Item 1. Financial Statements
Item 1. Financial Statements
ALTIMMUNE, INC.
CONSOLIDATED BALANCE SHEETS
September 30,
December 31,
2021
2020
(unaudited)
ASSETS
Current assets:
Cash and cash equivalents
$
174,863,565
$
115,917,807
Restricted cash
34,174
34,174
Total cash, cash equivalents and restricted cash
174,897,739
115,951,981
Short-term investments
25,020,738
100,005,558
Accounts receivable
1,573,760
4,610,202
Income tax receivable
9,476,435
7,762,793
Prepaid expenses and other current assets
7,294,360
1,926,675
Total current assets
218,263,032
230,257,209
Property and equipment, net
4,718,146
1,056,920
Intangible assets, net
12,993,575
12,823,846
Other assets
931,904
977,238
Total assets
$
236,906,657
$
245,115,213
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable
$
6,083
$
612,293
Accrued expenses and other current liabilities
19,120,902
11,408,154
Total current liabilities
19,126,985
12,020,447
Contingent consideration
6,950,000
5,390,000
Other long-term liabilities
1,565,611
1,828,443
Total liabilities
27,642,596
19,238,890
Commitments and contingencies (Note 16)
Stockholders’ equity:
Common stock, $ 0.0001 par value; 200,000,000 shares authorized; 39,702,768 and 37,142,946 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively
3,959
3,697
Additional paid-in capital
483,582,367
417,337,742
Accumulated deficit
( 269,282,102 )
( 186,420,599 )
Accumulated other comprehensive loss, net
( 5,040,163 )
( 5,044,517 )
Total stockholders’ equity
209,264,061
225,876,323
Total liabilities and stockholders’ equity
$
236,906,657
$
245,115,213
The accompanying notes are an integral part of the unaudited consolidated financial statements.
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ALTIMMUNE, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(unaudited)
For the Three Months Ended
For the Nine Months Ended
September 30,
September 30,
2021
2020
2021
2020
Revenues
$
157,559
$
2,937,991
$
1,132,698
$
5,872,321
Operating expenses:
Research and development
29,205,739
17,041,975
54,356,051
40,823,756
General and administrative
4,155,928
4,220,238
11,636,001
9,097,511
Impairment loss on construction-in-progress
—
—
8,070,000
—
Total operating expenses
33,361,667
21,262,213
74,062,052
49,921,267
Loss from operations
( 33,204,108 )
( 18,324,222 )
( 72,929,354 )
( 44,048,946 )
Other income (expense):
Interest expense
( 32,866 )
( 2,275 )
( 66,763 )
( 7,468 )
Interest income
12,485
45,127
87,847
278,154
Other (expense) income, net
( 286,199 )
29,218
( 293,233 )
48,882
Total other (expense) income, net
( 306,580 )
72,070
( 272,149 )
319,568
Net loss before income tax benefit
( 33,510,688 )
( 18,252,152 )
( 73,201,503 )
( 43,729,378 )
Income tax benefit
—
482,017
—
5,306,678
Net loss
( 33,510,688 )
( 17,770,135 )
( 73,201,503 )
( 38,422,700 )
Other comprehensive (loss) income — unrealized (loss) gain on short-term investments
( 1,923 )
( 10,569 )
4,354
( 22,116 )
Comprehensive loss
$
( 33,512,611 )
$
( 17,780,704 )
$
( 73,197,149 )
$
( 38,444,816 )
Net loss per share, basic and diluted
$
( 0.81 )
$
( 0.54 )
$
( 1.79 )
$
( 1.74 )
Weighted-average common shares outstanding, basic and diluted
41,370,768
33,056,971
40,843,905
22,058,424
The accompanying notes are an integral part of the unaudited consolidated financial statements.
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ALTIMMUNE, INC.
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
(unaudited)
Accumulated
Additional
Other
Total
Common Stock
Paid-In
Accumulated
Comprehensive
Stockholders’
Shares
Amount
Capital
Deficit
Loss
Equity
Balance at December 31, 2020
37,142,946
$
3,697
$
417,337,742
$
( 186,420,599 )
$
( 5,044,517 )
$
225,876,323
Stock-based compensation
—
—
1,218,351
—
—
1,218,351
Vesting of restricted stock awards including withholding, net
( 6,349 )
1
( 92,507 )
—
—
( 92,506 )
Issuance of common stock from Employee Stock Purchase Plan
8,733
1
106,000
—
—
106,001
Retirement of common stock in exchange for common stock warrant
( 1,000,000 )
( 100 )
( 7,539,900 )
( 9,660,000 )
—
( 17,200,000 )
Issuance of common stock warrant in exchange for retirement of common stock
—
—
17,200,000
—
—
17,200,000
Issuance of common stock in at-the-market offerings, net
2,110,800
211
34,178,020
—
—
34,178,231
Issuance of common stock upon cashless exercise of warrants
1,050
—
10,000
—
—
10,000
Unrealized gain on short-term investments
—
—
—
—
5,136
5,136
Net loss
—
—
—
( 14,864,108 )
—
( 14,864,108 )
Balance at March 31, 2021
38,257,180
3,810
462,417,706
( 210,944,707 )
( 5,039,381 )
246,437,428
Stock-based compensation
—
—
1,484,829
—
—
1,484,829
Exercise of stock options
38,217
4
94,425
—
—
94,429
Vesting of restricted stock awards including withholding, net
( 7,583 )
1
( 91,122 )
—
—
( 91,121 )
Issuance of common stock in at-the-market offerings, net
1,405,710
141
18,177,832
—
—
18,177,973
Unrealized gain on short-term investments
—
—
—
—
1,141
1,141
Net loss
—
—
—
( 24,826,707 )
—
( 24,826,707 )
Balance at June 30, 2021
39,693,524
3,956
482,083,670
( 235,771,414 )
( 5,038,240 )
241,277,972
Stock-based compensation
—
—
1,496,884
—
—
1,496,884
Exercise of stock options
398
—
5,970
—
—
5,970
Vesting of restricted stock awards including withholding, net
( 6,521 )
1
( 122,626 )
—
—
( 122,625 )
Issuance of common stock from Employee Stock Purchase Plan
15,367
2
118,469
—
—
118,471
Unrealized loss on short-term investments
—
—
—
—
( 1,923 )
( 1,923 )
Net loss
—
—
—
( 33,510,688 )
—
( 33,510,688 )
Balance at September 30, 2021
39,702,768
$
3,959
$
483,582,367
$
( 269,282,102 )
$
( 5,040,163 )
$
209,264,061
The accompanying notes are an integral part of the unaudited consolidated financial statements.
