MUST READ!!! (Thank you Tails) Rodman & Renshaw CTIX Transcript of Presentation by Leo Ehrlich, CEO Sept. 2012
Robert & Renshaw Presentation 9/11/2012 (transcribed from audio)
Thank you. Ladies and gentlemen, I’d first like to take a moment to remember all of those who lost their lives on this day 11 years ago during the attack on the United States that claimed nearly 3000 people and impacted our entire nation. You are not forgotten, thank you.
Now I’ll begin the presentation with the following statement regarding forward looking statements to the extent that statements in this presentation is not strictly historical including statements as to revenue projections, business strategies, outlook objectives, future milestones, plans, intentions, goals, future financial positions, future collaboration agreements to the success of the company’s development, events, conditions on stockholder or other approval or otherwise future events. Such statements are forward looking and are made pursuant to the Safe Harbor Provisions of the Private Security’s Litigation and Reform Act of 1995.
The forward looking statements contained in this presentation are subject to certain risks and uncertainties that could cause actual results to defer materially from the statements made. Factors that may impact Cellceutix’s success are both fully disclosed in the Cellceuitx’s more recent public filings with the US Securities and Exchange Commission.
Thank you for attending this presentation, thank you very much.
My name is Leo Ehrlich and I’m the Chief Executive Officer of Cellceutix Corporation. I’m joined by Dr. Krishna Menon, my partner and co-founder of Cellceutix. Today’s presentation will focus on our three leading compounds. I’ve spend most of my life as an accountant and as a business man, which we now call an entrepreneur. When I was thirteen years of age, I lost my father to cancer. In 2006, my mom was diagnosed with Stage 4 colon cancer. The family was advised that the chemo treatments would be difficult and painful to her and at best, her life expectancy will be quite short. I then became familiar with the various chemotherapies and saw firsthand the toxic effects of these drugs. It was during this time that I turned to Dr. Menon for advice. He explained he was working on a compound with lots less toxicity to fight cancer. I was intrigued and we formed Cellceutix. We were determined and motivated more than anyone else. We saw fit to follow a different course than the conventional one. We believe cancer drugs needn’t be poisons injected into people who are already suffering from cancer, and adding additional pain and suffering. We believe cancer drugs can be far better than those presently approved. We have not accepted the conventional thinking and have created a whole new class of chemistry and medicine. The drug is named Kevetrin.
Let me share with you some cancer statistics pertaining to cancer in America. About 1.7 million new cancer cases are expected to be diagnosed in 2012. Also in 2012, about 577000 Americans are expected to die of cancer, more than 1500 people a day. Cancer is the second most common cause of death in America exceeded only by heart disease accounting nearly one of every four deaths. I want to give you a little framework and familiarity of what our breakthrough anti-cancer compound Kevetrin is all about. Kevetrin is a novel drug that has shown extremely promising laboratory results as a new cancer treatment. Clinical trials of tests of Kevetrin are against advanced solid tumors are beginning at Harvard University’s Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center among the pinnacle of cancer research hospitals in the world. In addition, studies are being conducted and paid for by Beth Israel Deaconess to research Kevetrin in conjunction with two of Pfizer’s multi cinzen inhibitors as potential new therapies for renal cancer and melanoma.
In preparation for human trials, we dedicated years to pre-clinical research of Kevetrin to test out propriety compound against many different cancer lines and delineate its mechanism of action. What we discovered was potent anti-cancer activity against every type of cancer we tested, even mutated cancers that were resistant to present day medications. The data showed Kevetrin to be effective against lung, breast, colon, prostate, squamous cell carcinoma, a leukemia tumor model, and malignant glioma. In all our research, tumor delay growth and tumor size reduction was shown.
