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.
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 8, 2025 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 amounts)
| June 30, | December 31, | ||||
2025 | 2024 | |||||
(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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Term loan, noncurrent | |
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Other 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, | |||||||||||
2025 |
| 2024 |
| 2025 |
| 2024 | ||||||
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 before income taxes |
| ( |
| ( |
| ( |
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Income tax expense (benefit) |
| — |
| — |
| ( |
| — | ||||
Net loss |
| ( |
| ( |
| ( |
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Other comprehensive income — unrealized loss 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, 2024 | | $ | | $ | | $ | ( | $ | ( | $ | | ||||||
Stock-based compensation |
| — |
| — |
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| — |
| — |
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Exercise of stock options |
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| — |
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| — |
| — |
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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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| — |
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| — |
| — |
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Issuance of common stock in at-the-market offerings, net |
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| | — | — |
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Unrealized loss on short-term investments |
| — |
| — |
| — |
| — |
| ( |
| ( | |||||
Net loss | — | — | — | ( | — | ( | |||||||||||
Balance at March 31, 2025 |
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| $ | |
| $ | |
| $ | ( |
| $ | ( |
| $ | |
Stock-based compensation |
| — |
| $ | — |
| $ | |
| $ | — |
| $ | — |
| $ | |
Exercise of stock options | |
| — |
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| — |
| — |
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Vesting of restricted stock awards including withholding, net |
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| — |
| ( |
| — |
| — |
| ( | |||||
Issuance of common stock in at-the-market offerings, net | | | | — | — | | |||||||||||
Unrealized loss on short-term investments |
| — |
| — |
| — |
| — |
| ( |
| ( | |||||
Net loss |
| — |
| — |
| — |
| ( |
| — |
| ( | |||||
Balance at June 30, 2025 |
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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, 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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| — |
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Issuance of common stock upon exercise of warrants | | — | | — | — | | |||||||||||
Unrealized loss on short-term investments |
| — |
| — |
| — |
| — |
| ( |
| ( | |||||
Net loss | — | — | — | ( | — | ( | |||||||||||
Balance at March 31, 2024 |
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| $ | |
| $ | |
| $ | ( |
| $ | ( |
| $ | |
Stock-based compensation |
| — |
| $ | — |
| $ | |
| $ | — |
| $ | — |
| $ | |
Exercise of stock options |
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| — |
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| — |
| — |
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Vesting of restricted stock awards including withholding, net |
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| — |
| ( |
| — |
| — |
| ( | |||||
Unrealized loss on short-term investments |
| — |
| — |
| — |
| — |
| ( |
| ( | |||||
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.
4
ALTIMMUNE, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(In thousands)
| Six Months Ended | |||||
June 30, | ||||||
2025 | 2024 | |||||
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 | ( | ( | ||||
Amortization of debt discount and costs | | — | ||||
Loss on foreign currency exchange |
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Deferred income tax benefit | ( | — | ||||
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 |
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Net cash provided by (used in) 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 term loan | | — | ||||
Payment for debt issuance 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 |
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Payments for tax withholding in share-based compensation |
| ( |
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Net cash provided by (used in) financing activities |
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Net increase (decrease) 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 CASH FLOW INFORMATION: |
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Cash paid for interest | $ | | $ | — | ||
Cash received from income tax refunds | $ | | $ | — | ||
SUPPLEMENTAL NON-CASH ACTIVITIES: |
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Debt issuance cost in accrued expenses and other current liabilities | $ | | $ | — | ||
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 late clinical-stage biopharmaceutical company incorporated under the laws of the State of Delaware.
The Company is a late clinical-stage biopharmaceutical company focused on developing novel peptide-based therapeutics for liver and cardiometabolic diseases. The Company’s lead program is pemvidutide (formerly known as ALT-801), a GLP-1/glucagon dual receptor agonist for the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”), Alcohol Use Disorder (“AUD”), Alcohol-Associated Liver Disease (“ALD”) and obesity. The Company may also pursue additional indications for pemvidutide that leverage its differentiated clinical profile. 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, 2024, included in the Annual Report on Form 10-K which was filed with the SEC on February 27, 2025. 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 2025 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, 2025, 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, 2024, as filed with the SEC on February 27, 2025.
