Item 1. Financial Statements
Item 1. Financial Statements
ASSEMBLY BIOSCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands except for share amounts and par value)
March 31,
December 31,
2022
2021
(Unaudited)
ASSETS
Current assets
Cash and cash equivalents
$
51,174
$
45,627
Marketable securities - short-term
71,826
101,000
Accounts receivable from collaborations
524
336
Prepaid expenses and other current assets
7,253
7,241
Total current assets
130,777
154,204
Marketable securities - long-term
23,459
27,972
Property and equipment, net
1,019
1,139
Operating lease right-of-use (ROU) assets
5,300
6,042
Other assets
2,175
1,703
Total assets
$
162,730
$
191,060
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities
Accounts payable
$
1,407
$
2,659
Accrued research and development expenses
3,596
3,400
Other accrued expenses
2,499
6,863
Operating lease liabilities - short-term
3,207
3,151
Total current liabilities
10,709
16,073
Deferred revenue
2,733
2,733
Operating lease liabilities - long-term
2,497
3,325
Total liabilities
15,939
22,131
Commitments and contingencies
Stockholders' equity
Preferred stock, $ 0.001 par value; 5,000,000 shares authorized; no shares issued or outstanding
—
—
Common stock, $ 0.001 par value; 100,000,000 shares authorized as of March 31, 2022 and December 31, 2021; 48,132,937 and 48,120,437 shares issued and outstanding as of March 31, 2022 and December 31, 2021, respectively
48
48
Additional paid-in capital
802,170
800,728
Accumulated other comprehensive loss
( 908
)
( 419
)
Accumulated deficit
( 654,519
)
( 631,428
)
Total stockholders' equity
146,791
168,929
Total liabilities and stockholders' equity
$
162,730
$
191,060
See Accompanying Notes to Condensed Consolidated Financial Statements
2
ASSEMBLY BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands except for share and per share amounts)
(Unaudited)
Three Months Ended March 31,
2022
2021
Operating expenses
Research and development
$
17,205
$
18,554
General and administrative
5,957
8,704
Total operating expenses
23,162
27,258
Loss from operations
( 23,162
)
( 27,258
)
Other income
Interest and other income, net
71
58
Total other income
71
58
Net loss
$
( 23,091
)
$
( 27,200
)
Other comprehensive loss
Unrealized loss on marketable securities
( 489
)
( 1
)
Comprehensive loss
$
( 23,580
)
$
( 27,201
)
Net loss per share, basic and diluted
$
( 0.48
)
$
( 0.69
)
Weighted average common shares outstanding, basic and diluted
48,123,930
39,679,734
See Accompanying Notes to Condensed Consolidated Financial Statements
3
ASSEMBLY BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
(In thousands except for share amounts)
(Unaudited)
Common Stock
Additional
Accumulated
Other
Total
Shares
Amount
Paid-in
Capital
Comprehensive
Loss
Accumulated
Deficit
Stockholders'
Equity
Balance as of December 31, 2021
48,120,437
$
48
$
800,728
$
( 419
)
$
( 631,428
)
$
168,929
Issuance of common stock for settlement of restricted stock units (RSUs)
12,500
—
—
—
—
—
Unrealized loss on marketable debt securities
—
—
—
( 489
)
—
( 489
)
Stock-based compensation
—
—
1,442
—
—
1,442
Net loss
—
—
—
—
( 23,091
)
( 23,091
)
Balance as of March 31, 2022
48,132,937
$
48
$
802,170
$
( 908
)
$
( 654,519
)
$
146,791
Common Stock
Additional
Accumulated
Other
Total
Shares
Amount
Paid-in
Capital
Comprehensive
Loss
Accumulated
Deficit
Stockholders'
Equity
Balance as of December 31, 2020
34,026,680
$
34
$
742,387
$
( 270
)
$
( 501,573
)
$
240,578
Issuance of common stock under at-the-market (ATM) equity offering program, net of issuance costs
5,991,858
6
34,131
—
—
34,137
Issuance of common stock for settlement of RSUs
86,146
—
—
—
—
—
Unrealized loss on marketable debt securities
—
—
—
( 1
)
—
( 1
)
Stock-based compensation
—
—
( 270
)
—
—
( 270
)
Net loss
—
—
—
—
( 27,200
)
( 27,200
)
Balance as of March 31, 2021
40,104,684
$
40
$
776,248
$
( 271
)
$
( 528,773
)
$
247,244
See Accompanying Notes to Condensed Consolidated Financial Statements
4
ASSEMBLY BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)
Three Months Ended March 31,
2022
2021
Cash flows from operating activities
Net loss
$
( 23,091
)
$
( 27,200
)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
120
107
Stock-based compensation
1,443
( 286
)
Net amortization of investments in marketable debt securities
149
92
Non-cash rent expense
893
