8-K
0001971543false00019715432024-03-262024-03-26

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

Current Report Pursuant to

Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of Report (Date of Earliest Event Reported): March 26, 2024

Mural Oncology plc

(Exact name of Registrant as Specified in Its Charter)

_____________________________________________________________

Ireland

001-41837

98-1748617

(State or Other Jurisdiction
of Incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

10 Earlsfort Terrace

Dublin 2, D02 T380, Ireland

Not Applicable

(Address of Principal Executive Offices)

(Zip Code)

Registrant’s Telephone Number, Including Area Code: +353-1-905-8020

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

_____________________________________________________________

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):

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Ordinary Shares, nominal value $0.01

MURA

The Nasdaq Global Market

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 March 26, 2023, Mural Oncology plc (the "Company") issued a press release announcing the Company's financial results for the year ended December 31, 2023. 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
No.

Description

99.1

Press release issued by Mural Oncology plc on March 26, 2024.

104

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.

Mural Oncology plc

Dated: March 26, 2024

By:

/s/ Adam Cutler

 

Name:

Adam Cutler

Title:

Chief Financial Officer


EX-99.1

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Exhibit 99.1

 

 

 

Mural Oncology Announces Fourth Quarter and Year End 2023 Financial Results and Provides Business Update

 

Lead product candidate, nemvaleukin, is being developed to treat a wide range of solid tumors and is currently in two potentially registrational clinical trials with readouts for both expected in 1H 2025

 

Newly recommended phase 2 dose of nemvaleukin with increased dosage and less frequent dosing schedule to be explored in a cohort of ARTISTRY-6, the company’s ongoing phase 2 trial in patients with melanoma

 

Mural Oncology intends to nominate development candidates for its engineered therapies targeting interleukin-18 and interleukin-12 in 2024

 

The company reiterates cash runway projection into 4Q 2025

 

WALTHAM, Mass and DUBLIN – 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, today announced its financial results for the fourth quarter and year ended December 31, 2023, and provided a business update.

 

“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.

 

 

 

 


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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:
o
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.
o
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.
o
The company looks forward to presenting data from ARTISTRY-3 at an upcoming medical conference.

 

Enrollment in ARTISTRY-6 and ARTISTRY-7 is ongoing:

 

o
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.
o
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.
o
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 conference.
o
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.

 

 

 

 


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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.

 

 

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,

 

 

 


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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 general and administrative 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 Annual Report on Form 10-K for the fiscal year ended December 31, 2023 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 on which they were made. The company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

 

 

 

 

 

 


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Mural Oncology plc

Consolidated Balance Sheets

(in thousands)

 

 

 

December 31, 2023

 

 

December 31, 2022

 

ASSETS

 

 

 

 

 

 

CURRENT ASSETS:

 

 

 

 

 

 

Cash and cash equivalents

 

$

270,852

 

 

$

 

Receivable from Former Parent

 

 

5,548

 

 

 

 

Prepaid expenses

 

 

150

 

 

 

2,987

 

Other current assets

 

 

787

 

 

 

1,830

 

Total current assets

 

$

277,337

 

 

$

4,817

 

Property and equipment, net

 

 

11,403

 

 

 

10,617

 

Right-of-use assets

 

 

12,747

 

 

 

18,316

 

Restricted cash

 

 

258

 

 

 

 

TOTAL ASSETS

 

$

301,745

 

 

$

33,750

 

LIABILITIES AND EQUITY (DEFICIT)

 

 

 

 

 

 

CURRENT LIABILITIES:

 

 

 

 

 

 

Accounts payable

 

$

5,973

 

 

$

2,966

 

Accrued expenses

 

 

16,946

 

 

 

32,750

 

Operating lease liabilities — short-term

 

 

6,098

 

 

 

5,844

 

Total current liabilities

 

$

29,017

 

 

$

41,560

 

Operating lease liabilities — long-term

 

 

8,911

 

 

 

13,542

 

Other long-term liabilities

 

 

 

 

 

304

 

Total liabilities

 

 

37,928

 

 

 

55,406

 

Net parent investment

 

 

 

 

 

(21,656

)

Preferred shares

 

 

 

 

 

 

Ordinary shares

 

 

167

 

 

 

 

Additional paid-in capital

 

 

294,507

 

 

 

 

Accumulated deficit

 

 

(30,857

)

 

 

 

Total equity (deficit)

 

 

263,817

 

 

 

(21,656

)

TOTAL LIABILITIES AND
EQUITY (DEFICIT)

 

$

301,745

 

 

$

33,750

 

 

 

 

 


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Consolidated Statements of Operations

(in thousands except share and per share amounts)

 

 

 

Three months ended
December 31,
(unaudited)

 

 

Year ended
December 31,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Operating expenses

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

42,243

 

 

$

42,393

 

 

$

165,532

 

 

$

167,191

 

General and administrative

 

 

16,270

 

 

 

4,969

 

 

 

30,706

 

 

 

17,732

 

Total operating expenses

 

 

58,513

 

 

 

47,362

 

 

 

196,238

 

 

 

184,923

 

Operating loss

 

 

(58,513

)

 

 

(47,362

)

 

 

(196,238

)

 

 

(184,923

)

Other income (expense), net

 

 

951

 

 

 

 

 

 

951

 

 

 

 

Income tax provision

 

 

(1,975

)

 

 

(1,220

)

 

 

(12,160

)

 

 

(4,884

)

Net loss and comprehensive loss

 

$

(59,537

)

 

$

(48,582

)

 

$

(207,447

)

 

$

(189,807

)

Net loss per share - basic and diluted

 

$

(3.57

)

 

$

(2.91

)

 

$

(3.57

)

 

$

(2.91

)

Weighted average common shares
used in computing net loss per
share - basic and diluted

 

 

16,689,740

 

 

 

16,689,740

 

 

 

16,689,740

 

 

 

16,689,740

 

 

 

Investors:

David Borah, CFA

david.borah@muraloncology.com

 

Media:

Katie Sullivan

katie.sullivan@muraloncology.com