Altimmune, Inc. (ALT): Business Model Canvas [Dec-2025 Updated]

You're looking at a biotech, Altimmune, Inc. (ALT), that's definitely at a critical inflection point: the whole business model boils down to the success of one drug, pemvidutide, as they stand on the brink of Phase 3 trials for MASH. Honestly, the quick math shows they are running on a cash pile of $210.8 million (Q3 2025) to fund those expensive trials, which drove R&D costs to $15.0 million that same quarter, while current revenue is practically zero at $5K. As an analyst, mapping out their Business Model Canvas reveals a high-touch relationship with the FDA and key partners like CROs, all while they manage a cost structure dominated by clinical execution and zero commercial sales yet. Dive in below to see the nine building blocks of this high-stakes bet, from their value proposition of dual agonism to their future revenue streams dependent on licensing or eventual sales.

Altimmune, Inc. (ALT) - Canvas Business Model: Key Partnerships

You're looking at the external relationships Altimmune, Inc. (ALT) relies on to push pemvidutide through late-stage development as of late 2025. These partnerships are critical, especially given the company's focus on securing capital through debt rather than upfront commercial deals right now.

Clinical Research Organizations (CROs) for Phase 2/3 trial execution

Altimmune, Inc. relies on external CROs to manage the execution of its ongoing Phase 2 trials, specifically RECLAIM for Alcohol Use Disorder (AUD), which initiated in May 2025, and RESTORE for Alcohol-Associated Liver Disease (ALD), which began in July 2025. The company is also preparing for a potential Phase 3 trial in MASH following its End-of-Phase 2 meeting with the FDA scheduled for the fourth quarter of 2025. The financial impact of these external services is visible in the operating expenses; Research and development expenses for the three months ended September 30, 2025, were $15.0 million, with a noted decrease related to the timing of CRO development costs.

Hercules Capital for the $125 million credit facility financing

The financing structure with Hercules Capital, Inc. is a key partnership for extending the cash runway. Altimmune, Inc. amended its Loan and Security Agreement with Hercules Capital on November 5, 2025, increasing the available term loan from $100 million to $125 million. Upon this amendment, the company drew an additional $20 million. The original agreement, announced in May 2025, included an initial tranche of $15 million funded at closing, with an additional $25 million available in 2025 subject to milestones. The loan matures 48 months from closing and features an interest-only period for the first 24 months, extendable up to 42 months upon milestone achievement. The interest rate structure included a rate of the greater of prime rate plus 2.45% or (9.95% until December 31, 2025, and 9.45% thereafter). The end-of-term charge is set at 6.25% of the funded loan amount. As of September 30, 2025, Altimmune, Inc. reported cash, cash equivalents, and short-term investments totaling $210.8 million.

Academic Key Opinion Leaders (KOLs) for clinical trial design and data presentation

Academic experts are integral to validating and designing the clinical path for pemvidutide. Dr. Rohit Loomba, who is a Professor of Medicine, Chief of the Division of Gastroenterology and Hepatology, and Director of the MASLD Research Center at the University of California, San Diego, is serving as the principal investigator for the RESTORE Phase 2 trial in ALD. Furthermore, the Chief Medical Officer indicated flexibility in Phase 3 design to potentially pivot to non-invasive endpoints (NITs) and AI-based biopsy readings, pending alignment with the FDA following the End-of-Phase 2 meeting in the fourth quarter of 2025.

Contract Manufacturing Organizations (CMOs) for drug substance and product supply

While specific CMO names aren't detailed in the latest public filings, the operational reliance on external manufacturing partners is implied by the R&D spend structure. The R&D expense of $15.0 million for the third quarter of 2025 reflects costs associated with clinical development, which includes activities managed by CMOs for drug substance and product supply for the ongoing trials.

No major commercialization partner for pemvidutide as of late 2025

The focus of Altimmune, Inc.'s recent activities has been on advancing clinical data and securing non-dilutive financing, rather than establishing a co-commercialization agreement. The company recently strengthened its executive team with the appointment of a Chief Commercial Officer (CCO) in the third quarter of 2025, suggesting internal preparation for future commercial activities.

