BEVERLY, MA--(Marketwired - August 10, 2015) - Cellceutix Corporation (
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.
Mr. Ehrlich added,
"Although I don't like to give any publicity to ridiculous assertions made against me or Dr. Menon, I feel the need to address them at this time to hopefully put some things to rest for good. As far as my time at Saliva Diagnostic/StatSure Diagnostics, I began as CEO on October 8, 1999 (http://www.sec.gov/Archives/edgar/data/885534/000095013099005795/0000950130-99-005795.txt). The following is a link to the SSUR September 30, 1999 10Q filing showing the state of finances at SSUR:
http://www.sec.gov/Archives/edgar/data/885534/000100547700002048/0001005477-00-002048.txt.
At that time, the company showed $73,073 in cash, $107,471 in accounts receivable, $96,290 in inventories and $2,834 in prepaid expenses. Equipment, leasehold improvements and patents had not much value. Stepping in to try and right the ship, I could only immediately count on the cash on hand of $73,073. The current liabilities were $2,898,691 with expenses mounting daily. The stock was essentially not trading. A miracle was needed and, unfortunately, I couldn't produce that miracle, but I did give it my best.
With respect to Nanoviricides, I was one of the founders in 2005. On May 16, 2007, I resigned from the company. During my time there of approximately two years, I accomplished many things, including forming a corporate structure and having the company become SEC compliant. While I was there, the company grew in value. Since the day I left of May 16, 2007, I haven't spoken to Anil Diwan, its Chairman, not even one time; and perhaps (at most) five times to its CEO, Eugene Seymour.
As far as self-enrichment with CTIX, long-term shareholders know myself and Dr. Menon deferred our salaries for many years. We were working very hard to build the company without receiving a paycheck. Not only that, we loaned Cellceutix millions of dollars to help develop the company and its compounds when no other financing options were available. This can be seen in SEC filings for the years 2008-2011. Our spouses thought we were nuts, but we were on -- and remain on -- a mission to develop our drugs.
The maligned attack on the credentials of Dr. Menon and others associated with Cellceutix that seems to emerge as part of short campaigns is without merit. Dr. Menon is an incredible and well-respected scientist. Let me state some facts. Fact: Eli Lilly honored Dr. Menon with the prestigious President's Recognition Award (http://cellceutix.com/presidents-recognition-award/#sthash.2HCoVlCH.ptVZnKIC.dpbs). This is an award given very seldom to employees of Lilly, a corporation of tens of thousands of employees. The award was given because of Dr. Menon's excellence in lab research and discoveries that helped Lilly expand the potential of several cancer drugs. There was an administrative error stating that Dr. Menon earned his PhD from Harvard, when the fact is that Dr. Menon worked as a research scientist at Dana-Farber Cancer Institute. This error was corrected years ago. The article that was published by India New England years ago was simply absurd and was removed by the publisher with all its links as an admission that the story was false.
Fact: Dr. Emil Frei, a legend in the world of oncology, and Dr. Har Gobind Khorana, a Nobel Prize winner, were founders of CTIX and appear on the original transfer agent stockholder report of the Company.
Others laudable for their work in the growth of Cellceutix that were maliciously disparaged in the recent article include Dr. Sylvia Holden, an amazing researcher at Cellceutix, and Dr. Paul Ginsberg, a renowned patent attorney who was integral to Cellceutix's patents for Kevetrin and Prurisol. The author uses Google images to post pictures of these peoples' homes which incidentally are of high value, as a means of somehow trying to lend credence to the preposterous concepts that Dr. Holden and Dr. Ginsberg have no value to Cellceutix. The following are links to the Cellceutix patents that Dr. Ginsberg helped write: Kevetrin: http://www.google.com/patents/US8338454
Prurisol: http://www.google.com/patents/WO2013103601A1?cl=en
If one takes a moment to analyze our growth since we began to work with Aspire Capital in December 2012, when shares of CTIX were around $1.20 each, it is easy to see how their investment has provided us with the resources to grow our company and build shareholder value. In three years, shares are still ahead from that point, in spite of numerous, less-than-credible attacks on the Cellceutix in recent years, including this last one. See Chart
Other individuals mentioned were minor purchasers of the Company's stock. Also, we have not received any complaints from shareholders about our stock transfer agent or our law firm.
One last item, I would like to thank Dr. James Alexander who had retired from Cellceutix for medical reasons before the 'bash' story unfolded, for preparing the Kevetrin portion of our response on Friday.
It is impressive what Cellceutix has accomplished with a small group of very talented people attracting the attention of some of the best researchers and clinical sites in the world. As I've said many times, I believe the best is yet to come. None of our achievements would have been possible without the unwavering dedication of our team, partners and shareholders that this particular group went to great lengths to try to discredit. They used unethical and illegal methods from the historically effective playbook of shouting 'FIRE' for self-enrichment at the expense of our shareholders.
We will continue to try and get to the bottom of this. We are speaking with counsel about offering a reward for the identity of the short group so the company and shareholders can seek redress. We've hit record highs following these types of attacks and believe that our science will see to it that we do it again. Thank you for your ongoing support."
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About Cellceutix:
Headquartered in Beverly, Massachusetts, Cellceutix is a publicly traded company under the symbol "CTIX". Cellceutix is a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology and antimicrobial applications. Cellceutix believes it has a world-class portfolio of compounds and is now engaged in advancing its compounds and seeking strategic partnerships. Cellceutix's anti-cancer drug Kevetrin is currently in a Phase 1 clinical trial at Harvard Cancer Centers' Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center. In the laboratory Kevetrin has shown to induce activation of p53, often referred to as the "Guardian Angel Gene" due to its crucial role in controlling cell mutations. Cellceutix is in a Phase 2 clinical trial with its novel compound Brilacidin-OM for the prevention of Oral Mucositis in patients with head and neck cancer. Brilacidin-OM, a defensin mimetic compound, has shown in an animal model to reduce the occurrence of severe ulcerative oral mucositis by more than 94% compared to placebo. Cellceutix's anti-psoriasis drug Prurisol is in a Phase 2 trial. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix's lead antibiotic, Brilacidin, has completed a Phase 2b trial for Acute Bacterial Skin and Skin Structure Infections, or ABSSSI. Top-line data have shown a single dose of Brilacidin to deliver comparable clinical outcomes to the FDA-approved seven-day dosing regimen of daptomycin. Brilacidin has the potential to be a single-dose therapy for certain multi-drug resistant bacteria (Superbugs). Cellceutix has formed research collaborations with world-renowned research institutions in the United States and Europe, including MD Anderson Cancer Center, Beth Israel Deaconess Medical Center, and the University of Bologna. More information is available on the Cellceutix web site at www.cellceutix.com.
Forward-Looking Statements
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause Cellceutix's actual results and experience to differ materially from anticipated results and expectations expressed in these forward looking statements. Cellceutix has in some cases identified forward-looking statements by using words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "plans," "intends," "goal," "potential," "may," "suggest," and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are Cellceutix's need for, and the availability of, substantial capital in the future to fund its operations and research and development; including the amount and timing of the sale of shares of common stock to Aspire Capital; the fact that Cellceutix's compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in Cellceutix's filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. Cellceutix undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
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Contact Information:
INVESTOR AND MEDIA CONTACT:
Cellceutix Corporation
Leo Ehrlich
