Holding in Company

Faron Pharmaceuticals Ltd | Company announcement | April 17, 2025 at 15:15:00 EEST

Holding in Company

TURKU, FINLAND – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on developing novel immunotherapies, announces that, on 16 April 2025, A&B (HK) Company Ltd (“A&B”) divested its entire shareholding of 3,559,893 ordinary shares representing approximately 3.40% of the Company’s issued share capital.

A&B (HK) Company Ltd, an investment and development company based in Hong Kong, initially invested in the Company in 2015. This investment was part of a strategic agreement involving Faron’s lead drug candidate, Traumakine®, which was developed for the treatment of moderate to severe acute respiratory distress syndrome (ARDS). As Faron’s focus is on the development of its lead asset, bexmarilimab, this strategic investment by A&B no longer serves its original purpose and as such, A&B sold its holding and created a significant increase in the liquidity of Faron’s shares in the market.

For more information please contact:

IR Partners, Finland (media)
Riina Tuominen
+358 44 313 5005
riina.tuominen@irpartners.fi

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 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.

Inside Information: Faron Announces Positive Phase II results in higher-risk myelodysplastic syndrome

Faron Pharmaceuticals Ltd | Stock Exchange Release | April 15, 2025 at 09:00:00 EEST

Inside Information: BEXMAB Phase II trial met its primary endpoint in treatment-resistant High Risk MDS (r/r HR MDS)

Key Highlights

  • Topline read-out from the Phase II BEXMAB trial confirms earlier positive findings in both frontline and relapsed/refractory higher-risk myelodysplastic syndrome (HR MDS) patients
  • The combination of bexmarilimab and azacitidine remains very well tolerated
  • Full data has been submitted to the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting
  • Faron is planning for a Phase III trial, pending U.S Food and Drug Administration (FDA) End of Phase II meeting Feedback

TURKU, FINLAND – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on developing novel immunotherapies, today announced positive topline results of the BEXMAB trial, which shows a high overall response rate (ORR) among both frontline as well as relapsed/refractory (r/r) HR MDS patients treated with a combination of bexmarilimab and azacitidine.

According to this first fully enrolled Phase II analysis, the treatment continues to be well tolerated without any dose-limiting toxicity in r/r HR MDS patients with no other currently effective treatment options. A high objective response rate of 63% was observed in this initial data cut. The median overall survival remains at the same level as previously reported. Among treatment naïve (frontline phase 1) HR MDS patients, an ORR of 76% was observed. Many patients are still early in their treatment, which means responses may deepen over time and results are subject to minor changes as data matures. The full data has been submitted to the 2025 ASCO Annual Meeting.

“This is one of the strongest data set ever seen in an all-comer population of treatment resistant HR MDS”, says Dr. Juho Jalkanen, CEO of Faron Pharmaceuticals. “There is a significant unmet need in the treatment of HR MDS, as drug development in HR MDS and macrophage re-programming has proven to be extremely challenging, with a lot of previous failures. What really makes bexmarilimab stand out in this field is its good safety profile combined with very high efficacy especially in last line HR MDS. This gives us conviction that bexmarilimab is the long-awaited drug to overcome treatment resistance”.

For more information please contact:

IR Partners, Finland (media)
Riina Tuominen
+358 44 313 5005
riina.tuominen@irpartners.fi

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 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.

Inside Information: Faron enters into an up to EUR 35 million convertible bond arrangement and issues first tranche of bonds with a principal amount of EUR 15 million

Faron Pharmaceuticals Ltd | Stock Exchange Release | April 03, 2025 at 09:00:00 EEST

Inside Information: Faron enters into an up to EUR 35 million convertible bond arrangement to repay its secured loan to IPF and strengthen its financial position, and issues first tranche of bonds with a principal amount of EUR 15 million

Key highlights

  • Faron has entered into a convertible bond arrangement for to up to EUR 35 million with an entity managed by Heights Capital Management, Inc. and resolved to issue amortising unsecured convertible bonds with an aggregated principal amount of EUR 15 million with an option to issue, subject to certain conditions, two additional tranches of similar convertible bonds, each with a principal amount of EUR 10 million.
  • Bondholders have the option to convert the bonds into shares at an initial conversion price of EUR 2.94 per share, subject to adjustments in accordance with the terms and conditions of the bonds.
  • The bonds generally amortise in equal instalments every two months and the Company has the option to redeem the bonds by issue of shares against such repayment instalment or by payment in cash during the three year term of the bonds.
  • In order to facilitate conversion of the bonds into shares, Faron issues special rights entitling into shares, as referred to in the Finnish Companies Act, to the bondholder in connection with the issuance of the first tranche bonds.
  • The proceeds from the first tranche bonds will be used to repay the outstanding senior, secured loan from IPF and for general corporate purposes, extending the Company’s cash runway into Q1 2026 assuming that amortisations on the bonds are made in shares.
  • The Company’s assets will be released from security as a result of the early loan repayment to IPF.
  • The Company substantially strengthens its financial position and flexibility by reducing restrictive cash covenants with a runway extending well beyond the phase II topline readout in the BEXMAB r/r MDS study anticipated in April 2025.

TURKU, Finland – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company pursuing a CLEVER-1 receptor targeting approach to reprogramming myeloid cells to activate anti-tumor immunity in hematological and solid tumors, today announces that it has entered into a subscription agreement (the “Subscription Agreement”) with an entity managed by Heights Capital Management, Inc. (“HCM”) regarding the issuance and subscription of amortising senior unsecured convertible bonds with an aggregated principal amount of EUR 15 million (the “First Tranche Bonds”) with an option to issue, subject to certain conditions, two additional tranches of convertible bonds (the “Second Tranche Bonds” and “Third Tranche Bonds”, respectively, and collectively with the First Tranche Bonds, the “Bonds”) with an aggregated principal amount of EUR 10 million each, convertible into new and/or existing shares in the Company (the “Shares”) (the “Arrangement”). Bryan, Garnier & Co acted as Sole Placement Agent and Financial Adviser on the convertible bond arrangements.

