Continued progress on the development of
emavusertib
Strong balance sheet with $68.5 million in cash and investments; cash
runway into 2025
Management to host conference call today at
8:30 a.m. ET
LEXINGTON, Mass., Nov. 2, 2023 /PRNewswire/ -- Curis, Inc. (NASDAQ:
CRIS), a biotechnology company focused on the development of
emavusertib, an orally available, small molecule IRAK4 inhibitor
for the treatment of hematologic malignancies, today reported its
business update and financial results for the quarter ended
September 30, 2023.
"Since the removal of the partial clinical hold, we have
re-started patient enrollment in both the Phase 1/2 TakeAim
Leukemia monotherapy and TakeAim Lymphoma combination studies and
expect to initiate a triplet combination study in AML in the fourth
quarter. We also expect to present updated data from the TakeAim
Lymphoma combination study at ASH in December," said James Dentzer, President and CEO of Curis.
Third Quarter 2023 and Recent Operational Highlights
Emavusertib (IRAK4 Inhibitor)
TakeAim Leukemia
- Curis is currently enrolling relapsed or refractory (R/R)
AML/MDS patients with FLT3 or spliceosome mutation (U2AF1 or SF3B1)
who have received < 3 prior lines of treatment. The Company
expects additional data from this study in the first half of
2024.
- The Company expects to initiate a triplet combination study
of emavusertib with azacitidine and venetoclax in the fourth
quarter. This Phase 1 study is intended to evaluate emavusertib's
safety, as well as its ability enhance the effectiveness of
azacitidine and venetoclax. Initial data from this study is
expected in the second half of 2024.
TakeAim Lymphoma
- Curis is focusing its lymphoma clinical development efforts on
Primary CNS lymphoma (PCNSL), a rare form of extranodal non-Hodgkin
lymphoma for which there are limited treatment options. The Company
is currently enrolling PCNSL patients in its TakeAim Lymphoma study
in which patients are being treated with a combination of
emavusertib and ibrutinib. The Company will present updated data
from the study at the 65th ASH Annual Meeting
December 9-12, 2023, which will
include a PCNSL patient subset.
Upcoming Milestones
- Curis expects updated clinical data from the TakeAim Lymphoma
combination study with ibrutinib at the ASH Annual Meeting.
- The Company expects updated clinical data from the TakeAim
Leukemia monotherapy study in the first half of 2024.
- The Company expects initial clinical data from the triplet
combination study of emavusertib with azacitidine and
venetoclax to treat AML patients in the second half of 2024.
Corporate
In July 2023, Curis completed a
registered direct offering with net proceeds of approximately
$13.8 million.
On September 28, 2023, the Company
effected a 1-for-20 reverse stock split of its common stock.
Third Quarter 2023 Financial Results
For the third quarter of 2023, Curis reported a net loss of
$12.2 million or $2.13 per share on both a basic and diluted basis
as compared to $13.3 million or
$2.83 per share on both a basic and
diluted basis, for the same period in 2022. Curis reported a net
loss of $35.7 million or $6.96 per share on both a basic and diluted
basis, for the nine months ended September
30, 2023 as compared to a net loss of $45.3 million or $9.82 per share on both a basic and diluted basis
for the same period in 2022.
Revenues for the third quarters of 2023 and 2022 were both
$2.8 million. Revenues for both
periods consist of royalty revenues from Genentech and Roche's
sales of Erivedge®. Revenues for the nine months ended September 30, 2023 and 2022 were both
$7.3 million.
Research and development expenses were $10.4 million for the third quarter of 2023, as
compared to $10.8 million for the
same period in 2022. The decrease was primarily attributable to
lower employee-related costs due to a reduction in headcount,
partially offset by increased clinical costs. Research and
development expenses were $29.5
million for the nine months ended September 30, 2023, as compared to $34.6 million for the same period in 2022.
General and administrative expenses were $4.8 million for the third quarter of 2023, as
compared to $4.6 million for the same
period in 2022. The increase was primarily attributable to higher
professional, legal, and consulting services costs. General and
administrative expenses were $13.8
million for the nine months ended September 30, 2023, as compared to $15.3 million for the same period in 2022.
Other income, net was $0.2 million
for the third quarter of 2023, as compared to other expense, net of
$0.7 million for the same period in
2022. Other income (expense), net primarily consisted of interest
income partially offset by non-cash expense related to the sale of
future royalties. Other income, net was $0.4
million for the nine months ended September 30, 2023 compared to other expense, net
$2.5 million for the same period in
2022.
