ODT Odonate Therapeutics Inc.

36.13
-0.68  -2%
Previous Close 36.81
Open 36.61
52 Week Low 18.07
52 Week High 46.4999
Market Cap $1,160,749,233
Shares 32,127,020
Float 13,383,260
Enterprise Value $1,059,086,606
Volume 75,269
Av. Daily Volume 99,422
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Upcoming Catalysts

Drug Stage Catalyst Date
Tesetaxel - CONTESSA
Metastatic breast cancer (MBC)
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
Tesetaxel - Contessa 2
Metastatic breast cancer (MBC)
Phase 2
Phase 2
Phase 2 trial initiation announced March 4, 2019.

Latest News

  1.  

    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 six months ended June 30, 2020.

    As of June 30, 2020, Odonate had $125.4 million in cash, compared to $180.5 million as of December 31, 2019. Net cash used in operating activities for the six months ended June 30, 2020 was $56.5 million, compared to $50.3 million for the same period in 2019. Odonate's net loss for the three and six months ended June 30, 2020 was $33.4 million and $63.6 million, or $1.09 and $2.07 per share, respectively, compared to $28.7 million and $57.3 million, or $1.15 and $2.31 per…

     

    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 six months ended June 30, 2020.

    As of June 30, 2020, Odonate had $125.4 million in cash, compared to $180.5 million as of December 31, 2019. Net cash used in operating activities for the six months ended June 30, 2020 was $56.5 million, compared to $50.3 million for the same period in 2019. Odonate's net loss for the three and six months ended June 30, 2020 was $33.4 million and $63.6 million, or $1.09 and $2.07 per share, respectively, compared to $28.7 million and $57.3 million, or $1.15 and $2.31 per share, respectively, for the same periods in 2019.

    "We continue to expect to report top-line results from CONTESSA, Odonate's Phase 3 study investigating tesetaxel as a potential treatment for patients with metastatic breast cancer, in the third quarter of 2020," said Kevin Tang, Chief Executive Officer of Odonate.

    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.

    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 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. Patients with central nervous system (CNS) metastases are eligible. 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 CONTESSA 2

    CONTESSA 2 is a multinational, multicenter, Phase 2 study of tesetaxel, an investigational, orally administered taxane, in patients with metastatic breast cancer (MBC). CONTESSA 2 is investigating 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) in approximately 125 patients with human epidermal growth factor receptor 2 (HER2) negative, hormone receptor (HR) positive MBC not previously treated with a taxane. 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. Patients with central nervous system (CNS) metastases are eligible. The primary endpoint is objective response rate (ORR) as assessed by an Independent Radiologic Review Committee (IRC). The secondary efficacy endpoints are duration of response (DoR) as assessed by the IRC, progression-free survival (PFS) as assessed by the IRC, disease control rate (DCR) as assessed by the IRC and overall survival (OS).

    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 90 patients (with potential expansion to up to 150 patients) with locally advanced or metastatic triple-negative breast cancer (TNBC) 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 infusion on the first day of each 21-day cycle; (2) pembrolizumab at 200 mg by intravenous infusion on the first day of each 21-day cycle; or (3) atezolizumab at 1,200 mg by intravenous infusion on the first day of each 21-day cycle. Nivolumab and pembrolizumab (PD-1 inhibitors) and atezolizumab (a PD-L1 inhibitor) are immuno-oncology (IO) agents approved for the treatment of multiple types of cancer. One of these agents, atezolizumab, in combination with the intravenously delivered taxane, nab-paclitaxel, was recently approved by the U.S. Food and Drug Administration (FDA) as a first-line treatment for patients with metastatic TNBC. The dual primary endpoints for Cohort 1 are objective response rate (ORR) and progression-free survival (PFS). Secondary endpoints include 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 40 elderly patients (with potential expansion to up to 60 patients) with human epidermal growth factor receptor 2 (HER2) negative MBC will receive tesetaxel monotherapy dosed orally at 27 mg/m2 on the first day of each 21-day cycle. The primary endpoint for Cohort 2 is ORR. Secondary endpoints include PFS, DoR and OS. Patients with central nervous system (CNS) metastases are eligible for both cohorts.

    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 completion and outcome of CONTESSA, our Phase 3 study of tesetaxel in patients with metastatic breast cancer (MBC); expectations regarding the enrollment, completion and outcome of our other clinical studies, including CONTESSA 2 and CONTESSA TRIO; 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.

