Faron receives grant from Business Finland

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

Faron receives €800,000 grant from Business Finland as part of Cancer IO, Finland’s leading Personalized Health Program

–      Grant will enable state-of-the-art characterization of immunological responses in MATINS trial
–      Clevegen to be studied in experimental combinations with anti-cancer molecules from other consortium members

Company announcement, 11 May 2020 at 12.00 PM (EET)
Inside information

TURKU – FINLAND – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), the clinical stage biopharmaceutical company, announces today that it has joined a Finnish consortium,  Cancer IO, and received an €800,000 grant from Business Finland to conduct detailed, state-of-the-art characterization of the immunological responses seen in cancer patients in the Company’s MATINS trial.

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

As part of the Business Finland backed initiative, Faron will also study Clevegen in combination with other anti-cancer molecules, in experimental settings together with other consortium members. 

Cancer IO is a new cancer immunotherapy-focused €10 million top-level collaborative research and innovation project within Business Finland’s Personalized Health Program. Coordinated by the University of Helsinki, it integrates immuno-oncology (IO) activities at the universities of Helsinki and Turku, three Finnish university hospitals and one central hospital, eight Finnish SMEs, Finnish cancer patient organizations and nine of the largest IO-investing pharmaceutical companies operating in Finland. Cancer IO has been established to drive the creation of a Finnish IO ecosystem and national IO growth strategy, aiming to provide wealth and well-being through disruptive Nordic IO innovations and better care. Faron’s participation in this significant national immuno-oncology effort will include sharing clinical development expertise and samples from ongoing trials, and providing Clevegen for consortium experiments.

Dr. Markku Jalkanen, Faron’s CEO, said: “We are very pleased to join this leading initiative, which will deepen our understanding of Clevegen’s effects during the MATINS trial, enable us to better characterize and understand the immune responses of patients receiving novel treatments, test different therapies in combination with Clevegen in a variety of laboratories and experimental settings, as well as possibly find new leads to take further into development.”

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

For more information please contact:

Faron Pharmaceuticals Oy

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com 

Panmure Gordon (UK) Limited, Nomad and Broker

Emma Earl, Freddy Crossley (Corporate Finance)

James Stearns (Corporate Broking)

Phone: +44 207 886 2500

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen, Jussi Majamaa

Phone: +358 (0)40 555 4727

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

About Faron Pharmaceuticals Ltd

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

Caution regarding forward looking statements

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

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

Update on results of Placing and issue of equity

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.

Faron Pharmaceuticals Oy

Update on results of Placing

and

Issue of Equity

Capitalised terms used in this announcement have the meanings given to them in the announcement made at 4.45 p.m. BST/ 6.45 p.m. EEST on 21 April 2020 regarding the proposed placing of new ordinary shares in the Company (the “Launch Notice“) and the subsequent announcement released at 7.00 a.m. BST/ 9.00 a.m. EEST on 22 April 2020 (“Result Announcement“), unless the context provides otherwise.

Company announcement, 23 April 2020 at 1.00 p.m. BST/ 3.00 p.m. EEST

TURKU – FINLAND– Faron Pharmaceuticals Oy (“Faron” or the “Company“) (First North: FARON, AIM: FARN), the clinical stage biopharmaceutical company, is pleased to announce that following the Launch Notice and the Result Announcement, the proposed UK Placing has been subscribed for in full, in satisfaction of the UK Placee Condition. As a consequence, and conditional on, amongst other things, issue and registration of the Placing Shares, the Company has raised gross proceeds of approximately 14 million (£12.18 million) through the Placing.

The First Issue Shares (comprising 1,892,763 Placing Shares) are expected to be registered with the Finnish Trade Register today, 23 April 2020, and First Admission is expected to occur tomorrow as set out in the Result Announcement. The expected timing for issue, registration and admission to trading of the Second Issue Shares (comprising 950,000 Placing Shares) and the Third Issue Shares (comprising 657,237 Placing Shares) currently remains as set out in the Result Announcement. 

Faron’s enlarged issued number of shares immediately following registration of the First Issue Shares will be 45,183,510 Ordinary Shares with voting rights attached. The Company has no shares in Treasury; therefore upon, and subject to, registration of the First Issue Shares, the total number of voting rights in Faron will be 45,183,510 (the “Enlarged 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 Enlarged Number of Shares and Votes of the Company. Faron’s enlarged issued number of shares immediately following registration of the Second Issue Shares will be 46,133,510 Ordinary Shares with voting rights attached. Faron’s enlarged issued number of shares immediately following registration of the Third Issue Shares will be 46,790,747 Ordinary Shares with voting rights attached.

Exchange rate

Unless otherwise specified, this notice contains certain translations of euros into amounts in pounds sterling for the convenience of the reader based on the exchange rate of €1 = £0.87, being the published exchange rate by the European Central Bank at the close of business on 20 April 2020 (the latest practicable date prior to the date of the Launch Notice) rounded to 2 decimal places.

For more information please contact:

Faron Pharmaceuticals Oy

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com 

Carnegie Investment Bank AB, Financial Adviser

Mika Karikoski (Corporate Finance)

Phone: +358 40 741 6959

Panmure Gordon (UK) Limited, Nomad and Broker

Emma Earl, Freddy Crossley (Corporate Finance)

James Stearns (Corporate Broking)

Phone: +44 207 886 2892 

Consilium Strategic Communications

Mary-Jane Elliott

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 40 555 4727

Proposed Placing

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.

