Kitov Pharma Ltd. (KTOV) research, news, and more from GeoInvesting

Company description

Tue, 10 May 2016 15:04:37 GMT

Kitov Pharmaceuticals Holdings Ltd. engages in developing non-steroidal anti-inflammatory drugs that treat the pain of osteoarthritis without causing cardiovascular problems. It is developing KIT-301 and KIT-302 drugs for the treatment of osteoarthritis. The company was formerly known as Mainrom Line Logistics Ltd. and changed its name to Kitov Pharmaceuticals Holdings Ltd. in August 2013. Kitov Pharmaceuticals Holdings Ltd. is based in Jerusalem, Israel.

Research

Tue, 07 Feb 2017 17:02:35 GMT

KTOV ($2.55; marked down 25% pre market) - An Israeli article published yesterday claims that the CEO of KTOV had been investigated by securities authorities. The article states that the CEO was detained under to be investigated for providing misleading information in a prospectus ahead of the NASDAQ IPO. The article also states that the CEO was released as it seems that there was nothing further requested from the courts.

As we could only translate the article with the assistance of Google Translate, there certainly is the possibility some of the content was lost in translation. Back in May of 2016 we highlighted KTOV as a HIGHLY SPECULATIVE PLAY and stated we took a small speculative position. Due to the circumstances mentioned above, we will take the loss on KTOV and move on. The stock is currently halted.

Comments & Business Outlook

Thu, 12 May 2016 14:28:35 GMT

TEL-AVIV, Israel, May 12, 2016 /PRNewswire/ -- Kitov Pharmaceuticals (NASDAQ/TASE: KTOV), an innovative biopharmaceutical company focused on late-stage drug development, announced today the U.S. Patent and Trademark Office has issued a Notice of Allowance to the Company for claims covering important treatment methodologies, which form the basis of its lead drug candidate, KIT-302, and that ameliorate celecoxib-induced elevation of blood pressure, which can result from prolonged use of the drug.

A combination drug, KIT-302 simultaneously treats pain caused by osteoarthritis and treats hypertension, which is a common side effect of stand-alone drugs that treat osteoarthritis pain. KIT-302 is comprised of two FDA approved drugs, celecoxib (Celebrex®) for the treatment of pain caused by osteoarthritis and amlodipine besylate, a drug designed to treat hypertension. The Company plans to file a New Drug Application for KIT-302 at the end of 2016.

"This patent is expected to provide Kitov a proprietary position and long-term market exclusivity for its lead compound, KIT-302, creating a high barrier to entry for potential competitors in the U.S., our major target market" stated Kitov CEO, Isaac Israel.

In other news today...

KTOV announced it has received, from the U.S. Food and Drug Administration (FDA), meeting minutes from its recent pre-New Drug Application meeting for KIT-302 . Based on the details of the FDA's response, Kitov is on track to submit the NDA for marketing approval of KIT-302 by the end of 2016.

The meeting, which took place on April 11, 2016, had been requested by Kitov to seek FDA concurrence that the NDA content will meet the agency's requirements for NDA submission.

The FDA confirmed that an Advisory Committee Review should not be required for the NDA review, and that the FDA may accept 6 months data of long term stability at the time of submission. Furthermore, based on the minutes, the Company will include additional information as part of the planned NDA submission, such as market data and a medical literature review on the use of amlodipine and celecoxib in animals. The FDA requested that the statistical calculation for the primary efficacy endpoint be performed using an alternate mathematical technique. This calculation was subsequently performed by Kitov and also demonstrates that KIT-302 met its primary efficacy endpoint.

"These minutes bring us closer to submitting an NDA to the FDA for KIT-302 via the 505(b)(2) path at the end 2016, as currently planned. This paves the way for potential regulatory approval in 2017," stated Dr. J. Paul Waymack, Chairman of Kitov's Board and Chief Medical Officer.

A combination drug, KIT-302, simultaneously treats pain caused by osteoarthritis and treats hypertension, which is a common side effect of stand-alone drugs that treat osteoarthritis pain. KIT-302 is comprised of two FDA approved drugs, celecoxib (Celebrex®) for the treatment of pain caused by osteoarthritis and amlodipine besylate, a drug designed to treat hypertension.

Pain medications for osteoarthritis account for billions of dollars in annual sales globally. Most pain medications for osteoarthritis, including celecoxib, are non-steroidal anti-inflammatory drugs (NSAIDs) which have the side effect of elevating blood pressure, and increasing the risk of heart attacks, strokes and death. Of the 27 million Americans who live with osteoarthritis, 13.5 million also suffer from hypertension, which also increases the risk of heart attack, stroke, and death.

Research

Tue, 10 May 2016 15:04:58 GMT

10 Reasons Why We Are Beginning to Track KTOV

$KTOV ($6.00) is a pharmaceutical company focused on the development of therapeutic candidates for the simultaneous treatment of various clinical conditions. In particular, Kitov focuses on developing combinations of existing drugs in advanced stages of development. Kitov's lead drug, KIT-302, is formulated for the simultaneous treatment of two clinical conditions – pain caused by osteoarthritis (OA) and hypertension (high blood pressure), which can be pre-existing or caused by the treatment for OA.

