Enrollment Completed in Selection Phases (Part
A) of RAMP 201 and RAMP 202 Evaluating VS-6766 +/- Defactinib for
the Treatment of Low-Grade Serous Ovarian Cancer and KRAS G12V
Mutant Non-Small Cell Lung Cancer
Company Secured up to $150 Million in
Non-Dilutive Funding from Oxford Finance LLC; Expected Cash Runway
Through 2025 to Support Continued Development and Potential
Commercial Launches of VS-6766 and Defactinib
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 March
31, 2022 and highlighted recent progress.
“In the first quarter of this year, we made significant progress
building on our breakthrough therapy designation in recurrent
low-grade serous ovarian cancer and advancing our development
programs and scientific platform to establish VS-6766 as the
backbone therapy for RAS-driven solid tumors. This includes
completing enrollment for the selection phase of both our RAMP 201
trial in low-grade serous ovarian cancer and our RAMP 202 trial in
KRAS G12V-mutant non-small cell lung cancer, with topline results
planned for the second quarter and the second half of this year,
respectively. Further, we initiated enrollment in the Phase 1/2
trial with Amgen to evaluate VS-6766 in combination with LUMAKRASTM
(sotorasib) in patients with KRAS G12C-mutant non-small lung
cancer,” said Brian Stuglik, Chief Executive Officer of Verastem
Oncology. “At the same time, we strengthened our flexibility by
entering into a term loan facility with Oxford, which combined with
our financial resources will allow us to effectively advance our
current development and commercial objectives, working to bring
VS-6766 and defactinib to patients with high unmet needs.”
First Quarter 2022 and Recent Highlights
Low Grade Serous Ovarian Cancer (LGSOC)
- Planned enrollment is complete in the selection phase (Part A;
n=64) of the registration-directed Phase 2 RAMP 201 study
investigating VS-6766 alone or in combination with defactinib for
the treatment of recurrent LGSOC. Verastem plans to report topline
results from Part A during the second quarter of 2022, following
discussions with regulatory authorities.
- Enrollment has commenced in the expansion phase (Part B) of
RAMP 201, with both treatment arms (VS-6766 alone and in
combination with defactinib) currently advancing in all patients.
Verastem expects to complete enrollment in Part B during the second
half of 2022.
- Translational data presented at the American Association for
Cancer Research (AACR) meeting in April provided mechanistic
insights into the encouraging response rates and progression free
survival observed in patients with LGSOC treated with VS-6766 with
defactinib in the investigator-initiated FRAME study. These data
support the ongoing registration-directed Phase 2 RAMP 201 study
assessing VS-6766 with defactinib for patients with LGSOC
regardless of KRAS status.
KRAS Mutant Non-Small Cell Lung Cancer (NSCLC)
- Planned enrollment is now complete in the selection phase (Part
A; n=32) of the registration-directed RAMP 202 study investigating
VS-6766 alone and in combination with defactinib in patients with
KRAS G12V-mutant NSCLC. Enrollment has also been completed in the
non-G12Vmutant cohort in the expansion phase (Part B). The Company
expects to report topline results from Part A and initiate Part B
during the second half of 2022, following discussions with
regulatory authorities.
- Based on preclinical rationale, Verastem has added BRAF-mutant
cohorts to the RAMP 202 study to efficiently evaluate VS-6766 with
defactinib in BRAF-mutant NSCLC. In Part A of the study, the
Company expects to enroll two cohorts comprised of 15 patients each
to evaluate the combination in patients with V600E or non V600E
BRAF mutations, respectively. These cohorts are open and
enrolling.
- The Phase 1/2 RAMP 203 study evaluating VS-6766 in combination
with Amgen’s LUMAKRASTM (sotorasib) in G12C-mutant NSCLC opened and
is enrolling. The initial results are expected to be reported
during the second half of 2022.
Corporate Updates
- Secured debt facility with Oxford Finance LLC for up to $150
Million. Under the terms of the credit facility with Oxford Finance
LLC, Verastem drew an initial $25 million term loan at closing. The
Company has the ability to access up to an additional $125 million
in a series of tranches, $75 million of which is based on certain
pre-determined milestones and $50 million of which is available at
the lender’s discretion.
- With the credit facility and expected milestones related to the
sale of COPIKTRA® (duvelisb) to Secura Bio Inc. (Secura) in 2020,
the Company expects to have a cash runway through 2025 to support
the continued development and potential commercial launches of
VS-6766 and defactinib.
- Secura sublicensee, CSPC Pharmaceutical Group Limited (CSPC),
obtained drug registration approval for duvelisib granted by the
National Medical Products Administration of the People’s Republic
of China for the treatment of adult patients with relapsed or
refractory follicular lymphoma after at least two prior systematic
therapies, which entitles Verastem to a $2.5 million milestone
payment.