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ALTIMMUNE, INC.
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
(unaudited)
Accumulated
Additional
Other
Total
Common Stock
Paid-In
Accumulated
Comprehensive
Stockholders’
Shares
Amount
Capital
Deficit
Loss
Equity
Balance at December 31, 2019
15,312,167
$
1,508
$
187,914,916
$
( 137,376,122 )
$
( 5,020,156 )
$
45,520,146
Stock-based compensation
—
—
214,921
—
—
214,921
Vesting of restricted stock awards including withholding, net
( 5,974 )
1
( 17,080 )
—
—
( 17,079 )
Issuance of common stock from Employee Stock Purchase Plan
38,809
3
56,736
—
—
56,739
Issuance of common stock upon exercise of warrants
14,500
2
39,972
—
—
39,974
Unrealized loss on short-term investments
—
—
—
—
( 32,435 )
( 32,435 )
Net loss
—
—
—
( 3,885,649 )
—
( 3,885,649 )
Balance at March 31, 2020
15,359,502
1,514
188,209,465
( 141,261,771 )
( 5,052,591 )
41,896,617
Stock-based compensation
—
—
330,510
—
—
330,510
Exercise of stock options
13,935
1
36,174
—
—
36,175
Vesting of restricted stock awards including withholding, net
( 5,974 )
1
( 46,390 )
—
—
( 46,389 )
Issuance of common stock in at-the-market offerings, net
2,965,144
297
22,780,432
—
—
22,780,729
Issuance of common stock upon exercise of warrants
8,221,279
822
31,269,341
—
—
31,270,163
Unrealized gain on short-term investments
—
—
—
—
20,888
20,888
Net loss
—
—
—
( 16,766,916 )
—
( 16,766,916 )
Balance at June 30, 2020
26,553,886
2,635
242,579,532
( 158,028,687 )
( 5,031,703 )
79,521,777
Stock-based compensation
—
—
1,320,089
—
—
1,320,089
Issuance of common stock from exercise of stock options
32,189
3
90,267
—
—
90,270
Vesting of restricted stock awards including withholding, net
103,551
13
( 114,585 )
—
—
( 114,572 )
Issuance of common stock from Employee Stock Purchase Plan
53,852
5
78,727
—
—
78,732
Issuance of common stock and pre-funded warrants in public offering, net
4,119,564
412
124,027,403
—
—
124,027,815
Issuance of common stock in at-the-market offerings, net
247,865
25
2,834,082
—
—
2,834,107
Issuance of common stock upon exercise of warrants
1,962,128
196
9,728,125
—
—
9,728,321
Unrealized loss on short-term investments
—
—
—
—
( 10,569 )
( 10,569 )
Net loss
—
—
—
( 17,770,135 )
—
( 17,770,135 )
Balance at September 30, 2020
33,073,035
$
3,289
$
380,543,640
$
( 175,798,822 )
$
( 5,042,272 )
$
199,705,835
The accompanying notes are an integral part of the unaudited consolidated financial statements.
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ALTIMMUNE, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
Nine Months Ended September 30,
2021
2020
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss
$
( 73,201,503 )
$
( 38,422,700 )
Adjustments to reconcile net loss to net cash used in operating activities:
Change in fair value of contingent consideration liability
1,560,000
22,320,000
Impairment loss on construction-in-progress
8,070,000
—
Stock-based compensation expense
4,200,064
1,865,520
Depreciation and amortization
434,009
218,932
Unrealized losses (gains) on foreign currency exchange
297,135
( 44,323 )
Changes in operating assets and liabilities:
Accounts receivable
3,036,442
( 2,815,343 )
Prepaid expenses and other current assets
( 5,263,432 )
( 636,943 )
Accounts payable
( 606,210 )
856,653
Accrued expenses and other liabilities
6,916,132
1,199,708
Income tax receivable
( 1,713,642 )
( 5,564,759 )
Net cash used in operating activities
( 56,271,005 )
( 21,023,255 )
CASH FLOWS FROM INVESTING ACTIVITIES:
Proceeds from sales and maturities of short-term investments
82,406,000
39,385,689
Purchases of short-term investments
( 7,591,962 )
( 74,413,135 )
Purchases of property and equipment, net
( 11,970,179 )
( 100,329 )
Cash paid for internally developed patents
( 189,649 )
( 98,893 )
Net cash provided by (used in) investing activities
62,654,210
( 35,226,668 )
CASH FLOWS FROM FINANCING ACTIVITIES:
Payments of deferred offering costs
( 118,522 )
( 160,522 )
Proceeds from exercises of warrants
—
41,038,458
Proceeds from issuance of common stock in at-the-market offerings, net
52,356,204
25,614,836
Proceeds from issuance of common stock and pre-funded warrants in public offering, net
—
124,027,815
Proceeds from issuance of notes payable
—
632,000
Payments of notes payable
—
( 632,000 )
Proceeds from issuance of common stock from Employee Stock Purchase Plan
224,472
135,471
Proceeds from exercises of stock options
100,399
126,445
Net cash provided by financing activities
52,562,553
190,782,503
Net increase in cash and cash equivalents and restricted cash
58,945,758
134,532,580
Cash, cash equivalents and restricted cash at beginning of period
115,951,981
8,996,860
Cash, cash equivalents and restricted cash at end of period
$
174,897,739
$
143,529,440
SUPPLEMENTAL CASH FLOW INFORMATION:
Cash paid for interest
$
—
$
1,791
SUPPLEMENTAL NON-CASH FINANCING ACTIVITIES:
Operating lease liability and right of use asset addition
$
72,047
$
—
The accompanying notes are an integral part of the unaudited consolidated financial statements.
