Faron Pharmaceuticals Ltd: Approval of Share Subscriptions Based on Special Rights in connection with Advanced Amortisation of the First Tranche Bonds

Faron Pharmaceuticals Ltd | Company announcement | October 28, 2025 at 09:00:00 EET

Turku, Finland – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company developing novel immunotherapies, announces that the Company has approved the exercise of 451,803 special rights entitling to 451,803 new Shares, for an aggregate subscription price of EUR 844,645.71, in connection with an advanced amortisation payment of the First Tranche Bonds (as defined below), which will occur latest on 29 October 2025.

The Company announced on 3 April 2025 that it had entered into a convertible bond arrangement for up to EUR 35 million with an entity managed by Heights Capital Management, Inc. (“HCM”) and resolved upon the issuance of amortising senior unsecured convertible bonds with an aggregated principal amount of EUR 15 million (the “First Tranche Bonds”) due 2 April 2028 to HCM, convertible into new and/or existing shares in the Company (the “Shares”). HCM (or any future holders of the majority of the First Tranche Bonds) may, at any time between scheduled amortisations, exercise their right to bring forward up to two (2) additional amortisation payments (an “Accelerated Amortisation”) to be paid in advance, with a limit of no more than nine (9) Accelerated Amortisations in the first year of the term of the First Tranche Bonds. As previously announced, the Board of Directors of Faron has resolved to make amortisations and interest payments by converting the relevant amounts due into Shares (“Share Settlement Option”), unless it separately decides to make payments in cash. The exercise of the Company’s Share Settlement Option is effected by the bondholders exercising special rights entitling into Shares, as referred to in Chapter 10 of the Finnish Companies Act (“Special Rights”), issued in connection with the issuance of the First Tranche Bonds.

The Company has on 27 October 2025 received an amortised payment advancement notice from the bondholder for an aggregate amortised payment amount (including accrued interest) of EUR 844,647. As the Company has exercised its Share Settlement Option, the subscription price for the Shares subscribed for by the bondholder is EUR 1.8695 per Share, corresponding to the rate used in the Scheduled Amortisation on 2 October 2025. Therefore, the Company has approved the exercise of 451,803 Special Rights entitling to 451,803 new Shares, for an aggregate subscription price of EUR 844,645.71. The subscription price for the Shares subscribed for pursuant to the Special Rights is paid by setting off the Company’s debt to pay relevant amounts due under the First Tranche Bonds and recorded into the reserve for invested unrestricted equity. The new Maturity Date of the Bond is 2 October 2027.

Admission and Total Voting Rights
The 451,803 Shares subscribed for rank pari passu in all respects with the existing shares of the Company and are admitted to trading on Nasdaq First North Growth Market Finland (“First North“) maintained by Nasdaq Helsinki Ltd (“Nasdaq Helsinki“) and on AIM (“AIM“), the market of that name operated by London Stock Exchange plc (the “LSE“).

Following the issuance, the aggregate number of ordinary shares in the Company will be 118,045,348. Shares held in treasury by the Company do not confer a right to dividends or other shareholder rights. Following the issuance, the Company will continue to have 4,142,678 shares in treasury (issued by the Company to itself previously on 27 May 2025) and therefore, the total number of voting rights in Faron will be 113,902,670 (the “Number of Shares and Votes“). This figure may be used by shareholders as the denominator for the calculations by which they will determine whether they are required to notify an interest in, or a change to their interest in, the Number of Shares and Votes of the Company.

For more information, please contact:

IR Partners, Finland
(Media)

Kare Laukkanen

+358 50 553 9535 / +44 7 469 766 223
kare.laukkanen@irpartners.fi
FINN Partners, US
(Media) 
Alyssa Paldo 
+1 847 791-8085 
alyssa.paldo@finnpartners.com
Cairn Financial Advisers LLP
(Nominated Adviser and Broker)
Sandy Jamieson, Jo Turner
+44 (0) 207 213 0880
Sisu Partners Oy
(Certified Adviser on Nasdaq First North)
Juha Karttunen
Jukka Järvelä
+358 (0)40 555 4727
+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.

FARON PHARMACEUTICALS LTD: HOLDING(S) IN COMPANY

Faron Pharmaceuticals Ltd | Company announcement | October 21, 2025 at 16:10:00 EEST

TR-1: Standard form for notification of major holdings

NOTIFICATION OF MAJOR HOLDINGS (to be sent to the relevant issuer and to the FCA in Microsoft Word format if possible) i
1a. Identity of the issuer or the underlying issuer of existing shares to which voting rights are attached ii: Faron Pharmaceuticals Ltd
1b. Please indicate if the issuer is a non-UK issuer (please mark with an “X” if appropriate)
Non-UK issuer X
2. Reason for the notification (please mark the appropriate box or boxes with an “X”)
An acquisition or disposal of voting rights
An acquisition or disposal of financial instruments X
An event changing the breakdown of voting rights
Other (please specify) iii: Change due the Private Placement
3. Details of person subject to the notification obligation iv
Name Timo Syrjälä
City and country of registered office (if applicable) Monaco
4. Full name of shareholder(s) (if different from 3.) v
Name Acme Investments SPF Sarl
City and country of registered office (if applicable) Luxembourg
5. Date on which the threshold was crossed or reached vi: 20.10.2025
6. Date on which issuer notified (DD/MM/YYYY): 20.10.2025
7. Total positions of person(s) subject to the notification obligation
% of voting rights attached to shares (total of 8. A) % of voting rights through financial instruments
(total of 8.B 1 + 8.B 2)
Total of both in % (8.A + 8.B) Total number of voting rights held in issuer (8.A + 8.B) vii
Resulting situation on the date on which threshold was crossed or reached 15,18 17.225.396
Position of previous notification (if
applicable)
15,00 (14,997%) 16.918.396
8. Notified details of the resulting situation on the date on which the threshold was crossed or reached viii
A: Voting rights attached to shares
Class/type of
shares
ISIN code (if possible)
Number of voting rights ix % of voting rights
Direct
(DTR5.1)
Indirect
(DTR5.2.1)
Direct
(DTR5.1)
Indirect
(DTR5.2.1)
FI4000153309 5.296.452 11.928.944 4,67% 10,51%
SUBTOTAL 8. A 17.225.396 15,18%
B 1: Financial Instruments according to DTR5.3.1R (1) (a)
Type of financial instrument Expiration
date x
Exercise/
Conversion Period xi
Number of voting rights that may be acquired if the instrument is
exercised/converted.
% of voting rights
SUBTOTAL 8. B 1
B 2: Financial Instruments with similar economic effect according to DTR5.3.1R (1) (b)
Type of financial instrument Expiration
date x
Exercise/
Conversion Period xi
Physical or cash
Settlement xii
Number of voting rights % of voting rights
SUBTOTAL 8.B.2
9. Information in relation to the person subject to the notification obligation (please mark the
applicable box with an “X”)
Person subject to the notification obligation is not controlled by any natural person or legal entity and does not control any other undertaking(s) holding directly or indirectly an interest in the (underlying) issuer xiii
Full chain of controlled undertakings through which the voting rights and/or the
financial instruments are effectively held starting with the ultimate controlling natural person or legal entity (please add additional rows as necessary) xiv
X
Name xv % of voting rights if it equals or is higher than the notifiable threshold % of voting rights through financial instruments if it equals or is higher than the notifiable threshold Total of both if it equals or is higher than the notifiable threshold
Timo Syrjälä (Direct) 4,67% 4,67%
Acme Investments SPF Sarl (Indirect) 10,51% 10,51%
10. In case of proxy voting, please identify:
Name of the proxy holder
The number and % of voting rights held
The date until which the voting rights will be held
11. Additional information xvi
Acme Investment SPF Sarl is fully owned by Timo Syrjälä
Place of completion Monaco
Date of completion 20.10.2025

