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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark One)
| QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
or
| TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission file number
(Exact Name of Registrant as Specified in its Charter)
| ||
| ||
(State or Other Jurisdiction of Incorporation or Organization) |
| (I.R.S. Employer Identification No.) |
| ||
(Address of Principal Executive Offices) |
| (Zip Code) |
(
(Registrant’s Telephone Number, Including Area Code)
Securities registered pursuant to Section 12(b) of the Act:
Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer | ◻ |
| Accelerated filer | ◻ |
⌧ |
| Smaller reporting company | ||
Emerging growth company |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ◻
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes
As of August 5, 2022, there were
ALTIMMUNE, INC.
TABLE OF CONTENTS
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
ALTIMMUNE, INC.
CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share data)
| June 30, | December 31, | ||||
2022 | 2021 | |||||
(Unaudited) | ||||||
ASSETS |
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Current assets: |
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Cash and cash equivalents | $ | | $ | | ||
Restricted cash |
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Total cash, cash equivalents and restricted cash |
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Short-term investments |
| |
| — | ||
Accounts receivable |
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Income tax and RD incentive receivables |
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Prepaid expenses and other current assets |
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Total current assets |
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Property and equipment, net |
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Intangible assets, net |
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Other assets |
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Total assets | $ | | $ | | ||
LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Current liabilities: |
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Accounts payable | $ | | $ | | ||
Contingent consideration | — | | ||||
Accrued expenses and other current liabilities |
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Total current liabilities |
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Other long-term liabilities |
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Total liabilities |
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Commitments and contingencies (Note 14) |
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Stockholders’ equity: |
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Common stock, $ | | | ||||
Additional paid-in capital |
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Accumulated deficit |
| ( |
| ( | ||
Accumulated other comprehensive loss, net |
| ( |
| ( | ||
Total stockholders’ equity |
| |
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Total liabilities and stockholders’ equity | $ | | $ | | ||
The accompanying notes are an integral part of the unaudited consolidated financial statements.
1
ALTIMMUNE, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
(In thousands, except share and per share data)
Three Months Ended | Six Months Ended | ||||||||||||
June 30, | June 30, | ||||||||||||
2022 |
| 2021 |
| 2022 |
| 2021 | |||||||
Revenues | $ | | $ | | $ | | $ | | |||||
Operating expenses: |
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Research and development |
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General and administrative |
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Impairment loss on construction-in-progress |
| — |
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| — |
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Total operating expenses |
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Loss from operations |
| ( |
| ( |
| ( |
| ( | |||||
Other income (expense): |
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Interest expense |
| ( |
| ( |
| ( |
| ( | |||||
Interest income |
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Other income (expense), net |
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| ( | |||||
Total other income (expense), net |
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Net loss |
| ( |
| ( |
| ( |
| ( | |||||
Other comprehensive income — unrealized (loss) gain on short-term investments |
| ( |
| |
| ( |
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Comprehensive loss | $ | ( | $ | ( | $ | ( | $ | ( | |||||
Net loss per share, basic and diluted | ( | ( | ( | ( | |||||||||
Weighted-average common shares outstanding, basic and diluted |
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The accompanying notes are an integral part of the unaudited consolidated financial statements.
2
ALTIMMUNE, INC.
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
(Unaudited)
(In thousands, except share amounts)
Accumulated | |||||||||||||||||
Additional | Other | Total | |||||||||||||||
| Common Stock |
| Paid-In |
| Accumulated |
| Comprehensive |
| Stockholders’ | ||||||||
Shares | Amount | Capital | Deficit | Loss | Equity | ||||||||||||
Balance at December 31, 2021 | | $ | | $ | | $ | ( | $ | ( | $ | | ||||||
Stock-based compensation |
| — |
| — |
| |
| — |
| — |
| | |||||
Exercise of stock options |
| |
| — |
| |
| — |
| — |
| | |||||
Vesting of restricted stock awards including withholding, net | | — | ( | — | — | ( | |||||||||||
Issuance of common stock from Employee Stock Purchase Plan |
| |
| — |
| |
| — |
| — |
| | |||||
Issuance of common stock in at-the-market offerings, net |
| |
| — |
| | — | — |
| | |||||||
Issuance of common stock upon exercise of warrants | | — | — | — | — | — | |||||||||||
Net loss | — | — | — | ( | — | ( | |||||||||||
Balance at March 31, 2022 |
| |
| $ | |
| $ | |
| $ | ( |
| $ | ( |
| $ | |
Stock-based compensation |
| — |
| — |
| |
| — |
| — |
| | |||||
Exercise of stock options | |
| — |
| |
| — |
| — |
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Vesting of restricted stock awards including withholding, net |
| ( |
| — |
| ( |
| — |
| — |
| ( | |||||
Issuance of common stock in at-the-market offerings, net | | | | — | — | | |||||||||||
Issuance of common stock related to contingent consideration liability | | — | | — | — | | |||||||||||
Unrealized (loss) gain on short-term investments |
| — |
| — |
| — |
| — |
| ( |
| ( | |||||
Net loss |
| — |
| — |
| — |
| ( |
| — |
| ( | |||||
Balance at June 30, 2022 |
| |
| |
| |
| ( |
| ( |
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The accompanying notes are an integral part of the unaudited consolidated financial statements.
3
ALTIMMUNE, INC.
