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Atossa Therapeutics Reports Third Quarter 2026 Financial Results and Provides a Corporate Update

On November 10, 2026 Atossa Therapeutics, Inc. (Nasdaq: ATOS) (Atossa or the Company), a clinical-stage biopharmaceutical company developing novel therapies in oncology and other areas of high unmet clinical need, reported its financial results for the third quarter ended September 30, 2026 and provided an update on recent corporate developments.

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"In recent weeks, we took meaningful steps to enable shareholders to participate in potential future value from our rare disease programs," stated Steven C. Quay, M.D., Ph.D., Atossa’s Chairman, President and Chief Executive Officer. "Our recently announced contingent value rights agreement entitles holders to share in 25% of the net proceeds, up to $50 million, from the sale of the first priority review voucher awarded to Atossa from its rare disease development programs. At the same time, we continued to advance (Z)-endoxifen toward several near-term milestones, including anticipated FDA clearance of our IND applications in Duchenne Muscular Dystrophy and McCune-Albright Syndrome in early 2027. In December 2026, presentations at the San Antonio Breast Cancer Symposium will include Karisma follow-up results and selected data from the ongoing I-SPY2 study evaluating (Z)-endoxifen in combination with other therapies."

Third Quarter 2026 & Recent Highlights

Stapled Contingent Value Rights (CVR) Agreement
On October 8, 2026, the Company entered into a Stapled Contingent Value Rights Agreement (the CVR Agreement), and the Board of Directors (the Board) declared a dividend of one CVR for each share of Atossa common stock outstanding as of October 19, 2026 and issued thereafter. The CVRs remain attached to the underlying shares and will not trade separately unless the Board elects to detach them.
CVR holders will be entitled, in the aggregate, to 25% of the net proceeds from the sale or other monetization of the first qualifying U.S. Food and Drug Administration (FDA) priority review voucher (PRV) awarded to Atossa, subject to a maximum aggregate payment of $50 million.
No PRV has been awarded to the Company, and there can be no assurance that Atossa will receive or monetize a PRV or that any payment will ultimately be made under the CVR Agreement.
CFO Attendance at Global Genes RARE Drug Development Symposium
Mark Daniel, Atossa’s Chief Financial Officer, attended the Global Genes RARE Drug Development Symposium, held September 9–11, 2026, in Boston, Massachusetts. The symposium brought together patient advocates, researchers and biopharmaceutical industry leaders to explore research strategies, clinical trial readiness and collaboration in rare disease drug development. Atossa’s attendance supported its efforts to understand patient community priorities and explore approaches to advancing its rare disease development programs.
CEO Attendance at NORD Rare Diseases and Orphan Products Breakthrough Summit
Steven C. Quay, M.D., Ph.D., Atossa’s Chairman, President and Chief Executive Officer, attended the National Organization for Rare Disorders (NORD) Rare Diseases and Orphan Products Breakthrough Summit, held October 25–27, 2026, in Washington, D.C. The Summit brought together patient advocates, researchers, industry leaders and policymakers to discuss advances in rare disease research, drug development, patient engagement and access to treatments. Atossa’s attendance supported its continued engagement with the rare disease community as the Company advances its (Z)-endoxifen programs in Duchenne Muscular Dystrophy (DMD) and McCune-Albright Syndrome (MAS).
Anticipated Milestones

The Company anticipates Investigational New Drug (IND) application clearance from the FDA for (Z)-endoxifen in MAS and DMD by early 2027, with initiation of Phase 2 clinical trials expected in 2027.
The Karisma trial was completed and the results finalized in the clinical study report. The Company is presenting these data at the San Antonio Breast Cancer Symposium (SABCS) in December 2026, and will publicize the findings thereafter.
The Company anticipates topline data from the Phase 2 EVANGELINE study of (Z)-endoxifen plus goserelin as neoadjuvant therapy in premenopausal women with ER+/HER2- breast cancer in the second quarter of 2027. Enrollment for the study was completed during the second quarter of 2026.
Enrollment in the (Z)-endoxifen plus elagolix and (Z)-endoxifen plus abemaciclib arms of the Phase 2 I-SPY2 study is complete, and select data will be presented at SABCS in December 2026.
Financial Results for the Third Quarter Ended September 30, 2026

Operating Expenses. Total operating expenses were $5.9 million and $24.5 million for the three and nine months ended September 30, 2026, respectively, which represented a decrease of $3.4 million and $1.2 million from total operating expenses for the three and nine months ended September 30, 2025, which were $9.3 million and $25.7 million, respectively. Factors contributing to the changes in operating expenses during the three and nine months ended September 30, 2026, 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, 2026 and 2025, together with the dollar change and percentage change in those categories (dollars in thousands):

For the Three Months Ended September 30,

For the Nine Months Ended September 30,

2026

2025
Increase

(Decrease)

% Increase

(Decrease)

2026

2025

Increase

(Decrease)

% Increase

(Decrease)

Research and Development Expense

Clinical and non-clinical trials

2,483

4,318

(1,835)

(42) %

9,726

11,154

(1,428)

(13) %

Compensation

741

723

2 %

2,629

2,459

170

7 %

Professional fees and other

154

329

(175)

(53) %

699

1,416

(717)

(51) %

Research and Development Expense Total

3,378

5,370

(1,992)

(37) %

13,054

15,029

(1,975)

(13) %

As (Z)-endoxifen is our only product candidate for which we currently incur R&D expenses, we have not further disaggregated R&D expenses by product candidate.

