Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2021 | Jul. 22, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2021 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q2 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Title of 12(b) Security | Common Stock, $0.01 par value per share | |
Entity File Number | 001-38318 | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 82-2493065 | |
Trading Symbol | ODT | |
Security Exchange Name | NASDAQ | |
Entity Registrant Name | Odonate Therapeutics, Inc. | |
Entity Central Index Key | 0001717452 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Emerging Growth Company | true | |
Entity Small Business | true | |
Entity Ex Transition Period | true | |
Entity Common Stock, Shares Outstanding | 38,499,534 | |
Entity Address, State or Province | NY | |
Entity Shell Company | false | |
Entity Address, Address Line One | 3 East 28th Street | |
Entity Address, Address Line Two | 10th Floor | |
Entity Address, City or Town | New York | |
Entity Address, Postal Zip Code | 10016 | |
City Area Code | 332 | |
Local Phone Number | 206-0935 | |
Document Quarterly Report | true | |
Document Transition Report | false |
Condensed Balance Sheets (Unaud
Condensed Balance Sheets (Unaudited) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash | $ 110,127 | $ 157,265 |
Prepaid expenses and other current assets | 1,943 | 2,607 |
Total current assets | 112,070 | 159,872 |
Property and equipment, net | 2,001 | 2,286 |
Right-of-use lease assets | 3,734 | 4,017 |
Restricted cash | 714 | 714 |
Other | 54 | 997 |
Total assets | 118,573 | 167,886 |
Current liabilities: | ||
Accounts payable | 13,121 | 14,168 |
Accrued expenses | 15,800 | 12,247 |
Lease liabilities, current portion | 729 | 658 |
Total current liabilities | 29,650 | 27,073 |
Lease liabilities, less current portion | 4,298 | 4,668 |
Total liabilities | 33,948 | 31,741 |
Commitments and contingencies (Note 5) | ||
Stockholders' equity: | ||
Common stock, $0.01 par value—100,000,000 shares authorized; 38,499,534 and 38,562,281 shares issued and outstanding at June 30, 2021 and December 31, 2020, respectively | 368 | 367 |
Additional paid-in capital | 506,467 | 502,205 |
Accumulated deficit | (422,210) | (366,427) |
Total stockholders' equity | 84,625 | 136,145 |
Total liabilities and stockholders' equity | $ 118,573 | $ 167,886 |
Condensed Balance Sheets (Una_2
Condensed Balance Sheets (Unaudited) (Parenthetical) - $ / shares | Jun. 30, 2021 | Dec. 31, 2020 |
Statement Of Financial Position [Abstract] | ||
Common stock, par or stated value per share | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares issued | 38,499,534 | 38,562,281 |
Common stock, shares outstanding | 38,499,534 | 38,562,281 |
Condensed Statements of Operati
Condensed Statements of Operations (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Operating expenses: | ||||
Research and development | $ 18,625 | $ 30,777 | $ 49,553 | $ 58,724 |
General and administrative | 3,429 | 2,751 | 6,319 | 5,625 |
Total operating expenses | 22,054 | 33,528 | 55,872 | 64,349 |
Loss from operations | (22,054) | (33,528) | (55,872) | (64,349) |
Other income, net | 39 | 104 | 89 | 762 |
Net loss | $ (22,015) | $ (33,424) | $ (55,783) | $ (63,587) |
Net loss per share: | ||||
Basic and diluted | $ (0.58) | $ (1.09) | $ (1.48) | $ (2.07) |
Weighted-average shares outstanding: | ||||
Basic and diluted | 37,922,594 | 30,681,604 | 37,662,924 | 30,646,150 |
Condensed Statements of Stockho
Condensed Statements of Stockholders' Equity (Unaudited) - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Accumulated Deficit |
Beginning balance at Dec. 31, 2019 | $ 162,300 | $ 300 | $ 402,077 | $ (240,077) |
Beginning balance, shares at Dec. 31, 2019 | 32,050,906 | |||
Issuance of common stock under employee stock plans | 521 | $ 1 | 520 | |
Issuance of common stock under employee stock plans, shares | 27,532 | |||
Forfeiture of common stock underlying incentive units, shares | (2,343) | |||
Equity-based compensation expense | 2,586 | 2,586 | ||
Net loss | (30,163) | (30,163) | ||
Ending balance at Mar. 31, 2020 | 135,244 | $ 301 | 405,183 | (270,240) |
Ending balance, shares at Mar. 31, 2020 | 32,076,095 | |||
Beginning balance at Dec. 31, 2019 | 162,300 | $ 300 | 402,077 | (240,077) |
Beginning balance, shares at Dec. 31, 2019 | 32,050,906 | |||
Net loss | (63,587) | |||
Ending balance at Jun. 30, 2020 | 105,548 | $ 301 | 408,911 | (303,664) |
Ending balance, shares at Jun. 30, 2020 | 32,110,650 | |||
Beginning balance at Mar. 31, 2020 | 135,244 | $ 301 | 405,183 | (270,240) |
Beginning balance, shares at Mar. 31, 2020 | 32,076,095 | |||
Issuance of common stock under employee stock plans | 1,133 | 1,133 | ||
Issuance of common stock under employee stock plans, shares | 58,412 | |||
Forfeiture of common stock underlying incentive units, shares | (23,857) | |||
Equity-based compensation expense | 2,595 | 2,595 | ||
Net loss | (33,424) | (33,424) | ||
Ending balance at Jun. 30, 2020 | 105,548 | $ 301 | 408,911 | (303,664) |
Ending balance, shares at Jun. 30, 2020 | 32,110,650 | |||
Beginning balance at Dec. 31, 2020 | 136,145 | $ 367 | 502,205 | (366,427) |
Beginning balance, shares at Dec. 31, 2020 | 38,562,281 | |||
Issuance of common stock under employee stock plans | 825 | $ 1 | 824 | |
Issuance of common stock under employee stock plans, shares | 53,979 | |||
Forfeiture of common stock underlying incentive units, shares | (109,151) | |||
Equity-based compensation expense | 2,099 | 2,099 | ||
Net loss | (33,768) | (33,768) | ||
Ending balance at Mar. 31, 2021 | 105,301 | $ 368 | 505,128 | (400,195) |
Ending balance, shares at Mar. 31, 2021 | 38,507,109 | |||
