Faron Pharma Regulatory News (FARN)

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 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. NEITHER THIS ANNOUNCEMENT NOR THE FACT OF ITS DISTRIBUTION, SHALL FORM THE BASIS OF, OR BE RELIED ON IN CONNECTION WITH ANY INVESTMENT DECISION IN RESPECT OF FARON.

THE PROPOSED TRANSACTION REFERRED TO IN THIS ANNOUNCEMENT WOULD BE MADE PURSUANT TO A PRIVATE PLACEMENT EXEMPTION UNDER THE EUROPEAN DIRECTIVE 2003/71/EC (AND AMENDMENTS THERETO (THE "PROSPECTUS DIRECTIVE"), AS IMPLEMENTED IN THE MEMBER STATES OF THE EUROPEAN ECONOMIC AREA, FROM THE REQUIREMENTS TO PRODUCE A PROSPECTUS UNDER THE PROSPECTUS DIRECTIVE FOR OFFERS OF SECURITIES. FARON HAS NOT TAKEN ANY ACTION, NOR WILL IT TAKE ANY ACTION, TO OFFER ANY SECURITIES OR ANY OTHER DOCUMENTS RELATING TO THE PROPOSED TRANSACTION 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 HAVE NOT BEEN AND 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 OF THE PLACING SHARES IN THE UNITED STATES, THE UNITED KINGDOM OR ELSEWHERE. NO REPRESENTATION IS BEING MADE AS TO THE AVAILABILITY OF ANY EXEMPTION UNDER THE SECURITIES ACT FOR THE REOFFER, RESALE, PLEDGE OR TRANSFER OF THE PLACING SHARES. 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 Placing and Subscription to raise approximately €3 million

TURKU - FINLAND, 26 March 2019 - Faron Pharmaceuticals Oy ("Faron") (AIM: FARN), the clinical stage biopharmaceutical company, is pleased to announce a proposed placing and subscription of new ordinary shares in the capital of the Company (the "Placing" and the "Subscription" respectively and together the "Fundraise") to raise, in aggregate, approximately €3 million before expenses.

The Placing to institutional investors will be conducted by way of an accelerated bookbuild process (the "Bookbuild") which will be launched immediately following this announcement. The Fundraise is expected to be conducted at or around the prevailing market price with the final price to be determined during the Bookbuild ("Issue Price").

KEY HIGHLIGHTS

· Proposed placing of new ordinary shares ("Placing Shares") at the Issue Price with institutional investors and proposed subscription for new ordinary shares ("Subscription Shares") at the Issue Price by certain existing shareholders/investors to raise approximately €3 million (£2.5 million) in aggregate

· Certain Directors and a member of the Scientific Advisory Board intend to subscribe for, in aggregate, approximately €0.5 million through the Fundraise

· The net proceeds of the proposed Placing and Subscription would be used to, inter alia:

o Advance the Clevegen clinical development programme, the MATINS trial

o Further Traumakine development through the design and preparation of a global Phase III clinical trial, CALIBER

o Advance partnering discussions in respect of both Traumakine and Clevegen

· Approximate net proceeds of the Fundraise of approximately €2.8 million, if subscribed, are expected to provide the Company with working capital into Q3 2019

Panmure Gordon (UK) Limited ("Panmure Gordon") is acting as Nominated Adviser, Sole Bookrunner and Corporate Broker to the Company.

Admission of the Placing Shares and Subscription Shares to trading on AIM is expected to be on or around 29 March 2019.

As soon as practicable after closing of the Bookbuild, an announcement will be made to confirm the Issue Price and the number of Placing Shares and Subscription Shares to be issued by the Company (subject still to, inter alia, binding letters of commitment being received and the Issue Condition as described further below). A further announcement will be made once the Placing and Subscription have been finalised and binding letters of commitment received, with such announcement being made by no later than 5.00 p.m on 29 March 2019. Further terms of the proposed Placing and Subscription are set out below.

