Financial Performance - Revenues for the three months ended September 30, 2025, were $5, unchanged from the same period in 2024[90] - The net loss for the three months ended September 30, 2025, was $19.01 million, a decrease of $3.83 million, or 17%, from a net loss of $22.85 million in 2024[90] - Revenues for the nine months ended September 30, 2025, remained unchanged at $15,000 compared to the same period in 2024[98] - Net loss for the nine months ended September 30, 2025, was $60.7 million, a decrease of $11.1 million, or 16%, from a net loss of $71.9 million in 2024[98] Expenses - Research and development expenses decreased by $4.8 million, or 24%, to $14.96 million for the three months ended September 30, 2025, compared to $19.80 million in 2024[93] - General and administrative expenses increased by $0.9 million, or 19%, to $5.90 million for the three months ended September 30, 2025, compared to $4.97 million in 2024[95] - Research and development expenses decreased by $14.4 million, or 23%, to $48.0 million for the nine months ended September 30, 2025, from $62.4 million in 2024[100] - General and administrative expenses increased by $1.7 million, or 11%, to $17.6 million for the nine months ended September 30, 2025[102] Other Income and Cash Flow - Total other income (expense), net decreased by $0.1 million, or 4%, for the three months ended September 30, 2025, compared to the same period in 2024[96] - Total other income (expense), net decreased by $2.2 million, or 35%, to $4.2 million for the nine months ended September 30, 2025[103] - Net cash used in operating activities was $48.1 million for the nine months ended September 30, 2025, compared to $61.6 million in 2024, reflecting a decrease of $13.5 million[116] - Net cash provided by financing activities was $125.7 million during the nine months ended September 30, 2025, primarily from the issuance of common stock[118] Financial Position - Cash, cash equivalents, restricted cash, and short-term investments totaled $210.8 million as of September 30, 2025[105] - The accumulated deficit as of September 30, 2025, was $622.1 million, indicating significant losses since operations commenced[106] - The company plans to continue pursuing additional equity or debt financing to address long-term capital needs for clinical trials[119] Clinical Trials and Designations - In a Phase 2b trial for MASH, 58% and 52% of subjects achieved MASH resolution with pemvidutide doses of 1.2 mg and 1.8 mg, respectively, compared to 20% for placebo (p<0.0001) at 24 weeks[77] - Mean weight loss in pemvidutide-treated subjects was 4.8% and 5.8% at the 1.2 mg and 1.8 mg doses, respectively, versus 0.5% in the placebo group (p<0.001) at 24 weeks[79] - The U.S. FDA granted Fast Track designation to pemvidutide for the treatment of alcohol use disorder (AUD) on August 19, 2025[83] - The RECLAIM Phase 2 trial for AUD has enrolled approximately 100 subjects, with topline results expected in 2026[84] - The RESTORE Phase 2 trial for alcohol-associated liver disease (ALD) is enrolling approximately 100 patients, with a primary endpoint of liver stiffness measurement change at Week 24[85] Accounting and Reporting - Management's Discussion and Analysis is based on unaudited consolidated financial statements prepared in accordance with U.S. GAAP[121] - There have been no changes in critical accounting policies and significant judgments since the Annual Report for the year ended December 31, 2024[122] - As a smaller reporting company, the company is not required to provide quantitative and qualitative disclosures about market risk[123]

Altimmune Corporate Overview November 2025 Our Mission: To Revolutionize the Standard of Care for Serious Liver Diseases Forward Looking Statements Safe-Harbor Statement This presentation has been prepared by Altimmune, Inc. ("we," "us," "our," "Altimmune" or the "Company") and includes certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements relating to future financial or business performance, conditions, pla ...

