Faron Provides Update at R&D Day

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

Faron Provides Update at R&D Day

TURKU – FINLAND 14 June 2016 – Faron Pharmaceuticals Ltd (LON: FARN), the clinical stage biopharmaceutical company, today presents an update on the Company’s pipeline activities around Traumakine® and its novel cancer immunotherapy drug candidate Clevegen® at its R&D Day in London. On 26 May 2016 the Board of Directors announced that the development strategy for Clevegen has been expanded to open up new application opportunities in conditions where removal of suppression of local or systemic immunity is desirable. The Company has introduced two additional technology platforms related to Tumour Immunity Enabling Technology, or TIET to cover new development areas, chronic infections and inefficient vaccination.

The following updates are being presented at the R&D Day:

Clevegen:

  • An introduction of Chronic Infection Removal Therapy, CIRT, which would allow combat against bacteria, when they use M2 macrophages to hide host immune system
  • An introduction of Vaccination Response Enhancement Technology, VRET to use Clevegen as an adjuvant in vaccination protocols
  • A potential key target group for TIET program, hepatocellular carcinoma (HCC) patients

Traumakine:

  • Faron is currently preparing plans for US safety trial as requested by FDA
  • Confirmation that Faron plans to file Traumakine CTA in H2 2016 to the Finnish Medicines Agency (FIMEA) for clinical trial INFORAA on patients suffering from Rupture of Abdominal Aorta Aneurysm and operated surgically.

The updated Faron pipeline as of 14 June, 2016 can be found on the Company website: http://www.faronpharmaceuticals.com/pipeline

Dr. Markku Jalkanen, CEO of Faron, said: “We have clear plans to advance our exciting pipeline over the next two to three years and maintain focus on our most advanced projects Traumakine and Clevegen, which represent tremendous expansion potential into new indications and territories. Our Board fully recognise the potential of Clevegen towards several non-tumoural indications. Our scientific collaborators are already exploring these new CIRT and VRET technologies in order to provide pre-clinical data for our clinical plans. As stated on our TIET RNS on 26 May 2016, Faron plan to intensify commercial efforts around these three exciting technologies and make them available for interested licensing partners while at the same time focusing on our own development as well.”

“Tumour Immunity Enabling Technology”, or TIET, can be used alone or in combination with other immune checkpoint molecules for the treatment of cancer patients. The Directors also believe that Clevegen’s ability to convert M2 macrophages to M1 macrophages could provide additional applications to control immune suppression causing inadequate immune response. These are related to many chronic infections and inefficient vaccination due to low adjuvant effect. Faron will now introduce two additional technology platforms to cover these exciting development areas and starts to promote their development and use worldwide.

Presentations are available for viewing on Faron’s Company website: http://www.faronpharmaceuticals.com/investor-relations/events

For more information, please contact:

Faron Pharmaceuticals Oy

Katja Wallenlind

Phone +358 (50) 577 4807
E-mail: katja.wallenlind@faronpharmaceuticals.com

Hume Brophy, PR

Mary Clark, Eva Haas, Hollie Vile

Phone: +44 207 862 6390

E-mail: faron@humebrophy.com

Cairn Financial Advisers LLP, Nominated Adviser

Emma Earl, Tony Rawlinson and Rebecca Anderson

Phone: +44 207 148 7900

Panmure Gordon (UK) Limited, Joint Broker

Freddy Crossley, Duncan Monteith (Corporate Finance)

Tom Salvesen (Corporate Broking)

Phone: +44 207 886 2500

Whitman Howard Limited, Nominated Broker

Ranald McGregor-Smith, Francis North

Phone: +44 207 659 1234

About Faron Pharmaceuticals Ltd.

Faron is a drug discovery and development company focused on creating novel treatments for medical conditions with significant unmet needs. The Company is based in Turku, Finland. The Company currently has a pipeline of clinical stage products focusing on acute organ traumas, cancer immunotherapy and vascular damage. The Company’s lead candidate Traumakine®, has been developed to treat acute respiratory distress syndrome (“ARDS”), a rare, severe, life threatening medical condition characterised by widespread inflammation in the lungs. Traumakine® is now in a pan-European pivotal Phase III study (INTEREST). Besides Traumakine®, Faron’s pipeline consists of early stage assets including a pre-clinical anti-Clever-1 antibody named Clevegen. Clevegen is focused on converting the immune environment around a tumour from being immune suppressive to immune stimulating and represents a novel immuno-oncology approach called TIET (Tumour Immunity Enabling Technology). Faron Pharmaceuticals Ltd. is listed on AIM under the ticker ‘FARN’. Further information is available at www.faronpharmaceuticals.com

About Tumor Immunity Enabling Technology (TIET) 

The TIET technology is built around the humanised anti-Clever-1 antibody FP-1305, which binds to a specific Clever-1 proprietary epitope. Clevegen® binding to this epitope activates conversion of type 2 tumour associated macrophages to type 1 macrophages, resulting in the transformation of the tumour environment from immune suppression to immune activation. As the TIET technology is based on a humanised antibody, the Faron Directors believe it can be combined with a number of other immune therapies without a significant risk of increased adverse events. The TIET technology could provide a significant boost for the efficacy of other immune checkpoint molecules, as its target is unique and represents a completely separate control of immunity.

Faron Licenses Traumakine Rights to Pharmbio Korea

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

Faron Licenses Traumakine® Korean Rights to Pharmbio Korea Inc. (“Pharmbio”)

TURKU – FINLAND 13 June 2016 – Faron Pharmaceuticals Ltd (LON: FARN), the clinical stage biopharmaceutical company, announces today that it has entered into a licensing agreement with Pharmbio Korea Inc., for the development and commercialisation of Traumakine® in Korea. Pharmbio is based in Seoul and specialises in hospital sales of novel pharmaceutical products. Traumakine is in development for the treatment of Acute Respiratory Distress Syndrome (ARDS), a rare, severe, life threatening medical condition for which there is currently no approved pharmaceutical treatment. Traumakine is now in the pivotal pan-European Phase III INTEREST trial.

Under the terms of the agreement Pharmbio will obtain exclusive Korean rights to Traumakine. Faron will receive an initial signing fee of €750,000, which will be recorded as a revenue in H1-2016 financial results, and is entitled to receive additional, undisclosed development based milestones. In addition, Pharmbio will pay Faron one third of Traumakine profits, representing a double digit royalty on net sales, depending on end user pricing, and has agreed to cover development costs for Traumakine in Korea. Additionally, Faron will provide European approval material for Pharmbio to obtain market authorisation in Korea and will also supply Traumakine drug product to Pharmbio at an agreed transfer price.

Dr. Markku Jalkanen, CEO of Faron, said: “We are very pleased to have signed this agreement with Pharmbio which represents a great opportunity for Traumakine to enter the Korean market. Given the successful track record of Pharmbio sales team, achieving a steady 30% sales growth over the last five years, it is an excellent partner for Traumakine in the Korean market. This licensing deal follows our growth strategy to partner Traumakine in territories where Faron has limited presence, while maintaining rights in major territories including Europe and North America. We believe this agreement represents the best way to accelerate the development of Traumakine and create long term value for our shareholders.”

Dr. Junsang Nam, CEO of Pharmbio, said: “We are very excited to license Traumakine in Korea and for the opportunity to introduce this product targeting significant unmet medical need to Korean hospitals and ARDS patients. During the MERS virus outbreak in South Korea, a year ago many people suffered from serious lung infections and acute loss of respiration. We believe Traumakine, offers a new treatment option for these patients as well as ARDS patients with other underlying conditions.”

For more information, please contact:

Faron Pharmaceuticals Oy

Katja Wallenlind

Phone +358 (50) 577 4807
E-mail: katja.wallenlind@faronpharmaceuticals.com

Hume Brophy, PR

Mary Clark, Eva Haas, Hollie Vile

Phone: +44 207 862 6390

E-mail: faron@humebrophy.com

Cairn Financial Advisers LLP, Nominated Adviser

Emma Earl, Tony Rawlinson and Rebecca Anderson

Phone: +44 207 148 7900

Panmure Gordon (UK) Limited, Joint Broker

Freddy Crossley, Duncan Monteith (Corporate Finance)

Tom Salvesen (Corporate Broking)

Phone: +44 207 886 2500

Whitman Howard Limited, Nominated Broker

Ranald McGregor-Smith, Francis North

Phone: +44 207 659 1234

About Faron Pharmaceuticals Ltd

Faron is a drug discovery and development company focused on creating novel treatments for medical conditions with significant unmet needs. The Company is based in Turku, Finland. The Company currently has a pipeline of clinical stage products focusing on acute organ traumas, cancer immunotherapy and vascular damage. The Company’s lead candidate Traumakine®, has been developed to treat Acute Respiratory Distress Syndrome (“ARDS”), a rare, severe, life-threatening medical condition characterised by widespread inflammation in the lungs. Traumakine® is now in a pan-European pivotal Phase III study (INTEREST). Besides Traumakine®, Faron’s pipeline consists of early stage assets including a pre-clinical anti-Clever-1 antibody named Clevegen®. Clevegen is focused on converting the immune environment around a tumour from being immune suppressive to immune stimulating and represents a novel immuno-oncology approach called TIET (Tumour Immunity Enabling Technology). Faron Pharmaceuticals Ltd is listed on AIM under the ticker ‘FARN’. Further information is available at www.faronpharmaceuticals.com

About Pharmbio Korea Inc

Pharmbio started business in 1999 in South Korea and claims to have annual turnover of over USD 47 million. It has continued expanding its scope of services and growing its revenue by 24% (8-year CAGR). Pharmbio developed the first treatment of urinary stone in Korea, UROCITRA, and has provided a pipeline of innovative products in urology, gastroenterology, general surgery, ob-gyn among others. Pharmbio has licensed and marketed products in a close collaboration with pharmaceutical companies in the EU, Japan, and Canada and has exported its patent products to SE Asian countries including Myanmar, Philippines, Vietnam, and Pakistan to fulfill unmet worldwide medical needs. Further information is available at www.pharmbio.co.kr

About Traumakine®

Faron completed a Phase I/II trial in respect of Traumakine® in 2011 where treatment with Traumakine® was associated with an 81% reduction in the odds of 28 day mortality in patients with ARDS. These data were published in The Lancet Respiratory Medicine, a leading medical journal (Bellingan et al. 2014) 1.  Comparable results were obtained from Traumakine Phase II Japanese study conducted by Faron´s Japanese licencing partner Maruishi Pharmaceutical Co. Ltd. in Japan, as announced in January 2016.

