Waltham, MA and Dublin, Ireland, May 14, 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, today reported financial results for the first quarter ended March 31, 2024 and provided a business update.
"In the first quarter of 2024, we continued to make important progress advancing our lead product candidate, nemvaleukin, through potentially registrational clinical trials in mucosal melanoma and platinum-resistant ovarian cancer," said Caroline Loew, Chief Executive Officer of Mural Oncology. "We also continued to strengthen our organization and infrastructure as an independent, publicly traded company following our separation from Alkermes plc in November 2023."
Financial Results for the First Quarter Ended March 31, 2024
For the first quarter of 2024, Mural Oncology reported a net loss of $30.9 million, compared to a net loss of $46.5 million for the same period in 2023. The decrease in net loss was primarily due to lower research and development (R&D) expenses, partially offset by higher general and administrative (G&A) expenses.
R&D expenses for the first quarter of 2024 were $26.9 million, compared to $40.4 million for the same period in 2023. The decrease in R&D expenses was primarily due to decreased headcount compared to the headcount allocated to the company by Alkermes prior to the separation, decreased spend on the ARTISTRY-1 and ARTISTRY-2 trials as activities related to those trials wound down in 2023, and decreased manufacturing spend on other programs. These decreases were partially offset by increased spend on the ARTISTRY-7 trial related to increased enrollment and associated clinical trial expenses.
G&A expenses for the first quarter of 2024 were $7.2 million, compared to $3.7 million for the same period in 2023. The increase in G&A expenses was primarily due to increases in employee-related expenses and professional fees associated with operating as a standalone public company after the separation.
Other income for the first quarter of 2024 was $3.1 million, compared to $0 for the same period in 2023. The other income in the first quarter of 2024 was primarily due to interest income from interest-bearing cash accounts and money market mutual funds and from marketable securities.
As of March 31, 2024, Mural Oncology had cash, cash equivalents and marketable securities of $231.7 million.
Business Highlights and Upcoming Milestones
Nemvaleukin (IL-2 Cytokine Program)
- Continued enrollment in the ARTISTRY-6 trial, which is evaluating nemvaleukin as a monotherapy in patients with mucosal melanoma (Cohort 2) and in combination with pembrolizumab in patients with cutaneous melanoma (Cohorts 3 and 4). The company expects to report topline results from Cohort 2 in the first half of 2025 and from Cohorts 3 and 4 in the second half of 2025.
- Continued enrollment in the ARTISTRY-7 trial, which is evaluating nemvaleukin in combination with pembrolizumab in patients with platinum-resistant ovarian cancer (PROC). The company expects to report topline overall survival results for the interim analysis from this trial in the first quarter of 2025, subject to reaching the required number of events for the analysis.
- Continued enrollment in the ARTISTRY-3 trial, a Phase 1/2 open-label study of intravenous nemvaleukin in patients with advanced solid tumors after treatment failure or intolerance to one to three prior FDA-approved targeted therapies.
IL-18 and IL-12 Programs
- Continued discovery-phase activities for the company's IL-18 and IL-12 programs, with plans to nominate product candidates in each program in 2024.
Corporate Updates
- In January 2024, the company entered into a $1.7 million collateralized letter of credit that secures the obligations under the Winter Street Lease, which was assumed by the company in connection with the separation from Alkermes.
- In the first quarter of 2024, the company's Chief Financial Officer, Adam Cutler, and Chief Executive Officer, Caroline Loew, each entered into a Rule 10b5-1 trading arrangement that is intended to qualify as an "eligible sell-to-cover transaction" for restricted stock units granted to them.
