Faron’s Financial Calendar for 2023

Faron Pharmaceuticals Oy
(“Faron” or “Company”)

 

Faron’s Financial Calendar for 2023

 

Company announcement, December 23, 2022 at 9.00 am (EET) / 07:00 AM (GMT) / 02:00 AM (EDT)

 

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), a clinical stage biopharmaceutical company focused on tackling difficult-to-treat cancers and inflammation via precision immunotherapy, today announces the following dates for the Company’s financial reporting in 2023:

 

March 2 Financial statement release for the full year 2022 and Annual Report 2022 including financial statements for the full year

August 29  Half-year financial report for the period January 1 to June 30, 2023

 

The annual general meeting is planned to be held on March 24, 2023. A separate stock exchange notice will be issued by Faron’s board of directors to convene the meeting.

 

 

For more information please contact:

 

Investor Contact

Faron Pharmaceuticals

Julia Balanova

VP, Investor Relations

julia.balanova@faron.com

investor.relations@faron.com

Phone: +1 (917) 306-6096

Faron Pharmaceuticals

Toni Hänninen

CFO

toni.hanninen@faron.com

Phone: +41 79 387 2643

Media Contact

Faron Pharmaceuticals

Jennifer Smith-Parker

Head of Communications

Jennifer.Smith-Parker@faron.com

 

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

David Daley, Lindsey Neville, Namrata Taak

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 solid tumors and hematologic malignancies, 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 by 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.

 

BEXMAB Study Update

Faron Pharmaceuticals Oy

(“Faron” or “Company”)

 

Inside Information: Promising start to a new study investigating bexmarilimab for the treatment of hematological malignancies

 – BEXMAB Study Update

 

  • Dose escalation to the second predefined level in first clinical study to investigate bexmarilimab in hematological malignancies
  • No dose-limiting toxicities or safety concerns observed among five patients to have received initial dose at 1 mg/kg every week
  • Early signs of efficacy with partial response observed in one patient after three dosing cycles
  • New triplet cohort to be opened combining bexmarilimab with azacitidine and venetoclax
  • Good target coverage as shown by reduced Clever-1 levels in patients’ blood and bone marrow aspirates

 

Company announcement, October 31, 2022 at 03:00 AM (EDT) / 07:00 AM (GMT) / 09:00 AM (EET)

Inside information

 

TURKU, FINLAND / BOSTON, MA Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), a clinical stage biopharmaceutical company focused on tackling difficult-to-treat cancers and inflammation via precision immunotherapy, today announces that dosing has moved to the second level in the Company’s Phase I/II BEXMAB study. BEXMAB is investigating bexmarilimab, Faron’s wholly-owned precision immunotherapy asset, in combination with standard of care (SoC) in multiple hematological malignancies.

 

The primary objective of the BEXMAB study is to determine the safety and tolerability of bexmarilimab in combination with SoC (azacitidine and venetoclax) treatment and to identify the recommended Phase II dose. Secondary objectives include characterizing bexmarilimab’s pharmacokinetic profile in combination with SoC treatment and assessing its immunogenicity.

 

The first stage of the BEXMAB study comprises four predefined dose levels commencing at bexmarilimab 1mg/kg. Following the announcement of patient dosing commencement in June 2022, five patients have received 1mg/kg weekly dosing of bexmarilimab with no dose-limiting toxicities or safety concerns observed. These data warrant escalation of dosing with bexmarilimab to the second predefined weekly dosing level of 3mg/kg. 

 

All first stage cohort patients are alive. The longest treated patient at three cycles has revealed partial response as observed by reduced cancer activity with reduced blast (cancer cell) counts and normalised blood cell counts.

 

Initial data from patients dosed with bexmarilimab also show a significant reduction in levels of soluble Clever-1 protein in the blood of treated patients. Earlier research from the Company’s MATINS study, investigating the safety and efficacy of bexmarilimab monotherapy in solid tumor cohorts, indicates that this soluble form of the Clever-1 protein is a direct inhibitor of T cells and could have an immunosuppressive effect in all locations of the body, therefore decreasing the general immune capacity of patients. This initial finding will be followed in all patients throughout the BEXMAB study.

