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.

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 PHARMACEUTICALS OY (“FARON”) OR ANY OTHER ENTITY IN ANY JURISDICTION IN WHICH ANY SUCH OFFER WOULD BE UNLAWFUL.

FARON HAS NOT TAKEN ANY ACTION, NOR WILL IT TAKE ANY ACTION, TO OFFER ANY OF THE PLACING SHARES OR ANY DOCUMENTS RELATING TO THE PLACING TO THE PUBLIC IN FINLAND, SWEDEN, NORWAY OR DENMARK, OR IN ANY OTHER JURISDICTION IN ANY FORM WHICH WOULD CONSTITUTE AN OFFER TO THE PUBLIC.

THE PLACING SHARES WILL NOT BE REGISTERED UNDER THE UNITED STATES SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), OR UNDER THE SECURITIES LAWS OF ANY STATE OR OTHER JURISDICTION OF THE UNITED STATES, AND MAY NOT BE OFFERED, SOLD OR TRANSFERRED, DIRECTLY OR INDIRECTLY, IN OR INTO OR FROM THE UNITED STATES EXCEPT PURSUANT TO AN EXEMPTION FROM, OR IN A TRANSACTION NOT SUBJECT TO, THE REGISTRATION REQUIREMENTS OF THE SECURITIES ACT AND IN COMPLIANCE WITH ANY APPLICABLE SECURITIES LAWS OF ANY STATE OR OTHER JURISDICTION OF THE UNITED STATES. THERE IS NO PUBLIC OFFERING IN THE UNITED STATES, THE UNITED KINGDOM OR ELSEWHERE. 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

Proposed Placing of Shares and Appointment of Financial Adviser

TURKU – FINLAND, 7 November 2019 – Faron Pharmaceuticals Oy (AIM: FARN) (“Company“), the clinical stage biopharmaceutical company, today announces a proposed private placement to a limited number of institutional investors and certain members of the management and of the Board of Directors of Faron (“Placing“) of new shares in the Company, to issue a minimum number of 3,935,500 ordinary shares in the Company (“Placing Shares”).

The Placing, arranged by Carnegie Investment Bank AB (“Carnegie“), will be conducted in a private placement by way of an accelerated book-building process in which selected investors may submit bids for the Placing Shares (the “Bookbuild”). The subscription price per Placing Share is to be determined on the basis of the bids received in the Bookbuild. The Bookbuild is expected to commence immediately following this announcement and is expected to end by 9:00 EET on 8 November 2019 at the latest. Carnegie reserves the right to close the Bookbuild earlier or later without further notice. The Bookbuild may also be discontinued at any time during the book-building process. Following the close of the Bookbuild, the Board of Directors of Faron (the “Board“) will make the decision on the issue of the Placing Shares, including, as applicable, acceptance of the received bids, the number of Placing Shares to be issued and the subscription price per Placing Share (the “Issue Price“). As soon as practicable after the close of the Bookbuild, and following receipt of binding commitments from investors, an announcement will be made on the final number of the Placing Shares to be issued and the Issue Price as well as the expected registration date of the Placing Shares.

KEY HIGHLIGHTS

·     A private placement conducted by way of an accelerated book-building, directed to a limited number of institutional investors and certain members of the management and of the Board, in which Carnegie uses reasonable endeavours to procure subscriptions for the Placing Shares, which would correspond to a minimum of approximately 10.0 per cent. of all of the issued shares and votes in the Company immediately prior to the Placing.

·     The net proceeds of the Placing would be primarily used to advance the clinical development of Clevegen^® in several indications and to help advance the seamless continuation of Clevegen® development to optimise the value of the asset in advance of any partnership deal.

·     The cash balance held by the Company as at 30 September 2019 was c. €2.38 million.

Carnegie acts as Lead Manager and Sole Bookrunner of the Placing and Financial Adviser to the Company.

REASONS FOR THE PROPOSED PLACING

Advance the clinical development of Clevegen^® in several indications

·     Faron intends to initiate the cohort expansion (part II) of the MATINS trial in colorectal cancer after the dose optimisation (details of which were announced 9 October 2019) has been completed. Once the cohort expansion reaches meaningful size the Company plans to share the data with the US Food and Drug Administration (“FDA“) for discussions of the content of a biologics licence application; and

·     The Company also expects further analysis of patient data from part I of the MATINS trial to aid the selection of additional cohort expansions among the non-treatable and advanced solid cancers as indicated in the clinical pipeline available on the Company’s website and based on the substantial appearance of Clever-1 positive myeloid cells in these cancer types.

Advance seamless continuation of Clevegen® development to optimise value creation 

·     The Company has during the course of the MATINS trial to date learned that Clevegen has been shown to promote 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;

·     Clevegen has also been shown to be safe and well tolerated, which the Company believes to make it a low-risk candidate to be used together with existing cancer therapies;

·     The recent analysis of the MATINS data has also confirmed that lower doses may potentially induce a stronger immune response than higher doses, which forms the basis for additional dose optimisation to secure the best possible outcome of the ongoing clinical development under way currently; and

·     Combined, this MATINS data suggests there may be an increased value to a Clevegen partnership with a wider number of partners. As announced on 1 November 2019, the Company is working hard to optimise the structure to capture the most value from any potential deal with the best possible partner which is likely to result in discussions continuing into 2020.

Traumakine® program

·     The Company will have a face-to-face meeting with the FDA in early December 2019, which is expected to result in a written opinion of the FDA on the Company’s clinical development plan for Traumakine.

Dr Markku Jalkanen, Chief Executive Officer of Faron, said: “Over the last couple of months we have come to realise the significance of the data generated to date from the MATINS study, which has confirmed three important points: i) In Clevegen, we potentially have the first macrophage immune checkpoint drug which has promoted immune activation of all dosed patients to date, ii) Clevegen is safe and well tolerated, making it a low-risk candidate for combination with existing cancer therapies, and iii) Clevegen has shown early clinical benefits in patients who have exhausted all other options. These results open multiple new opportunities for Clevegen in combination with existing cancer therapies. The possibility to expand the Clevegen platform outside single-agent treatment has also widened Faron’s approach to its commercialisation strategy for Clevegen either alone or with a partner. This proposed private placement will not only strengthen the Company’s resources but also strengthen its position in partnership negotiations as it explores the best outcome for the Company and its shareholders.“

DETAILS OF THE PROPOSED PLACING AND ISSUE OF EQUITY

The proposed Placing is carried out on the basis of the authorisation granted to the Board by the Company’s Extraordinary General Meeting held on 25 October 2019 to issue a total of 7,871,00 ordinary shares in the Company in a directed share issue and in deviation from the shareholders’ pre-emptive rights.

