achv-10q_20200930.htm

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

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.

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 November 12, 2020, there were 3,617,664 shares of the registrant’s Common Stock, $0.001 par value per share, outstanding.

	September 30,			December 31,
	2020			2019

ASSETS
Current assets:
Cash and cash equivalents [note 5]	$	22,393		$	16,664
Prepaid expenses and other assets		1,669			670
Total current assets		24,062			17,334
Restricted cash [note 5]		50			50
Property and equipment, net		50			57
Right-of-use assets [note 7]		193			329
Other assets		308			187
License agreement [note 3 and 4]		1,920			2,087
Goodwill [note 4]		1,034			1,034
Total assets	$	27,617		$	21,078
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	326		$	859
Accrued liabilities other		360			304
Accrued clinical liabilities		93			387
Accrued compensation		940			1,116
Current portion of long-term obligations [note 7]		129			203
Total current liabilities		1,848			2,869
Long-term obligations [note 7]		94			159
Total liabilities		1,942			3,028
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 September 30, 2020 and zero issued and outstanding at December 31, 2019.		—			—
Series B convertible preferred stock, $0.001 par value, 6,256 shares designated, zero issued and outstanding at September 30, 2020 and 1,121 issued and outstanding at December 31, 2019		—			—
Common stock, $0.001 par value, 150,000,000 shares authorized, 3,616,414 issued and outstanding at September 30, 2020 and 1,474,258 issued and outstanding at December 31, 2019, respectively.		74			41
Additional paid-in capital		81,307			63,709
Accumulated deficit		(55,710	)		(45,704	)
Accumulated other comprehensive income		4			4
Total stockholders' equity		25,675			18,050
Total liabilities and stockholders' equity	$	27,617		$	21,078
Going concern [note 1]
Subsequent events [note 8]

	Three Months Ended						Nine Months Ended
	September 30,						September 30,
	2020			2019			2020			2019
EXPENSES
Research and development		1,891			1,824			4,535			7,911
General and administrative		1,863			1,893			5,494			5,408
Total operating expenses		3,754			3,717			10,029			13,319
OTHER INCOME (EXPENSE)
Interest income		2			40			47			143
Other expenses		(12	)		4			(24	)		(25	)
Total other income (expense)		(10	)		44			23			118
Net loss and comprehensive loss	$	(3,764	)	$	(3,673	)		(10,006	)		(13,201	)
Basic and diluted net loss per common share	$	(1.14	)	$	(9.07	)	$	(4.55	)	$	(35.96	)
Weighted average shares used in computation of basic and diluted net loss per common share		3,289,252			405,012			2,197,368			367,103

	Nine Months Ended
	September 30,
	2020			2019
Operating Activities:
Net loss	$	(10,006	)	$	(13,201	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization [note 3]		191			192
Stock-based compensation [note 6 [c] and note 6 [d]]		891			917
Changes in operating assets and liabilities:
Amounts receivable		8			—
Prepaid expenses and other assets		(1,128	)		597
Accounts payable		(533	)		430
Accrued liabilities other		56			(320	)
Accrued clinical liabilities		(294	)		(462	)
Accrued compensation		(176	)		39
Lease obligation [note 7]		(3	)		6
Net cash used in operating activities		(10,994	)		(11,802	)
Financing Activities:
Proceeds from the April 2020 financing, net of issuance costs		1,579			—
Financing costs relating to December 2019 public offering		(34	)		—
Proceeds from exercise of warrants		3,080			4,199
Proceeds from the July 2020 Registered Direct Offering, net of issuance costs		5,307			—
Proceeds from the August 2020 Public Offering, net of issuance costs		6,822			—
Proceeds from purchase agreement with Lincoln Park Capital, net of issuance costs		—			423
Financing costs relating to purchase agreement with Lincoln Park Capital		(14	)		—
Net cash provided by financing activities		16,740			4,622
Investing Activities:
Purchase of property and equipment		(17	)		(52	)
Purchase of investments		—			(25	)
Proceeds from maturities of investments		—			5,114
Net cash provided by (used in) investing activities		(17	)		5,037
Effect of exchange rate changes on cash		—			3
Net increase (decrease) in cash, cash equivalents and restricted cash		5,729			(2,140	)
Cash, cash equivalents and restricted cash at beginning of the period		16,714			9,565
Cash, cash equivalents and restricted cash at end of the period	$	22,443		$	7,425