    Condensed Balance Sheets

    (in thousands, except par value and share amounts)

     

     

    June 30,

     

     

    December 31,

     

     

     

    2020

     

     

    2019

     

     

     

    (Unaudited)

     

     

     

     

     

    Assets

     

     

     

     

     

     

     

     

    Current assets:

     

     

     

     

     

     

     

     

    Cash

     

    $

    125,417

     

     

    $

    180,460

     

    Prepaid expenses and other current assets

     

     

    2,391

     

     

     

    3,468

     

    Total current assets

     

     

    127,808

     

     

     

    183,928

     

    Property and equipment, net

     

     

    1,742

     

     

     

    1,663

     

    Right-of-use lease assets

     

     

    1,469

     

     

     

    1,581

     

    Restricted cash

     

     

    714

     

     

     

    714

     

    Other

     

     

    994

     

     

     

    941

     

    Total assets

     

    $

    132,727

     

     

    $

    188,827

     

    Liabilities and Stockholders' Equity

     

     

     

     

     

     

     

     

    Current liabilities:

     

     

     

     

     

     

     

     

    Accounts payable

     

    $

    15,066

     

     

    $

    15,583

     

    Accrued expenses

     

     

    10,205

     

     

     

    8,881

     

    Lease liabilities, current portion

     

     

    285

     

     

     

    315

     

    Total current liabilities

     

     

    25,556

     

     

     

    24,779

     

    Lease liabilities, less current portion

     

     

    1,623

     

     

     

    1,748

     

    Total liabilities

     

     

    27,179

     

     

     

    26,527

     

    Commitments and contingencies

     

     

     

     

     

     

     

     

    Stockholders' equity:

     

     

     

     

     

     

     

     

    Common stock, $0.01 par value—100,000,000 shares authorized; 32,110,650 and 32,050,906 shares issued and outstanding at June 30, 2020 and December 31, 2019, respectively

     

     

    301

     

     

     

    300

     

    Additional paid-in capital

     

     

    408,911

     

     

     

    402,077

     

    Accumulated deficit

     

     

    (303,664

    )

     

     

    (240,077

    )

    Total stockholders' equity

     

     

    105,548

     

     

     

    162,300

     

    Total liabilities and stockholders' equity

     

    $

    132,727

     

     

    $

    188,827

     

    ODONATE THERAPEUTICS, INC.

    Condensed Statements of Operations

    (Unaudited)

    (in thousands, except share and per share amounts)

     

     

    Three Months Ended

     

     

    Six Months Ended

     

     

     

    June 30,

     

     

    June 30,

     

     

     

    2020

     

     

    2019

     

     

    2020

     

     

    2019

     

    Operating expenses:

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Research and development

     

    $

    30,777

     

     

    $

    26,453

     

     

    $

    58,724

     

     

    $

    53,084

     

    General and administrative

     

     

    2,751

     

     

     

    2,783

     

     

     

    5,625

     

     

     

    5,374

     

    Total operating expenses

     

     

    33,528

     

     

     

    29,236

     

     

     

    64,349

     

     

     

    58,458

     

    Loss from operations

     

     

    (33,528

    )

     

     

    (29,236

    )

     

     

    (64,349

    )

     

     

    (58,458

    )

    Other income, net

     

     

    104

     

     

     

    534

     

     

     

    762

     

     

     

    1,111

     

    Net loss

     

    $

    (33,424

    )

     

    $

    (28,702

    )

     

    $

    (63,587

    )

     

    $

    (57,347

    )

    Net loss per share:

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Basic and diluted

     

    $

    (1.09

    )

     

    $

    (1.15

    )

     

    $

    (2.07

    )

     

    $

    (2.31

    )

    Weighted-average shares outstanding:

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Basic and diluted

     

     

    30,681,604

     

     

     

    24,893,232

     

     

     

    30,646,150

     

     

     

    24,788,404

     

    ODONATE THERAPEUTICS, INC.

    Condensed Statements of Cash Flows

    (Unaudited)

    (in thousands)

     

     

    Six Months Ended

     

     

     

    June 30,

     

     

     

    2020

     

     

    2019

     

    Cash flows from operating activities:

     

     

     

     

     

     

     

     

    Net loss

     

    $

    (63,587

    )

     

    $

    (57,347

    )

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

     

     

     

     

     

     

     

     

    Equity-based compensation expense

     

     

    5,181

     

     

     

    5,915

     

    Depreciation and amortization

     

     

    147

     

     

     

    180

     

    Loss on disposal of property and equipment

     

     

    83

     

     

     

    -

     

    Changes in operating assets and liabilities:

     

     

     

     

     

     

     

     

    Prepaid expenses and other assets

     

     

    1,024

     

     

     

    (2,253

    )

    Accounts payable

     

     

    (606

    )

     

     

    (2,822

    )

    Accrued expenses

     

     

    1,280

     

     

     

    5,995

     

    Net cash used in operating activities

     

     

    (56,478

    )

     

     

    (50,332

    )

    Cash flows from investing activities:

     

     

     

     

     

     

     

     

    Purchases of property and equipment

     

     

    (219

    )

     

     

    (103

    )

    Net cash used in investing activities

     

     

    (219

    )

     

     

    (103

    )

    Cash flows from financing activities:

     

     

     

     

     

     

     

     

    Proceeds from issuance of common stock, net of issuance costs

     

     

    -

     

     

     

    117,703

     

    Proceeds from issuance of common stock under employee stock plans

     

     

    1,654

     

     

     

    586

     

    Net cash provided by financing activities

     

     

    1,654

     

     

     

    118,289

     