In connection with the private placement announced on 5 February 2025, the Company communicated that it would continue to actively evaluate further financing alternatives and business transactions that would allow continued flexibility in pursuing the best commercial outcome for the Company and its shareholders with BEXMAB Phase II efficacy and safety readout available. The Arrangement will be used to finance early repayment in full of the Company’s outstanding senior secured loan pursuant to the facilities agreement entered into with IPF Fund II SCA, SICAV-FIAR (“IPF”) (the “IPF Facility”) and strengthen its financial position, while increasing its financial flexibility with fewer restrictive financial commitments. After the early repayment of the outstanding loan, the restrictive cash covenants set out in the IPF Facility will no longer apply, unlocking previously restricted cash reserves, and the Company’s assets, including valuable intellectual property rights, will be released from any pledges granted in favour of IPF. The remainder of the proceeds from the First Tranche Bonds will be used for general corporate purposes, such as the continuation of the BEXMAB Phase II trial to produce follow-up data (duration of response and survival), prepare the package for end of Phase II FDA meeting and for Phase III trial preparations, and to strengthen the Company’s balance sheet. The Arrangement with HCM will also enable the Company to continue evaluating further business transactions, such as licensing agreements, with a stronger financial position in addition to which the Company will, subject to certain conditions, also have access to additional financing in the aggregate amount of up to EUR 20 million, through the issuance of the Second Tranche Bonds and the Third Tranche Bonds. The Board has conducted an overall assessment of the Arrangement, considering its key terms and commercial merits, the reputable standing of the investor as well as other explored financing alternatives potentially available to the Company, and concluded that the issuance of the First Tranche Bonds, including the Special Rights to be attached to the bonds, is in the best interest of the Company and all of its shareholders, and that there is a weighty financial reason for the Company to issue the Special Rights to HCM.

“We are very happy to announce that Faron has secured new financing through convertible loans. The new funding and repayment of our outstanding loans significantly strengthens the Company’s financial position that importantly improves our ability to execute on the Company’s business opportunities. After finalisation of this arrangement the Company will no longer have restrictive cash covenants, and the security over the patents that have been pledged as security for the IPF loan will be released. The Board and management feel even more confident about the Company’s future as one of the leading Biotech companies in the Nordics with access to meaningful amounts of capital if needed. Having HCM, a well-respected global financier, on our side is very important as they have a long track record in supporting their portfolio companies in their journey and growth.” says Yrjö Wichmann, Chief Financial Officer.

The Convertible Bonds

Pursuant to the Subscription Agreement, the Board has resolved upon the issuance of EUR 15 million of First Tranche Bonds due 2 April 2028 to HCM, convertible into new and/or existing Shares in the Company. The First Tranche Bonds consists of 150 bonds with a principal value of EUR 100,000 each. The First Tranche Bonds will be issued at 92.5 per cent of their principal amount and carry an interest rate of 7.5 per cent per annum, payable every two months in arrears.

A holder of the First Tranche Bonds, shall be able to convert the outstanding principal amount of a First Tranche Bond or any instalment amount at any time during the term of the First Tranche Bonds. The initial Conversion Price (as defined in terms and conditions of the First Tranche Bonds, (“First Tranche Conditions”)) has been set at EUR 2.93952, which equals a 20 per cent premium to the reference share price, being the EUR price per Share that is the lowest of the six Volume Weighted Average Prices of a Share listed on Nasdaq First North Growth Market Finland on each of the six consecutive dealing days ending on (and including) the Issue Date of the First Tranche Bonds, representing EUR 2.4496. The Conversion Price is subject to adjustments in the event of certain corporate actions as well as customary anti-dilution adjustments and price reset mechanisms pursuant to the First Tranche Conditions.

The First Tranche Bonds will amortise in 18 equal instalments every two months during the term of the First Tranche Bonds (each an “Amortisation Payment Date”). Faron will have the option to elect, in its sole discretion, to make amortisation and/or interest payments either in cash or by converting the relevant amounts due into Shares (“Share Settlement Option”). In case the Company exercises its Share Settlement Option to amortise the principal amount of the First Tranche Bonds, the subscription price for the Shares will be the lower of (a) the Conversion Price in effect at the time, and (b) 90 per cent of the lowest of (i) the 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.

The Board has, in light of the frequent amortisations and need to secure continuous adherence with the Market Abuse Regulation obligating the Company to make payments in Shares in certain situations, resolved to make amortisations and interest payments by exercising its Share Settlement Option, unless it separately decides to make payments in cash. Pursuant to the First Tranche Conditions, the exercise of the Share Settlement Option is subject to certain liquidity conditions and HCM’s (including its affiliates) ownership in the Company not exceeding 9.99 per cent of the Shares at any time. The Company will publish an announcement each time the number of outstanding Shares in the Company increases following the issuance of Shares pursuant to the Arrangement.

In addition to the scheduled amortisation payments, 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 on a date specified in a notice sent to the Company, with a limit of no more than nine (9) Accelerated Amortisations in the first year of the term of the First Tranche Bonds. Additionally, HCM (or any future holders of the majority of the First Tranche Bonds) will also have the right to defer any upcoming amortisation payment to be paid on a later Amortisation Payment Date specified in the notice sent to the Company.

The exercise of the bondholders’ right to convert the First Tranche Bonds into Shares as well as the exercise of the Company’s Share Settlement Option will be 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 Special Rights will be attached to the First Tranche Bonds, and the subscription price for the Shares to be subscribed for pursuant to the Special Rights (in accordance with the First Tranche Conditions) will be paid by setting off the Company’s debt to pay relevant amounts due under the First Tranche Bonds.

The First Tranche Conditions include certain covenants and undertakings by the Company, including a negative pledge provision and restrictions to the incurrence of additional indebtedness as well as on the conduct of business by the Company such that it may only carry on matters in the ordinary course of business and not enter into certain transactions such as mergers, demergers or reorganisations, or disposal of assets, except in relation to any partnering or licencing arrangements related to development of its business, or on terms approved by the majority bondholders.

Second Tranche Bonds and the Third Tranche Bonds

If the Board considers it to be in the best interest of the Company and all of its shareholders at the time, the Company may, in its sole discretion, during a twelve-month period following the announcement of the Phase II topline readout (expected to be released in April 2025) require HCM to subscribe for the Second Tranche Bonds. During a period starting on the date falling six months and ending on the date falling 18 months after the issuance of the Second Tranche Bonds, either party may require that the Third Tranche Bonds are issued and subscribed for. The issuance and subscription of Second Tranche Bonds and the Third Tranche Bonds, respectively, are subject to certain customary conditions precedent, including that no material adverse change has occurred and that there has been no adverse change in the international financial markets.

  • With respect to the Second Tranche Bonds, it is further required that (a) Phase II topline readout in respect of its BEXMAB r/r MDS Study indicates an objective response rate of at least 60 per cent, (b) that the arithmetic mean of the daily traded value of the Shares on each dealing day comprised in the three-month period preceding the issuance of the Second Tranche Bonds is greater than EUR 500,000, and (c) that the Company has a market capitalisation greater than EUR 200 million on the date of issuance of the Second Tranche Bonds.
  • In order for the Company to have the right to require HCM to subscribe for the Third Tranche Bonds, it is required that (a) the arithmetic mean of the daily traded value of the Shares on each dealing day comprised in the three-month period preceding the issuance of the Third Tranche Bonds is greater than EUR 500,000, and (b) the Company’s market capitalisation on the date of issuance of the Third Tranche Bonds is greater than 120 per cent of its market capitalisation on the date of issuance of the Second Tranche Bonds.
  • HCM’s right to require issuance of the Third Tranche Bonds is not subject to the above conditions.

