LONDON (ShareCast) - (Sharecast News) - Faron Pharmaceuticals reported a series of first-half clinical and financial milestones on Wednesday, as it advanced its lead asset, bexmarilimab, through late-stage development in high-risk myelodysplastic syndromes (HR-MDS).
The AIM-traded company confirmed plans to move into a single phase two and three registrational trial following positive phase two results and regulatory feedback.

For the six months ended 30 June, Faron posted an operating loss of €11.9m, narrowing from €14.4m a year earlier, while research and development expenses rose slightly to €7.1m from €6.7m.

Cash and cash equivalents stood at €13.5m at period end, compared with €30m a year earlier, after the company completed a €12m share placing and the first €15m tranche of a €35m convertible bond arrangement with Heights Capital Management.

Faron said the financing extended its cash runway into the first quarter of 2026.

Chief executive Dr Juho Jalkanen said he was "extremely proud of our people and what we have accomplished in the first half of 2025," highlighting the "fully enrolled BEXMAB phase two study, very strong phase two efficacy data for bexmarilimab," multiple regulatory designations and a strengthened balance sheet.

Clinical data presented at major oncology conferences during the period showed a complete remission rate of 43% in treatment-naïve HR-MDS patients, up from 28% in earlier analyses, and a median overall survival of 13.4 months in relapsed or refractory patients, compared with the 5-6 months typically expected under standard care.

"These results, especially the new frontline MDS patient data, suggest a potential to transform the treatment paradigm for the entire disease," Jalkanen said.

In August, the US Food and Drug Administration confirmed that a single registrational trial could support an application for accelerated approval in HR-MDS, with complete remission and overall survival as co-primary endpoints.

Jalkanen said the feedback "makes the entire HR-MDS market accessible for Faron at one go."

Faron also advanced its solid tumour research, with studies suggesting bexmarilimab can stimulate responses in immunologically cold tumours and inhibit inflammation in treatment-resistant cancers.

The company said it had begun preparations for additional trials, including metastatic lung cancer, melanoma and breast cancer.

Jalkanen said the second half of 2025 would mark a shift toward commercial planning as the company prepared for the pivotal trial.

"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," he said.

At 0809 BST, shares in Faron Pharmaceuticals were down 3.37% at 215p.

Reporting by Josh White for Sharecast.com.

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