Key operational milestones tied to these partnerships include:

• Phase 2 trial initiation for AUD (RECLAIM) in May 2025.
• Phase 2 trial initiation for ALD (RESTORE) in July 2025.
• End-of-Phase 2 Meeting with the FDA for MASH scheduled for the fourth quarter of 2025.
• 48-week data from the IMPACT Phase 2b MASH trial expected before year-end 2025.

The financial health supporting these partnerships is summarized below:

Altimmune, Inc. (ALT) - Canvas Business Model: Key Activities

You're looking at the core engine driving Altimmune, Inc. (ALT) right now-the hands-on work that needs to happen to move pemvidutide forward. It's all about execution on the clinic and managing the money to get there.

Executing Phase 2b IMPACT trial for MASH and Phase 2 RECLAIM/RESTORE trials

The clinical pipeline is the main focus for Key Activities. The Phase 2b IMPACT trial for Metabolic Dysfunction-Associated Steatohepatitis (MASH) is nearing a major data point.

• The IMPACT trial enrolled 212 participants with biopsy-confirmed MASH and fibrosis stages F2 or F3.
• 24-week data previously showed up to 59.1% MASH resolution without worsening of fibrosis.
• The final readout of longer-term non-invasive tests (NITs) and weight loss data at 48 weeks of treatment is expected in the fourth quarter of 2025.

Beyond MASH, the company is running two other Phase 2 trials, both initiated in 2025.

Enrollment in the RECLAIM trial finished several months ahead of schedule.

Advancing regulatory strategy via End-of-Phase 2 meetings with the FDA

Regulatory alignment is critical to planning the next step, Phase 3 development for the MASH program.

• An in-person End-of-Phase 2 Meeting with the FDA for the MASH program is scheduled for the Fourth Quarter (Q4) of 2025.
• The goal of this meeting is to seek alignment with the FDA on the proposed design of the Phase 3 MASH trial.
• The FDA granted Fast Track Designation for pemvidutide in both MASH and AUD.

This designation helps streamline the approval process and potentially reduce development costs.

Research and Development (R&D) for pemvidutide's oral formulation

While specific spending on the oral formulation isn't broken out, general R&D activity related to pemvidutide development is tracked in the financials.

• Research and development expenses for the three months ended September 30, 2025, totaled $15.0 million.
• For the three months ended March 31, 2025, R&D expenses were $15.8 million, which included $9.2 million in direct costs related to pemvidutide development activities.

The company is focused on developing pemvidutide as a peptide-based therapeutic leveraging its 1:1 glucagon/GLP-1 dual receptor agonist activity.

Securing non-dilutive financing and managing the capital structure

Managing the balance sheet to fund these trials is a key activity, often involving debt facilities.

• Cash, cash equivalents, and short-term investments stood at $210.8 million as of September 30, 2025.
• This cash position represents an increase of approximately 60% compared to $131.9 million at December 31, 2024.
• Altimmune, Inc. amended its debt facility with Hercules Capital, increasing the overall size from $100 million to $125 million.
• The Company drew an additional $20 million upon execution of this amendment.

The net loss for the three months ended September 30, 2025, was $19.0 million.

Altimmune, Inc. (ALT) - Canvas Business Model: Key Resources

You're looking at the core assets Altimmune, Inc. (ALT) is relying on right now to push pemvidutide through late-stage development and toward commercial readiness. These aren't just ideas; they are hard numbers and regulatory statuses that define their current operational capacity.

The most immediate, tangible resource is the capital base. As of the third quarter of 2025, Altimmune, Inc. reported cash, cash equivalents, and short-term investments totaling $210.8 million as of September 30, 2025. That figure represents a significant strengthening of the balance sheet, showing an increase of approximately 60% compared to the $131.9 million they held at the close of 2024. This cash position is intended to bridge operations well into 2026 and 2027. Still, this is a clinical-stage company, so operating burn is present; the net loss for Q3 2025 was $19.0 million, with Research and development expenses for that quarter coming in at $15.0 million.

The intellectual property surrounding pemvidutide is central. This asset is the proprietary GLP-1/glucagon dual receptor agonist Intellectual Property, which is the basis for their lead candidate targeting Metabolic Dysfunction-Associated Steatohepatitis (MASH), Alcohol Use Disorder (AUD), and Alcohol-Associated Liver Disease (ALD). The mechanism itself is a key resource, leveraging balanced 1:1 glucagon/GLP-1 dual receptor agonist activity.

