Company: FTII
Filing Date: 2025-02-14
Form Type: S-4
Source: 0001493152-25-006997
Chunk: 145

Company: FutureTech II Acquisition Corp.
Filing Date: 2025-02-14
Form: S-4
Chunk 145
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render further development impossible. In addition, we may rely on CROs and clinical trial sites to ensure proper and timely conduct of
our future clinical trials and, while we intend to enter into agreements governing their services, we will be limited in our ability to
ensure their actual performance.

| 61 |

Changes in methods of product
candidate manufacturing or formulation may result in additional costs or delay.

As product candidates
proceed through preclinical studies to late-stage clinical studies towards potential approval and commercialization, it is common that
various aspects of the development program, such as manufacturing methods and formulation, are altered along the way in an effort to optimize
processes and results. Such changes carry the risk that they will not achieve these intended objectives. Any of these changes could cause
our product candidates to perform differently and affect the results of planned clinical studies or other future clinical studies conducted
with the altered materials. Such changes may also require additional testing and/or FDA or foreign regulatory authority approval or notified
body certification. This could delay completion of clinical studies, require bridging studies or the repetition of one or more clinical
studies, which would increase clinical study costs, delay approval of our product candidates and/or jeopardize our ability to commence
sales and generate revenue.

Our product candidates
may be studied in clinical trials sponsored by organizations other than us, or in investigator-initiated clinical trials, which means
we will have minimal or no control over the conduct of such trials.

We may support
third party research, including investigator-initiated clinical trials. Investigator- initiated clinical trials pose similar risks to
internally-sponsored clinical trials, but because we may not be the sponsors of these trials, we have less control over the protocols,
administration or conduct of these trials, including follow-up with patients and ongoing collection of data after treatment. The conduct
or findings of these trials may have a negative impact on our development programs notwithstanding that we have little involvement or
control over these trials. As a result, we are subject to additional risks associated with the way investigator-initiated trials are conducted.
In particular, we may be named in lawsuits that would lead to increased costs associated with legal defense. Additional risks include
difficulties or delays in communicating with investigators or administrators, procedural delays and other timing issues and difficulties
or differences in interpreting data. Third-party investigators may design clinical trials with clinical endpoints that are more difficult
to achieve, or in other ways that increase the risk of negative clinical trial results compared to clinical trials that we may design