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Berger Montague PC Investigating Claims on Behalf of Altimmune, Inc. (NASDAQ: ALT) Investors After Class Action Filing
Prnewswire· 2025-08-12 17:53
Group 1 - A class action lawsuit has been filed against Altimmune Inc. on behalf of investors who acquired its securities between August 10, 2023, and June 25, 2025 [1][2] - The lawsuit follows the announcement of disappointing results from the IMPACT Phase 2b trial of Pemvidutide for treating MASH, where the primary endpoint of fibrosis reduction did not achieve statistical significance [3] - Following the trial results announcement, Altimmune's stock price plummeted by 53.2%, closing at $3.61 on June 26, 2025, down from $7.71 the previous day [4] Group 2 - Altimmune is a clinical-stage biopharmaceutical company based in Gaithersburg, Maryland, focusing on therapeutics for obesity and liver disease, including MASH [2] - The company had previously made positive statements regarding the trial results, which ultimately did not materialize as expected [3]
SHAREHOLDER ACTION REMINDER: Faruqi & Faruqi, LLP Investigates Claims on Behalf of Investors of Altimmune
GlobeNewswire News Room· 2025-08-12 16:44
Core Viewpoint - Faruqi & Faruqi, LLP is investigating potential claims against Altimmune, Inc. following a significant decline in its stock price after the announcement of disappointing trial results for Pemvidutide [4][6][7] Group 1: Legal Investigation - Faruqi & Faruqi is encouraging investors who suffered losses in Altimmune to contact them to discuss legal options [1] - The firm has set an October 6, 2025 deadline for investors to seek the role of lead plaintiff in a federal securities class action against Altimmune [4] - The firm has a history of recovering hundreds of millions of dollars for investors since its founding in 1995 [5] Group 2: Trial Results and Stock Impact - On June 26, 2025, Altimmune announced topline results from the IMPACT Phase 2b MASH trial, which failed to achieve statistical significance in its primary endpoint of fibrosis reduction [6] - Following the announcement, Altimmune's stock price plummeted from $7.71 per share on June 25, 2025, to $3.61 per share on June 26, 2025, marking a decline of 53.2% in one day [7]
Altimmune(ALT) - 2025 Q2 - Quarterly Report
2025-08-12 14:15
[PART I. FINANCIAL INFORMATION](index=4&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) The company presents its unaudited consolidated financial statements, detailing significant changes in assets, liabilities, equity, and cash flows [Consolidated Balance Sheets](index=4&type=section&id=Consolidated%20Balance%20Sheets%20as%20of%20June%2030%2C%202025%20(unaudited)%20and%20December%2031%2C%202024) **Consolidated Balance Sheet Highlights (in thousands):** | Metric | June 30, 2025 | December 31, 2024 | Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Cash and cash equivalents | $183,105 | $36,926 | $146,179 | 396% | | Short-term investments | $— | $94,965 | $(94,965) | (100)% | | Total current assets | $188,422 | $137,254 | $51,168 | 37% | | Total assets | $190,350 | $139,306 | $51,044 | 37% | | Total current liabilities | $9,220 | $10,468 | $(1,248) | (12)% | | Term loan, noncurrent | $14,332 | $— | $14,332 | N/A | | Total liabilities | $28,983 | $15,798 | $13,185 | 83% | | Total stockholders' equity | $161,367 | $123,508 | $37,859 | 31% | [Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss%20for%20the%20three%20and%20six%20months%20ended%20June%2030%2C%202025%20and%202024%20(unaudited)) **Consolidated Statements of Operations and Comprehensive Loss Highlights (in thousands):** | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Revenues | $5 | $5 | $10 | $10 | | Research and development expenses | $17,236 | $21,155 | $33,063 | $42,642 | | General and administrative expenses | $5,691 | $5,595 | $11,684 | $10,907 | | Loss from operations | $(22,922) | $(26,745) | $(44,737) | $(53,539) | | Total other income (expense), net | $776 | $2,105 | $2,335 | $4,505 | | Net loss | $(22,146) | $(24,640) | $(41,721) | $(49,034) | | Net loss per share, basic and diluted | $(0.27) | $(0.35) | $(0.53) | $(0.69) | - Net loss **decreased by 10%** for the three months ended June 30, 2025, and by **15%** for the six months ended June 30, 2025, compared to the respective prior-year periods[10](index=10&type=chunk) - Research and development expenses **decreased by 19%** for the three months and **22%** for the six months ended June 30, 2025, primarily