Regulatory advantages act as significant non-financial resources that de-risk the development timeline. Altimmune, Inc. has secured specific designations that streamline development and review:

• FDA Fast Track designation granted for pemvidutide for the treatment of MASH.
• FDA Fast Track designation granted for pemvidutide for the treatment of Alcohol Use Disorder (AUD), granted in August 2025.

Key near-term milestones tied to these resources include the expected 48-week readout from the ongoing IMPACT Phase 2b MASH trial before the end of 2025, and the scheduled in-person End-of-Phase 2 Meeting with the FDA in the fourth quarter of 2025 to align on Phase 3 design.

The human capital, the core executive team focused on clinical development and commercial planning, has been actively reinforced. This team, led by President and Chief Executive Officer Vipin K. Garg, Ph.D., recently saw strategic additions to prepare for the transition to a pre-commercial entity.

• Strengthened executive leadership with appointments of a Chief Medical Officer (CMO), Chief Commercial Officer (CCO), and Chief Legal Officer (CLO) in late 2025.
• The Board of Directors expanded in February 2025 with Teri Lawver, former CCO of Dexcom, and Jerry Durso, former CEO of Intercept Pharmaceuticals, to guide commercialization strategy.
• The team has demonstrated execution capability, completing patient enrollment for the RECLAIM Phase 2 trial in AUD several months ahead of schedule.

Here's a quick look at the financial and clinical status as of the Q3 2025 update:

Altimmune, Inc. (ALT) - Canvas Business Model: Value Propositions

Pemvidutide is Altimmune, Inc. (ALT)'s lead product candidate, a GLP-1/glucagon dual receptor agonist designed to target both the hepatic and metabolic drivers of Metabolic dysfunction-associated steatohepatitis (MASH). This dual agonism is key to its differentiated profile for MASH resolution and weight management.

The potential for class-leading efficacy in liver fat reduction was suggested by data from a Phase 1b trial in MASLD (Metabolic dysfunction-associated steatotic liver disease), where relative liver fat content reduction reached up to 76% after 24 weeks at the 1.8mg and 2.4mg doses. More detailed Phase 1b data showed a reduction in Liver Fat Content (LFC) relative to baseline by up to 68.5% after 12 weeks of treatment in subjects with LFC $\ge$10%.

The 24-week data from the Phase 2b IMPACT trial demonstrated statistically significant MASH resolution without worsening of fibrosis, with the highest rate observed at 59.1% in the intent-to-treat analysis for the 1.2 mg dose, compared to 19.1% for placebo. The potential for this therapy is further supported by the following clinical performance metrics:

Clinically meaningful weight loss is a core component of the value proposition, with the IMPACT trial showing up to 6.2% weight loss at 24 weeks with no plateauing. Furthermore, the profile suggests favorable lean mass preservation, as one prior obesity study indicated only 22% lean mass loss in the context of a 15.6% relative weight loss over 52 weeks at the highest dose.

The administration method is designed for patient convenience, requiring a single, once-weekly subcutaneous injection. The IMPACT trial evaluated fixed weekly doses of 1.2 mg and 1.8 mg. Treatment discontinuation rates due to adverse events were low, with 0% and 1% in the respective treatment groups compared to 2% in placebo at 24 weeks.

The continued development of this asset is supported by the company's balance sheet, which reported cash, cash equivalents and short-term investments totaling $210.8 million as of September 30, 2025. Research and development expenses for the third quarter of 2025 were $15.0 million.

Altimmune, Inc. (ALT) - Canvas Business Model: Customer Relationships

You're looking at how Altimmune, Inc. (ALT) manages its critical external relationships as it moves toward potential Phase 3 planning for pemvidutide. This is all about direct, high-stakes dialogue with regulators, clinicians, and the capital markets.

Direct, high-touch engagement with the FDA for Phase 3 alignment

The relationship with the U.S. Food and Drug Administration (FDA) is centered on securing alignment for the next stage of development for pemvidutide in Metabolic Dysfunction-associated Steatohepatitis (MASH). The company has a scheduled, in-person End-of-Phase 2 Meeting with the FDA set for the fourth quarter of 2025. This meeting is specifically to seek agreement on the proposed design for the Phase III MASH trial. The strength of the 24-week data from the IMPACT Phase 2b trial supported the granting of this meeting. The planned Phase III design includes flexibility to potentially adopt non-invasive tests (NITs) and AI-based biopsy readings as approvable endpoints, pending regulatory discussions.

