Earnings Labs

Atossa Therapeutics, Inc. (ATOS)

Q1 2016 Earnings Call· Sun, May 8, 2016

$5.52

+1.28%

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Transcript

Operator

Operator

Good afternoon and welcome to the Atossa Genetics' Earnings Conference Call for First Quarter Ended March 31, 2016. [Operator Instructions] Please note this event is being recorded. I would now like to turn the conference call over to Scott Gordon, President of CorProminence. Please go ahead, sir.

Scott Gordon

Analyst

Thank you, Denise and thank you for joining today's conference call to discuss Atossa Genetics' corporate developments, financial results for the year ended March 31, 2016. With us today are Dr. Steven Quay, Chairman, CEO and President; and Mr. Kyle Guse, CFO and General Counsel. At 4:01 PM Eastern Time, Atossa released financial results for the quarter ended March 31, 2016. If you have not received Atossa’s earnings release, please visit www.atossagenetics.com. Before we begin, I would like to note that comments made during this call may include forward-looking statements regarding future events or the future financial performance of the Company. Such statements are predictions only and actual events or results could differ materially from those made in any forward-looking statements, due to a number of risks and uncertainties including assumptions about future events based on current expectations, plans, business development efforts, near and long-term objectives, regulatory actions, potential new business strategies or organizational changes, changing markets, future business performance and outlook. Please see Atossa's most recent filings with the SEC, including without limitations, Form 10-Q, 10-K and 8-K. I will now turn the call over to Dr. Quay.

Steven Quay

Analyst

Thank you, Scott and good afternoon. Atossa is a clinical stage pharmaceutical company focused on the development of novel therapeutics and delivery methods for the treatment of breast cancer and other breast conditions. Our leading program uses our patented intraductal microcatheters, which deliver locally administered pharmaceuticals through the breast ducts. We initiated a Phase II clinical study in March 2016 using our microcatheters to deliver fulvestrant as a potential treatment of ductal carcinoma in-situ or DCIS and breast cancer. Fulvestrant is commercially available in the U.S. as a monthly intramuscular injection. This study is being conducted by Columbia University Medical Center Breast Cancer Programs. Our second pharmaceutical program underdevelopment is Afimoxifene Topical Gel or AfTG for the treatment and prevention of hyperplasia of the breast. In addition to our clinical stage pharmaceuticals programs, we are in the process of evaluating several therapeutic candidates to treat other breast conditions including breast cancer. Factors we are considering in evaluating potential drug candidates include for example the ability to obtain expedited regulatory approval, significance of unmet medical need, the size of the patient population, intellectual property opportunities and the anticipated preclinical and clinical pathway. Before I provide an update, Kyle will summarize our 2015 financial results.

Kyle Guse

Analyst

Thank you, Steve, and good afternoon, everyone. As a result of the sale of NRLBH in December 2015 - the 2015 financial results, the NRLBH are presented separately as discontinued operations in the company's consolidated statement of operations. We did not generate revenue or cost of revenue for the three months ended March 2016 to NRLBH had totaled net revenue of $1.9 million and cost of revenue of $1.2 million for the three months ended March 31, 2015 and consisting of mainly pharmacogenomics testing. Total operating expenses were $2.3 million for the three months ended March 31, 2016, consisting of G&A expenses of $2.2 million and R&D expenses of $150,000. As a result of the sale of NRLBH, operating expenses related to the NRLBH are presented separately as discontinued operations for the three months ended March 31, 2015. Operating expenses from continuing operations decreased $945,000 or 29%, from $3.3 million for the three months ended March 31, 2015, which are consisted of G&A expenses of $2.4 million, R&D expenses of $566,000 and selling expenses of $346,000. The decrease in operating expenses is mainly attributed to the 2015 launch of new devices and services which are not being pursued in 2016 and from investing more in new R&D programs in the first quarter of 2015 compared to 2016. The Company recorded a net loss of $2.3 million for the three months ended March 31, 2016. The loss from discontinued operations for the three months ended March 31, 2016 was $61,000. Our cash and cash equivalents as of March 31, 2016 were approximately $2.9 million. During the first quarter of 2016, we drew on our facility from Aspire Capital raising $2.2 million, as a result. This substantially contributed to our cash resources particularly in light of the fact that our burn rate has been reduced significantly for the sale of the NRLBH. We've now fully utilized the facility with Aspire Capital and no shares remain available for sale to them under the terms of our agreement. That concludes my comments. I would like to turn the call back over to Steve.

Steven Quay

Analyst

Thank you, Kyle. As I mentioned on our March 30, 2016 conference call, Atossa Genetics has experienced a significant transformation last year from a device diagnostic company to a focused clinical stage company Now I'll spend our time today focusing on the progress we've made with our therapeutic program in developing pharmaceuticals to treat breast conditions including breast cancer. Difference where we are now focusing our financial and human resources and we'll continue to do for the foreseeable future. Our 007 trail, a Phase 2 study in women with DCIS or evasive cancer slated for mastectomy or lumpectomy opened for enrollment in March 2016 after gaining IRB approval. This study will assess the safety and tolerability of fulvestrant when delivered directly into the breast milk ducts of these patients. Although breast cancers and precancerous lesions are detected at an earlier stage and despite the use of systemically administered agents, such as tamoxifen or fulvestrant, marketed under the brand name Faslodex, serious side effects remain a major challenge, and may lead to poor patient compliance with these drug regimens. Clinically the American Cancer Society estimates that over 292,000 American women were diagnosed with breast cancer both local and invasive in 2015. They also estimate that over 40,000 women died in 2015 due to their disease. Providing drug directly into the ducts targeting the site of the localized cancerous lesions could reduce the need for systemic anti-cancer drugs and potentially reduce or eliminate the systemic side effects of the drugs and morbidity in such patients and ultimately improve drug regimen compliance. Let me now describe our clinical trial in more detail and provide further context regarding the end points of the trial to which we hope to begin reviewing study data in the second half of 2016. Our Phase II clinical trial…

Operator

Operator

Steven Quay

Analyst

Well, I want to thank you for your attention this afternoon and if you have any additional questions, by all means you can reach out to us at the company. Thank you very much for this call.