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
(Unaudited)
(In thousands, except share amounts)
Accumulated | |||||||||||||||||
Additional | Other | Total | |||||||||||||||
| Common Stock |
| Paid-In |
| Accumulated |
| Comprehensive |
| Stockholders’ | ||||||||
Shares | Amount | Capital | Deficit | Loss | Equity | ||||||||||||
Balance at December 31, 2020 | | $ | | $ | | $ | ( | $ | ( | $ | | ||||||
Stock-based compensation |
| — |
| — |
| | — | — |
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Vesting of restricted stock awards including withholding, net |
| ( |
| — |
| ( | — | — |
| ( | |||||||
Issuance of common stock from Employee Stock Purchase Plan |
| |
| — |
| | — | — |
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Retirement of common stock in exchange for common stock warrant |
| ( |
| — |
| ( | ( | — |
| ( | |||||||
Issuance of common stock warrant in exchange for retirement of common stock |
| — |
| — |
| | — | — |
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Issuance of common stock in at-the-market offerings, net |
| |
| — |
| | — | — |
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Issuance of common stock upon cashless exercise of warrants | | — | | — | — | | |||||||||||
Unrealized gain on short-term investments | — | — | — | — | | | |||||||||||
Net loss | — | — | — | ( | — | ( | |||||||||||
Balance at March 31, 2021 |
| |
| $ | |
| $ | |
| $ | ( |
| $ | ( |
| $ | |
Stock-based compensation |
| — |
| — |
| |
| — |
| — |
| | |||||
Exercise of stock options | | — | | — | — | | |||||||||||
Vesting of restricted stock awards including withholding, net |
| ( |
| — |
| ( |
| — |
| — |
| ( | |||||
Issuance of common stock in at-the-market offerings, net |
| |
| — |
| |
| — |
| — |
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Unrealized (loss) gain on short-term investments |
| — |
| — |
| — |
| — |
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Net loss |
| — |
| — |
| — |
| ( |
| — |
| ( | |||||
Balance at June 30, 2021 |
| |
| |
| |
| ( |
| ( |
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The accompanying notes are an integral part of the unaudited consolidated financial statements.
4
ALTIMMUNE, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(In thousands)
| Six Months Ended June 30, | |||||
2022 | 2021 | |||||
CASH FLOWS FROM OPERATING ACTIVITIES: |
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Net loss | $ | ( | $ | ( | ||
Adjustments to reconcile net loss to net cash used in operating activities: |
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Change in fair value of contingent consideration liability |
| |
| ( | ||
Impairment loss on construction-in-progress |
| — |
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Stock-based compensation expense |
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Depreciation and amortization |
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Unrealized (gains) losses on foreign currency exchange |
| ( |
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Changes in operating assets and liabilities: |
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| ||||
Accounts receivable |
| |
| ( | ||
Prepaid expenses and other current assets |
| |
| ( | ||
Accounts payable |
| |
| | ||
Accrued expenses and other liabilities |
| |
| ( | ||
Income tax and RD incentive receivables |
| ( |
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Net cash used in operating activities |
| ( |
| ( | ||
CASH FLOWS FROM INVESTING ACTIVITIES: |
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|
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| ||
Proceeds from sales and maturities of short-term investments |
| — |
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Purchases of short-term investments |
| ( |
| ( | ||
Purchases of property and equipment, net |
| ( |
| ( | ||
Cash paid for internally developed patents |
| — |
| ( | ||
Net cash (used in) provided by investing activities |
| ( |
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CASH FLOWS FROM FINANCING ACTIVITIES: |
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Payments of deferred offering costs | ( | ( | ||||
Proceeds from issuance of common stock in at-the-market offerings, net |
| |
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Proceeds from issuance of common stock from Employee Stock Purchase Plan |
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Proceeds from exercises of stock options, net |
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Net cash provided by financing activities |
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Net (decrease) increase in cash and cash equivalents and restricted cash |
| ( |
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Cash, cash equivalents and restricted cash at beginning of period |
| |
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Cash, cash equivalents and restricted cash at end of period | $ | | $ | | ||
SUPPLEMENTAL NON-CASH ACTIVITIES: |
|
| ||||
Common stock issued related to contingent consideration liability | $ | | $ | — | ||
The accompanying notes are an integral part of the unaudited consolidated financial statements.
5
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 next generation peptide therapeutics for obesity and non-alcoholic steatohepatitis (“NASH”) (for both, pemvidutide [proposed INN], formerly known as ALT-801), and for 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, 2021 included in the Annual Report on Form 10-K which was filed with the SEC on March 15, 2022. 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 2022 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 six months ended June 30, 2022, 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, 2021 as filed with the SEC.
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
6
impact the Company’s business, financial condition, and results of operations is highly uncertain and subject to change. 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 six months ended June 30, 2022. However, actual results could differ from those estimates and there may be changes to the Company’s estimates in future periods.
3. Fair Value Measurements
The Company’s assets measured at fair value on a recurring basis as of June 30, 2022 consisted of the following (in thousands):
Fair Value Measurement at June 30, 2022 | ||||||||||||
| Total |
| Level 1 |
| Level 2 |
| Level 3 | |||||
Assets: | ||||||||||||
Cash equivalents - money market funds | $ | | $ | | $ | — | $ | — | ||||
Short-term investments |
| |
| — |
| |
| — | ||||
Total | $ | | $ | | $ | | $ | — | ||||
The Company’s assets and liabilities measured at fair value on a recurring basis as of December 31, 2021 consisted of the following (in thousands):
Fair Value Measurement at December 31, 2021 | ||||||||||||
| Total |
| Level 1 |
| Level 2 |
| Level 3 | |||||
Assets: | ||||||||||||
Cash equivalents - money market funds | $ | |
| $ | |
| $ | — |
| $ | — | |
Total | | | — | — | ||||||||
Liabilities: | ||||||||||||
Contingent consideration liability (see Note 6) |
| |
| — |
| — |
| | ||||
Total | $ | | $ | — | $ | — | $ | | ||||
As described in Note 6, the remaining milestone payment underlying the contingent consideration liability was fully settled in shares of the Company’s common stock. As of June 30, 2022, the Company had no contingent consideration liability.
