Financial Data and Key Metrics Changes - The company is preparing for a significant data readout for its NASH drug candidate, pemidutide, expected by the end of the current quarter, which is crucial for future development plans [27][20]. - The highest dose in the MOMENTUM trial showed a weight loss of 15.6% at 48 weeks, indicating strong efficacy compared to competitors [30]. Business Line Data and Key Metrics Changes - The company is focusing on the dual mechanism of action of pemidutide, which combines weight loss with direct effects on liver health, positioning it uniquely in the market [15][18]. - The upcoming Phase 2b trial for NASH is designed to control placebo responses, which have been problematic in previous trials, aiming for a more accurate assessment of drug efficacy [12][14]. Market Data and Key Metrics Changes - NASH is now the leading cause of liver transplantation in the U.S., with a growing prevalence linked to the obesity epidemic, highlighting a significant unmet medical need [10][11]. - The company is expanding its pipeline to include Alcohol Use Disorder (AUD) and Alcoholic Liver Disease (ALD), both of which have critical unmet needs and overlap with obesity-related conditions [38][42]. Company Strategy and Development Direction - The company aims to treat serious conditions resulting from obesity rather than pursuing a pure obesity indication, which is becoming increasingly competitive and price-sensitive [36][39]. - The strategy includes leveraging a large safety database from previous trials to support the development of AUD and ALD treatments, enhancing the overall market opportunity [43][41]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming data readout and the potential for a Phase III program to start in early 2026, contingent on positive results [20][40]. - The company believes that the combination of metabolic and liver health benefits will allow it to cover a broad spectrum of patients with NASH and related conditions, improving treatment options [60][61]. Other Important Information - The company has noted that the weight loss profile of pemidutide is expected to be comparable to semaglutide at 48 weeks, with potential for even greater efficacy beyond that timeframe [24][25]. - The design of the IMPACT trial includes unique features aimed at controlling placebo responses, which could lead to more reliable results [12][14]. Q&A Session Summary Question: Can you tell us about the unmet need in NASH? - Management highlighted that there is only one approved drug for NASH with modest effects, and the condition is increasingly prevalent due to obesity, creating a significant need for more effective treatments [10][11]. Question: What are the expectations around the upcoming Phase 2b trial? - The company plans to have its end of Phase 2 meeting after the 24-week readout, focusing on the primary endpoint of biopsy results at that time [20][21]. Question: How does the company view the competitive landscape for obesity treatments? - Management indicated that the obesity market is changing, and the company is focusing on serious diseases related to obesity rather than solely on obesity itself, which is becoming a price-sensitive market [36][39]. Question: What are the key differentiators of pemidutide compared to other treatments? - The company believes that pemidutide's dual action of promoting weight loss while directly affecting liver health sets it apart from other drugs in development [15][18]. Question: What is the timeline for the AUD and ALD studies? - The AUD study has just started, and initial data readouts are expected by the end of next year, with the ALD study anticipated to begin in the third quarter [45][41].

Core Insights - Altimmune, Inc. has initiated the RECLAIM Phase 2 trial for pemvidutide, targeting Alcohol Use Disorder (AUD) [1][2] - Pemvidutide is a dual receptor agonist aimed at treating metabolic dysfunction-associated steatohepatitis (MASH), obesity, AUD, and alcohol liver disease (ALD) [1][4] - The trial will enroll approximately 100 subjects and assess changes in alcohol consumption and related biomarkers [2][3] Company Overview - Altimmune is a late clinical-stage biopharmaceutical company focused on peptide-based therapeutics for liver and cardiometabolic diseases [4] - The lead program, pemvidutide, is designed to address multiple conditions including MASH, obesity, AUD, and ALD [4] Industry Context - Over 28 million individuals in the U.S. are affected by AUD, with less than 10% currently receiving treatment [3] - Existing medications for AUD have limited effects and compliance rates, highlighting the need for new therapies [3] - Pemvidutide has shown promising preclinical results, significantly reducing alcohol preference in animal models [3]

PART I. FINANCIAL INFORMATION [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) This section presents Altimmune, Inc.'s unaudited consolidated financial statements for Q1 2025 and 2024, covering balance sheets, operations, equity changes, cash flows, and detailed notes on business and accounting policies [Consolidated Balance Sheets](index=4&type=section&id=Consolidated%20Balance%20Sheets) Consolidated Balance Sheet Highlights (in thousands) | Item | March 31, 2025 | December 31, 2024 | Change (QoQ) | | :-------------------------------- | :------------- | :---------------- | :------------- | | Total current assets | $155,262 | $137,254 | +$18,008 | | Total assets | $157,263 | $139,306 | +$17,957 | | Total current liabilities | $9,798 | $10,468 | -$670 | | Total liabilities | $15,101 | $15,798 | -$697 | | Total stockholders' equity | $142,162 | $123,508 | +$18,654 | - Total assets increased by **$17.96 million**, primarily driven by an increase in cash and cash equivalents and short-term investments[8](index=8&type=chunk) - Total stockholders' equity increased by **$18.65 million**, mainly due to additional paid-in capital