|
x
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
o
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
Delaware
|
|
20-8099512
|
(State of incorporation)
|
|
(I.R.S. Employer Identification No.)
|
Title of each class
|
Trading symbol(s)
|
Name of each exchange on which registered
|
Common Stock, $0.0001 par value per share
|
SLS
|
The Nasdaq Capital Market
|
Large accelerated filer
|
|
o
|
|
Accelerated filer
|
|
o
|
|
|
|
|
|||
Non-accelerated filer
|
|
x
|
|
Smaller reporting company
|
|
x
|
|
|
|
|
|
|
|
Emerging growth company
|
|
o
|
|
|
|
|
|
|
|
|
Page
|
|
|
PART I - FINANCIAL INFORMATION
|
|
Item 1
|
|
||
|
|
Condensed Consolidated Balance Sheets as of June 30, 2019 (unaudited) and December 31, 2018
|
|
|
|
Unaudited Condensed Consolidated Statements of Operations for the three and six months ended June 30, 2019 and 2018
|
|
|
|
Unaudited Condensed Consolidated Statement of Stockholders' Equity (Deficit) for the three and six months ended June 30, 2019 and 2018
|
|
|
|
Unaudited Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2019 and 2018
|
|
|
|
||
Item 2
|
|
||
Item 3
|
|
||
Item 4
|
|
||
|
|
PART II - OTHER INFORMATION
|
|
Item 1
|
|
Legal Proceedings
|
|
Item 1A
|
|
Risk Factors
|
|
Item 2
|
|
||
Item 3
|
|
||
Item 4
|
|
||
Item 5
|
|
||
Item 6
|
|
||
|
|
|
|
|
|
||
|
|
|
June 30, 2019
|
|
December 31, 2018
|
||||
|
(Unaudited)
|
|
|||||
ASSETS
|
|
|
|
||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
12,751
|
|
|
$
|
5,337
|
|
Restricted cash and cash equivalents
|
114
|
|
|
114
|
|
||
Prepaid expenses and other current assets
|
776
|
|
|
387
|
|
||
Total current assets
|
13,641
|
|
|
5,838
|
|
||
Operating lease right-of-use asset
|
390
|
|
|
—
|
|
||
In-process research and development
|
8,500
|
|
|
8,500
|
|
||
Goodwill
|
1,914
|
|
|
1,914
|
|
||
Deposits and other assets
|
589
|
|
|
663
|
|
||
Total assets
|
$
|
25,034
|
|
|
$
|
16,915
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
|
|
|
||||
Current liabilities:
|
|
|
|
||||
Accounts payable
|
$
|
3,762
|
|
|
$
|
3,755
|
|
Accrued expenses and other current liabilities
|
1,276
|
|
|
2,219
|
|
||
Operating lease liability, current
|
362
|
|
|
—
|
|
||
Total current liabilities
|
5,400
|
|
|
5,974
|
|
||
Operating lease liability, non-current
|
28
|
|
|
—
|
|
||
Deferred tax liability
|
357
|
|
|
357
|
|
||
Warrant liability
|
103
|
|
|
1,013
|
|
||
Contingent consideration
|
4,808
|
|
|
4,326
|
|
||
Total liabilities
|
10,696
|
|
|
11,670
|
|
||
Commitments and contingencies (Note 6)
|
|
|
|
||||
Stockholders’ equity:
|
|
|
|
||||
Preferred stock, $0.0001 par value; 5,000,000 shares authorized; Series A convertible preferred stock, 17,500 shares designated; no shares issued and outstanding at June 30, 2019 and December 31, 2018
|
—
|
|
|
—
|
|
||
Common stock, $0.0001 par value; 350,000,000 shares authorized, 100,135,175 and 22,026,476 shares issued and outstanding at June 30, 2019 and December 31, 2018, respectively.