Financial Data and Key Metrics Changes - Total cash as of September 30 was $211 million, representing a 60% increase from the beginning of the year [11] - R&D expenses for Q3 2025 were $15 million, down from $19.8 million in Q3 2024, primarily due to the timing of CRO development costs [12] - Net loss for Q3 2025 was $19 million or $0.21 per share, compared to a net loss of $22.8 million or $0.32 per share in Q3 2024 [13] Business Line Data and Key Metrics Changes - Direct costs related to Pemvidutide development in Q3 2025 included $9.2 million, with $3.7 million for the IMPACT phase 2b trial, $3.4 million for AUD and ALD startup costs, and $1.3 million for CMC [12] Market Data and Key Metrics Changes - Market research indicated that 70%-80% of surveyed physicians expressed a high likelihood to prescribe Pemvidutide based on its product profile [7] - Positive feedback from payers suggested broad coverage expectations across the EU for Pemvidutide [8] Company Strategy and Development Direction - The company is preparing for a scheduled end-of-phase two meeting with the FDA to review the proposed phase three MASH program [2][15] - Pemvidutide is positioned as a promising therapeutic candidate for MASH, AUD, and ALD, leveraging its dual mechanism of action [3][5] - The company aims to design a flexible phase three trial to adapt to potential regulatory changes regarding endpoints [20][21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strength of the 24-week data supporting the upcoming discussions with the FDA [18][19] - The company anticipates continued weight loss and improvements in NITs at the 48-week mark, reinforcing the efficacy of Pemvidutide [20][35] Other Important Information - The company has raised $127 million through various capital sourcing options to support key development milestones [11] - A $400 million shelf registration and a new $200 million ATM facility were filed to enhance financial flexibility [12] Q&A Session Summary Question: Upcoming 48-week data from the phase two IMPACT trial - Management indicated that the end-of-phase two meeting with the FDA was based on the 24-week data, and the 48-week data would be submitted later [18][19] Question: Probability of using NITs or AI-based histological reading - Management noted ongoing discussions and increasing interest in NITs, with flexibility built into the phase three design to adapt to regulatory changes [25] Question: Advantages of AI-based biopsy reading - AI provides a more comprehensive evaluation of fibrosis with less variability compared to traditional histology, which is subject to human error [25][26] Question: Clinically meaningful endpoint for the RECLAIM trial - The primary endpoint for the RECLAIM trial is the number of heavy drinking days per week, with a focus on assessing changes from baseline [28][31] Question: Competitive positioning against Retatrutide - Management believes Pemvidutide's dual mechanism of action provides a competitive advantage in the MASH space compared to Retatrutide [64][65] Question: Progress on the oral formulation of Pemvidutide - The company is advancing its oral formulation program and plans to share more data as it progresses [70]

