British Columbia, Canada
|
|
98-0597776
|
(State or Other Jurisdiction of
|
|
(I.R.S. Employer
|
Incorporation or Organization)
|
|
Identification No.)
|
Title of each class
|
Trading Symbol(s)
|
Name of each exchange on which registered
|
Common Shares, without par value
|
ABUS
|
The Nasdaq Stock Market LLC
|
Large accelerated filer [ ]
|
Accelerated filer [X]
|
Non-accelerated filer [ ]
|
Smaller reporting company [X]
|
Emerging growth company [ ]
|
|
|
Page
|
|
|
|
|
|
|
|
March 31, 2020
|
|
December 31, 2019
|
||||
Assets
|
|
|
|
||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
26,416
|
|
|
$
|
31,799
|
|
Investments in marketable securities, current
|
58,475
|
|
|
59,035
|
|
||
Accounts receivable
|
1,072
|
|
|
1,204
|
|
||
Prepaid expenses and other current assets
|
2,370
|
|
|
1,790
|
|
||
Total current assets
|
88,333
|
|
|
93,828
|
|
||
Property and equipment, net of accumulated depreciation of $6,142 (December 31, 2019: $5,642)
|
8,176
|
|
|
8,676
|
|
||
Investments in marketable securities, non-current
|
3,215
|
|
|
—
|
|
||
Right of use asset
|
2,657
|
|
|
2,738
|
|
||
Other non-current assets
|
233
|
|
|
293
|
|
||
Total assets
|
$
|
102,614
|
|
|
$
|
105,535
|
|
Liabilities and stockholders’ equity
|
|
|
|
||||
Current liabilities:
|
|
|
|
||||
Accounts payable and accrued liabilities
|
$
|
3,565
|
|
|
$
|
7,235
|
|
Liability-classified options
|
58
|
|
|
253
|
|
||
Lease liability, current
|
408
|
|
|
340
|
|
||
Total current liabilities
|
4,031
|
|
|
7,828
|
|
||
Liability related to sale of future royalties
|
19,375
|
|
|
18,992
|
|
||
Contingent consideration
|
3,065
|
|
|
2,953
|
|
||
Lease liability, non-current
|
2,887
|
|
|
3,018
|
|
||
Total liabilities
|
29,358
|
|
|
32,791
|
|
||
Stockholders’ equity:
|
|
|
|
||||
Preferred shares
|
|
|
|
||||
Authorized: unlimited number without par value
|
|
|
|
||||
Issued and outstanding: 1,164,000 (December 31, 2019: 1,164,000)
|
140,263
|
|
|
137,285
|
|
||
Common shares
|
|
|
|
||||
Authorized: unlimited number without par value
|
|
|
|
||||
Issued and outstanding: 68,961,395 (December 31, 2019: 64,780,314)
|
911,099
|
|
|
898,535
|
|
||
Additional paid-in capital
|
56,803
|
|
|
55,246
|
|
||
Deficit
|
(986,932
|
)
|
|
(970,093
|
)
|
||
Accumulated other comprehensive loss
|
(47,977
|
)
|
|
(48,229
|
)
|
||
Total stockholders’ equity
|
73,256
|
|
|
72,744
|
|
||
Total liabilities and stockholders’ equity
|
$
|
102,614
|
|
|
$
|
105,535
|
|
|
Three Months Ended March 31,
|
||||||
|
2020
|
|
2019
|
||||
Revenue
|
|
|
|
||||
Revenue from collaborations and licenses
|
$
|
835
|
|
|
$
|
508
|
|
Non-cash royalty revenue
|
656
|
|
|
171
|
|
||
Total Revenue
|
1,491
|
|
|
679
|
|
||
Operating expenses
|
|
|
|
|
|||
Research and development
|
10,416
|
|
|
14,712
|
|
||
General and administrative
|
3,553
|
|
|
4,412
|
|
||
Depreciation
|
500
|
|
|
509
|
|
||
Change in fair value of contingent consideration
|
112
|
|
|
125
|
|
||
Site consolidation
|
57
|
|
|
117
|
|
||
Total operating expenses
|
14,638
|
|
|
19,875
|
|
||
Loss from operations
|
(13,147
|
)
|
|
(19,196
|
)
|
||
Other income (loss)
|
|
|
|
||||
Interest income
|
345
|
|
|
600
|
|
||
Interest expense
|
(1,041
|
)
|
|
(12
|
)
|
||
Foreign exchange (losses) / gains
|
(18
|
)
|
|
8
|
|
||
Net equity investment loss
|
—
|
|
|
(4,651
|
)
|
||
Total other loss
|
(714
|
)
|
|
(4,055
|
)
|
||
Loss before income taxes
