Faron confirms plans under new leadership

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

 

Faron confirms plans for the coming months under new leadership

 

        Initial data from ongoing Phase 2 part of BEXMAB trial anticipated next month

        Incoming CEO, Juho Jalkanen, to accelerate discussions with US regulator to coordinate plans for obtaining marketing approval for MDS patients that have failed HMA

 

Press Release, April 16, 2024 at 9:00 (EEST) / 7:00 AM (BST) / 2:00 AM (EDT)  

 

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 ongoing plans and activities for the coming months following the recent announcement of the proposed appointment of Dr. Juho Jalkanen as Chief Executive Officer, effective 1 May 2024.

 

Initial data from the ongoing Phase 2 part of the BEXMAB trial, evaluating the safety and efficacy of bexmarilimab in combination with standard of care (SoC) in patients with hypomethylating agents (HMAs)-refractory or relapsed myelodysplastic syndrome (MDS), is expected to be announced during the week commencing 20 May 2024. This data read out will be important for ongoing partnering discussions and the major upcoming industry events that Faron will be attending, including the American Society for Clinical Oncology (ASCO) annual meeting and the Bio International Convention, taking place in June 2024.

 

Given the promising data already seen in the Phase 1 part of the trial, among HMA-failed MDS patients who have no approved treatment options, the Company plans to approach the US Food and Drug Administration (FDA) earlier than planned this year, seeking a Scientific Advice meeting regarding its registrational study plan, in order to coordinate and finalize plans that may lead to marketing approval. 

 

“2024 is set to be a pivotal year for Faron in the delivery of key milestones that will be critical to the further development of bexmarilimab,” said Dr. Juho Jalkanen, Faron’s incoming Chief Executive Officer. “In my new role as CEO I am excited to start executing on some of these key activities and to accelerating important discussions with the FDA as we map our future plans for bexmarilimab together. There is a tremendous need for an effective treatment in HMA-failed MDS patients and so we are very keen to ensure we get this treatment option to patients as soon as we can.”

 

 

For more information please contact:

 

Faron Pharmaceuticals

Investor Contact

LifeSci Advisors

Daniel Ferry

Managing Director

daniel@lifesciadvisors.com

+1 (617) 430-7576

 

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 Oy 

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 targeting 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 and as a monotherapy in last line solid cancers. Further information is available at www.faron.com.

 

Approval of Warrant Terms and Conditions

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

 

Approval of Warrant Terms and Conditions

 

Company announcement, April 8, 2024 at 12:10 AM (EDT) / 7:10 AM (BST) / 9:10 AM (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 that the Board of Directors of Faron has approved the terms and conditions of the remaining 832,934 warrants pursuant to the terms of the warrantholder agreement (the “Warrantholder Agreement”) entered into between the Company and IPF as announced on March 28, 2024. It was previously announced that the maximum total number of warrants to be granted pursuant to the Warrantholder Agreement is 1,500,000, and the Board of the Company shall cause the registration of the remaining warrants after the Annual General Meeting 2024 of the Company, held on April 5, 2024. Each warrant entitles its holder to subscribe for one new share in the Company.

 

Further, pursuant to the terms of the Warrantholder Agreement, the number of warrants to be issued to IPF may be further increased upon (and subject to) agreed adjustment events so that the total number of new shares in the Company (issued as a result of the exercise of the increased number of warrants) multiplied by the (adjusted) subscription price per share in any subsequent share offering undertaken by the Company is equal to EUR 1,000,000 (minus any amounts already paid). The Company announced on April 4, 2024, that the Company had resolved to issue an additional 53,570 warrants to IPF based on the placement of 3,200,298 newly issued treasury shares at the issue price of EUR 1.50.

 

The strike price of the IPF warrants is currently EUR1.50 and will be adjusted to any lower subsequent subscription price of shares in any future share issue. The Company will separately publish an announcement on the issuance of any of the additional warrants.

 

For more information please contact:

 

Investor Contact

LifeSci Advisors

Daniel Ferry

Managing Director

daniel@lifesciadvisors.com

+1 (617) 430-7576

 

ICR Consilium

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilimcomms.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 targeting 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 treatments and as a monotherapy in last line solid cancers. Further information is available at www.faron.com.

 

 

Additional Positive Data from Phase 1 of BEXMAB

Faron Pharmaceuticals Ltd.

 

(“Faron” or the “Company”)

 

 

Inside Information: Additional Positive Data from the Phase 1 Part of the BEXMAB Study in Both Higher-Risk HMA-Failed MDS and r/r AML

 

 

Company announcement, 18 March 2024 at 7:00 a.m. GMT / 9:00 a.m. EET

 

Key highlights

          Latest readout of the BEXMAB study shows more responding patients and good durability of remission amongst HR HMA-failed MDS patients.

