Odonate Therapeutics Announces Financial Results for the Three and Six Months Ended June 30, 2018

July 30, 2018

SAN DIEGO--(BUSINESS WIRE)--Jul. 30, 2018-- 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 six months ended June 30, 2018.

As of June 30, 2018, Odonate had $177.4 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 $29.1 million and $1.3 million, respectively, less net proceeds of $9.8 million from the sale of common stock pursuant to an option granted to the underwriters in our initial public offering. Odonate’s net loss for the three and six months ended June 30, 2018 was $19.4 million and $36.3 million, or $0.79 per share and $1.49 per share, respectively, compared to $3.9 million and $6.6 million, or $0.31 per share and $0.57 per share, for the same periods in 2017, respectively.

“Results from our multicenter Phase 2 study of tesetaxel were recently presented at the 2018 ASCO Annual Meeting. In this study, tesetaxel, administered orally as a single agent, resulted in a 45% confirmed response rate in patients with HER2 negative, HR positive, metastatic breast cancer,” said Kevin Tang, Chairman and Chief Executive Officer of Odonate. “With these results, we look forward to further characterizing tesetaxel’s therapeutic profile in CONTESSA, our ongoing Phase 3 study investigating tesetaxel in the treatment of HER2 negative, HR positive, locally advanced or metastatic breast cancer.”

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: significant activity against chemotherapy-resistant tumors; 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; and no history of hypersensitivity (allergic) reactions. More than 500 patients have been treated with tesetaxel in clinical studies. 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 belonging 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 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)
 
June 30, December 31,
2018 2017
(Unaudited)
Assets    
Current assets:
Cash $ 177,427 $ 198,105
Prepaid expenses       3,327   4,841
Total current assets 180,754 202,946
Property and equipment, net 1,504 165
Restricted cash 250 -
Other       498   383
Total assets $     183,006 $ 203,494
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable $ 4,702 $ 4,302
Accrued expenses 5,553 3,210
Deferred rent, current portion       39   -
Total current liabilities 10,294 7,512
Deferred rent, less current portion       390   -
Total liabilities 10,684 7,512
Commitments and contingencies
Stockholders' equity:
Common stock, $0.01 par value—100,000,000 shares authorized; 26,890,708 and 26,890,356 shares issued and outstanding at June 30, 2018 and December 31, 2017, respectively 244 240
Additional paid-in capital 247,641 235,034
Accumulated deficit       (75,563 )   (39,292 )
Total stockholders' equity       172,322   195,982
Total liabilities and stockholders' equity $     183,006 $ 203,494
 
   
ODONATE THERAPEUTICS, INC.
Condensed Statements of Operations
(Unaudited)
(in thousands, except share and per share amounts)
 
Three Months Ended Six Months Ended
June 30, June 30,
2018   2017 2018   2017
Operating expenses:
Research and development $ 17,024 $ 3,282 $ 31,484 $ 5,736
General and administrative   2,755   618   5,176   890
Total operating expenses   19,779   3,900   36,660   6,626
Loss from operations (19,779 ) (3,900 ) (36,660 ) (6,626 )
Interest income   389   -   389   -
Net loss $ (19,390 ) $ (3,900 ) $ (36,271 ) $ (6,626 )
Net loss per share:
Basic and diluted $ (0.79 ) $ (0.31 ) $ (1.49 ) $ (0.57 )
Weighted-average shares outstanding:
Basic and diluted   24,402,466   12,740,822   24,376,885   11,609,062
 
 
ODONATE THERAPEUTICS, INC.
Condensed Statements of Cash Flows
(Unaudited)
(in thousands)
 
Six Months Ended
June 30,
2018   2017
Cash flows from operating activities:
Net loss $ (36,271 ) $ (6,626 )
Adjustments to reconcile net loss to net cash used in operating activities:
Equity-based compensation 2,600 310
Non-cash contributions for expenses 64 1,688
Depreciation and amortization 60 5
Changes in operating assets and liabilities:
Prepaid expenses and other assets 1,399 23
Accounts payable 287 51
Accrued expenses 2,343 437
Deferred rent   433   -
Net cash used in operating activities (29,085 ) (4,112 )
Cash flows from investing activities:
Purchases of property and equipment   (1,289 )   (36 )
Net cash used in investing activities (1,289 ) (36 )
Cash flows from financing activities:
Proceeds from issuance of common stock, net of issuance costs 9,848 9,986
Proceeds from issuance of common stock under ESPP 98 -
Initial public offering costs   -   (3 )
Net cash provided by financing activities   9,946   9,983
Net (decrease) increase in cash and restricted cash (20,428 ) 5,835
Cash and restricted cash, beginning of period   198,105   2,599
Cash and restricted cash, end of period $ 177,677 $ 8,434
Supplemental disclosure of cash flow information:
Issuance costs included in accounts payable and accrued expenses $ - $ 51
Property and equipment purchases included in accounts payable $ 113 $ 33
 

Source: Odonate Therapeutics, Inc.

Odonate Therapeutics, Inc.
John G. Lemkey
Chief Financial Officer
858-731-8180
jlemkey@odonate.com

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