    Net (decrease) increase in cash and restricted cash

     

     

    (55,043

    )

     

     

    67,854

     

    Cash and restricted cash, beginning of period

     

     

    181,174

     

     

     

    139,301

     

    Cash and restricted cash, end of period

     

    $

    126,131

     

     

    $

    207,155

     

    Supplemental disclosure of cash flow information:

     

     

     

     

     

     

     

     

    Property and equipment purchases included in accounts payable and accrued expenses

     

    $

    133

     

     

    $

    7

     

    Initial recognition of right-of-use lease assets

     

    $

    -

     

     

    $

    2,215

     

     

    View Full Article Hide Full Article
  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, will present at the Jefferies Virtual Healthcare Conference on Wednesday, June 3, 2020, at 9:00 a.m. Eastern Time.

    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…

    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, will present at the Jefferies Virtual Healthcare Conference on Wednesday, June 3, 2020, at 9:00 a.m. Eastern Time.

    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.

    View Full Article Hide Full Article
  3. 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 months ended March 31, 2020.

    As of March 31, 2020, Odonate had $153.1 million in cash, compared to $180.5 million as of December 31, 2019. Net cash used in operating activities for the three months ended March 31, 2020 was $27.8 million, compared to $27.1 million for the same period in 2019. Odonate's net loss for the three months ended March 31, 2020 was $30.2 million, or $0.99 per share, compared to $28.6 million, or $1.16 per share, for the same period in 2019.

    "We continue to expect to report top-line results…

    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 months ended March 31, 2020.

    As of March 31, 2020, Odonate had $153.1 million in cash, compared to $180.5 million as of December 31, 2019. Net cash used in operating activities for the three months ended March 31, 2020 was $27.8 million, compared to $27.1 million for the same period in 2019. Odonate's net loss for the three months ended March 31, 2020 was $30.2 million, or $0.99 per share, compared to $28.6 million, or $1.16 per share, for the same period in 2019.

    "We continue to expect to report top-line results from CONTESSA, Odonate's Phase 3 study investigating tesetaxel, an investigational, orally administered chemotherapy, as a potential treatment for patients with metastatic breast cancer, in the third quarter of 2020," said Kevin Tang, Chief Executive Officer of Odonate.

    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.

    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 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. Patients with central nervous system (CNS) metastases are eligible. 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 CONTESSA 2

    CONTESSA 2 is a multinational, multicenter, Phase 2 study of tesetaxel, an investigational, orally administered taxane, in patients with metastatic breast cancer (MBC). CONTESSA 2 is investigating 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) in approximately 125 patients with human epidermal growth factor receptor 2 (HER2) negative, hormone receptor (HR) positive MBC not previously treated with a taxane. 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. Patients with central nervous system (CNS) metastases are eligible. The primary endpoint is objective response rate (ORR) as assessed by an Independent Radiologic Review Committee (IRC). The secondary efficacy endpoints are duration of response (DoR) as assessed by the IRC, progression-free survival (PFS) as assessed by the IRC, disease control rate (DCR) as assessed by the IRC and overall survival (OS).

    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 90 patients (with potential expansion to up to 150 patients) with locally advanced or metastatic triple-negative breast cancer (TNBC) 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 infusion on the first day of each 21-day cycle; (2) pembrolizumab at 200 mg by intravenous infusion on the first day of each 21-day cycle; or (3) atezolizumab at 1,200 mg by intravenous infusion on the first day of each 21-day cycle. Nivolumab and pembrolizumab (PD-1 inhibitors) and atezolizumab (a PD-L1 inhibitor) are immuno-oncology (IO) agents approved for the treatment of multiple types of cancer. One of these agents, atezolizumab, in combination with the intravenously delivered taxane, nab-paclitaxel, was recently approved by the U.S. Food and Drug Administration (FDA) as a first-line treatment for patients with metastatic TNBC. The dual primary endpoints for Cohort 1 are objective response rate (ORR) and progression-free survival (PFS). Secondary endpoints include 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 40 elderly patients (with potential expansion to up to 60 patients) with human epidermal growth factor receptor 2 (HER2) negative MBC will receive tesetaxel monotherapy dosed orally at 27 mg/m2 on the first day of each 21-day cycle. The primary endpoint for Cohort 2 is ORR. Secondary endpoints include PFS, DoR and OS. Patients with central nervous system (CNS) metastases are eligible for both cohorts.

    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 completion and outcome of CONTESSA, our Phase 3 study of tesetaxel in patients with metastatic breast cancer (MBC); expectations regarding the enrollment, completion and outcome of our other clinical studies, including CONTESSA 2 and CONTESSA TRIO; 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.

