Faron Pharmaceuticals (FARN) H1 2024 earnings summary

Executive summary

• Raised €35.5 million in H1 2024, significantly strengthening the financial position and supporting operations into Q1 2025.

• Achieved outstanding Phase II clinical results for bexmarilimab in relapsed/refractory MDS, with a 79% objective response rate and median survival of 13.4 months, surpassing historical options.

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

• Leadership changes included new CEO, CFO, CMO, and Chair, alongside operational restructuring and cost reductions.

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

Financial highlights

• Cash and cash equivalents at June 30, 2024: €30.3 million, up from €6.3 million a year earlier.

• Operating loss for H1 2024: €11.3 million, reduced from €12.8 million in H1 2023.

• Net assets improved to €1.4 million at June 30, 2024, from negative €9.5 million a year earlier.

• No revenue generated in H1 2024 or prior periods.

• 104.6 million shares outstanding as of June 30, 2024.

Outlook and guidance

• BEXMAB MDS recruitment expected to complete in Q4 2024, with major data releases planned at ASH (Dec 2024) and EHA/ASCO (June 2025).

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

• 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.

• Preparations underway for first bexmarilimab-PD1 inhibitor combination trial in solid tumors.