due to reduced MASH trial enrollment and manufacturing costs[10](index=10&type=chunk) [Consolidated Statements of Changes in Stockholders' Equity](index=6&type=section&id=Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity%20for%20the%20three%20and%20six%20months%20ended%20June%2030%2C%202025%20and%202024%20(unaudited)) **Changes in Stockholders' Equity (in thousands) for Six Months Ended June 30, 2025:** | Item | Amount | | :--- | :--- | | Balance at December 31, 2024 | $123,508 | | Stock-based compensation | $7,581 | | Issuance of common stock in at-the-market offerings, net | $72,571 | | Net loss | $(41,721) | | **Balance at June 30, 2025** | **$161,367** | - Total stockholders' equity **increased from $123.5 million** at December 31, 2024, to **$161.4 million** at June 30, 2025, primarily driven by proceeds from at-the-market offerings and stock-based compensation, partially offset by net loss[12](index=12&type=chunk) [Consolidated Statements of Cash Flows](index=8&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows%20for%20the%20six%20months%20ended%20June%2030%2C%202025%20and%202024%20(unaudited)) **Consolidated Statements of Cash Flows Highlights (in thousands) for Six Months Ended June 30:** | Activity | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | Net cash used in operating activities | $(36,190) | $(34,465) | $(1,725) | | Net cash provided by (used in) investing activities | $96,006 | $(43,217) | $139,223 | | Net cash provided by (used in) financing activities | $86,363 | $(307) | $86,670 | | Net increase (decrease) in cash and cash equivalents and restricted cash | $146,179 | $(77,989) | $224,168 | | Cash, cash equivalents and restricted cash at end of period | $183,147 | $57,169 | $125,978 | - Significant shift in investing activities from cash usage to provision, primarily due to proceeds from sales and maturities of short-term investments (**$143.6 million in 2025** vs $33.5 million in 2024)[17](index=17&type=chunk) - Financing activities provided substantial cash in 2025 (**$86.4 million**) due to at-the-market offerings (**$72.6 million**) and a new term loan (**$15.0 million**)[17](index=17&type=chunk) [1. Nature of Business and Basis of Presentation](index=9&type=section&id=1.%20Nature%20of%20Business%20and%20Basis%20of%20Presentation) - Altimmune, Inc. is a late clinical-stage biopharmaceutical company focused on developing novel peptide-based therapeutics for liver and cardiometabolic diseases[18](index=18&type=chunk)[19](index=19&type=chunk) - The company's lead program is pemvidutide, a GLP-1/glucagon dual receptor agonist, for the treatment of MASH, Alcohol Use Disorder (AUD), Alcohol-Associated Liver Disease (ALD), and obesity[19](index=19&type=chunk) - Altimmune has not generated any revenues from product sales to date and finances operations through equity, debt, and research grants[19](index=19&type=chunk) [2. Summary of Significant Accounting Policies](index=9&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) - No significant changes to the company's accounting policies during the six months ended June 30, 2025, compared to the Annual Report on Form 10-K for December 31, 2024[23](index=23&type=chunk) - A discrete tax benefit of approximately **$0.7 million** was recorded during the six months ended June 30, 2025, related to Maryland carryback claims[25](index=25&type=chunk) - The recently enacted One Big Beautiful Bill Act (OBBBA) is being assessed but is not expected to materially impact the estimated annual effective tax rate in 2025[26](index=26&type=chunk) [3. Fair Value Measurements](index=11&type=section&id=3.%20Fair%20Value%20Measurements) - As of June 30, 2025, the company had **no assets and liabilities measured at fair value** on a recurring basis, a change from December 31, 2024[28](index=28&type=chunk) - Recognized approximately **$0.1 million realized net loss** from sales of available-for-sale debt securities during the six months ended June 30, 2025[28](index=28&type=chunk) **Fair Value Measurement at December 31, 2024 (in thousands):** | Category | Total | Level 1 | Level 2 | Level 3 | | :--- | :--- | :--- | :--- | :--- | | Cash equivalents - money market funds | $27,279 | $27,279 | $— | $— | | Short-term investments | $94,965 | $— | $94,965 | $— | | **Total** | **$122,244** | **$27,279** | **$94,965** | **$—** | [4. Accrued Expenses](index=13&type=section&id=4.