10-Q

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended March 31, 2020

OR

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from                         to                        

Commission File Number: 001-38318

Odonate Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

Delaware	82-2493065
(State or other jurisdiction of incorporation or organization)	(I.R.S. Employer Identification No.)

4747 Executive Drive, Suite 510

San Diego, CA 92121

(858) 731-8180

(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:

Title of Each Class	Trading Symbol	Name of Each Exchange on Which Registered
Common Stock, $0.01 par value per share	ODT	Nasdaq Global Select Market

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 definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer	☐	Accelerated filer	☒
Non-accelerated filer	☐	Smaller reporting company	☒
		Emerging growth company	☒

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, there were 32,095,394 shares of common stock outstanding.

TABLE OF CONTENTS

		Page
	PART I. FINANCIAL INFORMATION
Item 1.	Financial Statements	3
	Condensed Balance Sheets as of March 31, 2020 (Unaudited) and December 31, 2019	3
	Condensed Statements of Operations for the Three Months Ended March 31, 2020 and 2019 (Unaudited)	4
	Condensed Statements of Stockholders’ Equity for the Three Months Ended March 31, 2020 and 2019 (Unaudited)	5
	Condensed Statements of Cash Flows for the Three Months Ended March 31, 2020 and 2019 (Unaudited)	6
	Notes to Condensed Financial Statements (Unaudited)	7
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	13
Item 3.	Quantitative and Qualitative Disclosures about Market Risk	20
Item 4.	Controls and Procedures	20
	PART II. OTHER INFORMATION
Item 1.	Legal Proceedings	21
Item 1A.	Risk Factors	21
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	21
Item 3.	Defaults upon Senior Securities	21
Item 4.	Mine Safety Disclosures	21
Item 5.	Other Information	21
Item 6.	Exhibits	22
	SIGNATURES	23

2

PART I. FINANCIAL INFORMATION

Item 1. Financial Statements

ODONATE THERAPEUTICS, INC.

Condensed Balance Sheets

(in thousands, except par value and share amounts)

	March 31,			December 31,
	2020			2019
	(Unaudited)
Assets
Current assets:
Cash	$	153,117		$	180,460
Prepaid expenses and other current assets		4,050			3,468
Total current assets		157,167			183,928
Property and equipment, net		1,594			1,663
Right-of-use lease assets		1,526			1,581
Restricted cash		714			714
Other		983			941
Total assets	$	161,984		$	188,827
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable	$	14,894		$	15,583
Accrued expenses		9,871			8,881
Lease liabilities, current portion		279			315
Total current liabilities		25,044			24,779
Lease liabilities, less current portion		1,696			1,748
Total liabilities		26,740			26,527
Commitments and contingencies (Note 5)
Stockholders' equity:
Common stock, $0.01 par value—100,000,000 shares authorized; 32,076,095 and 32,050,906 shares issued and outstanding at March 31, 2020 and December 31, 2019, respectively		301			300
Additional paid-in capital		405,183			402,077
Accumulated deficit		(270,240	)		(240,077	)
Total stockholders' equity		135,244			162,300
Total liabilities and stockholders' equity	$	161,984		$	188,827

See accompanying notes.

3

ODONATE THERAPEUTICS, INC.

Condensed Statements of Operations

(Unaudited)

(in thousands, except share and per share amounts)

	Three Months Ended
	March 31,
	2020			2019
Operating expenses:
Research and development	$	27,947		$	26,631
General and administrative		2,874			2,591
Total operating expenses		30,821			29,222
Loss from operations		(30,821	)		(29,222	)
Interest income		658			577
Net loss	$	(30,163	)	$	(28,645	)
Net loss per share:
Basic and diluted	$	(0.99	)	$	(1.16	)
Weighted-average shares outstanding:
Basic and diluted		30,610,696			24,682,410

See accompanying notes.

4

ODONATE THERAPEUTICS, INC.

Condensed Statements of Stockholders’ Equity

(Unaudited)

(in thousands, except share amounts)

	Common Stock					Additional Paid-in		Accumulated			Total Stockholders'
	Shares			Amount		Capital		Deficit			Equity
Balance at December 31, 2019		32,050,906		$	300	$	402,077	$	(240,077	)	$	162,300
Issuance of common stock under employee stock plans		27,532			1		520		-			521
Forfeiture of common stock underlying incentive units		(2,343	)		-		-		-			-
Equity-based compensation expense		-			-		2,586		-			2,586
Net loss		-			-		-		(30,163	)		(30,163	)
Balance at March 31, 2020		32,076,095		$	301	$	405,183	$	(270,240	)	$	135,244

	Common Stock					Additional Paid-in		Accumulated			Total Stockholders'
	Shares			Amount		Capital		Deficit			Equity
Balance at December 31, 2018		26,747,438		$	244	$	252,012	$	(128,252	)	$	124,004
Issuance of common stock under employee stock plans		10,606			-		159		-			159
Forfeiture of common stock underlying incentive units		(5,618	)		-		-		-			-
Equity-based compensation expense		-			-		2,925		-			2,925
Net loss		-			-		-		(28,645	)		(28,645	)
Balance at March 31, 2019		26,752,426		$	244	$	255,096	$	(156,897	)	$	98,443

See accompanying notes.

5

ODONATE THERAPEUTICS, INC.