|
10
|
|
|
2
|
|
||
Additional paid-in capital
|
103,854
|
|
|
87,098
|
|
||
Accumulated deficit
|
(89,526
|
)
|
|
(81,855
|
)
|
||
Total stockholders’ equity
|
14,338
|
|
|
5,245
|
|
||
Total liabilities and stockholders’ equity
|
$
|
25,034
|
|
|
$
|
16,915
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Operating expenses:
|
|
|
|
|
|
|
|
||||||||
Research and development
|
$
|
1,381
|
|
|
$
|
1,592
|
|
|
$
|
3,240
|
|
|
$
|
3,396
|
|
General and administrative
|
2,638
|
|
|
4,909
|
|
|
5,138
|
|
|
8,789
|
|
||||
Total operating expenses and operating loss
|
(4,019
|
)
|
|
(6,501
|
)
|
|
(8,378
|
)
|
|
(12,185
|
)
|
||||
Non-operating income (expense):
|
|
|
|
|
|
|
|
||||||||
Change in fair value of warrant liability
|
962
|
|
|
1,218
|
|
|
1,157
|
|
|
3,099
|
|
||||
Change in fair value of contingent consideration
|
(95
|
)
|
|
(452
|
)
|
|
(482
|
)
|
|
(3,863
|
)
|
||||
Loss on settlement of liability-classified warrants
|
—
|
|
|
(42
|
)
|
|
—
|
|
|
(727
|
)
|
||||
Interest income (expense), net
|
18
|
|
|
(122
|
)
|
|
32
|
|
|
(218
|
)
|
||||
Total non-operating income (expense), net
|
885
|
|
|
602
|
|
|
707
|
|
|
(1,709
|
)
|
||||
Loss before income taxes
|
(3,134
|
)
|
|
(5,899
|
)
|
|
(7,671
|
)
|
|
(13,894
|
)
|
||||
Income tax expense
|
—
|
|
|
163
|
|
|
—
|
|
|
163
|
|
||||
Net loss
|
(3,134
|
)
|
|
(6,062
|
)
|
|
(7,671
|
)
|
|
(14,057
|
)
|
||||
Deemed dividend arising from beneficial conversion feature of convertible preferred stock
|
—
|
|
|
(2,468
|
)
|
|
—
|
|
|
(4,436
|
)
|
||||
Deemed dividend arising from warrant modifications
|
(952
|
)
|
|
—
|
|
|
(1,391
|
)
|
|
—
|
|
||||
Net loss attributable to common stockholders
|
$
|
(4,086
|
)
|
|
$
|
(8,530
|
)
|
|
$
|
(9,062
|
)
|
|
$
|
(18,493
|
)
|
|
|
|
|
|
|
|
|
||||||||
Per share information:
|
|
|
|
|
|
|
|
||||||||
Net loss per common share attributable to common stockholders, basic and diluted
|
$
|
(0.13
|
)
|
|
$
|
(1.26
|
)
|
|
$
|
(0.33
|
)
|
|
$
|
(2.89
|
)
|
Weighted-average common shares outstanding, basic and diluted
|
32,298,234
|
|
|
6,767,200
|
|
|
27,360,621
|
|
|
6,391,948
|
|
|
Three Months Ended June 30, 2019
|
||||||||||||||||||||||||
|
Preferred Stock
|
|
Common Stock
|
|
Additional Paid-In Capital
|
|
Accumulated Deficit
|
|
Total Stockholders' Equity (Deficit)
|
||||||||||||||||
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
|
|
|||||||||||||||
Balance at March 31, 2019
|
—
|
|
|
$
|
—
|
|
|
24,176,475
|
|
|
$
|
2
|
|
|
$
|
89,340
|
|
|
$
|
(86,392
|
)
|
|
$
|
2,950
|
|
Issuance of common stock and common stock warrants, net of issuance costs
|
—
|
|
|
—
|
|
|
26,367,200
|
|
|
3
|
|
|
13,413
|
|
|
—
|
|
|
13,416
|
|
|||||
Issuance of common stock upon exercise of warrants, net of offering costs
|
—
|
|
|
—
|
|
|
1,000,000
|
|
|
—
|
|
|
1,045
|
|
|
—
|
|
|
1,045
|
|
|||||
Issuance of common stock upon exercise of pre-funded warrants
|
—
|
|
|
—
|
|
|
48,591,500
|
|
|
5
|
|
|
—
|
|
|
—
|
|
|
5
|
|
|||||
Impact of anti-dilution protection on liability-classified warrants
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(70
|
)
|
|
—
|
|
|
(70
|
)
|
|||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
126
|
|
|
—
|
|
|
126
|
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(3,134
|
)
|
|
(3,134
|
)
|
|||||
Balance at June 30, 2019
|
—
|
|
|
$
|
—
|
|
|
100,135,175
|
|
|
$
|
10
|
|
|
$
|
103,854
|
|
|
$
|
(89,526
|
)
|
