Odonate Therapeutics Announces Financial Results for the Three Months Ended March 31, 2019

April 25, 2019 Off By BusinessWire

SAN DIEGO–(BUSINESS WIRE)–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, 2019.

As of March 31, 2019, Odonate had $112.1 million in cash, compared to
$139.1 million as of December 31, 2018. This decrease in cash resulted
primarily from net cash used in operating activities of $27.1 million.
Odonate’s net loss for the three months ended March 31, 2019 was $28.6
million, or $1.16 per share, compared to $16.9 million, or $0.69 per
share, for the same period in 2018.

“In the first quarter of 2019, we expanded the development of tesetaxel
by initiating two new clinical studies, CONTESSA 2 and CONTESSA TRIO,
the first study to investigate tesetaxel in combination with PD-(L)1
inhibitors,” said Kevin Tang, Chief Executive Officer of Odonate. “We
continue to expect to complete enrollment in CONTESSA, our ongoing
multinational, multicenter, randomized, Phase 3 study of tesetaxel in
patients with metastatic breast cancer, in the second half of 2019 and
report top-line results in 2020.”

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 pharmacologic
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, tesetaxel was shown to have significant, single-agent antitumor
activity in two multicenter, Phase 2 studies. Tesetaxel currently is the
subject of multiple studies in breast cancer, including a multinational,
multicenter, randomized, Phase 3 study in patients with locally advanced
or metastatic breast cancer, known as CONTESSA.

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 (LA/MBC). CONTESSA is
comparing tesetaxel dosed orally at 27 mg/m² on the first day
of each 21-day cycle plus a reduced dose of capecitabine (1,650 mg/m²/day
dosed orally for 14 days of each 21-day cycle) to the approved dose of
capecitabine alone (2,500 mg/m²/day dosed orally for 14 days
of each 21-day cycle) in approximately 600 patients randomized 1:1 with
human epidermal growth factor receptor 2 (HER2) negative, hormone
receptor (HR) positive LA/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 LA/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) as assessed by an Independent Radiologic
Review Committee (IRC). CONTESSA’s secondary efficacy endpoints are
overall survival (OS), objective response rate (ORR) as assessed by the
IRC and disease control rate (DCR) as assessed by the IRC. To learn
more, please visit www.contessastudy.com.

About CONTESSA 2

CONTESSA 2 is a multinational, multicenter, Phase 2 study of tesetaxel,
an investigational, orally administered taxane, in patients with locally
advanced or metastatic breast cancer (LA/MBC). CONTESSA 2 is
investigating tesetaxel dosed orally at 27 mg/m² on the first
day of each 21-day cycle plus a reduced dose of capecitabine (1,650 mg/m²/day
dosed orally for 14 days of each 21-day cycle) in approximately 125
patients with human epidermal growth factor receptor 2 (HER2) negative,
hormone receptor (HR) positive LA/MBC not previously treated with a
taxane. Capecitabine is an oral chemotherapy agent that is considered a
standard-of-care treatment in LA/MBC. Where indicated, patients must
have received endocrine therapy with or without a cyclin-dependent
kinase (CDK) 4/6 inhibitor. The primary endpoint is objective response
rate (ORR) as assessed by an Independent Radiologic Review Committee
(IRC). The secondary efficacy endpoints are duration of response (DoR)
as assessed by the IRC, progression-free survival (PFS) as assessed by
the IRC, disease control rate (DCR) as assessed by the IRC and overall
survival (OS).

