Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage
oncology company developing targeted therapies for patients with
RAS-addicted cancers, today announced its financial results for the
quarter ended June 30, 2024, and provided an update on corporate
progress.
The company continues making progress on its
2024 development priorities:
- Advancing its RAS(ON)
multi-selective inhibitor RMC-6236 into monotherapy pivotal
trials.
- Pancreatic cancer:
The company recently provided updated data on the clinical safety,
tolerability and antitumor activity in patients with pancreatic
ductal adenocarcinoma (PDAC) from its ongoing RMC-6236 monotherapy
study. Strong preliminary progression-free survival (PFS) and
overall survival (OS) PDAC data support the company’s plans to
initiate a pivotal, randomized, controlled Phase 3 monotherapy
study in the second-line (2L) treatment of patients with metastatic
PDAC this year; work is underway toward this goal.
- Lung cancer: Data
from the RMC-6236 monotherapy study in patients with non-small cell
lung cancer (NSCLC) continue to mature. The company remains on
track to initiate a pivotal study in previously-treated patients
with RAS-mutated NSCLC this year.
- Expanding the reach of
RMC-6236 monotherapy and/or combinations into earlier lines of
therapy. Based on compelling preliminary monotherapy data
in 2L PDAC, the company plans to evaluate RMC-6236 in earlier lines
of treatment for pancreatic cancer including the first-line,
locally advanced, and resectable settings. In addition to
monotherapy, the company is currently evaluating RMC-6236 in
combination with chemotherapy, which is the current standard of
care for patients with PDAC.
- Qualifying its RAS(ON)
mutant-selective inhibitors, RMC-6291 (G12C-selective inhibitor)
and RMC-9805 (G12D-selective inhibitor), for late-stage
development.
- With the goal of moving RMC-6291
into early lines of therapy in NSCLC, the company is currently
evaluating the RAS(ON) inhibitor doublet of RMC-6291 with RMC-6236
as well as RMC-6291 with pembrolizumab.
- This doublet approach was recently
highlighted in the Cancer Discovery publication that demonstrated
robust antitumor activity by a RAS(ON) multi-selective inhibitor in
combination with a RAS(ON) G12C-selective inhibitor in preclinical
models of refractory KRAS G12X NSCLC.
- The company continues to enroll
patients with solid tumors harboring KRAS G12D mutations in the
RMC-9805 monotherapy study.
- In support of its continuing
pipeline momentum and commercial ambitions, the company
appointed Frank Clyburn to its board of directors; Mr. Clyburn
is a distinguished executive who led Merck’s global Keytruda®
franchise from its inception and helped establish Merck as a
global leader in oncology. The company also expanded its
senior management group with key new hires in medical affairs,
corporate affairs, drug safety and program leadership.
“Confidence in our RAS(ON) inhibitor platform
and assets continues to grow and has been bolstered particularly by
the strength of the interim safety, PFS and OS data shown in July
for patients with pancreatic cancer in the RMC-6236 monotherapy
study. Based on current benchmarks for first- and second-line
treatment of metastatic PDAC, we believe RMC-6236 has the potential
to become an important new therapeutic option to address large
unmet medical needs for patients with this threatening disease,”
said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and
chairman of Revolution Medicines. “The appointment of Frank Clyburn
to our board of directors and several strategic additions to our
executive team support our deep focus on enabling the next stage of
growth and maturation for Revolution Medicines. We have made
substantial progress in planning for the initiation of our first
pivotal, Phase 3 study for RMC-6236 in pancreatic cancer, and are
working actively to prepare to advance RMC-6236 into earlier lines
of therapy.”
Clinical Development
Highlights
Plans to Advance RMC-6236 Monotherapy
into Pivotal TrialsPancreatic cancer: On
July 15, 2024, the company reported updated data on the clinical
safety, tolerability and antitumor activity from its ongoing
monotherapy study evaluating RMC-6236 in patients with previously
treated metastatic PDAC across dose cohorts ranging from 160 mg
daily to 300 mg daily as of a May 11, 2024 data cutoff date. Key
findings included:
- A total of 127 patients treated
were evaluated for safety and tolerability.
- Approximately 22 percent of these
patients experienced a Grade 3 or higher treatment-related adverse
event (TRAE), and 96 percent of these patients experienced a TRAE
of any grade.