          4/5 of the initial Phase 1 HR HMA-failed MDS patients were still alive after eight months of follow-up.

          While data do not yet allow the precise estimation of median overall survival, the survival benefit seen with the current follow-up already for these 5 first patients is very encouraging. This compares favorably to what has been seen with contemporary comparators.

          3 additional HMA-failed HR MDS patients have been enrolled in Phase 1 part, leading to a total of 7 out of 8 patients responding, an overall response rate of 87.5%.

          Faron will be hosting a virtual webinar to discuss the additional data tomorrow, Tuesday, 19 March at 11.00 EET/9am GMT.

 

TURKU, Finland / BOSTON, Massachusetts – 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 provided further data from patients treated during the Phase 1 part of the ongoing BEXMAB trial that has moved into Phase 2 for higher-risk (HR) myelodysplastic syndrome (MDS) patients failed on previous hypomethylating agent (HMA).

 

Previous BEXMAB study results indicated a high overall response rate (ORR) of 5/5 amongst HR HMA-failed MDS patients, for whom there is no approved treatment. The majority of the initial Phase 1 patients have now been on treatment with bexmarilimab together with azacitidine for more than six months, and only one patient has been lost due to transformation of their HR MDS into acute myeloid leukemia (AML). Out of these initial 5 patients, 4 remain alive after eight months. Normally, patients with relapsed or refractory HR MDS have a median overall survival (mOS) of fewer than six months. The mOS of patients treated in the BEXMAB trial is not yet available but, based on the current data, it is estimated to be significantly higher than traditionally seen with current standard of care (or with current approved treatments).

 

After the already reported 5 HMA-failed HR MDS patients, 3 new HMA-failed HR MDS patients were enrolled, filling the remaining Phase 1 slots. Whilst it is too early to assess these patients for survival or durability, the previously seen high ORR has been corroborated with 2/3 responders. The third patient dropped out of the study early in cycle two due to an unrelated serious adverse event (SAE), bringing the current ORR to 7/8 patients (87.5%) in the HMA-failed HR MDS population. The best responses for these 8 patients are as follows: 1 complete response (CR), 3 marrow complete remissions (mCR), 1 partial response (PR), 2 hematological improvements, and 1 stable disease (SD) that dropped out early due to an unrelated SAE.

 

Mika Kontro, MD, PhD, Associate Professor at the Helsinki University Hospital Comprehensive Cancer Center and Principal Investigator of the BEXMAB trial, said: “We are continuing to see encouraging data from the BEXMAB trial with usually unresponsive patients going into remission after treatment with bexmarilimab and azacitidine. Whilst we don’t have median overall survival rates yet, it is encouraging to see that some patients are alive and, importantly, enjoying a good quality of life even up to 12+ months after treatment initiation. I continue to be very excited about the potential of bexmarilimab to considerably improve outcomes for patients suffering from these aggressive conditions.”

 

Dr. Markku Jalkanen, Chief Executive Officer of Faron, said: “These data are really remarkable and confirm our belief that we may finally have a treatment for this underserved patient population. The data are strongly supportive that a registrational trial would be positive against any contemporary comparator when the final endpoint is survival. We eagerly await completion of the Phase 2 part of the BEXMAB study so we can take these data to the FDA as soon as possible.”

 

For the 5 frontline HR MDS patients with 100% ORR previously reported at the American Society of Hematology (ASH) Annual Meeting last year, mOS has also not yet been reached. For the r/r AML patient cohort reported at ASH, which is bigger in size (n= 18) and more mature in follow-up (median follow-up six months), the mOS is currently estimated to be over 8 months (still subject to change as some patients are still ongoing). The historical mOS for this population is around six months, which means that the current data would support running a registrational trial with mOS also as the endpoint in this population.

 

Faron will be hosting a virtual webinar to discuss these data tomorrow, Tuesday, 19 March, at 11.00 EET/9am GMT.

 

There will be an opportunity to ask questions during the webcast. To register for the event visit: https://faron.videosync.fi/bexmab-study-update/ or contact the IR team for more information at investor.relations@faron.com.

 

 

For more information please contact:

 

Investor Contact

LifeSci Advisors

Daniel Ferry

Managing Director

daniel@lifesciadvisors.com

+1 (617) 430-7576

 

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 to Host BEXMAB Webcast

 

Faron Pharmaceuticals Ltd.

 

(“Faron” or the “Company”)

 

 

Faron to Host Webcast to Discuss Latest Data from Phase 1 Part of the BEXMAB Study of Bexmarilimab

 

Press Release, March 14, 2024

 

TURKU, Finland / BOSTON, Massachusetts – March 14, 2024 – 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 it will host a virtual BEXMAB update event on Tuesday, March 19 at 11.00 EET/9am GMT, following the most recent data cut-off and scheduled analysis.

