- Initial data from Phase 1 combination with
capecitabine in advanced ovarian cancer are expected in
mid-2023
- Dose for the Phase 1 combination trials
identified as 400mg daily
- Ended 2022 with approximately $147 million in
cash; Projected cash runway into 2026
Cyteir Therapeutics, Inc. (“Cyteir”) (Nasdaq: CYT), a clinical
stage oncology company, today reported financial results for the
fourth quarter and full year ended December 31, 2022 and provided
an update on recent operational highlights.
“We continue to be encouraged by the early clinical activity of
CYT-0851 in ovarian cancer and are committed to bringing CYT-0851
to patients,” said Markus Renschler, MD, President and Chief
Executive Officer of Cyteir. “Our significant cash runway gives us
the resources to focus our development on CYT-0851 and into a
potentially registrational trial as early as the second half of
2024.”
Recent Updates to the CYT-0851 Clinical Program
- In January, Cyteir reported encouraging preliminary clinical
activity in the Phase 1 dose escalation cohorts with CYT-0851, an
investigational oral monocarboxylate transporter inhibitor, in
combination with capecitabine for the treatment of advanced ovarian
cancer. Cyteir announced the prioritization of development of
CYT-0851 in combination with capecitabine in advanced ovarian
cancer and deferred development of additional indications with this
combination. Cyteir plans to enroll up to an additional nine
patients with advanced ovarian cancer in the capecitabine
combination at the 400 mg CYT-0851 dose level. If supported by the
data and regulatory feedback, Cyteir intends to pursue development
and potential registration of CYT-0851 in combination with
capecitabine as an all-oral treatment for platinum resistant
ovarian cancer. Preliminary data on the combination with
capecitabine are expected to be disclosed in mid-2023.
- Enrollment in the Phase 1 dose escalation cohorts of CYT-0851
in combination with gemcitabine in solid tumors continues. This
combination is currently being evaluated at 300 mg of CYT-0851 in
combination with gemcitabine, and if deemed tolerable, will advance
to 400 mg of CYT-0851 in combination with gemcitabine. Preliminary
data from the Phase 1 dose escalation cohorts of CYT-0851 in
combination with gemcitabine are expected to be disclosed in
mid-2023.
Recent Business Updates
- In conjunction with the prioritization of the clinical plan for
CYT-0851, Cyteir also ceased all discovery projects focused on
identifying inhibitors of DNA damage repair. Cyteir is pursuing out
licensing of its preclinical pipeline.
Fourth Quarter and Full Year 2022 Financial Results
Cash and cash equivalents: Cash and
cash equivalents as of December 31, 2022 were $147.1 million, which
are expected to fund planned operations into 2026.
Research and development (R&D)
expenses: R&D expenses were $7.5 million for the fourth
quarter of 2022 versus $8.3 million for the same period in 2021 and
$34.6 million for the full year 2022 versus $31.0 million for full
year 2021. The year-over-year increase in R&D spending was due
primarily to increased headcount and research activity. The
decrease in fourth quarter 2022 R&D spending versus 2021 was
due to lower clinical trial costs.
General and administrative (G&A)
expenses: G&A expenses were $2.6 million for the fourth
quarter of 2022 compared to $3.6 million for the same period in
2021 and $13.5 million for the full year 2022 compared to $11.3
million for full year 2021. The year-over-year increase in full
year 2022 G&A expenses was primarily due to employee-related
costs, as well as other administrative expenses associated with
company growth and operating as a public company. The decrease in
fourth quarter 2022 G&A spending versus 2021 was due to lower
employee-related costs and other administrative expenses.
Net loss: Net loss was $8.8
million, or $0.25 per share, in the fourth quarter of 2022 compared
to $11.8 million, or $0.34 per share, for the same period in 2021.
For the full year 2022, net loss was $46.1 million, or $1.31 per
share compared to $42.1 million, or $2.16 per share for full year
2021.
About Cyteir Therapeutics, Inc.
Cyteir is a clinical-stage oncology company that is focused on
the development of CYT-0851, an oral investigational drug that
inhibits monocarboxylate transporters. Cyteir’s current priority in
CYT-0851 development is in combination with capecitabine and
gemcitabine in a Phase 1/2 clinical study, including patients with
advanced ovarian cancer. Follow Cyteir on social media: LinkedIn
and Twitter and at www.cyteir.com.
Forward-Looking Statements
This press release contains “forward-looking statements” about
Cyteir’s strategy, future plans, and prospects, including
statements regarding the development of Cyteir’s compounds and
potential expansion opportunities, regulatory strategy, and path
for Cyteir’s compounds, the expected timing and reporting of
results of Cyteir’s preclinical and clinical studies, and Cyteir’s
expected cash runway. The words “anticipate,” “believe,”
“continue,” “could,” “estimate,” “expect,” “intend,” “likely,”
“may,” “might,” “plan,” “potential,” “project,” “seek,” “will,”
“would,” and similar expressions are intended to identify
forward-looking statements, although not all forward-looking
statements contain these identifying words. These forward-looking
statements include: the benefits and potential impact of our
portfolio prioritization; expected timing to receive clinical data
from current ongoing clinical studies; expected cost savings from
our prioritization and reduction in force; and our expected
extended cash runway.
