LEXINGTON, Mass., Aug. 4, 2020 /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, 2020.
"Our recent accomplishments represent meaningful progress for
Curis, as we advanced our clinical pipeline and achieved key
financial objectives. These recent developments set us up for
near-term data readouts, which we expect will provide durable
momentum into 2021," said James
Dentzer, President and Chief Executive Officer of Curis. "In
addition to advancing the ongoing Phase 1 study of our
first-in-class IRAK4 inhibitor, CA-4948, in patients with
non-Hodgkin's lymphoma (NHL), we initiated a new Phase 1 study of
CA-4948 in patients with relapsed or refractory (R/R) acute myeloid
leukemia (AML) and high-risk myelodysplastic syndromes (MDS). We
are particularly excited about this study, as AML and high-risk MDS
are driven, in over half of patients, by the long isoform of IRAK4,
which CA-4948 directly targets. Today, I am pleased to announce our
plans to initiate a study of CA-4948 before the end of the year,
which will evaluate CA-4948 in combination with ibrutinib, a BTK
inhibitor, in patients with NHL, including those with MYD88 altered
disease."
Mr. Dentzer continued, "For our VISTA program, we received clearance from the
U.S. Food and Drug Administration (FDA) on our Investigational New
Drug (IND) application for CI-8993 to initiate a Phase
1a/1b dose-escalation study in
patients with solid tumors. We look forward to building on our
pipeline-wide progress and expect to report data on all three
clinical studies, CA-4948 in NHL, CA-4948 in AML/MDS, and CI-8993
in solid tumors, by year-end."
Second Quarter 2020 and Recent Operational Highlights
Precision oncology, CA-4948 (IRAK4 Inhibitor; Aurigene
collaboration):
- Curis is evaluating CA-4948 in an ongoing Phase 1
dose-escalation study for the treatment of patients with R/R NHL,
including patients with diffuse large B-cell lymphoma (DLBCL),
Waldenström's macroglobulinemia (WM) and oncogenic MYD88 mutations.
As a result of COVID-19 pandemic, enrollment in this trial has been
slower than expected and the timeline of this clinical trial has
been delayed. The Company expects to report updated efficacy data
and the recommended Phase 2 dose for CA-4948 by the end of
2020.
- In July 2020, Curis announced the
dosing of the first patient in its open-label, Phase 1
dose-escalation study of CA-4948 in patients with R/R AML and
high-risk MDS, including patients with spliceosome mutations that
drive expression of the long isoform of IRAK4 (IRAK4-L). The
primary objective of the study is to determine the maximum
tolerated dose and recommended Phase 2 dose of CA-4948 based on
safety and tolerability, dose-limiting toxicities (DLTs), and
pharmacokinetic and pharmacodynamic findings. A minimum of three
patients will be enrolled at each dose level, starting with 200 mg
BID, which was determined to be safe, capable of achieving relevant
levels of drug exposure, and demonstrated signs of biologic
activity and clinical efficacy in a separate, ongoing Phase 1
study. Curis expects to provide initial data from this study by the
end of 2020.
- Today, Curis announced that it will initiate a Phase 1 study
evaluating CA-4948 in combination with ibrutinib, a BTK inhibitor,
in the second half of 2020. In preclinical models, CA-4948 has
demonstrated anti-cancer activity that is highly synergistic with
BTK inhibition.
Immuno-oncology, CI-8993 (anti-VISTA antibody; ImmuNext
collaboration):
- In June 2020, Curis announced
that the FDA cleared its IND application for CI-8993, a
first-in-class monoclonal anti-VISTA antibody. Curis expects to initiate a
Phase 1a/1b study of CI-8993 in
patients with relapsed / refractory solid tumors in the second half
of 2020.
Precision oncology, fimepinostat (HDAC/PI3K
inhibitor):
- Fimepinostat has previously been shown to induce durable
single-agent responses in difficult-to-treat lymphomas, including
MYC-driven and double-hit disease. Curis is collaborating with
DarwinHealth on ongoing analytical research to characterize
biomarkers and tumor subtype alignments, which may help guide
future clinical development opportunities with fimepinostat.
Corporate:
- In June 2020,
Curis completed a $17.5 million registered direct offering with
fundamental healthcare investors extending its cash runway into the
first half of 2021.
Upcoming 2020 Planned Milestones
- Declare the recommended Phase 2 dose for CA-4948 in the ongoing
lymphoma Phase 1 study and report updated efficacy data from the
study by year-end 2020.