from at-the-market offerings[8](index=8&type=chunk) [Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Consolidated Statements of Operations and Comprehensive Loss Highlights (in thousands) | Item | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | Change (YoY) | | :------------------------------------ | :-------------------------------- | :-------------------------------- | :------------- | | Revenues | $5 | $5 | $0 | | Research and development expenses | $15,827 | $21,487 | -$5,660 | | General and administrative expenses | $5,993 | $5,312 | +$681 | | Total operating expenses | $21,820 | $26,799 | -$4,979 | | Loss from operations | $(21,815) | $(26,794) | +$4,979 | | Interest income | $1,545 | $2,413 | -$868 | | Net loss | $(19,575) | $(24,394) | +$4,819 | | Net loss per share, basic and diluted | $(0.26) | $(0.34) | +$0.08 | | Weighted-average common shares outstanding | 75,547,746 | 70,801,713 | +4,746,033 | - Net loss decreased by **$4.8 million (20%)** year-over-year, primarily due to a **$5.7 million** reduction in research and development expenses[10](index=10&type=chunk) - Research and development expenses decreased by **26%** due to reductions in the IMPACT Phase 2b trial for MASH, other clinical activities, and manufacturing expenses, partially offset by increased expenses for new AUD and ALD trials[10](index=10&type=chunk)[67](index=67&type=chunk)[68](index=68&type=chunk) [Consolidated Statements of Changes in Stockholders' Equity](index=6&type=section&id=Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity) Changes in Stockholders' Equity (in thousands) | Item | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :------------------------------------------------ | :-------------------------------- | :-------------------------------- | | Balance at December 31 | $123,508 | $194,099 | | Stock-based compensation | $4,015 | $3,650 | | Issuance of common stock in at-the-market offerings, net | $34,747 | $0 | | Net loss | $(19,575) | $(24,394) | | Balance at March 31 | $142,162 | $172,937 | - Total stockholders' equity increased from **$123.5 million** at December 31, 2024, to **$142.2 million** at March 31, 2025, primarily driven by **$34.7 million** in net proceeds from at-the-market offerings[12](index=12&type=chunk) [Consolidated Statements of Cash Flows](index=8&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Consolidated Statements of Cash Flows Highlights (in thousands) | Item | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | Change (YoY) | | :------------------------------------ | :-------------------------------- | :-------------------------------- | :------------- | | Net cash used in operating activities | $(16,840) | $(16,357) | $(483) | | Net cash used in investing activities | $(5,101) | $(39,521) | +$34,420 | | Net cash provided by (used in) financing activities | $34,119 | $(261) | +$34,380 | | Net increase (decrease) in cash and cash equivalents and restricted cash | $12,178 | $(56,139) | +$68,317 | | Cash, cash equivalents and restricted cash at end of period | $49,146 | $79,019 | -$29,873 | - Net cash provided by financing activities significantly increased to **$34.1 million** in Q1 2025 from a net use of **$0.3 million** in Q1 2024, primarily due to **$34.7 million** in net proceeds from at-the-market offerings[16](index=16&type=chunk)[87](index=87&type=chunk) - Net cash used in investing activities decreased substantially from **$39.5 million** in Q1 2024 to **$5.1 million** in Q1 2025, driven by a smaller net purchase of short-term investments[16](index=16&type=chunk)[86](index=86&type=chunk) [Notes to Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) [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[17](index=17&type=chunk)[18](index=18&type=chunk) - The Company's lead program is pemvidutide (formerly ALT-801), a GLP-1/glucagon dual receptor agonist, targeting metabolic dysfunction-associated steatohepatitis (MASH), obesity, Alcohol Use Disorder (AUD), and Alcohol Liver Disease (ALD)[18](index=18&type=chunk) - The Company has not generated any revenues from product sales to date and has financed operations through equity, debt, research grants, and government contracts[18](index=18&type=chunk) [2. Summary of Significant Accounting Policies](index=11&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) - No significant changes to accounting policies occurred during the three months ended March 31, 2025, compared to the Annual Report on Form 10-K for December 31, 2024[22](index=22&type=chunk) - The Company recorded a discrete tax benefit of approximately **$0.7 million** in Q1 2025 related to Maryland carryback claims, but otherwise did not record income tax expense/benefit due to a full valuation allowance[24](index=24&type=chunk) [3. Fair Value Measurements](index=11&type=section&id=3.%20Fair%20Value%20Measurements) Fair Value Measurements of Assets (in thousands) | Asset Type | March 31, 2025 (Total) | December 31, 2024 (Total) | | :-------------------------------- | :----------------------- | :------------------------ | | Cash equivalents - money market funds | $22,880 | $27,279 | | Short-term investments | $100,722 | $94,965 | | **Total** | **$123,602** | **$122,244** | - Short-term investments are valued using Level 2 inputs, utilizing third-party pricing services and market observable data[25](index=25&type=chunk) - As of March 31, 2025, short-term investments primarily consisted of United States treasury securities (**$32.2 million**), commercial paper and corporate debt securities (**$59.5 million**), asset-backed securities (**$3.0 million**), and agency debt securities (**$6.0 million**)[26](index=26&type=chunk) [4. Accrued Expenses](index=12&type=section&id=4.