    Condensed Balance Sheets

    (in thousands, except par value and share amounts)

     

     

    March 31,

     

    December 31,

     

     

    2020

     

    2019

     

     

    (Unaudited)

     

     

    Assets

     

     

     

     

    Current assets:

     

     

     

     

    Cash

     

    $

    153,117

     

     

    $

    180,460

     

    Prepaid expenses and other current assets

     

     

    4,050

     

     

     

    3,468

     

    Total current assets

     

     

    157,167

     

     

     

    183,928

     

    Property and equipment, net

     

     

    1,594

     

     

     

    1,663

     

    Right-of-use lease assets

     

     

    1,526

     

     

     

    1,581

     

    Restricted cash

     

     

    714

     

     

     

    714

     

    Other

     

     

    983

     

     

     

    941

     

    Total assets

     

    $

    161,984

     

     

    $

    188,827

     

    Liabilities and Stockholders' Equity

     

     

     

     

    Current liabilities:

     

     

     

     

    Accounts payable

     

    $

    14,894

     

     

    $

    15,583

     

    Accrued expenses

     

     

    9,871

     

     

     

    8,881

     

    Lease liabilities, current portion

     

     

    279

     

     

     

    315

     

    Total current liabilities

     

     

    25,044

     

     

     

    24,779

     

    Lease liabilities, less current portion

     

     

    1,696

     

     

     

    1,748

     

    Total liabilities

     

     

    26,740

     

     

     

    26,527

     

    Commitments and contingencies

     

     

     

     

    Stockholders' equity:

     

     

     

     

    Common stock, $0.01 par value—100,000,000 shares authorized; 32,076,095 and 32,050,906 shares issued and outstanding at March 31, 2020 and December 31, 2019, respectively

     

     

    301

     

     

     

    300

     

    Additional paid-in capital

     

     

    405,183

     

     

     

    402,077

     

    Accumulated deficit

     

     

    (270,240

    )

     

     

    (240,077

    )

    Total stockholders' equity

     

     

    135,244

     

     

     

    162,300

     

    Total liabilities and stockholders' equity

     

    $

    161,984

     

     

    $

    188,827

     

    ODONATE THERAPEUTICS, INC.

    Condensed Statements of Operations

    (Unaudited)

    (in thousands, except share and per share amounts)

     

     

    Three Months Ended

     

     

    March 31,

     

     

    2020

     

    2019

    Operating expenses:

     

     

     

     

    Research and development

     

    $

    27,947

     

     

    $

    26,631

     

    General and administrative

     

     

    2,874

     

     

     

    2,591

     

    Total operating expenses

     

     

    30,821

     

     

     

    29,222

     

    Loss from operations

     

     

    (30,821

    )

     

     

    (29,222

    )

    Interest income

     

     

    658

     

     

     

    577

     

    Net loss

     

    $

    (30,163

    )

     

    $

    (28,645

    )

    Net loss per share:

     

     

     

     

    Basic and diluted

     

    $

    (0.99

    )

     

    $

    (1.16

    )

    Weighted-average shares outstanding:

     

     

     

     

    Basic and diluted

     

    30,610,696

     

     

    24,682,410

     

    ODONATE THERAPEUTICS, INC.

    Condensed Statements of Cash Flows

    (Unaudited)

    (in thousands)

     

     

    Three Months Ended

     

     

    March 31,

     

     

    2020

     

    2019

    Cash flows from operating activities:

     

     

     

     

    Net loss

     

    $

    (30,163

    )

     

    $

    (28,645

    )

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

     

     

     

     

    Equity-based compensation expense

     

     

    2,586

     

     

     

    2,925

     

    Depreciation and amortization

     

     

    62

     

     

     

    90

     

    Changes in operating assets and liabilities:

     

     

     

     

    Prepaid expenses and other assets

     

     

    (624

    )

     

     

    (2,744

    )

    Accounts payable

     

     

    (696

    )

     

     

    (3,023

    )

    Accrued expenses

     

     

    990

     

     

     

    4,289

     

    Net cash used in operating activities

     

     

    (27,845

    )

     

     

    (27,108

    )

    Cash flows from investing activities:

     

     

     

     

    Purchases of property and equipment

     

     

    (19

    )

     

     

    (41

    )

    Net cash used in investing activities

     

     

    (19

    )

     

     

    (41

    )

    Cash flows from financing activities:

     

     

     

     

    Proceeds from issuance of common stock under employee stock plans

     

     

    521

     

     

     

    159

     

    Net cash provided by financing activities

     

     

    521

     

     

     

    159

     

    Net decrease in cash and restricted cash

     

     

    (27,343

    )

     

     

    (26,990

    )

    Cash and restricted cash, beginning of period

     

     

    181,174

     

     

     

    139,301

     

    Cash and restricted cash, end of period

     

    $

    153,831

     

     

    $

    112,311

     

    Supplemental disclosure of cash flow information:

     

     

     

     

    Property and equipment purchases included in accounts payable and accrued expenses

     

    $

    7

     

     

    $

    47

     

    Initial recognition of right-of-use lease assets

     

    $

    -

     

     

    $

    2,215

     

     

    View Full Article Hide Full Article
  4. 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, 2019.

