Remy Blaire engages in a compelling conversation with Dr. Steven Quay, the CEO of Atossa Therapeutics, a clinical-stage biopharmaceutical company focused on developing advanced therapies for breast cancer and related conditions. As October marks Breast Cancer Awareness Month, the discussion highlights the ongoing challenges and advancements in the fight against this pervasive disease.
Dr. Quay begins by addressing the significance of breast cancer, emphasizing the urgency of Atossa’s mission. He introduces the company’s lead drug, V-endoxifen, which is currently seeking FDA approval. Dr. Quay outlines the critical milestones ahead, including anticipated guidance from the FDA and updates on their manufacturing processes, which he believes will position Atossa for effective progress in the coming months.
The conversation delves into the innovative approach Atossa is taking with V-endoxifen. Dr. Quay explains that the company has extracted the most effective component of tamoxifen, a long-standing treatment for breast cancer, to create zeindoxifen. This targeted strategy aims to reduce the side effects commonly associated with tamoxifen, offering a potentially safer alternative for patients.
Remy inquires about Atossa’s regulatory strategy, and Dr. Quay elaborates on the 505B2 process, a pathway that allows the FDA to utilize existing data on tamoxifen to evaluate the safety and efficacy of zeindoxifen. He reassures listeners about the promising safety profile observed in clinical trials, where over 700 women have participated, showing significantly fewer side effects compared to traditional treatments.
The discussion also covers Atossa’s competitive advantages, including a strong patent portfolio and trade secrets related to their manufacturing processes. Dr. Quay highlights the company’s financial health, reporting $58 million in cash with no debt, and emphasizes the importance of their experienced team in driving the company’s success.
In a succinct elevator pitch, Dr. Quay articulates the opportunity Atossa has to replace existing treatments for the 1.7 million women currently taking tamoxifen or aromatase inhibitors. He encourages listeners to stay informed by visiting Atossa’s website and reviewing their regulatory filings.
This content is brought to you by Atossa Therapeutics.