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Trial costs increased 60 percent from 2008 until 2013... Phase 3 is the most costly of the phases... So, expect any estimate (by company) to be a conservative amount. 30 million could easily be much more in a few years...
http://www.cuttingedgeinfo.com/press-release/as-early-stage-clinical-trial-costs-rise-late-stage-costs-level-off/
Data from the latest Cutting Edge Information study, “Clinical Development and Trial Operations: Protocol Design and Cost Per Patient Benchmarks,” found that costs have nearly doubled in five years, with the average Phase 3b trial now costing $48,500 per-patient. While pivotal studies saw a dramatic cost increase between 2008 and 2011, new data indicate that per-patient costs in Phase 3 trials have leveled off in 2013.
Must read on phase costs. Interesting how the average cost of trials increase a few million each-year. So the longer the delay "in any trial" the costs will increase. 30 million over 2 years could easily go up... So, the need to find better financing will only magnify. Once again, putting all-the-pressure on P to find a partner...
https://www.quora.com/How-much-do-clinical-trials-for-drugs-cost
So if P fails, you expect nothing to be effected, therefore CTIX can easily raise 30 million over 2 years? LOL
P's success will eliminate the need for Aspire (partnership) and let Leo operate with a looser budget. P failure would probably cut the PPS by 30 to 40 percent. Good luck raising 30 million (B phase 3) with an even worse PPS... Everything is riding on P... Look at the new hires, backgrounds to treat skin conditions. Who would have thought that P would command all-the-focus now? A mistake like "not up-listing" could be even larger if P fails...
Easy for the MM's to manipulate with low volume. Need to regain the old average (240K)...
Article on CTIX from the Oracle Dispatch...
http://oracledispatch.com/2016/09/20/major-milestones-ahead-for-cellceutix-corp-otcmktsctix/
Your assuming that P's trial is a success and they find a partner... Exactly what I've been posting as everything rides on P's success or failure... They cannot start the B trial until they have appropriate funds...
It's obvious the bigger issue is with "future funding" with the uncertainty being "stock price" and the market (OTC) they trade on. Good luck raising 30 million "over 2 years" with the current situation... Exactly why B is put on-hold regardless of FDA clearing the hurdles to start phase 3.
We are estimating that Phase 3 studies will cost approximately $30 million over about two years, which means we need to raise some additional capital to conduct that research and move forward with all the other drugs we're developing."
"I believe that it is best for us to focus on the other more cost-effective trials at present and wait for upcoming milestones that can assist in recovery of CTIX share value so as to minimize dilution when raising capital for the ABSSSI trial."
Dr. B. 7/13/16
24 to 30 months... CTIX doesn't have the funds for 2 phase 3 trials anyway. So whenever the FDA approves their studies, B phase 3 will be shelved regardless. The hope is a P partnership to help pay for everything. So, they've backed themselves against the wall (OTC funding) with everything riding on P success.
How long should be CTIX's new slogan... How long before Leo steps aside as CEO!!! Clearly the stock price indicates a needed change...
Agree 100 percent. If a potential investor read the press-releases "from the past 4 years" they would never believe the stock traded 1.27 on the OTC... Something doesn't add up and the CEO continues to have no answers on why there's no interest in-the-stock? Can't blame Mako no more!!!
Sure!!! Just like CTIX is going to be the next Regeneron? So says LEO!!! 22 months since those comments and the stock trades in-the-toilet... Must be the shorts... LOL
More Leo references on the Cubist deal. Patting himself on-the-back... From December 2014... Clearly, B has taken a backseat? almost 2 years and we're still waiting for phase 3 to start?
http://www.bizjournals.com/boston/blog/bioflash/2014/12/cellceutix-ceo-cubist-acquisition-made-us-look.html
You wouldn't expect the CEO of a company that last month issued a press release headlined "Cellceutix: December to Be Momentous Month in Company's History," to be shy about self-promotion.
And Leo Ehrlich, who heads the small Beverly biotech, does not disappoint. I spoke to Ehrlich earlier today about why his company's shares soared 32 percent to an all-time high Monday after the $9.5 billion acquisition of antibiotics-maker Cubist was announced.
His answer: "Because now it looks like we were absolute geniuses for purchasing our antibiotic from bankruptcy court a year ago for $5 million."
Ehrlich is referring to Brilacidin, a drug Cellceutix (OTC: CTIX) bought in September 2013 for a combination of cash and stock. The potential drug for acute skin infections finished Phase 2a trials by the time its former owner, PolyMedix of Radnor, Pa., went bankrupt in April 2013. Cellceutix, which at the time was testing it's experimental drug, Kevetrin, in various kinds of cancer, immediately announced plans to begin a Phase 2b trial of Brilacidin in acute bacterial skin and skin structure infections, a category of bacteria that includes methicillin-resistant S. aureus, an infection commonly known as MRSA.
