Company Reported Interim Findings from RAMP 201
Trial of VS-6766 +/- Defactinib in Low-Grade Serous Ovarian Cancer;
Continued Evaluation of Both Monotherapy and Combination Therapy
with Timing of Go Forward Treatment Regimen Selection Driven by
Data Maturity
Verastem Oncology Awarded Pancreatic Cancer
Action Network’s First Therapeutic Accelerator Award to Evaluate
the Combination of VS-6766 and Defactinib in Addition to Standard
of Care Chemotherapy in Front-Line Metastatic Pancreatic Cancer
U.S. Patent and Trademark Office Granted Patent
for Novel VS-6766 Dosing Regimen for Cancers with KRAS/NRAS/HRAS
Mutations; Extending Patent Protection Through 2038
Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company
committed to advancing new medicines for patients with cancer,
today reported financial results for the three months ended June
30, 2022, and highlighted recent progress.
“In the second quarter, we announced findings from the interim
analysis of our registration-directed RAMP 201 trial in low-grade
serous ovarian cancer and are encouraged by the anti-tumor activity
that we have seen to date in patients with both KRAS mutant and
KRAS wild-type tumors. We look forward to evaluating a more mature
data set to select the go forward regimen.” said Brian Stuglik, CEO
of Verastem Oncology. “We also advanced our broader development
program, including being honored by the Pancreatic Cancer Network
as the first recipient of their Therapeutic Accelerator Award. This
award will support a Phase 1b/2 clinical trial evaluating VS-6766
and defactinib in addition to standard of care chemotherapy in
front-line metastatic pancreatic cancer. The goal of the trial is
to increase response rate and survival through a more complete
blockade of tumorigenic signaling.”
Second Quarter 2022 and Recent Highlights
Low Grade Serous Ovarian Cancer (LGSOC)
- Verastem Oncology completed a planned interim analysis of the
registration-directed RAMP 201 trial with the goal of selecting a
go forward treatment regimen of either VS-6766 monotherapy or
VS-6766 in combination with defactinib. The analysis indicated
encouraging efficacy results with confirmed responses by
independent review in patients treated with VS-6766 monotherapy and
patients treated with VS-6766 in combination with defactinib. The
findings also include confirmed responses by independent review in
both KRAS mutant and KRAS wild-type LGSOC. To date, there have been
no additional safety signals with a continued favorable safety
profile in both the monotherapy and combination treatment arms with
approximately 6% of patients discontinuing due to adverse
events.
- With approximately 80% of patients in the RAMP 201 study
remaining on study treatment with a median duration of follow-up of
four months, data from the interim analysis were not mature enough
to make a final decision on the go forward treatment regimen and
the trial continues with all four cohorts. The Company plans to
complete enrollment of all four cohorts of the trial in the second
half of this year. Each cohort is expected to have approximately 36
patients for a total of 144 patients.
KRAS Mutant Non-Small Cell Lung Cancer (NSCLC)
- The registration-directed RAMP 202 study investigating VS-6766
alone and in combination with defactinib continues to enroll
patients with V600E or non-V600E BRAF mutations. Planned enrollment
is complete in the selection phase (Part A; n=32) in patients with
KRAS G12V-mutant NSCLC. Enrollment has also been completed in the
non-G12V mutant cohort in the selection phase (Part A). The Company
expects to report topline results from Part A, initiate Part B and
discuss the data with regulatory authorities during the second half
of 2022.
- The Phase 1/2 RAMP 204 clinical trial evaluating VS-6766 in
combination with Mirati’s adagrasib in KRAS G12C-mutant NSCLC
opened and is enrolling participants.
- The Phase 1/2 RAMP 203 clinical trial evaluating VS-6766 in
combination with Amgen’s LUMAKRASTM (sotorasib) in KRAS G12C-mutant
NSCLC continues to enroll and initial results are expected to be
reported during the second half of 2022.
Corporate Updates
- The U.S Patent and Trademark Office has granted Patent No.
11,400,090 which covers the novel, intermittent twice-weekly dosing
regimen used in the VS-6766 development program. This extends the
current patent protection for VS-6766 in RAS-driven cancers
(KRAS/NRAS/HRAS mutations) to 2038.
- The Company received the first “Therapeutic Accelerator Award”
from the Pancreatic Cancer Network (PanCAN). The award will support
a Phase 1b/2 clinical trial of the Company’s lead investigational
candidates, RAF/MEK Clamp, or VS-6766, with FAK inhibitor,
defactinib to evaluate whether a more complete blockade of KRAS
signaling in addition to standard of care chemotherapy will improve
outcomes for patients with front-line metastatic pancreatic cancer.