Condensed Statements of Cash Flows

(Unaudited)

(in thousands)

	Three Months Ended
	March 31,
	2020			2019
Cash flows from operating activities:
Net loss	$	(30,163	)	$	(28,645	)
Adjustments to reconcile net loss to net cash used in operating activities:
Equity-based compensation expense		2,586			2,925
Depreciation and amortization		62			90
Changes in operating assets and liabilities:
Prepaid expenses and other assets		(624	)		(2,744	)
Accounts payable		(696	)		(3,023	)
Accrued expenses		990			4,289
Net cash used in operating activities		(27,845	)		(27,108	)
Cash flows from investing activities:
Purchases of property and equipment		(19	)		(41	)
Net cash used in investing activities		(19	)		(41	)
Cash flows from financing activities:
Proceeds from issuance of common stock under employee stock plans		521			159
Net cash provided by financing activities		521			159
Net decrease in cash and restricted cash		(27,343	)		(26,990	)
Cash and restricted cash, beginning of period		181,174			139,301
Cash and restricted cash, end of period	$	153,831		$	112,311
Supplemental disclosure of cash flow information:
Property and equipment purchases included in accounts payable and accrued expenses	$	7		$	47
Initial recognition of right-of-use lease assets	$	-		$	2,215

See accompanying notes.

6

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 is on the development of tesetaxel, an investigational, orally administered chemotherapy agent that belongs to a class of drugs known as taxanes, which are widely used in the treatment of cancer. Tesetaxel has several pharmacologic properties that make it unique among taxanes, including: oral administration with a low pill burden; a long (~8-day) terminal plasma half-life in humans, enabling the maintenance of adequate drug levels with relatively infrequent dosing; no history of hypersensitivity (allergic) reactions; and significant activity against chemotherapy-resistant tumors. In patients with metastatic breast cancer (“MBC”), tesetaxel was shown to have significant, single-agent antitumor activity in two multicenter, Phase 2 studies. The Company is currently conducting three studies in breast cancer, including a multinational, multicenter, randomized, Phase 3 study in patients 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.

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

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 10 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.

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.

7

Summary of Significant Accounting Policies

During the three months ended March 31, 2020, 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.

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 1,451,202 and 1,974,793 outstanding shares of common stock held by Odonate Holdings, LLC (“Odonate Holdings”) as of March 31, 2020 and 2019, 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):

	March 31,			December 31,
	2020			2019
Leasehold improvements	$	1,113		$	1,113
Office equipment		724			698
Furniture and fixtures		420			420
Software		130			130
Total gross property and equipment		2,387			2,361
Less accumulated depreciation		(793	)		(698	)
Property and equipment, net	$	1,594		$	1,663

Depreciation expense was $0.1 million for both the three months ended March 31, 2020 and 2019.

Accrued expenses consisted of the following (in thousands):

	March 31,		December 31,
	2020		2019
Accrued clinical development costs	$	6,377	$	6,667
Accrued compensation and related expenses		3,424		2,122
Other accrued expenses		70		92
Total accrued expenses	$	9,871	$	8,881

8

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 Company has an option to extend the New York Lease for an additional three years at the end of the initial term. 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, $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 minimum lease payments under the New York Lease as of March 31, 2020 are as follows (in thousands):

2020	$	360
2021		386
2022		401
2023		428
2024		439
Thereafter		362
Total future minimum lease payments		2,376
Less discount		(401	)
Total lease liabilities	$	1,975

The Company recorded lease liabilities and right-of-use lease assets for the New York Lease based on the present value of lease payments over the expected lease term, discounted using the Company’s incremental borrowing rate. The option to extend the New York Lease was not recognized as part of the Company’s lease liability and right-of-use lease asset. Rent expense under leases was $0.2 million for both the three months ended March 31, 2020 and 2019.

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.

9

Contingencies

From time to time, the Company may become subject to claims and litigation arising in the ordinary course of business. The Company is not a party to any material legal proceedings, nor is it aware of any material pending or threatened litigation.

6. Stockholders’ Equity

On June 28, 2019, the Company closed an underwritten public offering (the “June 2019 Offering”) of 4,750,000 shares of common stock at a public offering price of $26.00 per share. On July 2, 2019, the underwriters exercised in full their option to purchase 712,500 additional shares of common stock. The aggregate gross proceeds from the June 2019 Offering were $142.0 million, and the net proceeds were $135.1 million after deducting underwriting discounts and commissions and offering costs.

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, 1,588,495 shares of common stock remained available for future grants under the 2017 Plan.

2017 Employee Stock Purchase Plan

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”). As of March 31, 2020, 445,966 shares of common stock remained available for future grants under the ESPP.

Management Plan

The Company issued an aggregate of 2,931,402 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, 1,451,202 outstanding shares of common stock were held by Odonate Holdings to be used to settle incentive units previously issued under the Management Plan.

10

Equity Awards

The activity related to equity awards, which are comprised of stock options and incentive units, during the three months ended March 31, 2020 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, 2019		5,972,765		$	18.46
Granted		196,318		$	30.89
Exercised		(24,387	)	$	17.11
Cancelled/forfeited		(127,805	)	$	25.09
Outstanding at March 31, 2020		6,016,891		$	18.73		8.8	$	59.6
Exercisable at March 31, 2020		2,107,957		$	10.73		8.2	$	35.6

⁽¹⁾     Represents the weighted-average remaining contractual term of stock options. The incentive units have no expiration.

