Faron, etusivu

Notice of 2021 Full-Year Results and Annual Report

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

 

Notice of 2021 Full-Year Results and Annual Report

 

Press Release, March 7, 2022 at 09:00 AM (EET) / 07:00 AM (GMT) / 02:00 AM (EST)

 

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Ltd (AIM: FARN, First North: FARON), a clinical stage biopharmaceutical company focused on building the future of immunotherapy by harnessing the power of the immune system to tackle cancer and inflammation, will publish its audited full-year results for the twelve months ended December 31, 2021 on Friday, March 25, 2022 at 9:00 am EET, 7:00 am GMT, 3:00 am EDT. The Annual Report 2021, including audited financial statements for the full year, will be published on the same day.

 

A virtual briefing and Q&A session for analysts will be hosted by Dr. Markku Jalkanen, Chief Executive Officer of Faron, and Toni Hänninen, Chief Financial Officer of Faron, at 2:00 pm EET / 12:00 pm GMT / 8:00 am EDT on the day of results. The Full-year results release for 2021, presentation, webcast details, and Annual Report 2021 will be made available at www.faron.com/investors. A replay of the analyst briefing will be made available shortly afterwards.

 

For more information please contact:

 

Media / Investor Contact

Faron Pharmaceuticals

Eric Van Zanten

Head of Communications

eric.vanzanten@faron.com

investor.relations@faron.com

Phone: +1 (610) 529-6219

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880

 

Peel Hunt LLP, Broker

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

 

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

 

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

faron@consilium-comms.com

Phone: +44 (0)20 3709 5700

 

About Faron Pharmaceuticals Ltd

Faron (AIM: FARN, First North: FARON) is a clinical stage biopharmaceutical company developing novel treatments for medical conditions with significant unmet needs caused by dysfunction of our immune system. The Company currently has a pipeline based on the receptors involved in regulation of immune response in oncology, organ damage and bone marrow regeneration. Bexmarilimab, a novel anti-Clever-1 humanized antibody, is its investigative precision immunotherapy with the potential to provide permanent immune stimulation for difficult-to-treat cancers through targeting myeloid function. Currently in Phase I/II clinical development as a potential therapy for patients with untreatable solid tumors, bexmarilimab has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules. Traumakine is an investigational intravenous (IV) interferon beta-1a therapy for the treatment of acute respiratory distress syndrome (ARDS) and other ischemic or hyperinflammatory conditions. Traumakine is currently being evaluated in global trials as a potential treatment for hospitalized patients with COVID-19 and with the 59th Medical Wing of the US Air Force and the US Department of Defense for the prevention of multiple organ dysfunction syndrome (MODS) after ischemia-reperfusion injury caused by a major trauma.  Faron is based in Turku, Finland. Further information is available at www.faron.com.

 

Forward Looking Statements

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

 

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

 

220303 2021 Full Year Results - Date and Time Announcement

Holdings in Company

TR-1: Standard form for notification of major holdings

NOTIFICATION OF MAJOR HOLDINGS (to be sent to the relevant issuer and to the FCA in Microsoft Word format if possible)i
1a. Identity of the issuer or the underlying issuer of existing shares to which voting rights are attachedii: Faron Pharmaceuticals Ltd
1b. Please indicate if the issuer is a non-UK issuer  (please mark with an “X” if appropriate)
Non-UK issuer X
2. Reason for the notification (please mark the appropriate box or boxes with an “X”)
An acquisition or disposal of voting rights x
An acquisition or disposal of financial instruments x
An event changing the breakdown of voting rights
Other (please specify)iii: (Decrease of holding due to issuance of new shares)
3. Details of person subject to the notification obligationiv
Name Timo Syrjälä
City and country of registered office (if applicable)
4. Full name of shareholder(s) (if different from 3.)v
Name
City and country of registered office (if applicable)
5. Date on which the threshold was crossed or reachedvi: 28.01.2022
6. Date on which issuer notified (DD/MM/YYYY): 31.01.2022
7. Total positions of person(s) subject to the notification obligation
% of voting rights attached to shares (total of 8. A) % of voting rights through financial instruments
(total of 8.B 1 + 8.B 2)		 Total of both in % (8.A + 8.B) Total number of voting rights of issuervii
Resulting situation on the date on which threshold was crossed or reached 17.27% 17.27%  53.232.032
Position of previous notification (if applicable) 16.67% 16.67%
8. Notified details of the resulting situation on the date on which the threshold was crossed or reachedviii
A: Voting rights attached to shares
Class/type of
sharesISIN code (if possible)		 Number of voting rightsix % of voting rights
Direct(Art 9 of Directive 2004/109/EC) (DTR5.1) Indirect(Art 10 of Directive 2004/109/EC) (DTR5.2.1) Direct(Art 9 of Directive 2004/109/EC) (DTR5.1) Indirect(Art 10 of Directive 2004/109/EC) (DTR5.2.1)
FI4000153309 2.663.573 6.528.926 5.00% 12.27%
SUBTOTAL 8. A 9.192.499 17.27%
B 1: Financial Instruments according to Art. 13(1)(a) of Directive 2004/109/EC (DTR5.3.1.1 (a))
Type of financial instrument Expiration
datex		 Exercise/
Conversion Periodxi		 Number of voting rights that may be acquired if the instrument is exercised/converted. % of voting rights
SUBTOTAL 8. B 1
B 2: Financial Instruments with similar economic effect according to Art. 13(1)(b) of Directive 2004/109/EC (DTR5.3.1.1 (b))
Type of financial instrument Expiration
datex		 Exercise/
Conversion Period xi		 Physical or cash settlementxii Number of voting rights % of voting rights
SUBTOTAL 8.B.2
9. Information in relation to the person subject to the notification obligation (please mark the applicable box with an “X”)
Person subject to the notification obligation is not controlled by any natural person or legal entity and does not control any other undertaking(s) holding directly or indirectly an interest in the (underlying) issuerxiii
Full chain of controlled undertakings through which the voting rights and/or the financial instruments are effectively held starting with the ultimate controlling natural person or legal entityxiv (please add additional rows as necessary) x
Namexv % of voting rights if it equals or is higher than the notifiable threshold % of voting rights through financial instruments if it equals or is higher than the notifiable threshold Total of both if it equals or is higher than the notifiable threshold
Timo Syrjälä (Direct) 5.00% 5.00%
Acme Investments SPF Sarl (Indirect) 12.27% 12.27%
10. In case of proxy voting, please identify:
Name of the proxy holder
The number and % of voting rights held
The date until which the voting rights will be held
11. Additional informationxvi
Place of completion Luxembourg
Date of completion 31.01.2022
Release

