Faron Pharmaceuticals (FARN) H1 2024 earnings summary

Executive summary

• H1 2024 marked a transformational period with record fundraising, leadership changes, and strong clinical progress in the BEXMAB trial for bexmarilimab in relapsed/refractory and HMA-failed MDS, including an ORR of 79% and a true remission rate of 64%.

• Achieved FDA Fast Track designation and positive feedback for bexmarilimab, supporting an accelerated development path.

• Recruitment for phase II trials is progressing well, with completion expected by end of 2024.

• Leadership changes included a new CEO, Chair, CMO, and permanent CFO.

• Cash position was significantly strengthened through €35.5 million raised via convertible loans and share placements.

Financial highlights

• Ended June 2024 with €30 million in cash and cash equivalents, sufficient to fund operations into Q1 2025.

• Operating loss for H1 2024 was €11.3 million, slightly lower year-over-year.

• Net loss for H1 2024 was €14.4 million; loss per share €0.20.

• No revenue generated in H1 2024 or prior periods.

• Net assets at June 30, 2024: €1.4 million.

Outlook and guidance

• Focus remains on advancing bexmarilimab through phase II and preparing for phase III, with further data expected in H2 2024.

• R&D Day and updated guidance on bexmarilimab’s development plan scheduled for October 2024.

• Next major data releases expected at ASH in December and ASCO/EHA in June.

• Cash resources expected to support operations until end of Q1 2025; further financing or partnership required for phase III.

• Adjusting clinical development plan following FDA feedback to potentially accelerate approval timelines.