New Data from Interim Analysis of Verastem
Oncology’s RAMP 201 Trial Evaluating Avutometinib and Defactinib in
Recurrent Low-Grade Serous Ovarian Cancer (LGSOC) to be Presented
at the American Society of Clinical Oncology Annual Meeting
Studies of Avutometinib Combinations in KRAS
G12C Mutant Non-Small Lung Cancer, Pancreatic Cancer and Other RAS
Pathway-Driven Cancers Advancing
Strong Financial Position with Company Cash,
Cash Equivalents, and Investments of $111.2 Million as of March 31,
2023
Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company
committed to advancing new medicines for patients with cancer,
today reported financial results for the first quarter ending March
31, 2023, and highlighted recent progress.
“During the first quarter of this year, we announced the
positive results from a planned interim analysis of Part A from our
RAMP 201 trial in LGSOC. This, combined with a productive meeting
with the FDA, has confirmed avutometinib and defactinib as the
go-forward treatment regimen and reaffirmed our goal of filing for
accelerated approval upon data maturity in the RAMP 201 trial and
initiation of a confirmatory study,” said Brian Stuglik, Chief
Executive Officer of Verastem Oncology. “We believe we are well
positioned to deliver on our 2023 goals to initiate a confirmatory
study of avutometinib and defactinib in recurrent LGSOC upon
agreement with the FDA on study design, advance our KRAS G12C
mutant NSCLC program and our frontline metastatic pancreatic cancer
and progress our signal-finding, investigator-initiated trial
program of combinations with avutometinib in additional RAS
pathway-driven cancers with high unmet need.”
First Quarter 2023 and Recent Highlights
Low Grade Serous Ovarian Cancer (LGSOC)
- The Company held a productive meeting with the FDA to discuss
the encouraging results to date of the ongoing RAMP 201 LGSOC trial
evaluating avutometinib ± defactinib among patients with recurrent
LGSOC, confirmed the go-forward treatment regimen selection of
avutometinib with defactinib based on a planned interim analysis
with prespecified criteria and discussed the regulatory path
forward.
- Completed enrollment in the primary cohort of 72 patients in
the combination arm of RAMP 201. Continued enrollment in the
combination arm of RAMP 201 is ongoing to expand the clinical
experience in anticipation of initiation of a confirmatory
study.
- Announced RAMP 201 abstract highlighting updated interim
results from Part A of the ongoing Phase 2, registration-directed
RAMP 201 trial has been selected for a presentation in a Poster
Discussion Session at the upcoming American Society of Clinical
Oncology (ASCO) Annual Meeting taking place June 2–6, 2023 in
Chicago, IL.
- Launched Let’s Talk About LGSOC, a new patient initiative that
provides detailed information about LGSOC and its symptoms, its
differences from the more common high-grade serous ovarian cancer
(HGSOC), tips and resources, and ways to connect with others in the
LGSOC community. The initiative, developed with advocacy groups,
clinicians, and patients, serves to bring broader attention to this
rare and underserved ovarian cancer.
Other Programs
- In the Company’s RAMP 203 and RAMP 204 Phase 1/2 clinical
trials, the combinations of avutometinib with Amgen’s LUMAKRAS®
(sotorasib) (RAMP 203) and with Mirati’s KRAZATI® (adagrasib) (RAMP
204) are evaluated in patients with KRAS G12C mutant NSCLC. RAMP
203 progressed to the recommendation of the Phase 2 dose
(avutometinib 4 mg BIW PO and sotorasib 960 mg QD PO) and
initiation of Part B dose expansion in patients who are G12C
inhibitor treatment naïve and in patients who experienced disease
progression on prior G12C inhibitor monotherapy. Dose escalation is
ongoing in RAMP 204.
- Opened and began enrollment in the Company’s RAMP 205 Phase
1b/2 clinical trial evaluating avutometinib and defactinib in
combination with standard of care chemotherapy (GEMZAR®
(gemcitabine) and ABRAXANE®) in patients with metastatic
adenocarcinoma of the pancreas. The trial is supported by the
Company’s receipt of the first “Therapeutic Accelerator Award” from
the Pancreatic Cancer Action Network (PanCAN).