Juho Jalkanen Appointed Chief Operating Officer

Faron Pharmaceuticals Ltd

(“Faron”)

 

Faron Appoints Juho Jalkanen, M.D., Ph.D., as Chief Operating Officer

 

Company announcement, January 31, 2022 at 02:00 AM (EST) / 07:00 AM (GMT) / 09:00 AM (EET)

 

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Ltd (AIM: FARN, First North: FARON), a clinical stage biopharmaceutical company focused on building the future of immunotherapy by harnessing the power of the immune system to tackle cancer and inflammation, is pleased to announce the appointment of Juho Jalkanen, M.D., Ph.D., as Chief Operating Officer of the Company. Dr. Jalkanen will continue to be based in Turku, Finland and his appointment is effective immediately. 

 

In his new role, Dr. Jalkanen will lead business strategy and daily operations for Faron. This includes oversight of academic and industry partnerships, resource prioritization and allocation, chemistry, manufacturing and controls, supply chain and driving performance measures. His priority will be the accelerated development of bexmarilimab, Faron’s wholly owned, novel precision cancer immunotherapy candidate. Bexmarilimab is currently in development as a potential monotherapy in patients with solid tumors. Faron is also advancing plans to study bexmarilimab in the neoadjuvant setting, in combination with checkpoint inhibitors and as a treatment for hematological malignancies.

 

“Dr. Jalkanen is an experienced biopharmaceutical industry executive with extensive leadership experience across key functional areas including operations, business development, clinical development, medical and regulatory affairs,” said Dr. Markku Jalkanen, Chief Executive Officer of Faron. “He has made important contributions to our company over the past four years and with him and Marie-Louise in their new roles, I am more confident than ever that we have the right team and strategy in place to quickly move bexmarilimab from the clinic to a commercial launch. With this as our goal, we are also recruiting a Chief Business / Commercial Officer who will be based in our US office and support the negotiation and execution of business development transactions such as fund raising, drug candidate licensing, and other potential partnerships.”

 

Dr. Jalkanen joined Faron in 2018 as the Company’s Chief Development Officer. In that role he was responsible for translational and clinical studies as well as market research and valuation of research projects and clinical programs. He also served as Faron’s interim Chief Medical Officer in 2021 prior to the appointment of Dr. Marie-Louise Fjällskog in that role at the beginning of this year. Dr. Jalkanen earned a master´s degree in economics and business administration from the Turku School of Economics and both his M.D. and Ph.D. degree from the University of Turku. 

 

For more information please contact:

 

Media Contact

Faron Pharmaceuticals

Eric Van Zanten

Head of Communications

eric.vanzanten@faron.com

Investor.relations@faron.com

+1 (610) 529-6219

 

Investor Contact

Stern Investor Relations

Julie Seidel

julie.seidel@sternir.com

Phone: +1 (212) 362-1200

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner, Mark Rogers

Phone: +44 (0) 207 213 0880

 

Peel Hunt LLP, Broker

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

 

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

 

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

 

 

