ODT Odonate Therapeutics Inc.

3.85
+0.33  (+9%)
Previous Close 3.52
Open 3.46
52 Week Low 3.02
52 Week High 46.4999
Market Cap $148,623,814
Shares 38,603,588
Float 16,309,987
Enterprise Value $-16,054,371
Volume 12,225,109
Av. Daily Volume 4,994,613
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Drug Pipeline

Drug Stage Notes
Tesetaxel - CONTESSA
Metastatic breast cancer (MBC)
Phase 3
Phase 3
Phase 3 trial met primary endpoint - August 24, 2020. Median PFS was 9.8 months for tesetaxel plus capecitabine vs 6.9 months capecitabine alone. Announced March 22, 2021 that development will be discontinued.

Latest News

  1. Following feedback from the U.S. Food and Drug Administration (FDA) in a pre-New Drug Application meeting, Odonate Therapeutics, Inc. (NASDAQ:ODT) has concluded that the clinical data package for tesetaxel is unlikely to support FDA approval. Therefore, Odonate is discontinuing the development of tesetaxel and will wind down the operations of the Company. The Company will work with clinical sites to transition patients in ongoing tesetaxel clinical studies to appropriate alternative therapies.

    "We thank the investigators, study team personnel, and especially the patients and their caregivers for their endeavors to improve treatments for patients with breast cancer," said Kevin Tang, Chief Executive Officer of Odonate.

    Following feedback from the U.S. Food and Drug Administration (FDA) in a pre-New Drug Application meeting, Odonate Therapeutics, Inc. (NASDAQ:ODT) has concluded that the clinical data package for tesetaxel is unlikely to support FDA approval. Therefore, Odonate is discontinuing the development of tesetaxel and will wind down the operations of the Company. The Company will work with clinical sites to transition patients in ongoing tesetaxel clinical studies to appropriate alternative therapies.

    "We thank the investigators, study team personnel, and especially the patients and their caregivers for their endeavors to improve treatments for patients with breast cancer," said Kevin Tang, Chief Executive Officer of Odonate.

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  2. 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…

    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

     

     

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  3. NEW YORK, Dec. 17, 2020 (GLOBE NEWSWIRE) -- BeyondSpring (the "Company" or "BeyondSpring") (NASDAQ:BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, today announced the appointment of Dr. Jeffrey Vacirca to its Board of Directors to help guide the company as it seeks commercial approval following announcement of positive Phase 3 data from the PROTECTIVE-2 study of plinabulin in combination with pegfilgrastim for protection against chemotherapy-induced neutropenia.

    "We are delighted to welcome Dr. Vacirca as a member of our Board of Directors, especially given his impressive leadership within the oncology community," said Dr. Lan Huang, Founder and Chief Executive Officer of BeyondSpring…

    NEW YORK, Dec. 17, 2020 (GLOBE NEWSWIRE) -- BeyondSpring (the "Company" or "BeyondSpring") (NASDAQ:BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, today announced the appointment of Dr. Jeffrey Vacirca to its Board of Directors to help guide the company as it seeks commercial approval following announcement of positive Phase 3 data from the PROTECTIVE-2 study of plinabulin in combination with pegfilgrastim for protection against chemotherapy-induced neutropenia.

    "We are delighted to welcome Dr. Vacirca as a member of our Board of Directors, especially given his impressive leadership within the oncology community," said Dr. Lan Huang, Founder and Chief Executive Officer of BeyondSpring. "In addition to his many years as an accomplished oncology clinician, Dr. Vacirca also has extensive experience as a key business leader in the oncology market, including as CEO of a large community oncology practice, New York Cancer & Blood Specialists. His demonstrated success in being able to collaborate with different groups of stakeholders in the oncology market is unique and very notable. Dr. Vacirca's deep engagement within the oncology community will be of much benefit to BeyondSpring."

    Jeffrey Vacirca, MD, FACP is a board-certified hematologist and oncologist and serves as CEO and Chairman of the Board of New York Cancer & Blood Specialists. Dr. Vacirca is the immediate past president of the Community Oncology Alliance (COA) and is Medical Director for International Oncology Network (ION) at AmerisourceBergen and for Oncology Network Development at Mt. Sinai Health Network. Dr. Vacirca serves on the board of directors of OneOncology, the American Red Cross of Greater New York, New York Cancer Foundation, and is chairman of the board of directors of New York Cancer Foundation. He is also co-founder & former Vice Chairman of Odonate Therapeutics (NASDAQ:ODT), and Director & Chair of the Compensation Committee of Spectrum Pharmaceuticals (NASDAQ:SPPI).