 

Participants of the webcast will include Dr. Mika Kontro, MD, PhD, Associate Professor at the University of Helsinki and BEXMAB Principal Investigator; Dr. Maija Hollmen, PhD, Chief Scientific Officer at Faron, Dr Juho Jalkanen, MD, PhD, Chief Operating Officer at Faron and members of Faron’s senior management team.

 

During the event the Company will discuss latest data from the ongoing BEXMAB trial in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) patients, with a particular focus on the durability of remission and objective responses following treatment with bexmarilimab in combination with standard of care. This interactive event will also include an introduction to myeloid leukemia, insights into bexmarilimab’s unique mode of action and the Company’s latest understanding of the early and long-term efficacy of bexmarilimab treatment. Faron will also provide an update on bexmarilimab’s future development pathway and business opportunity. Part of the discussion will be done in Finnish and summary in English.

 

There will be an opportunity to ask questions during the webcast. To register for the event visit: https://faron.videosync.fi/bexmab-study-update/ or contact the IR team for more information at investor.relations@faron.com.

 

 

For more information please contact:

 

Investor Contact

LifeSci Advisors

Daniel Ferry

Managing Director

daniel@lifesciadvisors.com

+1 (617) 430-7576

 

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.

 

Binding commitments for convertible loans

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

 

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

 

 

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

 

Inside Information: The Company has received binding commitments for convertible loans in the total amount of EUR 3.2 million enabling the Company to make critical payments and to continue preparing alternative short- and long-term financing options.

 

 

Company announcement, 4 March 2024 at 7:00 a.m. GMT / 9:00 a.m. EET

Inside information

 

Key highlights

          Binding commitments for convertible loans obtained from certain existing shareholders allowing the Company to make critical payments to third parties under agreed waivers with IPF.

          Active participation in the round by early investors of the Company.

          Receipt of the EUR 3.2 million committed funding enables the Company to secure its immediate short-term financing needs until the end of March 2024, in addition to which approximately EUR 5 million of further short-term bridge financing is required.

          The Company continues active endeavors and is in continuous discussions to secure longer term funding. In addition to the short-term bridge financing, the Board intends to propose to the Annual General Meeting an authorization for a larger share issue.

          The next BEXMAB readout will be provided to markets in mid-March. To complete the enrolment of the phase 2 of the BEXMAB study with interim and final readouts and to obtain regulatory feedback from the FDA, the Company expects to need EUR 35 million in total.

          The unaudited total cash and cash equivalents held by the Company was ca. EUR 4.3 million as of 19 February 2024. The Company further provides certain unaudited preliminary financial information in the announcement.

 

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Ltd (First North: FARON, AIM: FARN), a clinical stage biopharmaceutical company pioneering macrophage reprogramming for effective anticancer immunotherapies, today announces that it has obtained binding and irrevocable commitments amounting to a total of EUR 3.2 million (“Commitments”) from a limited number of the Company’s existing shareholders (“Investors”) to subscribe for convertible loan instruments to be issued by the Company (“Loans”).

 

As was announced by the Company on 19 February 2024, the Company was in breach of several undertakings agreed in the secured debt agreement with IPF Fund II SCA, SICAV-FIAR (“IPF”) as Lender and Faron Pharmaceuticals Ltd as Borrower (“Facilities Agreement”), and as a result of such Events of Default, IPF blocked the Company’s bank accounts which are pledged to IPF.

 

Based on the Commitments, IPF has allowed the Company to make certain critical payments and, upon the Company’s receipt of the Loan funds in full no later than 8 March 2024, agreed to waive certain Events of Default under the terms of the Facilities Agreement (“Waiver”) and to unblock the Company’s bank accounts, allowing the Company to make payments to third parties without a separate consent from IPF. The Loans are fully subordinated to the Facilities Agreement and the Company will not make any extraordinary payments to IPF other than agreed waiver fees. As part of the Waiver the minimum cash covenant will be lowered to EUR 4.5 million until 30 April 2024 and thereafter it returns to the previously agreed level. In accordance with the Waiver, the Company shall issue to IPF additional special rights which entitle them to subscribe for new ordinary shares in the Company (“Warrants”), with an exercise price equal to the volume-weighted average price of the Company’s share during the three trading days preceding the date of the Waiver (“Strike Price”). The number of Warrants is calculated by dividing 10% of the original loan amount (EUR 10 million) by the Strike Price. The Warrants are exercisable for a period of seven years and the Company will separately publish an announcement on the issuance of the Warrants. Simultaneously, the Company and IPF have agreed on certain amendments to the fee structure under the Facilities Agreement.

 

Receipt of the EUR 3.2 million pursuant to the Loans enables the Company to secure its immediate short-term financing needs until the end of March 2024. The Company continues active endeavors and is in discussions to secure its short and longer-term financing needs, including first additional bridge financing of approximately EUR 5 million, to secure publishing of the Company’s annual accounts for the year 2023 on 13 March 2024 and continued compliance with the cash covenants agreed in the Waiver.

