Atossa Genetics Inc. (NASDAQ:ATOS) Reports Topline Trial Results

Atossa Genetics Inc. (NASDAQ:ATOS)

Atossa Genetics Inc. (NASDAQ:ATOS) slumped 11.95% after announcing preliminary results from a Phase 1 study of its novel treatment for  breast cancer, Endoxifen.  Thursday’s sell-off came as a surprise given that it came after positive news. The stock has also been on an impressive run since the start of the month.

The stock is currently trading in a $0.54 – $0.93 trading range after gapping lower in March. It faces immediate resistance at the $1.00 a share mark above which it could rise to the $1.50.

Atossa Genetics Inc. (NASDAQ:ATOS)
One month ATOS stock price chart

Endoxifen Phase 1 Results

The clinical stage pharmaceutical company says its novel treatment for breast cancer, Endoxifen, was well tolerated at all dose levels, during the phase 1 trial. The treatment tropical formulation did not trigger any significant safety signals or adverse events. The top line results thus demonstrated its suitability for further clinical development.

“Based on these positive preliminary results, we are advancing our topical Endoxifen into Phase 2 studies,” commented Dr. Steven C. Quay, CEO, and President.  “We look forward to announcing the results from the oral arm of our Phase 1 study in the coming 30 to 60 days,” continued Dr. Quay.

Atossa Genetics Inc. (NASDAQ:ATOS) Endoxifen is an active metabolite of Tamoxifen, which is an FDA approved drug for preventing breast cancer. According to the company a topical formulation of the drug could help combat breast density, which is an independent breast cancer risk.

Endoxifen Edge

Tamoxifen has, to date, been used to prevent new and recurrent forms of breast cancers. However, its benefits-cost ratio has always raised concerns. Only 2% of women at a high risk of developing breast cancer currently use the formulation. The risk or actual side effects associated with the treatment has always been a big concern for patients and physicians.

Taking into consideration the number of women who are at a high risk of developing breast cancer, Atossa Genetics Inc. (NASDAQ:ATOS) could generate up to $1 billion in sales on the approval of its topical formulation Endoxifen.

Separately, Atossa Genetics Inc. (NASDAQ:ATOS) did not generate any revenue for the three and six months ended June 30, 2017. Total operating expenses for the three and six months totaled $1.9 million and $3.6 million respectively. During the quarter, the company completed a capital raise of $4.4 million to be use d on the clinical development of Endoxifen development as well as for working capital purposes.

I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.

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About the author: Monica has an undergraduate degree in Accounting and an MBA she earned – with Honors. She has six years of experience in the financial markets and has been an analyst for the past two years.

Atossa Genetics Inc (NASDAQ:ATOS)

More Down Force for Shares of Atossa Genetics Inc (NASDAQ:ATOS)

Atossa Genetics Inc (NASDAQ:ATOS)

Atossa Genetics Inc (NASDAQ:ATOS) has just eight employees and an ability to go through funding like a hot knife through butter. Today shares are down just over 11% but that is one of the smaller declines in a company that used to be, taking dilution into account, worth over $100 per share. Yet today the shares are trading below $0.50 – a decline of over 99%. Back in August the company announced a public offering of over 1.15 million shares at $2.50. Expected gross proceeds were to be around $2.875 million. That news sent shares tumble over 25%. In March, Atossa Genetics Inc (NASDAQ:ATOS) had gone through that money and was in the market for more. Another offering was announced. This time the amount was for $4 million but the offering was not going to be common shares – Atossa issued convertible preferred stock with warrants attached. ATOS shares plummeted another 27.5%.

Seattle, WA-based Atossa Genetics Inc (NASDAQ:ATOS) develops drugs and medical devices that treat breast cancer and other breast disorders. People with industry knowledge hint that Atossa has the potential to launch products that could generate revenue but that ability is in question given their funding needs and unattractive capital structure. At issue is whether a successful product launch has the ability to provide new funding with required returns given the equity stake on offer. In this case, the dilutive effects of previous offerings mandate an almost record-breaking product revenue stream for returns that would be anything but record-breaking.

The single bright spot for Atossa Genetics Inc (NASDAQ:ATOS) is their earnings trend. Although EPS has registered losses every year the company has been public, the trend is in the right direction. In 2013, the EPS loss was (-$10.45), that was followed each year by narrower losses of (-$7.59), (-$6.73), and (-$2.16) in 2016. But it is the uptrend in the number of outstanding shares that is really at the core. In 2012, there were 0.83 million shares, but by 2016 that number had exploded to 2.95 million shares. Of course, that is not inclusive of the rights of the convertible shareholders who hold warrants.

I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. All information, or data, is provided with no guarantees of accuracy.

About the author: Steve Clark is a 23-year Wall St professional with stints in M&A, risk management, and algorithm trading.

Atossa Genetics Inc (NASDAQ:ATOS) Prices $4,000,000 Public Offering

Atossa Genetics Inc (NASDAQ:ATOS)

Atossa Genetics Inc (NASDAQ:ATOS) has announced the pricing of its public offering which is expected to raise proceeds amounting to $4,000,000 before subtraction commissions, underwriting discounts, and other expenses attached to the offering. The offering made up of Class A Units amounting to 664,000 shares and Class B Units amounting to 3,502 shares of the company’s Series A Convertible Preferred Stock. Cumulatively, they have a face value of $1,000 and each can be converted into 1,333.33 shares of Common Stock as well as warrants which are exercisable into shares of Common Stock equivalent to the shares of Series A Convertible Preferred Stock.