Why is Kevetrin so unique, so different, and so effective in the studies? Kevetrin demonstrated the potential for a major breakthrough in cancer research by exhibiting an activation of P-53. Now P-53 is very important. P-53 is often referred to as the Guardian Angel gene or the Guardian Angel of the Human Genome due to its crucial role in controlling cell mutations if a tumor suppressed a protein that is encoded by the TP-53 gene in humans and has widely been regarded as possibly holding a key to the future of cancer therapies. As a potent anti-proliferative and a pro-apoptopic, P-53 has been shown to play critical roles in the homeostatic health of the human body by activating proteins required to repair DNA and plays a major role in the life cycles of cells by inducing cell cycle arrest and apoptosis, or program cell death to maintain cellular and genetic stability. The P-53 gene is the most commonly disrupted gene in cancer and more than 50% of all human carcinomas, P-53 is limited in its anti-tumor activities by mutations in the protein itself. Currently there are greater than 10 million people with tumors that contain inactivated P-53 while a similar number have tumors in which the P-53 pathway is partially abrogated by inactivation of other signaling components. This has left cancer researchers with the grand challenge of searching for therapies that could restore the protein’s protective function which Kevetrin appears to be doing a majority of the time.
Now I know this is a financial presentation and its crucial to discuss the silsutic opportunities here. Because of the abundance of cancers with P-53 disruptions, a multi-billion dollar opportunity is present for a new drug that addresses P-53 damage to restore to its normal role as a master regulator of the cell cycle. Nearly a decade ago, Roche began developing a series of molecules which they call nutlins as selective antagonists of P-53 and DM-2 binding that was heralded as a major breakthrough in oncology. While contributing invaluable knowledge to the industries, nutlin was shown to be geno-toxic, meaning they damage healthy DNA surrounding cancerous tumors. The next few comments are critically important. One, our research has shown Kevetrin which is structurally different from nutlins and other anti-cancer agents in the development of currently on the market is non geno-toxic. Two, additionally we have discovered that Kevetrin’s mechanism of action may also be connected with the retinoblastoma protein, RB, a second major component in controlling tumor progression. Primarily RB is responsible for stopping S phase’s entry of assault cycle at the G1 checkpoint and nearly 100% of cancers regardless of origin, RB or P-53 is dysfunctional. Three, if clinical trials show that Kevetrin restores damaged RB and P-53 in humans to their normal tumor surpressing status, it could be one of the greatest breakthroughs in cancer history. Kevetrin is thoroughly protected through pending patents which cover tens of thousands of possible future chemical combinations for new drugs, a potentially very valuable proposition for multiple drug developments in the future.
We are unaware of any other company that has actively in clinical trials with a non geno-toxic drug and utilizing the P-53 pathway as its mechanism of action, positioning us as a clear leader in the space. We are very pleased to be honored with such prestigious institutes as Dana Farber and Beth Israel Deaconess. We do not know of any company with the market capitalization the size of Cellceutix to be hosting a clinical trial at these sites. Most public companies that are accepted sponsor trials at Dana Farber have market capitalizations well into the hundreds of millions of dollars, giving us what we feel as strong upside potential based upon Kevetrin alone. Yesterday we released some real exciting news. Cellceutix was approached by one of Europe’s leading universities. They’re interested in testing Kevetrin as a combination therapy for leukemia with drugs manufactured by one of the world’s largest pharmaceutical companies. That would be great. Another Phase 1 study with Kevetrin. This European university will be responsible for funding this study. A Phase 1 clinical trial on blood cancer will save Cellceutix millions of dollars. This is strong validation to us that all we have worked on is now starting to receive recognition, recognition for our incredible accomplishments. Having universities begin studying our compounds is not only flattering, but hopefully will yield substantial returns to Cellceutix.