 

“The escalation of dosing with bexmarilimab to the second level in the BEXMAB study, following confirmation of no dose limiting toxicities, is an encouraging early signal as we pursue this immunotherapy’s potential to treat hematological malignancies in the combination setting,” said Marie-Louise Fjällskog, M.D., Ph.D., Chief Medical Officer of Faron. “We have also observed an early indicator of clinical benefit in the first patient dosed, alongside the observation of a reduction in levels of immunosuppressive soluble Clever-1 protein in the blood of treated patients. We look forward to generating further data as the trial progresses to help determine the optimal dose of bexmarilimab to take forward into Phase II.”  

 

“The safety findings in the trial’s first five patients, showing no dose-limiting toxicities or safety concerns with the 1mg/kg weekly dosing of bexmarilimab, is a very encouraging step supporting the scientific rationale to combine bexmarilimab and azacitidine with the aim to activate an immune response to control the disease,” said Mika Kontro, M.D., Ph.D., Helsinki University Hospital Comprehensive Cancer and Principal Investigator of the BEXMAB trial. “The initial safety data that we gather will inform the potential for expansion into a Phase II study in combination with azacitidine. The study may now also progress to include first-line triplet therapy with bexmarilimab, azacitidine and venetoclax in newly diagnosed acute myeloid leukemia patients not benefitting from conventional chemotherapy.”

 

“The BEXMAB study is off to a great start, and we are eagerly waiting to see the first data from the triplet therapy, where bexmarilimab could become a cornerstone of first-line treatment in newly diagnosed AML patients,” said CEO Markku Jalkanen. “We wish to thank our investigators, and especially patients, for the wonderful start of this trial, and their commitment in helping to find new treatments for this grave condition.”

 

“For investors these are very encouraging – though early – results. We should remember that AML is an extremely serious indication with over 90% mortality in five years and all new approaches that can change this are urgently needed,” said Yrjö Wichmann, Faron’s VP Funding and IR. “Earlier we were able to show clinical benefit in solid tumor cancers and now we have positive indication also in blood cancers, in which the Clever-1 target molecule is expressed directly on the surface of the cancer cells themselves. Additionally, as AML is a very serious condition, the route to regulatory approval can be faster if results are exceptional.”  

 

 

Further details of the BEXMAB study are available on ClinicalTrials.gov (Identifier: NCT05428969).

 

Faron will also host a special event in December where further details of the BEXMAB study will be presented together with current treatment practices for hematological malignancies.

 

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

 

 

 

 

For more information please contact:

 

Investor Contact

Faron Pharmaceuticals

Julia Balanova

VP, Investor Relations

julia.balanova@faron.com

investor.relations@faron.com

Phone: +1 (917) 306-6096

Faron Pharmaceuticals

Yrjö Wichmann

VP, Investor Relations and Funding

Yrjo.wichmann@faron.com

investor.relations@faron.com

Phone: +358 (0) 40 5868 979
 

 

Media Contact

Faron Pharmaceuticals

Jennifer Smith-Parker

Head of Communications

Jennifer.Smith-Parker@faron.com

 

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

David Daley, Lindsey Neville, Namrata Taak

faron@consilium-comms.com

Phone: +44 (0)20 3709 5700

 

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. As an immuno-oncology therapy, bexmarilimab has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules in both solid tumors and hematologic malignancies. Beyond immuno-oncology, it offers potential in infectious diseases, vaccine development and more.

 

About BEXMAB

The BEXMAB study is a first-in-human open label phase I/II clinical trial investigating bexmarilimab in combination with standard of care (SoC) in aggressive hematological malignancies including acute myeloid leukemia (AML) and myelodysplatic syndrome (MDS). The primary objective is to determine the safety and tolerability of bexmarilimab in combination with SoC (azacitidine) treatment and to identify the recommended Phase II dose. Based on initial safety data, there is potential for expansion to include a first line triplet therapy of bexmarilimab, azacitidine and venetoclax in newly diagnosed AML patients who are not able to tolerate chemotherapy. Clever-1 is highly expressed in both AML and MDS and associated with therapy resistance, limited T cell activation and poor outcomes. Directly targeting Clever-1 could limit the replication capacity of cancer cells, increase antigen presentation, ignite an immune response, and allow current chemotherapy treatments to be more effective.

 

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 solid tumors and hematologic malignancies, 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 by 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.

