Will O' Connor - Stern Investor Relations Joseph Patti - President and Chief Executive Officer Peter Azzarello - Vice President of Finance Anna Novotney Barry - Vice President, Clinical Development.

Good day, ladies and gentlemen. Welcome to the Biota Pharmaceuticals’ Third Quarter Fiscal Year 2015 Earnings Conference Call. At this time, all participants are in a listen-only mode. Following the formal remarks, we will open the call up 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 would like to welcome you to the Biota conference call and webcast to review the company’s third quarter fiscal year 2015 financial results and to provide an update on a number of recent corporate developments.

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

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 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. This morning, I will begin with an update on our development programs and conclude with an overview of our financial results for the quarter.

As we outlined in our press release this morning we are making excellent progress with our pipeline such that by the end of 2015 we anticipate having three active clinical trials.

These include our ongoing vapendavir Phase II B SPIRITUS trial, a Phase 1 single extending dose and multiple extending dose trial BTA-C585, our oral compound for the treatment of RSV and a Phase II trial with 074, a topical gel for the treatment of genital warts; we are in the process of obtaining via the Anaconda Pharma acquisition.

Let me walk you through a few highlights on our progress with each of these programs. I am happy to report today that we have 58 clinical sites in the U.S. and Central Europe actively screening and dosing patients with moderate-to-severe asthma in the Phase II B SPIRITUS trial.

The goal of this study is to enroll approximately 150 laboratory-confirmed Human rhinovirus infected patients with moderate-to-severe asthma and to report top-line data in approximately 12 months.

The screening process for the SPIRITUS trial involved identifying patients with upper respiratory infection leading to loss of asthma control or asthma exacerbation and that are classified as having moderate-to-severe asthma defined by the level of inhaled corticosteroids they are routinely taking.

Once screened, the patient will be randomized and will initiate study treatment if they subsequently present to the clinic within 48 hours of onset of symptoms consistent with the rhinovirus respiratory infection.

The primary endpoint of this multicenter, randomized, double blind placebo control study is the change from baseline to study day 14 in asthma symptoms and lung function as measured by asthma control questionnaire ACQ-6 total score.

Key secondary endpoints are focused on safety and tolerability, lung function assessments such as forced expiratory volume in one second, also known as FEV1, incident of asthma exacerbation, assessment of the severity and duration of cold symptoms measured by the Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) and virological assessments such as changes in viral load.

These are facts we recently initiated at this trial. It is premature to provide any guidance on how enrolment will track against our goal, but we are pleased with the number of patients that we have successfully screened today.

I'm also very pleased to report that we have successfully completed all required GLP studies to support an IND application for our respiratory syncytial virus fusion inhibitor, BTA-C585. We plan to file the IND next month and our goal is to initiate a Phase I single sending dose trial of BTA-585 in the third quarter.

We are very excited about the potential of this compound and prospects of moving into the clinic later this summer. In February, we announced that we had entered into a definite agreement to acquire Anaconda Pharma, a privately held biotechnology company based in Paris, France.

This morning we reported that we have received approval from the French ministry of Finance and Economics to proceed with the acquisition which was one of the closing conditions.

Closing is dependent upon finalization of other customary closing conditions pursuant to the purchase agreement and most importantly approval of the Phase II trial by the regulatory agency in Argentina known as ANMAT, where we intend to conduct the planned Phase II trial.

Once received formal approval of the protocol we anticipate -- which we anticipate will occur this month. We intend to proceed with the closing of the transaction.

Anaconda's lead candidate AP611074 or 074 as we refer to it is a patented direct acting antiviral in development for the treatment of condyloma or anogenital wart as well as the orphan disease recurrent respiratory papillomatosis also known as RRP; both of which are caused by human papilloma virus types 6 and 11.

Condyloma or genital warts caused by infection with HPV represents the most frequent viral sexually transmitted disease in adults worldwide. In the U.S. about 1% to 2% of the sexually active population between ages 15 and 49 developed condyloma as the primary clinical manifestation of HPV infection.