- Report initial data from the Phase 1 study of CA-4948 in
patients with AML/MDS, including patients with spliceosome
mutations that encode oncogenic IRAK4-L, by year-end 2020.
- Initiate Phase 1 study of CA-4948 in combination with ibrutinib
in the second half of 2020.
- Initiate Phase 1a/1b dose
escalation study of CI-8993 in patients with relapsed / refractory
solid tumors in the second half of 2020.
- Report initial safety data from Phase 1a/1b dose escalation study of CI-8993 in patients
with relapsed / refractory solid tumors by year-end 2020.
Second Quarter 2020 Financial Results
For the second quarter of 2020, Curis reported a net loss of
$6.7 million, or $0.17 per share on both a basic and diluted
basis, as compared to a net loss of $7.2
million, or $0.22 per share on
both a basic and diluted basis, for the same period in 2019. Curis
reported a net loss of $16.4 million,
or $0.44 per share on both a basic
and diluted basis, for the six months ended June 30, 2020, as compared to a net loss of
$17.1 million, or $0.52 per share on both a basic and diluted
basis, for the same period in 2019.
Revenues for the second quarter of 2020 were $2.4 million, as compared to $2.1 million for the same period in 2019.
Revenues for the six months ended June 30,
2020 were $5.1 million, as
compared to $3.9 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®.
Operating expenses for the second quarter of 2020 were
$7.8 million, as compared to
$8.2 million for the same period in
2019. Operating expenses for the six months ended June 30, 2020 were $19.0
million, as compared to $15.6
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 stable at $0.1 million
for the second quarter of 2020, as compared to $0.1 million for the same period in 2019. Cost of
royalty revenues for the six months ended June 30, 2020 were also stable at $0.2 million, as compared to $0.2 million for the same period in 2019.
Research and Development Expenses. Research
and development expenses were $5.3
million for the second quarter of 2020, as compared to
$5.6 million for the same period in
2019. The decrease in research and development expenses for the
quarter is primarily attributable to reduced clinical trial costs
related to CA-170 and fimepinostat. Research and development
expenses were $12.8 million for the
six months ended June 30, 2020 as
compared to $9.7 million for the same
period in 2019.
General and Administrative Expenses. General and
administrative expenses were $2.4
million for the second quarter of 2020, as compared to
$2.5 million for the same period in
2019. The decrease was driven primarily by lower stock-based
compensation costs as well as lower legal and professional services
fees, partially offset by higher occupancy costs. General and
administrative expenses were $6.0
million for the six months ended June
30, 2020, as compared to $5.7
million for the same period in 2019.
Other expense, net. Net other expense was $1.3 million for the second quarter of 2020, as
compared to $1.1 million for the same
period in 2019. Net other expense for the second quarter 2020
primarily consisted of imputed interest expense related to future
royalty payments. Net other expense was $2.5
million for the six months ended June
30, 2020, as compared to $5.4
million for the same period in 2019.
As of June 30, 2020, Curis' cash, cash equivalents,
marketable securities and investments totaled $23.6 million and there were approximately 50.6
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 the first half of 2021.This
forecast does not include potential proceeds from the Company's
stock purchase agreement with Aspire Capital or the Company's
at-the-market facility with JonesTrading.