Updated BEXMAB Phase I/II Data presented at ESMO 2025 shows further improvement, strengthening the clinical profile of bexmarilimab in treatment-naïve HR-MDS patients

Faron Pharmaceuticals Ltd | Company announcement | October 20, 2025 at 09:00:00 EEST

Updated BEXMAB Phase I/II Data presented at ESMO 2025 shows further improvement, strengthening the clinical profile of bexmarilimab in treatment-naïve HR-MDS patients with an 85% ORR and a 45% CR rate, bolstered by pharmacodynamic insights

New biomarker data reveals strong correlation between target engagement and clinical response with 100% ORR in treatment-naïve, low blast count (<5%) patients

Key highlights:

  • Bexmarilimab and azacitidine combination resulted in an 85% objective response rate (ORR; 17/20 evaluable patients) and a 45% complete remission (CR) rate (9/20) in treatment-naïve patients with higher-risk myelodysplastic syndrome (HR-MDS)
  • 55% (11/20) of treatment-naïve patients with HR-MDS showed full clearance of bone marrow (BM) blasts
  • Deeper BM engagement in treatment-naïve patients with <5% bone marrow blasts at baseline translated to 100% ORR, one of the best results ever reported in this patient population
  • 23% of patients across the BEXMAB study were successfully bridged to a potentially curative stem cell transplant (SCT)
  • Faron will be hosting a virtual webinar to discuss the updated BEXMAB data presented at ESMO 2025 on 23 October at 4pm EEST/9am ET.

Turku, Finland– Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on tackling cancers through novel immunotherapies, today announced that updated data from the Phase I/II BEXMAB study continues to show significant clinical activity for bexmarilimab. The findings, presented in an oral session at the European Society for Medical Oncology (ESMO) Congress 2025 by Dr. Mika Kontro from Helsinki University Hospital, not only confirm the high response rates seen in earlier analyses but also provide a clear pharmacodynamic rationale linking the drug’s mechanism of action directly to patient outcomes.  

The BEXMAB study evaluates bexmarilimab (1, 3, or 6 mg/kg weekly in 28-day cycles), a first-in-class monoclonal antibody targeting the Clever-1 receptor, in combination with azacitidine, a standard-of-care hypomethylating agent (HMA). By blocking Clever-1, bexmarilimab reprograms macrophages in the bone marrow, enhancing anti-tumor immunity. The data presented at ESMO 2025 included 21 treatment-naïve (20 evaluable for efficacy) and 32 relapsed/refractory (r/r) HMA-failed patients with HR-MDS.

The updated data presented at ESMO 2025 reinforces the efficacy previously observed for the bexmarilimab and azacitidine combination. In 20 evaluable treatment-naïve patients, the study confirmed an 85% ORR and a 45% CR rate. These high response rates were observed in a difficult-to-treat population, where over 66% of patients were classified as high to very high risk at baseline. The combination also showed robust activity in patients with high-risk mutations like mTP53, achieving an ORR of 78%.  

In the r/r HMA-failed population (n=32), the combination achieved a 63% ORR and a median overall survival (mOS) of 13.4 months. Notably, nearly a third of these patients (31.3%) had received prior therapy with the Bcl-2 inhibitor venetoclax.  

About 23% of patients across the BEXMAB study were successfully bridged to a potentially curative stem cell transplant (SCT).

The most significant update is the new pharmacodynamic data that provided a clear biological explanation for the strong clinical results. The analysis showed a statistically significant correlation (p=0.0006) between deeper engagement of the Clever-1 target in the bone marrow and a positive clinical response. This correlation was particularly striking in the subgroup of treatment-naïve patients with <5% bone marrow blasts at baseline (38% of the cohort), a population for which effective, non-intensive therapies are urgently needed. In these patients, deeper target engagement translated to a 100% ORR, supporting bexmarilimab’s unique mechanism of action as a truly disease modifying agent, differentiating it from other investigational HR-MDS therapies, such as Bcl-2 inhibitors. For patients with a higher blast count (>5% at baseline), the ORR remained high at 75%.

With the result of this data, Faron is preparing for the next stage of development. Following guidance from the FDA announced on 18 August 2025, the Company has begun preparations for the dose-optimization stage of its Phase II/III trial for bexmarilimab, after which the trial will transition into the registrational stage with accelerated approval possibility. The combination therapy continues to be well-tolerated, with a safety profile similar, or even better to, azacitidine monotherapy. Only 36% of treatment-emergent adverse events were considered related to bexmarilimab, with no Grade 5 events.

Dr. Mika Kontro, MD, PhD, Associate Professor at University of Helsinki and Helsinki University Hospital Comprehensive Cancer Center, Department of Hematology said, “The BEXMAB data are encouraging, and the new biomarker analysis provides a clear pharmacodynamic rationale for bexmarilimab’s clinical activity. The direct correlation between how deeply we engage the Clever-1 target in the bone marrow and a patient’s clinical response reinforces the drug’s mechanism. The 100% ORR in patients with low blast counts suggest that this therapy may help in a population where current investigational treatments, including Bcl-2 inhibitors, have significant limitations.”

Dr. Maija Hollmén, PhD, Chief Scientific Officer of Faron Pharmaceuticals, added, The selection of this BEXMAB data for an oral presentation at ESMO is a significant external validation of our science and the clinical potential of bexmarilimab. These findings help us understand why the drug works and for whom it works best. The clear biomarker impact in the bone marrow and unique efficacy in patients with low blast counts highlights Bex’s ability to change the course of the disease and provides a solid foundation for our late-stage clinical development, bringing this promising therapy to patients who desperately need better options.”

To register for the event visit: ESMO 2025. The details of the ESMO oral presentation are as follows:

Presentation title: Macrophage reprogrammer Bexmarilimab Plus Azacitidine in Myelodysplastic Syndrome: PK/PD and biomarker results from the Phase I/II BEXMAB Study

Presented by: Dr. Mika Kontro

Session type and title: Mini Oral Session: Haematological Malignancies

Room: Solingen Auditorium – Hall 23

Session date & time: Oct 19, 2025 (9:31 to 9:36 am CEST)

Abstract no.: 1249MO

This announcement contains inside information for the purposes of Article 7 of the EU Regulation 596/2014 (“MAR”) and Article 7 of MAR as incorporated into UK domestic law by virtue of the European Union (Withdrawal) Act 2018 (“UK MAR”).

For more information, please contact:

IR Partners, Finland
(Media)

Kare Laukkanen

+358 50 553 9535 / +44 7 469 766 223
kare.laukkanen@irpartners.fi
FINN Partners, US
(Media) 
Alyssa Paldo 
+1 847 791-8085 
alyssa.paldo@finnpartners.com
Cairn Financial Advisers LLP
(Nominated Adviser and Broker)
Sandy Jamieson, Jo Turner
+44 (0) 207 213 0880
Sisu Partners Oy
(Certified Adviser on Nasdaq First North)
Juha Karttunen
Jukka Järvelä
+358 (0)40 555 4727
+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.

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 Pharmaceuticals Ltd: Registration of New Shares

Faron Pharmaceuticals Ltd | Company announcement | October 03, 2025 at 13:00:00 EEST

Capitalised terms used in this announcement have the meanings given to them in the announcement made at 9.00 a.m. EEST 3 October 2025 regarding the amortisation payment and approval of share subscriptions based on special rights, unless the context provides otherwise.

Turku, Finland – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company developing novel immunotherapies, has, as announced earlier today on 3 October 2025, approved the exercise of 527,948 Special Rights entitling to 527,948 new Shares, for an aggregate subscription price of EUR 986,998.79.

