achv-10q_20210331.htm

10-Q 1 achv-10q_20210331.htm 10-Q achv-10q_20210331.htm

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington D.C. 20549

FORM 10-Q

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

FOR THE QUARTERLY PERIOD ENDED March 31, 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 033-80623

Achieve Life Sciences, Inc.

(Exact Name of Registrant as Specified in Its Charter)

Delaware		95-4343413
(State or Other Jurisdiction of		(I.R.S. Employer
Incorporation or Organization)		Identification Number)

1040 West Georgia Street, Suite 1030, Vancouver, British Columbia, Canada V6E 4H1

(Address of Principal Executive Offices)

(604) 210-2217

(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act:
Title of each class	Trading Symbol	Name of exchange on which registered
Common Stock, par value $0.001 per share	ACHV	The NASDAQ Capital 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 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 ☒

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.

As of May 13, 2021, there were 6,164,360 shares of the registrant’s Common Stock, $0.001 par value per share, outstanding.

Achieve Life Sciences, Inc.

Index to Form 10-Q

		Page Number

Part I. Financial Information		3

Item 1	Consolidated Financial Statements (unaudited)	3

	Consolidated Balance Sheets as of March 31, 2021 (unaudited) and December 31, 2020	3

	Consolidated Statements of Loss and Comprehensive Loss (unaudited) for the three months ended March 31, 2021 and March 31, 2020	4

	Consolidated Statements of Cash Flows (unaudited) for the three months ended March 31, 2021 and March 31, 2020	5

	Consolidated Statements of Stockholders’ Equity (unaudited) for the three months ended March 31, 2021 and March 31, 2020	6

	Notes to Consolidated Financial Statements (unaudited)	7

Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	17


Item 4.	Controls and Procedures	25

Part II. Other Information		26

Item 1A.	Risk Factors	27

Item 6.	Exhibits	51

Items 2, 3 and 4 are not applicable and therefore have been omitted.

Signatures		52

PART I. FINANCIAL INFORMATION

Item 1.

Consolidated Financial Statements

Achieve Life Sciences, Inc.

Consolidated Balance Sheets

(Unaudited)

(In thousands, except per share and share amounts)

	March 31,			December 31,
	2021			2020

ASSETS
Current assets:
Cash and cash equivalents [note 5]	$	29,637		$	35,853
Prepaid expenses and other assets		802			1,122
Total current assets		30,439			36,975
Property and equipment, net		33			42
Right-of-use assets [note 7]		108			146
Other assets and restricted cash [note 5]		239			237
License agreement [note 3 and 4]		1,809			1,864
Goodwill [note 4]		1,034			1,034
Total assets	$	33,662		$	40,298
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	585		$	332
Accrued liabilities other		211			584
Accrued clinical liabilities		2,130			453
Accrued compensation		522			1,474
Current portion of long-term obligations [note 7]		67			92
Total current liabilities		3,515			2,935
Long-term obligations [note 7]		59			77
Total liabilities		3,574			3,012
Commitments and contingencies [note 7]
Stockholders' equity:
Series A convertible preferred stock, $0.001 par value, 9,158 shares designated, zero issued and outstanding at March 31, 2021 and zero issued and outstanding at December 31, 2020.		—			—
Series B convertible preferred stock, $0.001 par value, 6,256 shares designated, zero issued and outstanding at March 31, 2021 and zero issued and outstanding at December 31, 2020		—			—
Common stock, $0.001 par value, 150,000,000 shares authorized, 6,149,917 issued and outstanding at March 31, 2021 and 6,111,735 issued and outstanding at December 31, 2020, respectively.		76			76
Additional paid-in capital		98,441			97,640
Accumulated deficit		(68,433	)		(60,434	)
Accumulated other comprehensive income		4			4
Total stockholders' equity		30,088			37,286
Total liabilities and stockholders' equity	$	33,662		$	40,298

See accompanying notes.

Achieve Life Sciences, Inc.

Consolidated Statements of Loss and Comprehensive Loss

(Unaudited)

(In thousands, except per share and share amounts)

	Three Months Ended
	March 31,
	2021			2020
EXPENSES
Research and development		5,642			1,541
General and administrative		2,342			1,816
Total operating expenses		7,984			3,357
OTHER INCOME (EXPENSE)
Interest income		8			42
Other expenses		(23	)		(5	)
Total other income (expense)		(15	)		37
Net loss and comprehensive loss	$	(7,999	)	$	(3,320	)
Basic and diluted net loss per common share	$	(1.30	)	$	(2.15	)
Weighted average shares used in computation of basic and diluted net loss per common share		6,131,821			1,546,839

See accompanying notes.

Achieve Life Sciences, Inc.

Consolidated Statements of Cash Flows

(Unaudited)

(In thousands)

	Three Months Ended
	March 31,
	2021	2020
Operating Activities:
Net loss

SEC Form 10-Q filed by Achieve Life Sciences, Inc.