LGVN — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-13

• our ability to successfully transition toward a more capital-efficient, asset-light operating model;

• our ability to secure one or more strategic licensing partnerships for our investigational product candidates in our development programs;

• the receipt of results from our clinical trials and other available evidence sufficient to support filings for regulatory approval of our investigational product candidates, including a potential future Biologics License Application with the FDA in the U.S. following the readout of top-line results …

• the willingness of regulatory authorities, including the FDA in the U.S., to deem any of our clinical trials (including ELPIS II) as pivotal or to otherwise reach alignment with us on a potential path toward regulatory approval of our investigational product candidates;

• our ability to obtain and maintain regulatory approval of our investigational product candidates in the U.S. and other jurisdictions;

Text removed vs the prior filing · source: 10-Q · 2025-11-04

• our ability to obtain and maintain regulatory approval of our investigational product candidates in the U.S., and other jurisdictions;

• the potential disruptive impact of the ongoing U.S. federal government shutdown upon our operations, clinical development programs, and capital raising efforts;

• The forward-looking statements contained in this 10-Q are made on the basis of the views and assumptions of management regarding future events and business performance as of the date this 10-Q is filed with the Securities and Exchange Commission (the “SEC”). We have based these forward-looking state…

• statements speak only as of the date of this 10-Q and are subject to a number of risks, uncertainties and assumptions described in the section titled “Risk Factors” and elsewhere in this 10-Q. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot …

• We are a clinical stage biotechnology company developing regenerative medicines to address unmet medical needs. Our lead investigational product candidate is laromestrocel, formerly referred to as Lomecel-B™.