%20Accrued%20Expenses) **Accrued Expenses and Other Current Liabilities (in thousands):** | Category | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Accrued professional services | $695 | $401 | | Accrued payroll and employee benefits | $1,828 | $3,079 | | Accrued research and development | $5,424 | $6,443 | | Lease obligation, current portion | $239 | $279 | | Accrued interest and other | $183 | $55 | | **Total** | **$8,369** | **$10,257** | - Total accrued expenses and other current liabilities **decreased by $1.9 million, or 18%**, from December 31, 2024, to June 30, 2025, primarily due to decreases in accrued payroll and R&D[35](index=35&type=chunk) [5. Term Loan](index=13&type=section&id=5.%20Term%20Loan) - On May 13, 2025, the company entered into a Loan and Security Agreement with Hercules Capital, Inc. for up to **$100.0 million** in term loans[36](index=36&type=chunk) - The first tranche of **$15.0 million** was drawn on the closing date; additional tranches are subject to milestones and lender approval[37](index=37&type=chunk)[39](index=39&type=chunk) - The Term Loan matures on January 1, 2029, bears interest at a rate based on prime plus 2.45% (or a floor of 9.95% until Dec 31, 2025, then 9.45%), and has an **effective interest rate of 14.4%**[40](index=40&type=chunk)[44](index=44&type=chunk) **Term Loan Details (in thousands) as of June 30, 2025:** | Item | Amount | | :--- | :--- | | Term loan principal amount | $15,000 | | End of term charge | $937 | | Unamortized discount and issuance costs | $(1,605) | | **Total term loan, net of current portion** | **$14,332** | [6. Other Noncurrent Liabilities](index=17&type=section&id=6.%20Other%20Noncurrent%20Liabilities) **Other Noncurrent Liabilities (in thousands):** | Category | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Research and development incentive credit | $3,981 | $3,746 | | Lease obligation, long-term portion | $1,278 | $1,402 | | Conditional economic incentive grants | $160 | $160 | | Other | $12 | $22 | | **Total** | **$5,431** | **$5,330** | - Total other noncurrent liabilities **increased slightly by $0.1 million, or 2%**, from December 31, 2024, to June 30, 2025, primarily due to an increase in research and development incentive credit[47](index=47&type=chunk) [7. Stockholders' Equity](index=17&type=section&id=7.%20Stockholders'%20Equity) - As of June 30, 2025, the company had **85,076,300 shares of common stock issued and outstanding**, out of 200,000,000 authorized shares[48](index=48&type=chunk) - During the six months ended June 30, 2025, the company sold 8,052,064 shares under the 2025 at-the-market (ATM) offering, generating approximately **$42.4 million in net proceeds**[50](index=50&type=chunk) - An additional **$106.2 million remained available** to be sold under the 2025 ATM Agreement as of June 30, 2025[50](index=50&type=chunk) - The 2023 ATM Agreement was terminated in February 2025, having sold 4,467,866 shares for approximately **$30.2 million in net proceeds** during the six months ended June 30, 2025[51](index=51&type=chunk) [8. Stock-Based Compensation](index=19&type=section&id=8.%20Stock-Based%20Compensation) - On January 1, 2025, the Omnibus Incentive Plan **increased by 3,193,659 shares** of common stock[52](index=52&type=chunk) - During the six months ended June 30, 2025, the company granted **1,954,950 stock options** and **481,700 Restricted Stock Units (RSUs)**[53](index=53&type=chunk)[55](index=55&type=chunk) **Stock-based Compensation Expense (in thousands) for Six Months Ended June 30:** | Category | 2025 | 2024 | | :--- | :--- | :--- | | Research and development | $3,329 | $3,249 | | General and administrative | $4,252 | $4,712 | | **Total** | **$7,581** | **$7,961** | [9. Net Loss Per Share](index=21&type=section&id=9.%20Net%20Loss%20Per%20Share) - Basic and diluted net loss per share are the same for the three and six months ended June 30, 2025 and 2024, due to the company reporting a net loss[58](index=58&type=chunk) - All unvested RSUs and stock options are excluded from the computation of diluted weighted-average shares outstanding as they are anti-dilutive[59](index=59&type=chunk) **Anti-Dilutive Potential Common Shares (Six Months Ended June 30):** | Security Type | 2025 | 2024 | | :--- | :--- | :--- | | Common stock options | 8,128,505 | 6,328,463 | | Restricted stock units | 1,039,950 | 786,102 | [10. Commitments and Contingencies](index=21&type=section&id=10.