In total 527,948 new shares in the Company have today on 3 October 2025 been registered in the Finnish Trade Register. The shares rank pari passu in all respects with the existing shares of the Company. Following the issuance, the aggregate number of ordinary shares in the Company is 117,593,545. Shares held in treasury by the Company do not confer a right to dividends or other shareholder rights. Following the registration, the Company continues to have 4,142,678 shares in treasury and therefore, the total number of voting rights in Faron is 113,450,867 (the “Number of Shares and Votes”). This figure may be used by shareholders as the denominator for the calculations by which they will determine whether they are required to notify an interest in, or a change to their interest in, the Number of Shares and Votes of the Company.

Trading in the new shares is expected to commence on First North and AIM on or around 6 October 2025.

For more information, please contact:

IR Partners, Finland
(Media)

Kare Laukkanen

+358 50 553 9535 / +44 7 469 766 223
kare.laukkanen@irpartners.fi
FINN Partners, US
(Media) 
Alyssa Paldo 
+1 847 791-8085 
alyssa.paldo@finnpartners.com
Cairn Financial Advisers LLP
(Nominated Adviser and Broker)
Sandy Jamieson, Jo Turner
+44 (0) 207 213 0880
Sisu Partners Oy
(Certified Adviser on Nasdaq First North)
Juha Karttunen
Jukka Järvelä
+358 (0)40 555 4727
+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.

Faron Pharmaceuticals Ltd: Approval of Share Subscriptions Based on Special Rights in connection with Amortisation of the First Tranche Bonds

Faron Pharmaceuticals Ltd | Company announcement | October 03, 2025 at 09:00:00 EEST

Turku, Finland – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company developing novel immunotherapies, announces that the Company has approved the exercise of 527,948 special rights entitling to 527,948 new Shares, for an aggregate subscription price of EUR 986,998.79, in connection with the scheduled amortisation payment of the First Tranche Bonds (as defined below), occurred on 2 October 2025.

The Company announced on 3 April 2025 that it had entered into a convertible bond arrangement for up to EUR 35 million with an entity managed by Heights Capital Management, Inc. (“HCM”) and resolved upon the issuance of amortising senior unsecured convertible bonds with an aggregated principal amount of EUR 15 million (the “First Tranche Bonds”) due 2 April 2028 to HCM, convertible into new and/or existing shares in the Company (the “Shares”). As previously announced, the Board of Directors of Faron has resolved to make amortisations and interest payments by converting the relevant amounts due into Shares (“Share Settlement Option”), unless it separately decides to make payments in cash. The exercise of the Company’s Share Settlement Option is effected by the bondholders exercising special rights entitling into Shares, as referred to in Chapter 10 of the Finnish Companies Act (“Special Rights”), issued in connection with the issuance of the First Tranche Bonds.

The Company has received a scheduled amortised payment notice from the bondholder for an aggregate amortised payment amount (including accrued interest) of EUR 987,000. As the Company has exercised its Share Settlement Option, the subscription price for the Shares subscribed for by the bondholder is EUR 1.8695 per Share, corresponding to 90 per cent of the lowest of (i) the volume weighted average price (“VWAP”) of a Share on the relevant payment date, and (ii) the lowest of the VWAPs of a Share on each of the five consecutive dealing days ending on (and including) the dealing day immediately preceding the relevant payment date. Therefore, the Company has approved the exercise of 527,948 Special Rights entitling to 527,948 new Shares, for an aggregate subscription price of EUR 986,998.79.The subscription price for the Shares subscribed for pursuant to the Special Rights is paid by setting off the Company’s debt to pay relevant amounts due under the First Tranche Bonds and recorded into the reserve for invested unrestricted equity.

The 527,948 Shares subscribed for and issued are expected to be registered in the Finnish Trade Register on or around 3 October 2025. The Shares will rank pari passu in all respects with the existing shares of the Company once they are registered with the Finnish Trade Register.

The Company will make applications for the admission of the newly issued Shares to trading on Nasdaq First North Growth Market Finland (“First North“) maintained by Nasdaq Helsinki Ltd (“Nasdaq Helsinki“) and on AIM (“AIM“), the market of that name operated by London Stock Exchange plc (the “LSE“) with said admissions expected to become effective and trading to commence on or around 6 October 2025 (the “Admissions”).

Following the issuance, the aggregate number of ordinary shares in the Company is 117,593,545. Shares held in treasury by the Company do not confer a right to dividends or other shareholder rights. Following the registration, the Company will continue to have 4,142,678 shares in treasury (issued by the Company to itself previously on 27 May 2025) and therefore, the total number of voting rights in Faron will be 113,450,867 (the “Number of Shares and Votes“). This figure may be used by shareholders as the denominator for the calculations by which they will determine whether they are required to notify an interest in, or a change to their interest in, the Number of Shares and Votes of the Company.

For more information, please contact:

IR Partners, Finland
(Media)
Kare Laukkanen
+358 50 553 9535 / +44 7 469 766 223
kare.laukkanen@irpartners.fi
FINN Partners, US
(Media) 
Alyssa Paldo 
+1 847 791-8085 
alyssa.paldo@finnpartners.com
Cairn Financial Advisers LLP
(Nominated Adviser and Broker)
Sandy Jamieson, Jo Turner
+44 (0) 207 213 0880
Sisu Partners Oy
(Certified Adviser on Nasdaq First North)
Juha Karttunen
Jukka Järvelä
+358 (0)40 555 4727
+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.

Faron Pharmaceuticals Ltd: Exercise of Options, Director Dealing and Issue of Equity

Faron Pharmaceuticals Ltd | Company announcement | September 19, 2025 at 09:00:00 EEST

Exercise of Options, Director Dealing and Issue of Equity

TURKU, FINLAND – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on developing novel immunotherapies, announces today that it has received notifications from option holders to exercise 2015D options over 111,000 ordinary shares in the Company at an exercise price of EUR 1.09 per share, raising gross proceeds of approximately EUR 120,990 under the Company’s 2015 Option Plan (“New Ordinary Shares”). The terms and conditions of the 2015 Option Plan are available on the Company’s website.

As part of the above exercise of 2015D options, Juho Jalkanen, Chief Executive Officer of the Company, has given notice to exercise options over 30,000 new ordinary shares and Yrjö Wichmann Chief Financial Officer, has given notice to exercise options over 30,000 new ordinary shares. Further details are set out in the Notification of Dealing Form below.

Director Holding prior to purchase Number of ordinary shares Resultant interest in ordinary shares in the Company Resultant percentage of voting rights in the Company
Juho Jalkanen 1,112,015 30,000 1,142,015 1.01%
Yrjö Wichmann 98,132 30,000 128,132 0.11%

Admission and Total Voting Rights
Applications will be made to Nasdaq First North Growth Market Finland (“First North“) maintained by Nasdaq Helsinki Ltd (“Nasdaq Helsinki“) and on AIM (“AIM“), the market of that name operated by London Stock Exchange plc (the “LSE“). Admission of the New Ordinary Shares is expected to occur on or around 10 October 2025 following issue and registration of the New Ordinary Shares on or around 9 October 2025 (“Registration”). The New Ordinary Shares will rank pari passu with existing ordinary shares.

Following the issuance, the aggregate number of ordinary shares in issue in the Company remains will be 117,065,597. Shares held in treasury by the Company do not confer a right to dividends or other shareholder rights. Following the issuance, the Company will have 4,142,678 shares in treasury and therefore, the total number of voting rights in Faron will be 112,922,919 (the “Number of Shares and Votes“). This figure may be used by shareholders as the denominator for the calculations by which they will determine whether they are required to notify an interest in, or a change to their interest in, the Number of Shares and Votes of the Company.