Currently there are no direct acting HPV topical or oral antiviral available for the treatment of condyloma. There are two key positive attributes of 074 that attracted us to the opportunity. First, is its favorable local skin tolerability profile.

In repeated topical application animal studies and in a six-week phase II A trial, 074 did not cause any erosions, ulcerations or edema.

This compares very favorably with Zyclara, Aldara or Veregen, currently approved topical treatments for genital warts, which in Phase III studies were shown to cause significant local skin reactions in one-third to one-half of those treated.

In addition to the favorable local skin tolerability profile a Phase II A study topical treatment with topical treatment of 074 resulted in a 38% decrease in mean baseline wart area compared to a 123 increased observe for placebo.

Further, 074 treatment resulted in a 56% overall response rate compared to a 38% rate shown in the placebo treated patients. Taking together we believe the emerging profile of 074 is promising and it will strengthen our pipeline and fits well with our focus on developing antiviral that address areas of unmet medical needs.

So we look forward to finalize the transaction as quickly as possible. Finally, I wanted to mention that our restructuring plan previous announced last year is ahead of schedule and all activities related to the closure of our Melbourne, Australian operation have been completed.

Now turning to our financial results; as usual, I want to remind everyone that this quarter we are reporting today, was ended March 31, 2015 is our third fiscal quarter as we have a June 30th fiscal year end.

Today we reported net income of 1.2 million for the three month period ended March 31, 2015 as compared to a net income of 3.2 million in the same period last year.

As outlined in more detail in our press release, this 2 million decrease in net income was primarily due to a significant decrease in contract revenue and related margin due to the termination in May 2014 of the contract we previously had with BARDA to develop laninamivir octanoate as well as $700,000 increase in research and development expense, a $700,000 increase in general and administrative expense and $200,000 loss on sale of assets that was associated with the closure of our facility in Australia.

These items were partially offset by a $4.1 million increase in foreign exchange due to the gain in U.S. dollar compared to the Australian dollar exchange rate and $100,000 increase in interest income.

The only items I like to further highlight this morning for our third quarter fiscal year are the increase in our research and development expense and increase in our G&A expense.

The $700,000 increase in our R&D expense was a result of advancing vapendavir into the Phase II B SPIRITUS trial in February including clinical and manufacturing cost as well as increased preclinical and manufacturing cost related to advancing BTA-585 towards an IND filing and initiation of a Phase I clinical trial.

These increased costs were offset in part by $300,000 reduction in salaries, benefits and share-based compensations and $200,000 decrease in expenses due to reduced research activities.

Our G&A cost increased by 700,000, due to $400,000 increase in professional legal fees related to the pending acquisition of Anaconda Pharma as well as $200,000 increase in salaries, benefits and shared-based compensation expense and $100,000 increase in other expenses.

Total transaction cost of approximately $800,000 associated with the pending acquisition of Anaconda Pharma recorded this quarter. At March 31, 2015, we held 74.4 million in cash, cash equivalents and short-term investments and long term investments.

We continue to maintain a strong financial position as our liquidity and networking capital position remains virtually unchanged from the end of our prior quarter ending December 31, 2014. That concludes my prepared remarks for today's call, and I will open it up for questions.

Operator?.

[Operator Instructions].

Unidentified Analyst:.

Unidentified Company Representative:.

Alright, and at this time I'm not showing any questions..

Okay. So as you can see the last few months have been very productive at Biota. We are actively screening and randomizing patients with moderate-to-severe asthma in the Phase II B SPIRITUS trial vapendavir at 58 clinical sites and expect to report top-line data next year.

Following the successful completion of all required GLP studies for BTA-585 we look forward to filing an IND next month and starting a Phase I trial next quarter.

And I'm pleased to report we anticipate closing the acquisition of Anaconda Pharma shortly and we look forward to initiating a Phase II trial with 074 in patients with anogenital warts in the second half of 2015. Thank you for joining us this morning and have a nice day. .

Ladies and gentleman, thank you for participating in today's conference. This does conclude the program, and you may all disconnect. Everyone have a great day..