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: (A) 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”); AND (B) IN THE UNITED KINGDOM, PERSONS WHO ARE: (I) “INVESTMENT PROFESSIONALS” WITHIN THE MEANING OF ARTICLE 19(5) OF THE FINANCIAL SERVICES AND MARKETS ACT 2000 (FINANCIAL PROMOTION) ORDER 2005 (THE “ORDER”); (II) PERSONS FALLING WITHIN ARTICLE 49(2)(A) TO (D) (“HIGH NET WORTH COMPANIES, UNINCORPORATED ASSOCIATIONS, ETC”) OF THE ORDER; OR (III) PERSONS TO WHOM IT MAY OTHERWISE BE LAWFULLY COMMUNICATED (ALL SUCH PERSONS TOGETHER BEING REFERRED TO AS “RELEVANT PERSONS”). 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. 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 THE UNITED KINGDOM, 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 fundraising of a minimum of approximately €10 million through the issue of new ordinary shares

Proposed broker option to raise up to £2 million

Company announcement, 21 April 2020 at 4.45 p.m. BST/ 6.45 p.m. EEST

Inside information

TURKU – FINLAND– Faron Pharmaceuticals Oy (First North: FARON, AIM: FARN)the clinical stage biopharmaceutical company is pleased to announce a proposed placing of new ordinary shares to raise a minimum of approximately 10 million before expenses (the “Placing“). The Placing is being conducted within the Directors’ existing authority to allot ordinary shares in the capital of the Company (“Ordinary Shares“) for cash on a non-pre-emptive basis.

The Placing will be effected via a proposed private placement of new Ordinary Shares to a limited number of institutional investors in the Nordic region (the “Nordic Placing Shares” and the “Nordic Placing”) and a concurrent proposed private placement of new Ordinary Shares to UK institutional investors (the (“UK Placing Shares” and “UK Placing“). Carnegie Investment Bank AB (“Carnegie“) is acting as sole bookrunner and financial adviser to the Company for the Nordic Placing and Panmure Gordon (UK) Limited (“Panmure Gordon“) is acting as sole bookrunner and corporate broker to the Company in respect of the UK Placing.

Both the Nordic Placing and the UK Placing will be conducted by way of an accelerated bookbuild process, in the Nordic region (“Nordic Bookbuild“) and in the United Kingdom (“UK Bookbuild“) (together the “Bookbuild“) in which selected investors may submit bids for the Nordic Placing Shares or the UK Placing Shares, as applicable (together the “Placing Shares“), and  which will be launched immediately following this announcement and is expected to end by 7:00 BST/ 9:00 EEST on 22 April 2020 at the latest.  

The subscription price per Nordic Placing Share and UK Placing Share will be determined on the basis of the bids received in the bookbuild process with an Euro issue price for Nordic Placing Shares (“Nordic Issue Price“) and an equivalent Pound Sterling issue price for the UK Placing Shares  (based on the prevailing EUR/GBP exchange rate on 20 April 2020) (“UK 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.

The Company has also authorised Panmure Gordon to raise up to a further £2 million before expenses by granting a broker option (the “Broker Option“), (the Broker Option together with the Placing, the “Fundraise“). The Broker Option will be exercisable from announcement of result of the Placing to approximately 13:00 BST/ 15:00 EEST on 22 April 2020. To the extent that the Broker Option is exercised, new Ordinary Shares issued pursuant to the Broker Option (Option Shares“) will be issued at the UK Issue Price.

As soon as practicable after closing of the Bookbuild, an announcement will be made to confirm the Nordic Issue Price and the equivalent UK Issue Price and the number of Nordic Placing Shares and UK Placing Shares to be issued by the Company (“Result Announcement“). Following the Result Announcement, the final number of UK Placing Shares to be issued under the UK Placing (excluding any Option Shares issued pursuant to the exercise of the Broker Option) will remain subject to and conditional upon, inter alia, legally binding placing letters being received from persons who have submitted bids as part of the UK Bookbuild, and inter alia, the UK Issue Condition as described below.  Further details on the terms and conditions of the Nordic Placing and the UK Placing are set out below. The Nordic Placing and the UK Placing are subject to separate placing agreements with the Company and as also described below. It should be noted that neither of those agreements, are conditional on the other save for in respect of a minimum aggregate fundraise of approximately €10 million being achieved across the Nordic Placing and UK Placing.

The Placing Shares and, subject to exercise of the Broker Option, the Option Shares, are expected to be issued and admitted to trading on Nasdaq First North Growth Market Finland (“First North“) and AIM in multiple tranches as set out below. VCT/EIS investors may participate in the UK Placing (excluding the Broker Option).

KEY HIGHLIGHTS

·    Proposed Placing with institutional investors for new Ordinary Shares to raise a minimum of approximately €10 million (£8.7 million) in aggregate across the Nordic Placing and UK Placing via the Nordic Bookbuild and UK Bookbuild;

·    Broker Option to raise up to £2 million;

·    The net proceeds of the proposed Fundraise would be primarily used to commence expansion of the Company’s precision immunotherapy candidate, Clevegen®, into planned additional cancer targets in the Company’s phase I/II Matins trial and expansion of Clevegen manufacturing.

·    The net proceeds of the Fundraise will also significantly strengthen the Company’s balance sheet to support the Company during the use of Traumakine ®in the ongoing REMAP-CAP trial to study the effect of interferon beta-1a in COVID-19 and whilst the Company continues its potential licensing discussions for Clevegen and explores third party funding options for Traumakine;

·    Cash balance of the Company at 31 December 2020: EUR 7.1 million.

Dr Markku Jalkanen, Chief Executive Officer of Faron, said: “We have made significant clinical progress with both our Clevegen and Traumakine projects during the last 12 months and expect both of them to bring significant value for shareholders during the next 8-12 months. Clevegen has shown very promising clinical response in MATINS Part I stage, which we believe will transform into significant opportunity when the study moves to Part II-III expansion stages. Traumakine, on the other hand, has a new corticosteroid-free setting through the global REMAP-CAP study, which we believe is one of the most important intensive care study of the current pandemic environment.”

