Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

MATINS study update

Substantial immune activation taking place post Clevegen administration

UK CTA approval

TURKU – FINLAND, 21 February 2019 – Faron Pharmaceuticals Ltd (“Faron”) (LON: FARN), the clinical stage biopharmaceutical company, today announces an update on early observations on immunity and clinical response of MATINS patients post Clevegen administration.

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. Dosing has moved to the second level (1mg/kg) with no signs of toxicity.

Clevegen is a novel anti-Clever-1 antibody, which causes changes in the immune environment of solid tumours by switching Clever-1 positive immune suppressive macrophages to immune active macrophages. In pre-clinical models, inhibition of Clever-1 decreases tumour associated macrophages and myeloid derived suppressor cells within the tumour, and activates tumour-killing CD8+ cells leading to robust anti-tumour activity (Viitala et al. (2019) Clinical Cancer Research, on-line DOI:10.1158/1078-0432.CCR-18-3016).

Early immune biomarker data from the first two patients dosed in the MATINS trial at 0.3mg/kg indicate an increase in CD8+ and CD4+ T cells, which play a central role in cell-mediated immunity. A single dose of Clevegen increased patients’ blood CD8+ cells and their CD8+/CD4+ ratio by 24% and 15%, respectively (mean of two). These patients also experienced a 22% decrease in their blood regulatory T-cell content (T-reg) on day two, which are linked to immune suppression in cancer patients. This change in immune activation resulted in a material increase in natural killer (NK) cells on day 15, by 16% in the first patient and 148% in the second patient from the pre-dose level. These alterations returned to near pre-dose levels ahead of the second dose.

During the second dosing level (1mg/kg) of the third MATINS patient, similar responses were observed but at significantly faster and higher rates. On day two CD8+ cells had increased 100%, the CD8+/CD4+ ratio by 26% and NK cells by 191%, while T-regs had declined -10% from the pre-dose value.

The Company believes these findings, while limited to the trial’s first three patients (one case of melanoma and two colorectal cancers), are encouraging, alongside biochemical tumour and tumour load markers showing a decrease in carcinoembryonic antigen (CEA) and lactate dehydrogenase (LDH) serum levels. Both indicate the potential early clinical benefit provided by Clevegen for these late state cancer patients.

The Company is currently opening two UK sites (London, Birmingham) to expand the trial, following recent CTA approval by the UK regulator, the Medicines & Healthcare products Regulatory Agency (MHRA). The Company also intends to seek pre-IND advice from the US Food and Drug Administration (FDA) to open sites in USA prior to entering the cohort expansion part of the trial.

Due to high interest in potential new therapies in the immuno-oncology field, either as monotherapy or in combination, the Company is currently engaged in partnering discussions with several parties and hopes for a positive outcome from these negotiations during 2019.

Dr Markku Jalkanen, Chief Executive Officer of Faron, said: “We have previously shown that Clevegen has the ability in experimental settings to convert the macrophage population from immune suppressive macrophages to immune active myeloid cells, which are believed to initiate the tumour fight by host immune cells. These initial data from the MATINS trial appear to confirm that this immune switch can also take place in cancer patients. We are very encouraged by these findings, and by the potential early clinical benefits indicated through the biochemical and tumour load indicators, following several lines of previous ineffective treatments. These biomarker data will prove valuable to help determine the optimal dose as the trial continues and we look forward to generating further data to assess durability of effect and efficacy in a larger number of patients.”

About the MATINS study

The MATINS study is a 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. The cancer patients with high Clever-1 expression will be identified with a simple blood myeloid cell staining with Clevegen (“liquid biopsy”).

The first part of the trial deals with safety and dose escalation to optimize dosing. As the trial is an open label study, the Company expects to report initial 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. During part three the main focus will be on assessing the efficacy of Clevegen on patients who show an increased number of Clever-1 positive circulating monocytes, making the treatment precisely targeted and maximizing the chances of success for efficacy. The treatment, if successful, may ultimately be used as a standalone therapy or in combination with other immunotherapies like PD-1 inhibitors.