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 attached ii:

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: (Increase of holding due to issuance of new shares)

 

3. Details of person subject to the notification obligation iv

Name

Varma Mutual Pension Insurance Company

City and country of registered office (if applicable)

Helsinki, Finland

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 reached vi:

14.10.2022

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

18.10.2022

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 held in issuer (8.A + 8.B) vii

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

3.16%

 

3.16%

1,891,891

Position of previous notification (if

applicable)

 

 

 

 

 

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

A: Voting rights attached to shares

Class/type of
shares

ISIN code (if possible)

Number of voting rights ix

% of voting rights

Direct

(DTR5.1)

Indirect

 (DTR5.2.1)

Direct

(DTR5.1)

Indirect

(DTR5.2.1)

FI4000153309

1,891,891

 

3.16%

 

 

 

 

 

 

 

 

 

 

 

SUBTOTAL 8. A

1,891,891

3.16%

 

 

B 1: Financial Instruments according to DTR5.3.1R (1) (a)

Type of financial instrument

Expiration
date x

Exercise/
Conversion Period xi

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 DTR5.3.1R (1) (b)

Type of financial instrument

Expiration
date x

Exercise/
Conversion Period xi

Physical or cash

Settlement xii

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) issuer xiii

X

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 entity (please add additional rows as necessary) xiv

 

Name xv

% 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

Varma Mutual Pension Insurance Company

3.16%

 

3.16%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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 information xvi

Faron share issue per 14.10.2022

 

Place of completion

Helsinki, Finland

Date of completion

18.10.2022

 

 

 

 

 

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 attached ii:

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: (Increase of holding due to issuance of new shares)

X

3. Details of person subject to the notification obligation iv

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 reached vi:

14.10.2022

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

14.10.2022

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 held in issuer (8.A + 8.B) vii

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

20.58%

 

20.58%

 12,306,957

Position of previous notification (if

applicable)

19.74%

 

19.74%

 

 

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

A: Voting rights attached to shares

Class/type of
shares

ISIN code (if possible)

Number of voting rights ix

% of voting rights

Direct

(DTR5.1)

Indirect

 (DTR5.2.1)

Direct

(DTR5.1)

Indirect

(DTR5.2.1)

FI4000153309

4,867,366

7,439,591

8.14%

12.44%

 

 

 

 

 

 

 

 

 

 

SUBTOTAL 8. A

12,306,957

20.58%

 

 

B 1: Financial Instruments according to DTR5.3.1R (1) (a)

Type of financial instrument

Expiration
date x

Exercise/
Conversion Period xi

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 DTR5.3.1R (1) (b)

Type of financial instrument

Expiration
date x

Exercise/
Conversion Period xi

Physical or cash

Settlement xii

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) issuer xiii

 

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 entity (please add additional rows as necessary) xiv

X

Name xv

% 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)

8.14%

 

8.14%

Acme Investments SPF Sarl (Indirect)

12.44%

 

12.44%

 

 

 

 

 

 

 

 

 

 

 

 

 

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 information xvi

Faron share issue per 14.10.2022

 

Place of completion

Lausanne

Date of completion

14.10.2022

 

 

 

 

 

Grant of Options

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

 

Grant of options

 

Company announcement, September 22, 2022 at 09:00 AM (EEST) / 07:00 AM (BST) / 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, announces that the Board of Faron has confirmed the grant of a total of 129,000 options options over ordinary shares in the Company (“Options”) under Company’s Share Option Plan 2019 (including its UK and US sub plans).

 

The Options have been allocated under the Share Option Plan 2019 and are exercisable between 24 August 2023 and 24 August 2027, vesting 25% per annum over a period of four years. The exercise price for Options allocated under the Share Option plan is €2.50 per share (£2.11), which 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 August 2022. The exercise price for Options allocated under the US sub plan is €2.38 per share (£2.01), which is calculated based on the average price per share at which the ordinary shares in the Company have been traded on AIM for 30 days preceding the allocation date of 24 August 2022. The terms of the Share Option Plan 2019 are available on the Company’s website at https://www.faron.com/investors/general-meetings/2020.   

