UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)

For the quarterly period ended March 31, 20202021

OR

For the transition period from                         to                        

Commission File Number: 001-38318

Odonate Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

4747 Executive Drive, Suite 5103 East 28th Street, 10th Floor

San Diego, CA 92121New York, New York 10016

(858) 731-8180(332) 206-0935

(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)

Securities registered pursuant to Section 12(b) of the Exchange Act:

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 (the “Exchange Act”) during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes  ☒    No  ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).    Yes  ☒    No  ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.    ☒

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).    Yes  ☐    No  ☒

As of April 17, 2020,May 7, 2021, there were 32,095,39438,507,109 shares of common stock outstanding.

TABLE OF CONTENTS

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PART I. FINANCIALFINANCIAL INFORMATION

Item 1. Financial Statements

ODONATE THERAPEUTICS, INC.

Condensed Balance Sheets

(in thousands, except par value and share amounts)

See accompanying notes.

3

ODONATE THERAPEUTICS, INC.

Condensed Statements of Operations

(Unaudited)

(in thousands, except share and per share amounts)

See accompanying notes.

4

ODONATE THERAPEUTICS, INC.

Condensed Statements of Stockholders’ Equity

(Unaudited)

(in thousands, except share amounts)

See accompanying notes.

5

ODONATE THERAPEUTICS, INC.

Condensed Statements of Cash Flows

(Unaudited)

(in thousands)

See accompanying notes.

ODONATE THERAPEUTICS, INC.

Notes to Condensed Financial Statements

(Unaudited)

1. Business

Odonate Therapeutics, Inc. (“Odonate” or the “Company”) is a pharmaceutical company dedicated to the development of best-in-class therapeutics that improve and extend the lives of patients with cancer. The Company’s initial focus isformerly 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. 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, enablingThe Company recently announced the maintenancediscontinuation of adequate drug levels with relatively infrequent dosing; no historydevelopment of hypersensitivity (allergic) reactions;tesetaxel and significant activity against chemotherapy-resistant tumors. In patients with metastatic breast cancer (“MBC”), tesetaxel was shownits intent to have significant, single-agent antitumor activity in two multicenter, Phase 2 studies.wind down tesetaxel-related operations. The Company is currently conducting threeworking with clinical sites to transition patients in ongoing tesetaxel studies in breast cancer, including a multinational, multicenter, randomized, Phase 3 study in patientsto appropriate alternative therapies or facilitate continuation of treatment with MBC, known as CONTESSA. The Company’s goal for tesetaxel is to develop an effective chemotherapy choice for patients that provides quality-of-life advantages over current alternatives.under compassionate use programs where appropriate.

As of March 31, 2020,2021, the Company had $153.1$133.2 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”).

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”)for interim financial information and with the instructions to Form 10-Q and Article 108 of SEC Regulation S-X. Accordingly, certain information and disclosures required by GAAP for annual financial statements have been omitted. In the opinion of management, all adjustments, consisting of normal recurring adjustments, considered necessary for a fair presentation have been included. Interim financial results are not necessarily indicative of results anticipated for the full year. These condensed financial statements should be read in conjunction with the Company’s audited financial statements and accompanying notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019.2020.

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 three months ended March 31, 2020,2021, 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, 2019.2020.

7

ODONATE THERAPEUTICS, INC.

Notes to Condensed Financial Statements

(Unaudited)

Restructuring Expense

The Company recognizes and measures a liability for one-time employee termination benefits for which no future service is required 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 termination benefits for which future service is required, a liability is 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.

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 1,451,202584,515 and 1,974,7931,451,202 outstanding shares of common stock held by Odonate Holdings, LLC (“Odonate Holdings”) as of March 31, 20202021 and 2019,2020, 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.

4. Balance Sheet Details

Property and equipment consisted of the following (in thousands):

Depreciation and amortization expense was $0.1 million for both the three months ended March 31, 20202021 and 2019.2020.

8

ODONATE THERAPEUTICS, INC.