- The most common TRAEs observed were
rash and gastrointestinal-related toxicities. Reported TRAEs led to
dose modifications (dose interruption and/or reduction) in 28
percent of these patients and there were no discontinuations due to
TRAEs.
- The company also reported
preliminary PFS and OS data in 2L treatment of patients with
metastatic PDAC.
- The median PFS for patients with
KRAS G12X mutations (n=42) was 8.1 months (95% confidence interval
(CI); 5.9 months – not-estimable (NE)) and for patients with any
RAS mutation (G12X, G13X and Q61X) (n=56) was 7.6 months (95% CI;
5.3 months – NE).
- For patients with KRAS G12X
mutations and those with any RAS mutation, the observed OS was not
estimable (95% CI for both groups; 8.5 months, NE).
- Based on initial feedback from the
U.S. Food and Drug Administration, including supportive discussions
on high-level trial design including a 300 mg daily dose, the
company expects to initiate its Phase 3 registrational trial in the
2L treatment of patients with metastatic PDAC, called RASolute 302,
this year.
Lung cancer: The company
expects to share updated NSCLC data from its ongoing RMC-6236
monotherapy study in the fourth quarter of 2024 and to launch a
registrational study to evaluate RMC-6236 in previously-treated
patients with advanced NSCLC in the fourth quarter of
2024. Evaluating
RMC-6236 in Earlier Lines of Therapy
- PDAC. Evaluation
is ongoing for RMC-6236 in combination with standard of care
chemotherapy in first-line PDAC.
- NSCLC. Evaluation
is ongoing for RMC-6236 in combination with pembrolizumab, with or
without chemotherapy, in patients with advanced RAS-mutated NSCLC.
The company expects to disclose initial clinical pharmacokinetic
(PK), safety, tolerability and antitumor activity data for the
combination of RMC-6236 with pembrolizumab in the fourth quarter of
2024.
Qualifying RMC-6291 for Late-Stage
Development
- Combination
Development. Evaluation of RMC-6291 with RMC-6236 and
RMC-6291 with pembrolizumab, with or without chemotherapy, is
ongoing. The company expects to disclose initial clinical PK,
safety, tolerability and antitumor activity data for the
combination of RMC-6291 with RMC-6236 in the fourth quarter of 2024
and for the combination RMC-6291 with pembrolizumab in the first
half of 2025.
Qualifying RMC-9805 for
Late-Stage Development
- Monotherapy
Development. The company expects to disclose initial
clinical PK, safety, tolerability and antitumor activity data for
RMC-9805 in the fourth quarter of 2024.
RAS Innovation EngineBeyond the
first wave of clinical-stage RAS(ON) inhibitors, additional
clinical development opportunities include the RAS(ON)
mutant-selective inhibitors RMC-5127 (G12V), RMC-0708 (Q61H) and
RMC-8839 (G13C) and the RAS companion inhibitors RMC-4630 (SHP2)
and RMC-5552 (mTORC1/4EBP1).
Corporate and Financial
Highlights
Update to Revolution Medicines’ Board of
DirectorsIn addition, the company has appointed Frank
Clyburn to its board of directors as a Class II director, with a
term expiring at the company’s 2025 annual meeting of stockholders.
Mr. Clyburn brings significant and relevant experience to
Revolution Medicines as it embarks on late-stage clinical
development and commercial planning for its RAS(ON) inhibitor
programs. Most recently, Mr. Clyburn served as the chief executive
officer and as a board director of International Flavors &
Fragrances (IFF). Notably, Mr. Clyburn previously served as
executive vice president and president of human health for Merck.
During his tenure, he built Merck’s leading oncology business,
directing the successful global launch and commercialization of
Keytruda® to create the dominant immuno-oncology franchise. Earlier
in his career, Mr. Clyburn served as vice president of the oncology
and internal medicine business units at Sanofi Aventis and held
several leadership roles within the company. Mr. Clyburn received
his M.B.A. from Arizona State University and his B.A. from Franklin
& Marshall College.
Addition of New LeadersThe
company has made several strategic leadership hires across research
and development, corporate affairs and program management,
including:
- Mary Pinder-Schenck, M.D., senior
vice president, head of medical affairs
- Ryan Asay, senior vice president,
corporate affairs
- Mason Shih, M.D., senior vice
president, head of drug safety
- Jing Yi, Ph.D., senior vice
president, head of program leadership
Second Quarter Results
Cash Position: Cash, cash
equivalents and marketable securities were $1.59 billion as of June
30, 2024.Revenue: Total revenue was zero for the
quarter ended June 30, 2024, compared to $3.8 million for the
quarter ended June 30, 2023. The decrease in revenue was due to the
termination of the company’s collaboration agreement with Sanofi in
2023.