For more information, please contact:

IR Partners, Finland
(Media)
Kare Laukkanen

+358 50 553 9535 / +44 7 469 766 223
kare.laukkanen@irpartners.fi

FINN Partners, US
(Media) 
Alyssa Paldo 

+1 847 791-8085 
alyssa.paldo@finnpartners.com
Cairn Financial Advisers LLP
(Nominated Adviser and Broker)
Sandy Jamieson, Jo Turner
+44 (0) 207 213 0880
Sisu Partners Oy
(Certified Adviser on Nasdaq First North)
Juha Karttunen
Jukka Järvelä
+358 (0)40 555 4727
+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 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 Juho Jalkanen
Yrjö Wichmann
2 Reason for notification  
a. Position/Status Chief Executive Officer
Chief Financial Officer
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 Ltd.
b. LEI 7437009H31TO1DC0EB42
4 Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducted
a. Description of the financial instrument, type of instrument

Identification Code

Options over ordinary shares

ISIN: FI4000153309

b. Nature of the transaction Exercise of Options
Purchase of ordinary shares
  Price(s) per share (p) Volume(s)
EUR 1.09
EUR 1.09
30,000
30,000
d. Aggregated information
Volume
Price

N/A

e. Date of the transaction 17 September 2025
f. Place of the transaction Nasdaq First North Growth Market

Correction: FARON PHARMACEUTICALS LTD: HALF-YEAR FINANCIAL RESULTS 1 JANUARY – 30 JUNE 2025

Faron Pharmaceuticals Ltd | Company announcement | September 12, 2025 at 18:25:00 EEST

TURKU, Finland – Faron Pharmaceuticals Ltd (AIM: FARN, First North: FARON) announces a correction to the company announcement of its half-year financial results 1 January – 30 June 2025, originally published on August 27, 2025. The original company announcement omitted the income statement, balance sheet and cash flow statements required by the AIM market rules to be included in the announcement. In the original announcement, they were only included as a pdf attachment as required by the rules of Nasdaq First North Growth Market. The aforementioned financial statements have been added to the original company announcement in this correction. The corrected company announcement in full can be found below. The full half-year report attached to this company announcement remains unchanged.

Significant clinical and financial milestones achieved in first half of 2025

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, has published its unaudited half-year financial results for the six months ended 30 June 2025, on 27 August 2025.

Figures in parentheses refer to the corresponding period of previous year, unless otherwise indicated.
This half-year report is unaudited.

January–June 2025 in brief

  • On 31 January 2025, Faron announced the identification of the final patient for the BEXMAB phase II dose optimization study in refractory or relapsed myelodysplastic syndrome (r/r MDS), as well as the BEXMAB phase I/II study in frontline high-risk (HR) MDS.
  • On 5 February 2025, Faron carried out a significantly oversubscribed private placement of newly issued treasury shares, raising gross proceeds of EUR 12 million in total.
  • On 27 February 2025, Faron received a positive opinion on orphan drug designation for bexmarilimab for the treatment of MDS by EMA, and on 3 March 2025, the FDA granted an orphan drug designation for bexmarilimab in MDS.
  • On 21 March 2025, Mr. Colin Bond and Dr. Juho Jalkanen, the CEO of the Company, were appointed as members to the Board of Directors.
  • On 3 April 2025, Faron entered into an up to EUR 35 million unsecured convertible bond arrangement with Heights Capital Management Inc. (“HCM”) to repay its secured loan to IPF Partners and strengthen its financial position and issued first tranche of bonds with a principal amount of EUR 15 million.
  • On 15 April 2025, Faron announced positive phase II results in HR-MDS.
  • During the review period, Faron gave multiple oral presentations of bexmarilimab data at the several prestigious scientific forums in the field; in May, the 18th International Congress on Myelodysplastic Syndromes (MDS 2025); in May–June, the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting; and in June, the 30th European Hematology Association’s (EHA 2025) Congress.
  • On 28 May 2025, Faron appointed seasoned commercial development expert, Ralph Hughes, as Chief Business Officer.
  • On 30 May 2025, Faron announced the publication of full phase I BEXMAB study data in one of the top medical journals – the Lancet Haematology.
  • On 12 June 2025, Faron presented the updated phase II data from the BEXMAB study, showing strong efficacy and survival outcomes with bexmarilimab in HR-MDS supporting the advancement to phase III.
  • Faron’s other operating income was EUR 0 (0)
  • R&D expenses were EUR 7.1 (6.7) million
  • Operating loss for the reporting period was EUR -11.9 (-11.3) million
  • Loss per share was EUR 0.18 (0.20)
  • On 30 June 2025, cash and cash equivalents were EUR 13.5 (30.0) million
  • Net assets were EUR -16.2 million (1.4) million

Significant events after the reporting period

  • On 7 July 2025, Faron announced the acceptance of two studies involving its lead candidate, bexmarilimab, for presentation at the 19th IUIS International Congress of Immunology in Vienna, Austria, in August 2025.
  • On 11 July 2025, Business Finland informed Faron that they had approved the Company’s application to forgive an R&D loan related to the development of Traumakine. The forgiveness applies also to accumulated interest. This will have a positive impact of EUR 1.3 million on Operating Profit on the second half of 2025.
  • On 30 July 2025, Faron announced that new clinical and translational data from the phase I/II BEXMAB study evaluating bexmarilimab in combination with azacitidine in HR-MDS will be orally presented at the 2025 European Society for Medical Oncology (ESMO) Congress, in October 2025, in Berlin, Germany.
  • On 6 August 2025, Faron announced an increase in the complete remission (CR) rate in patients with frontline or treatment-naïve HR-MDS, based on updated efficacy data from its phase I/II BEXMAB trial. According to the investigator-assessed response using IWG 2006 criteria, as per protocol, the CR rate has increased to 43% (9 out of 21 patients), a substantial improvement from the 28% rate, seen in the earlier data cut. This data builded on the phase II early results featured in recent oral presentation at the 2025 American Society of Clinical Oncology (ASCO) meeting.
  • On 18 August 2025, Faron announced positive feedback received from the U.S Food and Drug Administration (FDA) as part of the Company’s recent BEXMAB study’s end-of-phase II (EOP2) meeting. Faron will advance bexmarilimab into a registrational phase II/III study for patients with the treatment-naïve (frontline) HR-MDS. The FDA confirmed IWG 2023-defined CR + CReq as an acceptable primary endpoint with overall survival (OS) as a co-primary endpoint to support an application for accelerated approval making the entire HR MDS market accessible to Faron with one single trial and accelerated approval possibility for all HR MDS patients.

Consolidated key figures, IFRS

EUR ’000 unless otherwise indicated 1-6/2025 1-6/2024 1-12/2024 (audited)
Other operating income 0 0 0
Research and development expenses (7,115) (6,662) (11,744)
General and administrative expenses (4,794) (4,628) (6,929)
Operative loss for the reporting period (11,909) (14,395) (18,673)
Loss per share EUR (0,18) (0.20) (0.29)
Number of shares at end of period 111,954,597 104,624,864 104,624,864
Average number of shares 107,403,444 70,452,291 88,518,654
Cash and cash equivalents 13,532 29,979 9,503
Equity (16,246) 1,379 (9,762)
Balance sheet total 16,204 35,460 12,521

Outlook for 2025

Due to the nature of Faron Pharmaceuticals’ business, the company does not provide a short-term outlook.

CEO Statement

”I’m extremely proud of our people and what we have accomplished in the first half of 2025. We have achieved a number of our main business goals: fully enrolled our BEXMAB phase II study, published very strong phase II efficacy data for bexmarilimab and had the privilege to present it at the world’s leading oncology conferences, we received a series of regulatory designations, enhanced our management team and substantially strengthened our financial position. These are absolutely outstanding results from a team of our size.

Strong BEXMAB data supports path to single registrational trial for the entire HR MDS population

In the first half of the year, the clinical development program for our lead asset, bexmarilimab made strong and consistent progress. In January, we identified the final patient for the BEXMAB phase II part in refractory or relapsed myelodysplastic syndrome (r/r MDS), as well as the BEXMAB phase I/II study in frontline high-risk (HR) MDS.

