Atossa Therapeutics Announces Third Quarter 2024 Financial Results and Provides Corporate Update
Announced positive topline results from KARISMA-Endoxifen Phase 2 study which demonstrated that low doses of (Z)-endoxifen significantly reduced mammographic breast density (MBD), addressing a key breast cancer risk factor
Released a preliminary analysis from I-SPY 2 Endocrine Optimization Pilot (EOP) Phase 2 trial of (Z)-endoxifen which met the primary endpoint with 95 percent (19/20 patients) receiving > 75 percent of planned treatment
Announced the dosing of the first patient in a clinical trial conducted in partnership with Quantum Leap Healthcare Collaborativeä evaluating Atossa's proprietary (Z)-endoxifen in combination with abemaciclib (VERZENIO)
Received a new patent (U.S. Patent No. 12,071,391) covering certain compositions of (Z)-endoxifen in free base or salt forms with enteric material, as well as methods of administering these compositions
Ended third quarter 2024 with $74.8 million in cash and cash equivalents and no debt
SEATTLE, Nov. 12, 2024 (GLOBE NEWSWIRE) -- Atossa Therapeutics, Inc. (NASDAQ:ATOS) ("Atossa" or the "Company") a clinical-stage biopharmaceutical company developing innovative medicines for breast cancer, today announced financial results for the fiscal quarter ended September 30, 2024, and provided an update on recent company developments.
Key developments from Q3 2024 include:
Positive Topline Data from KARISMA-Endoxifen Phase 2 Study: Atossa reported topline results from its KARISMA-Endoxifen Phase 2 study conducted at the Karolinska Institute in Sweden, evaluating (Z)-endoxifen in premenopausal women with mammographic breast density (MBD). The study demonstrated significant MBD reductions of 19.3 percent and 26.5 percent in the 1 mg and 2 mg treatment arms, respectively, compared to placebo, over a six-month period. The treatment was well tolerated, with minimal side effects and no significant safety concerns. Although vasomotor symptoms slightly increased in active treatment groups, they were not a major reason for discontinuation. The Company believes that these findings support the potential of (Z)-endoxifen as a preventative therapy for women with dense breast tissue, an independent risk factor for breast cancer.
Promising Preliminary Analysis from Phase 2 I-SPY 2 EOP Trial: Atossa released a preliminary analysis from its Phase 2 trial of (Z)-endoxifen in ER+/HER2- breast cancer, showing that (Z)-endoxifen met the primary endpoint with 95 percent (19/20) of patients completing >75 percent of planned treatment. The data showed a rapid reduction in key breast cancer biomarkers, including a 69 percent reduction in Ki-67 and a 30.4 percent reduction in functional tumor volume after three weeks. The treatment was well tolerated, with mild side effects and no dose reductions or treatment discontinuations.
Initiation of Combination Trial with Quantum Leap Healthcare Collaborative™: Atossa, in collaboration with Quantum Leap Healthcare Collaborative™, announced that the first patient was dosed in their clinical trial evaluating (Z)-endoxifen in combination with abemaciclib (VERZENIO®) as a neoadjuvant treatment for high-risk women with newly diagnosed ER+/HER2- breast cancer. Part of the ongoing I-SPY 2 Endocrine Optimization Pilot Protocol (EOP), the trial targets patients whose tumors are predicted to be sensitive to endocrine therapy but unlikely to benefit from chemotherapy. The study is expected enroll approximately 80 participants, with pre- and postmenopausal women receiving daily (Z)-endoxifen and abemaciclib for 24 weeks prior to surgery. The trial aims to assess the efficacy and safety of this combination, with results anticipated in 2026.
New U.S. Patent Granted for (Z)-Endoxifen Compositions: The United States Patent and Trademark Office (USPTO) granted Atossa a new patent covering certain compositions of (Z)-endoxifen in free base or salt forms with enteric material, as well as methods of administering these compositions. This fourth issued patent for (Z)-endoxifen broadens Atossa's protection and validates its intellectual property strategy.
