LEXINGTON, Mass., May 12, 2020 /PRNewswire/ -- Curis, Inc.
(NASDAQ: CRIS), a biotechnology company focused on the development
of innovative therapeutics for the treatment of cancer, today
reported its financial results for the first quarter ended
March 31, 2020.
"The first quarter of 2020 was productive for Curis, as we
advanced our ongoing study for CA-4948 and accomplished several key
licensing and financial objectives to support future progress
across our pipeline and business," said James Dentzer, President and Chief Executive
Officer of Curis. "In response to the COVID-19 pandemic, we have
implemented both clinical and operational measures to help protect
patients, staff, study investigators and our community, and I am
incredibly proud of the resiliency and dedication our team
continues to demonstrate during this difficult period. We look
forward to updating efficacy data from our CA-4948 study in
patients with non-Hodgkin's lymphoma (NHL) and remain on track to
pursue clinical testing of CA-4948 in acute myeloid leukemia (AML)
and myelodysplastic syndromes (MDS), two areas of critical unmet
need."
First Quarter 2020 and Recent Operational Highlights
Precision oncology, CA-4948 (IRAK4 Inhibitor; Aurigene
collaboration):
- Curis is evaluating its IRAK4 inhibitor, CA-4948 in an ongoing
Phase 1 dose escalation study for the treatment of patients with
relapsed or refractory (R/R) NHL, including patients with diffuse
large B-cell lymphoma (DLBCL), Waldenström's macroglobulinemia (WM)
and oncogenic MYD88 mutations. The Phase 1 study is on track and
the Company expects to report updated efficacy data from the study
and declare the recommended Phase 2 dose in 2020.
-
- Due to the corona virus, certain sites for the Phase 1 study
remain open for enrollment, while other sites have temporarily
halted enrollment of new patients. Curis and its study
investigators continue to monitor the COVID-19 pandemic and are
focused on the safety and treatment of patients currently enrolled
in the study.
- Curis expects to initiate a separate Phase 1 trial of CA-4948
in patients with AML and MDS, including patients with spliceosome
mutations that encode oncogenic IRAK4-L, in the second quarter of
2020.
Immuno-oncology, CI-8993 (anti-VISTA antibody; ImmuNext
collaboration):
- In January 2020, Curis announced
it entered into an option and license agreement to acquire
exclusive, worldwide rights from ImmuNext Inc. (ImmuNext) to
develop and commercialize anti-VISTA antibodies for the treatment
of cancer, including ImmuNext's lead clinical-stage compound,
CI-8993. Ongoing non-clinical studies are underway, and the initial
clinical study will begin in the second half of 2020.
Precision oncology, fimepinostat (HDAC/PI3K
inhibitor):
- Fimepinostat has previously been shown to induce durable
single-agent responses in difficult-to-treat lymphomas, including
MYC-driven and double-hit disease. Curis is collaborating with
DarwinHealth on ongoing analytical research to characterize
biomarkers and tumor subtype alignments, which may help guide
future clinical development opportunities with fimepinostat.
COVID-19 and Business Operations:
- Curis has implemented several clinical and operational measures
to support the safety of patients, staff, and study investigators
and maintain rigorous clinical trial conduct. Curis currently
believes there will be no disruption to the clinical supply of
CA-4948 or CI-8993. The Company is in close contact with its
partners and manufacturers, and all parties have established
procedures to manage drug supply during the COVID-19 pandemic.
- Consistent with guidelines from the Centers for Disease Control
(CDC) and the Commonwealth of Massachusetts, Curis has implemented certain
measures, such as ordering all employees to work remotely and
restricting business travel, to help maintain the safety of its
employees, families and community.
Upcoming 2020 Planned Milestones
- Declare the recommended Phase 2 dose for CA-4948 in the ongoing
lymphoma Phase 1 study and report updated efficacy data from the
study.
- Initiate a Phase 1 study of CA-4948 in patients with AML and
MDS, including patients with spliceosome mutations that encode
oncogenic IRAK4-L, in the second quarter of 2020.