⁽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 as of March 31, 2020, and the exercise price.

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

Equity-based Compensation Expense

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

	Three Months Ended
	March 31,
	2020		2019
Expected volatility		81%		75%
Expected life	10 years		6 years
Risk-free interest rate		1.9%		2.5%
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. 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):

	Three Months Ended
	March 31,
	2020		2019
Equity-based compensation expense:
Research and development	$	2,302	$	2,500
General and administrative		284		425
Total equity-based compensation expense	$	2,586	$	2,925

11

As of March 31, 2020, total unrecognized compensation cost related to unvested equity awards was $61.2 million, which is estimated to be recognized over a weighted-average period of3.0years.As of March 31, 2020, there was no unrecognized compensation costrelated to shares of common stock issued under the ESPP.

8. Income Taxes

For the three months ended March 31, 2020 and 2019, 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 March 31, 2020 and December 31, 2019, 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, 2020 and December 31, 2019, the Company had no 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.

12

Item 2. Management’s Discussion and Analysis of 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.

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 statements concerning our plans, objectives, goals, strategies, future events, future revenues or performance, future expenses, financing needs, plans or intentions relating to acquisitions, business trends and other information referred to under this section titled “Management’s Discussion and Analysis of Financial Condition and Results of 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, 2019 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.

13

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 is on the development of tesetaxel, an investigational, orally administered chemotherapy agent that belongs to a class of drugs known as taxanes, which are widely used in the treatment of cancer. Tesetaxel has several pharmacologic properties that make it unique among taxanes, including: oral administration with a low pill burden; a long (~8-day) terminal plasma half-life in humans, enabling the maintenance of adequate drug levels with relatively infrequent dosing; no history of hypersensitivity (allergic) reactions; and significant activity against chemotherapy-resistant tumors. In patients with metastatic breast cancer (“MBC”), tesetaxel was shown to have significant, single-agent antitumor activity in two multicenter, Phase 2 studies. We are currently conducting three studies in breast cancer, as shown in the following table, including a multinational, multicenter, randomized, Phase 3 study in patients 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

HER2= human epidermal growth factor receptor 2; HR=hormone receptor; MBC=metastatic breast cancer;

TNBC=triple-negative breast cancer

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.

14

In May2019, 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.

• In Cohort 1, approximately 90 patients (with potential expansion to up to 150 patients) with locally advanced or metastatic triple-negative breast cancer (“TNBC”) who have not received prior chemotherapy for advanced disease will be randomized 1:1:1 to receive tesetaxel dosed orally at 27 mg/m² on the first day of each 21-day cycle plus either: (1) nivolumab at 360 mg by intravenous infusion on the first day of each 21-day cycle; (2) pembrolizumab at 200 mg by intravenous infusion on the first day of each 21-day cycle; or (3) atezolizumab at 1,200 mg by intravenous infusion on the first day of each 21-day cycle. Nivolumab and pembrolizumab (PD-1 inhibitors) and atezolizumab (a PD-L1 inhibitor) are immuno-oncology (“IO”) agents approved for the treatment of multiple types of cancer. One of these agents, atezolizumab, in combination with the intravenously delivered taxane, nab-paclitaxel, was recently approved by the U.S. Food and Drug Administration (“FDA”) as a first-line treatment for patients with metastatic TNBC. Patients with CNS metastases are eligible. The dual primary endpoints for Cohort 1 are ORR and PFS. Secondary endpoints include DoR and OS. Efficacy results for each of the three PD-(L)1 inhibitor combinations will be assessed for correlation with the results of each of the three approved PD-L1 diagnostic assays.

• In Cohort 2, approximately 40 elderly patients (with potential expansion to up to 60 patients) with HER2 negative MBC will receive tesetaxel monotherapy dosed orally at 27 mg/m² on the first day of each 21-day cycle. Patients with CNS metastases are eligible. The primary endpoint for Cohort 2 is ORR. Secondary endpoints include PFS, DoR and OS.

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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.

Results of Operations

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

	Three Months Ended
	March 31,
	2020		2019
Research and development expense	$	27,947	$	26,631
General and administrative expense	$	2,874	$	2,591
Interest income	$	658	$	577

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Research and Development Expense

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

	Three Months Ended
	March 31,
	2020		2019
Non-personnel expense:
Clinical development	$	16,535	$	16,348
Other		485		644
Total non-personnel expense		17,020		16,992
Personnel expense:
Salaries, bonuses and benefits		8,625		7,139
Equity-based compensation expense		2,302		2,500
Total personnel expense		10,927		9,639
Total research and development expense	$	27,947	$	26,631

Research and development expense was $27.9 million and $26.6 million for the three months ended March 31, 2020 and 2019, respectively. The increase in research and development expense was due primarily to increased headcount in connection with our tesetaxel clinical development program.

General and Administrative Expense

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

	Three Months Ended
	March 31,
	2020		2019
Non-personnel expense	$	1,442	$	1,118
Personnel expense:
Salaries, bonuses and benefits		1,148		1,048
Equity-based compensation expense		284		425
Total personnel expense		1,432		1,473
Total general and administrative expense	$	2,874	$	2,591

General and administrative expense of $2.9 million for the three months ended March 31, 2020 remained consistent compared to $2.6 million for the same period in 2019.

Interest Income

Interest income of $0.7 million for the three months ended March 31, 2020 remained consistent compared to $0.6 million for the same period in 2019.

