Altimmune, Inc 10-Q for FY2024 Q2
Altimmune, Inc. (ALT)
About this 10-Q
Altimmune, Inc filed this 10-Q on August 8, 2024, covering the quarter ended June 30, 2024 (FY2024 Q2).
Headline figures
Quarter ended June 30, 2024, as reported in this filing, compared with the same period a year earlier where the filing states it.
- Revenue
- $5000
- down 16.7% from $6000 a year earlier
- Net loss
- $24.64M
- compared with a net loss of $16.06M a year earlier
- Diluted EPS
- -$0.35
- compared with -$0.32 a year earlier
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)
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(State or Other Jurisdiction of Incorporation or Organization) |
| (I.R.S. Employer Identification No.) |
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(Address of Principal Executive Offices) |
| (Zip Code) |
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(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.
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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 2, 2024 there were
ALTIMMUNE, INC.
TABLE OF CONTENTS
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| Consolidated Balance Sheets as of June 30, 2024 (unaudited) and December 31, 2023 | 1 |
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| Consolidated Statements of Cash Flows for the six months ended June 30, 2024 and 2023 (unaudited) | 5 |
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Management’s Discussion and Analysis of Financial Condition and Results of Operations | 14 | |
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PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
ALTIMMUNE, INC.
CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per-share amounts)
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| June 30, | | December 31, | ||
| | 2024 | | 2023 | ||
| | (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 | |
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Accounts and other receivables | |
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Income tax and R&D 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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Other assets | |
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Total assets | | $ | | | $ | |
LIABILITIES AND STOCKHOLDERS’ EQUITY | |
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Current liabilities: | |
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Accounts payable | | $ | | | $ | |
Accrued expenses and other current liabilities | |
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Total current liabilities | |
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Noncurrent liabilities | |
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Total liabilities | |
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Commitments and contingencies (Note 10) | |
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Stockholders’ equity: | |
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Common stock, $ | | | | | | |
Additional paid-in capital | |
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Accumulated deficit | |
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Accumulated other comprehensive loss, net | |
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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 amounts)
| | Three Months Ended | | Six Months Ended | ||||||||
| | June 30, | | June 30, | ||||||||
| | 2024 |
| 2023 |
| 2024 |
| 2023 | ||||
Revenues | | $ | | | $ | | | $ | | | $ | |
Operating expenses: | |
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Research and development | |
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General and administrative | |
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Total operating expenses | |
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Loss from operations | |
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Other income (expense): | |
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Interest expense | |
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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 | |
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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 | |||
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| Common Stock |
| Paid-In |
| Accumulated |
| Comprehensive |
| Stockholders’ | |||||||
| | Shares | | Amount | | Capital | | Deficit | | Loss | | Equity | |||||
Balance at December 31, 2023 | | | | $ | | | $ | | | $ | ( | | $ | ( | | $ | |
Stock-based compensation |
| — |
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Exercise of stock options |
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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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Issuance of common stock upon exercise of warrants | | | | | — | | | | | | — | | | — | | | |
Unrealized (loss) gain on short-term investments |
| — |
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| | — |
| | — |
| | ( |
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Net loss | | — | | | — | | | — | | | ( | | | — | | | ( |
Balance at March 31, 2024 |
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| $ | |
| $ | |
| $ | ( |
| $ | ( |
| $ | |
Stock-based compensation |
| — |
| $ | — |
| $ | |
| $ | — |
| $ | — |
| $ | |
Exercise of stock options | | |
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Vesting of restricted stock awards including withholding, net |
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| | ( |
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Unrealized (loss) gain on short-term investments |
| — |
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| | — |
| | — |
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Net loss |
| — |
| | — |
| | — |
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| | — |
| | ( |
Balance at June 30, 2024 |
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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, 2022 | | | | $ | | | $ | | | $ | ( | | $ | ( | | $ | |
Stock-based compensation |
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Exercise of stock options |
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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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Unrealized (loss) gain on short-term investments |
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Net loss | | — | | | — | | | — | | | ( | | | — | | | ( |
Balance at March 31, 2023 |
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| $ | |
| $ | |
| $ | ( |
| $ | ( |
| $ | |
Stock-based compensation |
| — |
| $ | — |
| $ | |
| $ | — |
| $ | — |
| $ | |
Vesting of restricted stock awards including withholding, net |