Beginning balance at Dec. 31, 2020 | 136,145 | $ 367 | 502,205 | (366,427) |
Beginning balance, shares at Dec. 31, 2020 | 38,562,281 | |||
Net loss | (55,783) | |||
Ending balance at Jun. 30, 2021 | 84,625 | $ 368 | 506,467 | (422,210) |
Ending balance, shares at Jun. 30, 2021 | 38,499,534 | |||
Beginning balance at Mar. 31, 2021 | 105,301 | $ 368 | 505,128 | (400,195) |
Beginning balance, shares at Mar. 31, 2021 | 38,507,109 | |||
Forfeiture of common stock underlying incentive units, shares | (7,575) | |||
Equity-based compensation expense | 1,339 | 1,339 | ||
Net loss | (22,015) | (22,015) | ||
Ending balance at Jun. 30, 2021 | $ 84,625 | $ 368 | $ 506,467 | $ (422,210) |
Ending balance, shares at Jun. 30, 2021 | 38,499,534 |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Cash flows from operating activities: | ||
Net loss | $ (55,783) | $ (63,587) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Equity-based compensation expense | 3,438 | 5,181 |
Depreciation and amortization | 248 | 147 |
Non-cash lease expense | 283 | |
Loss on disposal of property and equipment | 63 | 83 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other assets | 1,607 | 1,024 |
Accounts payable | (1,047) | (606) |
Accrued expenses | 3,553 | 1,280 |
Lease liabilities | (299) | |
Net cash used in operating activities | (47,937) | (56,478) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (26) | (219) |
Net cash used in investing activities | (26) | (219) |
Cash flows from financing activities: | ||
Proceeds from issuance of common stock under employee stock plans | 825 | 1,654 |
Net cash provided by financing activities | 825 | 1,654 |
Net decrease in cash and restricted cash | (47,138) | (55,043) |
Cash and restricted cash, beginning of period | 157,979 | 181,174 |
Cash and restricted cash, end of period | $ 110,841 | 126,131 |
Supplemental disclosure of cash flow information: | ||
Property and equipment purchases included in accounts payable | $ 133 |
Business
Business | 6 Months Ended |
Jun. 30, 2021 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Business | 1. Business Odonate Therapeutics, Inc. (“Odonate” or the “Company”) is a pharmaceutical company formerly focused 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. In March 2021, the Company announced the discontinuation of development of tesetaxel and its intent to wind down tesetaxel-related operations. As of June 30, 2021, the Company has transitioned all patients in tesetaxel studies to appropriate alternative therapies or facilitated continuation of treatment with tesetaxel under compassionate use programs where appropriate. As of June 30, 2021, the Company had $110.1 million in cash. The Company has incurred operating losses and negative cash flows from operations since inception. Management believes that the Company’s existing cash will be sufficient to meet the Company’s anticipated cash requirements through at least one year from the date this Quarterly Report on Form 10-Q is filed with the U.S. Securities and Exchange Commission (the “SEC”). |
Basis of Presentation and Summa
Basis of Presentation and Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2021 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Summary of Significant Accounting Policies | 2. Basis of Presentation and Summary of Significant Accounting Policies Basis of Presentation and Use of Estimates The Company’s condensed financial statements contained in this Quarterly Report on Form 10-Q have been prepared in accordance with generally accepted accounting principles in the U.S. (“GAAP”) The preparation of the Company’s condensed financial statements requires management to make estimates and assumptions that impact the reported amounts of assets, liabilities and expenses and the disclosure of contingent assets and liabilities in the Company’s condensed financial statements and accompanying notes. The most significant estimates and assumptions in the Company’s condensed financial statements relate to accrued expenses and equity-based compensation expense. These estimates and assumptions are based on current facts, historical experience and various other factors believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources. Actual results may differ materially and adversely from these estimates. To the extent there are material differences between the estimates and actual results, the Company’s future results of operations will be affected. Summary of Significant Accounting Policies During the six months ended June 30, 2021, other than the policy described below, there were no changes to the Company’s significant accounting policies as described in Note 2 to the audited financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020. Restructuring Expense For one-time employee termination benefits for which no future service is required, the Company recognizes and measures a liability once the plan of termination meets all of the following criteria for an established communication date: (i) management commits to a plan of termination; (ii) the plan identifies the number of employees to be terminated and their job classifications or functions, locations and the expected completion date; (iii) the plan establishes the terms of the benefit arrangement; and (iv) it is unlikely that significant changes to the plan will be made or the plan will be withdrawn. For one-time employee termination benefits for which future service is required, a liability is recognized and measured at the communication date based on its fair value as of the termination date and recognized ratably over the future service period. The Company recognizes and measures a liability for other related costs in the period in which the liability is incurred. Recent Accounting Pronouncements The Company has considered all recently issued accounting pronouncements and has concluded that there are no recently issued accounting pronouncements that may have a material impact on its results of operations, financial condition or cash flows based on current information. |
