Atossa Therapeutics Inc (NASDAQ:ATOS) unveiled its second quarter financial results highlighted by a strong balance sheet to support the company in completing its Phase 2 trials for (Z)-endoxifen.
The Seattle-based biotech finished the three-month period ending June 30, 2023, with $99.4 million of cash and cash equivalents, according to its results statement.
Atossa is creating an innovative oral formulation of (Z)-endoxifen that sidesteps the need for liver metabolism to achieve therapeutic levels and designed to bypass stomach acidity, a factor that can convert a significant portion of (Z)-endoxifen to the inactive (E)-endoxifen.
The company is conducting three Phase 2 trials involving (Z)-endoxifen. One study is focused on healthy women with measurable breast density, while the other two are part of the EVANGELINE trial for women with ER+/HER2- breast cancer.
To that end, Atossa highlighted 2Q developments, including the successful completion of full enrollment for the 40 mg/day Pharmacokinetic Run-In Cohort in the Phase 2 EVANGELINE clinical trial; achieving 70% enrollment in the ongoing Phase 2 Karisma-Endoxifen trial, and progress in the Phase 2 I-SPY 2 trial, wherein (Z)-endoxifen's potential is being explored as a neoadjuvant treatment for newly diagnosed estrogen receptor-positive invasive breast cancer patients with a predicted sensitivity to endocrine therapy but not chemotherapy.
Atossa also received approval from Health Canada to conduct the Phase 2 EVANGELINE trial across Canada.
“Positive momentum established last quarter has accelerated into the second quarter of 2023,” Steven Quay, Atossa’s CEO told shareholders.
Quay noted the appointment of board member Greg Weaver as Atossa’s new CFO, and stronger intellectual property protection for our proprietary (Z)-endoxifen as additional 2Q highlights.
“Our balance sheet remains strong, and our focus remains squarely on completing our ongoing Phase 2 trials, designing Phase 3 protocols in coordination with the FDA and identifying the right partners to support pivotal trials and potential commercialization activities."
Atossa boosted its research and development spending in 2Q to $3.7 million compared to $3.4 million for same quarter prior year as a result of clinical trial expenses.
Net loss for the quarter was $9.8 million compared to a net loss $6.7 million for the second quarter of 2022.
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