Appointment of New Vice President of Investor and Public Relations: Atossa appointed Michael Parks as Vice President of Investor and Public Relations. With nearly 30 years of experience in investor relations and corporate communications, Mr. Parks leads Atossa's corporate, executive, and digital communications, investor relations, and branding.
Appointment of Claudia Lopez, DVM, MSc, as Vice President, Clinical Product Development: Dr. Lopez brings over 20 years of clinical development experience, including leadership roles at Landos Biopharma, Arena Pharmaceuticals, and Takeda Pharmaceuticals. Her expertise in global clinical programs and regulatory strategy will support Atossa's efforts to advance its clinical pipeline and develop next-generation cancer treatments.
"We are energized by the substantial progress Atossa has made this quarter, particularly the positive results from our KARISMA-Endoxifen Phase 2 study, which demonstrated that low doses of (Z)-endoxifen elicited significant reductions in mammographic breast density—an important risk factor for breast cancer," said Steven Quay, M.D., Ph.D., Atossa's President and Chief Executive Officer. "Combined with the promising preliminary data from the I-SPY 2 EOP trial of (Z)-endoxifen showing rapid reductions in Ki-67 and tumor volume, we believe these results further validate the substantial potential of our programs and demonstrate our commitment to developing innovative therapies that can meaningfully impact breast cancer treatment and prevention."
Comparison of Three and Nine Months Ended September 30, 2024 and 2023
Operating Expenses. Total operating expenses were $6.4 million and $20.5 million for the three and nine months ended September 30, 2024 which was a decrease of $1.1 million and $1.9 million, from total operating expenses for the three and nine months ended September 30, 2023 of $7.5 million and $22.4 million, respectively. Factors contributing to the decrease in operating expenses in the three and nine months ended September 30, 2024 are explained below.
Research & Development (R&D) Expenses. The following table provides a breakdown of major categories within R&D expenses for the three and nine months ended September 30, 2024 and 2023, together with the dollar change in those categories (dollars in thousands):
For the Three Months Ended September 30,
For the Nine Months Ended September 30,
2024
2023
Increase (Decrease)
% Increase (Decrease)
2024
2023
Increase (Decrease)
% Increase (Decrease)
Research and Development Expense
Clinical and non-clinical trials
$
2,490
$
3,365
$
(875
)
(26)%
$
7,875
$
8,239
$
(364
)
(4)%
Compensation
701
763
(62
)
(8)%
2,006
2,696
(690
)
(26)%
Professional fees and other
221
339
(118
)
(35)%
833
745
88
12%
Research and Development Expense Total
$
3,412
$
4,467
$
(1,055
)
(24)%
$
10,714
$
11,680
$
(966
)
(8%)
Clinical and non-clinical trial expense decreased $0.9 million and $0.4 million for the three and nine months ended September 30, 2024, respectively, compared to the prior year periods 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 $0.1 million and $0.7 million for the three and nine months ended September 30, 2024, respectively, compared to the prior year periods was primarily due to a decrease in non-cash stock-based compensation expense of $0.1 million and $0.8 million for the three and nine months ended September 30, 2024, respectively. Non-cash stock-based compensation expense decreased compared to the prior year periods due to the weighted average fair value of stock options amortizing in the 2024 periods being lower.
The decrease in R&D professional fees and other expense of $0.1 million for the three months ended September 30, 2024 compared to the prior year period was primarily due to the timing of the study cohorts in clinical and non-clinical trials. The increase in R&D professional fees and other expense of $0.1 million for the nine months ended September 30, 2024 compared to the prior year period was primarily due to higher consulting fees in 2024 related to our (Z)-endoxifen program.
General and Administrative (G&A) Expenses. The following table provides a breakdown of major categories within G&A expenses for the three and nine months ended September 30, 2024 and 2023, together with the dollar change in those categories (dollars in thousands):
For the Three Months Ended September 30,
For the Nine Months Ended September 30,
2024
2023
Increase (Decrease)
% Increase (Decrease)
2024
2023
Increase (Decrease)
% Increase (Decrease)
General and Administrative Expense