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 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 as of June 30, 2022 as shown below:
June 30, 2022 | |||||||||
Amortized Cost | Unrealized Loss | Market Value | |||||||
United States treasury securities |
| $ | |
| $ | ( |
| $ | |
Commercial paper and corporate debt securities | | ( | | ||||||
Asset backed securities |
| |
| ( |
| | |||
Total | $ | | $ | ( | $ | | |||
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 six months ended June 30, 2022, the Company had
7
basis. During the year ended December 31, 2021, the Company recorded non-cash impairment charges to property and equipment, net on a non-recurring basis (see below).
Lonza Manufacturing Agreement
In March 2021, the Company expanded its manufacturing collaboration with Lonza Houston, Inc. (“Lonza”) for the manufacture of AdCOVID or other adenovirus-based vaccines. Under the expanded agreement, the Company had committed approximately $
In connection with the discontinuation of further development of AdCOVID, the Company recorded a non-cash impairment charge of $
Furthermore, the remaining $
4. 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
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 six months ended June 30, 2022 and 2021 was $
Supplemental other information related to the operating leases balance sheet information is as follows (in thousands):
| |||||||
June 30, 2022 | December 31, 2021 |
| |||||
Operating lease obligations (see Note 5 and 7) |
| $ | |
| $ | | |
Operating lease right-of-use assets (included in Other assets in Balance Sheet) | $ | | $ | | |||
Weighted-average remaining lease term (years) |
|
| |||||
Weighted-average discount rate |
| | % |
| | % | |
8
5. Accrued Expenses
Accrued expenses and other current liabilities consist of the following (in thousands):
June 30, 2022 | December 31, 2021 | |||||
Accrued professional services |
| $ | |
| $ | |
Accrued payroll and employee benefits |
| |
| | ||
Accrued research and development |
| |
| | ||
Lease obligation, current portion (see Note 4) |
| |
| | ||
Accrued interest and other |
| |
| | ||
Total accrued expenses and other current liabilities | $ | | $ | | ||
6. Contingent Consideration
The Company entered into an Agreement and Plan of Merger and Reorganization, dated
The transaction closed on July 12, 2019. The Company issued
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 $
| ● | a one-time payment of $ |
| ● | a one-time payment of $ |
| ● | payments of up to $ |
The Regulatory Milestones were payable in shares of the Company’s common stock, with the number of shares of the Company’s common stock issued in connection with each milestone amount, if any, dependent on the share price at the time of achievement. The number of shares issued in consideration for the IND Milestone Consideration Amount was determined based on the lower of (A) the average of the closing prices of the Company’s common stock as reported on the Nasdaq Global Market for the (20) consecutive trading days prior to the IND Reference Date or (B) $
9
Global Market for the (20) consecutive trading days immediately preceding the date of the occurrence of the Phase 2 Milestone Event or (B) $
The contingent payments related to the Regulatory Milestones were 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
On November 3, 2020, the Company received acknowledgement from the Australian Government Department of Health on the Company’s submitted clinical trial notification (“CTN”) which triggered the obligation to settle the IND Milestone payment to the former owners. As a result, on November 19, 2020, the Company issued
On April 26, 2022, the Company dosed the first patient in the Phase 2 MOMENTUM trial of pemvidutide in obesity, which triggered the obligation to pay the Phase 2 Milestone Consideration Amount to the former owners. As a result, on June 10, 2022, the Company issued
Six Months Ended June 30, | ||||||
2022 | 2021 | |||||
Beginning balance |
| $ | |
| $ | |
Change in fair value |
| |
| ( | ||
Fair value of payments settled in common stock (Phase II Milestone) |
| ( |
| — | ||
Ending balance | $ | — | $ | | ||
7. Other Long-Term Liabilities
The Company’s other long-term liabilities are summarized as follows (in thousands):
June 30, 2022 | December 31, 2021 | |||||
Lease obligation, long-term portion (see Note 4) |
| $ | |
| $ | |
Conditional economic incentive grants |
| |
| | ||
Other |
| |
| | ||
Total other long-term liabilities | $ | | $ | | ||
10
8. Common Stock
Public Offering
On July 16, 2020, the Company offered and sold (i)
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 June 30, 2022,
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 $
During the six months ended June 30, 2022, the Company sold
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
11
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 $
9. Warrants
A summary of warrant activity during the six months ended June 30, 2022 is as follows:
Weighted-Average | |||||||
|
| Weighted | Remaining | ||||
Number of | Average | Contractual Term | |||||
Warrants | Exercise Price | (Years) | |||||
Warrants outstanding, December 31, 2021 |
| |
| ||||
Expired | ( | ||||||
Exercises (see Note 8) |
| ( |
| ||||
Warrants outstanding, June 30, 2022 |
| |
| $ |
The warrants outstanding as of June 30, 2022 included
10. Stock-Based Compensation
Stock Options
The Company’s stock option awards generally vest over
Information related to stock options outstanding as of June 30, 2022 is as follows (in thousands, except share and per share data):
|
|
| Weighted-Average |
| ||||||
Weighted- | Remaining | |||||||||
Number of | Average | Contractual Term | Aggregate Intrinsic | |||||||
Stock Options | Exercise Price | (Years) | Value | |||||||
Outstanding |
| | $ | |
| $ | | |||
Exercisable |
| | $ | |
| $ | | |||
Unvested |
| | $ | |
| $ | | |||
Restricted Stock
As of June 30, 2022, the Company had unvested restricted stock of
12
stock as a result of the vesting of
Restricted Stock Units (RSUs)
During the six months ended June 30, 2022, the Company granted
2019 Employee Stock Purchase Plan (ESPP)
Under the ESPP, employees purchased
Stock-based Compensation Expense
Stock-based compensation expense is classified in the unaudited consolidated statements of operations and comprehensive loss for the three and six months ended June 30, 2022 and 2021 as follows (in thousands):
| For the Three Months Ended |
| For the Six Months Ended | |||||||||
June 30, | June 30, | |||||||||||
2022 |
| 2021 | 2022 |
| 2021 | |||||||
Research and development | $ | | $ | | $ | | $ | | ||||
General and administrative |
| |
| |
| |
| | ||||
Total | $ | | $ | | $ | | $ | | ||||
11. U.S. Government Contracts and Grants
In June 2020, the Company was awarded $
In July 2016, the Company signed a
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June 30, 2022, the Company has recognized de minimis grant revenue related to the close-out of the BARDA contract. BARDA did not extend the contract beyond the end of December 2021.