1,135
Loss on disposal of property and equipment
—
1,611
Changes in operating assets and liabilities:
Accounts receivable from collaboration
( 188
)
1,027
Prepaid expenses and other current assets
( 12
)
303
Other assets
( 472
)
358
Accounts payable
( 1,252
)
( 1,036
)
Accrued research and development expenses
196
( 102
)
Other accrued expenses
( 4,365
)
( 8,312
)
Operating lease liabilities
( 923
)
( 1,041
)
Net cash used in operating activities
( 27,502
)
( 33,344
)
Cash flows from investing activities
Purchases of property and equipment
—
( 3,078
)
Proceeds from sale of property and equipment
—
857
Purchases of marketable securities
( 3,951
)
( 49,213
)
Proceeds from maturities of marketable securities
30,000
66,450
Proceeds from sale of marketable securities
7,000
3,000
Net cash provided by investing activities
33,049
18,016
Cash flows from financing activities
Proceeds from the issuance of common stock under ATM equity offering program, net of issuance costs
—
34,137
Net cash provided by financing activities
—
34,137
Net increase in cash and cash equivalents
5,547
18,809
Cash and cash equivalents at the beginning of the period
45,627
59,444
Cash and cash equivalents at the end of the period
$
51,174
$
78,253
Supplemental non-cash investing and financing activities
Operating lease liabilities arising from obtaining ROU assets
$
—
$
42
Remeasurement of lease liabilities arising from modification of ROU assets
$
—
$
( 788
)
See Accompanying Notes to Condensed Consolidated Financial Statements
5
ASSEMBLY BIOSCIENCES, INC.
NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
Note 1 - Nature of Business
Overview
Assembly Biosciences, Inc. (together with its subsidiaries, Assembly or the Company), incorporated in Delaware in October 2005, is a clinical-stage biotechnology company advancing a novel class of oral therapeutic candidates for the treatment of chronic hepatitis B virus (HBV) infection and other viral diseases. The Company operates in one segment and is headquartered in South San Francisco, California, with operations in California and China. Prior to the Company’s wind-down of its Microbiome program in January 2021, the Company also had operations in Connecticut.
The Company’s research and development programs are pursuing multiple drug candidates that inhibit the HBV replication cycle and block the generation of covalently closed circular DNA (cccDNA), with the aim of discovering and developing finite and curative therapies for patients with HBV. The Company has discovered several novel core inhibitors, which are small molecules that directly target and allosterically modify the HBV core (HBc) protein in a way that affects assembly and stability of HBV nucleocapsids and is currently advancing an early-stage program evaluating a novel small molecule approach to inhibit entry for both HBV and hepatitis delta viruses.
Liquidity
The Company has not derived any revenue from product sales to date and currently has no approved products. Once a product has been developed, it will need to be approved for sale by the U.S. Food and Drug Administration or an applicable foreign regulatory agency. Since inception, the Company’s operations have been financed primarily through the sale of equity securities, proceeds from the exercise of warrants and stock options, issuance of debt, and upfront payments related to collaboration agreements. The Company has incurred losses from operations since inception and expects to continue to incur substantial losses for the next several years as it continues its product development efforts. Management believes the Company currently has sufficient funds to meet its operating requirements for at least the next twelve months following the date these unaudited condensed consolidated financial statements are issued. If the Company cannot generate significant cash from its operations, it intends to obtain any additional funding it requires through strategic relationships, public or private equity or debt financings, grants or other arrangements. The Company cannot assure such funding will be available on reasonable terms, if at all. Market volatility resulting from the global novel coronavirus disease (COVID-19) pandemic or other factors could also adversely impact the Company’s ability to access capital when and as needed.