About Bexmarilimab

Bexmarilimab is Faron’s wholly-owned, investigative precision immunotherapy with the potential to provide permanent immune stimulation for difficult-to-treat cancers through targeting myeloid cell function. A novel anti-Clever-1 humanised antibody, bexmarilimab targets Clever-1 positive (Common Lymphatic Endothelial and Vascular Endothelial Receptor 1) tumour associated macrophages (TAMs) in the tumour microenvironment, converting these highly immunosuppressive M2 macrophages to immune stimulating M1 macrophages. In mouse models, bexmarilimab has successfully blocked or silenced Clever-1, activating antigen presentation and promoting interferon gamma secretion by leukocytes. Additional pre-clinical studies have proven that Clever-1, encoded by the Stabilin-1 or STAB-1 gene, is a major source of T cell exhaustion and involved in cancer growth and spread. Observations from clinical studies to date indicate that Clever-1 has the capacity to control T cell activation directly, suggesting that the inactivation of Clever-1 as an immune suppressive molecule could be more broadly applicable and more important than previously thought. As an immuno-oncology therapy, bexmarilimab has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules. Beyond immuno-oncology, it offers potential in infectious diseases, vaccine development and more.

 

About Faron Pharmaceuticals Ltd

Faron (AIM: FARN, First North: FARON) is a clinical stage biopharmaceutical company developing novel treatments for medical conditions with significant unmet needs caused by dysfunction of our immune system. The Company currently has a pipeline based on the receptors involved in regulation of immune response in oncology, organ damage and bone marrow regeneration. Bexmarilimab, a novel anti-Clever-1 humanized antibody, is its investigative precision immunotherapy with the potential to provide permanent immune stimulation for difficult-to-treat cancers through targeting myeloid function. Currently in Phase I/II clinical development as a potential therapy for patients with untreatable solid tumors, bexmarilimab has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules. Traumakine is an investigational intravenous (IV) interferon beta-1a therapy for the treatment of acute respiratory distress syndrome (ARDS) and other ischemic or hyperinflammatory conditions. Traumakine is currently being evaluated in global trials as a potential treatment for hospitalized patients with COVID-19 and with the 59th Medical Wing of the US Air Force and the US Department of Defense for the prevention of multiple organ dysfunction syndrome (MODS) after ischemia-reperfusion injury caused by a major trauma.  Faron is based in Turku, Finland. Further information is available at www.faron.com.

 

Forward Looking Statements

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

 

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

Faron Appoints Juho Jalkanen as Chief Operating Officer 310122

Grant of Options

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

Grant of Options
 

Company announcement, January 28, 2022 at 09:00 AM (EET) / 07:00 AM (GMT) / 02:00 AM (EDT)

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Ltd (AIM: FARN, First North: FARON), a clinical stage biopharmaceutical company focused on building the future of immunotherapy by harnessing the power of the immune system to tackle cancer and inflammation, announces that the Board of Faron has granted 100,000 options over ordinary shares in the Company (“Options”) under the Faron 2019 Option Plan to Dr. Marie-Louise Fjällskog, who was appointed as Faron’s new Chief Medical Officer on January 3, 2022. The Options have been allocated under the U.S. Sub-Plan of Faron’s 2019 Option Plan and are exercisable between 17 November 2022 and 17 November 2026 at an exercise price of €4.04 per share, vesting 25% per annum over a period of four years. The exercise price is calculated based on the average share price per share at which the Company’s ordinary shares have been traded on AIM over a period of 30 days immediately preceding the grant date. The terms of the 2019 Option Plan are available on the Company’s website.

The granted 100,000 Options entitle the option holder to subscribe for a total of 100,000 new ordinary shares in the Company, if exercised in full, and represent 0.19% of the fully-diluted ordinary share capital of the Company.

For more information please contact:

Media Contact

Faron Pharmaceuticals

Eric Van Zanten

Head of Communications

eric.vanzanten@faron.com

Investor.relations@faron.com

Phone: +1 (610) 529-6219

Investor Contact

Stern Investor Relations

Julie Seidel

julie.seidel@sternir.com

Phone: +1 (212) 362-1200

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880

Peel Hunt LLP, Broker

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

faron@consilium-comms.com

Phone: +44 (0)20 3709 5700

About Faron Pharmaceuticals Ltd

Faron (AIM: FARN, First North: FARON) is a clinical stage biopharmaceutical company developing novel treatments for medical conditions with significant unmet needs caused by dysfunction of our immune system. The Company currently has a pipeline based on the receptors involved in regulation of immune response in oncology, organ damage and bone marrow regeneration. Bexmarilimab, a novel anti-Clever-1 humanized antibody, is its investigative precision immunotherapy with the potential to provide permanent immune stimulation for difficult-to-treat cancers through targeting myeloid function. Currently in Phase I/II clinical development as a potential therapy for patients with untreatable solid tumors, bexmarilimab has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules. Traumakine is an investigational intravenous (IV) interferon beta-1a therapy for the treatment of acute respiratory distress syndrome (ARDS) and other ischemic or hyperinflammatory conditions. Traumakine is currently being evaluated in global trials as a potential treatment for hospitalized patients with COVID-19 and with the 59th Medical Wing of the US Air Force and the US Department of Defense for the prevention of multiple organ dysfunction syndrome (MODS) after ischemia-reperfusion injury caused by a major trauma.  Faron is based in Turku, Finland. Further information is available at www.faron.com.