Net Loss per Share
Net Loss per Share | 6 Months Ended |
Jun. 30, 2021 | |
Earnings Per Share [Abstract] | |
Net Loss per Share | 3. Net Loss per Share Basic net loss per share is calculated by dividing net loss by the weighted-average common shares outstanding during the period, without consideration of common stock equivalents. The basic net loss per share calculation excludes 576,940 and 1,400,231 outstanding shares of common stock held by Odonate Holdings, LLC (“Odonate Holdings”) as of June 30, 2021 and 2020, respectively, to be used to settle incentive units previously issued under the Odonate Management Holdings Equity Incentive Plan (the “Management Plan”). These shares of common stock are subject to transfer to the Company and cancellation until such incentive units are vested and exercised and, as such, are considered common stock equivalents. Therefore, the shares of common stock held by Odonate Holdings are excluded from the basic net loss per share calculation until the incentive units are exercised. Diluted net loss per share is calculated by adjusting the weighted-average common shares outstanding for the dilutive effect of common stock equivalents outstanding for the period. Common stock equivalents, which consist of shares of common stock underlying incentive units and vested stock options, were excluded from the calculation of diluted net loss per share because they were anti-dilutive. |
Balance Sheet Details
Balance Sheet Details | 6 Months Ended |
Jun. 30, 2021 | |
Balance Sheet Related Disclosures [Abstract] | |
Balance Sheet Details | 4. Balance Sheet Details Property and equipment consisted of the following (in thousands): June 30, December 31, 2021 2020 Leasehold improvements $ 1,955 $ 1,955 Office equipment 701 791 Furniture and fixtures 514 514 Software 130 130 Total gross property and equipment 3,300 3,390 Less accumulated depreciation and amortization (1,299 ) (1,104 ) Property and equipment, net $ 2,001 $ 2,286 Depreciation and amortization expense was $0.1 million and $0.2 million for the three and six months ended June 30, 2021, respectively, and for the same periods in 2020. Accrued expenses consisted of the following (in thousands): June 30, December 31, 2021 2020 Accrued restructuring expense (see Note 10) $ 8,151 $ - Accrued clinical development costs 4,626 9,537 Accrued compensation and related expenses 2,706 2,658 Other accrued expenses 317 52 Total accrued expenses $ 15,800 $ 12,247 |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2021 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 5. Commitments and Contingencies Lease Commitments In February 2018, the Company entered into an agreement to lease office space in New York, New York (the “New York Lease”) with aggregate payments of approximately $2.8 million over the 7-year term of the lease. The New York Lease commenced in October 2018. The Company has an option to extend the New York Lease for an additional three years at the end of the initial term. The Company can assign or sublease the premises with prior written consent from the landlord. If the Company proposes to assign or sublease all or substantially all of the premises for all or substantially all of the remaining term, the landlord has an option to terminate the lease. Further, the Company provided a standby letter of credit of $0.3 million in lieu of a security deposit during the term of the lease, subject to a reduction in December 2021. As of June 30, 2021, $0.3 million was pledged as collateral for the letter of credit and recorded as restricted cash. The New York lease is classified as an operating lease. In March 2018, the Company entered into an agreement, which was amended in August 2019, to lease office space in San Diego, California (the “Old San Diego Lease”) with aggregate payments of approximately $1.0 million over the 2.3-year term of the lease. The Old San Diego Lease commenced in March 2018. The Old San Diego Lease is classified as an operating lease. In October 2019, the Company entered into an agreement to lease office space in San Diego, California (the “New San Diego Lease”) with aggregate payments of approximately $4.1 million over the 7.5-year term of the lease. The New San Diego Lease commenced in July 2020. The Company has an option to extend the New San Diego Lease for an additional 5 years at the end of the initial term. The Company can assign or sublease the premises with prior written consent from the landlord. If the Company proposes to assign or sublease greater than 70% of the premises, the landlord has an option to terminate the lease. Further, the Company provided a standby letter of credit of $0.5 million in lieu of a security deposit during the term of the lease, subject to certain reductions beginning in July 2024. As of June 30, 2021, $0.5 million was pledged as collateral for the letter of credit and recorded as restricted cash. The New San Diego Lease is classified as an operating lease. The Company recorded lease liabilities and right-of-use lease assets for the operating leases based on the present value of lease payments over the expected lease term, discounted using the Company’s incremental borrowing rate. The options to extend the operating leases were not recognized as part of the Company’s lease liabilities and right-of-use lease assets. As of June 30, 2021, the weighted-average remaining lease term and the weighted-average discount