KRAS mutations occurs in more than 95% of pancreatic cancer
tumors.
- Results from a Phase 1 investigator-initiated trial evaluating
RAF/MEK clamp VS-6766 in combination with everolimus presented at
the American Society of Clinical Oncology (ASCO) found encouraging
responses across various RAS-driven tumor types as well as a
tolerable intermittent dosing schedule. The data also included a
median progression-free survival interval of 6.3 months in KRAS
mutant NSCLC and median progression-free survival of 35.8 and 41.8
months in two enrolled patients with KRAS mutant LGSOC,
respectively. The trial is continuing with an ongoing expansion
cohort for patients with KRAS mutant NSCLC.
Second Quarter 2022 Financial Results
Verastem Oncology ended the second quarter 2022 with cash, cash
equivalents and investments of $94.3 million. With proceeds
available upon achievement of certain milestones from the Oxford
Finance LLC credit facility and expected milestones and royalties
from the sale of COPIKTRA, Verastem Oncology expects that it has a
cash runway until at least 2025 to deliver on the current programs
for VS-6766 and defactinib, including expenditures and development
in LGSOC and KRAS mutant NSCLC.
Total revenue for the three months ending June 30, 2022 (2022
Quarter) was $0.0 million, compared to $0.5 million for the three
months ended June 30, 2021 (2021 Quarter).
Total operating expenses for the 2022 Quarter were $21.4
million, compared to $16.4 million for the 2021 Quarter.
Research & development expenses for the 2022 Quarter were
$14.9 million, compared to $9.7 million for the 2021 Quarter. The
increase of $5.2 million, or 53.6%, primarily resulted from an
increase in drug product and drug substance costs, contract
research organization costs and investigator fees.
Selling, general & administrative expenses for the 2022
Quarter were $6.5 million, compared to $6.7 million for the 2021
Quarter. The decrease of $0.2 million, or 3.0%, primarily resulted
from lower consulting and professional fees.
Net loss for the 2022 Quarter was $22.0 million, or $0.12 per
share (basic and diluted), compared to net loss of $16.9 million,
or $0.10 per share (basic and diluted), for the 2021 Quarter.
For the 2022 Quarter, non-GAAP adjusted net loss was $20.1
million, or $0.11 per share (diluted), compared to non-GAAP
adjusted net loss of $14.0 million, or $0.08 per share (diluted),
for the 2021 Quarter. Please refer to the GAAP to Non-GAAP
Reconciliation attached to this press release.
Use of Non-GAAP Financial Measures
To supplement Verastem Oncology’s condensed consolidated
financial statements, which are prepared and presented in
accordance with generally accepted accounting principles in the
United States (GAAP), the Company uses the following non-GAAP
financial measures in this press release: non-GAAP adjusted net
(loss) income and non-GAAP net (loss) income per share. These
non-GAAP financial measures exclude certain amounts or expenses
from the corresponding financial measures determined in accordance
with GAAP. Management believes this non-GAAP information is useful
for investors, taken in conjunction with the Company’s GAAP
financial statements, because it provides greater transparency and
period-over-period comparability with respect to the Company’s
operating performance and can enhance investors’ ability to
identify operating trends in the Company’s business. Management
uses these measures, among other factors, to assess and analyze
operational results and trends and to make financial and
operational decisions. Non-GAAP information is not prepared under a
comprehensive set of accounting rules and should only be used to
supplement an understanding of the Company’s operating results as
reported under GAAP, not in isolation or as a substitute for, or
superior to, financial information prepared and presented in
accordance with GAAP. In addition, these non-GAAP financial
measures are unlikely to be comparable with non-GAAP information
provided by other companies. The determination of the amounts that
are excluded from non-GAAP financial measures is a matter of
management judgment and depends upon, among other factors, the
nature of the underlying expense or income amounts. Reconciliations
between these non-GAAP financial measures and the most comparable
GAAP financial measures for the three and six months ended June 30,
2022, and 2021 are included in the tables accompanying this press
release after the unaudited condensed consolidated financial
statements.
About VS-6766
VS-6766 (formerly known as CH5126766 and RO5126766) is a RAF/MEK
clamp that induces inactive complexes of MEK with ARAF, BRAF and
CRAF potentially creating a more complete and durable anti-tumor
response through maximal RAS pathway inhibition. VS-6766 is
currently in late-stage development.