Liquidity and Capital Resources

As of March 31, 2020 and December 31, 2019, we had cash in the amount of $153.1 million and $180.5 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 losses in each year since our inception. Our net loss was $30.2 million and $28.6 million for the three months ended March 31, 2020 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

17

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):

	Three Months Ended
	March 31,
	2020			2019
Net cash (used in) provided by:
Operating activities	$	(27,845	)	$	(27,108	)
Investing activities		(19	)		(41	)
Financing activities		521			159
Net decrease in cash and restricted cash	$	(27,343	)	$	(26,990	)

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.

Net cash used in investing activities was $19,000 and $41,000 for the three months ended March 31, 2020 and 2019, respectively. Net cash used in investing activities was the result of purchases of property and equipment.

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, we expect to finance our cash needs through a combination of equity offerings, debt financings, collaborations, strategic partnerships and 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 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.

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In October 2019, we 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. 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 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. 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 with 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 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, 2019 are most critical to

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understanding and evaluating our reported financial results.During thethree months ended March 31, 2020,there were no changes to ourcritical accounting policies and estimates as described in Item 7 of ourAnnual Report on Form 10-K for the year endedDecember 31, 2019.

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, 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.

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PART II. OTHER INFORMATION

Item 1. Legal Proceedings

From time to time, we may become subject to claims and litigation arising in the ordinary course of business. We are not a party to any material legal proceedings, nor are we aware of any material pending or threatened litigation.

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. 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 factor set forth below.

The ongoing COVID-19 pandemic may disrupt our operations and affect our ability to successfully conduct clinical studies.

We are unable to accurately predict the full impact that the ongoing Coronavirus Disease 2019 (“COVID-19”) pandemic will have on our results from operations, financial condition and clinical studies due to numerous factors that are not within our control, including the duration and severity of the outbreak. Stay-at-home orders, business closures, travel restrictions, supply chain disruptions and employee illness or quarantines could result in disruptions to our operations, which could adversely impact our results from operations and financial condition. In addition, the COVID-19 pandemic has resulted in ongoing volatility in financial markets. If our access to capital is restricted or associated borrowing costs increase as a result of developments in financial markets relating to the COVID-19 pandemic, our operations and financial condition could be adversely impacted.

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.

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Item 6. Exhibits

Exhibit No.	Description
3.1	Certificate of Incorporation of Odonate (incorporated herein by reference to Exhibit 3.1 to the Company’s Registration Statement on Form S-1 (File No. 333-221533), as filed with the SEC on November 27, 2017)
3.2	First Amended and Restated Bylaws (incorporated herein by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K, as filed with the SEC on June 24, 2019)
31.1	Certification of the Principal Executive Officer pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934
31.2	Certification of the Principal Financial Officer pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934
32.1#	Certification of Principal Executive Officer and Principal Financial Officer pursuant to Rule 13a-14(b) or 15d-14(b) of the Exchange Act and 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
101.INS	XBRL Instance Document
101.SCH	XBRL Taxonomy Extension Schema Document
101.CAL	XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF	XBRL Taxonomy Extension Definition Linkbase Document
101.LAB	XBRL Taxonomy Extension Label Linkbase Document
101.PRE	XBRL Taxonomy Extension Presentation Linkbase Document

# Furnished herewith and not deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act.

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SIGNATURES

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.

	Odonate Therapeutics, Inc.
Date: April 28, 2020	By:	/s/    Kevin Tang
		Kevin Tang
		Chairman and Chief Executive Officer
		(principal executive officer)
		/s/    Michael Hearne
		Michael Hearne
		Chief Financial Officer
		(principal financial and accounting officer)

23

EX-31.1

EXHIBIT 31.1

SECTION 302 CERTIFICATION

I, Kevin Tang, certify that:

1. I have reviewed this Quarterly Report on Form 10-Q of Odonate Therapeutics, Inc.;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

a. designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant is made known to us by others within those entities, particularly during the period in which this report is being prepared;

b. designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c. evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

d. disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

a. all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

b. any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: April 28, 2020	By:	/s/    Kevin Tang
		Kevin Tang
		Chairman and Chief Executive Officer (principal executive officer)

EX-31.2

EXHIBIT 31.2

SECTION 302 CERTIFICATION

I, Michael Hearne, certify that:

1. I have reviewed this Quarterly Report on Form 10-Q of Odonate Therapeutics, Inc.;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

a. designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant is made known to us by others within those entities, particularly during the period in which this report is being prepared;

b. designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c. evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

d. disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

a. all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

b. any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: April 28, 2020	By:	/s/    Michael Hearne
		Michael Hearne
		Chief Financial Officer (principal financial and accounting officer)

EX-32.1

Exhibit 32.1

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350

AS ADOPTED PURSUANT TOSECTION 906

OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Quarterly Report on Form 10-Q of Odonate Therapeutics, Inc. (the “Company”) for the quarter ended March 31, 2020, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), each of the undersigned officers of the Company hereby certifies, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to the best of his knowledge:

• The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

• The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

Date: April 28, 2020

/s/    Kevin Tang

Kevin Tang

Chairman and Chief Executive Officer

(principal executive officer)

/s/    Michael Hearne

Michael Hearne

Chief Financial Officer

(principal financial and accounting officer)

The foregoing certification is being furnished solely to accompany the Report pursuant to 18 U.S.C. Section 1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, and is not to be incorporated by reference into any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

Note: A signed original of this written statement required by Section 906 has been provided to Odonate Therapeutics, Inc. and will be retained by Odonate Therapeutics, Inc. and furnished to the Securities and Exchange Commission or its staff upon request.

