Correction: Faron Pharmaceuticals Ltd’s Annual Report 2025 published

Faron Pharmaceuticals Ltd | Company announcement | March 04, 2026 at 18:45:00 EET

TURKU, FINLAND – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), announces a correction to the company announcement of its Annual Report 2025, originally published on 4 March 2026 at 09:15 EET. The Annual Report 2025 published did not contain the auditor’s report. An updated version of the Annual Report 2025 with the full auditor’s report, has been included as an attachment to this announcement.

The English version of Annual Report is available as a PDF file attached to this release and on the company’s website at https://faron.com/investors/reports-and-presentations/. Also the Finnish language version of the Financial Statements is available as a PDF file attached to this release and on the company’s website at https://faron.fi/sijoittajat/raportit-esitykset/.

Faron Pharmaceuticals Ltd
Board of Directors

For more information please contact:

IR Partners, Finland
(Media)
Kare Laukkanen
Phone: +358 50 553 9535
E-mail: kare.laukkanen@irpartners.fi

FINN Partners, US
(Media)
Alyssa Paldo
Phone: +1 847 791-8085
E-mail: alyssa.paldo@finnapartners.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.

About Bexmarilimab
Bexmarilimab is Faron’s wholly owned, investigational immunotherapy designed to overcome resistance to existing treatments by targeting Clever-1, a receptor on immunosuppressive macrophages and malignant blasts. By inhibiting Clever-1, bexmarilimab reprograms the tumor microenvironment to ignite a potent anti-tumor immune response.

About Faron Pharmaceuticals Ltd.
Faron Pharmaceuticals (AIM: FARN, First North: FARON) is a global, clinical-stage biopharmaceutical company, focused on creating innovative cancer treatments that leverage the patient’s own immune system. The Company’s lead asset bexmarilimab is currently being investigated in multiple clinical trials as a potential therapy for patients with hematological malignancies and solid tumors in combination with other standard treatments.

Forward-Looking Statements
This press release contains certain forward-looking statements relating to the business of Faron Pharmaceuticals. In addition, even if the actual results or development of Faron Pharmaceuticals are consistent with the forward-looking statements contained in this press release, those results or developments of Faron Pharmaceuticals may not be sustained in the future. In some cases, you can identify forward-looking statements by words such as “could,” “should,” “may,” “expects,” “anticipates,” “believes,” “intends,” “estimates,” “aims,” “targets,” or similar words. These forward-looking statements are based largely on the current expectations of Faron Pharmaceuticals as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, the expectations of Faron Pharmaceuticals could be affected by, among other things, uncertainties and delays involved in the development of product candidates, unexpected clinical trial results, unexpected regulatory actions or delays, competition in general, currency fluctuations, inflation, changes in tariff policies, political or macroeconomic developments, and the ability to obtain or maintain patent or other proprietary intellectual property protection. Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made in this press release will in fact be realized. Faron Pharmaceuticals is providing this information as of the date of this press release and disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

THE NEW SHARES ISSUED IN THE RIGHTS OFFERING 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.

Faron Pharmaceuticals Ltd’s Annual Report 2025 published

Faron Pharmaceuticals Ltd | Company announcement | March 04, 2026 at 09:15:00 EET

Faron Pharmaceuticals Ltd’s Annual Report 2025 published

TURKU, FINLAND – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on tackling cancers via novel immunotherapies, today published the Annual Report for 2025. The Annual Report contains the Report of the Board of Directors, the Financial Statements for 2025 and the Remuneration Report.

The English version of Annual Report is available as a PDF file attached to this release and on the company’s website at https://faron.com/investors/reports-and-presentations/. Also the Finnish language version of the Financial Statements is available as a PDF file attached to this release and on the company’s website at https://faron.fi/sijoittajat/raportit-esitykset/.

Faron Pharmaceuticals Ltd
Board of Directors

For more information please contact:

IR Partners, Finland
(Media)
Kare Laukkanen
Phone: +358 50 553 9535
E-mail: kare.laukkanen@irpartners.fi

FINN Partners, US
(Media)
Alyssa Paldo
Phone: +1 847 791-8085
E-mail: alyssa.paldo@finnapartners.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.

About Bexmarilimab
Bexmarilimab is Faron’s wholly owned, investigational immunotherapy designed to overcome resistance to existing treatments by targeting Clever-1, a receptor on immunosuppressive macrophages and malignant blasts. By inhibiting Clever-1, bexmarilimab reprograms the tumor microenvironment to ignite a potent anti-tumor immune response.

About Faron Pharmaceuticals Ltd.
Faron Pharmaceuticals (AIM: FARN, First North: FARON) is a global, clinical-stage biopharmaceutical company, focused on creating innovative cancer treatments that leverage the patient’s own immune system. The Company’s lead asset bexmarilimab is currently being investigated in multiple clinical trials as a potential therapy for patients with hematological malignancies and solid tumors in combination with other standard treatments.

Forward-Looking Statements
This press release contains certain forward-looking statements relating to the business of Faron Pharmaceuticals. In addition, even if the actual results or development of Faron Pharmaceuticals are consistent with the forward-looking statements contained in this press release, those results or developments of Faron Pharmaceuticals may not be sustained in the future. In some cases, you can identify forward-looking statements by words such as “could,” “should,” “may,” “expects,” “anticipates,” “believes,” “intends,” “estimates,” “aims,” “targets,” or similar words. These forward-looking statements are based largely on the current expectations of Faron Pharmaceuticals as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, the expectations of Faron Pharmaceuticals could be affected by, among other things, uncertainties and delays involved in the development of product candidates, unexpected clinical trial results, unexpected regulatory actions or delays, competition in general, currency fluctuations, inflation, changes in tariff policies, political or macroeconomic developments, and the ability to obtain or maintain patent or other proprietary intellectual property protection. Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made in this press release will in fact be realized. Faron Pharmaceuticals is providing this information as of the date of this press release and disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

THE NEW SHARES ISSUED IN THE RIGHTS OFFERING 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.

Faron’s Financial Statements Release 1 January to 31 December 2025

Faron Pharmaceuticals Ltd | Company announcement | March 04, 2026 at 09:00:00 EET

Continued steady progress with bexmarilimab and solidifying position as a leading macrophage based immunotherapy under development

Figures in parentheses refer to the corresponding period of previous year, unless otherwise indicated. The figures in this financial statements release are audited unless otherwise indicated.

January–December 2025 highlights

  • In 2025 Faron presented as an oral presentation the results of its BEXMAB Phase I/II trial at ASCO, EHA, ESMO and ASH congresses. Efficacy results are among the highest ever reported in HR-MDS prospective trials.
  • During the spring 2025 Faron received a positive opinion on orphan drug designation for bexmarilimab for the treatment of MDS by EMA and also the FDA granted an orphan drug designation for bexmarilimab in HR MDS.
  • Faron held an End of Phase 2 (EOP2) meeting with the FDA in the end of the summer and received positive and valuable feedback on its clinical development plan.
  • Faron strengthened its financial position by carrying out a significantly oversubscribed private placement of newly issued treasury shares, raising gross proceeds of EUR 12 million in total in the beginning of the year 2025. April, Faron entered into an up to EUR 35 million unsecured convertible bond arrangement with Heights Capital Management Inc. (“HCM”) and repaid its secured loan to IPF Partners. Faron issued first tranche of bonds with a principal amount of EUR 15 million simultaneously and in December Faron issued the EUR 10 million second tranche of the convertible bonds.
  • Faron’s other operating income was EUR 1.3 (0) million
  • R&D expenses were EUR 12.7 (11.7) million
  • Operating loss for the reporting period was EUR 19.0 (18.7) million
  • Loss per share was EUR 0.24 (0.29)
  • On 31 December 2025, cash and cash equivalents were EUR 12.3 (9.5) million
  • Net assets were EUR -18.5 (-9.8) million
  • The Companys comprehensive loss for the period was EUR 27,191,954. The Board of Directors proposes to the Annual General Meeting 2025 not to pay dividend.
  • The Annual General Meeting 2025 appointed Dr. Juho Jalkanen and Mr. Colin Bond as new members to the Board of Directors of Faron Pharmaceuticals Ltd.
  • Mr. Jurriaan Dekkers was appointed as the Company’s Chief Financial Officer as of 1 December 2025 as the previous Chief Financial Officer, Mr. Yrjö Wichmann, will retire.

Significant events after the reporting period

  • In January, the Company announced that the Board had approved the exercise of 453,979 special rights entitling to 453,979 existing treasury shares, for an aggregate subscription price of EUR 846,943.22. This exercise was linked to the advanced amortisation payment of the First Tranche Bonds. In February, the Company approved the exercise of 909,517 Special Rights entitling to 909,517 new Shares, for an aggregate subscription price of EUR 1,549,998.87. This exercise was linked to the scheduled amortisation of the First and Second Tranche Bonds. Following the registration, the Company continues to have 3,688,699 shares in treasury and therefore, the total number of voting rights in Faron is 115,783,961.
  • On 9 February 2026, the Company announced its plan to conduct a rights issue to raise gross proceeds of approximately EUR 40 million.
  • Faron held an Extraordinary General Meeting of Shareholders (EGM) on 2 March 2026.The EGM authorised the Board of Directors to issue up to 80,000,000 new shares and to resolve on all other terms and conditions of the rights offering, including the subscription and payment period and the grounds for determining the subscription price.

Consolidated key figures, IFRS

EUR ’000 unless otherwise indicated 7–12/2025
(unaudited)
6 months
7–12/2024
(unaudited)
6 months
1–12/2025
(audited)
12 months
1-12/2024
(audited)
12 months
Other operating income 1,308 0 1,308 0
Research and development expenses (5,540) (5,082) (12,655) (11,744)
General and administrative expenses (2,818) (2,301) (7,612) (6,929)
Operating loss for the reporting period (7,050) (7,383) (18,959) (18,673)
Loss per share, EUR (0.07) (0.11) (0.24) (0.29)
Number of shares at end of period 114,420,465 104,624,864 114,420,465 104,624,864
Average number of shares 112,574,382 104,624,864 111,718,219 88,518,654
Unaudited 30 June 2025 Unaudited 30 June 2024 31 December 2025 31 December 2024
Cash and cash equivalents 13,532 29,979 12,317 9,503
Equity (16,246) 1,379 (18,507) (9,762)
Balance sheet total 16,204 35,460 17,172 12,521

Outlook for 2026

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

CEO Statement

“In 2025, we continued to make steady progress in advancing our lead asset bexmarilimab and solidifying our leading position as a macrophage based immunotherapy. Throughout the year, we achieved significant clinical and regulatory milestones and presented continuously improving data from the BEXMAB trial in higher-risk myelodysplastic syndrome (HR MDS), demonstrating the potential of bexmarilimab to overcome treatment resistance in areas of high unmet need.

Increasingly convincing data from the bexmarilimab program

In January 2025, we identified the final patient for the BEXMAB Phase II trial in relapsed/refractory (r/r) MDS, as well as the Phase I/II study in frontline HR MDS. Consequently, we were able to announce the topline response rate read-out in April. The readout confirmed earlier positive findings in both frontline and r/r MDS, showing a high overall response rate (ORR) and median overall survival. We were honoured to present these results at the ASCO Annual Meeting 2025 in June.

While April’s data set was already one of the strongest ever seen in treatment-resistant MDS, the data only continued to improve as the year progressed. In June, we presented updated Phase II data at the EHA 2025 Congress. In October, we presented new data at ESMO 2025, highlighting bexmarilimab’s ability to modulate the bone marrow microenvironment and clear complex cytogenetics even in low blast count patients, further strengthening the clinical profile of bexmarilimab in HR MDS. Finally, in December, we presented BEXMAB data at ASH 2025, showing deep and durable responses in treatment-naïve HR MDS.

The acceptance of our results for oral presentations at these prestigious events reflects the scientific progress and interest we have been able to generate toward bexmarilimab. This continued momentum reinforces our conviction that bexmarilimab holds real promise as a much-needed therapeutic option for patients with HR MDS.

Positive interaction with regulatory authorities

Our clinical results supported ongoing constructive and pivotal discussions with regulatory authorities throughout the year. In early spring, both the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA) granted us Orphan Drug Designation for bexmarilimab for the treatment of MDS. These designations provide important regulatory guidance and protocol assistance for the development process. In addition, the designations offer market exclusivity after receiving marketing approval.

As the BEXMAB Phase II trial progressed as planned, we also focused on taking the data to the FDA and to fine tune the registrational approach. This interaction culminated in August, as we announced the feedback from the end-of-phase-II meeting. We were extremely encouraged by the collaborative and highly productive dialogue with the FDA, which provided a clear and actionable path for a registrational Phase II/III study of bexmarilimab in frontline HR MDS. Based on these discussions and the clinical data produced during the year, we are now ready to advance bexmarilimab to the next stages of development.

However, based on competitors’ past failures in Phase III HR MDS trials, namely the VERONA trial, as well as comprehensive discussions with pharma partner candidates, physicians and regulatory experts, we believe that the best way to secure a positive Phase III and approval of bexmarilimab is to run the Phase II part separately and not seamlessly from the Phase III, i.e. to un-blind and thoroughly analyse the result after the Phase II part to then make the final adjustments to the confirmatory Phase III.

For us the most important thing is to get this trial right as the MDS field cannot take another failed trial. This altered approach also offers Faron’s shareholders a new considerable value inflection point, which we are truly excited about.

Combination potential with solid tumours

In addition to the considerable progress of bexmarilimab in HR MDS, we keep advancing our research in solid tumours. In May, two articles were published in the Journal for ImmunoTherapy of Cancer, highlighting the significance of CLEVER-1 in solid tumours and deepening our understanding of the tumour microenvironment’s influence. These results contribute to the design of future solid tumour trials.

We are already in the process of planning with certain recognized hospitals several proof-of-concept investigator initiated trials (IITs) in solid tumours – FINPROVE, BLAZE, BEXAR. These trials are designed to evaluate bexmarilimab’s potential in the treatment of diseases such as breast cancer, lung cancer, melanoma and sarcoma. It is important to note that these trials are investigator-initiated trials, requiring minimal financial investment from Faron. In 2026, we are excited to support and advance these IITs and demonstrate bexmarilimab’s ability to overcome treatment resistance in new indications.

Important choices ahead in 2026

I could not be prouder of our team and their accomplishments during the year. At the same time, I look ahead to 2026 with great anticipation and optimism. We begin the year with two main themes: advancing bexmarilimab’s development in HR MDS and demonstrating that our lead asset is also suitable in other indications, especially in solid tumours. In HR MDS, we have already generated some of the best clinical data ever seen. We have adapted our clinical program to hopefully overcome all existing challenges in this space to eventually secure a positive Phase III and the long-awaited approval of a new drug for the treatment of HR MDS, subject to of course positive results.

In the broader market context, we believe that the pharmaceutical sector is poised for a resurgence. Major pharma companies are facing a patent cliff, threatening to put a significant portion of their revenues at risk through 2030. As some key patents expire, these companies face intense pressure to find new blockbuster assets. This is why it is so important for us to keep advancing bexmarilimab across several indications. A main theme for 2026 is to show that bexmarilimab is not just a drug for MDS.

As we have communicated before, we are constantly engaged in in-depth commercial discussions. I remain confident that we will find the right solution when the time is right.