    Dr. Vacirca added, "Joining the BeyondSpring Board will provide me the opportunity to participate in improving the standard of care for cancer patients by making plinabulin, in combination with pegfilgrastim, available to prevent chemotherapy-induced neutropenia and help ensure that patients are more likely to complete their planned chemotherapy regimen to achieve the optimal clinical outcome. I am also excited about the ongoing Phase 3 trial with plinabulin in NSCLC that will potentially demonstrate the anti-tumor effects of the product and could open up treatment options for other solid tumors."

    About BeyondSpring 

    BeyondSpring is a global, clinical-stage biopharmaceutical company focused on the development of innovative cancer therapies. BeyondSpring's lead asset, plinabulin, a first-in-class agent as an immune and stem cell modulator, is in a Phase 3 global clinical trial as a direct anticancer agent in the treatment of non-small cell lung cancer (NSCLC) and Phase 3 clinical programs in the prevention of CIN. The U.S. FDA granted Breakthrough Therapy designation to plinabulin for concurrent administration with myelosuppressive chemotherapeutic regimens in patients with non-myeloid malignancies for the prevention of chemotherapy-induced neutropenia (CIN). BeyondSpring has strong R&D capabilities with a robust pipeline in addition to plinabulin, including three immuno-oncology assets and a drug discovery platform utilizing the protein degradation pathway, which is being developed in a subsidiary company, Seed Therapeutics, Inc. The Company has a seasoned management team with many years of experience bringing drugs to the global market. BeyondSpring is headquartered in New York City.

    Cautionary Note Regarding Forward-Looking Statements

    This press release includes forward-looking statements that are not historical facts. Words such as "will," "expect," "anticipate," "plan," "believe," "design," "may," "future," "estimate," "predict," "objective," "goal," or variations thereof and variations of such words and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are based on BeyondSpring's current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, difficulties raising the anticipated amount needed to finance the Company's future operations on terms acceptable to the Company, if at all, unexpected results of clinical trials, delays or denial in regulatory approval process, results that do not meet our expectations regarding the potential safety, the ultimate efficacy or clinical utility of our product candidates, increased competition in the market, and other risks described in BeyondSpring's most recent Form 20-F on file with the U.S. Securities and Exchange Commission. All forward-looking statements made herein speak only as of the date of this release and BeyondSpring undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.

    Media Contacts

    Investor Contact:

    Ashley R. Robinson

    LifeSci Advisors, LLC

    +1 617-430-7577

    Media Contact:

    Darren Opland, Ph.D.

    LifeSci Communications

    +1 646-627-8387



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  4. CONTESSA Achieved Primary Endpoint – Tesetaxel Plus a Reduced Dose of Capecitabine Significantly Improved Progression-free Survival (PFS) Versus the Approved Dose of Capecitabine Alone (Hazard Ratio=0.716; p=0.003)

    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

    Company to Host Virtual Investor and Analyst Event Today at 1:00 p.m. CT / 2:00 p.m. ET

    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 that positive results from CONTESSA, a Phase 3 study of tesetaxel in patients…

    CONTESSA Achieved Primary Endpoint – Tesetaxel Plus a Reduced Dose of Capecitabine Significantly Improved Progression-free Survival (PFS) Versus the Approved Dose of Capecitabine Alone (Hazard Ratio=0.716; p=0.003)

    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

    Company to Host Virtual Investor and Analyst Event Today at 1:00 p.m. CT / 2:00 p.m. ET

    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 that positive results from CONTESSA, a Phase 3 study of tesetaxel in patients with metastatic breast cancer (MBC), were presented in an oral presentation at the 2020 San Antonio Breast Cancer Symposium (SABCS). The results were presented by Joyce O'Shaughnessy, M.D., Celebrating Women Chair in Breast Cancer Research, Baylor University Medical Center, Texas Oncology and Chair, Breast Cancer Research, US Oncology, and Co‑Principal Investigator of CONTESSA (please click here for slides).

    CONTESSA is a multinational, multicenter, randomized, Phase 3 study of tesetaxel, an investigational, orally administered taxane, in patients with 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 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 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 the 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. CONTESSA is being conducted at 180 investigational sites in 18 countries in North America, Europe and Asia.