rate for the operating leases was 5.9 Future minimum lease payments under operating leases as of June 30, 2021 are as follows (in thousands): 2021 $ 456 2022 935 2023 980 2024 1,010 2025 953 Thereafter 1,299 Total future minimum lease payments 5,633 Less discount (606 ) Total lease liabilities $ 5,027 Other Commitments The Company enters into contracts in the normal course of business with contract development and manufacturing organizations and other service providers and vendors. These contracts generally provide for termination on notice and, therefore, are cancellable contracts and not considered contractual obligations and commitments. Contingencies From time to time, the Company may become subject to claims and litigation arising in the ordinary course of business. Other than as described below, the Company is not a party to any material legal proceedings, nor is it aware of any material pending or threatened litigation. On September 16, 2020, a putative class action lawsuit was filed on behalf of stockholders of the Company against the Company, the Company’s Chief Executive Officer and the Company’s current and former Chief Financial Officers. The complaint was last amended on April 13, 2021. The complaint was filed in the United States District Court for the Southern District of California and alleges that the Company made material misrepresentations and omissions regarding the safety and tolerability of tesetaxel in the Company’s public statements in violation of federal securities laws. The lawsuit seeks damages allegedly sustained by the class and an award of plaintiffs’ costs and attorney fees. The Company believes that the complaint is without merit and that it has substantive defenses to the claims of liability and damages. The Company filed a motion to dismiss the complaint on May 13, 2021, and on June 26, 2021, plaintiffs filed their opposition to the motion to dismiss. Due to the early stage of this matter, the Company is unable to estimate the possible loss or range of loss, if any, that may result from this matter. |
Stockholders' Equity
Stockholders' Equity | 6 Months Ended |
Jun. 30, 2021 | |
Equity [Abstract] | |
Stockholders' Equity | 6. Stockholders’ Equity On September 1, 2020, the Company closed an underwritten public offering of 5,614,036 shares of common stock at a public offering price of $14.25 per share (collectively with the underwriters’ option, the “September 2020 Offering”). The underwriters exercised in full their option to purchase 842,105 additional shares of common stock. The aggregate gross proceeds from the September 2020 Offering were $92.0 million, and the net proceeds were $87.4 million after deducting underwriting discounts and commissions and offering costs. On February 23, 2021, the Company entered into an Open Market Sale Agreement (the “Sale Agreement”), pursuant to which the Company may offer and sell shares of the Company’s common stock having an aggregate offering price of up to $100 million, from time to time, in “at the market” offerings. As of June 30, 2021, the Company has not sold any shares of common stock under the Sale Agreement. |
Equity Incentive Plans
Equity Incentive Plans | 6 Months Ended |
Jun. 30, 2021 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Equity Incentive Plans | 7. Equity Incentive Plans 2017 Stock Option Plan A total of 6,300,000 shares of common stock have been reserved for issuance under the Odonate Therapeutics, Inc. 2017 Stock Option Plan (the “2017 Plan”). As of June 30, 2021, 3,371,290 shares of common stock remained available for future grants under the 2017 Plan. 2017 Employee Stock Purchase Plan In March 2021, with the announcement of the discontinuation of development of tesetaxel, the Compensation Committee of the Board of Directors of the Company approved suspending the Odonate Therapeutics, Inc. 2018 Employee Stock Purchase Plan (the “ESPP”). A total of 500,000 shares of common stock have been reserved for issuance under the ESPP. As of June 30, 2021, 403,856 shares of common stock remained available for future grants under the ESPP. Management Plan The Company no longer grants incentive units under the Management Plan. Equity Awards The activity related to equity awards, which are comprised of stock options and incentive units, during the six months ended June 30, 2021 is summarized as follows: Equity Awards Weighted- average Exercise Price per Share Weighted- average Remaining Contractual Term ( 1) (years) Aggregate Intrinsic Value ( 2) (millions) Outstanding at December 31, 2020 7,229,526 $ 18.16 Granted 44,429 $ 20.45 Exercised (706,757 ) $ 1.47 Cancelled/forfeited (3,364,406 ) $ 22.16 Outstanding at June 30, 2021 3,202,792 $ 17.67 7.2 $ 0.2 Exercisable at June 30, 2021 1,574,970 $ 14.14 4.9 $ 0.2 (1) (2) The total intrinsic value of equity awards exercised during the six months ended June 30, 2021 and 2020 was $2.5 million and $1.6 million, respectively. The total fair value of equity awards vested during the six months ended June 30, 2021 and 2020 was $2.7 million and $6.9 million, respectively. Equity-based Compensation Expense For the six months ended June 30, 2021 and 2020, the weighted-average grant-date fair value per share was $11.26 and $25.71, respectively. The Company estimated the fair value of each stock option on the date of grant using the Black-Scholes option-pricing model with the following assumptions: Six Months Ended June 30, 2021 2020 Expected volatility 79% 81–82% Expected term 10 years 10 years Risk-free interest rate 0.9% 0.6–1.9% Expected dividend yield 0% 0% Under the ESPP, eligible employees may purchase shares of the Company’s common stock twice per month at a price equal to 85% of the closing price of