Loan Agreement Details - Borrower has requested Lenders to make available up to four tranches of term loans totaling $125 million[33]. - The Loan Agreement was initially made on May 13, 2025, and has been amended by Amendment No. 1 as of November 5, 2025[31][2]. - Each Borrower must execute and deliver the Amendment to Lender for it to become effective[14]. - The Amendment constitutes a legal, valid, and binding obligation of the Borrower[11]. - The Loan Agreement will continue in full force and effect except as expressly amended[13]. - The maximum term loan amount is set at $125 million[98]. - The initial facility charge payable to lenders is $150,000[78]. - The company plans to draw a Term Loan Advance of $15 million on the Closing Date as part of the Tranche 1 Advance[156]. - A subsequent Term Loan Advance of $20 million is scheduled to be drawn on or before the First Amendment Effective Date as part of the Tranche 2 Advance[157]. - The company may request up to $10 million in additional Term Loan Advances under the Tranche 3 Advances, with minimum increments of $5 million[158]. - Borrower may request up to two additional Term Loan Advances in minimum increments of $5,000,000, totaling up to $80,000,000[161]. - The principal balance of each Term Loan Advance will bear interest at a floating Term Loan Interest Rate based on the Prime Rate[164]. - Borrower will pay accrued but unpaid interest on each Term Loan Advance on the first Business Day of each month, starting the month after the Advance Date[165]. - A Prepayment Charge of 3.00% applies if the principal amount is prepaid within 12 months of the First Amendment Effective Date, decreasing to 0.00% thereafter[170]. - An End of Term Charge of 6.25% will be applied to the principal amount of Term Loan Advances upon certain events, including full prepayment[171]. - In the event of a payment default, a default interest of 4% will be charged on the past due amount[168]. - The maximum aggregate outstanding Term Loan Advances shall not exceed the Maximum Term Loan Amount as defined in the agreement[162]. - Borrower must submit an Advance Request at least one Business Day before the Closing Date and five Business Days before each Advance Date[163]. - All payments under the agreement must be made without setoff or deduction, regardless of any counterclaim[166]. Borrower Obligations - Borrower must pay all reasonable and documented out-of-pocket Lender expenses incurred through the date of the Amendment[15]. - Borrower has the corporate power and authority to execute and deliver the Amendment[10]. - The execution of the Amendment has been duly authorized by all necessary corporate actions on the part of Borrower[10]. - Borrower must deliver various documents, including executed Loan Documents and a legal opinion, prior to the Closing Date to satisfy conditions for the Loan[185]. - Each Loan Party must maintain good standing and be duly organized under applicable laws to avoid a Material Adverse Effect[192]. - Borrower must ensure that no defaults exist under any material agreements or instruments related to its indebtedness[197]. - The obligations of Lenders to make the Loan are contingent upon the Borrower's compliance with all terms and conditions set forth in the Loan Documents[188]. - Borrower must use best efforts to obtain landlord and bailee consents for locations holding significant collateral[190]. - Borrower is required to provide insurance certificates and other documentation within specified timeframes post-Closing Date[190]. Compliance and Legal Matters - No Event of Default has occurred and is continuing as per Borrower's representations[9]. - The Company must comply with Anti-Corruption and Anti-Terrorism Laws, including the U.S. Foreign Corrupt Practices Act and the USA PATRIOT Act[46][47]. - A Change in Control is defined as any person or group obtaining 49% or more of the voting power for the election of directors[54]. - The Company must maintain compliance with the Employee Retirement Income Security Act (ERISA) regulations[68]. - The Company is required to provide a Compliance Certificate as part of its obligations under the Agreement[58]. - The Agreement outlines the conditions under which an Event of Default may occur, impacting the Company's obligations[69]. - Borrower and its Subsidiaries are not classified as an "investment company" under the Investment Company Act of 1940[198]. - Borrower has complied with the Federal Fair Labor Standards Act in all material respects[199]. - Borrower and its Subsidiaries have obtained all necessary consents and approvals from Governmental Authorities to continue their businesses[199]. - There are no violations of Anti-Terrorism Laws by Borrower or its Subsidiaries[200]. - None of the funds provided under the Agreement will be used for activities violating Anti-Corruption Laws or for payments to government officials[200]. Financial Definitions and Conditions - The Loan and Security Agreement includes provisions for cash proceeds from public or private sales of Qualified Equity Interests, with specific definitions for net proceeds and partnerships[43]. - The Amortization Date is set for December 1, 2027, with potential extensions based on milestone achievements[45]. - The definition of "Borrower Products" includes all products and technologies currently being developed or sold by the Company[51]. - The definition of "Equity Interests" encompasses various forms of capital stock and ownership interests in the Company[68]. - The definition of "indebtedness" includes all obligations for borrowed money and capital lease obligations[76]. - The term "material agreement" includes contracts involving amounts exceeding $10 million[95]. - Permitted Indebtedness includes up to $1,000,000 outstanding at any time secured by specific liens, and trade creditor indebtedness not exceeding $250,000[107]. - Unsecured indebtedness is capped at $500,000 at any time outstanding, with reimbursement obligations related to letters of credit not exceeding $200,000[108]. - Investments in newly-formed subsidiaries are allowed, provided they enter into a Joinder Agreement or Guaranty promptly after formation[111]. - Investments by a Loan Party in any Immaterial Subsidiary for clinical trial expenses are limited to $2,500,000 in the aggregate[111]. - Permitted Royalty Transactions can yield up to 7% of worldwide net sales or revenue in any calendar year[115]. - Transfers of assets with a fair market value not exceeding $500,000 in the aggregate are permitted in any fiscal year[116]. - Liens securing claims of materialmen and other similar persons are allowed if not delinquent or being contested in good faith[113]. - Indebtedness incurred in the ordinary course of business for netting services and overdraft protections is permitted[108]. - Investments consisting of loans to employees for purchasing equity securities are capped at $500,000 in aggregate[110]. - Extensions, refinancings, and renewals of permitted indebtedness are allowed without increasing the principal amount[108]. - The aggregate balance in the deposit account must not exceed $42,000 at any time[70].