- Initiate a Phase 1a/1b dose
escalation study of CI-8993 in in the second half of 2020.
First Quarter 2020 Financial Results
For the first quarter of 2020, Curis reported a net loss of
$9.7 million, or $0.28 per share on both a basic and diluted
basis, as compared to a net loss of $9.9
million, or $0.30 per share on
both a basic and diluted basis for the same period in 2019.
Revenues for the first quarter of 2020 were $2.7 million, as compared to $1.8 million for the same period in 2019.
Revenues for both periods comprise primarily royalty revenues
recorded on Genentech and Roche's net sales of
Erivedge®.
Operating expenses for the first quarter of 2020 were
$11.2 million, as compared to
$7.3 million for the same period in
2019, and comprised the following:
Costs of Royalty Revenues. Costs of royalty
revenues, primarily amounts due to third-party university patent
licensors in connection with Genentech and Roche's Erivedge net
sales, were $0.1 million for both the
first quarter of 2020 and 2019.
Research and Development Expenses. Research
and development expenses were $7.5
million for the first quarter of 2020, as compared to
$4.1 million for the same period in
2019. The increase was primarily due to in-license expenses
incurred from Curis' option and license agreement with ImmuNext,
and increased costs related to clinical activities including
consulting, outside lab expenses, and Contract Research
Organization (CRO) services.
General and Administrative Expenses. General and
administrative expenses were $3.6
million for the first quarter of 2020, as compared to
$3.1 million for the same period in
2019. The increase was driven primarily by higher legal services
during the period.
Other expense, net. Net other expense was $1.2 for the first quarter of 2020, as compared
to $4.3 million for the same period
in 2019. Net other expense for the first quarter 2020 primarily
consisted of imputed interest expense related to future royalty
payments, whereas in 2019 the expense related to the extinguishment
of debt.
As of March 31, 2020, Curis' cash, cash equivalents,
marketable securities and investments totaled $12.5 million and there were approximately 36.6
million shares of common stock outstanding. Curis expects that its
existing cash, cash equivalents and investments should enable it to
maintain its planned operations into the second half of 2020.
Conference Call Information
Curis management will host a conference call today, May 12,
2020, at 4:30 p.m. ET, to discuss
these financial results, as well as provide a corporate update.
To access the live conference call, please dial 1-888-346-6389
from the United States or
1-412-317-5252 from other locations, shortly before 4:30 p.m. ET. The conference call can also be
accessed on the Curis website at www.curis.com in the Investors
section.
About Curis, Inc.
Curis is a biotechnology company focused on the development of
innovative therapeutics for the treatment of cancer. In 2015, Curis
entered into a collaboration with Aurigene in the areas of
immuno-oncology and precision oncology. As part of this
collaboration, Curis has exclusive licenses to oral small molecule
antagonists of immune checkpoints including, the VISTA/PDL1
antagonist CA-170, and the TIM3/PDL1 antagonist CA-327, as well as
the IRAK4 kinase inhibitor, CA-4948. CA-4948 is currently
undergoing testing in a Phase 1 trial in patients with non-Hodgkin
lymphoma. In addition, Curis is engaged in a collaboration with
ImmuNext for development of CI-8993, a monoclonal anti-VISTA
antibody. Curis is also party to a collaboration with Genentech, a
member of the Roche Group, under which Genentech and Roche are
commercializing Erivedge® for the treatment of advanced
basal cell carcinoma. For more information, visit Curis' website at
www.curis.com.
