LEXINGTON, Mass., Nov. 9, 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 third quarter ended
September 30, 2021 and provided
business updates.
"During the third quarter of 2021, we continued to advance our
clinical trials of CA-4948, our first-in-class, small molecule
IRAK4 inhibitor in nine distinct patient populations across AML,
MDS and B cell cancers, including the recent initiation of our
Phase 1 combination study in AML/MDS. At the AACR-NCI-EORTC
Conference in October, we shared exciting preclinical data
highlighting potential applications for CA-4948 across different
hematologic malignancies, including pCNS lymphoma, an aggressive
lymphoma with severe unmet need for patients, further highlighting
the potential broad applicability of CA-4948," said James Dentzer, President and Chief Executive
Officer of Curis.
"As we look ahead, we plan to provide a clinical data update in
January from our ongoing clinical studies, including safety data
from our Phase 1 study of CI-8993 and the latest safety and
efficacy data from our CA-4948 study in AML/MDS patients with
spliceosome or FLT3 mutations."
"In our ongoing monotherapy AML/MDS study, we expect to achieve
our enrollment target of having 10-20 total patients with a
spliceosome mutation by year-end. We believe data from these
patients may provide for an opportunity to explore discussions with
the FDA on a registrational path forward in the first half of
2022," concluded Mr. Dentzer.
Third Quarter 2021 and Recent Operational Highlights
Precision oncology, CA-4948 (IRAK4 Inhibitor; Aurigene
collaboration):
- Enrollment remains on track in nine distinct patient
populations across AML, MDS and B cell cancers.
- In November 2021, Curis initiated
dosing in the combination stage of the Phase 1/2 study of CA-4948
plus azacitidine and CA-4948 plus venetoclax.
-
- The combination therapy portion includes two arms: CA-4948 plus
azacitidine, for patients naïve to HMA, and CA-4948 plus
venetoclax, for patients naïve to venetoclax.
- When combined with azacitidine, CA-4948 will be dosed at 200 mg
twice daily for 21 days of a 28-day cycle, followed by a 300 mg
dose cohort if tolerability allows. Azacitidine will be given in 7
consecutive doses or split doses starting at 75
mg/m2.
- When combined with venetoclax, the starting dose level for
CA-4948 will be 200 mg twice daily for 21 days of a 28-day cycle,
followed by a 300 mg dose cohort if tolerability allows. Venetoclax
will be administered at 100 mg orally with a ramp up over 3 days to
400 mg for 21 days of a 28-day cycle.
- In October 2021, Curis announced
new preclinical data highlighting the potential of CA-4948 in
additional hematologic malignancies in two presentations at the
AACR-NCI-EORTC Virtual Conference on Molecular Targets and Cancer
Therapeutics.
-
- Preclinical data concluded CA-4948 is synergistic with small
molecule BTKi therapies that target BCR signaling and suggest the
combination can overcome or reduce secondary resistance to BTKi
therapies in marginal zone lymphoma.
- CA-4948 is able to cross the blood-brain barrier in a
preclinical murine model of CNS lymphoma, producing significant and
dose-dependent anti-tumor activity and survival advantage.
- Curis expects to have 10-20 patients in AML/MDS patients with
SF3B1 or U2AF1 spliceosome mutation enrolled by year-end 2021.
-
- Curis plans to provide an update on efficacy and safety from
these patients in January. Data may not be fully matured or
complete at this time.
- Curis expects to present additional data from the 10-20
patients with spliceosome mutations in more detail in the first
half of 2022. Data from these patients may provide for an
opportunity to explore discussions with the FDA on a registrational
path forward in the first half of 2022.
Immuno-oncology, CI-8993 (anti-VISTA antibody; ImmuNext
collaboration):
- Enrollment remains on track 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 in
January.
- Curis will hold a poster presentation with new preclinical data
on CI-8993 at the Society for Immunotherapy of Cancer (SITC)
36th Annual Meeting being held from November 12-14, 2021.
- Title: Preclinical evaluation of anti-VISTA antibody CI-8993 in a syngeneic
huVISTA-KI model
- Presenting Author: Andrew M.
Scott, MD Olivia Newton-John Cancer Research Institute,
Tumour Targeting Laboratory, Melbourne, VIC, Australia
- Abstract Number: 324
- Abstracts were made available Tuesday,
November 9, 2021, at 8:00
a.m.
- Virtual ePoster presentations will be available Friday, November 12, 2021, at 7:00 a.m.
Upcoming Planned Milestones for 2022
- In January, provide a clinical data update on our ongoing
studies, including initial safety data from the ongoing Phase 1
monotherapy study of CI-8993 for the treatment of R/R solid tumors
and the latest safety and efficacy 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 and
patients with FLT3 mutations.
- In the first half of the year, provide additional data from the
ongoing Phase 1/2 monotherapy study of CA-4948 in patients with R/R
AML/MDS at a medical meeting.
- In the first half of the year, 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.
Third Quarter 2021 Financial Results
For the third quarter of 2021, Curis reported a net loss of
$11.1 million or $0.12 per share on both a basic and diluted
basis, as compared to a net loss of $6.0
million, or $0.11 per share on
both a basic and diluted basis for the same period in 2020. Curis
reported a net loss of $31.8 million
or $0.35 per share on both a basic
and diluted basis, for the nine months ended September 30, 2021, as compared to a net loss of
$22.4 million, or $0.52 per share on both a basic and diluted
basis, for the same period in 2020.