XML

Condensed Statements of Operations (Unaudited) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2020	Mar. 31, 2019
Operating expenses:
Research and development	$ 27,947	$ 26,631
General and administrative	2,874	2,591
Total operating expenses	30,821	29,222
Loss from operations	(30,821)	(29,222)
Interest income	658	577
Net loss	$ (30,163)	$ (28,645)
Net loss per share:
Basic and diluted	$ (0.99)	$ (1.16)
Weighted-average shares outstanding:
Basic and diluted	30,610,696	24,682,410

XML

Basis of Presentation and Summary of Significant Accounting Policies

3 Months Ended

Mar. 31, 2020

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”)for interim financial information and with the instructions to Form 10-Q and Article 10 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.

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, 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.

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.

XML

Equity Incentive Plans - Additional Information (Details) - USD ($)	3 Months Ended
	Mar. 31, 2020	Mar. 31, 2019	Aug. 31, 2016
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Total intrinsic value of equity awards exercised	$ 300,000	$ 2,000,000
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested in Period, Fair Value	$ 2,700,000	$ 4,000,000
Weighted average grant-date fair value per equity award	$ 25.22	$ 11.24
Unrecognized equity-based compensation expense not yet recognized	$ 61,200,000
Unrecognized equity-based compensation expense not yet recognized, period for recognition	3 years
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	1,588,495
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	445,966
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]
Aggregate number of incentive units issued			2,931,402
Outstanding shares of common stock underlying incentive units	1,451,202

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Business - Additional Information (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2020	Dec. 31, 2019
Organization Consolidation And Presentation Of Financial Statements [Abstract]
Cash	$ 153,117	$ 180,460
Cash requirements minimum period	1 year

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Balance Sheet Details - Summary of Accrued Expenses (Details) - USD ($) $ in Thousands	Mar. 31, 2020	Dec. 31, 2019
Payables And Accruals [Abstract]
Accrued clinical development costs	$ 6,377	$ 6,667
Accrued compensation and related expenses	3,424	2,122
Other accrued expenses	70	92
Total accrued expenses	$ 9,871	$ 8,881

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Stockholders' Equity

3 Months Ended

Mar. 31, 2020

Equity [Abstract]

Stockholders' Equity

6. Stockholders’ Equity

On June 28, 2019, the Company closed an underwritten public offering (the “June 2019 Offering”) of 4,750,000 shares of common stock at a public offering price of $26.00 per share. On July 2, 2019, the underwriters exercised in full their option to purchase 712,500 additional shares of common stock. The aggregate gross proceeds from the June 2019 Offering were $142.0 million, and the net proceeds were $135.1 million after deducting underwriting discounts and commissions and offering costs.

XML

Basis of Presentation and Summary of Significant Accounting Policies (Policies)

3 Months Ended

Mar. 31, 2020

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”)for interim financial information and with the instructions to Form 10-Q and Article 10 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.

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.

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 1,451,202 and 1,974,793 outstanding shares of common stock held by Odonate Holdings, LLC (“Odonate Holdings”) as of March 31, 2020 and 2019, 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.

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Equity Incentive Plans - Schedule of Estimated Fair Value of Equity Award on Grant Date Using Black-Scholes Option-pricing Model (Details)	3 Months Ended
	Mar. 31, 2020	Mar. 31, 2019
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract]
Expected volatility	81.00%	75.00%
Expected life	10 years	6 years
Risk-free interest rate	1.90%	2.50%
Expected dividend yield	0.00%	0.00%

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Equity Incentive Plans

3 Months Ended

Mar. 31, 2020

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 March 31, 2020, 1,588,495 shares of common stock remained available for future grants under the 2017 Plan.

2017 Employee Stock Purchase Plan

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”). As of March 31, 2020, 445,966 shares of common stock remained available for future grants under the ESPP.

Management Plan

The Company issued an aggregate of 2,931,402 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, 1,451,202 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, 2020 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, 2019		5,972,765		$	18.46
Granted		196,318		$	30.89
Exercised		(24,387	)	$	17.11
Cancelled/forfeited		(127,805	)	$	25.09
Outstanding at March 31, 2020		6,016,891		$	18.73		8.8	$	59.6
Exercisable at March 31, 2020		2,107,957		$	10.73		8.2	$	35.6

⁽¹⁾     Represents the weighted-average remaining contractual term of stock options. The incentive units have no expiration.

⁽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 as of March 31, 2020, and the exercise price.

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

Equity-based Compensation Expense

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

	Three Months Ended
	March 31,
	2020		2019
Expected volatility		81%		75%
Expected life	10 years		6 years
Risk-free interest rate		1.9%		2.5%
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. 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):

	Three Months Ended
	March 31,
	2020		2019
Equity-based compensation expense:
Research and development	$	2,302	$	2,500
General and administrative		284		425
Total equity-based compensation expense	$	2,586	$	2,925

As of March 31, 2020, total unrecognized compensation cost related to unvested equity awards was $61.2 million, which is estimated to be recognized over a weighted-average period of 3.0years. As of March 31, 2020, there was no unrecognized compensation cost related to shares of common stock issued under the ESPP.

