Financial Overview and Analysis of Longeveron Inc.

Longeveron Inc. is a clinical-stage biotechnology company developing regenerative medicines to address unmet medical needs. The company’s lead investigational product is Lomecel-B™ (laromestrocel), which has multiple modes of action including pro-vascular, pro-regenerative, and anti-inflammatory mechanisms. Longeveron is currently pursuing three pipeline indications for Lomecel-B™: Hypoplastic Left Heart Syndrome (HLHS), Alzheimer’s disease (AD), and Aging-related Frailty.

Revenue and Profit Trends

For the three months ended March 31, 2025, Longeveron reported revenues of $381,000, down from $548,000 in the same period in 2024. This 30% decrease was driven primarily by lower participant demand for the company’s Bahamas Registry Trials, partially offset by an increase in contract manufacturing revenue.

Cost of revenues decreased from $219,000 in Q1 2024 to $106,000 in Q1 2025, resulting in a gross profit of $275,000 and $329,000 for the respective periods. The flat year-over-year gross profit comparison reflects the offsetting effects of lower clinical trial revenue and higher contract manufacturing revenue.

Operating expenses increased from $4.4 million in Q1 2024 to $5.5 million in Q1 2025, a 23% rise. This was driven by a $0.7 million increase in general and administrative expenses, primarily related to higher personnel and equity-based compensation costs, as well as a $0.3 million increase in research and development expenses, mainly due to higher personnel, patent amortization, and supply costs.

The company reported a net loss of $5.0 million in Q1 2025, up from $4.1 million in the prior year period. This 23% increase in net loss was due to the factors outlined above.

Strengths and Weaknesses

Strengths:

• Diversified pipeline with three potential indications for lead product Lomecel-B™
• Positive clinical data for Lomecel-B™ in HLHS and Alzheimer’s disease
• Regulatory designations (Rare Pediatric Disease, Orphan Drug, Fast Track) for HLHS program
• In-house manufacturing capabilities and cGMP facility
• Non-dilutive grant funding to support research and development

Weaknesses:

• Recurring net losses and negative cash flows from operations
• Reliance on external funding sources (equity, debt, grants) to finance operations
• Limited commercial revenue, with most revenue coming from registry trials and contract manufacturing
• Uncertainty around future financing and ability to continue as a going concern

Outlook and Future Prospects

Longeveron’s future prospects hinge largely on the successful advancement of its Lomecel-B™ pipeline, particularly in the HLHS and Alzheimer’s disease indications. The company has made important regulatory and clinical progress in these areas:

• For HLHS, Longeveron is conducting a pivotal Phase 2b ELPIS II trial, which could support a future Biologics License Application (BLA) filing with the FDA if successful. The company has received Rare Pediatric Disease, Orphan Drug, and Fast Track designations for Lomecel-B™ in HLHS.

• In Alzheimer’s disease, Longeveron completed a positive Phase 2a CLEAR MIND trial, which demonstrated safety and potential therapeutic benefit of Lomecel-B™. The FDA has granted the program Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations.

However, the company faces significant challenges in funding these late-stage development programs. As of March 31, 2025, Longeveron had $14.3 million in cash, which it estimates will be sufficient to fund operations into the third quarter of 2025. The company will need to secure additional financing, through equity, debt, partnerships, or non-dilutive funding sources, to advance its pipeline and continue operations.

Longeveron’s management has expressed substantial doubt about the company’s ability to continue as a going concern, citing the need for additional capital and the risks and uncertainties associated with its clinical development programs. The successful execution of the company’s financing plans is critical to its future prospects.

If Longeveron is able to obtain the necessary funding and successfully advance its lead programs, particularly in HLHS and Alzheimer’s disease, the company could be well-positioned to bring novel regenerative therapies to patients with high unmet medical needs. However, the path forward remains uncertain, and investors should carefully consider the risks and challenges outlined in the company’s financial report.