UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
Current Report Pursuant to
Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported):
(Exact name of Registrant as Specified in Its Charter)
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instructions A.2. below):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 2.02. Results of Operations and Financial Condition.
On May 14, 2024, Mural Oncology plc (the "Company") issued a press release announcing the Company’s financial results for the three months ended March 31, 2024. A copy of the press release is furnished herewith as Exhibit 99.1 and is incorporated herein by reference.
The information in this Form 8-K, including Exhibit 99.1, attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits
Exhibit |
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Description |
99.1 |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Mural Oncology plc |
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Dated: May 14, 2024 |
By: |
/s/ Adam Cutler |
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Name: |
Adam Cutler |
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Title: |
Chief Financial Officer |
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Exhibit 99.1 |
Mural Oncology Announces First Quarter 2024 Financial Results and Provides Business Update
Mural’s lead product candidate, nemvaleukin alfa, is in two potentially registrational trials in platinum resistant ovarian cancer and mucosal melanoma, both of which are on track with readouts expected in 1H 2025
A new, less frequent IV dose of nemvaleukin is also being evaluated both as a single agent and in combination with pembrolizumab in patients with cutaneous melanoma with preliminary data readouts anticipated in 2025
In April 2024, Mural presented preclinical data on its investigational engineered cytokine therapies targeting IL-18 and IL-12 and continues to expect candidate nominations for each program by the end of 2024
The company reiterates cash runway projection into 4Q 2025, with sufficient capital to fund key clinical readouts
WALTHAM, Mass and DUBLIN – 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 announced financial results for the first quarter of 2024 and provided a business update.
“We remain on track to share data readouts in the first half of next year from our two late-stage, potentially registrational studies of nemvaleukin. We are also excited about the potential of our less frequent dosing regimen of nemvaleukin that we are evaluating in a clinical trial as announced in March,” said Caroline Loew, Ph.D., CEO of Mural Oncology. “As we look to further strengthen our pipeline, we have made progress with our preclinical programs for interleukin-18 (IL-18) and IL-12. Both are targets that have generated a great deal of interest in the immuno-oncology space, and we are diligently working to make candidate nominations for each program. We continue to be well capitalized to achieve our key clinical readouts and are laser-focused on the delivery of our goals.”
Recent Corporate Highlights and Upcoming Milestones
Financial Results for the Quarter Ended March 31, 2024
Financial Guidance
About Nemvaleukin
Nemvaleukin alfa (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.
About Mural Oncology’s IL-18 Program
IL-18 is a potent immune-stimulating cytokine, but its efficacy is blunted by IL-18 binding protein (IL-18BP), a high affinity decoy receptor that binds to, and neutralizes, IL-18, thereby rendering it ineffective. Native IL-18’s potency is also limited by its short half-life. Mural Oncology’s novel approach to protein engineering is designed to mitigate these issues. First, Mural introduced mutations to IL-18 that eliminate binding to IL-18BP while minimally impacting the native IL-18 structure. Second, it fused IL-18 to protein scaffolds which extend the half-life and increase IL-18’s exposure. Together, these have demonstrated more durable immunological effect in preclinical studies. Mural intends to nominate a development candidate for its IL-18 program by the end of this year.
About Mural Oncology’s IL-12 Program
Native IL-12 is a highly potent pro-inflammatory cytokine, but because of its very narrow therapeutic index, it can also be toxic with systemic exposure. To mitigate this hallmark toxicity, Mural, through its novel approach to protein engineering, split the IL-12p70 heterodimer into two inactive monomers: IL12p35 and IL-12p40. These individual subunits are then separately fused to antibody fragments and sequentially injected, which deliver and concentrate IL-12 specifically
in the tumor microenvironment to limit systemic exposure. In preclinical studies, Mural’s engineered IL-12 achieved the desired reduction in serum while maintaining tumor concentrations providing the potential to reduce systemic toxicities. Mural intends to nominate a development candidate for its IL-12 program by the end of this year.