Therapies for blood cancer such as leukemia are in great demand because so few viable treatments that are on the market today and only a select few showing strong promise in early clinical research. Nothing demonstrates the value of an early stage drug candidate for liquid cancers quite like recent acquisitions by the major pharmaceuticals. Celgene acquired Avila Therapeutics in a deal valued up to 925 million dollars. Celgene’s focus on the acquisition was AVL-292 as a treatment for patients with deep cell blood cancers. AVL-292 was in Phase 1 trials at the time of acquisition. The value of a promising drug to liquid cancers was also demonstrated on August 30th when a Johnson&Johnson unit signed a deal to obtain global licensing rights to blood cancer compound, Daratumumab, from Danish pharmaceutical group, Genmab. All told the deal could total 1.1 billion dollars for Genmab for a drug that is in Phase 1 too of clinical trials.
Because of these transactions, we are extremely encouraged by our early research on Kevetrin from the NCI 60 DTP human tumor cell blind screen which showed Kevetrin was effective in killing leukemia cells in vitro. In lab studies tumors treated with Kevetrin exhibited tumor growth delay of 110% and reduction in tumor volume by 84%, broadly outstripping standard leukemia therapies in Kriztin and Zanorubesen in the studies.
When you consider that we have solid tumor cancer studies at Harvard Cancer Center and now planned blood cancer clinical trials in Europe, Cellceutix has amazing opportunities that few companies have. We expect these collaborations to grow exponentially once clinical trials that coming. I’d like to add one last comment about Kevetrin. I remember my children when they were very young and we’d watch the same Disney video, over and over and over again. Each and every time they enjoyed it, they always saw something new. The same is true for Kevetrin. Every time we experiment with the drug, it reveals some new nuisances about its abilities. We believe we have an exceptional drug.
Our second drug in development is an anti-psoriasis compound called Prurisol. Prurisol is a small molecule acting on the principle of immune stimulation and PRINS reduction. It has found to be effective against psoriasis in animal models, both in induced psoriasis as well as xenograft model of human psoriatic tissue. It is taken as an oral dose, the preferred drug delivery method of patients worldwide. With more than 150 million people globally suffering from psoriasis and 150000 new patients of psoriasis per year in the US alone, Prurisol represents a very unique opportunity to potentially generate substantial revenue for Cellceutix.
Our research showed Prurisol most definitely and clearly outperform Methatrexate, a standard of cure treatment for advanced psoriasis as there was no recurrence of psoriasis on the animals. Visually, it eliminated all indications of psoriasis. You can clearly see the results on your screen here or on our website. The recent activity of GlaxoSmithKline spending approximately 350 million dollars to acquire rights to a Phase 2 topical psoriasis treatment demonstrates how valuable and in high demand new dermatological drugs are right now. We feel that our oral therapy is far greater value and will be at the same clinical stage in 2013. We are advancing Prurisol immediately into mid to late stage clinical trials based on the fact that the active moiety of Prurisol has already received US Food & Drug Administration approval. After meeting with the FDA in June regarding the regulatory pathway for Prurisol, the agency informed us that a 505B2 application would be an acceptable approach for the new drug candidate. With that guidance from the FDA, we are now moving forward with planning the first Phase 2 clinical trial for Prurisol.
Last week we announced that we have selected Dr. Reddy’s lab. They will manufacture the product for us in oral form. We expect with a clinical trial in Europe at that process is a little faster followed with trials in the United States.
Our final compound in development is KM-391, a novel compound being developed for the treatment of autism. While still early in development, our initial research is very encouraging. Neonatal serotonin depletion and reduced plasticity of the brain are salient features well documented in the autistic brain. We focused on these benchmarks in our research and showed that the brains of KM-391 treated animals exhibited increased brain plasticity and serotonin levels as compared to paired twins serving as controls. Additionally, specific behavior characteristics such as repetitive behavior and self induced injury were greatly reduced. There are currently no drugs available on the market and only a very limited number of drugs in development that address the core issues of autism in the manner that KM-391does. Again we feel that this drug puts us in a strong position for growth and partnering opportunities.