The presently ongoing pivotal Phase III trial called INTEREST is to be conducted in about 55 ICUs (Intensive Care Units) in seven European countries: Belgium, Finland, France, Germany, Italy, Spain and UK. A total of 300 adult patients with moderate or severe ARDS will be enrolled, and the first patient was enrolled in December 2015. INTEREST has received €6 million funding from the European Union Seventh Framework Programme (FP7).

The scientific rationale for Traumakine treatment is based on the proprietary use of room temperature stable formulation of interferon-beta-1a (FP-1201-lyo) for the restoration of the endothelial barrier function in ARDS patients. In Phase I/II trials interferon-beta was found to be safe and well tolerated in ARDS patients and the optimal tolerated dose was established. The selected pharmacodynamic marker for interferon-beta bioactivity showed clear dose response and the treatment target molecule CD73 levels were induced during the dosing period.

References:

1.   Bellingan, G., Maksimow, M., Howell D.C., Stoltz, M., Beale, R., Beatty, M., Walsh, T., Binning, A., Davidson, A., Kuper, M., Shah, S., Cooper, J., Waris, M., Yegutkin, G.G., Jalkanen, J., Salmi, M., Piippo, I., Jalkanen, M., Montgomery, H., Jalkanen, S.: “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 2014.

Faron Result of Annual General Meeting

RNS Number : 4092Z
Faron Pharmaceuticals Oy
26 May 2016
 

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

Result of Annual General Meeting

TURKU – FINLAND 26 May 2016 – Faron Pharmaceuticals Ltd (LON: FARN) is pleased to announce that all resolutions proposed at its Annual General Meeting held today and as set out in the Company’s announcement dated 4 May 2016, were duly passed by shareholders.

Commenting on the meeting, Frank Armstrong, Chairman of Faron, said: “We are delighted to have such support from our shareholders at the very first Annual General Meeting as a listed company. We thank our shareholders for sharing Faron´s mission of life-saving drug development. We are looking forward to making further significant progress with our innovations to develop new treatments for true unmet medical needs.”

For more information, please contact:

Faron Pharmaceuticals Oy

Katja Wallenlind

Phone +358 (50) 577 4807
E-mail: katja.wallenlind@faronpharmaceuticals.com

Cairn Financial Advisers LLP, Nominated Adviser

Emma Earl, Tony Rawlinson and Rebecca Anderson

Phone: +44 207 148 7900

Panmure Gordon (UK) Limited, Joint Broker

Freddy Crossley, Duncan Monteith (Corporate Finance)

Tom Salvesen (Corporate Broking)

Phone: +44 207 886 2500

Whitman Howard Limited, Nominated Broker

Ranald McGregor-Smith, Francis North

Phone: +44 207 659 1234

Hume Brophy, PR

Mary Clark, Eva Haas, Hollie Vile

Phone: +44 207 862 6390

E-mail: faron@humebrophy.com

 

About Faron Pharmaceuticals Ltd.

Faron is a drug discovery and development company focused on creating novel treatments for medical conditions with significant unmet needs. The Company is based in Turku, Finland. The Company currently has a pipeline of clinical stage products focusing on acute organ traumas, cancer immunotherapy and vascular damage. The Company’s lead candidate Traumakine®, has been developed to treat acute respiratory distress syndrome (“ARDS”), a rare, severe, life threatening medical condition characterised by widespread inflammation in the lungs. Traumakine® is now in a pan-European pivotal Phase III study (INTEREST). Besides Traumakine®, Faron’s pipeline consists of early stage assets including a pre-clinical anti-Clever-1 antibody named Clevegen. Clevegen is focused on converting the immune environment around a tumour from being immune suppressive to immune stimulating and represents a novel immuno-oncology approach called TIET (Tumour Immunity Enabling Technology). Faron Pharmaceuticals Ltd. is listed on AIM under the ticker ‘FARN’. Further information is available at www.faronpharmaceuticals.com


This information is provided by RNS
The company news service from the London Stock Exchange
 

END

 
 

RAGLIFEAELIRFIR

Faron Expands R&D Strategy for Clevegen

RNS Number : 3235Z
Faron Pharmaceuticals Oy
26 May 2016
 

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

Faron Expands R&D Strategy for Novel Immunotherapy Drug Candidate, Clevegen®

TURKU – FINLAND 26 May 2016 – Faron Pharmaceuticals Ltd (LON: FARN) announces today that its Board of Directors has expanded the development strategy for Clevegen®, its novel cancer immunotherapy drug candidate. As announced on 19 April 2016, Faron recently filed patents which have opened up new application opportunities for Clevegen in conditions where removal of suppression of local or systemic immunity is desirable.

Faron will now aim to extend the range of Clevegen indications through a technology platform called “Tumour Immunity Enabling Technology”, or TIET, which can be used alone or in combination with other immune checkpoint molecules. The Directors believe that Clevegen’s ability to convert pro-tumoural M2 macrophages to pro-inflammatory M1 macrophages could help the human body’s own immune system to combat cancer and significantly differentiates it from competing products. At the same time, the removal of immune suppression caused by M2 macrophages could provide a significant boost to the efficacy of other immune checkpoint molecules already in use or under development. Faron intends to develop Clevegen in-house for immune dependent cancers such as hepatocellular carcinoma and other cancers known to depend on tumour associated macrophages (TAM). In addition the strategic decision by Faron to leverage the TIET technology platform may allow licensing opportunities and wider use of Clevegen as part of combination cancer therapies, maximising the value to cancer patients.

Dr. Markku Jalkanen, CEO of Faron, said: “We have made significant progress with Clevegen this Spring, culminating in development of the new TIET technology platform. We will intensify our efforts in commercialising the TIET technology globally while also initiating our own cancer treatment programme. We will report these plans at our R&D day on 14 June, as announced on 13 May 2016, and welcome all interested parties to join the London event.”

The TIET technology could significantly enhance lymphocyte activation programmes enabling them to be more effective in their fight against cancer cells, making TIET attractive to potential collaborators and licensing partners. Faron was granted €1.5 million funding from Tekes, the Finnish Funding Agency for Innovation, in December 2015 to progress the preclinical development of Clevegen.

For more information, please contact:

Faron Pharmaceuticals Oy

Katja Wallenlind

Phone +358 (50) 577 4807
E-mail: katja.wallenlind@faronpharmaceuticals.com

Hume Brophy, PR

Mary Clark, Eva Haas, Hollie Vile

Phone: +44 207 862 6390

E-mail: faron@humebrophy.com

Cairn Financial Advisers LLP, Nominated Adviser

Emma Earl, Tony Rawlinson and Rebecca Anderson

Phone: +44 207 148 7900

Panmure Gordon (UK) Limited, Joint Broker

Freddy Crossley, Duncan Monteith (Corporate Finance)

Tom Salvesen (Corporate Broking)

Phone: +44 207 886 2500

Whitman Howard Limited, Nominated Broker

Ranald McGregor-Smith, Francis North

Phone: +44 207 659 1234

About Clevegen®

Faron´s preclinical drug development project Clevegen revolves around Clever-1, a cell surface receptor expressed mainly by endothelial cells and monocytes/macrophages. Clever-1 is involved in cancer growth and spread. The active pharmaceutical ingredient of Clevegen is a humanised anti-Clever-1 antibody.

Clevegen, by binding Clever-1 prevents Tumor Associated Macrophage (TAM) infiltration into a tumour and blocks TAM-to-Tumour cell interaction triggering TAM transformation into tumour supportive cell types. It therefore reduces 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 has a local tumour effect which also allows the cell-mediated immune response to attack infections in normal tissues. Removal of immune suppression locally also limits the 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 M2 TAMs which facilitate tumour growth, while leaving intact the M1 TAMs which support immune activation against tumours. Clever-1 blocking results especially in activation of Th1 mediated immunity.

About Tumor Immunity Enabling Technology (TIET) 

The TIET technology is built around the humanised anti-Clever-1 antibody FP-1305, which binds to a specific Clever-1 proprietary epitope. Clevegen® binding to this epitope activates conversion of type 2 tumour associated macrophages to type 1 macrophages, resulting in the transformation of the tumour environment from immune suppression to immune activation. As the TIET technology is based on a humanised antibody, the Faron Directors believe it can be combined with a number of other immune therapies without a significant risk of increased adverse events. The TIET technology could provide a significant boost for the efficacy of other immune checkpoint molecules, as its target is unique and represents a completely separate control of immunity.

About Faron Pharmaceuticals Ltd.

Faron is a drug discovery and development company focused on creating novel treatments for medical conditions with significant unmet needs. The Company is based in Turku, Finland. The Company currently has a pipeline of clinical stage products focusing on acute organ traumas, cancer immunotherapy and vascular damage. The Company’s lead candidate Traumakine®, has been developed to treat acute respiratory distress syndrome (“ARDS”), a rare, severe, life threatening medical condition characterised by widespread inflammation in the lungs. Traumakine® is now in a pan-European pivotal Phase III study (INTEREST). Besides Traumakine®, Faron’s pipeline consists of early stage assets including a pre-clinical anti-Clever-1 antibody named Clevegen. Clevegen is focused on converting the immune environment around a tumour from being immune suppressive to immune stimulating and represents a novel immuno-oncology approach called TIET (Tumour Immunity Enabling Technology). Faron Pharmaceuticals Ltd. is listed on AIM under the ticker ‘FARN’. Further information is available at www.faronpharmaceuticals.com


This information is provided by RNS
The company news service from the London Stock Exchange
 

END

 
 

MSCQELFLQEFBBBE

Faron Pharmaceuticals Ltd to host an R&D Day

RNS Number : 1338Y
Faron Pharmaceuticals Oy
13 May 2016
 

Faron Pharmaceuticals Ltd

R&D Day – Save The Date

10.30-13.00

Tuesday, 14th June 2016

Panmure Gordon, One New Change, London, EC4M 9AF

Faron Pharmaceuticals Ltd (“Faron”) is hosting an R&D Day which will take place on Tuesday, 14 June 2016. The event provides the opportunity to hear about the Company, its pipeline and R&D strategy. There will also be presentations from eminent Key Opinion Leaders – Prof Sirpa Jalkanen, a leading cell trafficking scientist in inflammation and cancer; Prof Geoff Bellingan, who is a world leading expert in Acute Respiratory Distress Syndrome (ARDS) and Principal Investigator of the INTEREST trial; and Prof David Adams, who directs the NIHR Birmingham Liver Biomedical Unit and is one of the leading scientists in liver diseases.