Notes to Condensed Financial Statements

(Unaudited)

Accrued expenses consisted of the following (in thousands):

5. Commitments and Contingencies

Lease Commitments

In March 2018, the Company entered into an agreement to lease office space in San Diego, California (the “San Diego Lease”) with aggregate payments of approximately $0.8 million over the term of the lease. The San Diego Lease originally provided for expiration on December 31, 2019. In August 2019, the Company entered into a First Amendment to the San Diego Lease to extend the term of the lease through the earlier of May 30, 2020 or 30 days from the date the Company provides written notice to the landlord. The 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 $4.3 million over the 7.5-year term of the lease. The San Diego Lease terminates on commencement of the New San Diego Lease. The Company has an option to extend the New San Diego Lease for an additional 5 years at the end of the initial term. Further, the Company provided a standby letter of credit of $0.5 million as a security deposit during the term of the lease, subject to certain reductions beginning 4 years after the lease commencement. As of March 31, 2020, $0.5 million was pledged as collateral for the letter of credit and recorded as restricted cash.

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 3.5 years after the lease commencement. As of March 31, 2020,2021, $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.

Future minimumIn 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 underof 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 YorkSan Diego Lease asfor 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 4 years after the lease commencement. As of March 31, 2020 are2021, $0.5 million was pledged as follows (in thousands):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 New York Leaseoperating leases based on the present value of lease payments over the expected lease term, discounted using the Company’s incremental borrowing rate. The optionoptions to extend the New York Lease wasoperating leases were not recognized as part of the Company’s lease liabilityliabilities and right-of-use lease asset.assets. As of March 31, 2021, the weighted-average remaining lease term and the weighted-average discount rate for the operating leases was 6.1 years and 4.0%, respectively. Rent expense under leases was $0.2 million for both the three months ended March 31, 2021 and 2020. Cash paid for amounts included in the measurement of lease liabilities was $0.2 million and $0.1 million for the three months ended March 31, 2021 and 2020, and 2019.respectively.

9

ODONATE THERAPEUTICS, INC.

Notes to Condensed Financial Statements

(Unaudited)

Future minimum lease payments under operating leases as of March 31, 2021 are as follows (in thousands):

Other Commitments

The Company enters into contracts in the normal course of business with third-party contract research organizations, 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. TheOther 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. 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.

6. Stockholders’ Equity

On June 28, 2019,September 1, 2020, the Company closed an underwritten public offering (the “June 2019 Offering”) of 4,750,0005,614,036 shares of common stock at a public offering price of $26.00$14.25 per share. On July 2, 2019,share (collectively with the underwriters’ option, the “September 2020 Offering”). The underwriters exercised in full their option to purchase 712,500842,105 additional shares of common stock. The aggregate gross proceeds from the June 2019September 2020 Offering were $142.0$92.0 million, and the net proceeds were $135.1$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 March 31, 2021, the Company has not sold any shares of common stock under the Sale Agreement.

10

ODONATE THERAPEUTICS, INC.

Notes to Condensed Financial Statements

(Unaudited)

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 March 31, 2020, 1,588,4952021, 1,072,055 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 Odonate Therapeutics, Inc. 2017 Employee Stock Purchase Plan (the “ESPP”).ESPP. As of March 31, 2020, 445,9662021, 403,856 shares of common stock remained available for future grants under the ESPP.

Management Plan

The Company issued an aggregate of 2,931,402 no longer grants incentive units under the Management Plan. Following the Company’s initial public offering in December 2017, the Company has not granted, and will no longer grant, any incentive units. As of March 31, 2020, 1,451,2022021, 584,515 outstanding shares of common stock were held by Odonate Holdings to be used to settle incentive units previously issued under the Management Plan.

Equity Awards

The activity related to equity awards, which are comprised of stock options and incentive units, during the three months ended March 31, 20202021 is summarized as follows:

⁽¹⁾     Represents the weighted-average remaining contractual term of stock options. The incentive units have no expiration.do not expire.

⁽²⁾     Aggregate intrinsic value represents the product of the number of equity awards outstanding or equity awards exercisable multiplied by the difference between the Company’s closing stock price per share on the last trading day of the period, which was $27.61$3.42 as of March 31, 2020,2021, and the exercise price.

The total intrinsic value of equity awards exercised during the three months ended March 31, 2021 and 2020 and 2019 was $0.3$2.5 million and $2.0$0.3 million, respectively. The total fair value of equity awards vested during the three months ended March 31, 2021 and 2020 was $2.2 million and 2019 was $2.7 million, and $4.0 million, respectively.

