Odonate Therapeutics, Inc. (NASDAQ: ODT), a pharmaceutical
company dedicated to the development of best-in-class therapeutics
that improve and extend the lives of patients with cancer, today
announced financial results for the three and twelve months ended
December 31, 2020.
As of December 31, 2020, Odonate had $157.3 million in cash,
compared to $180.5 million as of December 31, 2019. This decrease
in cash resulted primarily from cash used in operating activities
for the twelve months ended December 31, 2020 of $113.1 million,
partially offset by the receipt of $87.4 million of net proceeds
from Odonate’s September 2020 underwritten public offering.
Odonate’s net loss for the three and twelve months ended December
31, 2020 was $32.3 million and $126.4 million, or $0.87 and $3.84
per share, respectively, compared to $27.9 million and $111.8
million, or $0.91 and $4.05 per share, respectively, for the same
periods in 2019.
“Positive results of CONTESSA, Odonate’s Phase 3 study
investigating tesetaxel as a potential treatment for patients with
metastatic breast cancer, were recently presented at the 2020 San
Antonio Breast Cancer Symposium,” said Kevin Tang, Chief Executive
Officer of Odonate. “We continue to plan to submit a New Drug
Application for tesetaxel to the FDA in mid-2021.”
About Tesetaxel
Tesetaxel is an investigational, orally administered
chemotherapy agent that belongs to a class of drugs known as
taxanes, which are widely used in the treatment of cancer.
Tesetaxel has several properties that make it unique among taxanes,
including: oral administration with a low pill burden; a long
(~8-day) terminal plasma half-life in humans, enabling the
maintenance of adequate drug levels with relatively infrequent
dosing; no history of hypersensitivity (allergic) reactions; and
significant activity against chemotherapy-resistant tumors. In
patients with metastatic breast cancer (MBC), tesetaxel was shown
to have significant, single-agent antitumor activity in two
multicenter, Phase 2 studies. Tesetaxel currently is the subject of
three studies in MBC, including a multinational, multicenter,
randomized, Phase 3 study in patients with MBC, known as CONTESSA.
Positive results of CONTESSA were presented at the 2020 San Antonio
Breast Cancer Symposium in December.
About CONTESSA
CONTESSA is a multinational, multicenter, randomized, Phase 3
study of tesetaxel, an investigational, orally administered taxane,
in patients with metastatic breast cancer (MBC). CONTESSA is
comparing tesetaxel dosed orally at 27 mg/m2 on Day 1 of a 21-day
cycle plus a reduced dose of capecitabine (1,650 mg/m2/day dosed
orally for 14 days of a 21-day cycle) to the approved dose of
capecitabine alone (2,500 mg/m2/day dosed orally for 14 days of a
21-day cycle) in 685 patients randomized 1:1 with hormone receptor
(HR)-positive, human epidermal growth factor receptor 2
(HER2)‑negative MBC previously treated with a taxane in the
neoadjuvant or adjuvant setting. Capecitabine is an oral
chemotherapy agent that is considered a standard-of-care treatment
in MBC. Where indicated, patients must have been treated with
endocrine therapy with or without a cyclin-dependent kinase (CDK)
4/6 inhibitor. The primary endpoint is progression-free survival
(PFS) as assessed by an Independent Radiologic Review Committee
(IRC). The secondary endpoints are overall survival (OS), objective
response rate (ORR) as assessed by the IRC and disease control rate
(DCR) as assessed by the IRC.
Positive results of CONTESSA were presented at the 2020 San
Antonio Breast Cancer Symposium in December. The primary endpoint
was met: median PFS was 9.8 months for tesetaxel plus a reduced
dose of capecitabine versus 6.9 months for the approved dose of
capecitabine alone, an improvement of 2.9 months. The risk of
disease progression or death was reduced by 28.4% (hazard
ratio=0.716 [95% confidence interval [CI]: 0.573‑0.895; p=0.003]).
Neutropenia was the most common Grade ≥3 treatment‑emergent adverse
event.
About Odonate Therapeutics, Inc.
Odonate Therapeutics, Inc. is a pharmaceutical company dedicated
to the development of best‑in‑class therapeutics that improve and
extend the lives of patients with cancer. Odonate’s initial focus
is on the development of tesetaxel, an investigational, orally
administered chemotherapy agent that belongs to a class of drugs
known as taxanes, which are widely used in the treatment of cancer.
Odonate’s goal for tesetaxel is to develop an effective
chemotherapy choice for patients that provides quality‑of‑life
advantages over current alternatives. To learn more, please visit
www.odonate.com.
