News – Page 13

Phone: +44 (0)20 3709 5700

Investor Contact

Faron Pharmaceuticals

Julia Balanova

VP, Investor Relations

Faron Appoints Maija Hollmén PhD as Chief Scientific Officer 011222

Phone: +1 (917) 306-6096

Cairn Financial Advisers LLP, Nominated Adviser

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

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. 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 Faron Pharmaceuticals Oy

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 favorable 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 license its programs 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.

Amendment Terms and Conditions with IPF Partners

18.11.2022

Faron Pharmaceuticals Ltd.

(“Faron” or “Company”)

Inside Information: Amendment to Terms and Conditions of Warrants and Funding Agreement with IPF Partners

Company announcement, November 18, 2022 at 11:30 AM (EST) / 4:30 PM (GMT) / 6:30 PM (EET)

Inside information

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 Company and IPF Partners (“IPF”) have agreed to amend certain terms and conditions of the warrants issued to IPF (the “Warrants”) and certain terms and conditions of the secured debt agreement with IPF (the “Funding Agreement”), each originally announced by the Company on February 28, 2022.

Pursuant to the amended Warrant terms and conditions, the subscription price per share on the exercise of the 319,944 Warrants issued to IPF in connection with the utilization of the first tranche under the Funding Agreement shall now be the lower of either EUR 1.85 (equivalent to issue price of the placing announced on 14 October 2022) or the subscription price per share in any subsequent share offering undertaken by the Company (the subscription price was originally EUR 3.126 per share, equal to the 30-day volume-weighted average price of an ordinary share of Faron on the Nasdaq Helsinki First North exchange immediately preceding the drawdown date of the respective tranches, and subsequently amended to EUR 3.008 following further share issuances pursuant to the Warrant terms and conditions). The Board will separately resolve upon the Warrant terms and conditions applicable to Warrants to be issued in relation to the possible utilization of the second and third tranches under the Funding Agreement. The amendment of the Warrant terms and conditions has been resolved as a result of the Company and IPF entering into an amendment and restatement agreement dated November 18, 2022 which also amends certain covenant, margin and fee structure provisions of the Funding Agreement. The Company’s Board of Directors has resolved on the amendments based on the authorization granted to the Board by shareholders at the Company’s Extraordinary General Meeting on July 7, 2022.

The amended terms and conditions of the Warrants will be available on the Company’s website at https://www.faron.com/investors/aim-rule-26.

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

jennifer.smith-parker@faron.com

Phone: +1 (917) 306-6096

Media Contact

Faron Pharmaceuticals

Jennifer Smith-Parker

Head of Communications

Cairn Financial Advisers LLP, Nominated Adviser

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

Amendment to Terms and Conditions of Warrants and Funding Agreement with IPF Partners 181122

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 Poster Presentation at SITC

2.11.2022

Faron Pharmaceuticals Ltd.

(“Faron or “Company”)

Faron Pharmaceuticals Announces Poster Presentation of Targeted Immunotherapy Bexmarilimab at Society for Immunotherapy of Cancer (SITC) 2022 Annual Meeting

Press release, November 2, 2022 at 03:00 AM (EDT) / 07:00 AM (GMT) / 09:00 AM (EET)

TURKU, FINLAND / BOSTON, MA – MA: Faron Pharmaceuticals Ltd (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on tackling difficult-to-treat cancers and inflammation via precision immunotherapy, will have a poster outlining the BEXCOMBO clinical trial of its CLEVER-1 antibody bexmarilimab at the Society for Immunotherapy of Cancer’s (SITC) 37th Annual Meeting (2022) in Boston, MA.

Details of the poster presentations are as follows:

Title:	Phase II Study to Assess the Safety and Efficacy of the CLEVER-1 Antibody Bexmarilimab in Combination with PD-1 blockade in Patients with Advanced Solid Tumors – BEXCOMBO
Abstract ID:	709
Presenter:	Inka Pawlitzky, PhD, Faron
Date/Time:	Thursday, November 10, 2022, 9:00 a.m. – 9:00 p.m . ET

The abstract will be provided on the SITC Annual Meeting website at https://www.sitcancer.org/2022/abstracts/abstract-titles-publications and will be available in a Journal for ImmunoTherapy of Cancer (JITC) supplement, which will be published on Nov. 7 at 8 a.m. EST. The poster will also be presented on November 10 at 9 a.m. – 9 p.m. EST

About BEXCOMBO:

BEXCOMBO is a Phase II study that aims to enrol up to 120 patients in a single-arm, multicenter, adaptive design trial. A Simon’s 2-Stage design is planned to evaluate 15 patients in Stage 1 and an additional 25 patients in Stage 2 per indication. The study design includes a safety run-in and allows for enrichment of patient populations based on CLEVER-1 expression level, PD-L1 status or biomarkers predictive of response based on emerging non-clinical and clinical data. The study indications include metastatic or unresectable, recurrent HNSCC, locally advanced or metastatic UCC and metastatic NSCLC where first-line PD-1 blockade is approved standard of care. Enrollment is planned to begin in Q1 2023, with up to 10 clinical trial sites across the US and Europe. The primary objective is to evaluate the clinical efficacy of the combination therapy bexmarilimab plus PD-1 blockade based on objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST v1.1).