12. Income Taxes
Due to a full valuation allowance, the Company did
13. 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, restricted stock units, 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, restricted stock units, 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 Six Months Ended | |||||
June 30, | |||||
2022 | 2021 | ||||
Common stock warrants |
| |
| |
|
Common stock options |
| |
| |
|
Restricted stock units |
| |
| | |
Restricted stock |
| |
| |
|
14. Commitments and Contingencies
Spitfire Acquisition
As disclosed in Note 6, the Company is obligated to make payments of up to $
Litigation
In December 2019, a complaint was filed by Dr. De-Chu Christopher Tang (“Plaintiff”) against the Company, which was removed to the United States District Court for the Eastern District of Texas. The Plaintiff amended the complaint in February 2020 to include Vipin K. Garg and David J. Drutz as defendants, in addition to the Company (Dr. Garg, Dr. Drutz, and the Company are collectively referred to as “Defendants”). In March 2020 the Defendants filed a motion to dismiss the complaint. The Court denied the motion without prejudice and allowed Plaintiff an opportunity to file an amended complaint. Plaintiff’s second amended complaint was filed on April 17, 2020, and Defendants filed a motion to dismiss that complaint on May 1, 2020. A hearing on Defendants’ motion to dismiss was held on May 20, 2020. Plaintiff, who is representing himself, alleges five causes of action as follows: (1) Defendants’ alleged retention of Plaintiff’s lab notebooks after the termination of his employment in 2012; (2) alleged plagiarism based on publishing an article without naming Plaintiff as an author; (3) use of the Adhigh System, which Plaintiff alleges he developed; (4)
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allegations that Defendants manipulated the Company’s stock and caused a decrease in value; and (5) allegations that the Defendants “wast[ed] government grant money and poison[ed] science by leaving data to rot.” On September 30, 2020, Plaintiff filed a motion titled “Motion to Proscribe Defendants’ Allegedly Illegal Use of Plaintiff’s AdHigh System in Altimmune’s Human Clinical Trials,” to which Defendants filed an opposition on October 13, 2020. The court has not yet ruled on that motion, which also remains pending. On November 6, 2020, Defendants filed a motion for summary judgment on the basis of lack of personal jurisdiction, insufficient service of process, and failure to state a claim. The court ruled on that motion on March 25, 2021, which dismissed the case on the basis of lack of personal jurisdiction. On December 1, 2020, the magistrate judge assigned to the case issued a report and recommendation that Defendants’ motion to dismiss of May 1, 2020 be granted and that this action be dismissed for lack of personal jurisdiction. Plaintiff filed objections to the report and recommendation on December 14, 2020, and the resolution of those objections by the district court remains pending.
In December 2021, the Plaintiff refiled the complaint in the United States District Court for the District of Maryland. On February 24, 2022, Defendants filed a memorandum containing a brief description of the planned motion and a concise summary of the factual and legal support for it. On the basis of that memorandum, the Court granted Defendants’ request to file a motion to dismiss and allowed Plaintiff an opportunity to file an amended complaint. Plaintiff’s amended complaint was filed on March 3, 2022, and Defendants filed a motion to dismiss that complaint on April 4, 2022. The Company believes the allegations in the complaint are without merit and intends to vigorously defend the 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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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The following discussion and analysis of our financial condition and results of operations should be read together with our consolidated financial statements and related notes appearing elsewhere in this Quarterly Report on Form 10-Q and our consolidated financial statements and related notes for the year ended December 31, 2021 included in our Annual Report on Form 10-K, which was filed with the Securities and Exchange Commission on March 15, 2022.
This Quarterly Report on Form 10-Q contains forward-looking statements that involve substantial risks and uncertainties. The words “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “may,” “will,” “should,” “could,” “target,” “strategy,” “intend,” “project,” “guidance,” “likely,” “usually,” “potential,” or the negative of these words or variations of such words, similar expressions, or comparable terminology are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. There are a number of important risks and uncertainties that could cause our actual results to differ materially from those indicated by forward-looking statements. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. A further list and description of risks, uncertainties and other factors that could cause actual results or events to differ materially from the forward-looking statements that we make is included in the cautionary statements herein and in our other filings with the Securities and Exchange Commission, including those set forth under Part I, Item 1A, Risk Factors in our Annual Report on Form 10-K for the year ended December 31, 2021. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments that we may make.
