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About Mural Oncology PLC
Mural Oncology PLC (Nasdaq: MURA) is a clinical-stage biotechnology company dedicated to developing innovative immuno-oncology therapies to address critical unmet needs in cancer treatment. By leveraging its proprietary expertise in immune cell modulation and protein engineering, Mural Oncology is pioneering a new wave of cytokine-based immunotherapies designed to deliver meaningful clinical benefits for patients with difficult-to-treat cancers.
Core Focus and Expertise
The company’s mission centers on harnessing the therapeutic potential of cytokines—key signaling proteins in the immune system—while overcoming the limitations traditionally associated with these molecules, such as toxicity and short half-life. Mural’s unique approach involves advanced protein engineering to create novel therapies that selectively activate immune responses against tumors, while minimizing adverse effects.
Pipeline and Key Programs
Mural Oncology’s lead product candidate, nemvaleukin alfa, is an engineered interleukin-2 (IL-2) cytokine designed to amplify the antitumor effects of IL-2 while mitigating its hallmark toxicities. Nemvaleukin selectively targets the intermediate-affinity IL-2 receptor, promoting the expansion of CD8+ T cells and natural killer (NK) cells, which are critical for antitumor immunity, while minimizing the activation of immunosuppressive regulatory T cells (Tregs). Nemvaleukin is currently being evaluated in two potentially registrational trials:
- ARTISTRY-7: A Phase 3 trial investigating nemvaleukin in combination with pembrolizumab for platinum-resistant ovarian cancer (PROC), a condition with limited treatment options and poor outcomes.
- ARTISTRY-6: A Phase 2 trial assessing nemvaleukin as a monotherapy for mucosal melanoma, a rare and aggressive cancer subtype.
Beyond nemvaleukin, Mural Oncology is advancing two preclinical programs targeting interleukin-18 (IL-18) and interleukin-12 (IL-12). These programs aim to address the inherent challenges of native cytokines, such as short half-life and toxicity, through innovative protein engineering:
- IL-18 Program: Mural’s IL-18 candidate, MURA-8518, is a binding protein-resistant, half-life-extended cytokine designed to sustain immune activation and overcome the neutralizing effects of IL-18 binding proteins.
- IL-12 Program: MURA-7012 employs a split-subunit approach to deliver IL-12 directly to the tumor microenvironment, reducing systemic exposure and associated toxicities.
Strategic Positioning and Market Impact
Mural Oncology operates within the highly competitive immuno-oncology landscape, which includes both established pharmaceutical companies and emerging biotech firms. The company’s differentiation lies in its proprietary protein engineering platform and its strategic focus on cytokine-based therapies. By addressing the limitations of earlier cytokine treatments, Mural aims to unlock the full therapeutic potential of these molecules, positioning itself as a key player in the next wave of immuno-oncology advancements.
Commitment to Patients and Innovation
With its headquarters in Dublin, Ireland, and primary facilities in Waltham, Massachusetts, Mural Oncology is driven by a mission to improve the lives of cancer patients through scientific innovation and clinical excellence. The company’s robust pipeline and focus on addressing high unmet medical needs underscore its commitment to advancing the field of immuno-oncology.
Mural Oncology plc (Nasdaq: MURA) is hosting a virtual Investor Day to highlight progress in its late-stage clinical trials. Key data readouts for nemvaleukin are expected in late Q1/early Q2 2025 for platinum-resistant ovarian cancer and Q2 2025 for mucosal melanoma. The company will provide new insights into trial design and statistical assumptions for ARTISTRY-7 and ARTISTRY-6 studies.
ARTISTRY-7, a phase 3 trial for platinum-resistant ovarian cancer, has completed enrollment with 456 patients. The study's interim analysis is estimated to occur by late Q4 2024 or early Q1 2025, with data readout expected in late Q1 or early Q2 2025.
ARTISTRY-6, cohort 2, a potentially registrational study for mucosal melanoma, has completed enrollment with 92 patients. Top-line readout is anticipated in Q2 2025.
Mural also plans to submit an IND for its IL-18 program in Q4 2025.
Mural Oncology plc (Nasdaq: MURA) has announced the appointment of Sachiyo Minegishi to its board of directors, effective September 20, 2024. Minegishi will serve as Chair of the Audit Committee and join the Nominating and Corporate Governance Committee. With over 20 years of industry experience, she brings expertise in corporate strategy, finance, development, and commercialization.
Currently the Chief Operating Officer at Rectify Pharmaceuticals, Minegishi has previously held leadership roles at Akouos, bluebird bio, Human Genome Sciences, Genzyme, and Amgen. Her appointment comes as Mural Oncology prepares for key milestones, including candidate nominations for IL-18 and IL-12 programs this year and readouts in two potentially registrational studies of nemvaleukin in the first half of 2025.
Mural Oncology plc (Nasdaq: MURA) has announced its first Virtual Investor Day, scheduled for September 26, 2024, at 10 a.m. ET. The event will provide clinical insights and updates on the company's late-stage candidate, nemvaleukin alfa, an engineered IL-2 therapy. Mural remains on track to deliver key data readouts from potentially registrational trials in platinum-resistant ovarian cancer and mucosal melanoma in 1H 2025.