Commenting on the proposed Placing and Subscription Dr Markku Jalkanen, CEO of Faron, said: "Our staff and scientific collaborators have done a treamendous job of identifying reasons behind the unexpected INTEREST study results, as well as advancing the MATINS trial to dose escalation stage. This provides Faron with the opportunity to further two significant clinical programmes, which aim to help people with serious life threatening conditions like organ damage and cancer. I am also extremely happy with the level of support indicated by exisiting shareholders, Company directors and employees in this financing round. We are very excited to have two cinical programmes to progress further towards effective treatments."

REASONS FOR THE PROPOSED PLACING AND SUBSCRIPTION

In addition to providing working capital, the net proceeds of the Placing and Subscription will be used to fund the commercialisation preparation of Traumakine through:

· The design and preparation of a new Phase III study, called CALIBER, based on INTEREST data post hoc analysis

· Seeking approval for the CALIBER trial from both the FDA and EMA.

The regulatory feedback process with the EMA and FDA has been initiated in respect of the CALIBER trial design and feedback is expected in Q3 2019. The Company is exploring options for financing the study and intends to make a decision on this at a later stage.

The net proceeds will also be used to fund further clinical development of Clevegen by:

· Seeking pre-IND feedback from the FDA prior to filing a US IND to include US study sites in the MATINS trial

· Preparing filing documents to expand Clevegen clinical development in additional cancers such as glioblastoma.

The Company is seeking to partner Clevegen in 2019 and is currently engaged in numerous potential partnering negotiations including with several large pharma companies. The Company is targeting a significant upfront licence fee as part of an overall potential licence deal. The Company expects to have Clevegen safety and surrogate biomarker data, and potentially initial efficacy observations in H1 2019.

Shareholders and investors should note that the net proceeds of the Subscription and Placing are not expected to provide the Company with 12 months of working capital.

In addition to the Fundraise, the Company is exploring a variety of additional sources of funding and longer term funding arrangements, including discussions with potential licensees, grants, strategic investors, soft loans and an equity draw down facility. Discussions are ongoing across funding arrangements and further announcements will be made as and when required.

DETAILS OF THE PROPOSED PLACING AND SUBSCRIPTION AND ISSUE OF EQUITY

Subject to the Placing Shares and Subscription Shares being subscribed for in full, they will be issued by the Company at the Issue Price 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 31 May 2018. The Company has received non-binding indications of interest from potential investors for the Placing and Subscription during a pre-marketing process.

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

· the Placing Agreement having become unconditional in all respects;

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

· legally binding commitments being received (in the form of placing letters) in respect of all of the Placing Shares and the Subscription Shares (the "Placee Condition"); and

· the Placing Shares and the Subscription Shares being issued and being registered at the Finnish Trade Registry (the "Issue Condition").

The Placing will be conducted by way of an accelerated bookbuild process (the "Bookbuild") which will be launched immediately following this announcement. Panmure Gordon is acting as sole bookrunner in relation to the Placing. It is envisaged that the Bookbuild will be closed at 11:30 a.m. (GMT) on 26 March 2019, but Panmure Gordon reserve the right to close the book earlier or later, without further notice. Members of the public are not eligible to participate in the Placing.

Details of the results of the Placing, including the number of Placing Shares and Subscription Shares and the approximate gross proceeds will be announced as soon as possible following closure of the Bookbuild. As set out above, a further announcement will then be made once the Placing and Subscription have been finalised and binding letters of commitment received, with such announcement being made by no later than 5.00 p.m on 29 March 2019.

The 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 Placing Agreement in certain circumstances before satisfaction of the Issue 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 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 Placing. In order to comply with local securities law in Finland, the Issue Condition will be satisfied prior to the admission of the Placing Shares and Subscription Shares to trading on AIM ("Admission"). Accordingly, pursuant to the terms of the Placing Agreement, Panmure Gordon has agreed to underwrite the subscription for and payment to the Company of the Issue Price for the Placing Shares upon satisfaction of the Placee Condition.

The Subscription is not conditional on the Placing but is conditional on the receipt of binding commitment letters and issue of the Subscription Shares.

Subject to the Placing Shares and Subscription Shares ("New Shares") being fully subscribed for and all conditions being met, an application will be made for admission of the New Shares to trading on AIM. It is expected that Admission will become effective and that dealings in the New Shares will commence on or around 8.00 a.m. on 29 March 2019. As noted above, further update announcements will be made in due course.