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

For more information please contact:

Faron Pharmaceuticals 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

Westwicke Partners, IR (US)

Chris Brinzey

Phone: 01 339 970 2843

E-Mail: chris.brinzey@westwicke.com

Panmure Gordon (UK) Limited, Nomad and Broker

Emma Earl, Freddy Crossley

Phone: +44 207 886 2500

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 lead 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 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, 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 Ltd

(“Faron” or the “Company”)

INTEREST trial update

Routine corticosteroid treatment correlates with increased mortality and decreased Traumakine efficacy

INTEREST trial results and statistical analyses to be presented at 31^st ESICM (European Society of Intensive Care Medicine) meeting in Paris

TURKU – FINLAND, 22 October 2018 – Faron Pharmaceuticals Ltd (“Faron”) (LON: FARN), the clinical stage biopharmaceutical company, today announces more detailed analysis of data from the Traumakine INTEREST study related to corticosteroids used in parallel to Traumakine treatment and their effect on Traumakine efficacy. This follows the Company’s announcement of 13 September 2018 where it was noted that analysis of the INTEREST trial data had shown that other concurrent and widely used acute respiratory distress syndrome (ARDS) treatments had had a significant effect on mortality in the trial. These data will be presented today by INTEREST study investigators, Professors Geoff Bellingan (University College London Hospitals), and Marco Ranieri (University of Rome) at the 31^st ESICM (European Society of Intensive Care Medicine) meeting in Paris.

As previously reported, inconsistent interferon-beta (IFN-beta) biomarker (MxA and CD73) induction was observed across the treatment group, but a sub-group of patients with a biomarker response showed a reduced day 28 (D28) mortality. To further investigate this selective benefit among the Traumakine-treated ARDS patients, further post-hoc data analysis has been carried out by the trial investigators which has found that concomitant use of corticosteroids and Traumakine appeared to affect both the mortality and biomarker appearance in the INTEREST study patients.

The following key findings will be presented at ESICM:

·      Corticosteroid use was high among INTEREST trial patients (176/296, 59.5%)

·      Concomitant corticosteroid treatment had a significant impact on mortality in the Traumakine treatment group. Mortality was 10.6% (7/66) for those receiving Traumakine and not on corticosteroids, versus 39.7% (31/78) for those receiving Traumakine and on concomitant corticosteroids. This outcome is highly statistically significant (p<0.0001) and was a similar mortality to the treatment group in the phase I/II study

·      Concomitant corticosteroid use with Traumakine was also associated with worse outcomes measured by ventilator free days (VFD) compared to non-users (median 6 VFDs vs. 14 VFDs, p= 0.03)

·      IFN-beta has previously been demonstrated to increase CD73 expression in lung capillaries⁽¹⁾ which was associated with reduced mortality in ARDS patients in the phase I/II trial. However, concomitant exposure of human lung tissue samples to hydrocortisone in ex vivo culture conditions prevents Traumakine induced CD73 expression in lung capillaries

Of note, we also observed that the use of corticosteroids in the placebo group was associated with an increased mortality of 27.6% compared to no use of corticosteroids of 14.8% (p= 0.075). In the group receiving corticosteroids there was a significantly higher APACHE II (acute physiology and chronic health evaluation) score (23.4 versus 20.4, p=0.0007) and SOFA (sequential organ failure assessment) score (10.4 vs 9.5, p=0.0428) but this difference does not, we believe, explain the scale of mortality difference associated with corticosteroid use versus non-use. Additionally, in a genetic analysis of a subset of patients treated with Traumakine, Faron has identified an altered (polymorphic) regulatory motif for the glucocorticoid receptor of the interferon-alpha/beta receptor beta chain which Faron believes could be associated with those patients who responded to traumakine (p=0.007) and which may confer corticosteroid resistance and impact IFN-beta action.

The Company believed that the inconsistent FP-1201-lyo bioactivity observed in the INTEREST trial may well, in part, be due to corticosteroid interference of IFN-beta action. Therefore, further in vitro and ex vivo experiments with human endothelial HUVEC cells and human lung tissue samples were conducted.  Based on these results, no issues have been detected to date in the formulation of FP-1201-lyo used in the INTEREST trial and the formulation was as active as the formulation used in the phase I/II trial. In lung tissue samples, the concomitant corticosteroids prevented the CD73 induction by Traumakine, which indicates similar interference of corticosteroids on IFN-beta bioactivity as observed in the INTEREST study.

