LEXINGTON, Mass., May 12, 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 first quarter ended March 31, 2021.
"The first quarter of 2021 saw continued momentum for our
pipeline of next generation targeted cancer therapies designed to
meaningfully improve and extend patients' lives. We continued to
make important progress with CA-4948, our first-in-class, small
molecule inhibitor of IRAK4, now in three clinical trials after
expanding into one new study earlier this year with the Phase 2
LUCAS IST for patients with lower-risk MDS, as well as expanding
our previous Phase 1/2 study in patients with relapsed/refractory
(R/R) NHL to include the combination of CA-4948 plus ibrutinib. We
were also very pleased to announce that CA-4948 was
granted Orphan Drug designation from the U.S. Food and Drug
Administration (FDA) for the treatment of AML and MDS, highlighting
the unique potential of our IRAK4 program," said James Dentzer, President and Chief Executive
Officer of Curis. "We are especially excited about the AML/MDS data
published today in the EHA abstract, and we look forward to
providing additional data from this study in the oral presentation
at EHA next month."
Mr. Dentzer added, "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 and look forward to providing
initial data from this study later this year."
First Quarter 2021 and Recent Operational Highlights
Precision oncology, CA-4948 (IRAK4 Inhibitor; Aurigene
collaboration):
- Today, EHA released the Curis abstract reporting interim data
from the ongoing Phase 1/2 study of CA-4948 in patients with R/R
AML and MDS. The data are from 15 patients as of February 8, 2021 (the cut-off date) and are
consistent with previously announced findings, including marrow
blast reductions observed at all tested doses in 8 of 9 (89%)
evaluable patients with elevated blast counts at baseline, with 1
patient experiencing a full hematologic recovery complete response,
1 complete remission with incomplete hematologic recovery (CRi)
with negative minimal residual disease, and 2 bone marrow complete
responses (CRs).
-
- All 3 patients presenting with SF3B1 or U2AF1 spliceosome
mutations achieved marrow CR or better
- All patients with objective responses also saw signs of
hematologic recovery
- Updated safety, pharmacodynamic, and efficacy data, as well as
data from additional trial participants, will be featured in an
oral presentation at EHA on Friday, June
11 at 9:00 am CEST
(3:00 am EDT).
- Curis updated that the 500mg BID dosing regimen in the AML/MDS
study has exceeded the maximum tolerated dose according to protocol
guidelines. Two patients in the cohort were observed to have
dose-limiting toxicities, one of whom had Grade 3 rhabdomyolysis
and the other experienced Grade 3 syncope. Both AEs resolved after
discontinuation of dosing. Current enrollment is exploring lower
dose levels to determine the appropriate recommended phase 2 dose
(RP2D).
- Also today, Curis reported non-clinical data to be presented in
a poster at EHA demonstrating synergistic antitumor activity of
CA-4948 in combination with azacitidine and venetoclax in leukemia
cells, providing supportive rationale for evaluation of the
combinations in a clinical setting for AML and MDS patients.
- The Phase 1/2 study of CA-4948 in AML and MDS was expanded to
include both a combination dose escalation and a monotherapy dose
expansion:
-
- Combination dose escalation, which will start at 200mg BID,
will include two cohorts:
-
- 1) CA-4948 + azacitidine, for patients with AML or MDS who are
naïve to hypomethylating agents (HMA)
- 2) CA-4948 + venetoclax, for patients with AML or MDS after
first line therapy who are naïve to venetoclax
- Monotherapy dose expansion, which will begin after the RP2D is
determined, will include four cohorts:
-
- 1) MDS patients, R/R to HMA, with spliceosome mutations
- 2) MDS patients, R/R to HMA, without spliceosome mutations
- 3) R/R AML patients with FLT3-ITD mutation
- 4) R/R AML patients with FLT3 WT
- In April 2021, Curis announced
that the U.S. Food and Drug Administration (FDA) had granted Orphan
Drug designation for CA-4948 for the treatment of AML and for
treatment of MDS.
- Also in April, Curis presented updated data on a potentially
predictive biomarker demonstrating target engagement in a poster
presentation at the American Association for Cancer Research (AACR)
Annual Meeting 2021.
- In February, Curis announced the dosing of the first patient in
its Phase 1/2 combination study of CA-4948 plus ibrutinib, for the
treatment of patients with R/R NHL or other hematologic
malignancies. In preclinical models, CA-4948 demonstrated
synergistic anti-cancer activity when combined with a potent BTK
inhibitor such as ibrutinib. Curis expects to report initial data
from this study in the second half of 2021.
- Earlier in February, Curis announced the initiation of the
investigator-sponsored Phase 2 LUCAS study of CA-4948 for the
treatment of anemia in patients with very low, low, or
intermediate-risk MDS. The study is expected to start recruitment
in the second quarter of 2021.
Immuno-oncology, CI-8993 (anti-VISTA antibody; ImmuNext
collaboration):
- Curis continues to enroll patients in the ongoing Phase 1 dose
escalation study of its first-in-class monoclonal anti-VISTA
antibody for the treatment of R/R solid tumors and expects to
report initial clinical data in the second half of 2021.
Upcoming 2021 Planned Milestones
- Report additional clinical data at the EHA 2021 Virtual
Congress from the Phase 1/2 monotherapy study of CA-4948 in
patients with AML and MDS, including patients with spliceosome
mutations that result in aberrant splicing of oncogenic
IRAK4-L.
