Odonate Therapeutics Announces Presentations at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting

Odonate Therapeutics, Inc. 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 that there will be two poster presentations on tesetaxel at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting to be held June 1 – 5, 2018 in Chicago, Illinois. Abstracts for these presentations were made publicly available today and can be found on the ASCO website at http://abstracts.asco.org and by clicking the titles below.

Presentation Details:

Abstract 1042 (Poster Board #123): Activity of Tesetaxel, an Oral Taxane, Given as a Single-agent in Patients (Pts) with HER2-, Hormone Receptor + (HR+) Locally Advanced or Metastatic Breast Cancer (MBC) in a Phase 2 Study
Presenter: Andrew Seidman, M.D.
Poster Session: Breast Cancer – Metastatic
Date/Time: Saturday, June 2, 2018 / 8:00AM – 11:30AM (CT)
Location: Hall A

Abstract TPS1106 (Poster Board #184a): CONTESSA: A Multinational, Multicenter, Randomized, Phase 3 Registration Study of Tesetaxel in Patients (Pts) with HER2-, Hormone Receptor + (HR+) Locally Advanced or Metastatic Breast Cancer (MBC)
Presenter: Joyce O'Shaughnessy, M.D.
Poster Session: Breast Cancer – Metastatic
Date/Time: Saturday, June 2, 2018 / 8:00AM – 11:30AM (CT)
Location: Hall A

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. Odonate's initial focus is on the development of tesetaxel, an investigational, orally administered chemotherapy agent belonging to a class of drugs known as taxanes, which are widely used in the treatment of cancer. 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.

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