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| | — |
| | ( |
| | — |
| | — |
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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 |
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Balance at June 30, 2023 |
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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)
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| Six Months Ended | ||||
| | June 30, | ||||
| | 2024 | | 2023 | ||
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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Stock-based compensation expense | |
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Depreciation of property and equipment | |
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Accretion of discounts on short-term investments | | | ( | | | ( |
Loss (gain) on foreign currency exchange | |
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Changes in operating assets and liabilities: | |
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Accounts receivable | |
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Prepaid expenses and other assets | |
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Accounts payable | |
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Accrued expenses and other liabilities | |
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Income tax and R&D incentive receivables | |
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Net cash used in operating activities | |
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CASH FLOWS FROM INVESTING ACTIVITIES: | |
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Proceeds from sales and maturities of short-term investments | |
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Purchases of short-term investments | |
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Purchases of property and equipment, net | |
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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 exercises of warrants | |
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Proceeds from issuance of common stock in at-the-market offerings, net | |
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Payment of conditional economic incentive | |
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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 | |
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Payments for tax withholding in share-based compensation | |
| ( | |
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Net cash used in financing activities | |
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Net decrease in cash and cash equivalents and restricted cash | |
| ( | |
| ( |
Cash, cash equivalents and restricted cash at beginning of period | |
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Cash, cash equivalents and restricted cash at end of period | | $ | | | $ | |
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SUPPLEMENTAL NON-CASH ACTIVITIES: | |
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Operating lease liability and right-of-use asset addition | | $ | | | $ | — |
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 lead product candidate, pemvidutide (formerly known as ALT-801), is a novel, investigational, peptide-based GLP-1/glucagon dual receptor agonist in development for the treatment of obesity and metabolic dysfunction-associated steatohepatitis (“MASH”), previously termed non-alcoholic steatohepatitis (“NASH”). 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, 2023, included in the Annual Report on Form 10-K which was filed with the SEC on March 27, 2024. 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 2024 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 the Company be unable to continue as a going concern.
2. Summary of Significant Accounting Policies
During the six months ended June 30, 2024, 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, 2023, as filed with the SEC on March 27, 2024.
Use of Estimates
The preparation of 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. Significant estimates and assumptions made in the accompanying condensed consolidated financial statements include, but are not limited to,
6
the valuation of share-based awards, income taxes, and accruals for research and development activities. The Company bases its estimates on historical experience and on various other assumptions that are believed to be reasonable. However, actual results could differ from those estimates.
Income Taxes
Due to a full valuation allowance, the Company did
3. Fair Value Measurements
The Company’s assets measured at fair value on a recurring basis as of June 30, 2024 consisted of the following (in thousands):
| | Fair Value Measurement at June 30, 2024 | ||||||||||
|
| Total |
| Level 1 |
| Level 2 |
| Level 3 | ||||
Assets: | | | | | | | | | | | | |
Cash equivalents - money market funds | | $ | | | $ | | | $ | — | | $ | — |
Short-term investments | |
| | |
| — | |
| | |
| — |
Total | | $ | | | $ | | | $ | | | $ | — |
The Company’s assets measured at fair value on a recurring basis as of December 31, 2023 consisted of the following (in thousands):
| | Fair Value Measurement at December 31, 2023 | ||||||||||
|
| Total |
| Level 1 |
| Level 2 |
| Level 3 | ||||
Assets: | | | | | | | | | | | | |
Cash equivalents - money market funds | | $ | |
| $ | | | $ | — | | $ | — |
Short-term investments | |
| | |
| — | |
| | |
| — |
Total | | $ | | | $ | | | $ | | | $ | — |
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 with quoted prices as of June 30, 2024 as shown below (in thousands):
| | June 30, 2024 | ||||||||||
| | Amortized Cost | | Unrealized (Loss) Gain | | Credit loss | | Market Value | ||||
United States treasury securities |
| $ | |
| $ | ( |
| $ | — |
| $ | |
Commercial paper and corporate debt securities | | | | | | ( | | | — | | | |
Asset backed securities | |
| | |
| ( | |
| — | |
| |
Agency debt securities | | | | | | ( | | | — | | | |
Total | | $ | | | $ | ( | | $ | — | | $ | |
7
Short-term investments with quoted prices as of December 31, 2023 as shown below (in thousands):
| | December 31, 2023 | ||||||||||
| | Amortized Cost | | Unrealized (Loss) Gain | | Credit Loss | | Market Value | ||||
United States treasury securities |
| $ | |
| $ | |
| $ | — |
| $ | |
Commercial paper and corporate debt securities | | | | | | | | | — | | | |
Asset backed securities | |
| | |
| ( | |
| — | |
| |
Agency debt securities | | | | | | | | | — | | | |
Total | | $ | | | $ | | | $ | — | | $ | |
As of June 30, 2024 and December 31, 2023, none of the unrealized losses on the Company’s short-term investments are a result of credit loss; therefore, any unrealized losses were recognized in OCI.
