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 September 30, 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 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: |
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||
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Title of each class |
Trading Symbol |
Name of exchange on which registered |
|
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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 |
☐ |
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Accelerated filer |
☐ |
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Non-accelerated filer |
☒ |
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Smaller reporting company |
☒ |
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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 November 12, 2020, there were 3,617,664 shares of the registrant’s Common Stock, $0.001 par value per share, outstanding.
Index to Form 10-Q
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Page
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3 |
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Item 1 |
3 |
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Consolidated Balance Sheets as of September 30, 2020 (unaudited) and December 31, 2019 |
3 |
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4 |
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5 |
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6 |
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8 |
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Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
21 |
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Item 4. |
31 |
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33 |
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Item 1A. |
34 |
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Item 6. |
59 |
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Items 2, 3 and 4 are not applicable and therefore have been omitted. |
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61 |
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2
Achieve Life Sciences, Inc.
(Unaudited)
(In thousands, except per share and share amounts)
|
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September 30, |
|
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December 31, |
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|
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2020 |
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2019 |
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ASSETS |
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Current assets: |
|
|
|
|
|
|
|
|
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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 |
|
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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 |
|
|
|
|
|
|
|
|
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Current liabilities: |
|
|
|
|
|
|
|
|
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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] |
|
|
|
|
|
|
|
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Stockholders' equity: |
|
|
|
|
|
|
|
|
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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] |
|
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|
|
|
|
|
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Subsequent events [note 8] |
|
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|
|
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|
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|
|
|
|
|
|
|
|
|
See accompanying notes.
3
Consolidated Statements of Loss and Comprehensive Loss
(Unaudited)
(In thousands, except per share and share amounts)
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
||||||||||
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|
September 30, |
|
|
September 30, |
|
||||||||||
|
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2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
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||||
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EXPENSES |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Research and development |
|
|
1,891 |
|
|
|
1,824 |
|
|
|
4,535 |
|
|
|
7,911 |
|
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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) |
|
|
|
|
|
|
|
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|
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|
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|
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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 |
|
See accompanying notes.
4
Consolidated Statements of Cash Flows
(Unaudited)
(In thousands)
|
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Nine Months Ended |
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September 30, |
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|||||
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2020 |
|
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2019 |
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Operating Activities: |
|
|
|
|
|
|
|
|
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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 |
|
See accompanying notes.
5
Achieve Life Sciences, Inc.
Consolidated Statements of Stockholders’ Equity
(Unaudited)
(In thousands, except share amounts)
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
|
6
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
|
See accompanying notes.
7
Notes to Consolidated Financial Statements
(Unaudited)
1. NATURE OF BUSINESS, BASIS OF PRESENTATION AND GOING CONCERN UNCERTAINTY