If the minimum number of 3,935,500 Placing Shares are fully subscribed for, the number of Placing Shares corresponds to approximately 10.0 per cent. of all of the issued shares and votes in the Company immediately prior to the Placing. The Company may in its discretion resolve on the final number of the Placing Shares up to a total of 7,871,000 ordinary shares, depending on the demand in the Bookbuild.

The Placing, arranged by Carnegie, will be conducted in a private placement by way of the Bookbuild, which is an accelerated book-building process in which selected investors may submit bids for the Placing Shares. The Issue Price is to be determined on the basis of the bids received in the Bookbuild. The Bookbuild is expected to commence immediately following this announcement and is expected to end by 9:00 EET on 8 November 2019 at the latest. Carnegie reserves the right to close the Bookbuild earlier or later without further notice. The 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 Placing Shares, including, as applicable, acceptance of the received bids, the number of Placing Shares to be issued and the Issue Price. As soon as practicable after the close of the Bookbuild, receipt of binding commitments from investors and the Board having resolved on carrying out the Placing, an announcement will be made on the final outcome of the Bookbuild and, as applicable, the number of the Placing Shares to be issued and the Issue Price as well as the expected registration date of the Placing Shares.

In connection with the proposed Placing, the Company has entered into a placing agreement with Carnegie (the “Placing Agreement”). Pursuant to the terms of the Placing Agreement, Carnegie has agreed to use its reasonable endeavours to procure the subscription of Placing Shares.

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

The Placing is conditional upon, inter alia:

·     The Placing Agreement having become unconditional in all respects;

·     Binding commitments being received from investors;

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

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

In connection with the Placing, Faron has entered into a lock-up undertaking, under which it has, subject to certain exceptions, agreed not to issue or sell any shares in Faron for a period of 180 days after the closing of the Placing.

Subject to all conditions being met, the Placing Shares are expected to be entered in the Finnish Trade Register approximately on 12 November 2019. It is expected that Admission will become effective and that dealings in the Placing Shares (in the form of depositary interests) will commence at 10:00 Finnish time, 8:00 a.m. UK time, on or around 14 November 2019. As noted above, further update announcements will be made in due course. Upon registration with the Finnish Trade Register, the Placing Shares will rank pari passu in all respects with the existing shares of the Company.

As announced on 1 November 2019, the Company has been and is investigating various options to facilitate easier trading on the Company’s shares especially for Finnish investors, including possibility to dual list its shares on Nasdaq First North Growth Market. No decisions regarding a dual listing or otherwise have been made in this respect. 

MARKET ABUSE REGULATION

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

Carnegie, a public limited company duly incorporated and validly existing under the laws of Sweden, is acting as Financial Adviser to the Company and no one else in connection with the 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.

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

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 9 6187 1295

Panmure Gordon (UK) Limited, Nomad and Broker

Emma Earl, Freddy Crossley (Corporate Finance)

James Stearns (Corporate Broking)

Phone: +44 207 886 2500

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

Westwicke Partners, IR (US)

Chris Brinzey

Phone: 01 339 970 2843

E-mail: chris.brinzey@westwicke.com

About Faron Pharmaceuticals Ltd

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.

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.

NOTICE OF faron pharmaceuticals LTD’s extraordinary GENERAL MEETING

Shareholders of Faron Pharmaceuticals Ltd (the “Company“) are invited to attend the Extraordinary General Meeting to be held on 25 October 2019 at 10.00 a.m. (Finnish time) at the BioCity building, meeting room Manu at Tykistökatu 6, 20520 Turku, Finland. The registration of attendees and the distribution of voting slips will commence at the meeting venue at 9.00 a.m. (Finnish time).

The Company’s Annual Report 2018, the half-yearly report for the six months ended 30 June 2019 and the statement by the Board of Directors on events after the preparation of the half-yearly report with a material effect on the Company are available to view and download on the Company’s website at https://www.faron.com/ (link on the homepage).

A.  MATTERS ON THE AGENDA OF THE EXTRAORDINARY GENERAL MEETING

1.   Opening of the meeting

2.   Calling the meeting to order

3.   Election of persons to scrutinise the minutes and to supervise the counting of votes

4.   Recording the legality of the meeting

5.   Recording the attendance at the meeting and adoption of the list of votes

6.   Measures to remedy equity shortfall and authorising the Board of Directors to decide on the issuance of shares, options or other special rights entitling to shares

The Company is exploring possibilities for raising further capital in order to strengthen the financial position of the Company. The Board of Directors proposes that the Extraordinary General Meeting authorise the Board of Directors to resolve by one or several decisions on issuances of shares, options or other special rights entitling to shares referred to in chapter 10, section 1 of the Finnish Limited Liability Companies Act, which authorisation contains the right to issue new shares or dispose of the shares in the possession of the Company. The authorisation would consist of up to 7,871,000 shares in the aggregate (including shares to be received based on options or other special rights), which corresponds to approximately 20 per cent of the existing shares and votes in the Company.

The authorisation would not exclude the Board of Directors’ right to decide on the issuance of shares, options or other special rights entitling to shares in deviation from the shareholders’ pre-emptive rights. The authorisation is proposed to be used for material arrangements from the Company’s point of view, such as financing or implementing business arrangements, investments or for other such purposes determined by the Board of Directors in which case a weighty financial reason for issuing shares, options or other special rights entitling to shares and possibly deviating from the shareholders’ pre-emptive rights, would exist.

The Board of Directors would be authorised to resolve on all other terms and conditions of the issuance of shares, options or other special rights entitling to shares.

