Emavusertib data presented at ASH showed 3 of
5 patients achieved CR in R/R PCNSL
Expansion of clinical sites in US and
Europe in progress
Cash runway into 2025
Management to host conference call today at
8:30 a.m. ET
LEXINGTON, Mass., Feb. 8, 2024
/PRNewswire/ -- Curis, Inc. (NASDAQ: CRIS), a biotechnology company
focused on the development of emavusertib (CA-4948), an orally
available, small molecule IRAK4 inhibitor, today reported its
business update and financial results for the quarter ended
December 31, 2023.
Operational Highlights
In December at the 65th American Society of
Hematology Annual Meeting and Exposition (ASH), the Company
presented data from both the TakeAim Lymphoma and TakeAim Leukemia
studies. A summary of key findings of the data that were presented
from the on-going studies are as follows:
- TakeAim Lymphoma – data for patients with primary CNS lymphoma
(PCNSL) who had failed prior BTKi therapy showed 3 of 5 evaluable
patients achieved Complete Response (CR).
- TakeAim Leukemia – data for patients with relapsed/refractory
(R/R) AML with a FLT3 mutation who received < 3 prior lines of
treatment showed 2 of 3 patients achieved CR and the 3rd
patient achieved Morphological Leukemia Free State (MLFS).
In addition to the presentations at ASH, Curis announced in
December that it had entered into an agreement for an
Investigator-Initiated Trial to study the combination of
emavusertib and pembrolizumab in patients with metastatic melanoma.
In this study, Curis will be responsible for the supply of
emavusertib and Merck will be responsible for the supply of
pembrolizumab and clinical study costs.
"The R/R PCNSL data presented at ASH highlight the potential of
emavusertib in combination with ibrutinib to address a critical
unmet need, for a patient population with no approved treatments,
and achieve CR in patients who have failed prior BTKi therapy. The
R/R AML FLT3 data highlight emavusertib's potential to provide
targeted anti-cancer activity as a monotherapy. We have also begun
working with clinical investigators to initiate a Phase 1
clinical study of emavusertib as an add-on agent to the combination
of azacitidine and venetoclax in the front-line setting. Finally,
the study evaluating emavusertib and pembrolizumab in metastatic
melanoma will explore the potential of emavusertib and IRAK4
inhibition in solid tumors," said James
Dentzer, President and Chief Executive Officer of
Curis. "We are encouraged by the reaction of the clinical
community to the data released at ASH and are working to open
additional clinical sites in the US and Europe for both the TakeAim Leukemia and
Lymphoma studies."
Upcoming Milestones
- TakeAim Leukemia – updated clinical data from the on-going
monotherapy study in the first half of 2024.
- TakeAim Lymphoma – updated clinical data from the on-going
combination study of emavusertib with ibrutinib in the second half
of 2024.
- Curis expects initial clinical data from the recently initiated
triplet combination study of emavusertib with azacitidine and
venetoclax to treat AML patients in the second half of 2024.
Fourth Quarter 2023 Financial Results
For the year ended December 31,
2023, Curis reported a net loss of $47.4 million, or $8.96 per share on both a basic and diluted
basis, as compared to a net loss of $56.7
million, or $12.14 per share
on both a basic and diluted basis in 2022. For the fourth quarter
of 2023, Curis reported a net loss of $11.7
million or $2.03 per share on
both a basic and diluted basis as compared to a net loss of
$11.3 million or $2.35 per share on both a basic and diluted basis
for the same period in 2022.
Revenues, net for the year ended December
31, 2023, were $10.0 million
as compared to $10.2 million for the
same period in 2022. Revenues for both periods comprise primarily
royalty revenues related to Genentech and Roche's net sales of
Erivedge®. Revenues for the fourth quarters of 2023 and
2022 were $2.7 million and
$2.9 million, respectively.
Cost of royalties, which relate to third-party university patent
licensors in connection with Genentech and Roche's Erivedge net
sales, for the year ended December 31,
2023, were $0.2 million
compared to $0.3 million for the same
period in 2022. Cost of royalties for the fourth quarters of 2023
and 2022 were $0.1 million for both
periods.
Research and development expenses were $39.5 million for the year ended December 31, 2023, as compared to $43.3 million for the same period in 2022. The
decrease was primarily attributable to lower employee-related costs
due to reduced headcount. Research and development expenses were
$10.0 million and $8.7 million for the fourth quarters of 2023 and
2022, respectively.
General and administrative expenses were $18.6 million for the year ended December 31, 2023, as compared to $19.6 million for the same period in 2022. The
decrease was primarily attributable to lower employee-related costs
due to reduced headcount. General and administrative expenses were
$4.9 million and $4.3 million for the fourth quarters of 2023 and
2022, respectively.
