Odonate Therapeutics Announces Financial Results for the Three Months Ended March 31, 2019

Apr 25, 2019 08:15 am
SAN DIEGO -- 

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 months ended March 31, 2019.

As of March 31, 2019, Odonate had $112.1 million in cash, compared to $139.1 million as of December 31, 2018. This decrease in cash resulted primarily from net cash used in operating activities of $27.1 million. Odonate’s net loss for the three months ended March 31, 2019 was $28.6 million, or $1.16 per share, compared to $16.9 million, or $0.69 per share, for the same period in 2018.

“In the first quarter of 2019, we expanded the development of tesetaxel by initiating two new clinical studies, CONTESSA 2 and CONTESSA TRIO, the first study to investigate tesetaxel in combination with PD-(L)1 inhibitors,” said Kevin Tang, Chief Executive Officer of Odonate. “We continue to 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. Tesetaxel currently is the subject of multiple studies in breast cancer, including a multinational, multicenter, randomized, Phase 3 study in patients with locally advanced or 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 locally advanced or metastatic breast cancer (LA/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 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) 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. To learn more, please visit www.contessastudy.com.

About CONTESSA 2

CONTESSA 2 is a multinational, multicenter, Phase 2 study of tesetaxel, an investigational, orally administered taxane, in patients with locally advanced or metastatic breast cancer (LA/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 LA/MBC not previously treated with a taxane. 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 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 locally advanced or metastatic breast cancer (LA/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 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: the expected outcome of CONTESSA, our Phase 3 study of tesetaxel in patients with locally advanced or metastatic breast cancer (LA/MBC); the expected 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)
 
  March 31,   December 31,
  2019     2018  
(Unaudited)
Assets
Current assets:
Cash $ 112,060 $ 139,050
Prepaid expenses and other current assets   3,478     750  
Total current assets 115,538 139,800
Property and equipment, net 1,883 1,899
Right-of-use lease assets 2,066 -
Restricted cash 251 251
Other   737     723  
Total assets $ 120,475   $ 142,673  
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable $ 7,797 $ 10,777
Accrued expenses 11,657 7,365
Lease liabilities, current portion 603 -
Deferred rent, current portion   -     66  
Total current liabilities 20,057 18,208
Lease liabilities, less current portion 1,975 -
Deferred rent, less current portion   -     461  
Total liabilities 22,032 18,669
Commitments and contingencies
Stockholders' equity:
Common stock, $0.01 par value 244 244
Additional paid-in capital 255,096 252,012
Accumulated deficit   (156,897 )   (128,252 )
Total stockholders' equity   98,443     124,004  
Total liabilities and stockholders' equity $ 120,475   $ 142,673  
 
ODONATE THERAPEUTICS, INC.
Condensed Statements of Operations
(Unaudited)
(in thousands, except share and per share amounts)
 
  Three Months Ended
March 31,
  2019       2018  
Operating expenses:
Research and development $ 26,631 $ 14,460
General and administrative   2,591     2,421  
Total operating expenses   29,222     16,881  
Loss from operations (29,222 ) (16,881 )
Interest income   577     -  
Net loss $ (28,645 ) $ (16,881 )
Net loss per share:
Basic and diluted $ (1.16 ) $ (0.69 )
Weighted-average shares outstanding:
Basic and diluted   24,682,410     24,351,019  
 
ODONATE THERAPEUTICS, INC.
Condensed Statements of Cash Flows
(Unaudited)
(in thousands)
 
  Three Months Ended
March 31,
  2019       2018  
Cash flows from operating activities:
Net loss $ (28,645 ) $ (16,881 )
Adjustments to reconcile net loss to net cash used in operating activities:
Equity-based compensation expense 2,925 1,011
Depreciation and amortization 90 16
Non-cash contributions for expenses - 64
Changes in operating assets and liabilities:
Prepaid expenses and other assets (2,744 ) 1,199
Accounts payable (3,023 ) 815
Accrued expenses   4,289     1,323  
Net cash used in operating activities (27,108 ) (12,453 )
Cash flows from investing activities:
Purchases of property and equipment   (41 )   (4 )
Net cash used in investing activities (41 ) (4 )
Cash flows from financing activities:
Proceeds from issuance of common stock, net of issuance costs - 9,848
Proceeds from issuance of common stock under employee stock plans   159     -  
Net cash provided by financing activities   159     9,848  
Net decrease in cash and restricted cash (26,990 ) (2,609 )
Cash and restricted cash, beginning of period   139,301     198,105  
Cash and restricted cash, end of period $ 112,311   $ 195,496  
Supplemental disclosure of non-cash investing activities:
Property and equipment purchases included in accounts payable and accrued expenses $ 47 $ 49
Initial recognition of right-of-use lease assets $ 2,215 $ -

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