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”)

Inside information: Announcement of Placing of Newly Issued Treasury Shares to Raise EUR 6.6 Million and of

PDMR Dealings

Company announcement, June 29, 2023 at 9:00 EEST/ 7:00 a.m. BST

Inside information

KEY HIGHLIGHTS

• The Company has conducted a private placement directed to a limited number of institutional and other investors to raise EUR 6.6 million.
• Significant majority of the net proceeds of the Placing will be used for the acceleration of the bexmarilimab clinical development program and manufacturing.
• As disclosed in the Company’s full year report on March 3, 2023 total cash and cash equivalents held by the Company as of December 31, 2022 were ca. EUR 7.0 million.
• In January 2023, the Company successfully raised a total of EUR 12.0 million gross.
• Gross proceeds of the Placing together with other currently confirmed funding, are expected to provide the Company with working capital into Q4 of 2023.
• The Company plans to issue first–half 2023 financial results on August 29, 2023.

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Ltd (First North: FARON, AIM: FARN), a clinical-stage biopharmaceutical company focused on tackling cancers via novel immunotherapies, today announces that it has conducted a placement of  2,601,510 newly issued treasury shares (“Placing Shares”) to raise EUR 6.6 million before expenses to a limited number of institutional investors and other investors (“Placing”). Upon receipt of these proceeds the Company expects to have sufficient working capital into Q4 of 2023.

The Placing was carried out as a private placement by way of a firm placement of Placing Shares to a limited number of institutional and other investors. To implement the Placing, the Board of Directors of Faron (the “Board“) has decided to issue 2,601,510 shares to Faron itself without consideration (“Treasury Shares”) and, subject to the registration of the Treasury Shares, further convey all of such Treasury Shares as Placing Shares to the participating investors at the Issue Price of EUR 2.55 per Placing Share. The Issue Price represents a 11.8% discount to the close price on 28 June 2023 on NASDAQ Helsinki First North Growth.  The settlement of the Placing (delivery against payment) trades is  expected to complete on or around July 3, 2023.

“This fundraise will enable us to accelerate our ambitious bexmarilimab development program, with a specific focus on advancing our combination trials in hematologic malignancies,” said Dr. Markku Jalkanen, Chief Executive Officer of Faron. “Far too many patients are not benefiting from recently approved treatments because their immune system simply doesn’t recognize and mount a defence against their cancer. Bexmarilimab data so far indicates the potential to offer these patients a chance and improve their quality of life.”

“We are very pleased with the results of this Placing,” said James O’Brien, Chief Financial Officer of Faron. “These funds raised strengthen our balance sheet and will allow us to continue accelerating our bexmarilimab development program, which has so far demonstrated strong efficacy and safety data in patients left no other therapeutic options.”

USE OF PROCEEDS

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. Some of the proceeds will also be used to support general corporate purposes and other pipeline development, and to strengthen the Company’s balance sheet and to continue satisfying the covenants agreed with the Company’s financing providers (including the requirement to maintain a minimum cash balance of EUR 6.0 million while maintaining three months cash runway). Additionally, Faron and its lender, IPF Partners, have not negotiated final terms at this time to utilize the second EUR 5.0 million tranche of the agreed loan commitment between the parties.

Bexmarilimab

• Progress BEXMAB hematologic combination trial
• Advance bexmarilimab CMC commercial scale production

General corporate

• Strengthening of the Company’s balance sheet

DETAILS ON PLACING AND SHARE ISSUE

The Placing is carried out within the authorization granted to the Board by shareholders at the Company’s Annual General Meeting held on March 24, 2023 to issue up to a total of 12,500,000 new ordinary shares in the Company as well as to convey up to the same maximum number (12,500,000) of treasury shares in the possession of the Company, in a directed share issue and in deviation from the shareholders’ pre-emptive rights. The Placing is implemented in two phases, i.e. by the Company first issuing the Treasury Shares to itself without consideration and then immediately conveying all of such Treasury Shares as Placing Shares to the participating investors against their payment of the Issue Price. A total of 2,601,510 Treasury Shares have been issued and registered in the Finnish Trade Register today on June 29, 2023. As a result of the Placing, the number of ordinary shares in the Company will increase by 2,601,510 new shares (representing approximately 4.1 per cent of all the issued shares and votes in the Company immediately prior to the Placing).

