Odonate Therapeutics Announces Financial Results for the Three and Twelve Months Ended December 31, 2017

February 14, 2018

SAN DIEGO--(BUSINESS WIRE)--Feb. 14, 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 twelve months ended December 31, 2017.

As of December 31, 2017, Odonate had $198.1 million in cash, compared to $2.6 million as of December 31, 2016. This increase in cash resulted from net proceeds from common stock offerings of $221.4 million, less net cash used in operating activities of $25.9 million. Odonate’s net loss for the three and twelve months ended December 31, 2017 was $15.7 million and $32.7 million, or $0.81 per share and $2.31 per share, respectively, compared to $1.9 million and $3.1 million, or $0.19 per share and $0.54 per share, respectively, for the same periods in 2016.

“We are excited to have recently initiated CONTESSA, our Phase 3 study investigating tesetaxel in the treatment of locally advanced or metastatic breast cancer,” said Kevin Tang, Chairman and Chief Executive Officer of Odonate. “Despite recent advances in the treatment of advanced breast cancer, there remains a significant need for new therapies that allow patients to maintain a better quality of life. We are hopeful that tesetaxel’s oral bioavailability, low pill burden, lack of history of hypersensitivity reactions and robust activity against chemotherapy-resistant tumors seen in prior studies may translate into significant benefits for patients.”

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 potential therapeutic advantages over currently available taxanes, including: oral administration with a low pill burden and a patient-friendly dosing regimen; no history of hypersensitivity (allergic) reactions; and robust activity against chemotherapy-resistant tumors. More than 500 patients have been treated with tesetaxel across 22 clinical studies. In patients with locally advanced or metastatic breast cancer (MBC), tesetaxel was shown to have robust 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 (MBC). CONTESSA will compare 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 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. 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, disease control rate assessed by IRC and patient-reported outcomes. 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. The Company’s initial focus is on the development of tesetaxel, an investigational, orally administered chemotherapy agent belonging to the taxane class. Odonate recently initiated CONTESSA, a multinational, multicenter, randomized, Phase 3 study of tesetaxel in patients with locally advanced or metastatic breast cancer (MBC). 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 United States 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,
2017     2016
Assets
Current assets:
Cash $ 198,105 $ 2,599
Prepaid expenses   4,841   268
Total current assets 202,946 2,867
Property and equipment, net 165 14
Other   383   -
Total assets $ 203,494 $ 2,881
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable $ 4,302 $ 572
Accrued expenses   3,210   26
Total current liabilities 7,512 598
Commitments and contingencies
Stockholders' equity:
Common stock, $0.01 par value—100,000,000 shares authorized; 26,890,356 and 12,082,514 shares issued and outstanding at December 31, 2017 and 2016, respectively 240 102
Additional paid-in capital 235,034 8,729
Accumulated deficit   (39,292 )   (6,548 )
Total stockholders' equity   195,982   2,283
Total liabilities and stockholders' equity $ 203,494 $ 2,881
 
             

ODONATE THERAPEUTICS, INC.

Statements of Operations

(in thousands, except share and per share amounts)

 
Three Months Ended

December 31,

Year Ended

December 31,

2017     2016 2017     2016
(Unaudited)
Operating expenses:
Research and development $ 13,040 $ 1,766 $ 27,902 $ 2,622
General and administrative   2,706   180   4,842   463
Total operating expenses   15,746   1,946   32,744   3,085
Net loss $ (15,746 ) $ (1,946 ) $ (32,744 ) $ (3,085 )
Net loss per share:
Basic and diluted $ (0.81 ) $ (0.19 ) $ (2.31 ) $ (0.54 )
Weighted average shares outstanding:
Basic and diluted   19,339,389   10,147,798   14,169,464   5,762,419
 
             

ODONATE THERAPEUTICS, INC.

Statements of Cash Flows

(in thousands)

 
Three Months Ended

December, 31

Year Ended

December, 31

2017     2016 2017     2016
(Unaudited)
Cash flows from operating activities:
Net loss $ (15,746 ) $ (1,946 ) $ (32,744 ) $ (3,085 )
Adjustments to reconcile net loss to net cash used in operating activities:
Equity-based compensation 986 27 3,184 51
Non-cash contributions for expenses 82 565 1,812 1,012
Depreciation 10 - 20 -
Changes in operating assets and liabilities:
Prepaid expenses and other assets (4,092 ) (134 ) (4,956 ) (266 )
Accounts payable 3,692 481 3,642 529
Accrued expenses   993   26   3,184   26
Net cash used in operating activities (14,075 ) (981 ) (25,858 ) (1,733 )
Cash flows from investing activities:
Purchases of property and equipment   (15 )   -   (83 )   -
Net cash used in investing activities (15 ) - (83 ) -
Cash flows from financing activities:
Proceeds from issuance of common stock, net of issuance costs 137,691 - 221,447 5,017
Redemption of common stock - - - (32 )
Distributions   -   (791 )   -   (791 )
Net cash provided by financing activities   137,691   (791 )   221,447   4,194
Net increase in cash 123,601 (1,772 ) 195,506 2,461
Cash, beginning of period   74,504   4,371   2,599   138
Cash, end of period $ 198,105 $ 2,599 $ 198,105 $ 2,599
Supplemental disclosure of cash flow information:
Property and equipment purchases included in accounts payable $ 88 $ 14 $ 88 $ 14
 

Source: Odonate Therapeutics, Inc.

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

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