Atossa Therapeutics, Inc. - ATOS STOCK NEWS

Atossa Therapeutics (Nasdaq: ATOS) has announced the issuance of U.S. Patent No. 11,261,151, enhancing its intellectual property regarding Endoxifen, a therapy under development for breast cancer and related conditions. The patent, expected to expire in 2038, strengthens Atossa's position against generic competition. Atossa is advancing Endoxifen in two clinical studies: one for breast cancer treatment and another for addressing mammographic breast density, a significant public health issue affecting millions of women. The company plans to submit an IND to the FDA for further trials.

Atossa Therapeutics, Inc. (Nasdaq: ATOS) reported its fiscal year 2021 results, highlighting a cash position of $136 million. The company initiated a Phase 2 trial for its oral Z-endoxifen in Sweden, targeting premenopausal women with breast cancer. Notably, operating expenses rose by 40% to $20,521, driven by increased R&D costs of $9,210. The company aims to submit an IND for a U.S. study comparing Endoxifen to standard care and plans further development for its COVID-19 therapy, AT-H201, with completion expected in mid-2022.

Atossa Therapeutics (Nasdaq: ATOS) has emphasized its commitment to addressing significant health challenges, particularly in breast cancer and COVID-19. The company reported a successful Phase 2 study of Endoxifen, showing a 65.1% reduction in Ki-67, indicating reduced tumor activity. Atossa also initiated a Phase 2 study targeting women with increased mammographic breast density and advanced its AT-301 nasal spray and AT-H201 inhalation therapy for COVID-19. In 2021, Atossa raised over $110 million to further its clinical programs.

Atossa Therapeutics (Nasdaq: ATOS) announced the advancement of its Phase 1/2a clinical study of AT-H201, targeting lung function improvement in hospitalized COVID-19 patients and long-haul patients with post-infection pulmonary disease. After successfully completing Part A of the study, the Australian Human Research Ethics Committee approved the initiation of Part B, which will include 60 participants. AT-H201, a nebulized combination therapy, aims to address the urgent need for additional COVID-19 treatments amidst rising hospitalizations due to the Omicron variant.

Atossa Therapeutics, Inc. (Nasdaq: ATOS) announced the enrollment initiation of its Phase 2 clinical study of oral Z-Endoxifen in Sweden, targeting premenopausal women with elevated mammographic breast density. This milestone aims to assess the dose-response relationship between daily Z-Endoxifen doses and breast density reduction, alongside safety evaluations. The study, led by Dr. Per Hall, will involve around 240 participants over six months. With significant public health implications, this initiative strives to address a condition affecting over 10 million women in the U.S.

Physician-Scientist Steven Quay, MD, PhD, has published a significant e-print on the coronavirus BANAL-236, which exhibits high homology to SARS-CoV-2 and can infect human cells. This research, reported by the Institut Pasteur, indicates that BANAL-236 evolved to infect human cells through a previously unknown mechanism. Quay emphasizes the urgency for an international effort to investigate this virus due to its potential transmissibility and implications for current therapeutic strategies.

Atossa Therapeutics (Nasdaq: ATOS) announced a significant milestone with the completion of a pre-investigational new drug (PIND) meeting with the FDA regarding its proprietary Z-endoxifen for treating breast cancer in the neoadjuvant setting. The FDA's feedback will aid in preparing a request to open an IND for a Phase 2 study, focusing on pre-menopausal women with ER+/HER2- breast cancer. Atossa plans to initiate the IND request in Q2 2022 and conduct a pharmacokinetic study alongside the Phase 2 trial, seeking to compare Z-endoxifen against standard treatment options.

Atossa Therapeutics, Inc. (Nasdaq: ATOS) announces a live Q&A session on November 30, 2021, at 8 AM Pacific/11 AM Eastern. CEO Dr. Steven Quay and CFO Kyle Guse will address questions regarding Atossa's research initiatives focused on breast cancer and COVID-19. The event, hosted by Tribe Public, is complimentary, with registration available here. For more details about Atossa, visit atossatherapeutics.com.

Atossa Therapeutics, Inc. (Nasdaq: ATOS) reported its financial results for Q3 2021, ending September 30, with cash reserves of approximately $140 million. The company has no sustainable revenue and incurred operating expenses of about $5.16 million for Q3 2021, a 47% increase year-over-year. Key developments include initiating a clinical study for AT-H201 targeting COVID-19 patients and receiving Swedish regulatory approval for a Phase 2 trial of Endoxifen in women with mammographic breast density. The company anticipates ongoing increases in R&D expenses as trials progress.