In connection with the Placing, the Company has entered into a lock-up undertaking for a period of 90 days with customary and certain other exemptions, including the possibility to issue or convey further shares to qualifying long-only investors and within the existing authorities granted at the Company’s annual general meeting held in March 2023 (taking into account the authorities used in connection with the contemplated Share Issue).

All of the Treasury Shares are further conveyed as Placing Shares to the investors participating in the Placing, with the payment and settlement (delivery against payment of the Issue Price in full) expected to be completed on or about July 3, 2023.

Upon conveyance of the Placing Shares to investors, the Placing Shares will rank pari passu in all respects with the existing shares of the Company. The Placing Shares confer a right to dividends and other shareholder rights from the payment and settlement to investors. One Placing Share entitles the holder to one vote in the general meeting of the Company. The aggregate number of ordinary shares in the Company will be 66,161,373, this is also the figure to be used as the denominator for calculations of interests in the Company’s voting rights.

ADMISSION

The Company will make applications for the admission of the Placing Shares (and the remaining Treasury Shares) to trading on First North and AIM with said admissions expected to become effective and trading to commence on or around July 3, 2023 (the “Admissions“).

RELATED PARTY AND PDMR DEALING

Timo Syrjälä, an existing shareholder in the Company, has subscribed for and been allocated 460,588 Placing Shares in aggregate (subscribed for through Acme Investments SPF Sarl (“Acme“), an entity wholly owned by Mr. Syrjälä), for an aggregate subscription value of approximately EUR 1.2 million at the Issue Price. Following the completion of the Placing, Mr. Syrjälä’s total holding in the Company’s shares, which includes his indirect holding through Acme, will be 13,223,063 shares, representing 19.99 per cent of the issued shares and votes of the Company following the Placing. 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, Markku Jalkanen and Tuomo Pätsi, directors of the Company, as well as Vesa Karvonen, General Counsel of the Company have subscribed for 21,569, 11,765 and 4,000 shares respectively. Their beneficial interests in the issued shares and votes of the Company are set out below:

The participation of Markku Jalkanen and Tuomo Pätsi (“Directors Participation”) in the Placing constitute related party transactions for the purposes of the AIM Rules. The independent directors for the purpose of the Directors Participation, being Dr. Frank Armstrong, John Poulos, Anne Whitaker and Erik Ostrowski, having consulted with Cairn Financial Advisers LLP, the Company’s nominated adviser for the purposes of the AIM Rules, consider the terms of the Directors Participation in the Placing to be fair and reasonable insofar as shareholders are concerned.

For more information please contact:

Investor Contact, EUR

Faron Pharmaceuticals

Yrjö EC K Wichmann

SVP, Investor Relations

yrjo.wichmann@faron.com

investor.relations@faron.com

Phone: +358 (0) 40 5868 979

Investor Contact, US

Faron Pharmaceuticals

Julia Balanova

VP, Investor Relations

julia.balanova@faron.com

investor.relations@faron.com

Phone: +1 (917) 306-6096

Media Contact

Faron Pharmaceuticals

Jennifer C. 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

Mary-Jane Elliott, David Daley, Lindsey Neville

faron@consilium-comms.com

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 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 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.

THIS ANNOUNCEMENT IS NOT FOR PUBLICATION OR DISTRIBUTION, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES OF AMERICA. THIS ANNOUNCEMENT IS NOT AN OFFER OF SECURITIES FOR SALE INTO THE UNITED STATES. 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

Bexmarilimab is Faron’s wholly owned, investigational immunotherapy with the potential to provide immune stimulation for treatment-resistant cancers through targeting myeloid cell function. A novel anti-Clever-1 humanized antibody, bexmarilimab targets Clever-1 positive (Common Lymphatic Endothelial and Vascular Endothelial Receptor 1) tumor-associated macrophages (TAMs) in the tumor microenvironment, converting highly immunosuppressive M2 macrophages to immune-stimulating M1 macrophages. As an immuno-oncology therapy, bexmarilimab has therapeutic potential in combination with other standard treatments including immune checkpoint molecules in both solid tumors and hematologic malignancies. 