shares of the Company’s common stock on the date of each purchase. , which is equal to a 15% discount on the shares of the Company’s common stock purchased, is recognized as equity-based compensation expense on the date of each purchase. The classification of equity-based compensation expense is summarized as follows (in thousands): Three Months Ended Six Months Ended June 30, June 30, 2021 2020 2021 2020 Equity-based compensation expense: Research and development $ 1,080 $ 2,311 $ 2,909 $ 4,613 General and administrative 259 284 529 568 Total equity-based compensation expense $ 1,339 $ 2,595 $ 3,438 $ 5,181 As of June 30, 2021, total unrecognized compensation cost related to unvested equity awards was $25.2 million. Unrecognized compensation cost related to unvested equity awards that include a performance condition related to the Company's development program was $22.0 million. Unrecognized compensation cost related to unvested equity awards that do not include a performance condition related to the Company's development program was $3.2 million, which is estimated to be recognized over a weighted-average period of 0.7 |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2021 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 8. Income Taxes For the three and six months ended June 30, 2021 and 2020, the Company did not recognize a provision for income taxes due to having recorded a full valuation allowance against its deferred tax assets. As of June 30, 2021 and December 31, 2020, the Company established a full valuation allowance against its deferred tax assets due to the uncertainty surrounding the realization of such assets. |
License Agreement
License Agreement | 6 Months Ended |
Jun. 30, 2021 | |
License Agreement [Abstract] | |
License Agreement | 9. License Agreement In 2013, the Company licensed rights to tesetaxel in all major markets from Daiichi Sankyo Company, Limited (“Daiichi Sankyo”), the original inventor of the product. Under the Daiichi Sankyo license agreement, the Company is obligated to use commercially reasonable efforts to develop and commercialize tesetaxel in the following countries: France, Germany, Italy, Spain, the United Kingdom and the U.S. The Company is required to make aggregate future milestone payments of up to $ 31.0 million, contingent on attainment of certain regulatory milestones. Additionally, the Company is obligated to pay Daiichi Sankyo a tiered royalty that ranges from the low to high single digits, depending on annual net sales of tesetaxel. To date, no payments have been made to Daiichi Sankyo under the license agreement. The license agreement and accompanying royalty obligation terminate on a country-by-country basis on the last-to-expire patent in each such country, which the Company expects will be between 2026 and 2031 in the U.S., 2025 and 2030 in European countries and 2025 and 2030 in Japan, depending on the availability and application of patent term extensions. |
Restructuring
Restructuring | 6 Months Ended |
Jun. 30, 2021 | |
Restructuring Charges [Abstract] | |
Restructuring | 10. Restructuring In March 2021, the Company announced the discontinuation of development of tesetaxel and its intent to wind down tesetaxel-related operations. Additionally, the Company committed to a plan of termination involving the termination of certain employees previously supporting the development of tesetaxel (the “Restructuring”) . The Company estimates it will incur aggregate expense related to the Restructuring of $12.0 million. The Company recorded restructuring expense of $6.2 million and $11.7 million for the three and six months ended June 30, 2021, respectively, consisting of one-time employee termination benefits to the affected employees, including severance and healthcare benefits. The classification of restructuring expense is summarized as follows (in thousands): Three Months Ended Six Months Ended June 30, June 30, 2021 2020 2021 2020 Restructuring expense: Research and development $ 5,708 $ - $ 11,173 $ - General and administrative 465 - 482 - Total restructuring expense $ 6,173 $ - $ 11,655 $ - The activity related to accrued restructuring expense during the six months ended June 30, 2021 is summarized as follows (in thousands): Restructuring Expense Accrued restructuring expense at December 31, 2020 $ - Additions 11,655 Cash payments (3,504 ) Accrued restructuring expense at June 30, 2021 $ 8,151 |
Basis of Presentation and Sum_2
Basis of Presentation and Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2021 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Use of Estimates | Basis of Presentation and Use of Estimates The Company’s condensed financial statements contained in this Quarterly Report on Form 10-Q have been prepared in accordance with generally accepted accounting principles in the U.S. (“GAAP”) The preparation of the Company’s condensed financial statements requires management to make estimates and assumptions that impact the reported amounts of assets, liabilities and expenses and the disclosure of contingent assets and liabilities in the Company’s condensed financial statements and accompanying notes. The most significant estimates and assumptions in the Company’s condensed financial statements relate to accrued expenses and equity-based compensation expense. These estimates and assumptions are based on current facts, historical experience and various other factors believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources. Actual results may differ materially and adversely from these estimates. To the extent there are material differences between the estimates and actual results, the Company’s future results of operations will be affected. |