The event will take place at Panmure Gordon’s offices, One New Change, London, EC4M 9AF.

If you are interested in attending the Faron Pharmaceuticals Ltd R&D Day or have any questions on the event, please contact Angelina De Souza Callaghan at angelina.desouzacallaghan@humebrophy.com or telephone +44 (0)20 7862 6397.

About Faron Pharmaceuticals Ltd.

Faron is a drug discovery and development company focused on creating novel treatments for medical conditions with significant unmet needs. The Company is based in Turku, Finland. The Company currently has a pipeline of clinical stage products focusing on acute organ traumas, cancer immunotherapy and vascular damage. The Company’s lead candidate Traumakine®, has been developed to treat Acute Respiratory Distress Syndrome (“ARDS”), a rare, severe, life-threatening medical condition characterised by widespread inflammation in the lungs. Traumakine® is now in a pan-European pivotal Phase III study (INTEREST). Besides Traumakine®, Faron’s pipeline consists of early stage assets including a pre-clinical anti-Clever-1 antibody named Clevegen®. Clevegen® is focused on converting the immune environment around a tumour from being immune suppressive to immune stimulating and represents a novel immuno-oncology approach. Faron Pharmaceuticals is listed on AIM under the ticker ‘FARN’. Further information is available at www.faronpharmaceuticals.com


This information is provided by RNS
The company news service from the London Stock Exchange
 

END

 
 

MSCATMFTMBTBBIF

Notice of AGM

RNS Number : 1433X
Faron Pharmaceuticals Oy
04 May 2016
 

NOTICE OF faron pharmaceuticals LTD’s ANNUAL GENERAL MEETING

Shareholders of Faron Pharmaceuticals Ltd are invited to attend the Annual General Meeting to be held on 26 May 2016 at 10 a.m. at the premises of the BioCity building, Mauno Conference Center, address Tykistökatu 6, 20520 Turku, Finland. The registration of attendees and the distribution of voting slips will commence at the meeting venue at 9 a.m.

A. MATTERS ON THE AGENDA OF THE ANNUAL 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. Presentation of the financial statements, the Report of the Board of Directors and the Auditor’s Report for 2015

Review by the CEO

7. Adoption of the Financial Statements

8. Resolution on the use of the profit shown on the balance sheet and the payment of dividend

The Board of Directors proposes that no dividend for the financial year 2015 will be paid and that the losses of the Company for the financial year, amounting to EUR 6.2 million (IFRS), will be carried forward to reserve for invested unrestricted equity.

9. Resolution on the discharge of the members of the Board of Directors and the CEO of the Company from liability

10. Resolution on the remuneration of the members of the Board of Directors

The Board of Directors proposes, on the basis of the proposal of the Remuneration Committee, that the fees payable to the members and the Chairman of the Board will remain unchanged from 2015 and be as follows: an annual remuneration of EUR 35,000 will be paid to the Board members, in addition to which EUR 33,000 will be paid to the Chairman of the Board of Directors. In addition, it is proposed that a further annual remuneration of EUR 5,000 will be paid to Chairman of the Audit Committee, the Nomination Committee and the Remuneration Committee. Finally, it is proposed that all reasonable and properly documented expenses incurred in the performance of duties of the members of the Board of Directors would be compensated.

The Board of Directors also propose, on the basis of the proposal of the Remuneration Committee, that Markku Jalkanen as the Company’s CEO and Yrjö Wichmann as the Company’s CFO will not receive such remuneration as a member of the Board of Directors.

11. Resolution on the number of members of the Board of Directors

The Board of Directors proposes on the basis of the proposal of the Nomination Committee that eight (8) members be elected to the Board of Directors.

12. Election of members of the Board of Directors

The Board of Directors propose, on the basis of the proposal of the Nomination Committee, that Frank Armstrong, Markku Jalkanen, Juho Jalkanen, Jonathan Knowles, Matti Manner, Huaizheng Peng, Yrjö Wichmann and Leopoldo Zambeletti will be re-elected to the Board of Directors until the next Annual General Meeting.

The proposed Board members have informed the Company that in the event they are re-elected, they intend to elect Frank Armstrong as Chairman of the Board and Matti Manner as Deputy Chairman of the Board.

In addition, the proposed Board members have advised that the members of the Board committees would remain unchanged and would therefore be as follows: Leopoldo Zambeletti would be the Chairman and Frank Armstrong and Huaizheng Peng members to the Audit Committee, Frank Armstrong would be the Chairman and Leopoldo Zambeletti and Huaizheng Peng as members to the Remuneration Committee, and Matti Manner would be the Chairman and Frank Armstrong and Jonathan Knowles as members to the Nomination Committee.

13. Resolution on the remuneration of the Auditor

The Board of Directors propose to the Annual General Meeting, on the basis of the proposal of the Audit Committee, that the Auditor be remunerated in accordance with the invoice presented.

14. Election of the Auditor

The Board of Directors propose to the Annual General Meeting on the basis of the proposal of the Audit Committee that PricewaterhouseCoopers Oy, Authorised Public Accountants, continue to act as the Company’s auditor.

PricewaterhouseCoopers Oy has informed the Company that it will appoint Kalle Laaksonen, Authorised Public Accountant, as the Auditor with principal responsibility for the completion of the Audit.

15. Resolution on the amendment of the option programme

The Board of Directors propose, on the basis of the proposal of the Remuneration Committee, that the Annual General Meeting would resolve to amend the option programme adopted by the Extraordinary General Meeting of the Company on 15 September 2015 in respect of the total of 150,000 A options that have remained unallocated and unsubscribed for, to confirm the validity of the said 150,000 A options and that they are available to be allocated to key management and personnel and that the said A options may be subscribed during a term ending on 9 June 2016. Otherwise the terms and conditions would remain unchanged and apply also to the said A options (Appendix 1). Following the amendment, any A options that have not been subscribed at the latest on 9 June 2016 will lapse.

16. Authorising the Board of Directors to decide on the issuance of shares

The Board of Directors propose that the Annual General Meeting would authorise the Board of Directors to resolve by one or several decisions on issuances of shares 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 4,622,340 shares in the aggregate, 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 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, 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.

The authorisation will be effective until 30 June 2017. The Board of Directors propose that the authorisation would supersede the authorisation granted by the Extraordinary General Meeting held on 15 September 2015.

17. Authorisation to make communication to shareholders in electronic form and to communicate by means of a website

The Board of Directors propose that in future the Company shall be permitted to fulfil its obligations in respect of communication to its shareholders (including the Company’s annual accounts) through the use of the Electronic Communication methods as defined in the AIM Rules for Companies (as amended from time to time). Any such methods of communication will be established and operated in accordance with the requirements of the AIM Rules for Companies, the Company’s articles of association and any legal requirements in its jurisdiction of incorporation, Finland.

18. Closing of the meeting

B. DOCUMENTS OF THE ANNUAL GENERAL MEETING

The above-mentioned proposals to the Annual General Meeting and this notice are available on Faron Pharmaceutical’s website at www.faronpharmaceuticals.com under Investor Relations/Financial calendar. Faron Pharmaceutical’s financial statements, the Report of the Board of Directors and the Auditor’s report, are available on the front page of the Company’s website and under Investor Relations/Results and will be posted to all shareholders shortly. The Board proposals and the other above-mentioned documents will also be available at the Annual General Meeting. Copies of these documents and of this notice will be sent to shareholders upon request. The minutes of the Annual General Meeting will be available to be viewed on the Company’s website from 9 June 2016 at the latest.

C. INSTRUCTIONS FOR THE PARTICIPANTS

1. The right to participate and registration

Each shareholder who on the record date of the Annual General Meeting, being 16 May 2016, is registered in the Company’s shareholders’ register held by Euroclear Finland Ltd has the right to participate in the Annual General Meeting. A shareholder whose shares are registered on his/her 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 Annual General Meeting should register for the meeting by no later than 4 p.m. (Finnish time) on Friday 20 May 2016  by giving a prior notice of participation:

•     by completing the registration form on the Company’s website www.faronpharmaceuticals.com under Investor Relations/ Financial calendar;

•     by email to katja.wallenlind@faronpharmaceuticals.com; or

•     by mail to Faron Pharmaceuticals Ltd, C/o Katja Wallenlind, Joukahaisenkatu 6, FI-20520 Turku, Finland.

When registering, a shareholder shall state his/her 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 Faron Pharmaceuticals is used only in connection with the Annual General Meeting and the necessary processing of related registrations.

The shareholder, his/her authorised representative or proxy representative should, when necessary, be able to prove his/her identity and/or right of representation.

2. Proxy representative and powers of attorney

A shareholder may participate in the Annual General Meeting and exercise his/her 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 Annual 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 Annual General Meeting.

Possible proxy documents should be sent in originals to Faron Pharmaceuticals, 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 Annual 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 Annual General Meeting’s record date of 16 May 2016.

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 Monday 23 May 2016. Temporary registration in the shareholders’ register shall be deemed to be a registration for the Annual 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 Annual 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 Companies Act, shareholders who are present at the Annual General Meeting are entitled to request information regarding the matters addressed by the meeting.

On the date of this notice, 4 May 2016, the total number of shares and votes in Faron Pharmaceuticals is 23,111,704.