REASONS FOR THE PROPOSED FUNDRAISE

The primary reason for conducting the Fundraise is for expansion of the Company’s precision immunotherapy candidate, Clevegen®, into planned additional cancer targets in the Company’s phase I/II Matins trial and expansion of Clevegen manufacturing. The Company announced the completion and headline results of Part I of the Matins trial on 30 March 2020 including confirming that immune activation was observed in all subjects (except patients receiving 0.1 mg/kg) measured following treatment with Clevegen and was observed as increased circulating CD8+ T cells and CD8+/CD4+ ratio, decreased regulatory T-cells (T-regs) or a substantial increase in mobile natural killer (NK) cells in the blood. This activation was dose dependent. 12 patients showed at least a 20 per cent increase in interferon gamma and eight patients a similar increase in IP-10 chemokine production. Interferon gamma is known to restrict cancer growth and IP-10 to attract T-lymphocytes to infiltrate the tumour.

As previously announced and according to the RECIST classification, during Part I of the MATINS trial Clevegen treatment showed a clinical effect of two partial responses and seven cases of stable disease. None of the patients experiencing these effects had received the lowest dose level of 0.1mg/kg, therefore the response rate in Part I was 36 percent (9/25) among 0.3-10 mg/kg dose levels.

Subject to the outcome of the Fundraise, additional cancer types besides colorectal and ovarian to be included in Part II of the MATINS study are expected to be ER-positive breast cancer, hepatocellular carcinoma, cholangiocarcinoma (bile duct cancer) and gall bladder cancer, gastric cancer, cutaneous melanoma, uveal melanoma, and pancreatic ductal adenocarcinoma. Part II is expected to conclude in Q3 2021.  The Company is in the process of filing for Breakthrough Therapy status with the FDA and Prime Therapy status with the European Medicines Agency, which if granted, could provide an expedited development and review path.

The anticipated proceeds of the Fundraise will strengthen the Company’s balance sheet as it continues its licensing discussions in respect of Clevegen and seeks third party financing for Traumakine® to allow initiation of a US trial following acceptance by the FDA of the Company’s protocol for a new US Traumakine trial (announced 9 March 2020). As previously announced Traumakine has also recently been included in the approved protocol for the Global Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community-Acquired Pneumonia (“REMAP-CAP”) with Faron providing Traumakine and support to the trial sites.  A total of c. 7,000 ICU patients are expected to be recruited into the trial by 2022.  REMAP-CAP is a global network of leading experts, institutions and research networks with over fifty sites participating worldwide. The program recruits patients with community-acquired pneumonia, including COVID-19 patients, who require ICU care for the support of organ functions and uses an innovative trial design to efficiently evaluate multiple interventions simultaneously.  The Company is exploring options to re-establish future manufacturing of Traumakine. 

DETAILS OF THE PROPOSED PLACING AND ISSUE OF EQUITY

The proposed Fundraise is being carried out within the authorisation granted to the Board by shareholders at the Company’s Extraordinary General Meeting held on 25 October 2019 to issue up to a total of 7,871,000 ordinary shares in the Company in a directed share issue and in deviation from the shareholders’ pre-emptive rights. The remaining outstanding authority allows the Company to issue up to a maximum of 3,935,500 new Ordinary Shares pursuant to the Fundraise, which represents 9.1 per cent. of all the issued shares and votes in the Company immediately prior to the Fundraise.

Nordic Placing

The Nordic Placing, arranged by Carnegie, will be conducted in a private placement by way of the Nordic Bookbuild, which is an accelerated book-building process in which selected investors may submit bids for the Nordic Placing Shares. The Nordic Issue Price is to be determined on the basis of the bids received in the Nordic Bookbuild and is expected to be the equivalent Euro price of the UK Issue Price. The Nordic Bookbuild is expected to commence immediately following this announcement and is expected to end by 7:00 BST/ 9:00 EEST on 22 April 2020 at the latest. Carnegie reserves the right to close the Nordic Bookbuild earlier or later without further notice. The Nordic Bookbuild may also 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 Nordic Placing Shares, including, as applicable, acceptance of the received bids, the number of Nordic Placing Shares to be issued and the Nordic Issue Price and Carnegie will procure binding commitments from Nordic investors prior to announcement of the result of Placing (subject to any outstanding conditions).

In connection with the proposed Nordic Placing, the Company has entered into a placing agreement with Carnegie (the Nordic Placing Agreement“). Pursuant to the terms of the Nordic Placing Agreement, Carnegie has agreed to use its reasonable endeavours to procure subscribers for the Nordic Placing Shares. The Nordic Placing Agreement contains customary warranties and an indemnity from the Company in favour of Carnegie together with provisions which enable Carnegie to terminate the Nordic Placing Agreement in certain circumstances before the completion of the Nordic Bookbuild and the Board’s resolution on carrying out the Nordic Placing, including where there has been a material breach of any of the warranties contained in the Nordic 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 Carnegie certain commissions and fees in connection with the Nordic Placing. Pursuant to the terms of the Nordic Placing Agreement, Carnegie has agreed to a limited settlement underwriting covering payment of the subscription price to be made by subscribers of the Nordic Placing Shares to the Company upon the Board having resolved on carrying out the Nordic Placing after the close of the Bookbuild, at the Nordic Issue Price, on approving the binding subscriptions received through the Nordic Bookbuild and UK Bookbuild and on confirming such final number of Placing Shares to be issued.

The Nordic Placing is conditional upon, inter alia:

·    the Nordic Placing agreement having become unconditional in all respects;

·    binding commitments being received from investors;

·    the Minimum Fundraise Condition being satisfied;

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

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

In connection with the Nordic 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 180 days after the closing of the Fundraise.

UK Placing and Broker Option

The UK Placing will be conducted by way of an accelerated bookbuild process which will be launched immediately following this announcement. Panmure Gordon is acting as sole bookrunner in relation to the UK Placing. The UK Issue Price is to be determined on the basis of the bids received in the Bookbuild and is expected to be the equivalent Pounds Sterling price of the Nordic Issue Price.  It is envisaged that the UK Bookbuild will be closed by 7:00 BST/9:00 EEST on 22 April 2020 at the latest but Panmure Gordon (in conjunction with the Company) reserve the right to close the book earlier or later without further notice. The UK Bookbuild may also be discontinued at any time during the book-building process.   Venture capital trust and enterprise investment scheme funds may participate in the UK Placing.