HCM may, at its discretion, waive any of conditions precedent in respect of both Second Tranche Bonds and Third Tranche Bonds.

The Second Tranche Bonds and the Third Tranche Bonds are intended to be issued on substantially same terms as the First Tranche Bonds. The initial Conversion Price of the Second Tranche Bonds and the Third Tranche Bonds, respectively, will be determined based on a 20 per cent premium to the reference share price, being the EUR price per Share that is the lowest of the six Volume Weighted Average Prices of a Share listed on Nasdaq First North Growth Market Finland on each of the six consecutive dealing days ending on (and including) the Issue Date of the Second Tranche Bonds and the Third Tranche Bonds, as the case may be.

Special Rights attached to the First Tranche Bonds

In connection with the issuance of the First Tranche Bonds, the Board has resolved, based on the authorisation granted by the General Meeting held on 5 April 2024, to issue 12,000,000 Special Rights. The Special Rights are issued in deviation from the shareholders’ pre-emptive rights (directed issue) without consideration to HCM as the initial subscriber of the First Tranche Bonds. The Special Rights are attached to the First Tranche Bonds and cannot be separated from them. Should HCM use its right to transfer First Tranche Bonds, the Special Rights attached to the relevant bonds that have not been exercised at the time of the transfer would be simultaneously transferred to the new bondholder.

A total of 80,000 Special Rights will be attached to each First Tranche Bond with a principal value of EUR 100,000. Each Special Right entitles to one (1) new or existing Share of the Company. Should all First Tranche Bonds be converted into Shares at the initial Conversion Price EUR 2.93952 (assuming no amortisation and/or interest payments have been made), the number of new Shares to be issued by the Company pursuant to the Special Rights would be 5,102,874 Shares, corresponding to approximately 4.57 per cent of the current total amount of Shares in the Company (approximately 4.37 per cent of a fully diluted basis). If the Conversion Price is adjusted, as set out in the First Tranche Conditions, the Company may be obligated to issue further Special Rights in which case the Board will resolve upon said issuance in accordance with the relevant provisions in the Finnish Companies Act.

The Special Rights may only be exercised, and Shares may only be issued pursuant to such exercised Special Rights, in accordance with the First Tranche Conditions.

Additionally, in order to prepare especially for any advanced amortisation situations, the Company’s Board may separately resolve to issue treasury shares to Faron itself without consideration. Such Shares could only be used to convert the First Tranche Bonds in accordance with their terms and conditions, and such issuance, if resolved, would be separately announced.

Early Repayment of IPF Facility

Faron has exercised its right of early repayment in full of the IPF Facility in accordance with its terms and conditions. The amount repayable by the Company will be EUR 9,079,832, including outstanding principal amount, accrued interest, capitalised payment-in-kinds, and the exit fee. Subject to the Company receiving the issue price for the First Tranche Bonds, the repayment is expected to be made on 3 April 2025.

“We are very grateful for IPF’s support over the past years during challenging capital markets in biotech. For the next stages of growth, we are very pleased to partner with HCM, a leading provider of growth capital globally. We believe Faron has now all the flexibility and fire power it needs to fulfil its objectives for 2025 and make the most out of the up-coming BEXMAB Phase 2 read-out”, says Dr. Juho Jalkanen, CEO of Faron Pharmaceuticals.

For more information please contact:
ICR Healthcare
Mary-Jane Elliott, David Daley, Lindsey Neville
Phone: +44 (0)20 3709 5700
E-mail: faron@icrhealthcare.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 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.

Positive Phase 2 Interim Results from BEXMAB Trial

Faron Pharmaceuticals Ltd.

(“Faron” or “the Company”)

Inside Information: Faron Announces Positive Phase 2 Interim Results from BEXMAB Trial to be presented at ASH

Company announcement, Inside Information , 27 November 2024

Key highlights

–      Interim Phase 2 read-out from the BEXMAB Trial confirms earlier positive Phase 1 & 2 findings in MDS patients with prior HMA failure

–      In Phases 1 & 2, 20 MDS patients who are refractory or relapsed on HMA (r/r MDS) and have no effective treatment options, continue to show high objective response rate (ORR) at 80%

–      The BEXMAB Phase 1 & 2 MDS patients with prior HMA failure are experiencing an estimated median overall survival (mOS) of approximately 13.4 months currently, compared to the 5-6 months that would typically be expected under standard of care historically

TURKU, FINLAND  – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on tackling cancers via novel immunotherapies, today provides Interim Phase 2 results of the ongoing BEXMAB trial in myelodysplastic syndrome (MDS) patients that have failed a hypomethylating agent (HMA), also known as relapsed/refractory MDS (r/r MDS). Full analysis of the data will be presented at the 66th American Society of Hematology (ASH) Annual Meeting on 9 December 2024 in San Diego, US .

The initial BEXMAB Phase 2 results have already indicated a high ORR of 79% (11/14) amongst HMA-failed MDS patients treated with a combination of bexmarilimab + azacitidine. There is now a total of 20 HMA-failed MDS patients evaluable for read-out with this novel combination. The treatment has been well tolerated, without any dose-limiting toxicity. The ORR in this otherwise untreatable population is 80% (16/20). Similar size patient cohorts treated with existing alternatives have reported 0-20% ORR, without deep and durable remissions. The estimated median overall survival of the 20 r/r MDS patients remains 13.4 months.


In summary, the updated BEXMAB results show very encouraging efficacy and robust treatment benefit for the r/r MDS patients. The detailed efficacy, safety and biomarker results of the 20 r/r MDS patients treated in the BEXMAB trial will be presented at the 66th American Society of Hematology Annual Meeting. The BEXMAB trial is continuing to enroll patients as planned with the next efficacy data readout for the fully recruited BEXMAB trial patients expected around the end of Q1 2025.

Dr. Petri Bono, Chief Medical Officer of Faron, said: “r/r MDS is a life-threatening haematological malignancy with limited treatment options and high unmet medical need. Our updated trial results in r/r MDS further enforces bexmarilimab’s ability to overcome treatment leading to clinically meaningful deep responses. We look forward to sharing the detailed results with the haematology community and discussing these data with health authorities in H1 2025.”

Dr. Juho Jalkanen, Chief Executive Officer of Faron, said: “It is remarkable seeing the ORR continuing to be so strong even as the patient population grows, as it would typically be expected to settle at a lower level. For patients, I believe these results are truly exciting as we take another step closer to providing an additional option for their poorly met treatment needs. With our repeatedly strong data, we are very much looking forward to our continuing discussions with regulatory agencies and partner candidates.”

Faron will be hosting a virtual webinar to discuss the full analysis of data on Tuesday, December 10, 2024 at 16.00 EET/9am ET.