Revenues for the third quarter of 2021 and 2020 were
$3.0 million and $2.7 million, respectively. Revenues for the nine
months ended September 30, 2021 were
$7.5 million, as compared to
$7.8 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 third quarter of 2021 were
$13.1 million, as compared to
$7.5 million for the same period in
2020. Operating expenses for the nine months ended September 30, 2021 were $37.0 million, as compared to $26.4 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 $0.2 million for the
third quarter of 2021, as compared to $0.1
million for the same period in 2020. Cost of royalty
revenues for the nine months ended September
30, 2021 were $0.4 million, as
compared to $0.4 million for the same
period in 2020.
Research and Development Expenses. Research and
development expenses were $8.6
million for the third quarter of 2021 as compared to
$4.7 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 $2.3
million, primarily attributable to increased stock
compensation and personnel costs as a result of additional
headcount. Research and development expenses were $24.1 million for the nine months ended
September 30, 2021 as compared to
$17.5 million for the same period in
2020.
General and Administrative Expenses. General and
administrative expenses were $4.3
million for the third quarter of 2021, as compared to
$2.6 million for the same period in
2020. The increase in general administrative expense was driven
primarily by higher costs for stock-based compensation, personnel,
and professional and consulting services. General and
administrative expenses were $12.5
million for the nine months ended September 30, 2021, as compared to $8.6 million for the same period in 2020.
Other Expense, Net. For the third quarter of 2021 and
2020, net other expense was $1.0
million and $1.3 million,
respectively. Net other expense primarily consisted of imputed
interest expense related to future royalty payments. Net other
expense was $2.3 million for the nine
months ended September 30, 2021, as
compared to $3.8 million for the same
period in 2020.
As of September 30, 2021, Curis's
cash, cash equivalents and investments totaled $149.8 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, November 9, 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 trial 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 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 September
30,
|
|
Nine Months
Ended September
30,
|
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
Revenues,
net:
|
|
|
|
|
|
|
|
|
Royalties
|
|
$
|
3,058
|
|
|
$
|
2,720
|
|
|
$
|
7,593
|
|
|
$
|
7,681
|
|
Other
revenue
|
|
—
|
|
|
—
|
|
|
1
|
|
|
211
|
|
Contra
revenue
|
|
(19)
|
|
|
22
|
|
|
(80)
|
|
|
(81)
|
|
Total revenues,
net
|
|
3,039
|
|
|
2,742
|
|
|
7,514
|
|
|
7,811
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Cost of
royalties
|
|
151
|
|
|
135
|
|
|
376
|
|
|
382
|
|
Research and
development
|
|
8,602
|
|
|
4,705
|
|
|
24,112
|
|
|
17,459
|
|
General and
administrative
|
|
4,334
|
|
|
2,613
|
|
|
12,524
|
|
|
8,593
|
|
Total costs and
expenses
|
|
13,087
|
|
|
7,453
|
|
|
37,012
|
|
|
26,434
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
(10,048)
|
|
|
(4,711)
|
|
|
(29,498)
|
|
|
(18,623)
|
|
Other
expense:
|
|
|
|
|
|
|
|
|
Interest
income
|
|
54
|
|
|
3
|
|
|
158
|
|
|
58
|
|
Imputed interest
expense related to the sale of future royalty payments
|
|
(1,057)
|
|
|
(1,266)
|
|
|
(3,366)
|
|
|
(3,848)
|
|
Other income
(expense), net
|
|
—
|
|
|
—
|
|
|
890
|
|
|
22
|
|
Total other
expense
|
|
(1,003)
|
|
|
(1,263)
|
|
|
(2,318)
|
|
|
(3,768)
|
|
Net loss
|
|
(11,051)
|
|
|
(5,974)
|
|
|
(31,816)
|
|
|
(22,391)
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per common share
|
|
$
|
(0.12)
|
|
|
$
|
(0.11)
|
|
|
$
|
(0.35)
|
|
|
$
|
(0.52)
|
|
Basic and diluted
weighted average common shares outstanding
|
|
91,601,362
|
|
|
54,554,129
|
|
|
91,552,433
|
|
|
42,884,201
|
|
CURIS,
INC.
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
(UNAUDITED)
|
(In
thousands)
|
|
|
|
September 30,
2021
|
|
December 31,
2020
|
ASSETS
|
|
|
|
|
Cash, cash
equivalents and investments
|
|
$
|
149,826
|
|
|
$
|
183,058
|
|
Restricted
cash
|
|
726
|
|
|
816
|
|
Accounts
receivable
|
|
2,959
|
|
|
3,043
|
|
Property and
equipment, net
|
|
543
|
|
|
663
|
|
Operating lease
right-of-use asset
|
|
5,962
|
|
|
6,578
|
|
Goodwill
|
|
8,982
|
|
|
8,982
|
|
Prepaid expenses and
other assets
|
|
3,088
|
|
|
1,218
|
|
Total
assets
|
|
$
|
172,086
|
|
|
$
|
204,358
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
Accounts payable,
accrued liabilities and other liabilities
|
|
$
|
8,816
|
|
|
$
|
7,791
|
|
Operating lease
liability
|
|
5,194
|
|
|
6,771
|
|
Debt
obligations
|
|
—
|
|
|
891
|
|
Liability related to
the sale of future royalties, net
|
|
55,167
|
|
|
58,235
|
|
Total
liabilities
|
|
69,177
|
|
|
73,688
|
|
Total stockholders'
equity
|
|
102,909
|
|
|
130,670
|
|
Total liabilities and
stockholders' equity
|
|
$
|
172,086
|
|
|
$
|
204,358
|
|
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SOURCE Curis, Inc.