|
$
|
14,338
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
|
Six Months Ended June 30, 2019
|
||||||||||||||||||||||||
|
Preferred Stock
|
|
Common Stock
|
|
Additional Paid-In Capital
|
|
Accumulated Deficit
|
|
Total Stockholders' Equity (Deficit)
|
||||||||||||||||
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
|
|
|||||||||||||||
Balance at December 31, 2018
|
—
|
|
|
$
|
—
|
|
|
22,026,476
|
|
|
$
|
2
|
|
|
$
|
87,098
|
|
|
$
|
(81,855
|
)
|
|
$
|
5,245
|
|
Issuance of common stock and common stock warrants, net of issuance costs
|
—
|
|
|
—
|
|
|
26,367,200
|
|
|
3
|
|
|
13,413
|
|
|
—
|
|
|
13,416
|
|
|||||
Issuance of common stock upon exercise of warrants, net of offering costs
|
—
|
|
|
—
|
|
|
3,149,999
|
|
|
—
|
|
|
3,275
|
|
|
—
|
|
|
3,275
|
|
|||||
Issuance of common stock upon exercise of pre-funded warrants
|
—
|
|
|
—
|
|
|
48,591,500
|
|
|
5
|
|
|
—
|
|
|
—
|
|
|
5
|
|
|||||
Impact of anti-dilution protection on liability-classified warrants
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(243
|
)
|
|
—
|
|
|
(243
|
)
|
|||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
311
|
|
|
—
|
|
|
311
|
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(7,671
|
)
|
|
(7,671
|
)
|
|||||
Balance at June 30, 2019
|
—
|
|
|
$
|
—
|
|
|
100,135,175
|
|
|
$
|
10
|
|
|
$
|
103,854
|
|
|
$
|
(89,526
|
)
|
|
$
|
14,338
|
|
|
Three Months Ended June 30, 2018
|
||||||||||||||||||||||||
|
Preferred Stock
|
|
Common Stock
|
|
Additional Paid-In Capital
|
|
Accumulated Deficit
|
|
Total Stockholders' Equity (Deficit)
|
||||||||||||||||
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
|
|
|||||||||||||||
Balance at March 31, 2018
|
5,987
|
|
|
$
|
—
|
|
|
6,154,377
|
|
|
$
|
1
|
|
|
$
|
60,861
|
|
|
$
|
(62,180
|
)
|
|
$
|
(1,318
|
)
|
Issuance of Series A convertible preferred stock, net of offering costs
|
4,713
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
4,319
|
|
|
—
|
|
|
4,319
|
|
|||||
Fair value of liability-classified warrants issued in connection with Series A convertible preferred stock offering
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(2,452
|
)
|
|
—
|
|
|
(2,452
|
)
|
|||||
Beneficial conversion feature arising from Series A convertible preferred stock
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(2,468
|
)
|
|
—
|
|
|
(2,468
|
)
|
|||||
Deemed dividend arising from beneficial conversion feature of Series A convertible preferred stock
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2,468
|
|
|
—
|
|
|
2,468
|
|
|||||
Conversion of Series A Convertible Preferred Stock
|
(2,898
|
)
|
|
—
|
|
|
499,682
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Convertible preferred stock dividends
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(415
|
)
|
|
—
|
|
|
(415
|
)
|
|||||
Issuance of common stock as repayment of principal and interest on long-term debt
|
—
|
|
|
—
|
|
|
382,134
|
|
|
—
|
|
|
1,245
|
|
|
—
|
|
|
1,245
|
|
|||||
Issuance of common stock in connection with litigation settlements
|
—
|
|
|
—
|
|
|
228,672
|
|
|
—
|
|
|
1,250
|
|
|
—
|
|
|
1,250
|
|
|||||
Issuance of common stock upon conversion of promissory notes
|
—
|
|
|
—
|
|
|
118,644
|
|
|
—
|
|
|
825
|
|
|
—
|
|
|
825
|
|
|||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
125
|
|
|
—
|
|
|
125
|
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(6,062
|
)
|
|
(6,062
|
)
|