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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, the valuation of share-based awards, income taxes, prepaids, 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
During the six months ended June 30, 2025, the Company has recorded a discrete tax benefit of approximately $
On July 4, 2025, the One Big Beautiful Bill Act (“OBBBA”) was enacted in the U.S. The OBBBA includes significant provisions, such as the permanent extension of certain expiring provisions of the Tax Cuts and Jobs Act, modifications to the international tax framework and the restoration of favorable tax treatment for certain business provisions. The legislation has multiple effective dates, with certain provisions effective in 2025 and others implemented through 2027. The Company is currently assessing its impact on our consolidated financial statements; however, it does not expect the OBBBA Act to have a material impact on our estimated annual effective tax rate in 2025.
Debt discount and issuance costs
The Company accounts for fees paid to lenders, as compensation for services beyond their role as a creditor, and third parties whose costs are directly related to issuing debt as debt issuance cost. Amounts paid to the lender as a reduction in the proceeds received are considered a discount on the issuance. Debt issuance costs and discounts related to term loans are reported as a direct deduction from the outstanding debt and amortized over the term of the loan using the effective interest method as an additional interest expense.
3. Fair Value Measurements
During the six months ended June 30, 2025, the Company recognized approximately $
The Company’s assets measured at fair value on a recurring basis as of December 31, 2024 consisted of the following (in thousands):
Fair Value Measurement at December 31, 2024 | ||||||||||||
| Total |
| Level 1 |
| Level 2 |
| Level 3 | |||||
Assets: | ||||||||||||
Cash equivalents - money market funds | $ | | $ | | $ | — | $ | — | ||||
Short-term investments |
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| — |
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| — | ||||
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
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utilize industry standard valuation models, including both income and market-based approaches and observable market inputs to determine value. The Company’s short-term investments have a maturity date of one year or less.
Short-term investments with quoted prices as of December 31, 2024 as shown below (in thousands):
December 31, 2024 | ||||||||||||
Unrealized Gain | Unrealized Gain | |||||||||||
Amortized Cost | Unrealized (Loss) Gain | Credit Loss | Market Value | |||||||||
United States treasury securities |
| $ | |
| $ | |
| $ | — |
| $ | |
Commercial paper and corporate debt securities | | | — | | ||||||||
Asset backed securities |
| |
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| — |
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Agency debt securities | | | — | | ||||||||
Total | $ | | $ | | $ | — | $ | |
As of December 31, 2024, none of the unrealized losses on the Company’s short-term investments were a result of credit loss; therefore, any unrealized losses were recognized in OCI.
As of December 31, 2024, the Company had $
The carrying amounts of the Company’s debt approximate fair value because the rates are floating rates based on the prime lending rate, which approximates market rates (see Note 5). These represent Level 2 fair value measurement as the Company has determined the valuation of the liabilities can be obtained from readily available pricing sources via independent providers for market transactions involving similar liabilities.
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, 2025 and year ended December 31, 2024, the Company had
4. Accrued Expenses
Accrued expenses and other current liabilities consist of the following (in thousands):
June 30, 2025 | December 31, 2024 | |||||
Accrued professional services |
| $ | | $ | | |
Accrued payroll and employee benefits |
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Accrued research and development |
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Lease obligation, current portion |
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Accrued interest and other |
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Total accrued expenses and other current liabilities | $ | | $ | |
5. Term Loan
On May 13, 2025 (“Closing Date”), the Company and certain of its subsidiaries entered into a Loan and Security Agreement (“Loan Agreement”) with Hercules Capital, Inc. (“Hercules”) and the lenders party thereto, pursuant to which the lenders will make available up to
Under the terms of the Loan Agreement, the first Term Loan tranche was drawn down on the Closing Date in an aggregate principal amount of $
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principal amount of up to $
The Term Loan will mature on
The Loan Agreement includes customary representations and warranties and covenants associated with the Term Loan. Such terms include (1) covenants concerning financial and other reporting obligations, and (2) certain limitations on indebtedness, liens, investments, distributions (including dividends), collateral, transfers, mergers or acquisitions, taxes, corporate changes, and deposit accounts. Compliance with the financial covenant will be conditionally waived pursuant to the terms of the Loan Agreement when the Company’s market capitalization exceeds $
The obligation under the Loan Agreement is secured by a security interest in substantially all of the Company’s assets and the assets of its subsidiaries that are co-borrowers or guarantors. Upon the occurrence of an event of default, Hercules will be entitled to exercise remedies, including acceleration of the Term Loan obligations and foreclosure on collateral.