Close collaboration with Principal Investigators (PIs) at clinical trial sites

Collaboration with clinical investigators is evidenced by the data presentation schedule and trial enrollment success. Dr. Mazen Noureddin, identified as the lead investigator on the IMPACT trial, delivered a late-breaking oral presentation on the 24-week IMPACT results at The Liver Meeting® 2025. Furthermore, the RECLAIM Phase 2 trial in Alcohol Use Disorder (AUD) completed recruitment and randomization ahead of schedule, which signals strong engagement from the participating sites and investigators. The RESTORE Phase 2 trial for Alcohol-Associated Liver Disease (ALD), initiated in July 2025, is also currently enrolling subjects.

Investor Relations (IR) via conferences and webcasts to manage capital market perception

Altimmune, Inc. (ALT) actively manages capital market perception through frequent communication, especially following key data releases. The company reported its third quarter 2025 financial results on November 6, 2025, via a conference call and webcast at 8:30 a.m. ET. The replay of this call is available on the Investor Relations website for up to three months. The company strengthened its financial footing, reporting $210.8 million in cash, cash equivalents, and short-term investments as of September 30, 2025. To support future development, filings were made for a $400 million shelf registration and a $200 million At-The-Market (ATM) facility. The IR team was active in presenting data and updates to the investment community.

Scientific communication with hepatology and endocrinology KOLs

Scientific communication targets Key Opinion Leaders (KOLs) in relevant therapeutic areas. The presentation of data at AASLD The Liver Meeting® 2025, including a late-breaking oral presentation on the 24-week IMPACT trial results, directly engages the hepatology community. The Chief Commercial Officer noted plans to rekindle relationships with folks in hepatology and gastroenterology through meetings set up around this event. Furthermore, early commercial research indicated strong potential adoption interest from prescribers; specifically, 70% to 80% of surveyed physicians indicated a high or very high likelihood to prescribe Pemvidutide based on a blinded profile.

• IND applications for AUD and ALD were cleared by the FDA in the first quarter of 2025.
• The RECLAIM AUD trial completed enrollment ahead of schedule.
• The RESTORE ALD trial was initiated in July 2025.
• The 48-week data readout from the IMPACT trial is expected before the end of 2025.

Altimmune, Inc. (ALT) - Canvas Business Model: Channels

The channels Altimmune, Inc. (ALT) uses to reach its customer segments and disseminate critical information are multifaceted, spanning clinical operations, scientific engagement, regulatory dialogue, and investor relations.

Global clinical trial sites for patient recruitment and data generation

Patient recruitment relies on a network of clinical sites, primarily within the U.S. for current key trials. The speed of enrollment indicates strong site engagement and patient interest in the investigational product, pemvidutide.

• RECLAIM Phase 2 trial in Alcohol Use Disorder (AUD) enrolled approximately 100 patients across sites in the U.S..
• Enrollment for the RECLAIM trial was completed several months ahead of schedule on November 3, 2025.
• The IMPACT Phase 2b trial for Metabolic Dysfunction-Associated Steatohepatitis (MASH) evaluated 212 patients.

Here's a quick look at the Phase 2 trial timelines and patient numbers:

Scientific and medical conferences (e.g., AASLD) for data dissemination

Altimmune, Inc. (ALT) actively uses major medical and investor conferences to present clinical data and engage with the scientific community. The American Association for the Study of Liver Diseases (AASLD) meeting is a key venue for MASH data.

• Presented at AASLD The Liver Meeting® 2025 in November 2025, including a late-breaking oral presentation on 24-week IMPACT data.
• Presented poster on AI-Based Digital Pathology Analysis: Results from the Pemvidutide Phase 2b IMPACT Trial on November 6, 2025.
• Participated in the Piper Sandler 37th Annual Healthcare Conference on December 3, 2025.
• Participated in the Jefferies Global Healthcare Conference on November 20, 2025.
• Participated in the Stifel 2025 Healthcare Conference on November 12, 2025.

