KalVista Pharmaceuticals (KALV)

[Jk384]

The end of this statement tells me most likely the direction we are headed. There are many other things throughout the 10-k that point in this direction as well. It shouldn't take long with around 50 million in net cash on hand. Question again becomes how much are the patents worth, and add that to the appropriate $1.75 in cash on hand per share. My guess would be in the $3 to $6 per share range if we are acquired.

Since TA is an approved product in different pharmaceutical preparations, we may rely on the FDA’s prior findings of safety and efficacy for TA and, thus, the Hydros-TA new drug application, or NDA, could benefit from being filed under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act, or the FDCA, by eliminating the need for certain pre-clinical safety studies of TA. Hydros is considered a new molecular entity, or NME, and we are required to complete full pre-clinical testing to assure its safety profile. However, since Hydros-TA is our product candidate, not Hydros alone, in order to obtain regulatory approval of Hydros-TA, Hydros will not have to undergo any clinical testing independent of the Hydros-TA studies. While we are considering potential strategic alternatives, we are also considering the potential for the future clinical development of Hydros-TA.  

Another reference to it throughout the 10-k

In March 2016, we engaged a financial and strategic advisor, Wedbush PacGrow, to advise us on strategic alternatives.  Wedbush PacGrow will provide a range of advisory services aimed to enhance shareholder value.  The alternatives to be considered will include the potential for an acquisition, merger, strategic partnership or other strategic transactions.  We expect to devote substantial time and resources to exploring strategic alternatives, however, there can be no assurance that such activities will result in any agreements or transactions that will enhance shareholder value. Further, any strategic transaction that is completed ultimately may not deliver the anticipated benefits or enhance shareholder value.

Patents in 10-k

As of December 31, 2015, we have three issued U.S. patents and ten issued non-U.S. patents, the earliest of which will expire in 2030, and 25 patent applications worldwide covering our Hydros platform technology, including claims directed to composition of matter, methods of use and product-by-process.