Kitov Pharmaceuticals boosts an impressive team behind them with a multitude of years in the business. My personal favorite note about this team is the founder and Chief Medical Officer John Paul Waymack.
Not only does he have over 20 years of experiences in drug development working for huge companies, he has served as an FDA Medical Officer for years. If you are looking to piece the puzzle together let me try to make it a bit simpler. (FDA experience + Blockbuster drug (with safety numbers + no adverse effects) + upcoming May catalyst = Huge potential. Of course, all of this information must be taken with a grain of salt, however, if you look at everything presented it becomes a matter of “when” and not “if.”
Tech & Pipeline
The Kitov pipeline is generated by systematically identifying, validating and in-licensing therapeutic candidates that maintain advantages over current therapies or address unmet medical needs. Our pipeline consists of two therapeutic candidates:
- NT-219 – a first-in-class small molecule designed to overcome cancer drug resistance
- KIT-302 – a fixed-dose combination of two approved drug products that treat osteoarthritis pain and hypertension simultaneously. Kitov submitted a New Drug Application (NDA) in July 2017. The U.S. Food & Drug Administration (FDA) filed the NDA in September 2017, thereby accepting it for a full review.
So, as we begin to look at the data provided and timetables of KIT-302 as well as NT-219 it begins to present a compelling argument for both products in Kitov’s pipeline. KIT-302 trial results show primary efficacy endpoints successful met (p=0.019) with statistically significant reduction of serum creatine observed vs. baseline studies. Completion and submission of the report to FDA is expected to close at the end of this month (January) with PDUFA approval coming in May of 2018. Pancreatic cancer was selected as the first indication for NT-219 based off of outstanding results from 4/4 biopsies. Phase I/II trial are set to begin in 2019 testing the NT-219 combination with gemcitabine.
With a strong management team and proven track record in drug development and regulatory expertise, I expect to see a strong show heading into May 31, 2018. With the lead candidate KIT-302 set for May and NT-219 submission expected in 12-18 months, it is clear they are wasting no time as they look to target large populations and blockbuster potential in multiple malignancies.
Given that $KTOV is relatively newer it is very tough to break down a financial outlook for this company. For all those looking to have numbers support the theory, remember that when it comes to names like $KTOV you are investing in the future tech and potential not the cash generation at the moment. Based on the $8.1M cash on hand, and $2.9M burn rate per quarter I would expect them to be solvent until the latter part of 2018 which takes them well beyond the possible catalyst date that many will be looking for.
When it comes to $KTOV I have no fancy SWOT analysis, future cash flow projections or anything that will confuse those looking for a solid name. The trial numbers are stellar and by taking a quick look at who is behind them gives even more potential for the direction that this company will be heading. As we approach the PDUFA date I expect $KTOV to continue to pick up the heat but it is not the run-up or the news that intrigues me, but the application once approval has been reached. Given the tech behind this name, I would expect them to quickly and efficiently begin to break into the market both domestically and internationally allowing for an all hands on deck sales approach. $4.00 in the near-term is where I can easily see this name but once KIT-302 approval is met and NT-219 begins to attract suitors with the blockbuster tech, $7.00+ becomes my long-term target towards year end of 2018-2019. Yes, the market will try to have an affect on this name (Trade Wars, Rate Hikes, etc etc.) however, it has held up strong amongst the chaos the past couple of months and I expect that to continue as long as the chart continues to slowly move and remain intact.