing protection against serious lung complications and helping to prevent vascular leakage by enhancing endothelial barrier function. Traumakine is currently being evaluated in global trials as a potential treatment for hospitalised patients with COVID-19. As part of a working relationship established with Faron, the 59th Medical Wing of the US Air Force and the US Department of Defense are also evaluating Traumakine’s role in preventing multiple organ dysfunction syndrome (MODS) after ischemia-reperfusion injury caused by a major trauma.  Faron is based in Turku, Finland. Further information is available at www.faron.com.

IMPORTANT INFORMATION

Market Abuse Regulation

Market soundings, as defined in Regulation (EU) No 596/2014 (“MAR“), were taken in respect of the proposed Placing with the result that certain persons became aware of inside information, as permitted by MAR. That inside information in relation to the Placing is set out in this announcement and has been disclosed as soon as possible in accordance with paragraph 7 of article 17 of MAR. Therefore, those persons that received inside information in such market sounding are no longer in possession of inside information relating to the Company and its securities.

MiFID II

Solely for the purposes of the product governance requirements contained within: (a) EU Directive 2014/65/EU on markets in financial instruments, as amended (“MiFID II“); (b) Articles 9 and 10 of Commission Delegated Directive (EU) 2017/593 supplementing MiFID II; and (c) local implementing measures (together, the “MiFID II Product Governance Requirements“), and disclaiming all and any liability, whether arising in tort, contract or otherwise, which any “manufacturer” (for the purposes of the MiFID II Product Governance Requirements) may otherwise have with respect thereto, the Placing Shares have been subject to a product approval process, which has determined that the Placing Shares are: (i) compatible with an end target market of: (a) retail investors, (b) investors who meet the criteria of professional clients and (c) eligible counterparties (each as defined in MiFID II); and (ii) eligible for distribution through all distribution channels as are permitted by MiFID II (the “Target Market Assessment“). Notwithstanding the Target Market Assessment, distributors should note that: the price of the Placing Shares may decline and investors could lose all or part of their investment; the Placing Shares offer no guaranteed income and no capital protection; and an investment in the Placing Shares is compatible only with investors who do not need a guaranteed income or capital protection, who (either alone or in conjunction with an appropriate financial or other adviser) are capable of evaluating the merits and risks of such an investment and who have sufficient resources to be able to bear any losses that may result therefrom. The Target Market Assessment is without prejudice to the requirements of any contractual, legal or regulatory selling restrictions in relation to the offer.

Faron Pharmaceuticals Registration of Placing Shares

Results of Placing and Issue Price

THIS ANNOUNCEMENT AND THE INFORMATION CONTAINED HEREIN IS RESTRICTED AND IS NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN, INTO OR FROM THE UNITED STATES, AUSTRALIA, CANADA, JAPAN, THE REPUBLIC OF SOUTH AFRICA, SINGAPORE, HONG KONG OR ANY OTHER JURISDICTION IN WHICH SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL.

THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF THE EU REGULATION 596/2014 (“MAR”) AND ARTICLE 7 OF MAR AS INCORPORATED INTO UK DOMESTIC LAW BY VIRTUE OF THE EUROPEAN UNION (WITHDRAWAL) ACT 2018 (“UK MAR”).

THIS ANNOUNCEMENT IS ONLY DIRECTED AT PERSONS IN THE UNITED KINGDOM THAT ARE QUALIFIED INVESTORS WITHIN THE MEANING OF ARTICLE 2(E) OF REGULATION 2017/1129/EU AS INCORPORATED INTO UK DOMESTIC LAW BY VIRTUE OF THE EUROPEAN UNION (WITHDRAWAL) ACT 2018 THAT ARE ALSO (I) INVESTMENT PROFESSIONALS FALLING WITHIN ARTICLE 19(5) OF THE FINANCIAL SERVICES AND MARKETS ACT 2000 (FINANCIAL PROMOTION) ORDER 2005 (THE “ORDER”) AND/OR (II) HIGH NET WORTH ENTITIES, AND OTHER PERSONS TO WHOM IT MAY LAWFULLY BE COMMUNICATED, FALLING WITHIN ARTICLE 49(2)(A) TO (E) OF THE ORDER (EACH SUCH PERSON BEING REFERRED TO AS A “RELEVANT PERSON”). ACCORDINGLY, THIS ANNOUNCEMENT AND ITS CONTENTS MUST NOT BE ACTED ON OR RELIED ON BY PERSONS WHO ARE NOT RELEVANT PERSONS. ANY INVESTMENT OR INVESTMENT ACTIVITY TO WHICH THIS ANNOUNCEMENT RELATES IS AVAILABLE ONLY TO RELEVANT PERSONS AND WILL BE ENGAGED IN ONLY WITH RELEVANT PERSONS. PERSONS INTO WHOSE POSSESSION THIS ANNOUNCEMENT COMES ARE REQUIRED TO INFORM THEMSELVES ABOUT AND TO OBSERVE ANY SUCH RESTRICTIONS.

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

Results of Placing and Issue Price

Capitalised terms used in this announcement have the meanings given to them in the announcement made on 11 February 2021 regarding the proposed issue and placing of new ordinary shares in the Company (the “Launch Announcement“), unless the context provides otherwise.

Company announcement, 12 February 2021 at 7:00 a.m. GMT / 9:00 a.m. EET

Inside information

TURKU – FINLAND – Faron Pharmaceuticals Oy (First North: FARON, AIM: FARN), the clinical stage biopharmaceutical company, announces today that the Bookbuild, announced on 11 February 2021, is now closed. The Placing comprises the issue of 3,521,127 Placing Shares at an Issue Price of €4.26 per Placing Share, which represents a 5% discount to the 30 day volume weighted average price on NASDAQ Helsinki First North Growth.

The Placing Shares to be issued amount to approximately 7.5 per cent of the issued shares and votes in the Company, immediately prior to the Placing. The Company raised aggregate gross proceeds of EUR 15 million in the Placing. Several new high-quality Continental European institutional investors participated in the Placing, expanding Faron’s investor base, along with existing investors, as planned. The European Investment Council Fund, EIC, which had given a pre-commitment, was the largest of the new investors. Faron is the first publicly listed company that the EIC Fund has invested in.

Commenting on the successful Placing, Dr Markku Jalkanen, Chief Executive Officer of Faron, said: “We are delighted to have received this significant support from our existing and new investors in this successful financial round. In particular we would like to welcome the European Innovation Council Fund, a breakthrough initiative from the European Commission. With these additional resources we can further accelerate our pipeline projects, especially in the fight against cancer with our Clever-1 targeting precision immunotherapy, bexmarilimab. The recent discovery of free, soluble Clever-1 as an immune suppressive agent capable of directly restricting T-cell activation in all locations of the body may help us to control cancer-induced immune suppression in remote locations such as distant organs. Cancer clinicians have, for years, sought the ability to measure and control immune suppressive elements in their patients. Soluble Clever-1 is a prime candidate for this, with bexmarilimab offering significant potential as a breakthrough therapy.”

Commenting on the participation of the EIC in the Placing, Stéphane Ouaki, Head of Unit for Financial Instruments, DG Research and Innovation – European Commission, said: “I am glad to announce that the EIC Fund is supporting Faron via this successful investment.  This unique form of financing – combining grants and equity – is a signature feature of the European Innovation Council. It will bridge the funding gap for highly innovative companies, unlock additional private investments and enable the companies to scale up in Europe.”