%20Commitments%20and%20Contingencies) - The company has contingent payment obligations of up to **$80.0 million** related to the Spitfire acquisition upon achievement of specified worldwide net sales milestones[61](index=61&type=chunk) - A shareholder derivative complaint filed in June 2024 was **dismissed without prejudice** on February 3, 2025[63](index=63&type=chunk) - A new class action complaint was filed on August 5, 2025, alleging securities law violations related to pemvidutide and the IMPACT Phase 2b trial, which the company intends to vigorously defend[64](index=64&type=chunk) [11. Segment Information](index=22&type=section&id=11.%20Segment%20Information) - The company operates as a **single segment**, a late clinical-stage biopharmaceutical company focused on developing novel peptide-based therapeutics[66](index=66&type=chunk) - The chief operating decision maker assesses performance and allocates resources based solely on consolidated net loss[67](index=67&type=chunk) [12. Subsequent Events](index=24&type=section&id=12.%20Subsequent%20Events) - During July 2025 and through the issuance date of the financial statements, the company raised an additional **$12.8 million in net proceeds** by issuing 3,141,233 shares of common stock through its 2025 at-the-market offering[68](index=68&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial performance, liquidity, capital resources, and recent business updates including positive MASH trial results [Overview](index=25&type=section&id=Overview) - Altimmune, Inc. is a late clinical-stage biopharmaceutical company focused on developing novel peptide-based therapeutics for liver and cardiometabolic diseases[73](index=73&type=chunk) - The lead program, pemvidutide, is a GLP-1/glucagon dual receptor agonist for MASH, Alcohol Use Disorder (AUD), Alcohol-Associated Liver Disease (ALD), and obesity[73](index=73&type=chunk) [Recent Business Update](index=25&type=section&id=Recent%20Business%20Update) [MASH](index=25&type=section&id=MASH) - On June 26, 2025, topline results from the IMPACT Phase 2b trial in MASH were released, showing **statistically significant MASH resolution** without worsening of fibrosis[74](index=74&type=chunk)[75](index=75&type=chunk) **MASH Resolution without Worsening Fibrosis (24 weeks, ITT analysis):** | Pemvidutide Dose | MASH Resolution Rate | Placebo Rate | p-value | | :--- | :--- | :--- | :--- | | 1.2 mg | 59.1% | 19.1% | < 0.0001 | | 1.8 mg | 52.1% | 19.1% | < 0.0001 | - An AI-based analysis demonstrated statistically significant reductions in fibrosis, with **30.6% of subjects** on pemvidutide 1.8 mg achieving a 60% or more reduction compared to 8.2% on placebo (p<0.001)[76](index=76&type=chunk) **Mean Weight Loss (24 weeks):** | Pemvidutide Dose | Mean Weight Loss | Placebo Weight Loss | p-value | | :--- | :--- | :--- | :--- | | 1.2 mg | 5.0% | 1.0% | < 0.001 | | 1.8 mg | 6.2% | 1.0% | < 0.001 | - Pemvidutide demonstrated favorable safety and tolerability with **low overall treatment discontinuation rates** (0.0% for 1.2 mg and 1.2% for 1.8 mg due to adverse events, versus 2.4% for placebo)[78](index=78&type=chunk) [AUD and ALD](index=27&type=section&id=AUD%20and%20ALD) - The company is pursuing two additional indications for pemvidutide: Alcohol Use Disorder (AUD) and Alcohol-Associated Liver Disease (ALD)[79](index=79&type=chunk) - The RECLAIM Phase 2 trial for AUD enrolled its first subject on May 19, 2025, targeting 100 subjects to evaluate changes in alcohol consumption[80](index=80&type=chunk) - The RESTORE Phase 2 trial for ALD enrolled its first patient on July 9, 2025, targeting 100 patients to evaluate changes in liver stiffness[81](index=81&type=chunk) [Recent Global Events](index=27&type=section&id=Recent%20Global%20Events) - Global tariffs and counter-tariffs are causing uncertainties in global markets, potentially leading to inflationary pressures, supply chain disruptions, and volatility in capital markets, foreign exchange rates, and interest rates[82](index=82&type=chunk) [Results of Operations](index=28&type=section&id=Results%20of%20Operations) [Comparison of the three months ended June 30, 2025 and 2024](index=28&type=section&id=Comparison%20of%20the%20three%20months%20ended%20June%2030%2C%202025%20and%202024) **Results of Operations (Three Months Ended June 30, in thousands):** | Metric | 2025 | 2024 | Increase (Decrease) | % Change | | :--- | :--- | :--- | :--- | :--- | | Revenues | $5 | $5 | $— | 0% | | Research and development | $17,236 | $21,155 | $(3,919) | (19)% | | General and administrative | $5,691 | $5,595 | $96 | 2% | | Loss from operations | $(22,922) | $(26,745) | $(3,823) | (14)% | | Total