|
(13,861
|
)
|
|
(23,251
|
)
|
||
Income tax benefit
|
—
|
|
|
—
|
|
||
Net loss
|
(13,861
|
)
|
|
(23,251
|
)
|
||
Items applicable to preferred shares:
|
|
|
|
||||
Dividend accretion of convertible preferred shares
|
(2,978
|
)
|
|
(2,715
|
)
|
||
Net loss attributable to common shares
|
$
|
(16,839
|
)
|
|
$
|
(25,966
|
)
|
Net loss per common share
|
|
|
|
|
|
||
Basic and diluted
|
$
|
(0.25
|
)
|
|
$
|
(0.47
|
)
|
Weighted average number of common shares
|
|
|
|
|
|
||
Basic and diluted
|
67,683,586
|
|
|
55,740,121
|
|
||
Comprehensive income (loss)
|
|
|
|
||||
Unrealized gain on available-for-sale securities
|
251
|
|
|
—
|
|
||
Currency translation adjustment
|
—
|
|
|
(22
|
)
|
||
Comprehensive loss
|
$
|
(13,610
|
)
|
|
$
|
(23,273
|
)
|
|
Convertible Preferred Shares
|
|
Common Shares
|
|
|
|
|
|
|
|
|
||||||||||||||||||
|
Number of Shares
|
|
Share Capital
|
|
Number of Shares
|
|
Share Capital
|
|
Additional Paid-In Capital
|
|
Deficit
|
|
Accumulated Other Comprehensive Loss
|
|
Total Stockholders' Equity
|
||||||||||||||
Balance, December 31, 2019
|
1,164,000
|
|
|
$
|
137,285
|
|
|
64,780,314
|
|
|
$
|
898,535
|
|
|
$
|
55,246
|
|
|
$
|
(970,093
|
)
|
|
$
|
(48,229
|
)
|
|
$
|
72,744
|
|
Accretion of accumulated dividends on Preferred Shares
|
—
|
|
|
2,978
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(2,978
|
)
|
|
—
|
|
|
—
|
|
||||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,460
|
|
|
—
|
|
|
—
|
|
|
1,460
|
|
||||||
Certain fair value adjustments to liability stock option awards
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
180
|
|
|
—
|
|
|
—
|
|
|
180
|
|
||||||
Issuance of common shares pursuant to the Open Market Sales Agreement
|
—
|
|
|
—
|
|
|
4,147,081
|
|
|
12,315
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
12,315
|
|
||||||
Issuance of common shares pursuant to exercise of options
|
—
|
|
|
—
|
|
|
34,000
|
|
|
249
|
|
|
(83
|
)
|
|
—
|
|
|
—
|
|
|
166
|
|
||||||
Unrealized gain on available-for-sale securities
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
252
|
|
|
252
|
|
||||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(13,861
|
)
|
|
—
|
|
|
(13,861
|
)
|
||||||
Balance, March 31, 2020
|
1,164,000
|
|
|
$
|
140,263
|
|
|
68,961,395
|
|
|
$
|
911,099
|
|
|
$
|
56,803
|
|
|
$
|
(986,932
|
)
|
|
$
|
(47,977
|
)
|
|
$
|
73,256
|
|
|
Convertible Preferred Shares
|
|
Common Shares
|
|
|
|
|
|
|
|
|
||||||||||||||||||
|
Number of Shares
|
|
Share Capital
|
|
Number of Shares
|
|
Share Capital
|
|
Additional Paid-In Capital
|
|
Deficit
|
|
Accumulated Other Comprehensive Loss
|
|
Total Stockholders' Equity
|
||||||||||||||
Balance, December 31, 2018
|
1,164,000
|
|
|
126,136
|
|
|
55,518,800
|
|
|
$
|
879,405
|
|
|
$
|
48,084
|
|
|
$
|
(805,221
|
)
|
|
$
|
(48,170
|
)
|
|
$
|
200,234
|
|
|
Accretion of accumulated dividends on Preferred Shares
|
—
|
|
|
2,715
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(2,715
|
)
|
|
—
|
|
|
—
|
|
||||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,665
|
|
|
—
|
|
|
—
|
|
|
1,665
|
|
||||||
Certain fair value adjustments to liability stock option awards
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
47
|
|
|
—
|
|
|
—
|
|
|
47
|
|
||||||
Issuance of common shares pursuant to the Open Market Sales Agreement
|
—
|
|
|
—
|
|
|
614,401
|
|
|
2,248
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2,248