%20Accrued%20Expenses) Accrued Expenses and Other Current Liabilities (in thousands) | Item | March 31, 2025 | December 31, 2024 | | :------------------------------------ | :------------- | :---------------- | | Accrued professional services | $451 | $401 | | Accrued payroll and employee benefits | $1,004 | $3,079 | | Accrued research and development | $6,965 | $6,443 | | Total accrued expenses and other current liabilities | $8,721 | $10,257 | - Total accrued expenses and other current liabilities decreased by **$1.5 million**, primarily due to a **$2.0 million** decrease in accrued payroll and employee benefits, partially offset by a **$0.5 million** increase in accrued research and development[30](index=30&type=chunk) [5. Noncurrent Liabilities](index=13&type=section&id=5.%20Noncurrent%20Liabilities) Noncurrent Liabilities (in thousands) | Item | March 31, 2025 | December 31, 2024 | | :-------------------------------- | :------------- | :---------------- | | Research and development incentive credit | $3,785 | $3,746 | | Lease obligation, long-term portion | $1,342 | $1,402 | | Conditional economic incentive grants | $160 | $160 | | Total noncurrent liabilities | $5,303 | $5,330 | - Noncurrent liabilities remained relatively stable, with a slight decrease of **$27 thousand** from December 31, 2024, to March 31, 2025[31](index=31&type=chunk) [6. Stockholders' Equity](index=13&type=section&id=6.%20Stockholders'%20Equity) - As of March 31, 2025, Altimmune had **77,825,450 shares** of common stock issued and outstanding, with **200,000,000 shares** authorized[32](index=32&type=chunk) - The Company initiated a new at-the-market (ATM) offering program on February 27, 2025, for up to **$150.0 million**, selling **805,502 shares** for **$4.6 million** net proceeds by March 31, 2025[34](index=34&type=chunk) - The previous **$150.0 million** ATM program (2023 Agreement) was terminated in February 2025, having sold **4,467,866 shares** for **$30.2 million** net proceeds during Q1 2025, bringing total net proceeds from that program to **$126.8 million**[35](index=35&type=chunk) [7. Stock-Based Compensation](index=15&type=section&id=7.%20Stock-Based%20Compensation) - On January 1, 2025, the shares available under the Omnibus Incentive Plan increased by **3,193,659 shares**[36](index=36&type=chunk) - During Q1 2025, the Company granted **1,842,450 stock options** with a weighted-average exercise price of **$6.71** and **466,700 Restricted Stock Units (RSUs)** with a weighted-average grant date fair value of **$6.88**[37](index=37&type=chunk)[39](index=39&type=chunk) Stock-Based Compensation Expense (in thousands) | Category | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :-------------------------- | :-------------------------------- | :-------------------------------- | | Research and development | $1,776 | $1,675 | | General and administrative | $2,239 | $1,975 | | **Total** | **$4,015** | **$3,650** | [8. Net Loss Per Share](index=16&type=section&id=8.%20Net%20Loss%20Per%20Share) - Basic and diluted net loss per share are the same for Q1 2025 and Q1 2024 due to net losses, making all unvested RSUs and stock options anti-dilutive[42](index=42&type=chunk)[43](index=43&type=chunk) Anti-Dilutive Potential Common Shares (as of March 31) | Item | 2025 | 2024 | | :-------------------- | :--------- | :--------- | | Common stock options | 8,460,569 | 6,589,116 | | Restricted stock units | 1,053,337 | 902,952 | [9. Commitments and Contingencies](index=16&type=section&id=9.%20Commitments%20and%20Contingencies) - The Company has a contingent payment obligation of up to **$80.0 million** related to the 2019 Spitfire acquisition, payable upon achievement of specified worldwide net sales milestones for products developed using the acquired technology[45](index=45&type=chunk) - A shareholder derivative lawsuit filed in June 2024, consolidated in July 2024, was dismissed without prejudice on February 3, 2025[47](index=47&type=chunk)[49](index=49&type=chunk) [10. Segment Information](index=18&type=section&id=10.%20Segment%20Information) - Altimmune operates as a single segment, focusing on developing peptide-based therapeutics for liver and cardiometabolic diseases, with performance assessed based on net loss/income[51](index=51&type=chunk)[52](index=52&type=chunk) [11. Subsequent Events](index=18&type=section&id=11.%20Subsequent%20Events) - In April 2025, the Company raised an additional **$16.3 million** in net proceeds by issuing **3,278,902 shares** of common stock through its 2025 at-the-market offering[53](index=53&type=chunk) - On May 13, 2025, Altimmune entered into a Loan and Security Agreement with Hercules Capital, Inc. for up to **$100.0 million** in term loans, with the first **$15.0 million** tranche funded on the closing date[54](index=54&type=chunk) - The Term Loan matures on June 1, 2029, bears interest at prime rate plus **2.45%** (or **9.95%** until Dec 31, 2025, then **9.45%**), and allows for an initial interest-only payment period of up to **24 months**, extendable to **42 months**[54](index=54&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=20&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on Altimmune's financial condition and operational results for Q1 2025 and 2024, covering business updates, performance, liquidity, capital resources, and critical accounting estimates [Overview](index=20&type=section&id=Overview) - Altimmune is a late clinical-stage biopharmaceutical company developing peptide-based therapeutics for liver and cardiometabolic diseases[59](index=59&type=chunk) - The lead product candidate, pemvidutide, is a GLP-1/glucagon dual receptor agonist for MASH, obesity, AUD, and ALD[59](index=59&type=chunk) [Recent Business Update](index=20&type=section&id=Recent%20Business%20Update) - On March 13, 2025, Altimmune announced pursuing two new indications for pemvidutide: Alcohol Use Disorder (AUD) and Alcohol-Associated Liver Disease (ALD)[60](index=60&type=chunk) - A Phase 2 AUD trial for pemvidutide is expected to begin in Q2 2025, enrolling approximately **100 subjects** with moderate to severe AUD over **24 weeks**, with endpoints including changes in heavy drinking days, alcohol consumption biomarkers, and weight loss[61](index=61&type=chunk) - A Phase 2 ALD trial for pemvidutide is expected to begin in Q3 2025, enrolling approximately **100 subjects** with obesity and ALD over **48 weeks**, with endpoints including changes in liver stiffness, alcohol consumption, and biomarkers of steatosis, fibrosis, and inflammation[62](index=62&type=chunk)[63](index=63&type=chunk) [Recent Global Events](index=22&type=section&id=Recent%20Global%20Events) - Ongoing tariffs and counter-tariffs, along with global economic uncertainties, could negatively impact Altimmune's operations through inflationary pressures, supply chain disruptions, and capital market volatility[64](index=64&type=chunk) [Results of Operations](index=22&type=section&id=Results%20of%20Operations) Results of Operations (in thousands) | Item | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | Increase (Decrease) | | :------------------------------------ | :-------------------------------- | :-------------------------------- | :------------------ | | Revenues | $5 | $5 | $0 | | Research and development | $15,827 | $21,487 | $(5,660) (26%) | | General and administrative | $5,993 | $5,312 | $681 (13%) | | Total operating expenses | $21,820 | $26,799 | $(4,979) (19%) | | Loss from operations | $(21,815) | $(26,794) | $4,979 (19%) | | Interest income | $1,545 | $2,413 | $(868) (36%) | | Net loss before income taxes | $(20,256) | $(24,394) | $4,138 (17%) | | Income tax expense (benefit) | $(681) | $0 | $(681) (100%) | | Net loss | $(19,575) | $(24,394) | $(4,819) (20%) | [Revenue](index=22&type=section&id=Revenue) - Altimmune has not generated any revenue from product sales to date, with past revenues primarily from government and foundation grants[66](index=66&type=chunk) [Research and development expenses](index=22&type=section&id=Research%20and%20development%20expenses) - Research and development expenses decreased by **$5.7 million (26%)** to **$15.8 million** for Q1 2025 compared to Q1 2024[67](index=67&type=chunk) - The decrease was mainly due to a **$4.3 million** reduction in pemvidutide-related expenses (IMPACT Phase 2b trial, other clinical activities, MOMENTUM Phase 2 winddown, manufacturing) and a **$1.0 million** decrease related to the winddown and termination of HepTcell[68](index=68&type=chunk)[69](index=69&type=chunk) - These decreases were partially offset by a **$0.4 million** increase in expenses associated with the start of new AUD and ALD trials[68](index=68&type=chunk) [General and administrative expenses](index=24&type=section&id=General%20and%20administrative%20expenses) - General and administrative expenses increased by **$0.7 million (13%)** to **$6.0 million** for Q1 2025 compared to Q1 2024[70](index=70&type=chunk) - The increase was primarily driven by a **$0.5 million** rise in stock compensation and other labor-related expenses, and a **$0.2 million** increase in professional fees[70](index=70&type=chunk) [Total other income (expense), net](index=24&type=section&id=Total%20other%20income%20(expense)%2C%20net) - Total other income (expense), net decreased by **$0.8 million (35%)** for Q1 2025 compared to Q1 2024, mainly due to a **$0.9 million** decrease in interest income[71](index=71&type=chunk) [Income tax expense (benefit)](index=24&type=section&id=Income%20tax%20expense%20(benefit)) - Altimmune recorded a discrete tax benefit of approximately **$0.7 million** in Q1 2025 related to Maryland carryback claims, but no income tax expense/benefit was recorded in Q1 2024 due to a full valuation allowance[72](index=72&type=chunk) [Liquidity and Capital Resources](index=24&type=section&id=Liquidity%20and%20Capital%20Resources) [Overview](index=24&type=section&id=Overview%20(Liquidity)) - As of March 31, 2025, Altimmune had **$149.9 million** in cash, cash equivalents, restricted cash, and short-term investments[73](index=73&type=chunk) - The Company believes its current cash resources are sufficient to fund operations for at least **12 months** from the issuance date of the Q1 2025 financial statements[73](index=73&type=chunk) - Altimmune has an accumulated deficit of **$581.0 million** as of March 31, 2025, and continues to rely on equity or debt financing and potential partnership arrangements to fund its research and development activities[74](index=74&type=chunk) [Sources of Liquidity](index=24&type=section&id=Sources%20of%20Liquidity) [Loan Financing](index=24&type=section&id=Loan%20Financing) - On May 13, 2025, Altimmune secured a Loan and Security Agreement with Hercules Capital, Inc. for up to **$100.0 million** in term loans, with **$15.0 million** funded initially[75](index=75&type=chunk) - Additional tranches of **$25.0 million** and **$15.0 million** are available upon achieving certain milestones, and a fourth tranche of **$45.0 million** is subject to lender approval[75](index=75&type=chunk) - The loan matures on June 1, 2029, with interest-only payments for an initial period of up to **24 months**, extendable to **42 months**[76](index=76&type=chunk)[77](index=77&type=chunk) [Shelf Registrations](index=26&type=section&id=Shelf%20Registrations) - A new shelf registration statement (Form S-3) was filed on February 27, 2025, allowing the Company to offer and sell up to **$400.0 million** in various securities over **three years**[78](index=78&type=chunk) - The previous 2023 Shelf registration, which allowed for unlimited offerings, expired on February 27, 2025[79](index=79&type=chunk) [At-the-Market Offerings](index=26&type=section&id=At-the-Market%20Offerings) - Under the new 2025 ATM program, Altimmune sold **805,502 shares** for approximately **$4.6 million** in net proceeds during Q1 2025, with **$145.3 million** remaining available[80](index=80&type=chunk) - The 2023 ATM program, which expired in February 2025, generated approximately **$30.2 million** in net proceeds from **4,467,866 shares** sold during Q1 2025, bringing its total net proceeds to **$126.8 million**[81](index=81&type=chunk) [Cash Flows](index=26&type=section&id=Cash%20Flows) Cash Flow Summary (in thousands) | Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | Increase (Decrease) | | :------------------------ | :-------------------------------- | :-------------------------------- | :------------------ | | Operating activities | $(16,840) | $(16,357) | $(483) | | Investing activities | $(5,101) | $(39,521) | $34,420 | | Financing activities | $34,119 | $(261) | $34,380 | | Net increase (decrease) in cash | $12,178 | $(56,139) | $68,317 | [Operating Activities](index=26&type=section&id=Operating%20Activities) - Net cash used in operating activities increased slightly to **$16.8 million** in Q1 2025 from **$16.4 million** in Q1 2024, primarily due to changes in working capital accounts[83](index=83&type=chunk)[85](index=85&type=chunk) [Investing Activities](index=28&type=section&id=Investing%20Activities) - Net cash used in investing activities significantly decreased to **$5.1 million** in Q1 2025 from **$39.5 million** in Q1 2024[86](index=86&type=chunk) - This change was driven by **$38.0 million** in proceeds from sales and maturities of short-term investments, partially offsetting **$43.1 million** in purchases of short-term investments in Q1 2025[86](index=86&type=chunk) [Financing Activities](index=28&type=section&id=Financing%20Activities) - Net cash provided by financing activities was **$34.1 million** in Q1 2025, a substantial increase from **$0.3 million** net cash used in Q1 2024[87](index=87&type=chunk) - This was primarily due to **$34.6 million** in net proceeds from at-the-market offerings in Q1 2025[87](index=87&type=chunk) [Current Resources](index=28&type=section&id=Current%20Resources) - As of March 31, 2025, Altimmune held **$49.2 million** in cash, cash equivalents, and restricted cash, plus **$100.7 million** in short-term investments[88](index=88&type=chunk) - Management believes these resources are sufficient to fund operations for at least **12 months**, but additional capital may be required for long-term needs and planned clinical trials[88](index=88&type=chunk) [Critical Accounting Estimates](index=28&type=section&id=Critical%20Accounting%20Estimates) - There have been no changes to Altimmune's critical accounting policies, significant judgments, and estimates as disclosed in its Annual Report on Form 10-K for the year ended December 31, 2024[90](index=90&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=28&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a smaller reporting company, Altimmune, Inc. is not required to provide quantitative and qualitative disclosures about market risk in this quarterly report - Altimmune, Inc. is exempt from providing quantitative and qualitative disclosures about market risk as it qualifies as a 'smaller reporting company' under SEC regulations[91](index=91&type=chunk) [Item 4. Controls and Procedures](index=30&type=section&id=Item%204.%20Controls%20and%20Procedures) This section details the evaluation of Altimmune's disclosure controls and procedures, confirming their effectiveness and reporting no material changes in internal control over financial reporting [Evaluation of Disclosure Controls and Procedures](index=30&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) - Management, including the principal executive and financial officers, concluded that Altimmune's disclosure controls and procedures were effective as of March 31, 2025[93](index=93&type=chunk)[94](index=94&type=chunk) - These controls provide reasonable assurance that required information is recorded, processed, summarized, and reported timely[94](index=94&type=chunk) [Changes in Internal Control Over Financial Reporting](index=30&type=section&id=Changes%20in%20Internal%20Control%20Over%20Financial%20Reporting) - No changes in internal control over financial reporting materially affected, or are reasonably likely to materially affect, Altimmune's internal control during the quarter ended March 31, 2025[95](index=95&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=30&type=section&id=Item%201.%20Legal%20Proceedings) This section discloses legal proceedings involving Altimmune, specifically a shareholder derivative complaint that was dismissed in February 2025 - A shareholder derivative complaint, filed in June 2024 and consolidated in July 2024, was dismissed without prejudice on February 3, 2025[96](index=96&type=chunk) - The complaint alleged breaches of fiduciary duty, unjust enrichment, and waste of corporate assets by executive officers and board members[96](index=96&type=chunk) - The Company is involved in various contracts and disputes in the ordinary course of business, none of which are currently reasonably possible or probable of material loss[50](index=50&type=chunk) [Item 1A. Risk Factors](index=32&type=section&id=Item%201A.%20Risk%20Factors) This section updates risk factors, highlighting new risks related to economic uncertainty, geopolitical instability, and the impact of a new U.S. presidential administration on regulatory agencies, plus new term loan obligations - New risk factors include economic uncertainty, capital markets disruption, ongoing military conflicts, geopolitical instability, inflation, and interest rates, which could impact operations and supply chains[99](index=99&type=chunk) - Disruptions at government agencies like the FDA and SEC due to funding shortages, global health concerns, or changes under a new U.S. presidential administration could hinder product development and regulatory approvals[100](index=100&type=chunk)[103](index=103&type=chunk)[105](index=105&type=chunk) - The new **$100.0 million** term loan agreement with Hercules Capital, Inc. imposes restrictive covenants on Altimmune's operating activities