|||||
Balance at June 30, 2018
|
7,802
|
|
|
$
|
—
|
|
|
7,383,509
|
|
|
$
|
1
|
|
|
$
|
65,758
|
|
|
$
|
(68,242
|
)
|
|
$
|
(2,483
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
|
Six Months Ended June 30, 2018
|
||||||||||||||||||||||||
|
Preferred Stock
|
|
Common Stock
|
|
Additional Paid-In Capital
|
|
Accumulated Deficit
|
|
Total Stockholders' Equity (Deficit)
|
||||||||||||||||
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
|
|
|||||||||||||||
Balance at December 31, 2017
|
—
|
|
|
$
|
—
|
|
|
5,766,891
|
|
|
$
|
1
|
|
|
$
|
56,254
|
|
|
$
|
(54,185
|
)
|
|
$
|
2,070
|
|
Issuance of Series A convertible preferred stock, net of offering costs
|
10,700
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
9,647
|
|
|
—
|
|
|
9,647
|
|
|||||
Fair value of liability-classified warrants issued in connection with Series A convertible preferred stock offering
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(5,039
|
)
|
|
—
|
|
|
(5,039
|
)
|
|||||
Beneficial conversion feature arising from Series A convertible preferred stock
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(4,436
|
)
|
|
—
|
|
|
(4,436
|
)
|
|||||
Deemed dividend arising from beneficial conversion feature of Series A convertible preferred stock
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
4,436
|
|
|
—
|
|
|
4,436
|
|
|||||
Conversion of Series A Convertible Preferred Stock
|
(2,898
|
)
|
|
—
|
|
|
499,682
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Convertible preferred stock dividends
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(487
|
)
|
|
—
|
|
|
(487
|
)
|
|||||
Issuance of common stock as repayment of principal and interest on long-term debt
|
—
|
|
|
—
|
|
|
715,277
|
|
|
—
|
|
|
2,876
|
|
|
—
|
|
|
2,876
|
|
|||||
Issuance of common stock in connection with litigation settlements
|
—
|
|
|
—
|
|
|
228,672
|
|
|
—
|
|
|
1,250
|
|
|
—
|
|
|
1,250
|
|
|||||
Issuance of common stock upon conversion of promissory notes
|
—
|
|
|
—
|
|
|
118,644
|
|
|
—
|
|
|
825
|
|
|
—
|
|
|
825
|
|
|||||
Issuance of common stock in connection with warrant exchange agreements
|
—
|
|
|
—
|
|
|
54,343
|
|
|
—
|
|
|
285
|
|
|
—
|
|
|
285
|
|
|||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
147
|
|
|
—
|
|
|
147
|
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(14,057
|
)
|
|
(14,057
|
)
|
|||||
Balance at June 30, 2018
|
7,802
|
|
|
$
|
—
|
|
|
7,383,509
|
|
|
$
|
1
|
|
|
$
|
65,758
|
|
|
$
|
(68,242
|
)
|
|
$
|
(2,483
|
)
|
|
For the six months ended June 30,
|
||||||
|
2019
|
|
2018
|
||||
Cash flows from operating activities:
|
|
|
|
||||
Net loss
|
$
|
(7,671
|
)
|
|
$
|
(14,057
|
)
|
Adjustment to reconcile net loss to net cash used in operating activities:
|
|
|
|
||||
Non-cash interest expense
|
—
|
|
|
115
|
|
||
Deferred taxes
|
—
|
|
|
49
|
|
||
Non-cash stock-based compensation
|
311
|
|
|
147
|
|
||
Fair value of common stock issued in connection with litigation settlements
|
—
|
|
|
1,250
|
|
||
Change in fair value of common stock warrants
|
(1,153
|
)
|
|
(3,099
|
)
|
||
Change in fair value of contingent consideration
|
482
|
|
|
3,863
|
|
||
Loss on settlement of liability-classified warrants
|
—
|
|
|
727
|
|
||
Changes in operating assets and liabilities:
|
|
|
|
||||
Prepaid expenses and other assets
|
(315
|
)
|
|
(604
|
)
|
||
Accounts payable
|
(263
|
)
|
|
408
|
|
||
Accrued expenses and other current liabilities