To register for the event visit:  BEXMAB Study Update

The ASH Annual Meeting will take place from 7-10 December 2024, in San Diego, California and virtually. The poster will contain updated clinical data from the trial.

Poster presentation details:

Title:                            Encouraging Efficacy of Bexmarilimab with Azacitidine in Relapsed or Refractory MDS in Bexmab Ph1/2 Study

Session Time :                   Monday, 9 December 2024, 6:00 PM – 8:00 PM PST

Session Title:                 Acute Myeloid Leukemias: Investigational Drug and Cellular Therapies: Poster III

Location:                      San Diego Convention Center, Halls G-H

Lead Authors:               Dr. Mika Kontro, MD, PhD, Associate Professor at the University of Helsinki; Dr. Naval Daver, MD, Associate Professor of Leukemia at The University of Texas MD Anderson Cancer Center

Abstract Number:         4265

The full poster will be available on the Company’s website at https://www.faron.com/investors once presented at ASH.

For more information please contact:

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

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880

Peel Hunt LLP, Broker

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

About BEXMAB

The BEXMAB study is an open-label Phase I/II clinical trial investigating bexmarilimab in combination with standard of care (SoC) in the aggressive hematological malignancies of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The primary objective is to determine the safety and tolerability of bexmarilimab in combination with SoC (azacitidine) treatment. Directly targeting Clever-1 could limit the replication capacity of cancer cells, increase antigen presentation, ignite an immune response, and allow current treatments to be more effective. Clever-1 is highly expressed in both AML and MDS and associated with therapy resistance, limited T cell activation and poor outcomes.

About bexmarilimab

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

About Faron Pharmaceuticals Ltd

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

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.

Shareholders’ Nomination Board

(“Faron” or “the Company”)

 Composition of Faron Pharmaceutical’s Shareholders’ Nomination Board

Company Announcement, 5 November 2024

TURKU, FINLAND  – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on tackling cancers via novel immunotherapies, today announces that the following members have been appointed by a meeting of the Company’s five largest shareholders to Faron Pharmaceuticals Oy’s Shareholders’ Nomination Board:

·    Timo Syrjälä, representing himself (Chair)

·    Erkka Kohonen, representing Varma Mutual Pension Insurance Company , and

·    Joonas Haakana, representing UMO Capital

Faron’s Shareholders’ Nomination Board consists of three members, which represent the Company’s shareholders. The Chair of Faron’s Board of Directors, Mr. Tuomo Pätsi, will serve as an expert in the Nomination Board without being a member.

The Shareholders’ Nomination Board prepares and presents proposals to the Annual General Meeting on the number, composition and remuneration of the members of the Board as well as the Chair of the Board of Directors.

For more information please contact:

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

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880

Peel Hunt LLP, Broker

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

About BEXMAB

The BEXMAB study is an open-label Phase I/II clinical trial investigating bexmarilimab in combination with standard of care (SoC) in the aggressive hematological malignancies of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The primary objective is to determine the safety and tolerability of bexmarilimab in combination with SoC (azacitidine) treatment. Directly targeting Clever-1 could limit the replication capacity of cancer cells, increase antigen presentation, ignite an immune response, and allow current treatments to be more effective. Clever-1 is highly expressed in both AML and MDS and associated with therapy resistance, limited T cell activation and poor outcomes.

About bexmarilimab

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

About Faron Pharmaceuticals Ltd

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

Faron’s Capital Markets Day 2024

Faron Pharmaceuticals Ltd.

(“Faron” or “the Company”)

 Faron’s Capital Markets Day 2024 – BEXMAB follow-up data and update on drug development pipeline, partnering discussions and introducing new Scientific Advisory Board

Company Announcement, 22 October 2024

TURKU, FINLAND – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on tackling cancers via novel immunotherap ies , will host a Capital Markets Day for investors, analysts and media today, Tuesday, 22 October 2024 at 08:00 am (EDT) / 13:00 pm (BST) / 15:00 pm (EEST). Speakers are Dr. Mika Kontro, MD, PhD, Associate Professor at the University of Helsinki, Mr. Ralph Hughes, MSc, BSc, Senior Vice President at PharmaVentures and Faron’s senior management members.

BEXMAB Follow Up Data Continue to Indicate High Overall Response Rate

The BEXMAB Phase I/II trial results have already indicated a high overall response rate (ORR) of 79% (11 out 14) amongst relapsed and refractory myelodysplastic syndrome (r/r MDS) patients treated with a combination of bexmarilimab + azacitidine. Similar size patient cohorts treated with existing alternatives have reported 0-20% ORR, without deep and durable remissions.

Previously estimated median overall survival (mOS) was approximately 13.4 months with 14 r/r MDS patients and subject to change with longer follow up. Now, after median follow up of 275 days (doubled since May 2024), t he mOS among these 14 r/r MDS patients remains strong at 13.4 months, which is significantly longer than the 5-6 months typically expected with standard care, as reported in the literature. Median time on treatment for r/r MDS in the BEXMAB trial at the moment is 7.9 months, exceeding any prior expectations in this field. The treatment remains well tolerated according to the latest safety follow up.

Previously there were two (2/14) patients who moved on to receive bone marrow transplant and there are now a total of three patients (3/14) who have moved to bone marrow transplant which is seen as the only possibility for curative treatment of r/r MDS.

Business Update / Partnering Discussions


In June 2024, Faron completed a fully subscribed EUR 30.7 million share offering and published its focus areas for 2024:

1.    To obtain regulatory feedback from the USA Food and Drug Administration ( FDA) regarding measures required to obtain regulatory approval in the U.S.

2.    Aim to complete BEXMAB Phase II enrolment.

3.    Aim to conclude a global partnership deal to fund Phase III clinical research and to commercialize bexmarilimab.

4.    To have sufficient funding until the latter half of March 2025, allowing the Company to pursue readiness to move to Phase III in drug development, and in compliance with the financial covenants of the IPF Fund II SCA, SICAV-FIAR’s Facilities Agreement.

In July, Faron obtained positive feedback from the FDA regarding the registrational study plan for bexmarilimab in relapsed and refractory high risk MDS (HR MDS). In August 2024, the FDA granted Fast Track Designation (FTD) for bexmarilimab for the treatment of r/r MDS. Based on the FDA’s guidance, Faron made the decision to recruit additional frontline MDS patients. Full BEXMAB enrolment will include 32 r/r MDS patients and also 20 frontline HR MDS patients. According to the latest enrolment estimate, the BEXMAB trial (including also 20 frontline HR MDS patients) will be fully recruited in January 2025.