Clinical and non-clinical trial expenses decreased $1.8 million and $1.4 million for the three and nine months ended September 30, 2026, respectively, compared to the three and nine months ended September 30, 2025, due primarily to lower spend related to our ongoing (Z)-endoxifen trials for which enrollment was largely completed during the first nine months of 2026.
The increase in R&D compensation expense of $0.2 million for the nine months ended September 30, 2026, compared to the nine months ended September 30, 2025, was due primarily to increases in non-cash stock-based compensation expense.
The decrease in R&D professional fees and other of $0.2 million and $0.7 million for the three and nine months ended September 30, 2026, respectively, compared to the three and nine months ended September 30, 2025, was due primarily to lower regulatory consulting fees related to our (Z)-endoxifen programs during the current year periods.
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, 2026 and 2025, together with the dollar change and percentage change in those categories (dollars in thousands):

For the Three Months Ended September 30

For the Nine Months Ended September 30,

2026

2025

Increase

(Decrease)

% Increase

(Decrease)

2026

2025

Increase

(Decrease)

% Increase

(Decrease)

General and Administrative Expense

Compensation

1,119

1,453

(334)

(23) %

3,678

4,479

(801)

(18) %

Professional fees and other

1,402

2,428

(1,026)

(42) %

7,731

6,197

1,534

25 %

General and Administrative Expense Total

2,521

3,881

(1,360)

(35) %

11,409

10,676

733

7 %

The decrease in G&A compensation expenses of $0.3 million and $0.8 million for the three and nine months ended September 30, 2026, respectively, compared to the three and nine months ended September 30, 2025, was due primarily to a decrease in headcount in the current year periods compared to the same periods in the prior year.
The decrease in G&A professional fees and other of $1.0 million for the three months ended September 30, 2026, compared to the three months ended September 30, 2025, was due primarily to a decrease in legal fees of $0.8 million related to the resolution of patent litigation matters during the first half of 2026. The increase in G&A professional fees and other of $1.5 million for the nine months ended September 30, 2026 compared to the nine months ended September 30, 2025, was due primarily to higher spend on patent litigation matters during the first half of 2026, which have now been settled, and to a lesser extent, higher legal fees associated with management of our intellectual property portfolio and general legal costs related to SEC compliance and other stock administration matters incurred during the current year period.
Interest Income. Interest income was $0.2 million and $0.7 million for the three and nine months ended September 30, 2026, respectively, and decreased $0.4 million and $1.2 million compared to the three and nine months ended September 30, 2025, respectively. The decrease was due primarily to lower average cash balances invested in our money market account during the current year periods relative to the same periods in the prior year.

(Press release, Atossa Therapeutics, NOV 10, 2026, View Source [SID1234674586])

Nuvation Bio to Present at the Jefferies Global Healthcare Conference in London

On November 10, 2026 Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, reported that David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio, and Philippe Sauvage, Chief Financial Officer of Nuvation Bio, will participate in a fireside chat at the Jefferies Global Healthcare Conference in London on Tuesday, November 17, 2026, at 2:30 p.m. GMT.

A live webcast of the fireside chat will be available on the Investor Relations section of the Nuvation Bio website. An archived recording will be available for 90 days following each event.

(Press release, Nuvation Bio, NOV 10, 2026, View Source [SID1234674585])

CEL-SCI’s Dr. Eyal Talor Receives Second International Keynote Invitation on Multikine Head and Neck Cancer Research

On November 10, 2026 CEL-SCI Corporation (NYSE American: CVM) reported that the Company’s Chief Scientific Officer and Multikine (Leukocyte Interleukin, Injection)* inventor and developer, Dr. Eyal Talor, has received his second invitation to deliver a keynote address at an international head and neck cancer conference. Dr. Talor has been invited to speak at the 3 rd Global Congress on Otolaryngology, Head and Neck Surgery which will take place on June 9-10, 2027 in Lisbon, Portugal.

Dr. Talor’s presentation, titled "Disease/Tumor Biomarkers Prognosticate Overall Survival Benefit in Oral Squamous Cell Carcinoma: A Novel Neoadjuvant Cancer Immunotherapy" will address findings from CEL-SCI’s Phase 3 study of Multikine and the Company’s work using tumor and disease biomarkers to identify patients most likely to benefit from Multikine treatment before surgery.