The fundamentals concerning the business are solid and industry trends are in our favour: 1) bexmarilimab is one of the most advanced novel agents in development for HR MDS with some of the best efficacy and safety ever seen, 2) there is a profound need for new treatments in HR MDS, 3) commercial pharma companies are in need of new well selling drug candidates to overcome their patent cliffs, 4) further considerable value creation potential in solid tumours. Our time will come.”

Juho Jalkanen
CEO

Pipeline highlights in 2025

Bexmarilimab is Faron’s wholly owned, first-in-class investigational immunotherapy candidate designed to overcome resistance to existing treatments and improve clinical outcomes. Bexmarilimab binds to Clever-1, an immunosuppressive receptor found on macrophages leading to growth and metastases, and a novel immune checkpoint target for drug development.

Hematological cancers in combination with standard of care (SoC) – BEXMAB

Faron’s current priority is its Phase II BEXMAB trial, investigating bexmarilimab in combination with standard of care therapy azacitidine. In 2025, Faron achieved significant progress with bexmarilimab in myelodysplastic syndrome (MDS):

  • Faron received a positive opinion on orphan drug designation for bexmarilimab for the treatment of HR MDS by both EMA and FDA in Q1/2025.
  • On 30 May 2025 Phase I BEXMAB results were published in the prestigious Lancet Haematology.
  • On 2 June 2025, for the first time Faron presented phase II data from BEXMAB Study at ASCO congress, an oral presentation. On 12 June 2025, Faron presented updated translational Phase II data from BEXMAB Study at EHA 2025 congress.
  • On 18 August 2025, Faron announced positive results of the EOP2 meeting held with the FDA confirming study design and accelerated approval pathway for frontline patients with CR + CReq. On the basis of the EOP2 FDA meeting feedback, Faron started preparations for a Phase II/III frontline HR MDS study and discussing it widely with pharma partners, regulatory experts and key opinion leaders in the field.
  • On 20 October 2025, Faron oral presentation at ESMO: Deeper BM target engagement in treatment-naïve patients with <5% bone marrow blasts at baseline translated to 100% ORR.
  • On 8 December 2025, Faron presented strong follow-up data in an oral presentation at ASH 2025.
  • Median overall survival (mOS) with bexmarilimab and azacitidine in relapsed/refractory (r/r) HR MDS patients reached 14.5 months, a significant improvement in a population with historically poor survival of only 5-6 months.
  • 45% complete remission (CR) rate in treatment-naïve patients with higher-risk myelodysplastic syndrome (HR MDS) with duration of CR over 12 months.
  • For the first time, data shows 57% of frontline patients who were transfusion-dependent at baseline achieved transfusion independence, confirming restoration of healthy bone marrow function.

Combination potential with solid tumours – and further expansion

The Company is preparing to support the initiation of certain proof-of-concept investigator-initiated trials (IITs) in in the field of metastatic melanoma, metastatic lung cancer, soft tissue sarcoma, hormone positive breast cancer (ER+ BRC) as well as in acute myeloic leukemia and r/r MDS. The Company believes that these IITs could show for example that bexmarilimab can overcome treatment resistance, enhance chemotherapy sensitivity and that Clever-1 positivity could be used as a patient selection method in solid tumors.

Corporate Higlights

  • Faron strengthened its financial position by carrying out a significantly oversubscribed private placement of newly issued treasury shares, raising gross proceeds of EUR 12 million in total in the beginning of the year 2025.
  • In April, Faron entered into an up to EUR 35 million unsecured convertible bond arrangement with Heights Capital Management Inc. (“HCM”) and repaid its secured loan to IPF Partners. Faron issued first tranche of bonds with a principal amount of EUR 15 million simultaneously and in December Faron issued the second tranche of the convertible bonds.
  • Faron strengthened its Management Team by appointing seasoned commercial development expert Ralph Hughes as Chief Business Officer, enhancing the Company’s commercial strategy, business development, and market assessment capabilities. In addition, Jurriaan Dekkers was appointed Chief Financial Officer (CFO) as of 1 December 2025. The Company’s previous CFO, Yrjö Wichmann, will be retiring after playing a key role in supporting Faron’s strategic transition and growth over several years. Mr. Wichmann will remain with the Company through the end of Q1 2026 to ensure a smooth transition.
  • The Annual General Meeting 2025 appointed Dr. Juho Jalkanen and Mr. Colin Bond as new members to the Board of Directors of the Company.

Financial review January–December 2025

The financial status of the Company has remained acceptable during 2025 despite a slight increase in the expenses and loss for the financial year. In early February 2025, the Company conducted a private placement directed to a limited number of institutional and other investors raising EUR 12.0 million and in early April 2025 it made an agreement of a EUR 35 million Convertible Bond arrangement with CVI Investments Inc., an entity managed by Heights Capital Management Inc. The arrangement consists of three tranches, EUR 15 million, EUR 10 million and EUR 10 million. The first tranche was drawn down in April 2025 and the second tranche in December 2025. These actions helped the Company to strengthen its cash position by the end of the year.

Faron places a strategic emphasis on capital efficiency, a key element of efforts to extend its cash runway, without compromising the ability to advance its clinical development program. This capital efficiency has allowed the Company to achieve more with available resources, while focusing on clinical outcomes

Loss before income tax and total comprehensive loss in January–December 2025 was EUR -27.3
(-25.9) million, which represents a loss of EUR 0.24 (0.29) per share.

Operating expenses

In January–December 2025, Faron’s R&D costs were EUR 12.7 (11.7) million, a net increase of EUR 0.9 million. These costs were attributable to advancing clinical programs including completion of BEXMAB Phase I/II and preparations for Phase II/III. The main items of R&D costs are outsourced clinical trial costs, compensation and benefits for personnel directly responsible for R&D activities and legal and consulting costs. Outsourced costs include the cost of patient and site enrolment, CRO service costs including monitoring and investigator fees, and product supply costs. The costs of outsourced clinical trial services increased to EUR 5.8 million in 2025 compared to EUR 3.3 million in 2024. Compensation and benefits increased to EUR 2.8 million in 2025 from EUR 1.4 million in 2024 and included stock compensation expense of EUR 0.4 million and EUR 0.02 million in 2025 and 2024, respectively. Legal and consulting costs increased to EUR 1.5 million in 2025 from EUR 1.4 million in 2024. These increases were partially counterweighted by a EUR 0.9 million decrease in materials and services costs and analytics.

In January–December 2025, G&A expenses were EUR 7.6 (6.9) million. The net increase of EUR 0.7 million was mainly caused by an increase of EUR 1.2 million in compensation and benefits for personnel, EUR 4.5 million in 2025 and EUR 3.3 million in 2024, and a EUR 0.7 million decrease in legal and consulting costs, EUR 1.2 million in 2025 and EUR 1.9 million in 2024.

Financial costs

Net financial costs were EUR 8.3 million in 2025 compared to EUR 7.2 million in 2024, an increase of EUR 1.0 million. The net change was due to multiple factors. Largest single contributor was warrant value change, which turned from negative EUR 2.9 million in 2024 to positive EUR 1.3 million in 2025. Other positive was a EUR 2.7 million decrease in interest expense. These were counter-weighted by a negative EUR 3.7 million change in convertible bond (CB) valuation as well as by EUR 3.6 million transaction and structuring fees of the CB.

Taxation

The Company’s tax credit for the fiscal year 2025 can be recorded only after the Finnish tax authorities have approved the tax report and confirmed the amount of tax-deductible expenses. The total amount of cumulative tax losses carried forward approved by tax authorities on 31 December 2025 was EUR 57.8 million (2024: EUR 57.7 million). The Company can utilise these losses against potential taxable profits generated until 2034. In addition, the Company has EUR 131.8 million of R&D costs incurred in the financial years 2010–2024 that have not yet been deducted from taxation. This amount can be deducted over an indefinite period at the Company’s discretion.

Financial position and cash flows

The Faron Group generated a net loss of EUR -27.3 million in 2025 and recorded a EUR 17.9 million cash outflow from operating activities during the year ended 31 December 2025. At the end of the financial year, it had total negative equity of EUR -18.5 million including an accumulated deficit of EUR 222.9 million. As of that date, the Group had cash and cash equivalents of EUR 12.3 million.

Net cash flow in 2025 was slightly stronger than in 2024. Cash used for operating activities in 2025 was EUR 17.9 million compared to EUR 22.3 million in 2024. Net cash inflow from financing activities in 2025 was EUR 20.6 million compared to EUR 24.8 million in 2024.

Financing

On 6 February 2025, Faron concluded an oversubscribed private placement directed to a limited number of institutional and other investors raising EUR 12.0 million.

On 3 April 2025, Faron entered into a convertible bond arrangement for up to EUR 35 million with an entity managed by Heights Capital Management, Inc. (HCM), 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. The arrangement was mainly used to finance early repayment in full of the Company’s outstanding senior secured loan pursuant to the facilities agreement entered 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 no longer apply, the previously restricted cash reserves were unlocked, and the Company’s assets, including valuable intellectual property rights, were released from any pledges granted in favour of IPF. The remainder of the proceeds from the first tranche bonds were to be used for general corporate purposes and to strengthen the Company’s balance sheet.

According to the convertible bond arrangement, Faron has an option to issue, subject to certain conditions, two additional tranches of similar convertible bonds, each with a principal amount of EUR 10 million. The second tranche was drawn down in December 2025.

Going concern

As part of their going concern review, the Directors have followed International Accounting Standard 1, Presentation of Financial Statements (IAS 1). The Company and its subsidiaries are subject to a number of risks similar to those of other development state pharmaceutical companies. These risks include, amongst others, generation of revenues in due course from the development portfolio and risks associated with research, development, testing and obtaining related regulatory approvals of its pipeline products. The subsidiaries have limited economic activities and have immaterial assets and liabilities and thus the Group’s ability to continue as going concern is dependent on the Company. Ultimately, the attainment of profitable operations is dependent on future uncertain events which include obtaining adequate financing to fulfil the Group’s commercial and development activities and generate a level of revenue adequate to support the Group’s cost structure.

The Directors have prepared the detailed financial forecasts and cash flows looking beyond 12 months from the date of these financial statements. In developing these forecasts, the Directors have made assumptions based upon their view of the current and future economic conditions to the Company and the Group that are expected to prevail over the forecast period. The Directors estimate that the cash held by the Group with known receivables will be sufficient to support the current level of activities until Q2 2026.

Despite this, the Directors are continuing to explore sources of additional financing available, such as equity, debt financing and/or financing as a result of business development activities, and they believe they have a reasonable expectation that they will be able to secure additional sufficient cash inflows. Planned equity financing is disclosed in more detail in Note 24 in the Financial Statements. The Directors expect the additional funding to be sufficient for Faron to continue its activities for not less than 12 months from the date of approval of the Financial Statements; they have therefore prepared the Financial Statements on a going concern basis.

Because the additional financing is not committed at the date of issuance of the financial statements, these circumstances represent a material uncertainty that may cast significant doubt on Faron’s ability to continue as going concern. Should Faron be unable to obtain further financing such that the going concern basis of preparation were no longer appropriate, adjustments would be required, including to reduce balance sheet values of assets to their recoverable amounts.

Shares and share capital

On 31 December 2025, Faron had 118,563,143 aggregate number of ordinary shares in the company. The Company held 4,142,678 shares in treasury and therefore, the total number of voting rights in Faron were 114,420,465 on 31 December 2025. The Company’s share capital is EUR 2.69 million (EUR 2.69 million).

Faron’s shares are traded on the First North Growth Market Finland marketplace (FARON) and on the AIM market of the London Stock Exchange (FARN). In January–December 2025, the highest price of the Company’s share in First North Growth Market Finland was EUR 3.35 (3.77) and the lowest price was EUR 1.85 (1.05). Volume weighted average price was EUR 2.36 (1.39). Faron’s share price on the last day of trading was EUR 2.45 (1.19). On 31 December 2025, Faron’s market cap was EUR 286.0 (124.5) million.

Short-term risks and uncertainties

Faron is a clinical stage biopharmaceutical company and is subject to a number of risks and uncertainties similar to those of other development stage pharmaceutical companies.

These risks include, amongst others, generation of revenues in due course from the development portfolio and risks associated with research, development, testing and obtaining related regulatory approvals of its pipeline products, risks associated with vulnerability to general economic and business conditions, competition, environmental and other regulatory changes, actions by governmental authorities, the attainment of profitable operations is dependent on future uncertain events which include obtaining adequate financing to fulfil Faron’s commercial and development activities and generating a level of revenue adequate to support Faron’s cost structure, reliance on key personnel, uninsured and underinsured losses and other factors.

Proposal by the Board of Directors for the distribution of profit

The Company’s comprehensive loss for the period was EUR 27,191,954 (2024: EUR 25,999,608). The Board of Directors proposes to the Annual General Meeting 2026 not to pay dividend.

Conference call

A virtual briefing and Q&A session for investors, analysts and media will be hosted by Dr. Juho Jalkanen, Chief Executive Officer, and Jurriaan Dekkers, Chief Financial Officer, today, 4 March 2026 at 4:00 AM (EST) / 9:00 AM (GMT) / 11:00 AM (EET).

Webcast registration link: Annual report for the year ended 31 December, 2025

The financial statements release, presentation, and a replay of the webcast will be available on the Company’s website at https://www.faron.com/investors.

4 March 2026
Faron Pharmaceuticals Ltd.
Board of Directors

For more information please contact:

IR Partners, Finland (Media)
Kare Laukkanen
+358 50 553 9535 / +44 7 469 766 223
kare.laukkanen@irpartners.fi

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

Cairn Financial Advisers LLP, Nominated Advisor and Broker
Sandy Jamieson, Jo Turner
+44 (0) 207 213 0880

Sisu Partners Oy, Certified Adviser on Nasdaq First North
Juha Karttunen
+358 40 555 4727
Jukka Järvelä
+358 50 553 8990

Publication of financial information during year 2026

Faron’s financial statements for full year 2025 will be published today, 3 March 2026 and will also be available on Faron’s website at Reports and presentations – Faron. The half-year financial report for the period 1 January to 30 June 2026 is scheduled to be published on 26 August 2026. The Annual General Meeting is planned for 30 March 2026. A separate stock exchange notice will be issued by Faron’s Board of Directors to convene the meeting.

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 BEXMAB

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

About Faron Pharmaceuticals Ltd.

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

THE NEW SHARES ISSUED IN THE RIGHTS OFFERING 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.

Tables

Accounting principles for the financial statements release

The financial figures have been prepared in accordance with IFRS Accounting Standards as adopted by the European Union and the interpretations of the International Financial Reporting Standards Interpretations Committee (IFRIC). The figures in this financial statements release are audited unless otherwise indicated.

The financial statements incorporate the parent company, Faron Pharmaceuticals Ltd, and all subsidiaries (the “Group”). All amounts are presented in thousands of euros, unless otherwise indicated, rounded to the nearest euro thousand.