As of June 30, 2024 and December 31, 2023, the Company had $
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, 2024 and year ended December 31, 2023, the Company had
4. Operating Leases
The Company’s operating lease for office and laboratory space in the United States was set to expire on April 30, 2025. On May 20, 2024, the Company exercised its one-time
Rent expense under the Company’s operating leases was $
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 cash paid for operating lease liabilities for each of the six months ended June 30, 2024 and 2023 was $
8
Supplemental other information related to the operating leases balance sheet information is as follows (in thousands):
| | June 30, 2024 | | December 31, 2023 |
| | Balance Sheet Classification | ||
Operating lease obligations, current (see Note 5) |
| $ | |
| $ | | | | |
Operating lease obligations, noncurrent (see Note 6) | | $ | | | $ | | | | |
Operating lease right-of-use assets | | $ | | | $ | | | | Other assets |
Weighted-average remaining lease term (years) | |
| |
| | | | ||
Weighted-average discount rate | |
| | % |
| | % | | |
Maturities of operating lease liabilities as of June 30, 2024 are as follows (in thousands):
2024 - remainder of the year | | $ | |
2025 | |
| |
2026 | |
| |
2027 | |
| |
2028 | | | |
2029 | | | |
2030 | |
| |
Total operating lease payments | |
| |
Less: imputed interest | |
| ( |
Total operating lease liabilities | | $ | |
5. Accrued Expenses
Accrued expenses and other current liabilities consist of the following (in thousands):
| | June 30, 2024 | | December 31, 2023 | ||
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. Noncurrent Liabilities
The Company’s noncurrent liabilities are summarized as follows (in thousands):
| | June 30, 2024 | | December 31, 2023 | ||
Research and development incentive credit | | $ | | | $ | |
Lease obligation, long-term portion (see Note 4) |
| | | | | |
Conditional economic incentive grants | |
| | |
| |
Other | |
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| |
Total noncurrent liabilities | | $ | | | $ | |
7. Stockholders’ Equity
The Amended and Restated Certificate of Incorporation, as amended (“Charter”), authorizes the Company to issue
9
Each share of common stock entitles the holder to
The Charter also authorizes the Company to issue
At-the-Market Offerings
On February 28, 2023, the Company entered into an Equity Distribution Agreement (the “2023 Agreement”) with Evercore Group L.L.C., JMP Securities LLC 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, having an aggregate offering price of up to $
Warrants
On March 5, 2024, warrant holders exercised
8. Stock-Based Compensation
2017 Omnibus Incentive Plan (Omnibus Plan)
The Company’s Omnibus Plan provides for an annual increase on January 1 of each year, commencing in 2019 and ending on and including January 1, 2027, up to an amount equal to the lowest of (i)
Stock Options
The Company’s stock option awards generally vest over
10
Information related to stock options outstanding as of June 30, 2024 is as follows (in thousands, except share, exercise price and contractual term):
|
| |
| | |
| Weighted-Average |
| | |
| | | | Weighted- | | Remaining | | | | |
| | Number of | | Average | | Contractual Term | | Aggregate Intrinsic | ||
| | Stock Options | | Exercise Price | | (Years) | | Value | ||
Outstanding, December 31, 2023 |
| | | $ | |
| | $ | | |
Granted |
| | | $ | |
|
| |
|
|
Exercised |
| ( | | $ | |
|
| |
|
|
Forfeited or expired |
| ( | | $ | |
|
| |
|
|
Outstanding, June 30, 2024 |
| | | $ | |
| | $ | | |
Exercisable, June 30, 2024 |
| | | $ | |
| | $ | | |
Vested and expected to vest, June 30, 2024 |
| | | $ | |
| | $ | | |
Restricted Stock Units (RSUs)
During the six months ended June 30, 2024, the Company granted
2019 Employee Stock Purchase Plan (ESPP)
Under the ESPP, employees purchased
Stock-Based Compensation Expense
During the three months ended June 30, 2024, the Company recorded $
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, 2024 and 2023 as follows (in thousands):
|
| Three Months Ended |
| Six Months Ended | ||||||||
| | June 30, | | June 30, | ||||||||
| | 2024 |
| 2023 | | 2024 |
| 2023 | ||||
Research and development | | $ | | | $ | | | $ | | | $ | |
General and administrative | |
| | |
| | |
| | |
| |
Total | | $ | | | $ | | | $ | | | $ | |
9. Net Loss Per Share
Because the Company has reported net loss attributable to common stockholders for the three and six months ended June 30, 2024 and 2023, basic and diluted net loss per share attributable to common stockholders in each period are the same.
