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Odonate Therapeutics, Inc. (NASDAQ: ODT) received notice from Nasdaq on January 6, 2022, stating that Odonate is considered a 'public shell' under Listing Rule 5101. As a result, Nasdaq will suspend trading of Odonate's common stock at the opening of business on January 18, 2022. Odonate has decided not to appeal this decision and will file a Form 25-NSE with the SEC to remove its securities from Nasdaq listing and registration. Additionally, Odonate plans to submit a Form 15 to suspend its reporting obligations.
Odonate Therapeutics, Inc. (NASDAQ: ODT) announced a share repurchase plan to buy back up to 20 million shares as part of its strategy to return capital to stockholders. This decision follows the company's choice to discontinue the development of tesetaxel. The repurchases will occur at the company’s discretion, without a set time limit, and can be halted at any moment. The latest financial report indicates total stockholders’ equity of $71.4 million, equating to $1.85 per share based on 38.5 million shares outstanding.
Odonate Therapeutics reported financial results for the three and nine months ending September 30, 2021. The company holds $95.0 million in cash, down from $157.3 million at year-end 2020. Operating cash usage was $15.1 million for Q3 2021 and $63.0 million for the first nine months. The net loss narrowed to $14.0 million ($0.37 per share) for Q3 2021, compared to a loss of $30.5 million ($0.93 per share) in Q3 2020. For the nine months, the net loss was $69.8 million ($1.85 per share), down from $94.1 million ($3.00 per share) in the previous year.
Odonate Therapeutics, Inc. (NASDAQ: ODT) reported financial results for the six months ending June 30, 2021. The company announced the discontinuation of tesetaxel development and has transitioned patients to alternative therapies. As of June 30, 2021, Odonate held $110.1 million in cash, down from $157.3 million at the end of 2020, primarily due to $47.9 million in operating cash expenditures. The net loss for Q2 2021 was $22.0 million ($0.58 per share), and for the first half, it was $55.8 million ($1.48 per share), a decrease in losses from $33.4 million and $63.6 million in 2020.
Odonate Therapeutics, Inc. (NASDAQ: ODT) reported financial results for Q1 2021, announcing a net loss of $33.8 million, compared to $30.2 million in Q1 2020. The company has discontinued the development of tesetaxel and is winding down related operations while facilitating patient transitions to alternative therapies. Cash reserves decreased to $133.2 million from $157.3 million as of December 31, 2020, attributed to $24.9 million used in operating activities.
Odonate Therapeutics, Inc. (NASDAQ: ODT) has announced the discontinuation of its tesetaxel development following FDA feedback, indicating that the current clinical data will not support approval. The company will wind down operations and assist in transitioning patients in ongoing tesetaxel studies to alternative therapies. CEO Kevin Tang expressed gratitude to all involved in the research efforts for breast cancer treatments.
Odonate Therapeutics (NASDAQ: ODT) reported its 2020 financial results, revealing a cash balance of $157.3 million, down from $180.5 million in 2019. The net loss for 2020 was $126.4 million, with an EPS of $3.84, compared to $111.8 million and $4.05 per share in 2019. The company announced positive results from its CONTESSA Phase 3 study of tesetaxel for metastatic breast cancer, which showed a median progression-free survival of 9.8 months versus 6.9 months for standard treatment, with the risk of progression reduced by 28.4%. A New Drug Application is planned for mid-2021.
Odonate Therapeutics (NASDAQ: ODT) announced positive results from the CONTESSA Phase 3 study of tesetaxel in patients with metastatic breast cancer (MBC). The study demonstrated a median progression-free survival (PFS) of 9.8 months for tesetaxel plus a reduced dose of capecitabine, compared to 6.9 months for capecitabine alone, marking a 2.9-month improvement. The objective response rate (ORR) was 57% for the combination versus 41% for capecitabine alone. A New Drug Application (NDA) for tesetaxel is anticipated in mid-2021, with a focus on providing alternative treatment options for MBC patients.
Odonate Therapeutics (NASDAQ: ODT) has initiated Cohort 3 of CONTESSA TRIO, aiming to evaluate tesetaxel monotherapy in approximately 60 non-elderly patients with HER2-negative metastatic breast cancer (MBC). This follows the evaluation in Cohort 2, focusing on elderly patients. Tesetaxel, an oral chemotherapy agent, demonstrated a 45% response rate in a prior study. The CONTESSA TRIO study, which includes over 150 patients, positions tesetaxel as a promising treatment option with unique oral dosing advantages.
Odonate Therapeutics will host a virtual Investor and Analyst Event on December 11, 2020, at 1:00 p.m. CT, following the results presentation of the Phase 3 CONTESSA study on tesetaxel in metastatic breast cancer. Featured speakers include Lee Schwartzberg and Andrew Seidman. Tesetaxel is an investigational oral chemotherapy showing promise in combating metastatic breast cancer, with positive results from prior studies. The ongoing CONTESSA study is pivotal in comparing tesetaxel with capecitabine in patients previously treated with taxanes.
