Company expects to discuss lifting of partial
clinical hold on emavusertib with FDA in Q3
Curis strengthens executive team with
appointment of industry veteran Jonathan
Zung, Ph.D. as Chief Development Officer
Strong balance sheet with $71.8 million in cash and investments; cash
runway into 2025
Management to host conference call today at
4:30 p.m. ET
LEXINGTON, Mass., May 4, 2023
/PRNewswire/ -- Curis, Inc. (NASDAQ: CRIS), a biotechnology company
focused on the development of innovative therapeutics for the
treatment of cancer, today reported its business update and
financial results for the first quarter ended March 31, 2023.
"I am pleased with our progress in the TakeAim leukemia study.
We enrolled the additional patients requested by FDA ahead of
schedule in the first quarter – which is indicative of both the
clear unmet need in leukemia and the excitement among the clinical
community for this novel agent. We are on track to collect data
from these patients in the second quarter and discuss these data
with the FDA in the third quarter of this year. I am also pleased
to announce the expansion of the Curis Executive Team with the
addition of Jonathan Zung, Ph.D. as
our Chief Development Officer. Dr. Zung is a well-respected leader
in the industry and brings a wealth of experience from senior roles
across the industry, most recently at Evelo. We look forward to his
contributions toward our mission at Curis," said James Dentzer, President and CEO of Curis.
"I am excited to be joining the Curis team during this critical
time, as the company advances its first-in-class IRAK4 inhibitor,
emavusertib. In biotech, it is rare to find a novel target with
such broad therapeutic potential in that exciting period between
the initial demonstration of clear single agent activity and the
final stage of clinical development. I look forward to working with
the Curis team on the clinical development of emavusertib and
helping to establish it as a cornerstone therapy in hematologic
malignancies," said Dr. Zung.
First Quarter 2023 and Recent Operational Highlights
Appointed new CDO
Dr. Zung was appointed as Chief Development Officer of Curis on
May 1, 2023. Prior to joining Curis,
he served as CDO of Evelo Biosciences, where he was responsible for
the operational design and execution of Evelo's clinical programs.
Dr. Zung held previous leadership roles at WCG, Covance, UCB,
Bristol Myers Squibb, and Pfizer. He also serves on the advisory
board of Saama Technologies. He received his Ph.D. in analytical
chemistry from Emory University.
Upcoming Milestones
- Curis completed the enrollment of 9 additional patients at the
200mg BID dose level requested by FDA, is collecting data on those
patients in the second quarter, and expects to discuss those data
with FDA in the third quarter of 2023. Discussions with the FDA are
expected to determine the recommended Phase 2 dose and resolution
of the partial clinical hold on emavusertib development in
leukemia.
First Quarter 2023 Financial Results
For the first quarter of 2023, Curis reported a net loss of
$11.6 million or $0.12 per share on both a basic and diluted basis
as compared to $16.1 million or
$0.18 per share on both a basic and
diluted basis, for the same period in 2022.
Revenues for the first quarter of 2023 were $2.3 million as compared to $2.1 million for the same period in 2022.
Revenues for both periods consist of royalty revenues from
Genentech's and Roche's sales of Erivedge®.
Research and development expenses were $9.1 million for the first quarter of 2023, as
compared to $11.4 million for the
same period in 2022. The decrease is primarily attributable to the
timing of manufacturing costs and lower employee related costs due
to a reduction in headcount.
General and administrative expenses were $4.8 million for the first quarter of 2023, as
compared to $5.7 million for the same
period in 2022. The decrease was mainly attributable to lower
employee related costs due to a reduction in headcount.
Other income, net was $0.1 million
for the first quarter of 2023, as compared to other expense, net of
$1.0 million for the same period in
2022. Other income (expense), net primarily consisted of interest
income partially offset by expense related to future royalty
payments.
As of December 31, 2022, Curis's
cash, cash equivalents and investments totaled $71.8 million, and the Company had approximately
96.6 million shares of common stock outstanding. Curis expects its
existing cash, cash equivalents and investments should enable it to
maintain its planned operations into 2025.
Conference Call Information
Curis management will host a conference call today, May 4, 2023, at 4:30 p.m.
ET, to discuss the business update and these financial
results.
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 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, emavusertib (CA-4948). Emavusertib is
currently undergoing testing in the Phase 1/2 TakeAim Lymphoma
trial in patients with hematologic malignancies, such as
non-Hodgkin's lymphoma and other B cell malignancies, both as a
monotherapy and in combination with BTK inhibitor ibrutinib, and
the Phase 1/2 TakeAim Leukemia trial in patients with acute myeloid
leukemia and myelodysplastic syndrome, for which it has received
Orphan Drug Designation from the U.S. Food and Drug Administration.