other income (expense), net | $776 | $2,105 | $(1,329) | (63)% | | Net loss | $(22,146) | $(24,640) | $(2,494) | (10)% | - The decrease in R&D expenses was primarily due to ongoing enrollment for the IMPACT Phase 2b trial in MASH during the first half of 2024 and a **$1.6 million decrease in manufacturing expenses**, partially offset by new AUD and ALD trials[85](index=85&type=chunk) - Total other income (expense), net **decreased by $1.3 million**, primarily due to a $1.0 million decrease in interest income and a $0.3 million increase in interest expense related to the Term Loan[88](index=88&type=chunk) [Comparison of the six months ended June 30, 2025 and 2024](index=30&type=section&id=Comparison%20of%20the%20six%20months%20ended%20June%2030%2C%202025%20and%202024) **Results of Operations (Six Months Ended June 30, in thousands):** | Metric | 2025 | 2024 | Increase (Decrease) | % Change | | :--- | :--- | :--- | :--- | :--- | | Revenues | $10 | $10 | $— | 0% | | Research and development | $33,063 | $42,642 | $(9,579) | (22)% | | General and administrative | $11,684 | $10,907 | $777 | 7% | | Loss from operations | $(44,737) | $(53,539) | $(8,802) | (16)% | | Total other income (expense), net | $2,335 | $4,505 | $(2,170) | (48)% | | Net loss | $(41,721) | $(49,034) | $(7,313) | (15)% | - The **$9.6 million decrease in R&D expenses** was primarily due to reduced MASH trial enrollment costs ($6.1 million), a $3.3 million decrease in manufacturing expenses, and the termination of the HepTcell program ($2.0 million), partially offset by increased expenses for AUD and ALD trials ($3.0 million)[92](index=92&type=chunk)[93](index=93&type=chunk) - General and administrative expenses **increased by $0.8 million, or 7%**, primarily due to higher professional services[94](index=94&type=chunk) - Total other income (expense), net **decreased by $2.2 million**, primarily due to a $1.9 million decrease in interest income and a $0.3 million increase in interest expense from the Term Loan[95](index=95&type=chunk) [Liquidity and Capital Resources](index=33&type=section&id=Liquidity%20and%20Capital%20Resources) [Overview](index=33&type=section&id=Overview) - As of June 30, 2025, cash, cash equivalents, and restricted cash totaled **$183.1 million**[97](index=97&type=chunk) - Management believes current cash on hand is **sufficient to fund operations for at least a twelve-month period** from the issuance date of the financial statements[98](index=98&type=chunk) - The company has an **accumulated deficit of $603.1 million** as of June 30, 2025, and will require additional equity or debt financing or partnerships for long-term capital needs[99](index=99&type=chunk) [Sources of Liquidity](index=33&type=section&id=Sources%20of%20Liquidity) - Secured a new term loan facility of up to **$100.0 million** with Hercules Capital, Inc., with **$15.0 million drawn** on May 13, 2025[100](index=100&type=chunk) - Filed a shelf registration statement on Form S-3 on February 27, 2025, allowing the company to offer and sell up to **$400.0 million** in various securities[101](index=101&type=chunk) - Raised approximately **$42.4 million in net proceeds** from the 2025 at-the-market (ATM) offering during the six months ended June 30, 2025, with **$106.2 million remaining available**[103](index=103&type=chunk) - Raised approximately **$30.2 million in net proceeds** from the 2023 ATM offering during the six months ended June 30, 2025, before its termination in February 2025[105](index=105&type=chunk) [Cash Flows](index=35&type=section&id=Cash%20Flows) **Cash Flow Summary (Six Months Ended June 30, in thousands):** | Activity | 2025 | 2024 | Increase (Decrease) | | :--- | :--- | :--- | :--- | | Net cash used in operating activities | $(36,190) | $(34,465) | $1,725 | | Net cash provided by (used in) investing activities | $96,006 | $(43,217) | $139,223 | | Net cash provided by (used in) financing activities | $86,363 | $(307) | $86,670 | | **Net increase (decrease) in cash** | **$146,179** | **$(77,989)** | **$224,168** | - Net cash provided by investing activities **significantly increased to $96.0 million** in 2025 from $43.2 million used in 2024, primarily due to proceeds from sales and maturities of short-term investments[108](index=108&type=chunk) - Net cash provided by financing activities **increased to $86.4 million** in 2025 from $0.3 million used in 2024, driven by ATM offerings and the new term loan[109](index=109&type=chunk) [Current