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

Turku, 4 May 2016

FARON PHARMACEUTICALS LTD

Board of Directors

FOR MORE INFORMATION, PLEASE CONTACT:

Faron Pharmaceuticals Oy

Katja Wallenlind

Phone +358 (50) 577 4807

E-mail: katja.wallenlind@faronpharmaceuticals.com

Hume Brophy, PR

Mary Clark, Eva Haas, Hollie Vile

Phone: +44 207 862 6390

E-mail: faron@humebrophy.com

Cairn Financial Advisers LLP, Nominated Adviser

Emma Earl, Tony Rawlinson and Rebecca Anderson

Phone: +44 207 148 7900

Panmure Gordon (UK) Limited, Joint Broker

Freddy Crossley, Duncan Monteith (Corporate Finance)

Tom Salvesen (Corporate Broking)

Phone: +44 207 886 2500

Whitman Howard Limited, Joint Broker

Ranald McGregor-Smith, Francis North

Phone: +44 207 659 1234

About Faron Pharmaceuticals Ltd

Faron is a drug discovery and development company focused on creating novel treatments for medical conditions with significant unmet needs. The Company is based in Turku, Finland. The Company currently has a pipeline of clinical stage products focusing on acute organ traumas, cancer immunotherapy and vascular damage. The Company’s lead candidate Traumakine®, has been developed to treat Acute Respiratory Distress Syndrome (“ARDS”), a rare, severe, life-threatening medical condition characterised by widespread inflammation in the lungs. Traumakine® is now in a pan-European pivotal Phase III study (INTEREST). Besides Traumakine®, Faron’s pipeline consists of early stage assets including a pre-clinical anti-Clever-1 antibody named Clevegen®. Clevegen® is focused on converting the immune environment around a tumour from being immune suppressive to immune stimulating and represents a novel immuno-oncology approach. Faron Pharmaceuticals is listed on AIM under the ticker ‘FARN’. Further information is available at www.faronpharmaceuticals.com


This information is provided by RNS
The company news service from the London Stock Exchange
 

END

 
 

NOAEAFSDEASKEAF

Faron Appoints New Medical Director

RNS Number : 9490W
Faron Pharmaceuticals Oy
03 May 2016
 

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

Faron Strengthens Executive Team by Appointing New Medical Director

TURKU – FINLAND 3 May 2016 – Faron Pharmaceuticals Ltd (“Faron”) (LON: FARN) announced today that it has strengthened its Executive Management Team with the appointment of MD, PhD, eMBA Matti Karvonen as its new Medical Director. Dr. Karvonen will be responsible for overseeing Faron’s drug development strategy and will play a central role in expanding the clinical programmes of Traumakine® and Clevegen®.

Dr. Markku Jalkanen, CEO of Faron said: “We are delighted to welcome Dr. Karvonen to our ambitious Executive Management Team. His appointment comes at an important time for Faron as we expand our clinical activities. Our lead drug candidate Traumakine, for the treatment of Acute Respiratory Distress Syndrome (ARDS) is now in a pan-European Phase III INTEREST trial, while clinical development for Clevegen, our novel cancer immunotherapy drug candidate is under active planning. Dr. Karvonen’s experience in taking drugs through development programmes will provide an invaluable insight into the needs of both ARDS and cancer patients.”

Dr. Karvonen has a background in clinical neurology with a deep medical experience in many international pharmaceutical organisations, including Roche, Biogen Idec and Novartis and has participated in many clinical programmes, most recently in the pan-European launch of a new neurological drug. In the early part of his career Dr. Karvonen held several research positions and he has also co-founded several commercial medical organisations.

For more information, please contact:

Faron Pharmaceuticals Oy

Katja Wallenlind

Phone +358 (50) 577 4807

E-mail: katja.wallenlind@faronpharmaceuticals.com

Hume Brophy, PR

Mary Clark, Eva Haas, Hollie Vile

Phone: +44 207 862 6390

E-mail: faron@humebrophy.com

Cairn Financial Advisers LLP, Nominated Adviser

Emma Earl, Tony Rawlinson and Rebecca Anderson

Phone: +44 207 148 7900

Panmure Gordon (UK) Limited, Joint Broker

Freddy Crossley, Duncan Monteith (Corporate Finance)

Tom Salvesen (Corporate Broking)

Phone: +44 207 886 2500

Whitman Howard Limited, Joint Broker

Ranald McGregor-Smith, Francis North

Phone: +44 207 659 1234

About Faron Pharmaceuticals Ltd

Faron is a drug discovery and development company focused on creating novel treatments for medical conditions with significant unmet needs. The Company is based in Turku, Finland. The Company currently has a pipeline of clinical stage products focusing on acute organ traumas, cancer immunotherapy and vascular damage. The Company’s lead candidate Traumakine®, has been developed to treat Acute Respiratory Distress Syndrome (“ARDS”), a rare, severe, life-threatening medical condition characterised by widespread inflammation in the lungs. Traumakine® is now in a pan-European pivotal Phase III study (INTEREST). Besides Traumakine®, Faron’s pipeline consists of early stage assets including a pre-clinical anti-Clever-1 antibody named Clevegen®. Clevegen® is focused on converting the immune environment around a tumour from being immune suppressive to immune stimulating and represents a novel immuno-oncology approach. Faron Pharmaceuticals is listed on AIM under the ticker ‘FARN’. Further information is available at www.faronpharmaceuticals.com


This information is provided by RNS
The company news service from the London Stock Exchange
 

END

 
 

BOAUUSARNAAVRUR

Faron Appoints Panmure Gordon as Joint Broker

RNS Number : 9912V
Faron Pharmaceuticals Oy
22 April 2016
 

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

Faron Appoints Panmure Gordon as Joint Broker

TURKU – FINLAND 22 April 2016 – Faron Pharmaceuticals Ltd (“Faron”) (LON: FARN), a drug discovery and development company, announces today the appointment of Panmure Gordon (UK) Limited (“Panmure Gordon”) as Joint Broker to the Company with immediate effect. Whitman Howard will continue to act as Joint Broker to the Company.

– END –

For more information, please contact:

Faron Pharmaceuticals Oy

Katja Wallenlind

Phone: +358 (50) 577 4807

E-mail: katja.wallenlind@faronpharmaceuticals.com

Hume Brophy, PR

Mary Clark, Eva Haas, Hollie Vile

Phone: +44 207 862 6390

E-mail: faron@humebrophy.com

Cairn Financial Advisers LLP, Nominated Adviser

Emma Earl, Tony Rawlinson, Rebecca Anderson

Phone: +44 207 148 7900

Panmure Gordon (UK) Limited, Joint Broker

Freddy Crossley, Duncan Monteith (Corporate Finance)

Tom Salvesen (Corporate Broking)

Phone: +44 207 886 2500

Whitman Howard Limited, Joint Broker

Ranald McGregor-Smith, Francis North

Phone: +44 207 659 1234

About Faron Pharmaceuticals Ltd.

Faron is a drug discovery and development company focused on creating novel treatments for medical conditions with significant unmet needs. The Company is based in Turku, Finland. The Company currently has a pipeline of clinical stage products focusing on acute organ traumas, cancer immunotherapy and vascular damage. The Company’s lead candidate Traumakine®, has been developed to treat acute respiratory distress syndrome (“ARDS”), a rare, severe, life threatening medical condition characterised by widespread inflammation in the lungs. Traumakine® is now in a pan-European pivotal Phase III study (INTEREST). Besides Traumakine®, Faron’s pipeline consists of early stage assets including a pre-clinical anti-Clever-1 antibody named Clevegen. Clevegen is focused on converting the immune environment around a tumour from being immune suppressive to immune stimulating and represents a novel immuno-oncology approach. Faron Pharmaceuticals Oy is listed on AIM under the ticker ‘FARN’. Further information is available at www.faronpharmaceuticals.com


This information is provided by RNS
The company news service from the London Stock Exchange
 

END

 
 

APPUAABRNSASUAR

Faron Files Two New Patents to Protect Clevegen

RNS Number : 5680V
Faron Pharmaceuticals Oy
19 April 2016
 

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

Faron Files Two New Patents to Strengthen Protection for Novel Immunotherapy Drug Candidate, Clevegen®

TURKU – FINLAND 19 April 2016 – Faron Pharmaceuticals Ltd (“Faron”) (LON: FARN) announces today that it has filed two new patent applications on Clevegen®, its novel cancer immunotherapy drug candidate. The patents, which have been filed in Finland, are expected to be expanded to most countries over the next few years under the Patent Co-operation Treaty (PCT) and open up new opportunities for wider application of Clevegen® in conditions where removal of suppression of the local or systemic immunity is desired.

Dr. Markku Jalkanen, CEO of Faron said: “We are very excited about these new filings. The new patents, if granted, will provide a significant extension to our strong intellectual property coverage on Clever-1 and presents new opportunities for Clevegen, which also has the potential to be used in combination therapies with other immune checkpoint compounds. We believe that Clevegen also has the potential for use in chronic infections as well as vaccination protocols, both of which are dependent on immune balance between activation and suppression.”

The Directors believe that Clevegen is well differentiated from competing products as it specifically targets Clever-1 positive M2 macrophages while leaving intact the pro-inflammatory type 1 macrophages supporting immune activation against foreign antigens (e.g. cancer antigens).

Clevegen targets Clever-1 cell surface receptor, which is heavily expressed by tumour-associated macrophages (TAMs). Previous research has shown that when Clevegen binds to TAM Clever-1 the environment of the tumour changes from immune suppression to immune stimulation, but the precise mechanism for action has been partially unclear. On 30 November 2015, Faron announced findings that showed the active pharmaceutical ingredient of Clevegen (humanised anti-Clever-1 antibody) increases Th1-lymphocytes mediated immunity (Palani et al., 2016). This may indicate that Clevegen binding initiates a process that results in conversion of pro-tumoural M2 macrophages to pro-inflammatory M1 macrophages.

Cited reference: Palani et al. (2016) J. Immunol. 196: 115-123.

Filed patent numbers: FI 20165335 and FI 20165336

– END –

For more information, please contact:

Faron Pharmaceuticals Oy

Katja Wallenlind

Phone +358 (50) 577 4807

E-mail: katja.wallenlind@faronpharmaceuticals.com

Hume Brophy, PR

Mary Clark, Eva Haas, Hollie Vile

Phone: +44 207 862 6390

E-mail: faron@humebrophy.com

Cairn Financial Advisers LLP, Nominated Adviser

Emma Earl, Tony Rawlinson and Rebecca Anderson

Phone: +44 207 148 7900

Whitman Howard Limited, Nominated Broker

Ranald McGregor-Smith, Francis North

Phone: +44 207 659 1234

About Clevegen®

Faron´s preclinical drug development project Clevegen revolves around Clever-1, a cell surface receptor expressed mainly by endothelial cells and monocytes/macrophages. Clever-1 is involved in cancer growth and spread. The active pharmaceutical ingredient of Clevegen is a humanised anti-Clever-1 antibody.

Clevegen, by binding Clever-1 prevents Tumor Associated Macrophage (TAM) infiltration into a tumour and blocks TAM-to-Tumour cell interaction triggering TAM transformation into tumour supportive cell types. It therefore reduces 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 has a local tumour effect which also allows the cell-mediated immune response to attack infections in normal tissues and removal of immune suppression locally also 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 M2 TAMs which facilitate tumour growth, while leaving intact the M1 TAMs which support immune activation against tumours. Clever-1 blocking results especially in activation of Th1 mediated immunity.

About Faron Pharmaceuticals Ltd.