The authorisation will be effective until 30 June 2020. The proposed authorisation shall replace the authorisation for up to 7,095,000 shares in the aggregate granted by the Company’s Annual General Meeting held on 28 May 2019 (the “2019 AGM“) concerning the issuance of shares, options or other special rights entitling to shares. The proposed authorisation shall not replace the authorisation for up to 2,000,000 shares in the aggregate granted by the 2019 AGM concerning issuances of options or other special rights entitling to shares referred to in chapter 10, section 1 of the Finnish Limited Liability Companies Act.

7.   Closing of the meeting

B.   DOCUMENTS OF THE EXTRAORDINARY GENERAL MEETING

The above-mentioned proposals to the Extraordinary General Meeting, the Company’s Annual Report 2018 including the financial statements, the Report of the Board of Directors and the Auditor’s Report, the half-yearly report for the six months ended 30 June 2019, the statement by the Board of Directors on events after the preparation of the half-yearly report with a material effect on the Company and this notice are available on the Company’s website at https://www.faron.com/ (link on the homepage) as of the date of publication of this notice. The Board proposals and the other above-mentioned documents will also be available at the Extraordinary General Meeting. Copies of these documents and of this notice will be sent to shareholders upon request. The minutes of the Extraordinary General Meeting will be available to be viewed on the Company’s website from 8 November 2019 at the latest.

C.  INSTRUCTIONS FOR THE PARTICIPANTS

1.   The right to participate and registration

Each shareholder who on the record date of the Extraordinary General Meeting, being 15 October 2019, is registered in the Company’s shareholders’ register held by Euroclear Finland Ltd has the right to participate in the Extraordinary General Meeting. A shareholder whose shares are registered on their personal book-entry account is registered in the Company’s shareholders’ register.

A shareholder who is registered in the Company’s shareholders’ register and who wants to participate in the Extraordinary General Meeting should register for the meeting by no later than 4 p.m. (Finnish time) on Tuesday, 22 October 2019 by giving a prior notice of participation:

•     by email to virve.nurmi@faron.com; or

•     by mail to Faron Pharmaceuticals Ltd, attn. Virve Nurmi, Joukahaisenkatu 6, FI-20520 Turku, Finland.

When registering, a shareholder shall state their name, personal identification number / business identity code, address, telephone number and the name of a possible proxy representative or assistant and the personal identification number of the proxy representative. The personal data given by shareholders to the Company are used only in connection with the Extraordinary General Meeting and the necessary processing of related registrations.

Shareholders, and their authorised representatives or proxy representatives should, when necessary, be able to prove their identity and/or right of representation.

2.   Proxy representative and powers of attorney

Shareholders may participate in the Extraordinary General Meeting and exercise their rights at the meeting by way of proxy representation. A proxy representative must present a dated power of attorney or other reliable proof of their authority to represent the shareholder.

A shareholder may participate in the Extraordinary General Meeting by means of several proxy representatives, who represent the shareholder with shares held on different book-entry accounts. In such case, the shares represented by each proxy representative shall be identified when registering for the Extraordinary General Meeting.

Possible proxy documents should be sent in originals to Faron Pharmaceuticals Ltd, attn. Virve Nurmi, Joukahaisenkatu 6, FI-20520 Turku, Finland before the end of registration period.

3.   Holder of nominee-registered shares (including depositary interest holders)

A holder of nominee-registered shares (including depositary interest holders) has the right to participate in the Extraordinary General Meeting by virtue of such shares based on which the holder would be entitled to be registered in the Company’s shareholders’ register held by Euroclear Finland Ltd on the Extraordinary General Meeting’s record date of 15 October 2019.

Additionally, participation requires that the holder of nominee-registered shares is temporarily registered in the Company’s shareholders’ register held by Euroclear Finland Ltd by 10 a.m. (Finnish time) on Tuesday, 22 October 2019. Temporary registration in the shareholders’ register shall be deemed to be a registration for the Extraordinary General Meeting.

Holders of nominee-registered shares are advised to request the necessary instructions regarding the temporary registration in the shareholders’ register, the issuing of proxy documents and registration for the General Meeting from their custodian bank without delay. The account management organisation of the custodian bank shall notify a holder of nominee-registered shares who wants to participate in the Extraordinary General Meeting to be temporarily entered into the Company’s shareholders’ register by the above-mentioned time.

4.   Other instructions and information

Pursuant to chapter 5, section 25 of the Finnish Limited Liability Companies Act, shareholders who are present at the Extraordinary General Meeting are entitled to request information regarding the matters addressed by the meeting.

On the date of this notice, 4 October 2019, the total number of shares and votes in the Company is 39,355,247.

The Extraordinary General Meeting shall be held in Finnish and in English.

Turku, 4 October 2019

FARON PHARMACEUTICALS LTD

Board of Directors

The information contained within this announcement is deemed to constitute inside information as stipulated under the Market Abuse Regulation (EU) No. 596/2014. Upon the publication of this announcement, this inside information is now considered to be in the public domain.

For more information please contact:

Faron Pharmaceuticals Ltd

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com 

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

Panmure Gordon (UK) Limited, Nomad and Broker

Emma Earl, Freddy Crossley (Corporate Finance)

James Stearns (Corporate Broking)

Phone: +44 207 886 2500

Westwicke Partners, IR (US)

Chris Brinzey

Phone: 01 339 970 2843

E-mail: chris.brinzey@westwicke.com

About Faron Pharmaceuticals Ltd

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. 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. 

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

Update on Traumakine drug substance manufacturing

TURKU – FINLAND, 02 October 2019 – Faron Pharmaceuticals Oy (AIM: FARN), the clinical stage biopharmaceutical company, announces that further to the update provided in the H1 2019 interim results in relation to the active pharmaceutical ingredient (“API”) manufacturing process for Traumakine, Rentschler Biopharma SE (“Rentschler”) has sent Faron a letter in which Rentschler states that it terminates the agreement concerning the API manufacturing. It is the Company’s understanding that this relates to the fact that significant upgrading of the API manufacturing process would be required prior to MAA/BLA approval for Traumakine.