About Faron Pharmaceuticals Ltd. 

Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), together with its subsidiaries, is a clinical stage biopharmaceutical group focused on building the future of immunotherapy by harnessing the power of the immune system to tackle cancer. Bexmarilimab, a novel anti-Clever-1 humanized antibody, is its investigational immunotherapy with the potential to remove immunosuppression of cancers through targeting myeloid cell function. Bexmarilimab is being investigated in Phase I/II clinical trials as a potential therapy for patients with hematological and solid cancers in combination with other standard treatments including immune checkpoint molecules. Faron is headquartered in Turku, Finland. Further information is available at www.faron.com. 

IMPORTANT INFORMATION

Market Abuse Regulation

Market soundings, as defined in Regulation (EU) No 596/2014 (“MAR“), were taken in respect of the 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.

Announcement of Placing 290623

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

Inside Information: Encouraging Additional Data for Bexmarilimab for the Treatment of Hematological Malignancies

BEXMAB Study Update

      Two objective responses (ORR) and two stable disease (SD) patients, with one having > 50% reduction of blast cells, observed in the second doublet cohort

      Of the three patients with ORR in the first doublet cohort, two remain on the study after 10 and 9 months, respectively, and the third has undergone a potentially curative transplantation

      Second dose level in doublet well-tolerated and third cohort open for enrolment

      First dose level in triplet well tolerated and second cohort open for enrollment

      Plans to initiate the study’s Phase II in H2 2023

Company announcement, April 17, 2023

Inside information

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), a clinical stage biopharmaceutical company focused on tackling cancers via novel immunotherapies, today announces additional positive data from the Company’s Phase I/II BEXMAB study. BEXMAB is investigating bexmarilimab, Faron’s wholly owned immunotherapy asset, in combination with standard of care (SoC) in relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).

The responses from these patients are further defined as:

      In the second doublet cohort (3mg/kg + azacytidine), two patients have objective responses thus far, including one complete response with incomplete blood count recovery (CRi) and one patient with hematological improvement in platelets (HI-P). There are two patients with SD, of which one has > 50% reduction in bone marrow blasts, and one patient with progressive disease.

      The first doublet cohort (1mg/kg + azacytidine) has seen a complete response with incomplete hematological recovery (CRi) in a patient with relapsed/refractory AML. The patient is still responding after 10 months. Another patient with MDS that experienced CR is still in remission after 9 months. An additional patient that achieved a partial response has undergone a possibly curative allogenic stem cell transplantation.

      No bexmarilimab-related Grade 3 or higher adverse events (AEs) or serious adverse events (SAEs) observed in the second dosing cohort and enrolment into the third cohort (6mg/kg) ongoing.

      The first triplet cohort (1mg/kg + azacytidine + venetoclax) was well-tolerated and the second cohort (3mg/kg + azacytidine + venetoclax) has opened for enrollment.

      Additional efficacy read-outs for all cohorts expected in the upcoming months.

      On a potential path to a Biologics License Application (BLA) submission, the Company plans to seek FDA advice during Q3 2023.

“We are extremely encouraged by the continued efficacy of bexmarilimab and the long duration of the responses seen so far,” said Chief Medical Officer Marie-Louise Fjällskog. Dr. Fjällskog noted the success of the MDS patient who did not respond to previous azacytidine therapy, but with the addition of bexmarilimab, the patient is undergoing potentially curative transplantation.

The primary objective of the BEXMAB study (ClinicalTrials.gov: NCT05428969) is to determine the safety and tolerability of bexmarilimab in combination with SoC (azacytidine and venetoclax) treatment and to identify the recommended Phase II dose. Secondary objectives include characterizing preliminary efficacy as well as bexmarilimab’s pharmacokinetic profile in combination with SoC treatment and assessing its immunogenicity.

In January 2023, the Company announced objective responses in 3 out of 5 patients dosed in the first doublet cohort of the BEXMAB study. The Company also announced enrollment updates for the study’s cohorts, and that it had opened the first triplet cohort with bexmarilimab, azacytidine and venetoclax in newly diagnosed AML patients who are unable to tolerate chemotherapy.

