SANTA ROSA, Calif., Nov. 13, 2014 /PRNewswire/ -- Ruthigen, Inc. (NASDAQ: RTGN) today reported financial results for its fiscal second quarter 2015 ended September 30, 2014.
Company Highlights
- Ruthigen obtained DMC clearance to begin Phase 1/2 clinical trial.
- Ruthigen initiated activities and announced first patient enrollment in the Phase 1/2 clinical trial for RUT58-60. The Phase 1/2 trial will be a controlled, double blind, randomized, and multi-centered clinical trial to evaluate the safety, tolerability, and potential efficacy of RUT58-60 as an adjunct therapy to systemic antibiotics for the prevention of infection associated with abdominal surgery.
- Phase 1/2 clinical trial enrollment targeted to be completed in the first calendar quarter of 2015.
Results for the Three and Six Months Ending September 30, 2014
As of September 30, 2014, Ruthigen had cash of $12.9 million, compared with $15.6 million as of March 31, 2014. For the three months ended September 30, 2014, Ruthigen reported a net loss of $1.7 million, or $0.35 per share, compared with a net loss of $1.0 million, or $0.50 per share, for the same period in fiscal 2014. For the six months ended September 30, 2014, Ruthigen reported a net loss of $3.4 million, or $0.72 per share, compared with a net loss of $1.5 million, or $0.74 per share, for the same period in fiscal 2014. Non-cash stock-based compensation expenses during the three and six months ended September 30, 2014 were approximately $0.3 million and $0.5 million, respectively, compared with there being no stock-based compensation expenses during the same periods in fiscal 2014.
Research and development expenses for the three months ended September 30, 2014 were $0.6 million compared with $0.5 million for the same period in fiscal 2014. Research and development expenses for the six months ended September 30, 2014 were $1.3 million compared with $0.7 million for the same period in fiscal 2014. The increases were primarily a result of the commencement of Ruthigen’s clinical research operations and preparations for the Company’s Phase 1/2 clinical trial for RUT58-60, as well as higher personnel related costs.
Selling, general and administrative expenses for the three months ended September 30, 2014 were $1.1 million, compared to $0.5 million for the same period in fiscal 2014. Selling, general and administrative expenses for the six months ended September 30, 2014 were $2.1 million, compared to $0.8 million for the same period in fiscal 2014. The increases were primarily a result of increased legal, accounting, and other consulting and professional activities associated with being a public company, and stock-based compensation expenses associated with equity grants issued during fiscal 2015.
Conference Call
Ruthigen’s management will host a conference call at 1:30 p.m. PST (4:30 p.m. EST) on November 13, 2014, to discuss the Company’s fiscal second quarter 2015 results. Individuals interested in participating in the conference call may do so by dialing 1-888-347-1332 for domestic callers or 1-412-902-4278 for international callers. Those interested in listening to the conference call live via the internet may do so at http://www.videonewswire.com/event.asp?id=101000. Please log on approximately 30 minutes prior to the presentation in order to complete the registration process.
A telephone replay will be available for seven days following the conclusion of the call by dialing 877-344-7529 for domestic callers, or 412-317-0088 for international callers, and entering conference code 10056012. A webcast replay will be available on the site at http://www.videonewswire.com/event.asp?id=101000 for one year following the call.
About Ruthigen
Ruthigen is a biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics designed to prevent and treat infection in invasive applications. The Company’s lead drug candidate, RUT58-60, is a broad-spectrum anti-infective that Ruthigen is developing for the prevention and treatment of infection in surgical and trauma procedures. The addressable market for RUT58-60 is approximately 30 million surgical and trauma procedures that are performed annually in the United States. The Company’s clinical program targets an initial $700 million potential market in the prevention of infections associated with abdominal surgery, with the market for the prevention of infections associated with all types of surgery being estimated at $3 billion. The Company plans to complete its Phase 1/2 clinical trial in the first calendar quarter of 2015 and, pending the successful completion of that trial, Ruthigen plans to conduct pivotal clinical trials. For more information, visit www.ruthigen.com or call 707-525-9900.
About RUT58-60
RUT58-60 is a broad-spectrum anti-infective drug candidate designed for prophylactic use during invasive surgical procedures. The new chemical formulation contains hypochlorous acid (HOCl) with no hypochlorite, and utilizes other small molecule stabilizers. The drug candidate has been shown in laboratory tests, to eradicate both gram-positive and gram-negative bacteria, including antibiotic resistant bacteria, within the first 30 seconds of contact time. RUT58-60 was designed to improve patient lives, redefine infection control in surgical procedures and deliver cost savings to hospitals. RUT58-60 is proposed for use as an adjunct therapy in combination with prophylactic systemic antibiotics in abdominal surgical procedures. RUT58-60 is designed to improve patient outcomes, cut costs associated with hospital-acquired infections and reduce the emergence of harmful antibiotic-resistant bacteria. Because it is designed to be used in an intra-operative abdominal lavage -- a common procedure in invasive surgery -- it has the advantage of requiring no changes to surgeon or hospital procedures.
Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. These statements are often, but not always, made through the use of words or phrases such as “anticipates,” “expects,” “plans,” “believes,” “intends,” and similar words or phrases. These forward-looking statements include, without limitation, statements regarding the timing, progress and anticipated results of the clinical development of RUT58-60, including the timing of the initiation of planned clinical trials of RUT58-60 and regulatory submissions, statements regarding the indications for which we may seek approval of RUT58-60, statements regarding our ability to fund further development of our clinical programs, our ability to achieve our milestones, as well as Ruthigen’s strategy, future operations, outlook, future financial position, future financial results, plans and objectives. We may not actually achieve these plans, intentions or expectations and we caution investors not to place undue reliance on our forward-looking statements.
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