ADDED
All brand names or trademarks appearing in this Annual Report are the property of their respective owners.
We are substantially dependent on the success of our lead product candidate, telitacicept.
If we are unable to complete development of, obtain approval for and commercialize telitacicept in a timely manner, our business will be harmed.
We may derive results and data for telitacicept from clinical trials conducted by RemeGen in China; our access to the clinical results and data may be limited and there is no assurance that the clinical data from any such trials will be accepted or considered by the FDA, or other comparable regulatory authorities.
We are dependent on third parties accurately generating and reporting data related to our product candidate, and their conduct could adversely affect our business.
If we experience significant delays or difficulties in the enrollment or retention of patients in clinical trials, the cost of developing product candidates could increase and our receipt of necessary regulatory approvals could be delayed or prevented.
We will continue to contract with third parties for the manufacture and supply of materials for development of our product candidates, advancement of our current and future clinical trials, and potential commercialization of our product candidates.
This increases the risk that we will not have sufficient quantities and quality of such materials for the development of our product candidates, or that such supply will not be available to us at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.
("Vor Bio") is a clinical-stage biopharmaceutical company focused on developing a novel therapy in the treatment of autoimmune diseases.
In June 2025, we in-licensed telitacicept from RemeGen Co., Ltd.
REMOVED
All brand names or trademarks appearing in this Annual Report, including Mylotarg, are the property of their respective owners.
There is substantial doubt regarding our ability to continue as a going concern.
Engineered hematopoietic stem cells ( eHSCs ) is an emerging technology containing risk and might never lead to a commercially viable product.
We are substantially dependent on the success of our two most advanced product candidates, trem-cel and VCAR33 (previously called VCAR33 ALLO ).
If we are unable to complete development of, obtain approval for and commercialize trem-cel or VCAR33 in a timely manner, our business will be harmed.
2 We may not be successful in our efforts to identify, develop or commercialize additional product candidates.
If these efforts are unsuccessful, we may never become a commercial stage company or generate any revenues.
We are in the early stages of testing some of our product candidates in clinical trials and any favorable preclinical results are not predictive of results that may be observed in clinical trials.
Development of a product candidate such as trem-cel, which is intended for use in combination or in sequence with an already approved therapy, will present increased complexity and more or different challenges than development of a product candidate for use as a single agent.
Adverse public perception of genetic medicines, and of genome engineering in particular, including as a result of other trials out of our control, such as the VCAR33 AUTO trial currently sponsored by NMDP, may negatively impact regulatory approval of, and/or demand for, our potential products.