    As of December 31, 2019, Odonate had $180.5 million in cash, compared to $139.1 million as of December 31, 2018. This increase in cash resulted primarily from the receipt of $135.1 million of net proceeds from Odonate's June 2019 underwritten public offering, less net cash used in operating activities of $96.6 million. Odonate's net loss for the three and twelve months ended December 31, 2019 was $27.9 million and $111.8 million, or $0.91 and $4.05 per share, respectively…

    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, 2019.

    As of December 31, 2019, Odonate had $180.5 million in cash, compared to $139.1 million as of December 31, 2018. This increase in cash resulted primarily from the receipt of $135.1 million of net proceeds from Odonate's June 2019 underwritten public offering, less net cash used in operating activities of $96.6 million. Odonate's net loss for the three and twelve months ended December 31, 2019 was $27.9 million and $111.8 million, or $0.91 and $4.05 per share, respectively, compared to $28.8 million and $89.0 million, or $1.17 and $3.64 per share, respectively, for the same periods in 2018.

    "We are pleased to have recently announced the completion of enrollment in CONTESSA, Odonate's Phase 3 study investigating tesetaxel as a potential treatment for patients with metastatic breast cancer," said Kevin Tang, Chief Executive Officer of Odonate. "We expect to report top-line results from CONTESSA in the third quarter of 2020."

    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.

    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 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. Patients with central nervous system (CNS) metastases are eligible. 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 CONTESSA 2

    CONTESSA 2 is a multinational, multicenter, Phase 2 study of tesetaxel, an investigational, orally administered taxane, in patients with metastatic breast cancer (MBC). CONTESSA 2 is investigating 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) in approximately 125 patients with human epidermal growth factor receptor 2 (HER2) negative, hormone receptor (HR) positive MBC not previously treated with a taxane. 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. Patients with central nervous system (CNS) metastases are eligible. The primary endpoint is objective response rate (ORR) as assessed by an Independent Radiologic Review Committee (IRC). The secondary efficacy endpoints are duration of response (DoR) as assessed by the IRC, progression-free survival (PFS) as assessed by the IRC, disease control rate (DCR) as assessed by the IRC and overall survival (OS).

    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 90 patients (with potential expansion to up to 150 patients) with locally advanced or metastatic triple-negative breast cancer (TNBC) 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 infusion on the first day of each 21-day cycle; (2) pembrolizumab at 200 mg by intravenous infusion on the first day of each 21-day cycle; or (3) atezolizumab at 1,200 mg by intravenous infusion on the first day of each 21-day cycle. Nivolumab and pembrolizumab (PD-1 inhibitors) and atezolizumab (a PD-L1 inhibitor) are immuno-oncology (IO) agents approved for the treatment of multiple types of cancer. One of these agents, atezolizumab, in combination with the intravenously delivered taxane, nab-paclitaxel, was recently approved by the U.S. Food and Drug Administration (FDA) as a first-line treatment for patients with metastatic TNBC. The dual primary endpoints for Cohort 1 are objective response rate (ORR) and progression-free survival (PFS). Secondary endpoints include 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 40 elderly patients (with potential expansion to up to 60 patients) with human epidermal growth factor receptor 2 (HER2) negative MBC will receive tesetaxel monotherapy dosed orally at 27 mg/m2 on the first day of each 21-day cycle. The primary endpoint for Cohort 2 is ORR. Secondary endpoints include PFS, DoR and OS. Patients with central nervous system (CNS) metastases are eligible for both cohorts.

    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 completion and outcome of CONTESSA, our Phase 3 study of tesetaxel in patients with metastatic breast cancer (MBC); expectations regarding the enrollment, completion and outcome of our other clinical studies, including CONTESSA 2 and CONTESSA TRIO; 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,

     

     

     

    2019

     

     

    2018

     

    Assets

     

     

     

     

     

     

     

     

    Current assets:

     

     

     

     

     

     

     

     

    Cash

     

    $

    180,460

     

     

    $

    139,050

     

    Prepaid expenses and other current assets

     

     

    3,468

     

     

     

    750

     

    Total current assets

     

     

    183,928

     

     

     

    139,800

     

    Property and equipment, net

     

     

    1,663

     

     

     

    1,899

     

    Right-of-use lease assets

     

     

    1,581

     

     

     

    -

     

    Restricted cash

     

     

    714

     

     

     

    251

     

    Other

     

     

    941

     

     

     

    723

     

    Total assets

     

    $

    188,827

     

     

    $

    142,673

     

    Liabilities and Stockholders' Equity

     

     

     

     

     

     

     

     

    Current liabilities:

     

     

     

     

     

     

     

     

    Accounts payable

     

    $

    15,583

     

     

    $

    10,777

     

    Accrued expenses

     

     

    8,881

     

     

     

    7,365

     

    Lease liabilities, current portion

     

     

    315

     

     

     

    -

     

    Deferred rent, current portion

     

     

    -

     

     

     

    66

     

    Total current liabilities

     

     

    24,779

     

     

     

    18,208

     

    Lease liabilities, less current portion

     

     

    1,748

     

     

     

    -

     

    Deferred rent, less current portion

     

     

    -

     

     

     

    461

     

    Total liabilities

     

