Earnings summaries and quarterly performance for ATOSSA THERAPEUTICS.
Executive leadership at ATOSSA THERAPEUTICS.
Board of directors at ATOSSA THERAPEUTICS.
Research analysts who have asked questions during ATOSSA THERAPEUTICS earnings calls.
Recent press releases and 8-K filings for ATOS.
Atos Reports Preliminary FY 2025 Results, Exceeding Profitability and Cash Targets
ATOS
Earnings
Guidance Update
Revenue Acceleration/Inflection
- Atos Group's FY 2025 estimated revenue reached €8,001 million, meeting its target, while the operating margin is expected to exceed target at above €340 million (representing above 4% of revenues).
- The company achieved an inflexion point in its top line trajectory in Q4 2025, with estimated Group organic revenue performance improving to -9.3% year-over-year.
- The Q4 2025 book-to-bill ratio was 122%, aligning with expected acceleration in year-end order entry.
- Atos Group maintained a strong liquidity position of €1,707 million as of December 31, 2025, which is more than €1 billion above the minimum required level. The estimated net change in cash for FY 2025 was c. €-327 million, exceeding its target.
Jan 21, 2026, 7:00 AM
Atossa Therapeutics, Inc. Provides Q4 2025 Financial Update and Clinical Pipeline Milestones
ATOS
Guidance Update
New Projects/Investments
- Atossa Therapeutics, Inc. reported estimated cash and cash equivalents of approximately $40 million as of December 31, 2025. This estimate is preliminary and unaudited.
- The company maintains a strong financial position with over a year of runway and zero debt.
- Its lead candidate, oral (Z)-endoxifen, a potent selective estrogen receptor modulator/degrader (SERM/SERD), is currently in Phase 2 trials for various breast cancer indications.
- Upcoming milestones for (Z)-endoxifen include anticipated enrollment completion for the Karisma trial in Q1 2026, manuscript publication in Q1 2026, and anticipated results for the I-SPY2 EOP trial in H1 2026.
Jan 9, 2026, 1:15 PM
Atossa Therapeutics Receives FDA "Study May Proceed" Letter for (Z)-Endoxifen IND
ATOS
New Projects/Investments
- Atossa Therapeutics, Inc. (Nasdaq: ATOS) announced on January 6, 2026, that it received a "Study May Proceed" letter from the U.S. Food and Drug Administration (FDA) for its investigational new drug application for (Z)-endoxifen for metastatic breast cancer.
- This letter marks an important regulatory milestone for the company, potentially expanding the use of (Z)-endoxifen for metastatic ER+/HER2- Breast Cancer.
- (Z)-Endoxifen is a potent Selective Estrogen Receptor Modulator/Degrader (SERM/D) currently in development for oncology and rare diseases, and it is not yet approved for any indication.
Jan 6, 2026, 1:30 PM
Atossa Therapeutics Receives FDA Rare Pediatric Disease Designation for (Z)-Endoxifen
ATOS
New Projects/Investments
Regulatory Approval
- Atossa Therapeutics, Inc. (Nasdaq: ATOS) announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) designation to (Z)-Endoxifen for the treatment of Duchenne Muscular Dystrophy (DMD).
- This designation is a significant regulatory milestone that may qualify Atossa for a future Priority Review Voucher (PRV) upon approval, with disclosed PRV sales ranging from $100-$160 million in the last 18-24 months.
- The RPD designation provides a regulatory framework and an enhanced level of interaction with the FDA for defining the clinical development path in DMD.
- (Z)-Endoxifen is a potent Selective Estrogen Receptor Modulator/Degrader (SERM/D) being evaluated for potential applications in both oncology and rare diseases.
Dec 11, 2025, 1:00 PM
Atossa Therapeutics Announces New Patent Issuance
ATOS
New Projects/Investments
- Atossa Therapeutics announced on December 9, 2025, that the United States Patent and Trademark Office (USPTO) issued U.S. Patent No. 12,479,790 B2, titled, "Methods for Making and Using Endoxifen".
- The newly issued patent includes 100 claims directed to enteric oral formulations of highly pure (Z)-endoxifen free base, methods of using these compositions to treat hormone-dependent breast disorders and estrogen-related conditions, and specific solid oral dosage forms.
- This patent meaningfully extends and reinforces Atossa's robust endoxifen patent estate, supporting its long-term strategy to position (Z)-endoxifen as a differentiated therapy across the breast cancer spectrum and other hormone-driven conditions.
- Atossa is currently advancing its proprietary (Z)-endoxifen in multiple clinical settings, including metastatic breast cancer, neoadjuvant ER+/HER2- breast cancer (Phase 2 EVANGELINE trial), and breast cancer risk-reduction.
