ODT Odonate Therapeutics Inc

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, 2020.

As of September 30, 2020, Odonate had $188.3 million in cash, compared to $180.5 million as of December 31, 2019. This increase in cash resulted primarily from the receipt of $87.4 million of net proceeds from Odonate’s September 2020 underwritten public offering, less cash used in operating activities for the nine months ended September 30, 2020 of $81.6 million. Odonate’s net loss for the three and nine months ended September 30, 2020 was $30.5 million and $94.1 million, or $0.93 and $3.00 per share, respectively, compared to $26.6 million and $84.0 million, or $0.88 and $3.15 per share, respectively, for the same periods in 2019.

“We are pleased to have recently announced positive top-line results from 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. “These results have been selected for an oral presentation at the 2020 San Antonio Breast Cancer Symposium in December. We continue to plan to submit a New Drug Application for tesetaxel to the FDA in mid-2021.”

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 685 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) as assessed by an Independent Radiologic Review Committee (IRC). The 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. 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.

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 outcome of CONTESSA, our Phase 3 study of tesetaxel in patients with metastatic breast cancer; expectations regarding the enrollment, completion and outcome of our other clinical studies; expectations regarding the timing for our planned New Drug Application submission for tesetaxel; expectations regarding 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,

 

 

 

2020

 

 

2019

 

 

 

(Unaudited)

 

 

 

 

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash

 

$

188,258

 

 

$

180,460

 

Prepaid expenses and other current assets

 

 

2,469

 

 

 

3,468

 

Total current assets

 

 

190,727

 

 

 

183,928

 

Property and equipment, net

 

 

2,397

 

 

 

1,663

 

Right-of-use lease assets

 

 

4,160

 

 

 

1,581

 

Restricted cash

 

 

714

 

 

 

714

 

Other

 

 

994

 

 

 

941

 

Total assets

 

$

198,992

 

 

$

188,827

 

Liabilities and Stockholders' Equity

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

14,024

 

 

$

15,583

 

Accrued expenses

 

 

13,991

 

 

 

8,881

 

Lease liabilities, current portion

 

 

520

 

 

 

315

 

Total current liabilities

 

 

28,535

 

 

 

24,779

 

Lease liabilities, less current portion

 

 

4,856

 

 

 

1,748

 

Total liabilities

 

 

33,391

 

 

 

26,527

 

Stockholders' equity:

 

 

 

 

 

 

 

 

Common stock, $0.01 par value—100,000,000 shares authorized; 38,525,561 and 32,050,906 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively

 

 

366

 

 

 

300

 

Additional paid-in capital

 

 

499,376

 

 

 

402,077

 

Accumulated deficit

 

 

(334,141

)

 

 

(240,077

)

Total stockholders' equity

 

 

165,601

 

 

 

162,300

 

Total liabilities and stockholders' equity

 

$

198,992

 

 

$

188,827

 

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,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

28,242

 

 

$

25,097

 

 

$

86,966

 

 

$

78,181

 

General and administrative

 

 

2,408

 

 

 

2,666

 

 

 

8,033

 

 

 

8,040

 

Total operating expenses

 

 

30,650

 

 

 

27,763

 

 

 

94,999

 

 

 

86,221

 

Loss from operations

 

 

(30,650

)

 

 

(27,763

)

 

 

(94,999

)

 

 

(86,221

)

Other income, net

 

 

173

 

 

 

1,136

 

 

 

935

 

 

 

2,247

 

Net loss

 

$

(30,477

)

 

$

(26,627

)

 

$

(94,064

)

 

$

(83,974

)

Net loss per share:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted

 

$

(0.93

)

 

$

(0.88

)

 

$

(3.00

)

 

$

(3.15

)

Weighted-average shares outstanding:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted

 

 

32,821,835

 

 

30,268,295

 

 

 

31,376,672

 

 

 

26,635,107

 

ODONATE THERAPEUTICS, INC.

Condensed Statements of Cash Flows

(Unaudited)

(in thousands)

 

 

 

Nine Months Ended

 

 

 

September 30,

 

 

 

2020

 

 

2019

 

Cash flows from operating activities:

 

 

 

 

 

 

 

 

Net loss

 

$

(94,064

)

 

$

(83,974

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

 

 

Equity-based compensation expense

 

 

7,522

 

 

 

8,695

 

Depreciation

 

 

318

 

 

 

318

 

Non-cash lease expense

 

 

282

 

 

 

456

 

Loss on disposal of property and equipment

 

 

83

 

 

 

-

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Prepaid expenses and other assets

 

 

904

 

 

 

(3,313

)

Accounts payable

 

 

(1,559

)

 

 

2,186

 

Accrued expenses

 

 

5,110

 

 

 

4,020

 

Lease liabilities

 

 

(225

)

 

 

(505

)

Net cash used in operating activities

 

 

(81,629

)

 

 

(72,117

)

Cash flows from investing activities:

 

 

 

 

 

 

 

 

Purchases of property and equipment

 

 

(416

)

 

 

(164

)

Net cash used in investing activities

 

 

(416

)

 

 

(164

)

Cash flows from financing activities:

 

 

 

 

 

 

 

 

Proceeds from issuance of common stock, net of issuance costs

 

 

87,384

 

 

 

135,095

 

Proceeds from issuance of common stock under employee stock plans

 

 

2,459

 

 

 

2,381

 

Net cash provided by financing activities

 

 

89,843

 

 

 

137,476

 

Net increase in cash and restricted cash

 

 

7,798

 

 

 

65,195

 

Cash and restricted cash, beginning of period

 

 

181,174

 

 

 

139,301

 

Cash and restricted cash, end of period

 

$

188,972

 

 

$

204,496

 

Supplemental disclosure of cash flow information:

 

 

 

 

 

 

 

 

Initial recognition of right-of-use lease assets

 

$

2,861

 

 

$

2,215

 

Tenant improvement allowance

 

$

719

 

 

$

-

 

Property and equipment purchases included in accounts payable and accrued expenses

 

$

-

 

 

$

1

 

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20201028005416/en/

Odonate Therapeutics, Inc. Michael Hearne Chief Financial Officer (858) 281-5366 mhearne@odonate.com