Restructuring Expense | Restructuring Expense For one-time employee termination benefits for which no future service is required, the Company recognizes and measures a liability once the plan of termination meets all of the following criteria for an established communication date: (i) management commits to a plan of termination; (ii) the plan identifies the number of employees to be terminated and their job classifications or functions, locations and the expected completion date; (iii) the plan establishes the terms of the benefit arrangement; and (iv) it is unlikely that significant changes to the plan will be made or the plan will be withdrawn. For one-time employee termination benefits for which future service is required, a liability is recognized and measured at the communication date based on its fair value as of the termination date and recognized ratably over the future service period. The Company recognizes and measures a liability for other related costs in the period in which the liability is incurred. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements The Company has considered all recently issued accounting pronouncements and has concluded that there are no recently issued accounting pronouncements that may have a material impact on its results of operations, financial condition or cash flows based on current information. |
Net Loss per Share | Basic net loss per share is calculated by dividing net loss by the weighted-average common shares outstanding during the period, without consideration of common stock equivalents. The basic net loss per share calculation excludes 576,940 and 1,400,231 outstanding shares of common stock held by Odonate Holdings, LLC (“Odonate Holdings”) as of June 30, 2021 and 2020, respectively, to be used to settle incentive units previously issued under the Odonate Management Holdings Equity Incentive Plan (the “Management Plan”). These shares of common stock are subject to transfer to the Company and cancellation until such incentive units are vested and exercised and, as such, are considered common stock equivalents. Therefore, the shares of common stock held by Odonate Holdings are excluded from the basic net loss per share calculation until the incentive units are exercised.Diluted net loss per share is calculated by adjusting the weighted-average common shares outstanding for the dilutive effect of common stock equivalents outstanding for the period. Common stock equivalents, which consist of shares of common stock underlying incentive units and vested stock options, were excluded from the calculation of diluted net loss per share because they were anti-dilutive. |
Balance Sheet Details (Tables)
Balance Sheet Details (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Balance Sheet Related Disclosures [Abstract] | |
Summary of Property and Equipment | Property and equipment consisted of the following (in thousands): June 30, December 31, 2021 2020 Leasehold improvements $ 1,955 $ 1,955 Office equipment 701 791 Furniture and fixtures 514 514 Software 130 130 Total gross property and equipment 3,300 3,390 Less accumulated depreciation and amortization (1,299 ) (1,104 ) Property and equipment, net $ 2,001 $ 2,286 |
Summary of Accrued Expenses | Accrued expenses consisted of the following (in thousands): June 30, December 31, 2021 2020 Accrued restructuring expense (see Note 10) $ 8,151 $ - Accrued clinical development costs 4,626 9,537 Accrued compensation and related expenses 2,706 2,658 Other accrued expenses 317 52 Total accrued expenses $ 15,800 $ 12,247 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Commitments And Contingencies Disclosure [Abstract] | |
Future Minimum Lease Payments | Future minimum lease payments under operating leases as of June 30, 2021 are as follows (in thousands): 2021 $ 456 2022 935 2023 980 2024 1,010 2025 953 Thereafter 1,299 Total future minimum lease payments 5,633 Less discount (606 ) Total lease liabilities $ 5,027 |
Equity Incentive Plans (Tables)
Equity Incentive Plans (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Summary of Activity Related to Equity Awards Comprised of Stock Options and Incentive Units | The activity related to equity awards, which are comprised of stock options and incentive units, during the six months ended June 30, 2021 is summarized as follows: Equity Awards Weighted- average Exercise Price per Share Weighted- average Remaining Contractual Term ( 1) (years) Aggregate Intrinsic Value ( 2) (millions) Outstanding at December 31, 2020 7,229,526 $ 18.16 Granted 44,429 $ 20.45 Exercised (706,757 ) $ 1.47 Cancelled/forfeited (3,364,406 ) $ 22.16 Outstanding at June 30, 2021 3,202,792 $ 17.67 7.2 $ 0.2 Exercisable at June 30, 2021 1,574,970 $ 14.14 4.9 $ 0.2 (1) (2) |
Schedule of Estimated Fair Value of Equity Award on Grant Date Using Black-Scholes Option-pricing Model | The Company estimated the fair value of each stock option on the date of grant using the Black-Scholes option-pricing model with the following assumptions: Six Months Ended June 30, 2021 2020 Expected volatility 79% 81–82% Expected term 10 years 10 years Risk-free interest rate 0.9% 0.6–1.9% Expected dividend yield 0% 0% |
Summary of Equity-based Compensation Expense | The classification of equity-based compensation expense is summarized as follows (in thousands): Three Months Ended Six Months Ended June 30, June 30, 2021 2020 2021 2020 Equity-based compensation expense: Research and development $ 1,080 $ 2,311 $ 2,909 $ 4,613 General and administrative 259 284 529 568 Total equity-based compensation expense $ 1,339 $ 2,595 $ 3,438 $ 5,181 |
Restructuring (Tables)
Restructuring (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Restructuring Charges [Abstract] | |
