Cellceutix Reports Results for Quarter Ended March 31, 2015; Enrollment for Oral Mucositis Studies to Begin this Month

BEVERLY, MA–(Marketwired – May 13, 2015) Cellceutix Corporation (OTC: CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, and antimicrobial applications, today announced its financial results for the three months ended March 31, 2015.  A detailed report of the third quarter fiscal 2015 has been filed in a Form 10-Q with the Securities and Exchange Commission.

Highlights from the quarter ended March 2015 include:

» The start of the eleventh cohort of patients in the Phase 1 clinical trial of Kevetrin for advanced solid tumors being conducted at Harvard Cancer Center’s Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center.  Patients in the completed tenth cohort were administered 450 mg/m2 of Kevetrin. We have found Kevetrin to be extremely well-tolerated, including in one patient who received their first treatment at 750 mg/m2 – the highest dose yet administered and is 75x the initial study dose.  Maximum tolerated dose is yet to be determined.

» Manufacturing of additional quantities of Kevetrin, Brilacidin and Prurisol for planned clinical trials.

» The release of confidence interval statistics from the Company’s completed Phase 2b trial of Brilacidin, Cellceutix’s lead drug in a new class of antibiotics called defensin-mimetics, for Acute Bacterial Skin and Skin Structure Infections (ABSSSI).  The confidence interval statistics reinforced previous data from the trial showing Brilacidin to be comparable to the blockbuster antibiotic daptomycin marketed by Cubist Pharmaceuticals under the brand name Cubicin.

» Development of formulations of Brilacidin and our “1807” antifungal compounds for otic (ear) infections.  The compounds have been shipped to a leading university for ototoxicity testing.

» $30.0 million stock purchase agreement entered into with Aspire Capital.

» Applying to list Cellceutix common stock on the NASDAQ Capital Market

Additional information on the Cellceutix pipeline was disclosed in a comprehensive corporate update released on April 21, 2015.

“We made significant progress across our portfolio of compounds during the past quarter although not quite as much as I had hoped for.  We are moving forward vigilantly and the stage is set for what we anticipate will be an eventful June quarter 2015 at Cellceutix,” commented Leo Ehrlich, Chief Executive Officer at Cellceutix.  “We believe that we have a game-changing drug in Kevetrin because of its ability to act upon the tumor regulating protein p53.  For those not familiar with p53, an excellent book I would recommend is “p53: The Gene that Cracked the Cancer Code” by Sue Armstrong.  We are pleased with the meticulous care that Dana-Farber and partners have taken in the clinical trial of Kevetrin providing us with exciting data as we move forward with our plans to engage with the FDA for a mid-stage trial in solid tumors in 2015.“

“Fundamentally, we ended the quarter stronger than ever with $10.8 million in cash.  On March 30, 2015 we solidified our balance sheet with a $30 million stock purchase agreement with institutional investor Aspire Capital to continue to diversify and expand our portfolio of trials for cancer, antibacterial and psoriatic indications,” continued Mr. Ehrlich.  “To that point, I am pleased to inform shareholders that site initiation visits for the Phase 2 trial of Brilacidin-OM for the prevention and treatment of oral mucositis are underway and enrollment is on schedule to begin by the end of the month.  Additionally, we have been advised that Prurisol and placebo are being packaged and targeted for arrival at clinical sites for commencing the Phase 2 trial of Prurisol for plaque psoriasis by the end of June.  We anticipate www.clinicaltrials.gov to be updated to reflect ‘enrolling’ status for the trials in May and June, respectively.”

“In summary, we believe that the evidence compiled from trials to date suggests that we have one of the most promising cancer drugs in Kevetrin and antibiotic drugs in Brilacidin being in development today.  We are financially sound with a strong team developing a robust pipeline of novel compounds that are entering mid- and late-stage trials.  We are proud of what we accomplished during the quarter and greatly look forward to initiating the new trials this quarter and more throughout the year. I am proud to once again tell shareholders that the best is yet to come.”

First Quarter Results

For the three months ended March 31, 2015, research and development expenses were $2.32 million, compared to $1.83 million in the first quarter of 2014.  The increase of $488,000 was comprised primarily of increased expenses related to clinical trials and hiring of additional Cellceutix employees and officers.

Total operating expenses during the first quarter of 2015 totaled $2.85 million, compared to $2.28 million in the first quarter of 2014.  The $563,000 increase was primarily attributable to higher research and development costs and, to a lesser extent, a $42,000 increase in general and administrative expenses.

Net loss for the three months ended March 31, 2015 was $2.9 million, or 2 cents per share, compared to a net loss of $2.33 million, or 2 cents per share, for the quarter ended March 31, 2014.

As of March 31, 2015, Cellceutix had $10.8 million in cash, compared to $4.99 million in cash at the end of the first quarter in 2014.