The Loan Agreement provides for a prepayment charge equal to
The Company accounted for the End of Term Charge, Facility Charge, and other direct costs incurred in connection with the Loan Agreement as a debt discount and issuance costs, and they are being amortized over the term of the loan using the effective interest method. The effective interest rate on the Term Loan is
The Company incurred interest expense on the Term Loan, including debt discount and issuance costs amortization, of $
The Term Loan consists of the following (in thousands):
June 30, 2025 | December 31, 2024 | |||||
Term loan principal amount |
| $ | |
| $ | — |
End of term charge | | — | ||||
Unamortized discount and issuance costs | ( | — | ||||
Total term loan | | — | ||||
Less: current portion of term loan |
| — |
| — | ||
Total term loan, net of current portion | $ | | $ | — |
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Future principal loan payments on the currently outstanding Term Loan as of June 30, 2025 are as follows (in thousands):
2025 - remainder of the year | $ | — | |
2026 |
| — | |
2027 |
| | |
2028 |
| | |
2029 | | ||
Total future principal payments |
| | |
Add: End of term charge | | ||
Less: Unamortized discount and issuance costs |
| ( | |
Less: Current portion of term loan | — | ||
Total term loan, net of current portion | $ | |
6. Other Noncurrent Liabilities
The Company’s other noncurrent liabilities are summarized as follows (in thousands):
June 30, 2025 | December 31, 2024 | |||||
Research and development incentive credit | $ | | $ | | ||
Lease obligation, long-term portion |
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Conditional economic incentive grants |
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Other |
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Total other noncurrent liabilities | $ | | $ | |
7. Stockholders’ Equity
The Amended and Restated Certificate of Incorporation, as amended (“Charter”), authorized the Company to issue
Each share of common stock entitles the holder to
The Charter also authorized the Company to issue
At-the-Market Offerings
On February 27, 2025, the Company entered into an Equity Distribution Agreement (the “2025 Agreement”) with Leerink Partners LLC, Piper Sandler & Co. and Stifel, Nicolaus & Company, Incorporated, serving as sales agents (the “2025 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 $
10
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 “2023 Sales Agents”), with respect to an at-the-market offerings program under which the Company offered and sold shares of its common stock, having an aggregate offering price of up to $
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
Information related to stock options outstanding as of June 30, 2025 is as follows (in thousands, except share, exercise price, and contractual term):
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| Weighted-Average |
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Weighted- | Remaining | |||||||||
Number of | Average | Contractual Term | Aggregate Intrinsic | |||||||
Stock Options | Exercise Price | (Years) | Value | |||||||
Outstanding, December 31, 2024 |
| | $ | |
| $ | | |||
Granted |
| | $ | |
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Exercised |
| ( | $ | |
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Forfeited or expired |
| ( | $ | |
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Outstanding, June 30, 2025 |
| | $ | |
| $ | | |||
Exercisable, June 30, 2025 |
| | $ | |
| $ | | |||
Vested and expected to vest, June 30, 2025 |
| | $ | |
| $ | |
Restricted Stock Units (RSUs)
During the six months ended June 30, 2025, the Company granted
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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, 2025 and 2024 as follows (in thousands):
| Three Months Ended |
| Six Months Ended | |||||||||
June 30, | June 30, | |||||||||||
2025 |
| 2024 | 2025 |
| 2024 | |||||||
Research and development | $ | | $ | | $ | | $ | | ||||
General and administrative |
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| |
| |
| | ||||
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, 2025 and 2024, basic and diluted net loss per share attributable to common stockholders in each period are the same.
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 RSUs 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 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, | ||||
2025 | 2024 | |||
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 $
12
The contingent payments related to the Sales Milestones are predominately cash-based payments accounted for under FASB Accounting Standards Codification Topic 450, Contingencies. Accordingly, the Company will recognize the Sales Milestones when the contingency is probable and the amount can be reasonably estimated.
Litigation
On June 4, 2024,
On August 5, 2025, a class action complaint was filed in federal district court in the District of Maryland, Southern Division, naming as defendants the Company and two of the Company’s executive officers, captioned Collier v. Altimmune, Inc., et al., Case No. 8:25-cv-02581 (D. Md.) (the “Collier Class Action”). The Collier Class Action 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 the Company’s common stock between August 10, 2023 and June 25, 2025, including relating to pemvidutide and our IMPACT Phase 2b trial of pemvidutide in MASH. The plaintiff and class members seek, among other things, 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. The Company intends to defend vigorously against this 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.
11. Segment Information
The Company is a late clinical-stage biopharmaceutical company focused on developing novel peptide-based therapeutics for liver and cardiometabolic diseases. The Company’s lead program is pemvidutide, a GLP-1/glucagon dual receptor agonist for the treatment of MASH, AUD, ALD and obesity. To date, the Company has not generated any revenue from the sale of any products.
