LEXINGTON, Mass., Aug. 3, 2021 /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, 2021.
"In the second quarter of 2021, we continued executing on
planned milestones across our pipeline of next generation targeted
cancer therapies designed to meaningfully improve and extend
patients' lives. We drove important progress with our
first-in-class, small molecule IRAK4 inhibitor CA-4948, expanding
our clinical trials into nine distinct patient populations across
AML/MDS and B cell cancers. In June, we presented updated data from
our Phase 1/2 relapsed/refractory (R/R) AML/MDS study at EHA, which
showcased continued improvements in clinical activity and robust
tolerability in extremely fragile patients," said James Dentzer, President and Chief Executive
Officer of Curis. "At the 300mg BID dose we are seeing clear
anticancer activity and are achieving pharmacokinetic (PK) exposure
in patients that correlates to 98% inhibition in preclinical
models. In addition, we are encouraged by a predictable and
manageable safety profile with no dose-limiting toxicities related
to myelosuppression and no overlapping dose-limiting toxicities
with existing anticancer therapies planned for dosing in
combination with CA-4948. The data at EHA also highlighted that we
have identified a subset of patients with specific mutations that
may make their disease highly amenable to CA-4948 monotherapy; all
4 of 4 evaluable patients with spliceosome or FLT3 mutations
experienced an objective response. With further expansion of this
group of patients, we may be able to identify a rapid path to
regulatory approval for CA-4948. We also reported that even in
patients without these specific mutations, CA-4948 demonstrated
consistent tumor burden reduction, providing opportunities for
combination development in a broader population. We expect to begin
enrolling patients later this year in combination therapy
evaluating CA-4948 with azacitidine or venetoclax. In total, we are
exploring CA-4948 in four distinct cohorts in AML/MDS in addition
to lower risk MDS, which is the subject of a separate Investigator
Sponsored Trial (the LUCAS IST). We are also exploring CA-4948 in
combination with ibrutinib across four additional cohorts in B cell
cancers."
Mr. Dentzer added, "Lastly, we are also pleased with the
continuing dose escalation in our ongoing Phase 1 study of CI-8993,
our first-in-class monoclonal anti-VISTA antibody for the treatment
of patients with R/R solid tumors.
"We look forward to providing an update on enrollment progress
for all studies, including data updates for the spliceosome cohort
in AML/MDS and the VISTA study, later this year."
Second Quarter 2021 and Recent Operational Highlights
Precision oncology, CA-4948 (IRAK4 Inhibitor; Aurigene
collaboration):
- At EHA, Curis presented interim data from the ongoing Phase 1/2
study of CA-4948 monotherapy in patients with R/R AML/MDS. The data
were as of April 30, 2021 (the
cut-off date) and were consistent with previously announced
findings, including:
-
- Objective responses observed in 4 of 4 (100%) evaluable
patients in the enriched population of patients with a targeted
mutation (spliceosome or FLT3 mutation); these enriched populations
will be studied in monotherapy expansion cohorts
- Marrow blast reductions, or maintenance of blast level for
patients in the normal range at baseline, in 9 of 11 (82%) patients
without spliceosome or FLT3 mutations; this broader population will
be studied in combination therapy in expansion
- Efficacy confirmed with positive safety findings:
-
- Clear efficacy observed at 300mg twice daily dosing
- MTD not exceeded until 500mg BID
- No overlap in dose-limiting toxicities with azacitidine and
venetoclax, which are planned for combination with CA-4948
- No dose-limiting toxicities related to myelosuppression
- Dose-limiting side effect at higher doses consists of
uncomplicated rhabdomyolysis (elevated CPK and muscle soreness),
which was manageable, quickly and easily detected, readily
reversible, and did not limit further treatment at a reduced dose
level
- Of note, those patients who experienced rhabdomyolysis at
higher doses generally had predisposing factors, such as
concomitant administration of statins or strenuous exercise
- Alongside the EHA data, Curis determined 300mg BID to be the
recommended Phase 2 dose as it demonstrated clear anticancer
activity, a manageable and predictable safety profile and PK
exposure in patients that correlates to near complete target
engagement in preclinical models (98%)
- Also at EHA, Curis reported non-clinical data demonstrating
synergistic antitumor activity of CA-4948 in combination with
azacitidine and venetoclax in leukemia cells, providing supportive
rationale for clinical studies evaluating of combination therapy
for AML/MDS patients
- The Phase 1/2 study of CA-4948 in AML/MDS was expanded to