11
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.
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, RSUs, common stock 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 RSUs, 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:
| | Three and Six Months Ended | ||
| | June 30, | ||
| | 2024 | | 2023 |
Common stock warrants |
| — |
| |
Common stock options |
| |
| |
Restricted stock units |
| | | |
10. Commitments and Contingencies
Spitfire Acquisition
In July 2019, the Company entered into 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 novel peptide products for pharmaceutical indications, including pemvidutide for the treatment of MASH. As part of the agreement, the Company is obligated to make payments of up to $
Litigation
On May 6, 2024, class action complaint was filed in federal district court in the District of Maryland, Southern Division, naming as defendants the Company and
On June 4, 2024, shareholder derivative complaint was filed in federal district court in the District of Delaware, purportedly on behalf of the Company, naming as defendants
12
breaches of fiduciary duty, unjust enrichment, and waste of corporate assets based on the defendants purportedly making or causing to be made false and misleading statements and omissions of material fact between December 1, 2023 and April 26, 2024. The complaint seeks unspecified monetary relief, exemplary damages, restitution, contribution, and costs, as well as equitable relief. A similar shareholder derivative complaint was filed in the same court by another plaintiff on July 1, 2024, based upon substantially similar allegations, and alleges claims for contribution, breach of fiduciary duties, unjust enrichment, abuse of control, gross mismanagement, and waste of corporate assets. The complaint, captioned Alaraidah v. Garg, et al., No. 1:24-cv-00772-GBW (D. Del.), seeks unspecified monetary relief, restitution, costs, and equitable relief. These actions were consolidated on July 18, 2024 into case no. 1:24-cv-669-GBW (the “Derivative Action”). The Company intends to vigorously defend against the Derivative Action.
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, 2023 included in our Annual Report on Form 10-K, which was filed with the SEC on March 27, 2024.
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 SEC, 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, 2023. 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 (formerly known as ALT-801), is a novel, investigational, peptide-based GLP-1/glucagon dual receptor agonist in development for the treatment of obesity and metabolic dysfunction-associated steatohepatitis (“MASH”), previously termed non-alcoholic steatohepatitis (“NASH”). Except where the context indicates otherwise, references to “we,” “us,” “our,” “Altimmune”, or the “Company” refer to the company and its subsidiaries.
Recent Business Update
Pemvidutide
On June 23, 2024, we presented the full results of the body composition analysis from our 48-week MOMENTUM Phase 2 obesity trial of pemvidutide at the American Diabetes Association’s 84th Annual Scientific Sessions. The body composition analysis showed that 78.1% of weight loss was derived from adipose tissue and only 21.9% from lean mass. Historically, lean mass loss has been shown to be approximately 25% from diet and exercise programs.
As announced on November 30, 2023, the trial enrolled 391 subjects with obesity or overweight with at least one co-morbidity and without diabetes. Subjects were randomized 1:1:1:1 to 1.2 mg, 1.8 mg, 2.4 mg pemvidutide or placebo administered weekly for 48 weeks in conjunction with diet and exercise. The 1.2 mg and 1.8 mg doses were administered without dose titration, while a short 4-week titration period was employed for the 2.4 mg dose. At baseline, subjects had a mean age of approximately 50 years, mean body mass index (BMI) of approximately 37 kg/m2, and mean body weight of approximately 104 kg. Approximately 75% of subjects were female.
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HepTcell
On March 27, 2024, we announced that the overall response in the Phase 2 trial was deemed to be insufficient to warrant further advancement in clinical trials. As a result, any further development related to HepTcell has been stopped.
Results of Operations
Comparison of the three months ended June 30, 2024 and 2023
The following table summarizes our results of operations for the three months ended June 30, 2024 and 2023 (in thousands):
| | Three Months Ended June 30, | | |||||||||
|
| 2024 |
| 2023 |
| Increase (Decrease) |
| |||||
Revenues | | $ | 5 | | $ | 6 | | $ | (1) |
| 17 | % |
Operating expenses: | |
|
| |
|
| |
|
|
|
| |
Research and development | |
| 21,155 | |
| 13,253 | |
| 7,902 |
| 60 | % |
General and administrative | |
| 5,595 | |
| 4,760 | |
| 835 |
| 18 | % |
Total operating expenses | |
| 26,750 | |
| 18,013 | |
| 8,737 |
| 49 | % |
Loss from operations | |
| (26,745) | |
| (18,007) | |
| (8,738) |
| 49 | % |
Other income (expense): | |
|
| |
|
| |
|
|
|
| |
Interest expense | |
| (1) | |
| (2) | |
| 1 |
| (50) | % |
Interest income | |
| 2,182 | |
| 1,835 | |
| 347 |
| 19 | % |
Other income (expense), net | |
| (76) | |
| 113 | |
| (189) |
| 167 | % |
Total other income (expense), net | |
| 2,105 | |
| 1,946 | |
| 159 |
| 8 | % |
Net loss | | $ | (24,640) | | $ | (16,061) | | $ | (8,579) |
| 53 | % |
Revenue
We have not generated any revenues from the sale of any products to date. Our revenues in previous years consisted primarily of government and foundation grants and contracts that supported our efforts on specific research projects. We recently closed out one of the remaining such contracts, and any revenues reported during the three months ended June 30, 2024 and 2023 were for the final indirect rate adjustments.
