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Odonate Therapeutics Announces Financial Results for the Three Months Ended March 31, 2018

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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 months ended March 31, 2018.

As of March 31, 2018, Odonate had $195.2 million in cash, compared to
$198.1 million as of December 31, 2017. This decrease in cash resulted
primarily from net cash used in operating activities of $12.5 million,
less net proceeds of $9.8 million from the sale of common stock to the
underwriters in our initial public offering in connection with the
exercise of their option to purchase additional shares of common stock.
Odonate's net loss for the three months ended March 31, 2018 was $16.9
million, or $0.69 per share, compared to $2.7 million, or $0.26 per
share, for the same period in 2017.

"We are excited to have recently initiated CONTESSA, our Phase 3 study
investigating tesetaxel in the treatment of locally advanced or
metastatic breast cancer," said Kevin Tang, Chairman and Chief Executive
Officer of Odonate. "Despite recent advances in the treatment of
advanced breast cancer, there remains a significant need for new
therapies that allow patients to maintain a better quality of life. We
are hopeful that tesetaxel's oral bioavailability, low pill burden, lack
of history of hypersensitivity reactions and robust activity against
chemotherapy-resistant tumors seen in prior studies may translate into
significant benefits for patients."

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 potential therapeutic
advantages over currently available taxanes, including: oral
administration with a low pill burden and a patient-friendly dosing
regimen; no history of hypersensitivity (allergic) reactions; and robust
activity against chemotherapy-resistant tumors. More than 500 patients
have been treated with tesetaxel across 22 clinical studies. In patients
with locally advanced or metastatic breast cancer (MBC), tesetaxel was
shown to have robust single-agent antitumor activity in two,
multicenter, Phase 2 studies.

About CONTESSA

CONTESSA is a multinational, multicenter, randomized, Phase 3 study of
tesetaxel, an investigational, orally administered taxane, in patients
with locally advanced or metastatic breast cancer (MBC). CONTESSA will
compare tesetaxel dosed orally at 27 mg/m2 on the first day
of a 21-day cycle plus a reduced dose of capecitabine (1,650 mg/m2/day
dosed orally on days 1-14 of a 21-day cycle) to the approved dose of
capecitabine alone (2,500 mg/m2/day dosed orally on days 1-14
of a 21-day cycle) in approximately 600 patients randomized 1:1 with
human epidermal growth factor receptor 2 (HER2) negative, hormone
receptor (HR) positive 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 received endocrine therapy with or without
a cyclin-dependent kinase (CDK) 4/6 inhibitor. The primary endpoint is
progression-free survival (PFS) assessed by an Independent Radiologic
Review Committee (IRC). CONTESSA's secondary efficacy endpoints are
overall survival, objective response rate (ORR) assessed by IRC, disease
control rate assessed by IRC and patient-reported outcomes. To learn
more, please visit www.contessastudy.com.

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 belonging to a class of drugs known as taxanes, which
are widely used in the treatment of cancer. Odonate recently initiated
CONTESSA, a multinational, multicenter, randomized, Phase 3 study of
tesetaxel in patients with locally advanced or metastatic breast cancer
(MBC). 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: the outcome of CONTESSA, our Phase 3 study of tesetaxel in
patients with locally advanced or metastatic breast cancer; our ability
to obtain regulatory approval of tesetaxel; 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.
Condensed Balance Sheets
(in thousands, except par value and share amounts)
   
March 31, December 31,
2018 2017
(Unaudited)
Assets
Current assets:
Cash $ 195,246 $ 198,105
Prepaid expenses   3,568   4,841
Total current assets 198,814 202,946
Property and equipment, net 202 165
Restricted cash 250 -
Other   457   383
Total assets $ 199,723 $ 203,494
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable $ 5,166 $ 4,302
Accrued expenses   4,533   3,210
Total current liabilities 9,699 7,512
Commitments and contingencies
Stockholders' equity:
Common stock, $0.01 par value—100,000,000 shares authorized;
26,885,689 and 26,890,356 shares issued and outstanding at March 31,
2018 and December 31, 2017, respectively
244 240
Additional paid-in capital 245,953 235,034
Accumulated deficit   (56,173 )   (39,292 )
Total stockholders' equity   190,024   195,982
Total liabilities and stockholders' equity $ 199,723 $ 203,494
 
 
ODONATE THERAPEUTICS, INC.
Condensed Statements of Operations
(Unaudited)
(in thousands, except share and per share amounts)
 
Three Months Ended March 31,
2018   2017
Operating expenses:
Research and development $ 14,460 $ 2,454
General and administrative   2,421   272
Total operating expenses   16,881   2,726
Net loss $ (16,881 ) $ (2,726 )
Net loss per share:
Basic and diluted $ (0.69 ) $ (0.26 )
Weighted-average shares outstanding:
Basic and diluted   24,351,019   10,464,723
 
 
ODONATE THERAPEUTICS, INC.
Condensed Statements of Cash Flows
(Unaudited)
(in thousands)
 
Three Months Ended March 31,
2018   2017
Cash flows from operating activities:
Net loss $ (16,881 ) $ (2,726 )
Adjustments to reconcile net loss to net cash used in operating
activities:
Equity-based compensation 1,011 9
Non-cash contributions for expenses 64 766
Depreciation 16 2
Changes in operating assets and liabilities:
Prepaid expenses and other assets 1,199 6
Accounts payable 815 7
Accrued expenses   1,323   166
Net cash used in operating activities (12,453 ) (1,770 )
Cash flows from investing activities:
Purchases of property and equipment   (4 )   -
Net cash used in investing activities (4 ) -
Cash flows from financing activities:
Proceeds from issuance of common stock, net of issuance costs   9,848   10,000
Net cash provided by financing activities   9,848   10,000
Net (decrease) increase in cash and restricted cash (2,609 ) 8,230
Cash and restricted cash, beginning of period   198,105   2,599
Cash and restricted cash, end of period $ 195,496 $ 10,829
Supplemental disclosure of cash flow information:
Issuance costs included in accounts payable and accrued expenses $ - $ 14
Property and equipment purchases included in accounts payable $ 49 $ 21

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