The FDA has placed a partial clinical hold on the TakeAim Leukemia
trial during which no new patients will be enrolled in the
monotherapy expansion phase (Phase 2a) or the combination phase
(Phase 1b) of emavusertib with
azacitidine or venetoclax. 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'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, any statements with respect to
Curis's plans, strategies and objectives, cash runway, statements
concerning product research, development, clinical trials and
studies and commercialization plans, timelines, anticipated results
or the therapeutic potential of drug candidates including any
statements regarding the initiation, progression, expansion, use,
safety, efficacy, dosage and potential benefits of emavusertib in
clinical trials as a monotherapy and/or as a combination therapy,
the progression, use and potential benefits of CI-8993, Curis's
plans and timelines to provide preliminary, interim and/or
additional data from its ongoing or planned clinical trials, its
ability to resume and further patient enrollment in its TakeAim
Lymphoma trial and in the monotherapy dose escalation phase (Phase
1a) of the TakeAim Leukemia trial, its ability to resolve the
remaining partial clinical hold on the monotherapy expansion phase
(Phase 2a) and the combination therapy phase (Phase 1b) of the TakeAim Leukemia study, any statements
concerning Curis's expectations regarding its interactions with the
FDA, statements with respect to mutations or potential biomarkers,
and statements of assumptions underlying any of the foregoing.
Forward-looking statements may contain the words "believes,"
"expects," "anticipates," "plans," "intends," "seeks," "estimates,"
"assumes," "predicts," "projects," "targets," "will," "may,"
"would," "could," "should," "continue," "potential," "focus,"
"strategy," "mission," 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, the FDA may not remove the remaining partial clinical hold
on the monotherapy expansion phase (Phase 2a) and the combination
therapy phase (Phase 1b) of the
TakeAim Leukemia trial or may take further regulatory action with
regard to such trial. 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, or
the CRADA with NCI, 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
commercialize Erivedge in basal cell carcinoma (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. 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. Curis
faces substantial competition. Curis and its collaborators face the
risk of 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 fourth parties on which Curis depends and could
adversely impact Curis's operating results and its ability to raise
capital. For example, the periodic COVID-19 resurgence may result
in closures of third-party facilities, impact enrollment in
clinical trials or impact sales of Erivedge by Genentech and/or
Roche. Other 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
captions "Risk Factor Summary" and "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,
|
|
|
2023
|
|
2022
|
|
Revenues,
net:
|
$
2,297
|
|
$
2,057
|
|
Costs and
expenses:
|
|
|
|
|
Cost of royalty
revenues
|
24
|
|
82
|
|
Research and
development
|
9,140
|
|
11,435
|
|
General and
administrative
|
4,760
|
|
5,673
|
|
Total costs and
expenses
|
13,924
|
|
17,190
|
|
Loss from
operations
|
(11,627)
|
|
(15,133)
|
|
Other income (expense),
net:
|
68
|
|
(976)
|
|
Net loss
|
$
(11,559)
|
|
$
(16,109)
|
|
Net loss per common
share (basic and diluted)
|
$
(0.12)
|
|
$
(0.18)
|
|
Weighted average common
shares (basic and diluted)
|
96,613,544
|
|
91,645,369
|
|
CURIS,
INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
|
(UNAUDITED)
(In
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
March 31,
2023
|
|
December 31,
2022
|
ASSETS
|
|
|
|
|
Cash, cash equivalents
and investments
|
|
$
|
71,759
|
|
|
$
|
85,623
|
|
Restricted
cash
|
|
635
|
|
|
635
|
|
Accounts
receivable
|
|
2,314
|
|
|
2,975
|
|
Property and equipment,
net
|
|
625
|
|
|
689
|
|
Operating lease
right-of-use asset
|
|
4,076
|
|
|
4,401
|
|
Goodwill
|
|
8,982
|
|
|
8,982
|
|
Prepaid expenses and
other assets
|
|
6,153
|
|
|
5,543
|
|
Total
assets
|
|
$
|
94,544
|
|
|
$
|
108,848
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
Accounts payable,
accrued liabilities and other liabilities
|
|
$
|
6,888
|
|
|
$
|
8,872
|
|
Operating lease
liability
|
|
3,673
|
|
|
3,941
|
|
Liability related to
the sale of future royalties, net
|
|
47,393
|
|
|
49,483
|
|
Total
liabilities
|
|
57,954
|
|
|
62,296
|
|
Total stockholders'
equity
|
|
36,590
|
|
|
46,552
|
|
Total liabilities and
stockholders' equity
|
|
$
|
94,544
|
|
|
$
|
108,848
|
|
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SOURCE Curis, Inc.