Grant of options

Faron Pharmaceuticals Ltd.

(“Faron” or “the Company”)

Grant of options

Company announcement, August 30, 2024

TURKU, FINLAND – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on tackling cancers via novel immunotherap ies , today announces that the Company’s board has confirmed the grant of a total of 100,000 options over new ordinary shares in the Company (“Options”) under the Company’s Share Option Plan 2019. The Options have been allocated under the Share Option Plan 2019 and are exercisable between August 26, 2025 and August 26, 2028, vesting 25% per annum over four years. The exercise price for the 100,000 Options allocated under the Option Plan 2019 is €1.48 per share, which is calculated based on the 90-day average price of the Shares prior to the Grant Date.

The terms of the Share Option Plan 2019 are available on the Company’s website at https://www.faron.com/sites/faron-corp/files/faron/investor/general-meeting/2023/annex-1-amended-option-plan-2019.pdf .

The granted 100,000 Options entitle the option holders to subscribe for a total of 100,000 new ordinary shares in the Company, if exercised in full, and represent 0.1 % 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 other persons discharging managerial responsibilities (“PDMRs”):

Other PDMR

Petri Bono

100,00

Total other PDMRs

100,000

For the purposes of MAR and UK MAR, the person responsible for arranging for the release of this announcement on behalf of Faron is Juho Jalkanen, Chief Executive Officer.

For more information please contact:

ICR Consilium
Mary-Jane Elliott, David Daley, Lindsey Neville
Phone: +44 (0)20 3709 5700
E-mail:
  faron@consilium-comms.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

About BEXMAB

The BEXMAB study is an 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 (azacitidine) treatment. 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 bexmarilimab

Bexmarilimab is Faron’s wholly owned, investigational immunotherapy designed to overcome resistance to existing treatments and optimize clinical outcomes, by targeting myeloid cell function and igniting the immune system. Bexmarilimab binds to Clever-1, an immunosuppressive receptor found on macrophages leading to tumor growth and metastases (i.e. helps cancer evade the immune system). By targeting the Clever-1 receptor on macrophages, bexmarilimab alters the tumor microenvironment, reprogramming macrophages from an immunosuppressive (M2) state to an immunostimulatory (M1) one, upregulating interferon production and priming the immune system to attack tumors and sensitizing cancer cells to standard of care.

About Faron Pharmaceuticals Ltd

Faron (AIM: FARN, First North: FARON) is a global, clinical-stage biopharmaceutical company, focused on tackling cancers via novel immunotherapies. Its mission is to bring the promise of immunotherapy to a broader population by uncovering novel ways to control and harness the power of the immune system. The Company’s lead asset is bexmarilimab, a novel anti-Clever-1 humanized antibody, with the potential to remove immunosuppression of cancers through reprogramming myeloid cell function. Bexmarilimab is being investigated in Phase I/II clinical trials as a potential therapy for patients with hematological cancers in combination with other standard treatments. Further information is available at www.faron.com .

Notification of a Transaction pursuant to Article 19(1) of Regulation (EU) No. 596/2014

1

Details of the person discharging managerial responsibilities/person closely associated

a.

Name

Petri Bono

2

Reason for notification

a.

Position/Status

Person discharging managerial responsibilities/person closely associated

b.

Initial notification/

Amendment

Initial notification

3

Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor

a.

Name

Faron Pharmaceuticals Oy

b.

LEI

7437009H31TO1DC0EB42

4

Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducted

a.

Description of the financial instrument, type of instrument

Identification Code

Options over new ordinary shares

ISIN: FI4000153309

b.

Nature of the transaction

Grant of options made pursuant to the Faron 2019 Option Plan

c.

Price(s) and volume(s)

Exercise Price(s)

Volume(s)

€1.48

100,000

d.

Aggregated information

– Aggregated Volume

– Price

N/A

e.

Date of the transaction

26 August 2024

f.

Place of the transaction

Turku

Faron 2024 Half-Year Financial Results

Faron Pharmaceuticals Ltd.

(“Faron” or “the Company”)

Faron Reports Half-Year Financial Results, 1 January – 30 June 2024

Company Announcement, 27 August 2024

Summary Highlights  

·      Initial preliminary phase II data read-out from the BEXMAB trial confirmed earlier positive phase I findings in myelodysplastic syndrome (MDS) patients that have failed with hypomethylating agent (HMA) , reinforcing bexmarilimab’s potential to improve the therapeutic benefit for patients with aggressive hematological malignancies who do not respond to the current standard of care (SoC).   

·      The Company reported that there was a total of 14 HMA-failed MDS patients who had been treated in both the phase I and II arms of the BEXMAB trial with a combination of bexmarilimab and azacitidine, with an overall response rate (ORR) of 79% (11/14). For The BEXMAB Phase I MDS patients with prior HMA failure with adequate follow-up available the estimated median overall survival (mOS) was 13.4 months compared to the 5-6 months that would typically be expected under standard of care historically.

·      Dr. Juho Jalkanen was appointed as Faron’s new Chief Executive Officer, Mr. Tuomo Pätsi was elected as the Chair of the Board.

·      Faron founders and bexmarilimab developers, Dr. Markku Jalkanen and Dr. Sirpa Jalkanen, were selected as finalists for the European Inventor Award 2024.

·      Cash position was strengthened through a convertible loan issuance and two share placements successfully raising a total of EUR 35.5 million (gross).

·      Hybrid briefing and Q&A to be held tomorrow on 28 August 2024, at 8:00 am (EST) / 1:00 pm (BST) / 3:00 pm (EEST).

Post period events

·      The U.S. Food and Drug Administration ( FDA) granted bexmarilimab Fast Track Designation (FTD) for the treatment of relapsed or refractory myelodysplastic syndrome (r/r MDS) in combination with azacitidine.

·      The Company announced positive feedback from the FDA regarding the registrational clinical development plan for bexmarilimab for the treatment of higher-risk (HR) MDS, with a recommendation that the Company conducts a confirmatory phase III study in frontline HR MDS, without requiring a separate phase III in the relapsed / refractory setting, and accelerated approval for r/r MDS could be achieved with an interim read-out of the confirmatory phase III study .

·      Dr. Petri Bono was appointed Chief Medical Officer and Mr. Yrjö Wichmann was appointed as permanent Chief Financial Officer.

TURKU, FINLAND Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on tackling cancers via novel immunotherapies, today announces unaudited half-year financial results for 1 January to 30 June 2024 (the period ).

“After a tough start we have ended the first half of 2024 in a very strong position ,” said Dr. Juho Jalkanen, Chief Executive Officer of Faron. “We’ve continued to make significant progress in the clinical development of bexmarilimab, our wholly owned immunotherapy asset, in hematological malignancies, building on the highly encouraging data and regulatory feedback reinforcing our belief in the potential of bexmarilimab to address a very important clinical need. Our meeting with the FDA to discuss the registrational clinical development plan for bexmarilimab was highly favorable, with a proposal that significantly reduces development costs and timelines to bring bexmarilimab therapy to all HR MDS patients in an accelerated fashion .”

“Despite some financial challenges earlier in the year, we have significantly strengthened our balance sheet and are now in a strong position.  Everything is progressing as planned and our focus is to ensure that we are armed with adequate resources to be able to meet our objectives of completing Phase II of the BEXMAB trial and optimizing the outcome of partnering with Phase II data.  There remains an urgent unmet medical need for new treatment options for MDS patients, and we are committed t o rapidly advancing bexmarilimab through clinical development, to bring it to patients as soon as possible.”

Pipeline Highlights

Bexmarilimab Faron’s wholly-owned, novel precision cancer immunotherapy candidate, in phase I/II development for difficult-to-treat hematological and solid tumor cancers.

·      The BEXMAB phase I results have already indicated a high ORR of 87.5% (7/8) amongst HMA-failed MDS patients treated with a combination of bexmarilimab and azacitidine, and the study progressed into Phase II in this population.

·      There was a total of 14 HMA-failed MDS patients treated in both phase I and II with this novel combination by May 2024.

·      The ORR in this otherwise untreatable population was 79% (11/14). The current true remission rate was 64% (9/14).

·      For The BEXMAB phase I MDS patients with prior HMA failure with adequate follow-up available the estimated mOS was 13.4 months compared to the 5-6 months that would typically be expected under standard of care historically.

·      Further analysis of the patient profiles of the BEXMAB trial showed that patients had experienced disease progression following previous treatment with azacitidine monotherapy or combinations of up to four therapies that included azacitidine or decitabine with magrolimab, venetoclax and sabatolimab.

Corporate Highlights

·      The cash position has been significantly strengthened through a combination of a convertible note issuance, private placements directed to institutional and other investors, a public offering to Finnish retail investors and an open offering to UK retail and institutional investors to raise a total of EUR 35.5 million.

·      Dr. Juho Jalkanen was appointed as the Company’s new Chief Executive Officer (CEO), taking over from Dr. Markku Jalkanen, who retired as CEO, but who is continuing as a member of the Board of Directors of Faron. Dr. Juho Jalkanen has worked at Faron in various roles since 2006, most recently serving as its Chief Operating Officer.