Shortly following the closure of the UK Bookbuild and announcement of the result of the Placing, Panmure Gordon will issue placing letters to those persons who have submitted bids to subscribe for Placing Shares as part of the UK Bookbuild and which will contain the terms and conditions upon which they shall participate in the UK Placing. Accordingly, participation in the UK Placing and the determination of the precise number of UK Placing Shares to be issued under the UK Placing at the UK Issue Price will be conditional upon the receipt of signed placing letters back from potential investors.  

In addition, the Company has also granted the UK Broker Option to Panmure Gordon in order to cater for additional demand under the UK Placing. Any Option Shares issued pursuant to the exercise of the Broker Option will be issued on the same terms, and subject to the same conditions, as the UK Placing Shares and the return of signed placing letters corresponding to those Option Shares from relevant investors. The Broker Option is exercisable by Panmure Gordon, at any time from the date of announcement of the result of the Bookbuild to approximately 13.00 BST/ 15.00 EEST on 22 April 2020 in their absolute discretion, following consultation with the Company. However, there is no obligation on Panmure to exercise the Broker Option or to seek to procure subscribers for Option Shares pursuant to the Broker Option. The Broker Option will not qualify for investments made by venture capital trust and enterprise investment scheme funds.

In connection with the proposed UK Placing and the Broker Option, the Company has entered into a placing agreement with Panmure Gordon (the “UK Placing Agreement“). Pursuant to the terms of the UK Placing Agreement, Panmure Gordon has agreed to use its reasonable endeavours to procure placees for the UK Placing Shares. The UK Placing is conditional upon, inter alia:

·    the UK Placing Agreement having become unconditional in all respects;

·    the Company having performed, in all material respects, its obligations under the UK Placing Agreement and not being in material breach of the UK Placing Agreement;

·    legally binding commitments being received (in the form of placing letters) in respect of all of the UK Placing Shares and, to the extent exercised, the Option Shares (the “UK Placee Condition“);

·     minimum gross proceeds of €10 million being raised in aggregate under the Nordic Placing and UK Placing (“Minimum Fundraise Condition“); and

·    the UK Placing Shares and Option Shares being issued and being registered at the Finnish Trade Register (the “UK Issue Condition“).

The UK Placing Agreement contains customary warranties and an indemnity from the Company in favour of Panmure Gordon together with provisions which enable Panmure Gordon to terminate the UK Placing Agreement in certain circumstances before satisfaction of the UK Issue Condition and the Minimum Fundraise Condition in respect of each stage of the Placing, including where there has been a material breach of any of the warranties contained in the UK Placing Agreement (in the reasonable opinion of Panmure Gordon) or where there is a material adverse change in the business or financial affairs of the Company. The Company has agreed to pay Panmure Gordon certain commissions and fees in connection with the UK Placing.  In order to comply with local corporate law in Finland, the UK Issue Condition will be satisfied prior to the admission of the UK Placing Shares to trading on AIM (“UK Admission“). Accordingly, pursuant to the terms of the UK Placing Agreement, Panmure Gordon has agreed to limited settlement underwriting of payment of the subscription price to be made by subscribers of the UK Placing Shares to the Company subject to the Board having resolved to carry out the UK Placing after the close of the Bookbuild at the UK Issue Price and subject to satisfaction of the UK Placee Issue Condition.

ISSUE OF THE PLACING SHARES, OPTION 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 multiple tranches in anticipation of allowing investments made by certain venture capital trust and enterprise investment scheme funds, (the “EIS/VCT Investors“) in order to qualify under Venture Capital Trust and Enterprise Investment Scheme rules as part of the UK Placing (excluding the Broker Option) and to facilitate the limited settlement underwriting.

Based on indications of interest received as part of market soundings conducted in relation to the Fundraise then, subject to all conditions being met, UK Placing Shares issued to the EIS/VCT Investors are expected to be allotted and issued first alongside certain Nordic Placing Shares (“First Issue Shares“) followed by the remaining Nordic Placing Shares (“Second Issue Shares“) and then followed by the UK Placing Shares and Option Shares issued to non-EIS/VCT Investors (“Third Issue Shares“). To the extent shares are subscribed for and subject to all conditions being met, application will then be made for the admission of all such Placing Shares to trading on First North and AIM with admission of the First Issue Shares to First North and AIM expected to become effective and dealings to commence on or around 24 April 2020 (“First Admission“); admission of the Second Issue Shares to First North and AIM is expected to become effective and dealings to commence on or around 27 April 2020 (“Second Admission“) and admission of the Third Issue Shares (including any Option Shares to the extent subscribed for) to First North and AIM is expected to become effective and dealings  to commence on or around 29 April 2020 (“Third Admission“). (First Admission, Second Admission and Third Admission, together “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 UK Issue Condition) and to confirm the expected timing of issue of the Placing Shares and 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.

For more information please contact:

Faron Pharmaceuticals Oy

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com 

Carnegie Investment Bank AB, Financial Adviser

Mika Karikoski (Corporate Finance)

Phone: +358 40 741 6959

Panmure Gordon (UK) Limited, Nomad and Broker

Emma Earl, Freddy Crossley (Corporate Finance)

James Stearns (Corporate Broking)

Phone: +44 207 886 2892

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 40 555 4727

About Faron Pharmaceuticals Ltd

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

IMPORTANT INFORMATION

Market Abuse Regulation

Market soundings, as defined in Regulation (EU) No 596/2014 (“MAR“), were taken in respect of the proposed Fundraise with the result that certain persons became aware of inside information, as permitted by MAR. That inside information in relation to the Fundraise 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.