A snapshot of recent investor and scientific engagements in late 2025:

Direct communication with regulatory bodies like the U.S. FDA

Direct dialogue with the U.S. Food and Drug Administration (FDA) is critical for aligning on future development paths, especially for the lead candidate, pemvidutide.

• An in-person End-of-Phase 2 meeting with the FDA for the MASH program was scheduled for the fourth quarter of 2025.
• The company sought alignment with the Agency on the proposed Phase 3 MASH trial design.
• The FDA granted Fast Track designation to pemvidutide for both MASH and Alcohol Use Disorder (AUD).
• Investigational New Drug (IND) applications for AUD and ALD trials received FDA clearance in the first quarter of 2025.

Investor presentations and press releases to communicate milestones

Investor communications are used to update on financial health and clinical progress, which directly impacts valuation and funding flexibility. The company made three senior hires (CMO, CCO, CLO) to bolster leadership.

Financial status as of the Q3 2025 report on November 6, 2025:

• Cash, cash equivalents and short-term investments totaled $210.8 million as of September 30, 2025.
• This represented an approximate 60% increase compared to December 31, 2024.
• Research and development expenses for Q3 2025 were $15.0 million.
• The net loss for Q3 2025 was $19.0 million, or -$0.21 per share.

Key milestones communicated via press releases and investor calls in late 2025:

The company also secured a credit facility with Hercules Capital, with an initial tranche of $15 million funded, and an additional $100 million facility available across tranches.

Altimmune, Inc. (ALT) - Canvas Business Model: Customer Segments

You're looking at the specific patient populations Altimmune, Inc. (ALT) is targeting with pemvidutide right now, late in 2025. This is where the near-term value is tied up, especially with key data releases imminent.

Patients with Metabolic Dysfunction-Associated Steatohepatitis (MASH) with F2/F3 fibrosis.

The primary focus for Altimmune, Inc. is on patients with MASH who also have significant liver scarring, specifically fibrosis stages F2 or F3. This group represents a substantial, high-need patient pool in the US market.

• Estimated US population with MASH and clinically significant liver disease (F2/F3): nearly 9 million individuals.
• In the pivotal IMPACT Phase 2b trial, participants had biopsy-confirmed MASH with fibrosis stages F2 or F3.
• Of the 212 participants randomized in the IMPACT trial, 55% had F2 fibrosis and 45% had F3 fibrosis.
• The FDA granted Fast Track designation to pemvidutide for MASH treatment.

Here's a snapshot of the efficacy seen in the target population from the 24-week data of the IMPACT trial:

Also, remember that the 48-week data readout from this trial is expected before the end of the fourth quarter of 2025, which will give us a longer view of durability.

Patients with Alcohol Use Disorder (AUD) and Alcohol-Associated Liver Disease (ALD).

Altimmune, Inc. is expanding pemvidutide into the AUD and ALD space, which also carries a significant unmet need and large patient numbers. The FDA has granted Fast Track designation for AUD as well.

• Estimated US population with Alcohol Use Disorder (AUD) in the last year: 28 million people ages 12 or older.
• The Phase 2 trial for AUD, called RECLAIM, enrolled approximately 100 patients across US sites and completed enrollment early.
• The Phase 2 trial for ALD, called RESTORE, was initiated in July 2025 and is currently enrolling.
• Alcohol-related liver disease has more than doubled in the last 20 years.
• From 2010 to 2016, 1 in 3 liver transplants were the result of alcohol-related liver disease.

The customer base here is defined by the condition severity and treatment history. The RECLAIM trial is evaluating pemvidutide in AUD subjects with obesity or who are overweight.

Prescribing physicians: Hepatologists, Gastroenterologists, and Endocrinologists.

The specialists who will ultimately prescribe pemvidutide are those deeply involved in managing complex liver and metabolic conditions. You see this reflected in the key opinion leaders involved in the clinical program.

• Key opinion leaders presenting data at The Liver Meeting® 2025 included a Transplant Hepatologist and a Professor of Medicine specializing in Gastroenterology and Hepatology.
• The MASH indication inherently targets Hepatologists and Gastroenterologists who manage fibrosis progression.
• The dual mechanism of action (glucagon/GLP-1 agonist) also brings in Endocrinologists due to the strong weight loss and metabolic effects seen in trials.

