Odonate Therapeutics : Announces Financial Results for the Three and Nine Months Ended September 30, 2019

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 nine months ended September 30, 2019.

As of September 30, 2019, Odonate had $204.2 million in cash, compared to $139.1 million as of December 31, 2018. This increase in cash resulted primarily from the receipt of $135.1 million of net proceeds from Odonate’s June 2019 underwritten public offering, less net cash used in operating activities of $72.1 million. Odonate’s net loss for the three and nine months ended September 30, 2019 was $26.6 million and $84.0 million, or $0.88 and $3.15 per share, respectively, compared to $23.9 million and $60.2 million, or $0.98 and $2.47 per share, respectively, for the same periods in 2018.

“We are pleased to have recently announced the completion of enrollment in CONTESSA, Odonate’s Phase 3 study investigating tesetaxel as a potential treatment for patients with metastatic breast cancer,” said Kevin Tang, Chief Executive Officer of Odonate. “We expect to report top-line results from CONTESSA in the third quarter of 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 three studies in breast cancer, including a multinational, multicenter, randomized, Phase 3 study in patients with 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 metastatic breast cancer (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 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. Patients with central nervous system (CNS) metastases are eligible. 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.

About CONTESSA 2

CONTESSA 2 is a multinational, multicenter, Phase 2 study of tesetaxel, an investigational, orally administered taxane, in patients with metastatic breast cancer (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 MBC not previously treated with a taxane. 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. Patients with central nervous system (CNS) metastases are eligible. 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 metastatic breast cancer (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 (CNS) 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: expectations regarding the completion and outcome of CONTESSA, our Phase 3 study of tesetaxel in patients with metastatic breast cancer (MBC); expectations regarding the enrollment, completion and 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)
		September 30,				December 31,
		2019				2018
		(Unaudited)
Assets
Current assets:
Cash		$	204,245			$	139,050
Prepaid expenses and other current assets			3,951				750
Total current assets			208,196				139,800
Property and equipment, net			1,746				1,899
Right-of-use lease assets			1,759				-
Restricted cash			251				251
Other			835				723
Total assets		$	212,787			$	142,673
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable		$	12,964			$	10,777
Accrued expenses			11,385				7,365
Lease liabilities, current portion			398				-
Deferred rent, current portion			-				66
Total current liabilities			24,747				18,208
Lease liabilities, less current portion			1,839				-
Deferred rent, less current portion			-				461
Total liabilities			26,586				18,669
Commitments and contingencies
Stockholders' equity:
Common stock, $0.01 par value—100,000,000 shares authorized; 32,083,991 and 26,747,438 shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively			300				244
Additional paid-in capital			398,127				252,012
Accumulated deficit			(212,226	)			(128,252	)
Total stockholders' equity			186,201				124,004
Total liabilities and stockholders' equity		$	212,787			$	142,673

ODONATE THERAPEUTICS, INC. Condensed Statements of Operations (Unaudited) (in thousands, except share and per share amounts)
		Three Months Ended								Nine Months Ended
		September 30,								September 30,
		2019				2018				2019				2018
Operating expenses:
Research and development		$	25,097			$	21,667			$	78,181			$	53,151
General and administrative			2,666				2,960				8,040				8,136
Total operating expenses			27,763				24,627				86,221				61,287
Loss from operations			(27,763	)			(24,627	)			(86,221	)			(61,287	)
Interest income			1,136				701				2,247				1,090
Net loss		$	(26,627	)		$	(23,926	)		$	(83,974	)		$	(60,197	)
Net loss per share:
Basic and diluted		$	(0.88	)		$	(0.98	)		$	(3.15	)		$	(2.47	)
Weighted-average shares outstanding:
Basic and diluted			30,268,295				24,453,910				26,635,107				24,402,842

ODONATE THERAPEUTICS, INC. Condensed Statements of Cash Flows (Unaudited) (in thousands)
		Nine Months Ended
		September 30,
		2019				2018
Cash flows from operating activities:
Net loss		$	(83,974	)		$	(60,197	)
Adjustments to reconcile net loss to net cash used in operating activities:
Equity-based compensation expense			8,695				4,775
Depreciation and amortization			269				231
Non-cash contributions for expenses			-				64
Changes in operating assets and liabilities:
Prepaid expenses and other assets			(3,313	)			2,192
Accounts payable			2,186				1,443
Accrued expenses			4,020				5,733
Deferred rent			-				432
Net cash used in operating activities			(72,117	)			(45,327	)
Cash flows from investing activities:
Purchases of property and equipment			(164	)			(1,612	)
Net cash used in investing activities			(164	)			(1,612	)
Cash flows from financing activities:
Proceeds from issuance of common stock, net of issuance costs			135,095				9,848
Proceeds from issuance of common stock under employee stock plans			2,381				205
Net cash provided by financing activities			137,476				10,053
Net increase (decrease) in cash and restricted cash			65,195				(36,886	)
Cash and restricted cash, beginning of period			139,301				198,105
Cash and restricted cash, end of period		$	204,496			$	161,219
Supplemental disclosure of cash flow information:
Initial recognition of right-of-use lease assets		$	2,215			$	-
Property and equipment purchases included in accounts payable		$	1			$	272

 

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