Clinical data show that 65-80% of cancer patients do not respond to single agent PD-1 blockade and evolving data suggest that IFN-ɣ expression is required for response to PD-1 blockade. Bexmarilimab induces IFN-ɣ upregulation, which is required for immune modulation in the tumor microenvironment, T cell activation and ultimately response to PD-1/PD-L1 inhibition therapy. Bexmarilimab ignites the immune response in tumors without preexisting immune activation, and the BEXCOMBO study thereby offers the opportunity to expand the population of responders and provide meaningful benefit to more patients.

About Bexmarilimab:

For more information please contact:

Investor Contact

Faron Pharmaceuticals

Julia Balanova

VP, Investor Relations

Jennifer.Smith-Parker@faron.com

Phone: +1 (917) 306-6096

Media Contact

Faron Pharmaceuticals

Jennifer Smith-Parker

Head of Communications

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

FARON_221102_SITC Data Announcment_FINAL

Phone: +44 (0)20 3709 5700

About Faron Pharmaceuticals Ltd.

Forward Looking Statements

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.

BEXMAB Study Update

31.10.2022

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

Phone: +1 (917) 306-6096

Faron Pharmaceuticals

Yrjö Wichmann

VP, Investor Relations and Funding

Yrjo.wichmann@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 221031 Bexmab dose escalation advances Final

Phone: +44 (0)20 3709 5700

About Bexmarilimab

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.

Forward Looking Statements

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

19.10.2022

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

2022-10-18 Standard form for notification of major holdings

Holding(s) in Company

18.10.2022

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

TR-1 Standard form for notification of major holdings

Faron Pharmaceuticals Presents Results from PD-1 Blockade Refractory Melanoma Cohort of MATINS Trial at 19th International Congress of The Society for Melanoma Research

18.10.2022

Faron Pharmaceuticals Ltd.

(“Faron or Company”)

Faron Pharmaceuticals Presents Results from PD-1 Blockade Refractory Melanoma Cohort of MATINS Trial at 19th International Congress of The Society for Melanoma Research

100% overall survival at 12-months in PD-1 blockade refractory melanoma patients who experienced clinical benefit from bexmarilimab
Patients with cold tumors, defined by low baseline levels of pro-inflammatory cytokines, were more likely to experience clinical benefit following treatment with bexmarilimab
Patients who experienced clinical benefit from bexmarilimab had a seven-fold increase in serum interferon gamma (IFNγ), suggesting retreatment with anti-PD-1 could be beneficial

Press release, October 18, 2022 at 02:00 AM (EST) / 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, today announces that results from the melanoma cohort in the ongoing phase I/II MATINS (Macrophage Antibody to Inhibit Immune Suppression) trial, will be presented at the 19th International Congress of The Society for Melanoma Research, being held in Edinburgh, Scotland, October 17-20, 2022.

The melanoma cohort is one of the ten advanced treatment-resistant solid tumor types included in the MATINS study investigating the potential of bexmarilimab, Faron’s wholly owned investigational precision cancer immunotherapy, as a monotherapy. Bexmarilimab targets CLEVER-1 positive (Common Lymphatic Endothelial and Vascular Endothelial Receptor 1) on immune suppressive tumor associated macrophages. Around 50% of the tumor mass is made up of tumor associated macrophages, limiting the efficacy of currently approved cancer immunotherapies, including PD-1 blockade.

Within melanoma, anti-PD-1-based therapy failure occurs in 50-60% of advanced melanoma patients due to primary resistance. Additionally, 40% of patients who initially respond develop acquired resistance1. Bexmarilimab reinvigorates exhausted T-cells and converts immune suppressive macrophages into immunostimulatory macrophages, thus, converting cold tumors to hot tumors and creating an environment where retreatment with anti-PD-1 therapies may be successful.

Data from 22 melanoma patients will be presented at the congress. All patients had failed prior checkpoint inhibition and were treated with bexmarilimab monotherapy at varying doses. The median number of previous treatment lines was three and the median age of patients was 60.

– Of the 22 subjects, five patients (23%) experienced clinical benefit during therapy.

– Among patients who had 12-month follow-up completed, 100% (3/3) of patients who experienced clinical benefit were alive compared to 11% (1/9) of patients who did not experience clinical benefit.

– Median overall survival (OS) was 457 days for patients who experienced clinical benefit compared to 189 days for patients who did not experience clinical benefit. This represents a 2.4-fold increase in OS for patients with clinical benefit.

– Mean baseline IFNγ levels among patients experiencing clinical benefit was one-fourth of the mean value of patients who did not experience clinical benefit. Mean levels among these patients increased significantly and remained elevated over the course of a three-weekly treatment, indicating an immune response was activated and that the tumor was converted from cold to hot.

Mean increase from baseline among patients who experienced clinical benefit:
- A three-fold increase at 8 days
- A seven-fold increase at 15 days
- A five-fold increase at 22 days

– Receiver operating characteristic curves found that low levels of both IFNγ and TNFα was highly predictive of clinical benefit (AUC 0.87, 95% CI 0.71 to 1.00)

– Higher intratumoral CLEVER-1 levels at baseline were observed among patients experiencing clinical benefit and could become an essential component of future studies to build accompanying diagnostic tool for patient selection

“Checkpoint inhibitors have transformed the treatment of metastatic melanoma, but far too many patients are not benefiting from currently approved immunotherapies,” said Dr. Anna Minchom, Consultant Medical Oncologist at the Royal Marsden Hospital, Team Leader at the Institute of Cancer Research and MATINS investigator. “The biomarker analysis in this trial of bexmarilimab is very interesting, indicating immune activation and pointing the way for combining bexmarilimab with other immunotherapies.”