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Balance Sheet Details (Tables)

3 Months Ended

Mar. 31, 2020

Balance Sheet Related Disclosures [Abstract]

Summary of Property and Equipment

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

	March 31,			December 31,
	2020			2019
Leasehold improvements	$	1,113		$	1,113
Office equipment		724			698
Furniture and fixtures		420			420
Software		130			130
Total gross property and equipment		2,387			2,361
Less accumulated depreciation		(793	)		(698	)
Property and equipment, net	$	1,594		$	1,663

Summary of Accrued Expenses

Accrued expenses consisted of the following (in thousands):

	March 31,		December 31,
	2020		2019
Accrued clinical development costs	$	6,377	$	6,667
Accrued compensation and related expenses		3,424		2,122
Other accrued expenses		70		92
Total accrued expenses	$	9,871	$	8,881

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License Agreement - Additional Information (Details) $ in Millions	Dec. 31, 2013 USD ($)
Tesetaxel | Daiichi Sankyo
License Agreement [Line Items]
Aggregate future milestone payments	$ 31.0

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Equity Incentive Plans - Summary of Activity Related to Equity Awards Comprised of Stock Options and Incentive Units (Parenthetical) (Details)	Mar. 31, 2020 $ / shares
Stockholders Equity Note [Abstract]
Share price	$ 27.61

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Net Loss per Share

3 Months Ended

Mar. 31, 2020

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 1,451,202 and 1,974,793 outstanding shares of common stock held by Odonate Holdings, LLC (“Odonate Holdings”) as of March 31, 2020 and 2019, 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.

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Condensed Statements of Stockholders' Equity (Unaudited) - USD ($) $ in Thousands	Total	Common Stock	Additional Paid-in Capital	Accumulated Deficit
Beginning balance at Dec. 31, 2018	$ 124,004	$ 244	$ 252,012	$ (128,252)
Beginning balance, shares at Dec. 31, 2018		26,747,438
Issuance of common stock under employee stock plans	159		159
Issuance of common stock under employee stock plans, shares		10,606
Forfeiture of common stock underlying incentive units, shares		(5,618)
Equity-based compensation expense	2,925		2,925
Net loss	(28,645)			(28,645)
Ending balance at Mar. 31, 2019	98,443	$ 244	255,096	(156,897)
Ending balance, shares at Mar. 31, 2019		26,752,426
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

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Document and Entity Information - shares	3 Months Ended
	Mar. 31, 2020	Apr. 17, 2020
Cover [Abstract]
Document Type	10-Q
Amendment Flag	false
Document Period End Date	Mar. 31, 2020
Document Fiscal Year Focus	2020
Document Fiscal Period Focus	Q1
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	Accelerated Filer
Entity Emerging Growth Company	true
Entity Small Business	true
Entity Ex Transition Period	true
Entity Common Stock, Shares Outstanding		32,095,394
Entity Address, State or Province	CA
Entity Shell Company	false
Entity Address, Address Line One	4747 Executive Drive
Entity Address, Address Line Two	Suite 510
Entity Address, City or Town	San Diego
Entity Address, Postal Zip Code	92121
City Area Code	858
Local Phone Number	731-8180
Document Quarterly Report	true
Document Transition Report	false

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Net Loss per Share - Additional Information (Details) - shares	Mar. 31, 2020	Mar. 31, 2019
Management Plan
Earnings Per Share Basic [Line Items]
Outstanding shares of common stock underlying incentive units	1,451,202	1,974,793

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Commitments and Contingencies - Additional Information (Details) - USD ($) $ in Thousands	1 Months Ended				3 Months Ended
	Oct. 01, 2019	Aug. 31, 2019	Mar. 31, 2018	Feb. 28, 2018	Mar. 31, 2020	Mar. 31, 2019
Operating Lease [Line Items]
Aggregate payments under lease					$ 2,376
Aggregate payments under lease					2,376
Aggregate payment of rental expense					200	$ 200
San Diego
Operating Lease [Line Items]
Aggregate payments under lease	$ 4,300		$ 800
Initial lease expiration date			Dec. 31, 2019
Amended lease agreement, description		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.
Amended lease extended date		May 30, 2020
Aggregate payments under lease	$ 4,300		$ 800
Lease initial term	7 years 6 months
Existence of option to extend	true
Additional lease extended term	5 years
Restricted cash					500
New York
Operating Lease [Line Items]
Aggregate payments under lease				$ 2,800
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
Letter of Credit | San Diego
Operating Lease [Line Items]
Security deposit	$ 500
Period of reduction in security deposit	4 years
Letter of Credit | New York
Operating Lease [Line Items]
Security deposit				$ 300
Period of reduction in security deposit				3 years 6 months