The trial not only targeted the same infections for which Cubist's flagship antibiotic Cubicin was approved in 2003, but directly compared Cellceutix's Brilacidin to Cubicin. While full results from the 215-patient trial have not been published yet, the company announced in September that Brilacidin worked as well as Cubicin at treating the infection, which would mean likely approval if the data holds up in a larger, Phase 3 trial.
Ehrlich said he plans to meet with the U.S. Food and Drug Administration in coming days to diuscuss plans for Phase 3 trial upon which an approval for Brilacidin could be based, and declined to estimate when that trial might start pending the meeting. But he said that his company's drug has one distinct advantage: While Cubicin requires several subsequent days of intravenous administration, Brilacidin just requires a single IV, meaning no extended hospital sta
BigK what's the hold-up? 14 months later and we're still in-the-dark on this?
http://cellceutix.com/cellceutix-to-start-brilacidin-phase-3-program-in-absssi/#sthash.JWczd4s3.dpbs
BEVERLY, MA–(Marketwired – July 20, 2015) - Cellceutix Corporation (OTC: CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to announce that the U.S. Food and Drug Administration (FDA) has agreed to advancing brilacidin into phase 3 for the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI).
During a recently held End-of-Phase 2 Meeting, Cellceutix and the FDA discussed safety and efficacy data that support advancement into phase 3, as well as the basic elements of a phase 3 program. The planned phase 3 program would include two phase 3 ABSSSI studies, as required by FDA Guidance. In addition, the first study would include an interim analysis after a portion of the patients has been enrolled. This would provide an early assessment of both safety and efficacy. As part of the agreement, the Company would submit a Pediatric Study Plan (PSP) within 60 days of the End-of-Phase 2 Meeting.
Dr. Daniel Jorgensen, Cellceutix’s Chief Medical Officer and leader of the team that met with the FDA, was pleased with the outcome of the meeting. “This was a collaborative meeting, and the FDA was extremely helpful in providing guidance on our clinical development program in ABSSSI. The plan for an interim analysis makes sense, as this is a brand new class of antibiotics.”
Brilacidin is the lead compound in a new class of antibiotics known as the defensin-mimetics. These compounds mimic the host defense proteins of the innate immune system, and therefore, have both antibacterial and immunomodulatory properties. Brilacidin has been administered intravenously in over 400 subjects in phase 1 and phase 2, and is currently being evaluated in a phase 2 study as a topical rinse for the prevention and treatment of oral mucositis in cancer patients.
Brilacidin was granted Qualified Infectious Disease Product (QIDP) designation by the FDA in November 2014. The QIDP designation was established as part of the Generating Antibiotic Incentives Now (GAIN) Act for the purpose of encouraging development of new antimicrobial drugs to treat serious and life-threatening infections. Receiving QIDP designation means that brilacidin is now eligible for additional FDA incentives, including Fast Track designation and Priority Review for clinical development, and a five-year extension of market exclusivity.
- See more at: http://cellceutix.com/cellceutix-to-start-brilacidin-phase-3-program-in-absssi/#sthash.JWczd4s3.dpuf
Here's a classic one from Leo 400 days ago...
http://cellceutix.com/cellceutix-thank-you/#sthash.ZUXb314y.dpbs
BEVERLY, MA–(Marketwired – August 10, 2015)- Cellceutix Corporation (OTC: CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, would like to thank all the hospitals, scientists, physicians, and shareholders who have reached out to us on Thursday and Friday in support of Cellceutix. The volume and price action Friday speaks to the confidence of our supporters and shareholders as they had time to reflect upon and react to the absurdity of an article about Cellceutix.
Cellceutix has a robust pipeline with a full slate of ongoing and planned clinical trials. Our goal is to be the next Regeneron (REGN), a company built on novel science with the vision and strategy to grow exponentially. To accomplish this, Cellceutix is engaged in four clinical trials. Of course, it should be obvious to anyone that running a single clinical trial is a task requiring numerous personnel, much less the resources that are required to run four concurrently. Cellceutix is a lean and passionate Company and has a very productive and dedicated staff.
