Presented encouraging clinical data for the
combination of emavusertib plus ibrutinib showing tumor reduction
in 8 of 9 evaluable patients and the potential for overcoming
ibrutinib resistance at the 2022 American Society of Clinical
Oncology Annual Meeting (ASCO)
Appointed Industry Veteran Diantha Duvall
as Chief Financial Officer
Strong balance sheet with $107.2 million in cash and investments as of
June 30, 2022; cash
runway into 2024
Management to host conference call today at
4:30 p.m. ET
LEXINGTON, Mass., Aug. 4, 2022
/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
second quarter ended June 30, 2022
and provided business updates.
"This quarter, we issued the noteworthy first release of data
from the TakeAim Lymphoma trial's combination arm that examined
emavusertib combined with ibrutinib in B cell malignancies. This
data showed tumor reduction in 8 of 9 evaluable patients, and the
potential to help patients experiencing ibrutinib resistance. We
look forward to continuing the advancement of our first-in-class,
small molecule IRAK4 inhibitor in nine distinct patient populations
across acute myeloid leukemia (AML), myelodysplastic syndromes
(MDS) and B cell cancers. On the administrative front, I am also
pleased to announce the appointment of Diantha Duvall as our new Chief Financial
Officer. Diantha brings a wealth of experience from senior roles at
Merck, Biogen, Bioverativ, Genocea and PricewaterhouseCoopers. We
look forward to her contributions to the Curis mission," said
James Dentzer, President and Chief
Executive Officer of Curis.
"I am excited to join Curis at this critical time for the
company," said Ms. Duvall. "I found Curis to be particularly
compelling due to its novel, targeted approach and pipeline of
first-in-class cancer therapeutics with significant potential in
areas of unmet need. I look forward to supporting the Curis team's
mission to develop innovative and differentiated therapeutics that
improve the lives of cancer patients."
Second Quarter 2022 and Recent Operational Highlights
Precision oncology, emavusertib (IRAK4 Inhibitor; Aurigene
collaboration):
- The company presented the first preliminary dataset from the
combination arm in the TakeAim Lymphoma study at ASCO and at the
European Hematology Association (EHA) Hybrid Congress which
examined the use of emavusertib plus ibrutinib in patients with
relapsed or refractory (R/R) hematologic malignancies, such as
non-Hodgkin's lymphoma and other B cell malignancies. The
presentation included clinical data on 13 patients who received the
combination, 9 of whom had post-baseline response assessments and
were evaluable for response.
- Key findings in patients treated with the combination
included:
-
- The combination appeared to be well tolerated
- No dose-limiting toxicities (DLTs) at 200mg of emavusertib; 2
DLTs observed at 300mg (stomatitis and syncope)
- 8 of 9 evaluable patients experienced reduction in tumor
burden, including:
-
- 2 complete responses (CR) (primary CNS lymphoma and mantle cell
lymphoma)
- 2 partial responses (PR) (chronic lymphocytic leukemia and
mantle cell lymphoma)
- One of the CRs was in a patient who had received prior
treatment with ibrutinib, suggesting the combination may be able to
overcome ibrutinib resistance
- The company presented data from the TakeAim Leukemia study at
ASCO and EHA during the second quarter. The data showed encouraging
rates of response in three separate targeted patient populations,
namely those with: spliceosome-mutated R/R AML, spliceosome-mutated
R/R MDS, and FLT3-mutated R/R AML. In addition, emavusertib was
well-tolerated across multiple dose levels.
- The company also presented novel findings from its work
involving potential biomarker development for use with emavusertib
studies which described the previously unrecognized localization of
IRAK4 in the nucleus of cancer cells. The localization of IRAK4 in
the nucleus is being explored as a potential biomarker.
- Curis's collaborators also presented data on their work with
emavusertib. Two of these were in solid tumor indications: one in
gastric cancer by Dr. Kian-Huat
Lim's team at Washington
University School of Medicine, and the second by Dr.
Duane Mitchell's team at the
University of Florida, which
investigated emavusertib in melanoma brain metastasis. The third
presentation by the Company's collaborators was also from Dr.
Duane Mitchell's team, and this work
was in the treatment of patients with primary CNS lymphoma.
- The company is working closely with the FDA to resolve the
partial clinical holds on enrollment for the emavusertib
studies.