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Equity Incentive Plans - Summary of Activity Related to Equity Awards Comprised of Stock Options and Incentive Units (Details) $ / shares in Units, $ in Millions	3 Months Ended
	Mar. 31, 2020 USD ($) $ / shares shares
Equity Awards
Equity awards outstanding, Beginning balance | shares	5,972,765
Equity awards, Granted | shares	196,318
Equity awards, Exercised | shares	(24,387)
Equity awards, Cancelled/forfeited | shares	(127,805)
Equity awards outstanding, Ending balance | shares	6,016,891
Equity awards exercisable | shares	2,107,957
Weighted Average Exercise Price per Share
Weighted average exercise price per share outstanding, Beginning balance | $ / shares	$ 18.46
Weighted average exercise price per share outstanding, Granted | $ / shares	30.89
Weighted average exercise price per share outstanding, Exercised | $ / shares	17.11
Weighted average exercise price per share outstanding, Cancelled/forfeited | $ / shares	25.09
Weighted average exercise price per share outstanding, Ending balance | $ / shares	18.73
Weighted average exercise price per share, Exercisable | $ / shares	$ 10.73
Weighted-Average Remaining Contractual Term
Weighted average remaining contractual term (years), outstanding	8 years 9 months 18 days
Weighted average remaining contractual term (years), exercisable	8 years 2 months 12 days
Aggregate Intrinsic Value, Outstanding | $	$ 59.6
Aggregate Intrinsic Value, Exercisable | $	$ 35.6

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Equity Incentive plans - Summary of Equity-based Compensation Expense (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2020	Mar. 31, 2019
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items]
Total equity-based compensation expense	$ 2,586	$ 2,925
Research and Development
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items]
Total equity-based compensation expense	2,302	2,500
General and Administrative
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items]
Total equity-based compensation expense	$ 284	$ 425

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Equity Incentive Plans (Tables)

3 Months Ended

Mar. 31, 2020

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 three months ended March 31, 2020 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, 2019		5,972,765		$	18.46
Granted		196,318		$	30.89
Exercised		(24,387	)	$	17.11
Cancelled/forfeited		(127,805	)	$	25.09
Outstanding at March 31, 2020		6,016,891		$	18.73		8.8	$	59.6
Exercisable at March 31, 2020		2,107,957		$	10.73		8.2	$	35.6

⁽¹⁾     Represents the weighted-average remaining contractual term of stock options. The incentive units have no expiration.

⁽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 as of March 31, 2020, and the exercise price.

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 grant date using the Black-Scholes option-pricing model with the following assumptions:

	Three Months Ended
	March 31,
	2020		2019
Expected volatility		81%		75%
Expected life	10 years		6 years
Risk-free interest rate		1.9%		2.5%
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
	March 31,
	2020		2019
Equity-based compensation expense:
Research and development	$	2,302	$	2,500
General and administrative		284		425
Total equity-based compensation expense	$	2,586	$	2,925

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Commitments and Contingencies

3 Months Ended

Mar. 31, 2020

Commitments And Contingencies Disclosure [Abstract]

Commitments and Contingencies

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 Company has an option to extend the New York Lease for an additional three years at the end of the initial term. 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, $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 minimum lease payments under the New York Lease as of March 31, 2020 are as follows (in thousands):

2020	$	360
2021		386
2022		401
2023		428
2024		439
Thereafter		362
Total future minimum lease payments		2,376
Less discount		(401	)
Total lease liabilities	$	1,975

The Company recorded lease liabilities and right-of-use lease assets for the New York Lease based on the present value of lease payments over the expected lease term, discounted using the Company’s incremental borrowing rate. The option to extend the New York Lease was not recognized as part of the Company’s lease liability and right-of-use lease asset. Rent expense under leases was $0.2 million for both the three months ended March 31, 2020 and 2019.

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. The Company is not a party to any material legal proceedings, nor is it aware of any material pending or threatened litigation.

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License Agreement

3 Months Ended

Mar. 31, 2020

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.

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Business

3 Months Ended

Mar. 31, 2020

Organization Consolidation And Presentation Of Financial Statements [Abstract]

Business

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 is on the development of tesetaxel, an investigational, orally administered chemotherapy agent that belongs to a class of drugs known as taxanes, which are widely used in the treatment of cancer. Tesetaxel has several pharmacologic properties that make it unique among taxanes, including: oral administration with a low pill burden; a long (~8-day) terminal plasma half-life in humans, enabling the maintenance of adequate drug levels with relatively infrequent dosing; no history of hypersensitivity (allergic) reactions; and significant activity against chemotherapy-resistant tumors. In patients with metastatic breast cancer (“MBC”), tesetaxel was shown to have significant, single-agent antitumor activity in two multicenter, Phase 2 studies. The Company is currently conducting three studies in breast cancer, including a multinational, multicenter, randomized, Phase 3 study in patients 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.

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

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Condensed Balance Sheets (Unaudited) (Parenthetical) - $ / shares	Mar. 31, 2020	Dec. 31, 2019
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	32,076,095	32,076,095
Common stock, shares outstanding	32,050,906	32,050,906

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Balance Sheet Details - Additional Information (Details) - USD ($) $ in Millions	3 Months Ended
	Mar. 31, 2020	Mar. 31, 2019
Balance Sheet Related Disclosures [Abstract]
Depreciation Expense	$ 0.1	$ 0.1

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Stockholders' Equity - Additional Information (Details) - USD ($) $ / shares in Units, $ in Millions	Jul. 02, 2019	Jun. 28, 2019
Equity [Abstract]
Net proceeds from sale of common stock		$ 135.1
Gross proceeds from sale of common stock		$ 142.0
Sale of common stock, number of shares issued	712,500	4,750,000
Sale of common stock, price per share		$ 26.00