Commenting on the successful Placing, Toni Hänninen, Chief Financial Officer of Faron, said: “We are extremely pleased with the results of this Placing conducted on a very competitive market. This allows us to accelerate our development programmes and significantly strengthens our balance sheet.”

Use of Proceeds

The primary reason for conducting the Fundraise was to accelerate and expand the clinical development of the Company’s main drug candidates, bexmarilimab and Traumakine® (intravenous interferon beta).  In summary:

Bexmarilimab

  • testing higher frequency of dosing to investigate potential for enhanced clinical responses;
  • three new trials to study bexmarilimab treatment in a neoadjuvant setting, in combination with a PD(L)-1 checkpoint inhibitor and in haematological malignancies; and
  • continuation of the MATINS trial, where five solid tumour cohorts have demonstrated early signs of clinical benefit in the first two stages (Part I and II) of the study.

Traumakine

  • launch of the phase II/III HIBISCUS study in the US; and
  • preparations to expand into additional clinical indications. 

General corporate

  • establishment of an operational unit in the US;
  • investment in the manufacturing of both bexmarilimab and intravenous interferon beta; and
  • strengthening of the Company’s balance sheet. 

The Placing Shares will confer a right to dividends and other shareholder rights from their registration with the trade register kept by the Finnish Patent and Registration Office (the “Trade Register“) which is expected to be on or about 12 February 2021 (the “Registration“). Following the Registration, the Placing Shares will subsequently be entered in the book-entry system maintained by Euroclear Finland Oy and registered in the book-entry accounts of each investor. Trading in the Placing Shares is expected to commence on NASDAQ First North Growth and the AIM market of the London Stock Exchange latest on or around 16 February 2021.

Following issue and Registration of the Placing Shares, the number of shares in the Company will be 50,417,874 ordinary shares with voting rights attached. The Company has no shares in treasury; therefore, the total number of voting rights in Faron will be 50,417,874 (the “New Number of Shares and Votes“). This figure may be used by shareholders as the denominator for the calculations by which they will determine whether they are required to notify an interest in, or a change to their interest in, the New Number of Shares and Votes of the Company.

Related party transaction

Timo Syrjälä, an existing shareholder in the Company, has subscribed for 46,948 Placing Shares in aggregate (subscribed for through Acme Investments SPF Sarl (“Acme“), an entity wholly owned by Mr Syrjälä), for an aggregate subscription value of EUR 200,000 at the Issue Price. Following the Placing, Mr Syrjälä’s total holding in the Company’s shares, which includes his indirect holding through Acme, will be 6,839,239 shares, representing 13.57 per cent of the New Number of Shares and Votes. Mr Syrjälä is a “Substantial Shareholder” in the Company for the purposes of the AIM Rules for Companies (the “AIM Rules“). His subscription for Placing Shares pursuant to the Placing is a related party transaction for the purposes of the AIM Rules. The Directors of the Company, all of whom are independent of Mr Syrjälä, having consulted with Cairn Financial Advisors LLP, the Company’s nominated adviser for the purposes of the AIM Rules, consider the terms of the participation by Mr Syrjälä in the Placing to be fair and reasonable insofar as shareholders are concerned.

The information contained within this notice constitutes inside information stipulated under the Market Abuse Regulation (EU) No. 596/2014.

For more information please contact:

Faron Pharmaceuticals Oy

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com

 

Swedbank AB (publ), Finnish Branch, Financial Adviser

Mika Karikoski (Corporate Finance)

Phone: +358 (0)40 741 6959

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner, Mark Rogers

Phone: + 44 207 213 0880

 

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 40 555 4727

Jukka Järvelä

Phone: +358 50 553 8990

 

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

Julie Seidel, Naina Zaman

Phone: +1 (212) 362-1200

E-mail: 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. Bexmarilimab is its investigative precision immunotherapy with the potential to provide permanent immune stimulation for difficult-to-treat cancers through targeting myeloid function. A novel anti-Clever-1 humanised antibody, bexmarilimab targets Clever-1 positive (Common Lymphatic Endothelial and Vascular Endothelial Receptor 1) tumour associated macrophages (TAMs) in the tumour microenvironment, converting these highly immunosuppressive M2 macrophages to immune stimulating M1 macrophages. With the ability to switch immune suppression to immune activation in various conditions, bexmarilimab has potential across oncology, infectious diseases and vaccine development. Currently in phase I/II clinical development as a potential therapy for patients with untreatable solid tumours, bexmarilimab has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules. Traumakine is an investigational intravenous (IV) interferon beta-1a therapy for the treatment of acute respiratory distress syndrome (ARDS) and other ischemic or hyperinflammatory conditions. In addition to its profound antiviral effect, Traumakine upregulates the cell surface protein Cluster of Differentiation 73 (CD73), an enzyme that suppresses pro-inflammatory responses in endothelial cells. Using an IV administration of interferon beta-1a provides optimal exposure to the lung vasculature, increasing protection against serious lung complications and helping to prevent vascular leakage by enhancing endothelial barrier function. Traumakine is currently being evaluated in global trials as a potential treatment for hospitalised patients with COVID-19. As part of a working relationship established with Faron, the 59th Medical Wing of the US Air Force and the US Department of Defense are also evaluating Traumakine’s role in preventing multiple organ dysfunction syndrome (MODS) after ischemia-reperfusion injury caused by a major trauma.  Faron is based in Turku, Finland. Further information is available at www.faron.com.

About the European Innovation Council Fund

Established in June 2020, the European Innovation Council (“EIC“) Fund is a breakthrough initiative of the Commission to make direct equity and quasi-equity investments (between €500.000 and €15 million) in the capital of start-ups and SMEs. The EIC Fund aims to fill a critical financing gap faced by innovative companies when bringing their technologies to the commercialisation stage. The Fund helps to fill this financing gap at the start-up stage where the EU venture capital market still underperforms compared to the global venture capital market. Its main purpose is not to maximise the return on the investments, but to have a high impact by accompanying companies with breakthrough and disruptive technologies in their growth as patient capital investor.

IMPORTANT INFORMATION

Market Abuse Regulation

Market soundings, as defined in Regulation (EU) No 596/2014 (“MAR“), were taken in respect of the proposed Placing with the result that certain persons became aware of inside information, as permitted by MAR. That inside information in relation to the Placing is set out in this announcement and has been disclosed as soon as possible in accordance with paragraph 7 of article 17 of MAR. Therefore, those persons that received inside information in such market sounding are no longer in possession of inside information relating to the Company and its securities.

This announcement contains inside information for the purposes of Article 7 of MAR and Article 7 of UK MAR.

MiFID II

Solely for the purposes of the product governance requirements contained within: (a) EU Directive 2014/65/EU on markets in financial instruments, as amended (“MiFID II“); (b) Articles 9 and 10 of Commission Delegated Directive (EU) 2017/593 supplementing MiFID II; and (c) local implementing measures (together, the “MiFID II Product Governance Requirements“), and disclaiming all and any liability, whether arising in tort, contract or otherwise, which any “manufacturer” (for the purposes of the MiFID II Product Governance Requirements) may otherwise have with respect thereto, the Placing Shares have been subject to a product approval process, which has determined that the Placing Shares are: (i) compatible with an end target market of: (a) retail investors, (b) investors who meet the criteria of professional clients and (c) eligible counterparties (each as defined in MiFID II); and (ii) eligible for distribution through all distribution channels as are permitted by MiFID II (the “Target Market Assessment“). Notwithstanding the Target Market Assessment, distributors should note that: the price of the Placing Shares may decline and investors could lose all or part of their investment; the Placing Shares offer no guaranteed income and no capital protection; and an investment in the Placing Shares is compatible only with investors who do not need a guaranteed income or capital protection, who (either alone or in conjunction with an appropriate financial or other adviser) are capable of evaluating the merits and risks of such an investment and who have sufficient resources to be able to bear any losses that may result therefrom. The Target Market Assessment is without prejudice to the requirements of any contractual, legal or regulatory selling restrictions in relation to the offer.

