Mural Oncology Announces Second Quarter 2024 Financial Results and Provides Update on Pipeline Progress
13 Agosto 2024 - 6:15AM
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
second quarter of 2024 and provided a business update.
"We’ve seen resurgent interest across the industry in cytokines
as powerful tools to fight cancer and Mural is in a unique position
to deliver promising drug candidates that have the potential to
overcome the limitations of prior approaches,” said Caroline Loew,
Ph.D., Chief Executive Officer of Mural Oncology. “Since becoming
an independent company late last year, we’ve rapidly worked to
shape and grow a nimble organization focused on delivering
meaningful new immunotherapy treatments to cancer patients. We
believe each of our programs is engineered with a differentiated
approach that we hope will play out significantly in the clinic
starting early next year.”
Recent Corporate Highlights and Upcoming
Milestones
- Mural appointed George Golumbeski, Ph.D., to its board of
directors in July. Dr. Golumbeski currently serves as a partner at
DROIA Ventures, a specialist biotech investment firm focused on
therapeutics for oncology and genetic disease. Prior to DROIA, he
served as President and Head of Corporate Development for GRAIL and
Executive Vice President of Business Development for Celgene. He
has nearly 30 years of extensive experience with strategic
collaborations, M&A, in-licensing, out-licensing, and alliance
management.
- Mural’s late-stage clinical trials of nemvaleukin
alfa continue to progress toward readouts in the first
half of 2025. The company is focused on two foundational
indications for nemvaleukin, where the majority of patients do not
have any currently approved therapies.
- ARTISTRY-7 is a potentially
registrational, phase 3 clinical trial evaluating nemvaleukin in
combination with pembrolizumab compared to investigators’ choice of
chemotherapy in patients with platinum-resistant ovarian cancer.
Patient enrollment in this trial is now complete. Mural continues
to expect to report interim overall survival (OS) results based on
approximately 75% of events in the first quarter of 2025. The
company anticipates reporting final OS results in the second
quarter of 2026.
- Mural expects to report top-line data results from
cohort 2 of ARTISTRY-6 in the
first half of 2025. This is a potentially registrational, phase 2
clinical trial evaluating nemvaleukin as a monotherapy in patients
with mucosal melanoma.
- Mural is also evaluating a less-frequent intravenous
(LFIV) dose of nemvaleukin in patients with cutaneous
melanoma in cohort 3 (monotherapy) and cohort 4 (combination
therapy) in ARTISTRY-6. The company expects
preliminary data readouts in the monotherapy cohort in the first
half of 2025, and in the combination cohort with pembrolizumab in
the second half of 2025.
- In June, Mural presented data from ARTISTRY-3,
an evaluation of the LFIV dosing of nemvaleukin, at the American
Society of Clinical Oncology (ASCO) annual meeting. This data from
ARTISTRY-3 informed the LFIV dose currently being used in cohort 3
and cohort 4 of ARTISTY-6. In the ARTISTRY-3 trial, the company
evaluated escalating LFIV infusions, all of which were generally
well tolerated. The safety profile in all dosing schedules
evaluated was consistent with nemvaleukin’s known mechanism of
action, and no dose limiting toxicities were observed. Although
administering higher doses per cycle than in previous trials
evaluating nemvaleukin, no new safety signals were identified. The
desired pharmacodynamic (PD) effects were also seen across all
evaluated doses. Expansion of antitumor CD8+ T cells and natural
killer (NK) cells was observed concurrent with minimal expansion of
immunosuppressive regulatory T cells (Tregs).
- Mural’s preclinical interleukin-18 (IL-18) and
IL-12 programs remain on track, with nominations
for both development candidates expected this year.
- Mural’s enhanced IL-18 is engineered to
deliver a more sustained immune response for cancer treatment.
Native 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 with and neutralizes IL-18,
thereby rendering it ineffective. Native IL-18 is also limited by
its short half-life. Mural’s IL-18 variant contains mutations that
eliminate binding to IL-18BP while minimally impacting the native
IL-18 structure. The company has also fused IL-18 to protein
scaffolds to extend the half-life and increase IL-18’s exposure.
Together, Mural believes these have demonstrated a more durable
immunological effect in preclinical studies.
- The company’s enhanced IL-12 is engineered to
leverage native IL-12’s anti-tumor potency while mitigating its
hallmark toxicity. Native IL-12 is a highly potent pro-inflammatory
cytokine, but because of its very narrow therapeutic index, it can
also be incredibly toxic with systemic exposure. Mural’s IL-12
variant splits the molecule into two inactive monomers, and these
individual subunits are then separately fused to antibody fragments
and sequentially injected, which deliver and concentrate IL-12
specifically in the tumor microenvironment with the goal of
limiting systemic exposure. In preclinical studies, Mural believes
its engineered IL-12 achieved the desired reduction in serum while
maintaining tumor concentrations providing the potential to reduce
systemic toxicities.
Financial Results for the Quarter Ended June 30,
2024
- Cash Position: As of June 30, 2024, cash, cash
equivalents, and marketable securities were $204.7
million.
- R&D Expenses: Research and development
expenses were $27.5 million for the second quarter of 2024 compared
to $42.5 million for the second quarter of 2023. The decrease in
R&D expenses was primarily due to different team composition
compared to the personnel allocated to us by Alkermes, our former
parent, prior to the separation, as well as decreased spend on the
ARTISTRY-1 and ARTISTRY-2 trials as activities related to these
trials wound down in 2023 and decreased spend on the ARTISTRY-7
trial due to the timing of patient enrollment.
