Inside Information: Faron Pharmaceuticals Ltd is planning a rights offering of approximately EUR 40 million to strengthen its capital structure and to drive lead asset bexmarilimab to key milestones

Inside Information: Faron Pharmaceuticals Ltd is planning a rights offering of approximately EUR 40 million to strengthen its capital structure and to drive lead asset bexmarilimab to key milestones

TURKU, FINLAND – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON, “Faron” or the “Company”) announces that it is planning a share issue with pre-emptive subscription rights for the Company's existing shareholders to raise gross proceeds of approximately EUR 40 million (the “Offering”) The Offering is aimed to strengthen the Company's financial position and to accelerate the development of its lead asset bexmarilimab and to run the Phase II portion of the FDA agreed Phase II/III trial in frontline HR MDS. To seek shareholders' approval for the Offering, Faron will today publish a notice to convene an Extraordinary General Meeting of Shareholders (EGM), to be held on 2 March 2026.

Key Highlights

The objective of the Offering is to strengthen the Company's financial position and to finance the continued development of the Company’s lead asset bexmarilimab to the next set of key clinical milestones and expected value inflection points for 2026 and 2027.

Faron intends to raise approximately EUR 40 million in the Offering. The net proceeds from the Offering will be used to fund the Phase II portion of the Phase II/III trial agreed with the U.S. Food and Drug Administration (FDA) testing bexmarilimab + azacitidine against placebo + azacitidine in frontline high risk myelodysplastic syndrome (HR MDS), along with several investigator‑initiated combination trials across multiple cancers.

To align its clinical development plan with the recent FDA MDS guidelines from 2025, Faron plans to propose Complete Response (CR) as the approval endpoint, which would substantially shorten the confirmatory Phase III trial duration.

Faron believes that its staged and cost-efficient clinical development plan adapts well to the recent evolution in the HR MDS competitive landscape, particularly the failure of certain other drug candidates due to their clinical trial design and/or safety concerns.

Faron will host a virtual Business Update on Wednesday, 11 February 2026 at 3pm EET / 2pm CET / 8am ET. During the event, Faron’s Chief Executive Officer, Dr. Juho Jalkanen, will provide an update on the Company’s development plans and the rationale behind the planned Offering.

Background for the Offering

Faron has reached a critical stage in the advancement of bexmarilimab. In order to position the Company to achieve the next expected key value-inflection milestones, Faron’s Board of Directors has undertaken a detailed review of the development plan of bexmarilimab and forecasted funding requirements. With the proposed Offering Faron aims to fund the Phase II portion of a Phase II/III registrational trial of bexmarilimab in frontline high risk myelodysplastic syndrome (HR MDS) that was agreed with the FDA in H2 2025, along with supporting several investigator‑initiated combination trials across multiple solid tumors.

Chairman statement

“The Board has carefully considered a range of financing alternatives, including non-dilutive funding, debt instruments and equity-linked structures to fund the development of bexmarilimab. Having taken into account the Company’s development stage, market conditions and the importance of reaching a flexible balance sheet, we have concluded that equity financing by way of a rights offering is the most appropriate and prudent course of action at this time for the Company and its shareholders. We have therefore decided to convene the EGM to seek authorization from the shareholders for the Offering. The Board considers that a rights offering, offered to existing shareholders on a pre-emptive basis, represents a fair and equitable means of raising capital, allowing shareholders the opportunity to participate in the financing in proportion to their existing shareholdings and to mitigate dilution should they choose to do so. Accordingly, the Board unanimously believes that the rights offering is in the best interests of the Company and its shareholders as a whole and is necessary to support the execution of the Company’s strategy and the creation of long-term shareholder value, as this funding will enable the Company to facilitate progress toward multiple near-term clinical and regulatory milestones.

We trust that our shareholders will support the resolution to be proposed at the EGM to enable the planner rights offering to proceed,” says Tuomo Pätsi, the Chair of the Board.

Bexmarilimab’s clinical development plan aligned with FDA guidance and recent competitive landscape evolutions

Faron plans to start in the second half of 2026 the Phase II part of the randomized Phase II/III trial comparing two doses of bexmarilimab versus placebo, all in combination with standard-of-care azacitidine. At the end of the Phase II, anticipated late 2027, Faron aims to unblind the Phase II data and request an FDA meeting to select the final dose and primary endpoint for the confirmatory Phase III part. In the second half of 2025, the FDA published the first MDS guidelines for the industry. Accordingly, Faron intends to propose Complete Response (CR) as the final approval endpoint, which is expected to substantially shorten the confirmatory Phase III trial duration and cost. Of note, at the time of the frontline Phase II readout a discussion concerning accelerated approval for relapsed and refractory MDS (r/r MDS) could be re-visited with the FDA if the frontline Phase II results adequately address the FDA’s question on contribution of each agent in the efficacy of the bexmarilimab + azacitidine combination.

Faron believes that its staged and cost-efficient clinical development plan is appropriately aligned with recent changes in the HR MDS competitive landscape, particularly the failure of certain other drug candidates due to their clinical trial design and/or safety concerns.