The Investor Day will feature presentations from Mural's leadership, including CEO Caroline Loew and CMO Vicki Goodman, as well as expert clinicians. They will discuss the trial design, clinical proof of concept, and unmet needs in target cancer types. Additionally, Mural will provide an overview of its IL-18 pipeline program.
The event aims to showcase Mural's progress in developing novel, engineered cytokine therapies for various cancers. Interested parties can register for the webcast at ir.muraloncology.com/events-and-presentations.
Mural Oncology plc (Nasdaq: MURA), a clinical-stage immuno-oncology company, has granted stock options and restricted stock units to a newly hired employee. The company issued non-statutory stock options to purchase 21,500 ordinary shares and restricted stock units for 11,500 ordinary shares. These grants were made under Mural's 2024 Inducement Stock Option and Incentive Plan, in compliance with Nasdaq Listing Rule 5635(c)(4).
The stock options have an exercise price of $3.16 per share, equal to the closing price on September 3, 2024. They have a ten-year term and vest over four years, with 25% vesting after one year and 6.25% quarterly thereafter. The restricted stock units also vest over four years, with 25% vesting annually. Both grants are subject to continued employment and specific award agreements.
Mural Oncology plc (Nasdaq: MURA), a clinical-stage immuno-oncology company, has announced its participation in two upcoming investor conferences. The company, which develops novel engineered cytokine therapies for cancer patients, will be represented by key management team members at these events:
1. Morgan Stanley 22nd Annual Global Healthcare Conference on September 6 at 1:50 p.m. ET, featuring a fireside chat with CEO Caroline Loew, Ph.D., Chief Medical Officer Vicki Goodman, MD, and CFO Adam Cutler.
2. H.C. Wainwright 26th Annual Global Investment Conference on September 11 at 9:30 a.m. ET, where CEO Caroline Loew, Ph.D. will give a presentation.
Webcasts of both presentations will be available on the company's investor relations website. The management team will also be available for one-on-one meetings during these conferences.
Mural Oncology (Nasdaq: MURA) reported Q2 2024 financial results and provided a pipeline update. Key highlights include:
Financial Position: Cash, cash equivalents, and marketable securities stood at $204.7 million as of June 30, 2024. The company reaffirms its cash runway into Q4 2025.
Pipeline Progress: Mural is on track to report readouts from two late-stage clinical trials of its lead asset, nemvaleukin alfa, in 1H 2025. The company presented data on less frequent dosing of nemvaleukin at ASCO in June. Candidate nominations for IL-18 and IL-12 programs are expected later this year.
Financial Results: R&D expenses decreased to $27.5 million in Q2 2024 from $42.5 million in Q2 2023. G&A expenses increased to $6.7 million from $4.7 million. Net loss narrowed to $31.6 million from $50.2 million year-over-year.
Mural Oncology plc (Nasdaq: MURA), a clinical-stage immuno-oncology company, announced on August 2, 2024, that it granted stock options and restricted stock units to a newly hired employee on August 1. The grants include:
1. Non-statutory stock options to purchase 13,000 ordinary shares
2. Restricted stock units for 7,000 ordinary shares
These grants were made under the company's 2024 Inducement Stock Option and Incentive Plan, in accordance with Nasdaq Listing Rule 5635(c)(4). The stock options have an exercise price of $3.48 per share, equal to the closing price on August 1, 2024. They have a ten-year term and vest over four years. The restricted stock units also vest over four years, with 25% vesting annually.
Mural Oncology plc (Nasdaq: MURA) has appointed George Golumbeski, Ph.D., to its board of directors effective July 30, 2024. Dr. Golumbeski brings 30 years of leadership in business development, with extensive experience in strategic collaborations, M&A, licensing, and alliance management. He currently serves as a partner at DROIA Ventures and has held key positions at GRAIL, Celgene, Nabriva Therapeutics, Novartis Oncology, and Elan Biopharmaceuticals.
Mural Oncology, a clinical-stage immuno-oncology company, is developing engineered cytokine therapies for cancer treatment. The company has two potentially registrational studies reading out in the first half of 2025 and two preclinical programs approaching candidate nomination later this year. Dr. Golumbeski's appointment is expected to bring valuable expertise as Mural advances its current programs and explores potential partnerships.
Mural Oncology, a clinical-stage immuno-oncology company, announced on July 1, 2024, the granting of non-statutory stock options and restricted stock units under its 2024 Inducement Stock Option and Incentive Plan. The grants were made as inducements for four newly hired employees under Nasdaq Listing Rule 5635(c)(4). The stock options cover 15,470 ordinary shares at an exercise price of $3.11, with a ten-year term and a vesting schedule of four years. The restricted stock units cover 8,330 ordinary shares, also vesting over four years. Both grants are subject to the terms of respective award agreements and the company's 2024 Inducement Plan.
Mural Oncology (Nasdaq: MURA), a clinical-stage immuno-oncology company, announced that CEO Caroline Loew, Ph.D., will present at the 14th Annual East Coast IDEAS Investor Conference on June 13 at 9:15 a.m. EST.
The company focuses on developing engineered cytokine therapies to address unmet needs in cancer treatment. A webcast of the presentation will be available at www.threepartadvisors.com/east-coast and ir.muraloncology.com.
Mural will also host one-on-one investor meetings during the conference.