Our facility at 100 Cummings Center was previously occupied by Cell Signaling Technology. That should give you an idea as to the excellence of our labs. We even upgraded it for our specialized needs. As far as our antibiotic pipeline, the acquisition of Durata Therapeutics by Actavis Plc for $675 million to gain control of dalbavancin and Merck’s acquisition of Cubist Pharmaceuticals for about $9.5 billion, in part for the blockbuster drug daptomycin, proves the value of potent Gram-positive antibiotics and shows we’re in the right space with our novel antibiotic Brilacidin. Two Phase 2 trials have shown Brilacidin to be as effective as daptomycin in treating Acute Bacterial Skin and Skin Structure Infections (ABSSSI). In our upcoming Phase 3 trials, we intend to raise the bar again as part of our strategic plan to prove the potency and safety of Brilacidin, grow value and increase brand awareness.
We believe that Brilacidin, which is a new structural class called “defensin mimetics” and being developed under a QIDP designation from the FDA, will have a competitive edge over today’s antibiotics for ABSSSI should it make it to market. Drugs like oritavancin and dalbavancin come from existing classes of antibiotics, meaning that there is a higher likelihood of exhibiting cross-resistance because of their structural similarity to older antibiotics. In addition, they may have market acceptance challenges because they have long half-life, which Brilacidin does not. Brilacidin is a swift bacteria destroyer that bacteria have never seen before, making it an ideal drug candidate. Finally, Brilacidin can be given as a single-dose, which further differentiates it from multi-dose regimens for ABSSSI, such as daptomycin, vancomycin, or linezolid. For these reasons, our team is highly motivated to get the pivotal Phase 3 trial underway.
“I don’t typically engage in dialogue about whether or not Cellceutix is undervalued, but I encourage you to look at market caps of companies that have a fraction of our potential,” commented Leo Ehrlich, Chief Executive Officer at Cellceutix.
- See more at: http://cellceutix.com/cellceutix-thank-you/#sthash.ZUXb314y.dpuf
The shift in B strategy was questionable and still is...Supposedly? they (CTIX) have plenty of cash and a great partner (Aspire)? All those press-releases and IHUB posts promoting the Cubist/Merck deal?
Interesting how a company (CTIX) issues PR's for everything, never mentions Menon becoming C of B... And they still leave that out of his profile on the CTIX website... What I'm getting at is transparency issues regarding CTIX and whether that may effect them landing a partner? They have plenty to clean up before anyone will take them serious. That includes the market they trade on and PPS. Just my opinion, but it's obvious Leo couldn't land a partner as some suggested he could months ago...
Well, I'm sure Dr Menon updated his own Linkedin profile. His Bloomberg profile lists him as COO of Kard Scientific...
Since it says to June 30th 2016 as President of CTIX, I assume that it's close to current... Again, just curious of the entire situation.
http://www.bloomberg.com/research/stocks/people/person.asp?personId=23609262&privcapId=39474978
Kard Scientific... Not sure of many Biotechs who have a Chairman of Board who is President of Science and also serves as COO/President for Kard Scientific. Very strange... Any potential partner could throw a red-flag on this... My error he's not CEO for Kard...
https://www.linkedin.com/in/dr-krishna-menon-08b58b
Unfortunately, No cash for stocks that trade 1.30 on the OTC... Not up-listing last-year continues to haunt CTIX and it's shareholders...
LR, You would think a PR should have been issued when Menon was awarded Chairman? Also, why is there no mention of this on CTIX's website? I agree, who voted on this? Self appointed position... Menon is also CEO of another company... Maybe they should reduce his salary (400K) and use the savings for a VP of communication/investor relations....
You know my point... We'll see if Leo can get this above 1.40 one-of-these months?
Why isn't Menon listed as chairman on their website?
http://cellceutix.com/team/#sthash.GzFZwaIe.dpbs
Interesting to compare Tobira with Cellceutix to see what separates the 2. The 3 glaring differences "other than drug category" are the markets they trade on (OTC/Nasdaq), board members (CTIX= 5 no chairman, Tobira 9 including a chairman and last, Tobira has a VP of Investors Relations and Communications... The last 2 can be solved... Up-listing to Nasdaq has been this companies biggest hurdle so far...
http://www.businessinsider.com/allergan-acquiring-tobria-therapeutics-for-up-to-165-billion-2016-9
http://ir.tobiratx.com/management.cfm
You brought his name up? I doubt he'll join the board as he serves on many, so maybe a position? The stock would triple if he was hired as CEO. Nice thought though... The only other conclusion for bringing up his name would be if a partnership is announced Monday... But that's questionable as well.
George, So your guessing that George Golumbeski is going to be added to CTIX's board, even though he just joined Tizona Pharma? I believe that's 4 or 5 he serves on? He surely is not coming to CTIX to be another VP> Although, I'd take him as CEO!!!
http://www.mpmcapital.com/press/tizona-therapeutics-inc-appoints-george-golumbeski-ph-d-board-directors/
https://www.linkedin.com/in/george-golumbeski-3106848
Another example of why trading on the OTC hurts CTIX and shareholders. Possible Analyst coverage? How can Vitae have a 23 price target, while CTIX trades at 1.31? Amazing what a missed opportunity (up-listing) was lost... Hopefully, the buyers from 2014 return...