About CONTESSA TRIO

CONTESSA TRIO is a multi-cohort, multicenter, Phase 2 study of
tesetaxel, an investigational, orally administered taxane, in patients
with locally advanced or metastatic breast cancer (LA/MBC). In Cohort 1,
approximately 90 patients (with potential expansion to up to 150
patients) with locally advanced or metastatic triple-negative breast
cancer (TNBC) who have not received prior chemotherapy for advanced
disease will be randomized 1:1:1 to receive tesetaxel dosed orally at 27
mg/m² on the first day of each 21-day cycle plus either: (1)
nivolumab at 360 mg by intravenous infusion on the first day of each
21-day cycle; (2) pembrolizumab at 200 mg by intravenous infusion on the
first day of each 21-day cycle; or (3) atezolizumab at 1,200 mg by
intravenous infusion on the first day of each 21-day cycle. Nivolumab
and pembrolizumab (PD-1 inhibitors) and atezolizumab (a PD-L1 inhibitor)
are immuno-oncology (IO) agents approved for the treatment of multiple
types of cancer. One of these agents, atezolizumab, in combination with
the intravenously delivered taxane, nab-paclitaxel, was recently
approved by the U.S. Food and Drug Administration (FDA) as a first-line
treatment for patients with metastatic TNBC. The dual primary endpoints
for Cohort 1 are objective response rate (ORR) and progression-free
survival (PFS). Secondary endpoints include duration of response (DoR)
and overall survival (OS). Efficacy results for each of the three
PD-(L)1 inhibitor combinations will be assessed for correlation with the
results of each of the three approved PD-L1 diagnostic assays. In Cohort
2, approximately 40 elderly patients (with potential expansion to up to
60 patients) with human epidermal growth factor receptor 2 (HER2)
negative MBC will receive tesetaxel monotherapy dosed orally at 27 mg/m²
on the first day of each 21-day cycle. The primary endpoint for Cohort 2
is ORR. Secondary endpoints include PFS, DoR and OS. Patients with
central nervous system metastases are eligible for both cohorts.

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: the expected outcome of CONTESSA, our Phase 3 study of tesetaxel
in patients with locally advanced or metastatic breast cancer (LA/MBC);
the expected outcome of our other clinical studies, including CONTESSA 2
and CONTESSA TRIO; 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.
Condensed Balance Sheets
(in thousands, except par value and share amounts)

	March 31,			December 31,
		2019			2018
	(Unaudited)
Assets
Current assets:
Cash	$	112,060		$	139,050
Prepaid expenses and other current assets		3,478			750
Total current assets		115,538			139,800
Property and equipment, net		1,883			1,899
Right-of-use lease assets		2,066			–
Restricted cash		251			251
Other		737			723
Total assets	$	120,475		$	142,673
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	7,797		$	10,777
Accrued expenses		11,657			7,365
Lease liabilities, current portion		603			–
Deferred rent, current portion		–			66
Total current liabilities		20,057			18,208
Lease liabilities, less current portion		1,975			–
Deferred rent, less current portion		–			461
Total liabilities		22,032			18,669
Commitments and contingencies
Stockholders’ equity:
Common stock, $0.01 par value		244			244
Additional paid-in capital		255,096			252,012
Accumulated deficit		(156,897	)		(128,252	)
Total stockholders’ equity		98,443			124,004
Total liabilities and stockholders’ equity	$	120,475		$	142,673


ODONATE THERAPEUTICS, INC.
Condensed Statements of Operations
(Unaudited)
(in thousands, except share and per share amounts)

	Three Months Ended
	March 31,
		2019			2018
Operating expenses:
Research and development	$	26,631		$	14,460
General and administrative		2,591			2,421
Total operating expenses		29,222			16,881
Loss from operations		(29,222	)		(16,881	)
Interest income		577			–
Net loss	$	(28,645	)	$	(16,881	)
Net loss per share:
Basic and diluted	$	(1.16	)	$	(0.69	)
Weighted-average shares outstanding:
Basic and diluted		24,682,410			24,351,019


ODONATE THERAPEUTICS, INC.
Condensed Statements of Cash Flows
(Unaudited)
(in thousands)

	Three Months Ended
	March 31,
		2019			2018
Cash flows from operating activities:
Net loss	$	(28,645	)	$	(16,881	)
Adjustments to reconcile net loss to net cash used in operating activities:
Equity-based compensation expense		2,925			1,011
Depreciation and amortization		90			16
Non-cash contributions for expenses		–			64
Changes in operating assets and liabilities:
Prepaid expenses and other assets		(2,744	)		1,199
Accounts payable		(3,023	)		815
Accrued expenses		4,289			1,323
Net cash used in operating activities		(27,108	)		(12,453	)
Cash flows from investing activities:
Purchases of property and equipment		(41	)		(4	)
Net cash used in investing activities		(41	)		(4	)
Cash flows from financing activities:
Proceeds from issuance of common stock, net of issuance costs		–			9,848
Proceeds from issuance of common stock under employee stock plans		159			–
Net cash provided by financing activities		159			9,848
Net decrease in cash and restricted cash		(26,990	)		(2,609	)
Cash and restricted cash, beginning of period		139,301			198,105
Cash and restricted cash, end of period	$	112,311		$	195,496
Supplemental disclosure of non-cash investing activities:
Property and equipment purchases included in accounts payable and accrued expenses	$	47		$	49
Initial recognition of right-of-use lease assets	$	2,215		$	–