and includes provisions for accelerated repayment upon an event of default, which could materially adversely affect the business[106](index=106&type=chunk)[107](index=107&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=36&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section states that there were no unregistered sales of equity securities or use of proceeds to report for the period - There were no unregistered sales of equity securities or use of proceeds to report for the period[110](index=110&type=chunk) [Item 3. Defaults Upon Senior Securities](index=36&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section confirms that there were no defaults upon senior securities during the reporting period - There were no defaults upon senior securities during the reporting period[111](index=111&type=chunk) [Item 4. Mine Safety Disclosures](index=36&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to Altimmune, Inc. - This item is not applicable to Altimmune, Inc[112](index=112&type=chunk) [Item 5. Other Information](index=36&type=section&id=Item%205.%20Other%20Information) This section discloses a Rule 10b5-1 trading plan adopted by Dr. Vipin Garg, the President and CEO, for the sale of up to 80,000 shares of common stock - Dr. Vipin Garg, President and CEO, adopted a Rule 10b5-1 trading plan on March 26, 2025, to sell up to **80,000 shares** of common stock[113](index=113&type=chunk) - The plan commences on the later of June 24, 2025, or two business days after the Q1 2025 10-Q filing, and expires on June 24, 2026[113](index=113&type=chunk) - No other officers or directors adopted, modified, or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the three months ended March 31, 2025[114](index=114&type=chunk) [Item 6. Exhibits](index=37&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed as part of the Form 10-Q, including corporate governance documents, equity distribution agreements, a new loan and security agreement, and certifications - Key exhibits include the Amended and Restated Certificate of Incorporation and Bylaws, Equity Distribution Agreements (2025), a Consulting Agreement, and the new Loan and Security Agreement with Hercules Capital, Inc[117](index=117&type=chunk) - Certifications from the Principal Executive Officer and Principal Financial Officer pursuant to SEC rules are also included[117](index=117&type=chunk) [Signatures](index=39&type=section&id=Signatures) This section contains the required signatures of Altimmune, Inc.'s authorized officers, including the President and Chief Executive Officer and the Chief Financial Officer, certifying the filing of the report - The report is signed by Vipin K. Garg, President and Chief Executive Officer, and Gregory Weaver, Chief Financial Officer, on May 13, 2025[124](index=124&type=chunk)

Financial Data and Key Metrics Changes - The company ended Q1 2025 with $150 million in cash, cash equivalents, and short-term investments, an increase from $132 million at the end of 2024, primarily due to $35 million raised from the ATM facility [22][20] - R&D expenses for Q1 2025 were $15.8 million, down from $21.5 million in the same period of 2024, with $9.2 million specifically related to pemidutide development [22][24] - General and administrative expenses rose to $6 million from $5.3 million in Q1 2024, mainly due to increased non-cash stock compensation [23] Business Line Data and Key Metrics Changes - The company is focused on the development of pemidutide, with significant progress in the NASH program, including the upcoming readout of the IMPACT Phase 2b MATCH trial [8][12] - The trial enrolled 212 participants with biopsy-confirmed F2F3 NASH, enhancing the study's power [12] Market Data and Key Metrics Changes - The company is expanding into alcohol use disorder (AUD) and alcohol liver disease (ALD), with plans for Phase II trials in these areas [9][10] - The market research indicates that a drug like pemidutide, which reduces alcohol consumption and liver inflammation, would be well-received by patients and physicians [18] Company Strategy and Development Direction - The company aims to establish pemidutide as a foundational treatment across multiple fibrotic liver diseases, focusing on NASH, AUD, and ALD [10][19] - The strategic partnership with Hercules Capital for a $100 million credit facility is intended to support the ongoing development of pemidutide [9][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving the trial's key efficacy and safety objectives for pemidutide, which could become the first therapy to achieve statistical significance on NASH endpoints at 24 weeks [8][13] - The company anticipates 2025 to be a transformative year, with significant milestones expected from the IMPACT trial and the initiation of Phase II trials for AUD and ALD [19][24] Other Important Information - The company is preparing for an end-of-Phase II meeting with the FDA in Q4 2025, which will discuss the potential for accelerated approval in F4 cirrhosis [78][79] - The company has a large safety database for pemidutide, which may allow for more efficient trial designs in Phase III [73] Q&A Session Summary Question: Can you provide commentary on the distribution of F2 and F3 in the Phase 2b population? - Management indicated that the demographics of the final qualifying population are similar to other studies, but precise numbers will be presented later [28][29] Question: What is the ideal population for pemidutide post-IMPACT? - The focus is on treating NASH with obesity, as a significant percentage of NASH patients are obese, which is a key factor in the treatment strategy [30][31] Question: How are you handling study discontinuations? - Management reported satisfaction with the discontinuation rates and stated that data will be available at the time of the readout [36] Question: How important is weight loss in this study? - Weight loss is crucial, as it addresses comorbidities associated with NASH, and the company aims to achieve clinically meaningful weight loss [40][41] Question: What are the expected placebo responses for fibrosis and NASH resolution endpoints? - Management noted that placebo responses have varied historically, but they expect to control the placebo response effectively in their trial [87][88] Question: Will you discuss NASH F4 cirrhosis with the FDA? - The company intends to discuss F4 with the FDA and believes they will be successful in this area [78][79] Question: Can you confirm the cash runway with the Hercules facility? - The facility will provide $15 million upfront, with additional tranches available, potentially extending the cash runway into Q3 2026 [81][82]