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Condensed Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2020	Mar. 31, 2019
Cash flows from operating activities:
Net loss	$ (30,163)	$ (28,645)
Adjustments to reconcile net loss to net cash used in operating activities:
Equity-based compensation expense	2,586	2,925
Depreciation and amortization	62	90
Changes in operating assets and liabilities:
Prepaid expenses and other assets	(624)	(2,744)
Accounts payable	(696)	(3,023)
Accrued expenses	990	4,289
Net cash used in operating activities	(27,845)	(27,108)
Cash flows from investing activities:
Purchases of property and equipment	(19)	(41)
Net cash used in investing activities	(19)	(41)
Cash flows from financing activities:
Proceeds from issuance of common stock under employee stock plans	521	159
Net cash provided by financing activities	521	159
Net decrease in cash and restricted cash	(27,343)	(26,990)
Cash and restricted cash, beginning of period	181,174	139,301
Cash and restricted cash, end of period	153,831	112,311
Supplemental disclosure of cash flow information:
Property and equipment purchases included in accounts payable and accrued expenses	$ 7	47
Initial recognition of right-of-use lease assets		$ 2,215

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Condensed Balance Sheets (Unaudited) - USD ($) $ in Thousands	Mar. 31, 2020	Dec. 31, 2019
Current assets:
Cash	$ 153,117	$ 180,460
Prepaid expenses and other current assets	4,050	3,468
Total current assets	157,167	183,928
Property and equipment, net	1,594	1,663
Right-of-use lease assets	1,526	1,581
Restricted cash	714	714
Other	983	941
Total assets	161,984	188,827
Current liabilities:
Accounts payable	14,894	15,583
Accrued expenses	9,871	8,881
Lease liabilities, current portion	279	315
Total current liabilities	25,044	24,779
Lease liabilities, less current portion	1,696	1,748
Total liabilities	26,740	26,527
Commitments and contingencies (Note 5)
Stockholders' equity:
Common stock, $0.01 par value—100,000,000 shares authorized; 32,076,095 and 32,050,906 shares issued and outstanding at March 31, 2020 and December 31, 2019, respectively	301	300
Additional paid-in capital	405,183	402,077
Accumulated deficit	(270,240)	(240,077)
Total stockholders' equity	135,244	162,300
Total liabilities and stockholders' equity	$ 161,984	$ 188,827

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Balance Sheet Details - Summary of Property And Equipment (Details) - USD ($) $ in Thousands	Mar. 31, 2020	Dec. 31, 2019
Property Plant And Equipment [Line Items]
Total gross property and equipment	$ 2,387	$ 2,361
Less accumulated depreciation	(793)	(698)
Property and equipment, net	1,594	1,663
Leasehold Improvements
Property Plant And Equipment [Line Items]
Total gross property and equipment	1,113	1,113
Office Equipment
Property Plant And Equipment [Line Items]
Total gross property and equipment	724	698
Furniture and Fixtures
Property Plant And Equipment [Line Items]
Total gross property and equipment	420	420
Software
Property Plant And Equipment [Line Items]
Total gross property and equipment	$ 130	$ 130

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Commitments and Contingencies - Future Minimum Lease Payments (Details) $ in Thousands	Mar. 31, 2020 USD ($)
Commitments And Contingencies Disclosure [Abstract]
2020	$ 360
2021	386
2022	401
2023	428
2024	439
Thereafter	362
Total future minimum lease payments	2,376
Less discount	(401)
Total lease liabilities	$ 1,975

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Income Taxes - Additional Information (Details) - USD ($)	3 Months Ended
	Mar. 31, 2020	Mar. 31, 2019	Dec. 31, 2019
Income Tax Disclosure [Abstract]
Provision for income taxes	$ 0	$ 0
Unrecognized tax benefits	$ 0		$ 0

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Balance Sheet Details

3 Months Ended

Mar. 31, 2020

Balance Sheet Related Disclosures [Abstract]

Balance Sheet Details

4. Balance Sheet Details

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

	March 31,			December 31,
	2020			2019
Leasehold improvements	$	1,113		$	1,113
Office equipment		724			698
Furniture and fixtures		420			420
Software		130			130
Total gross property and equipment		2,387			2,361
Less accumulated depreciation		(793	)		(698	)
Property and equipment, net	$	1,594		$	1,663

Depreciation expense was $0.1 million for both the three months ended March 31, 2020 and 2019.

Accrued expenses consisted of the following (in thousands):

	March 31,		December 31,
	2020		2019
Accrued clinical development costs	$	6,377	$	6,667
Accrued compensation and related expenses		3,424		2,122
Other accrued expenses		70		92
Total accrued expenses	$	9,871	$	8,881

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Income Taxes

3 Months Ended

Mar. 31, 2020

Income Tax Disclosure [Abstract]

Income Taxes

8. Income Taxes

For the three months ended March 31, 2020 and 2019, 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 March 31, 2020 and December 31, 2019, 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, 2020 and December 31, 2019, the Company had no unrecognized tax benefits. The Company does not anticipate there will be a significant change in unrecognized tax benefits within the next 12 months.

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Commitments and Contingencies (Tables)

3 Months Ended

Mar. 31, 2020

Commitments And Contingencies Disclosure [Abstract]

Future Minimum Lease Payments

Future minimum lease payments under the New York Lease as of March 31, 2020 are as follows (in thousands):

2020	$	360
2021		386
2022		401
2023		428
2024		439
Thereafter		362
Total future minimum lease payments		2,376
Less discount		(401	)
Total lease liabilities	$	1,975