Mural Oncology Reports $128.5 Million Net Loss for 2024, Decreased R&D Expenses

Mural Oncology plc, a clinical-stage oncology company, reported a net loss of $128.5 million for the year ended December 31, 2024, compared to a net loss of $207.4 million in 2023. Research and development expenses decreased by $54.8 million to $110.7 million in 2024, primarily due to lower employee-related expenses and decreased spending on the ARTISTRY-1, ARTISTRY-2, and ARTISTRY-7 trials. General and administrative expenses also decreased by $3.1 million to $27.6 million, partially offset by increased costs associated with operating as a standalone company. Other income increased significantly to $9.7 million in 2024, primarily due to interest income from cash accounts and marketable securities.

Significant changes compared to the previous fiscal period include the company's separation from Alkermes plc on November 15, 2023, resulting in a $275 million cash contribution and the distribution of Mural Oncology plc shares to Alkermes shareholders. This separation led to a shift in the company's financial reporting from a combined basis with Alkermes to a standalone consolidated basis. The company's financial statements for periods prior to the separation were prepared on a standalone basis using Alkermes' historical accounting policies and expense allocations. These allocations may not reflect the actual expenses that would have been incurred had Mural operated independently.

Strategic developments included the nomination of product candidates MURA-8518 (IL-18 program) and MURA-7012 (IL-12 program) in 2024, with an anticipated IND application for MURA-8518 in the first half of 2026. The company is advancing nemvaleukin alfa through two potentially registrational trials: ARTISTRY-6 (Cohort 2) for mucosal melanoma and ARTISTRY-7 for platinum-resistant ovarian cancer. Interim overall survival results for ARTISTRY-7 are expected in the first or second quarter of 2025, and topline results for ARTISTRY-6 Cohort 2 in the second quarter of 2025. As of February 28, 2025, Mural Oncology plc had 116 full-time employees, approximately 33 of whom hold M.D. or Ph.D. degrees.

Key operational developments include the completion of enrollment in ARTISTRY-7 and Cohorts 1-3 of ARTISTRY-6. Cohort 4 of ARTISTRY-6 remains open for enrollment. The company is exploring alternative dosing regimens for nemvaleukin alfa, including subcutaneous and less frequent intravenous administration. The company's strategy focuses on advancing nemvaleukin alfa to commercialization, expanding its development into additional tumor types, and advancing its IL-18 and IL-12 programs. The company holds worldwide development and commercialization rights to its programs and product candidates.

The company's outlook includes reporting key clinical trial data in 2025, with potential BLA submissions to the FDA pending positive results. The company acknowledges substantial doubt about its ability to continue as a going concern due to recurring losses and the need for additional funding. The company's financial condition and future results may differ significantly from historical results due to the separation from Alkermes and the establishment of independent operations. The company also highlights numerous risks related to its financial position, product development, regulatory approvals, commercialization, intellectual property, and international operations.