Financial Data and Key Metrics Changes - The company ended Q1 2025 with $150 million in cash, cash equivalents, and short-term investments, an increase from $132 million at the end of 2024 [22] - R&D expenses were $15.8 million for Q1 2025, down from $21.5 million in the same period of 2024 [22] - The net loss for Q1 2025 was $19.6 million, or $0.26 per share, compared to a net loss of $24.4 million, or $0.34 per share, for Q1 2024 [23] Business Line Data and Key Metrics Changes - The company is focused on the development of pemidutide, with significant R&D investments directed towards its clinical trials [8][22] - The IMPACT Phase 2b MATCH trial has enrolled 212 participants, enhancing the study's power compared to the original target [12] Market Data and Key Metrics Changes - The company is expanding into alcohol use disorder (AUD) and alcohol liver disease (ALD), both of which have significant unmet medical needs [8][10] - The market research indicates that a drug like pemidutide, which reduces alcohol consumption and liver inflammation, would be well-received by patients and physicians [17] Company Strategy and Development Direction - The company aims to establish pemidutide as a foundational treatment across multiple fibrotic liver diseases, including NASH, AUD, and ALD [10][18] - The upcoming readout of the IMPACT Phase 2b MATCH trial is expected to be a transformative event for the company, with plans for Phase III trials in NASH following successful results [24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving the trial's key efficacy and safety objectives for pemidutide, which could become the first therapy to achieve statistical significance on NASH endpoints at 24 weeks [7][13] - The company anticipates 2025 to be a transformative year, with significant milestones expected in clinical development [24] Other Important Information - The company has entered into a credit facility with Hercules Capital for up to $100 million, providing flexibility to support the development of pemidutide [8][20] - The facility includes a $15 million upfront funding and additional tranches available based on milestones [21] Q&A Session Summary Question: Can you provide commentary on the distribution of F2 and F3 in the Phase 2b population? - Management indicated that the demographics of the final qualifying population will be similar to other studies, but precise numbers cannot be disclosed yet [28] Question: What is the ideal population for pemidutide post-IMPACT? - The focus is on treating NASH with obesity, as a significant percentage of NASH patients are obese, which is a key factor in the treatment strategy [30] Question: How are you handling study discontinuations? - Management reported satisfaction with the discontinuation rates and stated that data will be available at the time of the readout [38] Question: How important is weight loss in the study? - Weight loss is crucial, as it impacts the treatment of NASH patients, and the company aims to achieve clinically significant weight loss [41] Question: Will you consider taking a higher dose into Phase III? - The company is strongly considering the 2.4 mg dose for Phase III due to its expected better weight loss outcomes [49] Question: What is the expected range of placebo responses? - The company anticipates a placebo response range of 7% to 13% based on historical data and the trial's design [90] Question: Will you discuss NASH F4 cirrhosis with the FDA? - The company intends to discuss F4 with the FDA and believes it can be successful in this area [80]

Financial Position - Altimmune reported cash, cash equivalents, and short-term investments totaling $150 million as of March 31, 2025[10]. - The company secured a $100 million credit facility with Hercules Capital to enhance financial flexibility and support pemvidutide development[5]. Research and Development - Research and development expenses for Q1 2025 were $15.8 million, down from $21.5 million in Q1 2024, reflecting a decrease in clinical trial costs[10]. - Phase 2 trials for Alcohol Use Disorder (AUD) and Alcohol Liver Disease (ALD) are set to initiate in Q2 and Q3 2025, respectively[2]. - Top-line data from the IMPACT Phase 2b trial of pemvidutide in metabolic dysfunction-associated steatohepatitis (MASH) is expected in Q2 2025[1]. - A total of 212 participants were randomized in the IMPACT Phase 2b trial, exceeding the original plan of 190 participants[6]. - The proportion of participants achieving MASHResInd responses exceeded 90% after 24 weeks of treatment in the Phase 1b trial, indicating potential high rates of MASH resolution[6]. - Pemvidutide has received Fast Track designation from the U.S. FDA for the treatment of MASH, with top-line results from the ongoing IMPACT Phase 2b trial expected in late June 2025[9]. Expenses and Losses - General and administrative expenses increased to $6.0 million in Q1 2025 from $5.3 million in Q1 2024, primarily due to a $0.5 million rise in stock compensation and labor-related expenses[10]. - Net loss for Q1 2025 was $19.6 million, or $0.26 per share, compared to a net loss of $24.4 million, or $0.34 per share, in the same period in 2024[10].