In June, at EHA we presented the phase II response data from the BEXMAB study, showing strong response rates in frontline HR MDS and r/r MDS, as well exceptional survival in r/r MDS, for which the follow-up data is more mature. The results support the advancement into single phase II/III registrational trial in frontline HR MDS making the entire HR MDS market accessible for Faron at one go. This was later confirmed in August in BEXMAB’s EOP2 meeting with the FDA.

Especially for r/r MDS patients, for whom treatment options are limited, our data were highly encouraging. Bexmarilimab’s estimated median overall survival (mOS) was approximately 13.4 months, compared to the 5-6 months that would typically be expected under standard of care. The BEXMAB study also demonstrated significant efficacy in patients with r/r MDS with a high objective response rate (ORR) of 63%. An ORR of 81% and an outstanding CR rate of 43% was observed in frontline HR MDS patients according to the study protocol criteria. These results, especially the new frontline MDS patient data, suggest a potential to transform the treatment paradigm for the entire disease.

In the spring, both the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA) granted us opinion on Orphan Drug Designation for bexmarilimab for the treatment of MDS. The FDA and EMA designations allow us to receive important regulatory guidance and protocol assistance for the development of bexmarilimab. The FDA designation also qualifies the sponsor of the drug for certain development incentives, including tax credits for qualified clinical testing and prescription drug user fee exemptions. In addition, Orphan Drug Designations offer market exclusivity once the medicine is on the market.

Strengthening our financial position

We substantially strengthened our financial by an oversubscribed EUR 12 million placing in February and an up to EUR 35 million convertible bond arrangement in April. The first tranche of bonds with a principal amount of EUR 15 million was issued in April, and we have the option to issue two additional tranches, each with a principal amount of EUR 10 million. The proceeds from the first tranche were used to repay the outstanding loan from IPF Partners and for general corporate purposes, extending our cash runway into the first quarter of 2026. The bond arrangement also increased our flexibility by reducing restrictive cash covenants and releasing our patents that were pledged as a security for a loan from IPF Partners.

Challenging operating environment

Capital markets and uncertainty in the biopharma and life sciences sectors remained challenging in the first half of this year. This was partly driven by the concerns related to constrained access to funding, drug-pricing policy changes and cautious dealmaking amid regulatory and macroeconomic uncertainties. However, as the first six months of this year prove, there is always demand for high-quality biopharmaceutical companies – like Faron – that can show consistent progress and positive data from their clinical development programs. Late stage and close to market assets remain attractive to large pharmaceutical companies.

The FDA has become stricter on oncology drug approvals, moving away from single arm trials and surrogate endpoints and putting more weight on randomized data against a comparator with survival as the most important endpoint. This has had little impact on us, since thanks to our scientific advice meeting with the FDA last year, we have already been building the case around bexmarilimab with survival in our mind and using a randomized setting against a comparator, i.e. the frontline setting in HR MDS. We were very happy to see that the FDA was willing to accept a response based surrogate endpoint at an interim read out as the basis of accelerated approval in frontline HR MDS, which highlights the big unmet need in this indication.

New blood to our Board and Management Team

In the first half of this year, we reinforced our management team and Board of Directors. In March, Mr. Colin Bond joined our Board, bringing extensive international experience from the finance, CDMO and biopharma industries. At the same time, I was also proud to assume the role of a member of Faron’s Board, while continuing as CEO. In May, Mr. Ralph Hughes joined our management team to strengthen Faron’s commercial strategy, business development and market assessment functions. These appointments enhance our expertise enabling us to better navigate the complexities of our competitive and rapidly evolving sector and to reach our strategic objectives.

Unique achievements for Faron in scientific forums

The medical industry continues to recognize the therapeutic potential of bexmarilimab. We were proud to present our data in oral sessions at all three leading oncology conferences: the European Hematology Association’s (EHA) Congress, American Society of Clinical Oncology Annual Meeting (ASCO) and International Congress on Myelodysplastic Syndromes (MDS 2025). Securing oral presentation in all three conferences – recognized as the premier scientific forums in our field – and having our data published in Lancet are exceptional for any company and especially in the context of Finnish drug development, and we are humbled by them. I could not be prouder and more grateful of our incredible team. I would also like to deeply thank all our shareholders who have supported this important work to bring a new cancer treatment to life.

Solid tumor research progressing as planned

Our research on solid tumors continues to make important progress. In May 2025, two articles were published in the Journal for ImmunoTherapy of Cancer, highlighting the significance of CLEVER-1 in solid tumors and deepening our understanding of the tumor microenvironment’s influence. The results suggested that bexmarilimab stimulated response in immunologically-cold tumors and inhibited inflammation in treatment resistant tumors. The results can potentially impact the design of future trials for bexmarilimab in solid tumors. The BLAZE trial for the treatment of checkpoint inhibitor refractory metastatic lung cancer and melanoma has gained ethical approval and is in its final stages of contracting. In addition, Faron has reached an agreement with the Helsinki University Hospital to join the national FINPROVE Study to investigate bexmarilimab in combination with standard chemotherapy for the treatment of metastatic breast cancer. This will be the first ever bexmarilimab trial that will use prospective patient selection for Clever-1 positivity.

Outlook

Many BEXMAB patients in r/r MDS remain on drug and are doing well, so giving the final survival readout is delayed, which is a good thing. Same goes to frontline patients where many have moved on to transplant and if all go well for the patients, we will not be getting survival data for frontline HR MDS any time soon. Next, we’ll be reporting on the dynamic positive changes that happen in the body when treated with Bex and Aza together at the annual ESMO congress, and then further follow-up data at ASH towards the end of the year. Meanwhile we will be interacting with EMA and other regulatory agencies on the phase II/III trial. We are decisively progressing toward the initiation of the phase II/III registrational trial for HR MDS in parallel with partnering discussions. We are now well equipped to enter the next phase of commercial discussions and are continuously exploring different options we have to ensure maximising Faron’s shareholder value while progressing the development of bexmarilimab in both solid tumors and hematological malignancies. Faron’s financial position is good. Our current cash runway extends until 2026, and with the remaining two tranches of convertible bonds we have the needed flexibility to make the next business decisions. This gives us the opportunity to maximize shareholder value as we prepare to progress bexmarilimab into its final stage of development for the treatment of HR MDS.

Faron’s first half of 2025 was remarkable, and I am looking forward to the second half of this year with eager anticipation. If H1 was the time of strong and steady development, then H2 is the time for business.”

Tables

Consolidated Income Statement, IFRS

  Unaudited Unaudited Audited
EUR ’000 1-6/2025
 6 months
1-6/2024
 6 months
1-12/2024
 12 months
Other operating income 0 0 0
Research and development expenses (7,115) (6,662) (11,744)
General and administrative expenses (4,794) (4,628) (6,929)
Operating loss (11,909) (11,290) (18,673)
Financial income 602 1,292 434
Financial expense (8,115) (4,350) (7,676)
Loss before tax (19,423) (14,349) (25,915)
Tax expense 0 -46 (5)
Loss for the period (19,423) (14,395) (25,920)
       
Other comprehensive gain/loss 0 11 9
Total comprehensive loss for the period (19,423) (14,384) (25,911)
       
Loss per ordinary share      
Basic and diluted loss per share, EUR (0.18) (0.20) (0.29)

 
Consolidated Balance Sheet, IFRS

EUR ‘000 30 June 2025 30 June 2024
Assets    
Non-current assets    
Machinery and equipment 1 3
Right-of-use-assets 249 344
Intangible assets 1,111 1,086
Prepayments and other receivables 39 60
Total non-current assets 1,399 1,494
Current assets    
Prepayments and other receivables 1,273 3,987
Cash and cash equivalents 13,532 29,979
Total current assets 14,805 33,966
Total assets 16,204 35,460
     