R&D Expenses: Research and
development expenses were $134.9 million for the quarter ended June
30, 2024, compared to $98.0 million for the quarter ended June 30,
2023. The increase in expense was primarily due to increases in
clinical trial expenses for RMC-6236, RMC-6291 and RMC-9805,
preclinical portfolio expenses, personnel-related expenses related
to additional headcount and stock-based compensation expense.
G&A Expenses: General and
administrative expenses were $21.7 million for the quarter ended
June 30, 2024, compared to $14.6 million for the quarter ended June
30, 2023. The increase was primarily due to increases in
personnel-related expenses related to additional headcount,
commercial preparation activities and stock-based compensation
expense.
Net Loss: Net loss was $133.2
million for the quarter ended June 30, 2024, compared to net loss
of $98.3 million for the quarter ended June 30, 2023.
Financial GuidanceRevolution
Medicines is reiterating the updated projected full year 2024 GAAP
net loss guidance that it shared in July 2024 of between $560
million and $600 million, which includes estimated non-cash
stock-based compensation expense of between $70 million and $80
million. Based on the company’s current operating plan, the company
projects current cash, cash equivalents and marketable securities
can fund planned operations into 2027.
WebcastRevolution Medicines
will host a webcast this afternoon, August 7, 2024, at 4:30 p.m.
Eastern Time (1:30 p.m. Pacific Time). To listen to the live
webcast, or access the archived webcast, please visit:
https://ir.revmed.com/events-and-presentations. Following the live
webcast, a replay will be available on the company’s website for at
least 14 days.
About Revolution Medicines,
Inc.Revolution Medicines is a clinical-stage oncology
company developing novel targeted therapies for RAS-addicted
cancers. The company’s R&D pipeline comprises RAS(ON)
inhibitors designed to suppress diverse oncogenic variants of RAS
proteins, and RAS companion inhibitors for use in combination
treatment strategies. The company’s RAS(ON) inhibitors RMC-6236, a
RAS(ON) multi-selective inhibitor, RMC-6291, a RAS(ON)
G12C-selective inhibitor, and RMC-9805, a RAS(ON) G12D-selective
inhibitor, are currently in clinical development. Additional
RAS(ON) mutant-selective inhibitors in the company’s development
pipeline include RMC-5127 (G12V), RMC-0708 (Q61H) and RMC-8839
(G13C), in addition to RAS companion inhibitors RMC-4630 and
RMC-5552.
Forward-Looking Statements This
press release contains forward-looking statements within the
meaning of the U.S. Private Securities Litigation Reform Act of
1995. Any statements in this press release that are not
historical facts may be considered "forward-looking statements,"
including without limitation statements regarding the company’s
financial projections and expectations related to the company’s
capital resources; the company’s development plans and timelines
and its ability to advance its portfolio and R&D pipeline;
progression of clinical studies and findings from these studies,
including the safety, tolerability, potential efficacy and
durability of the company’s candidates being studied; the company’s
expectations regarding timing of data disclosures and clinical
study initiation; the company’s plans, priority and timing to
expand the reach of its RAS(ON) inhibitors into earlier lines of
therapy; the potential advantages and effectiveness of the
company’s clinical and preclinical candidates, including its
RAS(ON) inhibitors; initial feedback from the FDA regarding further
development of RMC-6236; the company’s plans for regulatory
engagement and initiation of pivotal and registrational clinical
trials for RMC-6236, including data to support the initiation of
these trials; and the company’s commercial plans. Forward-looking
statements are typically, but not always, identified by the use of
words such as "may," "will," "would," "believe," "intend," "plan,"
"anticipate," "estimate," "expect," and other similar terminology
indicating future results. Such forward-looking statements are
subject to substantial risks and uncertainties that could cause the
company’s development programs, future results, performance or
achievements to differ materially from those anticipated in the
forward-looking statements. Such risks and uncertainties include
without limitation risks and uncertainties inherent in the drug
development process, including the company’s programs’ current
stage of development, the process of designing and conducting
preclinical and clinical trials, risks that the results of prior
clinical trials may not be predictive of future clinical trials,
clinical efficacy, or other future results, the regulatory approval
processes, the timing of regulatory filings, the challenges
associated with manufacturing drug products, the company’s ability
to successfully establish, protect and defend its intellectual
property, other matters that could affect the sufficiency of the
company’s capital resources to fund operations, reliance on third
parties for manufacturing and development efforts, changes in the
competitive landscape, and the effects on the company’s business of
the global events, such as international conflicts or global
pandemics. For a further description of the risks and uncertainties
that could cause actual results to differ from those anticipated in
these forward-looking statements, as well as risks relating to the
business of Revolution Medicines in general, see Revolution
Medicines’ Quarterly Report on Form 10-Q filed with the Securities
and Exchange Commission (the “SEC”) on August 7, 2024, and its
future periodic reports to be filed with the SEC. Except as
required by law, Revolution Medicines undertakes no obligation to
update any forward-looking statements to reflect new information,
events or circumstances, or to reflect the occurrence of
unanticipated events.