Consolidated Income Statement

Unaudited Unaudited Audited Audited
EUR ’000 7–12/2025
6 months
7–12/2024
6 months
1–12/2025
12 months
1–12/2024
12 months
Other operating income 1,308 1,308
Research and development expenses (5,540) (5,082) (12,655) (11,744)
General and administrative expenses (2,818) (2,301) (7,612) (6,929)
Operating loss (7,050) (7,383) (18,959) (18,673)
Financial income 913 (858) 1,515 434
Financial expense (1,695) (3,325) (9,811) (7,676)
Loss before tax (7,832) (11,566) (27,255) (25,915)
Tax expense (2) 41 (2) (5)
Loss for the period (7,834) (11,525) (27,257) (25,920)
Translation difference (4) (2) (4) 9
Total comprehensive loss for the period (7,838) (11,527) (27,261) (25,911)
Loss per ordinary share
Basic and diluted loss per share, EUR (0.07) (0.11) (0.24) (0.29)

Consolidated Balance Sheet

EUR ‘000 31 December 2025 31 December 2024
Assets
Non-current assets
Machinery and equipment 0 1
Right-of-use-assets 189 296
Intangible assets 1,117 1,112
Prepayments and other receivables 41 46
Total non-current assets 1,347 1,456
Current assets
Prepayments and other receivables 3,508 1,563
Cash and cash equivalents 12,317 9,503
Total current assets 15,825 11,065
Total assets 17,172 12,521
Equity and liabilities
Capital and reserves attributable to the equity holders of Faron
Share capital 2,691 2,691
Reserve for invested unrestricted equity 201,649 184,955
Accumulated deficit (222,856) (197,421)
Translation difference 9 13
Total equity (18,507) (9,762)
Non-current liabilities
Borrowings 14,203 8,088
Lease liabilities 76 186
Other liabilities 2,526 3,839
Total non-current liabilities 16,805 12,113
Current liabilities
Borrowings 10,270 3,722
Lease liabilities 131 117
Trade payables 5,545 4,876
Accruals and other current liabilities 2,928 1,456
Total current liabilities 18,874 10,171
Total liabilities 35,679 22,283
Total equity and liabilities 17,172 12,521

Consolidated Statement of Changes in Equity

EUR ‘000 Share capital Reserve for invested
unrestricted equity
Translation
difference
Accumulated
deficit
Total
equity
Balance as at 31 December 2023 2,691 154,352 4 (172,208) (15,160)
Comprehensive loss for the period 9 (25,920) (25,911)
Transactions with equity holders of the Group
Issue of ordinary shares, net of transaction costs 30,609 30,609
Share-based compensation  – 694 694
Reserve on retained earnings for legal (5) 11 6
  30,603 9 (25,215) 5,398
Balance as at 31 December 2024 2,691 184,955 13 (197,421) (9,762)
Comprehensive loss for the period (4) (27,257) (27,261)
Transactions with equity holders of the Group
Issue of ordinary shares, net of transaction costs 16,694 16,694
Share-based compensation 1,822 1,822
Reserve on retained earnings for legal
16,694 (4) (25,435) (8,745)
Balance as at 31 December 2025 2,691 201,649 9 (222,856) (18,507)

Consolidated Cash Flow Statement

Unaudited Unaudited Audited Audited
EUR ‘000 7–12/2025
6 months
7–12/2024
6 months
1–12/2025
12 months
1–12/2024
12 months
Cash flow from operating activities
Loss before tax (7,832) (11,566) (27,255) (25,915)
Adjustments for:
Depreciation and amortisation 175 156 326 314
R&D loan forgiveness (1,308) (1,308)
Financial items 783 4,183 8,296 7,242
Share-based compensation 1,116 325 1,822 694
Adjusted loss from operations before changes in working capital (7,066) (6,901) (18,119) (17,665)
Change in net working capital:
Prepayments and other receivables (2,237) 2,570 (1,941) 444
Trade payables (89) (9,652) 669 (4,095)
Other liabilities 1,696 (354) 1,473 (947)
Cash used in operations (7,696) (14,337) (17,918) (22,263)
Income taxes paid (2) 109 (2) (41)
Net cash used in operating activities* (7,698) (14,228) (17,920) (22,304)
Cash flow from investing activities
Interest received* 183 361 202 361
Payments for intangible assets (121) (102) (222) (225)
Payments for tangible assets (1) (1)
Net cash used in investing activities* 62 258 (20) 135
Cash flow from financing activities
Proceeds from issue of shares 121 0 12,121 31,850
Share issue transaction cost (139) (4,453) (815) (4,951)
Proceeds from borrowings 11,108 0 25,000 3,200
Repayment of borrowings (897) (1,943) (8,890) (3,371)
Transaction and structuring fees of borrowings (3,740) 0 (6,240) (750)
Interest paid* (183) (411) (391) (1,028)
Payment of lease liabilities (91) (78) (141) (162)
Net cash from financing activities* 6,179 (6,885) 20,644 24,788
Effect of exchange rate changes on cash and cash equivalents 242 379** 110 (8)
Net increase (+) / decrease (-) in cash and cash equivalents (1,215) (20,476) 2,814 2,627
Cash and cash equivalents at 1 January / 1 July 13,532 29,979 9,503 6,876
Cash and cash equivalents at 31 December 12,317 9,503 12,317 9,503

* Comparative figures revised according to new presentation format implemented 2025, details in Note 2.22 in the Financial Statements.
** Effect of exchange rate changes on cash and cash equivalents for 2024 was incorrect and has been corrected.

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

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

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

Significant clinical and financial milestones achieved in first half of 2025

TURKU, Finland – Faron Pharmaceuticals Ltd (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company pursuing a CLEVER approach to reprogramming myeloid cells to activate anti-tumor immunity in hematological and solid tumor microenvironments, has published its unaudited half-year financial results for the six months ended 30 June 2025, on 27 August 2025.

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

January–June 2025 in brief

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

Significant events after the reporting period

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

Consolidated key figures, IFRS

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

Outlook for 2025

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

CEO Statement

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

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

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

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

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

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

Strengthening our financial position

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

Challenging operating environment

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

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

New blood to our Board and Management Team

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

Unique achievements for Faron in scientific forums

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

Solid tumor research progressing as planned

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

Outlook

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

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

Tables

Consolidated Income Statement, IFRS

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

 
Consolidated Balance Sheet, IFRS

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

 
Consolidated Cash Flow Statement, IFRS

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

 
Virtual briefing and Q&A session

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

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

For more information, please contact:

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

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

Cairn Financial Advisers LLP, Nominated Adviser and Broker
Sandy Jamieson, Jo Turner
Phone: +44 (0) 207 213 0880

Sisu Partners Oy, Certified Adviser on Nasdaq First North
Juha Karttunen
Phone: +358 (0)40 555 4727
Jukka Järvelä
Phone: +358 (0)50 553 8990

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

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

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

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

Significant clinical and financial milestones achieved in first half of 2025

TURKU, Finland – Faron Pharmaceuticals Ltd (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company pursuing a CLEVER approach to reprogramming myeloid cells to activate anti-tumor immunity in hematological and solid tumor microenvironments, has published its unaudited half-year financial results for the six months ended 30 June 2025, on 27 August 2025.

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

January–June 2025 in brief

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

Significant events after the reporting period

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

Consolidated key figures, IFRS

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

Outlook for 2025

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

CEO Statement

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

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

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

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

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

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

Strengthening our financial position

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

Challenging operating environment

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

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

New blood to our Board and Management Team

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

Unique achievements for Faron in scientific forums

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

Solid tumor research progressing as planned

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

Outlook

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

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

Virtual briefing and Q&A session

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

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

For more information, please contact:

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

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

Cairn Financial Advisers LLP, Nominated Adviser and Broker
Sandy Jamieson, Jo Turner
Phone: +44 (0) 207 213 0880

Sisu Partners Oy, Certified Adviser on Nasdaq First North
Juha Karttunen
Phone: +358 (0)40 555 4727
Jukka Järvelä
Phone: +358 (0)50 553 8990

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

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

Faron Pharmaceuticals Ltd’s Annual Report 2024 published

Faron Pharmaceuticals Ltd | Company announcement | February 27, 2025 at 09:15:00 EET

Faron Pharmaceuticals Ltd’s Annual Report 2024 published

TURKU, FINLAND – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company focused on tackling cancers via novel immunotherapies, today published the Annual Report for 2024. The Annual Report contains the Report of the Board of Directors, the Financial Statements for 2024 and the Remuneration Report.

The English version of Annual Report is available as a PDF file attached to this release and on the company’s website at https://faron.com/investors/reports-and-presentations/. Finnish language version of the Financial Statements is available as a PDF file attached to this release and on the company’s website at https://faron.fi/sijoittajat/raportit-esitykset/.

Faron Pharmaceuticals Ltd
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, 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 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’s Financial Statement Release 1 January to 31 December 2024

Faron Pharmaceuticals Ltd | Company announcement | February 27, 2025 at 09:00:00 EET

Faron’s Financial Statement Release 1 January to 31 December 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 audited full-year financial results for 1 January to 31 December 2024 (the “Period”) and provides an overview of recent corporate developments.

2024 Highlights

  • Interim Phase II read-out from the BEXMAB trial confirmed earlier positive Phase I and II findings in myelodysplastic syndrome (MDS) patients with prior hypomethylating agent (HMA) failure.
  • In Phases I and II, 20 MDS patients who are refractory or relapsed on HMA (r/r MDS) and have no effective treatment options, continued to show a high objective response rate (ORR) at 80%.
  • The BEXMAB Phase I and II MDS patients with prior HMA failure experienced an estimated median overall survival (mOS) of approximately 13.4 months, compared to the 5-6 months that would typically be expected under standard of care.
  • The U.S. Food and Drug Administration (FDA) granted bexmarilimab Fast Track Designation for the treatment of r/r MDS in combination with azacitidine.
  • The Company announced positive feedback from the FDA regarding the registrational clinical development plan for bexmarilimab for the treatment of higher-risk (HR) MDS, with a recommendation that the Company conducts a confirmatory phase III trial in frontline HR MDS, without requiring a separate phase III trial in the relapsed / refractory setting, and accelerated approval for r/r MDS could be achieved with an interim read-out of the confirmatory phase III study.
  • The Company received regulatory approval from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to conduct the BEXMAB trial in the UK and bexmarilimab received an Innovation Passport from the MHRA for the treatment of r/r MDS.
  • Further analysis of patient profiles from the Phase I part of the BEXMAB trial confirmed that prior to responding to bexmarilimab in combination with standard of care (SoC), patients had experienced disease progression following treatment with all of the leading azacitidine combinations such as venetoclax, sabatolimab and magrolimab.
  • The Company filed a patent application around the use of soluble Clever-1 for inactivating T-cells and the treatment of autoimmune diseases and inflammatory disorders.
  • Dr. Juho Jalkanen was appointed as Faron’s new Chief Executive Officer, Mr. Yrjö Wichmann was appointed Chief Financial Officer, Dr. Petri Bono was appointed Chief Medical Officer and Mr. Tuomo Pätsi was elected as the Chair of the Board.
  • Cash position was strengthened through a convertible loan issuance and two share placements successfully raising a total of EUR 35.5 million (gross).
  • A virtual briefing and Q&A will be held today, 27 February 2025 at 4:00 AM (EST) / 9:00 AM (GMT) / 11:00 AM (EET).

Subsequent events

  • In January 2025, Faron announced that the final MDS patient was identified for the BEXMAB Phase II trial, and that topline readout is expected in April 2025.
  • In early February 2025, Faron conducted a private placement directed to a limited number of institutional and other investors raising EUR 12.0 million.

“2024 was a year of success and transformation for the Company, with the positive clinical development of bexmarilimab solidifying our position in the field of immunotherapy. Faron’s progress, from both a clinical and regulatory perspective, only strengthens our confidence in the potential of bexmarilimab to address critical unmet needs in oncology and unlock significant value creation for the Company and shareholders. We remain steadfast in our mission to bring life-changing immunotherapies to patients who need them most and the exceptional progress we’ve achieved this year brings us closer to achieving that goal,” said Dr. Juho Jalkanen, Chief Executive Officer of Faron.

HIGHLIGHTS (including post period)

Pipeline Highlights

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

Hematological cancers in combination with standard of care (SoC) – BEXMAB

  • The Company announced Positive Phase II Interim data from the BEXMAB trial confirming earlier positive Phase I and II findings in MDS patients with prior HMA failure.
    • Overall response rate of 80% (16 out of 20) in refractory or relapsed HMA failed MDS patient population (r/r MDS).
    • Observed responses were primarily deep and durable with 70% (14 out of 20) r/r MDS patients achieving complete response (CR) / marrow complete remission (mCR) / partial response (PR).
    • Four patients have moved on to receive a bone marrow transplant.
    • Estimated mOS of approximately 13.4 months in r/r MDS population.
    • The combination of bexmarilimab and azacitidine remains well tolerated.
    • Clever-1 target engagement and expression in the bone marrow with an increased antigen presentation capacity and presence of CD8 T and NK cells supports bexmarilimab mechanism-of-action.
  • The FDA granted bexmarilimab Fast Track Designation for the treatment of r/r MDS in combination with azacitidine.
  • Faron received positive feedback from its formal Type D Scientific Advice Meeting with the FDA regarding the registrational clinical development plan for bexmarilimab in the treatment of HR MDS. The FDA acknowledged the difficulties of running a randomized study with a comparator in the r/r setting and instead proposed that Faron conduct a confirmatory phase III trial in frontline high-risk MDS (HR MDS), that would not require a separate phase III in r/r MDS. Accelerated approval for r/r MDS could possibly be obtained with the existing phase II trial in addition to an interim read-out from the confirmatory phase III trial as per the FDA’s Project FrontRunner.
  • The Company received regulatory approval from the MHRA to conduct the BEXMAB trial in the UK. This approval allows Faron to recruit in the UK hematology patients directly, accelerating its research efforts by increasing recruitment and enhancing the study’s diversity and scope by expanding the participant pool.
  • Bexmarilimab received an Innovation Passport, under the Innovative Licensing and Access Pathway (ILAP) from the MHRA, for the treatment of r/r MDS.
  • Further analysis of the patient profiles of those treated in the completed Phase I part of the BEXMAB trial confirmed that patients had experienced disease progression following previous treatment with azacitidine monotherapy or combinations of up to four therapies that included azacitidine or decitabine combined with magrolimab, venetoclax and sabatolimab.
  • Full analysis of the positive Phase II interim data from BEXMAB trial was presented at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition.

Combination potential with solid tumours – and further expansion

  • Preparations are ongoing for the initiation of three proof-of-concept studies in solid tumours.
    • BLAZE – Can bexmarilimab overcome resistance to PD-1 inhibitors? Resistance to first-line immunotherapy in NSCLC and melanoma is common. Targeting tumor-associated macrophages may overcome this resistance. The response to bexmarilimab combined with anti-PD-1 antibody will serve as proof-of-concept for reversing resistance. The study involves initial priming with bexmarilimab seven days before the combination treatment. Biomarker analysis will provide translational correlations of macrophage switch and immune activation. Blaze is an Investigator Initiated Trial.
    • BEXAR – Can bexmarilimab turn cold tumors hot in soft-tissue sarcomas? Early clinical trials with immune checkpoint inhibitors (ICIs) in soft tissue sarcoma (STS) have been disappointing, as these tumors are often “cold” due to an immunosuppressive tumor microenvironment rich in M2-like macrophages and Clever-1 expression. Studies show that Clever-1-positive macrophages are associated with poor chemotherapy response. In vitro, Clever-1 inhibition induces anti-tumor macrophages, and combining chemotherapy with an anti-Clever-1 antibody significantly increases survival in mice models. Targeting Clever-1 in immune cells may improve chemotherapy response in cancer patients by making primary refractory STS tumors more sensitive to treatment. Bexar is an Investigator Initiated Trial.
    • MATINS-02 – Can bexmarilimab overcome PD-1 primary resistance and expand the population of PD-1 responders? PD-1 inhibitors have shown disappointing results in immunologically cold tumors like gastric, gallbladder, cholangiocarcinoma, and ER+ breast cancer. Bexmarilimab has the potential to make these primary refractory (cold) tumors sensitive to PD-1. The study will also prospectively validate the use of intratumoral Clever-1 positivity as a predictive biomarker for treatment benefit. Matins-02 is a Faron Sponsored Trial.