 

Further, the Board of Directors of Faron intends to propose to the Annual General Meeting (scheduled to be held on 5 April 2024) an authorization for a larger share issue, contemplated to be launched as a public offering (with planned allocation preferences to existing shareholders and bridge finance lenders (including the Investors to enable the conversion of the Loans) and in compliance with the relevant securities markets regulation) as soon as practicable once the required preparations and approvals are in place. The receipt of long-term financing is necessary to secure funding for 2024 and especially the uninterrupted continuation of the Company’s BEXMAB study to full read out of the Phase II study and FDA feedback on registrational study design during 2024. The targeted size of the contemplated share issue is planned to be set accordingly, to meet these cash runway needs for 2024. The Company is also evaluating and continuously negotiating several business development alternatives that may result in non-dilutive funding.

 

This fundraise will enable us to meet our immediate financing needs and continue our ambitious bexmarilimab development program, with a focus on delivering next milestones,” said Dr. Markku Jalkanen, Chief Executive Officer of the Company. “These funds are part of the larger financing plan to secure cash runway for 2024 and to complete Phase II study and receive FDA’s guidance for the pivotal study part. We would like to thank support from our investors in developing this novel immunotherapy, especially for myeloid leukemia with very few treatment options”. To support the Company’s short-term financing, the Company’s CEO has agreed to give up his salary for the coming three months.

 

The Company expects to publish the next BEXMAB phase I read out in mid-March with special focus on durability of bexmarilimab efficacy on HMA-failed MDS patients known to have very short life expectancy post HMA failure. To complete the enrolment into the ongoing phase 2 of the BEXMAB study, to produce interim and final readouts from the study and to get regulatory feedback from the FDA, the Company expects to need EUR 35 million in total.

 

The unaudited total cash and cash equivalents held by the Company was ca. EUR 4.3 million as of 19 February 2024. The Company also provides the following preliminary, unaudited financial information: on 19 February 2024 the Company’s gross debts were around EUR 13.8 million and net debts around EUR 9.4 million. The Company’s financial statements bulletin for the financial year ended 31 December 2023 is planned to be published on 13 March 2024 subject to the receipt of the approximately EUR 5 million of additional bridge financing.

 

DETAILS OF THE EUR 3.2 MILLION LOAN ARRANGEMENT

 

In accordance with the Commitments from several Investors, the Company will by 8 March 2024 obtain Loans amounting to a total of approximately EUR 3.2 million which are fully subordinated to the Facilities Agreement. The Loans shall be converted to new shares in the Company as a part of (and at the subscription price of) the next investment round where shares or other equity securities are issued by the Company to existing shareholders and/or new third- party investors, with a minimum size of EUR 8 million (“Investment Round”). In the event that the subscription price in such Investment Round exceeds EUR 1.50 per share, an Investor shall have the right to postpone the conversion of the Loan until 10 June 2024 (“Due Date”). In the event that there is no Investment Round by the Due Date (or the subscription price of the Investment Round exceeds EUR 1.50 per share and the respective Investor has decided to postpone the conversion of the Loan) and the Loan has not been otherwise repaid prior to the Due Date (subject to a subordination agreement to be entered into between the Investors, the Company and IPF), then the Loan shall be at the request of the Investor converted into new shares in the Company in connection with the Due Date. In such case, the subscription price per share shall be EUR 1.50 per share. However, if then the Lender elects not to exercise its conversion right on the Due Date, (such option being only available if there has not been any Investment Round), the Due Date of the Loan will automatically be extended until 31 December 2024 (“Final Due Date”). On such Final Due Date, the Loan shall be either repaid in full in cash, subject to the terms of the subordination agreement, or converted into new shares in the Company with the subscription price of EUR 1.50 per share, subject to a valid share issue authorization being in place. In case the Loan is converted before the Due Date, each Investor is entitled to an arrangement fee of 15% of its respective Loan amount. If conversion has not taken place prior to the Due Date, the arrangement fee will be 30% of the Investor’s respective Loan amount. No interest shall be payable on the Loan if a conversion takes place before 30 May 2024, and thereafter the interest will be 12% + 3-months Euribor and paid subject to the subordination agreement.