The Company is exploring various options for future API manufacturing. This termination has no impact on the currently on-going clinical advice process with FDA/EMA, which focuses on the structure of the next Traumakine clinical study.

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

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

Westwicke Partners, IR (US)

Chris Brinzey

Phone: 01 339 970 2843

E-Mail: chris.brinzey@westwicke.com

About Faron Pharmaceuticals Ltd

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. 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) and progressing in phase II trial for the Rupture of Abdominal Aorta Aneurysm (“RAAA”). 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

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

Poster discussion presentation at ESMO Congress highlights effective immune switch in MATINS patients with advanced solid tumours

TURKU – FINLAND, 30 September 2019 – Faron Pharmaceuticals Oy (AIM: FARN), the clinical stage biopharmaceutical company, today announces details from a poster discussion presentation held at the European Society of Medical Oncology (ESMO) 2019 Congress to showcase recent data from its ongoing MATINS study.

The phase I/II MATINS clinical trial is investigating the 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. During the session Dr Petri Bono, principal investigator of the MATINS trial, presented data showing Clevegen’s potential early efficacy and good tolerability. The discussion highlighted:

·    Good tolerability across all dosing levels with no dose limiting toxicity (DLT) observed. Maximally tolerated dose (MTD) has not been reached yet.

·    Promising clinical anti-tumour activity, evidenced by the trial’s first long-lasting partial responder – a heavily pre-treated metastatic colorectal cancer (CRC) patient, whose tumour had been classified as microsatellite instability (MSI)-low and tumour mutation burden (TMB), and who had previously been treated with six different anti-cancer drugs, which had all failed. MSI-low colorectal patients represent around 90% of all colorectal cancers and over one million annual cases globally.

·    Th1 immune activation was observed in all subjects measured following treatment with Clevegen, confirming earlier ex vivo results with human cells (Palani et al., 2016). The patients also increased circulating CD8+ T cells and CD8+/CD4+ ratio,  decreased regulatory T-cells (T-regs) or had a substantial increase in mobile natural killer (NK) cells in the blood, all signs of this desired immune activation.

·    Clevegen’s potential to overcome the immunosuppressive environment in difficult-to-treat PD-1/PD-L1- resistant immunologically non-inflamed (cold) tumours, by converting them into inflamed (hot) tumours.

·    The ongoing development path investigating Clevegen as a monotherapy in CRC MSI-low patients and other advanced solid tumours (liver, pancreas, ovarian and melanoma), including targeting patients with hormone receptor-positive breast cancer, gastric cancer and uveal melanomas. The potential of Clevegen to bring a synergistic benefit to existing immunotherapies also warrants further investigation through future combination studies.

Commenting on the presented data, Dr. Petri Bono, principal investigator of the MATINS study, said: “We are very encouraged by the progress of this trial. The emerging tolerability profile and early signs of clinical benefit from this novel anti Clever-1 antibody are promising, particularly as the patients enrolled in the MATINS trial had already received several lines of treatment and exhausted all available options for further therapy. Early indications of its potential to convert cold tumours to hot are an important signal for the next wave of immunotherapies in development and we look forward to generating further data as the trial continues.”

The poster discussion was held at ESMO 2019, Barcelona, on 28 September 2019. The full abstract and poster are available online at the ESMO Congress website: https://www.esmo.org

Title: Immune activation with a novel immune switch anti-macrophage antibody (anti-Clever-1 mAb; FP-1305) in phase I/II first-in-human MATINS trial in patients with advanced solid tumours

Presenter: Dr. Petri Bono, MATINS trial principal investigator

Abstract Number: 6587

Further information, including poster and discussion slides, is also available at the company web pages (www.faron.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 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.

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

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

Westwicke Partners, IR (US)

Chris Brinzey

Phone: 01 339 970 2843

E-Mail: chris.brinzey@westwicke.com

About Faron Pharmaceuticals Ltd

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. 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.

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

MATINS study selected for presentation at ESMO 2019 congress

TURKU – FINLAND, 02 September 2019 – Faron Pharmaceuticals Oy (AIM: FARN), the clinical stage biopharmaceutical company, today announces that an abstract highlighting recent data from the Phase I/II MATINS study with Clevegen, its wholly-owned novel precision cancer immunotherapy, has been selected for a poster discussion presentation at the European Society of Medical Oncology (ESMO) 2019 Congress, taking place in Barcelona between 27 September and 1 October, 2019.

Title: Immune activation with a novel immune switch anti-macrophage antibody (anti-Clever-1 mAb; FP-1305) in phase I/II first-in-human MATINS trial in patients with advanced solid tumors

Presenter: Dr. Petri Bono, MATINS trial principal investigator

Abstract Number: 6587

Faron will release further information from the poster and discussion slides to coincide with the start of the official Congress session during which it features.

The full abstract and poster will be made available online at the ESMO Congress website: https://www.esmo.org

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.

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

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

Westwicke Partners, IR (US)

Chris Brinzey

Phone: 01 339 970 2843

E-Mail: chris.brinzey@westwicke.com

About Faron Pharmaceuticals Ltd

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. 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) and progressing in phase II trial for the Rupture of Abdominal Aorta Aneurysm (“RAAA”). 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

NEITHER THIS ANNOUNCEMENT NOR ANY PART OF IT CONSTITUTES AN OFFER TO SELL OR ISSUE OR THE SOLICITATION OF AN OFFER TO BUY, SUBSCRIBE FOR OR ACQUIRE ANY SECURITIES IN ANY JURISDICTION IN WHICH ANY SUCH OFFER OR SOLICITATION WOULD BE UNLAWFUL AND THE INFORMATION CONTAINED HEREIN IS NOT FOR PUBLICATION OR DISTRIBUTION, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES OF AMERICA, AUSTRALIA, CANADA, JAPAN, THE REPUBLIC OF SOUTH AFRICA, SINGAPORE, HONG KONG OR ANY JURISDICTION IN WHICH SUCH PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL.

THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF REGULATION 2014/596/EU. UPON THE PUBLICATION OF THIS ANNOUNCEMENT, THIS INSIDE INFORMATION IS NOW CONSIDERED TO BE IN THE PUBLIC DOMAIN

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

Result of Open Offer and Further Subscription

TURKU – FINLAND, 27 August 2019 – Faron Pharmaceuticals Oy (“Faron”) (AIM: FARN), the clinical stage biopharmaceutical company, announces that following its announcement on 6 August 2019 (the “Open Offer Announcement“), it has received valid acceptances and excess applications from Qualifying Shareholders in respect of a total of 859,513 Open Offer Shares pursuant to the terms of the Open Offer, raising gross proceeds of approximately €1.01 million (£0.92 million) at the Issue Price of £1.06 per share in respect of Qualifying DI Holders and at the Euro Issue Price of €1.19 in respect of Qualifying non-DI Holders.  

In addition to subscriptions under the Open Offer by Qualifying Shareholders the Company has accepted additional subscriptions for 320,000 new Ordinary Shares (being Open Offer Shares not subscribed for under the Open Offer) (“Further Subscription Shares“) at the Euro Issue Price of €1.19 to raise additional gross proceeds of approximately €0.38 million (the “Further Subscription“). The Company has therefore raised approximately €2.5 million (£2.3 million) (before expenses) in aggregate through the Subscription (details of which were included in the Open Offer Announcement), Further Subscription and Open Offer.

Shareholders and investors should note that the net proceeds of the Subscription, Open Offer and Further Subscription, of €2.5 million in aggregate, are expected to provide the Company with working capital into early Q1 2020.  

Result of Open Offer

The Open Offer closed for acceptances by Qualifying DI Holders through CREST at 11.00 a.m. on 22 August 2019 and by Qualifying Non-DI Holders at 11.00 a.m. on 23 August 2019. 519,433 Open Offer Shares were subscribed for by Qualifying DI Holders at the Issue Price and 340,080 Open Offer Shares were subscribed for by Qualifying non-DI Holders at the Euro Issue Price. Qualifying Shareholders who have validly applied for Open Offer Shares will receive their full Open Offer Entitlement. The Open Offer remains conditional upon, registration and issue of the Open Offer Shares, which is expected to occur shortly.

Further Subscription

320,000 Open Offer Shares not subscribed for pursuant to the Open Offer have been subscribed for by new and existing investors at the Issue Price of €1.19 per Ordinary Share, raising gross proceeds of approximately EUR 0.38 million (£0.35 million). The Further Subscription remains conditional on registeration and issue of the Futher Subscription Shares, which is expected shortly. The aggregate number of  shares subscribed for in the Open Offer and Further Subscription of 1,179,513 represents approximately 69.5 per cent. of the 1,696,699 shares available for subscription.

Related Party Transaction

Timo Syrjälä an existing shareholder in the Company, has subscribed for 70,000 Further Subscription Shares in aggregate (subscribed for through Acme Investments SPF Sarl (“Acme“), an entity wholly owned by Mr Syrjälä), for an aggregate subscription value of EUR 0.08 million (£ 0.08 million) at the Euro Issue Price. In addition, Mr Syrjälä and Acme subscribed for 168,198 Open Offer Shares in aggregate pursuant to the Open Offer. Following this Further Subscription and Open Offer, Mr Syrjälä’s total holding in the Company’s shares, which includes his indirect holding through Acme, is 5,718,573 shares, representing 14.53 per cent. of the enlarged issued share capital. Mr Syrjälä is a “Substantial Shareholder” in the Company for the purposes of the AIM Rules. His subscription for Further Subscription Shares and Open Offer Shares pursuant to the Capital Raising is a related party transaction for the purposes of the AIM Rules. The Directors, all of whom are independent of Mr Syrjälä, having consulted with Panmure Gordon, the Company’s nominated adviser for the purposes of the AIM Rules, consider the terms of the participation by Mr Syrjälä in the Further Subscription and Open Offer to be fair and reasonable insofar as Shareholders are concerned.

Admission

Applications have been made to the London Stock Exchange for 859,513 Open Offer Shares and 320,000 Further Subscription Shares, to be admitted to trading on AIM. It is expected that Admission of the Open Offer Shares and Further Subscription Shares will take place at 8.00 a.m. on 28 August 2019. The Open Offer Shares will rank pari passu with the existing Ordinary Shares. Following issue of the Open Offer Shares and Further Subscription Shares (expected later today), the Company’s issued share capital will consist of 39,355,247 Ordinary Shares. There are no Ordinary Shares held in treasury. Therefore, in accordance with the FCA’s Disclosure Guidance and Transparency Rule 5.6.1, the Company confirms that, the total number of voting rights in the Company will be 39,355,247.This figure may be used by shareholders as the denominator for the calculations by which they determine whether they are required to notify their interest in, or a change to their interest in, the Company under the Disclosure Guidance and Transparency Rules.

Defined terms used in this announcement have the same meanings as in Open Offer Announcement.

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 = €1.097, being the published exchange rate by the European Central Bank at the close of business on 22 August 2019.

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

Consilium Strategic Communications

Mary-Jane Elliott

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

Westwicke Partners, IR (US)

Chris Brinzey

Phone: 01 339 970 2843

E-Mail: chris.brinzey@westwicke.com

About Faron Pharmaceuticals Ltd

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. 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) and progressing in phase II trial for the Rupture of Abdominal Aorta Aneurysm (“RAAA”). 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.

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

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 PHARMACEUTICALS OY (“FARON”) OR ANY OTHER ENTITY IN ANY JURISDICTION IN WHICH ANY SUCH OFFER WOULD BE UNLAWFUL.

FARON HAS NOT TAKEN ANY ACTION, NOR WILL IT TAKE ANY ACTION, TO OFFER ANY OF THE SUBSCRIPTION SHARES OR ANY OTHER DOCUMENTS RELATING TO THE SUBSCRIPTION TO THE PUBLIC IN FINLAND, SWEDEN, NORWAY OR DENMARK, OR IN ANY OTHER JURISDICTION IN ANY FORM WHICH WOULD CONSTITUTE AN OFFER TO THE PUBLIC.