To understand the reduced biomarker response to Traumakine administration, even where corticosteroids were not administered in the INTEREST study, a new FP-1201-lyo pharmacokinetic/dynamic study, YODA, is already underway in approximately 50 healthy volunteers. This will determine the optimum mechanism of administration to achieve a full biomarker response with first results expected in Q4 2018. The YODA study may also be extended to examine concomitant use of Traumakine and corticosteroids to get final in vivo evidence for corticosteroid interference of interaction activity.

Dr Matti Karvonen, Chief Medical Officer of Faron, said: “At this stage it appears possible that unexpectedly high corticosteroid use in the INTEREST trial may have masked the treatment benefit of Traumakine in ARDS patients. Therefore, the Company and the investigators await data from the ongoing Phase III ARDS trial with Japanese partner Maruishi, expected later this year, and further experimental data on lung tissue samples and YODA results, to determine the next steps for Traumakine’s development.” 

Commenting on the results, Dr Geoff Bellingan, co-Principal Investigator of the INTEREST study, said: “The controversy around administration of corticosteroids to ARDS patients has been a puzzling topic for decades where there has been an ongoing debate as to whether corticosteroids have any beneficial role, early, late or for more severe un-resolving cases. These new findings from the INTEREST study, where some patients were also given corticosteroids as part of their treatment, now suggest that we should control or exclude corticosteroids from future clinical research in ARDS patients. Corticosteroids have been shown to interfere with interferon-beta signalling⁽²⁾ hence their use could block any beneficial effects of endogenous IFN-beta and may be particularly important when dosing with Traumakine. This brings fresh hope to ARDS patients as the study of Traumakine continues.”

Dr Marco Ranieri, co-Principal Investigator of the INTEREST study, said: “Whilst we were disappointed with the initial results from the INTEREST study, we have now made a very important observation that corticosteroid use significantly disturbs both administered and endogenous interferon-beta activity making it possibly a harmful drug in the acute phase of ARDS. This knowledge, if supported by the YODA study as well, is extremely important for ARDS patients and current practice, and it will help plan successful studies in the future for the defeat of ARDS. The concomitant use of corticosteroids and type I interferons could be prevalent in several other conditions as well (e.g. MS disease) and we believe, therefore, that the whole medical community should be more diligent with regard to their combined use.”

The cited references:

(1) Bellingan G, Maksimow M, Howell DC, Stotz M, Beale R, Beatty M, Walsh T, Binning A, Davidson A, Kuper M, Shah S, Cooper J, Waris M, Yegutkin GG, Jalkanen J, Salmi M, Piippo I, Jalkanen M, Montgomery H, Jalkanen S (2014) The effect of intravenous interferon-beta-1a (FP-1201) on lung CD73 expression and on acute respiratory distress syndrome mortality: an open-label study. Lancet Respiratory Medicine 2: 97-104.

(2) Flammer JR, Dobrovolna J, Kennedy MA, Chinenov Y, Glass CK, Ivashkiv LB and Rogatsky I (2010) The type I interferon signaling pathway is a target for glucocorticoid inhibition. Molecular and Cellular Biology 30: 4564.

Today’s presentation by INTEREST study investigators, Professors Geoff Bellingan and Marco Ranieri is available to view at www.faron.com 

For more information please contact:

Faron Pharmaceuticals Ltd

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com 

Consilium Strategic Communications

Mary-Jane Elliott, Matthew Neal, 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

Panmure Gordon (UK) Limited, Nomad and Broker

Emma Earl, Freddy Crossley

Phone: +44 207 886 2500

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 lead candidate Traumakine, to prevent vascular leakage and organ failures, is currently the only treatment for Acute Respiratory Distress Syndrome (ARDS) undergoing Phase III clinical trials and in 2017 received advice from US FDA to proceed directly to BLA submission following completion of EU and Japanese Phase III studies.  There is currently no approved pharmaceutical treatment for 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 pre-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

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

Faron Announces Filing of Clinical Trial Application for precision cancer immunotherapy Clevegen

TURKU – FINLAND, 17 September 2018 – Faron Pharmaceuticals Ltd (“Faron”) (AIM: FARN), the clinical stage biopharmaceutical company, today announces that it has filed a Clinical Trial Application (CTA)  for Clevegen, its wholly-owned novel precision cancer immunotherapy drug, in development for the treatment of selected metastatic or inoperable tumours.

