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havendale

02/23/15 9:38 PM

#92380 RE: To infinity and beyond! #92376

Great post Infinity, your points of view are appreciated.

All the best. Hope we all make some money.
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Waverunner1

02/23/15 9:55 PM

#92387 RE: To infinity and beyond! #92376

Carbapenem resistant bugs(Enterobacter)in the news recently are gm negative. Brilacidin likely has little or no activity against this bug, and the other CTIX drugs that might be relevant are far far away from clinical use.




Leo has said he was hoping the gram negative version would be ready for the Rio Olympics. That is very aggressive, but I don't think 2 years is out of the question if the need is urgent.

Even if Brilacidin is great, disappointing trial results with Kevetrin would have to lower share price.



Brilacidin on its own (and the defensin mimetics platform in general) can power the stock much higher from here. I take it you have seen the deal for Cubist?
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frrol

02/23/15 9:56 PM

#92388 RE: To infinity and beyond! #92376

Yes, you have to decide whether CTIX's risk is still priced in at $3.50. Given the potential pay-off, if you don't have a small holding now I think you're leaving money on the table. And if the good news continues to flow, you're just going to be chasing this stock.
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slcimmuno

02/23/15 10:46 PM

#92391 RE: To infinity and beyond! #92376

Thx infinity - didn't mean to ruffle your scrubs so to speak---appreciate the post and perspective. Is pretty amazing to think what we have in B et al via the Polyheist and might have in K. Anxiously awaiting what news may come on both fronts.
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TOB

02/23/15 11:34 PM

#92395 RE: To infinity and beyond! #92376

On this board there have been many comments about the superbugs and CTIX in the last several days. In the nicest way possible I simply wanted to point out that Brilacidin - so far as I know- would not kill those bacteria. This of course does not apply to what CTIX might have up its sleeve at Fox Chase etc- but these drugs are a long way out. Is that leading, or loaded? -TIAB



Yes, so far we have confirmation of Brilacidin efficacy against confirmed cases of 'superbug' MRSA in the MITT population. Other applications are more speculative. But the ABSSSI application is a big market already and Brilacidin looks poised to take the crown from Daptomycin.

i see that Klebsiella is also mentioned in a Polymedix article, in addition to E Coli. This in and of itself is sensational. Daptomycin and Vancomycin would have NO gm - activity for example. -TIAB



Not yet tested in humans. Some indications of broader use and even gram negative, but it looks like it is Brilacidin analogs such as CTIX-1278 and CTIX-1807 which show the most promise.

...
Initial research will focus on continuing the development of lead compounds active against CRE organisms, including CTIX 1807, which has shown robust activity against Klebsiella pneumoniae in a mouse tissue infection model.

...

Klebsiella pneumonia

In a thigh burden study of multi-drug resistant strain of Klebsiella pneumoniae in a mouse model, our defensin mimetic-compound CTIX-1278 was efficacious as compared to a carbapenem antibiotic that is widely used as a last line of defense against drug-resistant, Gram-negative bacteria. A second study is now being conducted at multiple dosing levels with various dosing parameters with the goal of increasing efficacy and further defining a treatment protocol for the compound.

... -CTIX



But "these drugs are a long way out" is relative, considering the QIDP potential to various accelerated tracks. Interesting that the CEO talks of having one of these analogs in the pipeline ready for the 2016 Olympics.

The killing ability of the compound against carbapenem-resistant Klebsiella pneumoniae [CRE] is astounding. Cellceutix is presently conducting safety testing and subsequently will determine if the drug is to be advanced to clinical trials. The Company continues to work with its collaborators at Fox Chase to develop a novel drug candidate as quickly as possible to be ready for the Rio 2016 Olympics where this may become a serious threat. -CTIX



Even if that time frame proves overly optimistic, it is quite realistic to expect Phase 1 and Phase 2 trials in the near future. Each stage of development is a potential share price support or boost.

Right now the real value is in Brilacidin, obviously, which has proven efficacy and safety for ABSSI, SA and MRSA. It is sure to progress to Phase 3 Clinical Trials, which should mean a higher share price, highly likely to attract a partnership, which should mean a higher share price, and with strong odds of approval which would certainly mean a much higher share price. Brilacidin could also prove efficacious for Oral Mucositis, Diabetic Foot infections/Ulcers, and Ocular and Otic applications. No doubt, Brilacidin is a near term winner, and a potential much larger winner.

Yes this pipeline of Brilacidin analogs has great promise as well. Certainly more speculative than Brilacidin for ABSSSI. Yet, with Brilacidin so far along, they are potential value added at this point, not priced into the current CTIX share price and not needed to have a significantly higher near term share price based solely on Brilacidin for ABSSSI.

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TOB

02/23/15 11:45 PM

#92397 RE: To infinity and beyond! #92376

Even if Brilacidin is great, disappointing trial results with Kevetrin would have to lower share price. At the point when Kevetrin proves its worth in trials, or maybe even with good results in the next cohort or two, all those who have locked in shares will be big winners, and I will be struggling to get shares at a much higher price. -TIAB



This I disagree with.

With Kevetrin I think you have misunderstood where it is in progression from a share price perspective. At this point it is a near certain positive Phase 1 Primary Outcome Measure result. This means a later phase trial which means an excellent chance at a higher share price. Plus a Phase 1b or 2 trial for Kevetrin in combination for AML is already standing by. So there really is only a slim chance at a "disappointing result" that could damage the share price at this stage. There is an all but sure chance at a successful result which should support higher share prices.

The wild cards are the Secondary Outcome Measures. Kevetrin does not need positive secondary results to move forward to an efficacy trial standalone and as already planned in combination for AML. Thus no hit to the share price should there be "disappointment", but with positive results, it is a big boost to the share price.

Brilacidin alone is well on tract for a much higher CTIX share price. Brilacidin doesn't need approval, just the progression to Phase 3. Other possible "disappointments" can't shake this potential.

JMO and analysis, as predicting share price reactions is fraught, but I don't see a binary event on the near term horizon to give significant risk, such as a pivotal Phase 3. But I do see multiple likely share price catalysts that should support or increase the CTIX share price. So for my investment thesis, CTIX is greatly de-risked at the current share price and likely significantly undervalued.

Once we've graduated to binary events, such as Phase 3 trials, I'll revise my view on risk. But there is an excellent possibility this will be at a significantly higher CTIX share price, with at least 3 key investigational drugs for multiple indications each providing a safety net for the others.
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jockinmikeg

02/24/15 1:15 AM

#92402 RE: To infinity and beyond! #92376

I have been stalking this board for quite a while and learning the CTIX "story". You and I both own no shares and have many of the same questions. Has the stock gotten ahead of itself? What data comes next that will determine the next wave of price action? My own question and main concern before putting money here: how far out are we until the Company sees revenue? The science looks great, and I am intrigued. I want someone who has intricate knowledge to tell me when Cellceutix expects to pad its balance sheet and stop raising cash. TIA.