There is a great and insightful interview with th
Post# of 72440
http://www.twst.com/interview/16845
Here are some of what I would consider to be the most relevant and interesting snippets.
(First off, a bio of the former CEO. What struck me here as stunning is this guy had an impressive resume, and had been successful in raising way large amount of $$$ in the past, how in the world did Polymedix unravel so badly financially under his guide? Perhaps some of our newer forum members that are former holders of Polymedix can chime in and comment. - TP)
"NICHOLAS LANDEKIC is President, Director, co-Founder and Chief ExecutiveOfficer of PolyMedix, Inc. He has been in the pharmaceutical andbiotechnology industry for over 20 years, and has done some of thelargest and most important financing and corporate licensing deals inthe healthcare industry. From 2000 to 2002, he was President and ChiefExecutive Officer and the first employee of Locus Discovery, where intwo years he raised $83 million in two record-breaking venturefinancings, hired over 50 employees, started 12 drug discovery programs,built one of the most powerful supercomputers in the world, and earnedfor the company the accolade 'One of the 10 hottest biotech startups'from Drug Discovery Today magazine. Prior to Locus, from 1995 to 2000 hewas Senior Vice President, Corporate Development and Investor Relationsat Guilford Pharmaceuticals, where he concluded a $465 million deal withAmgen and a $100 million deal with Rhone-Poulenc Rorer. His deals havetwice been nominated for 'Allicense Deal of the Year.' Prior toGuilford, from 1991 to 1995, he was Senior. Director, BusinessDevelopment at Cephalon; from 1988-1991 Senior Manager, StrategicMarketing at Bristol-Myers Squibb; from 1985 to 1988, he held positionsin Finance and Business Development at Johnson & Johnson Corporation(McNeil Pharmaceutical); and he also worked in the research laboratoriesat the Mt. Sinai Medical Center from 1982 to 1983. He holds an MBA fromthe State University of New York at Albany, an MS in Biology fromIndiana University and a BS in Biology from Marist College."
(Again, how in the world did they botch the financing so badly?? Sheesh. - TP)
TWST: What is it about this technology that intrigued you?
"Mr. Landekic: The heart of PolyMedix, what the company is trying to achieve with the technology that Bill DeGrado and Mike Klein have created, is the de novo design of biomimetic compounds. Biomimetics are organic compounds ' polymers, oligomers or small molecules ' that mimic the activity of proteins and peptides. Virtually all life functions, all biological processes, are controlled by proteins. Proteins turn things on, they turn things off; proteins make things happen. Most diseases have as their underlying cause a protein abnormality ' either too much, too little or the wrong protein being produced. There are many drugs that have been developed that are proteins themselves. Insulin, very widely used for many, many decades, is a protein. And there are other very successful and commonly used drugs, such as RheoPro, for clotting disorders, Procrit and Epogen to control side effects from cancer and kidney dialysis, and Enbrel for arthritis. These and many other protein drugs have aggregate sales of multiple billions of dollar. Unfortunately, all protein drugs have some significant limitations. They can't be taken orally; they can only be given by injection. They're very difficult and very expensive to produce. They're unstable, so even if they're given by injection, sometimes they break down very quickly in the body. The body can also have immune system reactions to proteins that cause the body to produce neutralizing antibodies that result in their losing effectiveness over time, sometimes limiting protein drugs to short-term use only. Despite that, many protein drugs have been developed and commercialized because organic small molecule compounds just haven't been able to do the job. One of the holy grails of medicine is to come up with a stable, simple and easy to synthesize organic molecule, one that could be taken orally as a pill, and would function like a protein itself. This truly is one of the great holy grails of pharmaceutical research. The technology and Bill DeGrado and Mick Klein have developed achieves exactly this, using a variety of computational algorithms to mathematically design compounds which mimic the activity of proteins themselves. These compounds can be polymers, which are larger compounds that can be used as materials, and oligomers and small molecules, which can be used as drugs. Thus, biomimetics. When I had seen the success that they had achieved just the early stages of a year ago, it was light years beyond what I believe any other company has ever been able to achieve. I couldn't say no, so we had to do this."
(Very interesting and ironic to hear both the mentions of another "holy grail" of pharmaceutical research, and all the discussion of the importance of proteins. sound familiar? "Proteins turn things on, they turn things off; proteins make things happen. Most diseases have as their underlying cause a protein abnormality ' either too much, too little or the wrong protein being produced." I can't help but get excited that we now own the compounds spawned from the fantastic tech that Polymedix was able to capitalize on. - TP)
TWST: What are you focusing on?