NEITHER THE SUBSCRIPTION SHARES NOR THE OPEN OFFER SHARES WILL 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. THERE IS NO PUBLIC OFFERING IN THE UNITED STATES, THE UNITED KINGDOM OR ELSEWHERE. NEITHER THE THE SUBSCRIPTION SHARES OR THE OPEN OFFER SHARES HAVE 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 SUBSCRIPTION OR THE OPEN OFFER 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”)

Subscription and Open Offer

TURKU – FINLAND, 5 August 2019 – Faron Pharmaceuticals Oy (“Faron”) (AIM: FARN), the clinical stage biopharmaceutical company, is pleased to announce a subscription of new ordinary shares in the capital of the Company (the “Subscription“) to raise proceeds of approximately € 1.12 million (£1.00 million) before expenses. The Subscription comprises the issue of 941,840 new ordinary shares (the “Subscription Shares“) at the issue price of of €1.19 per share (“Euro Issue Price“).

In addition, to provide Qualifying Shareholders (being those shareholders of the Company on the register of shareholders at the record date, which is expected to be on or shortly after 6 August 2019) (“the “Record Date“) with an opportunity to participate in the fundraise at a sterling equivalent issue price of £1.06 per per share (“Issue Price“), subject to completion of the Subscription, the Company proposes to make an open offer (the “Open Offer“) to all Qualifying Shareholders to raise additional gross proceeds for the Company of up to approximately €2.0 million (£1.8 million) through the issue of up to 1,696,699 new ordinary shares (“Open Offer Shares”) on the basis of 2 Open Offer Share for every 45 existing ordinary shares held by Qualifying Shareholders. Shareholders subscribing for their full entitlement under the Open Offer may also request additional Open Offer Shares through an excess entitlement application facility. The Subscription and Open Offer are together referred to as the “Capital Raising“. 

A circular and a basic information document relating to the Open Offer are expected to be published on or around 6 August 2019. 

Admission of the Subscription Shares to trading on AIM is expected to be on or around 6 August 2019 (“First Admission“) and, assuming successful completion of the Subscription and the subsequent launch of the Open Offer, admission of the Open Offer Shares to trading on AIM is expected to be on or around 28 August 2019 (“Second Admission“).

REASONS FOR THE PROPOSED CAPITAL RAISING

The net proceeds of the Capital Raising will primarily be used to fund further clinical development of Clevegen by:

·    Completing part I of the MATINS trial to determine the maximum tolerated dose and optimal dose for part II,  and to initiate cohort expansion in colorectal cancer (“CRC”) in Q4 2019

·    Providing working capital whilst Faron seeks to negotiate and enter into a licensing agreement in respect of Clevegen in H2 2019

In addition, the net proceeds of the Capital Raising will be used to fund the commercialisation preparation of Traumakine by seeking scientific advice and regulatory approval for the CALIBER study in H2 2019.

Subject to a significant proportion of the Open Offer Shares being subscribed for (and/or receipt of alternative sources of funding),  the Company plans to execute the Company’s plan to include US study sites to MATINS trial for expansion of distinct cancer cohorts in Q4 2019.

Shareholders and investors should note that the net proceeds of the Subscription are expected to extend the Company’s working capital to the end of Q4 2019 while the proceeds of the Capital Raising  (to the extent a significant proportion of the Open Offer Shares are subscribed for) are expected to provide the Company with working capital into early Q1 2020.  The Company continues to seek to partner Clevegen (targeting an upfront payment) and while it cannot be guaranteed, the Company hopes to conclude a licencing agreement by the end of 2019. In the meantime, as previously announced, the Company will continue to explore other potential sources of funding.

DETAILS OF THE SUBSCRIPTION AND OPEN OFFER AND ISSUE OF EQUITY

The Subscription Shares and Open Offer Shares will be issued by the Company at the Issue Price (or the Euro Issue Price where applicable) pursuant to the Directors’ existing authority to allot ordinary shares in the capital of the Company (“Ordinary Shares“) for cash on a non-pre-emptive basis, as approved by shareholders at the Company’s last annual general meeting which was held on 28 May 2019. Legally binding commitments have been in received (in the form of subscription letters) in respect of all Subscription Shares.

In order to comply with local securities law in Finland, the Open Offer Shares must be issued and registered at the Finnish Trade Registry prior to Second Admission. Accordingly, whilst application will be made for admission of the Subscription Shares and (in due course) the Open Offer Shares to trading on AIM, neither the Subscription nor the Open Offer are conditional on admission of the relevant shares to trading on AIM. The Subscription and the Open Offer are not being underwritten. The Open Offer is conditional on completion of the Subscription.

Application has been made for admission of the Subscription Shares to trading on AIM. It is expected that First Admission will become effective and that dealings in the Subscription Shares will commence on or around 8.00 a.m. on 6 August 2019.

Faron’s enlarged issued share capital immediately following registration of the Subscription Shares and  First Admission will be 38,175,734 Ordinary Shares with voting rights attached. The Company has no shares in Treasury; therefore upon, and subject to, registration, (which is expected to occur shortly) the total number of voting rights in Faron will be 38,175,734 (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.

Further details of the Open Offer will be made available in a circular and basic information document to Shareholders which, subject to completion of the Subscription, is expected to be published on or around 6  August 2019.

RELATED PARTY TRANSACTION

Timo Syrjälä an existing shareholder in the Company, has subscribed for 550,000 Subscription Shares in aggregate (250,000 Subscription Shares subscribed for directly and 300,000 Subscription Shares through Acme Investments SPF Sarl (“Acme“), an entity wholly owned by Mr Syrjälä), for an aggregate subscription value of EUR 0.65 million (£0.54 million) at the Euro Issue Price. Following this Subscription, Mr Syrjälä’s total holding in the Company’s shares, which includes his indirect holding through Acme, is 5,430,375 shares, representing 14.2 per cent. of the Enlarged Number of Shares and Votes. Mr Syrjälä is a “Substantial Shareholder” in the Company for the purposes of the AIM Rules. His subscription for Subscription Shares pursuant to the Capital Raising is a related party transaction for the purposes of the AIM Rules. The Directors, all of whom are independent of Mr Syrjälä, having consulted with Panmure Gordon, the Company’s nominated adviser for the purposes of the AIM Rules, consider the terms of the participation by Mr Syrjälä in the Subscription to be fair and reasonable insofar as Shareholders are concerned.

