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 | ||||
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Contacts:
John Lemkey
Chief Operating Officer
858-731-8180
jlemkey@odonate.com