|
(1,038
|
)
|
|
(501
|
)
|
||
Net cash used in operating activities
|
(9,647
|
)
|
|
(11,702
|
)
|
||
Cash flows from financing activities:
|
|
|
|
||||
Net proceeds from issuance of Series A convertible preferred stock and common stock warrants
|
—
|
|
|
9,647
|
|
||
Proceeds from issuance of common stock, net of offering costs
|
13,781
|
|
|
—
|
|
||
Net proceeds from exercise of warrants
|
3,280
|
|
|
—
|
|
||
Dividends paid
|
—
|
|
|
(111
|
)
|
||
Principal payments on long-term debt
|
—
|
|
|
(589
|
)
|
||
Net cash provided by financing activities
|
17,061
|
|
|
8,947
|
|
||
Net increase (decrease) in cash, cash equivalents, restricted cash, and restricted cash equivalents
|
7,414
|
|
|
(2,755
|
)
|
||
Cash, cash equivalents, restricted cash, and restricted cash equivalents at the beginning of period
|
5,451
|
|
|
12,750
|
|
||
Cash, cash equivalents, restricted cash, and restricted cash equivalents at the end of period
|
$
|
12,865
|
|
|
$
|
9,995
|
|
|
|
|
|
||||
Supplemental disclosure of cash flow information:
|
|
|
|
||||
Cash received during the periods for interest
|
$
|
32
|
|
|
$
|
79
|
|
Cash paid during the periods for interest
|
$
|
—
|
|
|
$
|
182
|
|
Supplemental disclosure of non-cash investing and financing activities:
|
|
|
|
||||
Fair value of liability-classified warrants issued in connection with Series A convertible preferred stock recorded as issuance cost
|
$
|
—
|
|
|
$
|
5,039
|
|
Repayment of interest and principal on long-term debt through issuance of common stock
|
$
|
—
|
|
|
$
|
3,701
|
|
Reclassification of warrant liabilities upon exchange for shares of common stock
|
$
|
—
|
|
|
$
|
285
|
|
Operating right of use asset and current and non-current liability
|
$
|
550
|
|
|
$
|
—
|
|
Impact of anti-dilution protection on liability-classified warrants
|
$
|
243
|
|
|
$
|
—
|
|
Offering expenses in accounts payable and accrued expenses and other current liabilities
|
$
|
365
|
|
|
$
|
—
|
|
Long-term debt issued in connection with warrant exchange agreements
|
$
|
—
|
|
|
$
|
966
|
|
|
June 30, 2019
|
|
December 31, 2018
|
||||
Cash and cash equivalents
|
$
|
12,751
|
|
|
$
|
5,337
|
|
Restricted cash and cash equivalents
|
114
|
|
|
114
|
|
||
Total cash, cash equivalents, restricted cash, and restricted cash equivalents
|
$
|
12,865
|
|
|
$
|
5,451
|
|
Description
|
June 30, 2019
|
|
Quoted Prices In
Active Markets
(Level 1)
|
|
Significant Other
Observable
Inputs (Level 2)
|
|
Unobservable
Inputs
(Level 3)
|
||||||||
Assets:
|
|
|
|
|
|
|
|
||||||||
Cash equivalents
|
$
|
12,334
|
|
|
$
|
12,334
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Total assets measured and recorded at fair value
|
$
|
12,334
|
|
|
$
|
12,334
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Liabilities:
|
|
|
|
|
|
|
|
||||||||
Warrant liability
|
$
|
103
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
103
|
|
Contingent consideration
|
4,808
|
|
|
—
|
|
|
—
|
|
|
4,808
|
|
||||
Total liabilities measured and recorded at fair value
|
$
|
4,911
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
4,911
|
|
Description
|
December 31, 2018
|
|
Quoted Prices In
Active Markets
(Level 1)
|
|
Significant Other
Observable
Inputs (Level 2)
|
|
Unobservable
Inputs
(Level 3)
|
||||||||
Assets:
|
|
|
|
|
|
|
|
||||||||
Cash equivalents
|
$
|
5,195
|
|
|
$
|
5,195
