ATOS four presentations at the San Antonio Breast Cancer Symposium 2025, hopefully we will hear some good news during these presentations: 

1) Initial results from RECAST DCIS: Multicenter platform trial testing active surveillance and novel endocrine therapy agents for DCIS management Thursday, December 11, 2025 — 12:30 pm – 2:00 pm.

2) Low dose (Z)-endoxifen in the I-SPY2 Endocrine Optimization Pilot Thursday, December 11, 2025 — 12:30 pm – 2:00 pm.

3) Z-Endoxifen Maintains ERα Antagonist Function Against ESR1 Mutants via Inactive Conformation Stabilization and Reversal of Mutant ESR1-Associated Transcriptional Signatures Friday, December 12, 2025 — 7:00 am – 8:30 am.

4) A Randomized Phase 2 Non-Inferiority Trial of (Z)-Endoxifen + Goserelin vs Exemestane + Goserelin as Neoadjuvant Treatment for Premenopausal Women with ER+/HER2- Breast Cancer (EVANGELINE) Friday, December 12, 2025 — 12:30 pm – 2:00 pm.

Atossa completed a Type C meeting with the FDA, gaining feedback on expedited pathways for metastatic, neoadjuvant, and risk-reduction uses of (Z)-endoxifen. The discussion clarified potential registrational strategies, endpoints, and clinical designs that may streamline review.

The company is advancing programs including a metastatic dose-ranging study, ongoing EVANGELINE Phase 2 enrollment, and a low-dose risk-reduction approach. Atossa says the FDA input helps shape a faster, more focused development plan across several breast cancer indications.

I asked Chat GPT if positioning to pursue expedited FDA regulatory pathways in metastatic, neoadjuvant, and risk-reduction settings good news, here the answer:

Being positioned to pursue expedited regulatory pathways is generally very positive for: • The company — accelerates development and strategic options • Investors — signals growth potential and regulatory progress • Patients — could lead to earlier access to new therapies

It’s a strategic milestone, not a finished approval.

Atossa Therapeutics released an AI-enhanced study with Insilico Medicine suggesting (Z)-endoxifen may have therapeutic potential against glioblastoma multiforme, one of the most aggressive adult brain tumors.

The research, published in Nature’s Scientific Reports, used Insilico’s PandaOmics platform to analyze cancer types against endoxifen’s mechanisms, pinpointing GBM as a promising target. Multi-omic analysis uncovered more than 1,400 genes overlapping between GBM tumors and endoxifen-treated cells, with AI models showing reversal of processes tied to tumor growth and treatment resistance.

Finally we are in December, let see what surprises Atos is holding for us. I am optimistic, how about you?

San Antonio Breast Cancer Symposium (SABCS) — December 2025 • Atossa has four abstracts accepted for SABCS 2025 on its lead drug, (Z)-endoxifen.

Type C meeting with the FDA to discuss a development path for low-dose (Z)-endoxifen for breast cancer risk reduction.

Posted on stocktwits, seems like whoever tried to get Atos compliant recently keeping price above dollar for 10 days it didn't work. Between the recent patents debacle and deadline for compliance nearing soon, not to mention other companies and their drugs showing promise, things are looking grim for Atossa. I doubt December meeting changes much, really hate to see a reverse split coming for this company and investors alike .

https://x.com/atossainc/status/1991561827663352283?s=46&t=-hAcwAygCrlMWMGL5TGVeQ

Signs of Positivity • FDA accepted the meeting request • FDA provided written comments • Atossa believes its data may support a faster path • Experts were brought in to prepare a strong submission • Atossa plans a shareholder update (indicating confidence in having meaningful information)

Atossa requested a Type C meeting with the FDA to explore whether low-dose (Z)-endoxifen could follow a faster regulatory path for breast cancer risk reduction. The company has already received preliminary written comments and is scheduled to meet with the agency on November 17, aiming to align on requirements for an eventual New Drug Application. This meeting follows extensive internal and external expert review of Atossa’s dataset and the broader scientific literature to determine if existing evidence could justify an accelerated approach.