Faron is a drug discovery and development company focused on creating novel treatments for medical conditions with significant unmet needs. The Company is based in Turku, Finland. The Company currently has a pipeline of clinical stage products focusing on acute organ traumas, cancer immunotherapy and vascular damage. The Company’s lead candidate Traumakine®, has been developed to treat acute respiratory distress syndrome (“ARDS”), a rare, severe, life threatening medical condition characterised by widespread inflammation in the lungs. Traumakine® is now in a pan-European pivotal Phase III study (INTEREST). Besides Traumakine®, Faron’s pipeline consists of early stage assets including a pre-clinical anti-Clever-1 antibody named Clevegen. Clevegen is focused on converting the immune environment around a tumour from being immune suppressive to immune stimulating and represents a novel immuno-oncology approach. Faron Pharmaceuticals Oy is listed on AIM under the ticker ‘FARN’. Further information is available at www.faronpharmaceuticals.com


This information is provided by RNS
The company news service from the London Stock Exchange
 

END

 
 

MSCSFIFAAFMSESL

Annual Results for the year ended 31 December 2015

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

Annual Results for the year ended 31 December 2015

TURKU – FINLAND, 10 March 2016 – Faron Pharmaceuticals Ltd (“Faron”) (LON: FARN), a drug discovery and development company, today announces its Annual Results for the year ended 31 December 2015. The Annual Report 2015 and accounts are available on the Company’s website and will be posted to Shareholders in due course.

KEY HIGHLIGHTS

Operational Highlights

Traumakine®

·      Established the pivotal pan-European Phase III INTEREST trial for Traumakine, which is in development for the treatment of Acute Respiratory Distress Syndrome (“ARDS”). This includes 55 hospitals with significant intensive care units in seven European countries (UK, France, Germany, Spain, Italy, Belgium and Finland).

·      First Patient recruited in Phase III INTEREST trial in December 2015.

·      Entered into agreements with A&B (HK) Company Limited and CMS Pharma Co. Ltd in mainland China, Hong Kong, Macau and Taiwan (the “Greater China Area”) to license Traumakine in May 2015.

·      Reported second contract period on the EU FP7 grant programme for Traumakine ending 30 November 2015, triggering next period payment.

Clevegen®

·      Entered into a collaboration agreement with the Turku PET Centre, one of the largest positron emission tomography centres in Europe, on the development of novel cancer immunotherapy Clevegen in June 2015.

·      Agreement with Swiss-based Selexis SA for SUREtechnology Platform™ and SURE CHO-M Cell Line™ for use in the development and production of Clevegen in November 2015.

·      Key Publication on Novel Cancer Immunotherapy Mechanism Related to Clevegen published in Journal of Immunology in November 2015.

·      Granted €1.5 million in funding by Tekes, the Finnish Funding Agency for Innovation, to progress the preclinical development of Clevegen in December 2015.

Financial Highlights

·      Successful AIM IPO in November 2015, raising €14.2 million in new funds for the Company.

·      €5.1 million pre-IPO funding from A&B (HK) Company Limited in May 2015, in conjunction with Traumakine agreement for Greater China.

·      Total equity raised of €19.3 million (net €16.9 million) to fund initial pan-European Phase III INTEREST trial of Traumakine for treatment of Acute Respiratory Distress Syndrome (“ARDS”) as well as progressing Clevegen, the Company’s early stage cancer immunotherapy programme.

·      Generated €0.5 million (2014: €1.0 million) revenues mainly from milestone payments from Maruishi Pharmaceutical Co., Ltd. In addition the Company recorded grant income of €0.7 million (2014: €0.1 million) from the EU FP7 grant.

·      Tekes granted a €1.5 million R&D loan to progress the Clevegen programme.

·      On 31 December 2015 the Company held cash balances of €11.1 million (2014: €0.2 million).

·      The operating loss for the financial year ended 31 December 2015 was €6.2 million (2014: €1.4 million loss).

·      Net assets on 31 December 2015 were €11.2 million (2014: €0.5 million)1

Post-Period End Highlights

·      On 7 January 2016, Faron announced positive results from the Phase II Japanese study for Traumakine conducted by Faron’s Japanese licensing partner, Maruishi Pharmaceutical Co., Ltd.

·      On 1 March 2016, Faron announced a patent application to further strengthen protection for its novel Traumakine formulation (FP-1201-lyo), seeking to protect this discovery for the next 20 years. This reinforces Faron’s global patent protection strategy for the product.

·      Recruitment is on track and Faron anticipates that all 55 sites for the Traumakine clinical trial will be open in April 2016.

Commenting on the results, Dr Markku Jalkanen, CEO of Faron, said:

“2015 was a transformational year for Faron as we took three significant steps in our strategic development. Firstly, we successfully financed our operations with €19.3 million equity investments. Secondly, we moved our lead product Traumakine targeting the treatment of ARDS into a pan-European pivotal Phase III INTEREST trial. Thirdly, we continued the pre-clinical development of our novel cancer immunotherapy drug candidate Clevegen, for which we obtained €1.5 million funding from Tekes. We are looking forward to making significant progress with these innovations to develop new treatments for these true unmet medical needs.”

____________
1 The net assets on 31 December 2014 include the €1.1 million convertible loan that was converted to equity in January 2015.

For more information contact:

Faron Pharmaceuticals Ltd

Katja Wallenlind

Phone +358 (50) 577 4807
E-mail:
katja.wallenlind@faronpharmaceuticals.com

Cairn Financial Advisers LLP, Nominated Adviser

Emma Earl, Tony Rawlinson and Rebecca Anderson

Phone: +44 207 148 7900

Whitman Howard Limited, Nominated Broker

Ranald McGregor-Smith, Francis North

Phone: +44 207 659 1234

Hume Brophy, PR

Mary Clark, Eva Haas, Hollie Vile

Phone: +44 207 862 6390

E-mail: faron@humebrophy.com

About Faron Pharmaceuticals Ltd

Faron Pharmaceuticals Ltd is a drug discovery and development company focused on creating novel treatments for medical conditions with significant unmet needs. Faron is based in Turku, Finland. The Company has identified several molecular mechanisms involved in the control of endothelial functions as a source of innovations. Faron currently has a pipeline of products focusing on acute organ traumas, cancer immunotherapy and vascular damage. The Company’s lead candidate Traumakine®, has been developed to treat Acute Respiratory Distress Syndrome (“ARDS”), a rare, severe, life threatening medical condition for which there is currently no approved pharmaceutical treatment. Traumakine® is now in a pan-European pivotal Phase III study (INTEREST). Besides Traumakine®, Faron’s pipeline consists of early stage assets including a pre-clinical anti-Clever-1 antibody named Clevegen®. Clevegen® is focused on converting the immune environment around a tumour from being immune suppressive to immune stimulating representing a novel immuno-oncology approach. Further information is available at www.faronpharmaceuticals.com.

 

Annual Results Statement

Introduction

Overview of the Company

Faron is a drug discovery and development company focused on creating novel treatments for medical conditions with significant unmet needs. The Company has a pipeline of clinical stage products for the treatment of acute organ traumas, cancer immunotherapy and vascular damage.

Strategy

Faron’s strategy is to maximise the potential of its pipeline of drug candidates and to progress the development of its lead product Traumakine. Faron has identified several new endothelial molecules involved in the maintenance of the endothelial barrier which is a thin layer or membrane of cells that lines blood and lymphatic vessels to separate blood content from tissues. The Company believes that the control of these molecules provides a unique way to treat many life-threatening conditions with high unmet medical needs. Faron collaborates with its strategic partners in research, manufacturing and drug development to bring new pharmaceutical products to market in a timely and cost-effective manner. Faron has formed a core team of leading scientists in capillary biology and diseases arising from vascular leakage. The Company has established links with leading laboratories and clinics based at Turku University in Finland, University College London and other institutions.

To date, Faron has operated on a relatively low cost basis by employing only key members of staff and outsourcing where possible. Typically all development work up to the proof-of-concept stage of drug development is carried out in the innovators’ laboratories.  The Company outsources all of its manufacturing activities in relation to its products to third parties and collaborates with Contract Research Organisations (CROs) to carry out the clinical development programmes. Faron monitors and evaluates potential commercial opportunities for its established drug candidates like Traumakine and Clevegen, as and when they arise, and will consider how best to crystallise as much value as possible for Shareholders, which may include holding rights in main territories for as long as it is feasible, and in certain circumstances up to the marketing stage.

Chairman’s Statement

Faron has made significant progress with its pipeline in the last year. The small but highly experienced management team is passionate about and committed to their work in life saving drug development. The Company has chosen to develop new drugs for true unmet medical needs in two critical areas, Acute Respiratory Distress Syndrome (ARDS) and cancer immunotherapy. These two apparently diverse clinical indications are built on Faron’s thorough scientific knowledge of the endothelial barrier function and control providing a solid basis to successfully execute the Traumakine and Clevegen projects.

Faron’s lead drug candidate Traumakine, now in the pivotal, pan-European Phase III INTEREST trial, is at the heart of the company’s mission. It aims to treat ARDS, an orphan, life-threatening medical condition which currently has no available drug treatment.

ARDS is not common, annually about 370,000 people across Europe and the US are diagnosed, but the condition is serious with about 30 to 45% mortality rate. Data from a Phase I/II study of Traumakine for ARDS, published in the Lancet, was associated with an 81% reduction in the odds of 28 day mortality rate. We believe that Traumakine represents a significant opportunity to help ARDS patients, the hospitals that treat these patients and the patients´ families.

Immunotherapy offers enormous potential for cancer treatment by stimulating the patient’s own natural immune response to combat the disease. Faron’s pre-clinical immunotherapy candidate Clevegen causes conversion of the immune environment around a tumour from immune suppressive to immune stimulating, by reducing the number of tumour-associated macrophages (TAMs). We believe that Clevegen is well differentiated from other immunotherapies through its specific targeting of M2 TAMs which facilitate tumour growth, while leaving intact the M1 TAMs that support immune activation against tumours.

In November 2015, Faron was admitted to trading on the AIM market of the London Stock Exchange. The capital raised is devoted to advancing the Company’s two programmes and provides a positive start for 2016.

With the AIM listing, I would like to welcome new Shareholders on behalf of the new Board, and thank the previous Board, employees and advisors for a successful 2015. At the time of the listing, the previous Chairman, Matti Manner, stepped down and became Vice-Chairman. We are all indebted to him for his previous leadership. A number of new Board members were appointed at the listing: Dr Jonathan Knowles, Mr Leopoldo Zambeletti, Dr Huaizheng Peng and myself, Dr Frank Armstrong as Chairman. It is a privilege to participate in the ongoing success achieved by Faron. The Board is very grateful to the staff of the Company and particularly to Dr Markku Jalkanen (CEO) and Mr Yrjö Wichmann (CFO) for their commitment and leadership. Faron is an ambitious company and this is reflected in the employees and leadership of the Company.

