On March 26, 2024 Mural Oncology plc (Nasdaq: MURA), a clinical-stage immuno-oncology company developing novel, investigational engineered cytokine therapies designed to address areas of unmet need for patients with a variety of cancers, reported its financial results for the fourth quarter and year ended December 31, 2023, and provided a business update (Press release, Mural Oncology, MAR 26, 2024, View Source [SID1234641450]).

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"We have made significant progress since becoming an independent company during the fourth quarter of 2023. We have amplified the company’s strong talent by bringing in world-class leaders in immuno-oncology. To date, nemvaleukin has generated promising data with durable responses both in monotherapy and in PD-1 combination across a range of solid tumor types. We expect our current cash reserves to fund our operations, including multiple clinical development programs, into 4Q 2025 and we are selectively exploring partnerships to further investigate the significant potential of both nemvaleukin and our preclinical programs," said Caroline Loew, Ph.D., Chief Executive Officer of Mural Oncology. "This year, we plan to continue to advance our late-stage clinical trials, including evaluating less frequent IV dosing for nemvaleukin. We also look forward to presenting pre-clinical data from our IL-18 and IL-12 programs at multiple oncology conferences and nominating candidates for each this year."

Recent Corporate Highlights and Upcoming Milestones

Mural Oncology spun out of Alkermes and became an independent, publicly traded immuno-oncology company in November 2023. Now led by an experienced and highly accomplished oncology-focused leadership team and board of directors, the company is leveraging its core competencies in immune cell modulation and protein engineering to develop a portfolio of investigational cytokine therapies designed to address areas of unmet need for patients with solid tumors.

Mural Oncology has completed evaluation of the less frequent IV (LFIV) dosing regimen of nemvaleukin in ARTISTRY-3, and determined the recommended phase 2 dose selection to be 30 µg/kg, to be evaluated in cohort 3 of ARTISTRY-6:

The new dosing regimen, a shift from five daily infusions (days 1-5) per three-week cycle to two infusions (on days 1 and 8) per three-week cycle, did not result in additional observed tolerability issues compared to previous studies of nemvaleukin. Notably, there were no dose-limiting toxicities at any dose tested and the desired pharmacodynamic effects were seen with twice per cycle dosing.
The company plans to evaluate the LFIV nemvaleukin dosing regimen in the open-label cohort 3 of ARTISTRY-6, the company’s ongoing phase 2 trial, to explore the safety and efficacy of this new dosing regimen in a homogeneous patient population.
The company looks forward to presenting data from ARTISTRY-3 at an upcoming medical conference.
Enrollment in ARTISTRY-6 and ARTISTRY-7 is ongoing:

Cohort 2 of ARTISTRY-6 is a potentially registrational, phase 2 trial evaluating nemvaleukin as a monotherapy in 90 mucosal melanoma patients. The company expects to report top-line data results from cohort 2 of ARTISTRY-6 in the first half of 2025.
Cohort 3 of ARTISTRY-6 is an open label extension of the trial that will evaluate the recommended phase 2 LFIV dosing regimen from ARTISTRY-3 as a monotherapy and in combination with pembrolizumab in approximately 50 patients with cutaneous melanoma. The company expects to report top-line data for monotherapy from cohort 3 of ARTISTRY-6 in the first half of 2025 and for the pembrolizumab combination in the second half of 2025.
ARTISTRY-7 is a potentially registrational, phase 3 trial evaluating nemvaleukin in combination with pembrolizumab compared to investigators’ choice chemotherapy in 448 patients with platinum-resistant ovarian cancer. Mural expects to report interim overall survival (OS) results based on approximately 75% of events in the first quarter of 2025 and final OS results in the second quarter of 2026.

Mural Oncology will present preclinical IL-18 and IL-12 data for the first time at the upcoming AACR (Free AACR Whitepaper) conference.

The company intends to nominate development candidates for these engineered IL-18 and IL-12 therapies later this year.
Financial Results for the Quarter Ended December 31, 2023

Cash Position: As of December 31, 2023, cash and cash equivalents were $270.9 million.

R&D Expenses: Research and development expenses were $42.2 million for the fourth quarter of 2023 and were primarily due to employee-related expenses and expenses related to ARTISTRY-7. These expenses included $5.6 million of non-cash, share-based compensation expenses.

G&A Expenses: General and administrative expenses were $16.3 million for the fourth quarter of 2023, including $9.7 million in non-cash, share-based compensation expenses.

Net Loss: Net loss was $59.5 million for the fourth quarter of 2023. This included $15.2 million non-cash, share-based compensation, of which approximately $11.7 million was driven by one-time charges related to the separation from Alkermes and conversion of employee equity during the fourth quarter of 2023.
Financial Guidance

The company’s cash resources are expected to fund its operations into the fourth quarter 2025.
After the spin out from Alkermes on November 15, 2023, the company incurred certain non-cash, share-based compensation, most of which was one-time in nature, and this is reflected in today’s reported results. Furthermore, the company’s 2023 financial results reflect carve-out financials until the date of the spin out. The company anticipates reporting lower operating expenses in the quarters going forward.
About Nemvaleukin
Nemvaleukin is a novel, engineered cytokine designed to leverage antitumor effects of the IL-2 pathway while mitigating its hallmark toxicities that limit its use. Nemvaleukin selectively binds to the intermediate-affinity IL-2 receptor (IL-2R) and is sterically occluded from binding to the high-affinity IL-2R. Because of this molecular design, nemvaleukin treatment leads to preferential expansion of antitumor CD8+ T cells and natural killer cells, with minimal expansion of immunosuppressive regulatory T cells. Nemvaleukin is currently being evaluated in two potentially registrational late-stage trials.