Notification of a Transaction pursuant to Article 19(1) of Regulation (EU) No. 596/2014
1 Details of the person discharging managerial responsibilities/person closely associated
a. Name Marie-Louise Fjällskog
2 Reason for notification
a. Position/Status Person discharging managerial responsibilities
b. Initial notification/Amendment Initial Notification
3 Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor
a. Name Faron Pharmaceuticals Oy
b. LEI 7437009H31TO1DC0EB42
4 Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducted
a. Description of the financial instrument, type of instrument

Identification Code

 Options over ordinary shares

ISIN: FI4000153309
 
b. Nature of the transaction Grant of options made pursuant to the Faron 2019 Option Plan exercisable at EUR 4,04 per Ordinary Share
c. Price(s) and volume(s)
Price(s) Volume(s)
Nil
 100,000
d. Aggregated information– Aggregated Volume– Price 100,000Nil
e. Date of the transaction January 27, 2022
f. Place of the transaction Turku
Faron_Grant of 2019 Options_FINAL - 1-28-22

Faron’s financial calendar for 2022

Faron Pharmaceuticals Ltd
(“Faron”)

Faron’s financial calendar for 2022

Company announcement, 21 December 2021 at 9.00 am (EET) / 07:00 AM (GMT) / 02:00 AM (EDT)

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Ltd (AIM: FARN, First North: FARON), a clinical stage biopharmaceutical company focused on building the future of immunotherapy by harnessing the power of the immune system to tackle cancer and inflammation, announces the following dates for the Company’s financial reporting in 2022:

25 March          Financial statement release for the full year 2021 and

                         Annual Report 2021 including financial statements for the full year

25 August         Half-year financial report for the period 1 January to 30 June 2022

The annual general meeting is planned to be held on Friday 22 April 2022. A separate stock exchange notice will be issued by Faron’s board of directors to convene the meeting.

For more information please contact:

Media Contact

Faron Pharmaceuticals

Eric Van Zanten

Head of Communications

eric.vanzanten@faron.com

Investor.relations@faron.com

Phone: +1 (610) 529-6219

Investor Contact

Stern Investor Relations

Julie Seidel

julie.seidel@sternir.com

Phone: +1 (212) 362-1200

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880

Peel Hunt LLP, Broker

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

faron@consilium-comms.com

Phone: +44 (0)20 3709 5700

About Faron Pharmaceuticals Ltd

Faron (AIM: FARN, First North: FARON) is a clinical stage biopharmaceutical company developing novel treatments for medical conditions with significant unmet needs caused by dysfunction of our immune system. The Company currently has a pipeline based on the receptors involved in regulation of immune response in oncology, organ damage and bone marrow regeneration. Bexmarilimab, a novel anti-Clever-1 humanized antibody, is its investigative precision immunotherapy with the potential to provide permanent immune stimulation for difficult-to-treat cancers through targeting myeloid function. Currently in Phase I/II clinical development as a potential therapy for patients with untreatable solid tumors, bexmarilimab has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules. Traumakine is an investigational intravenous (IV) interferon beta-1a therapy for the treatment of acute respiratory distress syndrome (ARDS) and other ischemic or hyperinflammatory conditions. Traumakine is currently being evaluated in global trials as a potential treatment for hospitalized patients with COVID-19 and with the 59th Medical Wing of the US Air Force and the US Department of Defense for the prevention of multiple organ dysfunction syndrome (MODS) after ischemia-reperfusion injury caused by a major trauma.  Faron is based in Turku, Finland. Further information is available at www.faron.com.

211221 Faron financial calendar for 2022

TR-1: Standard form for notification of major holdings

TR-1: Standard form for notification of major holdings

 

NOTIFICATION OF MAJOR HOLDINGS (to be sent to the relevant issuer and to the FCA in Microsoft Word format if possible)i

 

1a. Identity of the issuer or the underlying issuer of existing shares to which voting rights are attachedii:

Faron Pharmaceuticals Ltd

1b. Please indicate if the issuer is a non-UK issuer  (please mark with an “X” if appropriate)

Non-UK issuer

X

2. Reason for the notification (please mark the appropriate box or boxes with an “X”)

An acquisition or disposal of voting rights

x

An acquisition or disposal of financial instruments

x

An event changing the breakdown of voting rights

 

Other (please specify)iii: (Decrease of holding due to issuance of new shares)

x

3. Details of person subject to the notification obligationiv

Name

Timo Syrjälä

 

City and country of registered office (if applicable)

 

4. Full name of shareholder(s) (if different from 3.)v

Name

 

City and country of registered office (if applicable)

 

5. Date on which the threshold was crossed or reachedvi:

1.10.2021

6. Date on which issuer notified (DD/MM/YYYY):

5.10.2021

7. Total positions of person(s) subject to the notification obligation

 