The Board is committed to delivering the strategy described in the IPO Admission Document. Our key focus is to complete the recruitment for the Phase III INTEREST trial during 2016, as we regard this as a major value inflection point for Shareholders. We also believe that the progress on Clevegen by our scientific collaborators will provide exciting news in 2016. We will continue to look for opportunities to deliver and enhance value to our Shareholders as well as patients who will benefit from the new drugs Faron is developing.

Dr Frank M Armstrong – Chairman

Chief Executive Officer’s Review/ Operational Review

2015 has been a transformational year for Faron which saw the Company join AIM in November 2015 and achieve a number of scientific and development milestones. Faron’s business growth prospects continue as outlined in the IPO Admission Document in November 2015. We are very excited to become part of the international, publicly quoted biotech sector, which is a key driver in the generation of new pharmaceutical treatments for unmet medical needs.

The main reason for the IPO was to help us execute the further development of our exciting pipeline projects, Traumakine and Clevegen. The pre-IPO round in May 2015 allowed us to initiate preparation for the pivotal, pan-European Phase III INTEREST trial for Traumakine and the proceeds from the IPO round enabled full execution of all the required agreements to open study sites. We can now fully utilise the €6.0 million EU grant to support this final step of Traumakine development in Europe.

Traumakine Development

Faron’s lead drug Traumakine is currently in Phase III development for the treatment of Acute Respiratory Distress Syndrome (“ARDS”). ARDS is a severe, life-threatening medical condition characterised by widespread capillary leakage and inflammation in the lungs, most often as a result of sepsis, pneumonia or significant trauma. Currently there are no pharmacological treatments for ARDS, an orphan disease with a high, 30 to 45% mortality rate. Traumakine has been granted Orphan Drug Designation in Europe which allows a period of 10 years of market exclusivity following marketing approval by the EMA.

In December 2015, the first patient was recruited into the Traumakine pan-European Phase III INTEREST trial. The recruitment of the first patient, so soon after the Company’s recent IPO is consistent with the anticipated timeline of 12 to 18 months required to complete recruitment for the pivotal Phase III trial for Traumakine. The Phase III INTEREST trial is being led by Professor Geoff Bellingan from University College London Hospital and Professor Marco Ranieri from the University of Rome. Subject to the completion of successful Phase III INTEREST trial and achievement of regulatory approvals, Traumakine could be the first effective, mechanistically-targeted, disease-specific pharmacotherapy for ARDS patients.

To date, Faron has entered into agreements with two pharmaceutical companies to carry out the clinical development and commercialisation of Traumakine in Japan and the Greater China Area. Faron owns the IPR and marketing rights in respect of Traumakine in all other territories.

A&B (HK) Company Limited and CMS Pharma Co. LtdIn May 2015, Faron entered into a licence and asset transfer agreement with A&B (HK) for the commercialisation of Traumakine in the Greater China Area. It is intended that A&B (HK)’s commercialisation activities of Traumakine will be conducted by a member of the CMS Group, a rapidly growing pharmaceutical group listed on the Hong Kong Stock Exchange. Alongside this agreement, A&B (HK) provided equity funding of €5.1 million in aggregate. CMS Pharma Co. Ltd owns the right to import, register, market, distribute, promote and sell Traumakine in the Greater China Area.

Maruishi Pharmaceutical Co., Ltd – In 2011 Faron licensed to Maruishi, a Japanese pharmaceutical company, the rights to develop and commercialise Traumakine in Japan. In January 2016, Faron announced that Maruishi had obtained positive results from the Phase II Japanese study for Traumakine. Based on these results Maruishi is now planning a pivotal clinical trial to be conducted in Japan.

Clevegen Development

One of Faron’s key areas of focus is to develop a cancer treatment that supports the hosts’ immune defences against tumours, as these are often suppressed in cancer patients. Faron’s second most advanced drug development project, Clevegen, revolves around Clever-1, an endothelial cell surface molecule involved in cancer growth and spread. The active pharmaceutical ingredient of Clevegen is an anti-Clever-1 antibody.

In June 2015, Faron entered into a collaboration agreement with the Turku PET Centre, one of the largest positron emission tomography cents in Europe, for the development of Clevegen. The PET project will assist Faron in optimising the use of Clevegen for cancer treatment, as well as guide diagnosis, pre-clinical and clinical development and measure potentially novel clinical end points to demonstrate efficacy.

In November 2015, the Journal of Immunology, the highly ranked journal of the American Association of Immunology, published data on Clever-1 function related to Faron’s novel cancer immunotherapy antibody Clevegen.

Following this, in December 2015, Faron was granted €1.5 million funding from Tekes, the Finnish Funding Agency for Innovation, to progress the preclinical development of Clevegen. The funding is a government loan (“Loan”), which covers 50% of the budgeted cost of the preclinical development of Clevegen.

Future Outlook

The key aim for Faron over the next 12-14 months is the completion of the Phase III INTEREST trial recruitment. We anticipate that all 55 sites will be open in April 2016 and the observed recruitment is already higher than the anticipated 0.5 patients/site/month. We therefore reiterate that the INTEREST trial results should be available in mid 2017. We also expect our contracted, scientific collaborators to generate exciting new data on Clever-1 function in tumour immune suppression.

Financial Review

Key Performance Indicator

Faron is a late clinical stage drug development company with no recurring sales and thus the primary Key Performance Indicators (KPI) followed by the Board focus on cash balances and other related information. During 2015, the Company generated €10.8 million free cash flow mainly due to the successful fundraising. The Board will consider the appropriateness of monitoring additional KPIs as the Company’s operations advance.

Revenue and Other Operating Income

The Company’s revenue was €0.5 million for the year ended 31 December 2015 (2014: €0.9 million), which comprised of milestone income from license partner Maruishi and sale of excess API (Active Pharmaceutical Ingredient) material. The Company also recorded €0.7million (2014: €0.1 million) of other operational income. This comprised of income recognised from the European Commission FP7 grant in support of the Traumakine programme. There were no new sources of other operating income during the year.

Share-based Compensation

As part of the IPO process, a number of options were awarded to Directors and key personnel. This had no cash impact on the results for the year, however accounting standards require this share based compensation to be recognised in the Consolidated Statement of Comprehensive Income, resulting in a charge of €0.5million (2014: €0.0 million).

Taxation

The Company’s tax credit for the fiscal year 2015 can be recorded only after the Finnish tax authorities have approved the tax report and confirmed the amount of tax-deductible losses for 2015. The total amount of cumulative tax losses carried forward approved by tax authorities on 31 December 2015 was €5.7 million (2014: €3.2 million). These losses can be utilised during the years 2019 to 2024 by offsetting them against profits. In addition, Faron has €2.8 million research and development costs incurred in the financial years 2010 and 2011 that have not yet been deducted in its taxation. This amount can be deducted over an indefinite period at the Company’s discretion.

Losses

Loss before income tax was €6.2 million (2014: €1.4 million). Net loss for the year was €6.2 million (2014: €1.4 million), representing a loss of €0.30 per share (2014: €0.09 per share) (adjusted for the changes in share capital).

Cash Flows

The Company had a net cash inflow of €10.8 million for the year ended 31 December 2015, compared to a net cash inflow of €0.2 million for the previous year. Cash used by operating activities increased from €6.8 million to €7.1 million for the year, compared to €0.4 million for the year ended 31 December 2014. This was driven by an increase in research and development investments, as well as an overall increase in general and administration costs.

Net cash inflow from financing activities increased with €17.3 million to €18.1 million for the year due to the receipt of net proceeds of €18.1 million from an equity placings completed in May-June 2015 and the IPO in November 2015.

Financial Position

As at 31 December 2015, total cash and cash equivalents held were €11.1 million (2014: €0.2 million).

Headcount

Average headcount of the Company for the year was 6 (2014: 5). The increase in headcount is attributable to the commencement of the Phase III INTEREST trial.

Shares and Share Capital

On 24 February 2015, the number of Ordinary Shares was increased to 1,623,791 by the issue of 78,166 new Ordinary Shares at a subscription price of €14.40. The subscription price was credited in full to the Company’s reserve for invested unrestricted equity, and the share capital of the Company was not increased;

On 19 May 2015, the number of Ordinary Shares was increased to 1,843,356 by the issue of 219,565 new Ordinary Shares at a subscription price of €15.41. The subscription price was credited in full to the Company’s reserve for invested unrestricted equity, and the share capital of the Company was not increased;

On 9 June 2015, the number of Ordinary Shares was increased to 1,926,555 Ordinary Shares by the issue of 83,199 new Ordinary Shares at a subscription price of €20.03. The subscription price was credited in full to the Company’s reserve for invested unrestricted equity, and the share capital of the Company was not increased;

By resolution of the Extraordinary General Meeting held on 15 September 2015, the number of Ordinary Shares was increased to 19,265,550 by the issue of 17,338,995 new Ordinary Shares to the Shareholders without payment in proportion to their holdings so that nine Ordinary Shares were issued for each existing Ordinary Share (the “Share Split”);

By resolution of a Board Meeting held on 16 September 2015, the Company issued 151,400 warrants (each warrant representing an entitlement to subscribe for one Ordinary Share) to Whitman Howard (which were subscribed on 16 September 2015). The warrants are divided into two tranches: in the first tranche, 109,800 warrants with a subscription price of €1.55 (“A Warrants”), and in the second tranche, 41,600 warrants with a subscription price of €2.01 (“B Warrants”). Any “A” Warrants shall be exercised during the subscription period commencing on 2 November 2015 and ending on 7 May 2018. Any “B” Warrants shall be exercised during the subscription period commencing on 2 November 2015 and ending on 28 May 2018;

By resolution of the Extraordinary General Meeting held on 15 September 2015, the Company adopted the 2015 Share Option Plan and granted the Options detailed in Directors´ Remuneration Report set out in the Annual Report and Accounts.

By resolution of a Board Meeting held on 11 November 2015, the Company resolved to issue (i) 2,417,113 Ordinary Shares without payment into treasury, in order for such Ordinary Shares to be transferred to Placees pursuant to the Placing on a delivery versus payment basis on Admission, (ii) 44,044 Ordinary Shares and VCT shares and EIS shares pursuant to the placing, and (iii) 1,384,997 Ordinary Shares as subscription shares pursuant to the subscription.