In contrast to other MEK inhibitors, VS-6766 blocks both MEK
kinase activity and the ability of RAF to phosphorylate MEK. This
unique mechanism allows VS-6766 to block MEK signaling without the
compensatory activation of MEK that appears to limit the efficacy
of other inhibitors. The U.S. Food and Drug Administration granted
Breakthrough Therapy designation for the combination of Verastem
Oncology’s investigational RAF/MEK inhibitor VS-6766, with
defactinib, its FAK inhibitor, for the treatment of all patients
with recurrent low-grade serous ovarian cancer (LGSOC) regardless
of KRAS status after one or more prior lines of therapy, including
platinum-based chemotherapy.1
Verastem Oncology is conducting Phase 2 registration-directed
trials of VS-6766 alone and with defactinib in patients with
recurrent LGSOC and in patients with recurrent KRAS G12V-mutant
NSCLC as part of its RAMP (Raf And Mek Program) clinical trials,
RAMP 201 and RAMP 202, respectively. Verastem Oncology has also
established clinical collaborations with Amgen and Mirati to
evaluate LUMAKRAS™ (sotorasib) and adagrasib in combination with
VS-6766 in KRAS G12C-mutant NSCLC as part of the RAMP 203 and RAMP
204 trials, respectively.
About Verastem Oncology
Verastem Oncology (Nasdaq: VSTM) is a development-stage
biopharmaceutical company committed to the development and
commercialization of new medicines to improve the lives of patients
diagnosed with cancer. Our pipeline is focused on novel small
molecule drugs that inhibit critical signaling pathways in cancer
that promote cancer cell survival and tumor growth, including
RAF/MEK inhibition and focal adhesion kinase (FAK) inhibition. For
more information, please visit www.verastem.com.
Forward-Looking Statements Notice
This press release includes forward-looking statements about
Verastem Oncology’s strategy, future plans and prospects, including
statements related to cash runway, the potential clinical value of
various of its clinical trials, the timing of commencing and
completing trials, including topline data reports, and potential
for additional development programs involving Verastem Oncology’s
lead compound. The words "anticipate," "believe," "estimate,"
"expect," "intend," "may," "plan," "predict," "project," "target,"
"potential," "will," "would," "could," "should," "continue," “can,”
“promising” and similar expressions are intended to identify
forward-looking statements, although not all forward-looking
statements contain these identifying words. Each forward-looking
statement is subject to risks and uncertainties that could cause
actual results to differ materially from those expressed or implied
in such statement.
Applicable risks and uncertainties include the risks and
uncertainties, among other things, regarding: the success in the
development and potential commercialization of our product
candidates, including VS-6766 in combination with other compounds,
including defactinib, LUMAKRASTM and others; the occurrence of
adverse safety events and/or unexpected concerns that may arise
from additional data or analysis or result in unmanageable safety
profiles as compared to their levels of efficacy; our ability to
obtain, maintain and enforce patent and other intellectual property
protection for our product candidates; the scope, timing, and
outcome of any legal proceedings; decisions by regulatory
authorities regarding labeling and other matters that could affect
the availability or commercial potential of our product candidates;
whether preclinical testing of our product candidates and
preliminary or interim data from clinical trials will be predictive
of the results or success of ongoing or later clinical trials; that
the timing, scope and rate of reimbursement for our product
candidates is uncertain; that third-party payors (including
government agencies) may not reimburse; that there may be
competitive developments affecting our product candidates; that
data may not be available when expected; that enrollment of
clinical trials may take longer than expected; that our product
candidates will experience manufacturing or supply interruptions or
failures; that we will be unable to successfully initiate or
complete the clinical development and eventual commercialization of
our product candidates; that the development and commercialization
of our product candidates will take longer or cost more than
planned; that we or Chugai Pharmaceutical Co., Ltd. will fail to
fully perform under the VS-6766 license agreement; that we or our
other collaboration partners may fail to perform under our
collaboration agreements; that we may not have sufficient cash to
fund our contemplated operations; that we may be unable to obtain
adequate financing in the future through product licensing,
co-promotional arrangements, public or private equity, debt
financing or otherwise; that Secura Bio, Inc. will achieve the
milestones that result in payments to us under our asset purchase
agreement with Secura Bio, Inc.; that we will be unable to execute
on our partnering strategies for VS-6766 in combination with other
compounds; that we will not pursue or submit regulatory filings for
our product candidates; and that our product candidates will not
receive regulatory approval, become commercially successful
products, or result in new treatment options being offered to
patients.