"We have a lot of very complicated molecular dynamics, course grain, and force field algorithms underlying PolyMedix, but the only thing that matters is whether they work. Is it accurate, reliable, reproducable and consistent? Can we quickly, efficiently and cost-effectively get active molecules out of it? The first target we've picked to focus on is to develop novel classes of antibiotic drugs, and with polymer derivatives, self-sterilizing materials. The target we've picked to work on is the human defenses. All multicellular life forms, all higher life forms, have what are called host defense proteins. This is the body's first life of defense against bacterial, fungal, and now known to be also viral infection. These proteins are produced in every living creature at the site where bacteria or fungi enter the body. They're potent, broad spectrum, and work uniquely by directly disrupting and rupturing bacterial cell membranes, so it's virtually impossible for bacteria to develop resistance to them. But because these are proteins, they have the same limitations that I mentioned a few moments ago of the difficulties in developing them as protein drugs. Several companies over the last decade and a half have tried to develop host defense proteins themselves as drugs, and have not succeeded because of the limitations of these proteins. Many companies have tried to come up with organic biomimetics of these host defense proteins, but have not succeeded either. Coming up with a new mechanism of action for antibiotics is a major unmet medical need."
"Polymer derivatives of these compounds have been made, and we've shown that we can add them to paints, plastics and textiles to create products and surfaces that are intrinsically and permanently self-sterilizing by virtue of the material itself."
(Essentially this is discussion of the origins of and birth of the Polymedix pipeline. the second portion to me is a real eye opener!! - TP)
TWST: What is the route you have to go for approval of these?
"Another reason we picked the anti-infective applications for the first product is that, relatively speaking ' and studies have shown this ' this is one of the shortest paths to getting a drug on the market. There are many reasons for this, but primarily because the clinical trials are short. This isn't a two- or three-year trial, as we often have to do in a chronic degenerative disorder like Alzheimer's or cancer. It's a very short clinical trial with a clearly defined endpoint. For someone who is in the hospital with a serious bacterial infection, like drug-resistant Staph, which we've already shown activity against, we expect the duration of dosing of the drug will be a week or two. So it's a relatively short trial, and the end point is also relatively straightforward. We're not trying to interpret whether a person's memory is a little better or a little worse. It's pretty clear: either the person is dead or alive. If you've cured them, they walk out of the hospital."
(Extremely relevant comments here for us to consider and discuss. Much discussion has been had about the removal of POC Prurisol trial. The removal of a short term catalyst. But if Brilacidin is truly just about "turn key" and ready to enter a Phase 2b trial that will be considerably shorter in duration than a Prurisol POC, are we really that far off now time wise on having clinical trial results when comparing timing of POC Prurisol vs Brilacidin 2b? Just food for thought. But my interpretation and understanding of where Brilacidin stands is that a trial site was picked and ready to host the trial, there is plenty of inventory available for the trial, and all the FDA prep work was just about set, it was a lack of funds pure and simple that killed the 2b trial. can anyone confirm - perhaps i am off here? But I think Leo may surprise all of us here with how fast he gets this Brilacidin trial off the ground, and how quickly we get results. - TP)
"When you talk about bactericidal materials and you bring up the possibility of where in your home or your workplace you would like to have products or surfaces that are permanently self-sterilizing, intrinsically antimicrobial, the answer is pretty much everywhere, starting with your basement and bathroom. Most people don't realize it, but the average desk has 400 times more bacteria than the average toilet seat. It's no big surprise that people pick up colds and viral infections in the work place: bacteria and viruses are everywhere, and this is something that individuals can personally relate to."
(Probably getting ahead of myself here, but it is exciting to think that CTIX now owns the IP to the above. Imagine one day how many parents of little kids would buy a self sterilizing toilet seat or baby chair. What is that possibly worth? Just sayin - TP)
TWST: What kind of burn rate are you set up for at this point?
Mr. Landekic: Right now our burn rate is next to nothing. We'll manage our burn rate to make sure that we always have about two years worth of cash. The last thing any company should want to do is run out of money before achieving its milestones.
(Sad and ironic, isnt it? In retrospect, that's exactly what the company did, running out of money and crushing shareholders. Fortunately we have a CEO who I firmly believe will continue to stay ahead of our financing needs as he did with Aspire. With that said, it's always a very fair and relevant topic to question finances. The best tech in the world needs money to be proven, and that is something to stay acutely aware of as shareholders. - TP)
"This is also a testimony to the efficacy of our rational drug design. In the first program, the antibiotic drugs, we computationally designed, synthesized and tested about 200 compounds. Of those about 70%, or 140, were biologically active, and of those about 40 or 20% were potent, broad spectrum, and nontoxic. This report card, this quantitative success rate of 70% for designing hits and 20% for coming up with druggable leads, is by any objective measure nothing short of remarkable. The typical success rate with brute force is, if you're lucky, one in 10,000 will be a hit. With most other rational drug design approaches often it doesn't work at all, and if one in 100 works, you consider yourself fortunate. So I believe our track record of two out of three molecules being active and one out of five being worthy of taking forward as a lead speaks for itself."