If the Company is unable to generate enough revenue from its collaborations, secure additional sources of funding or receive full and timely collections of amounts due, it may be necessary to significantly reduce the current rate of spending through reductions in staff and delaying, scaling back, or stopping certain research and development programs, including more costly clinical trials.
Note 2 - Summary of Significant Accounting Policies
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements include the accounts of the Company and its subsidiaries. All intercompany balances and transactions have been eliminated in consolidation.
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with the accounting principles generally accepted in the United States of America (U.S. GAAP) for interim financial information and pursuant to the instructions to Form 10-Q and Rule 10-01 of Regulation S-X of the SEC. In management’s opinion, the unaudited condensed consolidated financial statements have been prepared on the same basis as the annual audited consolidated financial statements and include normal recurring adjustments necessary for the fair presentation of the Company’s financial position and its results of operations and comprehensive loss and its cash flows for the periods presented. These statements do not include all disclosures required by U.S. GAAP and should be read in conjunction with the Company’s audited consolidated financial statements and accompanying
6
notes for the fiscal year ended December 31, 2021 , which are contained in the 2021 Annual Report . The results for the three months ended March 31, 2022 are not necessarily indicative of results to be expected for the entire year ending December 31, 2022 or future operating periods.
Use of Estimates
The preparation of the unaudited condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that may affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of expenses during the reporting period. Actual results could differ from those estimates.
Estimates inherent in the preparation of the accompanying unaudited condensed consolidated financial statements include estimates of costs incurred but not yet invoiced for research and development accruals, recoverability and useful lives of our long-lived assets, amounts receivable under collaboration agreements, measurement of operating lease liabilities, and the fair value of stock options, stock appreciation rights, and RSUs granted to employees, directors, and consultants.
The Company’s estimates could be affected by external conditions, including those unique to the Company and general economic conditions. It is reasonably possible these external factors could have an effect on the Company’s estimates and could cause actual results to differ materially from those estimates and assumptions.
Other Risks and Uncertainties
In March 2020, the World Health Organization declared the COVID-19 outbreak a pandemic. The ongoing COVID-19 pandemic and its broad, global impacts, including supply chain disruptions, have impacted certain aspects of the Company’s business, including where and how the Company’s employees work in its labs and offices and how and when the Company’s nonclinical and clinical studies are conducted. Early in the pandemic, the Company’s clinical and preclinical studies were largely unaffected, but as the pandemic has continued, the Company has experienced enrollment delays for two of its multi-drug combination clinical studies, delayed animal studies and delayed shipping of compounds necessary for the Company’s research programs. Although the clinical studies that experienced enrollment delays are now fully enrolled, the lockdowns resulting from China’s strict “zero covid” policy are also impacting execution of one of these multi-drug clinical studies. The Company relies on contract research organizations (CROs), some of which are in China and India. While these CROs have experienced pandemic-related impacts from time to time, the latest shutdowns in China have impacted the Company more than earlier in the pandemic. The Company cannot at this time predict the specific extent, duration, or full impact the COVID-19 pandemic will have on its business, operations, strategy, prospects and financial condition and results. The impact of the COVID-19 pandemic on the Company’s financial performance will depend on future developments, including the duration and spread of the outbreak and related governmental advisories and restrictions. These developments and the impact of the COVID-19 pandemic on the financial markets and the overall economy are highly uncertain. If the financial markets and/or the overall economy are impacted for an extended period, the Company’s results may be adversely affected.