Other income, net was $0.9 million
for the year ended December 31, 2023,
as compared to other expense, net of $3.7
million for the same period in 2022. The increase was
attributable to an increase in interest income and a decrease in
the non-cash expense related to the sale of future royalties. Other
income, net was $0.5 million for the
fourth quarter of 2023 as compared to other expense, net of
$1.1 million for the same period in
2022.
As of December 31, 2023, Curis's
cash, cash equivalents and investments totaled $56.3 million, and the Company had approximately
5.9 million shares of common stock outstanding. Curis expects its
existing cash, cash equivalents and investments should enable its
planned operations into 2025.
Conference Call Information
Curis management will host a conference call today, February 8, 2024, at 8:30
a.m. ET, to discuss the business update and these financial
results.
To access the live conference call, please dial 1-888-346-6389
from the United States or
1-412-317-5252 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.
Emavusertib is currently undergoing testing in the Phase 1/2
TakeAim Lymphoma study in patients with relapsed/refractory primary
central nervous system lymphoma (PCNSL) in combination with the BTK
inhibitor ibrutinib, as a monotherapy in the Phase 1/2 TakeAim
Leukemia study in patients with relapsed/refractory acute myeloid
leukemia (AML) and relapsed/refractory high risk myelodysplastic
syndrome (hrMDS), for which it has received Orphan Drug Designation
from the U.S. Food and Drug Administration and as a frontline
combination therapy with azacitidine and venetoclax in patents with
AML. 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, commercialization plans, timelines, anticipated results or
the therapeutic potential of emavusertib, 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, its 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 Lymphoma and TakeAim Leukemia
studies as well as initiate and enroll patients in 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. 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. Curis depends
heavily on the success of emavusertib and any delays in the
development of emavusertib could have a material adverse effect on
its business. There can be no guarantee that the collaboration
agreement with Aurigene will continue for its full term, 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. 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 its development of emavusertib, including related
clinical trials and operating expenses, potentially delaying the
time to market for, or preventing the marketing of, emavusertib,
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
December
31,
|
|
Twelve Months
Ended
December
31,
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
Revenues,
net
|
2,696
|
|
2,887
|
|
10,023
|
|
10,162
|
Operating
expenses:
|
|
|
|
|
|
|
|
Cost of
royalties
|
54
|
|
71
|
|
212
|
|
257
|
Research and
development
|
9,964
|
|
8,706
|
|
39,496
|
|
43,277
|
General and
administrative
|
4,877
|
|
4,330
|
|
18,647
|
|
19,648
|
Total operating
expenses
|
14,895
|
|
13,107
|
|
58,355
|
|
63,182
|
Loss from
operations
|
(12,199)
|
|
(10,220)
|
|
(48,332)
|
|
(53,020)
|
Total other income
(expense)
|
487
|
|
(1,109)
|
|
919
|
|
(3,652)
|
Net loss
|
$
(11,712)
|
|
$
(11,329)
|
|
$
(47,413)
|
|
$
(56,672)
|
Net loss per common
share (basic and diluted)
|
$
(2.03)
|
|
$
(2.35)
|
|
$
(8.96)
|
|
$
(12.14)
|
Weighted average common
shares (basic and diluted)
|
5,772,201
|
|
4,821,283
|
|
5,293,294
|
|
4,669,626
|
CURIS,
INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
|
(UNAUDITED)
(In
thousands)
|
|
|
|
December 31,
2023
|
|
December 31,
2022
|
ASSETS
|
|
|
|
|
Cash, cash equivalents
and investments
|
|
$
|
56,334
|
|
|
$
|
85,623
|
|
Restricted
cash
|
|
544
|
|
|
635
|
|
Accounts
receivable
|
|
2,794
|
|
|
2,975
|
|
Prepaid expenses and
other assets
|
|
5,138
|
|
|
5,543
|
|
Property and equipment,
net
|
|
434
|
|
|
689
|
|
Operating lease
right-of-use asset
|
|
3,056
|
|
|
4,401
|
|
Goodwill
|
|
8,982
|
|
|
8,982
|
|
Total
assets
|
|
$
|
77,282
|
|
|
$
|
108,848
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
Accounts payable and
accrued liabilities
|
|
$
|
12,212
|
|
|
$
|
8,872
|
|
Operating lease
liability
|
|
2,794
|
|
|
3,941
|
|
Liability related to
the sale of future royalties, net
|
|
42,606
|
|
|
49,483
|
|
Total
liabilities
|
|
57,612
|
|
|
62,296
|
|
Total stockholders'
equity
|
|
19,670
|
|
|
46,552
|
|
Total liabilities and
stockholders' equity
|
|
$
|
77,282
|
|
|
$
|
108,848
|
|
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SOURCE Curis, Inc.