“The latest data are a powerful indication of the therapeutic potential for bexmarilimab in hematological malignancies,” said CEO Dr. Markku Jalkanen.

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

For more information please contact:

Media Contact

Faron Pharmaceuticals

Jennifer C. Smith-Parker

Head of Communications

Jennifer.Smith-Parker@faron.com

Investor Contact

Faron Pharmaceuticals

Julia Balanova

VP, Investor Relations

julia.balanova@faron.com

investor.relations@faron.com

Phone: +1 (917) 306-6096

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, investigational immunotherapy with the potential to provide immune stimulation for treatment-resistant cancers through targeting myeloid cell function. A novel anti-CLEVER-1 humanized antibody, bexmarilimab targets CLEVER-1 positive (Common Lymphatic Endothelial and Vascular Endothelial Receptor 1) tumor-associated macrophages (TAMs) in the tumor microenvironment, converting highly immunosuppressive M2 macrophages to immune-stimulating M1 macrophages. As an immuno-oncology therapy, bexmarilimab has therapeutic potential in combination with other standard treatments including immune checkpoint molecules in both solid tumors and hematologic malignancies.

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 the aggressive hematological malignancies of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The primary objective is to determine the safety and tolerability of bexmarilimab in combination with SoC (azacytidine) treatment and to identify the recommended Phase II dose. Directly targeting CLEVER-1 could limit the replication capacity of cancer cells, increase antigen presentation, ignite an immune response, and allow current treatments to be more effective. CLEVER-1 is highly expressed in both AML and MDS and associated with therapy resistance, limited T cell activation and poor outcomes.

About Faron Pharmaceuticals Oy

Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), together with its subsidiaries, is a clinical stage biopharmaceutical group focused on building the future of immunotherapy by harnessing the power of the immune system to tackle cancer. Bexmarilimab, a novel anti-CLEVER-1 humanized antibody, is its investigational immunotherapy with the potential to remove immunosuppression of cancers through targeting myeloid cell function. Bexmarilimab is being investigated in Phase I/II clinical trials as a potential therapy for patients with hematological and solid cancers in combination with other standard treatments including immune checkpoint molecules. Faron is headquartered 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 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.

Encouraging Additional Data for Bexmarilimab for Treatment of Hematological Malignancies 170423

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

Faron Appoints James O’Brien, CPA, MBA as Chief Financial Officer

Company announcement, March 29, 2023 at 09:00 AM (EEST) / 07:00 AM (BST) / 02:00 AM (EST)  

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), a clinical stage biopharmaceutical company focused on tackling difficult-to-treat cancers, is pleased to announce the appointment of James O’Brien, CPA, MBA as the Company’s new Chief Financial Officer (CFO), effective April 3, 2023. Mr. O’Brien succeeds Toni Hänninen, who is leaving Faron to pursue another career opportunity.

Mr. O’Brien is an accomplished biotech and financial executive with extensive experience in the US capital markets. His appointment highlights Faron’s progression towards becoming a global biopharmaceutical company.

“I am thrilled to welcome James to Faron considering his strong record of performance in public markets, capital raising in the US, business development and strategic planning,” said Markku Jalkanen, CEO of Faron Pharmaceuticals. “His US business acumen will be a crucial asset for our Company as we plot out the clinical development plan for our lead asset bexmarilimab.

“I would also like to thank Toni for his service to Faron over the years. His partnership and contributions have been invaluable and key to the success of our Company to date. We wish him the best in his next role.”

Most recently, Mr. O’Brien served as the CFO of Cognition Therapeutics, Inc. (NASDAQ: CGTX), a clinical-stage biopharmaceutical company which successfully completed an IPO in October 2021, raising USD 52 million. He previously served as Executive Vice President of Finance with Enzo Biochem, Inc. (NYSE: ENZ). Earlier in his career, he held positions with increasing responsibilities at pharmaceutical companies including Actavis PLC (now AbbVie, Inc. (NYSE: ABBV)), the US subsidiary of Swiss company Nycomed, which has since been acquired by Takeda Pharmaceuticals, and Bristol Myers Squibb. He spent close to a decade at PricewaterhouseCoopers and is a certified public accountant (CPA) with a Bachelor of Accountancy from George Washington University and a Master of Business Administration from Fordham University.