Traumakine® – Faron’s investigational intravenous (IV) interferon beta-1a therapy, in development for hyperinflammatory conditions.

  • Faron joined a research consortium which received a U.S. Department of Defence grant to investigate the use of intravenous interferon beta (Traumakine®) for the prevention of ischemia-reperfusion injury in battlefield victims when using a lifesaving torniquet for the prevention of excessive blood loss. The Study is named Resuscitation by Endothelial Stabilization and Targeted Oxygen Rescue (RESTOR) Platform for Battlefield Applications. Participating institutions are Duquesne University School of Pharmacy and Wake Forest Medical University Health Sciences.

Corporate Highlights

  • The cash position was significantly strengthened through a combination of a convertible note issuance, private placements directed to institutional and other investors, a public offering to Finnish retail investors and an open offering to UK retail and institutional investors to raise a total of EUR 35.5 million (gross).
  • In May 2024, Dr. Juho Jalkanen was appointed as the Company’s new Chief Executive Officer (CEO), taking over from Dr. Markku Jalkanen, who retired as CEO, but who is continuing as a member of the Board of Directors of Faron. Dr. Juho Jalkanen has worked at Faron in various roles since 2006, most recently serving as its Chief Operating Officer.
  • Mr. Tuomo Pätsi was elected as the Chair of the Board, following the departure of Dr. Frank Armstrong who did not stand for re-election. Mr. Pätsi was the President of the EMEA region and Worldwide Markets for Celgene Corporation, a global pharmaceutical company and currently wholly owned subsidiary of Bristol Myers Squibb, engaged primarily in the discovery, development, and commercialization of therapies for the treatment of cancer. He is an experienced biotech and pharmaceutical executive who was, until recently, the Executive Vice President for Seagen Inc., a US-based, cancer-focused biotechnology company.
  • In April 2024, Mr. Yrjö Wichmann was appointed as the Company’s interim Chief Financial Officer (CFO) and in August as the permanent CFO. Mr. Wichmann previously served as the Company’s CFO between 2014 and 2019 and as Senior Vice President, Financing & IR from 2019 to April 2024. Mr. Wichmann is an accomplished biotech and financial executive with over 20 years’ experience in financing and investment banking. 
  • In August 2024, Dr. Petri Bono was appointed as the Company’s Chief Medical Officer (CMO), succeeding Dr. Birge Berns, who will continue her role as part of Faron’s medical leadership team involved in developing bexmarilimab. Dr. Bono is an oncologist and has served as the CMO and member of the Group executive team of Terveystalo, the largest private healthcare service provider in Finland. Prior to joining Terveystalo he was the CMO at Helsinki University Hospital. He brings leading expertise in immunology, with his own research focusing on molecular and immunological oncology.
  • In May 2024, Dr. Markku Jalkanen, co-founder, Board member and former CEO of Faron, and Dr. Sirpa Jalkanen, co-founder and member of Faron’s Scientific Advisory Board, were selected as finalists for the European Inventor Award 2024, in recognition of their research developing Faron’s wholly owned precision cancer immunotherapy candidate, bexmarilimab.
  • The Company filed a patent application around the use of soluble Clever-1 for inactivating T-cells and the treatment of autoimmune diseases and inflammatory disorders. The Company will take the identified part of soluble Clever-1 and design the optimal drug composition with the desired characteristics for treating autoimmune diseases.

Full-year Financial Results

  • On December 31, 2024, Faron held cash balances of EUR 9.5 million (2023: EUR 6.9 million).
  • Loss for the period for the financial year ended December 31, 2024, was EUR -25.9million (2023: EUR -30.9 million).
  • Net assets on December 31, 2024, were EUR –9.8 million (2023: EUR -15.2 million).
  • In February 2024, Faron announced that it was in breach of several undertakings agreed in the facilities agreement entered into on 28 February 2022 between IPF Fund II SCA, SICAV-FIAR (“IPF”) as Lender and Faron Pharmaceuticals Ltd as Borrower (“Facilities Agreement”) and subsequent waiver letters provided by IPF, and therefore was in several Events of Default, as defined in the Facilities Agreement.
  • In March 2024, Faron successfully raised a total of EUR 3.2 million in subordinated convertible loan arrangements with certain existing shareholders allowing the Company to make critical payments to third parties under agreed waivers with IPF.
  • In April 2024 the Company conducted a private placement directed to a limited number of institutional and other investors to raise EUR 4.8 million which, together with the EUR 3.2 million convertible loan announced on 4 March 2024, secured the required short-term bridge financing totaling EUR 8 million.
  • In June 2024, the Company raised a total of approximately EUR 30.7 million, of which approximately EUR 3.7 million was paid by converting the convertible loan and related arrangement fees and interests into shares in the Company.
  • The primary reason for conducting the placings were to accelerate and expand the clinical development of the Company’s main drug candidate, bexmarilimab, advance bexmarilimab’s commercial scale production, support general corporate purposes and other pipeline development, and to strengthen the Company’s balance sheet.

Consolidated key figures, IFRS

EUR ’000 Unaudited
7-12/2024
6 months
Unaudited
7-12/2023
6 months
1-12/2024
12 months
1-12/2023
12 months
Other operating income 0 0 0 0
Research and Development expenses (5,082) (11,024) (11,744) (19,542)
General and Administrative expenses (2,301) (4,732) (6,929) (9,026)
Operative Loss for the period (7,383) (15,756) (18,673) (28,568)

Unaudited
7-12/2024
6 months
Unaudited
7-12/2023
6 months
1-12/2024
12 months
1-12/2023
12 months
Loss per share EUR (0.11) (0.26) (0.29) (0.48)
Number of shares at end of period 104,624,864 68,786,699 104,624,864 68,786,699
Average number of shares 104,624,864 67,137,790 88,518,654 65,055,036
EUR ’000 Unaudited
30 June 2024
Unaudited
30 June 2023
31 December 2024 31 December 2023
Cash and cash equivalents 29,979 6,315 9,503 6,875
Equity 1,379 (9,483) (9,762) (15,160)
Balance Sheet total 35,460 12,836 12,521 10,220

Board of Directors’ Proposal on the Dividend
The Group’s comprehensive loss for the period was EUR 25,910,878 (2023: EUR 30,943,935). The Board of Directors proposes to the Annual General Meeting 2025 not to pay a dividend.

27 February 2025
Faron Pharmaceuticals Ltd.
Board of Directors

Conference call information
A virtual briefing and Q&A session for investors, analysts and media will be hosted by Dr. Juho Jalkanen, Chief Executive Officer, and Mr. Yrjö Wichmann, Chief Financial Officer, today, 27 February 2025 at 4:00 AM (EST) / 9:00 AM (GMT) / 11:00 AM (EET)

Webcast registration link: Annual report for the year ended 31 December, 2024

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

For more information please contact:

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 Advisor 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

Publication of financial information during year 2025

Faron’s financial statements for full year 2024 will be published today, 27 February 2025 and will also be available on Faron’s website at Reports and presentations – Faron. The half-year financial report for the period 1 January to 30 June 2025 is scheduled to be published on 27 August 2025. The Annual General Meeting is planned for 21 March 2025. A separate stock exchange notice will be issued by Faron’s Board of Directors to convene the meeting.

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 BEXMAB

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

About Faron Pharmaceuticals Ltd.

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

CEO Statement

2024 was a year of success and transformation for Faron Pharmaceuticals, marking a new chapter in Faron’s story and solidifying our position as a leader in the field of immunotherapy.

With fresh leadership and renewed focus, we reinforced our organisational structure. We welcomed Tuomo Pätsi as the new Chairman of our Board, taking over from Dr. Frank Armstrong, alongside Yrjö Wichmann as our new CFO and Dr. Petri Bono as Chief Medical Officer, all of whose extensive expertise and fresh perspectives have invigorated our renewed strategy. I was also proud to assume the role of CEO this year, taking over from Dr. Markku Jalkanen. These changes, coupled with the strong foundation built by our predecessors, have enabled us to refine our mission and approach, making us well-equipped to navigate the complexities of a competitive and rapidly evolving sector and I would like to thank Markku and Frank for their commitment to Faron and for their support during this transition. Their contributions thus far, combined with the dedication of our entire team, have enabled us to sustain momentum even amidst challenging market conditions, setting a clear course for sustainable growth and innovation at Faron.

The theme of transformation has continued through the clinical development program for our lead asset, bexmarilimab. We have made significant progress, from both a clinical and regulatory perspective, further cementing our believe in the potential of bexmarilimab to address critical unmet needs in oncology. We had numerous positive interactions with regulatory authorities resulting in key milestones including Fast Track Designation (FTD) for bexmarilimab from the FDA for the treatment of relapsed or refractory myelodysplastic syndrome (r/r MDS) patients, underscoring the urgency for novel therapies in treating this aggressive blood cancer.

We also received positive feedback from our formal Type D Scientific Advice Meeting with the FDA regarding the registrational clinical development plan for bexmarilimab in the treatment of high-risk MDS (HR MDS). The FDA acknowledged the difficulties of running a randomized study with a comparator in the r/r setting and instead proposed that Faron conduct a confirmatory phase III trial in frontline HR MDS, that would not require a separate phase III in r/r MDS.

These two milestones significantly enhance our ability to advance bexmarilimab through the regulatory process, also allowing for frequent FDA interactions and streamlined development pathways, which will be invaluable as we prepare for pivotal studies and market approval.

In parallel, the Phase II interim data from our BEXMAB trial, presented at the 66th American Society of Hematology (ASH) Annual Meeting, demonstrated remarkable efficacy. The trial achieved an 80% overall response rate in r/r MDS patients, with 70% achieving deep and durable responses, including complete and partial remissions. Importantly, four patients progressed to potentially curative bone marrow transplants, and the combination therapy with azacitidine continued to show a favourable safety profile.

The regulatory recognition and the robust clinical results achieved to date highlight bexmarilimab’s ability to reprogram myeloid cells by engaging the Clever-1 receptor, overcoming resistance to hypomethylating agents (HMAs), and activating the immune system, demonstrating its potential as a transformative therapy for an underserved population. As we advance to pivotal efficacy readouts and prepare for the initiation of Phase III development in the second half of 2025 after having an end-of-phase 2 (EOP2) meeting with the FDA. We remain focused on our mission to bring this innovative therapy to patients facing significant unmet medical needs.

Also in 2024, we considerably strengthened our financial position, successfully raising EUR 35.5 million (gross) through an oversubscribed combined share offering, a strong reflection of our investors’ confidence in the potential of bexmarilimab. This additional financing played an essential role in the acceleration of our clinical programs – particularly our BEXMAB trial and provided a stronger foundation for advancing bexmarilimab towards commercialisation.

Looking ahead, 2025 promises to be a pivotal year as we aim to deliver crucial clinical data and engage in meaningful discussions with regulatory authorities. We remain steadfast in our mission to bring life-changing immunotherapies to patients who need them most and the exceptional progress we’ve achieved this year brings us closer to achieving that goal. I would like to extend my gratitude to our shareholders, partners, and the Faron team for their continuous support and commitment this year and I look forward to what 2025 brings.

Chairman Statement

2024 has seen us achieve significant clinical milestones and strategic advancements, showcasing our resilience in a challenging biotechnology landscape. Despite the obstacles encountered, we conclude the year in our strongest position to date.

Faron has continued to make significant strides in the clinical development of bexmarilimab, its wholly owned, investigational immunotherapy, through the progression of our BEXMAB trial. We were very pleased to dose the first patient in Phase II part of that trial at the start of the year, evaluating the safety and efficacy of bexmarilimab in combination with standard of care (SoC) in patients with hypomethylating agents (HMAs)-refractory or relapsed myelodysplastic syndrome (r/r MDS). Data generated continue to be highly encouraging with the latest positive interim Phase II data, presented at the American Society of Hematology (ASH) Annual Meeting, showing a remarkable 80% overall response rate. In July 2024, we received positive feedback from the FDA regarding the registrational study plan for bexmarilimab, providing clear guidance on the path to approval. Their proposal significantly reduces the devolvement costs and timelines to bring this promising therapy to a broader group of patients and is a significant achievement for Faron.

The financial landscape for biotechnology companies has been challenging but, despite this, Faron has demonstrated remarkable resilience. We successfully raised EUR 35.5 million (gross) through an oversubscribed combined share offering, supported by both existing and new shareholders. This financial achievement not only provides critical funding for our BEXMAB trial but also reflects the confidence of our investors in our scientific approach and further validates the potential of bexmarilimab.

In 2024 we had notable changes in our leadership and governance. We welcomed Juho Jalkanen (previously our COO) as our new CEO, while retaining the invaluable guidance of former CEO, Markku Jalkanen, as a member of the Board. We also appointed Yrjö Wichmann as our CFO, Dr. Petri Bono as Chief Medical Officer and I assumed the position of Chairman from Frank Armstong. I’d particularly like to thank both Markku and Frank for their support and guidance during their tenure at Faron. Their contributions have helped enormously in bringing Faron to the strong position that we find ourselves in today. Additionally, we established a Shareholders’ Nomination Board, comprised of representatives from our top five shareholders, which will provide direct input into our Board nominations and strategic direction.

One highlight of the year was the international recognition received by our founders, Dr. Markku Jalkanen and Prof. Sirpa Jalkanen, as finalists at the 2024 European Inventor Awards, underscoring the innovative spirit that continues to drive Faron.

Looking forward to 2025, we remain excited about the potential of our bexmarilimab program. We expect topline efficacy readouts from our Phase II trial in the first half of the year, which will be crucial in determining our next steps. The Board is optimistic about potentially initiating preparations for Phase III development in the second half of 2025, a significant milestone that would bring us ever closer to bringing this innovative therapy to patients who desperately need new treatment options.

I would like to extend my gratitude to our dedicated team, our invaluable shareholders, the physicians and patients, and all other stakeholders who have made our continued progress possible. We look forward to 2025 with optimism.

Mr. Tuomo Pätsi
Chairman

Financial Review

Despite continuing challenging market conditions in 2024, the Company significantly strengthened its cash position through a combination of a convertible note issuance, private placements directed to institutional and other investors, a public offering to Finnish retail investors and an open offering to UK retail and institutional investors to raise a total of EUR 35.5 million (gross). As a result of these fundraising efforts, the net cash increased from financing activities of EUR 25.8 million compared to EUR 24.0 million in 2023.

Faron places a strategic emphasis on capital efficiency, a key element of efforts to extend our cash runway, without compromising the ability to advance our clinical development program. This capital efficiency has allowed us to achieve more with available resources, while focusing on clinical outcomes.

RESEARCH AND DEVELOPMENT EXPENSES

R&D costs were EUR 11.7 million in 2024 compared to 19.5 million in 2023, a decrease of EUR 7.8 million. These costs are attributable to advancing our clinical programs including completion of BEXMAB Phase I and the initiation of Phase II. Clinical trial costs include the cost of patient and site enrollment, CRO service costs including monitoring, investigator fees, and compensation and benefits for personnel directly responsible for R&D activities, and product supply costs. The costs of outsourced clinical trial services were EUR 3.3 million in 2024 compared to EUR 4.0 million in 2023. Compensation and benefits were EUR 1.4 million in 2024 and EUR 3.2 million in 2023 and included stock compensation expense of EUR 0.02 million and EUR 0.7 million in 2024 and 2023, respectively.