% of voting rights attached to shares (total of 8. A)

% of voting rights through financial instruments
(total of 8.B 1 + 8.B 2)

Total of both in % (8.A + 8.B)

Total number of voting rights of issuervii

Resulting situation on the date on which threshold was crossed or reached

 16.67%

 

16.67%

 53.221.032

Position of previous notification (if

applicable)

14.09%

 

14.09%

 

 

8. Notified details of the resulting situation on the date on which the threshold was crossed or reachedviii

A: Voting rights attached to shares

Class/type of
shares

ISIN code (if possible)

Number of voting rightsix

% of voting rights

Direct

(Art 9 of Directive 2004/109/EC) (DTR5.1)

Indirect

(Art 10 of Directive 2004/109/EC) (DTR5.2.1)

Direct

(Art 9 of Directive 2004/109/EC) (DTR5.1)

Indirect

(Art 10 of Directive 2004/109/EC) (DTR5.2.1)

FI4000153309

2.561.402

6.312.000

4.81%

11.86%

 

 

 

 

 

 

 

 

 

 

SUBTOTAL 8. A

8.873.402

16.67%

 

 

B 1: Financial Instruments according to Art. 13(1)(a) of Directive 2004/109/EC (DTR5.3.1.1 (a))

Type of financial instrument

Expiration
datex

Exercise/
Conversion Periodxi

Number of voting rights that may be acquired if the instrument is

exercised/converted.

% of voting rights

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

SUBTOTAL 8. B 1

 

 

 

 

B 2: Financial Instruments with similar economic effect according to Art. 13(1)(b) of Directive 2004/109/EC (DTR5.3.1.1 (b))

Type of financial instrument

Expiration
datex

Exercise/
Conversion Period xi

Physical or cash

settlementxii

Number of voting rights

% of voting rights

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

SUBTOTAL 8.B.2

 

 

 

9. Information in relation to the person subject to the notification obligation (please mark the applicable box with an “X”)

Person subject to the notification obligation is not controlled by any natural person or legal entity and does not control any other undertaking(s) holding directly or indirectly an interest in the (underlying) issuerxiii

 

Full chain of controlled undertakings through which the voting rights and/or the financial instruments are effectively held starting with the ultimate controlling natural person or legal entityxiv (please add additional rows as necessary)

X

Namexv

% of voting rights if it equals or is higher than the notifiable threshold

% of voting rights through financial instruments if it equals or is higher than the notifiable threshold

Total of both if it equals or is higher than the notifiable threshold

Timo Syrjälä (Direct)

4.81%

 

4.81%

Acme Investments SPF Sarl (Indirect)

11.86%

 

11.86%

 

 

 

 

 

 

 

 

 

 

 

 

 

10. In case of proxy voting, please identify:

Name of the proxy holder

 

The number and % of voting rights held

 

The date until which the voting rights will be held

 

 

11. Additional informationxvi

See company announcement /stock exchange releases 1.10.2021. Placing of shares and announcement of subscription of 1.312.000 new shares by Acme Investments SPF Sarl and change of the number of Faron due to issuance of new shares.

 

Place of completion

Luxembourg

Date of completion

5.10.2021

 

Faron_ TS Acme_01102021_TR-1 Holding in Company_TS_updated 2021 10 05 (002)

Notice of Half-Year Report

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

Faron Pharmaceuticals to Report Half-Year Financial Results on Thursday, August 26, 2021

 

Company announcement, July 28, 2021 at 7:00 am BST / 9:00 am EEST

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), a clinical stage biopharmaceutical company focused on building the future of immunotherapy by harnessing the power of the immune system to tackle cancer and inflammation, today announces that it will report unaudited half-year financial results for the six months ended June 30, 2021 on Thursday, August 26, 2021 at 7:00 am BST / 9:00 am EEST.

A virtual briefing and Q&A session for analysts will be hosted by Dr. Markku Jalkanen, Chief Executive Officer, and Toni Hänninen, Chief Financial Officer, at 12:00 pm BST / 2:00 pm EEST / 7:00 am EDT on the day of results. The half-year report, presentation, and webcast details will be made available at www.faron.com/investors. Following the webcast, a replay will be available on the Company’s website.

 

ENDS

For more information please contact:

Media Contact

Eric Van Zanten

Head of Communications

eric.vanzanten@faron.com

+1 (610) 529-6219

 

Investor Contact

Julie Seidel

julie.seidel@sternir.com

Phone: +1 (212) 362-1200

 

Peel Hunt LLP, Broker

Dr Christopher Golden, James Steel

Phone: + 44 (0)20 7418 8900

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner, Mark Rogers

Phone. +44 (0)20 7213 0880

 

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 55 38 990

 

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

 