|
|
||||||
Issuance of common shares pursuant to exercise of options
|
—
|
|
|
—
|
|
|
122,603
|
|
|
490
|
|
|
(202
|
)
|
|
—
|
|
|
—
|
|
|
288
|
|
||||||
Currency translation adjustment
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(22
|
)
|
|
(22
|
)
|
||||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(23,251
|
)
|
|
—
|
|
|
(23,251
|
)
|
||||||
Balance, March 31, 2019
|
1,164,000
|
|
|
$
|
128,851
|
|
|
56,255,804
|
|
|
$
|
882,143
|
|
|
$
|
49,594
|
|
|
$
|
(831,187
|
)
|
|
$
|
(48,192
|
)
|
|
$
|
181,209
|
|
|
Three Months Ended March 31,
|
||||||
|
2020
|
|
2019
|
||||
OPERATING ACTIVITIES
|
|
|
|
||||
Net loss
|
$
|
(13,861
|
)
|
|
$
|
(23,251
|
)
|
Items not involving cash:
|
|
|
|
||||
Depreciation
|
500
|
|
|
509
|
|
||
Gain on sale of property and equipment
|
—
|
|
|
(9
|
)
|
||
Stock-based compensation expense
|
1,445
|
|
|
1,522
|
|
||
Unrealized foreign exchange losses (gains)
|
10
|
|
|
(38
|
)
|
||
Change in fair value of contingent consideration
|
112
|
|
|
125
|
|
||
Net equity investment gain (loss)
|
—
|
|
|
4,651
|
|
||
Non-cash royalty revenue
|
(656
|
)
|
|
(171
|
)
|
||
Non-cash interest expense
|
1,039
|
|
|
—
|
|
||
Net accretion and amortization of investments in marketable securities
|
(2
|
)
|
|
—
|
|
||
Net change in operating items:
|
|
|
|
||||
Accounts receivable
|
132
|
|
|
777
|
|
||
Prepaid expenses and other assets
|
(439
|
)
|
|
2,277
|
|
||
Accounts payable and accrued liabilities
|
(3,602
|
)
|
|
(2,885
|
)
|
||
Other liabilities
|
(131
|
)
|
|
(87
|
)
|
||
Net cash used in operating activities
|
(15,453
|
)
|
|
(16,580
|
)
|
||
INVESTING ACTIVITIES
|
|
|
|
||||
Purchase of investments
|
(24,369
|
)
|
|
(334
|
)
|
||
Disposition of investments
|
21,968
|
|
|
61,389
|
|
||
Proceeds from sale of property and equipment
|
—
|
|
|
9
|
|
||
Acquisition of property and equipment
|
—
|
|
|
(31
|
)
|
||
Net cash provided by / (used in) investing activities
|
(2,401
|
)
|
|
61,033
|
|
||
FINANCING ACTIVITIES
|
|
|
|
||||
Issuance of common shares pursuant to the Open Market Sale agreement
|
12,315
|
|
|
2,248
|
|
||
Issuance of common shares pursuant to exercise of options
|
166
|
|
|
288
|
|
||
Net cash provided by financing activities
|
12,481
|
|
|
2,536
|
|
||
Effect of foreign exchange rate changes on cash and cash equivalents
|
(10
|
)
|
|
38
|
|
||
Increase / (decrease) in cash and cash equivalents
|
(5,383
|
)
|
|
47,027
|
|
||
Cash and cash equivalents, beginning of period
|
31,799
|
|
|
36,942
|
|
||
Cash and cash equivalents, end of period
|
$
|
26,416
|
|
|
$
|
83,969
|
|
|
|
|
|
||||
Supplemental cash flow information
|
|
|
|
||||
Preferred shares dividends accrued
|
(2,978
|
)
|
|
(2,715
|
)
|
•
|
AB-729, a subcutaneously-delivered RNA interference (“RNAi”) product candidate currently in a Phase 1a/1b clinical trial with preliminary results announced in March 2020. Additional Week 12 single-dose results for the 60 mg dose cohort are expected in the second quarter of 2020. Results from a single-dose 90 mg cohort and a multi-dose 60 mg cohort are expected in the second half of 2020;
|
•
|
AB-836, a next-generation capsid inhibitor product candidate currently advancing through IND-enabling studies; and
|
•
|
other compounds early in the development process, including oral compounds that inhibit PD-L1 and next-generation oral HBV RNA destabilizers.