"Kitov is focusing on the simultaneous treatment of two clinical conditions through the development of combination drugs – drugs that integrate two existing effective drugs into one unit."

Here are some product notes from the Company's January Investor presentation :

“…
KIT-302 combines an NSAID, celecoxib (Celebrex®), the only COX-2 selective NSAID approved in the U.S., with a well-known anti-hypertensive (amlodipine besylate) to:

Treat OA pain, while
Treating the side effect of elevated blood pressure (which may cause HTN), or even
Treating pre-existing high blood pressure (hypertension)
…”

While KTOV certainly falls under the highly speculative biotech category, the recent momentum in the stock price and positive phase 3 data (which allegedly puts the company on track to receive marketing approval in 2017) has us looking at the stock closer than we would normally look at such a speculative stock, let alone a biotech. WE also think the stock's small float could attract momenutm players and "pump" on press release headlines. Please note that we pulled information from many sources including filings, press releases and other related articles. Further due diligence/confirmation of findings is needed.

We have taken a small speculative position.

10 Reasons for Tracking KTOV

Recent IPO hitting new highs. On November 25, 2015 KTOV completed its IPO resulting in 3,158,900 outstanding American Depository Shares (ADS), each representing 20 ordinary shares of the Company, and warrants to purchase up to 3,158,900 ADS. The ADS and warrants were issued in a fixed combination of (1) one ADS and (2) one warrant to purchase one ADS, for a combined price to the public of $4.13. Shares traded as low as the mid $2 level before recently reaching a new high of $6.85 on May 9, 2016.
Small float. The Company has 3.8 million shares outstanding and 7.4 million fully diluted shares.
The Company has $10.6 million in cash with no debt as of December 31, 2015.
Positive Phase 3 data could lead to product sales in 2017.
- On December 15, 2015 shares jumped over 50% on positive Phase 3 data from its clinical trial assessing lead product candidate KIT-302 in lowering high blood pressure. The Company plans to file an NDA for marketing approval in 2016 to address multi-billion dollar market.
“We are very pleased with the successful and final outcome of our pivotal Phase III trial and we look forward to meeting with the FDA in the near future to finalize plans for our NDA submission. We believe we will be ready to submit the NDA for KIT-302 in the second half of 2016. Should the NDA meet with the FDA's approval, we would expect to receive marketing approval in 2017," stated Kitov CEO Isaac Israel.”
On May 10, 2016 KTOV announced its KIT-302 study successfully meets the U.S. FDA Bioequivalence (BE) standards. These results mean KTOV has fulfilled the FDA standard for demonstrating BE under both fed and fasted conditions.
"We are pleased to complete our pharmacokinetic BE study on schedule this quarter. These results bring us one step closer towards submitting our New Drug Application to the FDA for KIT-302 at the end of this year and the anticipated marketing approval in 2017"
KIT-302 is a combination drug developed to treat osteoarthritis and hypertension, both massive markets worldwide. ($7 billion and over $35 billion respectively)
KTOV plans to license its drugs with larger pharmaceutical companies
A Seeking Alpha article by Amit Ghate offers in-depth analysis of KTOV's comparables and market opportunities which concludes with a price target of $22.50 (4 year PT).
KTOV shares some characteristic as recent biotech high flyer CPXX, which saw its shares skyrocket over 700% in the last 2 months. CPXX shares spiked on positive phase 3 trials of its combination drug VYXEOS to treat patients with high-risk acute myeloid leukemia. Both companies have enjoyed extremely high analyst price targets and both drugs will address large markets.
If KTOV is legit, the fully diluted market cap of $45 million is tiny when compared to the $550 million market cap of CPXX, as projected analyst sales figures are very similar. (Please note CPXX showed improvement in patients with high risk Leukemia, which to our knowledge is the only drug of its kind. While KIT-302 may be the only drug to help both Osteoarthritis and hypertension simultaneously, there are many drugs that treat these conditions separately.)

Caveats:

KTOV could face some industry headwinds as the biotech industry as a whole has been beaten down, mainly due to price gouging practices. VRX, ENDP, HZNP and PTX are just a few of the many names that have weighed on the biotech industry. HZNP and PTX are used as comparables in the Amit Ghate Seeking Alpha article as companies offering combination drugs. However, HZNP and PTX business plans center around building their pipelines through acquisitions, a strategy which has come under scrutiny due to the debacles of VRX and ENDP.
If and when KTOV drugs reach the market, pricing pressure will be key focus as many biotech companies are under scrutiny to rein in prices. This will be a hot topic in the 2016 election year.
It appears that management does not own a large percentage of the company’s stock - only 2.98% as of December 31, 2015.
We still need to look into the background of management.
We need to take a closer look at possible competition KTOV will face.
As the norm, KTOV will have to raise capital in the future.

"We believe that our current cash and cash equivalents are sufficient to complete the research and development of KIT-302 until its anticipated approval for marketing by the FDA in 2017. Since we do not know when we will begin to generate significant revenues from our therapeutic candidates, if ever, should we decide to develop KIT-301 and any additional therapeutic candidates, we may need substantial additional funds to acquire, develop, and/or commercialize such therapeutic candidates."

Reasons For Tracking

Tue, 10 May 2016 04:00:00 GMT