Clevegen is a novel anti-Clever-1 antibody which causes changes in the immune environment of solid tumours by switching Clever-1 positive immune suppressive macrophages to immune active macrophages. Clever-1, a cell surface receptor expressed mainly by tumour vascular endothelial cells and monocytes/macrophages, has been shown to control tumour growth (Karikoski et al., 2014), cell-mediated immunity (Palani et al. 2016) and to participate in the control of B cell response and humoral antibody production (Dunkel et al. 2018).

Today’s CTA filing is a key step towards initation of Faron’s MATINS study, a first-in-human open label Phase I/II adaptive design clinical trial 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.

The first part of the trial deals with safety and dose escalation to optimize the dosing. The cohort expansion parts II and III will recruit only patients who show 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 stand alone therapy or in combination with other immunotherapies like PD-1 inhibitors.

The Company plans to conduct the MATINS trial’s dose escalation part in Finland, UK and Netherlands with four to five sites, and increase site numbers during the cohort expansion stage. Patient recruitement for the study is expected to begin in Q4 2018.

Dr Petri Bono, the Principle Investigator of the MATINS trial, said: “I look forward to initiating the MATINS trial patient recruitment since a truly novel approach to break the tumour immune suppression is used in this phaseI/II study. I strongly believe that new immunosuppression releasing approaches (such as anti-Clever-1 antibody) have the potential to become the next wave of cancer treatments”

Dr Markku Jalkanen, CEO of Faron, said: “We are making rapid progress with our Clevegen programme and this CTA filing is an important milestone. This precision therapy for cancers with very few treatment options has a unique mechanism of action which, coupled with promising pre-clinical data and human ex-vivo data, already indicates the product’s potential in a broad range of indications. We look forward to beginning patient recruitment later this year and moving Clevegen into the clinic.”

For more information please contact:

Faron Pharmaceuticals Ltd

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com 

Consilium Strategic Communications

Mary-Jane Elliott, Matthew Neal, 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

Panmure Gordon (UK) Limited, Nomad and Broker

Emma Earl, Freddy CrossleyPhone: +44 207 886 2500

About Clevegen®

Clevegen is based on Faron’s turn-on-your-immunity technology platform. Potential indications include immuno-oncology, chronic infections and vaccination enhancement, which all involve the presence of these same macrophages as immune suppressive cell type.

In the context of cancer Clevegen, by binding Clever-1, prevents Tumor Associated Macrophage (TAM) infiltration into a tumour and blocks TAM-to-Tumour cell interaction triggering TAM transformation of tumour supportive cell types. It therefore reduces tumour associated suppression of the human immune system and converts the whole immune environment around a tumour to immune stimulating allowing a patient’s own immune system to combat cancer, known as “immunotherapy”. Clevegen elicts a local tumour effect which similar to the cell-mediated immune response against infections in normal tissues. This kind of removal of immune suppression locally limits risk of autoimmune reaction, a potentially severe side effect observed with some immune checkpoint inhibitors. The Directors of Faron believe that Clevegen is well differentiated from competing products as it specifically targets tumour promoting anti-inflammatory M2 TAMs and converts them into M1 TAMs while leaving intact the existing M1 TAMs. This unique mode of action of Clevegen induces immune activation against tumours. Clever-1 blocking results especially in activation of Th1 mediated immunity. The involvement of these Clever-1 positive myeloid cells in tumour progression can be verified from a simple blood sample analysis (liquid biopsy) making the treatment precise.

