- Enrollment continuing in trials with CYT-0851
in combination with capecitabine or gemcitabine with data expected
in mid-2023
- Ended first quarter of 2023 with
approximately $137.2 million in cash
Cyteir Therapeutics, Inc. (“Cyteir”) (Nasdaq: CYT), a clinical
stage oncology company, today reported financial results for the
first quarter ended March 31, 2023 and provided an update on recent
operational highlights.
“We have made encouraging progress enrolling patients in the
CYT-0851 Phase 1 combination trial with capecitabine and
gemcitabine, while maintaining our strong financial discipline,”
said Markus Renschler, MD, President and Chief Executive Officer of
Cyteir. “We look forward to sharing preliminary data on the Phase 1
combination cohorts with CYT-0851 in mid-year.”
Recent Updates to the CYT-0851 Clinical Program
- Enrollment in the Phase 1 trial with CYT-0851 in combination
with capecitabine in advanced ovarian cancer continues at the 400mg
dose of CYT-0851, which was determined to be the recommended Phase
2 dose in the capecitabine combination. 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. A
maximum tolerated dose and/or recommended Phase 2 dose of CYT-0851
in combination with gemcitabine is expected to be determined and
preliminary results to be disclosed in mid-2023.
- A poster of preliminary results of monotherapy and combination
data with CYT-0851 will be presented at the American Society of
Clinical Oncology during the Developmental Therapeutics—Molecularly
Targeted Agents and Tumor Biology poster session on June 3, 2023 at
8:00am.
- Poster title: Phase 1 results of CYT-0851, a monocarboxylate
transporter (MCT) inhibitor, in combination with capecitabine
(cape) or gemcitabine (gem) in advanced solid tumors. Abstract:
3099, Poster Bd #: 297
Recent Business Updates
- Cyteir is pursuing out-licensing of its preclinical DNA
polymerase theta (POLθ or POLQ) inhibitor program.
First Quarter 2023 Financial Results
Cash and cash equivalents: Cash and
cash equivalents as of March 31, 2023 were $137.2 million, which
are expected to fund planned operations into 2026.
Research and development (R&D)
expenses: R&D expenses were $9.3 million for the first
quarter of 2023 versus $10.1 million for the same period in 2022.
The year-over-year decrease in R&D spending was due primarily
to a decrease in costs related to our MCT inhibitor program, which
includes research activities and ongoing clinical trial costs,
partially offset by an increase in personnel severance-related
costs.
General and administrative (G&A)
expenses: G&A expenses were $4.1 million for the first
quarter of 2023 compared to $4.0 million for the same period in
2022. The year-over-year increase in G&A expenses was primarily
due to an increase in personnel severance-related costs, partially
offset by a decrease in insurance and state taxes.
Net loss: Net loss was $12.5
million, or $0.35 per share, in the first quarter of 2023 compared
to $14.1 million, or $0.40 per share, for the same period in
2022.
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 March
31,
2023
2022
Operating expenses: Research and development
$
9,312
$
10,088
General and administrative
4,110
4,043
Total operating expenses
13,422
14,131
Loss from operations
(13,422
)
(14,131
)
Other income (expense): Interest income
1,543
29
Loss on disposal of property and equipment
(925
)
-
Gain on lease terminations and modification
318
-
Total other income (expense)
936
29
Net loss
$
(12,486
)
$
(14,102
)
Net loss per share—basic and diluted
$
(0.35
)
$
(0.40
)
Weighted-average common stock outstanding—basic and diluted
35,587,806
35,241,251
Research and development expenses for both the first quarter-ended
March 31, 2023 and 2022 include stock-based compensation expense of
$0.4 million. General and administrative expenses for the first
quarter-ended March 31, 2023 include stock-based compensation
expense of $0.6 million compared to $0.8 million in the
corresponding periods of 2022.
Cyteir Therapeutics Inc
Condensed consolidated balance sheets (in thousands,
except share and per share amounts)(unaudited)
March 31,
December 31,
2023
2022
Assets Current assets: Cash and cash equivalents
$
137,204
$
147,120
Prepaid expenses and other current assets
1,190
2,089
Total current assets
$
138,394
$
149,209
Property and equipment, net
323
1,699
Other assets
259
2,324
Total assets
$
138,976
$
153,232
Liabilities and stockholders’ equity Current liabilities:
Accounts payable
$
674
$
1,128
Accrued expenses and other current liabilities
3,287
4,187
Total current liabilities
$
3,961
$
5,315
Other long term liabilities
39
1,631
Total liabilities
$
4,000
$
6,946
Commitments and contingencies (Note 10) Stockholders’ equity:
Preferred stock, $0.001 par value: 40,000,000 shares authorizedas
of March 31, 2023 and December 31, 2022, respectively;no shares
issued and outstanding as of March 31, 2023 andDecember 31, 2022
-
-
Common stock, $0.001 par value: 280,000,000 shares
authorized;35,658,429 and 35,575,694 shares issued as of March 31,
2023and December 31, 2022, respectively; 35,624,127 and
35,516,249shares outstanding as of March 31, 2023 and December 31,
2022,respectively
35
35
Additional paid-in capital
285,541
284,365
Accumulated deficit
(150,600
)
(138,114
)
Total stockholders’ equity
134,976
146,286
Total liabilities and stockholders’ equity
$
138,976
$
153,232
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230510005920/en/
Cyteir Investor Relations 857-285-4140 ir@cyteir.com
Cyteir Therapeutics (NASDAQ:CYT)
과거 데이터 주식 차트
부터 4월(4) 2024 으로 5월(5) 2024
Cyteir Therapeutics (NASDAQ:CYT)
과거 데이터 주식 차트
부터 5월(5) 2023 으로 5월(5) 2024