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”, ”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 addition, other factors which could cause actual results to differ materially include the ability of the Company to successfully licence its programmes, 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.

Release

Proposed Issue and Placing of Shares

THIS ANNOUNCEMENT AND THE INFORMATION CONTAINED HEREIN IS RESTRICTED AND IS NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN, INTO OR FROM THE UNITED STATES, AUSTRALIA, CANADA, JAPAN, THE REPUBLIC OF SOUTH AFRICA, SINGAPORE, HONG KONG OR ANY OTHER JURISDICTION IN WHICH SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL.

THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF THE EU REGULATION 596/2014 (“MAR”) AND ARTICLE 7 OF MAR AS INCORPORATED INTO UK DOMESTIC LAW BY VIRTUE OF THE EUROPEAN UNION (WITHDRAWAL) ACT 2018 (“UK MAR”).

MEMBERS OF THE PUBLIC ARE NOT ELIGIBLE TO SUBSCRIBE FOR, OTHERWISE ACQUIRE OR DISPOSE OF ANY SECURITIES IN FARON PHARMACEUTICALS OY (“FARON”) PURSUANT TO THE PROPOSED TRANSACTION REFERRED TO IN THIS ANNOUNCEMENT. THIS ANNOUNCEMENT IS THEREFORE DIRECTED ONLY AT, IN A MEMBER STATE OF THE EUROPEAN ECONOMIC AREA, PERSONS WHO ARE “QUALIFIED INVESTORS” AS DEFINED IN ARTICLE 2(E) OF THE EU PROSPECTUS REGULATION (WHICH MEANS REGULATION (EU) 2017/1129) (THE “PROSPECTUS REGULATION”). THIS ANNOUNCEMENT IS FOR INFORMATION PURPOSES ONLY AND DOES NOT CONSTITUTE OR CONTAIN ANY INVITATION, SOLICITATION, RECOMMENDATION, OFFER OR ADVICE TO ANY PERSON TO SUBSCRIBE FOR, OTHERWISE ACQUIRE OR DISPOSE OF ANY SECURITIES IN FARON OR ANY OTHER ENTITY IN ANY JURISDICTION IN WHICH ANY SUCH OFFER WOULD BE UNLAWFUL.

IN ADDITION, IN THE UNITED KINGDOM, THIS ANNOUNCEMENT IS ONLY DIRECTED AT PERSONS IN THE UNITED KINGDOM THAT ARE QUALIFIED INVESTORS WITHIN THE MEANING OF ARTICLE 2(E) OF THE PROSPECTUS REGULATION AS INCORPORATED INTO UK DOMESTIC LAW BY VIRTUE OF THE EUROPEAN UNION (WITHDRAWAL) ACT 2018 THAT ARE ALSO (I) INVESTMENT PROFESSIONALS FALLING WITHIN ARTICLE 19(5) OF THE FINANCIAL SERVICES AND MARKETS ACT 2000 (FINANCIAL PROMOTION) ORDER 2005 (THE “ORDER”) AND/OR (II) HIGH NET WORTH ENTITIES, AND OTHER PERSONS TO WHOM IT MAY LAWFULLY BE COMMUNICATED, FALLING WITHIN ARTICLE 49(2)(A) TO (E) OF THE ORDER (EACH SUCH PERSON, TOGETHER WITH QUALIFIED INVESTORS AS DEFINED IN THE PROSPECTUS REGULATION, BEING REFERRED TO AS A “RELEVANT PERSON”).

ACCORDINGLY, THIS ANNOUNCEMENT AND ITS CONTENTS MUST NOT BE ACTED ON OR RELIED ON BY PERSONS WHO ARE NOT RELEVANT PERSONS. ANY INVESTMENT OR INVESTMENT ACTIVITY TO WHICH THIS ANNOUNCEMENT RELATES IS AVAILABLE ONLY TO RELEVANT PERSONS AND WILL BE ENGAGED IN ONLY WITH RELEVANT PERSONS. PERSONS INTO WHOSE POSSESSION THIS ANNOUNCEMENT COMES ARE REQUIRED TO INFORM THEMSELVES ABOUT AND TO OBSERVE ANY SUCH RESTRICTIONS.

THE PROPOSED TRANSACTION REFERRED TO IN THIS ANNOUNCEMENT WOULD BE MADE PURSUANT TO A PRIVATE PLACEMENT EXEMPTION UNDER THE PROSPECTUS REGULATION FROM THE REQUIREMENTS TO PRODUCE A PROSPECTUS UNDER THE PROSPECTUS REGULATION FOR OFFERS OF SECURITIES. FARON HAS NOT TAKEN ANY ACTION, NOR WILL IT TAKE ANY ACTION, TO OFFER ANY OF THE PLACING SHARES THAT ARE TO BE SUBSCRIBED FOR PURSUANT TO THE TRANSACTION REFERRED TO IN THIS ANNOUNCEMENT OR ANY DOCUMENTS RELATING TO THE PLACING TO THE PUBLIC IN FINLAND, SWEDEN, NORWAY OR DENMARK, OR IN ANY OTHER JURISDICTION IN ANY FORM WHICH WOULD CONSTITUTE AN OFFER TO THE PUBLIC.

THE PLACING SHARES WILL NOT BE REGISTERED UNDER THE UNITED STATES SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), OR UNDER THE SECURITIES LAWS OF ANY STATE OR OTHER JURISDICTION OF THE UNITED STATES, AND MAY NOT BE OFFERED, SOLD OR TRANSFERRED, DIRECTLY OR INDIRECTLY, IN OR INTO OR FROM THE UNITED STATES EXCEPT PURSUANT TO AN EXEMPTION FROM, OR IN A TRANSACTION NOT SUBJECT TO, THE REGISTRATION REQUIREMENTS OF THE SECURITIES ACT AND IN COMPLIANCE WITH ANY APPLICABLE SECURITIES LAWS OF ANY STATE OR OTHER JURISDICTION OF THE UNITED STATES. THE PLACING SHARES HAVE NOT BEEN APPROVED OR DISAPPROVED BY THE US SECURITIES AND EXCHANGE COMMISSION, ANY STATE SECURITIES COMMISSION OR OTHER REGULATORY AUTHORITY IN THE UNITED STATES, NOR HAVE ANY OF THE FOREGOING AUTHORITIES PASSED UPON OR ENDORSED THE MERITS OF THE PLACING OR THE ACCURACY OR ADEQUACY OF THIS ANNOUNCEMENT. ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENCE IN THE UNITED STATES.

