Mural Oncology Announces Fourth Quarter and Year End 2023 Financial Results and Provides Business Update
26 Marzo 2024 - 5:00AM
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.
- 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:
- 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.
- 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.
- The company looks forward to presenting data from
ARTISTRY-3 at an upcoming medical conference.
- Enrollment in ARTISTRY-6 and
ARTISTRY-7 is ongoing:
- 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.
- 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.
- 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.
- 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.
- 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 NemvaleukinNemvaleukin 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 OncologyMural 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
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.
|
Mural Oncology plcConsolidated 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 |
|
|
|
|
|
|
|
|
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 |
|
|
Consolidated Statements of Operations(in
thousands except share and per share amounts) |
|
|
Three months endedDecember
31,(unaudited) |
|
Year endedDecember 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 |
) |
|
$ |
(12.43 |
) |
|
$ |
(11.37 |
) |
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,
CFAdavid.borah@muraloncology.com
Media:Katie
Sullivankatie.sullivan@muraloncology.com
Mural Oncology (NASDAQ:MURA)
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