LEXINGTON, Mass., May 14,
2019 /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,
2019.
"2019 has been a transformational year for Curis as we
demonstrate the results of our heightened focus on clinical
execution. We are currently on track or ahead of schedule in
the execution of all three of our clinical trials," said
James Dentzer, President and Chief
Executive Officer of Curis. "We look forward to discussing
clinical data from all three trials later this year: this
summer for CA-4948 and later in the second half for fimepinostat
and CA-170."
"Furthermore, with this quarter's agreement with Oberland
Capital, for $65 million upfront and
up to $70.7 million in additional
milestones, we secured the financial flexibility needed to ensure
we can continue to move forward aggressively in our clinical
execution of all three programs," he concluded.
First Quarter 2019 Financial Results
Curis reported a net loss of $9.9
million, or $0.30 per share on
both a basic and diluted basis for the first quarter of 2019, as
compared to a net loss of $10.7
million, or $0.33 per share on
both a basic and diluted basis for the same period in 2018.
Revenues for the first quarter of 2019 were $1.8 million, as compared to $2.5 million for the same period in 2018.
Revenues for both periods comprise primarily royalty revenues
recorded on Genentech and Roche's net sales of
Erivedge®.
Operating expenses were $7.3
million for the first quarter of 2019, as compared to
$12.4 million for the same period in
2018, 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 2019 and 2018.
Research and Development Expenses. Research
and development expenses were $4.1
million for the first quarter of 2019 as compared to
$8.3 million for the same period in
2018. The decrease was primarily due to decreased costs related to
ongoing clinical and manufacturing activities for fimepinostat and
CA-170. Employee-related expenses decreased from the prior quarter
primarily due to a reduction in headcount that occurred in the
fourth quarter of 2018. These changes reflect our shift in focus
toward clinical development, while down-sizing the in-house
discovery research organization. We have also focused the CA-170
program toward the VISTA-expressing mesothelioma indication, which
allowed substantial reduction in the number of sites and regions
required.
General and Administrative Expenses. General and
administrative expenses were $3.1
million for the first quarter of 2019 as compared to
$4.0 million for the same period in
2018. The decrease in general and administrative expenses was
driven primarily by lower personnel, legal, and stock-based
compensation for the period.
Other expense, net was $4.3
million for the first quarter of 2019, as compared to
$0.8 million for the same period in
2018. Other expense, net primarily consisted of the loss on
extinguishment of $3.5 million and
interest expense of $0.8 million
related to Curis Royalty's (a wholly
owned subsidiary of Curis) debt obligations.
As of March 31, 2019, Curis's cash, cash equivalents and
investments totaled $42.8 million and
there were approximately 33.2 million shares of common stock
outstanding.
Recent Operational Highlights
Precision oncology, fimepinostat (HDAC/PI3K
inhibitor):
- Curis is initiating a study of fimepinostat (a MYC suppressor)
with venetoclax (a BCL-2 inhibitor) combination regimen in diffuse
large B-cell lymphoma (DLBCL), including patients with
Double-Hit/Double-Expressor Lymphoma. In preclinical models,
fimepinostat administered in combination with venetoclax resulted
in an enhanced benefit relative to each agent alone.
Precision oncology, CA-4948 (IRAK4 Inhibitor; Aurigene
collaboration):
- In April 2019, Curis advanced to
the 200mg BID cohort in the CA-4948 study for treatment of patients
with non-Hodgkin lymphoma, including those with MYD88
alterations.
Immuno-oncology, CA-170 (VISTA / PDL1 antagonist; Aurigene
collaboration):
- In January 2019, Curis dosed the
first mesothelioma patient in its ongoing Phase 1 CA-170 trial
following evidence supporting high levels of VISTA expression in
mesothelioma tumor samples. Recent publications have identified
VISTA as a possible resistance mechanism to treatment with anti-PD1
antibodies in several cancer indications.
- In May 2019, Curis announced
completion of its target enrollment of mesothelioma patients in the
ongoing Phase 1 CA-170 trial.
First Quarter 2019 and Recent Corporate Highlights
- In March 2019, Curis announced
that it sold a portion of its Erivedge royalties to Oberland
Capital for up to $135.7 million,
including $65 million upfront.
2019 Data Catalysts
For the remainder of the year, Curis expects to:
- Report initial data on the combination of fimepinostat and
venetoclax regimen in patients with R/R DLBCL, including patients
with DH/DE Lymphoma, in the second half of 2019.
- Report initial efficacy data from its CA-4948 dose escalation
study in patients with NHL in mid-year 2019.
- Report initial efficacy data from its CA-170 Phase 1 trial in
patients with mesothelioma (high VISTA expressors) in the second
half of 2019.