In addition, the study plan of the Company’s triple combination study with Antios Therapeutics, Inc. (Antios) initially included a site in Ukraine, but the study will no longer be conducted there due to the instability resulting from Russia’s invasion. These changes to the Company’s study plan will result in a delayed data readout.
7
Income Taxes
Effective January 1, 2022, a provision of the Tax Cuts and Jobs Act (TCJA) has taken effect creating a significant change to the treatment of research and experimental expenditures under Section 174 of the IRC (Sec. 174 expenses). Historically, businesses have had the option of deducting Sec. 174 expenses in the year incurred or capitalizing and amortizing the costs over five years . The new TCJA provision, however, eliminates this option and will require Sec. 174 expenses associated with research conducted in the U.S to be capitalized and amortized over a five-year period. For expenses associated with research outside of the United States, Sec. 174 expenses will be capitalized and amortized over a 15 -year period. The Company prepared an analysis of the tax impact of capitalizing and amortizing these costs over the required periods and for calendar year 2022, it is expecting to be in a loss position after the estimated addback.
Net Loss per Share
Basic net loss per share of common stock excludes dilution and is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the period. Diluted net loss per share of common stock reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that then shared in the earnings of the entity unless inclusion of such shares would be anti-dilutive.
A reconciliation of the numerators and the denominators of the basic and diluted net loss per common share computations is as follows (in thousands, except per share amounts):
Three Months Ended March 31,
2022
2021
Numerator:
Net loss
$
( 23,091
)
$
( 27,200
)
Denominator:
Weighted average common shares and
pre-funded warrants outstanding - basic and diluted
48,123,930
39,679,734
Net loss per share - basic and diluted
$
( 0.48
)
$
( 0.69
)
Securities excluded from the computation of diluted net loss per share because including them would have been antidilutive are as follows:
March 31,
2022
2021
Options to purchase common stock
7,475,876
7,382,515
Common stock subject to purchase under our Employee Stock Purchase Plan (ESPP)
129,107
44,870
Unvested RSUs
1,553,755
666,574
Total
9,158,738
8,093,959
Note 3 – Fair Value Measurements and Investments in Marketable Securities
The carrying amounts of cash equivalents and marketable securities approximate their fair value based upon quoted market prices. Certain of the Company’s financial instruments are not measured at fair value on a recurring basis, but are recorded at amounts that approximate their fair value due to their liquid or short-term nature, such as cash, accounts receivable, accounts payable and accrued expenses.
The Company uses the following three-level hierarchy that maximizes the use of observable inputs and minimizes the use of unobservable inputs to value its financial instruments:
Level 1: Observable inputs such as unadjusted quoted prices in active markets for identical instruments.
Level 2: Quoted prices for similar instruments that are directly or indirectly observable in the marketplace.
8
Level 3: Significant unobservable inputs that are supported by little or no market activity and that are financial instruments whose values are determined using pricing models, discounted cash flow methodologies, or similar techniques, as well as instruments for which the determination of fair value requires significant judgment or estimation.
Investments in marketable securities consisted of the following (in thousands):
March 31, 2022
Amortized
Cost
Gross
Unrealized
Gain
Gross
Unrealized
Loss
Fair Value
Cash equivalents
Money market fund
$
48,361
$
—
$
—
$
48,361
Total cash equivalents
48,361
—
—
48,361
Short-term marketable securities
U.S. and foreign corporate debt securities
4,097
—
( 63
)
4,034
Asset-backed securities
21,978
—
( 97
)
21,881
U.S. and foreign commercial paper
45,913
—
( 2
)
45,911
Total short-term marketable securities
71,988
—
( 162
)
71,826
Long-term marketable securities
U.S. and foreign corporate debt securities
14,966
—
( 280
)
14,686
U.S. treasury securities
8,966
—
( 193
)
8,773
Total long-term marketable securities
23,932
—
( 473
)
23,459
Total cash equivalents and marketable securities
$
144,281
$
—
$
( 635
)
$
143,646
December 31, 2021
Amortized
Cost
Gross
Unrealized
Gain
Gross
Unrealized
Loss
Fair Value
Cash equivalents
Money market fund
$
42,507
$
—
$
—
$
42,507
Total cash equivalents
42,507
—
—
42,507
Short-term marketable securities
U.S. and foreign corporate debt securities
7,015
—
( 2
)
7,013
Asset-backed securities
29,097
—
( 38
)
29,059
U.S. and foreign commercial paper
64,929
—
( 1
)
64,928
Total short-term marketable securities
101,041
—
( 41
)
101,000
Long-term marketable securities
U.S. and foreign corporate debt securities
19,117
—
( 74
)
19,043
U.S. treasury securities
8,960
—
( 31
)
8,929
Total long-term marketable securities
28,077
—
( 105
)
27,972
Total cash equivalents and marketable securities
$
171,625
$
—
$
( 146
)
$
171,479
Short-term marketable securities held as of March 31, 2022 had contractual maturities of less than one year . Long-term marketable securities held as of March 31, 2022 had contractual maturities of at least one year but less than two years.