     

    26,527

     

     

     

    18,669

     

    Commitments and contingencies

     

     

     

     

     

     

     

     

    Stockholders' equity:

     

     

     

     

     

     

     

     

    Common stock, $0.01 par value—100,000,000 shares authorized; 32,050,906 and 26,747,438 shares issued and outstanding at December 31, 2019 and December 31, 2018, respectively

     

     

    300

     

     

     

    244

     

    Additional paid-in capital

     

     

    402,077

     

     

     

    252,012

     

    Accumulated deficit

     

     

    (240,077

    )

     

     

    (128,252

    )

    Total stockholders' equity

     

     

    162,300

     

     

     

    124,004

     

    Total liabilities and stockholders' equity

     

    $

    188,827

     

     

    $

    142,673

     

     

    ODONATE THERAPEUTICS, INC.

    Statements of Operations

    (in thousands, except share and per share amounts)

     

     

     

    Three Months Ended

     

     

    Twelve Months Ended

     

     

     

    December 31,

     

     

    December 31,

     

     

     

    2019

     

     

    2018

     

     

    2019

     

     

    2018

     

    Operating expenses:

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Research and development

     

    $

    25,853

     

     

    $

    26,797

     

     

    $

    104,034

     

     

    $

    79,948

     

    General and administrative

     

     

    2,856

     

     

     

    2,680

     

     

     

    10,896

     

     

     

    10,816

     

    Total operating expenses

     

     

    28,709

     

     

     

    29,477

     

     

     

    114,930

     

     

     

    90,764

     

    Loss from operations

     

     

    (28,709

    )

     

     

    (29,477

    )

     

     

    (114,930

    )

     

     

    (90,764

    )

    Interest income

     

     

    858

     

     

     

    714

     

     

     

    3,105

     

     

     

    1,804

     

    Net loss

     

    $

    (27,851

    )

     

    $

    (28,763

    )

     

    $

    (111,825

    )

     

    $

    (88,960

    )

    Net loss per share:

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Basic and diluted

     

    $

    (0.91

    )

     

    $

    (1.17

    )

     

    $

    (4.05

    )

     

    $

    (3.64

    )

    Weighted-average shares outstanding:

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Basic and diluted

     

     

    30,564,258

     

     

     

    24,638,708

     

     

     

    27,625,468

     

     

     

    24,462,293

     

     

    ODONATE THERAPEUTICS, INC.

    Statements of Cash Flows

    (in thousands)

     

     

     

    Year Ended

     

     

     

    December 31,

     

     

     

    2019

     

     

    2018

     

    Cash flows from operating activities:

     

     

     

     

     

     

     

     

    Net loss

     

    $

    (111,825

    )

     

    $

    (88,960

    )

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

     

     

     

     

     

     

     

     

    Equity-based compensation expense

     

     

    11,444

     

     

     

    6,721

     

    Depreciation and amortization

     

     

    381

     

     

     

    350

     

    Non-cash contributions for expenses

     

     

    -

     

     

     

    64

     

    Changes in operating assets and liabilities:

     

     

     

     

     

     

     

     

    Prepaid expenses and other assets

     

     

    (2,936

    )

     

     

    3,751

     

    Accounts payable

     

     

    4,782

     

     

     

    6,392

     

    Accrued expenses

     

     

    1,516

     

     

     

    4,155

     

    Deferred rent

     

     

    -

     

     

     

    433

     

    Net cash used in operating activities

     

     

    (96,638

    )

     

     

    (67,094

    )

    Cash flows from investing activities:

     

     

     

     

     

     

     

     

    Purchases of property and equipment

     

     

    (166

    )

     

     

    (1,907

    )

    Net cash used in investing activities

     

     

    (166

    )

     

     

    (1,907

    )

    Cash flows from financing activities:

     

     

     

     

     

     

     

     

    Proceeds from issuance of common stock, net of issuance costs

     

     

    135,096

     

     

     

    9,848

     

    Proceeds from issuance of common stock under employee stock plans

     

     

    3,581

     

     

     

    349

     

    Net cash provided by financing activities

     

     

    138,677

     

     

     

    10,197

     

    Net increase (decrease) in cash and restricted cash

     

     

    41,873

     

     

     

    (58,804

    )

    Cash and restricted cash, beginning of period

     

     

    139,301

     

     

     

    198,105

     

    Cash and restricted cash, end of period

     

    $

    181,174

     

     

    $

    139,301

     

    Supplemental disclosure of cash flow information:

     

     

     

     

     

     

     

     

    Initial recognition of right-of-use lease assets

     

    $

    2,215

     

     

    $

    -

     

    Property and equipment purchases included in accounts payable

     

    $

    24

     

     

    $

    83

     

     

    View Full Article Hide Full Article
  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 financial results for the three and nine months ended September 30, 2019.

