Faron Pharmaceuticals Ltd: Half-year financia...

Faron Pharmaceuticals Ltd | Company announcement | August 26, 2026 at 09:00:00 EEST

Strengthened balance sheet supports advancement into randomized Phase 2b trial in higher-risk MDS

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 2026, on 26 August 2026.

Figures in parentheses refer to the corresponding period of previous year, unless otherwise indicated. 

This half-year report is unaudited. The unaudited interim financial report incorporates the Company, Faron Pharmaceuticals Ltd only. Following the liquidation and closure of the Company’s subsidiaries during the reporting period, the Company no longer has subsidiaries and therefore does not prepare consolidated financial information. The comparative figures have been adjusted to include only the Company’s figures.

January – June 2026 in brief

• 27 January 2026 – Faron announced a significant expansion to the scope of clinical trials involving bexmarilimab by supporting the investigator-initiated trial (IIT) BEXAR, building evidence on the role of the Clever-1 pathway in solid tumors. The BEXAR trial evaluates Faron’s lead asset, bexmarilimab, in combination with standard-of-care (SoC) doxorubicin for patients with metastatic soft-tissue sarcoma.
• 9 February 2026 – Faron announced that it is planning a rights issue of approximately EUR 40 million to strengthen its capital structure and to drive its lead asset bexmarilimab to key value-creating milestones and convened an Extraordinary General Meeting to approve the related authorization to the Board of Directors.
• 19 February 2026 – Faron announced the Phase 2 BEAM IIT, led by the Nordic AML Group, evaluating bexmarilimab in combination with azacitidine to prevent relapse in measurable residual disease (MRD)-positive acute myeloid leukemia (AML) after allogeneic stem cell transplantation.
• 2 March 2026 – Faron and City of Hope (US) announced the development of a Phase 2 IIT of bexmarilimab in combination with an oral hypomethylating agent (HMA) in relapsed/refractory (r/r) myelodysplastic syndrome (MDS).
• 26 March 2026 – Faron appointed Mr. Heikki Jouttijärvi as Chief Technical Officer (CTO) to strengthen late-stage development, manufacturing and supply chain activities.
• 9 April 2026 – Faron published the final results of its rights issue, raising gross proceeds of approximately EUR 40.1 million.
• 16 April 2026 – Faron announced a collaboration with Parexel, a global clinical research organization, to support the randomized Phase 2b BEXERA trial (FP2CLI012) in frontline, treatment-naïve higher-risk (HR) MDS, planned to start in the second half of 2026.
• 4 May 2026 – The Annual General Meeting (AGM) adopted the 2025 financial statements, re-elected the auditor, approved a new stock option plan and elected Dr. George Stanley Golumbeski as a new member of the Board of Directors.
• 15 June 2026 – Faron announced the matured BEXMAB data presented at the European Hematology Association (EHA) 2026 Congress confirming durable efficacy and bone marrow reprogramming in HR-MDS. Median duration of complete remission (CR) in treatment-naïve HR-MDS patients extended to 16.1 months with bexmarilimab + azacitidine.
• R&D expenses were EUR 7.6 (7.1) million.
• Operating loss for the reporting period was EUR -11.1 (-11.8) million.
• Loss per share was EUR 0.06 (0.18).
• On 30 June 2026, cash and cash equivalents were EUR 32.0 (13.5) million.
• Net assets were EUR 11.6 (-16.7) million.

Significant events after the reporting period

• 1 July 2026 – The Company’ Board has confirmed the grant of a total of 2,173,000 options over ordinary shares in the Company under the Company’s Share Option Plan 2026.
• 13 July 2026 – Faron provided an update on its portfolio of Investigator-Initiated Trials (IITs) evaluating bexmarilimab, its wholly owned anti-Clever-1 immunotherapy, in multiple oncology indications. The update covers five IITs in solid tumors and hematological malignancies, reflecting both advances and adjustments across the program.
• 27 July 2026 – Faron announced that it has conducted its first overall survival (OS) data cut from treatment-naïve higher-risk myelodysplastic syndrome (HR-MDS) patients enrolled in the BEXMAB trial. At this time, after a median follow-up of 14.9 months, the only subgroup to have hit the median is the biallelic TP53 mutated population. This subgroup, historically associated with very poor outcomes, achieved a median OS of 8.8 months, which is in line with historical data and reassuring given the complex cytogenetics within the BEXMAB biallelic patient population.
• 3 August 2026 – Faron approved the exercise of 3,657,321 special rights entitling to 3,657,321 shares in the Company, for an aggregate subscription price of EUR 1,578,499.74 in connection with the scheduled amortisation payment of the First and Second Tranche Bonds.

Key figures, IFRS

Outlook for 2026

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

CEO Statement

“The first half of 2026 was a demanding period for Faron, which we successfully navigated with determination and hard work. We began 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 tumors. I am proud to say that we made decisive progress on both of these fronts during the first half and are very enthusiastic about the future.