FARON OVERVIEW

Faron is a clinical stage biopharmaceutical company developing novel treatments for medical conditions with significant unmet needs. Faron’s drug development is based on extensive knowledge of receptors involved in regulation of immune responses and vascular dysfunctions. The Company currently has two technology platforms (Clevegen® and Traumakine®) and a pipeline focusing on cancer immunotherapy, acute organ traumas and vascular damage.

The Company’s drug candidate, Clevegen, is an early clinical anti-Clever-1 antibody. The Directors believe that Clevegen has the ability to switch immune suppression to immune activation in various conditions, with potential across oncology, infectious disease and vaccine development. The other candidate is Traumakine, to prevent vascular leakage and organ failures.

Innovations for the business have primarily been sourced from academic institutions including, but not limited to Turku University, Finland. The inventions behind both Traumakine and Clevegen were sourced from scientists working at Turku University (Professor Sirpa Jalkanen, the wife of the Company’s CEO Markku Jalkanen, and Professor Marko Salmi).

The Company is developing its drug candidates through research and discovery, drug development and clinical trials. Discovery and development are guided by top-tier scientists in Faron’s network and the clinical development utilises Company’s in-depth pharmacological knowledge of the drug candidates. The Company aims to accelerate time to market via focusing on rare diseases and/or high unmet medical indications based on its proprietary molecules and IPR. In market access and commercialisation the Company seeks to complementary partner to optimise the usage of resources and to create value. The aim is to gradually build-up integrated global pharma functions

PROGRESS OF CLEVEGEN

In 2019, the Company’s focus has been on the development of Clevegen which is currently undergoing an open label phase I/II MATINS clinical trial. 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”).

Clevegen dosing reached its planned maximum of 10mg/kg in mid-June, which has continued to be well tolerated. No dose limiting toxicity (DLT) nor maximally tolerated dose (MTD) has been observed so far. The trial includes an option to administer a 20mg/kg dose, which the Company intends to propose to the trial’s independent data monitoring board.

Of the nine subjects dosed so far in the Clevegen trial, across three clinical trial sites in Finland and the UK, two subjects have shown clinical anti-cancer responses. The first patient, a partial responder with colorectal cancer (“CRC“) whose initial treatment progress was announced on 11 April 2019, showed a continuation of lung metastasis shrinkage according to the latest tumour imaging report at the end of May. The subject’s tumour load marker CEA (carcinogenic embryonal antigen), which measures tumour mass of CRC, has also normalised. A second subject with CRC has shown an initial decrease in CEA (-40%) and tumour stabilization.

The Directors believe that all of the study subjects dosed in the trial have experienced a switch in their immune cell profiles following treatment with Clevegen towards increased immune activation. Typically this has been observed by one or more of the following: increased CD8+ cells, an increased in the CD8+/CD4+ ratio, a decrease in regulatory T-cells (T-regs) and a substantial increase in mobile natural killer (NK) cells in the blood. These changes were measurable immediately post-dosing, indicating a dynamic response in the immunological switch to immune-activation after the immunotherapeutic blockade of Clever-1. Data indicates that dose escalation results in prolonged Clever-1 occupancy of the blood monocytes during the first two weeks of the three-week dosing cycle before a decrease to baseline levels prior to the next dosing cycle. 

The majority of patients in the trial have received 5-7 different treatment lines prior entering the MATINS study. Faron is investigating why the observed immune activation has not turned into anti-tumour activity in all study subjects but only in part. The Company believes the patient’s immune system receiving Clevegen as a last line of therapy could have been adversely affected by the underlying therapies they have received prior to taking part in the MATINS study, as previous chemotherapies can inactivate bone marrow, preventing revitalization of the immune system.

As the trial is an open label study, the Company expects to report findings as the dosing progresses. The planned distinct cohort expansions during Part II of the study 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 CRC has been selected as the first expansion cohort in Part II. Faron also intends, subject to regulatory approval, to amend the MATINS trial to allow inclusion of hormone receptor-positive breast cancer, gastric cancer and uveal melanoma, based on striking translational data on CLEVER-1 positive cancer types and current poor survival rates and associated with high Clever-1 expression. Additionally Faron has recently filed a pre-IND package to the FDA. If accepted, Faron plans to open new sites in the US and facilitate expansion of the CRC cohort as fast as possible. Similarly, Faron is planning to include top cancer centres in France and Spain as the next European countries to join the MATINS trial.

TRAUMAKINE UPDATE

Traumakine has previously undergone two phase III studies for the treatment of ARDS (one of these trials being conducted the Company’s Japanese partner, Maruishi). Topline data from the Company’s Phase III INTEREST trial was announced on 8 May 2018 showing that the trial did not meet its primary endpoint although reduced mortality was seen in a sub-group of patients with a biomarker response (MxA and CD73 induction). Further announcements have since been made (including but not limited to those made on 14 June 2018, 22 October 2018, 5 December 2018 and 14 June 2019) in respect of post-hoc analysis from the INTEREST trial and a follow-up pharmacokinetic/dynamic study in health volunteers (YODA).  In particular, post-hoc findings from INTEREST and YODA suggest that concomitant use of corticosteroids and Traumakine appeared to adversely affect both the mortality and biomarker appearance among INTEREST trial patients, indicating corticosteroid interference with Traumakine action. Results from the Japanese Traumakine Phase III trial for ARDS, which also included high levels of concomitant corticosteroid use and which were announced on 29 April 2019, were in line with results from the INTEREST trial.

Interim results of the Company’s Phase II study examining the effect of Traumakine on mortality (predominantly multi organ failures (MOF)) and pharmacodynamic biomarkers of surgically operated RAAA patients (INFORAAA trial) were announced 26 June 2019. Whilst biomarker (MxA and CD73) responses indicated a good interferon response from Traumakine, unexpectedly, concomitant corticosterone was recorded both in the active (28%) and placebo (30%) treatment arm. While the removal of corticosteroid-treated patients from statistical analysis reduced group sizes and made statistical interim mortality analysis meaningless, a trend toward reduction of mortality was seen in the Traumakine-treated patients who did not receive corticosteroids.