About MATINS study

MATINS study is a first-in-human open label adaptive design Phase I/II adaptive clinical trial in selected metastatic or inoperable solid tumours to investigate the safety and efficacy of Clevegen. The selected tumours are cutaneous melanoma, hepatobiliary, pancreatic, ovarian and colorectal cancer, which are all known to contain high amounts of Clever-1 positive tumour associated macrophages (TAMs). The trial is to be run in three parts. Part I will be conducted to determine the safe and tolerable dose of Clevegen, which will then be used in Part II to expand the cohorts of individual tumour types. Part III of the trial aims to confirm the efficacy of Clevegen with the cohorts selected based on Part II. The principle Investigator for the trial is Dr. Petri Bono from the Helsinki University Hospital, who has participated in several firat-in-man clinical trials in the area of immune oncology and is also a member of ESMO (European Society of Clinical Oncolgy) GU cancer Scientific Advisory Board.

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 lead candidate Traumakine, to prevent vascular leakage and organ failures, is currently the only treatment for Acute Respiratory Distress Syndrome (ARDS) undergoing Phase III clinical trials and in 2017 received advice from US FDA to proceed directly to BLA submission following completion of EU and Japanese Phase III studies.  There is currently no approved pharmaceutical treatment for 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 pre-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

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.

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

Results of the Placing and Subscription

and Issue of Equity

Successful over-subscribed fundraising of £15.0 million through Placing and Subscription

TURKU – FINLAND, 21 February 2018 – Faron Pharmaceuticals Oy (“Faron”) (AIM: FARN), the clinical stage biopharmaceutical company, is pleased to announce that, following the announcement on 16 February 2018, the proposed Placing and Subscription has been subscribed for in full, in satisfaction of the Placee Condition. Pursuant to the Placing and Subscription, the Company is raising approximately £15.0 million before expenses by way of the Placing of 1,729,350 Placing Shares and the Subscription of 134,000 Subscription Shares at the Issue Price of 805 pence per share. The Placing and Subscription have been supported by the participation of existing and new institutional shareholders. The Board of Directors of Faron has resolved on and approved the issuance of the Placing Shares and the Subscription Shares pursuant to the existing authorisation granted by shareholders at the Company’s Annual General Meeting held on 16 May 2017.

The First Issue Shares, being 837,200 Placing Shares, including those to be issued to the VCT Investors and the EIS Investors, and 93,000 Subscription Shares, are expected to be registered with the Finnish Trade Register shortly. The First Issue Shares will, when registered, be credited as fully paid and will rank pari passu with the existing Ordinary Shares in issue in all respects, including the right to receive all dividends or other distributions declared, made or paid by the Company by reference to record dates falling after the date of registration of the First Issue Shares with the Finnish Trade Register.

Application has been made to the London Stock Exchange for admission to trading on AIM of the 930,200 First Issue Shares (“Admission“), and it is expected that Admission of the First Issue Shares will become effective and that dealings in the First Issue Shares will commence on or around 8:00 a.m. (GMT) on 23 February 2018.

Faron’s enlarged issued number of shares immediately following registration and Admission of the First Issue Shares will be 30,094,744 Ordinary Shares with voting rights attached. The Company has no shares in Treasury; therefore upon, and subject to, registration, the total number of voting rights in Faron will be 30,094,744 (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.

A further announcement will be made regarding the issuance, and application for Admission, of the Second Issue Shares (being the remaining Placing Shares and Subscription Shares to be issued pursuant to the Placing and Subscription) and the new total number of voting rights in Faron following such Admission in due course. It is expected that Admission of the Second Issue Shares will take place on or around 28 February 2018. The issue and allotment of the Second Issue Shares remains conditional upon, inter alia, Admission of the First Issue Shares taking place, the Issue Condition relating to the Second Issue Shares being satisfied and the Placing Agreement otherwise remaining in full force and no material breach of its terms having occurred.

Commenting on the successful Placing and Subscription, Dr Markku Jalkanen, CEO of Faron, said: “We are delighted by the level of investor enthusiasm we received during this financing round, based on both the potential of Traumakine as we advance towards commercialisation, and for our second wholly-owned asset Clevegen. This funding will allow us to accelerate preparations for the anticipated market launch of Traumakine and also expedite our clinical development activities for Clevegen. We would like thank our current investors for their continued support and welcome our new institutional investors to Faron.”