Pre-IPO Financing

In May – June 2015 the Company raised a total of €5,049,972 issuing a total of 302,764 new shares to A&B (HK) Company Limited in two separate tranches with an average subscription price of €16.68. After the Share Split the number of shares increased to 3,027,640 and the average subscription price was €1.67. A&B is a Hong Kong company, which is related to CMS by virtue of both having a common controlling shareholder.

IPO

The Company was admitted to trading on AIM in November 2015 alongside the issue of 3,846,154 new shares with a subscription price of 260 pence, or €1.83, per share raising £10,000,000, or €14,210,967. A total of 16 investors participated in the IPO of which 12 were new investors in the Company. The majority of the funds raised and the new investors were from the UK. At 31 December 2015, the Company had issued a total of 23,111,704 shares. All shares are ordinary shares with equal rights.

Money Raised to Date

To date, the Company has been funded with a total of approximately €32.8 million, made up of a combination of equity, debt and grant funding, which has been used to develop the Company’s products and intellectual property. The Company has also generated revenues of €3.3 million to date through the receipt of milestone payments pursuant to certain of its licensing arrangements and the sale of surplus raw materials.

 

ANNUAL RESULTS

Statement of comprehensive income

Year ended

31 Dec
2015

Year ended

31 Dec
2014

€’000

€’000

Stated in Euro

Revenue

 520

 906

Cost of sales

(25)

(425)

Gross profit

 496

 481

Other operating income

 701

 111

Administrative expenses

(3 061)

(349)

Research and development expenses

(3 971)

(1 471)

Operating result

(5 835)

(1 228)

Financial income

 0

 15

Financial expenses

(311)

(146)

Net financial costs

(311)

(130)

Loss before income taxes

(6 146)

(1 358)

Income tax expense

(42)

(6)

Total comprehensive income
for the financial year

(6 188)

(1 364)

Total comprehensive income,
attributable to:

Equity holders of the Company

(6 188)

(1 364)

Loss per share attributable to
equity holders of the Company

Basic and diluted loss per share, euro

(0,30)

(0,09)

 

Balance sheet

31 Dec
2015

€’000

31 Dec
2014

€’000

Stated in Euro

Assets

Non-current assets

Property, plant and equipment

 28

 0

Intangible assets

 1 001

 1 184

 1 029

 1 184

Current assets

Inventories

 649

 699

Trade and other receivables

 2 074

 40

Cash and cash equivalents

 11 068

 242

 13 791

 980

Total assets

 14 821

 2 165

Equity and liabilities

Capital and reserves attributable to equity holders of the Company

Share capital

 2 691

 1 416

Unregistered share capital

 – 

 1 275

Reserve for invested non-restricted equity

 24 533

 6 453

Retained earnings

(16 046)

(10 332)

Total equity

 11 178

(1 188)

Non-current liabilities

Interest-bearing financial liabilities

 1 446

 1 691

 1 446

 1 691

Current liabilities

Interest-bearing financial liabilities

 – 

 – 

Non-interest-bearing financial liabilities

 681

 9

Other current liabilities

 1 517

 1 652

 2 197

 1 662

Total liabilities

 3 643

 3 352

Total equity and liabilities

 14 821

 2 165

 

Statement of changes in equity

Share capital

€’000

Un-

registered

 share

 capital1

€’000

Reserve

 for

 invested

 non

-restricted

 equity

€’000

Retained earnings

€’000

Total equity

€’000

Stated in Euro          

Balance at 31 December 2013

 1 416

 1 275

 5 328

(8 968)

(949)

Total comprehensive income
for the financial year 2014

(1 364)

(1 364)

Transactions with equity holders of
the Company, recognised directly in equity

Increase of share capital*

 1 275

(1 275)

 – 

 – 

 – 

Conversion of convertible notes

 – 

 1 126

 – 

 1 126

 1 275

(1 275)

 1 126

 – 

 1 126

Balance at 31 December 2014

 2 691

 – 

 6 453

(10 332)

(1 188)

Total comprehensive income
for the financial year 2015

(6 188)

(6 188)

 – 

Transactions with equity holders of
the Company, recognised directly in equity

 – 

Share base payment

 474

 474

 – 

Increase of share capital

 – 

 18 080

 – 

 18 080

Conversion of convertible notes

 – 

 – 

 – 

 – 

 – 

 18 080

(5 714)

 12 366

Balance at 31 December 2015

 2 691

 – 

 24 533

(16 046)

 11 178

 

Statements of cash flows

Year Ended

 31 Dec
2015

€’000

Year Ended

31 Dec
2014

€’000

Stated in Euro

Cash flow from operating activities

Loss(-) / profit(+) attributable to equity holders
of the Company

(6 144)

(1 364)

Adjustments for

Depreciation and amortisation

 184

 60

Financial items

 298

 130

Income taxes

 42

 6

Non-cash items (write-off R&D)

 78

Non-cash items (options granted)

 430

 – 

Change in net working capital:

Trade and other receivables

(2 035)

 6

Inventories

 50

 400

Trade and other current liabilities

 278

 510

Interest and other financial costs paid

(285)

(146)

Interest and other financial income received

 0

 15

Income taxes paid

(42)

(6)

Net cash used in / from operating activities  (A)

(7 146)

(389)

Cash flow from investment activities

Investments in machinery and equipment and intangible assets

(107)

(152)

Net cash from/used in investing activities (B)

(107)

(152)

Cash flow from financing activities

Proceeds from issue of share capital/issue

 18 080

 – 

Proceeds from issue of convertible notes

 1 126

Proceeds from current borrowings

 – 

 – 

Proceeds from non-current borrowings

 – 

 245

Repayment of current borrowings

 – 

(588)

Net cash used in financing activities (C)

 18 080

 783

Net increase(+) / decrease (-) in cash and cash equivalents (A+B+C)

 10 827

 242

Cash and cash equivalents at 1 January

 242

(0)

Cash and cash equivalents at 31 December

 11 068

 242

 

NOTES TO THE ANNUAL RESULTS

For the year ended 31 December 2015

Note 1         Basis of preparation

The audited financial information set out herein does not constitute statutory accounts as defined in Finnish Accounting Act. The financial information presented here for the year ended 31 December 2015 has been extracted from the Group’s audited financial statements which were approved by the Board of Directors on 9 March 2016 and which are available on the Company’s website.

Faron’s audited financial statements are prepared in accordance with International Financial Reporting Standards (IFRS)) as adopted by the European Union (and as published by the International Accounting Standards Board (IASB) and in force as at 31 December 2015. In the EU IFRS standards and their interpretations are adopted in accordance with the procedure laid down in regulation (EC) No 1606/2002 of the European Parliament and of the Council. Faron has consistently applied these policies to each year presented, unless otherwise stated. The Company has not applied any standard, interpretation or amendment thereto before its effective date.

Faron’s date of transition to IFRS is 1 January 2012. The Company has applied IFRS 1 First-time Adoption of International Financial Reporting Standards in preparing these financial statements. Until 31 December 2011 Faron’s separate financial statements were prepared in accordance with Finnish Accounting Standards (FAS).

The financial statements are prepared under the historical cost convention, except as disclosed in the accounting policies below.

The financial year of Faron is the calendar year ending 31 December. The figures in the financial statements are presented in thousands of euro unless otherwise stated. All figures presented have been rounded, and consequently the sum of individual figures may deviate from the presented aggregate figure.

The Company has not had any other comprehensive income in those years presented in these financial statements.

Faron’s financial statements are prepared on a going concern basis. It is the intention of the Company to continue the development of the products to the point where they can be either licensed at attractive terms to internationally active pharmaceutical companies who have the means to further develop these products, or to develop the products in-house until receipt of marketing approval from the relevant regulatory agencies is obtained. After such approval, Faron would primarily seek to form partnerships with strong global, regional or local pharmaceutical companies that have the necessary marketing and distribution capabilities and resources. In such partnerships, Faron will typically grant geographically limited licenses for products in exchange for contractually agreed payments, license fees and royalties on future product sales. In some cases, one element of such an agreement may include a collaboration in which Faron will also receive funding for R&D services provided at a cost plus basis. In addition to its normal R&D and corporate activities, Faron seeks, as a clinical stage drug discovery and development company, to advance the development of its lead compounds through clinical trials. The Company conducts these clinical trials either together with development partners or by itself, however, in both cases these activities require substantial funding. Faron primarily relies upon financing its activities through equity financing, license agreements, and public R&D loans and grants.

The preparation of financial statements under IFRS requires management to make judgments, estimates and assumptions that affect the reported amounts of assets and liabilities, and disclosure of contingent assets and liabilities at the end of the reporting period as well as the reported amounts of income and expenses during the reporting period. These estimates and assumptions are based on historical experience and other justified assumptions that are believed to be reasonable under the circumstances at the end of the reporting period and the time when they were made. Although these estimates are based on management’s best knowledge of current events and actions, actual results may ultimately differ from those estimates. The estimates and underlying assumptions are reviewed on an on-going basis and when preparing the financial statements. Changes in accounting estimates may be necessary if there are changes in the circumstances on which the estimate was based, or as a result of new information or more experience. Such changes are recognised in the period in which the estimate is revised.

 

Note 2         Intangible assets

Faron’s intangible assets include patents and internally developed intellectual property (“documentation-related assets”). An intangible asset is recognised only if it is probable that the future economic benefits attributable to the asset will flow to Faron and the cost of the asset can be measured reliably. All other expenditure is expensed as incurred. These intangible assets are initially recognised at cost. Cost comprises the purchase price and all costs directly attributable to bringing the asset ready for its intended use. Subsequently intangible assets are carried at cost less amortisation and any accumulated impairment losses.

Internally generated intangible assets arising from development are recognised if, and only if, all the criteria for recognition are fulfilled:

·    it is technically feasible to complete the intangible asset so that it will be available for use;

·    there is an ability to use or sell the intangible asset;

·    it can be demonstrated how the intangible asset will generate probable future economic benefits;

·    adequate technical, financial and other resources to complete the development and to use or sell the intangible asset are available; and

·    the expenditure attributable to the intangible asset during its development can be reliably measured.

·    The internally developed documentation asset is related to the re-development of the active pharmaceutical ingredient, API (“API documentation”) The development activities and documentation relate to stability testing of a drug substance (API), that is sellable as such, but the quality and value of which improves as the stability is proven and documented. In addition to its own use, Faron may also, for a fee, license the documentation to companies that can utilise documentation in their own drug candidate approval and registration documentation. Provision of such access does in no way limit Faron’s ability to use the documentation in its own application processes or ability to give such access to additional users.