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ALTIMMUNE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
1. Nature of Business and Basis of Presentation
Nature of Business
Altimmune, Inc., headquartered in Gaithersburg, Maryland, United States, together with its subsidiaries (collectively, the “Company” or “Altimmune”) is a clinical stage biopharmaceutical company incorporated under the laws of the State of Delaware.
The Company is focused on developing treatments for obesity and liver diseases. The Company’s pipeline includes proprietary intranasal vaccines and next generation peptide therapeutics for obesity, NASH (pemvidutide, proposed INN, formerly known as ALT-801) and chronic hepatitis B (HepTcell). Since its inception, the Company has devoted substantially all of its efforts to business planning, research and development, recruiting management and technical staff, and raising capital, and has financed its operations through the issuance of common and preferred stock, long-term debt, and proceeds from research grants and government contracts. The Company has not generated any revenues from the sale of any products to date, and there is no assurance of any future revenues from product sales.
Basis of Presentation
The accompanying unaudited consolidated financial statements are prepared pursuant to the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”) regarding interim financial reporting. Accordingly, they do not include all of the information and disclosures required by accounting principles generally accepted in the United States (“U.S. GAAP”) for complete consolidated financial statements and should be read in conjunction with the audited consolidated financial statements for the year ended December 31, 2020 included in the Annual Report on Form 10-K which was filed with the SEC on February 25, 2021. In the opinion of management, the Company has prepared the accompanying unaudited consolidated financial statements on the same basis as the audited consolidated financial statements, and these consolidated financial statements include all adjustments, consisting only of normal recurring adjustments, necessary for a fair presentation of the results of the interim periods presented. The operating results for the interim periods presented are not necessarily indicative of the results expected for the full year 2021 or any future years or periods.
The accompanying unaudited consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All significant intercompany accounts and transactions have been eliminated in consolidation.
The accompanying unaudited consolidated financial statements have been prepared on the basis of continuity of operations, realization of assets, and the satisfaction of liabilities in the ordinary course of business. The financial statements do not include any adjustments relating to the recoverability and classification of recorded assets and liabilities that might be necessary should we be unable to continue as a going concern.
2. Summary of Significant Accounting Policies
During the nine months ended September 30, 2021, there have been no significant changes to the Company’s summary of significant accounting policies contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 as filed with the SEC, except for the recently adopted accounting standard for income taxes.
Use of Estimates
The preparation of these financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. The extent to which the COVID-19 pandemic, including any resurgences or the emergence of new variants, may directly or indirectly impact the Company’s business, financial condition, and results of operations is highly uncertain and subject to change.
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The Company considered the potential impact of the COVID-19 pandemic on the Company’s estimates and assumptions and determined that there was not a material impact to the Company’s unaudited consolidated financial statements as of and for the three and nine months ended September 30, 2021. However, actual results could differ from those estimates and there may be changes to the Company’s estimates in future periods.
Recently Issued Accounting Pronouncements - Adopted
In December 2019, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2019-12, Income Taxes (Topic 740), Simplifying the Accounting for Income Taxes (“ASU No. 2019-12”). ASU 2019-12 amends the approaches and methodologies in accounting for income taxes during interim periods and makes changes to certain income tax classifications. The new standard eliminates the legacy exceptions to the general guidance for intra-period tax allocation, when there is a loss from continuing operations and income or a gain from other items, and to the general methodology for calculating income taxes in an interim period, when a year-to-date loss exceeds the anticipated loss for the year. The standard also requires franchise or similar taxes partially based on income to be reported as income tax and the effects of enacted changes in tax laws or rates to be included in the annual effective tax rate computation from the date of enactment. Lastly, in any future acquisition, the Company would be required to evaluate when the step-up in the tax basis of goodwill is part of the business combination and when it should be considered a separate transaction. The Company adopted the standard as of January 1, 2021 and has evaluated the effects of this standard and determined that the adoption did not have a material impact on the Company’s consolidated financial statements.
3. Fair Value Measurements
The Company’s assets and liabilities measured at fair value on a recurring basis at September 30, 2021 consisted of the following:
Fair Value Measurement at September 30, 2021
Total
Level 1
Level 2
Level 3
Assets:
Cash equivalents - money market funds
$
65,632,943
$
65,632,943
$
—
$
—
Short-term investments
25,020,738
—
25,020,738
—
Total
90,653,681
65,632,943
25,020,738
—
Liabilities:
Contingent consideration liability (see Note 8)
6,950,000
—
—
6,950,000
Total
$
6,950,000
$
—
$
—
$
6,950,000
The Company’s assets and liabilities measured at fair value on a recurring basis at December 31, 2020 consisted of the following:
Fair Value Measurement at December 31, 2020
Total
Level 1
Level 2
Level 3
Assets:
Cash equivalents - money market funds
$
90,389,473
$
90,389,473
$
—
$
—
Short-term investments
100,005,558
—
100,005,558
—
Total
190,395,031
90,389,473
100,005,558
—
Liabilities:
Contingent consideration liability (see Note 8)
5,390,000
—
—
5,390,000
Warrant liability
10,000
—
—
10,000
Total
$
5,400,000
$
—
$
—
$
5,400,000
The warrant liability is included in Other long-term liabilities in the consolidated balance sheet at December 31, 2020. The warrant liability was valued using the Monte Carlo simulation valuation model with Level 3 inputs.