The Company is conducting a full review of all the Traumakine data with key opinion leaders in order to make decisions on Traumakine’s future development (including continuance of the Company’s INFORAAA trial given the unexpected levels of concomitant corticosteroid use seen in the trial to date). The Company is currently in the process of designing a new global Phase III trial for Traumakine treatment (CALIBER) for the treatment of ARDS taking into account the high levels of concomitant used as a standard of care for ARDS and some RAAA patients and is in the process of seeking regulatory feedback on the proposed trial. The Company envisages that further Traumakine trials are likely to be funded through a third party.

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 = €1.124, being the published exchange rate by the European Central Bank at the close of business on 25 July 2019.

MARKET ABUSE REGULATION

Market Soundings, as defined in the Market Abuse Regulation (“MAR“), were taken in respect of the Capital Raising with the result that certain persons became aware of inside information, as permitted by MAR. That inside information in relation to the Capital Raising 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 a Market Sounding are no longer in possession of inside information relating to the Company and its securities.

Panmure Gordon (UK) Limited, which is regulated in the UK by the Financial Conduct Authority, is acting as Nominated Adviser and Corporate Broker to the Company and no one else in connection with the Capital Raising. 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.

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

Consilium Strategic Communications

Mary-Jane Elliott

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

Westwicke Partners, IR (US)

Chris Brinzey

Phone: 01 339 970 2843

E-Mail: chris.brinzey@westwicke.com

About Faron Pharmaceuticals Ltd

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 focusing on acute organ traumas, vascular damage and cancer immunotherapy. The Company’s first candidate Traumakine, to prevent vascular leakage and organ failures, has completed a Phase III clinical trial in Acute Respiratory Distress Syndrome (ARDS). An additional European Phase II Traumakine trial is underway for the Rupture of Abdominal Aorta Aneurysm (“RAAA”). Faron’s second candidate Clevegen is a ground breaking early clinical anti-Clever-1 antibody. Clevegen has the ability to switch immune suppression to immune activation in various conditions, with potential across oncology, infectious disease and vaccine development. This novel macrophage-directed immuno-oncology switch called Turn-on-your-Immunity or Turn-It may be used alone or in combination with other immune checkpoint molecules for the treatment of cancer patients. 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.

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

Final results from YODA study confirm previously reported findings

TURKU – FINLAND, 14 June 2019 – Faron Pharmaceuticals Oy (AIM: FARN), the clinical stage biopharmaceutical company, today announces results from its pharmacokinetic/dynamic YODA study examining the administration of concomitant steroids and Traumakine in healthy volunteers.

As previously reported, the post-hoc analysis of the phase III INTEREST study had indicated significant reduction of interferon-beta (“IFN-beta”) action by steroids and this finding was also observed in the Japanese phase III study. Steroid interference with IFN-beta was also reported in ex vivo human lung tissues and human primary lung endothelial cells. The YODA study was set out to further investigate this observed finding in a prospective study setting in human healthy volunteers by administrating Traumakine alone or Traumakine in combination with prednisolone (a corticosteroid).

As previously announced, parts I and II of the YODA study confirmed that the INTEREST study drug produced the expected levels of bioactivity, suggesting that drug formulation was not a factor in the outcome of the INTEREST trial and this observation was confirmed during part III of the YODA trial. The concomitant use of IFN beta-1a and prednisolone during part III reduced IFN beta-1a action, compared to subjects who received IFN beta-1a alone. This was evident during the YODA trial through both clinical signs of the subjects (fever, which is a typical pharmacodynamic effect of interferon beta-1a) and reduction of cluster of differentiation 73 (CD73) activity responses measured from blood samples of these subjects. For the final statistical analysis, 10 subjects were included in the Traumakine group (two drop outs due to strong “flu reaction”) and 12 subjects in the group receiving Traumakine in combination with prednisolone. The statistical AUC (area under curve) difference in CD73 activity between the two groups (10 versus 12 subjects) was p = 0.087. CD73 is regarded as the key molecule to maintain the endothelial barrier, which if it leaks, can cause impaired lung function and result in the life-threatening syndrome, ARDS. Traumakine is designed to prevent this leakage by upregulating CD73 expression.

Dr Markku Jalkanen, Chief Executive Officer of Faron, said: “These YODA results once again are consistent with the INTEREST data, supporting the conclusion that co-administration of steroids with Traumakine in patients inhibited interferon beta action. These findings are significant in explaining the lack of clinical response to Traumakine in the INTEREST trial. The YODA report will become an essential part of our communication dossier with the FDA and EMA when we justify our clinical double dummy design for the concomitant use of steroids for the next Traumakine studies.”  

The Company currently expects to receive the INFORAAA interim results in the near future, allowing full review of all the Traumakine data with key opinion leaders and to make final decisions on Traumakine’s development. The Company currently envisages that a further Traumakine trial is likely to be funded through third party funding. Low concomitant corticosteroid use is expected during the INFORAAA trial.

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

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

Westwicke Partners, IR (US)

Chris Brinzey

Phone: 01 339 970 2843

E-Mail: chris.brinzey@westwicke.com

About Faron Pharmaceuticals Ltd

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 focusing on acute organ traumas, vascular damage and cancer immunotherapy. The Company’s first candidate Traumakine, to prevent vascular leakage and organ failures, has completed a Phase III clinical trial in Acute Respiratory Distress Syndrome (ARDS). An additional European Phase II Traumakine trial is underway for the Rupture of Abdominal Aorta Aneurysm (“RAAA”). Faron’s second candidate Clevegen is a ground breaking early clinical anti-Clever-1 antibody. Clevegen has the ability to switch immune suppression to immune activation in various conditions, with potential across oncology, infectious disease and vaccine development. This novel macrophage-directed immuno-oncology switch called Turn-on-your-Immunity or Turn-It may be used alone or in combination with other immune checkpoint molecules for the treatment of cancer patients. Faron is based in Turku, Finland. Further information is available at www.faron.com