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

Proposed Issue and Placing of Shares to raise approximately EUR 15 million

Company announcement, 11 February 2021 at 4:30 p.m. GMT / 6:30 p.m. EET

Inside information

TURKU – FINLAND – Faron Pharmaceuticals Oy (First North: FARON, AIM: FARN), the clinical stage biopharmaceutical company, today announces a proposed private placement of new ordinary shares (“Placing Shares”) to raise approximately EUR 15 million before expenses to a limited number of institutional investors (“Placing”). Swedbank AB (publ), Finnish Branch (“Swedbank”) is acting as sole bookrunner and financial adviser to the Company for the Placing in association with Kepler Cheuvreux S.A.

The Placing will be conducted in a private placement by way of an accelerated book-building process in which selected investors may submit bids for the Placing Shares (the “Bookbuild”). The subscription price per Placing Share is to be determined on the basis of the bids received in the Bookbuild. The Bookbuild is expected to commence immediately following this announcement and is expected to end by 9:00 a.m. EET on 12 February 2021 at the latest. The Bookbuild may be discontinued at any time during the book-building process. Following the close of the Bookbuild, the Board of Directors of Faron (the “Board“) will make the decision on the issue of the Placing Shares, including, as applicable, acceptance of the received bids, the number of Placing Shares to be issued and the subscription price per Placing Share (the “Issue Price“). The Company has received non-binding indications of interest from potential investors to subscribe for the Placing Shares under the Placing during a pre-marketing process. In addition, the Company and Swedbank have obtained from the European Innovation Council (EIC) Fund (“EIC”) a binding and irrevocable pre-commitment to subscribe for one third (1/3) of the Placing Shares for an aggregate amount of maximum EUR 10 million and minimum EUR 3 million. EIC’s pre-commitment is subject to certain customary conditions.

As soon as practicable after the close of the Bookbuild, and following receipt of binding commitments from investors, an announcement will be made on the final number of the Placing Shares to be issued and the Issue Price as well as the expected registration date of the Placing Shares.

Further details on the terms and conditions of the Placing are set out below.

The Placing Shares are expected to be issued and admitted to trading on Nasdaq First North Growth Market Finland (“First North”) and AIM (“AIM”) in London as set out below.

KEY HIGHLIGHTS

  • A proposed private placement to raise approximately EUR 15 million conducted by way of an accelerated book-building, directed to a limited number of institutional and other investors, in which Swedbank uses reasonable endeavours to procure subscriptions for Placing Shares.
  • EIC has provided a binding and irrevocable pre-commitment to subscribe for one third (1/3) of the Placing Shares for an aggregate amount of maximum EUR 10 million and minimum EUR 3 million, subject to certain conditions.
  • The net proceeds of the Placing would be primarily used for the expansion of the bexmarilimab clinical development programme and manufacturing. Some proceeds would also be used to support the clinical development of TraumakineÒ and its new manufacturing process, and in strengthening the balance sheet.
  • As information not disclosed earlier, the cash balance held by the Company as of 31 December 2020 was ca. €4.1 million.
  • Swedbank acts as Lead Manager and Sole Bookrunner of the Placing and Financial Adviser to the Company in association with Kepler Cheuvreux.

Dr Markku Jalkanen, Chief Executive Officer of Faron, said: “We have continued to accelerate the clinical development of both of our lead pipeline programs, bexmarilimab and traumakine, over recent months and we are continually gaining valuable insights into these promising immunotherapy candidates. It is a significant achievement to  have the support from the European Innovation Council (EIC),  firstly in the form of a grant in summer 2020 and now with the pre-commitment,  which is EIC’s first investment in a publicly listed company.  This fundraise will enable us to continue driving our two clinical programmes forward. I am looking forward to providing further updates over the coming months.” 

REASONS FOR THE PROPOSED PLACING

The Faron pipeline has advanced significantly during the last 12-18 months. This pipeline development on both key projects (bexmarilimab and Traumakine) provides an opportunity to build further value for shareholders. The recent external support for Traumakine’s HIBISCUS study from the US Department of Defense (DoD) allows the Company to focus on the design of new pivotal bexmarilimab clinical trials, which could be accelerated with further resources. This additional data generation, especially to support bexmarilimab’s expansion into new combination studies in lung cancer and acute myeloid leukaemia, together with any MATINS study cancer cohorts (hard-to-treat-solid tumours) will allow full realisation of the potential upside connected to these projects. Part of this development includes establishing a Company unit in the US (Boston) to handle the increasing US activities (FDA and clinical site interactions) that the pipeline development requires.

The primary reason for conducting the Placing is to accelerate and expand the clinical development of the Company’s main drug candidates, bexmarilimab and Traumakine (intravenous interferon beta).

Bexmarilimab

  • testing higher frequency of dosing to investigate potential for enhanced clinical responses;
  • three new trials to study bexmarilimab treatment in a neoadjuvant setting, in combination with a PD(L)-1 checkpoint inhibitor and in haematological malignancies; and
  • continuation of the MATINS trial, where five solid tumour cohorts have demonstrated early signs of clinical benefit in the first two stages (Part I and II) of the study.

Traumakine

  • launch of the phase II/III HIBISCUS study in the US; and
  • prepararations to expand into additional clinical indications. 

General corporate

  • establishment of an operational unit in the US;
  • investment in the manufacturing of both bexmarilimab and intravenous interferon beta; and
  • strengthening of the Company’s balance sheet. 

DETAILS OF THE PROPOSED PLACING AND ISSUE OF EQUITY

The proposed Placing is being carried out within the authorisation granted to the Board by shareholders at the Company’s Annual General Meeting held on 18 May 2020 to issue up to a total of 8,650,000 ordinary shares in the Company in a directed share issue and in deviation from the shareholders’ pre-emptive rights. As no shares have been issued within the outstanding authority, the Company may issue up to a maximum of 8,650,000 new ordinary shares pursuant to the Placing, which represents approximately 18.4 per cent of all the issued shares and votes in the Company immediately prior to the Placing.

The Placing, arranged by Swedbank in association with Kepler Cheuvreux, will be conducted in a private placement by way of the Bookbuild, which is an accelerated book-building process in which selected investors may submit bids for the Placing Shares. The Issue Price is to be determined on the basis of the bids received in the Bookbuild. The Bookbuild is expected to commence immediately following this announcement and is expected to end by 9:00 EET a.m. on 12 February 2021 at the latest. The Bookbuild may be discontinued at any time during the book-building process. Following the close of the Bookbuild, the Board will make the decision on the issue of the Placing Shares, including, as applicable, acceptance of the received bids, the number of Placing Shares to be issued and the Issue Price. As soon as practicable after the close of the Bookbuild, receipt of binding commitments from investors and the Board having resolved on carrying out the Placing, an announcement will be made on the final outcome of the Bookbuild and, as applicable, the number of the Placing Shares to be issued and the Issue Price as well as the expected registration date of the Placing Shares.

In connection with the proposed Placing, the Company has entered into a placing agreement with Swedbank (the “Placing Agreement“). Pursuant to the terms of the Placing Agreement, Swedbank has agreed to use its reasonable endeavours to procure the subscription of Placing Shares. In addition, the Company and Swedbank have obtained a binding and irrevocable pre-commitment from EIC to subscribe for one third (1/3) of the total amount of the Placing Shares for an aggregate amount of maximum EUR 10 million and minimum EUR 3 million. EIC’s pre-commitment is subject to certain customary conditions.