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 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, 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.

Exchange rate

Unless otherwise specified, this announcement contains certain translations of Euros into amounts in Pounds Sterling for the convenience of the reader based on the exchange rate of €1.00 = £0.87, being the published exchange rate by the European Central Bank at the close of business on 20 April  2020 (the latest practicable date prior to the date of this announcement).

Advisers

Carnegie, a public limited company duly incorporated and validly existing under the laws of Sweden, is acting as Sole Bookrunner and Financial Adviser to the Company and no one else in connection with the Nordic Placing. Accordingly, it will not be responsible to any person other than the Company for providing the regulatory and legal protections afforded to its clients nor for providing advice in relation to the contents of this announcement or any matter, transaction or arrangement referred to in it.

Panmure Gordon (UK) Limited, which is regulated in the UK by the Financial Conduct Authority, is acting as Nominated Adviser, Sole Bookrunner and Corporate Broker to the Company and no one else in connection with the UK Placing. Accordingly, it will not be responsible to any person other than the Company for providing the regulatory and legal protections afforded to its clients nor for providing advice in relation to the contents of this Announcement or any matter, transaction or arrangement referred to in it.

Part 1 of the MATINS Phase I/II Study Completed

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

Completion of Part 1 dose finding stage of the MATINS Phase I/II Study

Study data monitoring committee recommends rapid expansion of study into new tumour types following promising results

Company announcement, 30 March 2020 at 9.00 AM (EET)
Inside information

TURKU – FINLAND – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), the clinical stage biopharmaceutical company, today announces positive feedback from the MATINS study data monitoring committee (“DMC”) following a comprehensive review and analysis of the data from the now completed Part 1 (dose finding) stage of the trial.  

The ongoing phase I/II MATINS clinical trial is investigating the tolerability, safety and efficacy of Clevegen, Faron’s wholly-owned novel precision cancer immunotherapy targeting Clever-1 positive tumour associated macrophages (TAM), in selected metastatic or inoperable solid tumours. The DMC has reviewed all available data, including imaging and biomarker analyses from the 30 patients treated in Part 1 of the trial. The reviewed biomarker (cellular and biochemical) data is from the first cycle of all 30 patients and target tumour lesion images according to RECIST between the third and fourth cycles (roughly 60-70 days from the first dose).

The following key findings were presented to the DMC:

Immune switch. Consistent with earlier analyses, immune activation was observed in all subjects (except patients receiving 0.1 mg/kg) measured following treatment with Clevegen and was observed as increased circulating CD8+ T cells and CD8+/CD4+ ratio, decreased regulatory T-cells (T-regs) or a substantial increase in mobile natural killer (NK) cells in the blood. This activation was dose dependent. Interestingly, 12 patients showed at least a 20 per cent increase in interferon gamma and eight patients a similar increase in IP-10 chemokine production. Interferon gamma is known to restrict cancer growth and IP-10 to attract T-lymphocytes to infiltrate the tumour.

Clinical response. According to the RECIST classification, Clevegen treatment showed a clinical effect of two partial responses (as previously announced), and seven cases of stable disease. None of the patients experiencing these effects had received the lowest dose level of 0.1mg/kg, therefore the response rate in Part I was 36 percent (9/25) among 0.3-10 mg/kg dose levels.

DMC recommendation. The MATINS DMC has now reviewed all available data on Part I patients and the Company has received advice to continue the trial as planned with the following notes:

·    Dose escalation reached its planned maximum level of 10mg/kg with Clevegen demonstrating good tolerability at all dosing levels (0.1 to 10 mg/kg) without dose limiting toxicity. A maximally tolerated dose (MTD) was not reached. The DMC recommends that all further administration of Clevegen should take place at 1mg/kg.

·    Part 2 of the study should now be expanded to include all cancer cohorts in the study protocol, beyond the colorectal and ovarian cancer cohorts previously selected and announced (see list below).

·    Patient recruitment for the expansion cohorts should follow standard of care for each cancer type and enable subjects with less compromised immune systems (i.e., earlier treatment lines whenever possible according to the study protocol) to be enrolled to the trial.

Dr. Markku Jalkanen, Faron’s CEO, said: “We welcome the support from the data monitoring committee to expand our studies, exploring the safety and efficacy of Clevegen in additional cancer types. We continue to be highly encouraged by the consistency of the data from the MATINS trial indicating Clevegen’s strong immune switch and the low dosing levels required to show these responses, but most importantly its clinical effect on tumour lesions in patients who have exhausted all treatment options.

“We will now work with trial sites in the MATINS network across Europe and the US to ensure expansion of the trial beyond the colorectal and ovarian cancer cohorts already recruiting. We look forward to generating further data to assess the durability of effect and efficacy of Clevegen in larger numbers of patients.”

Subject to funding, additional cancer types besides colorectal and ovarian to be included in Part 2 of the MATINS study are:

·     ER-positive breast cancer

·     Hepatocellular carcinoma

·     Cholangiocarcinoma (bile duct cancer) and gall bladder cancer

·     Gastric cancer

·     Hepatocellular carcinoma

·     Cutaneous melanoma

·     Uveal melanoma

·     Pancreatic ductal adenocarcinoma 

Ten patients are expected to be treated in each of the cohorts. The first colorectal cancer cohort has already been recruited and dosed at the previously agreed 0.3 mg/kg dosing level. As noted above, going forwards all future dosing will be at 1 mg/kg. The Company has received feedback from the study sites that the initiation of new cohorts may be delayed due to restricted resources caused by corona infections. The Company will work closely with these trial sites to ensure the trial progresses as smoothly as possible.

RECIST: Response evaluation criteria in solid tumours is a set of published rules that define when tumors in cancer patients improve (“respond”), stay the same (“stabilize”), or worsen (“progress”) during treatment.

