Core Insights - Altimmune, Inc. announced significant results from the IMPACT Phase 2b trial of pemvidutide, demonstrating reductions in liver fibrosis and improvements in non-invasive tests compared to placebo at 24 weeks [1][2][5] Group 1: Trial Results - The AI-based pathology tool Liver Explore™ showed significant reductions in early, advanced, and total liver fibrosis areas with pemvidutide treatment compared to placebo at 24 weeks [2] - In the trial, 58% of patients achieved MASH resolution, indicating the efficacy of the glucagon/GLP-1 balanced approach in pemvidutide [5] - Statistically significant reductions in total liver fibrosis were observed, with 31% of patients in the 1.8 mg group achieving a ≥ 60% reduction compared to 8% in the placebo group [7] Group 2: Study Design - The IMPACT Phase 2b trial was a randomized, placebo-controlled, double-blind study involving 212 participants with biopsy-confirmed MASH and fibrosis stages F2 or F3 [6] - Participants were randomized to receive weekly subcutaneous doses of pemvidutide at either 1.2 mg, 1.8 mg, or placebo for 48 weeks, with key efficacy endpoints measured at 24 weeks [6] Group 3: Mechanism and Future Outlook - Pemvidutide is a novel investigational peptide with dual receptor agonist activity targeting both glucagon and GLP-1, aimed at treating MASH, AUD, and ALD [8] - The FDA has granted Fast Track designations for pemvidutide in treating MASH and AUD, highlighting the unmet medical need in these areas [9] - The final readout of the ongoing 48-week IMPACT trial is anticipated in the fourth quarter of 2025, which will include longer-term data on non-invasive tests and weight loss [9]

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]

Pemvidutide's Potential in Liver Diseases - Pemvidutide targets both liver and metabolic components with a differentiated 1:1 glucagon/GLP-1 ratio, showing potential in various steatotic liver diseases[10] - The IMPACT Phase 2b trial of Pemvidutide in MASH patients showed promising 24-week data, with 48-week data and an FDA meeting expected in Q4 2025[14] - Pemvidutide demonstrated a favorable tolerability profile with no dose titration, and a low rate of AEs leading to treatment discontinuation (1.2% in the 1.8 mg group)[55] MASH (NASH) Market and Clinical Data - The IMPACT Phase 2b trial enrolled 212 subjects with MASH (F2/F3), liver fat content ≥ 8%, and BMI ≥ 27.0 kg/m2, HbA1c < 9.5%[23] - Pemvidutide shows potential for best-in-class MASH resolution without worsening of fibrosis[24] - IMPACT data shows significant weight loss at 24 weeks, addressing an underlying cause of MASH[48] - In a Phase 2 obesity study, Pemvidutide demonstrated a lean loss ratio of 21.9% at 48 weeks, indicating class-leading lean mass preservation[52] AUD and ALD Programs - The RECLAIM Phase 2 trial enrollment for AUD is expected to be completed in Q4 2025, while the RESTORE Phase 2 trial for ALD was initiated in Q3 2025[14] - Approximately 66% of AUD patients have obesity or overweight, similar to ALD patients, making them potential targets for Pemvidutide treatment[60] - ALD patients are approximately 3 times more likely to have liver-related disease progression compared to MASH patients[65] Financial Position - The company reported $211 million in total cash as of September 30, 2025, with access to a $125 million credit facility[75] - The company's 9-month year-to-date operating expenses (OPEX) were $54.5 million[75]

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.