Successful rights issue supports Faron’s lead position in HR-MDS

In April, we completed one of Finland’s largest biotechnology financing rounds ever with our EUR 40.1 million rights issue. We are very pleased with the results of the rights issue, which reflect the strong commitment and trust of both our existing shareholders and new cornerstone investors. The raised funds provide a decisive foundation for our next chapter and our most important value driver: the upcoming randomized Phase 2b BEXERA trial in frontline HR-MDS.

Preparations for the BEXERA trial are well underway, and we expect the trial to begin as planned in the second half of 2026. The trial is expected to enrol 90 participants across up to 35 sites in the United States (US), Europe and the United Kingdom (UK). The objective of the trial is to select the recommended Phase 3 dose and demonstrate the efficacy and safety of combining bexmarilimab with SoC azacitidine in a frontline randomized, placebo-controlled setting to support future registrational filings. In April, we entered into an agreement with Parexel, a leading global clinical research organization, to support the trial. The collaboration is focused on ensuring disciplined trial execution, timely delivery and operational efficiency as the program progresses.

Bexmarilimab continues to stand out as one of the most innovative and advanced development programmes in HR-MDS. In June, we presented matured data from the BEXMAB Phase 1/2 study at the EHA 2026 Congress, further reinforcing the clinical and biological potential of bexmarilimab to induce haematopoiesis, activate T cells and overcome treatment resistance in the bone marrow microenvironment. In our view, bexmarilimab remains at the forefront of innovation in MDS, representing a novel mechanism with the potential to transform treatment outcomes. While the field is attracting increasing interest from both existing players and new entrants, most competing approaches are built on previously failed treatment methods, such as BCL-2 and CD47 inhibitors. We have adapted our trial design based on clinical learnings, including redefining the approval endpoint to CR, and are now seeing others in the field beginning to follow a similar path. With our strengthened balance sheet, we are well positioned to advance the program, generate further clinical evidence and maintain strategic flexibility while continuing partnering discussions.

Investigator-initiated trials provide evidence in solid tumors

While our primary focus remains in HR-MDS, we continue to demonstrate bexmarilimab’s potential in solid tumors through a growing number of IITs. Last year, 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 bexmarilimab’s mode of action in the tumor microenvironment. These results contribute to the design of future trials.

IITs require minimal financial investment from Faron and are designed to evaluate bexmarilimab’s potential in overcoming treatment resistance in diseases such as lung cancer, melanoma and sarcoma. In January, we announced support for the BLAZE and BEXAR IITs, which significantly expands the range of clinical settings in which bexmarilimab is being investigated. The BEXAR trial evaluates bexmarilimab in combination with SoC doxorubicin for patients with metastatic soft-tissue sarcoma, while the BLAZE trial aims to overcome resistance to anti-PD-1 therapy in checkpoint-refractory melanoma and non-small cell lung cancer.

In addition to solid tumors, we are expanding our efforts in malignant haematology. While the BEXMAB trial primarily focuses on HR MDS, it also includes patients with AML. Insights gained from these patients have helped shape our AML development strategy and supported plans for a dedicated Phase 2 trial in AML, targeting biologically defined patient population with a differentiated competitive position. In February, we announced the Phase 2 BEAM IIT, led by the Nordic AML Group, evaluating bexmarilimab in combination with azacitidine to prevent relapse in measurable residual disease (MRD)-positive AML after allogeneic stem cell transplantation. This setting is supported by a strong biological rationale and represents a distinct opportunity within the AML treatment landscape. We are excited to advance these trials and generate further clinical evidence of bexmarilimab’s potential to overcome treatment resistance in new indications.

Looking ahead

For the second half of 2026, our priorities are clear: initiate BEXERA, continue generating evidence from our IIT portfolio, and translate this into further value creation for bexmarilimab. With funding in place through the completed EUR 40.1 million rights issue, we can proceed to the next major milestones.

As we move further into later stage development, we have also brought in new world-class expertise. Heikki Jouttijärvi, our new CTO appointed in March, brings decades of experience in biopharma manufacturing, supply chain management and commercial operations. Our new board member, Dr. George Stanley Golumbeski, is a highly experienced biotech business development leader, whose deep understanding of the biotechnology industry will be invaluable as we continue on our journey.

Faron is better positioned than ever to take bexmarilimab to the next major milestones. I want to thank our team, partners, patients and our shareholders for their continued commitment. Your support is instrumental as we work to transform the treatment landscape for patients with aggressive haematological cancers and prove the broader potential of our immunotherapy platform.”

Dr. Juho Jalkanen

Chief Executive Officer

Tables

Income Statement, IFRS

Balance Sheet, IFRS

Cash Flow Statement, IFRS

* Comparative figures revised according to new presentation format implemented year-end 2025

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, and Jurriaan Dekkers, Chief Financial Officer, today at 08:00 am (EDT) / 1:00 pm (BST) / 3:00 pm (EEST) on Wednesday, 26 August 2026.
Webcast registration link: Faron 2026 Half-Year Financial Results

The half-year report and replay of the webcast will be available on the Company’s website at http://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 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 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 1/2 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 commercialize 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 London AIM Rule and Helsinki First North 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.

Attachments
Faron Half Year Report 2026 Clean Docx