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 and full year ended December 31, 2023, and provided an
update on corporate progress.
The company’s strategic priorities for 2024 are
focused on its pioneering RAS(ON) inhibitors:
- Advancing its RAS(ON)
multi-selective inhibitor RMC-6236 into monotherapy pivotal trials.
Studies in second line (2L) non-small cell lung cancer (NSCLC) and
in 2L pancreatic ductal carcinoma (PDAC) are expected to begin in
the second half of 2024.
- Expanding the reach of RMC-6236
monotherapy and/or combination regimens into earlier lines of
therapy, RAS cancer genotypes beyond RAS G12X, and tumor types
beyond NSCLC and PDAC. Patient dosing is underway in studies
evaluating the combination of RMC-6236 + RMC-6291 and the
combination of RMC-6236 + pembrolizumab.
- Qualifying its mutant-selective
inhibitors, RMC-6291 (G12C-selective inhibitor) and RMC-9805
(G12D-selective inhibitor), for late-stage development. Patient
dosing is underway in the combination study evaluating RMC-6291 +
pembrolizumab.
“2023 was a transformative year for Revolution
Medicines and our pioneering RAS(ON) inhibitors. We showed that
both RMC-6236 and RMC-6291 as single agents can deliver clinically
meaningful antitumor responses at doses that are generally safe and
well tolerated, results we believe provide broad clinical
validation of our RAS(ON) inhibitor portfolio,” said Mark A.
Goldsmith, M.D., Ph.D., chief executive officer and chairman of
Revolution Medicines. “With a year-end cash and investments balance
of $1.85 billion after acquiring EQRx, we are well capitalized to
execute exciting plans this year and beyond to advance our
compelling development-stage pipeline, aiming to change the
treatment landscape for patients living with RAS-addicted
cancers.”
Clinical Development
Highlights
Studies to Support Advancing RMC-6236 into Pivotal
Trial(s)
RMC-6236-001 (NCT05379985) is a
clinical study of RMC-6236 monotherapy in patients with advanced
solid tumors harboring diverse RAS mutations.
- Following the preliminary safety
and antitumor activity data in patients with NSCLC and PDAC
presented at the Triple Meeting and ESMO Congress in October 2023,
the company shared an update across the 80 to 400 mg daily dose
range at the J.P. Morgan Healthcare Conference on January 9, 2024,
that supports initiating pivotal trials in the second half of 2024.
- With two months of additional
follow-up, the safety profile remained relatively consistent. The
company also shared favorable trends for the aggregate overall
response rate (ORR) for patients with NSCLC in the low- to mid-40
percent range, and aggregate ORR for patients with PDAC in the
mid-20 percent range. In the 300 mg dose cohort, patients with
NSCLC and PDAC response rates trended higher than the aggregate
ORR, with a disease control rate in the high-80 percent range.
- While a maximum tolerated dose was
not identified, dose escalation is now complete. Dose optimization
is now focused on dose levels at or below 300 mg daily to support
finalizing a recommended Phase 2 dose in NSCLC and PDAC.
- The company is developing a more
mature data package to support regulatory engagement for final dose
selection and the expected launch of pivotal trials with RMC-6236.
The company expects to disclose updated clinical safety,
tolerability, and antitumor activity data in the second half of
2024 supporting initiation of a Phase 3 study of 2L treatment of
patients with NSCLC and a Phase 3 study of 2L treatment of patients
with PDAC. The company plans to initiate both of these studies in
the second half of 2024.
Studies to Support Expanding the Reach
of RMC-6236 into Earlier Lines of Therapy, RAS
Cancer Genotypes Beyond RAS G12X, and Tumor
Types Beyond NSCLC and
PDACRMC-LUNG-101 (NCT06162221) is a
clinical study of RMC-6236 or RMC-6291 in combination with
pembrolizumab, with or without chemotherapy, in patients with
advanced RAS-mutated NSCLC or KRAS G12C-mutated NSCLC,
respectively.
- Patient dosing is underway in both
the RMC-6236 and RMC-6291 cohorts, and the company expects to
disclose initial clinical PK, safety, tolerability, and antitumor
activity data from both cohorts in the second half of 2024.
RMC-6236-001 (NCT05379985) is a
clinical study of RMC-6236 monotherapy, and expansion cohorts were
opened to evaluate patients with tumors harboring other RAS
mutations beyond G12X, including G13X and Q61X mutations, and/or
other tumor types, including colorectal cancer, melanoma, and
gynecological malignancies.
- Patient dosing is underway, and the
company expects to disclose initial clinical PK, safety,
tolerability, and activity data from the cohort expansions in the
second or third quarter of 2024.
Studies to Qualify Mutant-Selective
Inhibitors RMC-6291-001 (NCT05462717) is
a clinical study of RMC-6291 monotherapy in patients with advanced
solid tumors harboring KRAS G12C mutations.
