The Complaint alleges that, throughout the Class Period, Defendants made materially false and misleading statements regarding the Company's business, operational and compliance policies. Specifically, the Complaint alleges Defendants made false and/or misleading statements and/or failed to disclose that: (i) the SkinTE IND was deficient with respect to certain Chemistry, Manufacturing, and Control items; (ii) as a result, it was unlikely that the FDA would approve the SkinTE IND in its current form; (iii) accordingly, the Company had materially overstated the likelihood that the SkinTE IND would obtain FDA approval; and (iv) as a result, the Company's public statements were materially false and misleading at all relevant times.