SHOWCASE RECAP
hopefully my little bro's desc give a feel for folks, N=1, one person's take. he was very impressed w/ Mngmt (open, approachable, as excitable about the potential as investors) -- and Mngmt matters tons, as much if not more than the Tech as BioH rightly harps.
anyhow, I'm sure the recap will trigger followup Qs. if you have them, fire away... then I'll compile and have him respond to as best he can. he's a biz type so his ear is not as "sciency"---hopefully the other IHUBers in attendance will add their expert summaries, like NR has been doing.
Must say little bro did himself darn well and he's not the real writer in the Fam -- that's my other brother... Or my niece. She's got true word talent.
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Atmosphere:
The BioTech Showcase was packed. The Bio-tech market is frothy and that thought was confirmed by the featured panel at lunch (except the IBanker from China who didn't think so) but most of the others felt like this is like the "1999 tech bubble" and after having been to this conference I have to agree. I was hit up twice by bio-tech CEO who pulled out their iPads showing their tech and products (not once qualifying me for interest or ability to invest). The majority of companies are not going to make it, nor are they worthy of funding but the world is awash with cheap capital so we get froth. There are some game changers but most are just reformulations/tweaks of existing technologies. NR said he's identified a few potentials but needs to do more DD.
After lunch I headed down to the room where CTIX was doing their presentation and ran into KarinCA, NR and IncubusNow. It was fascinating to meet, in person, each of the "regulars" on the board. IncubusNow was reserved and seemed the perfect statesman. Noretreat is impressive, very bright and analytical with an incredible memory for detail. KarinCA was awesome as she guided the conversation and asked very astute questions. Leo seems to really value her opinion. Each of these CTIX longs are a testament to the value and potential of Cellceutix.
KarinCA made the introductions between management and us and I was surprised at how open and responsive each (Leo, Doctors, Menon/Alexander) were in addressing questions and talking about the successes and challenges they've faced. As we proceeded into the conference room I noted it was about half full (probably ~50 attendees) but filled in a bit toward the end of the presentation. The conference did not list their presentation in an email that went out this morning and that may have contributed to a non-full house.
Leo started it off and did a great job. CTIX has so much information to convey, they scripted the entire presentation. Many of the other presentations I attended had the CEO/presenter finish with time left. And most spoke at about 1/2 speed compared to CTIX presenters. It was hard to consume all the data that was being presented (fire hose analogy is good here). The story of the women who had her cancerous lesions disappear and still stopped treatment was illustrative and I loved how Dr. Alexander called a spade and spade by saying, "we didn't agree with the discontinuation of treatment due to higher counts of some marker" (MAYBE OTHERS CAN CLARIFY HERE). I really like Dr. Alexander, he is incredibly approachable and genuine. He mentioned over and over it's hard to think about how to value Brilacidin as "we don't really even know it's full potential, it seems to be effective against everything we throw at it". In comparison, the other companies I sat in on had about 1/4 of the material to cover and most were one trick pony's, they may think they are better ponys, but they are still a one pony show (or multiple indications using the same chemical). CTIX has three major platforms, all of which are disruptive, and Brilacidin is in it's own world given it MOA and anti-inflammatory nature. (MAYBE OTHERS CAN COMMENT ON ANTINFLAMMATION POTENTIAL)
After the presentation the CTIX team and IHuber's retreated to a meeting room where the shareholders peppered management for more than an hour with details question on compounds, trials, FDA, deals/partners, funding, management philosophy and goals. It was incredibly enlightening. I'll try and break out each below but I loved that Dr. Menon flat out said, as Dr. Alexander was nodding that they're, "not in this for the money but to leave a mark on the world for good"… I then said, "yes, but you're doctors" and Leo chimed in, "and I'm the business side and entrepreneur." Leo had made other comments about how so many Bio-techs are run by PhDs or MD and have no business running a company, which I totally agree with. The management team is a good mix of purists and capitalists.
Compounds:
Kevetrin:
KarinCA asked Dr. Menon if Kevetrin was performing better, worse or as expected per the animal models. He laughed and said, "other than the time it's taking, it's performing just as we have seen it perform in the lab". I asked what their biggest struggle with Kevetrin has been and Leo responded, "the lack of control." Based on what they were saying they cannot get data until DF is good and ready to give them the data. Management had been promised updates and many times those updates haven't happen. Leo said, "if if had to do it again, I'd mix the premier research schools with community hospitals as they move much quicker." But Dr. Menon added, "it is good we're doing this way because it is being done correctly. It may be slow but the data will be comprehensive and detailed". They also mentioned that the Bologna trial in Italy is waiting for data from DF but may opt to start at one of the higher Kevetrin doses (215mg if I remember correctly).