Research and development expenses
Research and development expenses consisted primarily of expenses related to product candidate development. Research and development expenses for the three months ended June 30, 2024 and 2023 are summarized as follows:
| | Three Months Ended June 30, | | |||||||||
Product candidates |
| 2024 |
| 2023 |
| Increase (Decrease) |
| |||||
Pemvidutide | | $ | 13,762 | | $ | 5,571 | | $ | 8,191 |
| 147 | % |
HepTcell | |
| 1,000 | |
| 1,778 | |
| (778) |
| (44) | % |
Non-project costs | |
| 6,393 | |
| 5,904 | |
| 489 |
| 8 | % |
Total research and development expenses | | $ | 21,155 | | $ | 13,253 | | $ | 7,902 |
| 60 | % |
The increase in research and development expenses for pemvidutide was primarily due to an $8.7 million increase related to the ramp up of the IMPACT Phase 2b trial in MASH, a $0.2 million increase for other clinical analysis and a $1.5 million increase in net manufacturing expenses for production of Good Manufacturing Practice drug substance materials. These increases were partially offset by a $1.9 million reduction in expense associated with the MOMENTUM Phase 2 trial in obesity, which was ongoing during the three months ended June 30, 2023 and wound down in the year ended December 31, 2023, and a $0.3 million reduction in expenses associated with Phase 1 safety trial which was substantially completed in 2023.
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The decrease in research and development expenses for HepTcell was primarily due to the winddown and completion of the in-life portion of the Phase 2 trial in 2023. The research and development expenses for the three months ended June 30, 2024 were due to program winddown activities. In the coming months, we expect to have some additional wrap up costs as we finalize these activities.
The increase in other non-project specific research and development expenses was primarily due to a $0.5 million initial cost for a new research and discovery project.
General and administrative expenses
General and administrative expenses increased by $0.8 million, or 18%, for the three months ended June 30, 2024, as compared to the three months ended June 30, 2023, primarily due to a $1.3 million increase in stock compensation and other labor related expense, including the $1.0 million incremental stock-based compensation expense because of modifications of stock awards (see Note 8).
Total other income (expense), net
Total other income (expense), net increased by $0.2 million, or 8%, for the three months ended June 30, 2024, as compared to the three months ended June 30, 2023. The net increase is primarily due to a $0.3 million increase in interest income earned on our cash equivalents and short-term investments.
Comparison of the six months ended June 30, 2024 and 2023
The following table summarizes our results of operations for the six months ended June 30, 2024 and 2023 (in thousands):
| | Six Months Ended June 30, | | |||||||||
|
| 2024 |
| 2023 |
| Increase (Decrease) |
| |||||
Revenues | | $ | 10 | | $ | 27 | | $ | (17) |
| 63 | % |
Operating expenses: | |
|
| |
|
| |
|
|
| | |
Research and development | |
| 42,642 | |
| 30,502 | |
| 12,140 |
| 40 | % |
General and administrative | |
| 10,907 | |
| 9,291 | |
| 1,616 |
| 17 | % |
Total operating expenses | |
| 53,549 | |
| 39,793 | |
| 13,756 |
| 35 | % |
Loss from operations | |
| (53,539) | |
| (39,766) | |
| (13,773) |
| 35 | % |
Other income (expense): | |
|
| |
|
| |
| |
|
| |
Interest expense | |
| (2) | |
| (4) | |
| 2 |
| (50) | % |
Interest income | |
| 4,595 | |
| 3,503 | |
| 1,092 |
| 31 | % |
Other income (expense), net | |
| (88) | |
| 132 | |
| (220) |
| 167 | % |
Total other income (expense), net | |
| 4,505 | |
| 3,631 | |
| 874 |
| 24 | % |
Net loss | | $ | (49,034) | | $ | (36,135) | | $ | (12,899) |
| 36 | % |
Revenues
We have not generated any revenues from the sale of any products to date. Our revenues in previous years consisted primarily of government and foundation grants and contracts that supported our efforts on specific research projects. We recently closed out one of the remaining such contracts, and any revenues reported during the six months ended June 30, 2024 and 2023 were for the final indirect rate adjustments.