Summary of Restructuring Expense | The classification of restructuring expense is summarized as follows (in thousands): Three Months Ended Six Months Ended June 30, June 30, 2021 2020 2021 2020 Restructuring expense: Research and development $ 5,708 $ - $ 11,173 $ - General and administrative 465 - 482 - Total restructuring expense $ 6,173 $ - $ 11,655 $ - |
Schedule of Accrued Restructuring Expense | The activity related to accrued restructuring expense during the six months ended June 30, 2021 is summarized as follows (in thousands): Restructuring Expense Accrued restructuring expense at December 31, 2020 $ - Additions 11,655 Cash payments (3,504 ) Accrued restructuring expense at June 30, 2021 $ 8,151 |
Business - Additional Informati
Business - Additional Information (Details) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2021 | Dec. 31, 2020 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | ||
Cash | $ 110,127 | $ 157,265 |
Cash requirements minimum period | 1 year |
Net Loss per Share - Additional
Net Loss per Share - Additional Information (Details) - shares | Jun. 30, 2021 | Jun. 30, 2020 |
Management Plan | ||
Earnings Per Share Basic [Line Items] | ||
Outstanding shares of common stock underlying incentive units | 576,940 | 1,400,231 |
Balance Sheet Details - Summary
Balance Sheet Details - Summary of Property And Equipment (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Property Plant And Equipment [Line Items] | ||
Total gross property and equipment | $ 3,300 | $ 3,390 |
Less accumulated depreciation and amortization | (1,299) | (1,104) |
Property and equipment, net | 2,001 | 2,286 |
Leasehold Improvements | ||
Property Plant And Equipment [Line Items] | ||
Total gross property and equipment | 1,955 | 1,955 |
Office Equipment | ||
Property Plant And Equipment [Line Items] | ||
Total gross property and equipment | 701 | 791 |
Furniture and Fixtures | ||
Property Plant And Equipment [Line Items] | ||
Total gross property and equipment | 514 | 514 |
Software | ||
Property Plant And Equipment [Line Items] | ||
Total gross property and equipment | $ 130 | $ 130 |
Balance Sheet Details - Additio
Balance Sheet Details - Additional Information (Details) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Balance Sheet Related Disclosures [Abstract] | ||||
Depreciation and amortization | $ 0.1 | $ 0.1 | $ 0.2 | $ 0.2 |
Balance Sheet Details - Summa_2
Balance Sheet Details - Summary of Accrued Expenses (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Payables And Accruals [Abstract] | ||
Accrued restructuring expense | $ 8,151 | |
Accrued clinical development costs | 4,626 | $ 9,537 |
Accrued compensation and related expenses | 2,706 | 2,658 |
Other accrued expenses | 317 | 52 |
Total accrued expenses | $ 15,800 | $ 12,247 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||
Oct. 01, 2019 | Feb. 28, 2018 | Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Mar. 31, 2018 | |
Operating Lease [Line Items] | |||||||
Aggregate payments under lease | $ 5,633 | $ 5,633 | |||||
Aggregate payment of rental expense | $ 200 | $ 200 | $ 300 | $ 400 | |||
Operating lease, Weighted average remaining lease term | 5 years 10 months 24 days | 5 years 10 months 24 days | |||||
Operating lease, Weighted average discount rate, Percent | 4.00% | 4.00% | |||||
Cash paid for amounts included in measurement of lease liabilities | $ 200 | $ 100 | $ 400 | $ 200 | |||
New York | |||||||
Operating Lease [Line Items] | |||||||
Aggregate payments under lease | $ 2,800 | ||||||
Lease initial term | 7 years | ||||||
Existence of option to extend | true | ||||||
Additional lease extended term | 3 years | ||||||
Restricted cash | 300 | 300 | |||||
Lease commencement period | 2018-10 | ||||||
San Diego | |||||||
Operating Lease [Line Items] | |||||||
Aggregate payments under lease | $ 4,100 | $ 1,000 | |||||
Lease initial term | 7 years 6 months | 2 years 3 months 18 days | |||||
Existence of option to extend | true | ||||||
Additional lease extended term | 5 years | ||||||
Restricted cash | $ 500 | $ 500 | |||||
Lease commencement period | 2020-07 | ||||||
San Diego | Minimum | |||||||
Operating Lease [Line Items] | |||||||
Sublease percentage | 70.00% | ||||||
Old San Diego [Member] | |||||||
Operating Lease [Line Items] | |||||||
Lease commencement period | 2018-03 | ||||||
Letter of Credit | New York | |||||||
Operating Lease [Line Items] | |||||||
Security deposit | $ 300 | ||||||
Letter of Credit | San Diego | |||||||
Operating Lease [Line Items] | |||||||
Security deposit | $ 500 |
Commitments and Contingencies_2
Commitments and Contingencies - Future Minimum Lease Payments (Details) $ in Thousands | Jun. 30, 2021USD ($) |
Commitments And Contingencies Disclosure [Abstract] | |
2021 | $ 456 |
2022 | 935 |
2023 | 980 |
2024 | 1,010 |
2025 | 953 |
Thereafter | 1,299 |
Total future minimum lease payments | 5,633 |
Less discount | (606) |
Total lease liabilities | $ 5,027 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Details) - USD ($) $ / shares in Units, $ in Millions | Feb. 23, 2021 | Sep. 01, 2020 | Jun. 30, 2021 |
Subsidiary Sale Of Stock [Line Items] | |||
Net proceeds from sale of common stock | $ 87.4 | ||
Gross proceeds from sale of common stock | $ 92 | ||
Sale of common stock, number of shares issued | 5,614,036 | 842,105 | |
Sale of common stock, price per share | $ 14.25 | ||
Sale Agreement | Maximum | |||
Subsidiary Sale Of Stock [Line Items] | |||
At-the-market offering, aggregate offering price | $ 100 |
Equity Incentive Plans - Additi
Equity Incentive Plans - Additional Information (Details) - USD ($) | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total intrinsic value of equity awards exercised | $ 2,500,000 | $ 1,600,000 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested in Period, Fair Value | $ 2,700,000 | $ 6,900,000 |