|
•
|
Level 1 inputs are quoted market prices for identical instruments available in active markets.
|
•
|
Level 2 inputs are inputs other than quoted prices included within Level 1 that are observable for the asset or liability either directly or indirectly. If the asset or liability has a contractual term, the input must be observable for substantially the full term. An example includes quoted market prices for similar assets or liabilities in active markets.
|
•
|
Level 3 inputs are unobservable inputs for the asset or liability and will reflect management’s assumptions about market assumptions that would be used to price the asset or liability.
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
||||||||
As of March 31, 2020
|
(in thousands)
|
||||||||||||||
Assets
|
|
|
|
|
|
|
|
||||||||
Cash and cash equivalents
|
$
|
26,416
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
26,416
|
|
Short-term investments
|
58,475
|
|
|
—
|
|
|
—
|
|
|
58,475
|
|
||||
Long-term investments
|
3,215
|
|
|
—
|
|
|
—
|
|
|
3,215
|
|
||||
Total
|
88,106
|
|
|
—
|
|
|
—
|
|
|
88,106
|
|
||||
Liabilities
|
|
|
|
|
|
|
|
||||||||
Liability-classified options
|
—
|
|
|
—
|
|
|
58
|
|
|
58
|
|
||||
Contingent consideration
|
—
|
|
|
—
|
|
|
3,065
|
|
|
3,065
|
|
||||
Total
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
3,123
|
|
|
$
|
3,123
|
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
||||||||
As of December 31, 2019
|
(in thousands)
|
||||||||||||||
Assets
|
|
|
|
|
|
|
|
||||||||
Cash and cash equivalents
|
$
|
31,799
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
31,799
|
|
Short-term investments
|
59,035
|
|
|
—
|
|
|
—
|
|
|
59,035
|
|
||||
Total
|
90,834
|
|
|
—
|
|
|
—
|
|
|
90,834
|
|
||||
Liabilities
|
|
|
|
|
|
|
|
||||||||
Liability-classified stock option awards
|
—
|
|
|
—
|
|
|
253
|
|
|
253
|
|
||||
Contingent consideration
|
—
|
|
|
—
|
|
|
2,953
|
|
|
2,953
|
|
||||
Total
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
3,206
|
|
|
$
|
3,206
|
|
|
Liability at beginning of the period
|
|
Fair value of liability-classified options exercised in the period
|
|
Increase (decrease) in fair value of liability
|
|
Liability at end of the period
|
||||||||
|
(in thousands)
|
||||||||||||||
Three months ended March 31, 2019
|
$
|
479
|
|
|
$
|
—
|
|
|
$
|
(65
|
)
|
|
$
|
414
|
|
Three months ended March 31, 2020
|
$
|
253
|
|
|
$
|
(9
|
)
|
|
$
|
(186
|
)
|
|
$
|
58
|
|
|
Liability at beginning of the period
|
|
Increase (decrease) in fair value of liability
|
|
Liability at end of the period
|
||||||
|
(in thousands)
|
||||||||||
Three months ended March 31, 2019
|
$
|
3,126
|
|
|
$
|
125
|
|
|
$
|
3,251
|
|
Three months ended March 31, 2020
|
$
|
2,953
|
|
|
$
|
112
|
|
|
$
|
3,065
|
|
|
Amortized Cost
|
|
