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(Sharecast News) - Clinical-stage biopharmaceutical company Faron Pharmaceuticals reported a year of strong progress on Wednesday, with significant overall response rates seen in both previously hypomethylating agent (HMA)-failed and higher-risk myelodysplastic syndrome (MDS) patient populations in the phase one part of the BEXMAB study.
The AIM-traded firm, which is pre-revenue, said most responses were deep and durable, with notable achievements such as complete remission/marrow complete remission (CR/mCR) and partial remission (PR) observed in treated patients.
It said the findings led to the start of the phase two part of the BEXMAB study, guided by the US Food and Drug Administration (FDA), investigating bexmarilimab in combination with standard of care (SoC) in patients with HMA-refractory or relapsed MDS.
Additionally, the FDA granted bexmarilimab orphan drug designation (ODD) for the treatment of acute myeloid leukaemia (AML).
The company also reported that the MATINS study demonstrated promising results in advanced solid tumour patients, with bexmarilimab showing tolerability, activation of intratumoral immunity, and favourable changes in the tumour microenvironment (TME), providing significant clinical benefit.
Throughout 2023, Faron successfully conducted three fundraising rounds, raising €25.7m.
Since the end of the year, in January, Faron dosed the first patients in the phase two part of the BEXMAB Study, marking progress towards evaluating the safety and efficacy of bexmarilimab in combination with SoC in HMA-refractory or relapsed MDS patients.
However, in February, the company disclosed breaches in undertakings agreed in a facilities agreement, leading to several events of default.
Despite that, Faron said it managed to secure €3.2m in subordinated convertible loan arrangements in March, allowing critical payments to third parties under agreed waivers with IPF.
The company said it was now in compliance with all IPF financial covenants, actively engaged in 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," said chief executive officer Dr Markku Jalkanen.
"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."
Dr Jalkanen described the findings as "highly significant", given the combinations of treatments the 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 haematological malignancies."
At 1012 GMT, Faron Pharmaceuticals shares were down 3.67% at 130.05p.
Reporting by Josh White for Sharecast.com.