Resources](index=37&type=section&id=Current%20Resources) - As of June 30, 2025, the company had **$183.1 million in cash, cash equivalents, and restricted cash**, deemed sufficient for operations for at least the next twelve months[110](index=110&type=chunk) - Long-term capital needs for planned clinical trials will require additional equity or debt financing, or monetization through partnerships[110](index=110&type=chunk) [Critical Accounting Estimates](index=37&type=section&id=Critical%20Accounting%20Estimates) - No material changes to critical accounting policies and significant judgments and estimates were reported compared to the Annual Report on Form 10-K for the year ended December 31, 2024[112](index=112&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=37&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a "smaller reporting company," Altimmune, Inc. is not required to provide these disclosures - The company is exempt from providing market risk disclosures as a "smaller reporting company" under Item 10 of Regulation S-K[113](index=113&type=chunk) [Item 4. Controls and Procedures](index=37&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective, with no material changes in internal control over financial reporting - Management, including the principal executive and financial officers, concluded that **disclosure controls and procedures were effective** as of June 30, 2025[114](index=114&type=chunk)[115](index=115&type=chunk) - There were **no changes in internal control over financial reporting** during the quarter ended June 30, 2025, that materially affected or are reasonably likely to materially affect internal control over financial reporting[116](index=116&type=chunk) [PART II. OTHER INFORMATION](index=38&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=38&type=section&id=Item%201.%20Legal%20Proceedings) A new class action complaint was filed on August 5, 2025, alleging securities law violations, which the company will vigorously defend - A shareholder derivative complaint (In re Altimmune, Inc. Stockholder Derivative Litigation) was **dismissed without prejudice** on February 3, 2025[117](index=117&type=chunk) - A new class action complaint (Collier v. Altimmune, Inc., et al.) was filed on August 5, 2025, alleging violations of the Securities Exchange Act of 1934 related to pemvidutide and the IMPACT Phase 2b trial[118](index=118&type=chunk) - The company intends to **vigorously defend** against the Collier Class Action litigation[118](index=118&type=chunk) [Item 1A. Risk Factors](index=38&type=section&id=Item%201A.%20Risk%20Factors) There have been no material changes to the risk factors previously disclosed in the company's Annual and Quarterly Reports - **No material changes** from the risk factors disclosed in the Annual Report on Form 10-K filed on February 27, 2025, and the latest Quarterly Report on Form 10-Q filed on May 13, 2025[120](index=120&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=38&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities or use of proceeds for the period - No unregistered sales of equity securities and use of proceeds to report[121](index=121&type=chunk) [Item 3. Defaults Upon Senior Securities](index=38&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities for the period - No defaults upon senior securities to report[122](index=122&type=chunk) [Item 4. Mine Safety Disclosures](index=38&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to Altimmune, Inc.'s operations - Not applicable to the company[123](index=123&type=chunk) [Item 5. Other Information](index=40&type=section&id=Item%205.%20Other%20Information) No officers or directors adopted, modified, or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the quarter - No officers or directors adopted, modified, or terminated a "Rule 10b5-1 trading arrangement" or "non-Rule 10b5-1 trading arrangement" during the three months ended June 30, 2025[124](index=124&type=chunk) [Item 6. Exhibits](index=41&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including corporate governance and financing agreement documents - Includes Amended and Restated Certificate of Incorporation, Loan and Security Agreement, and certifications of principal executive and financial officers[126](index=126&type=chunk) [Signatures](index=42&type=section&id=Signatures) The report was duly signed on August 12, 2025, by the President and Chief Executive Officer and the Chief Financial Officer - Report signed by Vipin K. Garg, President and Chief Executive Officer, and Gregory Weaver, Chief Financial Officer, on August 12, 2025[131](index=131&type=chunk)