11

ODONATE THERAPEUTICS, INC.

Notes to Condensed Financial Statements

(Unaudited)

Equity-based Compensation Expense

For the three months ended March 31, 20202021 and 2019,2020, the weighted-average grant-date fair value per share was $25.22$11.26 and $11.24,$25.22, respectively. The Company estimated the fair value of each stock option on the date of grant date using the Black-Scholes option-pricing model with the following assumptions:

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. The benefit received by the employees, 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):

As of March 31, 2020,2021, total unrecognized compensation cost related to unvested equity awards was $61.2$54.7 million, which is estimated to be recognized over a weighted-average period of 3.0years.2.5 years. As of March 31, 2020,2021, there was no0 unrecognized compensation cost related to shares of common stock issued under the ESPP.

8. Income Taxes

For the three months ended March 31, 20202021 and 2019,2020, the Company did not0t recognize a provision for income taxes due to having recorded a full valuation allowance against its deferred tax assets. As of March 31, 20202021 and December 31, 2019,2020, the Company established a full valuation allowance against its deferred tax assets due to the uncertainty surrounding the realization of such assets.As of March 31, 20202021 and December 31, 2019,2020, the Company had no0 unrecognized tax benefits. The Company does not anticipate there will be a significant change in unrecognized tax benefits within the next 12 months.

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-

12

ODONATE THERAPEUTICS, INC.

Notes to Condensed Financial Statements

(Unaudited)

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.

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, with substantially all of such expense being incurred by June 30, 2021. For the three months ended March 31, 2021, the Company recorded restructuring expense of $5.5 million, 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):

The activity related to accrued restructuring expense, which is recorded as accrued expenses, during the three months ended March 31, 2021 is summarized as follows (in thousands):

Item 2. Management’s Discussion and Analysis ofof Financial Condition and Results of Operations

You should read the following discussion and analysis of our financial condition and results of operations together with our condensed financial statements and accompanying notes included in this Quarterly Report on Form 10-Q and our audited financial statements and accompanying notes included in our Annual Report on Form 10-K for the year ended December 31, 2019.2020.

Forward-looking Statements

This Quarterly Report on Form 10-Q contains “forward-looking statements” within the meaning of the federal securities laws, and such statements may involve substantial risks and uncertainties. All statements, other than statements of historical facts included in this Quarterly Report on Form 10-Q, including, but not limited to, statements concerningconcerning: expectations regarding our plans, objectives, goals, strategies, future events, future revenues or performance, future expenses, financing needs, plans or intentionspotential liabilities relating to acquisitions, business trendslitigation and financing needs; and other information referred to under this section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations”Operations,” are forward-looking statements. Forward-looking statements generally relate to future events or our future financial or operating performance. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “plan,” “anticipate,” “target,” “forecast” or the negative of these terms and similar expressions intended to identify forward-looking statements. Forward-looking statements are not historical facts and reflect our current views with respect to future events. Forward-looking statements are also based on assumptions and are subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements.

There are a number of risks, uncertainties and other important factors that could cause our actual results to differ materially from the forward-looking statements contained in this Quarterly Report on Form 10-Q. Such risks, uncertainties and other factors are described under “Risk Factors” in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 20192020 and under “Risk Factors” in Item 1A of this Quarterly Report on Form 10-Q. We caution you that these risks, uncertainties and other factors may not contain all of the risks, uncertainties and other factors that are important to you. In addition, we cannot assure you that we will realize the results, benefits or developments that we expect or anticipate or, even if substantially realized, that they will result in the consequences or affect us or our business in the way expected. All forward-looking statements in this Quarterly Report on Form 10-Q apply only as of the date made and are expressly qualified in their entirety by the cautionary statements included in this Quarterly Report on Form 10-Q. We undertake no obligation to publicly update or revise any forward-looking statements to reflect subsequent events or circumstances.