We have based the forward-looking statements included in this Quarterly Report on Form 10-Q on information available to us on the date of this quarterly report, and we assume no obligation to update any such forward-looking statements, other than as required by law. Although we undertake no obligation to revise or update any forward-looking statements, whether as a result of new information, future events or otherwise, you are advised to consult any additional disclosures that we may make directly to you or through reports that we, in the future, may file with the SEC, including Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K.
Overview
Altimmune, Inc. is a clinical stage biopharmaceutical company focused on developing treatments for obesity and liver diseases. Our lead product candidate, pemvidutide (proposed INN, formerly known as ALT-801), is a dual GLP-1/glucagon receptor agonist that is being developed for the treatment of obesity and non-alcoholic steatohepatitis (“NASH”). In addition, we are developing HepTcell, an immunotherapeutic agent designed to achieve a functional cure for chronic hepatitis B.
Impact of COVID-19
We are closely monitoring how the spread of COVID-19, including any resurgences or the emergence of new variants, is affecting our employees, business, preclinical studies and clinical trials. We have reopened our executive office to allow employees to return to the office based on an approach that is intended to comply with federal and state guidelines, with a focus on employee safety and optimal work environment. We are continuing our regular interactions with the FDA and other regulatory agencies and, based on current information, we do not anticipate COVID-19 to materially affect our regulatory timelines for our ongoing clinical trials. Furthermore, as a government contractor, we are subject to the federal government vaccination mandate, which requires federal contractor employees, except in certain limited circumstances, to be vaccinated against COVID-19 by December 8, 2021. While the vaccination mandate remains subject to the interpretation of various government agencies and other entities, and questions remain regarding the specific application of the vaccination mandate, we are continuing to develop and implement health, safety, employment and operational protocols in order to timely comply with the vaccination mandate. As of and for the six months ended June 30, 2022, the vaccination mandate has not had a material impact on our employees or operations.
Although operations have not been materially affected by the COVID-19 pandemic as of and for the three and six months ended June 30, 2022, at this time, however, there is uncertainty relating to the trajectory of the pandemic and
16
the impact of related responses, and disruptions caused by the COVID-19 pandemic may result in difficulties or delays in initiating, enrolling, conducting or completing our planned and ongoing trials and the incurrence of unforeseen costs as a result of disruptions in clinical supply or preclinical study or clinical trial delays. The impact of COVID-19 on our future results will largely depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the ultimate geographic spread of the disease, the duration of the pandemic, travel restrictions and social distancing in the United States and other countries, business closures or business disruptions, the ultimate impact on financial markets and the global economy, and the effectiveness of actions taken in the United States and other countries to contain and treat the disease. In addition, a recurrence of COVID-19 cases, or variants thereof, could cause other widespread or more severe impacts depending on where infection rates are highest. We continue to monitor developments as we deal with the disruptions and uncertainties relating to the COVID-19 pandemic. See “Risk Factors” in Part II, Item 1A of this Quarterly Report on Form 10-Q and “Item 1A. Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2021.
Recent Global Events
Russia and Ukraine Conflict
The military conflict in Russia and Ukraine that began in February 2022 continues as of the date of this quarterly report. As the conflict continues to evolve, we are closely monitoring the impact on our business. The conflict, and the sanctions and counter-sanctions imposed in response to it, have created increased economic uncertainty and operational complexity globally. While we have no direct exposure to Russia and Ukraine, and do not at the moment believe the situation will have a material impact on our operating results, we are monitoring any broader economic impact from the situation. Should the conflict continue or escalate, it could have a significant negative effect on the global economy or on our operations, including continued inflationary pressures on raw materials, supply chain and logistics disruptions, volatility in foreign exchange rates and interest rates and heightened cybersecurity threats.
U.S. Government Contracts and Grants
In June 2020, we were 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 paid us 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 six months ended June 30, 2021, we recognized approximately $0.5 million of grant revenue under the contract, which completed the full recognition of this award. No revenue was recognized for this contract for the three and six months ended June 30, 2022.
In July 2016, we signed a five-year contract with Biomedical Advanced Research and Development Authority (“BARDA”). The contract, as amended, had a total value of up to $136.8 million to be used to fund clinical development of NasoShield. Under the contract, BARDA paid us a fixed fee and reimbursed 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 consisted of an initial base performance period providing approximately $30.9 million in funding for the period July 2016 through December 2021. BARDA had seven options to extend the contract to fund certain continued development and manufacturing activities for the anthrax vaccine, including Phase 2 clinical trials. Each option, if exercised by BARDA, would have provided additional funding ranging from approximately $1.1 million to $34.4 million for a three-year period beginning in 2021. For the three and six months ended June 30, 2021, we recognized approximately $0.1 million and $0.3 million, respectively, of grant revenue under the BARDA contract. For the three and six months ended June 30, 2022, we have recognized de minimis grant revenue related to the close-out of the BARDA contract. BARDA did not extend the contract beyond the end of December 2021.
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Critical Accounting Policies and Significant Judgment and Estimates
Management’s Discussion and Analysis of Financial Condition and Results of Operations is based upon our unaudited consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the U.S. and the rules and regulations of the SEC for interim financial reporting. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues, expenses and the disclosure of contingent liabilities in our consolidated financial statements. We base our estimates and judgments on historical experience, knowledge of current conditions and expectations of what could occur in the future given available information.