The Placing Agreement contains customary warranties and an indemnity from the Company in favour of Swedbank together with provisions which enable Swedbank to terminate the Placing Agreement in certain circumstances before the completion of the Bookbuild and the Board’s resolution on carrying out the Placing, including where there has been a material breach of any of the warranties contained in the Placing Agreement or where there is a material adverse change, e.g., in the business or financial affairs of the Company. The Company has agreed to pay Swedbank certain commissions and fees in connection with the Placing. Pursuant to the terms of the Placing Agreement, Swedbank has agreed to a limited settlement underwriting covering payments of the subscription prices to be made by subscribers of the Placing Shares to the Company upon the Board having resolved on carrying out the Placing after the close of the Bookbuild, on the Issue Price, on approving the binding subscriptions received through the Bookbuild and on confirming such final number of the Placing Shares.

 The Placing is conditional upon, inter alia:

·     the Placing Agreement having become unconditional in all respects;

·     binding commitments being received from investors;

·     the Board resolving to carry out the Placing at the Issue Price and the Company and Swedbank entering into a separate pricing agreement confirming the Issue Price and the number of the Placing Shares; and

·     the Placing Shares being issued and being registered with the Finnish Trade Register.

In connection with the Placing, Faron has entered into a lock-up undertaking, under which it has, subject to certain exceptions, agreed not to issue or sell any shares in Faron for a period of ninety days after the closing of the Placing.

Subject to all conditions being met, the Placing Shares are expected to be entered in the Finnish Trade Register approximately on 12 February 2021.

ISSUE OF THE PLACING SHARES AND ADMISSION TO TRADING

Subject to all conditions being met and the Placing Shares being subscribed for, the Placing Shares are expected to be issued in one tranche. To the extent shares are subscribed for and subject to all conditions being met, application will then be made for the admission of the Placing Shares to trading on First North and AIM with said admission expected to become effective and trading to commence on or around 16 February 2021 (the “Admission“). The dates above may be subject to change.

A further announcement will be made to confirm the outcome of the Placing (subject to, inter alia, satisfaction of the above conditions) and to confirm the expected timing of issue of the Placing Shares and the Admission.

Upon registration with the Finnish Trade Register, the Placing Shares will rank pari passu in all respects with the existing shares of the Company.

NOTE REGARDING THE COMPANY’S FINANCIAL REPORTING IN 2021

The Company will publish its Financial Statement Release and its Annual Report 2020 (including financial statements) on 25 March 2021.

For more information please contact:

Faron Pharmaceuticals Oy

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com

Swedbank AB (publ), Finnish Branch, Financial Adviser

Mika Karikoski (Corporate Finance)

Phone: +358 (0)40 741 6959

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner, Mark Rogers

Phone: + 44 207 213 0880

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 40 555 4727

Jukka Järvelä

Phone: +358 50 553 8990

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

Julie Seidel

Phone: +1 (212) 362-1200

E-mail: 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. Bexmarilimab is its investigative precision immunotherapy with the potential to provide permanent immune stimulation for difficult-to-treat cancers through targeting myeloid function. A novel anti-Clever-1 humanised antibody, bexmarilimab targets Clever-1 positive (Common Lymphatic Endothelial and Vascular Endothelial Receptor 1) tumour associated macrophages (TAMs) in the tumour microenvironment, converting these highly immunosuppressive M2 macrophages to immune stimulating M1 macrophages. With the ability to switch immune suppression to immune activation in various conditions, bexmarilimab has potential across oncology, infectious diseases and vaccine development. Currently in phase I/II clinical development as a potential therapy for patients with untreatable solid tumours, bexmarilimab has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules. Traumakine is an investigational intravenous (IV) interferon beta-1a therapy for the treatment of acute respiratory distress syndrome (ARDS) and other ischemic or hyperinflammatory conditions. In addition to its profound antiviral effect, Traumakine upregulates the cell surface protein Cluster of Differentiation 73 (CD73), an enzyme that suppresses pro-inflammatory responses in endothelial cells. Using an IV administration of interferon beta-1a provides optimal exposure to the lung vasculature, increasing protection against serious lung complications and helping to prevent vascular leakage by enhancing endothelial barrier function. Traumakine is currently being evaluated in global trials as a potential treatment for hospitalised patients with COVID-19. As part of a working relationship established with Faron, the 59th Medical Wing of the US Air Force and the US Department of Defense are also evaluating Traumakine’s role in preventing multiple organ dysfunction syndrome (MODS) after ischemia-reperfusion injury caused by a major trauma.  Faron is based in Turku, Finland. Further information is available at www.faron.com.

Aboutthe European Innovation CouncilFund

Established in June 2020, the European Innovation Council (“EIC”) Fund is a breakthrough initiative of the Commission to make direct equity and quasi-equity investments (between €500.000 and €15 million) in the capital of start-ups and SMEs. The EIC Fund aims to fill a critical financing gap faced by innovative companies when bringing their technologies to the commercialisation stage. The Fund helps to fill this financing gap at the start-up stage where the EU venture capital market still underperforms compared to the global venture capital market. Its main purpose is not to maximise the return on the investments, but to have a high impact by accompanying companies with breakthrough and disruptive technologies in their growth as patient capital investor.

IMPORTANT INFORMATION

Market Abuse Regulation

Market soundings, as defined in Regulation (EU) No 596/2014 (“MAR“), were taken in respect of the proposed Placing with the result that certain persons became aware of inside information, as permitted by MAR. That inside information in relation to the Placing is set out in this announcement and has been disclosed as soon as possible in accordance with paragraph 7 of article 17 of MAR. Therefore, those persons that received inside information in such market sounding are no longer in possession of inside information relating to the Company and its securities.

This announcement contains inside information for the purposes of Article 7 of MAR and Article 7 of UK MAR.

MiFID II

Solely for the purposes of the product governance requirements contained within: (a) EU Directive 2014/65/EU on markets in financial instruments, as amended (“MiFID II“); (b) Articles 9 and 10 of Commission Delegated Directive (EU) 2017/593 supplementing MiFID II; and (c) local implementing measures (together, the “MiFID II Product Governance Requirements“), and disclaiming all and any liability, whether arising in tort, contract or otherwise, which any “manufacturer” (for the purposes of the MiFID II Product Governance Requirements) may otherwise have with respect thereto, the Placing Shares have been subject to a product approval process, which has determined that the Placing Shares are: (i) compatible with an end target market of: (a) retail investors, (b) investors who meet the criteria of professional clients and (c) eligible counterparties (each as defined in MiFID II); and (ii) eligible for distribution through all distribution channels as are permitted by MiFID II (the “Target Market Assessment“). Notwithstanding the Target Market Assessment, distributors should note that: the price of the Placing Shares may decline and investors could lose all or part of their investment; the Placing Shares offer no guaranteed income and no capital protection; and an investment in the Placing Shares is compatible only with investors who do not need a guaranteed income or capital protection, who (either alone or in conjunction with an appropriate financial or other adviser) are capable of evaluating the merits and risks of such an investment and who have sufficient resources to be able to bear any losses that may result therefrom. The Target Market Assessment is without prejudice to the requirements of any contractual, legal or regulatory selling restrictions in relation to the offer.

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”, ”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 addition, other factors which could cause actual results to differ materially include the ability of the Company to successfully licence its programmes, 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.

