Conference call scheduled today at 9:00 a.m.
ET
ArQule, Inc. (Nasdaq: ARQL) today announced its financial
results for the second quarter of 2019.
For the quarter ended June 30, 2019, the Company reported a net
loss of $9.1 million, or $0.08 per basic share, compared with net
income of $5.2 million, or $0.05 per diluted share, for the quarter
ended June 30, 2018.
As of June 30, 2019, the Company had a total of approximately
$182.8 million in cash, cash equivalents, and marketable
securities.
Key Highlights from Q2,
2019
- In June 2019, the Company raised approximately $104 million of
gross proceeds in a public offering of common stock. Net proceeds
will be used to fund clinical programs and for general corporate
purposes
- ARQ 531, our potent and reversible dual inhibitor of both
wild-type and C481S-mutant BTK.
- Presented first-of-its kind clinical proof-of-concept data at
the 2019 European Hematology Association (EHA) Annual meeting from
the ongoing phase 1 trial, including 4 Partial Responses (PRs) out
of 6 evaluable CLL patients in the 65 mg QD dose cohort, a PR in a
Richter’s transformation patient at the same dose and a PR in a
follicular lymphoma patient on therapy for approximately two years.
Subsequent to the EHA presentation an additional PR was observed in
a DLBCL patient and was disclosed in the context of the recent
public offering
- Selected 65 mg QD as the recommended starting phase 2 dose
(RP2D) after assessing incremental clinical activity and
tolerability data from cohorts 7 (65 mg QD) and 8 (75 mg QD); no
additional dose limiting toxicities have been observed and a
maximum tolerated dose has not been reached
- Commenced preparations for the next phase of development,
including planned regulatory interactions and design of expansion
cohorts at the RP2D in multiple B-Cell malignancies, including
C481S mutant CLL
- Miransertib, our potent and selective first-generation AKT
inhibitor.
- Presented updated Proteus syndrome and PIK3CA-related
Overgrowth Spectrum (PROS) data at the 2019 European Society of
Human Genetics conference in Gothenburg, Sweden
- Finalized the registrational protocol, received initial IRB
approvals, nearing dosing of first patient
- ARQ 751, our highly potent and selective next-generation AKT
inhibitor.
- Continued the signal generation work in genetically-defined
solid tumors
- Derazantinib, our FGFR inhibitor, partnered with Basilea and
Sinovant, in a registrational trial for intrahepatic
cholangiocarcinoma.
- Clinical activities ongoing with our partners, Basilea and
Sinovant
Paolo Pucci, Chief Executive Officer of ArQule, commented, “Our
second quarter was punctuated by the proof-of-concept data
presented at EHA for ARQ 531, and we are gratified that our recent
public offering will allow us to pursue the next phase of clinical
development with ARQ 531.”
“Having observed substantial clinical activity with ARQ 531 at a
well-tolerated dose in the target populations, we have been able to
select a phase 2 dose and are aggressively taking the drug into the
expansion phase,” commented Dr. Brian Schwartz, Chief Medical
Officer of ArQule. “We are also excited to have opened additional
sites in our registrational MOSAIC study in Proteus syndrome and
PROS.”
Revenues and Expenses
Revenues for the second quarter, 2019, were $0.3 million
compared with revenues of $13.7 million for the second quarter,
2018.
Research and development expenses in the second quarter, 2019
were $6.3 million compared with $6.8 million for the second
quarter, 2018.
General and administrative expenses in the second quarter, 2019
were $3.2 million compared with $2.2 million for the second
quarter, 2018.
2019 Financial Guidance
For 2019, ArQule expects revenue to range between $3 and $5
million. Net loss is expected to range between $40 and $43 million,
and net loss per share to range between $(0.35) and $(0.37) for the
year. As a result of our common stock offering in June, we are
updating our cash guidance. ArQule now expects to end 2019 with
approximately $160 million in cash and marketable securities which
will support the current business plan into 2022.
Conference Call and
Webcast
ArQule will hold its second quarter financial results call
today, August 7, 2019 at 9:00 a.m. ET. The live webcast can be
accessed in the “Investors and Media” section of our website,
www.arqule.com, under “Events and Presentations.” You
may also listen to the call by dialing (877) 868-1831 within the
U.S. or (914) 495-8595 outside the U.S. A replay will be available
two hours after the completion of the call and can be accessed in
the “Investors and Media” section of our website, www.arqule.com,
under “Events and Presentations.”
About ArQule ArQule is a biopharmaceutical company
engaged in the research and development of targeted therapeutics to
treat cancers and rare diseases. ArQule’s mission is to discover,
develop and commercialize novel small molecule drugs in areas of
high unmet need that will dramatically extend and improve the lives
of our patients. Our clinical-stage pipeline consists of four drug
candidates, all of which are in targeted, biomarker-defined patient
populations, making ArQule a leader among companies our size in
precision medicine. ArQule’s pipeline includes: ARQ 531, an orally
bioavailable, potent and reversible dual inhibitor of both wild
type and C481S-mutant BTK, in phase 1 for patients with B-cell
malignancies refractory to other therapeutic options; miransertib
(ARQ 092), a potent and selective inhibitor of the AKT
serine/threonine kinase, in a planned registrational trial with
cohorts in Proteus syndrome and PROS to initiate in 2019; ARQ 751,
a next generation highly potent and selective AKT inhibitor, in
phase 1 for patients with AKT1 and PI3K mutations; and
derazantinib, a multi-kinase inhibitor designed to preferentially
inhibit the fibroblast growth factor receptor (FGFR) family, in a
registrational trial for iCCA in collaboration with Basilea and
Sinovant. ArQule’s current discovery efforts are focused on the
identification and development of novel kinase inhibitors,
leveraging the Company’s proprietary library of compounds.