Altimmune(ALT) - 2025 Q2 - Earnings Call Transcript
2025-08-12 13:30
Altimmune (ALT) Q2 2025 Earnings Call August 12, 2025 08:30 AM ET Speaker0Good morning, ladies and gentlemen, and welcome to the Altimmune Second Quarter twenty twenty five Financial Results Conference Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. A reminder, this call is being recorded. I'll now introduce your host for today's conference call, Lee Roth, President of Burns McClellan, Investor Relations Adviser t ...
Altimmune(ALT) - 2025 Q2 - Quarterly Results
2025-08-12 11:10
Exhibit 99.1 New data from the IMPACT trial demonstrates potentially class-leading improvements in corrected T1 (cT1), an important marker of liver inflammation and fibrosis End-of-Phase 2 Meeting with FDA expected in Q4 2025 Cash, cash equivalents and short-term investments of $183.1 million as of June 30, 2025 Webcast to be held today, August 12, 2025, at 8:30 a.m. ET Altimmune Announces Second Quarter 2025 Financial Results and Business Update Positive data from the IMPACT Phase 2b trial reinforces the p ...
Altimmune Announces Second Quarter 2025 Financial Results and Business Update
Globenewswire· 2025-08-12 11:00
Core Insights - Altimmune, Inc. announced positive results from the IMPACT Phase 2b trial for pemvidutide, indicating its potential as a differentiated therapy for Metabolic Dysfunction-Associated Steatohepatitis (MASH) with statistically significant MASH resolution and weight loss at 24 weeks [1][3][11] - The company is preparing for an End-of-Phase 2 Meeting with the FDA, expected in Q4 2025, to discuss the next steps for pemvidutide's development [5][11] - Financial results show a cash position of $183.1 million as of June 30, 2025, reflecting a 39% increase from the previous year [4][8] Clinical Trial Results - The IMPACT Phase 2b trial reported that up to 59.1% of patients receiving pemvidutide experienced statistically significant MASH resolution without worsening fibrosis [4] - Improvements in corrected T1 (cT1), a marker of liver inflammation and fibrosis, were observed, with mean decreases of 145.0 ms and 147.9 ms in the pemvidutide 1.2 mg and 1.8 mg groups, respectively, compared to a decrease of 27.5 ms in the placebo group [4][11] - Statistically significant weight loss of up to 6.2% was recorded at 24 weeks, with a trajectory indicating continued weight loss [4][11] Financial Overview - For the second quarter ended June 30, 2025, Altimmune reported a net loss of $22.1 million, or $0.27 per share, an improvement from a net loss of $24.6 million, or $0.35 per share, in the same period in 2024 [8][17] - Research and development expenses decreased to $17.2 million from $21.2 million year-over-year, attributed to the timing of clinical trial costs [8][17] - General and administrative expenses remained stable at approximately $5.7 million [8][17] Future Developments - The company plans to report full 48-week data from the IMPACT trial in Q4 2025, which will provide further insights into the long-term efficacy and safety of pemvidutide [3][4] - Altimmune has initiated two additional Phase 2 trials: RECLAIM for Alcohol Use Disorder (AUD) and RESTORE for Alcohol-Associated Liver Disease (ALD), both expected to enroll around 100 subjects [9][11]
ALTIMMUNE ALERT: Bragar Eagel & Squire, P.C. Announces that a Class Action Lawsuit Has Been Filed Against Altimmune, Inc. and Encourages Investors to Contact the Firm
GlobeNewswire News Room· 2025-08-11 23:10
Core Viewpoint - A class action lawsuit has been filed against Altimmune, Inc. for allegedly misleading investors regarding the results of its IMPACT Phase 2b MASH trial, leading to significant stock price decline [1][3]. Group 1: Lawsuit Details - The lawsuit is on behalf of all individuals and entities who purchased Altimmune securities between August 10, 2023, and June 25, 2025, with a deadline of October 6, 2025, for investors to apply as lead plaintiffs [1]. - The complaint highlights that Altimmune's announcement on June 26, 2025, revealed a failure to achieve statistical significance in the primary endpoint of fibrosis reduction in the trial, despite prior inflated expectations [3]. Group 2: Stock Price Impact - Following the announcement of the trial results, Altimmune's stock price plummeted from $7.71 per share on June 25, 2025, to $3.61 per share on June 26, 2025, marking a dramatic decline of 53.2% in just one day [4].