Forward-looking Statements
This press release contains “forward-looking statements” as
defined by the Private Securities Litigation Reform Act of 1995. We
caution investors that forward-looking statements are based on
management’s expectations and assumptions as of the date of this
press release and involve substantial risks and uncertainties that
could cause the actual outcomes to differ materially from what we
currently expect. These risks and uncertainties include, but are
not limited to, those associated with: expectations regarding the
outcome of CONTESSA, our Phase 3 study of tesetaxel in patients
with metastatic breast cancer; expectations regarding the
enrollment, completion and outcome of our other clinical studies;
expectations regarding the timing for our planned New Drug
Application submission for tesetaxel; expectations regarding the
timing of a regulatory decision on tesetaxel and our ability to
obtain regulatory approval of tesetaxel; the unpredictable
relationship between preclinical study results and clinical study
results; and other risks and uncertainties identified in our
filings with the U.S. Securities and Exchange Commission.
Forward-looking statements in this press release apply only as of
the date made, and we undertake no obligation to update or revise
any forward-looking statements to reflect subsequent events or
circumstances.
ODONATE THERAPEUTICS,
INC.
Balance Sheets
(in thousands, except par
value and share amounts)
December 31,
December 31,
2020
2019
Assets
Current assets:
Cash
$
157,265
$
180,460
Prepaid expenses and other current
assets
2,607
3,468
Total current assets
159,872
183,928
Property and equipment, net
2,286
1,663
Right-of-use lease assets
4,017
1,581
Restricted cash
714
714
Other
997
941
Total assets
$
167,886
$
188,827
Liabilities and Stockholders'
Equity
Current liabilities:
Accounts payable
$
14,168
$
15,583
Accrued expenses
12,247
8,881
Lease liabilities, current portion
658
315
Total current liabilities
27,073
24,779
Lease liabilities, less current
portion
4,668
1,748
Total liabilities
31,741
26,527
Stockholders' equity:
Common stock, $0.01 par value—100,000,000
shares authorized; 38,562,281 and 32,050,906 shares issued and
outstanding at December 31, 2020 and December 31, 2019,
respectively
367
300
Additional paid-in capital
502,205
402,077
Accumulated deficit
(366,427
)
(240,077
)
Total stockholders' equity
136,145
162,300
Total liabilities and stockholders'
equity
$
167,886
$
188,827
ODONATE THERAPEUTICS,
INC.
Statements of
Operations
(in thousands, except share
and per share amounts)
Three Months Ended
Twelve Months Ended
December 31,
December 31,
2020
2019
2020
2019
Operating expenses:
Research and development
$
30,075
$
25,853
$
117,041
$
104,034
General and administrative
2,359
2,856
10,392
10,896
Total operating expenses
32,434
28,709
127,433
114,930
Loss from operations
(32,434
)
(28,709
)
(127,433
)
(114,930
)
Other income, net
148
858
1,083
3,105
Net loss
$
(32,286
)
$
(27,851
)
$
(126,350
)
$
(111,825
)
Net loss per share:
Basic and diluted
$
(0.87
)
$
(0.91
)
$
(3.84
)
$
(4.05
)
Weighted-average shares outstanding:
Basic and diluted
37,287,893
30,564,258
32,862,552
27,625,468
ODONATE THERAPEUTICS,
INC.
Statements of Cash
Flows
(in thousands)
Year Ended
December 31,
2020
2019
Cash flows from operating
activities:
Net loss
$
(126,350
)
$
(111,825
)
Adjustments to reconcile net loss to net
cash used in operating activities:
Equity-based compensation expense
9,828
11,444
Depreciation and amortization
445
426
Non-cash lease expense
425
634
Loss on disposal of property and
equipment
83
-
Changes in operating assets and
liabilities:
Prepaid expenses and other assets
763
(2,936
)
Accounts payable
(1,415
)
4,782
Accrued expenses
3,366
1,516
Lease liabilities
(275
)
(679
)
Net cash used in operating activities
(113,130
)
(96,638
)
Cash flows from investing
activities:
Purchases of property and equipment
(432
)
(166
)
Net cash used in investing activities
(432
)
(166
)
Cash flows from financing
activities:
Proceeds from issuance of common stock,
net of issuance costs
87,383
135,096
Proceeds from issuance of common stock
under employee stock plans
2,984
3,581
Net cash provided by financing
activities
90,367
138,677
Net (decrease) increase in cash and
restricted cash
(23,195
)
41,873
Cash and restricted cash, beginning of
period
181,174
139,301
Cash and restricted cash, end of
period
$
157,979
$
181,174
Supplemental disclosure of cash flow
information:
Initial recognition of right-of-use lease
assets
$
2,861
$
2,215
Tenant improvement allowance
$
719
$
-
Property and equipment purchases included
in accounts payable
$
1
$
24
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210223005353/en/
Odonate Therapeutics, Inc. Michael Hearne Chief Financial
Officer (332) 208-7611 mhearne@odonate.com
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