Kitov Pharmaceuticals Hldgs L Sponsored ADR (KTOV)

[EM]

NICE SUMMARY BY DR. WAYMACK
https://www.sec.gov/Archives/edgar/data/1614744/000121390017011197/f6k110117ex99-2_kitovpharma.htm

The Company's principal achievements during the past year included:

i. Submitted an NDA to the FDA for KIT-302, which was subsequently filed by the FDA

ii.Signed a definitive License Agreement for KIT-302 for the territory of South Korea with Kuhnil Pharmaceutical Co. Ltd., a leading South Korea-based pharmaceutical company

iii. Received waiver from the FDA for the $2 Million New Drug Application fee for KIT-302

iv. Completed our renal function clinical trial, meeting its primary efficacy endpoint, and also demonstrating that KIT-302 improves renal function

v. Acquired a controlling interest in TyrNovo and subsequently entered into an agreement to acquire an additional 27% of the company

vi. Completed an equity offering for gross proceeds of $3.5 million

vii. Completed a successful preIND discussion with FDA for NT219, a small molecule currently being developed by TyrNovo that presents a new concept in cancer therapy by promoting the degradation of two oncology-related checkpoints, Insulin Receptor Substrates (IRS) 1 and 2, as well as the inhibition of signal transducer and activator of transcription 3 (STAT3)

2018 expected catalysts include:

i. FDA marketing clearance for KIT-302

ii. Additional marketing agreements for the distribution of KIT-302

iii. Complete CMC work on NT219 and begin non clinical work on NT219 towards submitting an IND with the FDA during the first half of 2019


"Importantly, we also enter 2018 in a strong financial position. Our balance sheet was further fortified in the third quarter through our successful follow-on offering. I am pleased to note that there continues to be strong U.S. institutional investor interest in our stock".