Atossa Therapeutics Inc. (NASDAQ: ATOS) has announced its financial results for the quarter and provided updates on its recent developments.
Atossa commenced AT-H201 study enrolment
In Australia, the company began enrolling subjects in its AT-H201 clinical trial. AT-H201, a nebulized formulation, is being studied as an inhalation therapy for COVID-19 patients who are moderate to seriously unwell in the hospital and “long-haul” patients having post-infection pulmonary disease.
Swedish regulators permitted the start of Phase 2 clinical research of Endoxifen to evaluate pharmacodynamics and safety in women with mammographic breast density (MBD).
The company scheduled a pre-IND meeting with the FDA to get feedback on the possible clinical and regulatory approach for using Endoxifen in the neoadjuvant (also known as “window of opportunity”) setting to treat breast cancer patients. The date for the meeting is tentatively set for December 2021.
CEO Steven Quay said, “Our progress in both the Endoxifen and COVID-19 programs, with our initiation of our trial in Australia for AT-H201, and our receipt of regulatory authorization in Sweden to commence an Endoxifen Phase 2 trial, have been key recent milestones, positioning us to move both of these programs forward and take the next steps toward developing therapies in urgent unmet patient needs.”
Quay added, “Further, our strong balance sheet will continue to facilitate our development plans as we not only execute on these trials but also explore additional options that could create significant shareholder value.”
Atossa had cash and equivalents of $140
The company didn’t have a sustainable revenue source, and no related revenue cost for the quarter ended. At the end of the quarter, the company has cash and cash equivalents and restricted cash or around $140 million. The company’s R&D expenses were $2.206 million increasing around 33% YoY. The increase in the quarter as a result of clinical trial expense increase and compensation increase by $380,000 attributed to non-cash stock-bases compensation and increase in R&D professional fees. The company’s R&D expenses continue to increase following the start of the AT-H2021 study.