Company Overview

We are a pharmaceutical company dedicated to the development of best-in-class therapeutics that improve and extend the lives of patients with cancer. Our initial focus isformerly 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. 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, enablingWe recently announced the maintenancediscontinuation of adequate drug levels with relatively infrequent dosing; no historydevelopment of hypersensitivity (allergic) reactions;tesetaxel and significant activity against chemotherapy-resistant tumors. In patients with metastatic breast cancer (“MBC”), tesetaxel was shownour intent to have significant, single-agent antitumor activity in two multicenter, Phase 2 studies.wind down tesetaxel-related operations. We are currently conducting threeworking with clinical sites to transition patients in ongoing tesetaxel studies in breast cancer, as shown in the following table, including a multinational, multicenter, randomized, Phase 3 study in patientsto appropriate alternative therapies or facilitate continuation of treatment with MBC, known as CONTESSA. Enrollment in CONTESSA is complete, and we expect to report top-line results from this study in the third quarter of 2020. Our goal for tesetaxel is to develop an effective chemotherapy choice for patients that provides quality-of-life advantages over current alternatives.

Ongoing Tesetaxel Clinical Studies

CONTESSA

We are conducting a multinational, multicenter, randomized, Phase 3 study, known as CONTESSA, that is comparing tesetaxel dosed orally at 27 mg/m² on the first day of a 21-day cycle plus a reduced dose of capecitabine (1,650 mg/m²/day on the first 14 days of a 21-day cycle) to the approved dose of capecitabine alone (2,500 mg/m²/day on the first 14 days of a 21-day cycle) in approximately 600 patients with human epidermal growth factor receptor 2 (“HER2”) negative, hormone receptor (“HR”) positive MBC previously treated with a taxane in the neoadjuvant (prior to surgery) or adjuvant (immediately following surgery) setting. Where indicated, patients must have received endocrine therapy with or without a cyclin-dependent kinase (“CDK”) 4/6 inhibitor. CONTESSA’s primary endpoint is progression-free survival (“PFS”) assessed by an Independent Radiologic Review Committee (“IRC”). CONTESSA’s secondary endpoints are overall survival (“OS”), objective response rate (“ORR”) assessed by IRC and disease control rate (“DCR”) assessed by IRC.

In May 2019, the Independent Data Monitoring Committee (the “IDMC”) for CONTESSA recommended that the study continue with no modifications following a planned interim efficacy futility analysis. The interim efficacy futility analysis was based on a pre-specified analysis of the first approximate 100 PFS events that occurred in the study. The purpose of the interim efficacy futility analysis was to facilitate the early termination of the study if the IDMC determined that achieving a positive outcome on the primary endpoint would be futile.

In October 2019, we announced that enrollment in CONTESSA was complete. We expect to report top-line results from CONTESSA in the third quarter of 2020.

CONTESSA 2

CONTESSA 2 is a multinational, multicenter, Phase 2 study of tesetaxel, an investigational, orally administered taxane, in patients with 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 HER2 negative, 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 CDK 4/6 inhibitor. Patients with central nervous system (“CNS”) metastases are eligible. The primary endpoint is ORR as assessed by an IRC. The secondary efficacy endpoints are duration of response (“DoR”) as assessed by the IRC, PFS as assessed by the IRC, DCR as assessed by the IRC and OS.

CONTESSA TRIO

CONTESSA TRIO is a multi-cohort, multicenter, Phase 2 study of tesetaxel, an investigational, orally administered taxane, in patients with MBC.

Components of Our Results of Operations

Research and Development Expense

Research and development expense consists primarily of costs associated with the development of our product candidates and includes: (i) salaries, benefits, travel, equity-based compensation expense and facility-related expense for personnel engaged in research and development functions; (ii) expense incurred under agreements with contract research organizations (“CROs”), investigative sites and consultants that conduct our nonclinical and clinical studies; (iii) manufacturing development and scale-up expense and the cost of acquiring and manufacturing clinical study materials and commercial materials, including manufacturing registration and validation batches; (iv) payments to consultants engaged in the development of our product candidates, including travel and other expense; and (v) costs related to compliance with quality and regulatory requirements.

Research and development expense is charged to operations as incurred when the expenditures relate to our research and development efforts and have no alternative future use. Payments made prior to the receipt of goods or services to be used in research and development are capitalized until the goods or services are received.