 

The granted Options entitle the option holders to subscribe for a total of 129,000 new ordinary shares in the Company, if exercised in full, and represent 0.23 % 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 a director or other persons discharging managerial responsibilities (“PDMRs”):

 

 

Director 

Options granted 

 

 

 

 

Erik Ostrowski (U.S Sub-Plan)

30,000 

 

 

 

 

Other PDMRs  

 

 

 

 

 

Vesa Karvonen (Share Option plan)

30,000 

 

Juuso Vakkuri (Share Option plan)

20,000 

 

 

 

 

For more information please contact: 

 

Investor Contact

Faron Pharmaceuticals

Julia Balanova

VP, Investor Relations

Julia.balanova@faron.com

investor.relations@faron.com

Phone: +1 (917) 306-6096

 

Media Contact

Faron Pharmaceuticals

Eric Van Zanten

VP, Communications

eric.vanzanten@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 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 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

a)       Erik Ostrowski

b)       Vesa Karvonen

c)       Juuso Vakkuri

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

c.

Price(s) and volume(s)

 

 

 

 

 

 

Price(s)

Volume(s)

 

 

a)       €2.38(£2.01)

b)       €2.50(£2.11)

c)       €2.50(£2.11)

 

a)       30,000

b)       30,000

c)       20,000

 

 

 

d.

Aggregated information

 

– Aggregated Volume

 

– Price

 

 

 

Nil

 

 

e.

Date of the transaction

19 September 2022

f.

Place of the transaction

Turku

 

 

Notice of Half-Year Financial Results

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

 

Faron Pharmaceuticals to Report Half-Year Financial Results on Thursday, August 25, 2022

 

Company Announcement, August 8, 2022 at 02:00 AM (EDT) / 07:00 AM (BST) / 09:00 AM (EEST)

 

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 report unaudited half-year financial results for the six months ended June 30, 2022 on Thursday, August 25, 2022 at 02:00 AM (EDT) / 07:00 AM (BST) / 09:00 AM (EEST).

 

A virtual briefing and Q&A session for investors, analysts and media will be hosted by Dr. Markku Jalkanen, Chief Executive Officer, and Toni Hänninen, Chief Financial Officer, at 7:00 am (EDT) / 12:00 pm (BST) / 2:00 pm (EEST) on the day of results.

 

Webcast registration link: https://faron.videosync.fi/2022-halfyear-results

 

The half-year report, presentation, and a replay of the webcast will be available on the Company’s website at www.faron.com/investors.

 

For more information please contact:

 

Investor Contact

Faron Pharmaceuticals

Julia Balanova

VP, Investor Relations

julia.balanova@faron.com

investor.relations@faron.com

Phone: +1 (917) 306-6096

 

Media Contact

Faron Pharmaceuticals

Eric Van Zanten

VP, Communications

eric.vanzanten@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 solid tumors and hematologic malignancies, 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 by 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.

 

 

Results of EGM

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

 

Results of

the Extraordinary General Meeting

 

Company Announcement, July 7, 2022 at 11:45 AM (EEST) / 9:45 AM (BST) / 04:45 AM (EDT)

 

TURKU  FINLAND / BOSTON, MA, 7 July 2022 – 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 extraordinary general meeting (the “EGM”) of the Company took place today, July 7, 2022 in Turku, Finland. The EGM approved the proposal of the board of directors (“Board”) to authorise the Board to decide on the issuance of shares, options or other special rights entitling to shares, as set out in the notice of the EGM published on June 16, 2022.

 

Decisions of the EGM – Authorisation of the Board to decide on the issuance of shares, options or other special rights entitling to shares

 

The Board was authorised to resolve by one or several decisions on issuances of shares, options or other special rights entitling to shares referred to in Chapter 10, Section 1 of the Finnish Limited Liability Companies Act (the “Companies Act”), which authorisation contains the right to issue new shares or dispose of the Company’s own shares in the possession of the Company. The authorisation consists of up to eleven million (11,000,000) new shares in the aggregate (including shares to be received based on options or other special rights), as well as the conveyance of up to the same maximum number (eleven million (11,000,000)) of treasury shares in the possession of the Company (the “Authorisation”).

The Authorisation includes the Board’s right to decide on the issuance of shares, options or other special rights entitling to shares in deviation from the shareholders’ pre-emptive rights. The Authorisation shall be used for material arrangements from the Company’s point of view, such as financing (including, without limitation, issuance of warrants under the funding agreement with IPF Partners announced on February 28, 2022) or implementing business arrangements, investments or for other such purposes determined by the Board where a weighty financial reason for issuing shares, options or other special rights entitling to shares, and possibly deviating from the shareholders’ pre-emptive rights, exists.

 

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

 

The authorisation is effective until June 30, 2023.