 

RELATED PARTY TRANSACTION

 

Timo Syrjälä, an existing shareholder in the Company, has committed to participate in the Loan in the amount of EUR 600,000. Mr. Syrjälä’s total holding in the Company’s shares, which includes his indirect holding through Acme Investments SPF Sarl (“Acme”), an entity wholly owned by Mr. Syrjälä, is on the date of this release 13,410,336 shares, representing 19.5 % of all shares and votes in the Company. Mr Syrjälä is a “Substantial Shareholder” in the Company for the purposes of the AIM Rules for Companies (the “AIM Rules”). His commitment to participate in the Loan is a related party transaction for the purposes of the AIM Rules, the First North Rulebook and the Finnish Limited Liability Companies Act. The members of the Board of Directors of the Company, all of whom are independent of Mr. Syrjälä, having consulted with Cairn Financial Advisers LLP, the Company’s nominated adviser for the purposes of the AIM Rules, consider the terms of the participation by Mr. Syrjälä in the Loan to be fair and reasonable insofar as shareholders are concerned.

 

 

For more information please contact:

 

Investor Contact, US  

LifeSci Advisors 

Daniel Ferry 

Managing Director 

daniel@lifesciadvisors.com

+1 (617) 430-7576 

 

Investor Contact, EUR

Faron Pharmaceuticals

Yrjö E K Wichmann

SVP, Funding & Investor Relations

yrjo.wichmann@faron.com

investor.relations@faron.com

Phone: +358 (0) 40 5868 979

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880

 

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

 

ICR Consilium

Mary-Jane Elliott, David Daley, Lindsey Neville

faron@consilium-comms.com

Phone: +44 (0)20 3709 5700

 

 

THIS ANNOUNCEMENT IS NOT FOR PUBLICATION OR DISTRIBUTION, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES OF AMERICA. THIS ANNOUNCEMENT IS NOT AN OFFER OF SECURITIES FOR SALE INTO THE UNITED STATES. THE LOANS, ANY SECURITIES ISSUED UPON CONVERSION OF THE LOANS AND ANY SECURITIES ISSUED IN THE INVESTMENT ROUND (COLLECTIVELY, THE “SECURITIES”) 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 SECURITIESIN THE UNITED STATES OR TO MAKE A PUBLIC OFFERING IN THE UNITED STATES. ANY SALE OF THE SECURITIES IN THE UNITED STATES WILL BE MADE SOLELY TO “QUALIFIED INSTITUTIONAL BUYERS” AS DEFINED IN RULE 144A IN RELIANCE ON AN EXEMPTION FROM THE REGISTRATION REQUIREMENTS OF THE U.S. SECURITIES ACT.

 

About Bexmarilimab

Bexmarilimab is Faron’s wholly owned, investigational immunotherapy 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 targeting 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.

 

Caution regarding forward-looking statements

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

 

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

Continued Negotiations Regarding Events of Default

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

 

THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF THE EU REGULATION 596/2014 (“MAR”) AND ARTICLE 7 OF MAR AS IT FORMS PART OF DOMESTIC LAW IN THE UNITED KINGDOM BY VIRTUE OF THE EUROPEAN UNION (WITHDRAWAL) ACT 2018 (“UK MAR”)

 

 

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

 

 

Company announcement, February 21, 2024 at 2 p.m. GMT / 4 p.m. EET

 

Inside information: the Company continues active negotiations regarding Events of Default under the terms of the Funding Agreement between IPF Fund II SCA, SICAV-FIAR and Faron Pharmaceuticals Ltd and contemplates alternative short- and long-term financing options

 

 

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Ltd (First North: FARON, AIM: FARN), a clinical stage biopharmaceutical company pioneering macrophage reprogramming for effective anticancer immunotherapies, today announces that, in relation to the Events of Default under the terms of the Funding Agreement between IPF Fund II SCA, SICAV-FIAR (“IPF”) and Faron, as announced by the Company on February 19, 2024, Faron Pharmaceuticals Ltd continues active negotiations to receive a waiver from IPF and to unblock the pledged bank accounts.

 

Faron is contemplating alternative short- and long-term financing options, and as a part of the possible long-term financing arrangements the Board of Directors of Faron intends as one of the alternatives to propose to the Annual General Meeting an authorisation for a rights issue contemplated to be launched when the required preparations and approvals are in place. The notice to the Annual General Meeting will be published separately at a later date.

 

For more information please contact:

 

Investor Contact, US  

LifeSci Advisors 

Daniel Ferry 

Managing Director 

daniel@lifesciadvisors.com 

+1 (617) 430-7576 

 

Investor Contact, EUR

Faron Pharmaceuticals

Yrjö E K Wichmann

SVP, Funding & Investor Relations

yrjo.wichmann@faron.com

investor.relations@faron.com

Phone: +358 (0) 40 5868 979

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880

 

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

 

ICR Consilium

Mary-Jane Elliott, David Daley, Lindsey Neville

faron@consilium-comms.com

Phone: +44 (0)20 3709 5700

 

THIS ANNOUNCEMENT IS NOT FOR PUBLICATION OR DISTRIBUTION, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES OF AMERICA. THIS ANNOUNCEMENT IS NOT AN OFFER OF SECURITIES FOR SALE INTO THE UNITED STATES. THE [RIGHTS] 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 [RIGHTS] IN THE UNITED STATES OR TO MAKE A PUBLIC OFFERING IN THE UNITED STATES.