Since the fundraise completed in June 2024, Faron has been in dialogue with several partner candidates to fund Phase III development and to commercialize bexmarilimab. These discussions have progressed according to Faron’s expectations. To date, the Company has chosen not yet to enter into a partnership agreement or grant exclusivity to any negotiating party. Faron continues to discuss and evaluate the received terms and their impact diligently. To enable more flexibility in pursuing the best commercial outcome for the Company and its shareholders in continued compliance with the financial covenants and to facilitate availability of high-quality Phase II BEXMAB efficacy data (also observing patient enrolment for full Phase II readout), Faron may, subject to market conditions, consider strengthening its financial position before concluding discussions concerning partnering.

Scientific Advisory Board Renewed

Faron has renewed its Scientific Advisory Board (SAB) to better correspond with the Company’s current drug development pipeline. The new Scientific Advisory Board consists of prestigious and internationally recognized clinical scientists with broad anti-cancer clinical development expertise within haematological neoplasms and solid tumors. The SAB will assist Faron’s management in making significant scientific judgements related to translational activities as well as its clinical portfolio. The members of Faron’s SAB are Dr. Toni Choueiri, Dr. Tom Powles, Dr. Amer Zeidan, Dr. Naval G. Daver, Dr. Mika Kontro and Dr. Christophe Massard.

Toni Choueiri, MD is the Jerome and Nancy Kohlberg Chair and Professor of Medicine at Harvard Medical School, Boston, MA, the Director of the Lank Center for Genitourinary (GU) Oncology and co-leader of the Kidney Cancer Program at Dana-Farber/Harvard Cancer Center. He serves on the US National comprehensive cancer network (NCCN) expert panel. He has over 800 PubMed-indexed publications and is the lead investigator in multiple international phase 1-3 clinical trials in genitourinary cancers. In a series of NEJM articles on which Dr Choueiri was either first or last author, he has made seminal observations leading to multiple FDA and EMA approvals.

Tom Powles, MBBS, MRCP, MD is a professor of urology cancer at the University of London and the Director of Barts Cancer Centre which is one of the UKs largest Cancer Centres. Prof Powles is also editor-in-chief of Annals of Oncology, the leading European oncology scientific journal. He has had a major role in the development of biomarkers and new drug strategies leading to multiple FDA and EMA approvals. He has authored 10 NEJM or Lancet publications with two first author NEJM publications and two first author Nature publications. He was named in December 2023 in TIME’s list among the most influential people in global health.

Amer Zeidan, MD, MBBS, MHS is an Associate Professor of Medicine, Chief of Hematologic Malignancies Division, Director of Hematology Early Therapeutics Research, and leader of the clinical program and the Clinical Research Team for Leukemia and Myeloid Malignancies at Yale Cancer Center. Dr. Zeidan specializes in the management of myeloid malignancies especially MDS and acute myeloid leukemia (AML). His research and clinical care focus on targeting therapies to a patient’s diagnosis and working with their own immune system to counter the malignancies. He has published over 330 peer-reviewed publications and is the principal investigator on numerous phase II and III clinical trials in the areas of acute myeloid leukemia and myelodysplastic syndromes.

Naval G. Daver, MD is a Professor and Director of the Leukemia Research Alliance Program in the Department of Leukemia at MD Anderson Cancer Center (MDACC) in Houston, TX. He is a clinical investigator with a focus on molecular and immune therapies in acute myeloid leukemia (AML) and myeloid disease and is principal investigator on more than 25 ongoing institutional, national, and international clinical trials in these diseases, including multiple registration and label enabling trials. Prof. Daver has published over 400 peer-reviewed manuscripts and is on the editorial board of numerous hemalotology journals.

Mika Kontro, MD, PhD is an adjunct professor and a consultant in clinical hematology at the Helsinki University Hospital Comprehensive Cancer Center. Dr. Mika currently works as K. Albin Johannson Cancer Research Fellow (Finnish Cancer Institute) and as a group leader in Finnish Institute of molecular medicine, FIMM. He has a strong background in running clinical trials and he currently chairs the Finnish AML group and is a board member of the Nordic AML Group.

Christophe Massard, MD, PhD is professor and a Head of Cancer Research at Gustave-Roussy, the first leading cancer hospital in Europe and in the top four in the world.  Dr. Christophe is a member of ESMO, ASCO and AACR and has participated in over 130 trials in the past five years. He has been the principal investigator over the last 10 years of 50 phase 1 trials and co-investigator in more than 100 trialsHis research focuses on early clinical trials and precision medicine. He has published over 100 peer-reviewed publications.

Development Plan for Solid Tumors Progressing

Faron has made significant progress with its development plan regarding bexmarilimab’s future potential in treating solid tumors. In today’s CMD, Faron will present its oncology pipeline for solid tumors to illustrate bexmarilimab’s potential as a first-in-class macrophage reprogrammer in various anti-cancer treatments. In addition, an update on the innovative approaches in improving recognition of tumor cells and preventing immunosuppression will be presented.

Dr. Juho Jalkanen, CEO of Faron, comments:

“As previously communicated, everything is progressing as planned and our focus is to ensure that we are armed with adequate resources to be able to meet our objectives of completing Phase II of the BEXMAB trial and optimizing the outcome of partnering with Phase II data.  The next business decision we make will be   crucial in how the value and future of bexmarilimab is divided. There is more than two decades of hard work behind the development of bexmarilimab, and our job is to see that the maximum potential of bexmarilimab comes to life for both patients and investors.”


Dr. Petri Bono, CMO of Faron, comments:

“We’ve continued to see extremely encouraging data from our ongoing BEXMAB trial, and I am very pleased to see that the data encourage us systematically as we go forward in our solid tumor development pipeline. Our purpose is to establish bexmarilimab as a cornerstone drug for cancers where Clever-1 macrophages are a source of treatment resistance and cancer progression. Now we’ve a world-leading Scientific Advisory Board supporting us, the likes of which I have never seen before, and I am very excited about what future holds.”

Presentation Materials and Webcast

The Capital Markets Day presentation material will be available at https://www.faron.com/investors . The CMD webcast can be followed online at https://faron.videosync.fi/cmd-2024

For more information please contact:

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

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880

Peel Hunt LLP, Broker

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

About BEXMAB

The BEXMAB study is an open-label Phase I/II clinical trial investigating bexmarilimab in combination with standard of care (SoC) in the aggressive hematological malignancies of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The primary objective is to determine the safety and tolerability of bexmarilimab in combination with SoC (azacitidine) treatment. Directly targeting Clever-1 could limit the replication capacity of cancer cells, increase antigen presentation, ignite an immune response, and allow current treatments to be more effective. Clever-1 is highly expressed in both AML and MDS and associated with therapy resistance, limited T cell activation and poor outcomes.

About bexmarilimab

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

About Faron Pharmaceuticals Ltd

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

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 Appoints Dr. Petri Bono as new CMO

Faron Pharmaceuticals Ltd.