- G&A Expenses: General and administrative
expenses were $6.7 million for the second quarter of 2024 compared
to $4.7 million for the second quarter of 2023. The increase in
expenses was primarily due to costs associated with operating as a
standalone company after the separation. This includes
employee-related expenses and professional fees.
- Net Loss: Net loss was $31.6 million for the
second quarter of 2024 compared to $50.2 million for the second
quarter of 2023.
Financial Guidance
- The company reaffirms guidance that its cash, cash equivalents,
and marketable securities are expected to fund its operations into
the fourth quarter of 2025.
- As noted previously, management forecasts lower operating
expenses in 2025 versus 2024 due to the timing of clinical trial
expenses.
About NemvaleukinNemvaleukin alfa (nemvaleukin)
is a novel, engineered cytokine designed to leverage antitumor
effects of the IL-2 pathway while mitigating the 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 ProgramNative
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 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 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 June 30, 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) |
|
|
|
|
|
|
|
June 30, 2024 |
|
|
December 31, 2023 |
|
ASSETS |
|
|
|
|
|
CURRENT ASSETS: |
|
|
|
|
|
Cash and cash equivalents |
$ |
121,587 |
|
|
$ |
270,852 |
|
Marketable securities |
|
83,117 |
|
|
|
— |
|
Receivable from Former Parent |
|
1,005 |
|
|
|
5,548 |
|
Prepaid expenses |
|
6,722 |
|
|
|
150 |
|
Other current assets |
|
628 |
|
|
|
787 |
|
Total current assets |
|
213,059 |
|
|
|
277,337 |
|
Property and equipment, net |
|
9,713 |
|
|
|
11,403 |
|
Right-of-use assets |
|
10,126 |
|
|
|
12,747 |
|
Restricted cash |
|
1,969 |
|
|
|
258 |
|
Other assets |
|
61 |
|
|
|
— |
|
TOTAL ASSETS |
$ |
234,928 |
|
|
$ |
301,745 |
|
LIABILITIES AND
EQUITY |
|
|
|
|
|
CURRENT LIABILITIES: |
|
|
|
|
|
Accounts payable |
$ |
3,108 |
|
|
$ |
5,973 |
|
Accrued expenses |
|
16,167 |
|
|
|
16,946 |
|
Operating lease liabilities—short-term |
|
5,350 |
|
|
|
6,098 |
|
Total current liabilities |
|
24,625 |
|
|
|
29,017 |
|
Operating lease liabilities—long-term |
|
5,730 |
|
|
|
8,911 |
|
Total liabilities |
|
30,355 |
|
|
|
37,928 |
|
Preferred shares, nominal value $0.01; 50,000,000 shares authorized
at June 30, 2024 and December 31, 2023; no shares issued or
outstanding at June 30, 2024 or December 31, 2023 |
|
— |
|
|
|
— |
|
Ordinary shares, nominal value $0.01; 450,000,000 ordinary shares
authorized at June 30, 2024 and December 31, 2023; 16,927,110 and
16,689,740 shares issued and outstanding at June 30, 2024 and
December 31, 2023, respectively |
|
169 |
|
|
|
167 |
|
Additional paid-in capital |
|
297,796 |
|
|
|
294,507 |
|
Unrealized loss on marketable securities |
|
(54 |
) |
|
|
— |
|
Accumulated deficit |
|
(93,338 |
) |
|
|
(30,857 |
) |
Total equity |
|
204,573 |
|
|
|
263,817 |
|
TOTAL LIABILITIES AND EQUITY |
$ |
234,928 |
|
|
$ |
301,745 |
|
Mural Oncology plc and Subsidiaries |
Consolidated Statements of Operations and Comprehensive
Loss |
(in thousands except share and per share
amounts) |
|
|
Three Months Ended June 30, |
|
|
2024 |
|
|
2023 |
|
Operating
expenses |
|
|
|
|
|
Research and development |
$ |
27,544 |
|
|
$ |
42,526 |
|
General and administrative |
|
6,733 |
|
|
|
4,731 |
|
Total operating expenses |
|
34,277 |
|
|
|
47,257 |
|
Operating
loss |
|
(34,277 |
) |
|
|
(47,257 |
) |
Other income |
|
2,713 |
|
|
|
— |
|
Income tax provision |
|
— |
|
|
|
(2,907 |
) |
Net loss |
$ |
(31,564 |
) |
|
$ |
(50,164 |
) |
Other comprehensive gain: |
|
|
|
|
|
Unrealized gain on marketable securities |
$ |
20 |
|
|
$ |
— |
|
Other comprehensive gain |
|
20 |
|
|
|
— |
|
Comprehensive
loss |
$ |
(31,544 |
) |
|
$ |
(50,164 |
) |
Net loss per ordinary share -
basic and diluted |
$ |
(1.86 |
) |
|
$ |
(3.01 |
) |
Weighted average ordinary shares
outstanding - basic and diluted |
|
16,924,842 |
|
|
|
16,689,740 |
|
Contact:Katie
Sullivankatie.sullivan@muraloncology.com
Mural Oncology (NASDAQ:MURA)
Gráfica de Acción Histórica
De Sep 2024 a Oct 2024
Mural Oncology (NASDAQ:MURA)
Gráfica de Acción Histórica
De Oct 2023 a Oct 2024