Realized gains and losses for the three months ended March 31, 2022 and 2021 were not significant. None of the Company’s investments have been in a continuous unrealized loss position for more than 12 months as of March 31, 2022.
9
The following tables present the fair value of the Company’s financial assets measured at fair value on a recurring basis (in thousands):
March 31, 2022
Level 1
Level 2
Level 3
Fair Value
Cash equivalents
Money market fund
$
48,361
$
—
$
—
$
48,361
Total cash equivalents
48,361
—
—
48,361
Short-term marketable securities
U.S. and foreign corporate debt securities
—
4,034
—
4,034
Asset-backed securities
—
21,881
—
21,881
U.S. and foreign commercial paper
—
45,911
—
45,911
Total short-term marketable securities
—
71,826
—
71,826
Long-term marketable securities
U.S. and foreign corporate debt securities
—
14,686
—
14,686
U.S. treasury securities
—
8,773
—
8,773
Total long-term marketable securities
—
23,459
—
23,459
Total assets measured at fair value
$
48,361
$
95,285
$
—
$
143,646
December 31, 2021
Level 1
Level 2
Level 3
Fair Value
Cash equivalents
Money market fund
$
42,507
$
—
$
—
$
42,507
Total cash equivalents
42,507
—
—
42,507
Short-term marketable securities
U.S. and foreign corporate debt securities
—
7,013
—
7,013
Asset-backed securities
—
29,059
—
29,059
U.S. and foreign commercial paper
—
64,928
—
64,928
Total short-term marketable securities
—
101,000
—
101,000
Long-term marketable securities
U.S. and foreign corporate debt securities
—
19,043
—
19,043
U.S. treasury securities
—
8,929
—
8,929
Total long-term marketable securities
—
27,972
—
27,972
Total assets measured at fair value
$
42,507
$
128,972
$
—
$
171,479
The Company estimates the fair value of its investments in marketable securities by taking into consideration valuations obtained from third-party pricing services. The pricing services utilize industry standard valuation models, including both income and market-based approaches, for which all significant inputs are observable, either directly or indirectly, to estimate fair value. These inputs include reported trades of and broker/dealer quotes on the same or similar securities, issuer credit spreads, benchmark securities, prepayment/default projections based on historical data, and other observable inputs.
There were no transfers between Level 1, Level 2 or Level 3 during the periods presented.
Note 4 – Other Accrued Expenses
Other accrued expenses consist of the following (in thousands):
March 31,
December 31,
2022
2021
Accrued expenses:
Accrued compensation
$
2,161
$
6,426
Accrued professional fees and other
338
437
Total accrued expenses
$
2,499
$
6,863
10
Note 5 – Sale of Common Stock
In August 2020, the Company filed a shelf registration statement on Form S-3 with the SEC, File No. 333-248469, that became effective on September 4, 2020 (the 2020 Registration Statement). The Company may from time to time sell any combination of the securities described in the 2020 Registration Statement in one or more offerings up to an aggregate offering price of $ 300.0 million. In connection with the filing of the 2020 Registration Statement, the Company entered into a sales agreement under which the Company may offer and sell shares of its common stock having an aggregate offering price of up to $ 100.0 million through “at-the-market” offerings (2020 ATM), which shares are included in the $ 300.0 million of securities registered pursuant to the 2020 Registration Statement. During the three months ended March 31, 2021, the Company sold 5,991,858 shares of common stock under the 2020 ATM, for which the Company received net proceeds of $ 34.1 million, after deducting commissions, fees and expenses. The Company did no t sell any shares of common stock under the 2020 ATM during the three months ended March 31, 2022.