Short-term investments have been initially valued at the transaction price and subsequently valued, at the end of each reporting period, utilizing third party pricing services or other market observable data (Level 2). The pricing services
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utilize industry standard valuation models, including both income and market-based approaches and observable market inputs to determine value.
Short-term investments had quoted prices at September 30, 2021 as shown below:
September 30, 2021
Unrealized Gain
Amortized Cost
(Loss)
Market Value
Certificate of deposit
$
25,020,738
$
—
$
25,020,738
Total
$
25,020,738
$
—
$
25,020,738
Short-term investments had quoted prices at December 31, 2020 as shown below:
December 31, 2020
Unrealized Gain
Amortized Cost
(Loss)
Market Value
United States treasury securities
$
20,052,757
$
1,843
$
20,054,600
Commercial paper and corporate debt securities
47,521,344
( 5,440 )
47,515,904
Asset backed securities
7,414,619
( 757 )
7,413,862
Certificate of deposit
25,021,192
—
25,021,192
Total
$
100,009,912
$
( 4,354 )
$
100,005,558
The fair value of contingent payments classified as a liability is based on the regulatory milestones described in Note 8 and estimated using the Monte Carlo simulation valuation model with Level 3 inputs.
The assumptions used to estimate the fair value of contingent payments that are classified as a liability at September 30, 2021 include the following significant unobservable inputs:
Unobservable input
Value or Range
Weighted Average
Expected volatility
78.0 %
78.0 %
Risk-free interest rate
0.06 %
0.06 %
Cost of capital
30 %
30 %
Discount for lack of marketability
10 %‑ 12 %
11 %
Probability of payment
81 %
81 %
Projected year of payment
2022
2022
If applicable, the Company will recognize transfers into and out of Level 3 within the fair value hierarchy at the end of the reporting period in which the actual event or change in circumstance occurs. There were no transfers into or out of Level 3 of the fair value hierarchy as of September 30, 2021 and December 31, 2020.
Separate disclosure is required for assets and liabilities measured at fair value on a recurring basis from those measured at fair value on a non-recurring basis. Assets recorded at fair value on a non-recurring basis, such as property and equipment and intangible assets are recognized at fair value when they are impaired. During the nine months ended September 30, 2021, the Company recorded a non-cash impairment charge to property and equipment, net on a non-recurring basis (see below). As of December 31, 2020, the Company had no significant assets or liabilities that were measured at fair value on a non-recurring basis.
Property and Equipment, Net
During the nine months ended September 30, 2021, the Company recorded a non-cash impairment charge of $ 8.1 million to property and equipment, net. The fair value of the impaired assets was $ 3.3 million at September 30, 2021. At September 30, 2021, the fair value of the construction-in-progress related assets was primarily determined utilizing the cost approach, which reflects the current replacement cost of the asset being appraised, adjusted for contractual restrictions
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on the assets, the probability of satisfying the contractual restrictions, physical deterioration, functional obsolescence, and economic obsolescence. The fair value measurement is considered a Level 3 measurement within the valuation hierarchy.
4. Property and Equipment, Net
Property and equipment, net consists of the following:
September 30, 2021
December 31, 2020
Furniture, fixtures and equipment
$
202,100
$
125,538
Laboratory equipment
1,039,805
959,585
Computers and telecommunications
279,026
220,316
Software
94,409
64,409
Leasehold improvements
1,731,934
1,285,883
Construction-in-progress
3,300,000
—
Property and equipment, at cost
6,647,274
2,655,731
Less: accumulated depreciation and amortization
( 1,929,128 )
( 1,598,811 )
Property and equipment, net
$
4,718,146
$
1,056,920
As of September 30, 2021, construction-in-progress primarily includes costs related to the procurement of long-lead equipment associated with the Company’s manufacturing collaboration with Lonza Houston, Inc. (“Lonza”) for the manufacture of AdCOVID or other adenovirus-based vaccines. Under the agreement, the Company has committed approximately $ 23.0 million to Lonza to procure long-lead equipment and construct a dedicated manufacturing suite for clinical and commercial production of adenovirus-based vaccines. This work is expected to be completed during the fourth quarter of 2021.
In June 2021, the Company announced the discontinuation of further development of AdCOVID following the Company’s review of findings from the Phase 1 clinical trial. Construction continues at Lonza, and the Company is currently assessing its strategic options with respect to the suite. The Company’s current expectation is that, more likely than not, the suite will be disposed of significantly before the end of its previously estimated useful life. As of September 30, 2021, the Company recorded $ 8.1 million of impairment loss on construction-in-progress in the accompanying unaudited consolidated statements of operations and comprehensive loss, with $ 3.3 million remaining capitalized in the unaudited consolidated balance sheet, as it represents expected recoveries available to the Company under the construction contract. Following the discontinuation of AdCOVID, incremental cost incurred under the construction contract has been recorded to research and development expenses in the accompanying unaudited consolidated statements of operations and comprehensive loss. Research and development expenses related to property and equipment was approximately $ 9.6 million and $ 17.7 million for the three and nine months ended September 30, 2021, respectively.
Depreciation expense related to property and equipment was approximately $ 0.1 million and $ 0.1 million for the three months ended September 30, 2021 and 2020, respectively, and $ 0.2 million and $ 0.2 million for the nine months ended September 30, 2021 and 2020, respectively.