About Faron Pharmaceuticals Ltd

Faron (AIM: FARN, First North: FARON) is a clinical stage biopharmaceutical company developing novel treatments for medical conditions with significant unmet needs caused by dysfunction of our immune system. The Company currently has a pipeline based on the receptors involved in regulation of immune response in oncology, organ damage and bone marrow regeneration. Bexmarilimab, a novel anti-Clever-1 humanised antibody, is its investigative precision immunotherapy with the potential to provide permanent immune stimulation for difficult-to-treat cancers through targeting myeloid function. Currently in Phase I/II clinical development as a potential therapy for patients with untreatable solid tumours, bexmarilimab has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules. Traumakine is an investigational intravenous (IV) interferon beta-1a therapy for the treatment of acute respiratory distress syndrome (ARDS) and other ischemic or hyperinflammatory conditions. Traumakine is currently being evaluated in global trials as a potential treatment for hospitalised patients with COVID-19 and with the 59th Medical Wing of the US Air Force and the US Department of Defense for the prevention of multiple organ dysfunction syndrome (MODS) after ischemia-reperfusion injury caused by a major trauma.  Faron is based in Turku, Finland. Further information is available at www.faron.com.

Faron notice of half year announcement press release 280721

US rights to patent related to Traumakine

 Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

Faron secures U.S. rights to patent related to Traumakine 

Company announcement, 14 May 2021 at 9.00 AM (EEST)
 

TURKU – FINLAND – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), the clinical stage biopharmaceutical company, announces today that it has signed a sub-license agreement for the rights to U.S. patent US9,376,478, which currently extends to 2033.

The agreement clarifies Faron’s intellectual property position in the U.S. ahead of any launch of Traumakine for the treatment of capillary leak and systemic inflammatory response syndromes (SIRS) including acute respiratory distress syndrome (ARDS) in the U.S. (subject to marketing approval from the U.S. Food and Drug Administration).  Faron will pay a small signing-fee, as well as single-digit standard market royalties from future sales of its intravenous (IV) IFN beta-1a (Traumakine) in the U.S.  This sub-licence specifically covers a manufacturing patent valid only in the U.S. (no corresponding patents exist in other countries) and adds to Faron’s existing comprehensive patent portfolio for Traumakine which includes use and IV formulation patents, as well as market exclusivity in Europe as an orphan medicine.

Dr. Markku Jalkanen, Faron’s CEO, said: “We are pleased to agree this sub-licence. We continue to believe in Traumakine’s potential as a much-needed new treatment for respiratory failure and organ protection.

“Several recent publications have connected type 1 IFN with the severity of COVID-19 infections1,2. Multiple associations have been drawn across the literature including deficiency of type 1 IFN3; inborn errors of IFN-beta signalling4; and the presence of auto-antibodies that neutralise the protective effect of type 1 IFN in viral infections5. Patients who do not have an early IFN response appear to develop severe disease irrespective of the underlying reason for the deficiency2,6. The continued further evidence supports the hypothesis that COVID-19 patients may become very ill because of an impaired interferon response.

“The administration of IFN is likely to benefit patients and relieve them from the hyper-inflammatory state that leads to severe disease3,7,8. We believe intravenous administration of IFN-beta is the optimal route9 to compensate for this loss of first line viral defence and, in tandem induce CD73 a critical enzyme in organ protection during severe illness10.”

References:

  1. C. Turk et al. Eur Rev Med Pharmacol Sci 10.26355/eurrev_202008_22660 (2020)

  2. V. Feuillet et al. Trends in Immunology. 10.1016/j.it.2020.11.003 (2021)
  3. J. Hadjadj et al. Science 10.1126/science.abc6027 (2020)
  4. Q. Zhang et al. Science 10.1126/science.abd4570 (2020)
  5.  P. Bastard et al. Science 10.1126/science.asd4585 (2020)
  6. L. Walz et al. BMC Infect Dis 10.1186/s12879-020-05730-z (2020)
  7. Z. Wang et al. Sig Transduct Target Ther. 10.1038/s41392-020-00306-4 (2020)
  8. G. Schreiber et al. Front. Immunol. 10.3389/fimmu.2020.595739 (2020)
  9. J. Jalkanen et al Crit Care. 10.1186/s13054-020-03048-5
  10. Hanidziar and Robson Am J Physiol Lung Cell Mol Physiol 10.1152/ajplung.00304.2020 (2021)

For more information please contact:

 

Faron Pharmaceuticals Oy

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com

 

Peel Hunt LLP, Broker

Dr Christopher Golden, James Steel        

Phone: + 44 (0)20 7418 8900

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner,  Mark Rogers

Phone. +44 (0)20 7213 0880      

 

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 55 38 990

 

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com

 

Stern Investor Relations

Julie Seidel

Phone: +1 212 362 1200

Email: julie.seidel@sternir.com

 

