On Tuesday, H.C. Wainwright maintained a Buy rating and a $6.00 stock price target for Atossa Genetics (NASDAQ:ATOS), following the announcement of positive results from a Phase 2 study.
The research focused on Z-endoxifen, aimed at reducing mammographic breast density (MBD) in premenopausal women. The trial, dubbed KARISMA-Endoxifen, involved 240 participants divided into three groups, each receiving either a 1 mg daily dose, a 2 mg daily dose, or a placebo for six months.
The study revealed significant reductions in MBD, with the 1 mg group showing a 19.3% decrease and the 2 mg group a 26.5% decrease, compared to the placebo. There was no notable difference between the effectiveness of the two dosages.
These results suggest Z-endoxifen could potentially be more effective than tamoxifen, a current treatment, which in a separate study showed lower reduction percentages at higher dosages and was not placebo-adjusted.
The company noted that the trial's arms were well-balanced, with no significant differences in background factors, although specific baseline characteristics were not disclosed. The outcomes of the KARISMA-Endoxifen study are seen as likely superior to those observed with tamoxifen, indicating that Z-endoxifen might offer greater MBD reductions at lower doses.
Atossa Genetics anticipates presenting the detailed findings at the San Antonio Breast Cancer Symposium (SABCS) in December 2024 and aims to publish the results in a peer-reviewed journal in 2025. These developments are viewed as supportive of advancing Z-endoxifen into a Phase 3 study, which would likely assess its efficacy in reducing the incidence of breast cancer.
In other recent news, Atossa Therapeutics has made significant strides in the development of its breast cancer treatment, (Z)-endoxifen. Positive preliminary results from a phase 2 trial showed the drug met its primary endpoint, with a significant reduction in key biomarkers for the disease.
The trial also revealed that the drug was well-tolerated with mild side effects and no treatment discontinuations due to adverse events. Atossa's ongoing projects include the development of (Z)-endoxifen in multiple phase 2 clinical trials and the support of the SMART study, a phase 2 trial using artificial intelligence to assess breast cancer risk.
Atossa has also been granted a new patent by the United States Patent and Trademark Office (USPTO) for compositions that include the active ingredient endoxifen. This expands Atossa's intellectual property portfolio and provides broader protection for its endoxifen-based compositions and their methods of administration.
In collaboration with Quantum (NASDAQ:QMCO) Leap Healthcare Collaborative, Atossa has initiated several clinical trials for breast cancer treatments. One such trial involves a combination of Atossa's proprietary (Z)-endoxifen and Eli Lilly (NYSE:LLY)'s abemaciclib, intended for high-risk women with newly diagnosed Estrogen Receptor positive (ER+) / Human Epidermal Growth Factor Receptor 2 negative (HER2-) breast cancer.
The outcomes of these trials, expected in 2026, could further validate (Z)-endoxifen's safety and efficacy. These are recent developments at Atossa Therapeutics.
InvestingPro Insights
As Atossa Genetics (NASDAQ:ATOS) progresses with its promising Z-endoxifen study, investors may find additional context from InvestingPro's real-time data and tips. The company's market capitalization stands at $177.32 million, reflecting the market's current valuation of its potential. An InvestingPro Tip highlights that Atossa holds more cash than debt on its balance sheet, which could provide financial flexibility as it moves towards a potential Phase 3 study.
Despite the positive study results, it's important to note that Atossa is not currently profitable, with an adjusted operating income of -$30.57 million over the last twelve months. However, the company has shown strong market performance, with a remarkable 101.43% price total return over the past year, aligning with the positive reception of its clinical progress.
For investors considering Atossa's long-term potential, InvestingPro offers 7 additional tips that could provide deeper insights into the company's financial health and market position. These tips, along with comprehensive financial metrics, are available through the InvestingPro product, offering a more complete picture for those looking to make informed investment decisions in the biotech sector.
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