Gross Unrealized Gain(1)
|
|
Gross Unrealized Loss(1)
|
|
Fair Value
|
||||||||
As of March 31, 2020
|
(in thousands)
|
||||||||||||||
Cash equivalents
|
|
|
|
|
|
|
|
||||||||
Money market fund
|
$
|
4,961
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
4,961
|
|
US government agency bonds
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||
US treasury bills
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||
Total
|
$
|
4,961
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
4,961
|
|
Investments in marketable securities
|
|
|
|
|
|
|
|
||||||||
US government agency bonds
|
$
|
25,214
|
|
|
$
|
88
|
|
|
$
|
—
|
|
|
$
|
25,302
|
|
US treasury bills
|
9,974
|
|
|
24
|
|
|
—
|
|
|
9,998
|
|
||||
US government bonds
|
26,249
|
|
|
141
|
|
|
—
|
|
|
26,390
|
|
||||
Total
|
$
|
61,437
|
|
|
$
|
253
|
|
|
$
|
—
|
|
|
$
|
61,690
|
|
|
Amortized Cost
|
|
Gross Unrealized Gain(1)
|
|
Gross Unrealized Loss(1)
|
|
Fair Value
|
||||||||
As of December 31, 2019
|
(in thousands)
|
||||||||||||||
Cash equivalents
|
|
|
|
|
|
|
|
||||||||
Money market fund
|
$
|
4,106
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
4,106
|
|
US government agency bonds
|
1,511
|
|
|
—
|
|
|
—
|
|
|
1,511
|
|
||||
US treasury bills
|
1,499
|
|
|
—
|
|
|
—
|
|
|
1,499
|
|
||||
Total
|
$
|
7,116
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
7,116
|
|
Investments in marketable securities
|
|
|
|
|
|
|
|
||||||||
US government agency bonds
|
$
|
19,863
|
|
|
$
|
2
|
|
|
$
|
(1
|
)
|
|
$
|
19,864
|
|
US treasury bills
|
15,926
|
|
|
2
|
|
|
(1
|
)
|
|
15,927
|
|
||||
US government bonds
|
23,246
|
|
|
—
|
|
|
(2
|
)
|
|
23,244
|
|
||||
Total
|
$
|
59,035
|
|
|
$
|
4
|
|
|
$
|
(4
|
)
|
|
$
|
59,035
|
|
|
March 31, 2020
|
|
December 31, 2019
|
||||
|
(in thousands)
|
||||||
Trade accounts payable
|
$
|
519
|
|
|
$
|
2,398
|
|
Research and development accruals
|
1,796
|
|
|
1,433
|
|
||
Professional fee accruals
|
360
|
|
|
809
|
|
||
Payroll accruals
|
867
|
|
|
2,314
|
|
||
Site consolidation accrual
|
19
|
|
|
137
|
|
||
Other accrued liabilities
|
4
|
|
|
144
|
|
||
|
$
|
3,565
|
|
|
$
|
7,235
|
|
7.
|
Sale of future royalties
|
|
Three Months Ended March 31, 2020
|
||
|
(in thousands)
|
||
Net liability related to sale of future royalties - beginning balance
|
$
|
18,992
|
|
Non-cash royalty revenue
|
(656
|
)
|
|
Non-cash interest expense
|
1,039
|
|
|
Net liability related to sale of future royalties - ending balance
|
$
|
19,375
|
|
|
Three Months Ended March 31,
|
||||||
|
2020
|
|
2019
|
||||
|
(in thousands)
|
||||||
Revenue from collaborations and licenses
|
|
|
|
||||
Acuitas Therapeutics, Inc.
|
$
|
753
|
|
|
$
|
252
|
|
Other milestone and royalty payments
|
82
|
|
|
256
|
|
||
Non-cash royalty revenue
|
|
|
|
||||
Alnylam Pharmaceuticals, Inc.