About Mural Oncology
Mural Oncology is leveraging its novel protein engineering platform to develop cytokine-based immunotherapies for the treatment of cancer. By combining our expertise in cytokine biology and immune cell modulation and our protein engineering platform, we are developing medicines to deliver meaningful and clinical benefits to people living with cancer. Our mission is to broaden the potential, and reach, of cytokine-based immunotherapies to improve the lives of patients. Our lead candidate, nemvaleukin, is currently in potentially registrational trials in mucosal melanoma and platinum-resistant ovarian cancer. Mural Oncology has its registered office in Dublin, Ireland, and its primary facilities in Waltham, Mass. For more information, visit Mural Oncology’s website at www.muraloncology.com and follow us on LinkedIn and X.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: the company’s pipeline and development programs, including the expected timing of clinical updates and candidate selection, the potential of the company’s product candidates and programs to address unmet medical needs, the continued progress of its pipeline and programs, the amount of operating expense to be incurred by the company in future periods and the sufficiency of its cash resources to fund its operations for the period anticipated. Any forward-looking statements in this statement are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include, among others, the inherent risks and uncertainties associated with competitive developments, preclinical development, clinical trials, recruitment of patients, product development activities and regulatory approval requirements; that preclinical or interim results and data from ongoing clinical studies of the company’s cytokine programs and product candidates may not be predictive of future or final results from such studies, results of future clinical studies or real-world results; future clinical trials or future stages of ongoing clinical trials may not be initiated or completed on time or at all; the company’s product candidates, including nemvaleukin, could be shown to be unsafe or ineffective; changes in the cost, scope and duration of development activities; the U.S. Food and Drug Administration may make adverse decisions regarding the company’s product candidates; the separation may adversely impact the company’s ability to attract or retain key personnel that support the company’s oncology business; and those other risks and uncertainties set forth in the company’s filings with the Securities and Exchange Commission (“SEC”), including its Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2024 and in subsequent filings the company may make with the SEC. All forward-looking statements contained in this press release speak only as of the date of this press release. The company anticipates that subsequent events and developments will cause its views to change. However, the company undertakes no obligation to update such statements to
reflect events that occur or circumstances that exist after the date of this press release, except as required by law.
Mural Oncology plc and Subsidiaries
Consolidated Balance Sheets
(in thousands)
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March 31, |
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December 31, |
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ASSETS |
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CURRENT ASSETS: |
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Cash and cash equivalents |
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$ |
107,263 |
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$ |
270,852 |
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Marketable securities |
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124,411 |
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— |
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Receivable from Former Parent |
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1,895 |
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5,548 |
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Prepaid expenses |
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5,239 |
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150 |
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Other current assets |
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620 |
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787 |
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Total current assets |
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239,428 |
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277,337 |
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Property and equipment, net |
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10,612 |
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11,403 |
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Right-of-use assets |
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11,418 |
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12,747 |
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Restricted cash |
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1,969 |
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258 |
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Other assets |
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77 |
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— |
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TOTAL ASSETS |
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$ |
263,504 |
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$ |
301,745 |
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LIABILITIES AND EQUITY |
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CURRENT LIABILITIES: |
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Accounts payable |
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$ |
1,567 |
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$ |
5,973 |
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Accrued expenses |
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13,524 |
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16,946 |
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Operating lease liabilities—short-term |
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6,156 |
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6,098 |
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Total current liabilities |
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21,247 |
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29,017 |
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Operating lease liabilities—long-term |
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7,330 |
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8,911 |
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Total liabilities |
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28,577 |
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37,928 |
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Preferred shares, nominal value $0.01; 50,000,000 shares authorized at |
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— |
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— |
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Ordinary shares, nominal value $0.01; 450,000,000 ordinary shares |
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169 |
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167 |
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Additional paid-in capital |
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296,606 |
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294,507 |
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Unrealized loss on marketable securities |
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(74 |
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— |
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Accumulated deficit |
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(61,774 |
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(30,857 |
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Total equity |
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234,927 |
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263,817 |
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TOTAL LIABILITIES AND EQUITY |
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$ |
263,504 |
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$ |
301,745 |
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Mural Oncology plc and Subsidiaries
Consolidated Statements of Operations and Comprehensive Loss
(in thousands except share and per share amounts)
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Three Months Ended March 31, |
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2024 |
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2023 |
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Operating expenses |
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Research and development |
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$ |
26,868 |
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$ |
40,410 |
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General and administrative |
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7,165 |
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3,746 |
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Total operating expenses |
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34,033 |
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44,156 |
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Operating loss |
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(34,033 |
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(44,156 |
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Other income |
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3,116 |
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— |
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Income tax provision |
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— |
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(2,311 |
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Net loss |
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$ |
(30,917 |
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$ |
(46,467 |
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Other comprehensive loss: |
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Unrealized loss on marketable securities |
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$ |
(74 |
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$ |
— |
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Other comprehensive loss |
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(74 |
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— |
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Comprehensive loss |
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$ |
(30,991 |
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$ |
(46,467 |
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Net loss per ordinary share - basic and diluted |
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$ |
(1.84 |
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$ |
(2.78 |
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Weighted average ordinary shares outstanding - basic and diluted |
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16,793,657 |
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16,689,740 |
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Investors:
David Borah, CFA
david.borah@muraloncology.com
781-614-0060
Media:
Katie Sullivan
katie.sullivan@muraloncology.com
781-614-0034