“These data, together with our biomarker analysis, reinforce bexmarilimab’s unique proposition – its capacity to ignite immunity in heavily pre-treated, last line cancer patients who either failed on or were ineligible for treatment with currently approved immunotherapy drugs,” said Marie-Louise Fjällskog, M.D., Ph.D., Chief Medical Officer of Faron. “Our development program exploring the potential of bexmarilimab across solid tumors and hematologic malignancies, both as a monotherapy and in combination with standard of care therapies, seeks to further explore this novel immunotherapy’s potential as a catalyst for the immune system.”

References

Mooradian, M. J. and Sullivan, R. J. (2019) What to do when anti-PD-1 therapy fails in Patients with Melanoma. Oncology. 33 (4) 141-8

For more information please contact:

Investor Contact

Faron Pharmaceuticals

Julia Balanova

VP, Investor Relations

Phone: +1 (917) 306-6096

Media Contact

Faron Pharmaceuticals

Eric Van Zanten

VP, Communications

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

221018 SMR Release 2022 - FINAL

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 in both solid tumors and hematologic malignancies. Beyond immuno-oncology, it offers potential in infectious diseases, vaccine development and more.

About MATINS

The MATINS (Macrophage Antibody To INhibit immune Suppression) study is a first-in-human open label phase I/II clinical trial investigating the tolerability, safety and efficacy of bexmarilimab in ten different hard-to-treat metastatic or inoperable solid tumour cohorts – cholangiocarcinoma, colorectal cancer, cutaneous melanoma, ER+ breast cancer, gastric cancer, hepatocellular carcinoma, ovarian cancer, uveal melanoma, pancreatic cancer and anaplastic thyroid carcinoma – which are all known to host a significant number of CLEVER-1 positive tumour-associated macrophages (TAMs). The completed Part I of the trial dealt with tolerability, safety and dose escalation. The ongoing Part II is focused on identifying patients who show an increased number of CLEVER-1 positive TAMs and exploring safety and efficacy. Part III will be focused on assessing efficacy. Data from MATINS have shown that bexmarilimab has the potential to be the first macrophage immune checkpoint therapy. To date, the investigational therapy has been shown to be safe and well-tolerated, making it a low-risk candidate for combination with existing cancer therapies, and has demonstrated early signs of clinical benefit in patients who have exhausted all other treatment options.

About Faron Pharmaceuticals Ltd.

Forward Looking Statements

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 Placing

14.10.2022

THIS ANNOUNCEMENT AND THE INFORMATION CONTAINED HEREIN IS RESTRICTED AND IS NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN, INTO OR FROM THE UNITED STATES, AUSTRALIA, CANADA, JAPAN, THE REPUBLIC OF SOUTH AFRICA, SINGAPORE, HONG KONG OR ANY OTHER JURISDICTION IN WHICH SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL.

THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF THE EU REGULATION 596/2014 (“MAR”) AND ARTICLE 7 OF MAR AS INCORPORATED INTO UK DOMESTIC LAW BY VIRTUE OF THE EUROPEAN UNION (WITHDRAWAL) ACT 2018 (“UK MAR”).

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

Announcement of the Results of Placing, the Issue Price, PDMR dealing and registration of New Shares with the Trade Register

Capitalised terms used in this announcement have the meanings given to them in the announcement made on 13 October 2022 regarding the proposed issue of new ordinary shares in the Company to the Company itself without consideration and placing of treasury shares in the Company (the “Launch Announcement“), unless the context provides otherwise.

Company announcement, 14 October 2022 at 7:00 a.m. BST / 9:00 a.m. EEST

Inside information

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Ltd (First North: FARON, AIM: FARN), 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 today that the Bookbuild, announced on 13 October 2022, is now closed. The Placing comprises of the issuance of 3,229,930 Treasury Shares to Faron itself without consideration, which have today been registered in the Trade Register, and subsequent conveyance of these Treasury Shares together with 1,311,800 treasury shares already held by the Company, in total 4,541,730 Placing Shares, to investors at the Issue Price of EUR 1.85 per Placing Share. 4,414,460 Placing Shares are conveyed to investors in the main tranche of the Placing organised by Swedbank, and in a separate tranche without the involvement of Swedbank, 6,270 Placing Shares are conveyed by the Company directly to the Chairman of the Board and the remaining 121,000 Placing Shares to certain other investors, at the same terms and conditions as the main tranche. The Issue Price represents a 5.5 % discount to the close price on 13 October 2022 on NASDAQ Helsinki First North Growth. The payment and settlement (delivery against payment of the Issue Price in full) of the Placing Shares is expected to be completed on or about 18 October 2022.

The Placing Shares conveyed to investors amount to approximately 8.0 % of the issued shares and votes in the Company, immediately prior to the Placing. The Company has raised aggregate gross proceeds of EUR 8.4 million in the Placing. The Placing was supported by existing shareholders as well as new investors. With these proceeds and the current level of activities the Company has sufficient working capital further into Q1 2023.

“We are extremely pleased with the results of this Placing and the interest we received from investors.” said Toni Hänninen, Chief Financial Officer of Faron. “These funds allow us to accelerate our bexmarilimab pipeline further, including the continuation of our BEXMAB study, preparation for the MATINS FDA EOP (end of phase) meeting and the initiation of our BEXCOMBO study in 2023. Additionally, we are further strengthening our presence and building the team in the US as previously communicated.”