|
656
|
|
|
171
|
|
||
Total revenue
|
$
|
1,491
|
|
|
$
|
679
|
|
|
Three Months Ended March 31, 2020
|
|
Three Months Ended March 31, 2019
|
||||
|
(in thousands, except share and per share data)
|
||||||
Options granted during period
|
2,097,237
|
|
|
1,604,500
|
|
||
Weighted average exercise price
|
$
|
3.35
|
|
|
$
|
4.57
|
|
|
|
|
|
||||
Research and development
|
$
|
853
|
|
|
$
|
727
|
|
General and administrative
|
592
|
|
|
795
|
|
||
Total stock compensation expense
|
$
|
1,445
|
|
|
$
|
1,522
|
|
•
|
our strategy, future operations, pre-clinical research, pre-clinical studies, clinical trials, prospects and the plans of management;
|
•
|
the potential impact of the COVID-19 pandemic on our business;
|
•
|
the discovery, development and commercialization of a curative combination regimen for chronic hepatitis B infection, a disease of the liver caused by the hepatitis B virus (“HBV”);
|
•
|
our beliefs and development path and strategy to achieve a curative combination regimen for HBV;
|
•
|
obtaining necessary regulatory approvals;
|
•
|
obtaining adequate financing through a combination of financing activities and operations;
|
•
|
using the results from our HBV studies to adaptively design additional clinical trials to test the efficacy of the combination therapy and the duration of the result in patients;
|
•
|
the expected timing of and amount for payments related to the Enantigen Therapeutics, Inc.’s transaction and its programs;
|
•
|
the potential of our drug candidates to improve upon the standard of care and contribute to a curative combination treatment regimen;
|
•
|
the potential benefits of the reversion of the Ontario Municipal Employees Retirement System (“OMERS”) royalty monetization transaction for our ONPATTRO™ (Patisiran) (“ONPATTRO”) royalty interest;
|
•
|
developing a suite of products that intervene at different points in the viral life cycle, with the potential to reactivate the host immune system;
|
•
|
using pre-clinical results to adaptively design clinical trials for additional cohorts of patients, testing the combination and the duration of therapy;
|
•
|
selecting combination therapy regimens and treatment durations to conduct Phase 3 clinical trials intended to ultimately support regulatory filings for marketing approval;
|
•
|
expanding our HBV drug candidate pipeline through internal development, acquisitions and in-licenses;
|
•
|
our expectation for AB-729 for additional results for the 12 week portion of the 60 mg single-dose cohort to be available in the second quarter of 2020
|
•
|
our expectation for AB-729 for preliminary results from a single-dose 90 mg cohort and a multi-dose 60 mg cohort Phase 1a/1b trial to be available in the second half of 2020;
|
•
|
our expectation that AB-729 could be combined with our lead capsid inhibitor candidate, AB-836, and approved NAs, in our first combination therapy for HBV patients;
|
•
|
the potential for an oral HBsAg-reducing agent and potential all-oral combination therapy;
|
•
|
our objective to complete IND/CTA-enabling studies for AB-836 by the end of 2020;
|
•
|
the potential for AB-836 to be low-dose with a wide therapeutic window and to address known capsid resistant variants T33N and 1105T;
|
•
|
the potential for AB-836 to have increased potency and an enhanced resistance profile, compared to our previous capsid inhibitor candidate, AB-506;
|
•
|
the potential for AB-836 to be once-daily dosing;
|
•
|
our expectation to pursue development of a next generation oral HBV RNA-destabilizer;
|
•
|
payments from our licensed agreement with Gritstone Oncology, Inc.;
|
•
|
the expected return from strategic alliances, licensing agreements, and research collaborations;
|
•
|
statements with respect to revenue and expense fluctuation and guidance;
|
•
|
having sufficient cash resources to fund our operations into mid-2021; and
|
•
|
obtaining funding to maintain and advance our business from a variety of sources including public or private equity or debt financing, collaborative arrangements with pharmaceutical companies, other non-dilutive commercial arrangements and government grants and contracts;
|
•
|
developing a broad portfolio of proprietary therapeutic assets that target multiple elements of the HBV viral lifecycle, most importantly suppressing HBV replication and HBsAg expression;
|
•
|
developing compounds that reawaken the host immune response;
|
•
|
identifying a combination of therapeutic assets with complementary mechanisms of action that can deliver higher cure rates with a finite treatment duration; and
|
•
|
advancing a curative combination regimen through clinical development, regulatory approval and commercial launch.
|
•
|
In Part 1, three cohorts of healthy subjects were randomized 4:2 to receive single doses (60 mg, 180 mg or 360 mg) of AB-729 or placebo.
|
•
|
In Part 2, non-cirrhotic, HBeAg positive or negative, chronic hepatitis B subjects (n="6") currently taking nucleos(t)ide antiviral therapy with HBV DNA below the limit of quantitation received single doses (60 mg, 90 mg or 180 mg) of AB-729. All subjects continued their nucleos(t)ide antiviral therapy throughout the trial. Part 2 may also include dosing of AB-729 in HBV DNA positive chronic hepatitis B subjects.
|
•
|
In Part 3, chronic hepatitis B subjects, HBV DNA negative first and HBV DNA positive later, will receive multiple doses of AB-729 for up to six months.
