odt-10q_20210930.htm

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 September 30, 2021

☐	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.)

3 East 28th Street, 10th Floor

New York, New York 10016

(332) 206-0935

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

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

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 the 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 October 29, 2021, there were 38,490,336 shares of common stock outstanding.

TABLE OF CONTENTS

		Page

	PART I. FINANCIAL INFORMATION
Item 1.	Financial Statements	3
	Condensed Balance Sheets as of September 30, 2021 (Unaudited) and December 31, 2020	3
	Condensed Statements of Operations for the Three and Nine Months Ended September 30, 2021 and 2020 (Unaudited)	4
	Condensed Statements of Stockholders’ Equity for the Three and Nine Months Ended September 30, 2021 and 2020 (Unaudited)	5
	Condensed Statements of Cash Flows for the Nine Months Ended September 30, 2021 and 2020 (Unaudited)	7
	Notes to Condensed Financial Statements (Unaudited)	8
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	15
Item 3.	Quantitative and Qualitative Disclosures about Market Risk	19
Item 4.	Controls and Procedures	19

	PART II. OTHER INFORMATION
Item 1.	Legal Proceedings	20
Item 1A.	Risk Factors	20
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	20
Item 3.	Defaults upon Senior Securities	20
Item 4.	Mine Safety Disclosures	20
Item 5.	Other Information	20
Item 6.	Exhibits	21
	SIGNATURES	22

PART I. FINANCIAL INFORMATION

Item 1. Financial Statements

ODONATE THERAPEUTICS, INC.

Condensed Balance Sheets

(in thousands, except par value and share amounts)

	September 30,			December 31,
	2021			2020
	(Unaudited)
Assets
Current assets:
Cash	$	95,028		$	157,265
Prepaid expenses and other current assets		4,554			2,607
Total current assets		99,582			159,872
Property and equipment, net		1,833			2,286
Right-of-use lease assets		3,590			4,017
Restricted cash		714			714
Other		54			997
Total assets	$	105,773		$	167,886
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable	$	11,661		$	14,168
Accrued expenses		17,892			12,247
Lease liabilities, current portion		744			658
Total current liabilities		30,297			27,073
Lease liabilities, less current portion		4,105			4,668
Total liabilities		34,402			31,741
Commitments and contingencies (Note 5)
Stockholders' equity:
Common stock, $0.01 par value—100,000,000 shares authorized; 38,490,336 and 38,562,281 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively		368			367
Additional paid-in capital		507,210			502,205
Accumulated deficit		(436,207	)		(366,427	)
Total stockholders' equity		71,371			136,145
Total liabilities and stockholders' equity	$	105,773		$	167,886

See accompanying notes.

ODONATE THERAPEUTICS, INC.

Condensed Statements of Operations

(Unaudited)

(in thousands, except share and per share amounts)

	Three Months Ended						Nine Months Ended
	September 30,						September 30,
	2021			2020			2021			2020
Operating expenses:
Research and development	$	2,869		$	28,242		$	52,422		$	86,966
General and administrative		11,148			2,408			17,467			8,033
Total operating expenses		14,017			30,650			69,889			94,999
Loss from operations		(14,017	)		(30,650	)		(69,889	)		(94,999	)
Other income, net		20			173			109			935
Net loss	$	(13,997	)	$	(30,477	)	$	(69,780	)	$	(94,064	)
Net loss per share:
Basic and diluted	$	(0.37	)	$	(0.93	)	$	(1.85	)	$	(3.00	)
Weighted-average shares outstanding:
Basic and diluted		37,922,594			32,821,835			37,750,432			31,376,672

See accompanying notes.

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, 2020		38,562,281		$	367	$	502,205	$	(366,427	)	$	136,145
Issuance of common stock under employee stock plans		53,979			1		824		-			825
Forfeiture of common stock underlying incentive units		(109,151	)		-		-		-			-
Equity-based compensation expense		-			-		2,099		-			2,099
Net loss		-			-		-		(33,768	)		(33,768	)
Balance at March 31, 2021		38,507,109		$	368	$	505,128	$	(400,195	)	$	105,301
Forfeiture of common stock underlying incentive units		(7,575	)		-		-		-			-
Equity-based compensation expense		-			-		1,339		-			1,339
Net loss		-			-		-		(22,015	)		(22,015	)
Balance at June 30, 2021		38,499,534		$	368	$	506,467	$	(422,210	)	$	84,625
Forfeiture of common stock underlying incentive units		(9,198	)		-		-		-			-
Equity-based compensation expense		-			-