Weighted average grant-date fair value per equity award | $ 11.26 | $ 25.71 |
Unrecognized equity-based compensation expense not yet recognized | $ 25,200,000 | |
Unrecognized equity-based compensation expense not yet recognized, period for recognition | 8 months 12 days | |
Unrecognized equity-based compensation expense including performance condition | $ 22,000,000 | |
Unrecognized equity-based compensation expense not including performance condition | $ 3,200,000 | |
2017 Plan | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Number of common stock reserved for issuance | 6,300,000 | |
Common stock available for future grants | 3,371,290 | |
ESPP | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Number of common stock reserved for issuance | 500,000 | |
Common stock available for future grants | 403,856 | |
Purchase price of common stock as percentage of fair value of common stock | 85.00% | |
Percentage of discount to employees on purchase of common stock | 15.00% | |
Unrecognized equity-based compensation expense not yet recognized | $ 0 | |
Management Plan | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Outstanding shares of common stock underlying incentive units | 576,940 |
Equity Incentive Plans - Summar
Equity Incentive Plans - Summary of Activity Related to Equity Awards Comprised of Stock Options and Incentive Units (Details) $ / shares in Units, $ in Millions | 6 Months Ended |
Jun. 30, 2021USD ($)$ / sharesshares | |
Equity Awards | |
Equity awards outstanding, Beginning balance | shares | 7,229,526 |
Equity awards, Granted | shares | 44,429 |
Equity awards, Exercised | shares | (706,757) |
Equity awards, Cancelled/forfeited | shares | (3,364,406) |
Equity awards outstanding, Ending balance | shares | 3,202,792 |
Equity awards exercisable | shares | 1,574,970 |
Weighted Average Exercise Price per Share | |
Weighted average exercise price per share outstanding, Beginning balance | $ / shares | $ 18.16 |
Weighted average exercise price per share outstanding, Granted | $ / shares | 20.45 |
Weighted average exercise price per share outstanding, Exercised | $ / shares | 1.47 |
Weighted average exercise price per share outstanding, Cancelled/forfeited | $ / shares | 22.16 |
Weighted average exercise price per share outstanding, Ending balance | $ / shares | 17.67 |
Weighted average exercise price per share, Exercisable | $ / shares | $ 14.14 |
Weighted-Average Remaining Contractual Term | |
Weighted average remaining contractual term (years), outstanding | 7 years 2 months 12 days |
Weighted average remaining contractual term (years), exercisable | 4 years 10 months 24 days |
Aggregate Intrinsic Value, Outstanding | $ | $ 0.2 |
Aggregate Intrinsic Value, Exercisable | $ | $ 0.2 |
Equity Incentive Plans - Summ_2
Equity Incentive Plans - Summary of Activity Related to Equity Awards Comprised of Stock Options and Incentive Units (Parenthetical) (Details) | Jun. 30, 2021$ / shares |
Stockholders Equity Note [Abstract] | |
Share price | $ 3.49 |
Equity Incentive Plans - Schedu
Equity Incentive Plans - Schedule of Estimated Fair Value of Equity Award on Grant Date Using Black-Scholes Option-pricing Model (Details) | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected term | 10 years | 10 years |
Expected dividend yield | 0.00% | 0.00% |
Minimum | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected volatility | 79.00% | 81.00% |
Risk-free interest rate | 0.90% | 0.60% |
Maximum [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected volatility | 82.00% | |
Risk-free interest rate | 1.90% |
Equity Incentive plans - Summ_3
Equity Incentive plans - Summary of Equity-based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total equity-based compensation expense | $ 1,339 | $ 2,595 | $ 3,438 | $ 5,181 |
Research and Development | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total equity-based compensation expense | 1,080 | 2,311 | 2,909 | 4,613 |
General and Administrative | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total equity-based compensation expense | $ 259 | $ 284 | $ 529 | $ 568 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |||||
Provision for income taxes | $ 0 | $ 0 | $ 0 | $ 0 | |
Unrecognized tax benefits | $ 0 | $ 0 | $ 0 |
License Agreement - Additional
License Agreement - Additional Information (Details) $ in Millions | Dec. 31, 2013USD ($) |
Tesetaxel | Daiichi Sankyo | |
License Agreement [Line Items] | |
Aggregate future milestone payments | $ 31 |
Restructuring - Additional Info
Restructuring - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | |
Restructuring And Related Activities [Abstract] | |||
Restructuring expenses | $ 6,173 | $ 11,655 | |
Expected restructuring expenses | $ 12,000 |
Restructuring - Summary of Rest
Restructuring - Summary of Restructuring Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended |
Jun. 30, 2021 | Jun. 30, 2021 | |
Restructuring Cost And Reserve [Line Items] | ||
Restructuring expenses | $ 6,173 | $ 11,655 |
Research and Development | ||
Restructuring Cost And Reserve [Line Items] | ||
Restructuring expenses | 5,708 | 11,173 |
General and Administrative | ||
Restructuring Cost And Reserve [Line Items] | ||
Restructuring expenses | $ 465 | $ 482 |
Restructuring - Schedule of Acc
Restructuring - Schedule of Accrued Restructuring Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended |
Jun. 30, 2021 | Jun. 30, 2021 | |
Restructuring And Related Activities [Abstract] | ||
Additions | $ 6,173 | $ 11,655 |
Cash payments | (3,504) | |
Accrued restructuring expense | $ 8,151 | $ 8,151 |