GENERAL AND ADMINISTRATION COSTS

G&A expenses were EUR 6.9 million in 2024 compared to EUR 9.0 million in 2023, and decrease of EUR 2.1 million. The decrease was mainly due to the recognition of the incremental fair value of amending the terms of 2015 option plan of EUR 1.1 million. Compensation and benefits were EUR 3.3 million in 2024 and EUR 5.7 million in 2023 and included stock compensation expense of EUR 0.7 million and EUR 1.7 million in 2024 and 2023, respectively.

TAXATION

The Company’s tax credit for the fiscal year 2024 can be recorded only after the Finnish tax authorities have approved the tax report and confirmed the amount of tax-deductible expenses. The total amount of cumulative tax losses carried forward approved by tax authorities on 31 December 2024 was EUR 57.7 million (2023: EUR 51.6 million). The Company can utilize these losses against potential taxable profits generated during the years 2025 to 2034. In addition, the Company has EUR 117.2 million of R&D costs incurred in the financial years 2010 – 2023 that have not yet been deducted from taxation. This amount can be deducted over an indefinite period at the Company’s discretion.

LOSSES

Loss before income tax and total comprehensive income in 2024 was EUR 25.9 million compared to EUR 30.9 million in 2023, which represents a loss of EUR 0.29 per share and EUR 0.48 per share in 2024 and 2023, respectively.

CASH FLOWS

Net cash flow 2024 and 2023 was essentially flat. Cash used for operating activities in 2024 was EUR 23.0 million compared to 2023 of EUR 23.8 million. Net cash inflow from financing activities in 2024 was EUR 25.8 million compared to 2023 of EUR 24.0 million.

FUNDRAISING

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

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

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

On 4 June 2024 Faron announced an offering of approximately EUR 30.7 million in total by offering for subscription preliminarily a maximum of 30,714,592 new and/or treasury shares at a subscription price of EUR 1.00 per Offer Share. The Offering was conducted as a directed share issue by way of
i.      a public offering to private individuals and legal entities in Finland,
ii.     an institutional offering to institutional investors in the European Economic Area.
iii.    a separate open offer to qualifying holders of depositary interests in the United Kingdom and elsewhere and
iv.    a separate retail offer to retail investors in the United Kingdom on the “REX” platform.
 
The results of the offering were announced on 20 June 2024, and it attracted significant interest from both existing shareholders and new investors and was oversubscribed. The Company raised a total of approximately EUR 30.7 million, of which approximately EUR 3.7 million was paid by converting the convertible loan and related arrangement fees and interests into shares in the Company. As a result of the share offering, with the gross proceeds of approximately EUR 27 million the Company believes it will have sufficient resources to execute its core business and deliver on its key milestones of the year 2024 under the current business plan and in compliance with the financial covenants of the IPF Fund. The Board of Directors of the Company decided to issue of a total of 30,709,056 newly issued treasury shares and new shares in the Company. As set out in the terms and conditions of the Offering, existing shareholders and DI (depositary interest) holders were given an allocation preference. Carnegie Investment Bank AB, Finland Branch (“Carnegie”) and Peel Hunt LLP (“Peel Hunt”) acted as lead managers (the “Lead Managers”) and bookrunners for the Offering. On 20 June 2024 the Company entered into 90-day lock-up agreement with Lead Managers.

As a post-period event, Faron conducted in early February 2025 a private placement directed to a limited number of institutional and other investors raising EUR 12.0 million.

FINANCIAL POSITION

As of 31 December 2024, total cash and cash equivalents held were EUR 9.5 million compared to 2023 of EUR 6.9 million.

GOING CONCERN

As part of their going concern review, the Directors have followed the Finnish Limited Liability Companies Act, the Finnish Accounting Act and the guidelines published by the Financial Reporting Council entitled “Guidance on the Going Concern Basis of Accounting and Reporting on Solvency and Liquidity Risks – Guidance for directors of companies that do not apply the UK Corporate Governance Code”. Faron is subject to a number of risks similar to those of other development stage pharmaceutical companies.

These risks include, amongst others, generation of revenues in due course from the development portfolio and risks associated with research, development, testing and obtaining related regulatory approvals of its pipeline products. Ultimately, the attainment of profitable operations is dependent on future uncertain events which include obtaining adequate financing to fulfil Faron’s commercial and development activities and generating a level of revenue adequate to support Faron’s cost structure.

Faron made a net loss of EUR 25.9 million during the year ended 31 December 2024. It had a negative equity of EUR 9.8 million including an accumulated deficit of EUR 197.4 million. As at 31 December 2024, Faron had cash and cash equivalents of EUR 9.5 million. As a post-period event, Faron conducted in early February 2025 a private placement directed to a limited number of institutional and other investors to raise EUR 12.0 million, which significantly strengthened its financial position.

The Directors have prepared detailed financial forecasts and cash flows looking beyond 12 months from the date of the approval of these financial statements. In developing these forecasts, the Directors have made assumptions based upon their view of the current and future economic conditions that are expected to prevail over the forecast period. Directors estimate that the cash held by Faron at 31 December 2024 together with the EUR 12.0 million funds raised post-period will be sufficient to support the current level of activities into the third quarter of 2025. Despite this the Directors are continuing to explore sources of additional financing and they believe they have a reasonable expectation that they will be able to secure additional cash inflows that are sufficient for Faron to continue its activities for not less than 12 months from the date of approval of these financial statements; they have therefore prepared the financial statements on a going concern basis. Because the additional finance is not committed at the date of issuance of these financial statements, these circumstances represent a material uncertainty that may cast significant doubt on Faron’s ability to continue as going concern. Should Faron be unable to obtain additional financing such that the going concern basis of preparation were no longer appropriate, adjustments would be required, including to reduce balance sheet values of assets to their recoverable amounts, to provide for further liabilities that might arise.

HEADCOUNT
Faron’s headcount at the end of year was 25 (2023: 34).

SHARES AND SHARE CAPITAL

During the period 1 January to 31 December 2024, the Company, using the share authorities granted at the Extraordinary General Meeting held on 22 September 2023 issued a total of 3,200,298 new ordinary shares at an issuance price of EUR 1.5 per share to investors. During the same period, the Company, using the share authorities granted at the Annual General Meeting held on 5 April 2024, issued a total of 30,709,056 shares at an issuance price of EUR 1.0 per share to investors. The subscription price net of costs was credited in full to the Company’s reserve for invested unrestricted equity, and the share capital of the Company was not increased. The Company has no shares in treasury; therefore, at the end of 2024 the total number of voting rights was 104,624,864.

Consolidated Income Statement, IFRS

EUR ’000 Unaudited
7-12/2024
6 months
Unaudited
7-12/2023
6 months
1-12/2024
12 months
1-12/2023
12 months
Other operating income 0 0 0 0
Research and development expenses (5,082) (11,024) (11,744) (19,542)
General and administrative expenses (2,301) (4,732) (6,929) (9,026)
Operating loss (7,383) (15,756) (18,673) (28,568)
Financial income (858) 233 434 233
Financial expense (3,325) (1,691) (7,676) (2,609)
Loss before tax (11,566) (17,214) (25,915) (30,944)
Tax expense 41 0 (5) 0
Loss for the period (11,525) (17,214) (25,920) (30,944)
Other comprehensive gain/loss (2) 2 9 2
Total comprehensive loss for the period (11,527) (17,212) (25,911) (30,942)
Loss per ordinary share
Basic and diluted loss per share, EUR (0.11) (0.26) (0.29) (0.48)

Consolidated Balance Sheet, IFRS
EUR ‘000 31 December 2024 31 December 2023
Assets
Non-current assets
Machinery and equipment 1 6
Right-of-use-assets 296 198
Intangible assets 1,112 1,088
Prepayments and other receivables 46 60
Total non-current assets 1,456 1,352
Current assets
Prepayments and other receivables 1,563 1,992
Cash and cash equivalents 9,503 6,875
Total current assets 11,065 8,868
Total assets 12,521 10,220
Equity and liabilities
Capital and reserves attributable to the equity holders of Faron
Share capital 2,691 2,691
Reserve for invested unrestricted equity 184,955 154,352
Accumulated deficit (197,421) (172,208)
Translation difference 13 4
Total equity (9,762) (15,160)
Provisions
Other provisions 0 0
Total provisions 0 0
Non-current liabilities
Borrowings 8,088 9,423
Lease liabilities 186 50
Other liabilities 3,839 895
Total non-current liabilities 12,113 10,369
Current liabilities
Borrowings 3,722 3,475
Lease liabilities 117 163
Trade payables 4,876 8,971
Accruals and other current liabilities 1,456 2,403
Total current liabilities 10,171 15,012
Total liabilities 22,283 25,380
Total equity and liabilities 12,521 10,220

Consolidated Statement of Changes in Equity, IFRS

EUR ‘000 Share capital Reserve for invested unrestrict-
ed equity
Trans-
lation
difference
Accumu-lated deficit Total equity
Balance as at 31 December 2022 2,691 129,544 2 (143,713) (11,476)
Comprehensive loss for the year 2023 0 0 2 (30,944) (30,942)
Transactions with equity holders of the Company
Issue of ordinary shares, net of transaction costs 0 24,808 0 0 24,808
Share-based compensation 0 0  0 2,450 2,450
  0 24,808 2 (28,494) (3,684)
Balance as at 31 December 2023 2,691 154,352 4 (172,208) (15,160)
Comprehensive loss for the year 2024 0 0 9 (25,920) (25,911)
Transactions with equity holders of the Company
Issue of ordinary shares, net of transaction costs 0 30,609 0 0 30,609
Share-based compensation 0 0 0 694 694
Legal reserve Retained earnings (5) 0 11 6
0 30,603 9 (25,215) (5,398)
Balance as at 31 December 2024 2,691 184,955 13 (197,421) (9,762)

Consolidated Cash Flow Statement, IFRS

EUR ‘000 Unaudited Unaudited 1-12.2024 1-12.2023
7-12.2024 7-12.2023 12 months 12 months
6 months 6 months
Cash flow from operating activities
Loss before tax (11,566) (17,214) (25,915) (30,944)
Adjustments for:
Received grant 0 (33) 0 (33)
Depreciation and amortization 156 172 314 346
Change in provision 0 0 0 (158)
Financial items 4,183 1,458 7,242 2,376
Share-based compensation 325 1,964 694 2,450
Adjusted loss from operations before changes in working capital (6,901) (13,653) (17,665) (25,963)
Change in net working capital:
Prepayments and other receivables 2,570 (728) 444 300
Trade payables (9,652) 3,002 (4,095) 2,994
Other liabilities 354 223 (846) (50)
Cash used in operations (14,337) (11,156) (22,263) (22,719)
Income tax paid 109 0 (41) 0
Interest received 361 243 361 243
Interest paid (411) (548) (1,028) (1,330)
Net cash used in operating activities (14,278) (11,461) (22,971) (23,806)
Cash flow from investing activities
Payments for intangible assets (102) (56) (225) (123)
Payments for equipment (1) 0 (1) 0
Net cash used in investing activities (103) (56) (226) (123)
Cash flow from financing activities
Proceeds from issue of shares 0 13,954 31,850 26,031
Share issue transaction cost (4,453) (542) (4,951) (1,190)
Proceeds from borrowings 0 0 3,200 64
Repayment of borrowings (1,943) (861) (3,371) (861)
Transaction and structuring fees of borrowings 0 (400) (750) (400)
Proceed from grants 0 99 0 481
Payment of lease liabilities (78) (58) (162) (142)
Net cash from financing activities (6,475) 12,192 25,816 23,983
Net increase (+) / decrease (-) in cash and cash equivalents (20,476) 560 2,627 (114)
Effect of exchange rate changes on cash and cash equivalents (173) (116) (197) (168)
Cash and cash equivalents at 1 January / 1 July 29,979 6,315 6,876 6,315
Cash and cash equivalents at 31 December 9,503 6,876 9,503 6,876

Faron 2024 Half-Year Financial Results

Faron Pharmaceuticals Ltd.

(“Faron” or “the Company”)

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

Company Announcement, 27 August 2024

Summary Highlights  

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

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

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

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

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

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

Post period events

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

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

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

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

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

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

Pipeline Highlights

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

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

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

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

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

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

Corporate Highlights

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

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

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

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

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

Financial highlights

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

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

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

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

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

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

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

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

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

Post period events

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

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

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

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

Half-Year Financial Results

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

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

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

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

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

Consolidated key figures, IFRS

 EUR’000

Unaudited

Unaudited     

Audited

1-6/2024

1-6/2023

1-12/2023

6 months

6 months

                12 months

Revenue

0

0

0

Other operating income

0

0

0

Research and Development expenses

(6 662)

(8 518)

(19 542)

General and Administrative expenses

(4 628)

(4 294)

(9 026)

Loss for the period

(14 395)

(13 730)

(30 944)

Unaudited

Unaudited

Audited

1-6/2024

1-6/2023

1-12/2023

6 months

6 months

                12 months

Loss per share, EUR

(0.20)

(0.22)

(0.48)

Number of shares at end of period

104 624 864

66 161 373

68 786 699

Average number of shares

70 452 291

62 985 028

65 055 036

 EUR’000

Unaudited

Unaudited

Audited

30 Jun 2024

30 Jun 2023

31 Dec 2023

Cash and cash equivalents

29 979

6 315

6 875

Equity

1 379

(9 483)

(15 160)

Balance sheet total

35 460

12 836

10 220

Conference call information

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

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

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

For more information please contact:

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

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

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880

Peel Hunt LLP, Broker

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

About Bexmarilimab

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

About BEXMAB

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

About Faron Pharmaceuticals Ltd.