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5. Intangible Assets
The Company’s intangible assets consist of the following:
September 30, 2021
Gross
Estimated
Carrying
Accumulated
Net Book
Useful Lives
Value
Amortization
Value
Internally developed patents
6 – 20 years
$
1,074,436
$
( 499,828 )
$
574,608
Acquired licenses
16 – 20 years
285,000
( 285,000 )
—
Total intangible assets subject to amortization
1,359,436
( 784,828 )
574,608
IPR&D assets
Indefinite
12,418,967
—
12,418,967
Total
$
13,778,403
$
( 784,828 )
$
12,993,575
December 31, 2020
Gross
Estimated
Carrying
Accumulated
Net Book
Useful Lives
Value
Amortization
Value
Internally developed patents
6 – 10 years
$
884,787
$
( 479,908 )
$
404,879
Acquired licenses
16 – 20 years
285,000
( 285,000 )
—
Total intangible assets subject to amortization
1,169,787
( 764,908 )
404,879
IPR&D assets
Indefinite
12,418,967
—
12,418,967
Total
$
13,588,754
$
( 764,908 )
$
12,823,846
Amortization expense of intangible assets was $ 6,641 and $ 10,406 for the three months ended September 30, 2021 and 2020, respectively, and $ 19,920 and $ 36,282 for the nine months ended September 30, 2021 and 2020, respectively. As of September 30, 2021, the weighted average amortization period remaining for intangible assets was 12.0 years. Amortization expense was classified as research and development expenses in the accompanying unaudited consolidated statements of operations and comprehensive loss.
6. Operating Leases
The Company rents office and laboratory space in the United States. The Company also leases office equipment under non-cancellable equipment leases through June 2026 . Rent expense during the three and nine months ended September 30, 2021 under all of the Company’s operating leases was $ 0.1 million and $ 0.4 million, respectively. Rent expense during the three and nine months ended September 30, 2020 under all of the Company’s operating leases was $ 0.1 million and $ 0.3 million, respectively. Rent expense includes short-term leases and variable lease costs that are not included in the lease obligation.
Short-term leases are leases having a term of twelve months or less. The Company recognizes short-term leases on a straight-line basis and does not record a related lease asset or liability for such leases.
The office space leases provide for increases in future minimum annual rental payments as defined in the lease agreements. The office space lease also includes an option to renew the lease as of the end of the term. The Company has determined that the lease renewal option is not reasonably certain of being exercised.
The cash paid for operating lease liabilities for the three and nine months ended September 30, 2021 was $ 0.1 million and $ 0.4 million, respectively, and for the three and nine months ended September 30, 2020 was $ 0.1 million and $ 0.3 million, respectively.
Supplemental other information related to the operating leases balance sheet information is as follows:
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September 30, 2021
December 31, 2020
Operating lease obligations (see Note 7 and 9)
$
1,631,867
$
1,824,840
Operating lease right-of-use assets (included in "Other assets" in Balance Sheet)
$
844,222
$
903,825
Weighted-average remaining lease term (years)
3.6
4.3
Weighted-average discount rate
7.2
%
7.3
%
7. Accrued Expenses
Accrued expenses and other current liabilities consist of the following:
September 30, 2021
December 31, 2020
Accrued professional services
$
729,434
$
1,350,194
Accrued payroll and employee benefits
2,006,675
2,351,599
Accrued interest
19,423
13,016
Accrued research and development
15,943,874
7,316,876
Lease obligation, current portion (see Note 6)
401,743
356,716
Deferred revenue
19,753
19,753
Total accrued expenses
$
19,120,902
$
11,408,154
8. Contingent Consideration
The Company entered into an Agreement and Plan of Merger and Reorganization, dated July 8, 2019 , by and among the Company, Springfield Merger Sub, Inc., Springfield Merger Sub, LLC, Spitfire Pharma, Inc. and David Collier, as the Stockholder Representative (the “Spitfire Merger Agreement”) to acquire all of the equity interests of Spitfire Pharma, Inc. (“Spitfire”). Spitfire was a privately held, preclinical pharmaceutical company developing a novel dual GLP-1/glucagon receptor agonist for the treatment of non-alcoholic steatohepatitis.
The transaction closed on July 12, 2019. The Company issued 1,887,250 unregistered shares of its common stock (the “shares”) as upfront consideration to certain former securityholders of Spitfire (collectively, the “Spitfire Equityholders”), representing an amount equal to $ 5.0 million less working capital and transaction expense adjustment amounts as defined in the agreement.
The acquisition of Spitfire was accounted for as an asset acquisition instead of a business combination because substantially all of the fair value of the gross assets acquired was concentrated in a single identifiable asset or group of similar identifiable assets, and therefore, the asset was not considered a business. The Company expensed the acquired intellectual property as of the acquisition date as in-process research and development with no alternative future uses.
The Spitfire Merger Agreement also includes future contingent payments up to $ 88.0 million in cash and shares of the Company’s common stock as follows (each, a “Milestone Event”):
● a one-time payment of $ 5.0 million (the “IND Milestone Consideration Amount”) within sixty days of the submission of an Investigational New Drug Application (“IND”) to the United States Food and Drug Administration (the “FDA”) or other applicable governmental authority in a foreign jurisdiction, which IND has not been rejected or placed on clinical hold by the FDA or such applicable foreign governmental authority within time specified in the Merger Agreement;
● a one-time payment of $ 3.0 million (the “Phase 2 Milestone Consideration Amount” and together with the IND Milestone Consideration Amount, the “Regulatory Milestones”) within sixty days of the initiation of a Phase 2 clinical trial of a product candidate anywhere in the world; and
● payments of up to $ 80.0 million upon the achievement of specified worldwide net sales (the “Sales Milestones”) of all products developed using the technology acquired in the License Agreement within ten years following the approval of a new drug application filed with the FDA.