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Total assets measured and recorded at fair value
|
$
|
5,195
|
|
|
$
|
5,195
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Liabilities:
|
|
|
|
|
|
|
|
||||||||
Warrant liability
|
$
|
1,013
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1,013
|
|
Contingent consideration
|
4,326
|
|
|
—
|
|
|
—
|
|
|
4,326
|
|
||||
Total liabilities measured and recorded at fair value
|
$
|
5,339
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
5,339
|
|
|
Fair Value
Measurements
Using Significant
Unobservable
Inputs
(Level 3)
|
||
Contingent consideration, December 31, 2018
|
$
|
4,326
|
|
Change in the estimated fair value of the contingent consideration
|
482
|
|
|
Contingent consideration, June 30, 2019
|
$
|
4,808
|
|
|
June 30, 2019
|
|
December 31, 2018
|
||||
Compensation and related benefits
|
$
|
388
|
|
|
$
|
675
|
|
Clinical trial costs
|
132
|
|
|
858
|
|
||
Professional fees
|
756
|
|
|
540
|
|
||
Rebates and returns of former commercial products
|
—
|
|
|
138
|
|
||
Other
|
—
|
|
|
8
|
|
||
Accrued expenses and other current liabilities
|
$
|
1,276
|
|
|
$
|
2,219
|
|
|
|
June 30, 2019
|
||
Year ending December 31, 2019 (remaining six months)
|
|
$
|
191
|
|
Year ending December 31, 2020
|
|
224
|
|
|
Total minimum lease payments
|
|
415
|
|
|
Less: imputed interest
|
|
(25
|
)
|
|
Operating lease liabilities
|
|
$
|
390
|
|
|
|
December 31, 2018
|
||
2019
|
|
$
|
377
|
|
2020
|
|
224
|
|
|
Total minimum lease payments
|
|
$
|
601
|
|
|
June 30, 2019
|
|
Warrants outstanding
|
142,739
|
|
Stock options outstanding
|
1,281
|
|
Options reserved for future issuance under the Company’s 2017 Equity Incentive Plan
|
416
|
|
Shares reserved for future issuance under the Employee Stock Purchase Plan
|
265
|
|
Restricted stock units
|
13
|
|
Total common stock reserved for future issuance
|
144,714
|
|
Warrant Issuance
|
Outstanding, December 31, 2018
|
|
Granted
|
|
Exercised
|
|
Canceled/Expired
|
|
Outstanding, June 30, 2019
|
|
Expiration
|
|||||
June 2019 Offering
|
—
|
|
|
100,000
|
|
|
—
|
|
|
—
|
|
|
100,000
|
|
|
June 2024
|
Pre-funded June 2019 Offering
|
—
|
|
|
73,633
|
|
|
(47,967
|
)
|
|
—
|
|
|
25,666
|
|
|
June 2024
|
March 2019 Exercise Agreement
|
—
|
|
|
3,150
|
|
|
—
|
|
|
—
|
|
|
3,150
|
|
|
March 2024
|
July 2018 Offering
|
15,268
|
|
|
—
|
|
|
(3,150
|
)
|
|
—
|
|
|
12,118
|
|
|
July 2023
|
Pre-funded July 2018 Offering
|
625
|
|
|
—
|
|
|
(625
|
)
|
|
—
|
|
|
—
|
|
|
July 2023
|
Series A Convertible Preferred
|
1,384
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,384
|
|
|
September 2023
|
2017 Equilibria
|
316
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
316
|
|
|
December 2022
|
Galena February 2017
|
33
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
33
|
|
|
February 2022
|
Galena Other
|
72
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
72
|
|
|
January 2022
|
|
17,698
|
|
|
176,783
|
|
|
(51,742
|
)
|
|
—
|
|
|
142,739
|
|
|
|
As of June 30, 2019
|
||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||
Warrant Issuance
|
Outstanding (in thousands)
|
|
Strike price (per share)
|
|
Expected term (years)
|
|
Volatility %
|
|
Risk-free rate %
|
|||||
Series A Convertible Preferred
|
1,384
|
|
|
$
|
0.15
|
|
|
4.26
|
|
99.14
|
%
|
|
1.74
|
%
|
Galena February 2017
|
33
|
|
|
$
|
33.00
|
|
|
2.63
|
|
105.00
|
%
|
|
1.71
|
%
|
Galena Other
|
72
|
|
|
