Odonate Therapeutics Announces 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.

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