- Opened and began enrollment in two new investigator sponsored
trials to support our avutometinib clinical trial program. One
trial investigating the use of avutometinib and defactinib in
advanced or recurrent mesonephric gynecologic cancers being
conducted by Dr Rachel Grisham at Memorial Sloan Kettering Cancer
Center. The other trial, investigating the single-dose brain
penetration of either avutometinib or defactinib in glioblastoma
patients who are undergoing debulking surgery being conducted by Dr
Jeffrey Olson at Emory University.
Corporate Updates
- The Company entered into a definitive agreement to sell up to
approximately 2.1 million shares of its Series B convertible
preferred stock to affiliates of BVF Partners L.P. in a private
placement to raise aggregate gross proceeds of up to approximately
$60 million in two tranches. On January 27, 2023, Verastem Oncology
closed on the initial tranche of 1.2 million shares of its Series B
convertible preferred stock and received gross proceeds of $30
million.
- The Company achieved the Term B Milestone pursuant to its
credit facility with Oxford Finance LLC and drew down an additional
$15 million in March 2023. Under the credit facility, Verastem can
access up to an additional $110 million in a series of tranches,
$60 million of which are based on certain pre-determined milestones
and $50 million of which are at the lender’s discretion.
First Quarter 2023 Financial Results
Verastem Oncology ended the first quarter of 2023 with cash,
cash equivalents and investments of $111.2 million.
Total operating expenses for the three months ended March 31,
2023 (the “2023 Quarter”) were $19.3 million, compared to $19.6
million for the three months ended March 31, 2022 (the “2022
Quarter”).
Research & development expenses for the 2023 Quarter were
$12.0 million, compared to $13.6 million for the 2022 Quarter. The
decrease of $1.6 million, or 11.8%, primarily resulted from a
decrease in drug product and drug substance costs, contract
research organization costs, and investigator fees.
Selling, general & administrative expenses for the 2023
Quarter were $7.3 million, compared to $5.9 million for the 2022
Quarter. The increase of $1.4 million, or 23.7%, was primarily
related to increased costs associated with financing activities,
and additional costs in anticipation of potential launch of
avutometinib and defactinib in LGSOC.
Net loss for the 2023 Quarter was $15.7 million, or $0.08 per
share (basic and diluted), compared to net loss of $17.0 million,
or $0.09 per share (basic and diluted) for the 2022 Quarter.
For the 2023 Quarter, non-GAAP adjusted net loss was $17.8
million, or $0.09 per share (diluted), compared to non-GAAP
adjusted net loss of $15.3 million, or $0.08 per share (diluted)
for the 2022 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 and non-GAAP adjusted net loss 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, 2023,
and 2022 are included in the tables accompanying this press release
after the unaudited condensed consolidated financial
statements.
About Avutometinib (VS-6766)
Avutometinib 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. Avutometinib is currently in late-stage
development.
In contrast to other MEK inhibitors, avutometinib blocks both
MEK kinase activity and the ability of RAF to phosphorylate MEK.
This unique mechanism allows avutometinib 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 clamp
avutometinib, 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.
Verastem Oncology is currently conducting clinical trials with
its RAF/MEK clamp avutometinib in RAS- driven tumors as part of its
(Raf And Mek Program). RAMP 201 is a
registration-directed trial of avutometinib in combination with
defactinib in patients with recurrent LGSOC. Verastem Oncology has
established clinical collaborations with Amgen and Mirati to
evaluate LUMAKRAS® (sotorasib) and KRAZATI® (adagrasib) in
combination with avutometinib in KRAS G12C mutant NSCLC as part of
the RAMP 203 and RAMP 204 trials, respectively. As part of the
“Therapeutic Accelerator Award” Verastem Oncology received from
PanCAN, Verastem Oncology is conducting RAMP 205, a Phase 1b/2
clinical trial evaluating avutometinib and defactinib with
gemcitabine/nab-paclitaxel in patients with front-line metastatic
pancreatic cancer.