·      Mr. Tuomo Pätsi was elected as the Chair of the Board, following the departure of Dr. Frank Armstrong who did not stand for re-election. Mr. Pätsi was the President of the EMEA region and Worldwide Markets for Celgene Corporation, a global pharmaceutical company and currently wholly owned subsidiary of Bristol Myers Squibb, engaged primarily in the discovery, development, and commercialization of therapies for the treatment of cancer. He is an experienced biotech and pharmaceutical executive who was, until recently, the Executive Vice President for Seagen Inc., a US-based, cancer-focused biotechnology company.

·      Mr. Yrjö Wichmann was appointed as the Company’s interim Chief Financial Officer (CFO, Int.)  Mr. Wichmann previously served as the Company’s CFO between 2014 and 2019 and as Senior Vice President, Financing & IR from 2019 to April 2024. Mr. Wichmann is an accomplished biotech and financial executive with over 20 years’ experience in financing and investment banking. In August 2024, Mr. Wichmann was appointed as the Company’s permanent Chief Financial Officer.

·      Dr. Markku Jalkanen, co-founder, Board member and former CEO of Faron, and Dr. Sirpa Jalkanen, co-founder and member of Faron’s Scientific Advisory Board, were selected as finalists for the European Inventor Award 2024, in recognition of their research developing Faron’s wholly owned precision cancer immunotherapy candidate, bexmarilimab.

Financial highlights

·      On 19 February 2024 the Company announced that it was in breach of several undertakings agreed in the secured debt agreement dated 28 February 2022, between IPF Fund II SCA, SICAV-FIAR (“IPF”) as Lender and Faron Pharmaceuticals Ltd as Borrower and subsequent waiver letters provided by IPF, and was therefore in several events of default. Faron’s bank accounts are pledged to IPF and IPF notified Faron’s banks of the blocking of the pledged accounts due to the above-mentioned breaches. After successful funding arrangements, the bank accounts were released in the beginning of March 2024.

·      On 4 March 2024 the Company raised a total of   EUR 3.2 million through convertible loan instruments subscribed by a limited number of the Company’s existing shareholders. The Convertible loans and related interest and fees were converted into shares in the June offering.

·      On 4 April 2024 the Company conducted a private placement directed to a limited number of institutional and other investors to raise EUR 4.8 million which, together with the EUR 3.2 million convertible loan announced on 4 March 2024, secured the required short-term bridge financing totaling EUR 8 million.

·      On 4 June 2024 Faron announced an offering of approximately EUR 30.7 million in total by offering for subscription preliminarily a maximum of 30,714,592 new and/or treasury shares at a subscription price of EUR 1.00 per Offer Share. The Offering was conducted as a directed share issue by way of

i.      a public offering to private individuals and legal entities in Finland,

ii.     an institutional offering to institutional investors in the European Economic Area.

iii.    a separate open offer to qualifying holders of depositary interests in the United Kingdom and elsewhere and

iv.    a separate retail offer to retail investors in the United Kingdom on the “REX” platform.

The results of the offering were announced on 20 June 2024, and it attracted significant interest from both existing shareholders and new investors and was oversubscribed. T he Company raised a total of approximately   EUR 30.7 million, of which approximately   EUR 3.7 million  was paid by converting the convertible loan and related arrangement fees and interests into shares in the Company. As a result of the share offering, with the   gross proceeds of approximately   EUR 27 million   the Company believes it will have sufficient resources to execute its core business and deliver on its key milestones of the year 2024 under the current business plan and in compliance with the financial covenants of the IPF Fund. The Board of Directors of the Company decided to issue of a total of 30,709,056 newly issued treasury shares and new shares in the Company. As set out in the terms and conditions of the Offering, existing shareholders and DI (depositary interest) holders were given an allocation preference. Carnegie Investment Bank AB, Finland Branch (“Carnegie”) and Peel Hunt LLP (“Peel Hunt”) acted as lead managers (the “Lead Managers”) and bookrunners for the Offering. On 20 June 2024 the Company entered into 90-day lock-up agreement with Lead Managers.

Post period events

·      The FDA granted bexmarilimab a Fast Track Designation (FTD) for the treatment of relapsed or refractory myelodysplastic syndrome (r/r MDS) in combination with azacitidine.

·      Faron received positive feedback from its formal Type D Scientific Advice Meeting with the FDA regarding the registrational clinical development plan for bexmarilimab in the treatment of HR MDS. The FDA acknowledged the difficulties of running a randomized study with a comparator in the r/r setting and instead proposed that Faron conduct a confirmatory phase III study in frontline high-risk MDS (HR MDS), that would not require a separate phase III in r/r MDS. Accelerated approval for r/r MDS could possibly be obtained with the existing phase II trial in addition to an interim read-out from the confirmatory phase III trial as per the FDA’s Project FrontRunner.

·      Dr. Petri Bono was appointed as the Company’s Chief Medical Officer (CMO), succeeding Dr. Birge Berns, who will continue her role as part of Faron’s medical leadership team involved in developing bexmarilimab. Dr. Bono is an oncologist and has served as the CMO and member of the Group executive team of Terveystalo, the largest private healthcare service provider in Finland. Prior to joining Terveystalo he was the CMO at Helsinki University Hospital. He brings leading expertise in immunology, with his own research focusing on molecular and immunological oncology.

·      Mr. Yrjö Wichmann was appointed as the Company’s Chief Financial Officer (CFO), having served as Faron’s interim CFO since April 2024.

Half-Year Financial Results

·      Cash balances of EUR 30.0 million on June 30, 2024 (2023: EUR 6.3 million).

·      Operating loss of EUR 11.3 million for the six months ended June 30, 2024 (2023: EUR 12.8 million).

·      Net assets of EUR 1.4 million on June 30, 2024 (2023: EUR -9.5 million).

·      The cash position has been strengthened with a convertible loan issuance and two share placements successfully raising a total of EUR 35.5 million (gross)

·      On June 30, 2024, the Company had outstanding borrowings of EUR 8.9 million under a loan facility with IPF which is subject to financial covenants. The Company is required to satisfy these agreed covenants including the requirement to maintain a minimum cash balance of EUR 6.0 million while maintaining three months cash runway. On 30 June 2024, and 27 August 2024, the Company was in compliance with all covenants while holding cash balances of EUR 30.0 million. The cash held by the Group together with known receivables will be sufficient to support the current level of activities until the end of Q1 2025.

Consolidated key figures, IFRS

 EUR’000

Unaudited

Unaudited     

Audited

1-6/2024

1-6/2023

1-12/2023

6 months

6 months

                12 months

Revenue

0

0

0

Other operating income

0

0

0

Research and Development expenses

(6 662)

(8 518)

(19 542)

General and Administrative expenses

(4 628)

(4 294)

(9 026)

Loss for the period

(14 395)

(13 730)

(30 944)

Unaudited

Unaudited

Audited

1-6/2024

1-6/2023

1-12/2023

6 months

6 months

                12 months

Loss per share, EUR

(0.20)

(0.22)

(0.48)

Number of shares at end of period

104 624 864

66 161 373

68 786 699

Average number of shares

70 452 291

62 985 028

65 055 036

 EUR’000

Unaudited

Unaudited

Audited

30 Jun 2024

30 Jun 2023

31 Dec 2023

Cash and cash equivalents

29 979

6 315

6 875

Equity

1 379

(9 483)

(15 160)

Balance sheet total

35 460

12 836

10 220

Conference call information

A hybrid briefing and Q&A session for investors, analysts and media will be hosted by Dr. Juho Jalkanen, Chief Executive Officer, and Yrjö Wichmann, Chief Financial Officer, tomorrow 28 August 2024, at 8:00 am (EST) / 1:00 pm (BST) / 3:00 pm (EEST).

Webcast registration link: https://faron.videosync.fi/q2-2024

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

For more information please contact:

Investor Contact
Faron Pharmaceuticals
E-mail:
investor.relations@faron.com

ICR Consilium
Mary-Jane Elliott, David Daley, Lindsey Neville
Phone: +44 (0)20 3709 5700
E-mail:  
faron@consilium-comms.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

About Bexmarilimab

Bexmarilimab is Faron’s wholly owned, investigational immunotherapy designed to overcome resistance to existing treatments and optimize clinical outcomes, by targeting myeloid cell function and igniting the immune system. Bexmarilimab binds to Clever-1, an immunosuppressive receptor found on macrophages leading to tumor growth and metastases (i.e. helps cancer evade the immune system). By targeting the Clever-1 receptor on macrophages, bexmarilimab alters the tumor microenvironment, reprogramming macrophages from an immunosuppressive (M2) state to an immunostimulatory (M1) state, upregulating interferon production and priming the immune system to attack tumors and sensitizing cancer cells to standard of care.

About BEXMAB

The BEXMAB study is an 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 (azacitidine) treatment. 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 Ltd.