|
|
Three Months Ended March 31,
|
||||||
|
2020
|
|
2019
|
||||
|
(in thousands except per share amounts)
|
||||||
Total revenue
|
$
|
1,491
|
|
|
$
|
679
|
|
Operating expenses
|
14,638
|
|
|
19,875
|
|
||
Loss from operations
|
(13,147
|
)
|
|
(19,196
|
)
|
||
Other income (loss)
|
(714
|
)
|
|
(4,055
|
)
|
||
Net loss
|
$
|
(13,861
|
)
|
|
$
|
(23,251
|
)
|
Dividend accretion of convertible preferred shares
|
(2,978
|
)
|
|
(2,715
|
)
|
||
Net loss attributable to common shares
|
$
|
(16,839
|
)
|
|
$
|
(25,966
|
)
|
|
Three Months Ended March 31,
|
||||||||||||
|
2020
|
|
% of Total
|
|
2019
|
|
% of Total
|
||||||
|
(in thousands, except percentages)
|
||||||||||||
Revenue from collaborations and licenses
|
|
|
|
|
|
|
|
||||||
Acuitas Therapeutics, Inc.
|
$
|
753
|
|
|
51
|
%
|
|
$
|
252
|
|
|
37
|
%
|
Other milestone and royalty payments
|
82
|
|
|
5
|
%
|
|
256
|
|
|
38
|
%
|
||
Non-cash royalty revenue
|
|
|
|
|
|
|
|
||||||
Alnylam Pharmaceuticals, Inc.
|
656
|
|
|
44
|
%
|
|
171
|
|
|
25
|
%
|
||
Total revenue
|
$
|
1,491
|
|
|
100
|
%
|
|
$
|
679
|
|
|
100
|
%
|
|
Three Months Ended March 31,
|
||||||||||||
|
2020
|
|
% of Total
|
|
2019
|
|
% of Total
|
||||||
|
(in thousands, except percentages)
|
||||||||||||
Research and development
|
$
|
10,416
|
|
|
71
|
%
|
|
$
|
14,712
|
|
|
74
|
%
|
General and administrative
|
3,553
|
|
|
24
|
%
|
|
4,412
|
|
|
22
|
%
|
||
Depreciation
|
500
|
|
|
3
|
%
|
|
509
|
|
|
3
|
%
|
||
Change in fair value of contingent consideration
|
112
|
|
|
1
|
%
|
|
125
|
|
|
1
|
%
|
||
Site consolidation
|
57
|
|
|
—
|
%
|
|
117
|
|
|
1
|
%
|
||
Total operating expenses
|
$
|
14,638
|
|
|
100
|
%
|
|
$
|
19,875
|
|
|
100
|
%
|
|
Three Months Ended March 31,
|
||||||
|
2020
|
|
2019
|
||||
|
(in thousands)
|
||||||
Interest income
|
$
|
345
|
|
|
$
|
600
|
|
Interest expense
|
(1,041
|
)
|
|
(12
|
)
|
||
Foreign exchange (losses) / gains
|
(18
|
)
|
|
8
|
|
||
Net equity investment loss
|
—
|
|
|
(4,651
|
)
|
||
Total other loss
|
$
|
(714
|
)
|
|
$
|
(4,055
|
)
|
|
Three Months Ended March 31,
|
||||||
|
2020
|
|
2019
|
||||
|
(in thousands)
|
||||||
Net loss
|
$
|
(13,861
|
)
|
|
$
|
(23,251
|
)
|
Items not involving cash:
|
2,448
|
|
|
6,589
|
|
||
Net change in operating items:
|
(4,040
|
)
|
|
82
|
|
||
Net cash used in operating activities
|
(15,453
|
)
|
|
(16,580
|
)
|
||
Net cash provided by / (used in) investing activities
|
(2,401
|
)
|
|
61,033
|
|
||
Net cash provided by financing activities
|
12,481
|
|
|
2,536
|
|
||
Effect of foreign exchange rate changes on cash and cash equivalents
|
(10
|
)
|
|
38
|
|
||
Increase / (decrease) in cash and cash equivalents
|
(5,383
|
)
|
|
47,027
|
|
||
Cash and cash equivalents, beginning of period
|
31,799
|
|
|
36,942
|
|
||
Cash and cash equivalents, end of period
|
$
|
26,416
|
|
|
$
|
83,969
|
|
•
|
the effects of the COVID-19 pandemic on our business, the medical community and the global economy;
|
•
|
revenue earned from our legacy collaborative partnerships and licensing agreements, including potential royalty payments from Alnylam’s ONPATTRO;
|
•
|
revenue earned from ongoing collaborative partnerships, including milestone and royalty payments;
|
•
|
the extent to which we continue the development of our product candidates, add new product candidates to our pipeline, or form collaborative relationships to advance our product candidates;
|
•
|
delays in the development of our product candidates due to pre-clinical and clinical findings;
|
•
|
our decisions to in-license or acquire additional products, product candidates or technology for development, in particular for our HBV therapeutics programs;
|
•
|
our ability to attract and retain corporate partners, and their effectiveness in carrying out the development and ultimate commercialization of our product candidates;
|
•
|
whether batches of drugs that we manufacture fail to meet specifications resulting in delays and investigational and remanufacturing costs;
|
•
|
the decisions, and the timing of decisions, made by health regulatory agencies regarding our technology and products;
|
•
|
competing technological and market developments; and
|
•
|
costs associated with prosecuting and enforcing our patent claims and other intellectual property rights, including litigation and arbitration arising in the course of our business activities.