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Research and development expenses
Research and development expenses consisted primarily of expenses related to product candidate development. Research and development expenses for the six months ended June 30, 2024 and 2023 are summarized as follows:
| | Six Months Ended June 30, | | |||||||||
Product candidates |
| 2024 |
| 2023 |
| Increase (Decrease) |
| |||||
Pemvidutide | | $ | 27,289 | | $ | 15,023 | | $ | 12,266 |
| 82 | % |
HepTcell | |
| 2,025 | |
| 3,896 | |
| (1,871) |
| (48) | % |
Non-project costs | |
| 13,328 | |
| 11,583 | |
| 1,745 |
| 15 | % |
Total research and development expenses | | $ | 42,642 | | $ | 30,502 | | $ | 12,140 |
| 40 | % |
The increase in research and development expenses for pemvidutide was primarily due to a $16.3 million increase related to the ramp up of the IMPACT Phase 2b trial in MASH, a $0.7 million increase for other clinical analysis, a $2.3 million increase in net manufacturing expenses for production of Good Manufacturing Practice drug substance materials, and a $1.1 million increase in nonclinical studies. These increases were partially offset by a $5.7 million reduction in expense associated with the MOMENTUM Phase 2 trial in obesity, which was ongoing during the six months ended June 30, 2023 and wound down in the year ended December 31, 2023, and a $1.7 million reduction in expenses associated with the metabolic dysfunction-associated steatotic liver disease (“MASLD”) trials and a $0.7 million reduction in expenses associated with Phase 1 safety trials, both of which were substantially completed in 2023.
The decrease in research and development expenses for HepTcell was primarily due to the winddown and completion of the in-life portion of the Phase 2 trial in 2023. The research and development expenses for the six months ended June 30, 2024 were due to program winddown activities. In the coming months, we expect to have some additional wrap up costs as we finalize these activities.
The increase in other non-project specific research and development expenses was primarily due to a $0.9 million increase in stock compensation expense and a $0.5 million initial cost for a new research and discovery project.
General and administrative expenses
General and administrative expenses increased by $1.6 million, or 17%, for the six months ended June 30, 2024, as compared to the six months ended June 30, 2023, primarily due to a $2.0 million increase in stock compensation and other labor related expense, including the $1.0 million incremental stock-based compensation expense because of modifications of stock awards (see Note 8).
Total other income (expense), net
Total other income (expense), net increased by $0.9 million, or 24%, for the six months ended June 30, 2024, as compared to the six months ended June 30, 2023. The net increase is primarily due to a $1.1 million increase in interest income earned on our cash equivalents and short-term investments.
Liquidity and Capital Resources
Overview
Our primary sources of cash during the six months ended June 30, 2024 were from equity transactions, interest and dividends from our money market funds and short-term investments, and proceeds from maturities of our short-term investments. Our cash, cash equivalents, restricted cash, and short-term investments were $164.9 million as of June 30, 2024. We believe, based on the operating cash requirements and capital expenditures expected for 2024 and 2025, our cash on hand as of June 30, 2024, together with expected cash receipts from our R&D incentives, is sufficient to fund operations for at least a twelve-month period from the issuance date of our June 30, 2024 consolidated financial statements.
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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. We have incurred significant losses since we commenced operations. As of June 30, 2024, we had an accumulated deficit of $515.4 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.
Sources of Liquidity
Shelf Registrations
On February 28, 2023, we filed a shelf registration statement on Form S-3ASR, which was declared effective immediately. This shelf registration allows us to offer and sell any amount of our common stock, preferred stock, debt securities, warrants, rights and units (the “2023 Shelf”) for a period of 3 years from effectiveness.
At-the-Market Offerings
On February 28, 2023, we entered into the 2023 Agreement with 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, the Shares through the Sales Agents from the 2023 Shelf. Since inception through June 30, 2024, we have sold 20,454,516 shares of common stock under the 2023 Agreement, resulting in approximately $86.6 million in net proceeds. During the six months ended June 30, 2024, we did not sell any shares of common stock under the 2023 Agreement, and as of June 30, 2024, $60.6 million remained available to be sold under the 2023 Shelf.
