Strong balance sheet with $120.7
million in cash and investments at March 31, 2022; no change to cash
guidance: cash runway into 2024
Potential opportunity for emavusertib in pancreatic cancer
highlighted in a publication from Washington
University in St.
Louis
Management to host conference call today at 4:30 p.m. ET
LEXINGTON, Mass., May 5, 2022 /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, 2022 and provided business updates.
"During the first quarter of 2022, we continued to advance the
clinical trials of emavusertib, previously referred to as CA-4948,
our first-in-class, small molecule IRAK4 inhibitor in nine distinct
patient populations across AML, MDS and B cell cancers. In January,
we provided additional preliminary data showing early anti-cancer
activity of emavusertib in AML/MDS patients with spliceosome or
FLT3 mutation. In addition, we presented initial data from the dose
escalation study of CI-8993, a monoclonal antibody targeting VISTA,
in patients with relapsed/refractory solid tumors. We also would
highlight that we have cleared the 0.3mg/kg dose level, which we
believe is an important initial safety hurdle," said James Dentzer, President and Chief Executive
Officer of Curis.
"Shortly after the close of the first quarter, our two TakeAim
studies were put on partial clinical hold by the U.S. Food and Drug
Administration ("FDA") as the agency is seeking additional data
relating to emavusertib, including data related to rhabdomyolysis
and our determination of the Recommended Phase 2 Dose. We are
working collaboratively with the FDA and hope to resolve the
partial hold on our studies quickly," continued Mr. Dentzer. "As we
gain clarity on the timing of this resolution, we will provide
updated guidance on our plan to discuss the potential for a rapid
registrational path for emavusertib with the FDA."
First Quarter 2022 and Recent Operational Highlights
Precision oncology, emavusertib (IRAK4 Inhibitor; Aurigene
collaboration):
- In January, the company hosted a conference call detailing
updated data from the TakeAim Leukemia study.
- The TakeAim Leukemia study is a Phase 1/2 dose escalation, dose
expansion study examining emavusertib use as both monotherapy and
in combination with azacitidine or venetoclax in patients with
relapsed or refractory ("R/R") acute myeloid leukemia ("AML") or
R/R high risk myelodysplastic syndrome ("MDS").
-
- In patients with spliceosome-mutated R/R AML, key findings
included:
-
- CR/CRh rate of 40% (2 out of 5 patients)
- Both patients who achieved CR/CRh have been on study > 6
months and achieved negative MRD (minimal residual disease)
status
- Consistent tumor burden reduction observed, 3 out of 5 patients
with elevated blast counts achieving ≥ 50% reduction in blast
counts
- In patients with spliceosome-mutated R/R MDS, key findings
included:
-
- Objective response rate of 57% (4 out of 7 patients)
- One of the patients who achieved a marrow CR ("mCR") proceeded
to stem cell transplant after 1 cycle
- Consistent tumor burden reduction observed, with 4 out of 6
patients with elevated baseline blast counts achieving ≥ 50%
reduction in blast counts
- In patients with a FLT3 mutated R/R AML, key findings
included:
-
- CR rate of 33% (1 out of 3 patients; this patient's AML also
had a spliceosome mutation)
- 2 out of 3 patients showed eradication of FLT3 mutation
following treatment, indicating potential for disease modification
with emavusertib
- Consistent tumor burden reduction observed; with 2 out of 3
patients with elevated blast counts achieving ≥ 50% reduction in
blast counts
- Curis collaborators at the Washington
University School of Medicine in St. Louis, published research suggesting the
potential use of emavusertib in solid tumors, such as pancreatic
cancer, a setting with very limited therapeutic options.
-
- The manuscript titled "IRAK4 signaling drives resistance to
checkpoint immunotherapy in pancreatic ductal adenocarcinoma"
concluded that tumor IRAK4 drives T-cell exhaustion in pancreatic
nonclinical ductal adenocarcinoma models and is a promising
therapeutic target when combined with checkpoint
immunotherapy.
- The manuscript is available online at
https://www.gastrojournal.org/article/S0016-5085(22)00201-3/pdf.
Immuno-oncology, CI-8993 (anti-VISTA antibody; ImmuNext
collaboration):
- Also discussed during the January update call were data from
the Phase 1 study of CI-8993, Curis's first-in-class monoclonal
anti-VISTA antibody, in patients with R/R solid tumors.