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

All capitalised terms in this announcement are made with reference to the announcement made by Faron at 7.00 a.m. (GMT) on 16 February 2018.  

ENDS

For more information please contact:

Faron Pharmaceuticals Oy

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com 

Consilium Strategic Communications

Mary-Jane Elliott, Philippa Gardner, Matthew Neal, Lindsey Neville

Phone: +44 203 709 5700

E-mail: faron@consilium-comms.com

Panmure Gordon (UK) Limited, Nomad and Broker

Freddy Crossley, Ryan McCarthy (Corporate Finance)

Tom Salvesen, Amy Sarra (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 Oy

Faron (AIM:FARN) is a clinical stage biopharmaceutical company developing novel treatments for medical conditions with significant unmet needs. The Company currently has a pipeline focusing on acute organ traumas, vascular damage and cancer immunotherapy. The Company’s lead candidate Traumakine, to prevent vascular leakage and organ failures, could be the first ever drug for Acute Respiratory Distress Syndrome (“ARDS”) undergoing Phase III clinical trials and in 2017 received advice from US FDA that it may proceed directly to BLA submission following successful completion of EU and Japanese Phase III studies.  There is currently no approved pharmaceutical treatment for 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 pre-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 Tumour Immunity Enabling Technology (“TIET”) 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 outcome of clinical trials (including, but not limited to the Company’s INTEREST trial) 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 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, 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 Ltd

(“Faron” or the “Company”)

FDA grants Fast Track Designation to Faron for Traumakine^®

Faron’s wholly-owned product for Acute Respiratory Distress Syndrome on track for Phase III data in H1 2018

TURKU – FINLAND, 29 January 2018 – Faron Pharmaceuticals Ltd (“Faron”) (AIM: FARN), the clinical stage biopharmaceutical company, announces it has received Fast Track designation from the US Food and Drug Administration (FDA) for Traumakine^®, the Company’s wholly-owned product for the treatment of Acute Respiratory Distress Syndrome (ARDS). Traumakine is currently in two Phase III trials (INTEREST in Europe and MR11A8-2 in Japan), with top-line data from the INTEREST study on track for the first half of 2018.

Fast Track designation is granted by the FDA to expedite the review and facilitate the development of drugs to treat serious conditions with significant unmet medical need. The purpose of the process is to get new drugs to patients quicker. Today’s announced Fast Track designation is in addition to Traumakine’s Promising Innovative Medicines (PIM) designation from the MHRA, which is the first stage of the MHRA’s Early Access Medicines Scheme (EAMS).

ARDS is a severe orphan disease with a reported mortality rate of approximately 30-45%^[1],[2],[3], for which there is currently no approved pharmacological treatment. It is characterised by widespread capillary leakage and inflammation in the lungs, most often as a result of pneumonia (e.g. following a pandemic influenza), sepsis, or significant trauma. Faron estimates there are around 300,000 plus annual cases in Europe and US alone. Faron completed the recruitment of 300 patients with moderate and severe ARDS for the pan-European pivotal trial INTEREST in December 2017.

Dr Markku Jalkanen, CEO of Faron, said: “We are very pleased that the FDA has granted Fast Track designation for Traumakine. This represents significant additional recognition of the potential that our drug holds to save lives and, in turn, relieve pressure and costs for healthcare systems. With Fast Track designation in the US, and PIM status in the UK, Traumakine is now ideally placed for an expedited route to market, following the top-line data which is on track and due in H1 2018. In accordance with our wider strategy, we continue to accelerate our plans to enable rapid and broad commercial adoption of Traumakine.”

Traumakine also has an orphan status in Europe, which normally expedites the review also at the European Medicine Agency (EMA). The Company also expects that Faron’s partner in Japan, Maruishi will file an orphan application this year following the INTEREST trial read-out.