Faron (AIM: FARN, First North: FARON) is a global, clinical-stage biopharmaceutical company, focused on tackling cancers via novel immunotherapies. Its mission is to bring the promise of immunotherapy to a broader population by uncovering novel ways to control and harness the power of the immune system. The Company’s lead asset is bexmarilimab, a novel anti-Clever-1 humanized antibody, with the potential to remove immunosuppression of cancers through reprogramming myeloid cell function. Bexmarilimab is being investigated in Phase I/II clinical trials as a potential therapy for patients with hematological cancers in combination with other standard treatments. 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”, ”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 Company’s current expectations and assumptions regarding the completion and use of proceeds from the Offering, 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 Company’s current beliefs and assumptions and are based on information currently available to the Company.

A number of factors could cause actual results to differ materially from the results and expectations dis-cussed 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 Company believes 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.

Chairman and Chief Executive Officer’s Review

Introduction

Following a challenging spring, Faron has ended the first half of 2024 in a very strong position, both financially and from a clinical development perspective. We’ve continued to see extremely encouraging data from our ongoing BEXMAB trial and now, with adequate resources secured, we can fully commit and concentrate on our most important task of progressing bexmarilimab through phase II trials in order to bring this important treatment to market, and to patients, as quickly as possible.

Bexmarilimab

Driving the clinical development of bexmarilimab continues to be Faron’s top priority. We reached a significant milestone in January this year when we dosed the first patient in phase II of the BEXMAB trial which is evaluating the safety and efficacy of bexmarilimab, in combination with SoC in patients with HMA r/r MDS, an aggressive myeloid leukemia with very few treatment options. We have continued to make good progress in the trial and in May this year, we announced initial positive phase II data, confirming our earlier positive phase I findings.

The BEXMAB phase I results had already indicated a high overall response rate (ORR) of 87.5% (7/8) amongst HMA-failed MDS patients treated with a combination of bexmarilimab + azacitidine. In May there were a total of 14 HMA-failed MDS patients treated in both phase 1 & 2 with this novel combination. The treatment has been well tolerated, without any dose-limiting toxicity. The ORR in this otherwise untreatable population is 79% (11/14). The current true remission rate is 64% (9/14). Similar size patient cohorts treated with existing alternatives have reported 0-20% ORR, without deep and durable remissions. For phase I patients with adequate follow-up available the estimated median overall survival (mOS) in May to be 13.4 months, which is still subject to change.

R/r MDS represents a significant therapeutic challenge and, based on the data gathered to date, we believe that bexmarilimab has the potential to fill a very important clinical gap and save and improve the lives of HMA-failed MDS patients.

Post period, we were particularly pleased to announce the outcome of our formal Type D Scientific Advice Meeting with the FDA regarding the registrational study plan for bexmarilimab in r/r HR MDS. Given the previously reported promising trial results, Faron had proposed to move into a randomized registrational phase III study for the treatment of r/r MDS using bexmarilimab + azacitidine against the investigator’s choice of a HMA. Instead, given the encouraging efficacy already seen in both frontline and r/r HR MDS and the well-established safety profile of bexmarilimab, the FDA proposed that after the ongoing phase II BEXMAB study in r/r MDS, Faron should move directly into a registrational blinded randomized frontline HR MDS study investigating bexmarilimab + azacitidine against placebo + azacitidine.

Subject to continued positive results, the FDA’s feedback means that a separate phase III in r/r MDS would not be required and Faron’s ongoing BEXMAB phase II study could be the registrational trial for patients with r/r MDS.  

This highly positive feedback exceeded our expectations, and we are now adjusting our development plan accordingly. The FDA’s proposal significantly reduces development costs and timelines to bring bexmarilimab therapy to all HR MDS patients, and underlines the high unmet need in HR MDS, a condition for which new treatment options are urgently needed.

We have made a number of changes to our leadership team and Board during the period, including the appointment of a new CEO and Chairman, and post-period CMO and CFO, building and strengthening the existing strong track record of the team, bringing leading expertise to support the Company’s continued progress. We would like to extend our deep gratitude to Dr. Markku Jalkanen, who retired as CEO earlier this year. Under his leadership, Faron has grown significantly, and we would like to acknowledge his efforts and commitment in progressing bexmarilimab through the clinic.

Financial review

Statement of comprehensive income

The operating loss for the six months ended 30 June 2024, was EUR 11.3 million (six months ended 30 June 2023: loss of EUR 12.8 million). No revenue was generated during the period or prior period. Research and development expenses decreased by EUR 1.8 million to EUR 6.7 million (2023: EUR 8.5 million). General and administrative expenses increased by EUR 0.3 million to EUR 4.6 million (2023: EUR 4.3 million).

The loss for the period was EUR 14.4 million (2023: loss of EUR 13.7 million) and the basic and diluted loss per share was EUR 0.20 (2023: loss per share of EUR 0.22).

Statement of financial position and cash flows

As of 30 June 2024, net assets amounted to EUR 1.4 million (30 June 2023: EUR -9.5 million). The net cash flow for the first six months in 2024 was EUR 23.1 million (2023: EUR -0.7 million). As of 30 June 2024, total cash and cash equivalents held were EUR 30.0 million (2023: EUR 6.3 million).

Corporate

Faron’s Annual General Meeting (AGM) was held on 5 April 2024 in Turku. The AGM adopted the financial statements of the Company and re-elected audit firm PricewaterhouseCoopers Oy (“PwC”) as the Company’s auditor. Additionally, the number of members of the Board was confirmed as five. Tuomo Pätsi, Markku Jalkanen, John Poulos, Marie-Louise Fjällskog and Christine Roth were re-elected to the Board for a term that ends at the end of the next AGM. The AGM also resolved to establish a Shareholders’ Nomination Board for the Company and its Charter as proposed by the Board was adopted. Authorization to the Board to decide on the issuance of twenty million shares, options or other special rights entitling to shares and conveyance of up to the same maximum number of treasury shares in the possession of the Company was granted to the Board. This authorization remains valid until 30 June 2025. In addition, the AGM authorized the Board to resolve on issuances of shares in connection with a larger share issuance, which authorization contains the right to issue new shares or dispose of the Company’s own shares in the possession of the Company in the amount on thirty million. This authorization was utilized in June when the Company organized a public offer of its shares.

Summary & outlook

During the remainder of 2024, our focus continues to be the progression of bexmarilimab through clinical development.  We are looking forward to reporting further data from the ongoing phase II part of the BEXMAB trial in H2.  We are also adjusting our clinical development plan for bexmarilimab following feedback from the FDA, and we will announce further details on that in due course. We are also actively continuing discussions with potential partners to take  bexmarilimab into phase III and approval.

On behalf of the Board, we would like to thank our shareholders, existing and new, for their support of Faron. We would also like to thank our employees for their continued commitment to our mission and the patients we serve. We look forward to updating the market on our progress throughout the course of the year.

Dr. Juho Jalkanen

Chief Executive Officer

Mr. Tuomo Pätsi

Chairman

Consolidated Income Statement, IFRS

EUR’000

Unaudited

1-6/2024

6 months

Unaudited

1-6/2023

6 months          

Audited

1-12/2023

12 months

Revenue

0

0

0

Other operating income

0

0

0

Research and development expenses

(6 662)

(8 518)

(19 542)

General and administrative expenses

(4 628)

(4 294)

(9 026)

Operating loss

(11 290)

( 12 812)

(28 568)

Financial income

1 292

0

233

Financial expense

(4 350)

(918)

(2 609)

Loss before tax

(14 349)

(13 730)

( 30 944)

Tax expense

-46

(0)

0

Loss for the period

(14 395)

(13 730)

(30 944)

Translation difference

11 

0

2

Comprehensive loss for the period attributable to the equity holders of the Parent company

(14 384)

(13 730)

(30 942)

Loss per ordinary share

Basic and diluted loss per share, EUR

(0.20)

(0.22)

(0.48)

Consolidated Balance Sheet, IFRS

EUR’000

Unaudited

Unaudited

Audited

31 Dec 2023

30 Jun 2024

30 Jun 2023

Assets

Non-current assets

Machinery and equipment

3

10

6

Right-of-use-assets

344

272

198

Intangible assets

1 086

1 127

1 088

Prepayments and other receivables

60

60

60

Total non-current assets

1 494

1 469

1 352

Current assets

Prepayments and other receivables

3 987

5 052

1 992

Cash and cash equivalents

29 979

6 315

6 875

Total current assets

33 966

11 367

8 868

Total assets

35 460

12 836

10 220

EUR’000

Unaudited

Unaudited

Audited

31 Dec 2023

30 Jun 2024

30 Jun 2023

Capital and reserves attributable to the equity holders of the Parent company

Share capital

2 691

2 691

2 691

Reserve for invested unrestricted equity

184 866

144 778

154 352

Accumulated deficit

(186 181)

(156 955)

(172 208)

Translation difference

3

2

4

Total equity

1 379

(9 483)

(15 160)