The chief operating decision maker assesses the performance of the Company and decides how to allocate resources based solely on net (loss) income, which is also reported on the consolidated statements of operations and consolidated loss as net (loss) income. The measure of segment assets is reported on the consolidated balance sheet as total assets.
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12. Subsequent Events
The Company evaluated subsequent events through the issuance date of the financial statements on this quarterly report on Form 10-Q.
During July 2025 and through the date of the issuance of the financial statements, the Company raised $
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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, 2024 included in our Annual Report on Form 10-K, which was filed with the SEC on February 27, 2025.
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, 2024. 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 late clinical-stage biopharmaceutical company focused on developing novel peptide-based therapeutics for liver and cardiometabolic diseases. Our lead program is pemvidutide (formerly known as ALT-801), a GLP-1/glucagon dual receptor agonist for the treatment of MASH, AUD, ALD and obesity. We may also pursue additional indications for pemvidutide that leverage our differentiated clinical profile. 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
MASH
On June 26, 2025, we released topline results from IMPACT, a Phase 2b trial in MASH. The Phase 2b trial enrolled 212 subjects with biopsy-confirmed MASH and fibrosis stages F2/F3 with and without diabetes randomized 1:2:2 to receive either weekly subcutaneous pemvidutide at 1.2 mg or 1.8 mg doses or placebo for 24 weeks.
In a rigorous intent-to-treat (“ITT”) analysis, in which subjects with missing biopsies were considered non-responders, the proportions of subjects achieving MASH resolution without worsening of fibrosis at 24 weeks were 59.1% and 52.1%, for pemvidutide 1.2 mg and 1.8 mg, respectively versus 19.1% for placebo (p< 0.0001 both doses). The effects on fibrosis improvement without worsening of MASH in an ITT analysis were 31.8% and 34.5% for pemvidutide 1.2 mg and 1.8 mg, respectively compared with 25.9% for placebo (differences not statistically significant). A supplemental AI-based analysis demonstrated statistically significant reductions in fibrosis, including 30.6% of subjects receiving pemvidutide 1.8 mg achieving a 60% or more reduction in fibrosis compared to 8.2% receiving placebo (p< 0.001).
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Statistically significant changes in well-established non-invasive tests of fibrosis, including ELF score and VCTE were also observed compared with placebo at both doses. Together, this data suggests strong evidence of anti-fibrotic activity of pemvidutide in the MASH population. At 24 weeks, mean weight loss in pemvidutide-treated subjects was 5.0% and 6.2% at the 1.2 mg and 1.8 mg doses, respectively, versus 1.0% in the placebo arm (p< 0.001, both doses).
Pemvidutide also demonstrated favorable safety and tolerability, with a low overall treatment discontinuation rates and rates of discontinuations due to adverse events were also low at 0.0% and 1.2% in the pemvidutide 1.2 mg and 1.8 mg groups versus 2.4% in the placebo group, an important finding given that no dose titration was used in the trial. There were no serious adverse events related to study medication.
AUD and ALD
On March 13, 2025, we announced that we are pursuing two additional indications for our lead product candidate, pemvidutide. The new indications are Alcohol Use Disorder (“AUD”) and Alcohol-Associated Liver Disease (“ALD”), also known as Alcohol Liver Disease.
AUD is a chronic disease characterized by excessive drinking. In addition to the underlying alcohol misuse by AUD patients, AUD patients have comorbidities that pose significant treatment and management challenges (including liver steatosis, obesity, hypertension and hyperlipidemia). On May 19, 2025, we announced the enrollment of the first subject in the RECLAIM Phase 2 trial evaluating the efficacy and safety of pemvidutide in subjects with AUD. RECLAIM is a randomized, placebo-controlled trial conducted across approximately 15 sites in the United States, targeting enrollment of approximately 100 subjects. Subjects will be randomized 1:1 to receive either 2.4 mg pemvidutide or placebo weekly for 24 weeks. The trial’s primary endpoint is a change in alcohol consumption, measured by the change from baseline in the average number of heavy drinking days per week at Week 24, with the key secondary endpoints including the proportion of subjects achieving a 2-level reduction in World Health Organization (“WHO”) risk drinking level and the absolute change from baseline in average levels of phosphatidylethanol (“PEth”), a serum biomarker of alcohol intake.
