Atossa Genetics Year-end 2024 slides: (Z)-endoxifen shows promise, expenses decline

Introduction & Market Context

Atossa Genetics Inc (NASDAQ:ATOS) presented its Year-end 2024 business update on March 25, 2025, highlighting progress with its lead drug candidate (Z)-endoxifen across multiple breast cancer treatment settings. The company’s presentation addressed significant unmet needs in breast cancer endocrine therapy, noting that 40-50% of patients discontinue adjuvant endocrine therapy, while approximately half of patients don’t respond to first-line aromatase inhibitors with CDK4/6 inhibitors.

The company’s stock has shown modest improvement recently, trading at $0.88 per share, up 1.81% according to recent market data, though still significantly below its 52-week high of $1.66.

(Z)-endoxifen Clinical Highlights

Atossa’s presentation emphasized (Z)-endoxifen’s potential as a superior endocrine therapy option, highlighting its differentiated mechanism of action and promising clinical results. The drug is described as 100-fold more potent versus other selective estrogen receptor modulators (SERMs) and demonstrates inhibition of clinically relevant ESR1 mutants.

As shown in the following clinical data slide, (Z)-endoxifen demonstrated significant improvement in progression-free survival in the metastatic setting:

The data reveals that (Z)-endoxifen more than tripled median progression-free survival compared to tamoxifen (7.2 months vs. 2.4 months) with a hazard ratio of 0.42 (95% CI 0.22-0.80) in a Phase II randomized trial with 40 evaluable patients in each arm. The presentation included before and after imaging showing disease regression in treated patients.

Atossa is pursuing multiple development pathways for (Z)-endoxifen, as illustrated in their parallel regulatory strategy:

In the prevention setting (KARISMA trial), (Z)-endoxifen at 1mg reduced mammographic breast density by 17.3 percentage points (p<0.01) with plasma concentrations of 4.8 ng/ml and no significant differences in adverse events compared to placebo.

The neoadjuvant EVANGELINE trial has shown promising early results with one complete response and five partial responses in the first six patients at the 40mg dose level. Additional data from the 80mg cohort is expected at the San Antonio Breast Cancer Symposium (SABCS) in late 2024.

Financial Performance

Atossa’s financial results showed improved efficiency and reduced losses for the year ended December 31, 2024:

Research and development expenses decreased to $14.1 million in 2024 from $17.3 million in 2023, while general and administrative expenses declined to $13.5 million from $14.0 million. The company’s operating loss improved to $27.6 million from $31.4 million in the prior year.

Net loss per share improved to $(0.20) in 2024 compared to $(0.24) in 2023, with a slight decrease in weighted average shares outstanding to 125.9 million from 126.1 million. These figures align with the earnings report, which noted that Q4 2024 EPS was -$0.04, beating the forecasted -$0.065.

According to the earnings article, Atossa maintained a strong balance sheet with $71.1 million in cash and cash equivalents at year-end, providing runway for continued clinical development.

Strategic Positioning & Outlook

Atossa positions (Z)-endoxifen as a potentially transformative therapy across the entire breast cancer treatment paradigm:

The company’s strategy targets multiple treatment settings, from prevention to metastatic disease. In the prevention setting, (Z)-endoxifen aims to improve early detection and cancer prevention. For neoadjuvant treatment, the drug could potentially improve breast conservation rates, while in the adjuvant setting, it may provide an option for patients who are refractory to tamoxifen or contraindicated for aromatase inhibitors.

The company’s differentiation strategy for (Z)-endoxifen highlights several key advantages:

These advantages include superior estrogen receptor antagonism, PKCβ1 inhibition, ESR1 mutant inhibition, improved safety and tolerability, and potential as a superior combination partner. The company believes these characteristics position (Z)-endoxifen as a novel, next-generation anti-estrogen with best-in-class potential.

Forward-Looking Statements

According to the earnings article, Atossa plans to prioritize (Z)-endoxifen development with FDA consultations expected within 4-6 months. The company aims to secure U.S. FDA approval in 2025, followed by global expansion in 2026.

Analyst price targets range from $4 to $7, suggesting significant upside potential if development milestones are met. However, investors should note potential risks including regulatory hurdles, competition from other breast cancer treatments, and ongoing cash burn despite the company’s improved financial efficiency.

The EVANGELINE trial’s 80mg dose data presentation at SABCS 2024 and monotherapy readout from the I-SPY2 trial expected in Q4 2024 represent key upcoming catalysts that could impact the company’s trajectory and market valuation.

Full presentation:

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