“I am pleased to join Faron, bringing my strong background in the US biotech and pharma financial sectors to drive the Company successfully forward,” said Mr. O’Brien.

For more information please contact:

Media Contact 

Faron Pharmaceuticals

Jennifer C. Smith-Parker

Head of Communications

Jennifer.Smith-Parker@faron.com

Investor Contact

Faron Pharmaceuticals

Julia Balanova

VP, Investor Relations

julia.balanova@faron.com

investor.relations@faron.com

Phone: +1 (917) 306-6096

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 Pharmaceuticals Oy (AIM: FARN, First North: FARON) together with its subsidiaries, is a clinical stage biopharmaceutical group focused on building the future of immunotherapy by harnessing the power of the immune system to tackle cancer and inflammation. 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 hematological cancers and untreatable solid tumors, bexmarilimab has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules. In terms of other pipeline assets, Traumakine® is an investigational intravenous (IV) interferon beta-1a therapy for the treatment of hyperinflammatory conditions. Faron is headquartered in Turku, Finland. Further information is available at www.faron.com.

Faron Appoints James O'Brien, CPA, MBA as Chief Financial Officer 290323

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

Inside Information: Faron Announces Positive US Food and Drug Administration (FDA) Feedback to Progress Bexmarilimab as a Monotherapy in Solid Tumors

      Green light for continued clinical development after data package review

      Alignment with company’s selection of 1 mg/kg IV once-every-3-weeks (Q3W) as dose for further evaluation

      Supportive of biomarker-driven approach with CLEVER-1 staining of tumor biopsy

Company announcement, March 22, 2023 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, announces positive FDA feedback and recommendations for the future development of bexmarilimab as a monotherapy in multiple solid tumors. The agency’s advice follows an end-of-Phase I/II meeting this month. The Phase I/II MATINS trial is investigating bexmarilimab, Faron’s wholly owned precision immunotherapy asset, in multiple cancer indications.

The official meeting minutes are consistent with the FDA’s Project Optimus initiative to reform dose optimization and the selection paradigm in oncology drug development, which MATINS sought to comply with through multiple dose and indication arms of the study.  FDA provided the following positive meeting feedback which further aligns the agency’s views on bexmarilimab with the Company’s, including:

      Completed toxicology studies are adequate to support further clinical development of single-agent (monotherapy) bexmarilimab into a registration trial

      Selection of 1 mg/kg IV Q3W as dose for further evaluation appears reasonable, although additional data are required to establish the recommended Phase II/III dose for specific cancer(s)

      Valuable feedback and guidance on further development of a simple, validated staining assay to identify patients with CLEVER-1 positive tumors for clinical trial inclusion

“We are pleased to have received these positive and supportive FDA recommendations for the continued clinical development of bexmarilimab as a monotherapy in solid tumors,” said CEO Markku Jalkanen. “As a first-in-human study for bexmarilimab, MATINS has laid the groundwork for multiple routes to market.”

Faron had previously announced a meeting with the agency would occur this quarter.

“FDA’s feedback on the MATINS study gives Faron an excellent roadmap to plot out bexmarilimab’s future strategy,” said Chief Medical Officer Marie-Louise Fjällskog. “We thank the FDA for its time and consideration of our briefing package and anticipate additional fruitful interactions.”

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

For more information please contact:

Media Contact

Faron Pharmaceuticals

Jennifer Smith-Parker

Head of Communications

Jennifer.Smith-Parker@faron.com

Investor Contact

Faron Pharmaceuticals

Julia Balanova

VP, Investor Relations

julia.balanova@faron.com

investor.relations@faron.com

Phone: +1 (917) 306-6096

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 MATINS

MATINS has demonstrated a positive safety profile in more than 200 patients treated with bexmarilimab. The study has observed an approximate 30% clinical benefit rate in several tumor types, which is associated with an interferon gamma (IFN-y) increase and leads to a significant survival benefit. Moreover, responding patients can be potentially identified using baseline IFN-y or CLEVER-1 expression. CLEVER-1 is a novel immune checkpoint, a receptor shown to promote an immunosuppressive environment.

