Odonate Therapeutics Announces Financial Results for the Three and Twelve Months Ended December 31, 2018

February 22, 2019 |

7 min read

Odonate Therapeutics, Inc. announced financial results for the three and twelve months ended December 31, 2018.

Feb. 22, 2019 13:15 UTC

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 and twelve months ended December 31, 2018.

As of December 31, 2018, Odonate had $139.1 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 and investing activities of $67.1 million and $1.9 million, respectively, less net cash provided by financing activities of $10.2 million, which includes $9.8 million from the exercise of the underwriters’ option to purchase additional shares of common stock in our initial public offering. Odonate’s net loss for the three and twelve months ended December 31, 2018 was $28.8 million and $89.0 million, or $1.17 per share and $3.64 per share, respectively, compared to $15.7 million and $32.7 million, or $0.81 per share and $2.31 per share, for the same periods in 2017, respectively.

“We remain committed to developing novel therapies that improve the lives of patients with cancer,” said Kevin Tang, Chief Executive Officer of Odonate. “Tesetaxel, our investigational, orally administered taxane, has been shown to have significant, single-agent antitumor activity in two multicenter, Phase 2 studies and may provide significant quality-of-life advantages over other chemotherapy options. We 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.

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 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 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) assessed by an Independent Radiologic Review Committee (IRC). CONTESSA’s secondary efficacy endpoints are overall survival, objective response rate (ORR) assessed by IRC and disease control rate assessed by IRC. 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 that belongs to a class of drugs known as taxanes, which are widely used in the treatment of cancer. In December 2017, Odonate initiated CONTESSA, a multinational, multicenter, randomized, Phase 3 study of tesetaxel in patients with locally advanced or metastatic breast 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 enrollment and 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. Balance Sheets (in thousands, except par value and share amounts)

	December 31,			December 31,
	2018			2017
Assets
Current assets:
Cash	$	139,050		$	198,105
Prepaid expenses		750			4,841
Total current assets		139,800			202,946
Property and equipment, net		1,899			165
Restricted cash		251			-
Other		723			383
Total assets	$	142,673		$	203,494
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable	$	10,777		$	4,302
Accrued expenses		7,365			3,210
Deferred rent, current portion		66			-
Total current liabilities		18,208			7,512
Deferred rent, less current portion		461			-
Total liabilities		18,669			7,512
Stockholders' equity:
Common stock, $0.01 par value—100,000,000 shares authorized; 26,747,438 and 26,890,356 shares issued and outstanding at December 31, 2018 and 2017, respectively		244			240
Additional paid-in capital		252,012			235,034
Accumulated deficit		(128,252	)		(39,292	)
Total stockholders' equity		124,004			195,982
Total liabilities and stockholders' equity	$	142,673		$	203,494


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

	Three Months Ended						Twelve Months Ended
	December 31,						December 31,
	2018			2017			2018			2017
Operating expenses:
Research and development	$	26,797		$	13,040		$	79,948		$	27,902
General and administrative		2,680			2,706			10,816			4,842
Total operating expenses		29,477			15,746			90,764			32,744
Loss from operations		(29,477	)		(15,746	)		(90,764	)		(32,744	)
Interest income		714			-			1,804			-
Net loss	$	(28,763	)	$	(15,746	)	$	(88,960	)	$	(32,744	)
Net loss per share:
Basic and diluted	$	(1.17	)	$	(0.81	)	$	(3.64	)	$	(2.31	)
Weighted-average shares outstanding:
Basic and diluted		24,638,708			19,339,389			24,462,293			14,169,464


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

	Year Ended
	December 31,
	2018			2017
Cash flows from operating activities:
Net loss	$	(88,960	)	$	(32,744	)
Adjustments to reconcile net loss to net cash used in operating activities:
Equity-based compensation expense		6,721			3,184
Depreciation and amortization		350			20
Non-cash contributions for expenses		64			1,812
Changes in operating assets and liabilities:
Prepaid expenses and other assets		3,751			(4,956	)
Accounts payable		6,392			3,642
Accrued expenses		4,155			3,184
Deferred rent		433			-
Net cash used in operating activities		(67,094	)		(25,858	)
Cash flows from investing activities:
Purchases of property and equipment		(1,907	)		(83	)
Net cash used in investing activities		(1,907	)		(83	)
Cash flows from financing activities:
Proceeds from issuance of common stock, net of issuance costs		9,848			221,447
Proceeds from issuance of common stock under employee stock plans		349			-
Net cash provided by financing activities		10,197			221,447
Net (decrease) increase in cash and restricted cash		(58,804	)		195,506
Cash and restricted cash, beginning of period		198,105			2,599
Cash and restricted cash, end of period	$	139,301		$	198,105
Supplemental disclosure of cash flow information:
Issuance costs included in accounts payable and accrued expenses	$	-		$	571
Property and equipment purchases included in accounts payable	$	83		$	88