Intangible assets are amortised over their expected or known useful lives on a straight-line basis beginning from the point they are available for use. The estimated useful life is the lower of the legal duration and the economic useful life. The estimated useful lives of intangible assets are regularly reviewed. The estimated useful life for intangible assets is currently 10 years. The effect of any adjustment to useful lives is recognised prospectively as a change of accounting estimate. Intellectual property-related costs for patents are part of the expenditure for the research and development projects.

The assets’ residual values and useful lives are reviewed, and adjusted if appropriate, at the end of each financial year.

Internal research costs are those costs incurred for the purpose of gaining new scientific or technical knowledge and understanding. Such costs are always expensed as incurred. Internal development costs are those costs incurred for the application of research findings or other knowledge to plan and develop new products for commercial production. As the drug product development projects undertaken by Faron are subject to technical feasibility, regulatory approval and other uncertainties, these criteria are considered to be met only after Faron has filed its submission to the regulatory authority for final approval after which all subsequent development costs will be capitalised. Before this trigger point all drug product related development costs are typically expensed as incurred. Faron has not capitalised any drug product related development expenditure as the related criteria have not been met yet. Development costs expensed in prior financial years are not capitalised at a later date.

 

Note 3         Currency risk

Currency risk is the risk that the fair value or future cash flows of a financial instrument, e.g. a trade receivable, will fluctuate because of changes in foreign exchange rates.

Faron’s functional currency is the euro and Faron is exposed to foreign exchange risk arising from currency exposure, currently mainly with respect to the Japanese Yen and pound sterling. The Company receives payments from its main licence partner Maruishi (based in Japan) in Japanese Yen. However, the impact of the foreign exchange risk arising from the Yen exposure is not considered significant in average.

Due to the commencement of the Phase III clinical trials with a UK based Clinical Research Organisation as main service provider, the Company’s’ pound denominated expenses and trade payables have become significant. The Company converted most of the pound denominated IPO proceeds into euros immediately after the IPO, but held and still holds a sizeable amount of pounds on its pound sterling bank accounts. This forms a natural hedge against Euro-pound sterling exchange rate changes, as the funds held in pounds roughly match with the estimated pound expenses during 2016. As a result of the sizeable pound sterling holdings, the depreciation of pound sterling against Euro had a negative effect on the financial statements. As the exchange rate may move also to other direction during 2016, the management believes that natural hedge strategy best protects the Company from adverse exchange rate changes and this protection overweighs short term currency rate losses.

Other foreign currency denominated trade receivables (and trade payables, if any) are small and short term in nature. The borrowings and other liabilities of Faron are denominated in Euro. As the currency exposure and risk is considered significant, the Company established natural hedging policy to manage the foreign exchange risk against the functional currency of the Company.

 

Note 4         Other operating income

Other operating income

2015

2014

€’000

€’000

Grants from EU

701

111

In the ended 31 December 2012, the pan-European “Traumakine” consortium, for which  Faron Pharmaceuticals is the coordinator, signed a grant agreement in respect of a EUR 5,963 thousand research grant awarded by the European Commission from the seventh framework program (FP7) to support the FP-1201-lyo clinical phase III program (“Traumakine”), focusing to develop a first pharmacological treatment for acute respiratory distress syndrome (ARDS). The first payment to the consortium under the grant, received by Faron in 2013, amounted to EUR 1,693 thousand, of which EUR 660 thousand has been recognised by Faron as other operating income. The second grant payment, EUR 1,018 thousand was received in the end of 2014, of which EUR 110 thousand has been recognised as other operating income. In 2015, 701 thousand was recognised as other operating income.

The Company will defer elements of the grant to the point in which the respective milestones are completed (i.e. the milestones which are set out within the EU Grant agreement). Once these milestones are met the amount due to the Company is recognised as other operating income.

 

Note 5         Financial income and expenses

Faron has received two government loans for research and development purposes with below-market interest rate from Tekes (The Finnish Funding Agency for Technology and Innovation). Both loans were drawn down before the date to transition to IFRS (i.e. prior to 1 January 2012). Thus, based on the exemption under IFRS 1, Faron has measured the government loans using the previous FAS carrying amount as the carrying amount of the loan. Subsequently, both loans are carried at amortized cost using the effective interest rate.

Other significant financial expense items are the exchange rate losses when transferring GBP to Euro, when issuing the new shares upon Admission to AIM, expenses on loan guarantees, interest on convertible loans and credit limit interest from bank.

Financial income

2015

€’000

2014

€’000

Interest from bank balances

0

0

Interest from account receivables

15

Total financial income

0

15

Financial expenses

Interest on government loans (Tekes)

(18)

(15)

Interest expenses on convertible bonds

(9)

(67)

Interest on bank loan

(10)

(26)

Interest on accounts payables

(1)

(1)

Exchange rate losses

(247)

(1)

Bank guarantee costs and provisions

(27)

(35)

Total financial expenses

(311)

(146)

Total financial income and expenses

(311)

(131)

 

Note 6         Income taxes

2015

‘000

2014

‘000

Withholding tax

(42)

(6)

Total income taxes

(42)

(6)

Withholding taxes paid in 2014 relate to payments of advisory fees to the non-Finnish members of the Clinical trial steering group. Taxes paid in 2015 relate to milestone payment to Maruishi.

Reconciliation of effective tax rate

2015

‘000

2014

‘000

The Finnish corporate tax rate applied was 20%.

Loss before income tax

(6 188)

(1 358)

Tax using Faron’s domestic corporate tax rate

1 238

272

Current-year losses for which no deferred tax asset is recognised

(1 238)

(272)

Taxes in the income statement

Items for which Faron has not recognised a deferred tax asset

R&D expenses not yet deducted in taxation1

2 816

2 816

The tax losses carried forward approved by tax authorities2

5 663

3 164

Deductible temporary differences for which no deferred asset have been recognised

8 479

5 979

1) Faron has incurred research and development costs in the financial years 2010 and 2011 that have not yet been deducted in its taxation. The amount can be deducted over an indefinite period with amounts that the Company may freely decide.

2) These losses expire over the years 2019 to 2024. The amount presented for the year-end 31 December 2015 does not include the deductible temporary difference arisen from the net loss for the financial year 2015 as the related loss has not yet been approved by tax authorities by the time of preparation of these financial statements.                               

The related deferred tax assets have not been recognised due to the uncertainty as to whether they can be utilised.

 

Note 7            Equity and reserves                                                       

Number of shares (pcs)

Share capital 

€’000

Reserve for invested non-restricted equity

€’000

Total 

€’000

In issue at 1 January 2013

1,453,380

1,296

5,328

6,624

Conversion of convertible notes to shares

3 688

120

0

120

Issued for merger consideration

1,000,000

0

0

0

Cancelled in merger

(1,000,000)

0

0

0

31 December 2013

1,457,068

1,416

5,328

6,744

Share issues,

issued for cash

35,424

1,275

0

1,275

Issue of convertible equity instrument

0

0

1,126

1,126

Warrants issue

53,133

0

0

0

 31 December 2014

1,545,625

2,691

6,453

9,144

Share base payments

0

0

0

Convertible issue

78,166

0

Share issues for cash

302,764

5,050

5,050

Total

1,926,555

0

Split 1:10

19,265,550

0

Emission of new shares

3,846,154

13,030

13,030

 31 December 2015

23,111,704

2,691

24,533

27,224

 

Note 8            Current receivables

2015

€’000

2014

€’000

Trade receivables

 37

 – 

Prepayments

 1,248

 – 

Accrued items

 17

 23

Other receivables

 773

 16

Total trade and other receivables

 2,074

 40

The majority of prepayments relate to the Clinical Service Agreement with the clinical research organisation (CRO) GAEA Clinical, which is the main service provider for the INTEREST study. The other receivables consist mainly of the EU FP7 grant income as described in Note 4.

 

Note 9         Current financial liabilities and other liabilities

Interest-bearing financial liabilities

2015

€’000

2014

€’000

Convertible notes

Government loans (current portion)

 245

 – 

Bank overdraft facility

 – 

 – 

 245

 – 

Non-interest-bearing financial liabilities

Trade payables

 436

 9

 436

 9

Other liabilities

Prepayments

973

 1 456

Accrued expenses

515

 150

Other liabilities

 29

 46

1 517

 1 652

Total current financial liabilities and

other liabilities

 2 198

 1 662

The item “Prepayments” above comprises portions of the awarded EU grant, received in 2013 and 2014. The major item under “Accrued expenses” are personnel related (short-term employee benefits).

 

Note 10       Transactions with related parties

Related parties of the Company

Faron’s related party comprise the following:

·    Marko Salmi, a private person having significant influence in Faron Pharmaceuticals Oy, following from the shareholding of 17.6%, as at 31 December 2015.

·    A&B (HK) Company Limited, an investment company existing under the laws of Hong Kong having significant influence in Faron Pharmaceuticals Oy, following from the shareholding of 15.2%, as at 31 December 2015.

·    Board of Directors; and the Company’s key management personnel (see below)

Faron had no interests in other entities at the end of the reporting periods presented in these financial statements.

Key management personnel

The Company’s key management personnel consist of the following:                     

·    members of the Board of Directors                                              

·    Management Team comprising CEO Markku Jalkanen, PhD; VP Ilse Piippo, MD, MSc (Pharm); VP Mikael Maksimow PhD and CFO Yrjö Wichmann MSc (Econ)

Remuneration of key management personnel*

2015

2014

€’000

€’000

Salaries and other short-term employee benefits

769

 472

Share based payment

122

Post-employment benefits

(defined contribution plans)

 – 

Total

891

472

Remuneration to the Board of Directors **                                                      

Salaries and other short-term benefits

 124

 50

Share based payment

 155

Total

 279

 50

*Presented information for the Management Includes the Executive Directors of the Board 

**Presented information for the Board includes only Non-Executive Directors.                   

 

Management and Board shareholding

Management* shareholding, 31 December 2015

Number of shares (pcs)

2,942,830

Shareholding, percentage

12.7 %

Board** shareholding, 31 December 2015

(excluding the shareholding of CEO)

Number of shares (pcs)

1,584,623

Shareholding, percentage

6.9 %

“Total number of shares outstanding at 31 December 2015 (pcs)”

23,111,704

*Presented information for the Management Includes the Executive Directors of the Board 

**Presented information for the Board includes only Non-Executive Directors.                   

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