(Just some interesting background info and statistics around the success rates of molecules in development. This really speaks volumes about the quality of the tech/algorithms used to build the Polymedix pipeline. I know for me it especially inspires confidence in Brilacidin, considering this became their flagship compound and had obvious trial success up to where we picked it up for pennies on the dollar today. - TP)
TWST: Given the success you're having, do you have any intellectual property to keep other people from copying what you're doing?
"Mr. Landekic: We most certainly do. We have an exclusive license agreement from the University of Pennsylvania, which covers the compositions of matter for the antibacterial compounds ' oligomers, polymers and small molecules. Those include some very broad claims on the basic mechanism of action of these compounds. Our composition of matter patents cover the oligomer backbones, the basic chemistry that we use to develop these compounds that will also be used in other programs. We also have an exclusive license with a number of patents and other proprietary software packages on the computational methods ' the platform that was used to design these compounds. There will always be competition. Any product that's successful and generates money will attract competition, but we think we've laid a fairly extensive three- dimensional minefield to make this as exclusive to PolyMedix as possible. Furthermore, a lot of the protection we have is the knowledge that it takes to do this. This isn't easy. We're not the first ones to try to come up with biomimetic compounds. Many companies both large and small have tried and have generally failed. A lot of our proprietary expertise comes from our scientific founders and the computational programs, the software they've developed. This isn't easily replicated or stolen."
(Although I'd love to have more clarity and specificity around exactly what the agreement is for IP and the licensing of the tech behind the IP, I am sure that under the careful consideration of Dr. Menon, CTIX at the very least got some outstanding intellectual property for bargain basement prices. This IP from the sounds of the above comments is not something that can be imitated easily. Makes it more exclusive for us, harder for competitors to rip off/outperform. - TP)
"Our antibiotics are the first of what could be many significant new drugs. We selected antibiotics from among many possible programs because it's a huge market opportunity and an enormous unfilled medical need, and also because it's relatively fast, inexpensive, and low risk to develop. If a compound kills bacteria in an animal, as long as you have a nontoxic dose in a human, it should kill the same bacteria in a human. It's a very different risk profile from trying to come up with a cure for cancer or Alzheimer's. I believe we have a very attractive combination of a near-term, very unique and very significant antibiotic product opportunity, but also a platform technology that can generate a sustainable pipeline. And a sustainable pipeline means a sustainable business. Too many companies are one-trick ponies. They have one product, and if the product works, that's great. But it's kind of like going to Atlantic City and putting your life savings in a slot machine and giving the arm a pull. If it turns out well you're happy, but the odds are heavily weighed against you. We have a sustainable pipeline and if any one or even several of our programs don't work, we'll miss them, but we have the capacity and we've proven from our quantitative success rate that we can design compounds and commercialize many other programs."
(Reading the above comments, you could see the reasons for Leo's excitement. In a way, the Brilacidin trial looks to be the polar opposite of the Kevetrin trial. Where the Dana Farber trial is a very challenging, time consuming, and strict trial in many respects, the brilacidin trial should be very rapid, straight forward, and hopefully quick to deliver results that the market will like, and more importantly bigger partners would be confident to partner with. Also ironic is the discussion of not being a one trick pony. CTIX shareholders are now benefitting from having an expanded pipeline that should have the careful financial backing it needs to be proven to the point of monetization. - TP)
So to summarize, after reading this interview, Karin's recent excellent interview, the most recent Polymedix PRs and company info, I can see why Leo is so enthusiastic about this asset acquisition, and I am very excited as well. I bet he is working like a mad man to get this Brilacidin trial up and running ASAP.
With that said, I do think that realistically speaking, as far as stock price is concerned, the biggest movers of SP next will be more concrete and impressive Kevetrin results, and the eventual announcement of further financing. I think its possible that Mr. Market will remain not overly impressed with more trials coming on line, and will continue to ask to "show me the money" before pushing to a significantly higher SP. of course ive been dead wrong so many times, im sure ill be way off again. Regardless, these are exciting times for the company, as the potential here is really something. Best 5 million buck asset takeover ever.
IMO IMO IMO
Man, this post took a long time to make. I hope it helps folks in their DD of these latest additions to the CTIX pipeline