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 twelve months ended December 31, 2020.

As of December 31, 2020, Odonate had $157.3 million in cash, compared to $180.5 million as of December 31, 2019. This decrease in cash resulted primarily from cash used in operating activities for the twelve months ended December 31, 2020 of $113.1 million, partially offset by the receipt of $87.4 million of net proceeds from Odonate’s September 2020 underwritten public offering. Odonate’s net loss for the three and twelve months ended December 31, 2020 was $32.3 million and $126.4 million, or $0.87 and $3.84 per share, respectively, compared to $27.9 million and $111.8 million, or $0.91 and $4.05 per share, respectively, for the same periods in 2019.

“Positive results of CONTESSA, Odonate’s Phase 3 study investigating tesetaxel as a potential treatment for patients with metastatic breast cancer, were recently presented at the 2020 San Antonio Breast Cancer Symposium,” said Kevin Tang, Chief Executive Officer of Odonate. “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 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 (MBC), 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 MBC, including a multinational, multicenter, randomized, Phase 3 study in patients with MBC, known as CONTESSA. Positive results of CONTESSA were presented at the 2020 San Antonio Breast Cancer Symposium in December.

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 Day 1 of a 21-day cycle plus a reduced dose of capecitabine (1,650 mg/m2/day dosed orally for 14 days of a 21-day cycle) to the approved dose of capecitabine alone (2,500 mg/m2/day dosed orally for 14 days of a 21-day cycle) in 685 patients randomized 1:1 with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)‑negative 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 been treated with 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 endpoints are overall survival (OS), objective response rate (ORR) as assessed by the IRC and disease control rate (DCR) as assessed by the IRC.

Positive results of CONTESSA were presented at the 2020 San Antonio Breast Cancer Symposium in December. The primary endpoint was met: median PFS was 9.8 months for tesetaxel plus a reduced dose of capecitabine versus 6.9 months for the approved dose of capecitabine alone, an improvement of 2.9 months. The risk of disease progression or death was reduced by 28.4% (hazard ratio=0.716 [95% confidence interval [CI]: 0.573‑0.895; p=0.003]). Neutropenia was the most common Grade ≥3 treatment‑emergent adverse event.

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 the timing of a regulatory decision on tesetaxel and 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.

Balance Sheets

(in thousands, except par value and share amounts)

 

 

 

December 31,

 

 

December 31,

 

 

 

2020

 

 

2019

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash

 

$

157,265

 

 

$

180,460

 

Prepaid expenses and other current assets

 

 

2,607

 

 

 

3,468

 

Total current assets

 

 

159,872

 

 

 

183,928

 

Property and equipment, net

 

 

2,286

 

 

 

1,663

 

Right-of-use lease assets

 

 

4,017

 

 

 

1,581

 

Restricted cash

 

 

714

 

 

 

714

 

Other

 

 

997

 

 

 

941

 

Total assets

 

$

167,886

 

 

$

188,827

 

Liabilities and Stockholders' Equity

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

14,168

 

 

$

15,583

 

Accrued expenses

 

 

12,247

 

 

 

8,881

 

Lease liabilities, current portion

 

 

658

 

 

 

315

 

Total current liabilities

 

 

27,073

 

 

 

24,779

 

Lease liabilities, less current portion

 

 

4,668

 

 

 

1,748

 

Total liabilities

 

 

31,741

 

 

 

26,527

 

Stockholders' equity:

 

 

 

 

 

 

 

 

Common stock, $0.01 par value—100,000,000 shares authorized; 38,562,281 and 32,050,906 shares issued and outstanding at December 31, 2020 and December 31, 2019, respectively

 

 

367

 

 

 

300

 

Additional paid-in capital

 

 

502,205

 

 

 

402,077

 

Accumulated deficit

 

 

(366,427

)

 

 

(240,077

)

Total stockholders' equity

 

 

136,145

 

 

 

162,300

 

Total liabilities and stockholders' equity

 

$

167,886

 

 

$

188,827

 

 

ODONATE THERAPEUTICS, INC.

Statements of Operations

(in thousands, except share and per share amounts)

 

 

 

Three Months Ended

 

 

Twelve Months Ended

 

 

 

December 31,

 

 

December 31,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

30,075

 

 

$

25,853

 

 

$

117,041

 

 

$

104,034

 

General and administrative

 

 

2,359

 

 

 

2,856

 

 

 

10,392

 

 

 

10,896

 

Total operating expenses

 

 

32,434

 

 

 

28,709

 

 

 

127,433

 

 

 

114,930

 

Loss from operations

 

 

(32,434

)

 

 

(28,709

)

 

 

(127,433

)

 

 

(114,930

)

Other income, net

 

 

148

 

 

 

858

 

 

 

1,083

 

 

 

3,105

 

Net loss

 

$

(32,286

)

 

$

(27,851

)

 

$

(126,350

)

 

$

(111,825

)

Net loss per share:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted

 

$

(0.87

)

 

$

(0.91

)

 

$

(3.84

)

 

$

(4.05

)

Weighted-average shares outstanding:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted

 

 

37,287,893

 

 

 

30,564,258

 

 

 

32,862,552

 

 

 

27,625,468

 

 

ODONATE THERAPEUTICS, INC.

Statements of Cash Flows

(in thousands)

 

 

 

Year Ended

 

 

 

December 31,

 

 

 

2020

 

 

2019

 

Cash flows from operating activities:

 

 

 

 

 

 

 

 

Net loss

 

$

(126,350

)

 

$

(111,825

)

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

 

 

 

 

 

 

 

 

Equity-based compensation expense

 

 

9,828

 

 

 

11,444

 

Depreciation and amortization

 

 

445

 

 

 

426

 

Non-cash lease expense

 

 

425

 

 

 

634

 

Loss on disposal of property and equipment

 

 

83

 

 

 

-

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Prepaid expenses and other assets

 

 

763

 

 

 

(2,936

)

Accounts payable

 

 

(1,415

)

 

 

4,782

 

Accrued expenses

 

 

3,366

 

 

 

1,516

 

Lease liabilities

 

 

(275

)

 

 

(679

)

Net cash used in operating activities

 

 

(113,130

)

 

 

(96,638

)

Cash flows from investing activities:

 

 

 

 

 

 

 

 

Purchases of property and equipment

 

 

(432

)

 

 

(166

)

Net cash used in investing activities

 

 

(432

)

 

 

(166

)

Cash flows from financing activities:

 

 

 

 

 

 

 

 

Proceeds from issuance of common stock, net of issuance costs

 

 

87,383

 

 

 

135,096

 

Proceeds from issuance of common stock under employee stock plans

 

 

2,984

 

 

 

3,581

 

Net cash provided by financing activities

 

 

90,367

 

 

 

138,677

 

Net (decrease) increase in cash and restricted cash

 

 

(23,195

)

 

 

41,873

 

Cash and restricted cash, beginning of period

 

 

181,174

 

 

 

139,301

 

Cash and restricted cash, end of period

 

$

157,979

 

 

$

181,174

 

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

 

$

1

 

 

$

24

 

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20210223005353/en/

Odonate Therapeutics, Inc. Michael Hearne Chief Financial Officer (332) 208-7611 mhearne@odonate.com