Larimar Therapeutics, Inc.

Current report

We initiated our rolling BLA submission to the FDA for marketing approval of nomlabofusp using the accelerated approval pathway and expect to submit the remaining modules in the second half of 2026; however, there can be no assurance that we will submit the remaining modules on our expected timeline, that the FDA will accept the BLA for filing or the FDA will approve our BLA submission for accelerated approval.

Current report

We submitted the first module of our BLA to the FDA in June 2026 to request marketing approval of nomlabofusp. We expect to submit the remaining modules in the second half of 2026. However, our anticipated submission timeline is based on our current development, manufacturing and regulatory plans and assumptions. The timing of submission of the remaining modules may be delayed for a variety of reasons, including for unforeseen reasons beyond our control, and even if we are able to complete our BLA submission on our anticipated timeline, the FDA may not accept or approve our BLA for a variety of reasons. There can be no assurance that the FDA will agree that the data submitted in the BLA is adequate to support approval, including accelerated approval. In addition, the FDA may refuse to accept our planned BLA for substantive review (thereby issuing a “refuse to file” letter) or may conclude after review of our data that our application is insufficient to obtain regulatory approval (thereby issuing a “complete response” letter). Further, as previously disclosed, the FDA stated that the adequacy of the safety database will be a matter of review at the time of BLA submission.

Current report

We also rely on third parties for non-clinical, clinical and manufacturing activities to support the conduct of our trials and our BLA submission. As part of the FDA review process, we are subject to inspections by FDA, as are each of our third-party sites, vendors and suppliers including our clinical sites, non-clinical sites and manufacturing sites, and there is no guarantee that these sites will pass the FDA’s inspection. Accordingly, any regulatory or other issues experienced by these third parties could impact the timing of our BLA submission or any subsequent approval. The FDA conducted a cGMP inspection of our third-party drug product (fill and finish) manufacturer related to the site’s processes and procedures and issued a Form 483 letter. The manufacturer has developed a remediation plan to address the FDA’s observations, but there can be no assurance that this plan will be adequate or address all the issues in a timely manner to the FDA’s satisfaction, which could result in a delay or warning letter. Our strategy is to to have back-up sources for key components in our supply chain. As we have done with our drug substance manufacturer, we are in the process of qualifying an additional drug product (fill and finish) manufacturer. The remediation of issues at our sites or vendors could have a material adverse effect on our business, operating results, financial condition and prospects.