    CONTESSA met the primary endpoint of improved PFS as assessed by the IRC. 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: 0.573-0.895); p=0.003] for tesetaxel plus a reduced dose of capecitabine versus the approved dose of capecitabine alone.

    The ORR as assessed by the IRC was 57% for tesetaxel plus a reduced dose of capecitabine versus 41% for the approved dose of capecitabine alone (p=0.0002). The DCR as assessed by the IRC was 67% for tesetaxel plus a reduced dose of capecitabine versus 50% for the approved dose of capecitabine alone (p<0.0001). While OS data are immature, a recent interim analysis indicated the absence of an adverse effect on OS with tesetaxel plus a reduced dose of capecitabine. A protocol‑specified final analysis of OS is expected to occur in 2022.

    Tesetaxel plus capecitabine was associated with a manageable side effect profile consistent with findings from previous clinical studies. Grade ≥3 treatment-emergent adverse events (TEAEs) that occurred in ≥5% of patients were: neutropenia (70.9% for tesetaxel plus capecitabine vs. 8.3% for capecitabine alone); diarrhea (13.1% for tesetaxel plus capecitabine vs. 8.9% for capecitabine alone); hand‑foot syndrome (6.8% for tesetaxel plus capecitabine vs. 12.2% for capecitabine alone); febrile neutropenia (13.1% for tesetaxel plus capecitabine vs. 1.2% for capecitabine alone); fatigue (8.6% for tesetaxel plus capecitabine vs. 4.5% for capecitabine alone); hypokalemia (8.6% for tesetaxel plus capecitabine vs. 2.7% for capecitabine alone); leukopenia (9.8% for tesetaxel plus capecitabine vs. 0.9% for capecitabine alone); and anemia (8.0% for tesetaxel plus capecitabine vs. 2.4% for capecitabine alone).

    Adverse events resulting in treatment discontinuation in ≥1% of patients were: neutropenia or febrile neutropenia (4.2% for tesetaxel plus capecitabine vs. 1.5% for capecitabine alone); neuropathy (3.6% for tesetaxel plus capecitabine vs. 0.3% for capecitabine alone); sepsis or septic shock (1.8% for tesetaxel plus capecitabine vs. 0.6% for capecitabine alone); diarrhea (0.9% for tesetaxel plus capecitabine vs. 1.5% for capecitabine alone); and hand-foot syndrome (0.6% for tesetaxel plus capecitabine vs. 2.1% for capecitabine alone). Treatment discontinuation due to any adverse event occurred in 23.1% of patients treated with tesetaxel plus capecitabine versus 11.9% of patients treated with capecitabine alone.

    Tesetaxel dose reductions occurred in 76% of patients treated with tesetaxel plus capecitabine, primarily due to neutropenia. Dose reductions occurred in 61% of patients treated with capecitabine alone, primarily due to hand-foot syndrome. The relative delivered dose intensity, which accounts for not only the frequency, but also the magnitude of reductions and treatment adherence, was higher in patients treated with tesetaxel plus capecitabine. Specifically, 81% of the intended dose of tesetaxel through cycle 12 was delivered in patients treated with tesetaxel plus capecitabine versus 76% of the intended dose of capecitabine through cycle 12 in patients treated with capecitabine alone.

    Grade 2 alopecia (hair loss) occurred in 8.0% of patients treated with tesetaxel plus capecitabine versus 0.3% of patients treated with capecitabine alone. Grade ≥3 neuropathy occurred in 5.9% of patients treated with tesetaxel plus capecitabine versus 0.9% of patients treated with capecitabine alone. There were no treatment-related hypersensitivity reactions.

    "Tesetaxel represents a potential important clinical advance for patients with metastatic breast cancer," said Joyce O'Shaughnessy, M.D. "There remains a significant unmet medical need for novel therapies that offer quality‑of‑life advantages for patients with metastatic breast cancer."

    "The PFS improvement observed in CONTESSA, along with once‑every‑three‑weeks oral dosing and low rates of clinically significant hair loss and neuropathy, could make tesetaxel an important new treatment option for patients with metastatic breast cancer," said Andrew Seidman, M.D., Medical Director, Bobst International Center, Memorial Sloan Kettering Cancer Center and Professor of Medicine, Weill Cornell Medical College, and Co‑Principal Investigator of CONTESSA.

    "We would like to thank all of the investigators, study team personnel, and especially the patients and their caregivers who made CONTESSA possible," said Kevin Tang, Chief Executive Officer of Odonate. "We look forward to working closely with global regulatory authorities to make tesetaxel available to patients with metastatic breast cancer. We plan to submit a New Drug Application for tesetaxel to the FDA in mid‑2021."

