Cellceutix Reports Positive Results of Brilacidin in Microbiological Intent-to-Treat Population in Phase 2b ABSSSI Trial

Additional Pharmacoinetic Information to be Submitted; Company Also Reports IRB Approval to Start Oral Mucositis Trial, Grant Awarded for HDP Mimics and Biotech Showcase on Tap

BEVERLY, MA–(Marketwired – Dec 22, 2014) – Cellceutix Corporation (OTCQB: CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, and antimicrobial applications, is pleased to provide additional information from the Company’s recently completed Phase 2b clinical trial of Brilacidin for the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI), as well as information on other pipeline developments.

On October 23rd 2014, Cellceutix announced positive top-line results for the randomized double-blind study comparing three dosing regimens of Brilacidin to daptomycin for the treatment of ABSSSI. The primary endpoint, defined as reduction of at least 20% in area of ABSSSI lesion, relative to baseline, was achieved in the intent-to-treat (ITT) population at 48-72 hours, for each of the three Brilacidin dosing regimens, including two single-dose regimens, with results that were comparable to the FDA-approved seven-day dosing regimen of daptomycin.

Cellceutix has continued to analyze the data within other populations in the study in addition to the intent-to-treat population. The Company is pleased to report that the results are also positive in the Microbiological Intent-to-Treat population (MITT). This is an important population, as it consists of patients enrolled in the trial who had cultures obtained at the baseline visit that were positive for common ABSSSI pathogens. Most of these cultures grew Staphylococcus aureus, and approximately 40% of these were Methicillin-Resistant Staphylococcus aureus (MRSA). This is currently the most important bacterial pathogen in patients with ABSSSI. As was seen in the ITT population, the primary endpoint in the patients with culture-positive ABSSSI was achieved for each of the three Brilacidin dosing regimens with similar results as for treatment with daptomycin for seven days.

In communication with the FDA last week, Cellceutix was encouraged to submit additional information from the Phase 2b study, including analyses of the recently obtained pharmacokinetic (PK) data. The Company has requested its vendors to assist in preparation of this information for submission as soon as possible. Thereafter, the Company will meet with the FDA to discuss the completed Phase 2b study and to discuss the plans for Phase 3 studies.

Oral Mucositis- Institutional Review Board (IRB) Approval

Cellceutix has received Institutional Review Board (IRB) approval to initiate its Phase 2 study of Brilacidin-OM, the Company’s novel oral rinse for the prevention of oral mucositis in patients undergoing chemoradiation for treatment of head and neck cancer. Study sites identified in the U.S. include MD Anderson Cancer Center at the University of Texas. A description of the study has now been submitted to www.clinicaltrials.gov and is expected to be published in the near term. In the U.S., no treatment is approved by the FDA to prevent the often debilitating condition of oral mucositis, the inflammation and ulceration that occurs in the mouth and affects the majority of patients who undergo chemoradiation.

$565,440 Grant Awarded for Research on Cellceutix Platform Technology

A key Cellceutix collaborator, Fox Chase Chemical Diversity Center, has received a 1-year extension on a subcontract from the University of Massachusetts (Amherst) under a UO1 National Institute of Health grant. The subcontract of $565,440 will be used to continue research on the development of the Cellceutix platform technology of host defense protein mimics (HDP mimics or defensin-mimetics) to combat serious and life-threatening infections caused by multi-drug resistant Gram-negative bacteria. The target pathogens include multi-drug resistant Acinetobacter baumanniiPseudomonas aeruginosa and the carbapenem-resistant Enterobacteriaceae (CRE)Klebsiella pneumoniae and Escherichia coli. Initial research will focus on continuing the development of lead compounds active against CRE organisms, including CTIX 1807, which has shown robust activity against Klebsiella pneumoniae in a mouse tissue infection model.

Biotech Showcase: Kevetrin and Prurisol

Cellceutix will be updating shareholders on the latest developments of the Kevetrin clinical trials for solid tumors ongoing at Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center and the upcoming trial of Kevetrin for Acute Myeloid Leukemia (AML) being sponsored by the University of Bologna and its partners during the Biotech Showcase conference being held in San Francisco on January 12, 2015. Updates on the Company’s Phase 2 trial of Prurisol (abacavir acetate) for plaque psoriasis will also be provided at the conference.

New IND filing planned

Cellceutix is preparing a request for a pre-IND meeting with the FDA to discuss clinical development plans to evaluate a Cellceutix defensin-mimetic for the treatment of serious gastrointestinal diseases. Updates on this important development will also be provided at Biotech Showcase.