Release

Update on TRAUMAKINE development

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

  • U.S. Food and Drug Administration (FDA) approval of new HIBISCUS study protocol in patients with COVID-19 infection
  • Company seeking patent protection for the sequential use of IV interferon beta-1a and corticosteroids
  • Pipeline expansion into additional organ protection indications
  • CMC scale-up in progress

Company announcement, 26 January 2021 at 9.00 AM (EET)
Inside information

TURKU – FINLAND – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), the clinical stage biopharmaceutical company, announces that the U.S. Food and Drug Administration (FDA) has approved the Phase II/III HIBISCUS trial assessing Traumakine, Faron’s intravenous (IV) IFN beta-1a, for the treatment of hospitalised patients with COVID-19. In the study Traumakine will be used prior to the current practice of corticosteroids, to prevent systemic inflammatory response syndrome (SIRS) and acute respiratory distress syndrome (ARDS), to improve clinical condition and reduce patient death. The study sponsorship has now been changed to Faron, with Professor Daniel Talmor from Harvard University’s Beth Israel Deaconess Medical Center, as the Principal Investigator.

The mode of action of Traumakine is, in addition to a profound antiviral effect, to upregulate the cell surface protein, Cluster of Differentiation 73 (CD73). SIRS may be caused by both infectious assaults such as COVID-19, influenza and other micro-organisms, as well as noninfectious insults, such as trauma, ischemia-reperfusion injury or burns. SIRS is characterised by early excessive inflammatory cytokine production, initiated by extracellular ATP, a potent mediator of inflammation and thrombosis, which can also lead to vascular dysfunction, capillary leak and thrombosis, ultimately leading to life-threatening multiple organ dysfunction syndrome (MODS).

HIBISCUS study

The Human intravenous Interferon Beta-Ia Safety and preliminary efficacy in hospitalized subjects with CoronavirUS (HIBISCUS) phase II/III study will be conducted in approximately 5-10 study sites across the US in hospitalised patients with COVID-19, who do not yet require mechanical ventilation, but maximally low flow oxygen support. Use of corticosteroids concomitantly with Traumakine is not possible in the study setting but enabled in a sequenced manner after Traumakine. Faron has also applied for new patent protection relating to the induction of CD73 for organ protection, followed by the use of steroids for the treatment of systemic inflammation. Hence, the best effects of both drugs are optimised in a sequence for patient benefit.

The study will recruit 140 hospitalised COVID-19 patients with 1:1 randomisation assessing Traumakine against placebo with a primary endpoint of clinical status (WHO 9-point ordinal scale) at day 14. Secondary endpoints are clinical status at day 28, and in-hospital mortality at day 28 and day 90. The study protocol will have an interim analysis once 70 trial subjects have been assessed for the primary efficacy endpoint (clinical status at day 14). A further assessment of the conditional power will also be conducted in the interim analysis based on the observed result and the sample size will be adjusted accordingly, allowing completion of the study with confidence for regulatory compliance.

Dr. Markku Jalkanen, Faron’s CEO, said: “We are pleased to have received approval from the FDA to commence our phase II/III HIBISCUS trial of intravenous IFN beta-1a in COVID-19 patients. IFN beta-1a has previously demonstrated a compelling scientific rationale as the body’s first line of defense against viral infections and might be advantageous over current standard of care when given intravenously to patients suffering from COVID-19 induced ARDS. This trial will allow us to gain important insights into Traumakine’s potential in this particular setting and we believe that this sequential administration of intravenous interferon beta, before corticosteroids, could become a standard of care in the future and as such have filed a patent application to protect the commercial opportunity.

“There have been no innovative new drugs in the field of emergency care for decades and it remains a highly underserved area of medicine in respect to therapeutics.  We strongly believe that vital organs can be better protected by the induction of CD73 and so we are pleased to be continuing the development of Traumakine through a number of important trials and collaborations. As such, we are continuing to scale up our manufacturing process with AGC Biologics as we work to create a new, state of the art manufacturing facility for Traumakine.”

Collaboration with US Department of Defense to explore additional organ protection indications

As previously communicated, the U.S. Department of Defense (“DoD”) has selected the HIBISCUS Study to receive $6.1 million of funding from the Coronavirus Aid, Relief, and Economic Security (CARES) Act. As part of a working relationship established with Faron, the 59th Medical Wing of the US Air Force and the DoD will continue primate studies to evaluate Traumakine’s role in preventing multiple organ dysfunction syndrome (MODS) after ischemia-reperfusion injury caused by a major trauma.

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

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner, Mark Rogers

Phone. +44 207 213 0880           

Panmure Gordon (UK) Limited, Broker

Rupert Dearden

Phone: +44 207 886 2500           

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 55 38 990

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

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 (bexmarilimab), its investigative 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 is currently being tested in several Phase III studies around the world against COVID-19. Traumakine is intravenous IFN beta-1a, which is a strong anti-viral and anti-inflammatory agent. 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.

Bexmarilimab (Clevegen) development update

  • Cholangiocarcinoma becomes fifth tumour cohort to show early signs of efficacy
  • Increased bexmarilimab dosing schedule and high baseline regulatory T cell count associated with clinical benefit
  • High levels of soluble Clever-1 observed in MATINS patients
  • Soluble Clever-1 has the capacity to suppress T cell activation
  • Increased bexmarilimab dosing frequency to counter high levels of soluble Clever-1 underway

 

Company announcement, 20 January 2021 at 9.00 AM PM (EEST)

Insider information
 

TURKU, FINLAND – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), a clinical stage biopharmaceutical company, today announces new observations from its ongoing MATINS trial and an update on the study.

The phase I/II MATINS clinical trial is investigating the tolerability, safety and preliminary efficacy of bexmarilimab, Faron’s wholly-owned novel precision cancer immunotherapy targeting Clever-1, a receptor known to be expressed on immunosuppressive macrophages in the tumour microenvironment.

Working with Kaiku Health Ltd (“Kaiku”), a health data science company (www.kaikuhealth.com), Faron is using Kaiku’s artificial intelligence platform designed to analyse patient outcomes following treatment with cancer immunotherapies to undertake further efficacy analysis of patient data from Part I of the MATINS trial. This platform provides insight through data analyses of the immunological and disease characteristics of the MATINS patients to better define patients who respond to bexmarilimab and should enable further refinement of bexmarilimab’s clinical development. 

Latest scientific observations from the trial include the identification of a new role for soluble Clever-1, related to its capacity to control T-cell activation. This suggests that the inactivation of Clever-1 as an immune suppressive molecule could be even broader and more important than previously thought as the immune-stimulating effects are not only limited to tumour associated macrophages (TAM) but may also act systemically.

Dr. Markku Jalkanen, Faron’s CEO, said: “I am extremely happy about these results and wish to thank our team, our scientific network and the MATINS clinical group for the impressive work they have done, both progressing the trial and undertaking complex analyses of the data during challenging times in the face of the current pandemic. Never during my career have I seen that a high baseline count of regulatory T cells (Tregs) predicts a good response to a therapy. Until now, it has always been the opposite. This is remarkable. Such observations now provide us with a much better understanding of the next steps required for bexmarilimab’s clinical development in pivotal studies and support its potential as a breakthrough therapy to deliver optimal clinical results in patients with hard to treat cancers.

“The new discovery of the role of soluble Clever-1 as an immune suppressive molecule is striking, indicating the soluble part of this receptor could cause systemic inhibition of T-cells in all locations of body, therefore controlling the general immune capacity in cancer patients. We hope to be able to overcome this inhibition just by increasing the dosing frequency of bexmarilimab to provide maximal binding and the removal of Clever-1 from body fluids and tissues, including tumours.” 

