Welcome to our dedicated page for Atossa Therapeutics news (Ticker: ATOS), a resource for investors and traders seeking the latest updates and insights on Atossa Therapeutics stock.
Atossa Therapeutics Inc (ATOS) is a clinical-stage biopharmaceutical company developing breast cancer therapies and targeted delivery technologies. The company's news flow reflects its position as an oncology-focused biotech advancing multiple programs through clinical development and regulatory pathways. Investors tracking Atossa Therapeutics can expect news spanning clinical trial results, regulatory interactions with the FDA, intellectual property developments, research partnerships, and quarterly financial reports.
Clinical development milestones represent the most significant category of news for Atossa Therapeutics. Updates on the endoxifen program—including patient enrollment, data readouts, and trial progression—directly impact the company's valuation and strategic direction. Similarly, developments in the intraductal microcatheter technology platform generate news when the company announces new therapeutic applications, partnership agreements, or technical achievements. These clinical and technological updates often include details about FDA feedback, regulatory designations such as Fast Track or Orphan Drug status, and advancement to new trial phases.
Regulatory news constitutes another major category, as interactions with the FDA and other regulatory bodies shape the company's development timeline and commercial prospects. This includes announcements of FDA meetings, guidance received on trial design, regulatory strategy updates, and submissions of clinical trial applications. Patent issuances and intellectual property developments also generate news, as these filings protect the company's therapeutic compounds and delivery technologies and can signal the breadth of potential applications for its platforms.
Research collaborations and strategic partnerships produce news when Atossa Therapeutics engages with contract research organizations, academic institutions, or biotechnology companies to advance its pipeline. These announcements often detail the scope of collaboration, the specific technologies or capabilities being contributed by each partner, and the therapeutic objectives of the joint effort. Financial news—including quarterly earnings reports, capital raises through equity offerings, and updates on cash runway—provides insight into the company's operational trajectory and ability to fund ongoing clinical programs.
Executive appointments, analyst coverage, and investor presentation announcements round out the news profile, offering context on the company's leadership team and its communication with the investment community. For investors evaluating Atossa Therapeutics, regular monitoring of this news flow provides visibility into clinical progress, regulatory momentum, and financial sustainability—the key determinants of value for clinical-stage biopharmaceutical companies.
Atossa Therapeutics (Nasdaq: ATOS) reported its financial results for the year ended December 31, 2022, highlighting significant clinical advancements. The company initiated its Phase 2 EVANGELINE study for neoadjuvant treatment in premenopausal women with ER+ breast cancer and continues enrollment in the Karisma-Endoxifen study. Notably, Atossa added a new arm to the ongoing I-SPY 2 trial, evaluating (Z)-endoxifen. Financially, the company reported an operating loss of $27.7 million, a 35% increase from 2021, driven mostly by rising R&D costs. Cash reserves stood at approximately $111 million, supporting ongoing clinical endeavors.
Atossa Therapeutics (Nasdaq: ATOS) announces its proprietary Selective Estrogen Receptor Modulator, (Z)-endoxifen, will be assessed in a new arm of the I-SPY 2 clinical trial targeting locally advanced breast cancer. This trial, involving approximately 20 patients, aims to evaluate treatment effectiveness prior to surgery. The study focuses on estrogen receptor-positive invasive breast cancer patients, who have high recurrence risks and require more effective treatments. Dr. Steven Quay highlighted the urgency of new alternatives for these patients. Atossa is also conducting two Phase 2 studies for (Z)-endoxifen with promising implications for breast cancer management.
Atossa Therapeutics, Inc. (Nasdaq: ATOS) has announced its participation in the Sidoti Small-Cap Virtual Conference, scheduled for March 22-23, 2023. Dr. Steven Quay, the Company’s President and CEO, along with Kyle Guse, General Counsel and CFO, will present on March 23 at 1:00 PM Eastern Time. Investors can register for the live webcast through the event's website. A recording will also be made available post-conference on Atossa's investor relations page. Atossa focuses on developing innovative medicines for unmet medical needs in oncology, particularly breast cancer.
Atossa Therapeutics (Nasdaq: ATOS) has initiated the Phase 2 EVANGELINE study, dosing its first patient for a trial evaluating the efficacy of (Z)-endoxifen versus exemestane plus goserelin in treating ER+/HER2- breast cancer in premenopausal women. This randomized study aims to assess the endocrine sensitive disease rate after four weeks of treatment with approximately 175 participants across 25 sites in the U.S. The previous study showed (Z)-endoxifen reduced Ki-67 by 65.1%, indicating potential efficacy. Atossa is also exploring (Z)-endoxifen's application in reducing mammographic breast density, an important breast cancer risk factor.
Atossa Therapeutics (Nasdaq: ATOS) announced the granting of a new patent (No. 11,572,334) by the USPTO for (Z)-endoxifen encapsulated in an enteric capsule, enhancing its intellectual property related to this compound. This patent positions Atossa as the sole provider of orally delivered (Z)-endoxifen with an enteric capsule in the U.S., aimed at optimizing drug delivery. The company is advancing Phase 2 trials, including the EVANGELINE study with approximately 175 participants and the Karisma-Endoxifen study with 240 participants, targeting unmet needs in breast cancer treatment. The new patent is expected to create long-term value for shareholders.
FAQ
What is the current stock price of Atossa Therapeutics (ATOS)?
What is the market cap of Atossa Therapeutics (ATOS)?