- Preclinical data presented at the American Association for
Cancer Research (AACR) meeting in April continued to support the
versatility of VS-6766 in RAS-driven tumors, including KRAS
G12C-mutant NSCLC, low-grade serous ovarian cancer and cutaneous
melanoma.
First Quarter 2022 Financial Results
Verastem Oncology ended the first quarter 2022 with cash, cash
equivalents and investments of $106.3 million.
Total revenue for the three months ending March 31, 2022 (2022
Quarter) was $2.6 million, compared to $1.0 million for the three
months ended March 31, 2021 (2021 Quarter). Revenue for the 2022
Quarter was primarily comprised of one regulatory milestone for
$2.5 million achieved by Secura’s sublicensee, CSPC. Revenue for
the 2021 Quarter was primarily comprised of one regulatory
milestone for $0.8 million achieved by Secura’s sublicensee,
Sanofi.
Total operating expenses for the 2022 Quarter were $19.6
million, compared to $15.1 million for the 2021 Quarter.
Research & development expenses for the 2022 Quarter were
$13.6 million, compared to $8.9 million for the 2021 Quarter. The
increase of $4.7 million, or 52.8%, 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 $5.9 million, compared to $6.2 million for the 2021
Quarter. The decrease of $0.3 million, or 4.8%, primarily resulted
from lower consulting and professional fees.
Net loss for the 2022 Quarter was $17.0 million, or $0.09 per
share (basic and diluted), compared to net loss of $15.0 million,
or $0.09 per share (basic and diluted), for the 2021 Quarter.
For the 2022 Quarter, non-GAAP adjusted net loss was $15.3
million, or $0.08 per share (diluted), compared to non-GAAP
adjusted net loss of $12.4 million, or $0.07 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 months ended March 31, 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 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 will achieve the milestones
that result in payments to us under our asset purchase agreement
with Secura Bio; 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 May 2022.
Verastem Oncology
Condensed Consolidated Balance
Sheets
(in thousands)
(unaudited)
March 31,
December 31,
2022
2021
Cash, cash equivalents, &
investments
$
106,278
$
100,256
Accounts receivable, net
2,644
516
Prepaid expenses and other current
assets
4,517
4,968
Property and equipment, net
180
210
Right-of-use asset, net
2,183
2,302
Restricted cash and other assets
346
410
Total assets
$
116,148
$
108,662
Current Liabilities
$
16,886
$
18,590
Convertible senior notes
255
249
Long term debt
24,157
—
Lease Liability, long-term
2,079
2,264
Stockholders’ equity
72,771
87,559
Total liabilities and stockholders’
equity
$
116,148
$
108,662
Verastem Oncology
Condensed Consolidated
Statements of Operations
(in thousands, except per share
amounts)
(unaudited)
Three months ended March
31,
2022
2021
Revenue:
Sale of COPIKTRA license and related
assets revenue
$
2,596
$
850
Transition services revenue
—
156
Total revenue
2,596
1,006
Operating expenses:
Research and development
13,642
8,896
Selling, general and administrative
5,934
6,218
Total operating expenses
19,576
15,114
Loss from operations
(16,980
)
(14,108
)
Other income
28
—
Interest income
46
52
Interest expense
(56
)
(975
)
Net loss
$
(16,962
)
$
(15,031
)
Net loss per share—basic and diluted
$
(0.09
)
$
(0.09
)
Weighted average common shares outstanding
used in computing:
Net loss per share – basic and diluted
186,264
171,586
Verastem, Oncology
Reconciliation of GAAP to
Non-GAAP Financial Information
(in thousands, except per share
amounts)
(unaudited)
Three months ended March
31,
2022
2021
Net loss reconciliation
Net loss (GAAP basis)
$
(16,962
)
$
(15,031
)
Adjust:
Stock-based compensation expense
1,646
1,980
Non-cash interest, net
17
636
Adjusted net loss (non-GAAP
basis)
$
(15,299
)
$
(12,415
)
Reconciliation of net loss per
share
Net loss per share – diluted (GAAP
Basis)
$
(0.09
)
$
(0.09
)
Adjust per diluted share:
Stock-based compensation expense
0.01
0.01
Non-cash interest, net
—
0.01
Adjusted net loss per share –
diluted
(non-GAAP Basis)
$
(0.08
)
$
(0.07
)
Weighted average common shares outstanding
used in computing net loss per share—diluted
186,264
171,586
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220509005801/en/
Investors: Ajay Munshi Vice President, Corporate
Development +1 781-469-1579 amunshi@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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