- Following the preliminary safety
and antitumor activity data presented at the Triple Meeting in
October 2023, the company continues dosing patients at 200 mg twice
daily.
RMC-6291-101 (NCT06128551) is a
clinical study of RMC-6291 in combination with RMC-6236 in patients
with advanced KRAS G12C-mutated solid tumors.
- Patient dosing is underway, and the
company expects to disclose initial clinical PK, safety,
tolerability, and activity data in the second half of 2024.
RMC-9805-001 (NCT06040541) is a
clinical study of RMC-9805 monotherapy in patients with advanced
KRAS G12D-mutated solid tumors.
- At the J.P. Morgan Healthcare
Conference, the company indicated that early study results
confirmed RMC-9805 is orally bioavailable in patients, consistent
with preclinical projections, including dose-dependent increases in
exposure with once daily dosing. RMC-9805 cleared several dose
levels with acceptable safety and tolerability, and no dose
limiting toxicities had been reported.
- The company expects to disclose
initial clinical PK, safety, tolerability, and activity data in the
second half of 2024.
RAS Innovation EngineBeyond the
first wave of clinical-stage RAS(ON) inhibitors, the company’s
pipeline includes the RAS(ON) inhibitor development candidates,
RMC-5127 (G12V), RMC-0708 (Q61H) and RMC-8839 (G13C).
Corporate and Financial
Highlights
EQRx AcquisitionOn November 9,
2023, the company completed its acquisition of EQRx, Inc. (EQRx),
which added approximately $1.1 billion in net cash proceeds to its
balance sheet after estimated post-closing EQRx wind-down and
transition costs. At the closing, Dr. Sandra Horning joined
the company’s board of directors. Wind-down of EQRx operations and
activities is nearing completion.
Fourth Quarter Results
Cash Position: Cash, cash
equivalents and marketable securities were $1.85 billion as of
December 31, 2023, compared to $644.9 million as of December 31,
2022. The increase was primarily attributable to the acquisition of
EQRx in November 2023 and the company’s public equity offering in
March 2023.
Revenue: Total revenue was $0.7
million for the quarter ended December 31, 2023, compared to $15.3
million for the quarter ended December 31, 2022. 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 $148.5 million for the quarter ended
December 31, 2023, compared to $66.1 million for the quarter ended
December 31, 2022. The increase was primarily due to an increase in
clinical supply manufacturing and clinical trial expenses for
RMC-6236, RMC-6291, and RMC-9805, an increase in personnel-related
expenses related to additional headcount, and an increase in
stock-based compensation. Research and development expenses for the
quarter ended December 31, 2023, included $13.1 million of expenses
related to the wind-down of EQRx, which primarily consisted of
non-recurring employee-related termination expenses and stock-based
compensation expense related to the acceleration of EQRx equity
awards in conjunction with the closing of the transaction.
G&A Expenses: General and
administrative expenses were $32.2 million for the quarter ended
December 31, 2023, compared to $10.9 million for the quarter ended
December 31, 2022. The increase was primarily due to an increase in
stock-based compensation and an increase in personnel-related
expenses related to additional headcount. General and
administrative expenses for the quarter ended December 31, 2023,
included $13.8 million of expenses related to the wind-down of
EQRx, which primarily consisted of non-recurring employee-related
termination expenses and stock-based compensation expense related
to the acceleration of EQRx equity awards in conjunction with the
closing of the EQRx transaction.
Net Loss: Net loss was $161.5
million for the quarter ended December 31, 2023, compared to net
loss of $56.5 million for the quarter ended December 31, 2022. Net
loss for the quarter ended December 31, 2023, included $26.9
million of operating expenses related to the wind-down of EQRx.
Full Year 2023 Financial
Highlights
Revenue: Total revenue was
$11.6 million for the year ended December 31, 2023, compared to
$35.4 million for the year ended December 31, 2022. 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 $423.1 million for the year ended
December 31, 2022, compared to $253.1 million for
the year ended December 31, 2022. The increase was primarily due to
an increase in clinical supply manufacturing and clinical trial
expenses for RMC-6236, RMC-6291, and RMC-9805, research expenses
associated with the company’s pre-clinical portfolio, an increase
in personnel-related expenses related to additional headcount, and
an increase in stock-based compensation. Research and development
expenses for the year ended December 31, 2023, included $13.1
million of expenses related to the wind-down of EQRx, which
primarily consisted of non-recurring employee-related termination
expenses and stock-based compensation expense related to the
acceleration of EQRx equity awards in conjunction with the closing
of the transaction.
G&A Expenses: General and
administrative expenses were $75.6 million for the year ended
December 31, 2023, compared to $40.6 million for the year ended
December 31, 2022. The increase was primarily due to an increase in
stock-based compensation and an increase in personnel-related
expenses related to additional headcount. General and
administrative expenses for the year ended December 31, 2023,
included $13.8 million of expenses related to the wind-down of
EQRx, which primarily consisted of non-recurring employee-related
termination expenses and stock-based compensation expense related
to the acceleration of EQRx equity awards in conjunction with the
closing of the EQRx transaction.