Use of Proceeds and registration of Treasury Shares in the Trade Register

The primary reason for conducting the Placing was to accelerate and expand the clinical development of the Company’s main drug candidate, bexmarilimab. Some of the proceeds will also be used to expand manufacturing capabilities, to support general corporate purposes and to strengthen the Company’s balance sheet.

A total of 3,229,930 Treasury Shares have been issued and registered in the Trade Register today on 14 October 2022. Following the issuance, the aggregate number of ordinary shares in the Company is 59,805,383. As a part of the Placing, the 3,229,930 Treasury Shares are further conveyed to investors as Placing Shares together with the 1,311,800 treasury shares already held by the Company, with payment and settlement (delivery against payment of the Issue Price in full) expected to be completed on or about 18 October 2022. The Placing Shares confer a right to dividends and other shareholder rights from the payment and settlement to investors. One Placing Share entitles to one vote in the general meeting of the Company. Following, and subject to, the completion of the settlement in full, the Company will have no shares in treasury and therefore, the total number of voting rights in Faron will be 59,805,383 (the “New Number of Shares and Votes“). This figure may be used by shareholders as the denominator for the calculations by which they will determine whether they are required to notify an interest in, or a change to their interest in, the New Number of Shares and Votes of the Company.

Trading in the Treasury Shares (and the Placing Shares) is expected to commence on First North and AIM latest on or about 18 October 2022.

Related Party Transaction and PDMR Dealing

Timo Syrjälä, an existing shareholder in the Company, has subscribed for 1,400,000 Placing Shares in aggregate, for an aggregate subscription value of EUR 2.6 million at the Issue Price. Following the Placing, Mr. Syrjälä’s total holding in the Company’s shares, which includes his indirect holding through Acme Investments SPF Sarl (“Acme“), an entity wholly owned by Mr. Syrjälä, will be 12,306,957 shares, representing 20.6 % of the New Number of Shares and Votes. Mr Syrjälä is a “Substantial Shareholder” in the Company for the purposes of the AIM Rules for Companies (the “AIM Rules“). His subscription for Placing Shares pursuant to the Placing is a related party transaction for the purposes of the AIM Rules, the First North Rulebook and the Finnish Limited Liability Companies Act. The Directors of the Company, all of whom are independent of Mr Syrjälä, having consulted with Cairn Financial Advisers LLP, the Company’s nominated adviser for the purposes of the AIM Rules, consider the terms of the participation by Mr. Syrjälä in the Placing to be fair and reasonable insofar as shareholders are concerned.

In addition, Frank Armstrong, director of the Company has subscribed for 6,270 shares respectively to be conveyed by the Company directly in a separate tranche without the involvement of Swedbank. The beneficial interest in the issued shares and votes of the Company is set out below:

	Before the Placing			Following the Placing
Director	Number of ordinary shares held	% of issued shares and votes	Number of Placing Shares subscribed for	Number of ordinary shares held	% of issued shares and votes
Frank Armstrong	64,792	0.1	6,270	71,062	0.1

The participation of Frank Armstrong (“Director Participation”) in the Placing constitutes a related party transaction. The independent directors for the purpose of the Director Participation, being all other members of the Board, having consulted with Cairn Financial Advisers LLP, the Company’s nominated adviser for the purposes of the AIM Rules, consider the terms of the Director Participation in the Placing to be fair and reasonable insofar as shareholders are concerned.

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	Frank Armstrong
2	Reason for notification
a.	Position/Status	Directors
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	Ordinary shares ISIN: FI4000153309
b.	Nature of the transaction	Purchase of ordinary shares
c.	Price(s) and volume(s)		Average
			Price(s)	Volume(s)
			1.85	6 270

d.	Aggregated information – Aggregated Volume – Price	6 270 1.85
e.	Date of the transaction	14 October 2022
f.	Place of the transaction	Nasdaq First North Growth Market

For more information please contact:

Investor Contact

Faron Pharmaceuticals

Julia Balanova

VP, Investor Relations

Phone: +1 (917) 306-6096

Media Contact

Faron Pharmaceuticals

Eric Van Zanten

VP, Communications

Phone: +1 (610) 529-6219

Swedbank AB (publ), Financial Adviser

Mika Karikoski

Phone: + 358 (0)40 7416959

Cairn Financial Advisers LLP, Nominated Adviser

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 Results of Placing 141022

Phone: +44 (0)20 3709 5700

THIS ANNOUNCEMENT IS ONLY DIRECTED AT PERSONS IN THE UNITED KINGDOM THAT ARE QUALIFIED INVESTORS WITHIN THE MEANING OF ARTICLE 2(E) OF REGULATION 2017/1129/EU AS INCORPORATED INTO UK DOMESTIC LAW BY VIRTUE OF THE EUROPEAN UNION (WITHDRAWAL) ACT 2018 THAT ARE ALSO (I) INVESTMENT PROFESSIONALS FALLING WITHIN ARTICLE 19(5) OF THE FINANCIAL SERVICES AND MARKETS ACT 2000 (FINANCIAL PROMOTION) ORDER 2005 (THE “ORDER”) AND/OR (II) HIGH NET WORTH ENTITIES, AND OTHER PERSONS TO WHOM IT MAY LAWFULLY BE COMMUNICATED, FALLING WITHIN ARTICLE 49(2)(A) TO (E) OF THE ORDER (EACH SUCH PERSON BEING REFERRED TO AS A “RELEVANT PERSON”). ACCORDINGLY, THIS ANNOUNCEMENT AND ITS CONTENTS MUST NOT BE ACTED ON OR RELIED ON BY PERSONS WHO ARE NOT RELEVANT PERSONS. ANY INVESTMENT OR INVESTMENT ACTIVITY TO WHICH THIS ANNOUNCEMENT RELATES IS AVAILABLE ONLY TO RELEVANT PERSONS AND WILL BE ENGAGED IN ONLY WITH RELEVANT PERSONS. PERSONS INTO WHOSE POSSESSION THIS ANNOUNCEMENT COMES ARE REQUIRED TO INFORM THEMSELVES ABOUT AND TO OBSERVE ANY SUCH RESTRICTIONS.