About Faron Pharmaceuticals Oy

Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON) together with its subsidiaries, is a clinical stage biopharmaceutical group focused on building the future of immunotherapy by harnessing the power of the immune system to tackle cancer and inflammation. 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 hematological cancers and untreatable solid tumors, bexmarilimab has potential as a single-agent therapy or in combination with other standard treatments including immune checkpoint molecules. In terms of other pipeline assets, Traumakine® is an investigational intravenous (IV) interferon beta-1a therapy for the treatment of hyperinflammatory conditions. Faron is headquartered 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 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.

Faron Announces Positive US FDA Feedback to Progress Bexmarilimab as a Monotherapy in Solid Tumors 220323

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

Update to Faron’s Financial Calendar for 2023

Company announcement, February 6, 2023 at 1:00 PM (EST) / 6:00 PM (GMT) / 8:00 PM (EET)

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 an update to its financial reporting calendar for 2023.

The Company’s financial statement release for the full year 2022 and Annual Report 2022, including financial statements for the full year, will now be published on Friday, March 3, 2023, at 02:00 AM (EST) / 07:00 AM (GMT) / 09:00 AM (EET), rather than on Thursday, March 2, 2023, as had been previously communicated.

The publication date of Tuesday, August 29, 2023, for Faron’s half-year financial report for the period January 1 to June 30, 2023, remains unchanged, as does the date for the Company’s annual general meeting, which is planned to be held on Friday, March 24, 2023. A separate stock exchange notice will be issued by Faron’s board of directors to convene the meeting.

Full Year Results Virtual Briefing

Following publication of Faron’s financial statement release for the full year 2022 on Friday, March 3, 2023, Dr. Markku Jalkanen, Chief Executive Officer, and Toni Hänninen, Chief Financial Officer, will host a virtual briefing and Q&A session for analysts on the day at 7:00 AM (EST) / 12:00 PM (GMT) / 2:00 PM (EET).

The full year results press release for 2022, presentation, virtual briefing webcast details, and Annual Report 2022 will be made available at www.faron.com/investors. A replay of the analyst briefing will be made available shortly afterwards.

For more details about the analyst briefing, please contact Faron@consilium-comms.com.

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.

Update to Farons Financial Calendar for 2023 060223

Faron Pharmaceuticals Oy

(“Faron” or “Company”)

Inside Information: Deepening Response of Bexmarilimab in Combination with SoC in Hematological Malignancies

BEXMAB Study Update

      Partial responder becomes complete responder with complete remission of blasts in blood and bone marrow followed by normalization of blood counts

      Second patient demonstrated a partial response

      Stable disease observed in the other treated patients

      Two patients enrolled in second cohort with increased bexmarilimab dose with azacitidine

      Enrolment initiated in the triplet cohort combining bexmarilimab with azacitidine and venetoclax

Company announcement, December 5, 2022 at 02:00 AM (EST) / 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 a further update on the Company’s Phase I/II BEXMAB study, investigating bexmarilimab, Faron’s wholly owned precision immunotherapy asset, in combination with standard of care (SoC) in multiple hematological malignancies.

In this latest update from the ongoing, open-label clinical trial, the Company reports that:

      An azacytidine-refractory acute myeloid leukemia (AML) patient with partial responses as communicated on October 31, 2022, achieved a complete remission, with incomplete blood cell count recovery after four treatment cycles. This was followed by full blood count recovery after five treatment cycles.

      The second patient, recently diagnosed with myelodysplastic syndrome (MDS), showed early signs of efficacy, with reduced blast counts. This pattern is similar to the first patient and as such the patient could be considered a partial responder.

      The remaining patients of the first cohort have reported stable disease (SD) status.

      Bexmarilimab continues to be well-tolerated with no dose-limiting toxicities or safety concerns observed in the five patients receiving 1mg/kg weekly dosing together with azacitidine.

      Study expansion to major hematological US centers is ongoing.