I’d like to introduce you to the world class team we have assembled at Cellceutix. Our President and Chief Scientific Officer is among the hardest workers I know. Dr. Menon has more than 30 years in drug development for academia and industry. Dr. Menon was a research associate scientist at Dana Farber Cancer Institute. He was also group leader of Cancer in Vivo Research and Clinical Development for Eli Lilly, where he played a key role in lead selection in pre-clinical development of Lilly’s blockbuster cancer drugs, Gemzar and Alimta, which generate billions of dollars in yearly sales. In 1999, Lilly honored Menon with a Presidential Recognition Award, the highest award at the company.
We have an amazing scientific advisory board consisting of Dr. Paul Marks, Dr. Emil Frei, Dr. Samuel Danishefsky, and Dr. Paul Ginsburg. To list all their accomplishments would have you sitting here for hours so I’ll be brief. Dr. Marks is internationally known for his service as President and Chief Executive Officer at Memorial Sloan-Kettering Cancer Center until 1999 and currently assists as President Emeritus and Member of the Sloan-Kettering Institute. Dr. Danishefsky is recognized as one of the world’s leading chemist in cancer research. He is the chairman of the Memorial Sloan-Kettering Cancer Center laboratory for Cancer research Bioorganic Chemistry. Dr. Ginsburg recently retired from Pfizer where he served as head of the New York Patent Department and worked on patent matters relating to several blockbuster products including Viagra and represented Pfizer on the intellectual property committees of the National Association of Manufacturers, the Chemical Manufacturers Association, and the Biotechnology Industry. Dr. Ginsburg is perhaps most well known for as the author of the patent covering Schering-Plough’s hugely successful product Claritin. Dr. Ginsburg has authored the patent application for Kevetrin and Prurisol. Dr. Frei is widely regarded as the world’s leading oncologist with more than 40 years experience. Dr. Frei is Physician in Chief Emeritus at the Dana Farber Cancer Institute and former Chief of Medicine at the National Cancer Institute. Dr. Frei has unparallel experience in developmental of new cancer drugs. He is often referred to as the “Father of the Cure for Childhood Leukemia” because of his collaborative work with Dr. Emil Freireich. Dr. Frei commented on the latest development at Cellceutix. He stated, “What Cellceutix is doing with Kevetrin can lead to a ground breaking moment in the world of oncology. In my career, including my tenure as Chief of Medicine at National Cancer Institute, I’ve seen countless companies throughout the world striving to bridge the gap between damaged or mutated P-53 in carcinomas with little or no success. P-53 can hold a vital key to the next generation of chemotherapy. Cellceutix’s discovery of Kevetrin which has been shown to reactivate P-53 in a non geno-toxic manner is a very promising advance in the fight against cancer.”
The market potential is certainly there for us, I’d like to share with you some figures. According to the National Cancer Institute, the cost associated with cancers was more than 124 billion in 2010. According to the National Psoriasis Foundation, in 2008 the annual cost of psoriasis in the US was estimated at 11.25 billion. Regarding autism, recent research by the University of Pennsylvania and the London School of Economics estimates that costs associated with autism which affects 1 in 88 US children equals 137 billion dollars annually.
Cellceutix is a now tiny biotech spearheading breakthrough research; however, I believe we are now reaching an inflection point, opening up the possibility of exponential growth going forward. We have an experienced team with a proven track record and compounds that have demonstrated robust results to date. We have non disclosure agreements with some of the world’s largest pharmaceutical companies that are interested in developments at Cellceutix. Now that we’re in a relationship with Dana Farber and Beth Israel Deaconess, we believe we are well positioned to quickly emerge as a formidable force in biotechnology. I’m convinced beyond a doubt if we are able to see in the clinical trials even a portion of the results that we’ve seen in the lab studies, Cellceutix will experience a wave of unprecedented growth. With P-53 in play, an eventual 10 billion dollar evaluation is not science fiction. I mean we’ve seen the takeovers this year; we’ll have to wait and see. Thank you. Also I’d like Dr. Menon to stand up; Dr. Menon is such an important part of this. I invested very heavily in this belief when we started out and we’ve really taken this a long way. Thank you very much.
