Faron Pharmaceuticals Limited (AIM:FARN), the AIM-quoted Finnish cancer immunotherapy developer, expects to start its randomised phase IIb BEXERA trial in the second half of this year, funded by a rights issue completed in April.
The trial is the company's most important value driver and will test lead drug bexmarilimab in previously untreated patients with higher-risk myelodysplastic syndrome (MDS), a bone marrow disorder in which blood cells fail to develop properly and which frequently progresses to acute myeloid leukaemia.
BEXERA will enrol 90 patients across up to 35 sites in the United States, Europe and the United Kingdom.
It is designed to select a dose for a future phase III study and to show the efficacy and safety of bexmarilimab combined with standard-of-care chemotherapy drug azacitidine, in support of eventual regulatory filings.
Faron appointed Parexel, a global clinical research organisation, in April to run the trial.
The company said the field was drawing increased competition, but argued most rival approaches rest on treatment methods that have previously failed.
Bexmarilimab targets Clever-1, a receptor on immune cells called macrophages that tumours exploit to evade attack, with the aim of switching those cells back into an anti-tumour state.
Matured data from the earlier BEXMAB study, presented at the European Hematology Association congress in June, showed median duration of complete remission in treatment-naïve higher-risk MDS patients extended to 16.1 months.
In July, Faron reported its first overall survival readout from that trial, in which patients carrying biallelic TP53 mutations, a group historically associated with very poor outcomes, achieved median survival of 8.8 months.
Turning to the financials, Faron raised €40.1 million in a rights issue in April, one of the largest biotechnology fundraisings ever completed in Finland.
Cash and cash equivalents stood at €32 million at 30 June, against €13.5 million a year earlier.
Net assets were €11.6 million, compared with negative €16.7 million at the same point last year. The operating loss for the six months narrowed slightly to €11.1 million from €11.8 million.
Research and development spending rose to €7.6 million from €7.1 million, while administrative costs fell to €3.5 million from €4.7 million.
The loss per share was €0.06, against €0.18, reflecting a near doubling of the share count following the fundraising.
Chief executive Juho Jalkanen said the first half was demanding but that the company was better positioned than ever to advance bexmarilimab.
