Atossa Therapeutics Inc (NASDAQ:ATOS), a clinical stage biopharmaceutical company specializing in breast cancer treatments, outlined its progress over the past year in a letter to shareholders.
The company reported notable progress in 2023, marked by four ongoing Phase 2 trials investigating their proprietary (Z)-endoxifen.
With primary data from two trials expected in H2 2024, the Phase 2 Karisma-Endoxifen trial has reached full enrollment, focusing on (Z)-endoxifen's impact on premenopausal women with measurable breast density.
CEO Steven Quay emphasized the severity of breast density as a health crisis, impacting the efficacy of mammograms and increasing the risk of breast cancer.
“Almost half of the women in the world over the age of 40 have dense breasts and this condition not only makes mammograms far less effective, but it also significantly increases the likelihood that a woman will develop breast cancer in their lifetime,” Quay told shareholders.
The company's upcoming milestone includes data from the Karisma-Endoxifen trial, aiming to demonstrate (Z)-endoxifen's ability to reduce breast density and associated cancer risks.
Quay encouraged women to have ongoing discussions with their doctors.
“It’s our hope that one day, these conversations will include a discussion about (Z)-endoxifen and its ability to safely reduce both breast density and the increased risk that women with dense breasts have of developing breast cancer. We look forward to seeing data from the Karisma-Endoxifen study in the second half of this year and using it to further our discussions with regulatory authorities and our plans for a Phase 3 registrational study.”
The full shareholder letter and Atossa’s plans for 2024 are available here.