Dec 9, 2025, 1:00 PM
Atossa Therapeutics Details Accelerated FDA Strategy for (Z)-Endoxifen
ATOS
New Projects/Investments
- Atossa Therapeutics, Inc. completed a Type C meeting with the U.S. Food and Drug Administration (FDA) on November 17, 2025, to review the regulatory strategy for advancing (Z)-endoxifen.
- The FDA provided feedback on potential expedited regulatory pathways and development options for (Z)-endoxifen across metastatic disease, neoadjuvant treatment, and breast cancer risk-reduction settings.
- Atossa believes this interaction clarified routes to accelerate clinical development and regulatory review, positioning the company for a faster and more focused development strategy.
- The company recently submitted an Investigational New Drug (IND) application for its metastatic breast cancer program and anticipates additional IND submissions in 2026 for combination strategies.
Dec 4, 2025, 1:15 PM
Atossa Therapeutics outlines expedited FDA pathways for (Z)-endoxifen
ATOS
New Projects/Investments
- Atossa Therapeutics completed a Type C meeting with the FDA on November 17, 2025, to review the regulatory strategy for its drug candidate, (Z)-endoxifen, receiving feedback on potential expedited regulatory pathways across metastatic disease, neoadjuvant treatment, and breast cancer risk-reduction settings.
- The company believes this FDA interaction clarified routes to accelerate clinical development and regulatory review for (Z)-endoxifen, enabling a faster and more focused development strategy.
- Atossa recently submitted an Investigational New Drug (IND) application to the FDA for its metastatic breast cancer program and anticipates additional IND submissions in 2026 to advance combination strategies.
- The clinical program for (Z)-endoxifen includes a dose-ranging study in preparation for metastatic breast cancer, ongoing enrollment in the Phase 2 EVANGELINE trial for neoadjuvant ER+/HER2- breast cancer, and a low-dose strategy for breast cancer risk-reduction.
Dec 4, 2025, 1:00 PM
Atossa Therapeutics and Insilico Medicine Publish AI-Driven Study on (Z)-Endoxifen for Glioblastoma
ATOS
New Projects/Investments
- Atossa Therapeutics (Nasdaq: ATOS) and Insilico Medicine published a joint study in Nature's Scientific Reports evaluating the potential of (Z)-endoxifen for glioblastoma multiforme (GBM).
- The study, utilizing Insilico's AI-powered PandaOmics platform, identified GBM as a top candidate for further investigation of endoxifen's therapeutic potential.
- AI-driven analyses revealed that endoxifen was predicted to counteract pathways associated with uncontrolled proliferation, inflammation, metabolic dysregulation, and aggressive tumor behavior in GBM.
- Laboratory validation confirmed computational predictions, with (Z)-endoxifen significantly suppressing GBM cell proliferation and inducing apoptosis in vitro, and being well tolerated in vivo.
- This collaboration provides a new indication for endoxifen, potentially addressing an urgent and unmet need in glioblastoma patients.
Dec 2, 2025, 1:00 PM
Atossa Therapeutics Reports Q3 2025 Financial Results and Provides Corporate Update
ATOS
Earnings
CFO Change
New Projects/Investments
- Atossa Therapeutics reported a net loss of $(8.692) million and total operating expenses of $9.3 million for the third quarter ended September 30, 2025.
- The company is progressing its (Z)-endoxifen development, targeting a planned Investigational New Drug (IND) submission in Q4 2025 for metastatic breast cancer and expecting to meet with the FDA on November 17, 2025, to discuss accelerating development for breast cancer risk reduction.
- In October 2025, Mark Daniel was appointed Chief Financial Officer and Janet R. Rea was named Senior Vice President, R&D, to support (Z)-endoxifen development and commercial readiness.
- As of September 30, 2025, Atossa Therapeutics held $51.845 million in cash and cash equivalents.
Nov 12, 2025, 1:40 PM
Atossa Therapeutics Reports Q3 2025 Financial Results and Key Clinical & Leadership Updates
ATOS
Earnings
Management Change
New Projects/Investments
- Atossa Therapeutics reported a net loss of $(8.692) million or $(0.07) per share for the third quarter ended September 30, 2025, with total operating expenses reaching $9.251 million.
- The company is targeting a potential Investigational New Drug (IND) submission in Q4 2025 for its (Z)-endoxifen monotherapy study in metastatic breast cancer.
- Atossa requested a Type C meeting with the FDA in September 2025 to discuss accelerating the development of (Z)-endoxifen for breast cancer risk reduction, with a meeting scheduled for November 17, 2025.
- In October 2025, Mark Daniel, CPA, was appointed Chief Financial Officer, and Janet R. Rea, MSPH, was named Senior Vice President, R&D, to advance (Z)-endoxifen development and commercialization.
Nov 12, 2025, 1:15 PM
Quarterly earnings call transcripts for ATOSSA THERAPEUTICS.
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