Other risks and uncertainties include those identified under the
heading “Risk Factors” in the Company’s Annual Report on Form 10-K
for the year ended December 31, 2021 as filed with the Securities
and Exchange Commission (SEC) on March 28, 2022 and in any
subsequent filings with the SEC. The forward-looking statements
contained in this press release reflect Verastem Oncology’s views
as of the date hereof, and the Company does not assume and
specifically disclaims any obligation to update any forward-looking
statements whether as a result of new information, future events or
otherwise, except as required by law.
References
1 Verastem Oncology Press Release. Verastem Oncology Receives
Breakthrough Therapy Designation for VS-6766 with Defactinib in
Recurrent Low-Grade Serous Ovarian Cancer. May 24, 2021. Available
at:
https://investor.verastem.com/news-releases/news-release-details/verastem-oncology-receives-breakthrough-therapy-designation-vs.
Accessed March 2022.
Verastem Oncology
Condensed Consolidated Balance
Sheets
(in thousands)
(unaudited)
June 30,
December 31,
2022
2021
Cash, cash equivalents, &
investments
$
94,307
$
100,256
Accounts receivable, net
131
516
Prepaid expenses and other current
assets
3,437
4,968
Property and equipment, net
151
210
Right-of-use asset, net
2,058
2,302
Restricted cash and other assets
325
410
Total assets
$
100,409
$
108,662
Current Liabilities
$
20,092
$
18,590
Convertible senior notes
262
249
Long term debt
24,276
—
Lease Liability, long-term
1,887
2,264
Stockholders’ equity
53,892
87,559
Total liabilities and stockholders’
equity
$
100,409
$
108,662
Verastem Oncology
Condensed Consolidated
Statements of Operations
(in thousands, except per share
amounts)
(unaudited)
Three months ended June
30,
Six months ended June
30,
2022
2021
2022
2021
Revenue:
Sale of COPIKTRA license and related
assets revenue
$
—
$
52
$
2,596
$
902
Transition services revenue
—
448
—
604
Total revenue
—
500
2,596
1,506
Operating expenses:
Research and development
14,888
9,730
28,530
18,626
Selling, general and administrative
6,514
6,714
12,448
12,932
Total operating expenses
21,402
16,444
40,978
31,558
Loss from operations
(21,402)
(15,944)
(38,382)
(30,052)
Other expense
6
—
34
—
Interest income
84
49
130
101
Interest expense
(640)
(1,007)
(696)
(1,982)
Net loss
$
(21,952)
$
(16,902)
$
(38,914)
$
(31,933)
Net loss per share—basic and diluted
$
(0.12)
$
(0.10)
$
(0.21)
$
(0.19)
Weighted average common shares outstanding
used in computing:
Net loss per share – basic and diluted
186,463
171,985
186,364
171,811
Verastem Oncology
Reconciliation of GAAP to
Non-GAAP Financial Information
(in thousands, except per share
amounts)
(unaudited)
Three months ended June
30,
Six months ended June
30,
2022
2021
2022
2021
Net loss reconciliation
Net loss (GAAP basis)
$
(21,952)
$
(16,902)
$
(38,914)
$
(31,933)
Adjust:
Stock-based compensation expense
1,758
2,170
3,404
4,150
Non-cash interest, net
94
692
111
1,328
Adjusted net loss (non-GAAP
basis)
$
(20,100)
$
(14,040)
$
(35,399)
$
(26,455)
Reconciliation of net loss per
Share
Net loss per share – diluted (GAAP
Basis)
(0.12)
(0.10)
(0.21)
(0.19)
Adjust per diluted share:
Stock-based compensation expense
0.01
0.01
0.02
0.03
Non-cash interest, net
—
0.01
—
0.01
Adjusted net loss per share –
diluted
(non-GAAP basis)
$
(0.11)
$
(0.08)
$
(0.19)
$
(0.15)
Weighted average common shares outstanding
used in computing net loss per share—diluted
186,463
171,985
186,364
171,811
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220808005195/en/
Investors: Dan Calkins +1 781-469-1694 Investor Relations
dcalkins@verastem.com
Nate LiaBraaten +1 212-600-1902 nate@argotpartners.com
Media: Lisa Buffington Corporate Communications +1
781-292-4205 lbuffington@verastem.com
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