Forward-Looking Statements:
This press release contains forward-looking statements within
the meaning of the U.S. Private Securities Litigation Reform Act of
1995, including without limitation statements regarding the
Company's planned prioritization of resources, its plans to declare
the recommended Phase 2 dose for CA-4948 in the ongoing lymphoma
Phase 1 study and to report efficacy data from the trial in
2020, its plan to initiate a Phase 1 trial of 4948 in AML and MDS
in the second quarter of 2020, its plans to initiate a Phase
1a/1b trial of CI-8993 in the second
half of 2020, the impacts of the COVID-19 pandemic and the measures
implemented in response thereto, the period in which Curis expects
that its existing cash, cash equivalents and investments will
enable it to fund its operations, its ability to access financing
under its purchase agreement with Aspire or under its at-the-market
sales agreement with JonesTrading, statements with respect to the
plans, strategies and objectives of management for future
operations, and the Company's expectations regarding the potential
therapeutic benefit of its proprietary drug candidates.
Forward-looking statements may contain the words "believes,"
"expects," "anticipates," "plans," "intends," "seeks," "estimates,"
"assumes," "will," "may," "could" or similar expressions. These
forward-looking statements are not guarantees of future performance
and involve risks, uncertainties, assumptions and other important
factors that may cause actual results to be materially different
from those indicated by such forward-looking statements. For
example, Curis may experience adverse results, delays and/or
failures in its drug development programs and may not be able to
successfully advance the development of its drug candidates in the
time frames it projects, if at all. Curis's drug candidates may
cause unexpected toxicities, fail to demonstrate sufficient safety
and efficacy in clinical studies and/or may never achieve the
requisite regulatory approvals needed for commercialization.
Favorable results seen in preclinical studies and early clinical
trials of Curis's drug candidates may not be replicated in later
trials. There can be no guarantee that the collaboration agreements
with Aurigene and ImmuNext will continue for their full terms, that
Curis or its collaborators will each maintain the financial and
other resources necessary to continue financing its portion of the
research, development and commercialization costs, or that the
parties will successfully discover, develop or commercialize drug
candidates under the collaboration. Regulatory authorities may
determine to delay or restrict Genentech's and/or Roche's ability
to continue to develop or commercialize Erivedge in BCC. Erivedge
may not demonstrate sufficient or any activity to merit its further
development in disease indications other than BCC. Competing drugs
may be developed that are superior to Erivedge. In connection with
its agreement with Oberland Capital, Curis faces risks relating to
the transfer and encumbrance of certain royalty and royalty-related
payments on commercial sales of Erivedge, including the risk that,
in the event of a default by Curis or its wholly-owned subsidiary,
Curis could lose all retained rights to future royalty and
royalty-related payments, Curis could be required to repurchase
such future royalty and royalty-related payments at a price that is
a multiple of the payments it has received, and its ability to
enter into future arrangements may be inhibited, all of which could
have a material adverse effect on its business, financial condition
and stock price. Curis will require substantial additional capital
to fund its business. Based on its available cash resources, it
does not have sufficient cash on hand to support current operations
within the next 12 months from the date of this press release. If
it is not able to obtain sufficient funding, it will be forced to
delay, reduce in scope or eliminate some of its research and
development programs, including related clinical trials and
operating expenses, potentially delaying the time to market for, or
preventing the marketing of, any of its product candidates, which
could adversely affect its business prospects and its ability to
continue operations, and would have a negative impact on its
financial condition and its ability to pursue its business
strategies. If it is unable to continue as a going concern, it may
have to liquidate its assets and may receive less than the value at
which those assets are carried on its audited financial statements,
and it is likely that investors will lose all or a part of their
investment. Curis faces substantial competition. Curis also
faces risks relating to potential adverse decisions made by the FDA
and other regulatory authorities, investigational review boards,
and publication review bodies. Curis may not obtain or maintain
necessary patent protection and could become involved in expensive
and time-consuming patent litigation and interference proceedings.