As Faron continues to advance its frontline development plan and addressing the FDA’s remaining question on contribution of each agent testing bexmarilimab + azacitidine against placebo + azacitidine, investigators from the BEXMAB Phase I/II trial believe that the benefit of bexmarilimab in r/r MDS is clear given the data produced to date in the BEXMAB trial. Hence, led by City of Hope (USA) an investigator-initiated trial (IIT) in r/r MDS is also planned to commence in 2026 to produce more data in the last line setting while Faron pursues the frontline setting. This IIT data in r/r MDS is planned to be used for further validation of the benefit of bexmarilimab in last line HR MDS and support the discussion by Faron of potential accelerated approval in r/r MDS with the FDA at the time of the frontline Phase II read out.

Faron also plans to support up to five investigator-initiated trials to further validate bexmarilimab’s potential in combination trials in melanoma, lung cancer (NSCLC), soft tissue sarcoma, breast cancer (ER+ BRC) and leukemia (AML). The Company believes that these additional trials can further strengthen and expand the potential of bexmarilimab in solid tumors, which it expects to increase bexmarilimab’s attractiveness for a potential commercial partnership with biopharmaceutical companies on a global basis.

• Juho Jalkanen, CEO and co-founder of Faron said: “We have now reached an important milestone with bexmarilimab, achieving deep and durable responses as well as favorable safety profile in HR MDS where lack of new treatments has prevailed. We remain convinced that bexmarilimab has potential to become the next standard of care in HR MDS and possible other indications, and we are confident that our clinical development plan is well designed to address the needs of patients with high unmet medical need.”

Extraordinary General Meeting

Faron intends to raise approximately EUR 40 million in equity capital, which is expected to fund the Phase II portion of the Phase II/III trial agreed with the FDA testing bexmarilimab + azacitidine against placebo + azacitidine in frontline HR MDS, along with several investigator‑initiated combination trials across multiple cancers. The remainder of the funds would support working capital needs and general corporate purposes for the Company.

The Offering is subject to an authorization by shareholders at the Extraordinary General Meeting (EGM) and a resolution by the Board of Directors of Faron Pharmaceuticals Ltd.

Faron seeks an authorization for the Offering in the EGM of Faron Pharmaceuticals Ltd, which is to be held on 2 March 2026. Preliminarily and depending on the market conditions, the subscription period for the Offering is currently expected to commence and end during the first quarter of 2026. The meeting documents will be made available at the following link: https://faron.com/investors/governance/general-meeting/

The Company may carry out an additional offering by way of a directed share issue to allocate shares to potential non-shareholder investors based on previous authorization granted by the Company’s last general meeting.

Background – bexmarilimab emerging as potential next standard of care in HR MDS

Faron’s lead asset bexmarilimab is an investigational immunotherapy designed to overcome resistance to existing cancer treatments by harnessing the power of immune cells and igniting the immune system.

The mechanism of action of bexmarilimab consists of reprogramming immune cells called macrophages, which are a key source of treatment resistance to cancer, helping tumor cells evade the immune system. This mechanism of action triggers the immune system to attack tumors and sensitizes cancer cells to chemotherapies as well as other classical cancer drugs.

Based on the strength of data already generated with bexmarilimab, Faron has been granted Orphan Drug Designation and Fast Track Designation for the treatment of the difficult-to-treat blood cancer called high-risk myelodysplastic syndrome (HR MDS) by the FDA, as well as Orphan Drug Designation by the European Medicines Agency (EMA).

The updated Phase I/II BEXMAB study data presented at the American Society of Hematology (ASH) 2025 Annual Meeting in December 2025 highlighted significant improvement in survival outcomes in patients with HR MDS treated with bexmarilimab in combination with standard-of-care azacitidine, suggesting the combination could effectively bridge to a potentially curative therapy in this otherwise deadly cancer:

Deep and durable complete remissions (CRs), reaching 70% in most difficult to treat patients bearing a genetic mutation called TP53 mutants;

Durable effect in patients with complete remissions, with a median of 12.1 months for all and 10.2 months for TP53 mutants and both continuing to increase as follow-up mature;

Deep eradication of cancer cells with 67% of CR patients with no residual disease (MRD);

Meaningful reduction of blood transfusions, with 57% of frontline patients that were transfusion dependent becoming transfusion independent; and

Meaningful survival benefit in patients with resistant or refractory HR MDS, last line survival improvement to 14.5 months compared to 5-6 months, historically.

Sole Global Coordinator and Bookrunner

Faron has appointed Stifel Europe Securities SAS as Sole Global Coordinator and Bookrunner of the Offering.

Webcast

Faron will host a virtual Business Update on Wednesday, 11 February 2026 at 3pm EET / 2pm CET / 8am ET. During the event, Faron’s Chief Executive Officer, Dr. Juho Jalkanen, will provide an update on the Company’s development plans and the rationale behind the planned Offering.

Webcast registration link: https://faron.videosync.fi/business-update-02-2026

About bexmarilimab

Caution regarding forward-looking statements