THE PLACING SHARES HAVE NOT BEEN AND WILL NOT BE REGISTERED UNDER THE UNITED STATES SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), OR UNDER THE SECURITIES LAWS OF ANY STATE OR OTHER JURISDICTION OF THE UNITED STATES, AND MAY NOT BE OFFERED, SOLD OR TRANSFERRED, DIRECTLY OR INDIRECTLY, IN OR INTO OR FROM THE UNITED STATES EXCEPT PURSUANT TO AN EXEMPTION FROM, OR IN A TRANSACTION NOT SUBJECT TO, THE REGISTRATION REQUIREMENTS OF THE SECURITIES ACT AND IN COMPLIANCE WITH ANY APPLICABLE SECURITIES LAWS OF ANY STATE OR OTHER JURISDICTION OF THE UNITED STATES. THERE IS NO INTENTION TO REGISTER THE PLACING SHARES IN THE UNITED STATES OR TO MAKE A PUBLIC OFFERING IN THE UNITED STATES. ANY SALE OF THE PLACING SHARES IN THE UNITED STATES WAS MADE SOLELY TO “QUALIFIED INSTITUTIONAL BUYERS” AS DEFINED IN RULE 144A IN RELIANCE ON AN EXEMPTION FROM THE REGISTRATION REQUIREMENTS OF THE U.S. SECURITIES ACT.

About Bexmarilimab

About Faron Pharmaceuticals Ltd.

IMPORTANT INFORMATION

Market Abuse Regulation

Market soundings, as defined in Regulation (EU) No 596/2014 (“MAR“), were taken in respect of the proposed Placing with the result that certain persons became aware of inside information, as permitted by MAR. That inside information in relation to the Placing is set out in this announcement and has been disclosed as soon as possible in accordance with paragraph 7 of article 17 of MAR. Therefore, those persons that received inside information in such market sounding are no longer in possession of inside information relating to the Company and its securities.

This announcement contains inside information for the purposes of Article 7 of MAR and Article 7 of UK MAR.

MiFID II

Solely for the purposes of the product governance requirements contained within: (a) EU Directive 2014/65/EU on markets in financial instruments, as amended (“MiFID II“); (b) Articles 9 and 10 of Commission Delegated Directive (EU) 2017/593 supplementing MiFID II; and (c) local implementing measures (together, the “MiFID II Product Governance Requirements“), and disclaiming all and any liability, whether arising in tort, contract or otherwise, which any “manufacturer” (for the purposes of the MiFID II Product Governance Requirements) may otherwise have with respect thereto, the Placing Shares have been subject to a product approval process, which has determined that the Placing Shares are: (i) compatible with an end target market of: (a) retail investors, (b) investors who meet the criteria of professional clients and (c) eligible counterparties (each as defined in MiFID II); and (ii) eligible for distribution through all distribution channels as are permitted by MiFID II (the “Target Market Assessment“). Notwithstanding the Target Market Assessment, distributors should note that: the price of the Placing Shares may decline and investors could lose all or part of their investment; the Placing Shares offer no guaranteed income and no capital protection; and an investment in the Placing Shares is compatible only with investors who do not need a guaranteed income or capital protection, who (either alone or in conjunction with an appropriate financial or other adviser) are capable of evaluating the merits and risks of such an investment and who have sufficient resources to be able to bear any losses that may result therefrom. The Target Market Assessment is without prejudice to the requirements of any contractual, legal or regulatory selling restrictions in relation to the offer.

Caution regarding forward-looking statements

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

A number of factors could cause actual results to differ materially from the results and expectations discussed in the forward-looking statements, many of which are beyond the control of the Company. In addition, other factors which could cause actual results to differ materially include the ability of the Company to successfully licence its programmes, risks associated with vulnerability to general economic and business conditions, competition, environmental and other regulatory changes, actions by governmental authorities, the availability of capital markets or other sources of funding, reliance on key personnel, uninsured and underinsured losses and other factors. Although any forward-looking statements contained in this announcement are based upon what the Directors believe to be reasonable assumptions, the Company cannot assure investors that actual results will be consistent with such forward-looking statements. Accordingly, readers are cautioned not to place undue reliance on forward-looking statements. Subject to any continuing obligations under applicable law or any relevant AIM Rule requirements, in providing this information the Company does not undertake any obligation to publicly update or revise any of the forward-looking statements or to advise of any change in events, conditions or circumstances on which any such statement is based.

