Longeveron Inc. — Third Quarter 2026 Earnings Summary

Financial Performance:

• Total revenues for the three months ended September 30, 2026, were $0.1 million, a 16% decrease from $0.1 million in the same period in 2025, driven by the absence of $43,000 in contract manufacturing revenue.
• Clinical trial revenue was $0.1 million for both the three months ended September 30, 2026, and September 30, 2025.
• Gross profit was approximately $0.1 million for the quarter ended September 30, 2026, a 43% decrease ($54,000) compared to the same period in 2025.
• General and administrative expenses were $3.3 million for the quarter ended September 30, 2026, an 8% decrease from $3.6 million in 2025, primarily due to a $0.9 million reduction in personnel costs, partially offset by increases in legal and finance fees.
• Research and development expenses were $4.0 million for the quarter ended September 30, 2026, a 3% increase from $3.9 million in 2025, driven by $0.7 million higher ELPIS II clinical trial expenses, partially offset by $0.6 million in technology transfer costs recorded in 2025.
• Other income was $1.1 million for the quarter ended September 30, 2026, compared to $0.1 million in 2025, primarily consisting of a $1.0 million XPRIZE Healthspan Milestone 2 Award and $0.1 million in interest income.
• Net loss was $6.1 million for the three months ended September 30, 2026, a 15% decrease from $7.2 million in the same period in 2025.
• Cash and cash equivalents were $7.2 million as of September 30, 2026, compared to $4.7 million as of December 31, 2025.
• Total liabilities were $7.3 million as of September 30, 2026, compared to $4.6 million as of December 31, 2025, including a new $778,000 liability related to the sale of future PRV proceeds.
• Accumulated deficit was $(149.3) million as of September 30, 2026, compared to $(132.3) million as of December 31, 2025.

Guidance and Future Outlook:

• The Company anticipates its existing cash and cash equivalents will fund operating expenses and capital expenditure requirements into the first quarter of 2027 based on current operating budgets and cash flow forecasts.
• The Company has requested a meeting with the FDA to review ELPIS II results to determine potential next steps for the HLHS development program.
• The Company is evaluating a range of strategic and financing alternatives, including a strategic partnership, additional financing, sale, merger, or business combination, with no definitive timeline for completion.
• The Company is seeking strategic collaborations or partnerships for the advancement of laromestrocel in addressing Alzheimer's disease.

Business Segments and Product Lines:

• HLHS: The ELPIS II Phase 2b clinical trial did not meet the primary efficacy endpoint of change from baseline in right ventricular ejection fraction (RVEF) at Month 12. However, laromestrocel was associated with fewer adjudicated clinical and safety events than the standard of care, with statistical significance in major adverse cardiac events (MACE) showing 8 events in the SOC arm versus 1 in the treatment arm (P=0.043).
• PDCM: The Investigational New Drug (IND) application for laromestrocel as a treatment for Pediatric Dilated Cardiomyopathy became effective in July 2025, enabling a direct move to a single Phase 2 registrational clinical trial.
• Alzheimer's Disease: The FDA has granted laromestrocel Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations for the treatment of mild Alzheimer's disease.
• Aging-related Frailty: Laromestrocel data from the Phase 2b clinical trial was published in Cell Stem Cell in February 2026.
• XPRIZE Healthspan: The Company was selected as a Finalist Team in the XPRIZE Healthspan global competition and received a $1.0 million Milestone 2 Award, with the opportunity to compete for a Grand Prize of up to $81 million.

Market and Competitive Landscape:

• HLHS is a rare pediatric congenital heart birth defect where the left ventricle is severely underdeveloped or missing; laromestrocel holds Orphan Drug, Fast Track, and Rare Pediatric Disease designations for this indication.
• Pediatric Dilated Cardiomyopathy (PDCM) affects nearly 40% of children requiring a heart transplant or resulting in death within two years of diagnosis.
• No FDA-approved therapies currently exist for Aging-related Frailty.

Risks and Challenges:

• There is no assurance that the strategic review process will result in any transaction or that such transaction will be completed on favorable terms.
• The exploration of strategic options may not result in a definitive transaction or enhance stockholder value and may create uncertainty affecting business, financial condition, or investor perception.
• The Company faces risks regarding the ability to successfully contain costs, attain future financing, or secure strategic partnerships on favorable terms.
• Clinical trials may fail to demonstrate safety and efficacy, and the Company may not reach alignment with the FDA on a path toward regulatory approval.
• The Company's cash position may be insufficient to fund future operations, potentially requiring additional capital that could be dilutive.

Management Commentary and Tone:

• CEO Stephen H. Willard stated that with ELPIS II results available, the Company has requested an FDA meeting to determine next steps for the HLHS program while continuing to review strategic alternatives to maximize stockholder value.
• The Company has implemented cash conservation measures to optimize cost containment.
• The Company determined not to hold a conference call to review third-quarter results due to the ongoing review of strategic alternatives.

Analyst Questions and Answers:

• No analyst questions and answers section is included in the press release.

Other Key Points:

• Lucid Capital Markets was retained as the Company's financial advisor to explore potential strategic opportunities, including a potential business combination.
• A 1-for-10 reverse split of Class A and Class B common stock became effective on August 26, 2026.
• Deborah Ascheim, M.D., was elected to the Board of Directors in July 2026.
• Nirav Jhaveri, CFA, was appointed Chief Financial Officer in August 2026.
• The Company received a $1.0 million Milestone 2 Award from the XPRIZE Healthspan competition in August 2026.