The Vitae sale drawing interest from the blood thirsty law-firms. All because an analyst had a price target of 23?
http://finance.yahoo.com/news/investor-alert-brower-piven-commences-190100629.html
The securities litigation law firm of Brower Piven, A Professional Corporation, has commenced an investigation into possible breaches of fiduciary duty and other violations of state law by the Board of Directors of Vitae Pharmaceuticals, Inc. (NASDAQ: VTAE) (“Vitae” or the “Company”) relating to the proposed buyout of Vitae by Allergan plc.
Under the terms of the agreement, Vitae shareholders are anticipated to receive $21.00 in cash for each share of Vitae common stock held. The firm’s investigation seeks to determine, among other things, whether the Company’s Board of Directors failed to satisfy their duties to shareholders, including whether the Board adequately pursued alternatives to the acquisition and whether the Board obtained the best price possible for the Company’s shares of common stock. For example, according to Yahoo! Finance, at least one Wall Street analyst has issued a price target for Vitae stock at $23.00 per share.
If you currently own common stock of Vitae and believe that the proposed buyout price is too low, or you would like to learn more about the investigation being conducted by Brower Piven,
Goerge's prediction was based on a "10 billion" market cap rumor that was floating around the past 2 weekends. Figuring the price has to go up some year...
What's amusing is when I read how corrupt the OTC market is which prevented an up-listing. And now, Leo's on the Wall Street trail trying to convince others to buy? For those that suggest an up-listing was useless, try convincing potential investors that...
I guess very few have an answer for why those who suggest the OTC market is rigged, why should any new investor buy shares? I took heat for saying an up-listing was critical at any cost and yet we sit here a year later at bankrupt prices... So the option to stay on the OTC has pushed they're whole strategy back and now they have no answers for new investment...
I got the 12 to 16 month part... I'm having a hard time grasping of what "fully financed" means when it's evident they're in a cash crunch. All because the line-of-credit is a crap shoot. Based on X amount of shares NEEDED to be purchased on a corrupted market. The business world should crack down on the Aspire's who continue to benefit from the losses of others. Lets see a list of Aspire's success stories? Businesses who prospered from diluting shares on the OTC/pinks...
Sox, To those that suffered severe losses believing a strategy that has now shifted several times, maybe this is not a scam, but Leo has not given the shareholders (Price appreciation) any reward for paying the bills. How can anyone justify ALL THOSE PR'S pumping this investment and we're sitting here hoping P (forgotten child) saves the day at a 1.24? Why, it's because they're financing is at the mercy (OTC) of the same market Leo is critical of. So why should NEW investors buy shares on the same market LEO and others suggest is corrupt? Exactly why a move to the Nasdaq is/was NEEDED ASAP...
Sort of like the strategy to shift from B to P after heavily promoting B's potential in multiple PRs. Remembering the Cubist deal and how B was going to be the fastest way to partnership... Then we read how they're fully financed? RIGHT, fully financed to pay 400k salaries and wait 12 to 16 months for results of pending trials... Lets face it, they're in a cash crunch dictated by the same market that Leo blames for manipulation... GREAT STRATEGY!!!
Investors are lining up to buy shares...
Really, most? I don't think many do it at all (corporate updates). Except those in dire need of investment. Successful companies report hard facts and substance. The Q reports and shareholder meetings are for more detailed info... All the info is on their website to see, the info from yesterday was known. When you continue to "blow your own horn" without stock-price results it appears suspect.
Not interested in adding yet. I do own shares, but not happy with Leo's latest update... I thought the company turned the corner from corporate updates when DR B arrived.
The phantom publication for K? Disappeared the same way as B ABSSSI.. Must be the lack of funds... The next Cubist, CTIX!!!
Company Reports Successful End-of-Phase 2 Meeting With FDA
BEVERLY, MA–(Marketwired – July 20, 2015) - Cellceutix Corporation (OTC: CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to announce that the U.S. Food and Drug Administration (FDA) has agreed to advancing brilacidin into phase 3 for the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI).
Hello everyone, welcome to our presentation, please buy shares of our stock at 1.23 and you will see results in 2018... Worst mistake Leo has made since the up-listing fumble.
The downtrend continues since Mid 2015... Just wait, 10 billion market cap around-the-corner...
Wow 1.42 to 1.23 in a week's time... This is after the investors presentation. Like I said last week, not many attended at 8:30 AM except Leo. Dr B even mentioned his name to no applause.