include both a monotherapy dose expansion and a combination dose
escalation:
-
- Monotherapy:
-
- R/R MDS patients with/without spliceosome mutation
- R/R AML patients with/without FLT3 mutation
- Combination therapy:
-
- CA-4948 + azacitidine, for patients naïve to HMA
- CA-4948 + venetoclax, for patients naïve to venetoclax
- The Phase 1/2 study of CA-4948 in B cell cancers was expanded
to include a combination dose escalation and dose expansion across
four patient cohorts
- Combination therapy:
-
- BTKi-naïve patients with marginal zone lymphoma
- BTKi-naïve patients with primary CNS lymphoma
- BTKi-naïve patients with ABC-DLBCL
- Patients who have developed adaptive resistance to
ibrutinib
Immuno-oncology, CI-8993 (anti-VISTA antibody; ImmuNext
collaboration):
- Enrollment is continuing in the ongoing Phase 1 dose escalation
study of CI-8993, Curis's first-in-class monoclonal anti-VISTA
antibody for the treatment of R/R solid tumors
- Curis expects to report initial safety data from this trial
later in 2021
- In June 2021, Curis hosted a
virtual symposium entitled: VISTA: A New Immune Checkpoint in
Cancer, Autoimmunity, and Beyond, gathering thought-leaders in
industry and academia to discuss emerging understanding and
opportunities surrounding the immune checkpoint
Upcoming Planned Milestones
- In the second half of 2021, initiate dosing in the combination
stage of the Phase 1/2 study of CA-4948 plus azacitidine and
CA-4948 plus venetoclax
- By year-end 2021, report additional clinical data from the
Phase 1/2 monotherapy study of CA-4948 in AML/MDS patients with
spliceosome mutations that result in aberrant splicing of oncogenic
IRAK4-L
- By year-end 2021, report initial safety data from the ongoing
Phase 1 monotherapy study of CI-8993 for the treatment of R/R solid
tumors
- In the first half of 2022, report initial data at a medical
meeting from the ongoing Phase 1/2 combination study of CA-4948
plus ibrutinib in patients with B cell cancers
Second Quarter 2021 Financial Results
For the second quarter of 2021, Curis reported a net loss of
$10.8 million or $0.12 per share on both a basic and diluted
basis, as compared to a net loss of $6.7
million, or $0.17 per share on
both a basic and diluted basis for the same period in 2020. Curis
reported a net loss of $20.8 million,
or $0.23 per share on both a basic
and diluted basis, for the six months ended June 30, 2021, as compared to a net loss of
$16.4 million, or $0.44 per share on both a basic and diluted
basis, for the same period in 2020.
Revenues for the second quarter of 2021 and 2020 were
$2.3 million and $2.4 million, respectively. Revenues for the six
months ended June 30, 2021 were
$4.5 million, as compared to
$5.1 million for the same period in
2020. 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 2021 were
$12.9 million, as compared to
$7.8 million for the same period in
2020. Operating expenses for the six months ended June 30, 2021 were $23.9
million, as compared to $19.0
million for the same period in 2020, and comprised the
following:
Costs of Royalty Revenues. Costs of royalty
revenues, primarily amounts due to third-party university patent
licensors in connection with Genentech and Roche's Erivedge net
sales, were $0.1 million for the
second quarter of 2021, as compared to $0.1
million for the same period in 2020. Cost of royalty
revenues for the six months ended June 30,
2021 were $0.2 million, as
compared to $0.2 million for the same
period in 2020.
Research and Development Expenses. Research and
development expenses were $8.8
million for the second quarter of 2021 as compared to
$5.3 million for the same period in
2020. The increase in direct research and development expenses for
the quarter is primarily attributable to increased clinical and
manufacturing costs for our programs. Additionally, employee
related costs increased by $1.4
million, primarily attributable to increased stock
compensation and personnel costs as a result of additional
headcount. Research and development expenses were $15.5 million for the six months ended
June 30, 2021 as compared to
$12.8 million for the same period in
2020.
General and Administrative Expenses. General and
administrative expenses were $4.1
million for the first second quarter of 2021, as compared to
$2.4 million for the same period in
2020. The increase in general administrative expense was driven
primarily by higher costs for stock-based compensation, personnel,
professional and consulting services, and legal services. General
and administrative expenses were $8.2
million for the six months ended June
30, 2021, as compared to $6.0
million for the same period in 2020.
Other Expense, Net. For the second quarter of 2021 and
2020, net other expense was $0.2
million and $1.3 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 $1.3 million
for the six months ended June 30,
2021, as compared to $2.5
million for the same period in 2020.