Proposed Issue and Placing of Shares

13.10.2022

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

Proposed Issue and Placing of Shares to raise approximately EUR 8 million

Company announcement, 13 October 2022 at 17:30 p.m. BST / 19:30 p.m. EEST

Inside information

KEY HIGHLIGHTS

A proposed private placement to raise approximately EUR 8 million conducted by way of an accelerated book-building, directed to a limited number of institutional and other investors.
The Company has substantial anchor demand in place for the Placing.
Significant majority of the net proceeds of the Placing would be used for the acceleration of the bexmarilimab clinical development program and manufacturing.
As disclosed in the Company’s half year report on 25 August 2022 total cash and cash equivalents held by the Company as of 30 June 2022 was ca. EUR 9.9 million.
Gross proceeds of the Placing, if subscribed, together with other currently confirmed funding, are expected to provide the Company with working capital further into Q1 2023.

Placing may be conducted in two tranches. Swedbank AB (publ) (“Swedbank”) is acting as sole bookrunner and financial adviser to the Company for the main tranche of the Placing in cooperation with Kepler Cheuvreux S.A. In addition to the main tranche the Company may convey shares directly to the Chairman of the Board in a separate tranche at the same terms and conditions as the main tranche, without the involvement of Swedbank.

The Placing will be conducted as a private placement by way of an accelerated book-building process in which selected investors may submit bids for the Placing Shares (the “Bookbuild”). The subscription price per Placing Share is to be determined on the basis of the bids received in the Bookbuild. The Bookbuild is expected to commence immediately following this announcement and is expected to end by 9:00 a.m. EEST (7:00 a.m. BST) on 14 October 2022 at the latest. The Bookbuild may be discontinued at any time during the book-building process. Following the close of the Bookbuild, the Board of Directors of Faron (the “Board“) will first make the decision to issue the relevant number of treasury shares to Faron itself without consideration (the “Treasury Shares”), taking into consideration the 1,311,800 treasury shares currently held by the Company itself, followed by the decision to further issue and convey the Placing Shares, including, as applicable, acceptance of the received bids, the number of Placing Shares to be conveyed to investors and the subscription price per Placing Share (the “Issue Price“). The Company has received non-binding indications of interest from potential investors to subscribe for the Placing Shares under the Placing during a pre-marketing process.

As soon as practicable after the close of the Bookbuild, an announcement will be made on the final number of the Treasury Shares to be issued first to Faron itself without consideration and then the final number of Placing Shares conveyed in the Placing, the expected registration date of the Treasury Shares and the Issue Price.

Further details on the terms and conditions of the Placing are set out below. The Placing Shares are expected to be admitted to trading on Nasdaq First North Growth Market Finland (“First North”) and AIM (“AIM”) in London as set out below.

“The biomarker data we have reported this year on late-stage, heavily pre-treated cancer patients clearly indicate which patients are likely to respond to treatment with bexmarilimab resulting in a powerful immune system activation,” said Dr. Markku Jalkanen, Chief Executive Officer of Faron. “These patients also represent the majority of PD-1 blockade resistant cancer patients and could benefit from bexmarilimab treatment in combination settings. This fundraise will enable us to further accelerate our ambitious bexmarilimab development plan which now covers both solid tumors and haematological malignancies.”

REASONS FOR THE PROPOSED PLACING

The development of bexmarilimab has advanced significantly over the past 12 – 18 months and the furthering of its development provides an opportunity to build additional value for shareholders. The primary reason for conducting the Placing is to accelerate and expand the clinical development of this drug candidate.

Bexmarilimab

Conclude MATINS trial for FDA EOP Meeting to obtain advice for pivotal pathway with last line cancer patients
Complete Part I of the BEXMAB combination trial with AML/MSD patients
Initiate BEXCOMBO with PD-1 Blockade
Advance Bex CMC commercial scale production

General corporate

Development of Faron’s operational unit in the US
Strengthening of the Company’s balance sheet.

DETAILS OF THE PROPOSED PLACING AND ISSUE OF EQUITY

The proposed Placing is being carried out within the authorisation granted to the Board by shareholders at the Company’s Extraordinary General Meeting held on 7 July 2022 to issue up to a total of eleven million (11,000,000) new ordinary shares in the Company as well as to convey up to the same maximum number (11,000,000) of treasury shares in the possession of the Company (the “Authorisation”). The Authorisation includes the right to issue new shares or dispose of the shares in the possession of the Company, in a directed share issue and in deviation from the shareholders’ pre-emptive rights.

The Placing will be implemented in two phases, each requiring the use of the Board’s share issue authorisation, i.e. by the Company first issuing the Treasury Shares to itself without consideration and then immediately conveying the Treasury Shares together with treasury shares currently held by the Company as Placing Shares to the participating investors against their payment of the Issue Price. As the Company plans to convey up 4,200,000 Placing Shares to investors, it will issue up to 2,888,200 (= 4,200,000 – 1,311,800) new Treasury Shares to itself. The Placing Shares represent approximately 7.4 per cent of all the issued shares and votes in the Company immediately prior to the Placing.