Note 6 – Stock Plans and Stock-Based Compensation
Equity Incentive Plans
In May 2021, the Company’s stockholders approved an amendment to the Assembly Biosciences, Inc. 2018 Stock Incentive Plan (2018 Plan) that increased the aggregate number of shares of common stock reserved under the 2018 Plan to 6,600,000 and an Amended and Restated Assembly Biosciences, Inc. 2018 Employee Stock Purchase Plan (the 2018 ESPP) that, among other things, increased the number of shares of common stock reserved to an aggregate of 1,300,000 .
As of March 31, 2022, the Company had awards outstanding under the following shareholder-approved plans: the 2010 Equity Incentive Plan (the 2010 Plan), which has been frozen; the Amended and Restated 2014 Stock Incentive Plan (the 2014 Plan); and the 2018 Plan. Shares of common stock underlying awards that are forfeited under the 2010 Plan on or after June 2, 2016 will become available for issuance under the 2014 Plan. As of March 31, 2022, the Company also had awards outstanding under the Assembly Biosciences, Inc. 2017 Inducement Award Plan, the Assembly Biosciences, Inc. 2019 Inducement Award Plan and the Assembly Biosciences, Inc. 2020 Inducement Award Plan.
The Company issues new shares of common stock to settle options exercised and vested RSUs. The Company also issues new shares of common stock in connection with purchases of shares of common stock by eligible employees under the Company’s 2018 ESPP.
Stock Plan Activity
Stock Options
A summary of the Company’s option activity and related information for the three months ended March 31, 2022 is as follows:
Number
of Shares
Weighted
Average
Exercise
Price
Per Share
Weighted
Average
Remaining
Contractual
Term
(Years)
Total
Intrinsic
Value (in
thousands)
Outstanding as of December 31, 2021
6,161,901
$
11.77
6.4
$
53
Granted
1,479,550
2.29
Forfeited
( 141,264
)
16.46
Expired
( 24,311
)
26.86
Outstanding as of March 31, 2022
7,475,876
$
9.76
6.9
$
6
Options vested and exercisable as of March 31, 2022
4,120,830
$
12.87
5.1
$
—
11
The weighted-average grant-date fair value of options granted was $ 1.63 and $ 3.15 during the three months ended March 31, 2022 and 2021, respectively. There were no options exercised during the three months ended March 31, 2022 or 2021.
RSUs
A summary of the Company’s RSUs and related information for the three months ended March 31, 2022 is as follows:
Number
of RSUs
Weighted
Average Fair
Value Per RSU
at Grant Price
Nonvested as of December 31, 2021
970,339
$
7.04
Granted
730,275
2.30
Vested
( 92,286
)
12.10
Forfeited
( 54,573
)
6.81
Nonvested as of March 31, 2022
1,553,755
$
4.96
The total fair value of RSUs vested and settled during the three months ended March 31, 2022 and 2021 was $ 1.1 million and $ 2.5 million, respectively. The total intrinsic value of RSUs vested and settled during the three months ended March 31, 2022 and 2021 was $ 0.2 million and $ 0.6 million, respectively.
In September 2019, the Company granted 100,000 RSUs with performance-based vesting conditions to its chief executive officer. On March 31, 2021, 25,000 of these awards were forfeited back to the Company due to the expiration of the time period to complete one of the performance conditions. On July 31, 2021, an additional 25,000 of these awards were forfeited back to the Company due to the expiration of the time period to complete one of the performance conditions. The outstanding 50,000 awards with an aggregate fair value of $ 0.4 million vest upon performance conditions not yet deemed probable. Accordingly, no stock-based compensation expense has been recognized as of March 31, 2022.