(“Faron” or the “Company”)

Faron Appoints Dr. Petri Bono as new CMO

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

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

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

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

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

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

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

For more information please contact:

Investor Contact

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

Media Contact

ICR Consilium

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com  

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880

Peel Hunt LLP, Broker

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

About BEXMAB

The BEXMAB study is an open-label Phase 1/2 clinical trial investigating bexmarilimab in combination with standard of care (SoC) in the aggressive hematological malignancies of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The primary objective is to determine the safety and tolerability of bexmarilimab in combination with SoC (azacitidine) treatment. Directly targeting Clever-1 could limit the replication capacity of cancer cells, increase antigen presentation, ignite an immune response, and allow current treatments to be more effective. Clever-1 is highly expressed in both AML and MDS and associated with therapy resistance, limited T cell activation and poor outcomes.

About Bexmarilimab

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

About Faron Pharmaceuticals Ltd.

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

Forward-Looking Statements

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

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

Faron Announces Positive FDA Feedback

Faron Pharmaceuticals Ltd.

(“Faron” or the “Company”)

Inside Information: Faron Announces Positive FDA Feedback

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

Key highlights

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

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

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

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

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

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

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

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

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

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

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

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

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

For more information please contact:

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

Media Contact

ICR Consilium

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com  

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880

Peel Hunt LLP, Broker

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

About BEXMAB

The BEXMAB study is an open-label Phase 1/2 clinical trial investigating bexmarilimab in combination with standard of care (SoC) in the aggressive hematological malignancies of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The primary objective is to determine the safety and tolerability of bexmarilimab in combination with SoC (azacitidine) treatment. Directly targeting Clever-1 could limit the replication capacity of cancer cells, increase antigen presentation, ignite an immune response, and allow current treatments to be more effective. Clever-1 is highly expressed in both AML and MDS and associated with therapy resistance, limited T cell activation and poor outcomes.

About Bexmarilimab

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

About Faron Pharmaceuticals Ltd.

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

Forward-Looking Statements

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

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

New shares registered with Finnish Trade Register

Faron Pharmaceuticals Ltd

(“Faron” or the “Company“)

New shares of Faron registered with the Finnish Trade Register

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

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

Company announcement, 20 June 2024 at 3pm (EEST) / 1pm (BST) / 8am (EDT)

TURKU, FINLAND  – Faron Pharmaceuticals Ltd (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company pursuing a CLEVER-1 receptor targeting approach to reprogramming myeloid cells to activate anti-tumor immunity in hematological and solid tumor microenvironments, announced earlier today results of the share offering (the “Offering“) and the issuance of a total of 30,709,056 newly issued treasury shares and new shares in the Company in the Offering, as well as the issuance of 308,158 new shares to certain subscription guarantors in the Offering and the issuance of 1,600,153 new shares to investors who participated in the private placement announced on 4 April 2024 (together the “New Shares“), as well as the registration of the first part of the New Shares, i.e. a total of 20,727,359 shares to Faron itself without consideration, to be further conveyed to institutional investors and in the UK offerings.

Faron announces that also the remaining 11,890,008 New Shares have now been registered with the Trade Register maintained by the Patent and Registration Office. These New Shares are issued to private individuals and legal entities in Finland in the public offering, to lenders of the convertible capital loans, and to subscription guarantors.

Following the completion of the registrations, the total number of registered shares in Faron is 104,624,864. The New Shares together account for approximately 45.3 per cent of the Company’s outstanding shares and votes prior to the Offering and 31.2 per cent following the Offering.

As previously announced, the New Shares will be recorded on investors’ book-entry accounts on or about 24 June 2024. The first part of the New Shares has been registered first as treasury shares of the Company and will be recorded upon their conveyance on investors’ book-entry accounts (delivery against payment) and, as applicable, settled as DIs in the UK open offer and the REX retail offer on or about 24 June 2024. No shares will be held in treasury.

Applications will be made for the admission to trading of the New Shares on the Nasdaq First North Growth Market Finland (“First North“) maintained by Nasdaq Helsinki Ltd (“Nasdaq Helsinki“) under the current trading code “FARON”, and on AIM (“AIM“), the market of that name operated by London Stock Exchange plc under the trading code “FARN”. Trading in the New Shares is expected to commence on or around 10:00 a.m. EEST / 8:00 a.m. BST on 24 June 2024 subject to the admission of the New Shares to trading on First North and AIM.

Faron Pharmaceuticals Ltd

For more information please contact:

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

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880

Peel Hunt LLP, Broker

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

About BEXMAB

The BEXMAB study is an open-label Phase I/II clinical trial investigating bexmarilimab in combination with standard of care (SoC) in the aggressive hematological malignancies of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The primary objective is to determine the safety and tolerability of bexmarilimab in combination with SoC (azacitidine) treatment. Directly targeting Clever-1 could limit the replication capacity of cancer cells, increase antigen presentation, ignite an immune response, and allow current treatments to be more effective. Clever-1 is highly expressed in both AML and MDS and associated with therapy resistance, limited T cell activation and poor outcomes.

About bexmarilimab

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

About Faron Pharmaceuticals Ltd

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

Important notice

This announcement is not an offer of securities for sale into the United States. The Offer Shares have not been and will not be registered under the United States Securities Act of 1933, as amended (the “Securities Act“), or under the securities laws of any state or other jurisdiction of the United States, and may not be offered, sold or transferred, directly or indirectly, in or into or from the United States except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and in compliance with any applicable securities laws of any state or other jurisdiction of the United States. There is no intention to register the Offer Shares in the United States or to make a public offering in the United States. Any sale of the Offer Shares in the United States will be made solely to a limited number of “qualified institutional buyers” or accredited investors, each as defined in Rule 144A in reliance on an exemption from the registration requirements of the Securities Act.

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

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

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

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

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

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

Caution regarding forward-looking statements

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

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

Proposed REX Retail Offer

THIS ANNOUNCEMENT IS RESTRICTED AND IS NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN, INTO OR WITHIN THE UNITED STATES OR THE DISTRICT OF COLUMBIA (COLLECTIVELY THE “UNITED STATES”), AUSTRALIA, CANADA, NEW ZEALAND, SOUTH AFRICA OR JAPAN, OR ANY MEMBER STATE OF THE EUROPEAN ECONOMIC AREA (THE “EEA”), OR ANY OTHER JURISDICTION IN WHICH SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL. PLEASE SEE THE IMPORTANT NOTICE AT THE END OF THIS ANNOUNCEMENT.

 

THIS ANNOUNCEMENT AMOUNTS TO A FINANCIAL PROMOTION FOR THE PURPOSES OF SECTION 21 OF THE FINANCIAL SERVICES AND MARKETS ACT 2000 (“FSMA”) AND HAS BEEN APPROVED BY PEEL HUNT LLP WHICH IS AUTHORISED AND REGULATED BY THE FINANCIAL CONDUCT AUTHORITY (FRN 530083). THIS IS A FINANCIAL PROMOTION AND IS NOT INTENDED TO BE INVESTMENT ADVICE.