Financial Guidance
Mural Oncology believes that its existing cash, cash equivalents and marketable securities will be sufficient to fund its current operating plan into the fourth quarter of 2025.Business Overview
Mural Oncology is a clinical-stage immuno-oncology company focused on discovering and developing novel, investigational engineered cytokine therapies designed to address areas of unmet need for patients with a variety of cancers. The company's lead product candidate, nemvaleukin, is an investigational, engineered interleukin-2 (IL-2) cytokine designed to capture and expand the therapeutic benefits of high-dose recombinant human IL-2, while mitigating its hallmark toxicities.In the company's clinical proof of concept study, nemvaleukin generated durable responses as a single agent and in combination with pembrolizumab across a range of tumor types. Nemvaleukin is currently in two potentially registrational studies, the ARTISTRY-6 (Cohort 2) trial for the treatment of mucosal melanoma as a monotherapy and the ARTISTRY-7 trial for the treatment of platinum-resistant ovarian cancer (PROC) in combination with pembrolizumab.
In addition to nemvaleukin, Mural Oncology is also developing engineered therapies targeting the interleukin-18 (IL-18) and interleukin-12 (IL-12) pathways, which have demonstrated therapeutic potential in third-party preclinical and clinical studies. The company is currently conducting discovery-phase activities for its IL-18 and IL-12 programs, and plans to nominate product candidates in each program in 2024.
Mural Oncology was established as a standalone public company in November 2023 through the separation of Alkermes plc's oncology business. The company has its registered office in Dublin, Ireland, and its primary facilities in Waltham, Massachusetts.
Financial Position and Liquidity
As of March 31, 2024, Mural Oncology had cash, cash equivalents and marketable securities of $231.7 million. The company believes that its existing cash, cash equivalents and marketable securities will be sufficient to fund its current operating plan into the fourth quarter of 2025.For the first quarter of 2024, the company reported a net loss of $30.9 million, compared to a net loss of $46.5 million for the same period in 2023. The decrease in net loss was primarily due to lower R&D expenses, partially offset by higher G&A expenses.
R&D expenses for the first quarter of 2024 were $26.9 million, compared to $40.4 million for the same period in 2023. The decrease in R&D expenses was primarily due to decreased headcount compared to the headcount allocated to the company by Alkermes prior to the separation, decreased spend on the ARTISTRY-1 and ARTISTRY-2 trials as activities related to those trials wound down in 2023, and decreased manufacturing spend on other programs. These decreases were partially offset by increased spend on the ARTISTRY-7 trial related to increased enrollment and associated clinical trial expenses.
G&A expenses for the first quarter of 2024 were $7.2 million, compared to $3.7 million for the same period in 2023. The increase in G&A expenses was primarily due to increases in employee-related expenses and professional fees associated with operating as a standalone public company after the separation.
Other income for the first quarter of 2024 was $3.1 million, compared to $0 for the same period in 2023. The other income in the first quarter of 2024 was primarily due to interest income from interest-bearing cash accounts and money market mutual funds and from marketable securities.
For the full year 2023, Mural Oncology reported a net loss of $207.4 million, no revenue, an operating cash flow of -$194.2 million, and a free cash flow of -$197.7 million.
Risks and Uncertainties
Mural Oncology's business is subject to a number of risks and uncertainties, including:- The company's limited operating history as a standalone public company, which makes it challenging to value the business and predict its prospects.
- The company's history of significant losses and its expectation that it will continue to incur significant losses for the foreseeable future.
- The company's need to raise additional funding to advance its product candidates, which may not be available on acceptable terms or at all.
- The risks and uncertainties associated with the development, regulatory approval, and commercialization of the company's product candidates.
- The company's reliance on third parties to conduct certain aspects of its preclinical studies and clinical trials, as well as to manufacture and supply its product candidates.
- The company's ability to attract and retain key personnel, which could be materially harmed if the company is unable to do so.
- The potential for the Separation from Alkermes to disrupt the company's relationships with its strategic business partners.
- The tax-related risks associated with the Separation, including the company's potential obligation to indemnify Alkermes for certain tax liabilities.
- The company's status as an emerging growth company and a smaller reporting company, which may make its ordinary shares less attractive to investors.
- The volatility of the company's share price and the potential for it to decline.