Enrollment Underway in Phase 2b Study of Prurisol for Moderate to Severe Plaque Psoriasis
Positive Initial Data Reported in Phase 2a Proof of Concept Open-Label Study of Brilacidin for Inflammatory Bowel Disease
Phase 2a Study of Kevetrin for Ovarian Cancer Planned to Demonstrate p53 Modulation in Tumor
Video Presentation and Q&A to be Released Tuesday, November 15, 2016 at 10:00 AM Eastern Time
BEVERLY, Mass., Nov. 14, 2016 (GLOBE NEWSWIRE) – Cellceutix Corporation (OTCQB:CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies including dermatology, oncology, anti-inflammatory, and antibiotic applications, today provided a general business update and announced select financial results for the first quarter of fiscal year 2017 ended September 30, 2016.
Recent Highlights
Management Team Additions
- Arthur P. Bertolino, MD, PhD, MBA - President and Chief Medical Officer
- Jane Harness – Vice President of Clinical Sciences and Portfolio Management
- Dr. LaVonne Lang – Vice President of Regulatory Affairs
Dr. Bertolino, Ms. Harness and Dr. Lang are distinguished in their respective fields and cumulatively bring about 70 years of drug development experience to Cellceutix earned during highly relevant positions at major pharmaceutical companies including Parke-Davis, Pfizer and Novartis. “In their brief time at Cellceutix, Dr. Bertolino, Ms. Harness and Dr. Lang have proven to be extremely valuable in efficiently moving our pipeline forward,” said Leo Ehrlich, CEO of Cellceutix.
Portfolio Development
- Brilacidin (Inflammatory Bowel Disease)
- Initial comments received on the first patient in the Company’s Phase 2a trial of Brilacidin for ulcerative proctitis (UP) / ulcerative proctosigmoiditis (UPS), (Inflammatory Bowel Disease; IBD), showed a significant decrease in symptoms within one week of the lowest scheduled dose of Brilacidin therapy
- New data received during the current quarter shows clinically meaningful improvements in the first four patients of the first cohort who completed the trial at the lowest dosing level. The final two patients in the first cohort are currently receiving Brilacidin therapy
- In four patients evaluated to date, concentrations of Brilacidin in plasma were undetectable, meaning that risk of systemic exposure during localized treatment appears to be minimized
- Completion of the first cohort and start of second cohort is anticipated in December 2016
- Visiongain forecasts IBD medicines market to rise to $9.3 billion in 2019
- Brilacidin-OM (Oral Mucositis)
- Phase 2 trial evaluating the oral rinse Brilacidin-OM for treating and preventing chemoradiation-induced oral mucositis (OM) in head and neck cancer patients remains ongoing
- Interim analysis anticipated 1H 2017
- Data from UP/UPS trial provide evidentiary support to the anti-inflammatory activity of Brilacidin in localized therapy; Cellceutix is optimistic the lack of systemic exposure will translate to the OM trial
- Brilacidin (Anti-Infective)
- Phase 2b trial was successfully completed previously showing Brilacidin non-inferior with similar safety profile to blockbuster daptomycin in treating Acute Skin and Skin Structure Infections (ABSSSI)
- Now working with U.S. Food and Drug Administration on a Special Protocol Assessment (SPA) agreement – will be positioned to move into Phase 3 research upon finalizing SPA and securing funding as to not impede other pipeline developments
- Kevetrin (Solid Tumors)
- Phase 1 successfully completed previously in patients with advanced solid tumors
- Now preparing for Phase 2a study to better define the mechanism of action of Kevetrin, specifically the modulation of p53 within the tumor
- Phase 2a trial planned to be initiated
- Laboratory work being conducted to develop an oral formulation of Kevetrin with the goal of capitalizing on Kevetrin’s short half-life of only approximately two hours
- Oral dosing is the preferred method for patients; the value of a new oral drug can be significant
- An oral delivery formulation greatly increases ease of treatment and viability of multiple daily or weekly doses of Kevetrin
- Cellceutix is attempting to develop and commercialize not only the world’s first p53-modulating drug, but the first oral formulation of a p53-modulating drug
- Prurisol (Chronic Plaque Psoriasis)
- Phase 1 (healthy subjects) and Phase 2a (mild to moderate psoriasis patients) already successfully completed
- Phase 2b underway in patients with moderate to severe psoriasis
- Value of new oral treatment for psoriasis demonstrated by high valuations in recent M&A activity
- Interim analysis from the Phase 2b trial expected 1H 2017
“It was a great quarter for Cellceutix as we achieved some of the most important developments yet in the history of our Company. Specifically, we demonstrated limited systemic risk in localized Brilacidin therapy, with drug concentrations in plasma below the lower limit of quantification (<100 ng/mL); advancements have been made for an oral formulation of Kevetrin; and we are progressing in our clinical trials,” commented Leo Ehrlich, Chief Executive Officer at Cellceutix. “These discoveries and advancements are proving the potential of our drug candidates and attracting attention from larger peers, as measured by the fact that we have engaged in more high level meetings recently than at any other time since inception. We have yet to fail in any clinical trial with any of our drug candidates and remain on target with our long-term goal to grow shareholder value by developing our drugs for hard-to-treat indications to provide relief for millions of people suffering worldwide. I believe that is more than ample reason to be excited about all that we have accomplished, our future and the litany of catalysts expected in 2017.”
Financial Results for the First Quarter of Fiscal 2017
The current primary potential source of cash available to the Company are equity investments through its equity purchase agreement with Aspire Capital. The Company has financed its operations to date through the sale of its common stock. The Company had raised approximately $8.2 million for the fiscal year ended June 30, 2016 and $1.9 million for the three months ended September 30, 2016, through its equity purchase agreement with Aspire Capital.
At September 30, 2016, the Company had approximately $5.6 million in cash compared to approximately $6.3 million in cash at June 30, 2016. Stockholders’ equity was approximately $2.1 million compared to approximately $3.0 million at June 30, 2016.
For the three months ended September 30, 2016, the Company’s net loss was approximately $3.0 million, or a loss of $0.02 per share compared to a net loss of $2.6 million, or a loss of $0.02 per share, for the three months ended September 30, 2015.
Stock-based compensation expense was $0.3 million for the three months ended September 30, 2016 compared to $0.1 million for the three months ended September 30, 2015. For the three months ended September 30, 2016, the Company’s cash flows used in operating activities were $2.6 million versus $2.1 million for the three months ended September 30, 2015. This is primarily due to an increase in our operating expenses, which includes research and development expenses, in 2016.
Video Presentation and Q&A Information
Cellceutix management has prepared a video presentation discussing the latest results, inclusive of a corporate and financial update by Leo Ehrlich, a scientific and clinical presentation by Dr. Bertolino and a question and answer session covering pre-submitted questions by analysts and shareholders. The video is pre-recorded and will be released tomorrow, Tuesday, November 15, 2016, at 10:00 AM Eastern Time. The webcast conference call will be available on the investor relations page of the Company’s website at http://cellceutix.com/events. A web-based archive of the conference call will also be available at the above website following the call.
A comprehensive review of fiscal 2017 and the most recent quarter is available through Cellceutix’s regularly submitted 10-Q and 10-K regulatory filings with the Securities and Exchange Commission at www.sec.gov and on the Cellceutix website.