There have been no changes in our critical accounting policies and significant judgment and estimates as disclosed in our Annual Report on Form 10-K for the year ended December 31, 2021. For more information regarding our critical accounting policies, we encourage you to read the discussion contained in Item 7 under the heading “Critical Accounting Policies and Significant Judgments and Estimates” and Note 2 “Summary of Significant Accounting Policies” included in the notes to the consolidated financial statements contained in our Annual Report on Form 10-K for the year ended December 31, 2021.
Results of Operations
Comparison of the three months ended June 30, 2022 and 2021:
For the Three Months Ended | ||||||||||||
June 30, | ||||||||||||
(in thousands) |
| 2022 |
| 2021 |
| Increase (Decrease) |
| |||||
Revenue | $ | 8 | $ | 137 | $ | (129) |
| (94) | % | |||
Operating expenses: |
|
|
|
|
|
|
|
| ||||
Research and development |
| 15,993 |
| 13,272 |
| 2,721 |
| 21 | % | |||
General and administrative |
| 4,410 |
| 3,659 |
| 751 |
| 21 | % | |||
Impairment loss on construction-in-progress | — | 8,070 | (8,070) | (100) | % | |||||||
Total operating expenses |
| 20,403 |
| 25,001 |
| (4,598) |
| (18) | % | |||
Loss from operations |
| (20,395) |
| (24,864) |
| 4,469 |
| 18 | % | |||
Other income (expense): |
|
|
|
|
|
|
|
| ||||
Interest expense |
| (65) |
| (22) |
| (43) |
| (195) | % | |||
Interest income |
| 328 |
| 33 |
| 295 |
| 894 | % | |||
Other income (expense), net |
| 25 |
| 26 |
| (1) |
| (4) | % | |||
Total other income (expense), net |
| 288 |
| 37 |
| 251 |
| 678 | % | |||
Net loss | $ | (20,107) | $ | (24,827) | $ | 4,720 |
| 19 | % | |||
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Comparison of the six months ended June 30, 2022 and 2021:
For the Six Months Ended | ||||||||||||
June 30, | ||||||||||||
(in thousands) |
| 2022 |
| 2021 |
| Increase (Decrease) |
| |||||
Revenue | $ | 40 | $ | 975 | $ | (935) |
| (96) | % | |||
Operating expenses: |
|
|
|
|
|
|
| |||||
Research and development |
| 31,097 |
| 25,150 |
| 5,947 |
| 24 | % | |||
General and administrative |
| 8,837 |
| 7,480 |
| 1,357 |
| 18 | % | |||
Impairment loss on construction-in-progress | — | 8,070 | (8,070) | 100 | % | |||||||
Total operating expenses |
| 39,934 |
| 40,700 |
| (766) |
| (2) | % | |||
Loss from operations |
| (39,894) |
| (39,725) |
| (169) |
| (0) | % | |||
Other income (expense): |
|
|
|
|
|
|
| |||||
Interest expense |
| (127) |
| (34) |
| (93) |
| (274) | % | |||
Interest income |
| 349 |
| 75 |
| 274 |
| 365 | % | |||
Other income (expense), net |
| 135 |
| (7) |
| 142 |
| 2,029 | % | |||
Total other income (expense), net |
| 357 |
| 34 |
| 323 |
| (950) | % | |||
Net loss | $ | (39,537) | $ | (39,691) | $ | 154 |
| 0 | % | |||
Revenue
Revenue consists primarily of research grants in the United States from MTEC for our T-COVID product candidate and BARDA for our NasoShield vaccine product candidate. These grants consist of firm fixed fee contracts based on milestones and cost reimbursement contracts, with a fixed fee based on either costs incurred or milestones met. Our T-COVID and NasoShield programs were discontinued as of the end of 2021.
Revenue decreased by $0.1 million, or 94% for the three months ended June 30, 2022 and $0.9 million, or 96%, for the six months ended June 30, 2022, as compared to the three and six months ended June 30, 2021. The decrease was primarily the result of the discontinuation of development work on both T-COVID and NasoShield programs as described above.
Research and development expenses
Research and development expense increased by $2.7 million, or 21%, for the three months ended June 30, 2022, as compared to the three months ended June 30, 2021. The increase was primarily the result of:
| ● | an increase of $6.9 million due to the development activities for pemvidutide primarily due to the ongoing NAFLD trials and initiation of the MOMENTUM Phase 2 trial in obesity; |
| ● | an increase of $0.8 million due to development activities for HepTcell; |
| ● | a net increase of $0.8 million due to development activities related to our other programs, along with costs associated with our pre-clinical projects and non-project specific research and development costs including employee compensation and facility costs; |
| ● | an increase of $2.9 million due to change in the fair value of contingent consideration liability with respect to the acquisition of pemvidutide, which was fully paid on June 10, 2022: and |
| ● | a decrease of $8.7 million due primarily to development activities for our COVID-19 programs, which included AdCOVID and T-COVID (which were discontinued in 2021). |
Research and development expense increased by $5.9 million, or 24%, for the six months ended June 30, 2022, as compared to the six months ended June 30, 2021. The increase was primarily the result of:
| ● | an increase of $16.1 million due to the development activities for pemvidutide primarily due to the ongoing NAFLD trials and initiation of the MOMENTUM Phase 2 trial in obesity; |
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| ● | an increase of $2.7 million due to development activities for HepTcell; |
| ● | a net increase of $1.2 million due to development activities related to our other programs, along with costs associated with our pre-clinical projects and non-project specific research and development costs including employee compensation and facility costs; |
| ● | an increase of $0.2 million due to change in the fair value of contingent consideration liability with respect to the acquisition of pemvidutide, which was fully paid on June 10, 2022: and |
| ● | a decrease of $14.3 million due primarily to development activities for our COVID-19 programs, which included AdCOVID and T-COVID (which were discontinued in 2021). |
General and administrative expenses
General and administrative expense increased by $0.8 million, or 21% for the three months ended June 30, 2022 and $1.4 million, or 18%, for the six months ended June 30, 2022, as compared to the three and six months ended June 30, 2021. The increase was due primarily to an increase in stock compensation and other labor related costs.