Core Viewpoint - Altimmune, Inc. has secured a credit facility of up to $100 million from Hercules Capital to support the development of its novel peptide-based therapeutic, pemvidutide, aimed at treating liver and cardiometabolic diseases [1][2]. Financial Strength and Flexibility - The credit facility enhances Altimmune's balance sheet, which had $150 million in cash and cash equivalents as of March 31, 2025 [2]. - The initial tranche of $15 million will be drawn at closing, with additional funds available upon meeting specific clinical and financial milestones [3]. Development Plans for Pemvidutide - Pemvidutide is currently in a Phase 2b trial for metabolic dysfunction-associated steatohepatitis (MASH), with top-line data expected in Q2 2025 [2]. - Phase 2 trials for pemvidutide in Alcohol Use Disorder (AUD) and Alcohol Liver Disease (ALD) are anticipated to start in the second and third quarters of 2025, respectively [2]. Partnership and Future Outlook - The partnership with Hercules Capital is expected to extend Altimmune's cash runway under flexible terms, allowing for continued development of pemvidutide [3]. - Hercules Capital expresses enthusiasm in supporting Altimmune through its clinical development journey, particularly with the upcoming data release from the IMPACT trial [3]. Company Overview - Altimmune is a late clinical-stage biopharmaceutical company focused on developing peptide-based therapeutics for liver and cardiometabolic diseases, with pemvidutide as its lead program [4].

Top-line data from IMPACT Phase 2b trial of pemvidutide in metabolic dysfunction-associated steatohepatitis (MASH) expected in Q2 2025 Phase 2 trials in Alcohol Use Disorder (AUD) and Alcohol Liver Disease (ALD), expected to initiate in Q2 and Q3 2025, respectively Cash, cash equivalents and short-term investments of $150 million as of March 31, 2025 Top-line data from the IMPACT Phase 2b trial of pemvidutide in biopsy-confirmed F2/F3 MASH expected in Q2 2025 Top-line data is expected to include rates of MA ...

Shares of Altimmune, Inc. (ALT) have gained 39.4% over the past four weeks to close the last trading session at $5.80, but there could still be a solid upside left in the stock if short-term price targets of Wall Street analysts are any indication. Going by the price targets, the mean estimate of $22.38 indicates a potential upside of 285.9%.The mean estimate comprises eight short-term price targets with a standard deviation of $5.32. While the lowest estimate of $12 indicates a 106.9% increase from the cur ...

Core Insights - Altimmune, Inc. presented new analyses at the EASL Congress™ highlighting the predictive capability of the MASH Resolution Index (MASHResInd) for MASH resolution in patients treated with pemvidutide, a dual receptor agonist [1][2] Group 1: MASH Resolution Index (MASHResInd) - MASHResInd is a composite score that integrates multiple non-invasive tests, including MRI-PDFF, ALT, and AST levels, to predict MASH resolution on biopsy [2] - In a trial involving pemvidutide for MASLD, MASHResInd indicated a high probability of MASH resolution with treatment [2] Group 2: Pemvidutide Treatment Results - After 24 weeks of treatment, MASHResInd responses were observed in 69.2%, 92.3%, and 90.9% of subjects receiving 1.2 mg, 1.8 mg, and 2.4 mg of pemvidutide, respectively, compared to 22.2% in the placebo group [3][4] - The results suggest that pemvidutide may lead to significant histologic improvements in MASH, with high response rates at the higher doses [3][4] Group 3: Future Developments - The upcoming IMPACT Phase 2b Trial readout is anticipated to be reported this quarter, with confidence in achieving statistical significance based on the trial's results [4] - Pemvidutide has received Fast Track designation from the U.S. FDA for the treatment of MASH and is also being studied for obesity, alcohol use disorder, and alcohol-related liver disease [8][9]