Core Insights - Altimmune, Inc. is approaching significant milestones in the development of pemvidutide for metabolic dysfunction-associated steatohepatitis (MASH) and alcohol use disorder (AUD) [2][12] - The company has strengthened its executive leadership team with key appointments to support its growth strategy [2][9] - Financial results indicate a robust cash position and a reduction in research and development expenses compared to the previous year [7][19] MASH Program Updates - The 48-week data from the Phase 2b IMPACT trial of pemvidutide is expected to be released before the end of 2025 [2][12] - An End-of-Phase 2 meeting with the FDA is scheduled for the fourth quarter of 2025 to discuss the proposed design of the Phase 3 trial [5][12] - The trial design may include flexibility to adapt based on regulatory discussions regarding non-invasive tests and AI-based biopsy readings [2] AUD and ALD Trials - The RECLAIM trial for pemvidutide in AUD has completed patient recruitment ahead of schedule, indicating strong interest in new therapies for this condition [9][12] - The RESTORE trial for pemvidutide in alcohol-associated liver disease (ALD) has also been initiated, with a focus on safety and efficacy [9][12] Executive Leadership Changes - Recent appointments include Dr. Christophe Arbet-Engels as Chief Medical Officer, Linda Richardson as Chief Commercial Officer, and Robin Abrams as Chief Legal Officer [2][9] - These leaders bring extensive experience in clinical development, commercial strategy, and legal compliance to the company [9] Financial Performance - As of September 30, 2025, the company reported cash, cash equivalents, and short-term investments totaling approximately $211 million, a 60% increase from $131.9 million at the end of 2024 [7][19] - Research and development expenses decreased to $15 million from $19.8 million year-over-year, reflecting a strategic focus on cost management [19] - The net loss for the quarter was $19 million, or $0.21 per share, an improvement from a net loss of $22.8 million, or $0.32 per share, in the same period in 2024 [19]

Core Insights - Altimmune, Inc. has completed patient enrollment in the RECLAIM Phase 2 clinical trial for pemvidutide in adults with alcohol use disorder (AUD) ahead of schedule, indicating strong interest from the patient community [1][2] - The trial involves approximately 100 patients and aims to announce topline results in 2026 [1][2] - Pemvidutide is positioned as a potential therapeutic advance for AUD, targeting cravings and addressing alcohol-related liver damage [2][6] Company Overview - Altimmune is a late clinical-stage biopharmaceutical company focused on developing peptide-based therapeutics for liver and cardiometabolic diseases [9] - The lead product candidate, pemvidutide, is a dual receptor agonist targeting metabolic dysfunction-associated steatohepatitis (MASH), AUD, and alcohol-associated liver disease (ALD) [9] Clinical Trials - The RECLAIM trial evaluates the safety and efficacy of pemvidutide in AUD, with a primary endpoint of reducing heavy drinking days and secondary endpoints including changes in WHO risk drinking levels and serum biomarker levels [2][8] - Concurrently, Altimmune is enrolling patients in the RESTORE Phase 2 trial for ALD [3][8] - The FDA has granted Fast Track designations to pemvidutide for both MASH and AUD, highlighting the significant unmet medical need in these areas [7] Market Context - Approximately 28 million adults in the U.S. suffer from AUD, with a significant portion presenting with comorbidities such as obesity and liver fat [5] - Current FDA-approved treatments for AUD have limited efficacy and are used by less than 2% of patients, indicating a substantial unmet need for more effective therapies [5]

Core Insights - Altimmune, Inc. (ALT) is conducting multiple trials of pemvidutide, which allows the company to differentiate its asset in the market [1] - As of July, ALT was rated a hold, indicating a cautious approach to its stock performance [1] - The company has not yet secured a partner or been acquired, which may impact its future growth prospects [1] Company Overview - Altimmune is focused on trading around significant events such as trial results and NDA/BLA approvals, which are critical in the biotech sector [1] - The company operates in an industry regulated by the FDA, highlighting the importance of compliance and regulatory approvals for its products [1]

Core Points - Altimmune, Inc. is a late clinical-stage biopharmaceutical company focused on developing novel peptide-based therapeutics for liver and cardiometabolic diseases [3] - The company will report its third quarter 2025 financial results on November 6, 2025 [1] - A conference call will be held on the same day at 8:30 a.m. ET to discuss the financial results and provide a business update [2] Company Overview - Altimmune's lead product candidate is pemvidutide, a glucagon/GLP-1 dual receptor agonist targeting metabolic dysfunction-associated steatohepatitis (MASH), alcohol use disorder (AUD), alcohol-associated liver disease (ALD), and obesity [3] - The company is committed to developing innovative treatments for significant health issues related to liver and cardiometabolic conditions [3]