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

For more information please contact:

Faron Pharmaceuticals Oy

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com 

Panmure Gordon (UK) Limited, Nomad and Broker

Emma Earl, Freddy Crossley (Corporate Finance)

James Stearns (Corporate Broking)

Phone: +44 207 886 2500

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen, Jussi Majamaa

Phone: +358 (0)40 555 4727

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

About the MATINS study

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

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

About Faron Pharmaceuticals Ltd

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

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.

FDA accepts protocol for new Traumakine trial

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

FDA accepts protocol for new Traumakine trial in ARDS  

Company announcement, 09 March 2020 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 U.S. Food and Drug Administration (FDA) has accepted the proposed protocol design for the next Traumakine study in ARDS patients, following the Company’s protocol submission announced on 6 February 2020. 

The trial protocol reflects the feedback and conclusions from the FDA that further studies with interferon-beta (IFN beta-1a) should exclude the use of concomitant glucocorticoids since they are likely to block the desired therapeutic effect of Traumakine and may have a potentially deleterious impact on patient survival. This harmful interaction has been previously evidenced both clinically in the INTEREST study, where concomitant glucocorticoids use was associated with increased mortality, and experimentally ex vivo using human lung tissue and pulmonary endothelial cells.

Faron is planning to split the clinical development of Traumakine in ARDS into two steps, commencing with INTEGRITY, a pilot randomised and placebo controlled study with approximately 60 patients. The INTEGRITY data will then serve as final adjustment for adequate statistical powering and sample size justification for the pivotal CALIBER study, subjected for FDA review. The Company expects that the sample size of the CALIBER study will not exceed 200 patients based on the post hoc analysis of the INTEREST trial data. As previously announced, the Company envisages that future Traumakine trials (including INTEGRITY and CALIBER) are  likely to be funded through a third party or parties.

Dr. Markku Jalkanen, Faron’s CEO, said: “FDA’s acceptance of our proposed study design and protocol is a significant step for the future development of Traumakine. Our learnings from previous trials in this development programme have enabled us to refocus our efforts on Traumakine, which we continue to believe holds great potential as a future treatment for ARDS, including flu or corona virus infected people. We look forward to providing further updates as our funding discussions with third parties progress.”

Ends

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

For more information please contact:

Faron Pharmaceuticals Oy

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com 

Panmure Gordon (UK) Limited, Nomad and Broker

Emma Earl, Freddy Crossley (Corporate Finance)

James Stearns (Corporate Broking)

Phone: +44 207 886 2500

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen, Jussi Majamaa

Phone: +358 (0)40 555 4727

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

About Faron Pharmaceuticals Ltd

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

Caution regarding forward looking statements

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

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

MATINS update

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

MATINS update

Second tumour regression identified, now in a melanoma patient

Company announcement, 05 March 2020 at 9.00 AM (EET)
Inside information

TURKU – FINLAND – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), the clinical stage biopharmaceutical company, announces that in the ongoing dose finding part of the MATINS trial (Part I) a partial response has been identified in target lesions of a melanoma patient who has previously been heavily treated with immuno-oncology (“IO”) and chemo therapies. According to Response Evaluation Criteria in Solid Tumors (RECIST), a partial response in target lesion is defined as a decrease of greater than 30% in that same lesion.

The patient had previously been treated with three different immune checkpoint inhibitors (pembrolizumab alone and ipililumab/nivolumab combination therapy) and had been on dabrafenib/trametinib anti-cancer treatment (BRAF-MEK inhibition) until December 2019.  Data showed that the size of the target lesion tumour (a lung metastasis) reduced by 44 percent and other non-target lesions stabilized. Biochemical tumour load marker also declined and clearance of pleura fluid was observed. The patient had received two doses of Clevegen at 1 mg/kg with 3-week interval.

During treatment with Clevegen, however, scans revealed that the patient had haemorrhagic brain metastases.  These were not previously identified due to a lack of baseline brain scans prior to Clevegen administration and,  according to the study protocol, resulted in the patient being removed from the trial. To prevent similar situations occurring in the future, the MATINS study protocol has been amended to include baseline brain imaging to rule out existing brain metastases.

Dr. Markku Jalkanen, Faron’s CEO, said: “We are very encouraged to have a second partial target lesion responder in our dose finding part of the trial, suffering from a non-treatable melanoma and resistant to all existing anti-melanoma treatments, including  immune checkpoint inhibitor combinations. Our earlier finding from the MATINS study patients indicated that Clevegen administration downregulates various negative immune checkpoint inhibitors (announced 11 December, 2019) and, based on this observed melanoma target lesion response, (IO-pre-treated) melanoma may represent a patient group which may require Clevegen-induced downregulation of checkpoints to initiate immune reaction against tumour. “

The further analysis of other MATINS Part I patients (30 patients at five different dosing levels, from 0.3 to 10 mg/kg) will continue and Company expects further analysis to become available post the next Data Monitoring Committee (DMC) meeting in late March, including recommendations of the future steps on dosing and cohort expansions.

Ends

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

For more information please contact:

Faron Pharmaceuticals Oy

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com 

Panmure Gordon (UK) Limited, Nomad and Broker

Emma Earl, Freddy Crossley (Corporate Finance)

James Stearns (Corporate Broking)

Phone: +44 207 886 2500

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen, Jussi Majamaa

Phone: +358 (0)40 555 4727

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

About Faron Pharmaceuticals Ltd

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

Caution regarding forward looking statements

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

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

Ovarian cancer selected as 2nd MATINS trial cohort

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

MATINS TRIAL UPDATE 

Ovarian cancer selected as second expansion cohort

Company announcement, 27 January 2020 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 second expansion cohort in its phase I/II MATINS clinical trial investigating the safety and efficacy of Clevegen will be in patients with ovarian cancer.

