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Atossa Therapeutics, Inc. (NASDAQ: ATOS) is a pioneering biopharmaceutical company headquartered in Seattle, Washington. Established in 2009, Atossa focuses on developing innovative and proprietary medicines targeting unmet medical needs in oncology, with a particular emphasis on breast cancer. The company is currently in the clinical stage, advancing several key programs designed to improve cancer treatment and prevention.
Atossa's core program is the development of (Z)-endoxifen, a potent metabolite of tamoxifen, crucial for treating and preventing breast cancer. Currently, (Z)-endoxifen is in Phase II clinical trials aimed at various breast cancer conditions, including estrogen receptor-positive breast cancer, ductal carcinoma in situ (DCIS), and mammographic breast density. The company is also exploring its efficacy in combination therapies with drugs like abemaciclib, a CDK 4/6 inhibitor.
In addition to breast cancer, Atossa has ventured into COVID-19 therapeutics with two potential treatments: AT-H201 for improving lung function in severe COVID-19 patients and AT-301, a nasal spray for at-home use.
Recently, Atossa has achieved several milestones, including the successful dosing of the first patient in the RECAST DCIS study, full enrollment of its Phase II Karisma-Endoxifen trial, and promising preliminary data from the 40mg cohort in the EVANGELINE study. The company also regained compliance with Nasdaq's minimum bid price requirement.
Atossa's collaborative efforts include partnerships with Quantum Leap Healthcare Collaborative and Weill Cornell Medicine, advancing studies in combination therapies and breast cancer risk assessment through innovative AI models. With a strong financial position, including $84 million in cash and no debt as of Q1 2024, Atossa is well-positioned to continue its groundbreaking work in oncology.
Dr. Steven Quay, M.D., PhD, recently shared insights into COVID-19's origins and spread, linking early cases to the People's Liberation Army Hospital in Wuhan, China, and the city's Metro Line 2. He noted a genetic cluster among four patients with a similar virus version, suggesting rapid global transmission via the subway system. Quay emphasized the importance of understanding these origins for improving treatments. His research continues to explore whether COVID-19's emergence was due to a market or laboratory incident, with potential revelations expected soon.
Atossa Therapeutics, Inc. (Nasdaq: ATOS) announced a securities purchase agreement with institutional investors to raise $25.2 million through a registered direct offering. 23,850,000 shares of common stock and warrants for 17,887,500 shares will be sold, priced at $1.055 each. The offering's gross proceeds are expected to close by January 8, 2021, subject to customary conditions. Maxim Group LLC acts as the placement agent for this offering, which is conducted under a shelf registration statement effective from September 10, 2020.
Atossa Therapeutics (Nasdaq: ATOS) has entered into a securities purchase agreement with institutional investors for approximately $14.0 million of its common stock in a direct registered offering priced at-the-market. The offering includes the sale of 14,000,000 shares at $1.00 per share, along with warrants for 10,500,000 shares concurrently. The expected closing date is December 21, 2020. Maxim Group LLC is the placement agent, and the offering is made under a previously effective registration statement with the SEC.
Atossa Therapeutics (Nasdaq: ATOS) has announced a public offering priced to yield gross proceeds of $20 million. The offering consists of 14,575,000 Units, each including one share of common stock and 0.75 Warrants priced at $1.00 per Unit, alongside 5,425 Units of Series C Convertible Preferred Stock. This offering is set to close around December 11, 2020, pending typical conditions. Maxim Group LLC is the sole book-running manager and has an option to purchase an additional 3 million shares and 2.25 million Warrants.
Atossa Therapeutics (Nasdaq: ATOS) reported its third-quarter financial results for the period ending September 30, 2020. The company has no sustainable revenue and reported total operating expenses of approximately $3.5 million for Q3 2020, a slight increase from Q3 2019. Significant advancements include the completion of a Phase 1 study of its AT-301 nasal spray for COVID-19, showing safety and tolerability. Atossa also applied for regulatory approval for a Phase 2 study of Endoxifen in Sweden to address mammographic breast density.
Atossa Therapeutics (Nasdaq: ATOS) announced positive preliminary results from its Phase 1 clinical study of AT-301, a nasal spray for treating COVID-19. In this study involving 32 participants, AT-301 was found to be safe and well-tolerated, with no serious adverse events reported. Following this success, Atossa plans to advance AT-301 into a Phase 2 study and prepare for a pre-IND meeting with the FDA. The company aims to co-develop AT-301 with COVID-19 diagnostic partners, targeting at-home use and potentially preventing infection in high-risk groups.
A recent study by Dr. Steven Quay, head of COVID-19 therapeutic programs at Atossa Therapeutics (NASDAQ: ATOS), published on Zenodo, suggests that the SARS-CoV-2 pandemic may have originated at the PLA Hospital in Wuhan, China. The research indicates that early patient records dated back to December 10, 2019, prior to official announcements. The study highlights that the hospital is near the Wuhan Institute of Virology, where genetic links to bat coronaviruses exist. Additionally, it identifies the Wuhan Metro Line 2 as a significant conduit for virus transmission.
Atossa Therapeutics (Nasdaq: ATOS) has completed enrollment in its Phase 1 clinical study of AT-301, a nasal spray drug candidate aimed at treating COVID-19. This is a significant milestone as the ongoing pandemic intensifies. The study, conducted in Australia with 32 healthy adults, assesses the safety and tolerability of AT-301. Atossa plans to report preliminary results soon and is also seeking partners for co-development of AT-301 while preparing for a Phase 2 study in the first half of 2021.
Atossa Therapeutics (Nasdaq: ATOS) is set to present on October 13, 2020, at a Tribe Public Zoom Webinar during Breast Cancer Awareness Month. CEO Dr. Steven Quay and CFO Kyle Guse will lead a discussion titled “Atossa Therapeutics: Tackling our Greatest Health Challenges – COVID-19 and Breast Cancer”. The event, beginning at 8 AM PT/11 AM ET, will include a Q&A on Atossa’s breast cancer initiatives and COVID-19 treatment programs, particularly the nasal spray therapy AT-301. Registration for the event is complimentary but limited.
On October 2, 2020, Dr. Steven Quay, CEO of Atossa Therapeutics (NASDAQ: ATOS), gifted 50 copies of his book, "Stay Safe: a Physician's Guide to Survive Coronavirus," to the White House after President Trump and the First Lady tested positive for COVID-19. The book provides essential advice on preventing and managing COVID-19, aiming to aid recovery. Profits from the book sales are donated to a military veterans group assisting COVID-19 impacted communities. Dr. Quay's extensive experience in drug development underpins the book's insights.
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