														Accumulated
											Additional			Other					Total,
	Common Stock					Preferred Stock					Paid-in			Comprehensive		Accumulated			Stockholders’
	Shares			Amount		Shares			Amount		Capital			Income (Loss)		Deficit			Equity
Balance, December 31, 2019		1,474,258		$	41		1,121		$	—	$	63,709		$	4	$	(45,704	)	$	18,050
Stock-based compensation expense		—			—		—			—		302			—		—			302
Costs relating to December 2019 financing		—			—		—			—		(34	)		—		—			(34	)
Costs relating to purchase agreement with Lincoln Park Capital		—			—		—			—		(13	)		—		—			(13	)
Shares issued on conversion of Series B preferred shares		93,379			2		(1,121	)		—		(2	)		—		—			—
Net loss		—			—		—			—		—			—		(3,320	)		(3,320	)
Balance, March 31, 2020		1,567,637		$	43		—		$	—	$	63,962		$	4	$	(49,024	)	$	14,985
Stock-based compensation expense		—			—		—			—		308			—		—			308
Costs relating to purchase agreement with Lincoln Park Capital		—			—		—			—		(1	)		—		—			(1	)
Shares issued on exercise of warrants		89,281			—		—			—		589			—		—			589
Shares issued - April 2020 private placement		280,782			6		—			—		1,573			—		—			1,579
Shares issued on conversion of preferred shares		—			2		—			—		(2	)		—		—			—
Adjustment of fractional shares on reverse stock split		3			—		—			—		—			—		—			—
Net loss		—			—		—			—		—			—		(2,922	)		(2,922	)
Balance, June 30, 2020		1,937,703		$	51		—		$	—	$	66,429		$	4	$	(51,946	)	$	14,538
Stock-based compensation expense		—			—		—			—		281			—		—			281
Shares issued - July 2020 Registered Direct Offering		731,707			15		—			—		5,292			—		—			5,307
Shares issued - August 2020 Public Offering		569,043			1		—			—		6,821			—		—			6,822
Shares issued on exercise of warrants		377,845			7		—			—		2,484			—		—			2,491
Restricted stock unit settlements		128			—		—			—		—			—		—			—
Adjustment of fractional shares on reverse stock split		(12	)		—		—			—		—			—		—			—
Net loss		—			—		—			—		—			—		(3,764	)		(3,764	)
Balance, September 30, 2020		3,616,414		$	74		—		$	—	$	81,307		$	4	$	(55,710	)	$	25,675

												Accumulated
										Additional		Other					Total,
	Common Stock				Preferred Stock					Paid-in		Comprehensive		Accumulated			Stockholders’
	Shares		Amount		Shares			Amount		Capital		Income (Loss)		Deficit			Equity
Balance, December 31, 2018		336,055	$	18		579		$	—	$	41,161	$	4	$	(25,381	)	$	15,802
Restricted stock unit settlements		4		—		—			—		—		—		—			—
Stock-based compensation expense		—		—		—			—		290		—		—			290
Adjustments to final October 2018 financing costs		—		—		—			—		4		—		—			4
Cumulative adjustment on adoption of lease standard		—		—		—			—		—		—		(3	)		(3	)
Net loss		—		—		—			—		—		—		(5,904	)		(5,904	)
Balance, March 31, 2019		336,059	$	18		579		$	—	$	41,455	$	4	$	(31,288	)	$	10,189
Stock-based compensation expense		—		—		—			—		317		—		—			317
Shares issued - from purchase agreement with Lincoln Park Capital		6,200		—		—			—		423		—		—			423
Shares issued on exercise of warrants		55,390		1		—			—		4,198		—		—			4,199
Issuance of inducement warrants		—		—		—			—		3,925		—		(3,925	)		—
Shares issued on conversion of preferred shares		7,237		—		(579	)		—		—		—		—			—
Net loss		—		—		—			—		—		—		(3,624	)		(3,624	)
Balance, June 30, 2019		404,886	$	19		—		$	—	$	50,318	$	4	$	(38,837	)	$	11,504
Stock-based compensation expense		—		—		—			—		310		—		—			310
Restricted stock unit settlements		250		—		—			—		—		—		—			—
Net loss		—		—		—			—		—		—		(3,673	)		(3,673	)
Balance, September 30, 2019		405,136	$	19		—		$	—	$	50,628	$	4	$	(42,510	)	$	8,141

Achieve Life Sciences, Inc. (referred to as “Achieve,” “we,” “us,” or “our”) is a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation. We were incorporated in the state of Delaware, and operate out of Vancouver, British Columbia and Seattle, Washington.

The unaudited consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States, or U.S. GAAP, for interim financial information and with the instructions to Form 10-Q. Accordingly, they do not include all of the information and footnotes required to be presented for complete financial statements. The accompanying unaudited consolidated financial statements reflect all adjustments (consisting only of normal recurring items) which are, in the opinion of management, necessary for a fair presentation of the results for the interim periods presented. The accompanying consolidated Balance Sheet at December 31, 2019 has been derived from the audited consolidated financial statements included in our Annual Report on Form 10-K for the year then ended. The unaudited consolidated financial statements and related disclosures have been prepared with the assumption that users of the interim financial information have read or have access to the audited consolidated financial statements for the preceding fiscal year. Accordingly, these financial statements should be read in conjunction with the audited consolidated financial statements and the related notes thereto included in the Annual Report on Form 10-K for the year ended December 31, 2019 and filed with the United States Securities and Exchange Commission, or the SEC, on March 13, 2020.