 

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 targeting 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 Directors’ current expectations and assumptions regarding the Company’s future growth, results of operations, performance, future capital and other expenditures (including the amount, nature and sources of funding thereof), competitive advantages, business prospects and opportunities. Such forward-looking statements reflect the Directors’ current beliefs and assumptions and are based on information currently available to the Directors.

 

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

Events of Default

THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF THE EU REGULATION 596/2014 (“MAR”) AND ARTICLE 7 OF MAR AS IT FORMS PART OF DOMESTIC LAW IN THE UNITED KINGDOM BY VIRTUE OF THE EUROPEAN UNION (WITHDRAWAL) ACT 2018 (“UK MAR”)

 

 

Faron Pharmaceuticals Ltd

(“Faron” or the “Company”)

 

 

Company announcement, February 19, 2024 at 10:30 a.m. GMT / 12:30 p.m. EET

 

Inside information: the Company is in Events of Default under the terms of the Funding Agreement between IPF Fund II SCA, SICAV-FIAR and Faron Pharmaceuticals Ltd

 

 

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Ltd (First North: FARON, AIM: FARN), a clinical stage biopharmaceutical company pioneering macrophage reprogramming for effective anticancer immunotherapies, today announces that it is in breach of several undertakings agreed in the secured debt agreement dated February 28, 2022 between IPF Fund II SCA, SICAV-FIAR (“IPF”) as Lender and Faron Pharmaceuticals Ltd as Borrower (“Funding Agreement”) and subsequent waiver letters provided by IPF, and is therefore in several Events of Default, as defined in the Funding Agreement.

 

Faron’s bank accounts are pledged to IPF and IPF has notified Faron’s banks of the blocking of the Pledged Accounts due to the above mentioned breaches.  The Company presently does not have ability to remedy the breaches, nor make payments to third parties without separate consent from IPF.  Negotiations related to possible restructuring of the loan facility as well as waiver of covenant obligations are ongoing with IPF.  A further announcement will be made in due course.

 

The total cash and cash equivalents held by the Company is currently ca. EUR 4.3 million, which are enough to cover the company’s financing needs until the beginning of April, 2024.

 

For more information please contact:

 

Investor Contact, US  

LifeSci Advisors 

Daniel Ferry 

Managing Director 

daniel@lifesciadvisors.com 

+1 (617) 430-7576 

 

Investor Contact, EUR

Faron Pharmaceuticals

Yrjö E K Wichmann

SVP, Funding & Investor Relations

yrjo.wichmann@faron.com

investor.relations@faron.com

Phone: +358 (0) 40 5868 979

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880

 

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

 

ICR Consilium

Mary-Jane Elliott, David Daley, Lindsey Neville

faron@consilium-comms.com

Phone: +44 (0)20 3709 5700

 

About Faron Pharmaceuticals Ltd. 

Faron (AIM: FARN, First North: FARON) is a 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 targeting 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 Directors’ current expectations and assumptions regarding the Company’s future growth, results of operations, performance, future capital and other expenditures (including the amount, nature and sources of funding thereof), competitive advantages, business prospects and opportunities. Such forward-looking statements reflect the Directors’ current beliefs and assumptions and are based on information currently available to the Directors.

 

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

BEXMAB Insights into Patient Profiles

Faron Pharmaceuticals Ltd.

 

(“Faron” or the “Company”)

 

 

Detailed Analysis of BEXMAB Data Provides Insights into Patient Profiles of Responding HMA-Failed MDS Population

 

Company Announcement

 

TURKU, Finland / BOSTON, Massachusetts – January 25, 2024 – 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 provided details from its further analysis of data from the completed Phase 1 part of the ongoing BEXMAB trial.

 

Patients are currently being enrolled in the Phase 2 of the BEXMAB trial, which is evaluating the safety and efficacy of investigational immunotherapy bexmarilimab at two dose levels (Project Optimus part), in combination with standard of care (SoC), in patients with hypomethylating agents (HMAs)-refractory or -relapsed myelodysplastic syndrome (MDS), an aggressive myeloid leukemia with very few treatment options.

 

The new analysis of data from the Phase 1 part of the trial explores the 100% overall response rate (ORR) achieved among both the higher-risk frontline and HMA-failed MDS patients treated with a bexmarilimab/azacitidine combination – 5 out of 5 patients in each population – and examines previous therapies in the patients’ treatment pathways.