ALD is a condition that damages the liver due to excessive and chronic alcohol use. ALD progression (like MASH progression) begins with liver steatosis, which may lead to inflammation, fibrosis and, ultimately, to cirrhosis. On July 9, 2025, we announced the enrollment of the first patient in the RESTORE Phase 2 trial evaluating the efficacy and safety of pemvidutide in subjects with ALD. RESTORE is a randomized, placebo-controlled trial enrolling approximately 100 patients across 34 sites in the United States. Subjects will be randomized 1:1 to receive either 2.4mg pemvidutide or placebo weekly for 48 weeks. The trial’s primary endpoint is the change from baseline in liver stiffness measurement (“LSM”) by Vibration Controlled Transient Elastography (“VCTE”) at Week 24. Key secondary endpoints include the change from baseline in LSM by VCTE at Week 48, changes in Enhanced Liver Fibrosis (“ELF”) score at Weeks 24 and 48, and changes in alcohol consumption and body weight at the same time points.
Recent Global Events
Tariffs
The United States recently imposed reciprocal and additional tariffs on many countries around the world. Such tariffs and counter tariffs by other countries against the U.S. have been causing uncertainties in the global markets. If the tariffs and counter tariffs continue or escalate, they 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, and volatility in the capital markets, foreign exchange rates and interest rates.
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Results of Operations
Comparison of the three months ended June 30, 2025 and 2024
The following table summarizes our results of operations for the three months ended June 30, 2025 and 2024 (in thousands):
Three Months Ended June 30, | ||||||||||||
| 2025 |
| 2024 |
| Increase (Decrease) |
| ||||||
Revenues | $ | 5 | $ | 5 | $ | — |
| — | % | |||
Operating expenses: |
|
|
|
|
|
|
|
| ||||
Research and development |
| 17,236 |
| 21,155 |
| (3,919) |
| (19) | % | |||
General and administrative |
| 5,691 |
| 5,595 |
| 96 |
| 2 | % | |||
Total operating expenses |
| 22,927 |
| 26,750 |
| (3,823) |
| (14) | % | |||
Loss from operations |
| (22,922) |
| (26,745) |
| (3,823) |
| (14) | % | |||
Other income (expense): |
|
|
|
|
|
|
|
| ||||
Interest expense |
| (264) |
| (1) |
| 263 |
| |||||
Interest income |
| 1,132 |
| 2,182 |
| (1,050) |
| (48) | % | |||
Other income (expense), net |
| (92) |
| (76) |
| (16) |
| 21 | % | |||
Total other income (expense), net |
| 776 |
| 2,105 |
| (1,329) |
| (63) | % | |||
Net loss | $ | (22,146) | $ | (24,640) | $ | (2,494) |
| (10) | % |
Revenues
We have not generated any revenues from the sale of any products to date. Our revenue in previous years consisted primarily of government and foundation grants and contracts that supported our efforts on specific research projects.
Research and development expenses
Research and development expenses consisted primarily of expenses related to product candidate development. Research and development expenses decreased by $3.9 million, or 19%, for the three months ended June 30, 2025, as compared to the same period ended June 30, 2024:
Three Months Ended June 30, | ||||||||||||
| 2025 |
| 2024 |
| Increase (Decrease) |
| ||||||
Pemvidutide | ||||||||||||
MASH | $ | 6,469 | $ | 10,175 | $ | (3,706) |
| (36) | % | |||
Alcohol-Associated Liver Disease | 1,538 | — | 1,538 |
| 100 | % | ||||||
Alcohol Use Disorder | 1,096 | — | 1,096 |
| 100 | % | ||||||
Other pemvidutide expenses | 2,058 | 3,587 | (1,529) |
| (43) | % | ||||||
Total pemvidutide expenses | 11,161 | 13,762 | (2,601) | (19) | % | |||||||
HepTcell |
| — | 1,000 | (1,000) |
| 100 | % | |||||
Non-project costs |
| 6,075 | 6,393 | (318) |
| (5) | % | |||||
Total research and development expenses | $ | 17,236 | $ | 21,155 | $ | (3,919) |
| (19) | % |
The decrease in research and development expenses for MASH was primarily due to ongoing enrollment for the IMPACT Phase 2b trial in MASH during the first half of 2024. The decrease in other pemvidutide expenses was primarily due to a $1.6 million decrease in manufacturing expenses. These decreases were partially offset by the increase in expense associated with the start of the AUD and ALD trials.
The decrease in research and development expenses for HepTcell was due to the termination of HepTcell in March 2024.