Provisions

Other provisions

0

0

0

Total provisions

0

0

0

Non-current liabilities

Borrowings

8 706

10 892

9 423

Lease liabilities

239

163

50

Other liabilities

1 643

702

895

Total non-current liabilities

10 588

11 757

10 369

Current liabilities

Borrowings

3 672

2 304

3 475

Lease liabilities

105

119

163

Trade payables

17 473

6 002

8 971

Accruals and other current liabilities

2 243

2 137

2 403

Total current liabilities

23 493

10 562

15 012

Total liabilities

34 081

22 319

25 380

Total equity and liabilities

35 460

12 836

10 220

Consolidated Statement of Changes in Equity, IFRS

EUR’000

Share capital

Reserve for invested unrestricted equity

Translation difference

Accumulated deficit

Total equity

Balance as at
31 December 2022 (Audited)

2 691

129 544

2

(143 713)

(11 476)

Comprehensive loss for the last six months 2023

0

0

0

(13 730)

(13 730)

Transactions with equity holders of the Parent company

Issue of ordinary shares

0

15 233

0

0

15 233

Share-based compensation

0

0

0

489

489

0

15 233

0

(13 241)

1 992

Balance as at 30 June 2023 (Unaudited)

2 691

144 778

2

(156 955)

(9 483)

Comprehensive loss for the year 2023

0

0

2

(30 944)

(30 942)

Transactions with equity holders of the Company

Issue of ordinary shares, net of transaction costs

0

24 808

0

0

24 808

Share-based compensation

0

0

0

2 450

2 450

0

24 808

2

(28 494)

(3 684)

Balance as at
31 December 2023 (Audited)

2 691

154 352

4

(172 208)

(15 160)

Comprehensive loss for the last six months 2024

0

0

11

(14 395)

(14 384)

Transactions with equity holders of the Company

Issue of ordinary shares, net of transaction costs

0

30 514

0

0

30 514

Share-based compensation

0

0

0

369

369

0

30 514

11

(14 026)

16 499

Balance as at 30 June 2024 (Unaudited)

2 691

184 866

15

(186 234)

1 338

Consolidated Cash Flow Statement, IFRS

€’000

Unaudited

1-6/2024

6 months

Unaudited

1-6/2023

6 months

    Audited

1-12/2023

12 months

Cash flow from operating activities

Loss before tax

(14 349)

(13 730)

(30 944)

Adjustments for:

Received grants

0

(0)

(33)

Depreciation and amortization

158

174

346

Change in provision

0

(158)

(158)

Financial items

3059

918

2376

Tax expense

0

0

0

Share-based compensation

369

489

2450

Adjusted loss from operations before changes in working capital

(10 764)

(12 308)

(25 963)

Change in net working capital:

Prepayments and other receivables (increase -)

(2 127)

1 028

300

Trade payables (increase +)

5 557

(8)

2 994

Other liabilities (increase +)

(593)

(272)

(50)

Cash used in operations

(7 926)

(11 561)

(22 719)

Income taxes paid

(150)

0

0

Transaction costs related to loans and borrowings

0

0

(0)

Interest received

0

0

243

Interest paid

(617)

(782)

(1 330)

Net cash used in operating activities

(8 693)

(12 343)

(23 806)

Cash flow from investing activities

Payments for intangible assets

(123)

(68)

(123)

Payments for tangible assets

0

0

(0)

Net cash used in investing activities

(123)

(68)

(123)

Cash flow from financing activities

Proceeds on issue of shares

35 500

12 077

26 031

Share issue transaction cost

(498)

(648)

(1 190)

Proceeds from borrowings

3 200

64

64

Repayment of borrowings

(5 314)

0

(861)

Transaction and structuring fees of borrowings

(750)

0

(400)

Proceeds from grants

(28)

382

481

Payment of lease liabilities

(337)

(84)

(142)

Net cash from financing activities

31 773

11 791

23 983

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

23 103

(675)

(114)

Effect of exchange rate changes

(145)

(55)

(168)

Cash and cash equivalents at 1 January

6 876

6 990

6 990

Cash and cash equivalents at the end of period

29 979

6 315

6 876

Notes to the interim financial report

1.   Corporate information

Faron Pharmaceuticals Ltd (the “Company”) is a clinical stage biopharmaceutical company incorporated and domiciled in Finland, with its headquarters at Joukahaisenkatu 6, 20520 Turku, Finland. The Company currently has a pipeline based on the endothelial receptors involved in regulation of immune response, in oncology and organ damage.

The Company has been listed on the London Stock Exchange’s AIM market since November 17, 2015, with a ticker FARN, and since December 3, 2019, the Company has been listed on the Nasdaq First North Growth Market with a ticker FARON.

2.   Summary of significant accounting policies

 

2.1.   Basis of preparation

The unaudited H1 interim financial report has been prepared in accordance with the International Financial Reporting Standards of the International Accounting Standards Board (IASB) and as adopted by the European Union (IFRS) and the interpretations of the International Financial Reporting Standards Interpretations Committee (IFRIC) .


The principal accounting policies applied in the preparation of these interim financial report is set out below. The Company has consistently applied these policies to all the periods presented, unless otherwise stated. The areas of the report involving a higher degree of judgment or complexity, or areas where assumptions and estimates are significant to the interim financial report, are disclosed in note 2.21 of the Financial Statement of 2023 Annual Report. 


The unaudited interim financial report incorporates the parent company, Faron Pharmaceuticals Ltd, and all subsidiaries (the “Group”).


All amounts are presented in thousands of euros, unless otherwise indicated, rounded to the nearest euro thousand.

2.2.      Going concern

The Group has forecasted its estimated cash requirements over the next twelve months. To make these forecasts the Group has made a number of assumptions regarding the quantity and timing of future expenditure and income as well as other key factors. Though these estimates have been made with caution and care, they continue to contain a significant amount of uncertainty. The Group also has debt obligations which carry financial covenants that could adversely impact the Group’s liquidity and operating flexibility. Based on the forecast the Group believes that it has adequate financial resources to continue its operations until the year end of 2024.   

The Group has taken several actions to secure further financing. The Directors believe that the Group can gain access to further resources to sustain operations over the next 12 months. Therefore, this unaudited financial report has been prepared on a going concern basis. At this stage the Group cannot disclose any of these options.

Because the additional finance is not committed at the date of issuance of this H1 2024 report, these circumstances represent a material uncertainty that may cast significant doubt on the Group’s ability to continue as a going concern. Should the Group be unable to obtain further finance such that the going concern basis of preparation were no longer appropriate, adjustments would be required, including to reduce balance sheet values of assets to their recoverable amounts, to provide for further liabilities that might arise.

2.3.      Financial covenants

At 30 June 2024, the Company had outstanding borrowings of EUR 8.9 million under a loan facility with IPF Partners which is subject to financial covenants. The financial covenants are minimum cash covenant and gross gearing covenant. The cash covenant obliges the to maintain a minimum cash balance of EUR 6.0 million while maintaining three months cash burn rate, historically or on forward looking basis. In May 2024 the Company agreed in advance with IPF a deviation to the required level of the minimum cash covenant until the end of October 2024. The gross gearing covenant (which may not exceed 25 per cent at any time) is calculated as the ratio of borrowings to market capitalisation and when determining the “borrowings”, the aggregate principal amount of the financial indebtedness of the group will be taken into account save for any financial indebtedness owed by a member of the group to another member of the group or R&D loans to Business Finland. The level of the minimum cash covenant is linked to the level of the gross gearing covenant so that it is either the three-month or six-month cash burn. At 30 June 2024 the Company was in compliance with all covenants while holding cash balances of EUR 30.3 million. The cash held by the Group together with known receivables will be sufficient to support the current level of activities until the end of Q1 2025.

3.   Subsequent events

In its meeting on 26 August 2024, the Board of Directors of the Company approved the publishing of this interim financial report.

FDA Grants Fast Track Designation for Bexmarilimab

Faron Pharmaceuticals Ltd.

(“Faron” or the “Company”)

Inside Information: FDA Grants Fast Track Designation for Bexmarilimab in r/r MDS

Company announcement, Inside Information, 26 August 2024 at 7:00 a.m. BST / 9:00 a.m. EEST

Key highlights

–      Given the strong data seen in Phase 1 and continuing in Phase 2 of Faron’s BEXMAB trial, the FDA has granted Fast Track Designation (FTD) for bexmarilimab for the treatment of r/r MDS

–      FTD further strengthens the bexmarilimab program by offering clinical development and commercialization benefits

TURKU, Finland – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company pursuing a CLEVER-1 receptor targeting approach to reprogramming myeloid cells to activate anti-tumor immunity in hematological and solid tumors, today announces that their lead candidate bexmarilimab has been granted Fast Track Designation for the treatment of relapsed or refractory myelodysplastic syndrome  (r/r MDS) in combination with azacitidine by the USA Food and Drug Administration (the FDA).

Fast Track Designation is granted by the FDA for products that are intended for the treatment of serious or life-threatening disease or conditions, which demonstrate the potential to address an unmet medical need. The designation offers the opportunity for frequent interactions with the FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval, as well as eligibility for rolling submission of a New Drug Application.