Equity and liabilities    
Capital and reserves attributable to the equity holders of Faron
Share capital 2,691 2,691
Reserve for invested unrestricted equity 197,187 184,866
Accumulated deficit (216,137) (186,181)
Translation difference 13 3
Total equity (16,246) 1,379
Provisions    
Other provisions 0 0
Total provisions 0 0
Non-current liabilities    
Borrowings 21,309 8,706
Lease liabilities 138 239
Other liabilities 3,176 1,643
Total non-current liabilities 24,623 10,588
Current liabilities    
Borrowings 834 3,672
Lease liabilities 127 105
Trade payables 5,634 17,473
Accruals and other current liabilities 1,232 2,243
Total current liabilities 7,827 23,493
Total liabilities 32,450 34,081
Total equity and liabilities 16,204 35,460

 
Consolidated Cash Flow Statement, IFRS

  Unaudited Unaudited Audited
  1-6.2025 1-6.2024 1-12-2024
12 months
EUR ‘000 6 months 6 months  
       
Cash flow from operating activities      
Loss before tax (19,423) (14,349) (25,915)
Adjustments for:      
Received grant 0 0 0
Depreciation and amortization 151 158 314
Change in provision 0 0 0
Financial items 7,513 3,059 7,242
       
Share-based compensation 706 369 694
Adjusted loss from operations before changes in working capital (11,052) (10,764) (17,665)
Change in net working capital:      
Prepayments and other receivables 296 (2,127) 444
Trade payables 758 5,557 (4,095)
Other liabilities (223) (593) (947)
Cash used in operations (10,221) (7,926) (22,263)
       
Income tax paid 0 (150) (41)
Interest received 19 0 361
Interest paid (208) (617) (1,028)
Net cash used in operating activities (10,410) (8,693) (22,971)
       
Cash flow from investing activities      
Payments for intangible assets (101) (123) (225)
Payments for equipment 0 0 (1)
Net cash used in investing activities (101) (123) (226)
       
Cash flow from financing activities      
Proceeds from issue of shares 12,000 35,500 31,850
Share issue transaction cost (676) (498) (4,951)
Proceeds from borrowings 13,892 3200 3,200
Repayment of borrowings (7,993) (5,314) (3,371)
Transaction and structuring fees of borrowings (2,500) (750) (750)
Proceed from grants 0 (28) 0
Payment of lease liabilities (50) (337) (162)
Net cash from financing activities 14,673 31,773 25,816
       
Net increase (+) / decrease (-) in cash and cash equivalents 4,029 23,103 2,627
Effect of exchange rate changes on cash and cash equivalents (133) (145) (8)
       
Cash and cash equivalents at 1 January / 1 July 9,503 6,876 6,876
Cash and cash equivalents at 31 December 13,532 29,979 9,503

 
Virtual briefing and Q&A session

A virtual briefing and Q&A session for investors, analysts and media will be hosted by Dr. Juho Jalkanen, Chief Executive Officer, Yrjö Wichmann, Chief Financial Officer and Dr. Petri Bono, Chief Medical Officer, at 09:00 am (EDT) / 2:00 pm (BST) / 4:00 pm (EEST) on Wednesday, 27 August 2025. Webcast registration link: Faron 2025 Half-Year Financial Results

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

For more information, please contact:

Kare Laukkanen
+358 50 553 9535 / +44 7 469 766 223
kare.laukkanen@irpartners.fi

FINN Partners, US (media) 
Alyssa Paldo 
+1 847 791-8085 
alyssa.paldo@finnpartners.com

Cairn Financial Advisers LLP, Nominated Adviser and Broker
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

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.

FARON PHARMACEUTICALS LTD: HALF-YEAR FINANCIAL RESULTS 1 JANUARY – 30 JUNE 2025

Faron Pharmaceuticals Ltd | Company announcement | August 27, 2025 at 09:00:00 EEST

Significant clinical and financial milestones achieved in first half of 2025

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, has published its unaudited half-year financial results for the six months ended 30 June 2025, on 27 August 2025.

Figures in parentheses refer to the corresponding period of previous year, unless otherwise indicated.
This half-year report is unaudited.

January–June 2025 in brief

  • On 31 January 2025, Faron announced the identification of the final patient for the BEXMAB phase II dose optimization study in refractory or relapsed myelodysplastic syndrome (r/r MDS), as well as the BEXMAB phase I/II study in frontline high-risk (HR) MDS.
  • On 5 February 2025, Faron carried out a significantly oversubscribed private placement of newly issued treasury shares, raising gross proceeds of EUR 12 million in total.
  • On 27 February 2025, Faron received a positive opinion on orphan drug designation for bexmarilimab for the treatment of MDS by EMA, and on 3 March 2025, the FDA granted an orphan drug designation for bexmarilimab in MDS.
  • On 21 March 2025, Mr. Colin Bond and Dr. Juho Jalkanen, the CEO of the Company, were appointed as members to the Board of Directors.
  • On 3 April 2025, Faron entered into an up to EUR 35 million unsecured convertible bond arrangement with Heights Capital Management Inc. (“HCM”) to repay its secured loan to IPF Partners and strengthen its financial position and issued first tranche of bonds with a principal amount of EUR 15 million.
  • On 15 April 2025, Faron announced positive phase II results in HR-MDS.
  • During the review period, Faron gave multiple oral presentations of bexmarilimab data at the several prestigious scientific forums in the field; in May, the 18th International Congress on Myelodysplastic Syndromes (MDS 2025); in May–June, the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting; and in June, the 30th European Hematology Association’s (EHA 2025) Congress.
  • On 28 May 2025, Faron appointed seasoned commercial development expert, Ralph Hughes, as Chief Business Officer.
  • On 30 May 2025, Faron announced the publication of full phase I BEXMAB study data in one of the top medical journals – the Lancet Haematology.
  • On 12 June 2025, Faron presented the updated phase II data from the BEXMAB study, showing strong efficacy and survival outcomes with bexmarilimab in HR-MDS supporting the advancement to phase III.
  • Faron’s other operating income was EUR 0 (0)
  • R&D expenses were EUR 7.1 (6.7) million
  • Operating loss for the reporting period was EUR -11.9 (-11.3) million
  • Loss per share was EUR 0.18 (0.20)
  • On 30 June 2025, cash and cash equivalents were EUR 13.5 (30.0) million
  • Net assets were EUR -16.2 million (1.4) million

Significant events after the reporting period

  • On 7 July 2025, Faron announced the acceptance of two studies involving its lead candidate, bexmarilimab, for presentation at the 19th IUIS International Congress of Immunology in Vienna, Austria, in August 2025.
  • On 11 July 2025, Business Finland informed Faron that they had approved the Company’s application to forgive an R&D loan related to the development of Traumakine. The forgiveness applies also to accumulated interest. This will have a positive impact of EUR 1.3 million on Operating Profit on the second half of 2025.
  • On 30 July 2025, Faron announced that new clinical and translational data from the phase I/II BEXMAB study evaluating bexmarilimab in combination with azacitidine in HR-MDS will be orally presented at the 2025 European Society for Medical Oncology (ESMO) Congress, in October 2025, in Berlin, Germany.
  • On 6 August 2025, Faron announced an increase in the complete remission (CR) rate in patients with frontline or treatment-naïve HR-MDS, based on updated efficacy data from its phase I/II BEXMAB trial. According to the investigator-assessed response using IWG 2006 criteria, as per protocol, the CR rate has increased to 43% (9 out of 21 patients), a substantial improvement from the 28% rate, seen in the earlier data cut. This data builded on the phase II early results featured in recent oral presentation at the 2025 American Society of Clinical Oncology (ASCO) meeting.
  • On 18 August 2025, Faron announced positive feedback received from the U.S Food and Drug Administration (FDA) as part of the Company’s recent BEXMAB study’s end-of-phase II (EOP2) meeting. Faron will advance bexmarilimab into a registrational phase II/III study for patients with the treatment-naïve (frontline) HR-MDS. The FDA confirmed IWG 2023-defined CR + CReq as an acceptable primary endpoint with overall survival (OS) as a co-primary endpoint to support an application for accelerated approval making the entire HR MDS market accessible to Faron with one single trial and accelerated approval possibility for all HR MDS patients.

