LEXINGTON, Mass., March 16, 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 fourth quarter and year
ended December 31, 2020.
"2020 was a transformative year for Curis, as we made
significant progress in our mission to develop the next generation
of targeted cancer therapies that meaningfully improve and extend
the lives of patients. Despite the difficulties and uncertainty
brought about by the ongoing coronavirus pandemic, we significantly
advanced and expanded each program in our clinical pipeline,
headlined by the very encouraging data from our Phase 1 trials of
lead asset, CA-4948, presented in December in conjunction with
ASH," said James Dentzer, President
and Chief Executive Officer of Curis. "We look forward to providing
additional updates on our IRAK4 program throughout the year, with
clinical data readouts from our ongoing studies, including the
CA-4948 monotherapy study in AML/MDS and the CA-4948/ibrutinib
combination study for patients with R/R hematologic malignancies
that we initiated in early 2021. We also continue to enroll
patients and bring additional trial sites online in our Phase
1a/1b trial 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
preliminary data from this exciting study later this year."
Mr. Dentzer continued, "2020 was also a pivotal year on the
corporate side for Curis. Through the execution of several key
financings and partnerships, we have the resources needed to
advance our programs through their next data catalysts, while also
providing us the ability to invest efficiently in our pipeline of
first-in-class cancer therapeutics. We are excited about the
opportunities stemming from our Q4 signing of the CRADA with the
NCI in addition to the recently announced Phase 2 IST of CA-4948
for the treatment of anemia in patients with lower-risk MDS led by
Dr. Uwe Platzbecker at Universität
Leipzig. These new partnerships
provide powerful validation of our IRAK4 platform and allow us to
leverage the resources of premier research organizations to
significantly expand the reach of our clinical and preclinical
programs."
Fourth Quarter 2020 and Recent Operational Highlights
Precision oncology, CA-4948 (IRAK4 Inhibitor; Aurigene
collaboration):
- In December 2020, Curis announced
positive preliminary data from its ongoing Phase 1 study of CA-4948
monotherapy in patients with R/R AML and high-risk MDS, including
marrow blast reductions observed in all evaluable patients and 2 of
6 evaluable patients experiencing a marrow complete response. Curis
continues to enroll patients, is currently enrolling in the 500mg
BID dose cohort of the study and expects to report additional data
in mid-year 2021.
- In December 2020, Curis provided
updated preliminary data from its ongoing Phase 1 study of CA-4948
showing durable and dose-dependent reductions in tumor burden in
patients with R/R NHL and announced the recommended Phase 2 dose,
in addition to the identification of two potentially predictive
biomarkers demonstrating target engagement and potential for
patient enrichment, in an oral presentation at the 62nd
American Society of Hematology (ASH) Annual Meeting and
Exposition.
- In February 2021, Curis announced
the dosing of the first patient in its Phase 1 dose-escalation and
expansion study of CA-4948, an IRAK4 kinase inhibitor, and the BTK
inhibitor, ibrutinib, for the treatment of patients with relapsed
or refractory hematologic malignancies. In preclinical models,
CA-4948 demonstrated synergistic anti-cancer activity when combined
with a potent BTK inhibitor such as ibrutinib.
-
- Approximately 18 patients will be enrolled in the
dose-escalation portion and will receive starting dose and
escalation doses that have been observed to be safe and effective,
combined with ibrutinib doses appropriate for their respective NHL
subtype.
- The primary endpoints of Part 1 will be determination of
maximum tolerated dose (MTD), and the recommended Phase 2 dose
(RP2D).
- Part 2 of the study will enroll patients across a basket of
four cohorts:
-
- Marginal zone lymphoma (MZL)
- Activated B-cell subtype of Diffuse Large B-cell Lymphoma
(ABC-DLBCL)
- Primary central nervous system lymphoma (PCNSL)
- NHL with adaptive ibrutinib resistance.
- An interim futility analysis will be conducted after
approximately 15-20 patients are enrolled in each cohort.
- Primary endpoints of Part 2 will be complete response or
objective response rate and duration of response.
- Curis expects to report initial data from the study in the
fourth quarter of 2021.
- In February 2021, Curis announced
the initiation of the investigator-sponsored Phase 2 LUCAS trial of
CA-4948 for the treatment of anemia in patients with very low, low,
or intermediate-risk MDS. The trial is expected to start
recruitment in the second quarter of 2021 and is expected to enroll
84 patients across two cohorts:
-
- Cohort A: Erythropoiesis stimulating agent (ESA)
refractory/intolerant patients
- Cohort B: ESA naïve patients with transfusion dependence (min.
