NEW YORK, NY / ACCESSWIRE / June 30, 2016 / SeeThruEquity, a leading independent equity research and corporate access firm focused on smallcap and microcap public companies, today announced it has initiated coverage of Atossa Genetics, Inc. (ATOS).
The report is available here: ATOS Initiation Report. SeeThruEquity is an approved equity research contributor on Thomson First Call, Capital IQ, FactSet, and Zack's. The report will be available on these platforms. The firm also contributes its estimates to Thomson Estimates, the leading estimates platform on Wall Street.
Atossa is a clinical-stage pharmaceutical company focused on developing novel therapeutics and delivery methods for the treatment of breast conditions, including breast cancer. The company's current clinical-stage pipeline includes: 1) Intraductal Microcatheters, which deliver locally-administered pharmaceuticals through the breast ducts; as well as 2) Oral Endoxifen, for the treatment of breast cancer patients who are refractory to tamoxifen. Atossa management is also actively evaluating several additional therapeutic candidates for the treatment of breast conditions and/or breast cancer.
Additional highlights from the initiation report are as follows:
Aspire financing to support clinical program development
Atossa recently received commitments from longtime financing partner Aspire Capital for up to $10mn in at-the-market new equity sales over the next 30 months. While the financing will involve the issuance of new common shares, importantly, the deal provides Atossa with discretion over when Aspire will make purchases, and should provide sufficient capital to advance the company's clinical development into 2017E. With the company's ongoing "007" Phase 2 clinical study at Columbia University and the planned initiation of a Phase 2 study for oral endoxifen, the commitment should allow management to focus on operational and regulatory execution as well as the further development of its pipeline.
007 Phase 2 study underway; data expected
On the clinical front, in March Atossa began its "007" Phase 2 study for its lead clinical program, which is investigating the delivery of fulvestrant via Atossa's intraductal microcatheters in patients with DCIS and invasive breast cancer taking place at Columbia University. This study is currently underway, and Atossa expects to be in a position to review data by the end of 2016E. The hope is that the study will show positive safety data and potentially support its view that the localized drug delivery enabled by its intraductal microcatheters will allow for potentially higher drug exposure versus systematically delivered agents. If Atossa is able to show positive data with fulvestrant, it reasons that the company would seek to collaborate with other pharmaceutical companies to test the effectiveness of its intraductal microcatheters with other drugs to improve breast cancer / DCIS treatment. With 60,000 new DCIS patients and 235,000 new breast cancer patients announced each year in the US, and an average cost per dose of fulvestrant of $14,000, there is clearly a large potential market for this program.
Atossa's second clinical program, oral endoxifen for breast cancer patients who are refractory to tamoxifen, also holds promise. According to comments by management, Atossa expects to seek a 505(b)(2) regulatory pathway for oral endoxifen, leveraging extensive phase 1 and preclinical data, which, if accepted by the FDA, could potentially accelerate its path to commercialization. Oral endoxifen has a large market, estimated at more than $2 billion by Atossa, targeting as many as 500,000 women, who are seeking to prevent a recurrence and/or reduce their risk of breast cancer but for whom tamoxifen is not effective.
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About Atossa Genetics, Inc.
Atossa Genetics, Inc. is a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions. For more information, please visit www.atossagenetics.com.
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