Altimmune, Inc. Sued for Securities Law Violations – Investors Should Contact Levi & Korsinsky for More Information – ALT
GlobeNewswire News Room· 2025-08-11 20:26
Core Viewpoint - Altimmune, Inc. is facing a class action securities lawsuit due to alleged securities fraud that affected investors between August 10, 2023, and June 25, 2025 [1] Group 1: Lawsuit Details - The lawsuit was initiated following Altimmune's announcement on June 26, 2025, regarding the topline results from the IMPACT Phase 2b MASH trial of Pemvidutide, which failed to achieve statistical significance in its primary endpoint of fibrosis reduction [2] - The company's stock price plummeted from $7.71 per share on June 25, 2025, to $3.61 per share on June 26, 2025, marking a significant decline of 53.2% in just one day [2] Group 2: Next Steps for Investors - Investors who suffered losses during the specified timeframe have until October 6, 2025, to request appointment as lead plaintiff, although participation in any recovery does not require serving as a lead plaintiff [3] - Class members may be entitled to compensation without incurring any out-of-pocket costs or fees [3] Group 3: Firm Background - Levi & Korsinsky, LLP has a strong track record in securities litigation, having secured hundreds of millions of dollars for shareholders over the past 20 years [4] - The firm has been recognized in ISS Securities Class Action Services' Top 50 Report for seven consecutive years as one of the leading securities litigation firms in the United States [4]
Shareholders of Altimmune, Inc. Should Contact The Gross Law Firm Before October 6, 2025 to Discuss Your Rights - ALT
Prnewswire· 2025-08-11 12:45
NEXT STEPS FOR SHAREHOLDERS: Once you register as a shareholder who purchased shares of ALT during the timeframe listed above, you will be enrolled in a portfolio monitoring software to provide you with status updates throughout the lifecycle of the case. The deadline to seek to be a lead plaintiff is October 6, 2025. There is no cost or obligation to you to participate in this case. Shareholders who purchased shares of ALT during the class period listed are encouraged to contact the firm regarding possible ...
Altimmune Board of Directors Appoints Jerry Durso as Chairman
Globenewswire· 2025-08-11 11:30
Core Viewpoint - Altimmune, Inc. has appointed Jerry Durso as Chairman of the Board, succeeding Mitchel Sayare, as the company prepares for Phase 3 development of pemvidutide in metabolic dysfunction-associated steatohepatitis (MASH) [1][2][3] Group 1: Leadership Transition - The leadership change is part of the Board's succession planning and aligns with the company's advancement into Phase 3 development of pemvidutide [2] - Jerry Durso has over 30 years of leadership experience in the life sciences industry, with expertise in corporate and commercial strategy [3] - Mitchel Sayare will continue to serve on the Board as an Independent Director after his tenure as Chairman [1][3] Group 2: Pemvidutide Development - Altimmune's lead program, pemvidutide, is a GLP-1/glucagon dual receptor agonist aimed at treating MASH, Alcohol Use Disorder (AUD), Alcohol-Associated Liver Disease (ALD), and obesity [4] - The company expects to hold an End-of-Phase 2 Meeting with the FDA for MASH in the fourth quarter of 2025 [2] Group 3: Company Background - Altimmune is a late clinical-stage biopharmaceutical company focused on developing novel peptide-based therapeutics for liver and cardiometabolic diseases [4]