$
|
829.88
|
|
|
1.93
|
|
105.00
|
%
|
|
1.71
|
%
|
|
|
|
|
|
|
|
|
|
|
|||||
As of December 31, 2018
|
||||||||||||||
Warrant Issuance
|
Outstanding (in thousands)
|
|
Strike price (per share)
|
|
Expected term (years)
|
|
Volatility %
|
|
Risk-free rate %
|
|||||
Series A Convertible Preferred
|
1,384
|
|
|
$
|
2.10
|
|
|
4.76
|
|
88.80
|
%
|
|
2.50
|
%
|
Galena February 2017
|
33
|
|
|
$
|
33.00
|
|
|
3.12
|
|
94.12
|
%
|
|
2.46
|
%
|
Galena Other
|
72
|
|
|
$
|
829.88
|
|
|
2.43
|
|
94.73
|
%
|
|
2.46
|
%
|
Warrant Issuance
|
Warrant liability, December 31, 2018
|
|
Fair value of warrants granted
|
|
Fair value of warrants canceled
|
|
Adjustment to exercise price of warrants
|
|
Change in fair value of warrants
|
|
Warrant liability, June 30, 2019
|
||||||||||||
Series A Convertible Preferred
|
$
|
1,010
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
243
|
|
|
$
|
(1,153
|
)
|
|
$
|
100
|
|
Galena February 2017
|
3
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
3
|
|
||||||
|
$
|
1,013
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
243
|
|
|
$
|
(1,153
|
)
|
|
$
|
103
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Research and development
|
$
|
(43
|
)
|
|
$
|
27
|
|
|
$
|
(4
|
)
|
|
$
|
33
|
|
General and administrative
|
169
|
|
|
98
|
|
|
315
|
|
|
114
|
|
||||
Total stock-based compensation
|
$
|
126
|
|
|
$
|
125
|
|
|
$
|
311
|
|
|
$
|
147
|
|
|
Six Months Ended June 30,
|
||||
|
2019
|
|
2018
|
||
Risk free interest rate
|
2.49
|
%
|
|
2.73
|
%
|
Volatility
|
96.57
|
%
|
|
80.83
|
%
|
Expected lives (years)
|
6.20
|
|
|
6.20
|
|
Expected dividend yield
|
—
|
%
|
|
—
|
%
|
|
Total
Number of
Shares
(In Thousands)
|
|
Weighted
Average
Exercise
Price
|
|
Weighted Average Remaining Contractual Term (in years)
|
|
Aggregate
Intrinsic
Value
(In Thousands)
|
|||||
Outstanding at December 31, 2018
|
395
|
|
|
$
|
37.09
|
|
|
9.01
|
|
$
|
—
|
|
Granted
|
940
|
|
|
1.38
|
|
|
|
|
—
|
|
||
Canceled
|
(54
|
)
|
|
5.24
|
|
|
|
|
$
|
—
|
|
|
Outstanding at June 30, 2019
|
1,281
|
|
|
$
|
12.21
|
|
|
9.38
|
|
$
|
—
|
|
Options exercisable at June 30, 2019
|
157
|
|
|
$
|
85.51
|
|
|
8.25
|
|
$
|
—
|
|
•
|
expenses incurred under agreements with contract research organizations, or CROs, as well as investigative sites and consultants that conduct our preclinical studies and clinical trials;
|
•
|
manufacturing expenses;
|
•
|
outsourced professional scientific development services;
|
•
|
employee-related expenses, which include salaries, benefits and stock-based compensation;
|
•
|
payments made under our license agreements, under which we acquired certain intellectual property;
|
•
|
expenses relating to certain regulatory activities, including filing fees paid to regulatory agencies;
|
•
|
laboratory materials and supplies used to support our research activities; and
|
•
|
allocated expenses, utilities and other facility-related costs.
|
•
|
the number of clinical sites included in the trials;
|
•
|
the length of time required to enroll suitable patients;
|
•
|
the number of patients that ultimately participate in the trials;
|
•
|
the number of doses patients receive;
|
•
|
the duration of patient follow-up;
|
•
|
the results of clinical trials;
|
•
|
the expenses associated with manufacturing;
|
•
|
the receipt of marketing approvals; and
|
•
|
the commercialization of current and future product candidates.