    The Company will host a Virtual Investor and Analyst Event today at 1:00 p.m. CT / 2:00 p.m. ET.

    Virtual Investor and Analyst Event Information

    Date: December 11, 2020

    Time: 1:00 p.m. CT / 2:00 p.m. ET

    Webcast Link: Please click here

    Dial-in (domestic): (866) 300-4090

    Dial-in (international): (636) 812‑6660

    Conference ID: 8698553

    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. Positive results of CONTESSA were recently presented at the 2020 San Antonio Breast Cancer Symposium.

    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 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 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 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.

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  5. 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 the initiation of Cohort 3 of CONTESSA TRIO, which will evaluate tesetaxel monotherapy in approximately 60 non-elderly patients with human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (MBC). Cohort 3 of CONTESSA TRIO will complement Cohort 2 of CONTESSA TRIO, which is evaluating tesetaxel monotherapy in approximately 60 elderly patients with HER2-negative MBC.

    Cohorts 2 and 3 of CONTESSA TRIO will expand on results from TOB203, a Phase 2 study that evaluated tesetaxel monotherapy in 38 patients with hormone receptor-positive…

    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 the initiation of Cohort 3 of CONTESSA TRIO, which will evaluate tesetaxel monotherapy in approximately 60 non-elderly patients with human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (MBC). Cohort 3 of CONTESSA TRIO will complement Cohort 2 of CONTESSA TRIO, which is evaluating tesetaxel monotherapy in approximately 60 elderly patients with HER2-negative MBC.

    Cohorts 2 and 3 of CONTESSA TRIO will expand on results from TOB203, a Phase 2 study that evaluated tesetaxel monotherapy in 38 patients with hormone receptor-positive, HER2-negative MBC. In this study, the confirmed response rate was 45%. Neutropenia was the most common Grade ≥3 adverse event and occurred in 32% of patients, and febrile neutropenia occurred in 5% of patients. The results of TOB203 were presented at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting.

    "Taken together, TOB203 and CONTESSA TRIO will evaluate tesetaxel monotherapy in more than 150 patients with metastatic breast cancer," said Lee Schwartzberg, M.D., FACP, Chief Medical Director, West Cancer Center & Research Institute. "The promising clinical results to date, combined with tesetaxel's unique, once-every-three-weeks oral dosing regimen, make this investigational agent an exciting potential new treatment option for patients."

    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. Odonate recently announced positive top-line results from CONTESSA, and full results are scheduled to be presented at the San Antonio Breast Cancer Symposium in December 2020.

    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 200 patients with triple-negative MBC 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 (IV) infusion on the first day of each 21-day cycle; (2) pembrolizumab at 200 mg by IV infusion on the first day of each 21-day cycle; or (3) atezolizumab at 1,200 mg by IV infusion on the first day of each 21-day cycle. Nivolumab and pembrolizumab (programmed cell death protein 1 [PD-1] inhibitors) and atezolizumab (a programmed death-ligand 1 [PD-L1] inhibitor) are immuno-oncology (IO) agents approved for the treatment of multiple types of cancer. Two of these agents, atezolizumab and pembrolizumab, have been approved by the U.S. Food and Drug Administration (FDA) as a first-line treatment for patients with triple-negative MBC. The primary endpoints for Cohort 1 are objective response rate (ORR) and progression-free survival (PFS) in patients with PD-L1 positive status. The secondary endpoints are ORR and PFS in all patients, 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 60 elderly patients with human epidermal growth factor receptor 2 (HER2)‑negative MBC who have not received prior chemotherapy for advanced disease will receive tesetaxel monotherapy dosed orally at 27 mg/m2 on the first day of each 21-day cycle. The primary endpoints for Cohort 2 are ORR and PFS in patients with hormone receptor‑positive, HER2‑negative disease. The secondary endpoints are ORR and PFS in patients with triple‑negative disease, DoR and OS.
    • In Cohort 3, approximately 60 non-elderly adult patients with HER2-negative MBC who have not received prior chemotherapy for advanced disease will receive tesetaxel monotherapy dosed orally at 27 mg/m2 on the first day of each 21-day cycle. The primary endpoints for Cohort 3 are ORR and PFS in patients with hormone receptor-positive, HER2-negative disease. The secondary endpoints are ORR and PFS in patients with triple-negative disease, 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.

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