Philogen (PHIL) H1 2024 earnings summary

Executive summary

• Announced a global commercialization agreement with Sun Pharma for Nidlegy™ and Fibromun, expanding previous regional deals and granting worldwide rights with a 45/55 post-commercialization economic split.

• Pipeline progress includes promising clinical results for Nidlegy™ in melanoma and non-melanoma skin cancers, and for Fibromun in soft tissue sarcoma and glioblastoma, with late-stage trials advancing and a marketing application for Nidlegy™ submitted to EMA in June 2024.

• Chemistry pipeline advances highlighted, especially with the OncoACP3 ligand for prostate cancer, showing superior targeting and imaging compared to current PSMA ligands.

• The company operates two GMP-certified facilities in Siena and a research center in Zurich, supporting clinical and commercial production.

• Transitioning from a research-focused to a product-focused company, with revised management structure and executive roles.

Financial highlights

• Revenues for H1 2024 were €1.71 million, down over 90% year-over-year, mainly due to the absence of milestone payments recorded in H1 2023.

• Operating expenses rose 22% year-over-year to €16.96 million, reflecting accelerated clinical trials, manufacturing expansion, and workforce growth.

• EBITDA was negative €15.25 million and net loss reached €15.52 million for H1 2024.

• Liquidity at end of June 2024 was €64.6 million, with a positive net cash position of €50.7 million after lease allocations.

• Management expects financials to improve significantly by year-end, driven by new deals and ongoing activities.

Outlook and guidance

• EMA review of Nidlegy™ for melanoma expected to complete by mid-2025, with the first round of questions scheduled for October 2024; U.S. Phase III trial ongoing with 104/186 patients enrolled.

• Plans to launch pivotal Phase III trials for Nidlegy™ in 3rd line LaBCC and 2nd line LacSCC in 2025, each with fewer than 100 patients.

• Fibromun registration trials in glioblastoma and soft tissue sarcoma are progressing, with full enrollment in key studies and anticipated readouts between December 2024 and April 2025.

• First patient enrollment for three new clinical trials expected by year-end 2024.

• Continued investment in expanding GMP capacity and further clinical and regulatory milestones expected in 2024-2025.