Atossa Therapeutics Announces Full Year 2024 Financial Results and Provides Corporate Update
Ended 2024 with $71.1 million of cash and cash equivalents and no debt
Conference Call and Webcast Scheduled for Tuesday, March 25, 2025, at 8:30 a.m. Eastern Time
SEATTLE, March 25, 2025 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (NASDAQ:ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company developing innovative medicines for breast cancer, today announced its financial results for the full year ended December 31, 2024 and provided an update on recent company developments.
Fourth Quarter and Early 2025 Highlights
Strategic Decision to Pursue Metastatic Breast Cancer Indication: Atossa plans to advance its lead program, (Z)-endoxifen, to target metastatic breast cancer. The Company believes this approach may offer a more streamlined regulatory pathway to deliver (Z)-endoxifen to patients with urgent unmet medical needs, as the current treatment options for metastatic breast cancer often provides limited durability of response and substantial side effects. (Z)-endoxifen—a potent and well-tolerated selective estrogen receptor modulator (SERM)—has shown encouraging signs in previous clinical trials, which Atossa believes supports its potential to fill this critical gap in treatment. Atossa also intends to continue engagement with the U.S. Food and Drug Administration (FDA) to advance additional indications, including breast cancer prevention and neoadjuvant therapy, which typically require larger and longer clinical trials.
Tolerability and Pharmacokinetic Data from Phase 2 Evangeline Trial: Atossa presented three posters at the San Antonio Breast Cancer Symposium (SABCS) highlighting pharmacokinetic (PK) and tolerability data from the Phase 2 EVANGELINE trial. This randomized, non-inferiority study evaluates (Z)-endoxifen in premenopausal women with primary ER+/HER2- breast cancer as a neoadjuvant treatment. Substantial tumor suppression was observed across all dosing levels, with or without ovarian function suppression (OFS or goserelin). The 4-week Ki-67 ≤ 10 percent response rate was generally above 85 percent across dose levels, with or without the presence of OFS. Overall, (Z)-endoxifen was well tolerated and target tissue steady state concentration (Css) levels were achieved without significant Grade 3 or 4 toxicities. Given the gynecologic events that were previously reported in the 80 mg groups, the study is expected to continue under an amended protocol as a randomized trial that compares (Z)-endoxifen 40 mg per day with OFS to exemestane plus OFS, using the 4-week Ki-67 reduction as the primary endpoint. Additionally, the trial is expected to include a single arm cohort with a 40 mg (Z)-endoxifen monotherapy neoadjuvant treatment, using a 24-week Ki-67 endpoint.
Full Results from Phase 2 KARISMA-Endoxifen Study: Additional SABCS data showcased the potential of low-dose (Z)-endoxifen to significantly reduce mammographic breast density (MBD). In the trial, a 1 mg dose reduced MBD by 17.3 percentage points (p<0.01), while a 2 mg dose achieved a 23.5 percentage-point reduction (p<0.01), compared to just 0.27 percentage points in the placebo arm, which we believe highlights the effectiveness of the lower dose in achieving significant reductions. Importantly, no significant differences in adverse events of special interest were observed between the 1 mg dose and the placebo. The 2 mg dose was associated with higher rates of hot flashes, night sweats and vaginal discharge compared to the placebo group. We believe these findings further support the therapy's favorable safety and efficacy profile.
"Metastatic breast cancer remains an area of critical unmet need, where improved therapies are urgently required," said Steven Quay, M.D., Ph.D., President and Chief Executive Officer of Atossa. "(Z)-endoxifen has demonstrated promising anti-estrogenic and anti-tumor effects alongside a favorable tolerability profile, which we believe positions it as a potential next-generation therapy. We believe that pursuing an initial approval in metastatic breast cancer could offer a more efficient regulatory pathway, potentially enabling us to make (Z)-endoxifen available sooner to the patients who need it most. We also believe this strategy further supports our ability to expand the broader potential of (Z)-endoxifen to address multiple stages of breast cancer, from reducing tumor growth to preventing recurrence after successful treatment."
Conference Call Information:The webcast will be available at the investor relations section of the Company's website at atossatherapeutics.com. Alternatively, to access the conference call by telephone, U.S.-based callers should dial 1-800-836-8184 and international listeners should dial 1-646-357-8785. All listeners should provide the operator with the conference call name "Atossa Therapeutics Business Update" to join.
Following the conclusion of the conference call, a replay will be available for 30 days on the investor relations section of the Company's website at atossatherapeutics.com.
Comparison of Years Ended December 31, 2024 and 2023
Operating Expenses. Total operating expenses were $27.6 million for the year ended December 31, 2024, which was a decrease of $3.8 million, from the year ended December 31, 2023 of $31.4 million. Factors contributing to the decreased operating expenses in the year ended December 31, 2024 are explained below.
Research & Development (R&D) Expenses. The following table provides a breakdown of major categories within R&D expenses for the years ended December 31, 2024 and 2023, together with the dollar change in those categories (dollars in thousands):
Year Ended December 31, 2024
Year Ended December 31, 2023
Increase (Decrease)
% Increase (Decrease)
Research and Development Expense
Clinical and pre-clinical trials
$
10,107
$
12,722
$
(2,615
)
(21
)%
Compensation
2,928
3,474
(546
)
(16
)%
Professional fees and other
1,082
1,138
(56
)
(5
)%
Research and Development Expense Total
$
14,117
$
17,334
$
(3,217
)
(19
)%
•
Clinical and pre-clinical trial expense decreased $2.6 million for the year ended December 31, 2024 compared to the prior year due to a decrease in spending for the (Z)-endoxifen trials, including a decrease in drug development costs.
•
The decrease in R&D compensation expense of $0.5 million for the year ended December 31, 2024 compared to the prior year was primarily due to a decrease in non-cash stock-based compensation expense of $0.9 million. Non-cash stock-based compensation expense decreased compared to the prior year due to the weighted average fair value of stock options amortizing in 2024 being lower than 2023. The decrease in compensation expense was partially offset by an increase in cash compensation expense of $0.4 million due to the hiring in early 2024 of additional R&D employees.
General and Administrative (G&A) Expenses. The following table provides a breakdown of major categories within G&A expenses for the years ended December 31, 2024 and 2023, together with the dollar change in those categories (dollars in thousands):
Year Ended December 31, 2024
Year Ended December 31, 2023
Increase (Decrease)
% Increase (Decrease)
General and Administrative Expense
Compensation
$
5,458
$
7,388
$
(1,930
)
(26
)%
Professional fees and ...
