investment in our common stock involves a number of very significant risks.
−Removed: You should carefully consider the risk factors included in
−Removed: the “Risk Factors” section of Amendment No.
−Removed: 1 to our Annual Report on Form 10-K/A for the year ended December 31, 2023, as
−Removed: filed with the SEC on June 11, 2024, in addition to other information contained in that report and in this quarterly report in evaluating
−Removed: the Company and its business before purchasing shares of our Common Stock.
−Removed: The Company’s business, operating results and financial
−Removed: condition could be adversely affected due to any of those risks.
+Added: You should carefully consider the risk factor set forth below,
+Added: the risk factors included in the “Risk Factors” section of Amendment No.
+Added: 1 to our Annual Report on Form 10-K/A for the year
+Added: ended December 31, 2023, as filed with the SEC on June 11, 2024, and the other information contained in that report and in this quarterly
+Added: report in evaluating the Company and its business before purchasing shares of our common stock.
+Added: The Company’s business, operating
+Added: results and financial condition could be adversely affected due to any of those risks.
+Added: Related to Our Cell Therapy Product Development Efforts
+Added: activity as a contract manufacturer of biologic-based cosmetics could result in FDA enforcement for reasons outside of our control, which
+Added: could disrupt the development of our own product candidates or harm our reputation.
+Added: manufacture a commercial product as a contract manufacturer for a third-party company, Cartessa Aesthetics, LLC (“Cartessa”).
+Added: While we believe the product we manufacture for Cartessa is intended for cosmetic uses, we (as the contract manufacturer) do not ultimately
+Added: have control over how the product is marketed.
+Added: It is possible that the FDA could determine, based on how the product is marketed (among
+Added: other considerations), that it is intended for unapproved therapeutic use(s), which could result in the temporary or permanent suspension
+Added: of manufacturing and/or commercialization of the product and/or a wide range of enforcement actions, such as warning letters, recall,
+Added: ‘dear doctor’ letters, and others.
+Added: If the FDA takes enforcement action against Cartessa or us in connection with this product,
+Added: it could have an adverse impact on our operations and/or harm our reputation as a biologics company.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.