 

Minutes of the EGM

 

The minutes of the EGM will be available on the Company’s website from July 21, 2022 at the latest.

 

For more information please contact:

 

Investor Contact

Faron Pharmaceuticals

Julia Balanova

VP, Investor Relations

julia.balanova@faron.com

investor.relations@faron.com

Phone: +1 (917) 306-6096

 

Media Contact

Faron Pharmaceuticals

Eric Van Zanten

VP, Communications

eric.vanzanten@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 solid tumors and hematologic malignancies, 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 by 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.

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

x

An event changing the breakdown of voting rights

 

Other (please specify)iii: (share issue 27.6 and acquisition of 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:

27.6.2022

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

30.6.2022

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

19.74%

 

19.74%

55.263.653

Position of previous notification (if

applicable)

17.27%

 

17.27%

 

 

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

3.467.366

7.439.591

6.27%

13.46%

 

 

 

 

 

 

 

 

 

 

SUBTOTAL 8. A

10.906.957

19.74%

 

 

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)

6.27 %

 

6.27 %

Acme Investments SPF Sarl (Indirect)

13.46%

 

13.46%

 

 

 

 

 

 

 

 

 

 

 

 

 

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 28.6.2022.

 

Place of completion

Luxembourg

Date of completion

30.6.2022

 

Faron notice of EGM

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

 

Notice of Faron Pharmaceuticals LTD’s Extraordinary General Meeting

 

Company Announcement, June16, 2022 at 07:00 AM (EST) / 12:00 PM (BST) / 02:00 PM (EEST)

 

Shareholders of Faron Pharmaceuticals Ltd (the “Company”) are invited to attend the Extraordinary General Meeting to be held on 7 July 2022 at 9:00 a.m. (Finnish time) at the Radisson Blu Marina Palace Hotel, meeting room “Meri” at Linnankatu 32, 20100 Turku, Finland. The registration of attendees and the distribution of voting slips will commence at the meeting venue at 8:30 a.m. (Finnish time).

 

The Board has summoned the Extraordinary General Meeting in order to resolve on authorising the Board to decide on the issuance of shares, options or other special rights entitling to shares. Due to the nature of the Company’s line of business and also taking into account the debt funding arrangement with IPF Partners announced on 28 February 2022, the authorisation to decide on the issuance of shares, options or other special rights entitling to shares provides the Company with customary and necessary means of raising capital in order to finance its business operations.

 

The Company operates in a global industry, is listed on two stock exchanges and has been raising capital from international markets. The increasingly competitive capital markets require the Company to conduct its capital raises in a manner that fit the changing market demands. In equity raises the common practice on international capital markets is “delivery-versus-payment” (DVP) settlement, where the investors pay for the shares at the same moment they receive the shares.

 

To further facilitate DVP without outside interim financing in the Finnish corporate law environment observing the demands of the international markets, the Company’s Board proposes an authorization to enable a two-step share issuance mechanism, where the Company may first issue shares to itself without consideration (treasury shares) and then convey such treasury shares to investors against payment. As Finnish corporate law defines both the issuance of new shares and the conveyance of existing treasury shares as share issuances, this mechanism requires an authorization for both steps. Therefore, the Board technically needs to propose the same size authorization twice. The proposal would result in a maximum dilution of twenty (20) per cent. Therefore, the proposed authorisation is proportionally the same size as the Company’s Board’s outstanding authorisation to decide on the issuance of shares, options or other special rights entitling to shares, resolved upon by the Annual General Meeting on 23 April 2021.

 

The Company’s Annual Report 2021 and the statement by the Board of Directors on events after the preparation of the financial statements with a material effect on the Company are available to view and download on the Company’s website at https://www.faron.com/.

 

  1. MATTERS ON THE AGENDA OF THE EXTRAORDINARY GENERAL MEETING

 

  1. Opening of the meeting
  2. Calling the meeting to order
  3. Election of persons to scrutinise the minutes and to supervise the counting of votes
  4. Recording the legality of the meeting
  5. Recording the attendance at the meeting and adoption of the list of votes
  6. Authorising the Board of Directors to decide on the issuance of shares, options or other special rights entitling to shares

 

The Board of Directors proposes that the Extraordinary General Meeting authorise the Board of Directors to resolve by one or several decisions on issuances of shares, options or other special rights entitling to shares referred to in Chapter 10, Section 1 of the Finnish Limited Liability Companies Act, which authorisation contains the right to issue new shares or dispose of the Company’s own shares in the possession of the Company. The authorisation would consist of up to eleven million (11,000,000) new shares in the aggregate (including shares to be received based on options or other special rights), which corresponds to approximately twenty (20) per cent of the existing shares and votes in the Company, as well as the conveyance of up to the same maximum number (eleven million (11,000,000)) of treasury shares in the possession of the Company.

