Atossa Genetics (ATOS) Stock Flies On Positive Data

Atossa Therapeutics ATOS Stock News

Atossa Genetics Inc (NASDAQ: ATOS) is making a run for the top today, trading on gains of more than 23%. The growth comes after the company announced positive clinical data from a Phase 2 study of topical Z Endoxifen. Here’s what’s happening:

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ATOS Stock Flies On Positive Clinical Data

In a press release issued early this morning, Atossa Genetics announced positive clinical data from a Phase 2 study of topical Z Endoxifen. The treatment is being developed as a potential option for patients with breast cancer and other breast conditions.

In the release, ATOS said that the data showed significant and rapid reduction in mammographic breast density. The company also pointed to third party studies that demonstrated that density reduction induced by tamoxifen is associated with a significant reduction in breast cancer incidence.

The Data

According to the press release issued by ATOS this morning, MBD was reduced by 14.3% on average in the group that applied 20mg daily topical Endoxifen. This proved to be statistically significant with a p value of 0.02. In the lower 10mg dose group, MBD was reduced by an average of 9%.

The results provided by the company were based on MBD measurements at the time of enrollment and at the time that dosing ended. The mean time period was 55 days for the 20mg dose and 88 days for the 10mg dose.

Moreover, about 70% of patients receiving the 20mg dose of topical Endoxifen experienced an MBD reduction, with a mean reduction among these patients of 27%.

Also, Atossa Genetics said that there was no significant difference in systemic endocrine or vascular side effects when comparing results from the placebo group to active groups. Finally, the treatment showed to be safe and well tolerated with the most common side effect for both active groups being skin rash and local irritation.

Management Commentary

In a comment, Dr. Steven C. Quay, CEO at ATOS, had the following to offer:

We are thrilled that our proprietary topical Endoxifen significantly reduced breast density. We believe that no other drug, other than tamoxifen, has been clinically demonstrated to significantly reduce breast density. We observed both a strong and a rapid treatment effect, as demonstrated by our topical Endoxifen producing treatment results in only 55 days of dosing for the 20mg dose.

This compares to the one year of dosing previously used in oral tamoxifen studies. Our study also demonstrated that topical Endoxifen did not produce the systemic endocrine and vascular side effects that are often experienced with tamoxifen, such as hot flashes. Because the 20mg dose produced a treatment effect in only 55 days and because daily dosing eventually produced skin rashes and local irritation in most women, the topical form appears to be particularly well-suited for short-term use – perhaps less than 60 days with dosing every-other day.

These data will now inform our decisions about dosing as well as development of our oral form of Endoxifen. Our goal is to ultimately reduce the incidence of breast cancer – by reducing MBD with our Endoxifen, which we believe can reduce the number of women getting estrogen dependent (ER+) breast cancer. This is analogous to statins rapidly reducing cholesterol which has now been shown to reduce the risk of heart attack long term.

The Market Potential Is Hard To Ignore

Should topical Endoxifen continue to produce such promising results, the drug could prove to be a massive opportunity for ATOS and its investors. After all, the market for breast cancer is absolutely massive.

At the moment, experts at Grand View Research expect the breast cancer market to grow to be worth more than $38 billion annually by the year 2025. While it would be unreasonable to expect that Atossa Genetics would take the whole market or even the lion’s share with topical Endoxifen, it doesn’t need to.

The truth of the matter is that the stock trades with a market cap under $25 million. With such a small market cap, accessing even 1% of the market or $380 million annually, would be a significant increase of value for investors. Considering the data, this is far from an unreasonable expectation should the treatment receive regulatory approval.

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