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The Regulatory Milestones will be payable in shares of the Company’s Common Stock, with the number of shares of the Company’s Common Stock to be issued in connection with each milestone amount, if any, are dependent on the share price at the time of achievement. The number of any shares issued in consideration for the IND Milestone Consideration Amount will be determined based on lower of (A) the average of the closing prices of our Common Stock as reported on the Nasdaq Global Market for the twenty (20) consecutive trading days prior to the IND Reference Date or (B) $ 2.95 . The value of any shares issued in consideration for the Phase 2 Milestone Consideration Amount shall be determined based the lower of (A) on the average of the closing trading prices of our Common Stock as reported on the Nasdaq Global Market for the twenty (20) consecutive trading days immediately preceding the date of the occurrence of the Phase 2 Milestone Event or (B) $ 3.54 .
The future contingent payments related to the Regulatory Milestones are stock-based payments accounted for under FASB Accounting Standards Codification Topic 480, Distinguishing Liabilities From Equity (“ASC 480”). Such stock-based payments are subject to a lock-up whereby 50 % of the shares are released at 3 months and 50 % are released at 6 months. The future contingent payments related to the Sales Milestones are predominately cash-based payments accounted for under FASB Accounting Standards Codification Topic 450, Contingencies . Accordingly, the Company will recognize the Sales Milestones when the contingency is resolved and the amount is paid or payable.
The Company estimates the future contingent consideration for the Regulatory Milestones based upon a Monte Carlo simulation valuation model that is risk adjusted based on the probability of achieving the milestones and a discount for lack of marketability. The Company remeasures the fair value of the contingent consideration at each reporting period. During the fourth quarter of 2020, the Company achieved the IND Milestone and paid the obligation in shares according to the calculation above. Below is a summary of the contingent consideration activity:
Nine Months Ended September 30,
2021
2020
Beginning balance
$
5,390,000
$
2,750,000
Change in fair value
1,560,000
22,320,000
Ending balance
$
6,950,000
$
25,070,000
As of September 30, 2021 and 2020, the increase in fair value was primarily attributable to an increase in the closing share price of the Company’s common stock and in the probability of milestone achievement. Any changes in fair value have been recorded within research and development expense during the respective periods presented.
9. Other Long-Term Liabilities
The Company’s other long-term liabilities are summarized as follows:
September 30, 2021
December 31, 2020
Lease obligation, long-term portion (see Note 6)
$
1,230,124
$
1,468,124
Conditional economic incentive grants
250,000
250,000
Other
85,487
110,319
Total other long-term liabilities
$
1,565,611
$
1,828,443
10. Common Stock
Public Offering
On July 16, 2020, the Company offered and sold (i) 3,369,564 shares of common stock, at a price to the public of $ 23.00 per share, and (ii) pre-funded warrants of the Company to purchase 1,630,436 shares of common stock at an exercise price equal to $ 0.0001 per share (the “Pre-Funded Warrants”), at a price to the public of $ 22.9999 per share of common stock underlying the Pre-Funded Warrants (equal to the public offering price per share of Common Stock, minus the exercise price of each Pre-Funded Warrant). The Pre-Funded Warrants are exercisable at any time, provided that each Pre-Funded Warrant holder will be prohibited from exercising such Pre-Funded Warrants into shares of the Company’s
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common stock if, as a result of such exercise, the holder, together with its affiliates, would own more than 4.99 % of the total number of shares of the Company’s common stock then issued and outstanding, which percentage may change at the holders’ election to any other number less than or equal to 19.99 % upon 61 days ’ notice to the Company. The gross proceeds of this offering were approximately $ 132.2 million, which includes the exercise in full of the underwriters’ option to purchase an additional 750,000 shares of common stock, before deducting underwriting discounts and commissions and offering expenses during the third quarter of 2020. The net proceeds of this offering were approximately $ 124.0 million, after deducting underwriting discounts and commissions and offering expenses payable by the Company.
The Company has assessed the Pre-Funded Warrants for appropriate equity or liability classification and determined that the Pre-Funded Warrants are freestanding instruments that do not meet the definition of a liability pursuant to ASC 480 and do not meet the definition of a derivative pursuant to FASB Accounting Standards Codification Topic 815, Derivatives and Hedging (“ASC 815”). The Pre-Funded Warrants are indexed to the Company’s common stock and meet all other conditions for equity classification under ASC 480 and ASC 815. Accordingly, the Pre-Funded Warrants are classified as equity and are accounted for as a component of additional paid-in capital at the time of issuance. As of September 30, 2021, no Pre-Funded Warrants were exercised.
At-the-Market Offerings
On February 25, 2021, the Company entered into an Equity Distribution Agreement (the “2021 Agreement”) with Piper Sandler & Co., Evercore Group L.L.C., and B. Riley Securities, Inc., serving as sales agents (the “Sales Agents”) with respect to an at-the-market offerings program under which the Company may offer and sell, from time to time at its sole discretion, shares of its common stock, par value $ 0.0001 per share (the “Common Stock”), having an aggregate offering price of up to $ 125.0 million (the “Shares”) through the Sale Agents (the “2021 Offering”). Any Shares offered and sold in the 2021 Offering will be issued pursuant to the Company’s Registration Statement on Form S-3 filed with the Securities and Exchange Commission (the “SEC”) on December 31, 2020, which was declared effective on January 11, 2021, the prospectus supplement relating to the 2021 Offering filed with the SEC on February 25, 2021 and any applicable additional prospectus supplements related to the 2021 Offering that form a part of the Registration Statement.