 

In practise, the above authorisation includes that the Board may first resolve on one or several share issues (up to the maximum number of eleven million (11,000,000) new shares) without consideration to the Company itself and then further convey such treasury shares (up to the maximum number of eleven million (11,000,000) shares) against consideration.

 

The authorisation would not exclude the Board’s right to decide on the issuance of shares, options or other special rights entitling to shares in deviation from the shareholders’ pre-emptive rights. The authorisation is proposed to be used for material arrangements from the Company’s point of view, such as financing (including, without limitation, issuance of warrants under the funding agreement with IPF Partners announced on 28 February 2022) or implementing business arrangements, investments or for other such purposes determined by the Board in which case a weighty financial reason for issuing shares, options or other special rights entitling to shares, and possibly deviating from the shareholders’ pre-emptive rights, would exist.

 

For the sake of clarity, it is noted that in no circumstances can the total number of new shares to be registered under this authorisation exceed eleven million (11,000,000) new shares in aggregate.

 

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

 

The authorisation would be effective until 30 June 2023.

 

  1. Closing of the meeting

 

  1. DOCUMENTS OF THE EXTRAORDINARY GENERAL MEETING

The above-mentioned proposals to the Extraordinary General Meeting, the Company’s Annual Report 2021 including the financial statements, the Report of the Board of Directors and the Auditor’s Report, and the statement by the Board of Directors on events after the preparation of the financial statements with a material effect on the Company and this notice are available on the Company’s website at https://www.faron.com/ as of the date of publication of this notice. The Board’s proposals and the other above-mentioned documents will also be available at the Extraordinary General Meeting. Copies of these documents and of this notice will be sent to shareholders upon request. The minutes of the Extraordinary General Meeting will be available on the Company’s website from 21 July 2022 at the latest.

  1. INSTRUCTIONS FOR THE PARTICIPANTS

 

  1. The right to participate and registration

Each shareholder who on the record date of the Extraordinary General Meeting, being 27 June 2022, is registered in the Company’s shareholders register held by Euroclear Finland Oy has the right to participate in the Extraordinary General Meeting. A shareholder whose shares are registered on their personal Finnish book-entry account is registered in the Company’s shareholders register. If you do not have a Finnish book-entry account, see section C3 “Holder of nominee-registered shares (including depositary interest holders)”.

 

A shareholder who is registered in the Company’s shareholders register and who wants to participate in the Extraordinary General Meeting should register for the meeting by no later than 4:00 p.m. (Finnish time) on Monday, 4 July 2022 by giving a prior notice of participation:

 

          by email to general.meeting@faron.com or

          by mail to Faron Pharmaceuticals Ltd, attn. Kaisa Kyttä, Joukahaisenkatu 6, FI-20520 Turku, Finland.

 

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

 

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

 

  1. Proxy representative and powers of attorney

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

 

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

 

Possible proxy documents should be sent by email to general.meeting@faron.com and in originals to Faron Pharmaceuticals Ltd, attn. Kaisa Kyttä, Joukahaisenkatu 6, FI-20520 Turku, Finland before the end of registration period.

 

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

A holder of nominee-registered shares (including depositary interest holders) has the right to participate in the Extraordinary General Meeting by virtue of such shares based on which the holder would be entitled to be registered in the Company’s shareholders register held by Euroclear Finland Oy on the Extraordinary General Meeting’s record date of 27 June 2022.

 

Additionally, participation requires that the holder of nominee-registered shares is temporarily registered in the Company’s shareholders’ register held by Euroclear Finland Oy by 10:00 a.m. (Finnish time) on Monday, 4 July 2022. Temporary registration in the shareholders register shall be deemed to be a registration for the Extraordinary General Meeting.

 

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

 

  1. Other instructions and information

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

 

On the date of this notice, 16 June 2022, the total number of shares and votes in the Company is 53,257,032.