Actual results could differ materially from those included in
the forward-looking statements due to various factors, risks and
uncertainties, including, but not limited to: that Cyteir’s
clinical trials may fail to demonstrate adequately the safety and
efficacy of CYT-0851; that preclinical testing of CYT-0851 may not
be predictive of the results or success of clinical trials; that
the clinical development of CYT-0851 may be delayed or otherwise
take longer and/or cost more than planned; that Cyteir may be
unable to initiate, enroll or complete clinical development of
CYT-0851; that the continuing global outbreak of COVID-19
(including any resurgences or variants) may result in development
or manufacturing delays, supply shortages, or shortages of
qualified healthcare personnel; that synthetic lethality, as an
emerging class of precision medicine targets, could result in
negative perceptions of the efficacy, safety or tolerability of
this class of targets, which could adversely affect our ability to
conduct our business, advance our drug candidates or obtain
regulatory approvals; and that Cyteir’s compounds may not receive
regulatory approvals or become commercially successful products.
These and other risks and uncertainties are identified under the
heading “Risk Factors” in Cyteir’s most recent Annual Report on
Form 10-K and other filings Cyteir has made and may make with the
Securities and Exchange Commission ("SEC") in the future, available
on the SEC's website at www.sec.gov.
The forward-looking statements contained in this press release
are based on management's current views, plans, estimates,
assumptions, and projections with respect to future events, and
Cyteir does not undertake and specifically disclaims any obligation
to update any forward-looking statements.
Cyteir Therapeutics Inc Condensed consolidated statements
of operations (in thousands, except share and per share
amounts)(unaudited) Three Months Ended December
31, Years Ended December 31,
2022
2021
2022
2021
Operating expenses: Research and development
$
7,470
$
8,255
$
34,624
$
30,959
General and administrative
2,583
3,607
13,546
11,300
Total operating expenses
10,053
11,862
48,170
42,259
Loss from operations
(10,053)
(11,862)
(48,170)
(42,259)
Other income (expense): Other income (expense)
1,260
47
2,109
133
Total other income (expense)
1,260
47
2,109
133
Net loss
$
(8,793)
$
(11,815)
$
(46,061)
$
(42,126)
Net loss per share—basic and diluted
$
(0.25)
$
(0.34)
$
(1.31)
$
(2.16)
Weighted-average common stock outstanding—basic and diluted
35,375,849
35,136,168
35,272,831
19,499,292
Research and development expenses for the fourth
quarter and full year-ended December 31, 2022 include stock-based
compensation expense of $0.5 million and $1.9 million,
respectively, compared to $0.4 million and $1.2 million,
respectively, in the corresponding periods of 2021. General and
administrative expenses for the fourth quarter and full year-ended
December 31, 2022 include stock-based compensation expense of $0.4
million and $2.8 million, respectively, compared to $0.8 million
and $2.3 million, respectively, in the corresponding periods of
2021.
Cyteir Therapeutics Inc Condensed consolidated
balance sheets (in thousands, except share and per share
amounts)(unaudited) December 31,
2022
2021
Assets Current assets: Cash and cash equivalents
$
147,120
$
189,723
Prepaid expenses and other current assets
2,089
3,354
Total current assets
$
149,209
$
193,077
Property and equipment, net
1,699
2,055
Other assets
2,324
256
Total assets
$
153,232
$
195,388
Liabilities and stockholders’ equity Current liabilities:
Accounts payable
$
1,128
$
1,785
Accrued expenses and other current liabilities
4,187
5,726
Total current liabilities
$
5,315
$
7,511
Deferred rent, net of current portion
-
384
Other long term liabilities
1,631
201
Total liabilities
$
6,946
$
8,096
Commitments and contingencies (Note 12) Stockholders’ equity:
Preferred stock, $0.001 par value: 40,000,000 shares authorized as
of December 31, 2022 and 2021; no shares issued and outstanding as
of December 31, 2022 and 2021
-
-
Common stock, $0.001 par value: 280,000,000 shares authorized;
35,575,694 and 35,389,453 shares issued as of December 31, 2022 and
2021, respectively; 35,516,249 and 35,219,834 shares outstanding as
of December 31, 2022 and 2021, respectively
35
35
Additional paid-in capital
284,365
279,310
Accumulated deficit
(138,114)
(92,053)
Total stockholders’ equity
146,286
187,292
Total liabilities and stockholders’ equity
$
153,232
$
195,388
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230323005237/en/
Cyteir Investor Relations 857-285-4140 ir@cyteir.com
Cyteir Therapeutics (NASDAQ:CYT)
Gráfica de Acción Histórica
De May 2024 a Jun 2024
Cyteir Therapeutics (NASDAQ:CYT)
Gráfica de Acción Histórica
De Jun 2023 a Jun 2024