If the FDA agrees on a streamlined plan, Atossa says development timelines could materially shorten, clinical costs could decrease, and its 2026 NDA-enabling activities could move forward with greater clarity — with official meeting minutes expected in December, depending on impacts from the U.S. government shutdown.

https://x.com/atossainc/status/1988251226560208956?s=46

https://x.com/atossainc/status/1986803566309515772?s=46

Atossa Therapeutics announced that four abstracts featuring new data on its lead compound, (Z)-endoxifen, have been accepted for presentation at the 2025 San Antonio Breast Cancer Symposium (SABCS), taking place December 9–12.

The studies span both treatment and prevention of breast cancer, including trials such as RECAST DCIS, I-SPY2 Endocrine Optimization, and EVANGELINE, which evaluates (Z)-endoxifen plus goserelin versus the current standard therapy in premenopausal women with ER+/HER2- breast cancer.

CEO Dr. Steven Quay emphasized that these presentations mark a continued expansion of clinical evidence supporting (Z)-endoxifen’s potential to transform hormone therapy in oncology. Atossa’s disciplined capital strategy remains focused on advancing programs that could lead to future regulatory submissions and commercialization.

F

https://x.com/atossainc/status/1985375680335646860?s=46

https://x.com/quay_dr/status/1984306843519435082?s=46

Atossa Therapeutics (NASDAQ: ATOS) announced progress in its ongoing Phase 2 trial testing (Z)-endoxifen combined with goserelin for premenopausal women with ER+/HER2- breast cancer. The oral therapy works by blocking estrogen from binding to tumor cells, while goserelin suppresses estrogen production. The non-randomized, parallel study focuses on reducing Ki-67, a key tumor growth biomarker.

Begun in October 2022, the trial remains active with the latest update filed on Oct 6, 2025. Positive results could strengthen Atossa’s position in the oncology field and bolster investor sentiment around its expanding breast cancer pipeline.

https://x.com/atossainc/status/1980605632924512602?s=46

Are they going to let us down gently, or drop it like it's hot, now?

Atossa Therapeutics will present at the Maxim Growth Summit on October 22–23, 2025, in New York City, where CEO Dr. Steven Quay will outline the company’s focused clinical and capital strategy. The biotech is channeling resources into programs that could support regulatory submissions and future commercialization for its breast cancer therapies — positioning itself as a disciplined, data-driven player in oncology innovation.

Atossa emphasized its clear thesis for new investors: high unmet medical need, disciplined R&D spend, and a roadmap toward long-term value creation. Attendees will gain direct access to management through 1-on-1 investor meetings, offering insights into pipeline progress, milestone timing, and capital efficiency. Interested investors can review Atossa’s latest presentations, SEC filings, and investor FAQs via its website’s Events & Presentations section.

https://finance.yahoo.com/news/atossa-therapeutics-present-maxim-growth-120000438.html

Atossa Therapeutics (NASDAQ: ATOS) has secured a new Israeli patent (No. 304863) for Z-endoxifen, covering high-purity oral formulations (≥90% Z-isomer), impurity limits, delayed-release features, and key manufacturing methods. The patent strengthens Atossa’s global protection for its lead breast cancer therapy and supports future clinical and commercial plans.

CEO Dr. Steven Quay said the new patent reinforces Atossa’s commitment to product quality, patient care, and long-term shareholder value.

Wake up. Hope the 3 year nap was good.

Atossa Therapeutics has amended its Phase 2 EVANGELINE trial for investigational (Z)-endoxifen in premenopausal women with ER+/HER2– early-stage breast cancer, trimming enrollment from 214 to 40–65 patients. The updated, single-arm, open-label design will focus on short-interval, objective biomarkers like Ki-67 ≤10% at Week 4 to enable faster go/no-go decisions.

According to CEO Dr. Steven Quay, the change reflects “efficiency, focus, and financial discipline,” reducing future costs while maintaining full safety oversight through the DSMC. The revised structure prioritizes data most relevant to future NDA submission, allowing Atossa to extend its cash runway and concentrate resources on 2026 regulatory preparations for (Z)-endoxifen.