Conference Call Information
Curis management will host a conference call today, May 14,
2019, at 4:30 p.m. EDT, 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. EDT. 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, including
fimepinostat, which is being investigated in clinical studies in
patients with DLBCL and solid tumors. Curis is also engaged in a
collaboration with Aurigene to develop first-in-class therapeutics
in 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-170 is currently undergoing
testing in a Phase 1 trial in patients with mesothelioma and in a
Phase 2 trial in patients with advanced solid tumors and lymphomas
in India conducted by Aurigene.
CA-4948 is currently undergoing testing in a Phase 1 trial in
patients with non-Hodgkin lymphoma. 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's website at www.curis.com.
Cautionary Note Regarding 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 any
expectations of revenue, expenses, earnings or losses from
operations, or other financial results, statements with respect to
the plans, strategies and objectives of management for future
operations, the potential for the Company's proprietary drug
candidates, including fimepinostat, CA-4948, CA-170, the potential
advantages and benefits of small molecule checkpoint antagonists,
the Company's plans and expectations for the collaboration with
Aurigene, including its plans to discover and develop multiple
first-in-class oral, small molecule checkpoint antagonists for the
treatment of patients with cancer, and the Company's plans to
advance its development programs, including the timing of IND
filings and the Company's plans for fimepinostat. 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 agreement
with Aurigene will continue for its full term, that Curis or
Aurigene 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 us or our wholly-owned subsidiary, we
could lose all retained rights to future royalty and
royalty-related payments, we could be required to repurchase such
future royalty and royalty-related payments at a price that is a
multiple of the payments we have received, and our ability to enter
into future arrangements may be inhibited, all of which could have
a material adverse effect on our business, financial condition and
stock price. Curis will require substantial additional capital to
fund its business and such capital may not be available on
reasonable terms, or at all. 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 and unplanned
expenses may adversely affect Curis's financial conditions and its
ability to access the substantial additional capital needed to fund
the growth of its business. Important factors that may cause or
contribute to such differences 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,
|
|
|
2019
|
|
2018
|
Revenues:
|
|
|
|
|
Royalties
|
|
$
|
2,137
|
|
$
|
2,474
|
Contra
revenue
|
|
(370)
|
|
(6)
|
Total
revenues:
|
|
1,767
|
|
2,468
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
Costs of royalty
revenues
|
|
108
|
|
129
|
Research and
development
|
|
4,074
|
|
8,266
|
General and
administrative
|
|
3,143
|
|
3,981
|
Total operating
expenses
|
|
7,325
|
|
12,376
|
|
|
|
|
|
Net loss from
operations
|
|
(5,558)
|
|
(9,908)
|
|
|
|
|
|
Loss on debt
extinguishment
|
|
(3,495)
|
|
—
|
Interest
income
|
|
108
|
|
186
|
Non-cash imputed
interest expense related to the sale of future royalty
payments
|
|
(131)
|
|
—
|
Interest
expense
|
|
(808)
|
|
(1,025)
|
Total other expense,
net
|
|
(4,326)
|
|
(839)
|
Net loss
|
|
(9,884)
|
|
(10,747)
|
|
|
|
|
|
Basic and diluted net
loss per common share
|
|
$
|
(0.30)
|
|
$
|
(0.33)
|
Basic and diluted
weighted average common shares outstanding
|
|
33,150,869
|
|
33,053,702
|
CURIS,
INC.
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
|
(UNAUDITED)
|
(In
thousands)
|
|
|
|
|
March 31,
2019
|
|
December 31,
2018
|
ASSETS
|
|
|
|
|
|
|
|
|
|
Cash, cash
equivalents and investments
|
|
$
|
42,796
|
|
$
|
24,270
|
Investment –
restricted
|
|
153
|
|
153
|
Accounts
receivable
|
|
1,786
|
|
2,864
|
Property and
equipment, net
|
|
226
|
|
267
|
Operating lease right
of-use asset
|
|
822
|
|
—
|
Goodwill
|
|
8,982
|
|
8,982
|
Other
assets
|
|
684
|
|
829
|
Total
assets
|
|
$
|
55,449
|
|
$
|
37,365
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
Accounts payable,
accrued expenses and other liabilities
|
|
$
|
3,753
|
|
$
|
6,377
|
Operating lease
liability
|
|
878
|
|
—
|
Debt obligations,
net
|
|
—
|
|
35,484
|
Liability related to
the sale of future royalties, net
|
|
64,547
|
|
—
|
Total
liabilities
|
|
69,178
|
|
41,861
|
Total stockholders'
equity
|
|
(13,729)
|
|
(4,496)
|
Total liabilities and
stockholders' equity
|
|
$
|
55,449
|
|
$
|
37,365
|
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SOURCE Curis, Inc.