Cash Flows
The following table provides information regarding our cash flows for the six months ended June 30, 2024 and 2023:
| | Six Months Ended June 30, | |||||||
(in thousands) |
| 2024 |
| 2023 |
| Increase (Decrease) | |||
Net cash (used in) provided by: |
| |
|
| |
|
| |
|
Operating activities | | $ | (34,465) | | $ | (38,790) | | $ | 4,325 |
Investing activities | |
| (43,217) | |
| 17,289 | |
| (60,506) |
Financing activities | |
| (307) | |
| 12,763 | |
| (13,070) |
Net decrease in cash and cash equivalents and restricted cash | | $ | (77,989) | | $ | (8,738) | | $ | (69,251) |
Operating Activities
Net cash used in operating activities was $34.5 million for the six months ended June 30, 2024 compared to $38.8 million during the six months ended June 30, 2023. 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 $4.3 million year over year is due to changes in working capital accounts of $15.5 million, partially offset by an increase in net loss as adjusted for non-cash items of $11.2 million.
Investing Activities
Net cash used in investing activities was $43.2 million for the six months ended June 30, 2024 compared to $17.3 million net cash provided by during the six months ended June 30, 2023. The net cash used in investing activities during the six months ended June 30, 2024 was primarily due to purchases of $76.7 million of short-term investments, partially offset by $33.5 million proceeds from sales and maturities of short-term investments. The net cash provided by investing
18
activities during the six months ended June 30, 2023 was primarily due to $60.6 million proceeds from sales and maturities of short-term investments, partially offset by $43.2 million purchases of short-term investments.
Financing Activities
Net cash used in financing activities during the six months ended June 30, 2024 was $0.3 million compared to $12.8 million cash provided by financing activities during the six months ended June 30, 2023. The net cash used in financing activities during the six months ended June 30, 2024 was primarily due to $0.8 million net payments for tax withholding obligations related to share-based compensation, partially offset by $0.2 million in proceeds from the employee stock purchase plan, $0.2 million proceeds from exercises of stock options, and $0.2 million proceeds from exercises of stock warrants. The net cash provided by financing activities during the six months ended June 30, 2023 was primarily the result of the receipt of $13.2 million in net proceeds from the issuance of common stock from our at-the-market offerings program, partially offset by $0.5 million net payments for tax withholding obligations related to share-based compensation.
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, 2024, we had $57.2 million of cash, cash equivalents, and restricted cash, and $107.8 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, 2024 financial statements. However, in order to address our capital needs in the long-term, 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.
Critical Accounting 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 U.S. GAAP 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, 2023.
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.
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Based on this evaluation, our principal executive officer and principal financial officer concluded that, as of June 30, 2024, 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, 2024 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
On May 6, 2024, a class action complaint was filed in federal district court in the District of Maryland, Southern Division, naming as defendants us and three of our executive officers, captioned Mogan v. Altimmune, Inc., et al., No. 24-cv-01315 (D. Md.) (the “Class Action”). The complaint alleges that the defendants violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, as amended, and Rule 10b-5 thereunder, by making false and misleading statements and omissions of material fact to the investing public including the plaintiff and class members, who purchased or otherwise acquired our common stock between December 1, 2023 and April 26, 2024. The plaintiff and class members seek to have the action maintained as a class action under Rule 23 of the Federal Rules of Civil Procedure and for the defendants to pay damages, interest, and an award of costs, including attorneys’ fees. On June 14, 2024, the Court entered an order stating that defendants were not required to answer, move to dismiss, or otherwise respond to the initial complaint filed on May 6, 2024, and that within 14 days of the Court’s entry of an order appointing a lead plaintiff the parties are to confer and submit a proposed schedule to the court for the filing of an amended complaint (if any) and the filing of a motion to dismiss or other response to the amended complaint. A substantially similar complaint, captioned Campanile v. Altimmune, Inc., et al., No. 8:24-cv-01918 (D. Md.), was also filed in the same court by another plaintiff on July 1, 2024 against the Company and three of its executive officers, based upon the same general set of allegations and class period. On July 5, 2024, two movants moved to consolidate the two actions and to be appointed lead plaintiff. On July 12, 2024, these movants filed a stipulation and proposed order to consolidate the related actions, and to be appointed co-lead plaintiffs. We intend to vigorously defend against this class action litigation.