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

Initiation of this second expansion cohort follows approval from the MATINS trial’s data monitoring committee earlier this month to initiate the study’s first expansion cohort in patients suffering from late-stage colorectal cancer (CRC). Ovarian cancer is a tumour type known to host a significant number of Clever-1 positive tumour associated macrophages (TAM). It presents a high unmet medical need with few available treatments for patients. Large transcript analysis of ovarian tumours indicates significant outcome differences between patients with either high or low Clever-1 expression. Patients with high Clever-1 expression have short life expectancies under current treatment options.

Dr. Markku Jalkanen, Faron’s CEO, said: “Data collected so far in the MATINS trial are highly encouraging, with Clevegen establishing itself as a potential immunotherapy capable of downregulating a range of major inhibitory immune checkpoints (PD-1, PD-L1, CTLA-4) across several cancers. Initiation of this additional expansion cohort signals our commitment to rapidly progress the development of Clevegen in patients with limited effective treatment options.”

Dr. Tyler Curiel, Professor and The Daisy M. Skinner President’s Chair in Cancer Immunology Research, UT Health San Antonio, and MATINS trial site investigator and principal investigator for USA, said: “Ovarian cancer is devastating and there remains a huge need for new treatments. Expanding the MATINS trial to include ovarian cancer patients will help us to understand this novel potential immunotherapy in a patient group where we desperately need to improve outcomes. We are very excited to join the MATINS trial and to start US recruitment.”

Existing MATINS trial sites in Europe are currently recruiting for the first expansion cohort in late-stage CRC patients and this second cohort, in a total of 10 patients with ovarian cancer, is expected to follow in the coming weeks. With good tolerability and no dose limiting toxicity signals established across all dosing levels explored in the MATINS trial to date, the dosing for this additional cohort is likely to be higher (e.g. 1 mg/kg) than for the first CRC cohort. MATINS trial sites in the US are expected to begin opening in the short term. 

Primarily intended to investigate safety and tolerability, the completed Part I of the MATINS trial has already shown that Clevegen administration promoted immune activation in all of the dosed patients to date. This would potentially make Clevegen a new and effective macrophage immune checkpoint drug for cancer patients, who frequently suffer from supressed immune capacity toward tumour elimination. Previously announced data also indicate that Clevegen can down regulate a range of major inhibitory immune checkpoints, that current immuno-oncology therapies aim to suppress.

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

For more information please contact:

Faron Pharmaceuticals Oy

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com 

Panmure Gordon (UK) Limited, Nomad and Broker

Emma Earl, Freddy Crossley (Corporate Finance)

James Stearns (Corporate Broking)

Phone: +44 207 886 2500

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen, Jussi Majamaa

Phone: +358 (0)40 555 4727

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

About the MATINS study

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

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

About Faron Pharmaceuticals Ltd

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

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.

DMC approves colorectal cancer cohort expansion

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

MATINS TRIAL UPDATE 

Data monitoring committee approves initiation of expansion cohort in colorectal cancer patients

Company announcement, 13 January 2020 at 9.00 AM (EET)
Inside information

TURKU – FINLAND – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), the clinical stage biopharmaceutical company, today announces approval from the MATINS trial’s data monitoring committee (“DMC”) to initiate the study’s first expansion cohort, Part II, in patients suffering from late-stage colorectal cancer (CRC), following a successful conclusion of the dose escalation in Part I.

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

The DMC has accepted the Company’s proposal that the initial Clevegen dose for Part II of the study should be 0.3 mg/kg. This follows analysis of the data from patients in Part I of the study who received doses of 0.1 mg/kg, 0.3 mg/kg, 1.0 mg/kg, 3.0 mg/kg and 10 mg/kg. All dose levels tested showed good tolerability with no dose limiting toxicity signals. While the dose of 0.3 mg/kg has been associated with a clinical response and has produced the strongest immune response (Natural killer cell activation, CD8+ T-cell increase), the efficacy of another Part I dose level cohort (1.0 or 3.0 mg/kg) may be tested separately during Part II following completion and final analysis of Part I.

A total of 10 late-stage CRC patients are expected to be dosed in this 0.3 mg/kg cohort, including two patients who had previously received this dose in the earlier Part I of the study. Commencement of other distinct cancer cohorts will follow the CRC cohort.

Dr. Markku Jalkanen, Faron’s CEO, said: “We continue to be impressed by the potential of Clevegen and are very pleased to have the DMC’s support for the commencement of Part II of the MATINS trial. At just 0.3 mg/kg the dose could provide an unusually high safety margin for the use of this potential therapy as a stand-alone treatment or in combination with other cancer therapies. The decline in expression of negative immune checkpoint receptors post Clevegen dosing warrants expansion of Clevegen testing in numerous cancer types and therefore we will now ensure a rapid expansion of Part II of the MATINS trial to continue investigating the safety and efficacy of Clevegen in various cancer cohorts.”

Primarily intended to investigate safety and tolerability, the completed Part I of the MATINS trial has already shown that Clevegen administration promoted immune activation in all of the dosed patients. This would potentially make Clevegen a new and effective macrophage immune checkpoint drug for cancer patients, who frequently suffer from supressed immune capacity toward tumour elimination. Previously announced data also indicate that Clevegen can down regulate a range of major inhibitory immune checkpoints, that current immuno-oncology therapies aim to suppress.

As previously announced, following approval of the Company’s Investigational New Drug (IND) application for Clevegen by the Food and Drug Administration (FDA) in November 2019, the Company is opening new MATINS trial sites in the US to facilitate its rapid expansion beyond existing and new sites in Europe. Data from Part I of the study continue to be examined to determine which different candidate cohorts will be investigated in Part II, alongside CRC. A move to Part III requires prior discussions with regulators but could take place in mid-2020.

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

For more information please contact:

Faron Pharmaceuticals Oy

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com 

Panmure Gordon (UK) Limited, Nomad and Broker

Emma Earl, Freddy Crossley (Corporate Finance)

James Stearns (Corporate Broking)

Phone: +44 207 886 2500

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen, Jussi Majamaa

Phone: +358 (0)40 555 4727

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

About the MATINS study

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

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

About Faron Pharmaceuticals Ltd

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

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.