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 initial treatment efficacy is followed by measuring cancer cell blast number in blood and bone marrow.

The BEXMAB study has opened the second predefined weekly dosing level of 3mg/kg and the start of dosing in the new triplet cohort combining bexmarilimab with azacitidine and venetoclax.

“We continue to be encouraged by the promising early data observed in this trial, notably the patients who have already shown control of blast counts in blood and bone marrow,” said Dr. Marie-Louise Fjällskog, M.D., Ph.D., Chief Medical Officer of Faron. “These observations support the potential for synergy of bexmarilimab in combination with standard of care. In addition, patient recruitment has started in the first-line triplet therapy with bexmarilimab, azacitidine and venetoclax in newly diagnosed acute myeloid leukemia patients deemed unsuitable for conventional chemotherapy. “

This and other earlier data will be shared with the current BEXMAB study group and potential new US study site investigators who will convene for the 64th American Society for Hematology (ASH) meeting in New Orleans, Louisiana from December 10-13, 2022.

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

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, Financing and Investor Relations

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, bexmarilimabtargets 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 myelodysplastic 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.

221204 ASH 2022 Final

Faron Pharmaceuticals Ltd.

(“Faron or “Company”)

Faron Appoints Maija Hollmén, Ph.D., as Chief Scientific Officer

Company announcement, December 1, 2022, at 02:00 AM (EST) / 07:00 AM (GMT) / 09:00 AM (EET)

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 macrophage immunotherapy, today announces the appointment of Faron Co-founder Maija Hollmén, Ph.D., as Chief Scientific Officer.

In her new role, Dr. Hollmén will oversee preclinical and support clinical development for Faron. Her priority will be the further development of bexmarilimab, Faron’s wholly owned, novel precision cancer immunotherapy candidate. Bexmarilimab is currently being evaluated for safety and efficacy in a Phase I/II clinical trial, in combination with standard of care (SoC), in aggressive hematological malignancies including acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The potential therapy has already achieved a strong safety and overall survival benefit profile in the Phase I/II MATINS trial as a monotherapy in late-stage solid tumors.

“Dr. Hollmén is the world-leading expert on CLEVER-1 biology and Clever-1-expressing tumor-associated macrophages,” said Marie-Louise Fjällskog, Chief Medical Officer of Faron. “Her support is essential to bexmarilimab’s development. Faron is pleased to have her on board in the Chief Scientific Officer role to bring her knowledge of the target molecule and develop it further.”

Dr. Hollmén is an Adjunct Professor of Tumor Immunology on the Faculty of Medicine at the University of Turku in Finland, as well as a Principal Investigator. Dr. Hollmén earned both her PhD and MSc degrees from the University of Turku.

“I am excited to join the team at Faron as we work to advance bexmarilimab’s development for the treatment of advanced cancers,” said Dr. Hollmén. “I am inspired by the possibility to make a difference for patients who have no other options and to be part of the pioneering work Faron is currently doing in developing next-generation immunotherapies.”

Dr. Hollmén’s post-doctoral studies were conducted at ETH Zurich alongside Professor Michael Detmar, focusing on tumor immunology and how cancer cells educate macrophages to support tumor growth. Dr. Hollmén returned to Turku and formed her own laboratory to develop strategies to resolve immunosuppressive cells and pathways and during this time, concentrated working on CLEVER-1.

For more information please contact:

Media Contact

Faron Pharmaceuticals

Jennifer Smith-Parker

Head of Communications

Jennifer.Smith-Parker@faron.com

Consilium Strategic Communications

David Daley, Lindsey Neville

faron@consilium-comms.com

Phone: +44 (0)20 3709 5700

Investor Contact

Faron Pharmaceuticals

Julia Balanova

VP, Investor Relations

Julia.balanova@faron.com

investor.relations@faron.com

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

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. 

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.

Faron Appoints Maija Hollmén PhD as Chief Scientific Officer 011222

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

julia.balanova@faron.com

investor.relations@faron.com

Phone: +1 (917) 306-6096

Media Contact

Faron Pharmaceuticals

Jennifer Smith-Parker

Head of Communications

jennifer.smith-parker@faron.com

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@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.

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