-
- Dose escalation has proceeded to the 0.6mg/kg dose level, past
the 0.15mg/kg dose level where toxicities were seen previously,
namely cytokine release syndrome, or CRS. Dose escalation will
continue until the Recommended Phase 2 Dose ("RP2D") has been
determined
- Pharmacodynamic data suggest CI-8993 has multiple anticancer
mechanisms that may position it for combination with existing
checkpoint inhibitors, in addition to monotherapy
Presentations at the 2022 American Society of Clinical
Oncology Annual Meeting
Curis Presentations
- TakeAim Lymphoma
-
- Abstract Number: 7575
- Abstract Title: Open-label, dose-escalation, and expansion
trial of CA-4948 in combination with ibrutinib in patients with
relapsed or refractory hematologic malignancies.
- Session Type/Title: Poster Session/ Hematologic
Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
- Session Date and Time: Saturday, June 4,
2022, 8:00 AM-11:00 AM
CDT
- TakeAim Leukemia
-
- Abstract Number: 7016
- Abstract Title: Phase 1/2a study of the IRAK4 inhibitor
CA-4948 as monotherapy or in combination with azacitidine or
venetoclax in patients with relapsed/refractory (R/R) acute myeloid
leukemia or myelodysplastic syndrome.
- Session Type/Title: Poster Discussion Session/ Hematologic
Malignancies—Leukemia, Myelodysplastic Syndromes, and
Allotransplant
- Session Date and Time: Saturday, June 4,
2022, 1:15 PM-2:45 PM;
8:00 AM-11:00 AM CDT
Collaborator Presentations
- Gastric and Esophageal Cancer
-
- Abstract Number: TPS4168
- Abstract Title: Phase I trial of CA-4948, an IRAK4
inhibitor, in combination with FOLFOX/PD-1 inhibitor +/-
trastuzumab for untreated unresectable gastric and esophageal
cancer
- Session Type/Title: Poster Session/Gastrointestinal
Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
- Session Date and Time: Saturday, June 4,
2022, 8:00 AM-11:00 AM
CDT
- Melanoma Brain Metastases
-
- Abstract Number: 2011
- Abstract Title: CA-4948 for the treatment of melanoma brain
metastasis.
- Session Type/Title: Poster Discussion Session/ Central Nervous
System Tumors
- Session Date and Time: Sunday, June 5,
2022, 11:30 AM-1:00 PM;
8:00 AM-11:00 AM CDT
Upcoming Planned Milestones for 2022
- Report data from the TakeAim Lymphoma study
-
- In the first half of 2022, we plan to present new data for
approximately 12 patients who have received treatment with the
combination of emavusertib and ibrutinib at the upcoming American
Society of Clinical Oncology ("ASCO") and European Hematology
Association ("EHA") meetings in June
2022
- Report data from the TakeAim Leukemia study
-
- In the first half of 2022, we plan to present the monotherapy
data released on our January update call in a peer-reviewed setting
at the ASCO and EHA conferences
- In the second half of 2022, we plan to present an update with
additional monotherapy data
- In the second half of 2022, we plan to present initial data for
the study of emavusertib in combination with azacitadine or
venetoclax
- Report data from the CI-8993 (VISTA checkpoint inhibitor)
study
-
- In the second half of 2022, we plan to present an update with
additional monotherapy data
First Quarter 2022 Financial Results
For the first quarter of 2022, Curis reported a net loss of
$16.1 million or $0.18 per share on both a basic and diluted
basis, as compared to a net loss of $9.9
million, or $0.11 per share on
both a basic and diluted basis for the same period in 2021.
Revenues for the first quarter of 2022 and 2021 were
$2.1 million and $2.2 million, respectively. Revenues for both
periods comprise primarily royalty revenues recorded on Genentech
and Roche's net sales of Erivedge®.
Operating expenses for the first quarter of 2022 were
$17.2 million, as compared to
$11.0 million for the same period in
2021, and comprised the following:
Cost of Royalty Revenues. Cost of royalty revenues,
represents 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
2022 and 2021.
Research and Development Expenses. Research and
development expenses were $11.4
million for the first quarter of 2022 as compared to
$6.8 million for the same period in
2021. The increase in direct research and development expenses for
the quarter is primarily attributable to increased manufacturing
costs for our programs and increased consulting services.
Additionally, personnel related costs increased by $2.4 million and stock compensation increased
$0.4 million, primarily as a result
of additional headcount.