All of our research and development expense incurred to date has been incurred in connection with the development of tesetaxel. We expect our research and development expense to increase in the near term in connection with the development of tesetaxel.

General and Administrative Expense

General and administrative expense consists primarily of salaries, benefits, travel, equity-based compensation expense and facility-related expense for personnel engaged in finance and administrative functions. General and administrative expense also includes professional fees for legal, patent, consulting, accounting and audit services and other related costs. We do not expect our general and administrative expense to change significantly in the near term.

Interest Income

Interest income consists of income generated from cash held in savings accounts.compassionate use programs where appropriate.

Results of Operations

The following table summarizes our results of operations for each of the periods below (in thousands):

Research and Development Expense

All of our research and development expense incurred until recently had been incurred in connection with the development of tesetaxel and recently includes the wind-down of tesetaxel-related operations. Research and development expense includes non-personnel-related and personnel-related expense. Non-personnel-related expense primarily consists of expense incurred prior to the discontinuation of development of tesetaxel and includes expense related to: (i) manufacturing development and scale-up, including manufacturing registration and validation batches of tesetaxel; (ii) clinical study site payments; (iii) acquiring clinical study materials and the clinical study supply chain; (iv) pharmacokinetic studies; and (v) clinical and quality systems. Personnel-related expense includes expense related to salaries, benefits, restructuring expense and equity-based compensation for personnel engaged in research and development functions. We expect our research and development expense to decrease significantly due to the discontinuation of development of tesetaxel and wind-down of tesetaxel-related operations.

The following table summarizes our research and development expense for each of the periods below (in thousands):

Research and development expense was $27.9$30.9 million and $26.6$27.9 million for the three months ended March 31, 20202021 and 2019,2020, respectively. The increase in research and development expense was due primarily to increased$5.5 million recorded for restructuring expense related to one-time employee termination benefits in connection with the discontinuation of development of tesetaxel, offset by a decrease in activities and headcount in connection with our tesetaxel clinical development program.

General and Administrative Expense

General and administrative expense includes non-personnel and personnel-related expense. Non‑personnel-related expense includes expense related to: (i) professional fees for legal, patent, consulting, accounting and audit services; (ii) facilities and information technology; and (iii) insurance. Personnel‑related expense includes expense related to salaries, benefits, restructuring expense and equity-based compensation for personnel engaged in finance and administrative functions. We expect our general and administrative expense to decrease significantly due to the discontinuation of development of tesetaxel and wind‑down of tesetaxel-related operations.

The following table summarizes our general and administrative expense for each of the periods below (in thousands):

General and administrative expense of $2.9 million for the three months ended March 31, 20202021 remained consistent compared to $2.6$2.9 million for the same period in 2019.2020.

InterestOther Income, Net

InterestOther income, net consists primarily of interest income generated from cash held in savings accounts. Other income, net also includes losses on disposal of property and equipment and gains and losses on foreign currency transactions.

Other income, net was $0.1 million and $0.7 million for the three months ended March 31, 2021 and 2020, remained consistent comparedrespectively. The decrease in other income, net was due primarily to $0.6 million for the same period in 2019.decreased interest income.

Liquidity and Capital Resources

As of March 31, 20202021 and December 31, 2019,2020, we had cash in the amount of $153.1$133.2 million and $180.5$157.3 million, respectively. We believe that our existing cash will be sufficient to meet our 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”).

We have incurred lossesNet cash used in each year since our inception. Our net lossoperating activities was $30.2$24.9 million and $28.6$27.8 million for the three months ended March 31, 20202021 and 2019, respectively. As of March 31, 2020, and December 31, 2019, we had an accumulated deficit of $270.2 million and $240.1 million, respectively. Substantially all of our operating losses resulted from expenses incurred in connection with

advancing tesetaxel through development activities and general and administrative costs associated with our operations.

To date, we have funded our operations through the sale of equity securities. Since our inception, we have raised $377.6 million in net proceeds from the sale of equity securities.

The following table summarizes our net cash flow activity for each of the periods below (in thousands):

Net cash used in operating activities was $27.8 million and $27.1 million for the three months ended March 31, 2020 and 2019, respectively. Net cash used in operating activities was primarily the result of our net loss and change in working capital, partially offset by equity-based compensation expense, and depreciation and amortization expense and non-cash lease expense.

