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 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 |
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Description |
99.1 |
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Press release issued by Mural Oncology plc on March 26, 2024. |
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: March 26, 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 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
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Financial Results for the Quarter Ended December 31, 2023
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Financial Guidance
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)
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December 31, 2023 |
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December 31, 2022 |
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ASSETS |
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CURRENT ASSETS: |
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Cash and cash equivalents |
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$ |
270,852 |
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$ |
— |
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Receivable from Former Parent |
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5,548 |
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— |
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Prepaid expenses |
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150 |
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2,987 |
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Other current assets |
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787 |
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1,830 |
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Total current assets |
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$ |
277,337 |
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$ |
4,817 |
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Property and equipment, net |
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11,403 |
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10,617 |
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Right-of-use assets |
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12,747 |
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18,316 |
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Restricted cash |
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258 |
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— |
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TOTAL ASSETS |
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$ |
301,745 |
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$ |
33,750 |
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LIABILITIES AND EQUITY (DEFICIT) |
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CURRENT LIABILITIES: |
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Accounts payable |
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$ |
5,973 |
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$ |
2,966 |
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Accrued expenses |
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16,946 |
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32,750 |
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Operating lease liabilities — short-term |
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6,098 |
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5,844 |
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Total current liabilities |
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$ |
29,017 |
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$ |
41,560 |
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Operating lease liabilities — long-term |
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8,911 |
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13,542 |
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Other long-term liabilities |
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— |
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304 |
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Total liabilities |
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37,928 |
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55,406 |
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Net parent investment |
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— |
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(21,656 |
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Preferred shares |
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— |
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— |
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Ordinary shares |
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167 |
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— |
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Additional paid-in capital |
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294,507 |
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— |
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Accumulated deficit |
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(30,857 |
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— |
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Total equity (deficit) |
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263,817 |
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(21,656 |
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TOTAL LIABILITIES AND |
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$ |
301,745 |
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$ |
33,750 |
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Consolidated Statements of Operations
(in thousands except share and per share amounts)
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Three months ended |
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Year ended |
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2023 |
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2022 |
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2023 |
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2022 |
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Operating expenses |
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Research and development |
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$ |
42,243 |
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$ |
42,393 |
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$ |
165,532 |
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$ |
167,191 |
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General and administrative |
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16,270 |
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4,969 |
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30,706 |
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17,732 |
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Total operating expenses |
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58,513 |
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47,362 |
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196,238 |
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184,923 |
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Operating loss |
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(58,513 |
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(47,362 |
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(196,238 |
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(184,923 |
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Other income (expense), net |
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951 |
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— |
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951 |
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— |
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Income tax provision |
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(1,975 |
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(1,220 |
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(12,160 |
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(4,884 |
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Net loss and comprehensive loss |
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$ |
(59,537 |
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$ |
(48,582 |
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$ |
(207,447 |
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$ |
(189,807 |
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Net loss per share - basic and diluted |
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$ |
(3.57 |
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$ |
(2.91 |
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$ |
(3.57 |
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$ |
(2.91 |
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Weighted average common shares |
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16,689,740 |
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16,689,740 |
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16,689,740 |
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16,689,740 |
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Investors:
David Borah, CFA
david.borah@muraloncology.com
Media:
Katie Sullivan
katie.sullivan@muraloncology.com