Presented data from EVANGELINE study showing 100% disease control rate at 24-weeks
Initiated study evaluating (Z)-endoxifen in combination with abemaciclib (VERZENIO®)
Ended first quarter 2024 with $84.0 million of cash and cash equivalents and no debt
SEATTLE, May 13, 2024 (GLOBE NEWSWIRE) — Atossa Therapeutics, Inc. (NASDAQ:ATOS) (“Atossa” or the “Company”) today announced financial results for the fiscal quarter ended March 31, 2024, and provides an update on recent company developments. Atossa is a clinical stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a focus on breast cancer
Key developments from Q1 2024 and the year to date include:
Presented data from 40mg pharmacokinetic run-in cohort of ongoing EVANGELINE study at the AACR annual meeting – data showed 100% disease control rate, 37% average MRI-based lesion size decrease and a 92% reduction in Ki-67, at 24 weeks. Treatment related toxicities included grade 3 headache (one patient), grade 2 amenorrhea (one patient), and grade 2 hot flashes (one patient). There were no grade 4 or 5 treatment related toxicities.
Initiated study evaluating (Z)-endoxifen in combination with abemaciclib (VERZENIO®) – the study will enroll 20 women with newly diagnosed Estrogen Receptor positive (ER+) / Human Epidermal Growth Factor Receptor 2 negative (HER2-) invasive breast cancer. Participants will receive (Z)-endoxifen daily in combination with abemaciclib, a cyclin-dependent kinase (CDK) 4/6 inhibitor marketed by Eli Lilly and Company, twice daily for a total of 24 weeks prior to surgery.
Expanded access patient concluded five-years of (Z)-endoxifen treatment – the pre-menopausal, ER+ / HER2-, breast cancer patient who received neoadjuvant and adjuvant (Z)-endoxifen therapy under an FDA-approved “expanded access” program completed five-years of successful treatment. The patient remains cancer-free and reported no significant safety or tolerability issues over the course of her treatment.
Fully enrolled Phase 2 I-SPY 2 Clinical Trial – (Z)-endoxifen is being evaluated as a neoadjuvant treatment in a study arm of the ongoing I-SPY 2 clinical trial. The study arm targets patients with newly diagnosed estrogen receptor-positive breast cancer whose tumors are predicted to be sensitive to endocrine therapy but for whom chemotherapy is expected to provide little or no benefit. Full enrollment was achieved in February 2024 and data is expected in the second half of 2024.
First patient dosed with (Z)-endoxifen in RECAST DCIS study – the Re-Evaluating Conditions for Active Surveillance Suitability as Treatment: Ductal Carcinoma In Situ (RECAST DCIS) study is an ongoing Phase 2 platform study designed to offer women diagnosed with DCIS six months of neoadjuvant endocrine therapy with the intent of determining their suitability for long-term active surveillance without surgery.
Appointed Tessa Cigler, M.D., M.P.H to Atossa’s Board of Directors – Dr. Cigler is a medical oncologist and clinical investigator at the Weill Cornell Breast Center in New York City. As a member of the Weill Cornell Breast Center research team, she heads several clinical trials designed to provide her patients with access to the new promising options for therapy and supportive care.
“The first quarter of 2024 was a period of significant progress for our Company,” said Steven Quay, M.D., Ph.D., Atossa’s President and Chief Executive Officer. “We initiated a new combination study, presented extremely promising monotherapy data at AACR and fully enrolled the second of our five ongoing Phase 2 studies. Our focus for the remainder of 2024 will be to continue driving our (Z)-endoxifen development program forward, preparing for critical data readouts expected in the second half of this year and further progressing conversations with regulatory authorities and prospective partners. Even with all of our significant accomplishments in the quarter, our cash balance remains strong, at $84.0 million.”
Comparison of Three Months Ended March 31, 2024 and 2023
Revenue and Cost of Revenue. For the three months ended March 31, 2024 and 2023, we had no source of revenue and no associated cost of revenue.
Operating Expenses. Total operating expenses were $7.0 million for the three months ended March 31, 2024, which was a decrease of $0.1 million, from total operating expenses for the three months ended March 31, 2023 of $7.1 million. Factors contributing to the decreased operating expenses in the three months ended March 31, 2024 are explained below.
R&D Expenses. R&D expenses for the three months ended March 31, 2024, were $3.7 million, an increase of $0.2 million from R&D expenses for the three months ended March 31, 2023 of $3.5 million
The following table provides a breakdown of major categories within R&D expense for the three months ended March 31 2024 and 2023, together with the dollar change in those categories (in thousands):
For the Three Months Ended
March 31,
2024
2023
Increase
(Decrease)
Research and Development Expense
Clinical and non-clinical trials
$
2,884
$
2,336
$
548
Compensation
626
1,034
(408
)
Professional fees and other
238
138
100
Research and Development Expense Total
$
3,748
$
3,508
$
240
The increase in R&D expense was primarily due to increased spending on clinical and non-clinical trials of $0.5 million compared to the prior year period for (Z)-endoxifen trials, including drug development costs.
The decrease in R&D compensation expense for the three months ended March 31, 2024 compared to the prior year period was primarily due to a decrease in non-cash stock-based compensation of $0.4 million. Non-cash stock-based compensation decreased compared to the prior year period due to the weighted average fair value of options amortizing in 2024 being lower period over period.
The increase in R&D professional fees of $0.1 million for the three months ended March 31, 2024 compared to the prior year period was primarily attributable to higher consulting fees in 2024 related to our endoxifen program.
General and Administrative (G&A) Expenses. G&A expenses for the three months ended March 31, 2024 were $3.2 million, a decrease of $0.4 million from total G&A expenses for the three months ended March 31, 2023 of $3.6 million.
The following table provides a breakdown of major categories within G&A expenses for the three months ended March 31, 2024 and 2023, together with the dollar change in those categories (in thousands):
For the Three Months Ended
March 31,
2024
2023
Increase
(Decrease)
General and Administrative Expense
Compensation
$
1,325
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