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

Forward-Looking Statements

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

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

Chairman and Chief Executive Officer’s Review

Introduction

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

Bexmarilimab

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

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

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

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

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

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

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

Financial review

Statement of comprehensive income

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

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

Statement of financial position and cash flows

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

Corporate

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

Summary & outlook

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

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

Dr. Juho Jalkanen

Chief Executive Officer

Mr. Tuomo Pätsi

Chairman

Consolidated Income Statement, IFRS

EUR’000

Unaudited

1-6/2024

6 months

Unaudited

1-6/2023

6 months          

Audited

1-12/2023

12 months

Revenue

0

0

0

Other operating income

0

0

0

Research and development expenses

(6 662)

(8 518)

(19 542)

General and administrative expenses

(4 628)

(4 294)

(9 026)

Operating loss

(11 290)

( 12 812)

(28 568)

Financial income

1 292

0

233

Financial expense

(4 350)

(918)

(2 609)

Loss before tax

(14 349)

(13 730)

( 30 944)

Tax expense

-46

(0)

0

Loss for the period

(14 395)

(13 730)

(30 944)

Translation difference

11 

0

2

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

(14 384)

(13 730)

(30 942)

Loss per ordinary share

Basic and diluted loss per share, EUR

(0.20)

(0.22)

(0.48)

Consolidated Balance Sheet, IFRS

EUR’000

Unaudited

Unaudited

Audited

31 Dec 2023

30 Jun 2024

30 Jun 2023

Assets

Non-current assets

Machinery and equipment

3

10

6

Right-of-use-assets

344

272

198

Intangible assets

1 086

1 127

1 088

Prepayments and other receivables

60

60

60

Total non-current assets

1 494

1 469

1 352

Current assets

Prepayments and other receivables

3 987

5 052

1 992

Cash and cash equivalents

29 979

6 315

6 875

Total current assets

33 966

11 367

8 868

Total assets

35 460

12 836

10 220

EUR’000

Unaudited

Unaudited

Audited

31 Dec 2023

30 Jun 2024

30 Jun 2023

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

Share capital

2 691

2 691

2 691

Reserve for invested unrestricted equity

184 866

144 778

154 352

Accumulated deficit

(186 181)

(156 955)

(172 208)

Translation difference

3

2

4

Total equity

1 379

(9 483)

(15 160)

Provisions

Other provisions

0

0

0

Total provisions

0

0

0

Non-current liabilities

Borrowings

8 706

10 892

9 423

Lease liabilities

239

163

50

Other liabilities

1 643

702

895

Total non-current liabilities

10 588

11 757

10 369

Current liabilities

Borrowings

3 672

2 304

3 475

Lease liabilities

105

119

163

Trade payables

17 473

6 002

8 971

Accruals and other current liabilities

2 243

2 137

2 403

Total current liabilities

23 493

10 562

15 012

Total liabilities

34 081

22 319

25 380

Total equity and liabilities

35 460

12 836

10 220

Consolidated Statement of Changes in Equity, IFRS

EUR’000

Share capital

Reserve for invested unrestricted equity

Translation difference

Accumulated deficit

Total equity

Balance as at
31 December 2022 (Audited)

2 691

129 544

2

(143 713)

(11 476)

Comprehensive loss for the last six months 2023

0

0

0

(13 730)

(13 730)

Transactions with equity holders of the Parent company

Issue of ordinary shares

0

15 233

0

0

15 233

Share-based compensation

0

0

0

489

489

0

15 233

0

(13 241)

1 992

Balance as at 30 June 2023 (Unaudited)

2 691

144 778

2

(156 955)

(9 483)

Comprehensive loss for the year 2023

0

0

2

(30 944)

(30 942)

Transactions with equity holders of the Company

Issue of ordinary shares, net of transaction costs

0

24 808

0

0

24 808

Share-based compensation

0

0

0

2 450

2 450

0

24 808

2

(28 494)

(3 684)

Balance as at
31 December 2023 (Audited)

2 691

154 352

4

(172 208)

(15 160)

Comprehensive loss for the last six months 2024

0

0

11

(14 395)

(14 384)

Transactions with equity holders of the Company

Issue of ordinary shares, net of transaction costs

0

30 514

0

0

30 514

Share-based compensation

0

0

0

369

369

0

30 514

11

(14 026)

16 499

Balance as at 30 June 2024 (Unaudited)

2 691

184 866

15

(186 234)

1 338

Consolidated Cash Flow Statement, IFRS

€’000

Unaudited

1-6/2024

6 months

Unaudited

1-6/2023

6 months

    Audited

1-12/2023

12 months

Cash flow from operating activities

Loss before tax

(14 349)

(13 730)

(30 944)

Adjustments for:

Received grants

0

(0)

(33)

Depreciation and amortization

158

174

346

Change in provision

0

(158)

(158)

Financial items

3059

918

2376

Tax expense

0

0

0

Share-based compensation

369

489

2450

Adjusted loss from operations before changes in working capital

(10 764)

(12 308)

(25 963)

Change in net working capital:

Prepayments and other receivables (increase -)

(2 127)

1 028

300

Trade payables (increase +)

5 557

(8)

2 994

Other liabilities (increase +)

(593)

(272)

(50)

Cash used in operations

(7 926)

(11 561)

(22 719)

Income taxes paid

(150)

0

0

Transaction costs related to loans and borrowings

0

0

(0)

Interest received

0

0

243

Interest paid

(617)

(782)

(1 330)

Net cash used in operating activities

(8 693)

(12 343)

(23 806)

Cash flow from investing activities

Payments for intangible assets

(123)

(68)

(123)

Payments for tangible assets

0

0

(0)

Net cash used in investing activities

(123)

(68)

(123)

Cash flow from financing activities

Proceeds on issue of shares

35 500

12 077

26 031

Share issue transaction cost

(498)

(648)

(1 190)

Proceeds from borrowings

3 200

64

64

Repayment of borrowings

(5 314)

0

(861)

Transaction and structuring fees of borrowings

(750)

0

(400)

Proceeds from grants

(28)

382

481

Payment of lease liabilities

(337)

(84)

(142)

Net cash from financing activities

31 773

11 791

23 983

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

23 103

(675)

(114)

Effect of exchange rate changes

(145)

(55)

(168)

Cash and cash equivalents at 1 January

6 876

6 990

6 990

Cash and cash equivalents at the end of period

29 979

6 315

6 876

Notes to the interim financial report

1.   Corporate information

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

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

2.   Summary of significant accounting policies

 

2.1.   Basis of preparation

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


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


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


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

2.2.      Going concern

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

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

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

2.3.      Financial covenants

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

3.   Subsequent events

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

Faron´s Annual Report 2023

Faron Pharmaceuticals Oy

(“Faron” or the “Company”)

 

Faron´s Annual Report 2023

 

Company announcement, March 26, 2024

TURKU, Finland / BOSTON, Massachusetts – March 26, 2024 – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company pursuing a CLEVER approach to reprogramming myeloid cells to activate anti-tumor immunity in hematological and solid tumor microenvironments, announces today that its Annual Report for the year 2023 and audited financial statements for the accounting period January 1- December 31, 2023 in English, and its financial statements in Finnish are now available on the Company’s website: Faron Full-year results for the twelve months ended December 31, 2023 | Faron

 

For more information please contact:

 

Investor Contact

LifeSci Advisors

Daniel Ferry

Managing Director

daniel@lifesciadvisors.com

+1 (617) 430-7576

 

Media Contact

ICR Consilium

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com  

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880

 

Peel Hunt LLP, Broker

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

 

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

 

 

About BEXMAB

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

 

About Bexmarilimab

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

 

About Faron Pharmaceuticals Ltd.

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

 

Forward-Looking Statements

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

 

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

 

Click on, or paste the following link into your web browser, to view the associated PDF document:

https://www.faron.com/sites/faron-corp/files/Faron-Pharmaceuticals_Annual-Report-2023.pdf

 

 

Financial Statement January 1 to December 31 2023

 

 

 

 

 

Faron Pharmaceuticals Ltd.

(“Faron” or “the Company”)

 

Faron’s Financial Statement Release January 1 to December 31, 2023

 

 

Financial statement release March 13, 2024 at 03:00 AM (EDT) / 07:00 AM (GMT) / 09:00 AM (EET)

 

TURKU, FINLAND / BOSTON, MA – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical- stage biopharmaceutical company focused on tackling cancers via novel myeloid cell targeted immunotherapies, today announced audited full-year financial results for January 1 to December 31, 2023 (the “Period”) and provided an overview of recent corporate developments.

 

2023 Highlights

  • Data from the completed Phase I part of the BEXMAB study demonstrated significant overall response rates (ORR) in both previously hypomethylating agent (HMA)-failed (5 out of 5) and higher-risk myelodysplastic syndrome (MDS) patient (5 out of 5) populations. Most responses were deep and durable with 7 out of 10 MDS patients achieving complete remission/ marrow complete remission (CR/mCR) and two demonstrating partial remission (PR), one of whom moved on to receive a stem cell transplantation and the other, hematological improvement without remission (HI-P).
  • Further analysis of the patient profiles of those treated in the Phase I part of the BEXMAB trial showed that prior to responding to bexmarilimab in combination with standard of care (SoC), patients had experienced disease progression following treatment with all of the leading azacitidine combinations such as venetoclax, sabatolimab and magrolimab.
  • The Company made the decision to commence the Phase II part of the BEXMAB study based on guidance from the U.S. Food and Drug Administration (FDA), investigating bexmarilimab in combination with SoC in patients with HMA-refractory or-relapsed MDS.
  • The FDA granted bexmarilimab Orphan Drug Designation (ODD) for the treatment of acute myeloid leukemia (AML).
  • The first in human MATINS study was completed in advanced solid tumor patients. The study results were published in the journal Cell Reports Medicine. Bexmarilimab was well tolerated, showed activation of intratumoral immunity and reprogramming tumor associated macrophages, resulting in an increase in IFN-gamma signature and changes in the tumor microenvironment (TME), and providing significant clinical benefit.
  • The Company conducted three successful fundraising rounds in 2023, successfully raising EUR 25.7 million.
  • A virtual briefing and Q&A will be held today, March 13, 2024 at 8:00 AM (EDT) / 12:00 PM (GMT) / 2:00 PM (EET)

 

Subsequent events

  • In January 2024, Faron dosed the first patients in the Phase II part of its BEXMAB Study, to evaluate the safety and efficacy of bexmarilimab in combination with SoC, in HMA-refractory or relapsed MDS patients. This project Optimus part will provide the final dosing of bexmarilimab for the registrational part.
  • In February 2024, Faron announced that it was in breach of several undertakings agreed in the facilities agreement entered into on February 28, 2022 between IPF Fund II SCA, SICAV-FIAR (“IPF”) as Lender and Faron Pharmaceuticals Ltd as Borrower (“Facilities Agreement”) and subsequent waiver letters provided by IPF, and therefore was in several Events of Default, as defined in the Facilities Agreement.
  • In March 2024, Faron successfully raised a total of EUR 3.2 million in subordinated convertible loan arrangements with certain existing shareholders allowing the Company to make critical payments to third parties under agreed waivers with IPF. As at March 13, 2024, the Company is in compliance with all IPF financial covenants as agreed with the waiver letter. In accordance with the waiver letter, the Company shall issue to IPF additional special rights which entitle them to subscribe for new ordinary shares in the Company.
  • In March 2024, Faron announced that endeavors are continuing and it is in active discussions to secure short- and long-term funding.

 

 

“I am pleased to report that we have made strong progress in 2023 advancing our BEXMAB study of bexmarilimab, our wholly owned immunotherapy asset. Throughout the course of the year, we have reported highly encouraging data for bexmarilimab, showing a remarkable overall response rate in both higher-risk frontline MDS patients as well as HMA-failed MDS patients. These are highly significant findings, given the combinations of treatments these patients had previously failed on and the very limited options available for future therapy. They provide us with a path to market and only bolster our confidence in the potential of this novel immunotherapy to treat patients with aggressive hematological malignancies,” said Dr. Markku Jalkanen, Chief Executive Officer of Faron.

 

HIGHLIGHTS (including post period)

 

Pipeline Highlights

 

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

 

Hematological cancer with standard of care (SoC) – BEXMAB

 

  • The Phase II part of the BEXMAB study commenced based on guidance from the U.S. Food and Drug Administration (FDA), investigating bexmarilimab in combination with SoC in patients with HMA-refractory or -relapsed MDS. The first patient was dosed in January 2024.
  • Data from the completed Phase I part of the BEXMAB study demonstrated significant ORR in both previously HMA-failed (5 out of 5) and higher-risk MDS patient (5 out of 5) populations. Most responses were deep and durable with 7 out of 10 MDS patients achieving CR/mCR and two demonstrating PR, one of whom moved on to receive a stem cell transplantation and the other, hematological improvement without remission (HI-P).
  • Further analysis of the patient profiles of those treated in the completed Phase I part of the BEXMAB trial showed that patients had experienced disease progression following previous treatment with azacitidine monotherapy or combinations of up to four therapies that included azacitidine or decitabine + magrolimab, venetoclax and sabatolimab. 3 of the 5 patients were refractory to previous HMA-therapy, with progressive disease (PD) or stable disease (SD) being the best responses achieved from that therapy. 2 patients had relapsed after treatment with azacitidine or an azacitidine+venetoclax combination.
  • The FDA granted ODD for bexmarilimab for the treatment of AML.
  • BEXMAB phase I/II clinical data were presented at key scientific conferences including the American Society of Hematology (ASH) Annual Meeting and the European Hematology Association Congress 2023.
  • Post period, In January 2024, Faron dosed the first patients in the Phase II part of its BEXMAB Study, to evaluate additional safety and efficacy data for bexmarilimab in combination with SoC, in HMA-refractory or relapsed MDS patients, to obtain regulatory feedback from the FDA on a final regulatory pathway for market application (BLA)

 

Single-agent safety and activity in advanced solid tumors – MATINS

  • The first in human MATINS study was completed and the full safety and anti-tumor efficacy results from the first-in-human Phase I/II MATINS trial of bexmarilimab in patients with treatment-refractory late-stage solid tumors was published in Cell Reports Medicine.
  • The Company presented two posters at the American Association for Cancer Research Annual Meeting 2023 on its Phase I/II MATINS study of bexmarilimab in solid tumors and published a manuscript in Cell Reports Medicine.
  • The findings from MATINS, which have established strong foundations for Faron’s ongoing development program, showed activation of intratumoral immunity and reprogramming tumor associated macrophages resulting in increase in IFN-gamma signature and changes in the tumor microevironment (TME), resulting in disease control and prolonged survival in late-stage cancer. Furthermore, targeting Clever-1 with bexmarilimab was well-tolerated.
  • A positive Phase I/II meeting with the FDA supported the potential to continue development of bexmarilimab in solid tumors both as a single agent and in combination with anti-PD-1.

 

Combination potential with PD-1 blockade – BEXCOMBO – and further expansion

  • Preparations are ongoing for the initiation of the Phase II BEXCOMBO trial evaluating bexmarilimab with PD-1 blockade, aimed at improving the clinical benefits from standard-of-care PD-1 blockade. The first proof-of-concept cohort under investigation will be head and neck cancer, followed by non-small cell lung cancers. Patient cohorts will comprise between 15 and 40 subjects, with the opportunity for subgroup enrichment.
  • Given the positive results to date, the Company is exploring bexmarilimab’s potential in frontline HR MDS, chronic myelomonocytic leukaemia (CMML) patients and considering further development and expansion opportunities with bexmarilimab in hematological cancers in the form of further partnerships.

 

 

Traumakine® – Faron’s investigational intravenous (IV) interferon beta-1a therapy, in development for hyperinflammatory conditions.

  • The Company is in collaboration with the Fred Hutchinson Cancer Research Center in Seattle, Washington, to further investigate the use of IV IFN beta-1a for the prevention of organ damage from cytokine release syndrome (CRS) and other CAR-T therapy side effects, such as neurotoxicity (ICANs).

 

 

Corporate Highlights

  • The balance sheet was strengthened through three private placements directed to institutional and other investors to raising EUR 25.7 million during 2023.
  • James O’Brien, CPA, MBA, joined as Chief Financial Officer. Mr. O’Brien is an accomplished biotech and financial executive with extensive experience in the US capital markets. Strengthening of the Board of Directors with the appointments of Dr. Marie-Louise Fjällskog, Ms. Christine Roth and Mr. Tuomo Pätsi, who joined the Board as Non-Executive Directors of the Company. Dr. Marie-Louise Fjällskog was previously the Chief Medical Officer at Faron. In her position as a Board member, she continues to play an integral role in the development of bexmarilimab, by providing her clinical and regulatory expertise to support the Company’s progress. Ms. Christine Roth is a pharmaceutical executive with over three decades of experience in the industry, with expertise across various therapy areas including Oncology, Cardiovascular, Metabolic, and Infectious Diseases. Mr. Pätsi is an experienced biotech and pharmaceutical executive who was until recently Executive Vice President for Seagen Inc., a US-based, cancer-focused biotechnology company.
  • Mr. Leopoldo Zambeletti, who joined Faron’s Board as a Non-Executive Director in September 2015, stepped down from the Board, to take on a business development consulting role within Faron. He is a highly respected figure within the life sciences and investment banking industries and, since 2013, has been an independent strategic advisor to life science companies on mergers and acquisitions, out-licensing deals, and financing strategy.
  • Dr. Birge Berns, MD, joined Faron as the Company’s interim Chief Medical Officer.  Dr. Berns is a seasoned senior pharmaceuticals executive with a background in oncology, clinical medicine, rheumatology and immunology. She brings more than 25 years’ experience from senior leadership roles in global pharmaceutical companies, including Sanofi Aventis and Johnson & Johnson.
  • Dr. Gregory B. Brown and Ms. Anne Whitaker stepped down from their positions as a Non-Executive Directors.