Conference Call Information
Curis management will host a conference call today,
August 4, 2020, 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 trial
in patients with non-Hodgkin lymphoma and 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 planned to be tested
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 the
Company's planned prioritization of resources, the timing and
reporting of potential data, its plans to declare the recommended
Phase 2 dose for CA-4948 in the ongoing lymphoma Phase 1 study, its
plans to initiate a combination study with CA-4948, its plans to
initiate a Phase 1a/1b trial of
CI-8993 in the second half of 2020, the impacts of the COVID-19
pandemic and the measures implemented in response thereto, the
period in which Curis expects that its existing cash, cash
equivalents and investments will enable it to fund its operations,
its ability to access financing under its purchase agreement with
Aspire or under its at-the-market sales agreement with
JonesTrading, statements with respect to the plans, strategies and
objectives of management for future operations, and the Company's
expectations regarding the potential therapeutic benefit of its
proprietary drug candidates. 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. Based on its available cash resources, it
does not have sufficient cash on hand to support current operations
within the next 12 months from the date of this press release. 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. If it is unable to continue as a going concern, it may
have to liquidate its assets and may receive less than the value at
which those assets are carried on its audited financial statements,
and it is likely that investors will lose all or a part of their
investment. 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 Curis's ongoing or
planned 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. 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
June
30,
|
|
Six Months
Ended
June
30,
|
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
Revenues,
net:
|
|
|
|
|
|
|
|
|
Royalties
|
|
$
|
2,446
|
|
|
$
|
2,142
|
|
|
$
|
4,961
|
|
|
$
|
4,279
|
|
Other
revenue
|
|
—
|
|
|
—
|
|
|
211
|
|
|
—
|
|
Contra revenue,
net
|
|
(86)
|
|
|
(48)
|
|
|
(104)
|
|
|
(418)
|
|
Total revenues,
net:
|
|
2,360
|
|
|
2,094
|
|
|
5,068
|
|
|
3,861
|
|
|
|
|
|
|
|
|
|
|
Costs and
expenses:
|
|
|
|
|
|
|
|
|
Costs of
royalties
|
|
122
|
|
|
89
|
|
|
247
|
|
|
197
|
|
Research and
development
|
|
5,282
|
|
|
5,620
|
|
|
12,754
|
|
|
9,694
|
|
General and
administrative
|
|
2,386
|
|
|
2,526
|
|
|
5,980
|
|
|
5,669
|
|
Total costs and
expenses
|
|
7,790
|
|
|
8,235
|
|
|
18,981
|
|
|
15,560
|
|
|
|
|
|
|
|
|
|
|
Net loss from
operations
|
|
(5,430)
|
|
|
(6,141)
|
|
|
(13,913)
|
|
|
(11,699)
|
|
|
|
|
|
|
|
|
|
|
Loss on debt
extinguishment
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(3,495)
|
|
Interest
income
|
|
5
|
|
|
235
|
|
|
55
|
|
|
343
|
|
Imputed interest
expense related to the sale
of future royalties
|
|
(1,284)
|
|
|
(1,287)
|
|
|
(2,581)
|
|
|
(1,417)
|
|
Interest
expense
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(791)
|
|
Other income
(expense), net
|
|
1
|
|
|
(20)
|
|
|
22
|
|
|
(38)
|
|
Total other
expense
|
|
(1,278)
|
|
|
(1,072)
|
|
|
(2,504)
|
|
|
(5,398)
|
|
Net loss
|
|
(6,708)
|
|
|
(7,213)
|
|
|
(16,417)
|
|
|
(17,097)
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per common share
|
|
$
|
(0.17)
|
|
|
$
|
(0.22)
|
|
|
$
|
(0.44)
|
|
|
$
|
(0.52)
|
|
Basic and diluted
weighted average
common shares outstanding
|
|
39,517,045
|
|
|
33,154,566
|
|
|
36,985,117
|
|
|
33,158,222
|
|
CURIS,
INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
|
(UNAUDITED)
(In
thousands)
|
|
|
|
June 30,
2020
|
|
December 31,
2019
|
ASSETS
|
|
|
|
|
|
|
|
|
|
Cash, cash
equivalents and investments
|
|
$
|
23,622
|
|
|
$
|
20,543
|
|
Restricted
cash
|
|
969
|
|
|
969
|
|
Accounts
receivable
|
|
2,486
|
|
|
3,244
|
|
Property and
equipment, net
|
|
737
|
|
|
154
|
|
Operating lease
right-of-use asset
|
|
7,149
|
|
|
149
|
|
Goodwill
|
|
8,982
|
|
|
8,982
|
|
Prepaid expenses and
other assets
|
|
1,005
|
|
|
1,066
|
|
Total
assets
|
|
$
|
44,950
|
|
|
$
|
35,107
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' DEFICIT
|
|
|
|
|
Accounts payable and
accrued liabilities
|
|
$
|
7,054
|
|
|
$
|
6,375
|
|
Operating lease
liability
|
|
7,197
|
|
|
166
|
|
Debt
obligations
|
|
890
|
|
|
—
|
|
Liability related to
the sale of future royalties, net
|
|
60,189
|
|
|
62,477
|
|
Total
liabilities
|
|
75,330
|
|
|
69,018
|
|
Total stockholders'
deficit
|
|
(30,380)
|
|
|
(33,911)
|
|
Total liabilities and
stockholders' deficit
|
|
$
|
44,950
|
|
|
$
|
35,107
|
|
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SOURCE Curis, Inc.