20 patients) or transfusion independence (min. 20 patients)
Patients in both cohorts will
receive 300mg CA-4948 twice-daily (BID) for 21 days in at least
four repeating cycles lasting 28 days each.
- The primary endpoint of the study is to evaluate the proportion
of patients that develop an erythroid response (HI-E) according to
IWG 2018 criteria.
Immuno-oncology, CI-8993 (anti-VISTA antibody; ImmuNext
collaboration):
- In November 2020, Curis published
trial design details from its ongoing Phase 1a/1b dose-escalation study of its first-in-class
monoclonal anti-VISTA antibody for the treatment of R/R solid
tumors.
- Curis continues to enroll patients in the study and expects to
report initial safety and efficacy data in the second half of
2021.
Corporate:
- In December 2020, Curis closed an
underwritten public offering of 29,500,000 shares of its common
stock, including the exercise in full by the underwriters of their
option to purchase up to an additional 3,847,826 shares, raising
gross proceeds of approximately $169.6
million before deducting underwriting discounts and
commissions and offering expenses.
- In November 2020, Curis entered
into a CRADA with the NCI. Under the CRADA, Curis will collaborate
with the NCI Experimental Therapeutics Program (NExT) and the NCI
Cancer Therapy Evaluation Program to conduct non-clinical and
clinical studies of Curis' proprietary compound, CA-4948, an IRAK4
kinase inhibitor that acts as a Toll-like Receptor (TLR)
suppressor, as an anti-cancer agent.
Upcoming 2021 Planned Milestones
- Report additional clinical data from the Phase 1 study of
CA-4948 in patients with AML and high-risk MDS, including patients
with spliceosome mutations that encode oncogenic IRAK4-L in
mid-year 2021.
- Report additional clinical biomarker data gathered in the Phase
1 study of CA-4948 in patients with R/R NHL in mid-year 2021.
- Announce initial safety and efficacy data from the ongoing
Phase 1 study of CA-4948 in combination with ibrutinib in patients
with R/R NHL in the second half of 2021.
- Report initial safety and efficacy data from the ongoing Phase
1a/1b dose-escalation study of
CI-8993 for the treatment of R/R solid tumors in the second half of
2021.
Full Year and Fourth Quarter 2020 Financial Results
For the year ended December 31, 2020, Curis reported a net
loss of $29.9 million, or
$0.61 per share on both a basic and
diluted basis, as compared to a net loss of $32.1 million, or $0.97 per share on both a basic and diluted basis
in 2019. For the fourth quarter of 2020, Curis reported a net
loss of $7.5 million or $0.11 per share on both a basic and diluted
basis, as compared to a net loss of $8.6
million, or $0.26 per share on
both a basic and diluted basis for the same period in 2019.
Revenues for the year ended December 31, 2020, were
$10.8 million as compared to
$10.0 million for the same period in
2019. Revenues for both periods comprise primarily royalty revenues
recorded on Genentech and Roche's net sales of Erivedge®. Revenues
for the fourth quarters of 2020 and 2019 were $3.0 million and $3.3
million, respectively.
Operating expenses for the year ended December 31, 2020
were $35.7 million as compared to
$34.4 million for the same period in
2019. Operating expenses for the fourth quarter of 2020 were
$9.3 million, as compared to
$10.6 million for the same period in
2019, 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 $0.5 million for the
years ended December 31, 2020 and 2019. Cost of royalty
revenues were $0.2 million for the
fourth quarter of 2020 and 2019.
Research and Development Expenses. Research and
development expenses were $23.1
million for the year ended December 31, 2020, as
compared to $22.3 million for the
same period in 2019. Research and development expenses were
$5.6 million for the fourth quarter
of 2020 as compared to $7.5 million
for the same period in 2019. The decrease was primarily due to a
decrease in clinical and manufacturing costs related to CA-170 and
fimepinostat.
General and Administrative Expenses. General and
administrative expenses were $12.1
million for the year ended December 31, 2020, as
compared to $11.6 million for the
same period in 2019. General and administrative expenses were
$3.5 million for the fourth quarter
of 2020, as compared to $3.0 million
for the same period in 2019. The increase was primarily due to an
increase in personnel related costs.
Other Expense, Net. Net other expense was $5.0 million for the year ended December 31,
2020, as compared to $7.8 million for
the same period in 2019. For the fourth quarter of 2020 and 2019,
net other expense was $1.2 million
and $1.3 million, respectively. Net
other expense primarily consisted of imputed interest expense
related to future royalty payments.