REVOLUTION MEDICINES, INC.CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS(in thousands, except share and per
share data)(unaudited) |
|
|
Three Months EndedJune 30, |
|
|
Six Months EndedJune 30, |
|
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration revenue |
|
$ |
— |
|
|
$ |
3,824 |
|
|
$ |
— |
|
|
$ |
10,838 |
|
Total revenue |
|
|
— |
|
|
|
3,824 |
|
|
|
— |
|
|
|
10,838 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
134,932 |
|
|
|
97,981 |
|
|
|
252,953 |
|
|
|
166,928 |
|
General and administrative |
|
|
21,711 |
|
|
|
14,640 |
|
|
|
44,549 |
|
|
|
27,864 |
|
Total operating expenses |
|
|
156,643 |
|
|
|
112,621 |
|
|
|
297,502 |
|
|
|
194,792 |
|
Loss from operations |
|
|
(156,643) |
|
|
|
(108,797) |
|
|
|
(297,502) |
|
|
|
(183,954) |
|
Other income (expense), net: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
21,487 |
|
|
|
10,499 |
|
|
|
45,247 |
|
|
|
17,558 |
|
Other income (expense), net |
|
|
16 |
|
|
|
— |
|
|
|
(2,793) |
|
|
|
— |
|
Change in fair value of warrant liability and contingent earn-out
shares |
|
|
1,907 |
|
|
|
— |
|
|
|
5,812 |
|
|
|
— |
|
Total other income, net |
|
|
23,410 |
|
|
|
10,499 |
|
|
|
48,266 |
|
|
|
17,558 |
|
Loss before income taxes |
|
|
(133,233) |
|
|
|
(98,298) |
|
|
|
(249,236) |
|
|
|
(166,396) |
|
Net loss |
|
$ |
(133,233) |
|
|
$ |
(98,298) |
|
|
$ |
(249,236) |
|
|
$ |
(166,396) |
|
Net loss per share attributable to common stockholders, basic and
diluted |
|
$ |
(0.81) |
|
|
$ |
(0.92) |
|
|
$ |
(1.51) |
|
|
$ |
(1.65) |
|
Weighted-average common shares used to compute net loss per share,
basic and diluted |
|
|
165,141,936 |
|
|
|
106,884,185 |
|
|
|
164,935,542 |
|
|
|
100,891,375 |
|
REVOLUTION MEDICINES, INC.SELECTED
CONDENSED CONSOLIDATED BALANCE SHEETS(in
thousands, unaudited) |
|
|
|
|
|
|
June 30,2024 |
|
|
December 31,2023 |
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and marketable securities |
|
$ |
1,590,715 |
|
|
$ |
1,852,955 |
|
Working capital (1) |
|
|
1,519,398 |
|
|
|
1,735,430 |
|
Total assets |
|
|
1,808,437 |
|
|
|
2,061,705 |
|
Total liabilities |
|
|
189,589 |
|
|
|
235,511 |
|
Total stockholders' equity |
|
|
1,618,848 |
|
|
|
1,826,194 |
|
(1) Working capital is defined as current assets
less current liabilities.
Media & Investor Contact
Erin Graves
650-779-0136
egraves@revmed.com
Revolution Medicines (NASDAQ:RVMD)
Gráfica de Acción Histórica
De Nov 2024 a Dic 2024
Revolution Medicines (NASDAQ:RVMD)
Gráfica de Acción Histórica
De Dic 2023 a Dic 2024