Net Loss: Net loss was $436.4
million for the year ended December 31, 2023, compared to net loss
of $248.7 million for the year ended December 31, 2022. Net loss
for the year ended December 31, 2023, included $26.9 million of
operating expenses related to the wind-down of EQRx.
2024 Financial
GuidanceRevolution Medicines expects full year 2024 GAAP
net loss to be between $480 million and $520 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, February 26, 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).
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; whether the company is well capitalized to
execute plans this year and beyond to advance its compelling
development-stage pipeline; 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 tolerability, safety, and potential efficacy
of the company’s candidates being studied; the company’s
expectations regarding timing of data disclosures; the company’s
plans to expand the reach of RMC-6236 into earlier lines of
therapy, additional RAS cancer genotypes, and additional tumor
types; the company’s plans to qualify RMC-6291 and RMC-9805 for
late-stage development; the potential advantages and effectiveness
of the company’s clinical and preclinical candidates, including its
RAS(ON) inhibitors; the company’s plans for regulatory engagement
and initiation of Phase 3 clinical trials for RMC-6236; and the
timing of completion of wind-down of EQRx operations and activities
and related estimated costs. 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’ early stage of development, the
process of designing and conducting preclinical and clinical
trials, 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, the risk
that the wind-down of EQRx may take longer than anticipated or
result in unexpected costs, 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’ Annual Report on Form 10-K filed with the
Securities and Exchange Commission (the “SEC”) on February 26,
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 Ended December 31, |
|
|
Year Ended December 31, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration revenue |
|
$ |
742 |
|
|
$ |
15,330 |
|
|
$ |
11,580 |
|
|
$ |
35,380 |
|
Total revenue |
|
|
742 |
|
|
|
15,330 |
|
|
|
11,580 |
|
|
|
35,380 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
148,481 |
|
|
|
66,127 |
|
|
|
423,144 |
|
|
|
253,073 |
|
General and administrative |
|
|
32,244 |
|
|
|
10,910 |
|
|
|
75,621 |
|
|
|
40,586 |
|
Total operating expenses |
|
|
180,725 |
|
|
|
77,037 |
|
|
|
498,765 |
|
|
|
293,659 |
|
Loss from operations |
|
|
(179,983 |
) |
|
|
(61,707 |
) |
|
|
(487,185 |
) |
|
|
(258,279 |
) |
Other income (expense), net: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
18,977 |
|
|
|
5,077 |
|
|
|
47,482 |
|
|
|
9,154 |
|
Interest and other expense |
|
|
(303 |
) |
|
|
- |
|
|
|
(303 |
) |
|
|
- |
|
Change in fair value of warrant liability and contingent earn-out
shares |
|
|
115 |
|
|
|
- |
|
|
|
115 |
|
|
|
- |
|
Total other income, net |
|
|
18,789 |
|
|
|
5,077 |
|
|
|
47,294 |
|
|
|
9,154 |
|
Loss before income taxes |
|
|
(161,194 |
) |
|
|
(56,630 |
) |
|
|
(439,891 |
) |
|
|
(249,125 |
) |
Benefit (loss) from income
taxes |
|
|
(343 |
) |
|
|
123 |
|
|
|
3,524 |
|
|
|
420 |
|
Net loss |
|
$ |
(161,537 |
) |
|
$ |
(56,507 |
) |
|
$ |
(436,367 |
) |
|
$ |
(248,705 |
) |
Net loss per share attributable
to common stockholders - basic and diluted |
|
$ |
(1.14 |
) |
|
$ |
(0.63 |
) |
|
$ |
(3.86 |
) |
|
$ |
(3.08 |
) |
Weighted-average common shares
used to compute net loss per share, basic and diluted |
|
|
141,183,907 |
|
|
|
89,158,785 |
|
|
|
113,149,869 |
|
|
|
80,626,525 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
REVOLUTION MEDICINES, INC.SELECTED
CONDENSED CONSOLIDATED BALANCE SHEETS(in
thousands, unaudited) |
|
|
|
|
|
|
|
|
|
|
|
December 31,2023 |
|
|
December 31,2022 |
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and
marketable securities |
|
$ |
1,852,955 |
|
|
$ |
644,943 |
|
Working capital (1) |
|
|
1,735,430 |
|
|
|
598,201 |
|
Total assets |
|
|
2,061,705 |
|
|
|
811,930 |
|
Deferred revenue |
|
|
- |
|
|
|
4,459 |
|
Total liabilities |
|
|
235,511 |
|
|
|
126,742 |
|
Total stockholders' equity |
|
|
1,826,194 |
|
|
|
685,188 |
|
|
|
|
|
|
|
|
|
|
(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)
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