Net cash used in investing activities was $19,000 and $41,000 forWe entered into an Open Market Sale Agreement during the three months ended March 31, 2020 and 2019, respectively. Net cash used2021; see Note 6 to our condensed financial statements included in investing activities was the resultItem 1 of purchases of property and equipment.this Quarterly Report on Form 10-Q.

Net cash provided by financing activities was $0.5 million and $0.2 million for the three months ended March 31, 2020 and 2019, respectively. Net cash provided by financing activities was the result of proceeds from the issuance of common stock under employee stock plans.

Until such time as we can generate substantial product revenues, weWe expect to finance our future cash needs with cash on hand. If necessary or appropriate, we may raise additional capital through a combination of equity offerings, debt financings, collaborations, strategic partnerships andor licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders will be or could be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through collaborations, strategic partnerships or licensing arrangements with third parties, we may have to relinquish valuable rights to our product candidates, associated intellectual property our other technologies, future revenue streams or research programs or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market our product candidate even if we would otherwise prefer to develop and market such product candidate ourselves.

Contractual Obligations and Commitments

In March 2018, we entered into an agreement to lease office space in San Diego, California (the “San Diego Lease”) with aggregate payments of approximately $0.8 million over the term of the lease. The San Diego Lease originally provided for expiration on December 31, 2019. In August 2019, the Company entered into a First AmendmentSee Note 5 to the San Diego Lease to extendcondensed financial statements included in Item 1 of this Quarterly Report on Form 10-Q, under the term of thesubheading “Lease Commitments,” for information regarding our material lease through the earlier of May 30, 2020 or 30 days from the date the Company provides written notice to the landlord.

In October 2019, we entered into anagreements and Note 9 for information regarding our license agreement to lease office space in San Diego, California (the “New San Diego Lease”) with aggregate payments of approximately $4.3 million over the 7.5-year term of the lease. The San Diego Lease terminates on commencement of the New San Diego Lease. We have an option to extend the New San Diego Lease for an additional 5 years at the end of the initial term. Further, we provided a standby letter of credit of $0.5 million as a security deposit during the term of the lease, subject to certain reductions beginning 4 years after the lease commencement. As of March 31, 2020, $0.5 million was pledged as collateral for the letter of credit and recorded as restricted cash.

In February 2018, we 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. We have an option to extend the New York Lease for an additional three years at the end of the initial term. Further, we 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 3.5 years after the lease commencement. As of March 31, 2020, $0.3 million was pledged as collateral for the letter of credit and was recorded as restricted cash.

We enter into contracts in the normal course of business with CROs, 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.

In 2013, we 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, we are obligatedfor rights 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. We are required to make aggregate future milestone payments of up to $31.0 million, contingent on attainment of certain regulatory milestones. Additionally, we are obligated to pay Daiichi Sankyo a tiered royalty that ranges from the low to high single digits, depending on annual net sales of tesetaxel.

Off–Balance Sheet Arrangements

During the periods presented, we did not have, nor do we currently have, any off–balance sheet arrangements as defined under the rules of the SEC.

Jumpstart Our Business Startups Act

We are an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”). Under this act, an emerging growth company can delay the adoption of new or revised accounting standards issued subsequent to the enactment of the JOBS Act until those standards would otherwise apply to private companies. We have irrevocably elected not to avail ourselves of this exemption from new or revised accounting standards and, therefore, will be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies. However, we intend to rely on other exemptions provided by the JOBS Act, including without limitation, not being required to comply withan exemption from the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley Act of 2002, as amended. We will remain an emerging growth company until December 31, 2023 unless, prior to that time, we: (i) have more than $1.07 billion in annual gross revenue; (ii) have a market value for shares of our common stock held by non-affiliates of more than $700 million as of the last day of our second quarter of any year; or (iii) issue more than $1.0 billion of non-convertible debt over a three-year period.

Critical Accounting Policies and Significant Judgments and Estimates

We believe the estimates, assumptions and judgments involved in the accounting policies described in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Item 7 of our Annual Report on Form 10-K for the year ended December 31, 20192020 are most critical to

understanding and evaluating our reported financial results. During the three months ended March 31, 2020,2021, there were no changes to our critical accounting policies and estimates as described in Item 7 of our Annual Report on Form 10-K for the year ended December 31, 2019.2020.