Curis's cash, cash equivalents and investments totaled
$68.5 million, and the Company had
approximately 5.9 million shares of common stock outstanding. Curis
expects its existing cash, cash equivalents and investments to
enable its planned operations into 2025.
Conference Call Information
Curis management will host a conference call today, November 2, 2023, at 8:30
a.m. ET, to discuss the business update and these financial
results.
To access the live conference call, please dial 1-888-390-0546
from the United States or
1-416-764-8688 from other locations, shortly before 8:30 a.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
emavusertib, an orally available, small molecule IRAK4 inhibitor
for the treatment of hematologic malignancies. Emavusertib is
currently undergoing testing in the Phase 1/2 TakeAim Lymphoma
study in patients with hematologic malignancies, such as
non-Hodgkin's lymphoma and other B cell malignancies in combination
with the BTK inhibitor, ibrutinib, and as a monotherapy in the
Phase 1/2 TakeAim Leukemia study 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.
Curis, through its 2015 collaboration with Aurigene, has the
exclusive license to emavusertib (CA-4948). Curis licensed its
rights to Erivedge® to Genentech, a member of the Roche Group,
under which they 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,
Curis's plans and timelines to provide preliminary, interim and/or
additional data from its ongoing or planned clinical trials, its
ability to further patient enrollment in its TakeAim Leukemia and
TakeAim Lymphoma studies, and initiate its AML triplet 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 take further regulatory action with regard to
Curis's clinical trials. 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. 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 third
parties on which Curis depends and could adversely impact Curis's
operating results and its ability to raise capital. 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.
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
September
30,
|
|
Nine Months
Ended
September
30,
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
Revenues,
net:
|
$
|
2,833
|
|
$
|
2,825
|
|
$
|
7,327
|
|
$
|
7,275
|
Costs and
expenses:
|
|
|
|
|
|
|
|
Cost of royalty
revenues
|
60
|
|
62
|
|
158
|
|
186
|
Research and
development
|
10,380
|
|
10,813
|
|
29,532
|
|
34,571
|
General and
administrative
|
4,761
|
|
4,556
|
|
13,770
|
|
15,318
|
Total costs and
expenses
|
15,201
|
|
15,431
|
|
43,460
|
|
50,075
|
Loss from
operations
|
(12,368)
|
|
(12,606)
|
|
(36,133)
|
|
(42,800)
|
Other income (expense),
net
|
187
|
|
(688)
|
|
432
|
|
(2,543)
|
Net loss
|
$
|
(12,181)
|
|
$
|
(13,294)
|
|
$
|
(35,701)
|
|
$
|
(45,343)
|
Net loss per common
share (basic and diluted)
|
$
|
(2.13)
|
|
$
|
(2.83)
|
|
$
|
(6.96)
|
|
$
|
(9.82)
|
Weighted average common
shares (basic and diluted)
|
5,720,789
|
|
4,689,559
|
|
5,131,904
|
|
4,618,518
|
CURIS,
INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
|
(UNAUDITED)
(In
thousands)
|
|
|
|
September 30,
2023
|
|
December 31,
2022
|
ASSETS
|
|
|
|
|
Cash, cash equivalents
and investments
|
|
$
|
68,498
|
|
|
$
|
85,623
|
|
Restricted
cash
|
|
544
|
|
|
635
|
|
Accounts
receivable
|
|
2,848
|
|
|
2,975
|
|
Prepaid expenses and
other assets
|
|
5,204
|
|
|
5,543
|
|
Property and equipment,
net
|
|
497
|
|
|
689
|
|
Operating lease
right-of-use asset
|
|
3,402
|
|
|
4,401
|
|
Goodwill
|
|
8,982
|
|
|
8,982
|
|
Total
assets
|
|
$
|
89,975
|
|
|
$
|
108,848
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
Accounts payable,
accrued liabilities and other liabilities
|
|
$
|
12,446
|
|
|
$
|
8,872
|
|
Operating lease
liability
|
|
3,093
|
|
|
3,941
|
|
Liability related to
the sale of future royalties, net
|
|
44,845
|
|
|
49,483
|
|
Total
liabilities
|
|
60,384
|
|
|
62,296
|
|
Total stockholders'
equity
|
|
29,591
|
|
|
46,552
|
|
Total liabilities and
stockholders' equity
|
|
$
|
89,975
|
|
|
$
|
108,848
|
|
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SOURCE Curis, Inc.