The consolidated financial statements include the accounts of Achieve and our wholly owned subsidiaries, Achieve Life Sciences Technologies Inc., Achieve Life Science, Inc., Extab Corporation, and Achieve Pharma UK Limited. All intercompany balances and transactions have been eliminated.

On July 29, 2020, we filed a certificate of amendment to our Second Amended and Restated Certificate of Incorporation, as amended, and effected as of July 31, 2020 a 1-for-20 reverse stock split of our issued and outstanding shares of common stock. As a result of the reverse stock split, each 20 shares of the outstanding common stock were combined into one share of common stock without any change to the par value per share. The reverse stock split did not affect the number of authorized shares of common stock which remains at 150,000,000. The reverse stock split was approved by our board of directors and stockholders and is intended to allow us to regain compliance with the NASDAQ’s continued listing criteria related to the Minimum Bid Price Rule. On August 14, 2020, we received written confirmation from NASDAQ that we regained compliance with the Minimum Bid Price Rule and the matter has been closed.

Unless otherwise noted, impacted amounts and share information included in the financial statements and notes thereto have been retroactively adjusted for the stock split as if such stock split occurred on the first day of the first period presented. Certain amounts in the notes to the financial statements may be slightly different than previously reported due to rounding of fractional shares as a result of the reverse stock split.

The accompanying financial statements have been prepared assuming we will continue to operate as a going concern, which contemplates the realization of assets and liabilities and commitments in the normal course of business.

We have historically experienced recurring losses from operations that have generated an accumulated deficit of $55.7 million through September 30, 2020. During the three and nine months ended September 30, 2020, we incurred a net loss of $3.8 million and $10.0 million. As of September 30, 2020, we had a cash and cash equivalents balance of $22.4 million and a positive working capital balance of $22.2 million. During the nine months ended September 30, 2020, net cash used in operations was $11.0 million.

Substantial doubt exists as to our ability to continue as a going concern. Our ability to continue as a going concern is uncertain and dependent on our ability to obtain additional financing. There is no assurance that we will obtain financing from other sources. We have, thus far, financed our operations through the closing of the arrangement between us and OncoGenex Pharmaceuticals, Inc. pursuant to a Merger Agreement dated January 5, 2017, or the Arrangement, and through debt and equity financings (Note 6—Common Stock). Without additional funds, we may be forced to delay, scale back or eliminate some of our research and development activities or other operations and potentially delay product development in an effort to provide sufficient funds to continue our operations. If any of these events occurs, our ability to achieve our development and commercialization goals would be adversely affected.

Our current resources are insufficient to fund our planned operations for the next 12 months. We will continue to require substantial additional capital to continue our clinical development activities. Accordingly, we will need to raise substantial additional capital to continue to fund our operations from the sale of our securities, partnering arrangements or other financing transactions in order to finance the commercialization of our product candidate. The amount and timing of our future funding requirements will depend on many factors, including the pace and results of our clinical development efforts. Failure to raise capital as and when needed, on favorable terms or at all, will have a negative impact on our financial condition and our ability to develop our product candidate. The uncertainty with respect to our operations and the market generally due to the COVID-19 pandemic may also make it challenging to raise additional capital on favorable terms, if at all. We expect our research and development expenses to substantially increase in connection with our ongoing activities, particularly as we advance our product candidate in clinical development.

The consolidated financial statements do not include any adjustments to the amounts and classification of assets and liabilities that might be necessary should we be unable to continue as a going concern. Such adjustments could be material.

The preparation of financial statements in accordance with U.S. GAAP requires management to make estimates and assumptions that affect reported amounts and related disclosures. We have discussed those estimates that we believe are critical and require the use of complex judgment in their application in our audited financial statements for the year ended December 31, 2019 in our Annual Report on Form 10-K filed with the SEC, on March 13, 2020. Since December 31, 2019, there have been no material changes to our critical accounting policies or the methodologies or assumptions we apply under them.

All of our intangible assets are subject to amortization and are amortized using the straight-line method over their estimated useful life.

We acquired license and supply agreements in relation to cytisinicline upon the acquisition of Extab Corporation, or Extab, on May 18, 2015. The agreements were determined to have a fair value of $3.1 million with an estimated useful life of 14 years.

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

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

		Page Number

Part I. Financial Information		3

Item 1	Consolidated Financial Statements (unaudited)	3

	Consolidated Balance Sheets as of September 30, 2020 (unaudited) and December 31, 2019	3

	Consolidated Statements of Loss and Comprehensive Loss (unaudited) for the three and nine months ended September 30, 2020 and September 30, 2019	4

	Consolidated Statements of Cash Flows (unaudited) for the nine months ended September 30, 2020 and September 30, 2019	5

	Consolidated Statements of Stockholders’ Equity (unaudited) for the three and nine months ended September 30, 2020 and September 30, 2019	6

	Notes to Consolidated Financial Statements (unaudited)	8

Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	21


Item 4.	Controls and Procedures	31

Part II. Other Information		33

Item 1A.	Risk Factors	34

Item 6.	Exhibits	59

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

Signatures		61

Large accelerated filer	☐	Accelerated filer	☐

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