Consolidated key figures, IFRS

EUR ’000 unless otherwise indicated 1-6/2025 1-6/2024 1-12/2024 (audited)
Other operating income 0 0 0
Research and development expenses (7,115) (6,662) (11,744)
General and administrative expenses (4,794) (4,628) (6,929)
Operative loss for the reporting period (11,909) (14,395) (18,673)
Loss per share EUR (0,18) (0.20) (0.29)
Number of shares at end of period 111,954,597 104,624,864 104,624,864
Average number of shares 107,403,444 70,452,291 88,518,654
Cash and cash equivalents 13,532 29,979 9,503
Equity (16,246) 1,379 (9,762)
Balance sheet total 16,204 35,460 12,521

Outlook for 2025

Due to the nature of Faron Pharmaceuticals’ business, the company does not provide a short-term outlook.

CEO Statement

”I’m extremely proud of our people and what we have accomplished in the first half of 2025. We have achieved a number of our main business goals: fully enrolled our BEXMAB phase II study, published very strong phase II efficacy data for bexmarilimab and had the privilege to present it at the world’s leading oncology conferences, we received a series of regulatory designations, enhanced our management team and substantially strengthened our financial position. These are absolutely outstanding results from a team of our size.

Strong BEXMAB data supports path to single registrational trial for the entire HR MDS population

In the first half of the year, the clinical development program for our lead asset, bexmarilimab made strong and consistent progress. In January, we identified the final patient for the BEXMAB phase II part in refractory or relapsed myelodysplastic syndrome (r/r MDS), as well as the BEXMAB phase I/II study in frontline high-risk (HR) MDS.

In June, at EHA we presented the phase II response data from the BEXMAB study, showing strong response rates in frontline HR MDS and r/r MDS, as well exceptional survival in r/r MDS, for which the follow-up data is more mature. The results support the advancement into single phase II/III registrational trial in frontline HR MDS making the entire HR MDS market accessible for Faron at one go. This was later confirmed in August in BEXMAB’s EOP2 meeting with the FDA.

Especially for r/r MDS patients, for whom treatment options are limited, our data were highly encouraging. Bexmarilimab’s estimated median overall survival (mOS) was approximately 13.4 months, compared to the 5-6 months that would typically be expected under standard of care. The BEXMAB study also demonstrated significant efficacy in patients with r/r MDS with a high objective response rate (ORR) of 63%. An ORR of 81% and an outstanding CR rate of 43% was observed in frontline HR MDS patients according to the study protocol criteria. These results, especially the new frontline MDS patient data, suggest a potential to transform the treatment paradigm for the entire disease.

In the spring, both the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA) granted us opinion on Orphan Drug Designation for bexmarilimab for the treatment of MDS. The FDA and EMA designations allow us to receive important regulatory guidance and protocol assistance for the development of bexmarilimab. The FDA designation also qualifies the sponsor of the drug for certain development incentives, including tax credits for qualified clinical testing and prescription drug user fee exemptions. In addition, Orphan Drug Designations offer market exclusivity once the medicine is on the market.

Strengthening our financial position

We substantially strengthened our financial by an oversubscribed EUR 12 million placing in February and an up to EUR 35 million convertible bond arrangement in April. The first tranche of bonds with a principal amount of EUR 15 million was issued in April, and we have the option to issue two additional tranches, each with a principal amount of EUR 10 million. The proceeds from the first tranche were used to repay the outstanding loan from IPF Partners and for general corporate purposes, extending our cash runway into the first quarter of 2026. The bond arrangement also increased our flexibility by reducing restrictive cash covenants and releasing our patents that were pledged as a security for a loan from IPF Partners.

Challenging operating environment

Capital markets and uncertainty in the biopharma and life sciences sectors remained challenging in the first half of this year. This was partly driven by the concerns related to constrained access to funding, drug-pricing policy changes and cautious dealmaking amid regulatory and macroeconomic uncertainties. However, as the first six months of this year prove, there is always demand for high-quality biopharmaceutical companies – like Faron – that can show consistent progress and positive data from their clinical development programs. Late stage and close to market assets remain attractive to large pharmaceutical companies.

The FDA has become stricter on oncology drug approvals, moving away from single arm trials and surrogate endpoints and putting more weight on randomized data against a comparator with survival as the most important endpoint. This has had little impact on us, since thanks to our scientific advice meeting with the FDA last year, we have already been building the case around bexmarilimab with survival in our mind and using a randomized setting against a comparator, i.e. the frontline setting in HR MDS. We were very happy to see that the FDA was willing to accept a response based surrogate endpoint at an interim read out as the basis of accelerated approval in frontline HR MDS, which highlights the big unmet need in this indication.

New blood to our Board and Management Team

In the first half of this year, we reinforced our management team and Board of Directors. In March, Mr. Colin Bond joined our Board, bringing extensive international experience from the finance, CDMO and biopharma industries. At the same time, I was also proud to assume the role of a member of Faron’s Board, while continuing as CEO. In May, Mr. Ralph Hughes joined our management team to strengthen Faron’s commercial strategy, business development and market assessment functions. These appointments enhance our expertise enabling us to better navigate the complexities of our competitive and rapidly evolving sector and to reach our strategic objectives.

Unique achievements for Faron in scientific forums

The medical industry continues to recognize the therapeutic potential of bexmarilimab. We were proud to present our data in oral sessions at all three leading oncology conferences: the European Hematology Association’s (EHA) Congress, American Society of Clinical Oncology Annual Meeting (ASCO) and International Congress on Myelodysplastic Syndromes (MDS 2025). Securing oral presentation in all three conferences – recognized as the premier scientific forums in our field – and having our data published in Lancet are exceptional for any company and especially in the context of Finnish drug development, and we are humbled by them. I could not be prouder and more grateful of our incredible team. I would also like to deeply thank all our shareholders who have supported this important work to bring a new cancer treatment to life.

Solid tumor research progressing as planned

Our research on solid tumors continues to make important progress. In May 2025, two articles were published in the Journal for ImmunoTherapy of Cancer, highlighting the significance of CLEVER-1 in solid tumors and deepening our understanding of the tumor microenvironment’s influence. The results suggested that bexmarilimab stimulated response in immunologically-cold tumors and inhibited inflammation in treatment resistant tumors. The results can potentially impact the design of future trials for bexmarilimab in solid tumors. The BLAZE trial for the treatment of checkpoint inhibitor refractory metastatic lung cancer and melanoma has gained ethical approval and is in its final stages of contracting. In addition, Faron has reached an agreement with the Helsinki University Hospital to join the national FINPROVE Study to investigate bexmarilimab in combination with standard chemotherapy for the treatment of metastatic breast cancer. This will be the first ever bexmarilimab trial that will use prospective patient selection for Clever-1 positivity.