About Faron Pharmaceuticals Ltd

Faron (AIM: FARN, First North: FARON) is a clinical stage biopharmaceutical company developing novel treatments for medical conditions with significant unmet needs caused by dysfunction of our immune system. The Company currently has a pipeline based on the receptors involved in regulation of immune response in oncology, organ damage and bone marrow regeneration. Bexmarilimab, a novel anti-Clever-1 humanised antibody, is an investigative precision immunotherapy with the potential to provide permanent immune stimulation for difficult-to-treat cancers by targeting myeloid function. This programme is currently in phase I/II clinical development as a potential therapy for patients with untreatable solid tumours. Bexmarilimab has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint inhibitors. Traumakine is an investigational intravenous (IV) interferon beta-1a therapy for the treatment of acute respiratory distress syndrome (ARDS) and other ischemic or hyperinflammatory conditions. Traumakine is currently being evaluated in global clinical trials as a potential treatment for hospitalised patients with COVID-19 and with the 59th Medical Wing of the US Air Force and the US Department of Defense for the prevention of multiple organ dysfunction syndrome (MODS) after ischaemia-reperfusion injury caused by a major trauma.  Faron is based in Turku, Finland. Further information is available at www.faron.com.

Caution regarding forward looking statements

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

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

Faron secures US rights to patent related to Traumakine 140521

Holding(s) in Company

TR-1: Standard form for notification of major holdings

NOTIFICATION OF MAJOR HOLDINGS (to be sent to the relevant issuer and to the FCA in Microsoft Word format if possible)i
1a. Identity of the issuer or the underlying issuer of existing shares to which voting rights are attachedii: Faron Pharmaceuticals Ltd
1b. Please indicate if the issuer is a non-UK issuer  (please mark with an “X” if appropriate)
Non-UK issuer X
2. Reason for the notification (please mark the appropriate box or boxes with an “X”)
An acquisition or disposal of voting rights x
An acquisition or disposal of financial instruments
An event changing the breakdown of voting rights
Other (please specify)iii: (Decrease of holding due to issuance of new shares)
3. Details of person subject to the notification obligationiv
Name Timo Syrjälä
City and country of registered office (if applicable)
4. Full name of shareholder(s) (if different from 3.)v
Name
City and country of registered office (if applicable)
5. Date on which the threshold was crossed or reachedvi:  7.5.2021
6. Date on which issuer notified (DD/MM/YYYY): 10.5.2021
7. Total positions of person(s) subject to the notification obligation
% of voting rights attached to shares (total of 8. A) % of voting rights through financial instruments
(total of 8.B 1 + 8.B 2)		 Total of both in % (8.A + 8.B) Total number of voting rights of issuervii
Resulting situation on the date on which threshold was crossed or reached  14.09% 14.09%  50,457,874
Position of previous notification (if applicable) 13.57% 13.57%
8. Notified details of the resulting situation on the date on which the threshold was crossed or reachedviii
A: Voting rights attached to shares
Class/type of
sharesISIN code (if possible)		 Number of voting rightsix % of voting rights
Direct(Art 9 of Directive 2004/109/EC) (DTR5.1) Indirect(Art 10 of Directive 2004/109/EC) (DTR5.2.1) Direct(Art 9 of Directive 2004/109/EC) (DTR5.1) Indirect(Art 10 of Directive 2004/109/EC) (DTR5.2.1)
FI4000153309 2,561,402 4,550,285 5.08% 9.02%
SUBTOTAL 8. A 7,111,687 14.09%
B 1: Financial Instruments according to Art. 13(1)(a) of Directive 2004/109/EC (DTR5.3.1.1 (a))
Type of financial instrument Expiration
datex		 Exercise/
Conversion Periodxi		 Number of voting rights that may be acquired if the instrument is exercised/converted. % of voting rights
SUBTOTAL 8. B 1
B 2: Financial Instruments with similar economic effect according to Art. 13(1)(b) of Directive 2004/109/EC (DTR5.3.1.1 (b))
Type of financial instrument Expiration
datex		 Exercise/
Conversion Period xi		 Physical or cash settlementxii Number of voting rights % of voting rights
SUBTOTAL 8.B.2
9. Information in relation to the person subject to the notification obligation (please mark the applicable box with an “X”)
Person subject to the notification obligation is not controlled by any natural person or legal entity and does not control any other undertaking(s) holding directly or indirectly an interest in the (underlying) issuerxiii
Full chain of controlled undertakings through which the voting rights and/or the financial instruments are effectively held starting with the ultimate controlling natural person or legal entityxiv (please add additional rows as necessary) X
Namexv % of voting rights if it equals or is higher than the notifiable threshold % of voting rights through financial instruments if it equals or is higher than the notifiable threshold Total of both if it equals or is higher than the notifiable threshold
Timo Syrjälä (Direct) 5.08% 5.08%
Acme Investments SPF Sarl (Indirect) 9.02% 9.02%
10. In case of proxy voting, please identify:
Name of the proxy holder
The number and % of voting rights held
The date until which the voting rights will be held
11. Additional informationxvi
Place of completion Luxembourg
Date of completion 10.05.2021
Faron TR-1 100521

Grant of options

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

Grant of options

Company announcement, 29 April 2021 at 14.45 (EEST)

TURKU, FINLAND – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), the clinical-stage biopharmaceutical company, announces that the Company’s board has confirmed the grant of a total of 728,333 options over ordinary shares in the Company (“Options”) under the Company’s Share Option Plan 2019. The Options have been allocated under the Share Option Plan 2019 and are exercisable between 24 March 2022 and 24 March 2026 at an exercise price of €3.99 per share (£3.47), vesting 25% per annum over four years. The exercise price is calculated based on the average price per share at which the ordinary shares in the Company have been traded on AIM for 90 days preceding the allocation date of 24 March 2021. The terms of the Share Option Plan 2019 are as attached to the notice of the Company’s 2020 annual general meeting, available on the Company’s website at https://www.faron.com/investors/general-meetings/2020.