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General and administrative expenses
General and administrative expenses increased by $0.1 million, or 2%, for the three months ended June 30, 2025, as compared to the three months ended June 30, 2024.
Total other income (expense), net
Total other income (expense), net decreased by $1.3 million, or 63%, for the three months ended June 30, 2025, as compared to the three months ended June 30, 2024. The net decrease was primarily due to a $1.0 million decrease in interest income earned on our cash equivalents and short-term investments and a $0.3 million increase in interest expense related to the Term Loan.
Comparison of the six months ended June 30, 2025 and 2024
The following table summarizes our results of operations for the six months ended June 30, 2025 and 2024 (in thousands):
Six Months Ended June 30, | ||||||||||||
| 2025 |
| 2024 |
| Increase (Decrease) |
| ||||||
Revenues | $ | 10 | $ | 10 | $ | — |
| — | % | |||
Operating expenses: |
|
|
|
|
|
|
| |||||
Research and development |
| 33,063 |
| 42,642 |
| (9,579) |
| (22) | % | |||
General and administrative |
| 11,684 |
| 10,907 |
| 777 |
| 7 | % | |||
Total operating expenses |
| 44,747 |
| 53,549 |
| (8,802) |
| (16) | % | |||
Loss from operations |
| (44,737) |
| (53,539) |
| (8,802) |
| (16) | % | |||
Other income (expense): |
|
|
|
|
|
|
| |||||
Interest expense |
| (265) |
| (2) |
| 263 |
| |||||
Interest income |
| 2,677 |
| 4,595 |
| (1,918) |
| (42) | % | |||
Other income (expense), net |
| (77) |
| (88) |
| 11 |
| (13) | % | |||
Total other income (expense), net |
| 2,335 |
| 4,505 |
| (2,170) |
| (48) | % | |||
Net loss before income taxes | (42,402) | (49,034) | 6,632 |
| (14) | % | ||||||
Income tax expense (benefit) |
| (681) |
| — |
| (681) |
| 100 | % | |||
Net loss | $ | (41,721) | $ | (49,034) | $ | (7,313) |
| (15) | % |
Revenues
We have not generated any revenues from the sale of any products to date. Our revenue in previous years consisted primarily of government and foundation grants and contracts that supported our efforts on specific research projects.
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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 decreased by $9.6 million, or 22%, for the six months ended June 30, 2025, as compared to the same period ended June 30, 2024:
Six Months Ended June 30, | ||||||||||||
| 2025 |
| 2024 |
| Increase (Decrease) |
| ||||||
Pemvidutide | ||||||||||||
MASH | $ | 12,786 | $ | 18,912 | $ | (6,126) | (32) | % | ||||
Alcohol-Associated Liver Disease | 1,596 | — | 1,596 |
| 100 | % | ||||||
Alcohol Use Disorder | 1,412 | — | 1,412 | 100 | % | |||||||
Other pemvidutide expenses | 4,598 | 8,377 | (3,779) | (45) | % | |||||||
Total pemvidutide expenses | 20,392 | 27,289 | (6,897) | (25) | % | |||||||
HepTcell |
| — |
| 2,025 |
| (2,025) |
| (100) | % | |||
Non-project costs |
| 12,671 |
| 13,328 |
| (657) |
| (5) | % | |||
Total research and development expenses | $ | 33,063 | $ | 42,642 | $ | (9,579) |
| (22) | % |
The decrease in research and development expenses for MASH was primarily due to ongoing enrollment for the IMPACT Phase 2b trial in MASH during the first half of 2024. The decrease in other pemvidutide expenses was primarily due to a $3.3 million decrease in manufacturing expenses. These decreases were partially offset by the increase in expense associated with the start of the AUD and ALD trials.
The decrease in research and development expenses for HepTcell was due to the termination of HepTcell in March 2024.
General and administrative expenses
General and administrative expenses increased by $0.8 million, or 7%, for the six months ended June 30, 2025, as compared to the six months ended June 30, 2024, primarily due to a $0.8 million increase in expenses for professional services.
Total other income (expense), net
Total other income (expense), net decreased by $2.2 million, or 48%, for the six months ended June 30, 2025, as compared to the six months ended June 30, 2024. The net decrease was primarily due to a $1.9 million decrease in interest income earned on our cash equivalents and short-term investments and a $0.3 million increase in interest expense related to our Term Loan.
Income tax expense (benefit)
During the six months ended June 30, 2025, we have recorded a discrete tax benefit of approximately $0.7 million related to a portion of carryback claims with the State of Maryland of which we previously held an uncertain tax position against. Other than the discrete tax benefit discussed above, due to a full valuation allowance, the Company did not record an income tax expense (benefit) for either of the six months ended June 30, 2025 and 2024.
