Company: FTII
Filing Date: 2025-02-14
Form Type: S-4
Source: 0001493152-25-006997
Chunk: 239

Company: FutureTech II Acquisition Corp.
Filing Date: 2025-02-14
Form: S-4
Chunk 239
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 Candidate” section below for more information regarding the assumptions relied upon by Longevity’s
management in preparing the Projections.

As noted above,
the Projections (i) span an eight-year time period and (ii) assume that all product candidates receive regulatory approval. A ten-year
time period for the presentation of the Projections was selected because development timelines for biomedical products typically span
multiple years. Based on the estimated time required for FDA approval of each product candidate and the estimated time required to achieve
peak market penetration, each of which are reflected in the Projections, Longevity’s management and the FutureTech Board believed
that a ten-year projection period was both appropriate and necessary to provide a comprehensive understanding of the potential future
performance of Longevity. As discussed below, the estimated time required for FDA approval was based on Longevity’s management’s
review of the premarket approval review timelines specified in 21 CFR. 814 and the Prescription Drug User Fee Act (“PDUFA”),
and the estimated time required for peak market penetration was based on Longevity’s management’s review of published medical
literature and the current competitive landscape for each product. Further, Longevity’s management and the FutureTech Board believed
this time period was appropriate and typical in determining a valuation of a clinical stage biotech company such as Longevity. Based on
the foregoing, Longevity’s management and the FutureTech Board believed the selection of a ten-year period as the basis for the
Projections was reasonable, subject to and in light of the various assumptions, uncertainties and limitations described herein.

The Projections
include the assumption that all product candidates receive regulatory approval in order to provide the total potential future performance
of Longevity. Longevity management prepared the Projections for internal use to provide the estimated costs and revenues which could then
be utilized to perform a risk-based analysis of the enterprise value of Longevity. Typically, the earlier the product is in the development
cycle, the lower the probability of success compared to products that are further along in the development cycle. The clinical study process
required to obtain regulatory approvals carries substantial risks and is lengthy and expensive with uncertain outcomes. If the clinical
studies are unsuccessful or significantly delayed, or if the clinical studies are not completed, Longevity’s business may be harmed,
and the Projections will not be achieved. Failure of clinical studies can occur at any stage of clinical testing. Longevity’s clinical
studies may produce negative or inconclusive results. In addition, the Projections span a