    As of September 30, 2019, Odonate had $204.2 million in cash, compared to $139.1 million as of December 31, 2018. This increase in cash resulted primarily from the receipt of $135.1 million of net proceeds from Odonate's June 2019 underwritten public offering, less net cash used in operating activities of $72.1 million. Odonate's net loss for the three and nine months ended September 30, 2019 was $26.6 million and $84.0 million, or $0.88 and $3.15 per share, respectively…

    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 nine months ended September 30, 2019.

    As of September 30, 2019, Odonate had $204.2 million in cash, compared to $139.1 million as of December 31, 2018. This increase in cash resulted primarily from the receipt of $135.1 million of net proceeds from Odonate's June 2019 underwritten public offering, less net cash used in operating activities of $72.1 million. Odonate's net loss for the three and nine months ended September 30, 2019 was $26.6 million and $84.0 million, or $0.88 and $3.15 per share, respectively, compared to $23.9 million and $60.2 million, or $0.98 and $2.47 per share, respectively, for the same periods in 2018.

    "We are pleased to have recently announced the completion of enrollment in CONTESSA, Odonate's Phase 3 study investigating tesetaxel as a potential treatment for patients with metastatic breast cancer," said Kevin Tang, Chief Executive Officer of Odonate. "We expect to report top-line results from CONTESSA in the third quarter of 2020."

    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.

    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 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. Patients with central nervous system (CNS) metastases are eligible. The primary endpoint is progression-free survival (PFS) as assessed by an Independent Radiologic Review Committee (IRC). CONTESSA's 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 CONTESSA 2

    CONTESSA 2 is a multinational, multicenter, Phase 2 study of tesetaxel, an investigational, orally administered taxane, in patients with metastatic breast cancer (MBC). CONTESSA 2 is investigating 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) in approximately 125 patients with human epidermal growth factor receptor 2 (HER2) negative, hormone receptor (HR) positive MBC not previously treated with a taxane. 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. Patients with central nervous system (CNS) metastases are eligible. The primary endpoint is objective response rate (ORR) as assessed by an Independent Radiologic Review Committee (IRC). The secondary efficacy endpoints are duration of response (DoR) as assessed by the IRC, progression-free survival (PFS) as assessed by the IRC, disease control rate (DCR) as assessed by the IRC and overall survival (OS).

    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 90 patients (with potential expansion to up to 150 patients) with locally advanced or metastatic triple-negative breast cancer (TNBC) 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 infusion on the first day of each 21-day cycle; (2) pembrolizumab at 200 mg by intravenous infusion on the first day of each 21-day cycle; or (3) atezolizumab at 1,200 mg by intravenous infusion on the first day of each 21-day cycle. Nivolumab and pembrolizumab (PD-1 inhibitors) and atezolizumab (a PD-L1 inhibitor) are immuno-oncology (IO) agents approved for the treatment of multiple types of cancer. One of these agents, atezolizumab, in combination with the intravenously delivered taxane, nab-paclitaxel, was recently approved by the U.S. Food and Drug Administration (FDA) as a first-line treatment for patients with metastatic TNBC. The dual primary endpoints for Cohort 1 are objective response rate (ORR) and progression-free survival (PFS). Secondary endpoints include 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 40 elderly patients (with potential expansion to up to 60 patients) with human epidermal growth factor receptor 2 (HER2) negative MBC will receive tesetaxel monotherapy dosed orally at 27 mg/m2 on the first day of each 21-day cycle. The primary endpoint for Cohort 2 is ORR. Secondary endpoints include PFS, DoR and OS. Patients with central nervous system (CNS) metastases are eligible for both cohorts.

    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 completion and outcome of CONTESSA, our Phase 3 study of tesetaxel in patients with metastatic breast cancer (MBC); expectations regarding the enrollment, completion and outcome of our other clinical studies, including CONTESSA 2 and CONTESSA TRIO; 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.

    Condensed Balance Sheets

    (in thousands, except par value and share amounts)

     

     

    September 30,

     

     

    December 31,

     

     

     

    2019

     

     

    2018

     

     

     

    (Unaudited)

     

     

     

     

     

    Assets

     

     

     

     

     

     

     

     

    Current assets:

     

     

     

     

     

     

     

     

    Cash

     

    $

    204,245

     

     

    $

    139,050

     

    Prepaid expenses and other current assets

     

     

    3,951

     

     

     

    750

     

    Total current assets

     

     

    208,196

     

     

     

    139,800

     

    Property and equipment, net

     

     

    1,746

     

     

     

    1,899

     

    Right-of-use lease assets

     

     

    1,759

     

     

     

    -

     

    Restricted cash

     

     

    251

     

     

     

    251

     

    Other

     

     

    835

     

     

     

    723

     

    Total assets

     

    $

    212,787

     

     

    $

    142,673

     

    Liabilities and Stockholders' Equity

     

     

     

     

     

     

     

     

    Current liabilities:

     

     

     

     

     

     

     

     

    Accounts payable

     

    $

    12,964

     

     

    $

    10,777

     

    Accrued expenses

     

     

    11,385

     

     

     

    7,365

     

    Lease liabilities, current portion

     

     

    398

     

     

     

    -

     

    Deferred rent, current portion

     