 

Data details

Five solid tumour types showing early signs of efficacy

As previously communicated, four solid tumour cohorts in the first expansion stage (Part II) of the study (cutaneous melanoma, colorectal cancer (CRC), hepatocellular cancer and ovarian cancer) have demonstrated early signs of clinical efficacy from bexmarilimab therapy. This group is now joined by cholangiocarcinoma (also known as bile duct cancer) as a fifth responsive tumour cohort. The exact way how these cohorts will be taken forward into the protocol for Part III of the MATINS trial will be decided in Q3-2021 after further data on the effect of increased dosing frequency is available (recruitment currently ongoing). More frequent dosing either weekly or at two week intervals could increase bexmarilimab treatment efficacy further, compared to the original dosing interval of every three weeks, which has already led to some very promising results in several advanced cancer types.

Regulatory T cell (Treg) marker FOXP3 and increased bexmarilimab dosing associated with increased clinical benefit

Part I MATINS study patients had received a median of three previous cancer treatments (mainly various chemotherapy combinations). Half of the study patients had received four or more lines of therapy before joining the MATINS study. Patient blood samples have indicated reduced immune capacity reflected in low counts of effector immune cells. To better understand patient outcomes after bexmarilimab treatment around 50 biomarkers have now been analysed using Kaiku’s Immuno-Oncology platform resulting in the following findings:

  • Increased bexmarilimab dosing level with three week interval was associated with a clinical response

  • High baseline count of Treg cell marker FOXP3 was associated with a clinical response

These findings are consistent with the Company’s previous findings and understanding that cellular immune activation and the removal of immunosuppressive elements are required for clinical benefit from bexmarilimab. The association of clinical benefit in patients with a high baseline count of Tregs indicates that patients were significantly immunosuppressed before the treatment. In these subjects, removal of immunosuppression using bexmarilimab to inactivate Clever-1 positive myeloid cells could therefore result in removal of Tregs known to be supported by macrophages. The Company believes that increased dosing frequency has the potential to produce more complete inactivation of Clever-1, either expressed on the surface of myeloid cells or circulating in blood and lymph as a soluble immunosuppressive molecule.

Cancer patient plasma can contain significant amounts of soluble Clever-1

The transient Clever-1 receptor occupancy observed in all MATINS Part I dose levels (0.1-10 mg/kg) supports the decision to increase dosing frequency from every three weeks to either weekly or two week intervals. Latest data show that MATINS patients’ plasma (blood devoid of cells) could contain up to a 10-fold increased level of soluble Clever-1 compared to healthy controls. These elevated values could explain the rapid uptake of bexmarilimab in cancer patients. This finding also supports the potential of higher administration frequency, which is currently ongoing in CRC patients, with first results expected in H1-2021.

Soluble Clever-1 has the capacity to suppress T cell activation

The role of increased soluble Clever-1 in the circulation was tested in experimental settings. The most interesting finding from this experimental work elucidated a new role for Clever-1:  it can control T cell activation directly, including naïve T cells. This is a significant finding because it proposes that by producing soluble Clever-1 the malignant process can also suppress T cell activation in remote locations and, by targeting naïve T cells, can prevent expansion of the T cell repertoire. Soluble Clever-1 can therefore be a substantial inhibitor of T cell activating therapies.

A new patent application has been filed seeking global protection for these findings and related applications.

The observations detailed in this statement are being prepared for peer-reviewed publication and/or presentation at future scientific congresses.

 

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

About bexmarilimab

Bexmarilimab is Faron’s investigative precision immunotherapy, 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.

 

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 bexmarilimab in ten selected metastatic or inoperable solid tumours – cholangiocarcinoma, colorectal cancer, cutaneous melanoma, ER+ breast cancer, gastric cancer, hepatocellular carcinoma, ovarian cancer, uveal melanoma, pancreatic cancer and anaplastic thyroid carcinoma – all known to host a significant number of Clever-1 positive tumour associated macrophages (TAM).

Part I of the trial dealt 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 is focused on identifying patients who show an increased number of Clever-1 positive tumour macrophages and the safety and efficacy of the treatment. 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.

 

For more information please contact:

 

Faron Pharmaceuticals Oy

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com

 

Cairn Financial Advisers LLP, Nomad
Sandy Jamieson, Jo Turner, Mark Rogers
Phone: +44 207 213 0880   

 

Panmure Gordon (UK) Limited, Broker

Rupert Dearden

Phone: +44 207 886 2500

 

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

 

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

Julie Seidel, Naina Zaman

Phone: +1 212 362 1200

E-mail: faron@sternir.com
 

 

About Faron Pharmaceuticals Oy

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 the immune response in oncology and organ damage. Clevegen (bexmarilimab), its investigative 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 is currently being tested in several Phase III studies around the world against COVID-19. Traumakine is intravenous IFN beta-1a, which is a strong anti-viral and anti-inflammatory agent. 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.

Release

US Department of Defense (DoD) to support TRAUMAKINE development

· The DoD grants $6.1 million for the HIBISCUS study
· Faron and the US Air Force to explore Traumakine’s wider potential to prevent multi-organ failure after ischemia and reperfusion

Company announcement, 18 January 2021 at 9.00 AM (EET)
Inside information
 

TURKU – FINLAND – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), the clinical stage biopharmaceutical company, today announces that the US Department of Defense (“DoD”) has selected the HIBISCUS Study to receive $6.1 million of funding from the Coronavirus Aid, Relief, and Economic Security (CARES) Act. The Phase II/III HIBISCUS trial will assess Traumakine, Faron’s IV IFN beta-1a, for the treatment of hospitalized COVID-19 patients in the US.

The $6.1 million funding support for HIBISCUS requires final contracting between Faron and DoD’s designated military unit, the 59th Medical Wing of the US Air Force, and is under preparation. Faron has already established a working relationship with the 59th Medical Wing and US Army Institute of Surgical Research to explore the use of Traumakine for organ protection in combat wounds leading to multi-organ failure from ischemia and reperfusion.

Dr. Markku Jalkanen, Faron’s CEO, said: “IFN beta-1a has previously demonstrated a compelling argument as the body’s first line of defence against viral infection. Deficiency of either IFN beta or the activation of its receptor (IFNAR) have been associated with severe COVID-19 and poor outcome. This validation from the DoD represents important progress for both our science and intravenous IFN beta as a potential treatment for severe COVID-19 patients. We look forward to working with the  DoD, 59th Medical Wing of the Air Force, University of Colorado Medical School Anschutz Campus and Harvard to fight COVID-19 and protect central organs.”

Traumakine also continues to be investigated in the ongoing global REMAP-CAP (Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community-Acquired Pneumonia) trial, which is evaluating potential treatments for community-acquired pneumonia, including in COVID-19 patients, and is currently ongoing across more than 200 sites and 19 countries.

 

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

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner, Mark Rogers

Phone. +44 207 213 0880            

 

Panmure Gordon (UK) Limited, Broker

Rupert Dearden

Phone: +44 207 886 2500            

 

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 55 38 990

 

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

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 (bexmarilimab), its investigative 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 is currently being tested in several Phase III studies around the world against COVID-19. Traumakine is intravenous IFN beta-1a, which is a strong anti-viral and anti-inflammatory agent. 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.

Release

Faron to Present at H.C. Wainwright BioConnect

TURKU – FINLAND, January 4, 2021 – Faron Pharmaceuticals Ltd (“Faron”) (LON: FARN), the clinical stage biopharmaceutical company, today announced that Dr. Markku Jalkanen, Chief Executive Officer of Faron Pharmaceuticals, will present in a pre-recorded presentation at the virtual H.C. Wainwright BioConnect Conference that will be available on-demand starting Monday, January 11, 2021 at 6:00 a.m. ET.