|
•
|
interruption of key manufacturing, research and clinical development activities due to limitations on work and travel imposed or recommended by federal or state governments, employers and others;
|
•
|
delays or difficulties in clinical trial site operations, including difficulties in recruiting clinical site investigators and clinical site staff and difficulties in enrolling patients or treating patients in active trials;
|
•
|
interruption of key business activities due to illness and/or quarantine of key individuals and delays associated with recruiting, hiring and training new temporary or permanent replacements for such key individuals, both internally and at our third party service providers;
|
•
|
delays in research and clinical trial sites receiving the supplies and materials needed to conduct preclinical studies and clinical trials, due to work stoppages, travel and shipping interruptions or restrictions or other reasons;
|
•
|
difficulties in raising additional capital needed to pursue the development of our programs due to the slowing of our economy and near term and/or long term negative effects of the pandemic on the financial, banking and capital markets;
|
•
|
changes in local regulations as part of a response to the COVID-19 coronavirus outbreak that may require us to change the ways in which research, including clinical development, is conducted, which may result in unexpected costs; and
|
•
|
delays in necessary interactions with regulators and other important agencies and contractors due to limitations in employee resources, travel restrictions or forced furlough of government employees.
|
Number
|
|
Description
|
3.1
|
|
|
|
|
|
3.2
|
|
|
|
|
|
4.1
|
|
|
|
|
|
31.1*
|
|
|
|
|
|
31.2*
|
|
|
|
|
|
32.1**
|
|
|
|
|
|
32.2**
|
|
|
|
|
|
101
|
|
The following materials from Arbutus Biopharma Corporation’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, formatted in XBRL (eXtensible Business Reporting Language): (i) Condensed Consolidated Balance Sheets; (ii) Condensed Consolidated Statements of Operations; (iii) Condensed Consolidated Statements of Comprehensive Loss; (iv) Condensed Consolidated Statements of Stockholders’ Equity; (v) Condensed Consolidated Statements of Cash Flows; and (vi) Notes to Condensed Consolidated Financial Statements
|
|
ARBUTUS BIOPHARMA CORPORATION
|
|
|
|
|
|
By:
|
/s/ William H Collier
|
|
|
William H Collier
|
|
|
President and Chief Executive Officer
|
1.
|
I have reviewed this Quarterly Report on Form 10-Q of Arbutus Biopharma Corporation;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
(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 (the registrant’s fourth fiscal quarter in the case of an the annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
(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
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(b)
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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.
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/s/ William Collier
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Name: William Collier
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Title: President and Chief Executive Officer
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1.
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I have reviewed this Quarterly Report on Form 10-Q of Arbutus Biopharma Corporation;
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2.
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Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
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3.
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Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
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4.
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The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
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(a)
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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;
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(b)
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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;
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(c)
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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
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(d)
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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 (the registrant’s fourth fiscal quarter in the case of an the annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
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5.
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The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
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(a)
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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
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(b)
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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.
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/s/ David Hastings
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Name: David Hastings
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Title: Chief Financial Officer
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1.
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The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
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2.
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The information contained in the Report fairly represents, in all material respects, the financial condition and results of the operations of the Company.
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/s/ William Collier
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Name: William Collier
|
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Title: President and Chief Executive Officer
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1.
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The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
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2.
|
The information contained in the Report fairly represents, in all material respects, the financial condition and results of the operations of the Company.
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/s/ David Hastings
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Name: David Hastings
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Title: Chief Financial Officer
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