Summary of the Conference Call on Altimmune and Pemvidutide Company Overview - **Company**: Altimmune - **Product**: Pemvidutide - **Focus**: Clinical-stage biotechnology company developing treatments for metabolic dysfunction-associated steatohepatitis (MASH) Key Industry Insights - **Event**: HC Wainwright Virtual Liver Disease Conference - **Context**: The conference combined discussions on viral hepatitis, MASH, and liver cancer, highlighting the growing interest in liver disease therapeutics Core Points and Arguments 1. **Pemvidutide Mechanism**: Pemvidutide is a dual GLP-1/glucagon receptor agonist, designed to treat multiple components of MASH through direct liver effects and metabolic benefits [2][3] 2. **Clinical Data**: The 24-week study showed class-leading MASH resolution of approximately 59% of patients, with expectations for even better results at the upcoming 48-week data readout [5][8] 3. **Weight Loss and Liver Fat**: At the 1.8 mg dose, patients experienced over 6% weight loss, with about 50% normalizing liver fat [6][8] 4. **Tolerability Profile**: Pemvidutide demonstrated the lowest rates of adverse event discontinuations among incretins, with only 1% overall discontinuation due to adverse events [16][17] 5. **Regulatory Strategy**: The company is preparing for an end of phase 2 meeting with the FDA, focusing on the design of the phase 3 program and the potential use of non-invasive tests (NITs) as surrogates for biopsies [13][15] 6. **Market Opportunity**: MASH represents a significant commercial opportunity, targeting patients across various fibrosis stages (F2 to F4) [22][23] 7. **Competitive Positioning**: Altimmune believes that pemvidutide's dual mechanism provides a unique advantage over other therapies that typically focus on either metabolic or liver effects [20][25] Additional Important Insights - **Upcoming Milestones**: The company anticipates presenting 48-week data and having an end of phase 2 meeting with the FDA in the fourth quarter, which are critical for advancing to phase 3 trials [26] - **Combination Therapies**: There is a trend in the industry towards combination therapies for MASH, and pemvidutide's ability to address both liver and metabolic issues in a single molecule positions it favorably [24][25] - **Investor Sentiment**: The management team expressed confidence in pemvidutide's differentiation and readiness for phase 3, emphasizing the importance of upcoming data and regulatory discussions for investor interest [26] This summary encapsulates the key points discussed during the conference call, focusing on Altimmune's pemvidutide and its implications for the MASH treatment landscape.

Core Insights - Altimmune, Inc. is set to present 24-week efficacy and safety data from its Phase 2b IMPACT trial of pemvidutide for metabolic dysfunction-associated steatohepatitis (MASH) at The Liver Meeting 2025 [1][4] - The company anticipates announcing 48-week data in Q4 2025, indicating ongoing development and potential for further insights into the treatment's effectiveness [4] Presentation Details - The late-breaking presentations will focus on the recent 24-week data readout from the IMPACT Phase 2b trial [4] - A poster will feature AI-based analyses of liver fibrosis reduction, showcasing innovative approaches in the study [1][8] Study Overview - The IMPACT trial enrolled 212 participants with biopsy-confirmed MASH and fibrosis stages F2/F3, randomized to receive weekly subcutaneous pemvidutide doses of either 1.2 mg, 1.8 mg, or placebo for 24 weeks [5] - Key efficacy endpoints include MASH resolution without worsening of fibrosis and fibrosis improvement without worsening of MASH at 24 weeks, with secondary endpoints focusing on weight loss and non-invasive tests of fibrosis [5] About Pemvidutide - Pemvidutide is a novel peptide-based dual receptor agonist targeting GLP-1 and glucagon receptors, aimed at treating MASH, Alcohol Use Disorder (AUD), and Alcohol-Associated Liver Disease (ALD) [6] - The FDA has granted Fast Track designations for pemvidutide in both MASH and AUD, highlighting significant unmet medical needs in these areas [6] Company Background - Altimmune is a late clinical-stage biopharmaceutical company focused on developing peptide-based therapeutics for liver and cardiometabolic diseases, with pemvidutide as its lead product candidate [9]