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

 

Turku, 16 June 2022

FARON PHARMACEUTICALS LTD

Board of Directors

 

For more information please contact:

 

Investor Contact

Faron Pharmaceuticals

Julia Balanova

VP, Investor Relations

julia.balanova@faron.com

investor.relations@faron.com

Phone: +1 (917) 306-6096

 

Media Contact

Faron Pharmaceuticals

Eric Van Zanten

VP, Communications

eric.vanzanten@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 solid tumors and hematologic malignancies, 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 by 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 Announces US Food and Drug Administration and Finnish Medicines Agency Approval to Initiate Phase I/II Bexmarilimab Combination Study in Hematologic Malignancies

Faron Pharmaceuticals Ltd.

(“Faron” or “Company”)

 

Faron Announces US Food and Drug Administration and Finnish Medicines Agency Approval to Initiate

Phase I/II Bexmarilimab Combination Study in Hematologic Malignancies

 

  • Phase 1 dose escalation study will evaluate the safety and tolerability of combination therapy and determine the recommended dose for Phase 2 expansion
  • Patient recruitment will commence in the coming weeks
  • Supporting pre-clinical bexmarilimab hematology data was presented at recent European Hematology Association 2022 Congress
     

Company Announcement, May 16, 2022 at 09:00 AM (EEST) / 07:00 AM (BST) / 2:00 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, today announces that both the U.S. Food and Drug Administration (FDA) and Finnish Medicines Agency (FIMEA) have cleared Faron’s Investigational New Drug (IND) application to begin the Company sponsored BEXMAB study. BEXMAB is a novel Phase I/II study to assess safety, tolerability and preliminary efficacy of bexmarilimab, Faron’s wholly-owned investigational precision cancer immunotherapy, in combination with standard of care (SoC) therapy in patients with relapsed acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or chronic myelomonocytic leukemia (CML). This marks the first time bexmarilimab will be assessed as part of a clinical study in hematologic malignancies.

 

“We are pleased that our IND application was cleared to proceed, and we can further explore the strong scientific rationale for combining bexmarilimab and azacitidine.” said Marie-Louise Fjällskog, M.D., Ph.D., Chief Medical Officer of Faron. “Research has shown a clear survival benefit among certain blood cancer patients with low Clever-1 expression, a receptor known to be expressed on immunosuppressive macrophages in the tumor microenvironment. By adding bexmarilimab to standard of care we expect to downregulate Clever-1 expression, thereby increasing antigen presentation and allowing the immune system to better identify and kill cancer cells.”

 

The primary objective of the BEXMAB study is to determine the safety and tolerability of bexmarilimab in combination with SoC treatment and to identify the recommended Phase 2 dose. Secondary objectives include characterizing the pharmacokinetic profile of bexmarilimab in combination with SoC treatment (azacitidine) and to assess the immunogenicity of bexmarilimab. Based on initial safety data, there is potential for Phase II expansion and to include a first line triplet therapy of bexmarilimab, azacitidine and venetoclax in newly diagnosed AML patients who are not able to tolerate chemotherapy. Patient recruitment is expected to begin in the coming weeks.

 

“We know from pre-clinical research, some of which was presented recently at EHA, that certain blood cancer cells, especially with myeloid background, carry significant amounts of cell surface Clever-1,” said Dr. Markku Jalkanen, Chief Executive Officer of Faron. “This corresponds with the presence of considerable amounts of soluble Clever-1, which limits T cell activation leading to a possible systemic loss of immune capacity. Directly targeting Clever-1 could ignite the immune system, limit the replication capacity of cancer cells, and allow current chemotherapy treatments to be more effective.”

 

In addition to the BEXMAB study focused on hematologic malignancies, Faron is also investigating bexmarilimab in solid tumors. The ongoing Phase I/II MATINS clinical trial is assessing bexmarilimab as a potential monotherapy in late-stage, heavily pre-treated patients across multiple tumor types. Additionally, the Company expects to initiate a trial assessing the safety and tolerability of bexmarilimab in combination with an approved anti-PD-1 molecule in multiple solid tumors later this year.

 

For more information please contact:

 

Investor Contact

Faron Pharmaceuticals

Julia Balanova

VP, Investor Relations

julia.balanova@faron.com

investor.relations@faron.com

Phone: +1 (917) 306-6096

 

Media Contact

Faron Pharmaceuticals

Eric Van Zanten

VP, Communications

eric.vanzanten@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 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.

 

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