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 Ltd

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com 

Consilium Strategic Communications

Mary-Jane Elliott, Matthew Neal, Philippa Gardner, 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

Panmure Gordon (UK) Limited, Nomad and Broker

Freddy Crossley (Corporate Finance)

Tom Salvesen (Corporate Broking)

Phone: +44 207 886 2500

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 lead candidate Traumakine, to prevent vascular leakage and organ failures, is currently the only treatment for Acute Respiratory Distress Syndrome (ARDS) undergoing Phase III clinical trials and in 2017 received advice from US FDA to proceed directly to BLA submission following completion of EU and Japanese Phase III studies.  There is currently no approved pharmaceutical treatment for 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 pre-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 Tumour Immunity Enabling Technology (“TIET”) 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

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

Recruitment completed in Traumakine INTEREST Trial

The upcoming read-out will collate intact 90 day morbidity/mortality data alongside 28 day mortality data as requested by the study IDMC

Phase III INTEREST top line results expected in H1 2018

TURKU – FINLAND, 11 December 2017 – Faron Pharmaceuticals Ltd (“Faron”) (AIM: FARN), the clinical stage biopharmaceutical company, announces that it has completed recruitment, on track, for its Phase III INTEREST trial of Traumakine^® for the treatment of moderate to severe Acute Respiratory Distress Syndrome (ARDS).

In addition to the completion of recruitment, the Company reports that it has adopted recommendations from the INTEREST trial’s Independent Data Monitoring Committee (IDMC) and Steering Committee (SC) to present patient data showing blinded ARDS outcomes (mortality/morbidity) at 90 days (D90), in addition to the day 28 (D28) mortality endpoint. Outcomes at D90 are widely recognised to be as important clinically when judging the benefit of treatment alongside the D28 data. This recommendation was made following the FDA’s recent proposal for Faron to proceed directly to BLA filing for Traumakine in the US using data obtained from the European and Japanese trials. The Company expects therefore that the INTEREST top-line data from the trial will become available in H1 2018 following collation of the D90 data. Faron’s Japanese partner Maruishi also expects Japanese phase III results in 2018. 

The INTEREST trial is a Phase III double-blind, randomised, parallel-group comparison of efficacy and safety of Traumakine (FP-1201-lyo) and placebo in the treatment of patients with moderate to severe ARDS. The study, which has successfully recruited its target of 300 patients, is currently being conducted in more than 60 hospital intensive care units (ICU) in Belgium, Finland, France, Germany, Italy, Spain, UK and Czech Republic. The key efficacy endpoint in the INTEREST trial is the all-cause mortality rate at day 28. The INTEREST trial protocol is targeting a 50% reduction in all cause mortality at day 28 between placebo and treatment arm (from 30% down to 15%).

ARDS is a severe orphan disease with a reported mortality rate of approximately 30-45%, for which there is currently no approved pharmacological treatment. It is characterised by widespread capillary leakage and inflammation in the lungs, most often as a result of pneumonia (e.g. following a pandemic influenza), sepsis, or significant trauma with around 300,000 plus annual cases in Europe and US alone.

Dr Markku Jalkanen, CEO of Faron, said: “We are extremely pleased to have completed recruitment for the INTEREST study within our expected timelines and are grateful for all parties involved in reaching this milestone. Closing the recruitment marks another important step for Traumakine and Faron. Our focus is now on closing the data basis for read-out purposes and bringing this product to the market as expediously as possible in order to provide patients with this life threathening condition a treatment option where currently there is none.”

Professor Geoff Bellingan from the University College London Hospital and the Co-principal Investigator of the INTEREST trial, added: “All  of us who have been involved with this study have shared the excitement of the INTEREST trial as it offers the potential to finally have an effective pharmacological treatment for ARDS patients. We fully support the advice from the IDMC and SC to hold reporting results until we have both D28 and D90 data as this offers the ideal non-biased means of protecting the data integrity for regulatory purposes. We are aware that the FDA, in particular, has appreciated the inclusion of D90 survival data alongside the D28 endpoints. Given the need for this treatment for our patients, we now look forward to completing the data verification and presenting top line results in the first half of 2018.”  