 

 

Faron Pharmaceuticals Ltd

 

(“Faron” or the Company“)

 

Proposed REX Retail Offer

 

Company announcement, 5 June 2024 at 10:00 a.m. (EEST) / 8:00 a.m. (BST) / 3:00 a.m. (EDT)

 

Key Highlights

 

  • Faron will conduct an offer to retail investors in the United Kingdom on the “REX” platform. The REX Offer (as defined below) is part of an Offering (as defined below) raising approximately EUR 30.7 million. Details of the Offering can be found in the Company’s announcement dated 4 June 2024 and available on the Company’s website at www.faron.com/investors/publicoffer.

 

TURKU, FINLAND – Faron Pharmaceuticals Ltd (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company pursuing a CLEVER-1 receptor targeting approach to reprogramming myeloid cells to activate anti-tumor immunity in hematological and solid tumor microenvironments, today announces its intention to raise funds by means of a proposed retail offer via the Retail Capital Markets ‘REX’ portal (the “REX Offer“) of ordinary shares (“Ordinary Shares“) in the capital of the Company (the “REX Offer Shares“).

 

The Company is conducting the Offering to raise approximately EUR 30.7 million in total through the issue of up to 30,714,592 Ordinary Shares (the “Offer Shares“) at a subscription price of EUR 1 per Offer Share (or GBP 0.85 per Offer Share in respect of the UK Open Offer and the REX Offer) by way of:

  • a public offering of Offer Shares to private individuals and legal entities in Finland (the “Public Offering“);
  • an institutional offering of Offer Shares to institutional investors in the European Economic Area and, in accordance with applicable laws, internationally (the “Institutional Offering“);
  • an open offer to qualifying holders of depositary interests in the United Kingdom (the “UK Open Offer“); and
  • the REX Offer (together with the Public Offering, the Institutional Offering and the UK Open Offer, the “Offering“).

The price of the REX Offer Shares is 85 pence per REX Offer Share (the “Offer Price“), which is the same issue price as for the UK Open Offer and is equivalent to the EUR 1 subscription price of the Public Offering and the Institutional Offering based on an exchange rate of GBP 1 : EUR 1.1714 on 31 May 2024. The Offer Price represents a 54 per cent. discount to the closing price of the Ordinary Shares on 31 May 2024 (being the latest practicable date prior to the announcement of the Offering dated 4 June 2024). The aggregate gross proceeds of the REX Offer and the UK Open Offer shall not exceed £6.8 million (the GBP equivalent of EUR 8 million based on an exchange rate of GBP 1 : EUR 1.1714 on 31 May 2024).

 

For the avoidance of doubt, the REX Offer is not part of the Public Offering, Institutional Offering or the UK Open Offer.

 

REX Offer

 

The REX Offer is conditional upon, among other things:

 

  1. completion of the Public Offering, Institutional Offering and the UK Open Offer;

 

  1. the REX Offer Shares being admitted to trading on AIM, the market of that name operated by London Stock Exchange plc, and Nasdaq First North Growth Market Finland of Nasdaq Helsinki Ltd (Admission“). Admission is expected to take place at or around 8.00 a.m. on 24 June 2024.

  

The Company values its retail shareholder base in the United Kingdom and believes that it is appropriate to provide retail investors in the United Kingdom the opportunity to participate in the current fundraising.

 

Therefore, the Company is making the REX Offer open to eligible investors in the United Kingdom following release of this announcement through certain financial intermediaries.

 

Investors should contact their broker or wealth manager to participate in the REX Offer.

 

The REX Offer is expected to close at or around 7:30 a.m. on 19 June 2024. Investors should note that financial intermediaries may have earlier closing times.

 

At the time of this announcement the following intermediaries have confirmed their participation in the REX Offer:

 

  • AJ Bell
  • interactive investor

 

Retail brokers wishing to participate in the REX Offer on behalf of retail investors, should contact info@rexretail.com.

 

To be eligible to participate in the REX Offer, applicants must be a customer of a participating intermediary, which may include individuals aged 18 years or over, companies and other bodies corporate, partnerships, trusts, associations and other unincorporated organisations.

  

There is a minimum subscription of £50 per investor. The terms and conditions on which investors subscribe will be provided by the relevant financial intermediaries, including relevant commission or fee charges.

 

The Company reserves the right in its absolute and sole discretion to: (i) scale back any order under the REX Offer; and (ii) reject any application for subscription under the REX Offer without giving any reason for such rejection.

 

Allocations under the REX Offer are expected to be in keeping with the principle of soft pre-emption, subject to the Company’s discretion.

 

It is vital to note that once an application for REX Offer Shares has been made and accepted via an intermediary, it cannot be withdrawn.

 

The REX Offer Shares, when issued, will be credited as fully paid and will rank pari passu in all respects with the Company’s then existing Ordinary Shares, including the right to receive all dividends and other distributions declared, made or paid in respect of such shares after the date of issue.

 

It is a term of the REX Offer that the aggregate total value of the Offer Shares to be allotted and issued pursuant to the REX Offer and the UK Open Offer does not exceed £6.8 million (the GBP equivalent of EUR 8 million based on an exchange rate of GBP 1 : EUR 1.1714 on 31 May 2024). Allocations under the REX Offer will be scaled back, as necessary, to ensure that the total aggregate consideration under the REX Offer and the UK Open Offer will not exceed this amount.

 

The REX Offer is being made in the United Kingdom under the exemption from the requirement to publish a prospectus in section 86(1)(e) of FSMA. As such, there is no need for publication of a prospectus pursuant to the Prospectus Regulation Rules of the Financial Conduct Authority, or for approval of the same by the Financial Conduct Authority. The REX Offer is not being made into any jurisdiction other than the United Kingdom.

 

No offering document, prospectus or admission document has been or will be prepared or submitted to be approved by the Financial Conduct Authority (or any other authority) in relation to the REX Offer, and investors’ commitments will be made solely on the basis of the information contained in this announcement and information that has been published by or on behalf of the Company prior to the publication of this announcement by notification to a Regulatory Information Service in accordance with the Financial Conduct Authority’s Disclosure Guidance and Transparency Rules, the Market Abuse Regulation (EU Regulation No. 596/2014) (“MAR“) and MAR as assimilated into United Kingdom domestic law by virtue of the European Union (Withdrawal) Act 2018 (as amended).

  

Investors should make their own investigations into the merits of an investment in the Company. Nothing in this announcement amounts to a recommendation to invest in the Company or amounts to investment, taxation or legal advice. In relation to the Public Offering, the Institutional Offering and the UK Open Offer, please refer to Company’s announcement on 4 June 2024, published at 7:00 a.m (BST), and materials available on the Company’s website www.faron.com/investors/publicoffer 

It should be noted that a subscription for REX Offer Shares and investment in the Company carries a number of risks. Investors should take independent advice from a person experienced in advising on investment in securities such as the REX Offer Shares if they are in any doubt.