Given the previously reported promising results in both Phase 1 and 2 of Faron’s BEXMAB trial when treating r/r MDS patients using a combination of bexmarilimab and azacitidine to overcome primary or developed resistance to azacitidine, bexmarilimab has been granted Fast Track Designation subsequent to the accelerated development plan proposed by the FDA in July 2024. “This news highlights the urgency for new treatment options besides HMAs for the treatment of higher-risk MDS and solidifies our case that bexmarilimab can overcome resistance to HMAs”, says Dr. Juho Jalkanen CEO of Faron. Relapsed or refractory myelodysplastic syndrome is an aggressive and deadly form of blood cancer, for which there is very limited treatment option and a median survival of only 5-6 months. The standard of care for higher-risk MDS is azacitidine or another hypomethylating agent (HMA). Unfortunately, the majority of patients eventually relapse or are non-responsive to HMAs, which then leads to r/r MDS. Currently around 180,000 – 510,000 people globally live with an MDS diagnosis.

“r/r MDS is a serious life-threatening condition with limited treatment options and therefore highly significant unmet medical need. Our trial results to date in hypomethylating agent (HMA)-failed MDS have shown bexmarilimab’s efficacy to induce deep, clinically meaningful responses for these patients. This FDA Fast Track Designation significantly strengthens bexmarilimab’s position to become a new cornerstone treatment of r/r MDS and will facilitate the development of bexmarilimab for full market approval in r/r MDS. It also represents a significant additional recognition of the potential of myeloid cell reprogramming in overcoming resistance and activating immune system in the treatment of various hematological and solid tumors” says Dr. Bono, the CMO of Faron.

For more information please contact:

Investor Contact

Media Contact

ICR Consilium

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.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

About BEXMAB

The BEXMAB study is an open-label Phase 1/2 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 (azacitidine) treatment. 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 Bexmarilimab

Bexmarilimab is Faron’s wholly owned, investigational immunotherapy designed to overcome resistance to existing treatments and optimize clinical outcomes, by targeting myeloid cell function and igniting the immune system. Bexmarilimab binds to Clever-1, an immunosuppressive receptor found on macrophages leading to tumor growth and metastases (i.e. helps cancer evade the immune system). By targeting the Clever-1 receptor on macrophages, bexmarilimab alters the tumor microenvironment, reprogramming macrophages from an immunosuppressive (M2) state to an immunostimulatory (M1) one, upregulating interferon production and priming the immune system to attack tumors and sensitizing cancer cells to standard of care.

About Faron Pharmaceuticals Ltd.

Faron (AIM: FARN, First North: FARON) is a global, clinical-stage biopharmaceutical company, focused on tackling cancers via novel immunotherapies. Its mission is to bring the promise of immunotherapy to a broader population by uncovering novel ways to control and harness the power of the immune system. The Company’s lead asset is bexmarilimab, a novel anti-Clever-1 humanized antibody, with the potential to remove immunosuppression of cancers through reprogramming myeloid cell function. Bexmarilimab is being investigated in Phase I/II clinical trials as a potential therapy for patients with hematological cancers in combination with other standard treatments. 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.

Notice of Half-Year Financial Results

Faron Pharmaceuticals Ltd.

(“Faron” or the “Company”)

Faron Pharmaceuticals

Notice of Half-Year Financial Results

Company Announcement, 20 August 2024

TURKU, Finland Faron Pharmaceuticals Ltd (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company pursuing a CLEVER approach to reprogramming myeloid cells to activate anti-tumor immunity in hematological and solid tumor microenvironments, will report its unaudited half-year financial results for the six months ended June 30, 2024, on Tuesday, 27 August 2024 .

A live hybrid briefing and Q&A session for investors, analysts and media will be hosted by Dr. Juho Jalkanen, Chief Executive Officer, and Yrjö Wichmann, Chief Financial Officer, at 08:00 am (EDT) / 13:00 pm (BST) / 15:00 pm (EEST) on Wednesday, 28 August 2024.

Webcast registration link: https://faron.videosync.fi/q2-2024

Live participation

In addition to the webcast, there are a number of spaces available to attend the briefing in-person at Studio Eliel in Sanomatalo at Töölönlahdenkatu 2, Helsinki. To register, please contact

investor.relations@faron.com no later than 10:00 a.m. EEST on Monday, 26 August 2024. Please note that places are limited, and you will receive a separate email confirmation.

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

For more information please contact:

Investor Contact
Faron Pharmaceuticals
E-mail: investor.relations@faron.com

Media Contact

ICR Consilium

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail:  faron@consilium-comms.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

About BEXMAB

The BEXMAB study is an open-label Phase 1/2 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 (azacitidine) treatment. 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 Bexmarilimab

Bexmarilimab  is Faron’s wholly owned, investigational immunotherapy designed to overcome resistance to existing treatments and optimize clinical outcomes, by targeting myeloid cell function and igniting the immune system. Bexmarilimab binds to Clever-1, an immunosuppressive receptor found on macrophages leading to tumor growth and metastases (i.e. helps cancer evade the immune system). By targeting the Clever-1 receptor on macrophages, bexmarilimab alters the tumor microenvironment, reprogramming macrophages from an immunosuppressive (M2) state to an immunostimulatory (M1) one, upregulating interferon production and priming the immune system to attack tumors and sensitizing cancer cells to standard of care.

About Faron Pharmaceuticals Ltd.

Faron (AIM: FARN, First North: FARON) is a global, clinical-stage biopharmaceutical company, focused on tackling cancers via novel immunotherapies. Its mission is to bring the promise of immunotherapy to a broader population by uncovering novel ways to control and harness the power of the immune system. The Company’s lead asset is bexmarilimab, a novel anti-Clever-1 humanized antibody, with the potential to remove immunosuppression of cancers through reprogramming myeloid cell function. Bexmarilimab is being investigated in Phase I/II clinical trials as a potential therapy for patients with hematological cancers in combination with other standard treatments. 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.

Traumakine Research Collaboration and DoD Grant

Faron Pharmaceuticals Ltd.

(“Faron” or the “Company”)

Faron Announces Traumakine Research Collaboration and DoD Grant

Press release, 13 August 2024 at 7:00 a.m. BST / 9:00 a.m. EEST

TURKU, Finland – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company with its lead immune oncology program bexmarilimab, also pursuing induction of CD73 for organ protection, announces it has joined a research consortium that has received a Department of Defense (DoD) Grant to investigate the use of intravenous interferon beta (Traumakine Ò ) for the prevention of ischemia-reperfusion injury in battlefield victims when using a lifesaving torniquet for the prevention of excessive blood loss. The Study is named Resuscitation by Endothelial Stabilization and Targeted Oxygen Rescue (RESTOR) Platform for Battlefield Applications. Participating institutions are Duquesne University School of Pharmacy and Wake Forest Medical University Health Sciences.

As previously investigated under another DoD grant by the same team, Traumakine Ò was highly effective for limb salvage and prevention of systemic inflammation and organ damage when given at the time of placing the torniquet, but not when given later. In the current setting Traumakine Ò will be investigated when given as a preventative treatment prior to placing the torniquet, simulating a situation where operational units going into a mission would be pre-treated with Traumakine Ò before going into combat where injury could result in the need for a torniquet. The aim of Traumakine Ò in this setting would be to improve survival and limb salvage by attenuating ischemia-reperfusion injury if a torniquet was needed.

If the results of these upcoming pre-clinical experiments are positive, this could open an avenue for approval without extensive human clinical studies. In conditions where controlled clinical studies cannot be conducted, a drug could be approved by using pre-clinical studies simulating the intended use. As a widely used and well tolerated drug with a large amount of human exposure, interferon beta could potentially qualify as such a drug. Previous examples of such approvals also relate to defense, where the investigational drug cannot be tested in humans in the desired indication, but is proven to be safe in man while the efficacy is proven based on the mode of action and pre-clinical studies.

“We are very pleased to see the DoD’s continued support to this research group and the Traumakine Ò program. From our learnings from previous clinical trials with Traumakine Ò , we envision that the best outcomes with intravenous interferon beta can be achieved when the drug is used for the prevention, and not necessarily treatment, of systemic inflammation and organ damage. RESTOR is a pilot study to test Traumakine Ò in this preventative setting, and paid by the DoD, but if positive, it could bolster Traumakine’s Ò path to market in this setting, and the Company should consider investing further into the program or find a partner for it.” said Dr. Juho Jalkanen, Chief Executive Officer of Faron.

For more information on research collaboration, please visit: Duquesne Receives New $1.5 Million Grant to Expand Transplantation Research

For more information please contact:

Investor Contact

Media Contact

ICR Consilium

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.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

About Faron Pharmaceuticals Ltd.

Faron (AIM: FARN, First North: FARON) is a global, clinical-stage biopharmaceutical company, focused on tackling cancers via novel immunotherapies. Its mission is to bring the promise of immunotherapy to a broader population by uncovering novel ways to control and harness the power of the immune system. The Company’s lead asset is bexmarilimab, a novel anti-Clever-1 humanized antibody, with the potential to remove immunosuppression of cancers through reprogramming myeloid cell function. Bexmarilimab is being investigated in Phase I/II clinical trials as a potential therapy for patients with hematological cancers in combination with other standard treatments. 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.