As of September 30, 2021, the Company has sold 3,516,510 shares of Common Stock under the 2021 Agreement resulting in approximately $ 52.4 million in net proceeds, with $ 70.9 million remaining available to be sold under the 2021 Agreement. As of September 30, 2021, the Company recorded approximately $ 0.1 million of offering costs which offset the proceeds received from the shares sold through September 30, 2021 and recognized approximately $ 0.1 million of deferred offering costs which will offset future proceeds received under the 2021 Agreement.
O n March 27, 2020, the Company entered into an Equity Distribution Agreement (the “2020 Agreement”) with JMP Securities LLC, serving as placement agent (the “Placement Agent”) with respect to an at-the-market offerings program under which the Company may offer and sell, from time to time at its sole discretion, shares of its common stock, par value $ 0.0001 per share (the “Common Stock”), having an aggregate offering price of up to $ 50.0 million (the “Shares”) through the Placement Agent (the “2020 Offering”). Any Shares offered and sold in the 2020 Offering were issued pursuant to the Company’s Registration Statement on Form S-3 filed with the SEC on April 4, 2019, which was declared effective on April 12, 2019, the prospectus supplement relating to the 2020 Offering filed with the SEC on March 27, 2020 and any applicable additional prospectus supplements related to the 2020 Offering that form a part of the Registration Statement. The aggregate market value of Shares eligible for sale in the 2020 Offering and under the 2020 Agreement were subject to the limitations of General Instruction I.B.6 of Form S-3, to the extent required under such instruction. The Company offered Shares having an aggregate offering price of $ 18.9 million pursuant to the prospectus supplement filed with the SEC on March 27, 2020. On June 1, 2020, the Company filed an amendment to the 2020 Agreement which amended the prospectus supplement dated March 27, 2020 to increase the aggregate offering price to $ 50.0 million. As of September 30, 2020, the Company sold 3,213,009 shares of Common Stock under the amended 2020 Agreement resulting in $ 25.6 million in net proceeds. The 2020 Agreement was fully utilized during the year ended December 31, 2020, and no Shares were sold under the 2020 Agreement during the three and nine months ended September 30, 2021.
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Exchange Agreement
On February 25, 2021, the Company entered into an exchange agreement (the “Exchange Agreement”) with an Investor and its affiliates (the “Exchanging Stockholders”), pursuant to which the Company exchanged an aggregate of 1,000,000 shares of the Company’s common stock, par value $ 0.0001 per share, owned by the Exchanging Stockholders for pre-funded warrants (the “Exchange Warrants”) to purchase an aggregate of 1,000,000 shares of common stock (subject to adjustment in the event of any stock dividends and splits, reverse stock split, recapitalization, reorganization or similar transaction, as described in the Exchange Warrants), with an exercise price of $ 0.0001 per share. The Exchange Warrants do not expire and are exercisable at any time except that the Exchange Warrants cannot be exercised by the Exchanging Stockholders if, after giving effect thereto, the Exchanging Stockholders would beneficially own more than 9.99 % of the Company’s common stock, subject to certain exceptions. In accordance with FASB Accounting Standards Codification Topic 505, Equity , the Company recorded the retirement of the common stock exchanged as a reduction of common shares outstanding and a corresponding debit to additional paid-in-capital and accumulated deficit at the fair value of the Exchange Warrants on the issuance date. The Exchange Warrants were classified as equity in accordance with ASC 480 and the fair value of the Exchange Warrants was recorded as a credit to additional paid-in-capital and is not subject to remeasurement. The Company determined that the fair value of the Exchange Warrants is substantially similar to the fair value of the retired shares on the issuance date due to the negligible exercise price for the Exchange Warrants. As of September 30, 2021, none of the Exchange Warrants have been exercised.
11. Warrants
A summary of warrant activity during the nine months ended September 30, 2021 is as follows:
Warrants outstanding, December 31, 2020
1,777,611
Exchanges (see Note 10)
1,000,000
Exercises
( 1,420 )
Warrants outstanding, September 30, 2021
2,776,191
As of September 30, 2021, all of the common stock warrants that were previously classified as a liability were exercised in full.
12. Stock-Based Compensation
Stock Options
The Company’s stock option awards generally vest over four years and typically have a contractual life of ten years . At September 30, 2021, there was $ 11.3 million of unrecognized compensation cost related to stock options, which is expected to be recognized over a weighted-average period of 2.6 years. During the nine months ended September 30, 2021, the Company granted 1,075,700 stock options with a weighted average exercise price of $ 15.07 and per share weighted average grant date fair value of $ 12.38 .
Information related to stock options outstanding at September 30, 2021 is as follows:
Weighted-Average
Weighted-
Remaining
Number of
Average
Contractual Term
Aggregate Intrinsic
Stock Options
Exercise Price
(Years)
Value
Outstanding
2,612,585
$
8.74
5.9
$
14,034,500
Exercisable
984,613
$
5.45
5.8
$
7,851,439
Unvested
1,627,972
$
10.73
6.0
$
6,183,061
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Restricted Stock
At September 30, 2021, the Company had unvested restricted stock of 94,181 shares with total unrecognized compensation expense of $ 0.3 million, which the Company expects to recognize over a weighted average period of approximately 1.2 years. During the nine months ended September 30, 2021, the Company released 60,545 shares of common stock from restriction as a result of the vesting of restricted stock.
During the nine months ended September 30, 2021, the Company granted 196,279 shares of restricted stock units which vest over four years . At September 30, 2021, the Company had unvested restricted stock units of 207,529 shares with total unrecognized compensation expense of $ 2.5 million, which the Company expects to recognize over a weighted average period of approximately 3.4 years. During the nine months ended September 30, 2021, the Company released 3,750 shares of common stock from restriction as a result of the vesting of restricted stock units.