 

An investment in the Company will place capital at risk. The value of your investment in the Company and any income from it is not guaranteed and can fall as well as rise due to stock market and currency movements. When you sell your investment, you may get back less than the amount originally invested.

 

Neither past performance nor any forecasts should be considered a reliable indicator of future results.

 

For Further Information

 

Investor 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

 

 

 

REX Retail

 

 

Info@rexretail.com

 

Further information on the Company can be found on its website at www.faron.com.

 

The Company’s LEI is 7437009H31TO1DC0EB42.

 

This announcement should be read in its entirety. In particular, the information in the “Important Notices” section of this announcement should be read and understood.

 

Important Notices

 

The content of this announcement has been prepared by and is the sole responsibility of the Company.

 

 

THIS ANNOUNCEMENT IS RESTRICTED AND IS NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN, INTO OR WITHIN THE UNITED STATES OR THE DISTRICT OF COLUMBIA (COLLECTIVELY THE UNITED STATES), AUSTRALIA, CANADA, NEW ZEALAND, SOUTH AFRICA OR JAPAN, OR ANY MEMBER STATE OF THE EUROPEAN ECONOMIC AREA (THE EEA), OR ANY OTHER JURISDICTION IN WHICH SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL.

 

No action has been taken by the Company or any person acting on its behalf or any of its or their affiliates that would permit an offer of the REX Offer Shares or possession or distribution of this announcement or any other offering or publicity material relating to such REX Offer Shares in any jurisdiction where action for that purpose is required. Persons into whose possession this announcement comes are required to inform themselves about, and to observe, such restrictions.

 

This announcement is not for publication or distribution, directly or indirectly, in or into the United States of America.  The REX Offer Shares have not been and will not be registered under the US Securities Act of 1933, as amended (the “US Securities Act“) or under the applicable state securities laws of the United States and may not be offered or sold directly or indirectly in or into the United States, except pursuant to an applicable exemption from registration. No public offering of the REX Offer Shares is being made in the United States. The REX Offer Shares are being offered and sold outside the United States in “offshore transactions”, as defined in, and in compliance with, Regulation S under the US Securities Act (“Regulation S“). In addition, the Company has not been, and will not be, registered under the US Investment Company Act of 1940, as amended.

 

The REX Offer has not been approved or disapproved by the US Securities and Exchange Commission, any state securities commission in the United States or any United States regulatory authority, nor have any of the foregoing authorities passed upon or endorsed the merits of the Institutional Offering, the UK Open Offer, the Public Offering or REX Offer, or the accuracy or adequacy of this announcement. Any representation to the contrary is a criminal offence in the United States.

 

This announcement or any part of it does not constitute an offer to sell or issue or a solicitation of an offer to buy or subscribe for REX Offer Shares in the United States, Australia, Canada, New Zealand, Japan, the Republic of South Africa, any member state of the EEA or any other jurisdiction in which such offer or solicitation is or may be unlawful. No public offer of the REX Offer Shares referred to herein is being made in any such jurisdiction.

 

The distribution of this announcement may be restricted by law in certain jurisdictions and persons into whose possession any document or other information referred to herein comes should inform themselves about and observe any such restriction. Any failure to comply with these restrictions may constitute a violation of the securities laws of any such jurisdiction.

 

REX is a proprietary technology platform owned and operated by Peel Hunt LLP (registered address at 7th Floor, 100 Liverpool Street, London EC2M 2AT; FRN 530083). Peel Hunt LLP (“Peel Hunt“) is authorised and regulated in the United Kingdom by the Financial Conduct Authority, is acting exclusively for the Company and for no-one else and will not regard any other person (whether or not a recipient of this announcement) as its client in relation to the REX Offer and will not be responsible to anyone other than the Company for providing the protections afforded to its clients, nor for providing advice in connection with the REX Offer, Admission and the other arrangements referred to in this announcement.

 

The value of Ordinary Shares and the income from them is not guaranteed and can fall as well as rise due to stock market and currency movements. When you sell your investment, you may get back less than you originally invested. Figures refer to past performance and past performance is not a reliable indicator of future results. Returns may increase or decrease as a result of currency fluctuations.

 

Certain statements in this announcement are forward-looking statements which are based on the Company’s expectations, intentions and projections regarding its future performance, anticipated events or trends and other matters that are not historical facts. These forward-looking statements, which may use words such as “aim”, “anticipate”, “believe”, “intend”, “estimate”, “expect” and words of similar meaning, include all matters that are not historical facts. These forward-looking statements involve risks, assumptions and uncertainties that could cause the actual results of operations, financial condition, liquidity and dividend policy and the development of the industries in which the Company’s businesses operate to differ materially from the impression created by the forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and other factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements. Given those risks and uncertainties, prospective investors are cautioned not to place undue reliance on forward-looking statements.

 

These forward-looking statements speak only as at the date of this announcement and cannot be relied upon as a guide to future performance. The Company and Peel Hunt expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein to reflect actual results or any change in the assumptions, conditions or circumstances on which any such statements are based unless required to do so by the Financial Conduct Authority, the London Stock Exchange plc or applicable law.

 

The information in this announcement is for background purposes only and does not purport to be full or complete. Neither Peel Hunt nor any of its affiliates, accepts any responsibility or liability whatsoever for, or makes any representation or warranty, express or implied, as to this announcement, including the truth, accuracy or completeness of the information in this announcement (or whether any information has been omitted from the announcement) or any other information relating to the Company or associated companies, whether written, oral or in a visual or electronic form, and howsoever transmitted or made available or for any loss howsoever arising from any use of the announcement or its contents or otherwise arising in connection therewith. Peel Hunt and its affiliates, accordingly disclaim all and any liability whether arising in tort, contract or otherwise which they might otherwise be found to have in respect of this announcement or its contents or otherwise arising in connection therewith.

 

Any indication in this announcement of the price at which the Ordinary Share have been bought or sold in the past cannot be relied upon as a guide to future performance. Persons needing advice should consult an independent financial adviser. No statement in this announcement is intended to be a profit forecast and no statement in this announcement should be interpreted to mean that earnings or target dividend per share of the Company for the current or future financial years would necessarily match or exceed the historical published earnings or dividends per share of the Company.

 

Neither the content of the Company’s website (or any other website) nor the content of any website accessible from hyperlinks on the Company’s website (or any other website) is incorporated into or forms part of this announcement. The REX Offer Shares to be issued or sold pursuant to the REX Offer will not be admitted to trading on any stock exchange other than the AIM market of the London Stock Exchange plc.

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