Appointed new CFO:
- Curis appointed Diantha Duvall
Chief Financial Officer effective August 5,
2022. Ms. Duvall joins the company from Genocea, where she
served as the CFO since 2019. Prior to that, she held senior
finance roles at Bioverativ, Biogen and Merck, where her roles
spanned commercial finance, venture investment, business
development, joint ventures, alliances, technical accounting and
controls. She received a bachelor's degree in Economics and Public
Policy from Colby College and masters'
degrees in both Accounting and Business Administration from
Northeastern University. She is also a
Certified Public Accountant licensed in the state of Massachusetts. Ms. Duvall succeeds
Bill Steinkrauss, who as previously
announced is resigning from the company on August 5, 2022, to pursue an entrepreneurial
opportunity in consulting. Mr. Steinkrauss will continue to work
with the company as a consultant as needed through the end of 2022
to ensure a smooth transition.
Upcoming Planned Milestones for the remainder of 2022
- Report data from the TakeAim Leukemia study
-
- We plan to present an update with additional monotherapy
data
- We plan to present initial data for the study of emavusertib in
combination with azacitadine or venetoclax
- Report data from the CI-8993 (VISTA checkpoint inhibitor)
study
-
- We plan to present an update with additional monotherapy
data
- Annual VISTA symposium planned for September 23, 2022
- Annual IRAK4 symposium planned for October 7, 2022
Second Quarter 2022 Financial Results
For the second quarter of 2022, Curis reported a net loss of
$15.9 million or $0.17 per share on both a basic and diluted
basis, as compared to a net loss of $10.8
million, or $0.12 per share on
both a basic and diluted basis for the same period in 2021. Curis
reported a net loss of $32.0 million
or $0.35 per share on both a basic
and diluted basis, for the six months ended June 30, 2022 as compared to a net loss of
$20.8 million, or $0.23 per share on both a basic and diluted basis
for the same period in 2021.
Revenues for the second quarter of 2022 and 2021 were
$2.4 million and $2.3 million, respectively. Revenues for the six
months ended June 30, 2022 and
June 30, 2021 were $4.5 million. Revenues for both periods comprise
primarily royalty revenues recorded on Genentech and Roche's net
sales of Erivedge®.
Operating expenses for the second quarter of 2022 were
$17.5 million, as compared to
$12.9 million for the same period in
2021. Operating expenses for the six months ended June 30, 2022 were $34.6
million, as compared to $23.9
million for the same period in 2021, and comprised the
following:
Cost of Royalty Revenues. Cost of royalty revenues,
which represents amounts due to third-party university patent
licensors in connection with Genentech and Roche's Erivedge net
sales, were less than $0.1 million
for the second quarter of 2022 and $0.1
million for the same period in 2021. Cost of royalty
revenues for the six months ended June 30,
2022 were $0.1 million, as
compared to $0.2 million for the same
period in 2021.
Research and Development Expenses. Research and
development expenses were $12.3
million for the second quarter of 2022 as compared to
$8.8 million for the same period in
2021. The increase in direct research and development expenses for
the quarter is primarily attributable to increased consulting
services. Additionally, personnel related costs increased by
$2.5 million and stock compensation
increased $0.4 million, primarily as
a result of additional headcount. Research and development expenses
were $23.8 million for the six months
ended June 30, 2022 as compared to
$15.5 million for the same period in
2021.
General and Administrative Expenses. General and
administrative expenses were $5.1
million for the second quarter of 2022, as compared to
$4.1 million for the same period in
2021. The increase in general and administrative expenses was
driven primarily by higher costs for personnel, stock-based
compensation, and insurance costs. General and administrative
expenses were $10.8 million for the
six months ended June 30, 2022, as
compared to $8.2 million for the same
period in 2021.
Other Expense, Net. For the second quarter of 2022 and
2021, total other expense was $0.9
million and $0.2 million,
respectively. Net other expense primarily consisted of imputed
interest expense related to future royalty payments, partially
offset in the second quarter of 2021 by a gain of $0.9 million related to extinguishment of debt.
Net other expense was $1.9 million
for the six months ended June 30,
2022, as compared to $1.3
million for the same period in 2021.
As of June 30, 2022, Curis's cash,
cash equivalents and investments totaled $107.2 million, and there were approximately 91.8
million shares of common stock outstanding. Curis expects that its
existing cash, cash equivalents and investments should enable it to
maintain its planned operations into 2024.