Appointment of Chief Financial Officer

Faron Pharmaceuticals Ltd.

(“Faron” or the “Company”)

Appointment of Chief Financial Officer

Company announcement, 8 August 2024 at 2:00 a.m. EDT / 7:00 a.m. BST / 9:00 a.m. EEST

TURKU, FINLAND / BOSTON, MA   – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company pursuing a CLEVER approach to reprogramming myeloid cells to activate anti-tumor immunity in hematological and solid tumor microenvironments, today announces   the appointment of Yrjö Wichmann, Faron’s current interim Chief Financial Officer (CFO, int.), as the Company’s permanent Chief Financial Officer (CFO).

Mr. Wichmann has served as Faron’s interim CFO since April 2024, having previously served as the Company’s CFO between 2014 and 2019 and as Senior Vice President, Financing & IR 2019 to April 2024. He is an accomplished biotech and financial executive with over 20 years’ experience in financing and investment banking. Prior to his roles at Faron, Mr Wichmann held a number of senior positions within the life sciences and biotechnology sector at IP Finland Oy, Biohit Oyj (NASDAQ OMX Helsinki), CapMan Oyj, FibroGen Europe Oyj (NASDAQ) and D. Carnegies & Co AB. He is a member of the Investment Committee at Dasos Timberland Fund I and II and a board member at Nordic Science Investment Oy investment fund. Mr Wichmann holds a Master’s in Economics from Helsinki University.  

“Mr. Wichmann has played a pivotal role in the financial turnaround of the Company over the past months. I am very pleased to see his continued dedication to the Company and I am looking forward to working alongside him as we continue to advance bexmarilimab through clinical development in order to bring this very promising therapy to patients as soon as possible, whilst also delivering value to investors” said Chief Executive Officer of Faron, Dr. Juho Jalkanen.

Mr. Wichmann, incoming Chief Financial Officer, said: “I am thrilled to be appointed as permanent CFO of Faron and deeply honored by the confidence shown to me by the Board. Faron is entering a very exciting phase and I’m looking forward to continuing to participate in the Company’s development under Juho’s new leadership.”

For more information please contact:

Investor Contact
Faron Pharmaceuticals
E-mail: investor.relations@faron.com

Media Contact

ICR Consilium

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.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

About BEXMAB

The BEXMAB study is an open-label Phase 1/2 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 (azacitidine) treatment. 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 Bexmarilimab

Bexmarilimab is Faron’s wholly owned, investigational immunotherapy designed to overcome resistance to existing treatments and optimize clinical outcomes, by targeting myeloid cell function and igniting the immune system. Bexmarilimab binds to Clever-1, an immunosuppressive receptor found on macrophages leading to tumor growth and metastases (i.e. helps cancer evade the immune system). By targeting the Clever-1 receptor on macrophages, bexmarilimab alters the tumor microenvironment, reprogramming macrophages from an immunosuppressive (M2) state to an immunostimulatory (M1) one, upregulating interferon production and priming the immune system to attack tumors and sensitizing cancer cells to standard of care.

About Faron Pharmaceuticals Ltd.

Faron (AIM: FARN, First North: FARON) is a global, clinical-stage biopharmaceutical company, focused on tackling cancers via novel immunotherapies. Its mission is to bring the promise of immunotherapy to a broader population by uncovering novel ways to control and harness the power of the immune system. The Company’s lead asset is bexmarilimab, a novel anti-Clever-1 humanized antibody, with the potential to remove immunosuppression of cancers through reprogramming myeloid cell function. Bexmarilimab is being investigated in Phase I/II clinical trials as a potential therapy for patients with hematological cancers in combination with other standard treatments. 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.

Grant of options

Faron Pharmaceuticals Ltd.

(“Faron” or “the Company”)

Grant of options

Company announcement, August 7, 2024 at 10.00 a.m. BST / 12:00 p.m. EEST

TURKU, FINLAND – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on tackling cancers via novel immunotherap ies , today announces that the Company’s board has confirmed the grant of a total of 645,000 options over new ordinary shares in the Company (“Options”) under the 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 June 25, 2025 and June 25, 2029, vesting 25% per annum over four years. The exercise price for Options allocated under the Share Option plan and the UK sub plan corresponds to the subscription price of €1.00 per share, being the same subscription price in the Company’s public offering that was closed and announced on 20 June 2024. The exercise price for the 90,000 Options allocated under the US sub plan is €1.35 per share, which is calculated based on the 30-day average price of the Shares prior to the Grant Date. The terms of the Share Option Plan 2019 are available on the Company’s website at https://www.faron.com/sites/faron-corp/files/faron/investor/general-meeting/2023/annex-1-amended-option-plan-2019.pdf.

The granted 645,000 Options entitle the option holders to subscribe for a total of 645,000 new ordinary shares in the Company, if exercised in full, and represent 0.61 % of the fully diluted ordinary share capital of the Company.

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

Director

Options granted

Marie-Louise Fjällskog

30,000

Markku Jalkanen​

30,000

John Poulos

30,000

Tuomo Pätsi​

100,000

Christine Roth​

30,000

Total directors

220,000

Other PDMR

Juho Jalkanen

200,000

Maija Hollmén

6,000

Vesa Karvonen

30,000

Yrjö Wichmann

60,000

Kaisa Kyttä

11,000

Total other PDMRs

307,000

Total Company personnel

118,000

For the purposes of MAR and UK MAR, the person responsible for arranging for the release of this announcement on behalf of Faron is Juho Jalkanen, Chief Executive Officer.

For more information please contact:

ICR Consilium
Mary-Jane Elliott, David Daley, Lindsey Neville
Phone: +44 (0)20 3709 5700
E-mail:
  faron@consilium-comms.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

About BEXMAB

The BEXMAB study is an 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 (azacitidine) treatment. 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 bexmarilimab

Bexmarilimab is Faron’s wholly owned, investigational immunotherapy designed to overcome resistance to existing treatments and optimize clinical outcomes, by targeting myeloid cell function and igniting the immune system. Bexmarilimab binds to Clever-1, an immunosuppressive receptor found on macrophages leading to tumor growth and metastases (i.e. helps cancer evade the immune system). By targeting the Clever-1 receptor on macrophages, bexmarilimab alters the tumor microenvironment, reprogramming macrophages from an immunosuppressive (M2) state to an immunostimulatory (M1) one, upregulating interferon production and priming the immune system to attack tumors and sensitizing cancer cells to standard of care.

About Faron Pharmaceuticals Ltd

Faron (AIM: FARN, First North: FARON) is a global, clinical-stage biopharmaceutical company, focused on tackling cancers via novel immunotherapies. Its mission is to bring the promise of immunotherapy to a broader population by uncovering novel ways to control and harness the power of the immune system. The Company’s lead asset is bexmarilimab, a novel anti-Clever-1 humanized antibody, with the potential to remove immunosuppression of cancers through reprogramming myeloid cell function. Bexmarilimab is being investigated in Phase I/II clinical trials as a potential therapy for patients with hematological cancers in combination with other standard treatments. Further information is available at www.faron.com .

Notification of a Transaction pursuant to Article 19(1) of Regulation (EU) No. 596/2014

1

Details of the person discharging managerial responsibilities/person closely associated

a.

Name

a)    Marie-Louise Fjällskog

b)    Markku Jalkanen

c)    John Poulos

d)    Tuomo Pätsi

e)    Christine Roth

f)     Juho Jalkanen

g)    Maija Hollmén

h)    Vesa Karvonen

i)     Yrjö Wichmann

j)     Kaisa Kyttä

2

Reason for notification

a.

Position/Status

Person discharging managerial responsibilities/person closely associated

b.

Initial notification/

Amendment

Initial notification

3

Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor

a.

Name

Faron Pharmaceuticals Oy

b.

LEI

7437009H31TO1DC0EB42

4

Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducted

a.

Description of the financial instrument, type of instrument

Identification Code

Options over new ordinary shares

ISIN: FI4000153309

b.

Nature of the transaction

Grant of options made under the Faron Share Option Plan 2019 – under the UK and US sub plans the options are exercisable at €1.00 per ordinary share, and at €1.35 per ordinary share respectively.

c.

Price(s) and volume(s)

Price(s)

Volume(s)

a)     €1.35

b)    €1.00

c)     €1.35

d)    €1.00

e)    €1.35

f)     €1.00

g)     €1.00

h)    €1.00

i)      €1.00

j)      €1.00

a)     30,000

b)    30,000

c)     30,000

d)    100,000

e)    30,000

f)     200,000

g)     6,000

h)    30,000

i)      60,000

j)      11,000

d.

Aggregated information

– Aggregated Volume

– Price

Nil

e.

Date of the transaction

7 August 2024

f.

Place of the transaction

Turku

Faron Appoints Dr. Petri Bono as new CMO

Faron Pharmaceuticals Ltd.

