Removal of partial clinical hold – enrolling
patients at confirmed RP2D in the TakeAim Leukemia Study
Enrolling patients in the TakeAim Lymphoma
Study in combination with ibrutinib
Strong balance sheet with $77.4 million in cash and investments; cash
runway into 2025
Management to host conference call today at
4:30 p.m. ET
LEXINGTON, Mass., Aug. 3, 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 second quarter ended June
30, 2023.
"We are very pleased with our progress this quarter, as we were
able to work with the FDA to remove the partial clinical hold on
the TakeAim Leukemia study a quarter ahead of schedule. In that
process, we also gained alignment with FDA in confirming 300 mg BID
as the RP2D for monotherapy, which we believe is the optimal
monotherapy dose. We appreciate the strong support of our clinical
investigators during our discussions with FDA and we are excited to
expand patient enrollment in the TakeAim Leukemia study at the
RP2D," said James Dentzer, President
and CEO of Curis.
Second Quarter 2023 and Recent Operational Highlights
Precision Oncology, Emavusertib (IRAK4 Inhibitor)
TakeAim Leukemia
- In July, the Company announced that the U.S. Food and Drug
Administration (FDA) removed the partial clinical hold on the
TakeAim Leukemia Phase 1/2 study of emavusertib. Further, the
recommended phase 2 dose (RP2D) for emavusertib as a monotherapy
has been confirmed at 300 mg BID in patients with Acute Myelogenous
Leukemia (AML) or Myelodysplastic Syndromes (MDS).
- The Company is currently enrolling relapsed or refractory (R/R)
AML patients with FLT3 mutation or a spliceosome mutation (U2AF1 or
SF3B1 mutation) who have received ≤ 2 prior lines of treatment in
the monotherapy study.
- The Company is also planning a combination study of emavusertib
with azacitidine and venetoclax to treat AML patients in the
front-line setting.
TakeAim Lymphoma
- The Company 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.
Upcoming Milestones
- We expect updated clinical data in both the monotherapy and
combination studies in 2024.
Corporate
In July 2023, the Company
completed a registered direct offering with net proceeds of
approximately $13.8 million.
First Quarter 2023 Financial Results
For the second quarter of 2023, Curis reported a net loss of
$12.0 million or $0.12 per share on both a basic and diluted basis
as compared to $15.9 million or
$0.17 per share on both a basic and
diluted basis, for the same period in 2022. Curis reported a net
loss of $23.5 million or $0.24 per share on both a basic and diluted
basis, for the six months ended June 30,
2023 as compared to a net loss of $32.0 million or $0.35 per share on both a basic and diluted basis
for the same period in 2022.
Revenues for the first quarter of 2023 were $2.2 million as compared to $2.4 million for the same period in 2022.
Revenues for both periods consist of royalty revenues from
Genentech's and Roche's sales of Erivedge®. Revenues for the six
months ended June 30, 2023 and 2022
were both $4.5 million.
Research and development expenses were $10.0 million for the second quarter of 2023, as
compared to $12.3 million for the
same period in 2022. The decrease was primarily attributable to
lower employee related costs due to a reduction in headcount.
Research and development expenses were $19.2
million for the six months ended June
30, 2023, as compared to $23.8
million for the same period in 2022.
General and administrative expenses were $4.2 million for the second quarter of 2023, as
compared to $5.1 million for the same
period in 2022. The decrease was mainly attributable to lower
employee related costs due to a reduction in headcount. General and
administrative expenses were $9.0
million for the six months ended June
30, 2023, as compared to $10.8
million for the same period in 2022.
Other income, net was $0.2 million
for the second quarter of 2023, as compared to other expense, net
of $0.9 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. Other income, net was $0.2
million for the six months ended June
30, 2023 compared to other expense, net $1.9 million for the same period in 2022.
Including the impact of the July Registered Direct offering,
Curis's cash, cash equivalents and investments totaled $77.4 million, and the Company had approximately
117.7 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, August 3, 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
emavusertib, an orally available, small molecule IRAK4 inhibitor
for the treatment of hematologic malignancies. 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
study in patients with hematologic malignancies, such as
non-Hodgkin's lymphoma and other B cell malignancies both as a
monotherapy and in combination with the BTK inhibitor ibrutinib,
and 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. 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 further patient enrollment in its TakeAim Leukemia and
TakeAim Lymphoma studies, 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
June
30,
|
|
Six Months
Ended
June
30,
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
Revenues,
net:
|
$
|
2,197
|
|
$
|
2,393
|
|
$
|
4,494
|
|
$
|
4,450
|
Costs and
expenses:
|
|
|
|
|
|
|
|
Cost of royalty
revenues
|
74
|
|
42
|
|
98
|
|
124
|
Research and
development
|
10,012
|
|
12,323
|
|
19,152
|
|
23,758
|
General and
administrative
|
4,249
|
|
5,089
|
|
9,009
|
|
10,762
|
Total costs and
expenses
|
14,335
|
|
17,454
|
|
28,259
|
|
34,644
|
Loss from
operations
|
(12,138)
|
|
(15,061)
|
|
(23,765)
|
|
(30,194)
|
Other income (expense),
net
|
177
|
|
(879)
|
|
245
|
|
(1,855)
|
Net loss
|
$
|
(11,961)
|
|
$
|
(15,940)
|
|
$
|
(23,520)
|
|
$
|
(32,049)
|
Net loss per common
share (basic and diluted)
|
$
|
(0.12)
|
|
$
|
(0.17)
|
|
$
|
(0.24)
|
|
$
|
(0.35)
|
Weighted average common
shares (basic and diluted)
|
96,685,924
|
|
91,650,950
|
|
96,649,934
|
|
91,648,175
|
CURIS,
INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
(In
thousands)
|
|
|
|
June 30,
2023
|
|
December 31,
2022
|
ASSETS
|
|
|
|
|
Cash, cash equivalents
and investments
|
|
$
|
63,487
|
|
|
$
|
85,623
|
|
Restricted
cash
|
|
635
|
|
|
635
|
|
Accounts
receivable
|
|
2,386
|
|
|
2,975
|
|
Prepaid expenses and
other assets
|
|
4,517
|
|
|
5,543
|
|
Property and equipment,
net
|
|
561
|
|
|
689
|
|
Operating lease
right-of-use asset
|
|
3,740
|
|
|
4,401
|
|
Goodwill
|
|
8,982
|
|
|
8,982
|
|
Total
assets
|
|
$
|
84,308
|
|
|
$
|
108,848
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
Accounts payable,
accrued liabilities and other liabilities
|
|
$
|
8,462
|
|
|
$
|
8,872
|
|
Operating lease
liability
|
|
3,384
|
|
|
3,941
|
|
Liability related to
the sale of future royalties, net
|
|
46,238
|
|
|
49,483
|
|
Total
liabilities
|
|
58,084
|
|
|
62,296
|
|
Total stockholders'
equity
|
|
26,224
|
|
|
46,552
|
|
Total liabilities and
stockholders' equity
|
|
$
|
84,308
|
|
|
$
|
108,848
|
|
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SOURCE Curis, Inc.