As of December 31, 2020, Curis's cash, cash equivalents and
investments totaled $183.1 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,
March 16, 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 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
trial in patients with acute myeloid leukemia and myelodysplastic
syndromes. 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 1a/1b 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, statements regarding any
expectations of the potential for the Company's proprietary drug
candidates, including the potential developments of any clinical
biomarker data, statements with respect to the timing of the
Company's studies, including enrollment and reporting of data, and
any statements with respect to the LUCAS IST, the CRADA with NCI,
and the Company's ability to advance and broaden its clinical
programs. Forward-looking statements may contain the words
"believes," "expects," "anticipates," "plans," "intends," "seeks,"
"estimates," "assumes," "will," "may," "could" 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, 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 also faces risks relating to 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 caption "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
December 31,
|
|
Year Ended
December 31,
|
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
Revenues,
net:
|
|
|
|
|
|
|
|
|
Royalties
|
|
$
|
3,043
|
|
|
$
|
3,233
|
|
|
$
|
10,724
|
|
|
$
|
10,418
|
|
Other
revenue
|
|
4
|
|
|
—
|
|
|
214
|
|
|
—
|
|
Contra revenue,
net
|
|
(23)
|
|
|
54
|
|
|
(103)
|
|
|
(414)
|
|
Total revenues,
net:
|
|
3,024
|
|
|
3,287
|
|
|
10,835
|
|
|
10,004
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Costs of
royalties
|
|
151
|
|
|
161
|
|
|
534
|
|
|
503
|
|
Research and
development
|
|
5,609
|
|
|
7,461
|
|
|
23,068
|
|
|
22,302
|
|
General and
administrative
|
|
3,539
|
|
|
2,999
|
|
|
12,131
|
|
|
11,555
|
|
Total costs and
expenses
|
|
9,299
|
|
|
10,621
|
|
|
35,733
|
|
|
34,360
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
(6,275)
|
|
|
(7,334)
|
|
|
(24,898)
|
|
|
(24,356)
|
|
|
|
|
|
|
|
|
|
|
Loss on debt
extinguishment
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(3,495)
|
|
Interest
income
|
|
4
|
|
|
101
|
|
|
63
|
|
|
614
|
|
Imputed interest
expense related to the sale
of future royalties
|
|
(1,246)
|
|
|
(1,334)
|
|
|
(5,095)
|
|
|
(4,055)
|
|
Interest expense,
debt
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(791)
|
|
Other income
(expense), net
|
|
—
|
|
|
(42)
|
|
|
22
|
|
|
(58)
|
|
Total other
expense
|
|
(1,242)
|
|
|
(1,275)
|
|
|
(5,010)
|
|
|
(7,785)
|
|
Net loss
|
|
(7,517)
|
|
|
(8,609)
|
|
|
(29,908)
|
|
|
(32,141)
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per common share
|
|
$
|
(0.11)
|
|
|
$
|
(0.26)
|
|
|
$
|
(0.61)
|
|
|
$
|
(0.97)
|
|
Basic and diluted
weighted average common
shares outstanding
|
|
66,363,229
|
|
|
33,209,217
|
|
|
48,670,381
|
|
|
33,180,516
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURIS,
INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
(In
thousands)
|
|
|
December 31,
2020
|
|
December 31,
2019
|
ASSETS
|
|
|
|
|
Cash, cash
equivalents and investments
|
|
$
|
183,058
|
|
|
$
|
20,543
|
|
Restricted
cash
|
|
816
|
|
|
969
|
|
Accounts
receivable
|
|
3,043
|
|
|
3,244
|
|
Property and
equipment, net
|
|
663
|
|
|
154
|
|
Operating lease
right-of-use asset
|
|
6,578
|
|
|
149
|
|
Goodwill
|
|
8,982
|
|
|
8,982
|
|
Other
assets
|
|
1,218
|
|
|
1,066
|
|
Total
assets
|
|
$
|
204,358
|
|
|
$
|
35,107
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
(DEFICIT)
|
|
|
|
|
Accounts payable,
accrued liabilities and other
liabilities
|
|
$
|
7,791
|
|
|
$
|
6,375
|
|
Operating lease
liability
|
|
6,771
|
|
|
166
|
|
Debt
obligations
|
|
891
|
|
|
—
|
|
Liability related to
the sale of future royalties, net
|
|
58,235
|
|
|
62,477
|
|
Total
liabilities
|
|
73,688
|
|
|
69,018
|
|
Total stockholders'
equity (deficit)
|
|
130,670
|
|
|
(33,911)
|
|
Total liabilities and
stockholders' equity (deficit)
|
|
$
|
204,358
|
|
|
$
|
35,107
|
|
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SOURCE Curis, Inc.