(“Faron” or the “Company”)

Faron Appoints Dr. Petri Bono as new CMO

Company announcement, 6 August 2024 at 8:30 a.m. BST / 10:30 a.m. EEST

TURKU, Finland – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company pursuing a CLEVER-1 receptor targeting approach to reprogramming myeloid cells to activate anti-tumor immunity in treatment resistant hematological malignancies and solid tumors, is pleased to announce the appointment of Dr. Petri Bono (M.D., Ph.D.) as the new Chief Medical Officer (CMO) starting the 15th of August.

Previously Dr. Bono has served as the Chief Medical Officer and member of the Group executive team of Terveystalo, the largest private healthcare service provider in Finland. Prior to Terveystalo he was the Chief Medical Officer at Helsinki University Hospital. In addition to being Associate Professor of Cancer Biology at University of Helsinki, Dr. Bono has held various leadership positions within Helsinki University Hospital, including as the Director and Physician-in-Chief of the Comprehensive Cancer Center. Dr. Bono has participated in numerous oncology trials from Phase 1 to 3, including early phase immuno-oncological trials and published 102 peer reviewed papers in international journals including New England Journal of Medicine, Lancet Oncology, JAMA as well as Cancer Cell.

Dr. Bono’s own research has been focusing on molecular and immunological oncology. Given his translational and clinical studies in targeted therapies and applied immunology, he is uniquely suited to support Faron’s immuno-oncology program to tackle cancers via novel myeloid cell targeting immunotherapies that will bring the promise of immunotherapy to much broader patient populations, especially in the solid tumors space. 

Bexmarilimab is an exceptional asset. It is an industry-leading agent in macrophage re-programming and has wide applicability in the treatment of a variety of cancers. Macrophages remain a key source of treatment resistance in solid tumors and in many instances bexmarilimab has shown it can induce responses and overcome this resistance. I am thrilled to develop further Faron’s novel and innovative immunotherapy program, and make bexmarilimab a cornerstone of future cancer care”, says Dr. Bono the in-coming CMO of Faron.

“We are delighted to have such an experienced and proactive oncologist join us as the new CMO”, says Dr. Juho Jalkanen, CEO of Faron . “This especially strengthens us in respect to our up-coming expansion plans into solid tumors, as we expect to benefit from the experience and broader shoulders of a partner for late-stage development in hematology. This means maximizing our expertise and development capabilities in both solid tumors and hematological malignancies using a mix of internal know-how and strategic partnerships to generate broader value for both patients and investors.”

Dr. Birge Berns, the acting CMO seconded from tranScrip Ltd. will continue her role as part of the medical leadership involved in developing bexmarilimab. “We are very grateful for tranScrip and Dr. Berns’ services and look forward to continuing this partnership. Dr. Berns has had a vital role in our success with the FDA and bringing Bexmarilimab to where it is today., She will continue to have an important role in shaping our development and regulatory strategy as we go forward”, continues Dr. Jalkanen.

For more information please contact:

Investor Contact

Faron Pharmaceuticals
E-mail: investor.relations@faron.com

Media Contact

ICR Consilium

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.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

About BEXMAB

The BEXMAB study is an open-label Phase 1/2 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 (azacitidine) treatment. 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 Bexmarilimab

Bexmarilimab is Faron’s wholly owned, investigational immunotherapy designed to overcome resistance to existing treatments and optimize clinical outcomes, by targeting myeloid cell function and igniting the immune system. Bexmarilimab binds to Clever-1, an immunosuppressive receptor found on macrophages leading to tumor growth and metastases (i.e. helps cancer evade the immune system). By targeting the Clever-1 receptor on macrophages, bexmarilimab alters the tumor microenvironment, reprogramming macrophages from an immunosuppressive (M2) state to an immunostimulatory (M1) one, upregulating interferon production and priming the immune system to attack tumors and sensitizing cancer cells to standard of care.

About Faron Pharmaceuticals Ltd.

Faron (AIM: FARN, First North: FARON) is a global, clinical-stage biopharmaceutical company, focused on tackling cancers via novel immunotherapies. Its mission is to bring the promise of immunotherapy to a broader population by uncovering novel ways to control and harness the power of the immune system. The Company’s lead asset is bexmarilimab, a novel anti-Clever-1 humanized antibody, with the potential to remove immunosuppression of cancers through reprogramming myeloid cell function. Bexmarilimab is being investigated in Phase I/II clinical trials as a potential therapy for patients with hematological cancers in combination with other standard treatments. 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.

Faron Announces Positive FDA Feedback

Faron Pharmaceuticals Ltd.

(“Faron” or the “Company”)

Inside Information: Faron Announces Positive FDA Feedback

Company announcement, Inside Information, 11 July 2024 at 7:00 a.m. BST / 9:00 a.m. EEST

Key highlights

–       Faron had a formal meeting with the FDA to discuss the registrational clinical development plan for bexmarilimab in the treatment myelodysplastic syndrome (MDS).

–       The FDA acknowledged the difficulties of running a randomized study with a comparator in the relapsed / refractory setting (r/r) and instead proposed that Faron conduct a confirmatory Phase III study in frontline high-risk MDS (HR MDS), that would not require a separate Phase III in r/r MDS.

–      This FDA guidance is part of Project Frontrunner, an initiative intended to bring promising new cancer treatments as early as possible to a broader patient population.

–       The Phase III suggested by the FDA targets a significantly larger patient population with potential for faster approval earlier than anticipated, speeding up and increasing our sales forecast for bexmarilimab.

TURKU, Finland – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company pursuing a CLEVER-1 receptor targeting approach to reprogramming myeloid cells to activate anti-tumor immunity in hematological and solid tumor microenvironments, today provides information on the result of its formal Type D Scientific Advice Meeting with the USA Food and Drug Administration (the FDA) regarding the registrational study plan for its drug candidate bexmarilimab in relapsed and refractory high risk MDS (r/r MDS).

Given the previously reported promising results of treating r/r MDS using a combination of bexmarilimab + azacitidine to overcome primary or developed resistance to azacitidine, Faron had proposed to move into a randomized registrational Phase III study for the treatment of r/r MDS using bexmarilimab + azacitidine against the investigator’s choice of a hypomethylating agent (HMA). Instead, given the encouraging efficacy already seen in both frontline and r/r HR MDS and the well-established safety profile of bexmarilimab, the FDA proposed that after the ongoing Phase II BEXMAB study in r/r MDS, Faron should move directly into a registrational blinded randomized frontline HR MDS study investigating bexmarilimab + azacitidine against placebo + azacitidine. The FDA noted that given the relatively modest efficacy of single agent azacitidine and the current response rates with bexmarilimab that the size of such a frontline study may not have to be substantially larger than the proposed study in the r/r setting.

Further, the FDA suggested such a frontline study could be seen in the context of FDA’s Project Frontrunner. Project FrontRunner is an FDA Oncology Center of Excellence (OCE) initiative to encourage drug sponsors to develop and seek approval of promising new cancer drugs for advanced diseases in an earlier clinical setting, rather than the usual approach to develop and seek approval of a new drug for treatment of patients who have received numerous prior lines of therapies or have exhausted available treatment options. The FDA guidelines give different possible approval strategies to sponsors, including the conduct of a frontline trial supporting an accelerated approval in the r/r settings. Project FrontRunner | FDA

Subject to continued positive results, the FDA’s feedback means that a separate Phase III in r/r MDS would not be required and Faron’s ongoing BEXMAB Phase II study could be the registrational trial for patients with r/r MDS, given that the benefit of bexmarilimab + azacitidine against azacitidine alone will be confirmed in an interim read-out of the response rate from a Phase III in frontline HR MDS study. Accelerated approval for frontline HR MDS would come from the response rate of this single Phase III study and the full approval from the survival read-out of the same study.

“Faron is now adjusting its development plan accordingly”, says Dr. Juho Jalkanen, Chief Executive Officer of Faron . “This is very positive feedback and exceeds our expectations. The FDA’s proposal significantly reduces development costs and timelines to bring bexmarilimab therapy to all HR MDS patients. This feedback underlines that the FDA sees the high unmet need in HR MDS, a condition for which new treatment options are urgently needed. The FDA’s proposal has provided Faron with clear guidance on the path to approval that will confirm the highly encouraging results bexmarilimab has already obtained in overcoming resistance to azacitidine. We are extremely grateful for this feedback and will work hard to deliver on this recommendation.”

“The suggested Phase III targets a significantly bigger patient population sooner than anticipated, speeding up and increasing our sales forecast for bexmarilimab. This does not significantly impact our ongoing activities and cash runway, as the Phase II in r/r MDS continues as planned. In addition, we will enroll more frontline HR MDS patients into the Phase I part of BEXMAB to better understand the effect size, which will enable us to successfully power and design the proposed frontline Phase III study. We believe we can offset this additional clinical investment through other savings, so that it will not have a significant impact on our cash runway. The only deviation from the original plan is that instead of a Phase III in r/r MDS, we will start preparations for a Phase III in frontline HR MDS, which is a remarkable achievement.”, continues Dr. Jalkanen.

Faron will be hosting a virtual webinar to discuss the FDA feedback and updated clinical development plans July 15th, at 15.00 EEST / 13.00 BST.