|
(dollars in thousands)
|
Three Months Ended June 30,
|
|
|
||||||||
|
2019
|
|
2018
|
|
Change
|
||||||
Operating expenses:
|
|
|
|
|
|
||||||
Research and development
|
$
|
1,381
|
|
|
$
|
1,592
|
|
|
$
|
(211
|
)
|
General and administrative
|
2,638
|
|
|
4,909
|
|
|
(2,271
|
)
|
|||
Total operating expenses and operating loss
|
(4,019
|
)
|
|
(6,501
|
)
|
|
2,482
|
|
|||
Non-operating income, net
|
885
|
|
|
602
|
|
|
283
|
|
|||
Loss before income taxes
|
(3,134
|
)
|
|
(5,899
|
)
|
|
2,765
|
|
|||
Income tax expense
|
—
|
|
|
163
|
|
|
(163
|
)
|
|||
Net loss
|
$
|
(3,134
|
)
|
|
$
|
(6,062
|
)
|
|
$
|
2,928
|
|
(dollars in thousands)
|
Six Months Ended June 30,
|
|
|
||||||||
|
2019
|
|
2018
|
|
Change
|
||||||
Operating expenses:
|
|
|
|
|
|
||||||
Research and development
|
$
|
3,240
|
|
|
$
|
3,396
|
|
|
$
|
(156
|
)
|
General and administrative
|
5,138
|
|
|
8,789
|
|
|
(3,651
|
)
|
|||
Total operating expenses and operating loss
|
(8,378
|
)
|
|
(12,185
|
)
|
|
3,807
|
|
|||
Non-operating income (expense), net
|
707
|
|
|
(1,709
|
)
|
|
2,416
|
|
|||
Loss before income taxes
|
(7,671
|
)
|
|
(13,894
|
)
|
|
6,223
|
|
|||
Income tax expense
|
—
|
|
|
163
|
|
|
(163
|
)
|
|||
Net loss
|
$
|
(7,671
|
)
|
|
$
|
(14,057
|
)
|
|
$
|
6,386
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||||||||||
|
2019
|
|
2018
|
|
Change
|
|
2019
|
|
2018
|
|
Change
|
||||||||||||
Change in fair value of warrant liability
|
$
|
962
|
|
|
$
|
1,218
|
|
|
$
|
(256
|
)
|
|
$
|
1,157
|
|
|
$
|
3,099
|
|
|
$
|
(1,942
|
)
|
Change in fair value of contingent consideration
|
(95
|
)
|
|
(452
|
)
|
|
357
|
|
|
(482
|
)
|
|
(3,863
|
)
|
|
3,381
|
|
||||||
Loss on settlement of liability-classified warrants
|
—
|
|
|
(42
|
)
|
|
42
|
|
|
—
|
|
|
(727
|
)
|
|
727
|
|
||||||
Interest income (expense), net
|
18
|
|
|
(122
|
)
|
|
140
|
|
|
32
|
|
|
(218
|
)
|
|
250
|
|
||||||
Total non-operating income (expense), net
|
$
|
885
|
|
|
$
|
602
|
|
|
$
|
283
|
|
|
$
|
707
|
|
|
$
|
(1,709
|
)
|
|
$
|
2,416
|
|
|
Six Months Ended June 30,
|
||||||
|
2019
|
|
2018
|
||||
Net cash (used in) provided by:
|
|
|
|
||||
Operating activities
|
$
|
(9,647
|
)
|
|
$
|
(11,702
|
)
|
Financing activities
|
17,061
|
|
|
8,947
|
|
||
Net decrease in cash, cash equivalents, restricted cash, and restricted cash equivalents
|
$
|
7,414
|
|
|
$
|
(2,755
|
)
|
(a)
|
our disclosure controls and procedures were effective to provide reasonable assurance that information required to be disclosed by us in the reports we file or submit under the Exchange Act was recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms; and
|
(b)
|
our disclosure controls and procedures were effective to provide reasonable assurance that material information required to be disclosed by us in the reports we file or submit under the Exchange Act was accumulated and communicated to our management, including the Certifying Officers, as appropriate to allow timely decisions regarding required disclosure.
|
*
|
Filed herewith
|
**
|
The certification attached as Exhibit 32.1 accompany this Quarterly Report on Form 10-Q pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, and shall not be deemed “filed” by the Company for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference into any filing of the registrant under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date hereof, regardless of any general incorporation language in such filing
.
|
|
SELLAS Life Sciences Group, Inc.
|
||
|
|
|
|
|
By:
|
|
/s/ Angelos M. Stergiou
|
|
|
|
|
|
|
|
Angelos M. Stergiou, MD, ScD h.c.
|
|
|
|
President and Chief Executive Officer
|
|
|
|
|
|
|
|
Date: August 14, 2019
|
|
|
|
|
|
|
|
|
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, including its consolidated subsidiaries, 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 that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
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.
|
|
/s/ Angelos M. Stergiou
|
|
|
|
Angelos M. Stergiou, MD, ScD h.c.
|
|
President and Chief Executive Officer
(Principal Executive Officer and Principal Financial Officer)
|
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, including its consolidated subsidiaries, 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 that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
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.
|
|
/s/ Angelos M. Stergiou
|
|
|
|
Angelos M. Stergiou, MD, ScD h.c.
|
|
President and Chief Executive Officer
(Principal Executive Officer and Principal Financial Officer)
|
|
By:
|
|
/s/ Angelos M. Stergiou
|
|
|
|
|
|
|
|
Angelos M. Stergious, MD, ScD h.c.
|
|
|
|
President and Chief Executive Officer
(Principal Executive Officer and Principal Financial Officer)
|
|
|
|
|
|
|
|
Date: August 14, 2019
|