Recent Accounting Pronouncements

See Note 2 to our condensed financial statements included in Item 1 of this Quarterly Report on Form 10-Q.

Item 3. Quantitative and Qualitative Disclosures about Market Risk

We are a smaller reporting company, as defined by Rule 12b-2 under the Securities and Exchange Act of 1934 and in Item 10(f)(1) of Regulation S-K, and are not required to provide the information under this item.

Item 4. Controls and Procedures

Management’s Evaluation of our Disclosure Controls and Procedures

Our management, with the participation of our principal executive officer and our principal financial officer, evaluated, as of the end of the period covered by this Quarterly Report on Form 10-Q, the effectiveness of our disclosure controls and procedures. Based on that evaluation of our disclosure controls and procedures as of March 31, 2020,2021, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures as of such date are effective at the

reasonable assurance level. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934 (the “Exchange Act”), means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act are recorded, processed, summarized and reported within the time periods specified in the U.S. Securities and Exchange Commission’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by us in the reports we file or submit under the Exchange Act is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives, and our management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

Changes in Internal Control over Financial Reporting

There was no change in our internal control over financial reporting that occurred during our most recent quarter that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

PART II. OTHEROTHER INFORMATION

Item 1. Legal Proceedings

From timeSee Note 5 to time, we may become subject to claims and litigation arisingthe condensed financial statements included in the ordinary courseItem 1 of business. We are not a party to any material legal proceedings, nor are we aware of any material pending or threatened litigation.this Quarterly Report on Form 10-Q.

Item 1A. Risk Factors

Our business is subject to various risks, including those described in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2019.2020. There have been no material changes from the risk factors disclosed in Item 1A of our Annual Report on Form 10-K, except for the additional risk factorfactors set forth below.

The ongoing COVID-19 pandemicRisks Related to Our Business

If we decide to dissolve and liquidate our company, the amount of cash that may disruptbe available for distribution to our operationsstockholders is uncertain.

If our board of directors decides to pursue a dissolution and affectliquidation of our abilitycompany, the amount of cash that may be available for distribution to successfully conduct clinical studies.

We are unableour stockholders is uncertain. This amount will depend on the resolution of our financial commitments and contingent liabilities and the timing of the decision to accurately predict the full impact that the ongoing Coronavirus Disease 2019 (“COVID-19”) pandemic will have on our results from operations,liquidate. Our financial conditioncommitments and contingent liabilities include: (i) personnel costs, including severance; (ii) contractual obligations to vendors and clinical studies duestudy sites; (iii) non-cancelable lease obligations; and (iv) existing and potential litigation against us.

Risks Related to numerous factors thatOwnership of Shares of Our Common Stock

If we are not within our control, includingable to comply with the duration and severityapplicable continued listing requirements or standards of the outbreak. Stay-at-home orders, business closures, travel restrictions, supply chain disruptionsNasdaq Global Select Market, our common stock could be delisted.

Our common stock is currently listed on the Nasdaq Global Select Market. To maintain this listing, we must satisfy continued listing requirements and employee illness or quarantines could result in disruptionsstandards. There can be no assurances that we will be able to our operations, which could adversely impact our results from operationscomply with the applicable listing requirements and financial condition. In addition, the COVID-19 pandemic has resulted in ongoing volatility in financial markets. standards.

If our access to capitalcommon stock is restricteddelisted from the Nasdaq Global Select Market and is not eligible for quotation or associated borrowing costs increase as a resultlisting on another market or exchange, trading of developments in financial markets relating to the COVID-19 pandemic, our operations and financial conditionshares of common stock could be adversely impacted.conducted only in the over-the-counter market or on an electronic bulletin board established for unlisted securities. In such event, it would likely become more difficult to dispose of, or obtain accurate price quotations for, shares of our common stock.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

None.

Item 3. Defaults upon Senior Securities

None.

Item 4. Mine Safety Disclosures

Not applicable.

Item 5. Other Information

None.

Item 6. Exhibits

Exhibits

104

Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)

SIGNATURESSIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.