In July 2021, the Company granted a total of 324,214 RSUs with performance-based vesting conditions upon the achievement of clinical milestones to the majority of employees, including its executive officers. The awards had a grant date fair value of $ 1.2 million and vest upon performance conditions not yet deemed probable. Accordingly, no stock-based compensation expense has been recognized as of March 31, 2022.
In March 2022, the Company granted 255,000 RSUs with market-based vesting conditions to members of management, including its executive officers. The awards had a grant date fair value of $ 0.4 million and are being recognized over the derived service period of 1.5 years and vest upon the achievement of certain market-based conditions which have not been achieved as of March 31, 2022. Stock-based compensation expense for the awards was nominal during the three months ended March 31, 2022.
ESPP
There were no shares purchased under the 2018 ESPP during the three months ended March 31, 2022 or 2021.
Valuation Assumptions
The fair value of the stock options granted or modified during the periods indicated was estimated using the Black-Scholes option pricing model, based on the following assumptions:
Three Months Ended March 31,
2022
2021
Exercise price
$1.53 - $2.45
$4.33 - $5.79
Expected volatility
79.2% - 81.6%
81.4% - 91.2%
Risk-free rate
1.41% - 2.48%
0.50% - 1.37%
Expected term (years)
5.5 - 7.0
5.5 - 7.0
Expected dividend yield
0 %
0 %
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The fair value of RSUs granted is determined based on the price of the Company’s common stock on the date of grant. The fair value of market-based RSUs granted is determined using the Monte-Carlo simulation model.
The fair value of ESPP purchase rights were not material for any period presented.
Stock-Based Compensation Expense
The following table summarizes the components of total stock-based compensation expense included in the condensed consolidated statements of operations and comprehensive loss (in thousands):
Three Months Ended March 31,
2022
2021
Research and development
$
778
$
( 2,091
)
(1)
General and administrative
665
1,805
Total stock-based compensation expense
$
1,443
$
( 286
)
(1)
Includes the reversal of previously recognized stock-based compensation expense of $ 3.6 million related to forfeited awards of terminated employees, $ 2.7 million of which resulted from the wind-down of the Company’s Microbiome program.
As of March 31, 2022, there was $ 10.9 million of total unrecognized stock-based compensation related to outstanding equity awards, which is expected to be recognized over a weighted average remaining amortization period of 1.8 years.
Note 7 - Collaboration Agreements
BeiGene Agreement
In July 2020, the Company and BeiGene, Ltd. (BeiGene) entered into a Collaboration Agreement (the BeiGene Agreement) to develop and commercialize the Company’s novel core inhibitor product candidates VBR, ABI-H2158 and ABI-H3733 (the Licensed Product Candidates) for chronic HBV infection in the People’s Republic of China, Hong Kong, Taiwan and Macau.
As of March 31, 2022 the only remaining performance obligation under the BeiGene Agreement not considered to be complete is the transfer of the ABI-H3733 License. The transaction price allocated to ABI-H3733 of $ 2.7 million was recognized as a long-term deferred revenue contract liability as of both March 31, 2022 and December 31, 2021, and will be recognized as revenue when the Company provides pre-Phase 3 clinical study know-how and development results for ABI-H3733 to BeiGene or a termination of the BeiGene Agreement for ABI-H3733. During the three months ended March 31, 2022 and 2021, the Company did no t recognize any revenue or increase or reduction of research and development expense under the BeiGene Agreement.
The Company incurred $ 3.5 million in incremental costs of obtaining the BeiGene Agreement in 2020. These contract costs have been capitalized and are being recognized consistent with the pattern of recognition of revenue associated with the Licensed Product Candidates. As of March 31, 2022 and December 31, 2021, the remaining unamortized contract costs are $ 0.2 million and are included in other assets on the condensed consolidated balance sheet.