 

In the HMA-failed MDS patient group:

  • Patients had been previously treated with azacitidine monotherapy or combinations of up to four therapies that included azacitidine or decitabine + magrolimab, venetoclax and sabatolimab
  • 3 of the 5 patients were refractory to previous HMA-therapy, with progressive disease (PD) or stable disease (SD) being the best responses achieved from that therapy
  • 2 out of the 5 patients had relapsed after treatment with azacitidine or an azacitidine/venetoclax combination

 

“This analysis shows the deep and durable responses that can be achieved with bexmarilimab in combination with standard of care, in MDS patients who are refractory to HMA therapy or who have relapsed on HMA therapy or HMA/venetoclax combination therapy,” said Dr. Markku Jalkanen, Chief Executive Officer of Faron. “Patients with high-risk MDS who have failed HMA therapy face a poor prognosis and median overall survival in refractory MDS is just 4-6 months with no viable treatment options. Yet here we have data showing that patients are surpassing anticipated survival rates and maintaining remission. It is remarkable to see patients going into remission with bexmarilimab/azacitidine after showing disease progression on all the leading azacitidine combinations such as venetoclax, sabatolimab and magrolimab. These are highly significant findings that provide us with continued confidence in the potential of bexmarilimab to provide better patient outcomes and improve the quality of life of those suffering from these aggressive conditions.”

 

An updated corporate deck now contains these data and is available on the Company’s website.

 

For more information please contact:

 

Investor Contact

LifeSci Advisors

Daniel Ferry

Managing Director

daniel@lifesciadvisors.com

+1 (617) 430-7576

 

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.

 

Phase 1 BEXMAB data presented at ASH

 

Faron Pharmaceuticals Ltd.

 

(“Faron” or the “Company”)

 

Inside information: Faron Presents Phase 1 Data from BEXMAB in Myeloid Malignancies Trial at the 65th American Society of Hematology (ASH) Annual Meeting

          Significant overall Response Rate (ORR) achieved in both HR-MDS (5/5) and HMA-failed MDS (5/5) patients

          The vast majority of responses are deep and durable with 7/10 MDS patients achieving CR/mCR and one additional patient transferred to stem cell transplantation

Company Announcement, Inside Information

TURKU, Finland / BOSTON, Massachusetts – December 11, 2023 – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company pioneering macrophage reprogramming for effective anticancer immunotherapies, today announced very positive Phase 1 data from the ongoing BEXMAB study in myeloid malignancies, being presented at the 65th American Society of Hematology (ASH) Annual Meeting & Exposition taking place until tomorrow, December 12, 2023, in San Diego, California, and virtually.

The BEXMAB study is a multicenter study, taking place in Finland and the U.S., evaluating the safety and efficacy of bexmarilimab, a novel anti-Clever-1 humanized antibody, with standard of care in patients with aggressive myeloid leukemias.

“The BEXMAB results continue to improve over time showing remarkable overall response rate in both higher-risk frontline as well as hypomethylating agent (HMA)-failed myelodysplastic syndrome (MDS) patients,” said Dr. Markku Jalkanen, Chief Executive Officer of Faron. “The combination is well-tolerated and generates strong and durable leukemic blast eradication and immune responses. This solidifies bexmarilimab’s unique and leading mechanism of action in the field of myeloid cell re-programming. With this compelling evidence we are well positioned to advance to the Phase 2 part of the BEXMAB study and actively pursue further regulatory interactions to navigate and refine the pivotal pathway for BLA filing”.

Dr. Naval Daver, MD, Professor of Leukemia at The University of Texas MD Anderson Cancer Center and site Principal Investigator of the BEXMAB trial commented: “Addressing MDS poses a considerable therapeutic challenge given the limited efficacy of the current standard of care resulting in relatively low response rate and poor overall survival, especially in TP53 mutated and HMA-failed MDS patient populations. The data presented at ASH are promising, demonstrating a higher ORR and prolonged response duration in this trial compared to published historical benchmarks. These findings underscore the future potential of this combination in advancing the treatment of higher-risk and HMA-failed MDS.”

Poster highlights include:

  • Significant overall response rate observed in both previously HMA-failed (5 out of 5) and higher-risk MDS patient (5 out of 5) populations
  • Observed responses were primarily deep and durable with 7/10 MDS patients achieving CR/mCR, and two demonstrating PR, out of which one moved on to receive a stem cell transplantation and one hematological improvement without remission (HI-P)
  • The majority of higher-risk MDS patients were also TP53 mutated, typically associated with poor responsiveness to standard therapy, however all of them achieved CR/mCR upon receiving the treatment
  • Clinical activity with 13/28 (48%) objective responses observed across all the indications, including r/r AML, and dose levels tested
  • The combination of bexmarilimab and azacitidine remains well tolerated with immune-related adverse events observed at higher dose levels
  • Clever-1 target engagement was confirmed in the bone marrow of treated patients together with an increased antigen presentation capacity and increased numbers of CD8 T and NK cells in patients

 

Poster presentation details:

Title:  Encouraging Efficacy Observed in BEXMAB Study: A Phase 1/2 Study to Assess Safety and Efficacy of Bexmarilimab in Combination with Standard of Care in Myeloid Malignancies

Session Date and Time:  Sunday, December 10, 2023, 6:00 PM – 8:00 PM PST

Session Title: Acute Myeloid Leukemias: Investigational Therapies, Excluding Transplantation and Cellular Immunotherapies: Poster II

Location:  San Diego Convention Center, Halls G-H

Lead Authors:  Mika Kontro, Helsinki University Hospital and University of Helsinki and Naval Daver, The University of Texas MD Anderson Cancer Center

Abstract Number:  2915

For more information on ASH poster, please visit www.faron.com

 

For more information on BEXMAB, please visit ClinicalTrials.gov and reference Identifier NCT05428969.

 

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

For more information please contact:

Investor Contact

LifeSci Advisors

Daniel Ferry

Managing Director

daniel@lifesciadvisors.com

+1 (617) 430-7576

 

ICR Consilium

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilimcomms.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 targeting 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 treatments and as a monotherapy in last line solid cancers. 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.

 

 

 

 

MATINS Trial in Cell Reports Medicine

Faron Pharmaceuticals Ltd.

 

(“Faron” or the “Company”)

 

Faron Announces Publication of Full Analysis from Phase 1/2 MATINS Trial of Bexmarilimab in Solid Tumors in Cell Reports Medicine

 

 

          Bexmarilimab monotherapy shows efficacy in achieving disease control and prolonged survival in late-stage metastatic solid tumors

          CLEVER-1 targeting is safe and well-tolerated with no serious adverse effects

          Bexmarilimab induced macrophage activation and increased IFNɣ signaling in patients who achieved disease control and prolonged survival

 

Press release, December 07, 2023

TURKU, Finland / BOSTON, Massachusetts – December 7, 2023 – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company pioneering macrophage reprogramming for effective anticancer immunotherapies, today announces the publication of the full safety and anti-tumor efficacy results from the first-in-human Phase 1/2 MATINS trial of bexmarilimab in patients with treatment-refractory late-stage solid tumors in Cell Reports Medicine.

The publication, entitled, “Bexmarilimab-induced macrophage activation leads to treatment benefit in solid tumors: the phase I/II first-in-human MATINS trial” is available online at Bexmarilimab-induced macrophage activation leads to treatment benefit in solid tumors: The phase I/II first-in-human MATINS trial: Cell Reports Medicine

“Positive Phase 1/2 data published in Cell Reports Medicine highlights bexmarilimab’s potential to overcome cancer immune resistance by restoring macrophage immune function” said Petri Bono, MD, PhD., Chief Medical Officer, Terveystalo Finland and Principal Investigator of the MATINS study. “We are pleased to see that bexmarilimab was safe and very well-tolerated, achieving disease control and prolonged survival in a proportion of patients with very late-stage solid tumors who have exhausted all standard treatment options. The observed stimulation of immune responses including macrophage activation increased IFNɣ signaling, and improved survival are particularly compelling given the challenging context of the late-stage, treatment-refractory disease patient population and the inclusion of nonimmunogenic cold tumors in this first-in-human trial. These results validate the macrophage-targeted approach and underscore bexmarilimab’s potential as a novel immunotherapy in late-stage cancers, especially resistant to PD-1 blockade. We look forward to generating additional data with this novel and innovative macrophage-targeting immunotherapeutic antibody bexmarilimab.”

 

Clever-1 is highly expressed by the most immunosuppressive macrophages and contributes to impaired antigen presentation and suppression of anti-tumor immunity. Bexmarilimab is a humanized monoclonal anti-CLEVER-1 antibody that activates the immune system and evokes anti-tumor responses. The Phase 1/2 first-in-human MATINS trial evaluated the safety and efficacy of CLEVER-1 blockade with bexmarilimab in patients with treatment-refractory solid tumors.  The monotherapy showed no dose-limiting toxicities and exhibited excellent safety and tolerability in over 200 patients. Observed disease control rates were associated with improved survival and were consistent with higher pre-treatment intratumoral CLEVER-1 levels and low baseline IFNɣ signaling that then increased during treatment. Transcriptomics profiling of the tumors demonstrated that bexmarilimab activates intra-tumoral macrophages and stimulates IFNɣ and T-cell receptors in a proportion of patients, which then leads to disease control and prolonged survival.  

 

For more information on MATINS, please visit ClinicalTrials.gov and reference Identifier NCT03733990.

 

 

 

For more information please contact:

 

Investor Contact

LifeSci Advisors

Daniel Ferry

Managing Director

daniel@lifesciadvisors.com

+1 (617) 430-7576

 

ICR Consilium

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilimcomms.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) 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 targeting 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 and as a monotherapy in last line solid cancers. 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.

 

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