Outlook

Many BEXMAB patients in r/r MDS remain on drug and are doing well, so giving the final survival readout is delayed, which is a good thing. Same goes to frontline patients where many have moved on to transplant and if all go well for the patients, we will not be getting survival data for frontline HR MDS any time soon. Next, we’ll be reporting on the dynamic positive changes that happen in the body when treated with Bex and Aza together at the annual ESMO congress, and then further follow-up data at ASH towards the end of the year. Meanwhile we will be interacting with EMA and other regulatory agencies on the phase II/III trial. We are decisively progressing toward the initiation of the phase II/III registrational trial for HR MDS in parallel with partnering discussions. We are now well equipped to enter the next phase of commercial discussions and are continuously exploring different options we have to ensure maximising Faron’s shareholder value while progressing the development of bexmarilimab in both solid tumors and hematological malignancies. Faron’s financial position is good. Our current cash runway extends until 2026, and with the remaining two tranches of convertible bonds we have the needed flexibility to make the next business decisions. This gives us the opportunity to maximize shareholder value as we prepare to progress bexmarilimab into its final stage of development for the treatment of HR MDS.

Faron’s first half of 2025 was remarkable, and I am looking forward to the second half of this year with eager anticipation. If H1 was the time of strong and steady development, then H2 is the time for business.”

Virtual briefing and Q&A session

A virtual briefing and Q&A session for investors, analysts and media will be hosted by Dr. Juho Jalkanen, Chief Executive Officer, Yrjö Wichmann, Chief Financial Officer and Dr. Petri Bono, Chief Medical Officer, at 09:00 am (EDT) / 2:00 pm (BST) / 4:00 pm (EEST) on Wednesday, 27 August 2025. Webcast registration link: Faron 2025 Half-Year Financial Results

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

For more information, please contact:

Kare Laukkanen
+358 50 553 9535 / +44 7 469 766 223
kare.laukkanen@irpartners.fi

FINN Partners, US (media) 
Alyssa Paldo 
+1 847 791-8085 
alyssa.paldo@finnpartners.com

Cairn Financial Advisers LLP, Nominated Adviser and Broker
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

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.

Faron Pharmaceuticals Ltd: Notice of Half-Year Financial Results

Faron Pharmaceuticals Ltd | Company announcement | August 19, 2025 at 09:00:00 EEST

Faron Pharmaceuticals will publish its half-year financial results for January-June 2025 on Wednesday 27 August 2025

TURKU, Finland – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on tackling cancers through novel immunological pathways, will report its unaudited half-year financial results for the six months ended 30 June 2025, on Wednesday, 27 August 2025.

A virtual briefing and Q&A session for investors, analysts and media will be hosted by Dr. Juho Jalkanen, Chief Executive Officer, Yrjö Wichmann, Chief Financial Officer and Dr. Petri Bono, Chief Medical Officer, at 09:00 am (EDT) / 2:00 pm (BST) / 4:00 pm (EEST) on Wednesday, 27 August 2025. Webcast registration link: Faron 2025 Half-Year Financial Results

The half-year report, presentation, and a replay of the webcast will be published afterward on the Company’s website at: Reports and presentations – Faron

For more information, please contact:

Kare Laukkanen
+358 50 553 9535 / +44 7 469 766 223
kare.laukkanen@irpartners.fi

FINN Partners, US (media) 
Alyssa Paldo 
+1 847 791-8085 
alyssa.paldo@finnpartners.com

Cairn Financial Advisers LLP, Nominated Adviser and Broker
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

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.

Inside Information: Faron to advance bexmarilimab into a registrational Phase 2/3 study in treatment-naïve (frontline) HR-MDS after positive meeting with the FDA

Faron Pharmaceuticals Ltd | Company announcement | August 18, 2025 at 09:00:00 EEST

Inside Information: Accelerated approval pathway confirmed for frontline patients with CR + CReq, and Overall Survival as primary endpoints

TURKU, FINLAND – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on tackling cancers through novel immunotherapies, today announces it has received positive and valuable feedback from the U.S. Food and Drug Administration (FDA) regarding the proposed clinical development plan leading to approval for bexmarilimab, its wholly-owned, novel precision cancer immunotherapy.

The feedback was received as part of the Company’s recent BEXMAB study’s end-of-phase 2 (EOP2) meeting with the FDA. The FDA advised Faron to focus on frontline development since possible frontline approval enables use across the entire HR MDS indication. The meeting was requested to gain alignment on the design of a planned registrational phase 2/3 trial evaluating bexmarilimab in combination with azacitidine for patients with treatment-naïve (frontline) higher-risk myelodysplastic syndrome (HR-MDS). Key objectives included obtaining the FDA’s input on the proposed trial design, dosing strategy and clinical endpoints intended to support regulatory approval.

Following the FDA’s guidance, the trial will begin with a dose optimisation run-in period comparing 1 mg/kg and 3 mg/kg regimens with placebo, all in combination with azacitidine. Once the optimal dose has been determined, the trial will seamlessly transition into the registrational stage, which includes an interim analysis to support accelerated approval based on IWG 2023 response criteria in frontline patients.

“We are extremely encouraged by the collaborative and highly productive dialogue with the FDA, which provided a clear and actionable path for the clinical development of bexmarilimab in frontline HR-MDS, an area of profound unmet medical need,” said Dr. Juho Jalkanen, Chief Executive Officer of Faron. “The agency’s guidance has endorsed a direct route towards accelerated approval using Complete Response (CR) + CR equivalent (CReq) per International Working Group (IWG) 2023 criteria as a co-primary endpoint with Overall Survival (OS). This is a significant step forward in our mission to provide a potentially transformative new treatment option to patients and represents a major regulatory de-risking milestone, as we are now only one study away from getting bexmarilimab approved for the benefit of HR MDS patients.”

The FDA confirmed IWG 2023-defined CR + CReq as an acceptable primary endpoint to support an application for accelerated approval in frontline patients. In line with this guidance, Faron will include CR + CReq as a co-primary efficacy endpoint along with Overall Survival (OS) in the phase 2/3 trial. The Company will seek accelerated approval based on an interim readout on the CR + CReq data in frontline patients. Composite complete remission (cCR) will be evaluated as the key secondary endpoint. In addition to the clinical discussion, the FDA was satisfied with Faron’s approach to non-clinical and CMC activities for phase 2/3 and subsequent steps to approval.

“Improving outcomes of patients with HR-MDS continues to be a top priority for our field. Bexmarilimab is an antibody with a novel mechanism of action that has demonstrated promising safety and activity in combination with azacitidine in phase 1/2 clinical trials in the first- and second-line settings for HR-MDS,” added Dr. Amer Zeidan, MBBS, MHS, Professor of Medicine at Yale School of Medicine and Chief of the Division of Hematologic Malignancies at Yale Cancer Center and Smilow Cancer Hospital. “I am thrilled that we have agreed with the regulators on a pathway to explore the full potential of bexmarilimab in the frontline setting for patients with HR-MDS. I also would like to highlight the FDA accepting the use of CR+CReq IWG 2023 criteria as part of the primary endpoint, making this the first registrational clinical trial to do so. Many experts, including myself, strongly believe the IWG 2023 criteria to be more patient centric and reflect clinically meaningful benefits to patients in a more robust fashion than the old IWG 2006 criteria, which have been used for all past (and failed) phase 3 clinical trials for HR-MDS,” concluded Dr. Zeidan.

Disclosure: Dr Amer Zeidan has consulted and received honoraria from Faron. The views expressed as his personal views and not necessarily those of his employer.

For more information, please contact:

IR Partners, Finland
(Media)

Kare Laukkanen

+358 50 553 9535 / +44 7 469 766 223
kare.laukkanen@irpartners.fi

FINN Partners, US
(Media) 
Alyssa Paldo 
+1 847 791-8085 
alyssa.paldo@finnpartners.com
Cairn Financial Advisers LLP
(Nominated Adviser and Broker)
Sandy Jamieson, Jo Turner
+44 (0) 207 213 0880
Sisu Partners Oy
(Certified Adviser on Nasdaq First North)
Juha Karttunen
Jukka Järvelä
+358 (0)40 555 4727
+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.

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.

Back to top