 

Full-year Financial Results

 

  • On December 31, 2023, Faron held cash balances of EUR 6,9 million (2022: EUR 7,0 million). 
  • Loss for the period for the financial year ended December 31, 2023, was EUR 30,9 million (2022: EUR 28,7 million).  
  • Net assets on December 31, 2023, were EUR -15,2 million (2022: EUR -11,5 million).
  • In January 2023 the Company successfully raised a total of EUR 12,0 million gross through the issuance of 3,692,308 ordinary shares to investors.
  • In June 2023, Faron conducted a placement of 2,601,510 newly issued treasury shares to investors to raise EUR 6,6 million gross.
  • In October 2023, the Company successfully raised EUR 7,1 million gross through the issuance of 2,491,998 ordinary shares to investors. 
  • The primary reason for conducting the placings were to accelerate and expand the clinical development of the Company’s main drug candidate, bexmarilimab, advance bexmarilimab’s commercial scale production, support general corporate purposes and other pipeline development, and to strengthen the Company’s balance sheet.
  • Post period, in February 2024, the Company announced that it is in breach of several undertakings agreed in the Facilities Agreement with IPF and subsequent waiver letters provided by IPF and is therefore in several events of default.
  • Post period, in March 2024, the Company successfully raised a total of EUR 3,2 million in convertible loans allowing the Company to secure short-term financing.  The company continues active endeavors to secure longer term funding.

 

 

 

 

Consolidated key figures, IFRS

 

EUR ’000

Unaudited

7-12/2023
6 months

Unaudited

7-12/2022
6 months

1-12/2023
12 months

1-12/2022
12 months

Other operating income

0

318

0

803

Research and Development expenses

(11,024)

(10,683)

(19,542)

(20,730)

General and Administrative expenses

(4,732)

(3,697)

(9,026)

(7,498)

Loss for the period

(15,756)

(14,062)

(28,568)

(28,730)

 

 

Unaudited

7-12/2023
6 months

Unaudited

7-12/2022
6 months

1-12/2023
12 months

1-12/2022
12 months

Loss per share EUR

(0.26)

(0.27)

(0.48)

(0.52)

Number of shares at end of period

68,786,699

59,805,383

68,786,699

59,805,383

Average number of shares

67,137,790

57,230,625

65,055,036

55,229,835

 

EUR ’000

Unaudited

30 June 2023

Unaudited

30 June 2022

31 December 2023

31 December 2022

Cash and cash equivalents

6,315

9,936

6,875

6,990

Equity

(9,483)

(5,194)

(15,160)

(11,476)

Balance Sheet total

12,836

16,729

10,220

11,271

 

Board of Directors’ Proposal on the Dividend

The Group’s comprehensive loss for the period was EUR 30,943,935 (2022: EUR 28,924,250). The Board of Directors proposes to the Annual General Meeting 2024 not to pay a dividend.

 

March 13, 2023

Faron Pharmaceuticals Oy

Board of Directors

 

 

 

 

Conference call information

A virtual briefing and Q&A session for investors, analysts and media will be hosted by Dr. Markku Jalkanen, Chief Executive Officer, and James O’Brien, Chief Financial Officer, today, March 13, 2024, at 8:00 AM (EDT) / 12:00 PM (GMT) / 2:00 PM (EET).

 

Webcast registration link: https://faron.videosync.fi/q4-2023

 

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

 

 

For more information please contact:

 

Investor Contact

LifeSci Advisors

Daniel Ferry

Managing Director

daniel@lifesciadvisors.com

+1 (617) 430-7576

 

Media Contact

ICR Consilium

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: +44 (0)20 3709 5700

E-mail: faron@consilium-comms.com 

 

Cairn Financial Advisers LLP, Nomad

Sandy Jamieson, Jo Turner

Phone: +44 (0) 207 213 0880

 

Peel Hunt LLP, Broker

Christopher Golden, James Steel

Phone: +44 (0) 20 7418 8900

 

Sisu Partners Oy, Certified Adviser on Nasdaq First North

Juha Karttunen

Phone: +358 (0)40 555 4727

Jukka Järvelä

Phone: +358 (0)50 553 8990

Publication of financial information during year 2024

Faron’s financial statements for full year 2023 will be published today, March 13, 2024 and will also be available on Faron’s website at https://www.faron.com/investors/results. The half-year financial report for the period January 1 to June 30, 2024 is scheduled to be published on August 27, 2024. The Annual General Meeting is planned for April 5, 2024. A separate stock exchange notice will be issued by Faron’s Board of Directors to convene the meeting.

 

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 BEXMAB

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

 

About Faron Pharmaceuticals Ltd.

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

 

Forward-Looking Statements

 

Certain statements in this announcement are, or may be deemed to be, forward-looking statements. Forward looking statements are identified by their use of terms and phrases such as ”believe”, ”could”, “should”, “expect”, “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.

 

 

CEO Statement

 

2023 was a year of significant progress for Faron with momentum building in our ambitious bexmarilimab development program and a continued laser focus on proving the potential of this novel myeloid cell re-programming immunotherapy to treat patients with aggressive hematological malignancies.

Initial promising results emerged early in 2023 from the first part of our Phase I/II BEXMAB study, investigating bexmarilimab in combination with standard of care (azacitidine and venetoclax) in relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) patients who had failed hypomethylating agents (HMAs). These early, positive responses in a very difficult to treat refractory setting were extremely exciting, given patients in the trial had failed standard of care and were left with few treatment options.

Throughout 2023 the trial delivered highly encouraging results which continued to improve over time. And by the time the first part of the trial had completed, the data was no less compelling. The bexmarilimab combination therapy had shown a strong overall response rate (ORR) in both higher-risk frontline MDS patients (5/5 patients) as well as HMA-failed MDS patients (5/5 patients). Observed responses were deep and durable with 7/10 MDS patients achieving complete remission/ marrow complete remission (CR/mCR), and two demonstrating partial remission (PR), one of whom moved on to receive a stem cell transplantation and the other, hematological improvement without remission (HI-P).

The combination continued to be well-tolerated and generated strong and durable leukemic blast eradication and immune responses. These were tremendous data, supporting bexmarilimab’s unique mechanism of action in the field of myeloid cell re-programming. And providing compelling evidence for us to continue development, at pace.

We rapidly initiated the second phase of the BEXMAB study in November, selecting HMA-refractory or -relapsed MDS as the initial indication, based on guidance from the U.S. Food and Drug Administration (FDA). MDS presents a considerable patient burden given the limited efficacy of the current standard of care, resulting in relatively low response rates and poor overall survival. Our data from the first part of the study underscored the potential of combining bexmarilimab with existing treatments to advance care for patients who so desperately need help. Post period, in January 2024, the first patients were dosed in the second phase of the study and the team secured additional trial sites to speed up its recruitment.

This is an incredibly important stage in bexmarilimab’s development as data from this phase of the trial will enable us to discuss a potential registrational study plan with the FDA.

We are thrilled with this progress and our absolute priority is to pursue an accelerated path to approval for bexmarilimab in its initial indication, where we know the need is so great. We also understand the broader opportunities for this immunotherapy. The FDA has granted Orphan Drug Designation (ODD) to bexmarilimab for the treatment of acute myeloid leukemia (AML), another hematological cancer with too few treatment options. Armed with the wealth of data generated so far in the BEXMAB study, we are exploring bexmarilimab’s potential in low risk MDS as well as chronic myelomonocytic leukaemia (CMML) patients. These are development and expansion opportunities that we will consider in the form of partnerships as our research continues.

Communicating to the broader healthcare community was an important aspect of our work in 2023 and I am delighted that the team was able to share and discuss the strong data emerging from the BEXMAB program at many of the leading scientific conferences, including the American Association for Cancer Research Annual Meeting, the European Hematology Association (EHA) 2023 Congress and the 65th American Society of Hematology (ASH) Annual Meeting. It was also a significant moment in December of 2023 when the leading scientific journal, Cell Reports Medicine, published the full safety and anti-tumor efficacy results from the Company’s first-in-human Phase I/II MATINS trial of bexmarilimab monotherapy in solid tumors. That trial achieved disease control and prolonged survival in a proportion of patients with very late-stage cancers who had exhausted all standard treatment options. It formed the bedrock of our understanding of the potential of bexmarilimab.

Alongside bexmarilimab’s significant advancements we have continued to strengthen the Company’s foundations. The appointment of Mr. James O’Brien, CPA, MBA, as Chief Financial Officer, supports our journey to becoming a global pharmaceutical company, given his extensive experience in the US capital markets and strong track record as an accomplished biotech and financial executive. When Dr. Marie-Louise Fjällskog stepped down as Faron’s Chief Medical Officer, we were delighted that she agreed to continue playing an integral role in the development of bexmarilimab, by providing clinical and regulatory expertise through her Non-Executive Director role on our Board. Dr. Birge Berns, who we appointed interim Chief Medical Officer, is a seasoned senior pharmaceuticals executive with a background in oncology, clinical medicine, rheumatology and immunology. She brings a wealth of global pharmaceutical experience that is critical to this business.

I am excited for the Company’s future in 2024. The latest stage of the BEXMAB trial will provide important data to support our continued discussions with the FDA and, we hope, provide us with a clear pathway to bringing bexmarilimab to patients. Our confidence grows in the potential of this novel therapy to provide better patient outcomes and improve the quality of life of those suffering from aggressive hematological cancers. The excellent BEXMAB data have intensified numerous ongoing partnering discussions, and we are looking forward to advancing these discussions over the coming year.

None of this work would be possible without the ongoing support from our shareholders, to whom I express my sincere thanks. And to my colleagues on the management team, and the wider Faron community, thank you for your continued commitment to making this Company’s vision a reality and bringing the promise of bexmarilimab to patients.

Markku Jalkanen

Chief Executive Officer

March 13, 2024
 

Chairman Statement

2023 has been another solid year of clinical trial progress for Faron. We continue to see bexmarilimab, our novel, wholly owned investigational immunotherapy candidate as the major value driver for Faron, and so our focus has been, and remains, to continue to advance bexmarilimab through clinical development.

We were pleased to conclude the MATINS trial, which provided a huge amount of information around the safety of bexmarilimab in a monotherapy setting and we were honoured to present and publish the data at several conferences and in important scientific Journals.   As we have said for a long time, we believe the future of cancer therapy for later-stage treatment is in the combination setting and we strongly believe, reinforced by the remarkable clinical data from the last year, that bexmarilimab will be part of the backbone of a combination setting.

Our most advanced program, and our main focus at Faron, is our Phase I/II BEXMAB trial investigating the safety, tolerability and preliminary efficacy of bexmarilimab in combination with standard of care therapies. Over the course of the year, we have seen very encouraging data from the BEXMAB trial with bexmarilimab continuing to show real clinical benefit in specific patient populations. We have consistently provided updates to the market and presented the data at several prestigious scientific conferences where we have had very positive feedback from key opinion leaders as well as from the clinicians in our trials.  This has given us continued confidence in the potential of bexmarilimab to provide better patient outcomes and improve the quality of life in patients suffering from these aggressive conditions.  We will continue to explore the best options to commercialize bexmarilimab in the combination setting and, as we move to next year, we are looking to have substantial interactions with the US FDA about the best path to market in our chosen indications.

We are very fortunate at Faron to have long-term supportive investors and so, despite the incredibly challenging funding environment seen this past year in both Europe and the US, we were pleased to raise additional capital throughout the period totalling EUR 25,7 million.  Amongst other things, these funds have allowed us to accelerate our bexmarilimab program, bringing this much needed potential treatment one step closer to patients.  We will look to strengthen our shareholder base as we move into 2024.

We had several Board and management changes over the course of the year. Dr. Gregory B. Brown and Ms. Anne Whitaker both stepped down from their positions as a Non-Executive Directors of the Company and Faron Board Member Mr. Leopoldo Zambeletti also stepped down to assume a transactional advisor role within the Company on business development opportunities.  We were pleased, however, to welcome Mr. Tuomo Pätsi and Ms. Christine Roth as Non-Executive Directors of the Company. Ms. Roth has played key roles in the development and launch of several therapies, including the first immune-oncology therapy and intentionally designed targeted therapy combinations.

Dr. Marie-Louise Fjällskog, moved from Chief Medical Officer to assume a Board position and we are very grateful that when she decided to retire, she had the confidence to continue with the Company in this role.  We also appointed a new Chief Financial Officer, Mr. James O’Brien, a very experienced US based CFO who has already made a big impact, and Dr. Birge Berns, MD as Interim Chief Medical Officer.

I would like to take this opportunity to thank our outgoing Board members for their service and guidance to Faron during their tenure and to Mr. Toni Hänninen, our previous CFO, for his service to Faron over the years.

As always, I would like to thank the whole management team, led by Dr. Markku Jalkanen, Chief Executive Officer, for their continued dedication and guidance, my colleagues on the Board for their commitment to the Company and our partner organisations and steering committee members for their support and expertise. I would also like to extend thanks to all the employees at Faron for their hard work and dedication.  Most importantly, I would like to thank all the patients on our clinical trials, their families, and our trial investigators without whom we would not be where we are today. 2024 is set to be a pivotal for Faron when BEXMAB will deliver key data giving us a clearer direction towards commercialization. I look forward to providing further updates as we continue to progress our innovative pipeline. 

Dr Frank Armstrong

Chairman

 

Financial Review

 

Despite continuing challenging market conditions in 2023, the Company was able to conduct three successful fundraising rounds. Combined, these financings raised EUR 25,7 million.  As a result of these fundraising efforts, the net cash from financing activities of EUR 23,9 million compared to EUR 23,5 million in 2022. Post period in March 2024, the Company successfully raised a total of EUR 3.2 million in subordinated convertible loan arrangements with existing shareholders.

Faron places a strategic emphasis on capital efficiency, a key element of efforts to extend our cash runway, without compromising the ability to advance our clinical development program. This capital efficiency has allowed us to achieve more with available resources, while focusing on clinical outcomes. During 2023, nearly 70% of cash expenses were spent directly in support of our bexmarilimab clinical development program including manufacturing. General and administrative expenses were flat in 2023 when compared to 2022 excluding one-time items and financing costs.