General and Administrative Expenses. General and
administrative expenses were $5.7
million for the first quarter of 2022, as compared to
$4.1 million for the same period in
2021. The increase in general and administrative expense was driven
primarily by higher costs for personnel, stock-based compensation,
and insurance costs.
Other Expense, Net. For the third quarter of 2022 and
2021, net other expense was $1.0
million and $1.1 million,
respectively. Net other expense primarily consisted of imputed
interest expense related to future royalty payments.
As of March 31, 2022, Curis's
cash, cash equivalents and investments totaled $120.7 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, May 5, 2022, 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, emavusertib (CA-4948). Emavusertib is
currently undergoing testing in the Phase 1/2 TakeAim Lymphoma
trial, in patients with hematologic malignancies, such as
non-Hodgkins lymphoma and other B cell malignancies, both as a
monotherapy and in combination with BTK inhibitor ibrutinib, and
the Phase 1/2 TakeAim Leukemia trial in patients with acute myeloid
leukemia and myelodysplastic syndrome, for which it has received
Orphan Drug Designation from the U.S. Food and Drug Administration.
The FDA has placed a partial clinical hold on the TakeAim Leukemia
and TakeAim Lymphoma trials during which no new patients will be
enrolled, and current study participants benefiting from treatment
may continue to be treated with emavusertib at doses of 300mg BID
or lower. 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.
Cautionary Note Regarding 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, any
statements concerning Curis's expectations regarding its
interactions with the FDA or its ability to resolve the partial
clinical hold of the TakeAim Leukemia study or the partial clinical
hold of the TakeAim Lymphoma study, 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, the FDA may not remove the partial
clinical hold on the Phase 1/2 TakeAim Leukemia trial or the
partial clinical hold on the Phase 1/2 TakeAim Lymphoma trial, or
may take further regulatory action with regard to such trials;
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,
|
|
2022
|
|
2021
|
Revenues,
net:
|
|
|
|
Royalties
|
$
2,060
|
|
$
2,187
|
Contra revenue, net
|
(3)
|
|
2
|
Total revenues, net
|
2,057
|
|
2,189
|
Costs and
expenses:
|
|
|
|
Cost of royalty revenues
|
82
|
|
109
|
Research and development
|
11,435
|
|
6,757
|
General and administrative
|
5,673
|
|
4,123
|
Total costs and
expenses
|
17,190
|
|
10,989
|
Loss from operations
|
(15,133)
|
|
(8,800)
|
Other
expense:
|
|
|
|
Interest income
|
80
|
|
46
|
Imputed interest expense related to the sale of future
royalties
|
(1,056)
|
|
(1,173)
|
Total other expense
|
(976)
|
|
(1,127)
|
Net loss
|
$
(16,109)
|
|
$
(9,927)
|
Net loss per common
share (basic and diluted)
|
$
(0.18)
|
|
$
(0.11)
|
Weighted average common
shares (basic and diluted)
|
91,645,369
|
|
91,507,518
|
CURIS,
INC.
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
|
(UNAUDITED)
|
(In
thousands)
|
|
|
|
March 31,
2022
|
|
December 31,
2021
|
ASSETS
|
|
|
|
|
Cash, cash equivalents
and investments
|
|
$
|
120,653
|
|
|
$
|
139,848
|
|
Restricted
cash
|
|
726
|
|
|
726
|
|
Accounts
receivable
|
|
2,060
|
|
|
3,224
|
|
Property and equipment,
net
|
|
479
|
|
|
505
|
|
Operating lease
right-of-use asset
|
|
4,413
|
|
|
5,749
|
|
Goodwill
|
|
8,982
|
|
|
8,982
|
|
Prepaid expenses and
other assets
|
|
3,426
|
|
|
3,267
|
|
Total assets
|
|
$
|
140,739
|
|
|
$
|
162,301
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
Accounts payable,
accrued liabilities and other liabilities
|
|
$
|
8,867
|
|
|
$
|
12,756
|
|
Operating lease
liability
|
|
3,765
|
|
|
5,040
|
|
Liability related to
the sale of future royalties, net
|
|
52,133
|
|
|
53,798
|
|
Total liabilities
|
|
64,765
|
|
|
71,594
|
|
Total stockholders'
equity
|
|
75,974
|
|
|
90,707
|
|
Total liabilities and stockholders' equity
|
|
$
|
140,739
|
|
|
$
|
162,301
|
|
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SOURCE Curis, Inc.