Impairment loss on construction-in-progress
Impairment loss on construction-in-progress of $8.1 million reported during the three and six months ended June 30, 2021 represents non-cash impairment charges recorded for assets that were previously capitalized in connection with the construction of the Lonza facility and subsequent discontinuation of AdCOVID. There were no such impairment charges reported during the three and six months ended June 30, 2022.
Total other income (expense), net
Total other income (expense), net increased by $0.3 million for each of the three and six months ended June 30, 2022, as compared to the three and six months ended June 30, 2021, respectively, primarily due to increase in interest income.
Liquidity and Capital Resources
Overview
Our primary sources of cash during the six months ended June 30, 2022 were from equity transactions. Our cash, cash equivalents, restricted cash and short-term investments were $184.8 million as of June 30, 2022. We believe, based on the operating cash requirements and capital expenditures expected for 2022 and 2023, our cash on hand as of June 30, 2022, together with expected cash receipts from our income tax refunds and RD incentives, are sufficient to fund operations for at least a twelve-month period from the issuance date of our June 30, 2022 consolidated financial statements.
We have not generated any revenues from the sale of any products to date, and there is no assurance of any future revenues from product sales. Our sources of revenue have consisted of grant revenues under our arrangements with BARDA for the development of NasoShield, MTEC for a clinical trial and development work on T-COVID, and to a lesser degree from other licensing arrangements. We have incurred significant losses since we commenced operations. As of June 30, 2022, we had an accumulated deficit of $332.7 million. In addition, we have not generated positive cash flows from operations. We have had to rely on a variety of financing sources, including the issuance of debt and equity securities. As capital resources are consumed to fund our research and development activities, we may require additional capital beyond our currently anticipated amounts. In order to address our capital needs, including our planned clinical trials, we must continue to actively pursue additional equity or debt financing, government funding, and monetization of our existing programs through partnership arrangements or sales to third parties.
On December 31, 2020, we filed a shelf registration statement on Form S-3, which was declared effective by the SEC on January 11, 2021. This shelf registration statement covered the offering, issuance and sale by us of up to an aggregate of $250.0 million of our common stock, preferred stock, debt securities, warrants, rights and units (the “2021 Shelf”). As of June 30, 2022, approximately $157.9 million remained available to be sold under the 2021 Shelf.
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In June 2020, we were 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 paid us 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. Through June 30, 2022, we have collected approximately $4.7 million in cash under the contract, which completed the full recognition of this award.
In July 2016, we signed a five-year contract with BARDA. The contract, as amended, had a total value of up to $136.8 million to be used to fund clinical development of NasoShield. Under the contract, BARDA paid us a fixed fee and reimbursed 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 consisted of an initial base performance period providing approximately $30.9 million in funding for the period July 2016 through December 2021. BARDA had seven options to extend the contract to fund certain continued development and manufacturing activities for the anthrax vaccine, including Phase 2 clinical trials. Each option, if exercised by BARDA, would have provided additional funding ranging from approximately $1.1 million to $34.4 million for a three-year period beginning in 2021. Through June 30, 2022, we have collected approximately $29.3 million in cash under the BARDA contract. BARDA did not extend the contract beyond the end of December 2021.
Cash Flows
The following table provides information regarding our cash flows for the six months ended June 30, 2022 and 2021:
Six Months Ended June 30, | ||||||
(in thousands) |
| 2022 |
| 2021 | ||
Net cash (used in) provided by: |
|
|
|
| ||
Operating activities | $ | (30,230) | $ | (38,496) | ||
Investing activities |
| (48,977) |
| 44,243 | ||
Financing activities |
| 24,764 |
| 52,438 | ||
Net (decrease) increase in cash and cash equivalents and restricted cash | $ | (54,443) | $ | 58,185 | ||
Operating Activities
Net cash used in operating activities was $30.2 million for the six months ended June 30, 2022 compared to $38.5 million during the six months ended June 30, 2021. The primary uses of cash from our operating activities include payments for labor and labor-related costs, professional fees, research and development costs associated with our clinical trials and other general corporate expenditures. The decrease in cash used in operations of $8.3 million year over year is due to an increase in net loss as adjusted for non-cash items of $6.4 million offset by changes in working capital accounts of $14.7 million.
Investing Activities
Net cash used in investing activities was $49.0 million for the six months ended June 30, 2022 compared to $44.2 million net cash provided during the six months ended June 30, 2021. The net cash used in investing activities during the six months ended June 30, 2022 was primarily due to purchase of short-term investments. The net cash provided by investing activities during the six months ended June 30, 2021 was primarily due to net proceeds from short-term investment activity, partially offset by purchases of property and equipment.
Financing Activities
Net cash provided by financing activities during the six months ended June 30, 2022 was $24.8 million compared to $52.4 million for the six months ended June 30, 2021. The net cash provided by financing activities during the six
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months ended June 30, 2022 was primarily the result of the receipt of $24.3 million in proceeds from the issuance of common stock from our at-the-market offerings program and $0.4 million in net proceeds from exercise of stock options. The net cash provided by financing activities during the six months ended June 30, 2021 was primarily the result of the receipt of $52.4 million in proceeds from the issuance of common stock from our at-the-market offerings program.