On June 4, 2024, a shareholder derivative complaint was filed in federal district court in the District of Delaware, purportedly on behalf of us, naming as defendants three of our executive officers and eight of our board members, captioned Stourbridge Investments LLC v. Garg, et al., No. 1:24-cv-669-GBW (D. Del.). The complaint is based upon allegations that are similar to those alleged in the Class Action and alleges claims for contribution, breaches of fiduciary duty, unjust enrichment, and waste of corporate assets based on the defendants purportedly making or causing to be made false and misleading statements and omissions of material fact between December 1, 2023 and April 26, 2024. The complaint seeks unspecified monetary relief, exemplary damages, restitution, contribution, and costs, as well as equitable relief. A similar shareholder derivative complaint was filed in the same court by another plaintiff on July 1, 2024, based upon substantially similar allegations, and alleges claims for contribution, breach of fiduciary duties, unjust enrichment, abuse of control, gross mismanagement, and waste of corporate assets. The complaint, captioned Alaraidah v. Garg, et al., No. 1:24-cv-00772-GBW (D. Del.), seeks unspecified monetary relief, restitution, costs, and equitable relief. These actions were consolidated on July 18, 2024 into case no. 1:24-cv-669-GBW (the “Derivative Action”). We intend to vigorously defend against the Derivative Action.
From time to time, we may be involved in various legal proceedings or investigations, which could be costly and 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.
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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 27, 2024.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item 3. Default upon Senior Securities
None.
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
During the six months ended June 30, 2024, none of our officers or directors
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Item 6. Exhibits
| | Exhibit Index |
| | |
Exhibit No. |
| Description |
3.1 |
| |
| | |
3.2 |
| |
| | |
3.3 |
| |
| | |
3.4 |
| |
| | |
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. |
22
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 8, 2024 | By: | /s/ Vipin K. Garg |
| Name: | Vipin K. Garg |
| Title: | President and Chief Executive Officer (Principal Executive Officer) |
| | |
Dated: August 8, 2024 | By: | /s/ Andrew Shutterly |
| Name: | Andrew Shutterly |
| Title: | Acting Chief Financial Officer (Principal Financial and Accounting Officer) |
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Exhibit 31.1
Certification of Principal Executive Officer
Pursuant to SEC Rule 13a-14(a)/15d-14(a)
I, Vipin K. Garg, certify that:
1. | I have reviewed this report on Form 10-Q of Altimmune, Inc. for the period ended June 30, 2024; |
2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
4. | The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
(a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
(b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
(c) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
(d) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. | The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
(a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
(b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
Dated: August 8, 2024 | /s/ Vipin K. Garg |
| Name: Vipin K. Garg |
| Title: President and Chief Executive Officer |
Exhibit 31.2
Certification of Principal Financial Officer
Pursuant to SEC Rule 13a-14(a)/15d-14(a)
I, Andrew Shutterly, certify that:
1. | I have reviewed this report on Form 10-Q of Altimmune, Inc. for the period ended June 30, 2024; |
2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
4. | The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
(a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
(b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
(c) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
(d) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. | The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
(a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
(b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
Dated: August 8, 2024 | /s/ Andrew Shutterly |
| Name: Andrew Shutterly |
| Title: Acting Chief Financial Officer |
Exhibit 32.1
Certification Pursuant to Section 1350 of Chapter 63
of Title 18 of the United States Code
In connection with the quarterly report on Form 10-Q of Altimmune, Inc. (the “Company”) for the period ended June 30, 2024, as filed with the Securities and Exchange Commission (the “Report”), I, Vipin K. Garg, President and Chief Executive Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to the best of my knowledge:
1. | The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934. |
2. | The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
/s/ Vipin K. Garg | |
Vipin K. Garg | |
President and Chief Executive Officer | |
August 8, 2024 | |
A signed original of this written statement required by Section 906 of the Sarbanes-Oxley Act of 2002 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.
This certification is being furnished pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, or otherwise subject to the liability of that section. This certification will not be deemed to be incorporated by reference into any filing under the Securities Act of 1933 or the Securities Exchange Act of 1934.
Exhibit 32.2
Certification Pursuant to Section 1350 of Chapter 63
of Title 18 of the United States Code
In connection with the quarterly report on Form 10-Q of Altimmune, Inc. (the “Company”) for the period ended June 30, 2024, as filed with the Securities and Exchange Commission (the “Report”), I, Andrew Shutterly, acting Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to the best of my knowledge:
1. | The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934. |
2. | The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
/s/ Andrew Shutterly | |
Andrew Shutterly | |
Acting Chief Financial Officer | |
August 8, 2024 | |
A signed original of this written statement required by Section 906 of the Sarbanes-Oxley Act of 2002 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.
This certification is being furnished pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, or otherwise subject to the liability of that section. This certification will not be deemed to be incorporated by reference into any filing under the Securities Act of 1933 or the Securities Exchange Act of 1934.