As of June 30, 2021, Curis's cash,
cash equivalents and investments totaled $160.7 million, and there were approximately 91.6
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 3, 2021, 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, CA-4948. CA-4948 is currently
undergoing testing in a Phase 1/2 in patients with non-Hodgkin's
lymphoma both as a monotherapy and in combination with BTK
inhibitor ibrutinib. Curis is also evaluating CA-4948 in a Phase
1/2 trial in patients with acute myeloid leukemia and
myelodysplastic syndromes, 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,
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.
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 LUCAS IST, 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, 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, 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 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,
|
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
Revenues,
net:
|
|
|
|
|
|
|
|
|
Royalties
|
|
$
|
2,348
|
|
|
$
|
2,446
|
|
|
$
|
4,535
|
|
|
$
|
4,961
|
|
Other
revenue
|
|
1
|
|
|
—
|
|
|
1
|
|
|
211
|
|
Contra
revenue
|
|
(63)
|
|
|
(86)
|
|
|
(61)
|
|
|
(104)
|
|
Total revenues,
net
|
|
2,286
|
|
|
2,360
|
|
|
4,475
|
|
|
5,068
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Cost of
royalties
|
|
116
|
|
|
122
|
|
|
225
|
|
|
247
|
|
Research and
development
|
|
8,753
|
|
|
5,282
|
|
|
15,510
|
|
|
12,754
|
|
General and
administrative
|
|
4,067
|
|
|
2,386
|
|
|
8,190
|
|
|
5,980
|
|
Total costs and
expenses
|
|
12,936
|
|
|
7,790
|
|
|
23,925
|
|
|
18,981
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
(10,650)
|
|
|
(5,430)
|
|
|
(19,450)
|
|
|
(13,913)
|
|
Other
expense:
|
|
|
|
|
|
|
|
|
Interest
income
|
|
58
|
|
|
5
|
|
|
104
|
|
|
55
|
|
Imputed interest
expense related to the sale of future royalty payments
|
|
(1,136)
|
|
|
(1,284)
|
|
|
(2,309)
|
|
|
(2,581)
|
|
Other income
(expense), net
|
|
890
|
|
|
1
|
|
|
890
|
|
|
22
|
|
Total other
expense
|
|
(188)
|
|
|
(1,278)
|
|
|
(1,315)
|
|
|
(2,504)
|
|
Net loss
|
|
(10,838)
|
|
|
(6,708)
|
|
|
(20,765)
|
|
|
(16,417)
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per common share
|
|
$
|
(0.12)
|
|
|
$
|
(0.17)
|
|
|
$
|
(0.23)
|
|
|
$
|
(0.44)
|
|
Basic and diluted
weighted average common shares outstanding
|
|
91,547,390
|
|
|
39,517,045
|
|
|
91,527,563
|
|
|
36,985,117
|
|
CURIS,
INC. CONDENSED CONSOLIDATED BALANCE SHEETS
|
|
(UNAUDITED) (In
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
June 30,
2021
|
|
December 31,
2020
|
ASSETS
|
|
|
|
|
Cash, cash
equivalents and investments
|
|
$
|
160,682
|
|
|
$
|
183,058
|
|
Restricted
cash
|
|
816
|
|
|
816
|
|
Accounts
receivable
|
|
2,379
|
|
|
3,043
|
|
Property and
equipment, net
|
|
580
|
|
|
663
|
|
Operating lease
right-of-use asset
|
|
6,171
|
|
|
6,578
|
|
Goodwill
|
|
8,982
|
|
|
8,982
|
|
Prepaid expenses and
other assets
|
|
1,583
|
|
|
1,218
|
|
Total
assets
|
|
$
|
181,193
|
|
|
$
|
204,358
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
Accounts payable,
accrued liabilities and other liabilities
|
|
$
|
7,234
|
|
|
$
|
7,791
|
|
Operating lease
liability
|
|
5,345
|
|
|
6,771
|
|
Debt
obligations
|
|
—
|
|
|
891
|
|
Liability related to
the sale of future royalties, net
|
|
56,140
|
|
|
58,235
|
|
Total
liabilities
|
|
68,719
|
|
|
73,688
|
|
Total stockholders'
equity
|
|
112,474
|
|
|
130,670
|
|
Total liabilities and
stockholders' equity
|
|
$
|
181,193
|
|
|
$
|
204,358
|
|
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SOURCE Curis, Inc.