RESEARCH AND DEVELOPMENT EXPENSES 

R&D costs were EUR 19,5 million in 2023 compared to 20,7 million in 2022, a decrease of EUR 1,2 million. These costs are attributable to advancing our clinical programs including completion of BEXMAB Phase I and the initiation of Phase II. Clinical trial costs include the cost of patient and site enrollment, CRO service costs including monitoring, investigator fees, and compensation and benefits for personnel directly responsible for R&D activities, and product supply costs.  The costs of outsourced clinical trial services were EUR 4,0 million in 2023 compared to EUR 5,1 million in 2022. Compensation and benefits were EUR 3,2 million in 2023 and EUR 5,2 million in 2022 and included stock compensation expense of EUR 0,7 million and EUR 0,3 million in 2023 and 2022, respectively.

GENERAL AND ADMINISTRATION COSTS

G&A expenses were EUR 9,0 million in 2023 compared to EUR 7,5 million in 2022, an increase of EUR 1,5 million. The increase was mainly due to the recognition of the incremental fair value of amending the terms of 2015 option plan of EUR 1,2 million.  Compensation and benefits were EUR 5,7 million in 2023 and EUR 4,5 million in 2022 and included stock compensation expense of EUR 1,7 million and EUR 1,0 million in 2023 and 2022, respectively.

TAXATION

The Company’s tax credit for the fiscal year 2023 can be recorded only after the Finnish tax authorities have approved the tax report and confirmed the amount of tax-deductible expenses. The total amount of cumulative tax losses carried forward approved by tax authorities on December 31, 2023 was EUR 51,6 million (2022: EUR 47,1 million). The Company estimates that it can utilize most of these during the years 2024 to 2034 by offsetting them against potential future profits. In addition, the Company has EUR 95,2 million of R&D costs incurred in the financial years 2010 – 2023 that have not yet been deducted from taxation. This amount can be deducted over an indefinite period at the Company’s discretion.

LOSSES

Loss before income tax and total comprehensive income in 2023 was EUR 30,9 million compared to EUR 28,7 million in 2022, which represents a loss of EUR 0.48 per share and EUR 0.52 per share in 2023 and 2022, respectively.

CASH FLOWS

Net cash flow in each of the years ended December 31, 2023 and 2022 was essentially flat. Cash used for operating activities in 2023 was EUR 23,8 million compared to 2022 of EUR 23,0 million. Net cash inflow from financing activities in 2023 was EUR 24,0 million compared to 2022 of EUR 23,5 million.

FUNDRAISING

In January 2023 the Company successfully raised a total of EUR 12,0 million gross through the issuance of 3,692,308 ordinary shares to investors. In June 2023, Faron conducted a placement of 2,601,510 newly issued treasury shares to raise EUR 6.6 million gross. In October 2023, the Company successfully raised EUR 7,1 million gross through the issuance of 2,491,998 ordinary shares to investors. Post period, In March 2024, the Company successfully raised a total of EUR 3,2 million in subordinated convertible loan arrangements with certain existing shareholders.

 

FINANCIAL POSITION

As of 31 December 2023, total cash and cash equivalents held were EUR 6,9 million compared to 2022 of EUR 7,0 million.

GOING CONCERN

As part of their going concern review, the Directors have followed International Accounting Standard 1, Presentation of Financial Statements (IAS 1). The Company and its subsidiaries are subject to a number of risks similar to those of other development state pharmaceutical companies. These risks include, amongst others, generation of revenues in due course from the development portfolio and risks associated with research, development, testing and obtaining related regulatory approvals of its pipeline products. Ultimately, the attainment of profitable operations is dependent on future uncertain events which include obtaining adequate financing to fulfill the Group’s commercial and development activities and generate a level of revenue adequate to support the Group’s cost structure.

The Group generated a net loss of EUR30,9 million and recorded EUR 23,8 million cash outflow from operating activities during the year ended 31 December 2023. At the end of the financial year, it had total negative equity of EUR15,2 million including an accumulated deficit of EUR 172,2 million. As of that date, the group had cash and cash equivalents of EUR6,9 million.

The Directors have prepared detailed financial forecasts and cash flows looking beyond 12 months from the date of the approval of these financial statements. In developing these forecasts, the Directors have made assumptions based upon their view of the current and future economic conditions that are expected to prevail over the forecast period. The Director’s estimate that the cash held by the Group, together with known receivables will be sufficient to support the current level of activities into the second quarter of 2024. The Group also maintains loan agreements which include financial covenants related to minimum cash balance and thus loan amounts (EUR 9,4 million on December 31, 2023) become due if the Group is not able to maintain minimum cash balances or negotiate a waiver with the lender. The directors are continuing to explore sources of finance available to the Group and they believe that they have a reasonable expectation that they will be able to secure sufficient cash inflows for the Group to continue its activities for not less than 12 months from December 31, 2023; they have therefore prepared the financial statements on a going concern basis.

During the financial period ended 31, December 2023, the Group raised EUR 25.7 million in three successful fundraising rounds. . Subsequently, in March 2024, the Group received EUR 3,2 million Capital Loan to secure immediate short-term financing needs until the end of March 2024. The Capital Loan shall be governed by the provisions of Chapter 12 of the Finnish Companies Act (624/2006, as amended) (the “Finnish Companies Act”) concerning capital loans (in Finnish: pääomalaina).

The Loans shall be converted to new shares in the Company as a part of (and at the subscription price of) the next investment round where shares or other equity securities are issued by the Company to existing shareholders and/or new third- party investors, with a minimum size of EUR 8.0 million (“Investment Round”).

In the event that the subscription price in such Investment Round exceeds EUR 1.50 per share, an Investor shall have the right to postpone the conversion of the Loan until June 10, 2024 (“Due Date”). In the event that there is no Investment Round by the Due Date (or the subscription price of the Investment Round exceeds EUR 1.50 per share and the respective Investor has decided to postpone the conversion of the Loan) and the Loan has not been otherwise repaid prior to the Due Date (subject to a subordination agreement to be entered into between the Investors, the Company and IPF), then the Loan shall be at the request of the Investor converted into new shares in the Company in connection with the Due Date. In such case, the subscription price per share shall be EUR 1.50 per share. However, if then the Investor elects not to exercise its conversion right on the Due Date, (such option being only available if there has not been any Investment Round), the Due Date of the Loan will automatically be extended until December 31, 2024 (“Final Due Date”). On such Final Due Date, the Loan shall be either repaid in full in cash, subject to the terms of the subordination agreement, or converted into new shares in the Company with the subscription price of EUR 1.50 per share, subject to a valid share issue authorization being in place.

In case the Loan is converted before the Due Date, each Investor is entitled to an arrangement fee of 15% of its respective Loan amount. If conversion has not taken place prior to the Due Date, the arrangement fee will be 30% of the Investor’s respective Loan amount. No interest shall be payable on the Loan if a conversion takes place before May 30, 2024, and thereafter the interest will be 12% + 3-months Euribor and paid subject to the subordination agreement.

The Group is actively pursuing the following activities during 2024:

  • Securing approximately EUR5,0 million of short-term bridge financing to extend the Group’s cash runway until longer-term financing can be obtained.
  • Securing longer-term funding of approximately EUR 35.0 million in total. The Directors intend to propose to the Annual General Meeting on 5 April 2024 an authorization for a larger share issuance contemplated to be launched as a public offering (with planned allocation preferences to existing shareholders and bridge finance lenders, including the Investors to enable the conversion of the Capital Loan and in compliance with the relevant securities markets regulation) as soon as practicable once the required preparations and approvals are in place. The targeted size of the contemplated share issue is planned to be set accordingly, to meet cash runway needs for 2024.
  • Evaluating and negotiating several business development alternatives that may result in non-dilutive funding.
  • Evaluating new sources of financing from third parties on acceptable terms. With respect to the availability of additional funding from IPF, the respective term allowing the Group to draw on Tranche B and Tranche C has expired and the availability of Funds from IPF would be subject to further negotiations. The Group does not anticipate, at this time, having the ability to draw on Tranche B or Tranche C under favorable terms, in the near future. 
  • Because the additional finance is not committed at the date of issuance of these financial statements, these circumstances represent a material uncertainty that may cast significant doubt on the Group’s ability to continue as a going concern. Should the Group be unable to obtain further financing such that the going concern basis of preparation were no longer appropriate, adjustments would be required, including to reduce balance sheet values of assets to their recoverable amounts.

HEADCOUNT

Faron’s headcount at the end of year was 34 (2022: 40).

SHARES AND SHARE CAPITAL

During the period January 1 to December 31, 2023, the Company, using the share authorities granted at the Extraordinary General Meeting held on July 7, 2022, issued a total of 3,692,308 new ordinary shares at an issuance price of EUR 3.25 per share to investors. During the same period, the Company, using the share authorities granted at the Annual General Meeting held on March 24, 2023, issued a total of 2,601,510 shares at an issuance price of EUR 2.55 per share to investors. During the same period, the Company, using the share authorities granted at the Annual General Meeting held on March 24, 2023, issued a total of 2,491,998 new ordinary shares at an issuance price of EUR 2.85 to investors. The subscription price net of costs was credited in full to the Company’s reserve for invested unrestricted equity, and the share capital of the Company was not increased. The Company has no shares in treasury; therefore, at the end of 2023 the total number of voting rights was 68,786,699.

 

 

 

 

 

Consolidated Income Statement, IFRS

 EUR ’000

Unaudited

7-12/2023
6 months

Unaudited

7-12/2022
6 months

1-12/2023
12 months

1-12/2022
12 months

Other operating income

0

318

0

803

Research and development expenses

(11,024)

(10,683)

(19,542)

(20,730)

General and administrative expenses

(4,732)

(3,697)

(9,026)

(7,498)

Operating loss

(15,756)

(14,062)

(28,568)

(27,426)

Financial income

233

(596)

233

96

Financial expense

(1,691)

(970)

(2,609)

(1,400)

Loss before tax

(17,214)

(15,628)

(30,944)

(28,730)

Tax expense

0

19

0

0

Loss for the period

(17,214)

(15,609)

(30,944)

(28,730)

 

 

 

 

 

Other comprehensive gain/loss

2

6

2

17

Total comprehensive loss for the period

(17,212)

(15,603)

(30,942)

(28,713)

 

 

 

 

 

Loss per ordinary share

 

 

 

 

Basic and diluted loss per share, EUR

(0.26)

(0.27)

(0.48)

(0.52)

 

 

Consolidated Balance Sheet, IFRS

 

 

EUR ‘000

31 December 2023

31 December 2022

Assets

 

 

Non-current assets

 

 

Machinery and equipment

6

13

Right-of-use-assets

198

314

Intangible assets

1,088

1,154

Prepayments and other receivables

60

60

Total non-current assets

1,352

1,541

 

 

 

Current assets

 

 

Prepayments and other receivables

1,992

2,740

Cash and cash equivalents

6,875

6,990

Total current assets

8,868

9,730

 

 

 

Total assets

10,220

11,271

 

 

 

Equity and liabilities

 

 

 

 

 

Capital and reserves attributable to the equity holders of Faron

 

 

Share capital

2,691

2,691

Reserve for invested unrestricted equity

154,352

129,544

Accumulated deficit

(172,208)

(143,713)

Translation difference

4

2

Total equity

(15,160)

(11,476)

 

 

 

Provisions

 

 

Other provisions

0

158

Total provisions

0

158

 

 

 

Non-current liabilities

 

 

Borrowings

9,423

11,102

Lease liabilities

50

163

Other liabilities

895

853

Total non-current liabilities

10,369

12,118

 

 

 

Current liabilities

 

 

Borrowings

3,475

1,851

Lease liabilities

163

153

Trade payables

8,971

6,014

Accruals and other current liabilities

2,403

2,453

Total current liabilities

15,012

10,471

 

 

 

Total liabilities

25,380

22,748

 

 

 

Total equity and liabilities

10,220

11,271

 

 

 

 

 

 

Consolidated Statement of Changes in Equity, IFRS

EUR ‘000

Share capital

Reserve for invested unrestrict-
ed equity

Trans-
lation
difference

Accumu-lated deficit

Total equity

 

 

 

 

 

 

Balance as at 31 December 2021

2,691

116,507

(15)

(116,265)

2,919

 

 

 

 

 

 

Comprehensive loss for the year 2022

0

0

17

(28,730)

(28,713)

 

 

 

 

 

 

Transactions with equity holders of the Company

 

 

 

 

Issue of ordinary shares, net of transaction costs

0

13,037

0

0

13,037

Share-based compensation

0

0

 0

1,297

1,297

Other movements

 0

0

0

(16)

(16)

 

0

13,037

17

(27,448)

(14,395)

 

 

 

 

 

 

Balance as at 31 December 2022

2,691

129,544

2

(143,713)

(11,476)

 

 

 

 

 

 

 

 

 

 

 

 

Comprehensive loss for the year 2023

0

0

2

(30,944)

(30,942)

 

 

 

 

 

 

Transactions with equity holders of the Company

 

 

 

 

 

Issue of ordinary shares, net of transaction costs

0

24,808

0

0

24,808

Share-based compensation

0

0

0

2,450

2,450

 

0

24,808

2

(28,494)

(3,684)

 

 

 

 

 

 

Balance as at 31 December 2023

2,691

154,352

4

(172,208)

(15,160)

 

 

 

 

Consolidated Cash Flow Statement, IFRS

 

EUR ‘000

Unaudited

Unaudited

1-12.2023

1-12.2022

7-12.2023

7-12.2022

12 months

12 months

6 months

6 months

 

 

Cash flow from operating activities

 

 

 

 

Loss before tax

(17,214)

(15,628)

(30,944)

(28,730)

Adjustments for:

 

 

 

 

Received grant

(33)

(388)

(33)

(803)

Depreciation and amortization

172

149

346

300

Change in provision

0

(158)

(158)

(158)

Financial items

1,458

787

2,376

1,304

 

 

 

 

 

Tax expense

0

19

0

0

 

 

 

 

 

Share-based compensation

1,964

632

2,450

1,297

Adjusted loss from operations before changes in working capital

(13,653)

(14,587)

(25,963)

(26,790)

Change in net working capital:

 

 

 

 

Prepayments and other receivables

(728)

2,045

300

2,864

Trade payables

3,002

(657)

2,994

719

Other liabilities

223

2,197

(50)

1,183

Cash used in operations

(11,156)

(11,001)

(22,719)

(22,023)

 

 

 

 

 

Transaction costs related to loans and borrowings

0

0

0

(165)

Interest received

243

11

243

11

Interest paid

(548)

(708)

(1,330)

(816)

Net cash used in operating activities

(11,461)

(11,698)

(23,806)

(22,993)

 

 

 

 

 

Cash flow from investing activities

 

 

 

 

Payments for intangible assets

(56)

(218)

(123)

(385)

Payments for equipment

0

0

0

0

Net cash used in investing activities

(56)

(218)

(123)

(385)

 

 

 

 

 

Cash flow from financing activities

 

 

 

 

Proceeds from issue of shares

13,954

8,923

26,031

13,445

Share issue transaction cost

(542)

(174)

(1,190)

(365)

Proceeds from borrowings

0

(0)

64

10,389

Repayment of borrowings

(861)

0

(861)

(105)

Transaction and structuring fees of borrowings

(400)

0

(400)

0

Proceed from grants

99

231

481

231

Payment of lease liabilities

(58)

(20)

(142)

(116)

Net cash from financing activities

12,192

8,959

23,983

23,478

 

 

 

 

 

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

560

(2,946)

(114)

137

Effect of exchange rate changes on cash and cash equivalents

(116)

11

(168)

37

 

 

 

 

 

Cash and cash equivalents at 1 January / 1 July

6,315

9,936

6,315

6,853

Cash and cash equivalents at 31 December

6,876

6,990

6,876

6,6990

 

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