The granted 728,333 Options entitle the option holders to subscribe for a total of 728,333 new ordinary shares in the Company, if exercised in full, and represent 1.4% of the fully diluted ordinary share capital of the Company.

Included in the number of Options granted are the following Options which were issued to directors, other persons discharging managerial responsibilities (“PDMRs”), scientific advisory board (“SAB”) members and Company personnel:

Director Options granted
Armstrong Frank 60,000
Brown Gregory 30,000
Jalkanen Markku 120,000
Manner Matti 30,000
Poulos John 30,000
Whitaker Anne 30,000
Zambeletti Leopoldo 30,000
Total directors 330,000
Other PDMR
Honkasalo Pessi 12,000
Hänninen Toni 43,333
Jalkanen Juho 32,500
Karvonen Matti 32,500
Lahtinen Maria 21,000
Mandelin Jami 21,000
Total other PDMRs 162,333
SAB member
Curiel Tyler 10,000
Jalkanen Sirpa* 10,000
Knowles Jonathan 10,000
Total SAB 30,000
*Jalkanen Sirpa is a person closely associated (“PCA”) to Jalkanen Markku
Total Company personnel 206,000

For more information please contact:

Faron Pharmaceuticals Oy

Dr Markku Jalkanen, Chief Executive Officer

investor.relations@faron.com

Peel Hunt LLP, Broker

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner, Mark Rogers

Phone: +44 (0) 20 7213 0880

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0) 40 555 4727

Jukka Järvelä

Phone: +358 (0) 50 553 8990

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0) 20 3709 5700

Email: faron@consilium-comms.com

Stern Investor Relations

Julie Seidel, Alexa Comai

Phone: +1 (212) 362-1200

Email: julie.seidel@sternir.com

 
About Faron Pharmaceuticals Oy

Faron (AIM: FARN, First North: FARON) is a clinical stage biopharmaceutical company developing novel treatments for medical conditions with significant unmet needs caused by dysfunction of our immune system. The Company currently has a pipeline based on the receptors involved in regulation of immune response in oncology, organ damage and bone marrow regeneration. Bexmarilimab, a novel anti-Clever-1 humanised antibody, is its investigative precision immunotherapy with the potential to provide permanent immune stimulation for difficult-to-treat cancers through targeting myeloid function. Currently in Phase I/II clinical development as a potential therapy for patients with untreatable solid tumours, bexmarilimab has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules. Traumakine® is an investigational intravenous (IV) interferon beta-1a therapy for the treatment of acute respiratory distress syndrome (ARDS) and other ischemic or hyperinflammatory conditions. Traumakine® is currently being evaluated in global trials as a potential treatment for hospitalised patients with COVID-19 and with the 59th Medical Wing of the US Air Force and the US Department of Defense for the prevention of multiple organ dysfunction syndrome (MODS) after ischemia-reperfusion injury caused by a major trauma.  Faron is based in Turku, Finland. Further information is available at www.faron.com.

Notification of a Transaction pursuant to Article 19(1) of Regulation (EU) No. 596/2014
1 Details of the person discharging managerial responsibilities/person closely associated
a. Name Armstrong Frank
Brown Gregory
Honkasalo Pessi
Hänninen Toni
Jalkanen Juho
Jalkanen Markku
Jalkanen Sirpa
Karvonen Matti
Lahtinen Maria
Mandelin Jami
Manner Matti
Poulos John
Whitaker Anne
Zambeletti Leopoldo
2 Reason for notification
a. Position/Status Person discharging managerial responsibilities/person closely associated
b. Initial notification/Amendment Initial notification
3 Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor
a. Name Faron Pharmaceuticals Oy
b. LEI 7437009H31TO1DC0EB42
4 Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducted
a. Description of the financial instrument, type of instrument

Identification Code

 Options over ordinary shares

ISIN: FI4000153309
b. Nature of the transaction Grant of options made under the Faron Share Option Plan 2019 exercisable at €3.99 per ordinary share
c. Price(s) and volume(s)
Price(s) Volume(s)
Nil
60,000
30,000
12,000
43,333
32,500
120,000
10,000
32,500
21,000
21,000
30,000
30,000
30,000
30,000
d. Aggregated information– Aggregated Volume– Price 502,333Nil
e. Date of the transaction 28 April 2021
f. Place of the transaction Turku
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