To register for the event visit: https://faron.videosync.fi/fda-feedback-update or contact the IR team for more information at investor.relations@faron.com .

For the purposes of MAR and UK MAR, the person responsible for arranging for the release of this announcement on behalf of Faron is Juho Jalkanen, Chief Executive Officer.

For more information please contact:

Investor Contact
Faron Pharmaceuticals
E-mail: investor.relations@faron.com

Media Contact

ICR Consilium

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.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

About BEXMAB

The BEXMAB study is an open-label Phase 1/2 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 (azacitidine) treatment. 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 Bexmarilimab

Bexmarilimab is Faron’s wholly owned, investigational immunotherapy designed to overcome resistance to existing treatments and optimize clinical outcomes, by targeting myeloid cell function and igniting the immune system. Bexmarilimab binds to Clever-1, an immunosuppressive receptor found on macrophages leading to tumor growth and metastases (i.e. helps cancer evade the immune system). By targeting the Clever-1 receptor on macrophages, bexmarilimab alters the tumor microenvironment, reprogramming macrophages from an immunosuppressive (M2) state to an immunostimulatory (M1) one, upregulating interferon production and priming the immune system to attack tumors and sensitizing cancer cells to standard of care.

About Faron Pharmaceuticals Ltd.

Faron (AIM: FARN, First North: FARON) is a global, clinical-stage biopharmaceutical company, focused on tackling cancers via novel immunotherapies. Its mission is to bring the promise of immunotherapy to a broader population by uncovering novel ways to control and harness the power of the immune system. The Company’s lead asset is bexmarilimab, a novel anti-Clever-1 humanized antibody, with the potential to remove immunosuppression of cancers through reprogramming myeloid cell function. Bexmarilimab is being investigated in Phase I/II clinical trials as a potential therapy for patients with hematological cancers in combination with other standard treatments. 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.

Update on settlement

Faron Pharmaceuticals Ltd

(“Faron” or the “Company“)

Update on settlement under the UK Open Offer and the REX Retail Offer

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, AUSTRALIA, CANADA, JAPAN, NEW ZEALAND OR THE REPUBLIC OF SOUTH AFRICA OR ANY OTHER JURISDICTION IN WHICH THE DISTRIBUTION OR RELEASE WOULD BE UNLAWFUL.

THIS ANNOUNCEMENT IS FOR INFORMATION PURPOSES ONLY AND DOES NOT CONSTITUTE OR CONTAIN ANY INVITATION, SOLICITATION, RECOMMENDATION, OFFER OR ADVICE TO ANY PERSON TO ACQUIRE ANY SECURITIES. PLEASE SEE THE IMPORTANT NOTICES AT THE END OF THIS ANNOUNCEMENT.

Company announcement, 25 June 2024 at 4pm (EEST) / 2pm (BST) / 9am (EDT)

TURKU, FINLAND  – Faron Pharmaceuticals Ltd (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company pursuing a CLEVER-1 receptor targeting approach to reprogramming myeloid cells to activate anti-tumor immunity in hematological and solid tumor microenvironments, announces an update on settlement of the UK Open Offer and the REX Retail Offer, which are part of the fully subscribed EUR 30.7 million share offering.  Capitalised terms used but not defined herein have the meaning given to them in the announcement of final results of the share offering dated 20 June 2024.

The New Shares were admitted to trading on First North and AIM at 8:00 a.m. BST on 24 June 2024. Due to a technical delay with settlement, CREST accounts are now expected to be credited in respect of shares under the UK Open Offer on 26 June 2024 and settlement of the REX Retail Offer is expected to occur on 25 June 2024.

Faron Pharmaceuticals Ltd

For more information please contact:

ICR Consilium
Mary-Jane Elliott, David Daley, Lindsey Neville
Phone: +44 (0)20 3709 5700
E-mail:
  faron@consilium-comms.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

About BEXMAB

The BEXMAB study is an 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 (azacitidine) treatment. 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 bexmarilimab

Bexmarilimab is Faron’s wholly owned, investigational immunotherapy designed to overcome resistance to existing treatments and optimize clinical outcomes, by targeting myeloid cell function and igniting the immune system. Bexmarilimab binds to Clever-1, an immunosuppressive receptor found on macrophages leading to tumor growth and metastases (i.e. helps cancer evade the immune system). By targeting the Clever-1 receptor on macrophages, bexmarilimab alters the tumor microenvironment, reprogramming macrophages from an immunosuppressive (M2) state to an immunostimulatory (M1) state, upregulating interferon production and priming the immune system to attack tumors and sensitizing cancer cells to standard of care.

About Faron Pharmaceuticals Ltd

Faron (AIM: FARN, First North: FARON) is a global, clinical-stage biopharmaceutical company, focused on tackling cancers via novel immunotherapies. Its mission is to bring the promise of immunotherapy to a broader population by uncovering novel ways to control and harness the power of the immune system. The Company’s lead asset is bexmarilimab, a novel anti-Clever-1 humanized antibody, with the potential to remove immunosuppression of cancers through reprogramming myeloid cell function. Bexmarilimab is being investigated in Phase I/II clinical trials as a potential therapy for patients with hematological cancers in combination with other standard treatments. Further information is available at www.faron.com .

Important notice

This announcement is not an offer of securities for sale into the United States. The Offer 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 Offer Shares in the United States or to make a public offering in the United States. Any sale of the Offer Shares in the United States will be made solely to a limited number of “qualified institutional buyers” or accredited investors, each as defined in Rule 144A in reliance on an exemption from the registration requirements of the Securities Act.

The distribution of this release may be restricted by law and persons into whose possession any document or other information referred to herein comes should inform themselves about and observe any such relevant legal restrictions. The information contained herein is not for publication or distribution, directly or indirectly, in or into the United States, Australia, Canada, Japan, New Zealand or the Republic of South Africa. Any failure to comply with these restrictions may constitute a violation of the securities laws of any such aforementioned jurisdiction. This release is not directed to, and is not intended for distribution to or use by, any person or entity that is a citizen, resident or located in any locality, state, country or other jurisdiction where such distribution, publication, availability or use would violate law or regulation or which would require any registration or licensing within such jurisdiction.

In any European Economic Area Member State, other than Finland, this release is only addressed to and is only directed at “qualified investors” in that Member State within the meaning of Article 2(e) of Regulation (EU) 2017/1129 (the “Prospectus Regulation“).

In the United Kingdom, this release is only being distributed to and is only directed at “qualified investors” within the meaning of Article 2(e) of the Prospectus Regulation as it forms part of domestic law in the United Kingdom by virtue of the European Union (Withdrawal) Act 2018 (the “UK Prospectus Regulation“) who are (i) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the “Order“) or (ii) high net worth companies, and other persons to whom it may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as “UK Relevant Persons“). Any investment activities to which this announcement relates will only be available to and will only be engaged in with UK Relevant Persons. Any person who is not a UK Relevant Person should not act or rely on this release or any of its contents.

This release does not constitute a prospectus as defined in either the Prospectus Regulation or the UK Prospectus Regulation and, as such, it does not constitute or form part of, and should not be construed as, an offer to sell, or a solicitation or invitation of any offer to buy, acquire or subscribe for, any securities or an inducement to enter into investment activity in relation to any securities.

No part of this release, nor the fact of its distribution, should form the basis of, or be relied on in connection with, any contract or commitment or investment decision whatsoever. The information contained in this release has not been independently verified. No representation, warranty or undertaking, expressed or implied, is made as to, and no reliance should be placed on, the fairness, accuracy, completeness or correctness of the information or the opinions contained herein. The Company or any of its respective affiliates, advisors or representatives or any other person, shall have no liability whatsoever (in negligence or otherwise) for any loss, however arising from any use of this release or its contents or otherwise arising in connection with this release. Each person must rely on their own examination and analysis of the Company, its subsidiaries, its securities and the transactions, including the merits and risks involved.

Carnegie Investment Bank AB, Finland Branch and Peel Hunt LLP are acting as lead managers (the “Lead Managers“) and bookrunners for the Offering. The Lead Managers are acting exclusively for the Company and no one else in connection with the Offering. They will not regard any other person as their respective client in relation to the Offering. The Lead Managers will not be responsible to anyone other than the Company for providing the duties afforded to their respective clients, nor for giving advice in relation to the Offering or any transaction or arrangement referred to herein.

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 Company’s current expectations and assumptions regarding the completion and use of proceeds from the Offering, 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 Company’s current beliefs and assumptions and are based on information currently available to the Company.

A number of factors could cause actual results to differ materially from the results and expectations dis-cussed 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 Company believes to be reasonable assumptions, the Company cannot assure investors that actual results will be consistent with such forward-looking statements. Accordingly, readers are cautioned not to place undue reliance on forward-looking statements. Subject to any continuing obligations under applicable law or any relevant AIM Rule requirements, in providing this information the Company does not undertake any obligation to publicly update or revise any of the forward-looking statements or to advise of any change in events, conditions or circumstances on which any such statement is based.

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