Forward-Looking Statements This press release contains
forward-looking statements, including without limitation under the
headings “Key Highlights from Q2, 2019,” and quotes of management
in connection with the Company’s clinical trials and planned
clinical trials with ARQ 531, miransertib, ARQ 751 and
derazantinib, as well as under “2019 Financial Guidance” with
respect to projected financial results. These statements are based
on the Company’s current beliefs and expectations and are subject
to risks and uncertainties that could cause actual results to
differ materially from those set forth in this press release. For
example, while initial results from the development of ARQ 531,
miransertib, ARQ 751 and derazantinib have been promising, such
results are not necessarily indicative of results that will be
obtained from ongoing or subsequent trials and the results achieved
in ongoing or later stage trials may not be sufficient to meet
applicable regulatory standards or to justify further development.
In addition, they may not demonstrate appropriate safety profiles
in current or later stage or larger scale clinical trials as a
result of known or as yet unanticipated side effects. Problems or
delays may arise prior to the initiation of planned clinical
trials, during clinical trials or in the course of developing,
testing or manufacturing these compounds that could lead the
Company or its collaborators to fail to initiate or to discontinue
development. Even if later stage clinical trials are successful,
unexpected concerns may arise from subsequent analysis of data or
from additional data. Regulatory authorities may disagree with the
Company’s or its collaborators’ view of data or require additional
data or information or additional studies. In addition, the planned
timing of completion of clinical trials is subject to the ability
of the Company and, in certain cases, its collaborators to enroll
patients, enter into agreements with clinical trial sites and
investigators, and overcome technical hurdles and other issues
related to the conduct of the trials for which each of them is
responsible. In addition, the Company uses or expects to use
companion diagnostics in biomarker-guided clinical trials with its
product candidates. The Company or its collaborators may encounter
difficulties in developing and obtaining approval for companion
diagnostics, including issues relating to access to certain
technologies, selectivity/specificity, analytical validation,
reproducibility, or clinical validation. Any delay or failure by
our collaborators or ourselves to develop or obtain regulatory
approval of companion diagnostics could delay or prevent approval
of our product candidates. Drug development involves a high degree
of risk. Only a small number of research and development programs
result in the commercialization of a product. Furthermore, the
Company may not have the financial or human resources to
successfully pursue drug discovery in the future. With respect to
partnered programs, even if certain compounds show initial promise
our collaborators may decide not to continue to develop them. Our
collaborators in the development of derazantinib have certain
rights to unilaterally terminate their agreement with ArQule. If
either were to do so, the Company might not be able to complete
development and commercialization of derazantinib on its own in the
affected territory. For more detailed information on the risks and
uncertainties associated with the Company’s drug development and
other activities, see the Company’s periodic reports filed with the
Securities and Exchange Commission. The Company disclaims any
obligation to update the information contained in this press
release as new information becomes available.
ArQule, Inc. Condensed
Statement of Operations and Comprehensive Income (Loss) (In
Thousands, Except Per Share Amounts) (Unaudited)
Three Months Ended June
30,
Six Months Ended June
30,
2019
2018
2019
2018
Research and development revenue
$
281
$
13,706
$
1,626
$
17,844
Costs and expenses:
Research and development
6,330
6,787
13,778
12,599
General and administrative
3,168
2,234
7,468
4,585
Total costs and expenses
9,498
9,021
21,246
17,184
Income (loss) from operations
(9,217
)
4,685
(19,620
)
660
Interest income
558
170
1,124
329
Interest expense
(433
)
(417
)
(863
)
(813
)
Other income (expense) (1)
—
718
—
(1,552
)
Net income (loss)
(9,092
)
5,156
(19,359
)
(1,376
)
Unrealized gain (loss) on marketable
securities
58
19
175
(6
)
Comprehensive income (loss)
$
(9,034
)
$
5,175
$
(19,184
)
$
(1,382
)
Basic and diluted net income (loss) per
share:
Basic net income (loss) per share
$
(0.08
)
$
0.06
$
(0.18
)
$
(0.02
)
Diluted net income (loss) per share
$
(0.08
)
$
0.05
$
(0.18
)
$
(0.02
)
Weighted average shares used in
calculating:
Basic net income (loss) per share
109,860
92,241
109,442
89,691
Diluted net income (loss) per share
109,860
100,532
109,442
89,691
- Includes non-cash income (expense) associated with the change
in fair value of our preferred stock warrant liability which was
converted to common stock and common stock warrants in May 2018.
Accordingly, at June 30, 2019 and at June 30, 2018 there was no
remaining balance in the warrant liability.
Balance sheet data (in thousands)
(Unaudited):
June 30, 2019
December 31, 2018
Cash, equivalents and marketable
securities- short term
$
179,121
$
99,558
Marketable securities-long term
3,638
—
$
182,759
$
99,558
Total assets
$
187,193
$
106,676
Stockholders’ equity
$
161,616
$
78,968
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190807005066/en/
Corporate Contact: Kathleen Farren Investor Relations and
Executive Assistant to the CFO ir@arqule.com
Media Contact: Cait Williamson, Ph.D. LifeSci Public
Relations (646) 751-4366 cait@lifescipublicrelations.com
www.ArQule.com
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