For more information please contact:

Faron Pharmaceuticals Ltd

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com 

Consilium Strategic Communications

Mary-Jane Elliott, Chris Welsh, Philippa Gardner, 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

Panmure Gordon (UK) Limited, Nomad and Broker

Freddy Crossley (Corporate Finance)

Tom Salvesen (Corporate Broking)

Phone: +44 207 886 2500

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 lead candidate Traumakine, to prevent vascular leakage and organ failures, is currently the only treatment for Acute Respiratory Distress Syndrome (ARDS) undergoing Phase III clinical trials and in 2017 received advice from US FDA to proceed directly to BLA submission following completion of EU and Japanese Phase III studies.  There is currently no approved pharmaceutical treatment for 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 pre-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 Tumour Immunity Enabling Technology (“TIET”) 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

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, THE REPUBLIC OF IRELAND, NEW ZEALAND OR ANY OTHER JURISDICTION IN WHICH SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL.

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

Issue of Equity
and
PDMR Shareholding

TURKU – FINLAND, 2.00 P.M. BST, 11 October 2017 – Faron Pharmaceuticals Oy (“Faron” or “Company“) (LON: FARN), the clinical stage biopharmaceutical company, is pleased to announce the registration and issue of the Second Issue Shares in relation to the Placing and Subscription announced on 5 October 2017.

The Second Issue Shares, being 586,037 Placing Shares and 66,365 Subscription Shares, are credited as fully paid and rank pari passu with the existing Ordinary Shares in issue in all respects, including the right to receive all dividends or other distributions declared, made or paid by the Company.

Application has been made to the London Stock Exchange for admission to trading on AIM of the 652,402 Second Issue Shares (“Admission“), and it is expected that Admission of the Second Issue Shares will become effective and that dealings in the Second Issue Shares will commence on or around 8.00 a.m. (BST) on 13 October 2017.

Faron’s enlarged issued number of shares immediately following registration and Admission of the Second Issue Shares will be 29,164,544 Ordinary Shares with voting rights attached. The Company has no shares in Treasury; therefore upon, and subject to, registration, the total number of voting rights in Faron will be 29,164,544 (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.

Director/PDMR Shareholding

Dr Frank Armstrong has subscribed for 1,250 Subscription Shares at the Issue Price, to be completed within Admission of the Second Issue Shares. The beneficial interests of Dr Frank Armstrong in the issued shares and votes of the Company is set out below:

The participation by Dr Frank Armstrong in the Placing and Subscription constitutes a related party transaction for the purposes of the AIM Rules. The independent directors for the purpose of the Placing and Subscription, being all directors of the Company other than Dr Frank Armstrong, having consulted with the Company’s nominated adviser, Cairn, consider that the terms of the related party transaction are fair and reasonable insofar as the Shareholders are concerned.

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

All capitalised terms in this announcement are with reference to the announcement made by Faron at 7.00 a.m. (BST) on 5 October 2017.

ENDS

For more information please contact:

Faron Pharmaceuticals Oy

Dr Markku Jalkanen, Chief Executive Officer

E-mail: investor.relations@faron.com

Consilium Strategic Communications

Mary-Jane Elliott, Chris Welsh, Philippa Gardner, Lindsey Neville

Phone: +44 203 709 5700

E-Mail: faron@consilium-comms.com

Westwicke Partners, IR (US)

Chris Brinzey

Phone: +1 339 970 2843

E-Mail: chris.brinzey@westwicke.com

Cairn Financial Advisers LLP, Nominated Adviser

Emma Earl, Tony Rawlinson

Phone: +44 207 213 0880

Panmure Gordon (UK) Limited, Sole Bookrunner and Corporate Broker

Freddy Crossley, Duncan Monteith (Corporate Finance)

Tom Salvesen (Corporate Broking)

Phone: +44 207 886 2500

Whitman Howard Limited, Joint Corporate Broker

Ranald McGregor-Smith, Francis North

Phone: +44 207 659 1234

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 lead candidate Traumakine, to prevent vascular leakage and organ failures, is currently the only treatment for Acute Respiratory Distress Syndrome (ARDS) undergoing Phase III clinical trials.  There is currently no approved pharmaceutical treatment for 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 pre-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 Tumour Immunity Enabling Technology (“TIET”) 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 outcome of clinical trials (including, but not limited to the Company’s INTEREST trial) 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 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, 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.