Unstable market and economic conditions, natural disasters, public
health crises, political crises and other events outside of Curis's
control could significantly disrupt its operations or the
operations of third parties on which Curis depends, and could
adversely impact Curis's operating results and its ability to raise
capital. For example, the COVID-19 pandemic may result in closures
of third party facilities, impact enrollment in Curis's ongoing or
planned clinical trials or impact sales of Erivedge by
Genentech and/or Roche. The extent to which the COVID-19
pandemic may impact Curis's business or operating results is
uncertain. Important factors that may cause or contribute to
actual results being materially different from those indicated by
forward-looking statements include the factors set forth under the
caption "Risk Factors" in our most recent Form 10-K and Form 10-Q
and the factors that are discussed in other filings that we
periodically make with the Securities and Exchange Commission
("SEC"). In addition, any forward-looking statements represent the
views of Curis only as of today and should not be relied upon as
representing Curis's views as of any subsequent date. Curis
disclaims any intention or obligation to update any of the
forward-looking statements after the date of this press release
whether as a result of new information, future events or otherwise,
except as may be required by law.
CURIS,
INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
|
(UNAUDITED)
(In thousands,
except share and per share data)
|
|
|
|
|
Three Months
Ended
March 31,
|
|
|
2020
|
|
2019
|
Revenues:
|
|
|
|
|
Royalties
|
|
$
|
2,515
|
|
|
$
|
2,137
|
|
Other
revenue
|
|
211
|
|
|
—
|
|
Contra
revenue
|
|
(17)
|
|
|
(370)
|
|
Total
revenues:
|
|
2,709
|
|
|
1,767
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
Costs of royalty
revenues
|
|
125
|
|
|
108
|
|
Research and
development
|
|
7,473
|
|
|
4,074
|
|
General and
administrative
|
|
3,593
|
|
|
3,143
|
|
Total operating
expenses
|
|
11,191
|
|
|
7,325
|
|
|
|
|
|
|
Net loss from
operations
|
|
(8,482)
|
|
|
(5,558)
|
|
|
|
|
|
|
Loss on debt
extinguishment
|
|
—
|
|
|
(3,495)
|
|
Interest
income
|
|
50
|
|
|
108
|
|
Imputed interest
expense related to the sale of future royalty payments
|
|
(1,298)
|
|
|
(131)
|
|
Interest
expense
|
|
—
|
|
|
(791)
|
|
Other income
(expense), net
|
|
21
|
|
|
(17)
|
|
Total other expense,
net
|
|
(1,227)
|
|
|
(4,326)
|
|
Net loss
|
|
(9,709)
|
|
|
(9,884)
|
|
|
|
|
|
|
Basic and diluted net
loss per common share
|
|
$
|
(0.28)
|
|
|
$
|
(0.30)
|
|
Basic and diluted
weighted average common shares outstanding
|
|
34,453,189
|
|
|
33,150,869
|
|
CURIS,
INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
|
(UNAUDITED)
(In
thousands)
|
|
|
|
|
March 31,
2020
|
|
December 31,
2019
|
ASSETS
|
|
|
|
|
|
|
|
|
|
Cash, cash
equivalents and investments
|
|
$
|
12,538
|
|
|
$
|
20,543
|
|
Restricted
cash
|
|
969
|
|
|
969
|
|
Accounts
receivable
|
|
2,507
|
|
|
3,244
|
|
Property and
equipment, net
|
|
396
|
|
|
154
|
|
Operating lease
right-of-use asset
|
|
—
|
|
|
149
|
|
Goodwill
|
|
8,982
|
|
|
8,982
|
|
Other
assets
|
|
1,314
|
|
|
1,066
|
|
Total
assets
|
|
$
|
26,706
|
|
|
$
|
35,107
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' DEFICIT
|
|
|
|
|
Accounts payable,
accrued liabilities and other liabilities
|
|
$
|
5,986
|
|
|
$
|
6,375
|
|
Operating lease
liability
|
|
—
|
|
|
166
|
|
Liability related to
the sale of future royalties, net
|
|
60,989
|
|
|
62,477
|
|
Total
liabilities
|
|
66,975
|
|
|
69,018
|
|
Total stockholders'
deficit
|
|
(40,269)
|
|
|
(33,911)
|
|
Total liabilities and
stockholders' deficit
|
|
$
|
26,706
|
|
|
$
|
35,107
|
|
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SOURCE Curis, Inc.