Financing
Public Offering
On July 16, 2020, we offered and sold (i) 3,369,564 shares of our common stock, at a price to the public of $23.00 per share, and (ii) pre-funded warrants to purchase 1,630,436 shares of our 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 our 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 our 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 us. 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 us. As of June 30, 2022, 760,870 of the Pre-Funded Warrants were exercised, leaving 869,566 remaining Pre-Funded Warrants unexercised.
At-the-Market Offerings
On February 25, 2021, we 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 we may offer and sell, from time to time at our sole discretion, shares of our common stock, par value $0.0001 per share (the “Common Stock”), having an aggregate offering price of up to $125.0 million through the Sales Agents from the 2021 Shelf.
During the six months ended June 30, 2022, we sold 2,493,202 shares of Common Stock under the 2021 Agreement resulting in approximately $24.3 million in net proceeds. As of June 30, 2022, we sold 7,293,656 shares of Common Stock under the 2021 Agreement resulting in approximately $89.2 million in net proceeds, with $32.9 million remaining available to be sold under the 2021 Agreement.
Current Resources
We have financed our operations to date principally through our equity offerings and proceeds from issuances of our preferred stock, common stock and warrants. As of June 30, 2022, we had $135.9 million of cash, cash equivalents and restricted cash and $48.9 million of short-term investments. Accordingly, management believes that we have sufficient capital to fund our plan of operations for at least a twelve-month period from the issuance date of our June 30, 2022 financial statements. However, in order to address our capital needs in the long-term, including potential future clinical trials, we must continue to actively pursue additional equity or debt financing, government funding, and monetization of our existing programs through partnership arrangements or sales to third parties.
Off-Balance Sheet Arrangements
We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined in the rules and regulations of the Securities and Exchange Commission.
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Item 3. Quantitative and Qualitative Disclosures about Market Risk
As a “smaller reporting company” as defined by Item 10 of Regulation S-K, we are not required to provide the information required by this Item.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our principal executive officer and principal financial officer, evaluated the effectiveness of our disclosure controls and procedures pursuant to Rule 13a-15 under the Securities Exchange Act of 1934, as amended (“the “Exchange Act”) as of the end of the period covered by this Quarterly Report on Form 10-Q.
Based on this evaluation, our principal executive officer and principal financial officer concluded that, as of June 30, 2022, our disclosure controls and procedures were effective to provide reasonable assurance that information we are required to disclose in reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate, to allow timely decisions regarding required disclosure.
Changes in Internal Control Over Financial Reporting
There were no changes in our internal control over financial reporting (as defined in Rule 13a-15(f) and Rule 15d-15(f) under the Exchange Act) during the quarter ended June 30, 2022 identified in connection with the evaluation thereof by our management, including the Chief Executive Officer and Chief Financial Officer, that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART II. OTHER INFORMATION
Item 1. Legal Proceedings
From time to time, we may be involved in various legal proceedings arising from the normal course of business activities. Defending such proceedings is costly and can impose a significant burden on management and employees. The results of any current or future litigation cannot be predicted with certainty, and regardless of the outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources, and other factors.
In December 2019, a complaint was filed by Dr. De-Chu Christopher Tang (“Plaintiff”) against us, which we removed to the United States District Court for the Eastern District of Texas. The Plaintiff amended the complaint in February 2020 to include Vipin K. Garg and David J. Drutz as defendants, in addition to the Company (Dr. Garg, Dr. Drutz, and the Company are collectively referred to as “Defendants”). In December 2021, the Plaintiff refiled the complaint in the United States District Court for the District of Maryland. See Note 14 to the consolidated financial statements appearing in Item 1 of this report for further details.
Item 1A. Risk Factors
There have been no material changes from the risk factors disclosed in our Annual Report on Form 10-K filed with the SEC on March 15, 2022.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
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Item 3. Default upon Senior Securities
None.
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
None.
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Item 6. Exhibits
Exhibit Index | ||
Exhibit No. |
| Description |
31.1 † |
| Certification of Principal Executive Officer Pursuant to SEC Rule 13a-14(a)/15d-14(a) |
31.2 † |
| Certification of Principal Financial Officer Pursuant to SEC Rule 13a-14(a)/15d-14(a) |
32.1 † |
| Certification Pursuant to Section 1350 of Chapter 63 of Title 18 of the United States Code |
32.2 † |
| Certification Pursuant to Section 1350 of Chapter 63 of Title 18 of the United States Code |
101.INS |
| Inline XBRL Instance Document (the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document) |
101.SCH |
| Inline XBRL Taxonomy Extension Schema Document |
101.CAL |
| Inline XBRL Taxonomy Extension Calculation Linkbase Document |
101.DEF |
| Inline XBRL Taxonomy Extension Definition Linkbase Document |
101.LAB |
| Inline XBRL Taxonomy Extension Label Linkbase Document |
101.PRE |
| Inline XBRL Taxonomy Extension Presentation Linkbase Document |
104 | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) | |
† | This certification will not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section. Such certification will not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except to the extent specifically incorporated by reference into such filing. |
§ | Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused the report to be signed on its behalf by the undersigned, thereunto duly authorized.
ALTIMMUNE, INC. | ||
Dated: August 11, 2022 | By: | /s/ Vipin K. Garg |
Name: | Vipin K. Garg | |
Title: | President and Chief Executive Officer (Principal Executive Officer) | |
Dated: August 11, 2022 | By: | /s/ Richard Eisenstadt |
Name: | Richard Eisenstadt | |
Title: | Chief Financial Officer (Principal Financial and Accounting Officer) | |
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