- Initiate dosing in the Phase 1/2 combination study of CA-4948
plus azacitidine and CA-4948 plus venetoclax in patients with
R/R AML and MDS.
- In the second half of 2021, report initial data from the
ongoing Phase 1/2 combination study of CA-4948 plus ibrutinib in
patients with R/R NHL.
- In the second half of 2021, report initial data from the
ongoing Phase 1 monotherapy study of CI-8993 for the treatment
of R/R solid tumors.
First Quarter 2021 Financial Results
For the first quarter of 2021, Curis reported a net loss of
$9.9 million or $0.11 per share on both a basic and diluted
basis, as compared to a net loss of $9.7
million, or $0.28 per share on
both a basic and diluted basis for the same period in 2020.
Revenues for the first quarter of 2021 and 2020 were
$2.2 million and $2.7 million, respectively.
Operating expenses for the first quarter of 2021 were
$11.0 million, as compared to
$11.2 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
first quarter of 2021 and 2020.
Research and Development Expenses. Research and
development expenses were $6.8
million for the first quarter of 2021 as compared to
$7.5 million for the same period in
2020. The decrease in direct research and development expenses for
the quarter is primarily attributable to the upfront license fee
expense from our option and license agreement with ImmuNext that
occurred during the first quarter of 2020. These costs were
partially offset by a $0.3 million
increase in employee related costs.
General and Administrative Expenses. General and
administrative expenses were $4.1
million for the first quarter of 2021, as compared to
$3.6 million for the same period in
2020. The increase in general administrative expense was driven
primarily by higher costs for stock-based compensation and
professional and consulting services, partially offset by lower
legal services costs during the three months ended March 31, 2021.
Other Expense, Net. For the first quarter of 2021 and
2020, net other expense was $1.1
million and $1.2 million,
respectively. Net other expense primarily consisted of imputed
interest expense related to future royalty payments.
As of March 31, 2021, Curis's cash, cash equivalents and
investments totaled $168.4 million,
and there were approximately 91.5 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, May 12,
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 the 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' 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 and potential benefits of CA-4948 in clinical trials
as a monotherapy and 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 clinical trials, and statements with respect to 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
March 31,
|
|
|
2021
|
|
2020
|
Revenues,
net:
|
|
|
|
|
|
|
Royalties
|
|
$
|
2,187
|
|
|
$
|
2,515
|
|
Other
revenue
|
|
—
|
|
|
211
|
|
Contra revenue,
net
|
|
2
|
|
|
(17)
|
|
Total revenues,
net:
|
|
2,189
|
|
|
2,709
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
Costs of
royalties
|
|
109
|
|
|
125
|
|
Research and
development
|
|
6,757
|
|
|
7,473
|
|
General and
administrative
|
|
4,123
|
|
|
3,593
|
|
Total costs and
expenses
|
|
10,989
|
|
|
11,191
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
(8,800)
|
|
|
(8,482)
|
|
Interest
income
|
|
46
|
|
|
50
|
|
Imputed interest
expense related to the sale of
future royalties
|
|
(1,173)
|
|
|
(1,298)
|
|
Other income
(expense), net
|
|
—
|
|
|
21
|
|
Total other
expense
|
|
(1,127)
|
|
|
(1,227)
|
|
Net loss
|
|
(9,927)
|
|
|
(9,709)
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per common share
|
|
$
|
(0.11)
|
|
|
$
|
(0.28)
|
|
Basic and diluted
weighted average common
shares outstanding
|
|
91,507,518
|
|
|
34,453,189
|
|
|
|
|
|
|
|
|
CURIS,
INC. CONDENSED CONSOLIDATED BALANCE SHEETS
|
|
(UNAUDITED) (In
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31,
2021
|
|
December 31,
2020
|
ASSETS
|
|
|
|
|
Cash, cash
equivalents and investments
|
|
$
|
168,350
|
|
|
$
|
183,058
|
|
Restricted
cash
|
|
816
|
|
|
816
|
|
Accounts
receivable
|
|
2,183
|
|
|
3,043
|
|
Property and
equipment, net
|
|
620
|
|
|
663
|
|
Operating lease
right-of-use asset
|
|
6,376
|
|
|
6,578
|
|
Goodwill
|
|
8,982
|
|
|
8,982
|
|
Other
assets
|
|
3,266
|
|
|
1,218
|
|
Total
assets
|
|
$
|
190,593
|
|
|
$
|
204,358
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
Accounts payable,
accrued liabilities and other
liabilities
|
|
$
|
5,491
|
|
|
$
|
7,791
|
|
Operating lease
liability
|
|
5,490
|
|
|
6,771
|
|
Debt
obligations
|
|
891
|
|
|
891
|
|
Liability related to
the sale of future royalties, net
|
|
56,806
|
|
|
58,235
|
|
Total
liabilities
|
|
68,768
|
|
|
73,688
|
|
Total stockholders'
equity
|
|
121,915
|
|
|
130,670
|
|
Total liabilities and
stockholders' equity
|
|
$
|
190,593
|
|
|
$
|
204,358
|
|
View original content to download
multimedia:http://www.prnewswire.com/news-releases/curis-reports-first-quarter-2021-financial-results-301290116.html
SOURCE Curis, Inc.