Longeveron Inc.

Except with respect to the item noted below, there have been no material changes to the risk factors affecting the Company from those disclosed in the 2024 Form 10-K.

Our CMC readiness and ability to manufacture for commercialization may be delayed or unsuccessful.

Our BLA-enabling activities, including comparability protocols, process and analytical method validation are complex and subject to regulatory review. Any delays or failures in these activities could impact our ability to meet regulatory and investor expectations for product approval or commercial launch of our product candidates. Our ability to complete BLA-enabling activities may impact the clinical and commercial success of our current and any future product candidates. In addition, the FDA or other relevant regulatory authorities may find our CMC data insufficient to support the quality of our product candidates. The FDA’s approval of a BLA is not guaranteed, and the review and approval process is expensive, uncertain and may take several years. The FDA also has substantial discretion in the approval process. These matters are subject to confirmation and interpretation by regulatory authorities, which could delay, limit, or prevent regulatory approval. Our clinical development efforts may fail at any stage. Our financial condition may be materially adversely affected by any delay or inability to complete our CMC readiness and BLA-enabling activities.