Liquidity and Capital Resources
Overview
Our primary sources of cash during the six months ended June 30, 2025 were from equity transactions, interest from our money market funds and short-term investments, and proceeds from maturity of our short-term investments. Our cash, cash equivalents, and restricted cash were $183.1 million as of June 30, 2025. We believe, based on the operating
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cash requirements and capital expenditures expected for 2025 and 2026, our cash on hand as of June 30, 2025, together with expected cash receipts from our R&D incentives, are sufficient to fund operations for at least a twelve-month period from the issuance date of our June 30, 2025 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. We have incurred significant losses since we commenced operations. As of June 30, 2025, we had an accumulated deficit of $603.1 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, and monetization of our existing programs through partnership arrangements or sales to third parties.
Sources of Liquidity
Loan Financing
On May 13, 2025 (“Closing Date”), we entered into a Loan and Security Agreement (“Loan Agreement”) with Hercules Capital, Inc. (“Hercules”) and the lenders party thereto, pursuant to which the lenders will make available up to four tranches of term loans in an aggregate principal amount of $100.0 million (the “Term Loan”), subject to certain terms and conditions. The first Term Loan tranche was made on the Closing Date in an aggregate principal amount of $15.0 million. Upon the achievement of certain milestones and subject to other terms and conditions set out in the Loan Agreement, (i) the second Term Loan tranche will be made available in an aggregate principal amount of up to $25.0 million and (ii) the third Term Loan tranche will be made available in an aggregate principal amount of up to $15.0 million. The fourth Term Loan tranche will be made available in an aggregate principal amount of up to $45.0 million subject to the approval of the lenders. The Term Loan will mature on June 1, 2029 (the “Maturity Date”). The Term Loan bears interest equal to the greater of (a) the prime rate as reported in The Wall Street Journal plus 2.45% and (b) (i) 9.95% until December 31, 2025, and (ii) 9.45% thereafter. We may make interest-only payments for an initial period of up to 24 months from the Closing Date, which may be extended up to 42 months upon achievement of certain milestones and subject to other terms and conditions set out in the Loan Agreement (the “Interest-Only Period”). After the Interest-Only Period, we will be required to repay in equal monthly installments the principal and interest until the Maturity Date.
Shelf Registrations
On February 27, 2025, we filed a shelf registration statement on Form S-3, which was declared effective on March 13, 2025. This shelf registration allows us to offer and sell up to $400.0 million of our common stock, preferred stock, debt securities, warrants, rights and units (the “2025 Shelf”) for a period of 3 years from effectiveness.
On February 28, 2023, we filed a shelf registration statement on Form S-3ASR, which was declared effective immediately. This shelf registration allowed us to offer and sell any amount of our common stock, preferred stock, debt securities, warrants, rights and units (the “2023 Shelf”). The 2023 Shelf expired on February 27, 2025.
At-the-Market Offerings
On February 27, 2025, we entered an Equity Distribution Agreement (the “2025 Agreement”) with Leerink Partners LLC, Piper Sandler & Co. and Stifel, Nicolaus & Company, Incorporated, serving as sales agents, with respect to an at-the-market offerings program under which we offered and sold shares of our common stock having an aggregate offering price of up to $150.0 million through the sale agents from the 2025 Shelf. During the six months ended June 30, 2025, we have sold 8,052,064 shares of common stock under the 2025 Agreement resulting in approximately $42.4 million in net proceeds, and as of June 30, 2025, $106.2 million remained available to be sold under the 2025 Agreement.
On February 28, 2023, we entered 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, with respect to an at-the-market offerings program under which we offered and sold shares of our common stock having an aggregate offering price of up
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to $150.0 million through the sale agents from the 2023 Shelf. During the six months ended June 30, 2025, we have sold 4,467,866 shares of common stock under the 2023 Agreement, resulting in approximately $30.2 million in net proceeds. Since inception through the expiration of the 2023 Agreement in February 2025, we raised approximately $126.8 million in net proceeds through the issuance of 26,129,903 shares of our common stock. As of June 30, 2025, there were no remaining shares available under the 2023 Agreement as the 2023 Agreement was terminated.