The Placing, with the main tranche being arranged by Swedbank, will be conducted in a private placement by way of the Bookbuild, which is an accelerated book-building process in which selected investors may submit bids for the Placing Shares. The Issue Price is to be determined on the basis of the bids received in the Bookbuild. The Bookbuild is expected to commence immediately following this announcement and is expected to end by 9:00 EEST a.m. (7:00 a.m. BST) on 14 October 2022 at the latest. The Bookbuild may be discontinued at any time during the book-building process. Following the close of the Bookbuild, the Board will make the decision to issue the relevant number of new Treasury Shares to the Company itself and subsequently convey the Placing Shares to the investors in the Placing, including deciding upon, as applicable, the acceptance of the received bids, the number of Placing Shares to be conveyed and the Issue Price. As soon as practicable after the close of the Bookbuild, receipt of binding commitments from investors and the Board having resolved on carrying out the Placing, an announcement will be made on the final outcome of the Bookbuild and, as applicable, the number of Treasury Shares to be issued to the Company itself and further the number of Placing Shares issued to investors, the Issue Price as well as the expected registration date of the Treasury Shares.

In connection with the proposed Placing, the Company has entered into a placing agreement concerning the main tranche with Swedbank (the “Placing Agreement”). Pursuant to the terms of the Placing Agreement, Swedbank has agreed to use its reasonable endeavours to procure the subscription of Placing Shares in the main tranche.

The Placing Agreement contains customary warranties and an indemnity from the Company in favour of Swedbank together with provisions which enable Swedbank to terminate the Placing Agreement in certain circumstances before the completion of the Bookbuild, the Board’s resolution on carrying out the Placing and the settlement of the Placing Shares to investors, including where there has been a material breach of any of the warranties contained in the Placing Agreement or where there is a material adverse change, e.g., in the business or financial affairs of the Company. The Company has agreed to pay Swedbank certain commissions and fees in connection with the Placing. Pursuant to the terms of the Placing Agreement, Swedbank shall collect payment of the gross Issue Price from the investors in respect of the Placing Shares allocated in the main tranche of the Placing, paying such amounts to the Company on behalf of the investors and organizing the delivery of the Placing Shares to the investors against payment of the Issue Price in full (DVP).

The Placing is conditional upon, inter alia:

the Placing Agreement having become unconditional in all respects;
binding commitments being received from investors;
the Board resolving to carry out the Placing at the Issue Price and the Company and Swedbank entering into a separate pricing agreement confirming the Issue Price and the number of the Placing Shares; and
the Treasury Shares being issued and being registered with the Finnish Trade Register.

In connection with the Placing, Faron has entered into a lock-up undertaking, under which it has, subject to certain exceptions, agreed not to issue or sell any shares in Faron for a period of 90 days after the closing of the Placing.

Subject to all conditions being met, the Treasury Shares are expected to be entered in the Finnish Trade Register approximately on 14 October 2022.

ISSUE OF THE PLACING SHARES AND ADMISSION TO TRADING

The Treasury Shares are expected to be issued in one tranche to the Company itself and subsequently the Placing Shares conveyed to the investors, with the payment and settlement (delivery against payment of the Issue Price in full) expected to be completed on or about 18 October 2022. Applications will be made for the admission of the Treasury Shares to trading on First North and AIM with said admissions expected to become effective and trading to commence on or around 18 October 2022 (the “Admissions“). The dates above may be subject to change.

A further announcement will be made to confirm the outcome of the Placing (subject to, inter alia, satisfaction of the above conditions) and to confirm the expected timing of issue of the Treasury Shares to the Company itself and subsequent conveyance of Placing Shares to investors, and the Admissions.

Upon registration with the Finnish Trade Register and further conveyance of the Placing Shares to investors (DVP), the Placing Shares will rank pari passu in all respects with the existing shares of the Company.

For more information please contact:

Investor Contact

Faron Pharmaceuticals

Julia Balanova

VP, Investor Relations

Phone: +1 (917) 306-6096

Media Contact

Faron Pharmaceuticals

Eric Van Zanten

VP, Communications

Phone: +1 (610) 529-6219

Swedbank AB (publ), Financial Adviser

Mika Karikoski,

Phone: +358 (0) 407416959

Cairn Financial Advisers LLP, Nominated Adviser

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

20221013 Faron Proposed Issue and Placing of Shares

Phone: +44 (0)20 3709 5700

MEMBERS OF THE PUBLIC ARE NOT ELIGIBLE TO SUBSCRIBE FOR, OTHERWISE ACQUIRE OR DISPOSE OF ANY SECURITIES IN FARON PHARMACEUTICALS OY (“FARON”) PURSUANT TO THE PROPOSED TRANSACTION REFERRED TO IN THIS ANNOUNCEMENT. THIS ANNOUNCEMENT IS THEREFORE DIRECTED ONLY AT, IN A MEMBER STATE OF THE EUROPEAN ECONOMIC AREA, PERSONS WHO ARE “QUALIFIED INVESTORS” AS DEFINED IN ARTICLE 2(E) OF THE EU PROSPECTUS REGULATION (WHICH MEANS REGULATION (EU) 2017/1129) (THE “PROSPECTUS REGULATION”). THIS ANNOUNCEMENT IS FOR INFORMATION PURPOSES ONLY AND DOES NOT CONSTITUTE OR CONTAIN ANY INVITATION, SOLICITATION, RECOMMENDATION, OFFER OR ADVICE TO ANY PERSON TO SUBSCRIBE FOR, OTHERWISE ACQUIRE OR DISPOSE OF ANY SECURITIES IN FARON OR ANY OTHER ENTITY IN ANY JURISDICTION IN WHICH ANY SUCH OFFER WOULD BE UNLAWFUL.