Future commercial partners and global pharmaceutical companies.

The need for commercial partners is driven by the capital required to execute large-scale Phase 3 trials and subsequent global commercialization. Altimmune, Inc. is clearly managing its cash burn to reach these inflection points.

• Cash, cash equivalents, and short-term investments as of September 30, 2025: $210.8 million.
• Net loss for the third quarter of 2025 was $19.0 million.
• Research and development expense for Q3 2025 was $15.0 million.

The company is approaching an End-of-Phase 2 meeting with the FDA in the fourth quarter of 2025, which will directly influence the design and cost of the Phase 3 program, a key factor for any potential partner discussion.

Altimmune, Inc. (ALT) - Canvas Business Model: Cost Structure

You're looking at the expense side of Altimmune, Inc. (ALT) as they push pemvidutide through late-stage development. For a clinical-stage biotech, the cost structure is almost entirely driven by the science and the trials needed to get regulatory approval. Here's a breakdown based on the third quarter of 2025.

The dominant cost is definitely Research and Development (R&D), which is where the bulk of the cash goes to fund the clinical programs. For the three months ended September 30, 2025, Altimmune, Inc. reported R&D expenses totaling $15.0 million.

Supporting the R&D engine is the necessary overhead, categorized as General and Administrative (G&A) expenses. In Q3 2025, these overhead costs were reported at $5.9 million. This figure was higher than the $5.0 million reported in the same period in 2024, primarily due to increases in professional fees and non-cash stock-based compensation.

The R&D spend itself has a clear focus, heavily weighted toward the lead candidate, pemvidutide. The total Q3 2025 R&D spend of $15.0 million included specific direct costs allocated to the various development efforts. Honestly, seeing this breakdown helps you understand where the burn rate is going.

The costs associated with advancing pemvidutide into later-stage planning are significant, particularly for the MASH program, which is gearing up for Phase 3. The R&D costs for the quarter reflect these critical activities:

• Direct costs related to pemvidutide development activities totaled $9.2 million.
• Of that, approximately $3.7 million was allocated to the ongoing IMPACT Phase 2b trial.
• Start-up costs for the Alcohol Use Disorder (AUD) and Alcohol-Associated Liver Disease (ALD) trials (RECLAIM and RESTORE) accounted for roughly $3.4 million.
• Chemistry, Manufacturing, and Controls (CMC) activities, which cover clinical manufacturing needs, were about $1.3 million.

Financing costs are another structural element, tied to the debt facility Altimmune, Inc. uses to supplement its cash position. You know that cash, cash equivalents, and short-term investments stood at $210.8 million as of September 30, 2025. To support this, the company amended its credit facility with Hercules Capital. The available term loan was increased from $100 million to $125 million, and the interest-only period was extended. While the specific Q3 2025 interest expense related to this facility isn't itemized separately from G&A in the summary data, the facility amendment itself signals a planned increase in future debt-related costs, though the company did report $2.4 million in interest income for the quarter.

Altimmune, Inc. (ALT) - Canvas Business Model: Revenue Streams

For Altimmune, Inc. (ALT) as of late 2025, the revenue streams are heavily weighted toward non-operational funding sources, given its late clinical-stage status. The current, minimal revenue is distinct from the significant capital raised through financing activities necessary to fund its development pipeline, particularly pemvidutide.

Current Minimal Revenue

The reported revenue for the third quarter of 2025 was extremely low, typical for a pre-commercial biopharmaceutical company focused on R&D. This small amount is primarily attributed to non-sales related income, such as grants.

• Minimal current revenue reported for Q3 2025: $5K (or $0.005 million).
• This revenue was primarily sourced from grants.

Financing and Capital Inflow

To bridge the gap until potential commercialization, Altimmune, Inc. relies on strategic financing. This includes debt amendments and the filing of large-scale equity facilities to ensure sufficient cash runway for pivotal studies.

Future Potential Revenue Streams

The primary long-term revenue potential for Altimmune, Inc. is tied directly to the clinical and regulatory success of its lead candidate, pemvidutide, across its targeted indications (MASH, AUD, ALD).

• Future potential for upfront payments from a licensing partnership.
• Potential milestone payments contingent on clinical trial success or regulatory filings.
• Potential royalties or profit-sharing from eventual commercial sales of pemvidutide.