Will O'Connor - Stern Investor Relations, Inc. Joseph Patti - President &CEO Mark Colonnese - EVP & CFO Anna Novotney-Barry - VP, Clinical Development.

Analysts:.

Good morning ladies and gentlemen and welcome to the Biota Pharmaceuticals First Quarter 2016 Earnings Conference Call. At this time, all participants are in a listen-only mode. Following the formal remarks, we will open up the call for your questions. I would now like to turn the call over to Will O'Connor of Stern Investor Relations. Please proceed..

Thank you, Operator. My name is Will O'Connor of Stern Investor Relations. I'd like to welcome you to the Biota conference call and webcast to review the company's first quarter 2016 earnings results and to provide an update on recent pipeline and corporate developments.

This morning, we issued a press release which outlines the topics that we plan to discuss today. The release is available at biotapharma.com. With me today from Biota are President and CEO, Dr. Joseph Patti; EVP and CFO, Mark Colonnese; and Vice President of Clinical Development, Anna Novotney-Barry.

Before we begin the call, I would like to remind you that today's discussion will contain forward-looking statements that involve risks and uncertainties. These risks and uncertainties are outlined in today's press release and in the company's recent filings with the Securities and Exchange Commission, which we urge you to read.

Our actual results may differ materially from what is discussed on today's call. With that, I will now turn the call over to Biota's CEO, Dr. Joseph Patti..

Thanks Will, and good morning everyone. Before I begin my remarks I want to start by welcoming Mark Colonnese, who joined us as CFO on Monday. We are expected to him on Board and with us on today's call. In the recent months we've made substantial progress advancing our pipeline of first-in-class direct anti-viral and growing our leadership team.

And I look forward to reviewing these accomplishments today. First, let's start with BTA585, our fusion inhibitor in the development for the treatment of acute respiratory syncytial virus infections in the children, elderly, and immunocompromised patients.

We are currently conducting a 50-subject, randomized, placebo-controlled, Phase 1 single ascending dose or SAD clinical trial to evaluate the safety and PK in healthy volunteers. This trial has five dose level cohorts ranging from 50 milligrams to 500 milligrams and includes an evaluation of whether the PK of BTA585 is effect if it's dosed with food.

To-date, four cohorts have completed the study and top-line PK and safety data are anticipated by year-end. We also anticipate beginning dosing in a Phase 1 multiple ascending dose trial this month and data with top-line results are expected to be available in the first quarter of calendar year 2016.

Now, I'll turn to our Phase 2 clinical candidate, BTA075, a first-in-class drug antiviral in the development for the treatment genital warts, or condyloma, which are caused by human papillomavirus type 6 and 11.

As you may recall, we are planning to conduct a double-blind placebo controlled randomized Phase 2 study to assess the safety, tolerability, pharmacokinetics, and efficacy of BTA075 -- BTA074 5% gel dose topically twice a day for up to 16 weeks in approximately 210 adult condyloma patients.

We have made good progress with the clinical activities involved in the start-up of this study in Argentina, but there are few remaining administrative items still outstanding, coupled with the upcoming Holiday season on the near horizon we believe that dosing in the trial will commence early next year.

Turning next to our Vapendavir, an oral treatment for human rhinovirus infection in moderate to severe asthmatics and the ongoing Phase 2b SPIRITUS trial.

The Phase 2b trial is a multicenter randomized double-blind placebo controlled dose ranging study designed and powered to easily randomize approximately 190 laboratory confirmed HRV infected patients across three treatment arms.

The primary endpoint of the change from baseline to study day 14 in asthma symptoms and lung function, as measured by the asthma control questionnaire total score.

Key secondary endpoints of the study include safety tolerability, specific lung function assessments, such as FEV 1, daily beta-2 agonist use, and the incidence of moderate and severe asthma exacerbations.

Screening of patients has progressed well at the 68 sites participating in the trial, however, lower than expected rate of upper respiratory sections in this have been reserved in patients thus far. Consequently, we anticipate top-line data will be available in the second half of 2016.

With that, I would like to turn to the recent additions to our leadership team at Biota. In September, we announced that both Armando Anido and Michael Dunne, M.D. joined our Board of Directors. Mr. Anido is currently Chairman of the Board and Chief Executive Officer of Zynerba Pharmaceuticals, and Dr.

Dunne is currently Chief Science Officer of Iterum Pharmaceuticals. They both bring to us a deep success and leadership in the development and commercialization of infectious disease products. On Monday, we welcome Mark Colonnese, as Executive Vice President and Chief Financial Officer.

Mark joins us from Stealth BioTherapeutics and has broad and extensive industry experience and has been implementing strategic financial strategies for over 30 years. We are happy to have him back in Atlanta and part of the Biota team. With that, I will turn the call over to Mark to review our financials..

Thanks Joe. I would like to start today by saying how excited I am to be joining Biota. I had been greatly impressed by the experience and expertise of the team here in the development of anti-viral therapies, as well as by the potential of our drug candidates to address a number of critical unmet medical needs.

Together, these factors give me confidence and the potential for significant value creation for our shareholders and other stakeholders. Now, let me turn to a brief review of our financials for the company's first quarter of fiscal 2016.

Revenue increased to $1.7 million for the three months period ended September 30, 2015, from $0.7 million in the same period last year, due to $1.7 million increase in royalty revenues in 2015 related to a Relenza government stockpile order, offset by a $0.7 million decrease in service revenue due to the termination of our BARDA contract in 2014.

Cost of revenue decreased to zero in this year's quarter from $1.7 million in the same period last year due to the aforementioned termination of the BARDA contract. Research and development expense increased to $5.5 million for the three month period ended September 30, 2015 from $4.9 million in the same period last year.

The increase in R&D expenses is primarily associated with $2 million of cost for preclinical, clinical, manufacturing and chemistry costs related to the ongoing Phase 2b SPIRITUS trial for Vapendavir, the Phase 1 single ascending dose trial for BTA585, startup expenses for upcoming Phase 2 trials for BTA074, and chemistry and preclinical expenses for our non-fusion RSV compounds.

These increases were offset in part by a $0.6 million decrease in compensation expense, and a decrease of $0.7 million in depreciation and facility related expenses also associated with the closure of the Australian facility last March.

In summary, we reported a net loss of $6.6 million for the three month period ended September 30, 2015, as compared to a net loss of $6.9 million in the same quarter of the prior fiscal year.

Basic and diluted net loss per share were $0.17 for the three month period ended this September, as compared to a basic and diluted net loss per share of $0.20 for the same period in 2014. For the quarter ended September 30, 2015, we held $66.3 million in cash, cash equivalents, and short and long-term investments.

At this point, let's open up the call for questions from our listeners. Operator.

And I'm showing no questions at this time. I would now like to hand the call back to management for any further remarks..

Yes, thank you. Looking ahead to the coming months, we anticipate commencing dosing in a multiple semi-dose trial with BTA585, a Phase 2 trial with BTA074. With an enhanced leadership team and many upcoming Phase 2 data readouts and trial initiations we believe 2016 is going to be an important year for Biota.

Thank you for joining us this morning and have a great weekend..

Ladies and gentlemen, thank you for participating in today's program. This concludes today's conference. You may all disconnect. Everyone have a great day..