2019 Employee Stock Purchase Plan
Under the Employee Stock Purchase Plan, employees purchased 24,100 shares for $ 0.2 million during the nine months ended September 30, 2021. During the three and nine months ended September 30, 2021, the Company recognized compensation expense of $ 28,811 and $ 0.3 million, respectively.
Stock-based Compensation Expense
Stock-based compensation expense is classified in the unaudited consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2021 and 2020 as follows:
For the Three Months Ended
For the Nine Months Ended
September 30,
September 30,
2021
2020
2021
2020
Research and development
$
449,486
$
143,844
$
1,211,164
$
250,783
General and administrative
1,047,398
1,176,245
2,988,900
1,614,737
Total
$
1,496,884
$
1,320,089
$
4,200,064
$
1,865,520
13. U.S. Government Contracts and Grants
In June 2020, the Company was awarded $ 4.7 million from the U.S. Army Medical Research & Development Command (“USAMRDC”) to fund our Phase 1/2 clinical trial of T-COVID. The competitive award was granted by USAMRDC in collaboration with the Medical Technology Enterprise Consortium (“MTEC”), a 501(c)(3) biomedical technology consortium working in partnership with the Department of Defense (“DoD”). Under the contract, MTEC will pay the Company a firm fixed fee based upon the achievement of certain milestones for conduct and completion of a Phase 1/2 study and research and development work on the replication-deficient adenovirus 5 (“RD-Ad5”) vector vaccine platform. For the nine months ended September 30, 2021, the Company has recognized approximately $ 0.5 million of grant revenue under the contract. For the three and nine months ended September 30, 2020, the Company recognized $ 2.3 million of grant revenue under the contract.
In July 2016, the Company signed a five-year contract with BARDA. The contract, as amended, has a total value of up to $ 136.8 million and is used to fund clinical development of NasoShield. Under the contract, BARDA pays the Company a fixed fee and reimburses certain costs for the research and development of an Ad5-vectored, protective antigen-based intranasal anthrax vaccine through cGMP manufacture and conduct of a Phase 1 clinical trial dose ranging assessment of safety and immunogenicity. The contract consists of an initial base performance period providing approximately $ 30.9 million in funding for the period July 2016 through December 2021. BARDA has seven options to extend the contract to fund certain continued development and manufacturing activities for the anthrax vaccine, including Phase 2 clinical studies. Each option, if exercised by BARDA, would provide additional funding ranging from approximately $ 1.1 million to $ 34.4 million for a three-year period beginning in 2021. For the three and nine months ended September 30, 2021, the Company has recognized approximately $ 0.1 million and $ 0.4 million, respectively, of grant
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revenue under the current BARDA contract. For the three and nine months ended September 30, 2020, the Company recognized approximately $ 0.6 million and $ 2.7 million, respectively, of grant revenue under the current BARDA contract.
14. Income Taxes
Due to a full valuation allowance, the Company did not record an income tax benefit for the nine months ended September 30, 2021.
With respect to the prior year, on March 27, 2020, President Donald Trump signed into law the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”). The CARES Act provided both stimulus measures and a number of tax provisions, including: temporary changes regarding the utilization and carry back of net operating losses, temporary changes to the prior and future limitations on interest deductions, technical corrections from prior tax legislation for tax depreciation of qualified improvement property, and certain refundable employee retention credits. As of September 30, 2020, the Company recognized a total tax benefit of $ 5.3 million related to the carry back of losses back to obtain a refund of its 2016 tax liability.
15. Net Loss Per Share
Because the Company has reported a net loss attributable to common stockholders for all periods presented, basic and diluted net loss per share attributable to common stockholders are the same for all periods presented.
Basic net loss per share attributable to common stockholders is computed by dividing the net loss attributable to common stockholders by the weighted average numbers of shares of common stock outstanding for the period. Basic shares outstanding includes the weighted average effect of the Company’s outstanding pre-funded warrants, the exercise of which requires little or no consideration for the delivery of shares of common stock.
Diluted net loss per share is calculated by adjusting weighted average shares outstanding for the dilutive effect of common stock equivalents outstanding for the period. As such, all unvested restricted stock, common stock warrants, and stock options have been excluded from the computation of diluted weighted average shares outstanding because such securities would have an anti-dilutive impact for all periods presented.
Potential common shares issuable upon conversion, vesting or exercise of unvested restricted stock, common stock warrants, and stock options that are excluded from the computation of diluted weighted-average shares outstanding, as they are anti-dilutive, are as follows:
For the Three and Nine
For the Three and Nine
Months Ended
Months Ended
September 30, 2021
September 30, 2020
Common stock warrants
145,755
147,175
Common stock options
2,626,482
1,627,394
Restricted stock
301,710
189,908
16. Commitments and Contingencies
Spitfire Acquisition
As disclosed in Note 8, the Company is obligated to make payments of up to $ 80.0 million upon the achievement of specified worldwide net sales of all products developed using the technology acquired from Spitfire Pharma Inc. within ten years following the approval of a new drug application filed with the FDA.
Lonza Manufacturing Agreement
In March 2021, the Company expanded its manufacturing collaboration with Lonza in connection with the Manufacturing Agreement entered into in November 2020 for the manufacture of AdCOVID or other adenovirus-based
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vaccines. Under the expanded agreement, the Company has committed approximately $ 23.0 million to Lonza to procure long-lead equipment and construct a dedicated manufacturing suite for clinical and commercial production of adenovirus-based vaccines. As of September 30, 2021, the Company had $ 2.0 million in remaining commitments under the agreement. In June 2021, the Company discontinued further development of AdCOVID. Refer to Note 4 for further details.
Litigation
The Company is a party in various contracts and subject to disputes, litigation, and potential claims arising in the ordinary course of business, none of which are currently reasonably possible or probable of material loss.
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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.