Brilacidin:
From the in-depth conversations with each manager, they are thrilled with Brilacidin. Noretreat and Leo disagreed on the protocol for PIII (which dose they should pursue, Leo said 1 course ... NR said he wanted 3) but I'll let NR comment about that if he wants. NR also pushed for "all" the Brilacidin PIIb data to which Leo asked Dr. Alexander, "haven't we already released that?" To which NR said, "I want to see the data from days 7, 14 and 28…" and Leo seemed willing to get that data out. They did give a caveat that they have submitted an abstract for the meeting in April in Copenhagen and cannot pre-release data if the poster is accepted. They should know in a few weeks if it's accepted. Additionally, Dr. Alexander is coming up with daily application for Brilacidin that he thinks, "this may work on…" one anecdote was acne, he said "I think there is a whole division of the company that could be devoted to dermatology". Dr. Menon said, "how can we sell something when we don't even know the extent of the potential."
Purisol:
Wasn't really addressed other than NR saying this is a "big deal" and potentially a game changer to which Leo agreed (others can comment as I'm sure I'm missing more detail here as we were all having individual discussions).
Trials:
Kevetrin:
Leo/team does not know when Kevetrin will max out or end. He made a side comment about what happens if we're dosing "1000-2000mg" in a year? So there is no sign right now it's slowing down. Management is perturbed that they don't have more control over the trial. No timelines or expectations for when it wraps up but again Menon is happy as, "it's being done right".
Brilacidin:
The next step for the Brilacidin PIII is a meeting with the FDA (Leo mentioned that the infectious disease department of the FDA is the hardest of the nuts to crack) as they are hyper conscious about making sure new drugs are protected from overuse. The FDA required more PIIb data and Leo is waiting for his contractors to supply it. Dr. Alexander said, "if we had 30 staff devoted to doing the work, we'd have it done sooner" (then NR offered his help, I also put in a word for my research-y brother, slcimmuno). Leo does not know if the FDA will require one or two PIII trials but does expect each PIII to cost between 12-15M and take about a year.
Purisol:
Again not much on purisol and the conversations and questions were focused on Kevetrin and Brilacidin.
Trials:
As mentioned in the presentation, CTIX expects 5 trials to be happening in 2015. With the one or two PIII Brilacidin trials to be done by the end of the year or early next.
FDA:
They are getting quick responses from FDA on the Brilacidin requests. Dr. Alexander applied for QIPD in late Sept/early Oct and got the designation in early December. They are guaranteed to get a response from the FDA within 60 days of submitting their requests/data. The "in person" Brilacidin meeting scheduled for December with the FDA happened via the phone as the FDA sent a three page request for additional data just days before the scheduled meeting. Leo said, "I now know better what to expect going forward concerning the FDA".
Deals, Partners and Funding:
Leo and Dr. Menon said they are fielding inquiries daily from companies who want more information or partnership information. Leo and team feel the best value will be realized once Brilacidin PIII is underway and maybe completed. I floated the idea to Dr Alexander, to sell one indication of Brilacidin to accelerate the company's prospects and he asked several questions actually acting like he heard the idea instead of totally ignored it (even if it isn't the desired course-he didn't immediately put me off). After today's meetings I'm more in the boat of waiting because Brilacidin is performing so well… a part of me still would like a deal, as it would make a huge splash but I also understand the reservation of Leo to do a deal too early. He said he wouldn't even entertain an offer for Kevetrin until PII trials have started.
Leo also mentioned that he wasn't worried about funding. He has great relationships with several funding sources in addition to the shelf registration. He said Aspire has been a great partner where both parties have made good money and Aspire would love to do another deal if necessary and desired by CTIX. He also put to rest the idea that Aspire was just flipping the stock. He said they do liquidate shares but have retained a good portion (but as NR pointed out less than 5%). Given the frenzied atmosphere at the show, I have no question that CTIX could fund any amount they desired. Maybe that changes if the markets reverse but it's currently not an issue today.
I can't explain how impressed I am with the CTIX management team. They are genuine and candid. Dr. Alexander and Menon are true "do-gooders" (in the most positive way) and Leo is a talented manager and hart nosed negotiator (they laughed that Leo pressured the bankruptcy court to sell him the Brilacidin assets or he'd pull the deal) and then Dr. Alexander said, "but we did have to raise our offer 10%" with a smile. Leo was very clear that his goals are aligned with the shareholders as he's a large shareholder as well. I don't think they are into building the next Merck but they won't accept an offer that doesn't fit the potential of the drugs and company. Overall a great day and a great company (meeting NR, KarinCA and Incubas was awesome as well)!!!
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