Cash Flows
The following table provides information regarding our cash flows for the six months ended June 30, 2025 and 2024:
Six Months Ended June 30, | |||||||||
(in thousands) |
| 2025 |
| 2024 |
| Increase (Decrease) | |||
Net cash (used in) provided by: |
|
|
|
|
|
| |||
Operating activities | $ | (36,190) | $ | (34,465) | $ | 1,725 | |||
Investing activities |
| 96,006 |
| (43,217) |
| 139,223 | |||
Financing activities |
| 86,363 |
| (307) |
| 86,670 | |||
Net increase (decrease) in cash and cash equivalents and restricted cash | $ | 146,179 | $ | (77,989) | $ | 224,168 |
Operating Activities
Net cash used in operating activities was $36.2 million for the six months ended June 30, 2025 compared to $34.5 million during the six months ended June 30, 2024. 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 increase in cash used in operations of $1.7 million year over year is due to changes in working capital accounts of $8.8 million, partially offset by an increase in net loss as adjusted for non-cash items of $7.1 million.
Investing Activities
Net cash provided by investing activities was $96.0 million for the six months ended June 30, 2025 compared to $43.2 million net cash used in investing activities during the six months ended June 30, 2024. The net cash provided by investing activities during the six months ended June 30, 2025 was primarily due to a $143.6 million in proceeds from sale and maturities of short-term investments, partially offset by the purchases of $47.6 million of short-term investments. The net cash used in investing activities during the six months ended June 30, 2024 was primarily due to a $76.7 million purchase of short-term investments, partially offset by a $33.5 million in proceeds from sale and maturities of short-term investments.
Financing Activities
Net cash provided by financing activities was $86.4 million during the six months ended June 30, 2025 compared to $0.3 million cash used in financing activities during the six months ended June 30, 2024. The net cash provided by financing activities during the six months ended June 30, 2025 was primarily the result of the receipt of $72.3 million in net proceeds from the issuance of common stock from our at-the-market offerings program, $14.6 million in net proceeds from the term loan, and $0.2 million in proceeds from the ESPP, partially offset by $0.7 million net payments for tax withholding obligations related to share-based compensation. 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 proceeds from the ESPP and $0.2 million in proceeds from exercise of stock warrants.
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Current Resources
We have financed our operations to date principally through our equity offerings and proceeds from issuances of our common stock. As of June 30, 2025, we had $183.1 million of cash, cash equivalents, and restricted cash. 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, 2025 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, 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, 2024.
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, 2025, 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, 2025 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.
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PART II. OTHER INFORMATION
Item 1. Legal Proceedings
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, which is now captioned In re Altimmune, Inc. Stockholder Derivative Litigation, No. 1:24-cv-669 (D. Del.) (the “Derivative Action”). The complaint is based upon allegations that are similar to those alleged in a class action complaint previously filed against us In re Altimmune, Inc. Securities Litigation, No. 24-cv-01315 (D. Md.) (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, captioned Alaraidah v. Garg, et al., No. 1:24-cv-00772 (D. Del.), 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 and seeks unspecified monetary relief, restitution, costs, and equitable relief. These actions were consolidated for all purposes on July 18, 2024 into the Derivative Action. On February 3, 2025, pursuant to a joint stipulation of the parties, the court ordered that the Derivative Action be dismissed without prejudice and the case was closed.
On August 5, 2025, a class action complaint was filed in federal district court in the District of Maryland, Southern Division, naming as defendants the Company and two of the Company’s executive officers, captioned Collier v. Altimmune, Inc., et al., Case No. 8:25-cv-02581 (D. Md.) (the “Collier Class Action”). The Collier Class Action 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 the Company’s common stock between August 10, 2023 and June 25, 2025, including relating to pemvidutide and our IMPACT Phase 2b trial of pemvidutide in MASH. The plaintiff and class members seek, among other things, 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. We intend to defend vigorously against this litigation.
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.
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 February 27, 2025and the latest Quarterly Report on Form 10-Q filed with the SEC on May 13, 2025.
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.
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Item 6. Exhibits
Exhibit Index | ||
Exhibit No. |
| Description |
3.1 |
| |
3.2 |
| |
3.3 |
| |
3.4 |
| |
10.1 § | ||
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 in accordance with Item 601(b)(10)(iv) of Regulation S-K. |
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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 12, 2025 | By: | /s/ Vipin K. Garg |
Name: | Vipin K. Garg | |
Title: | President and Chief Executive Officer (Principal Executive Officer) | |
Dated: August 12, 2025 | By: | /s/ Gregory Weaver |
Name: | Gregory Weaver | |
Title: | Chief Financial Officer (Principal Financial and Accounting Officer) |
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