The exercise price for the warrants is $0.9375, which can be exercised upon issuance and have an expiry date five years from the issuance date. Atossa Genetics Inc (NASDAQ:ATOS) has issued a 45-day option to all underwriters to buy the additional 800,000 Common Stock shares in addition to 800,000 warrants to take care of the over-allotment in case any arises. The offering will end on April 2, 2017 subject to fulfillment of all customary closing conditions.

Atossa Genetics Inc (NASDAQ:ATOS) has appointed Aegis Capital Corp to act as the sole book manger of the offering.

In other segment, the company has started the enrollment of a Phase I study of its endoxifen which has been approved by FDA for treatment of breast cancer. The aim of the trial which has so far admitted 48 female subjects to study the patented pharmacokinetics formulations of both oral and topical endoxifen doses for a period of 28 days as well as evaluating the level of safety and tolerability. The trial is being conducted on behalf of a company called CPR Pharma Services Pty Ltd. Atossa is a clinical-phase pharmaceutical company engaged in the development of unique therapeutics as well as delivery processes towards breast cancer cure in addition to other breast disorders.

Atossa Genetics Inc (NASDAQ:ATOS) in January announced shifting the site for the Phase II study of fulvestrant which is concurrently administered with microcatheters toward breast cancer treatment. The study was launched in one of the leading centers in New York and will now be moved to Montefiore Medical Center.

The shift in locations has been necessitated by the relocation of the principle investigator who relocated to Montefiore and is now working with Montefiore Medical Center in several capacities. The Montefiore Health System is made of 11 hospitals, over 180 locations of specialty care network.

Ticker ATOS
Market Cap $2.89M
P/E
EPS (ttm) -$2.59
Shares Outstanding 3.66M
Shares Float 3.46
Insider Ownership
Float Short 6.21%
Short Ratio 1.56
Performance (Quarter) -42.34%
Performance (Year) -87.15%
Performance (YTD) -43.97%
Beta 1.44
Average Volume 137.7K
Price $0.79
Volume 1,815,027
Target Price $26.25

I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 96 hours. All information, or data, is provided with no guarantees of accuracy.

About the author: Monica Gray has an undergraduate degree in Accounting and an MBA – earned with Honors. She has six years of experience in the financial markets and has been a securities analyst for the past two years.

Atossa Genetics Inc (NASDAQ:ATOS) Commences Enrollment In Endoxifen Trial

Atossa Genetics Inc (NASDAQ:ATOS)

Atossa Genetics Inc (NASDAQ:ATOS) has commenced enrollment of a Phase I trial of endoxifen, which is an FDA approved medication for breast cancer. The goals of this study, comprising 48 healthy female subjects, is to evaluate the pharmacokinetics of patented formulations of both topical and oral endoxifen dosage forms for 28 days, and to assess tolerability and safety. The study is being carried out on behalf of company by CPR Pharma Services Pty Ltd. Atossa is a clinical-stage pharmaceutical firm developing unique therapeutics and delivery processes to cure breast cancer and other breast ailments.

The buzz

Earlier in January, Atossa Genetics Inc (NASDAQ:ATOS) reported that it is transferring the site of its Phase II trial of fulvestrant administered with microcatheters in subjects with breast cancer or ductal carcinoma in situ who are scheduled for mastectomy or lumpectomy. The trial was commenced in a leading center of New York and is now being moved to Montefiore Medical Center.

This change comes about as the study’s principal investigator has relocated to Montefiore and is now associated with the Montefiore Medical Center in multiple roles. Montefiore Health System comprises of 11 hospitals; a major and specialty care network of over 180 locations across the lower Hudson Valley and Westchester County; the Bronx, the Albert Einstein College of Medicine and the Montefiore School of Nursing.

Dr. Steve Quay, the CEO and President of Atossa Genetics Inc (NASDAQ:ATOS), reported that they look forward to progressing their Phase 2 trial at Montefiore. Although enrollment in the trial has been slower than the company anticipated, particularly as the trial site is being shifted, they anticipate that Montefiore Medical’s large hospital system and pioneer breast cancer care center will support faster registration, which they now expect closing by August 2017.

As per latest 13F Filing of the company, at the close of December reporting period, as many as six institutional holders increased their stake in Atossa by around 109,236 shares, 1 reduced stake by 4,969 while 5 maintained their stake. That brings total institutional holdings at around 202,000 shares, as per the SEC filings. The stock attracted new institutional investments summing 193 shares whereas institutional investors liquidated their positions totaling shares.

In the last trading session, the stock price of Atossa Genetics Inc (NASDAQ:ATOS) jumped more than 4% to close the trading session at $1.17. The gains came at a share volume of 94,871 compared to average share volume of 79,521.

3/27/2017
Ticker Symbol ATOS
Last Price a/o 3:21 PM EST  $1.17
Average Volume 104.96K
Market Cap (mlns) $4.28M
Shares Outstanding (mlns) 3.66M
Share Float (mlns) 3.46M
Inside Ownership
Short Float 6.21%
Short Interest Ratio 2.05
Quarterly Return -16.43%
YTD Return -17.02%
Year Return -76.36%

I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 96 hours. All information, or data, is provided with no guarantees of accuracy.

About the author: Monica Gray has an undergraduate degree in Accounting and an MBA – earned with Honors. She has six years of experience in the financial markets and has been a securities analyst for the past two years.