IN ADDITION, IN THE UNITED KINGDOM, THIS ANNOUNCEMENT IS ONLY DIRECTED AT PERSONS IN THE UNITED KINGDOM THAT ARE QUALIFIED INVESTORS WITHIN THE MEANING OF ARTICLE 2(E) OF THE PROSPECTUS REGULATION AS INCORPORATED INTO UK DOMESTIC LAW BY VIRTUE OF THE EUROPEAN UNION (WITHDRAWAL) ACT 2018 THAT ARE ALSO (I) INVESTMENT PROFESSIONALS FALLING WITHIN ARTICLE 19(5) OF THE FINANCIAL SERVICES AND MARKETS ACT 2000 (FINANCIAL PROMOTION) ORDER 2005 (THE “ORDER”) AND/OR (II) HIGH NET WORTH ENTITIES, AND OTHER PERSONS TO WHOM IT MAY LAWFULLY BE COMMUNICATED, FALLING WITHIN ARTICLE 49(2)(A) TO (E) OF THE ORDER (EACH SUCH PERSON, TOGETHER WITH QUALIFIED INVESTORS AS DEFINED IN THE PROSPECTUS REGULATION, BEING REFERRED TO AS A “RELEVANT PERSON”).

ACCORDINGLY, THIS ANNOUNCEMENT AND ITS CONTENTS MUST NOT BE ACTED ON OR RELIED ON BY PERSONS WHO ARE NOT RELEVANT PERSONS. ANY INVESTMENT OR INVESTMENT ACTIVITY TO WHICH THIS ANNOUNCEMENT RELATES IS AVAILABLE ONLY TO RELEVANT PERSONS AND WILL BE ENGAGED IN ONLY WITH RELEVANT PERSONS. PERSONS INTO WHOSE POSSESSION THIS ANNOUNCEMENT COMES ARE REQUIRED TO INFORM THEMSELVES ABOUT AND TO OBSERVE ANY SUCH RESTRICTIONS.

THE PROPOSED TRANSACTION REFERRED TO IN THIS ANNOUNCEMENT WOULD BE MADE PURSUANT TO A PRIVATE PLACEMENT EXEMPTION UNDER THE PROSPECTUS REGULATION FROM THE REQUIREMENTS TO PRODUCE A PROSPECTUS UNDER THE PROSPECTUS REGULATION FOR OFFERS OF SECURITIES. FARON HAS NOT TAKEN ANY ACTION, NOR WILL IT TAKE ANY ACTION, TO OFFER ANY OF THE PLACING SHARES THAT ARE TO BE SUBSCRIBED FOR PURSUANT TO THE TRANSACTION REFERRED TO IN THIS ANNOUNCEMENT OR ANY DOCUMENTS RELATING TO THE PLACING TO THE PUBLIC IN FINLAND, SWEDEN, NORWAY OR DENMARK, OR IN ANY OTHER JURISDICTION IN ANY FORM WHICH WOULD CONSTITUTE AN OFFER TO THE PUBLIC.

THE PLACING SHARES HAVE NOT BEEN AND WILL NOT BE REGISTERED UNDER THE UNITED STATES SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), OR UNDER THE SECURITIES LAWS OF ANY STATE OR OTHER JURISDICTION OF THE UNITED STATES, AND MAY NOT BE OFFERED, SOLD OR TRANSFERRED, DIRECTLY OR INDIRECTLY, IN OR INTO OR FROM THE UNITED STATES EXCEPT PURSUANT TO AN EXEMPTION FROM, OR IN A TRANSACTION NOT SUBJECT TO, THE REGISTRATION REQUIREMENTS OF THE SECURITIES ACT AND IN COMPLIANCE WITH ANY APPLICABLE SECURITIES LAWS OF ANY STATE OR OTHER JURISDICTION OF THE UNITED STATES. THERE IS NO INTENTION TO REGISTER THE PLACING SHARES IN THE UNITED STATES OR TO MAKE A PUBLIC OFFERING IN THE UNITED STATES. ANY SALE OF THE PLACING SHARES IN THE UNITED STATES WILL BE MADE SOLELY TO “QUALIFIED INSTITUTIONAL BUYERS” AS DEFINED IN RULE 144A IN RELIANCE ON AN EXEMPTION FROM THE REGISTRATION REQUIREMENTS OF THE U.S. SECURITIES ACT.

About Bexmarilimab

About Faron Pharmaceuticals Ltd.

IMPORTANT INFORMATION

Market Abuse Regulation

This announcement contains inside information for the purposes of Article 7 of MAR and Article 7 of UK MAR.

MiFID II

Caution regarding forward-looking statements

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 addition, other factors which could cause actual results to differ materially include the ability of the Company to successfully licence its programmes, risks associated with vulnerability to general economic and business conditions, competition, environmental and other regulatory changes, actions by governmental authorities, the availability of capital markets or other sources of funding, reliance on key personnel, uninsured and underinsured losses and other factors. Although any forward-looking statements contained in this announcement are based upon what the Directors believe to be reasonable assumptions, the Company cannot assure investors that actual results will be consistent with such forward-looking statements. Accordingly, readers are cautioned not to place undue reliance on forward-looking statements. Subject to any continuing obligations under applicable law or any relevant AIM Rule requirements, in providing this information the Company does not undertake any obligation to publicly update or revise any of the forward-looking statements or to advise of any change in events, conditions or circumstances on which any such statement is based.

Grant of Options

22.9.2022

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

Phone: +1 (917) 306-6096

Media Contact

Faron Pharmaceuticals

Eric Van Zanten

VP, Communications

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