Matins Trial Update

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

Clevegen downregulates a range of major immuno-oncology (IO) checkpoints in MATINS cancer patients

Biomarker analysis could guide future combination therapies with Clevegen

Company announcement, 11 December 2019 at 9.00 AM (EET)
Inside information

TURKU – FINLAND – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), the clinical stage biopharmaceutical company, today announces new data from MATINS -trial patients to be presented at the ESMO Immuno-Oncology Congress 2019 in Geneva, Switzerland. Faron’s scientific network will present the data in a plenary lecture and more detailed biomarker data in a Mini Oral session.

The phase I/II MATINS clinical trial is investigating the tolerability, safety and efficacy of Clevegen, Faron’s wholly-owned novel precision cancer immunotherapy (Clevegen) targeting Clever-1 positive tumour associated macrophages (TAM), in selected metastatic or inoperable solid tumours. The Company has previously announced that Clevegen administration results in an immune switch from immune suppression to immune activation.

First available set of cell surface biomarker data from a group of seven patients to be presented at the congress show that: 1) anti-Clever-1 treatment in cancer patients decreases a broad range of checkpoints including PD-1, PD-L1, CTLA-4, OX40, 41BB, LAG3 and 2) co-stimulation markers CD28 and ICOS on circulating T cell populations whereas 3) it increases the expression of activation markers CD25 (IL-2RA), CXCR3 and CD69. In addition, anti-tumour responses with anti-Clever-1 treatment are found to associate with an increase in plasma interferon gamma (IFN-gamma), which is one of the tools the immune system is using to fight against cancer.

The analysis of checkpoints (also known as exhaustion markers) and activation markers can potentially also be used to guide the best possible checkpoint inhibitor(s) combination treatment with anti-Clever-1 therapy. Cell surface markers like PD-1, PD-L1, CTLA-4, LAG3, and TIM, can then be used to monitor a patient’s response to anti-Clever-1 therapy and to evaluate the need for combination therapy in addition to anti-Clever-therapy. The present finding potentially provides a method for choosing the best combination agent(s) to initiate treatment together with anti-Clever-1 therapy after observed changes in one or more checkpoint or activation marker expression. The Company has filed a related patent to protect this method.

Commenting on these findings, Dr. Markku Jalkanen, Faron’s CEO, said: “We have always believed Clever-1 to be a master regulator of immunity, but we are very encouraged to find that Clevegen can down regulate a range of major inhibitory immune checkpoints, that current IO therapies aim to suppress. We intend to carry out further analysis of other MATINS patients and aim to understand which combination of IO therapies would build the optimal host immune activation for various cancer types or individuals. To have one single and safe treatment as early as possible would improve patient outcome. These results indicate that Clevegen treatment could potentially allow increased efficacy of other IO treatments through the biomarker analysis of patient’s blood cells post Clevegen induced immune activation, finally offering a biological rational to guide combination therapies.”  

About the MATINS study

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

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

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

For more information please contact:

Faron Pharmaceuticals Oy

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com 

Panmure Gordon (UK) Limited, Nomad and Broker

Emma Earl, Freddy Crossley (Corporate Finance)

James Stearns (Corporate Broking)

Phone: +44 207 886 2500

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen, Jussi Majamaa

Phone: +358 (0)40 555 4727

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

About Faron Pharmaceuticals Ltd

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

Caution regarding forward looking statements

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

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

LIQUIDITY PROVIDING AGREEMENT

RNS Number : 1193V
Faron Pharmaceuticals Oy
29 November 2019
 

Faron Pharmaceuticals Oy

LIQUIDITY PROVIDING AGREEMENT

Appointment of Lago Kapital as Liquidity Provider

Company announcement, Turku, 29 November 2019 at 9.31 AM (EET)

Inside information

TURKU – FINLAND– Faron Pharmaceuticals Oy (AIM: FARN) (“Faron” or the “Company“), the clinical stage biopharmaceutical company, announces that it has entered into a liquidity providing agreement (the “LP Agreement“) with Lago Kapital Ltd (“Lago Kapital“).

Under the LP Agreement, Lago Kapital will quote bids and offers for the Company’s share within the framework for the Nasdaq First North Growth Market Finland (“Nasdaq First North“) rules for liquidity provision. The spread of the bid and offer prices is a maximum of 4 per cent calculated on the bid price. The quotes on bid and offer must be at least EUR 3,000 worth of shares. The intention is to promote liquidity in the share.

Subject to the applied listing of the Company’s share on Nasdaq First North being accepted, Lago Kapital will quote bids and offers for the Company’s share in the trading system of Nasdaq First North on each trading day for at least 85 per cent of the continuous trading period and in the auction procedures applicable to the share.

Liquidity providing in accordance with the LP Agreement will commence on 3 December 2019. The LP Agreement will be in force initially for a fixed term of three (3) months and thereafter until further notice with a notice period of one (1) calendar month.

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

For more information please contact:

Faron Pharmaceuticals Oy
Dr Markku Jalkanen, Chief Executive Officer
investor.relations@faron.com  

Panmure Gordon (UK) Limited, Nomad and Broker on AIM
Emma Earl, Freddy Crossley
Phone: +44 (0)20 7886 2500

Sisu Partners Oy, Certified Adviser on Nasdaq First North
Juha Karttunen, Jussi Majamaa
Phone: +358 (0)40 555 4727

Consilium Strategic Communications
Mary-Jane Elliott, David Daley, Lindsey Neville
Phone: +44 (0)20 3709 5700
Email:
faron@consilium-comms.com

Distribution:
Nasdaq Helsinki Ltd
Key media
www.faron.com

About Faron Pharmaceuticals Oy:

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


This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com or visit
www.rns.com.
 

END

 
 

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