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 its financial condition, its potential
borrowings, the potential clinical value of various of its clinical
trials, the timing of commencing and completing trials, including
topline data reports and interactions with regulators. 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 avutometinib in combination with other
compounds, including defactinib, LUMAKRAS® 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 trial design, labeling and
other matters that could affect the timing, 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, including as a result of conducting
additional studies; that we or Chugai Pharmaceutical Co., Ltd. will
fail to fully perform under the avutometinib 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 will achieve the milestones
that result in payments to us under our asset purchase agreement
with Secura; that we will be unable to execute on our partnering
strategies for avutometinib 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 Verastem Oncology’s Annual Report on Form
10-K for the year ended December 31, 2022 as filed with the
Securities and Exchange Commission (SEC) on March 14, 2023 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 Verastem Oncology 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.
Verastem Oncology
Condensed Consolidated Balance
Sheets
(in thousands)
(unaudited)
March 31,
December 31,
2023
2022
Cash, cash equivalents, &
investments
$
111,204
$
87,894
Accounts receivable, net
—
31
Prepaid expenses and other current
assets
7,689
4,945
Property and equipment, net
62
92
Right-of-use asset, net
1,645
1,789
Restricted cash and other assets
277
299
Total assets
$
120,877
$
95,050
Current Liabilities
$
22,359
$
21,663
Long term debt
39,574
24,526
Lease liability, long-term
1,250
1,470
Preferred stock tranche liability
3,510
—
Convertible preferred stock
21,159
—
Stockholders’ equity
33,025
47,391
Total liabilities, convertible
preferred stock and stockholders’ equity
$
120,877
$
95,050
Verastem Oncology
Condensed Consolidated
Statements of Operations
(in thousands, except per share
amounts)
(unaudited)
Three months ended March
31,
2023
2022
Revenue:
Sale of COPIKTRA license and related
assets revenue
$
—
$
2,596
Total revenue
—
2,596
Operating expenses:
Research and development
12,015
13,642
Selling, general and administrative
7,329
5,934
Total operating expenses
19,344
19,576
Loss from operations
(19,344
)
(16,980
)
Other income (expense)
(7
)
28
Interest income
976
46
Interest expense
(769
)
(56
)
Change in fair value of preferred stock
tranche liability
3,430
—
Net loss
$
(15,714
)
$
(16,962
)
Net loss per share—basic and
diluted
$
(0.08
)
$
(0.09
)
Weighted average common shares outstanding
used in computing:
Net loss per share – basic and diluted
200,679
186,264
Verastem Oncology
Reconciliation of GAAP to
Non-GAAP Financial Information
(in thousands, except per share
amounts)
(unaudited)
Three months ended March
31,
2023
2022
Net loss reconciliation
Net loss (GAAP basis)
$
(15,714
)
$
(16,962
)
Adjust:
Stock-based compensation expense
1,313
1,646
Non-cash interest, net
(36
)
17
Change in fair value of preferred stock
tranche liability
(3,430
)
—
Severance and other
38
—
Adjusted net loss (non-GAAP
basis)
$
(17,829
)
$
(15,299
)
Reconciliation of net loss per
share
Net loss per share – diluted (GAAP
basis)
$
(0.08
)
$
(0.09
)
Adjust per diluted share
Stock-based compensation expense
0.01
0.01
Non-cash interest, net
—
—
Change in fair value of preferred stock
tranche liability
(0.02
)
—
Severance and other
—
—
Adjusted net loss per share –
diluted
(non-GAAP basis)
$
(0.09
)
$
(0.08
)
Weighted average common shares
outstanding used in computing net loss per
share—diluted
200,679
186,264
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230509005047/en/
Investors:
Dan Calkins +1 781-469-1694 dcalkins@verastem.com
Nate LiaBraaten +1 212-600-1902 nate@argotpartners.com
Media: Lisa Buffington +1 781-292-4205
lbuffington@verastem.com
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