Conference Call Information
Curis management will host a conference call today, August 4, 2022, at 4:30
p.m. ET, 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. ET. 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. 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
and TakeAim Lymphoma trials during which no new patients will be
enrolled, and current study participants benefiting from treatment
may continue to be treated with emavusertib at doses of 300mg BID
or lower. In addition, Curis is engaged in a collaboration with
ImmuNext for development of CI-8993, a monoclonal anti-VISTA
antibody, which is currently undergoing testing in a Phase 1 trial
in patients with solid tumors. 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, objectives or financial results;
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, efficacy, dosage and potential benefits of CA-4948
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, any
statements concerning Curis's expectations regarding its
interactions with the FDA or its ability to resolve the partial
clinical hold of the TakeAim Leukemia study or the partial clinical
hold of the TakeAim Lymphoma study, and 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 partial
clinical hold on the Phase 1/2 TakeAim Leukemia trial or the
partial clinical hold on the Phase 1/2 TakeAim Lymphoma trial, or
may take further regulatory action with regard to such 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 develop or commercialize Erivedge in
basal cell carcinoma (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 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. For example,
the COVID-19 pandemic may result in closures of third-party
facilities, impact enrollment in clinical trials or impact sales of
Erivedge by Genentech and/or Roche. The extent to which
the COVID-19 pandemic may impact Curis's business or operating
results is uncertain. 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
June
30,
|
|
Six Months
Ended
June
30,
|
|
|
2022
|
|
2021
|
|
2022
|
|
2021
|
|
Revenues,
net:
|
|
|
|
|
|
|
|
|
Royalties
|
$2,474
|
|
$2,348
|
|
$4,534
|
|
$4,535
|
|
Other
revenue
|
—
|
|
1
|
|
—
|
|
1
|
|
Contra revenue,
net
|
(81)
|
|
(63)
|
|
(84)
|
|
(61)
|
|
Total revenues,
net
|
2,393
|
|
2,286
|
|
4,450
|
|
4,475
|
|
Costs and
expenses:
|
|
|
|
|
|
|
|
|
Cost of royalty
revenues
|
42
|
|
116
|
|
124
|
|
225
|
|
Research and
development
|
12,323
|
|
8,753
|
|
23,758
|
|
15,510
|
|
General and
administrative
|
5,089
|
|
4,067
|
|
10,762
|
|
8,190
|
|
Total costs and
expenses
|
17,454
|
|
12,936
|
|
34,644
|
|
23,925
|
|
Loss from
operations
|
(15,061)
|
|
(10,650)
|
|
(30,194)
|
|
(19,450)
|
|
Other
expense:
|
|
|
|
|
|
|
|
|
Interest
income
|
162
|
|
58
|
|
242
|
|
104
|
|
Imputed interest
expense related to the sale of future
royalties
|
(1,041)
|
|
(1,136)
|
|
(2,097)
|
|
(2,309)
|
|
Other income (expense),
net
|
—
|
|
890
|
|
—
|
|
890
|
|
Total other
expense
|
(879)
|
|
(188)
|
|
(1,855)
|
|
(1,315)
|
|
Net loss
|
$(15,940)
|
|
$(10,838)
|
|
$(32,049)
|
|
$(20,765)
|
|
Net loss per common
share (basic and diluted)
|
$(0.17)
|
|
$(0.12)
|
|
$(0.35)
|
|
$(0.23)
|
|
Weighted average common
shares (basic and diluted)
|
91,650,950
|
|
91,547,390
|
|
91,648,175
|
|
91,527,563
|
|
CURIS,
INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
|
(UNAUDITED)
(In
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
June 30,
2022
|
|
December 31,
2021
|
ASSETS
|
|
|
|
|
Cash, cash equivalents
and investments
|
|
$
|
107,200
|
|
|
$
|
139,848
|
|
Restricted
cash
|
|
635
|
|
|
726
|
|
Accounts
receivable
|
|
2,395
|
|
|
3,224
|
|
Property and equipment,
net
|
|
789
|
|
|
505
|
|
Operating lease
right-of-use asset
|
|
5,032
|
|
|
5,749
|
|
Goodwill
|
|
8,982
|
|
|
8,982
|
|
Prepaid expenses and
other assets
|
|
3,801
|
|
|
3,267
|
|
Total
assets
|
|
$
|
128,834
|
|
|
$
|
162,301
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
Accounts payable,
accrued liabilities and other
liabilities
|
|
$
|
11,086
|
|
|
$
|
12,756
|
|
Operating lease
liability
|
|
4,455
|
|
|
5,040
|
|
Liability related to
the sale of future royalties, net
|
|
51,248
|
|
|
53,798
|
|
Total
liabilities
|
|
66,789
|
|
|
71,594
|
|
Total stockholders'
equity
|
|
62,045
|
|
|
90,707
|
|
Total liabilities and
stockholders' equity
|
|
$
|
128,834
|
|
|
$
|
162,301
|
|
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SOURCE Curis, Inc.