     

    -

     

     

     

    66

     

    Total current liabilities

     

     

    24,747

     

     

     

    18,208

     

    Lease liabilities, less current portion

     

     

    1,839

     

     

     

    -

     

    Deferred rent, less current portion

     

     

    -

     

     

     

    461

     

    Total liabilities

     

     

    26,586

     

     

     

    18,669

     

    Commitments and contingencies

     

     

     

     

     

     

     

     

    Stockholders' equity:

     

     

     

     

     

     

     

     

    Common stock, $0.01 par value—100,000,000 shares authorized; 32,083,991 and 26,747,438 shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively

     

     

    300

     

     

     

    244

     

    Additional paid-in capital

     

     

    398,127

     

     

     

    252,012

     

    Accumulated deficit

     

     

    (212,226

    )

     

     

    (128,252

    )

    Total stockholders' equity

     

     

    186,201

     

     

     

    124,004

     

    Total liabilities and stockholders' equity

     

    $

    212,787

     

     

    $

    142,673

     

    ODONATE THERAPEUTICS, INC.

    Condensed Statements of Operations

    (Unaudited)

    (in thousands, except share and per share amounts)

     

     

    Three Months Ended

     

     

    Nine Months Ended

     

     

     

    September 30,

     

     

    September 30,

     

     

     

    2019

     

     

    2018

     

     

    2019

     

     

    2018

     

    Operating expenses:

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Research and development

     

    $

    25,097

     

     

    $

    21,667

     

     

    $

    78,181

     

     

    $

    53,151

     

    General and administrative

     

     

    2,666

     

     

     

    2,960

     

     

     

    8,040

     

     

     

    8,136

     

    Total operating expenses

     

     

    27,763

     

     

     

    24,627

     

     

     

    86,221

     

     

     

    61,287

     

    Loss from operations

     

     

    (27,763

    )

     

     

    (24,627

    )

     

     

    (86,221

    )

     

     

    (61,287

    )

    Interest income

     

     

    1,136

     

     

     

    701

     

     

     

    2,247

     

     

     

    1,090

     

    Net loss

     

    $

    (26,627

    )

     

    $

    (23,926

    )

     

    $

    (83,974

    )

     

    $

    (60,197

    )

    Net loss per share:

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Basic and diluted

     

    $

    (0.88

    )

     

    $

    (0.98

    )

     

    $

    (3.15

    )

     

    $

    (2.47

    )

    Weighted-average shares outstanding:

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Basic and diluted

     

    30,268,295

     

     

     

    24,453,910

     

     

     

    26,635,107

     

     

     

    24,402,842

     

    ODONATE THERAPEUTICS, INC.

    Condensed Statements of Cash Flows

    (Unaudited)

    (in thousands)

     

     

    Nine Months Ended

     

     

     

    September 30,

     

     

     

    2019

     

     

    2018

     

    Cash flows from operating activities:

     

     

     

     

     

     

     

     

    Net loss

     

    $

    (83,974

    )

     

    $

    (60,197

    )

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

     

     

     

     

     

     

     

     

    Equity-based compensation expense

     

     

    8,695

     

     

     

    4,775

     

    Depreciation and amortization

     

     

    269

     

     

     

    231

     

    Non-cash contributions for expenses

     

     

    -

     

     

     

    64

     

    Changes in operating assets and liabilities:

     

     

     

     

     

     

     

     

    Prepaid expenses and other assets

     

     

    (3,313

    )

     

     

    2,192

     

    Accounts payable

     

     

    2,186

     

     

     

    1,443

     

    Accrued expenses

     

     

    4,020

     

     

     

    5,733

     

    Deferred rent

     

     

    -

     

     

     

    432

     

    Net cash used in operating activities

     

     

    (72,117

    )

     

     

    (45,327

    )

    Cash flows from investing activities:

     

     

     

     

     

     

     

     

    Purchases of property and equipment

     

     

    (164

    )

     

     

    (1,612

    )

    Net cash used in investing activities

     

     

    (164

    )

     

     

    (1,612

    )

    Cash flows from financing activities:

     

     

     

     

     

     

     

     

    Proceeds from issuance of common stock, net of issuance costs

     

     

    135,095

     

     

     

    9,848

     

    Proceeds from issuance of common stock under employee stock plans

     

     

    2,381

     

     

     

    205

     

    Net cash provided by financing activities

     

     

    137,476

     

     

     

    10,053

     

    Net increase (decrease) in cash and restricted cash

     

     

    65,195

     

     

     

    (36,886

    )

    Cash and restricted cash, beginning of period

     

     

    139,301

     

     

     

    198,105

     

    Cash and restricted cash, end of period

     

    $

    204,496

     

     

    $

    161,219

     

    Supplemental disclosure of cash flow information:

     

     

     

     

     

     

     

     

    Initial recognition of right-of-use lease assets

     

    $

    2,215

     

     

    $

    -

     

    Property and equipment purchases included in accounts payable

     

    $

    1

     

     

    $

    272

     

     

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