FURTHERING TRAUMAKINE DEVELOPMENT

As previously reported, detailed analyses undertaken by the Company and its scientific network during the last eight months have revealed the potential causes of the INTEREST trial results. Topline data from the trial was announced on 8 May 2018 and subsequent announcements in respect of post-hoc analysis include those made on 14 June 2018, 22 October 2018 and 5 December 2018. In particular, these findings include 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. The Company has confirmed this interference in human ex vivo lung samples and expects similar results from the ongoing YODA study with healthy volunteers which is expected to conclude in Q2 2019.

The Company continues to await the outcome of the trial and clinical study report from the phase III Traumakine ARDS trial that has been conducted by Japanese partner, Maruishi. This data is expected to be received by the Company in March or April 2019, however the timing and presentation of the data is outside of the control of the Company. A further announcement will be made when the translated trial data has been provided to the Company however, as with the INTEREST trial, concomitant corticosteroid use is understood to have been high during the trial and accordingly, the topline results of the Japanese trial are expected to reflect those of the INTEREST trial whereby the study did not meet the primary composite end point for efficacy of Traumakine.

Interim (futility) data from the phase II INFORAA study investigating Traumakine in post-operative Ruptured Abdominal Aorta Aneurysm (RAAA) patients are also expected in H1 2019 and will determine further clinical development. Corticosteroid use within the INFORAA trial is expected to be low.

The Company remains confident of the use of Traumakine for a subset of ARDS patients. Subject to completion of the Subscription and the outcome of the YODA trial, and to enable Faron to make a marketing approval application, the Company is planning for a new phase III trial of Traumakine in the treatment of ARDS. If approved, this double dummy CALIBER study will allow corticosteroid use within the standard of care (SOC) arm, but will be excluded from the treatment arm receiving Traumakine. This trial structure would allow physicians to choose their preference while creating a blinded readout between Traumakine and SOC patients. It is currently intended that CALIBER will be a global trial and Faron hopes to partner with one or more pharma companies to support this planned trial.

CLINICAL PROGRESS OF CLEVEGEN

As recently announced on 21 February 2019 ("Matins Announcement"), the phase I/II MATINS clinical trial investigating the safety and efficacy of Clevegen, Faron's wholly-owned novel precision cancer immunotherapy in selected metastatic or inoperable solid tumours, is advancing as expected at trial sites in Finland and soon in the UK and Holland.

The MATINS study has now recruited four subjects with no safety concerns at 0.3 and 1.0 mg/kg dosing. In the Matins Announcement the Company reported potential early clinical benefits in dosed patients together with a switch in their immune profile towards more immune stimulatory function. The Company has now also received a tumour imaging report on patient number 2 (colorectal cancer), indicating a partial response. This patient had previously been treated with six different anti-cancer drugs, which all had failed.

As the trial is an open label study, the Company receives new information on the progress of dose escalation and safety as the trial progresses and will announce material updates when appropriate.

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 = €1.172, being the published exchange rate by the Bank of England at the close of business on 22 March 2019 (the latest practicable date prior to the date of this announcement).

MARKET ABUSE REGULATION

Market Soundings, as defined in the Market Abuse Regulation ("MAR"), were taken in respect of the proposed Placing and Subscription with the result that certain persons became aware of inside information, as permitted by MAR. That inside information in relation to the Placing and Subscription 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, Sole Bookrunner and Corporate Broker 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.

Information to Distributors

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 retail investors and investors who meet the criteria of professional clients and 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 Placing. Furthermore, it is noted that, notwithstanding the Target Market Assessment, Panmure Gordon (UK) Ltd has only procured investors who meet the criteria of professional clients and eligible counterparties.

For the avoidance of doubt, the Target Market Assessment does not constitute: (a) an assessment of suitability or appropriateness for the purposes of MiFID II; or (b) a recommendation to any investor or group of investors to invest in, or purchase, or take any other action whatsoever with respect to the Placing Shares.

Each distributor is responsible for undertaking its own target market assessment in respect of the Placing Shares and determining appropriate distribution channels.

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", ''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.