Arbutus Biopharma Agreement
In August 2020, the Company and Arbutus Biopharma Corporation (Arbutus Biopharma) entered into a Clinical Trial Collaboration Agreement (the Arbutus Biopharma Agreement) to conduct a randomized, multi-center, open-label Phase 2 clinical trial to explore the safety, PK and antiviral activity of the triple combination of VBR, AB-729 and an NrtI compared to the double combinations of VBR with an NrtI and AB-729 with an NrtI. Under the Arbutus Biopharma Agreement, Assembly and Arbutus Biopharma share responsibility for the costs of the trial equally, excluding manufacturing supply which are the burden of each company to supply their respective drugs, VBR and AB-729.
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During the three months ended March 31, 2022 and 2021, the Company recognized a reduction of research and development expenses of $ 0.6 million and $ 0.5 million, respectively, under the Arbutus Biopharma Agreement.
Antios Agreement
In July 2021, the Company and Antios entered into a Clinical Trial Collaboration Agreement (the Antios Agreement) to collaborate on a triple combination therapy using VBR and Antios’s active site polymerase inhibitor nucleotide ATI-2173 for the treatment of HBV. Assembly and Antios are individually responsible for the study’s manufacturing costs but will equally share the remaining costs of the study.
During the three months ended March 31, 2022 , the Company incurred $ 0.1 million in research and development expenses under the Antios Agreement.
Note 8 - Milestones and Research Agreements
HBV Research Agreement with Indiana University
Since September 2013, the Company has been party to an exclusive License Agreement dated September 3, 2013 with Indiana University Research and Technology Corporation (IURTC) from whom it has licensed aspects of the Company’s HBV program held by IURTC. The license agreement requires the Company to make milestone payments based upon the successful accomplishment of clinical and regulatory milestones. The aggregate amount of all performance milestone payments under the IURTC license agreement, should all milestones through development be met, is $ 0.8 million, with a portion related to the first performance milestone having been paid. The Company is obligated to pay IURTC royalty payments based on net sales of the licensed technology as well as a portion of any sublicensing revenue Assembly receives. The Company is also required to pay diligence maintenance fees each year to the extent that the royalty, sublicensing, and milestone payments to IURTC are less than such fees for that year. The Company paid IURTC $ 0.1 million in diligence maintenance fees during the three months ended March 31, 2022. No amounts were paid during the three months ended March 31, 2021.
Microbiome Targeted Colonic Delivery Platform
In November 2013, the Company entered into a License and Collaboration Agreement with Therabiome, LLC (Therabiome), for all intellectual property and know-how owned or controlled by Therabiome relating to the oral delivery of pharmaceutical drugs to specific sites in the intestine, using a pH sensitive controlled release capsule-in-capsule technology.
In connection with the wind-down of the Microbiome program, the License and Collaboration Agreement with Therabiome was terminated in January 2021, and the termination became effective in April 2021. No amounts were accrued for this agreement as of and for the three months ended March 31, 2022 or 2021.
Door Pharma Agreement
In November 2020, the Company and Door Pharmaceuticals, LLC (Door Pharma) entered into an exclusive, two-year Collaboration Agreement and Sublicense Agreement (collectively, the Door Pharma Agreement) focused on the development of a novel class of HBV inhibitors.
During the three months ended March 31, 2022 and 2021, the Company incurred research and development funding of $ 0.7 million and $ 0.4 million, respectively, under the Door Pharma Agreement. No success-based milestones were determined to have occurred under this agreement during the three months ended March 31, 2022 or 2021. The Company terminated the Door Pharma Agreement in May 2022, effective September 2022, to focus its resources on its other internal HBV programs and its programs targeting other viruses .
Under the consolidation accounting standard, the Company determined Door Pharma is a variable interest entity. The Company does not have the power to direct the activities which most significantly affect the economic performance of Door Pharma and as such the Company is not the primary beneficiary and consolidation is not required. As of March 31, 2022, the Company has not provided financial or other support to Door Pharma that was not contractually required.
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Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.