An audio webcast of the presentations will be available in the “Investors” section on Faron’s website at https://www.faron.com/investors

ENDS

For more information please contact:

Stern Investor Relations, Inc.

Julie Seidel, Naina Zaman
Phone: +(1)212 362 1200
Email: faron@sternir.com

 

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 (bexmarilimab), its investigative 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 is currently being tested in several Phase III studies around the world against COVID-19. Traumakine is intravenous IFN beta-1a, which is a strong anti-viral and anti-inflammatory agent. Faron is based in Turku, Finland. Further information is available at www.faron.com

Release

Faron’s financial calendar for 2021

Company announcement, 21 December 2020 at 9.00 am (EET)

TURKU – FINLAND – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), the clinical stage biopharmaceutical company, announces the following dates for the Company’s financial reporting in 2021:

25 March    Financial statement release for the full year 2020 and Annual Report 2020 including financial statements for the full year

26 August   Half-year financial report for the period 1 January to 30 June 2021

The annual general meeting is planned to be held on Friday 23 April 2021. A separate stock exchange notice will be issued by Faron’s board of directors to convene the meeting.

 

For more information please contact:

Faron Pharmaceuticals Oy

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner, Mark Rogers

Phone: +44 207 213 0880

 

Panmure Gordon (UK) Limited, Broker

Rupert Dearden

Phone: +44 207 886 2500

 

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

 

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

Email: faron@consilium-comms.com

 

Stern Investor Relations

Julie Seidel, Naina Zaman

Phone: +1 (212) 362-1200

Email: faron@sternir.com

 

About Faron Pharmaceuticals Oy

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® (bexmarilimab), its investigative 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 is currently being tested in several phase III studies around the world against COVID-19. Traumakine® is intravenous IFN beta-1a, which is a strong anti-viral and anti-inflammatory agent. Faron is based in Turku, Finland. Further information is available at www.faron.com.

Release

Presentations at ESMO Immuno-Oncology Virtual Congress build case for CLEVER-1 as a new immune checkpoint target

Data from ongoing PhI/II MATINS trial showcased
Role of myeloid cells in shaping the tumour microenvironment highlighted

Company announcement, 10 December 2020 at 9.00 AM (EET)

TURKU – FINLAND – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), the clinical stage biopharmaceutical company, today announces that two presentations at the European Society of Medical Oncology (ESMO) Immuno-Oncology Virtual Congress 2020 will showcase data from the Company’s PhI/II MATINS study and explore the role of myeloid cells in shaping the tumour microenvironment (TME).

‘CLEVER-1 a new immune checkpoint target with activity in GI cancers’, Thursday 10 December, 15.25 CET:

The ongoing phase I/II MATINS clinical trial is investigating the tolerability, safety and efficacy of bexmarilimab, Faron’s wholly-owned novel precision cancer immunotherapy which targets Clever-1 (Common Lymphatic Endothelial and Vascular Endothelial Receptor 1) positive tumour-associated macrophages (TAMs), converting them from being highly immunosuppressive to  immune-stimulating.

Full data from Part I (dose ranging) of the MATINS trial, to be presented during an educational session by principal investigator Petri Bono, M.D., Ph.D., show bexmarilimab to be well tolerated and demonstrating immune activation and promising clinical anti-tumour activity. The first expansion stage (Part II) of the study across ten different hard-to-treat solid tumour types is ongoing and 87 percent currently recruited.

‘The role of myeloid cells in shaping TME’, Friday 11 December, 15.25 CET:

Tumour-associated myeloid cells, including TAMs, are known to promote tumour growth by favouring tumour cell proliferation and survival, thereby creating  a highly immunosuppressive microenvironment. This characteristic makes them an attractive target for new immunotherapeutic approaches. During her educational session, Professor Maija Hollmén, MediCity, Turku University, Finland, will explore opportunities to overcome the undesired effects of TAMs, including the potential of an immunotherapeutic blockade of Clever-1 to switch immunosuppressive TAMs to immune-stimulating TAMs and induce T-cell activation.

Dr. Markku Jalkanen, Faron’s CEO, said: “Our growing understanding of how the tumour microenvironment shields a cancer from the immune system and fuels its growth makes it a clear target for the next generation of immunotherapies. Everything we are learning about bexmarilimab from its rapidly advancing development programme across a broad range of cancer types gives us continued confidence in the potential of this anti-Clever-1 antibody to activate the immune system and remove T cell exhaustion.”    

For more information on the ESMO Immuno-Oncology Virtual Congress 2020  visit:

https://www.esmo.org/meetings/esmo-immuno-oncology-virtual-congress-2020

About bexmarilimab

Bexmarilimab is Faron’s investigative precision immunotherapy, 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.

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 bexmarilimab in ten selected metastatic or inoperable solid tumours – cholangiocarcinoma, colorectal cancer, cutaneous melanoma, ER+ breast cancer, gastric cancer, hepatocellular carcinoma, ovarian cancer, uveal melanoma, pancreatic cancer and anaplastic thyroid carcinoma – all known to host a significant number of Clever-1 positive tumour associated macrophages (TAM).

Part I of the trial dealt with tolerability, safety and dose escalation to optimise dosing. As the trial is an open label study, the Company expects to report findings as the dosing progresses. The cohort expansion during the current Part II of the trial is focused on identifying patients who show an increased number of Clever-1 positive circulating monocytes and the safety and efficacy of the treatment. 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.

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 (bexmarilimab), its investigative 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 is currently being tested in several Phase III studies around the world against COVID-19. Traumakine is intravenous IFN beta-1a, which is a strong anti-viral and anti-inflammatory agent. Faron is based in Turku, Finland. Further information is available at www.faron.com 

 

For more information please contact:

Faron Pharmaceuticals Oy

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner,  Mark Rogers

Phone. +44 (0)20 7213 0880       

 

Panmure Gordon (UK) Limited, Broker

Rupert Dearden

Phone: +44 (0)20 7886 2500       

 

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 55 38 990

 

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

Julie Seidel

Phone: +1 212 362 1200

Email: julie.seidel@sternir.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.

Release

Faron Pharmaceuticals to Participate in Upcoming Investor Conferences

TURKU – FINLAND, 23 November 2020  – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), the clinical stage biopharmaceutical company, today announced that management will participate in the following virtual investor conferences:

  • 32nd Annual Piper Sandler Virtual Healthcare Conference
    Pre-recorded fireside chat available on-demand starting Monday, 23 November 2020 at 10:00 a.m. ET
     
  • 3rd Annual Evercore ISI HealthCONx Conference
    Fireside Chat on Wednesday, 2 December 2020 at 8:25 a.m. ET

Audio webcasts of the presentations will be available in the “Investors” section on Faron’s website at https://www.faron.com/investors

END

For more information please contact:

 

Stern Investor Relations, Inc.

Julie Seidel, Naina Zaman

Phone: +(1)212 362 1200

Email: faron@sternir.com

 

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 (bexmarilimab), its investigative 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 is currently being tested in several Phase III studies around the world against COVID-19. Traumakine is intravenous IFN beta-1a, which is a strong anti-viral and anti-inflammatory agent. Faron is based in Turku, Finland. Further information is available at www.faron.com 

Release
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