This follows Dr. Talor’s recent keynote speech at the 6th World Congress on Otology, Rhinology and Laryngology in Rome on October 26. Both invitations came after recent peer-reviewed publications of CEL-SCI’s IT-MATTERS Phase 3 research. The series of scientific publications and keynote invitations is expanding the visibility of CEL-SCI’s biomarker-based approach among specialists who diagnose and treat head and neck cancer.

"We believe these keynote invitations reflect growing scientific interest in what we have demonstrated with Multikine: the first overall survival advantage for a neoadjuvant treatment in this patient population in many decades, and a biomarker-based method that can identify at diagnosis the patients most likely to achieve this substantial survival benefit," said CEL-SCI CEO Geert Kersten. "This combination is what makes our findings potentially groundbreaking for head and neck cancer patients. We are now applying this patient selection method prospectively in our Registration Study of 212 patients."

CEL-SCI’s completed 928-patient IT-MATTERS Phase 3 study identified disease and tumor biomarkers which can be applied at diagnosis to select previously untreated, locally advanced head and neck cancer patients most likely to benefit from neoadjuvant Multikine administration, a pre-surgery treatment. CEL-SCI is applying these biomarkers prospectively as patient selection criteria in its 212-patient Registration Study, which is designed with approximately 97% statistical power to detect the survival effect previously observed in this population.

Surgeons, healthcare professionals, academic scholars and researchers from around the world are expected to participate in the 3rd Global Congress on Otolaryngology, Head and Neck Surgery in Lisbon. The Congress provides a forum for scientific research, surgical advances and clinical developments in otolaryngology and head and neck surgery. The theme of the 2027 Congress is "Transforming ENT Care through Research, Innovation, and Clinical Excellence."

About Multikine

Multikine is a novel cancer immunotherapy administered before surgery as a treatment for newly diagnosed previously untreated locally advanced head and neck cancer. Its goal is to activate a person’s immune system to fight cancer before the ravages of surgery, radiation and chemotherapy have weakened the immune system. In the world’s largest locally advanced, resectable head and neck cancer Phase 3 study, Multikine increased the 5-year survival rate of the target patient population to 73% vs 45% in patients treated with standard of care alone and halved the risk of death from 55% to 27%. The results of the IT-MATTERS global Phase 3 study represent the first overall survival advantage for a neoadjuvant treatment, in the treatment naïve resectable locally advanced head and neck squamous cell carcinoma (cancer) patients, in many decades.

(Press release, Cel-Sci, NOV 10, 2026, View Source;storyId=4505652807261336 [SID1234674584])

Compugen to Present UnigenX™ Platform at the 18th Annual PEGS Europe Summit

On November 10, 2026 Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN), a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery powered by AI, reported an oral presentation at the 18th Annual Protein and Antibody Engineering Summit (PEGS) Europe, taking place November 16-19, 2026, in Lisbon, Portugal.

The presentation will showcase UnigenX, an expansion of the Company’s computational discovery platform into targeted immune activation modalities, such as T cell engagers, designed to discover novel tumor-associated antigen targets and combinations for selective targeting of tumor cells.

Title: UnigenX: AI-Powered Discovery Platform for Novel Tumor-Associated Antigens for Targeted Immune Activation
Track: Advancing Multispecific Antibodies and Combination Therapy to the Clinic
Speaker: Dr. Roy Granit, Head of Computational Discovery at Compugen
Date & Time: Wednesday, November 18, 2026 at 18:30 GMT
Link: PEGS Europe 2026

(Press release, Compugen, NOV 10, 2026, View Source [SID1234674583])

FDA Approves PIMJETMI® (pimicotinib) for Patients with Tenosynovial Giant Cell Tumor

On November 10, 2026 Merck, a leading science and technology company, reported that the U.S. Food and Drug Administration (FDA) has approved PIMJETMI (pimicotinib), a once-daily oral colony stimulating factor-1 receptor (CSF-1R) inhibitor, as a systemic treatment for adults with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection may cause worsening functional limitation or severe morbidity.

"People living with TGCT have long faced difficult treatment decisions as they navigate a disease that can significantly affect their daily lives including their mobility," said Danny Bar-Zohar, CEO Healthcare and Member of the Executive Board for the Healthcare business of Merck. "Translating scientific innovation into clinically meaningful advances for people living with rare tumors is a strategic imperative for our company, as we continue our commitment to addressing significant unmet needs. With the approval of PIMJETMI in the U.S., we strengthen our leadership position and growing portfolio in rare tumors and bring real hope to patients and their families."

TGCT is a rare, locally aggressive tumor occurring in or around the joints leading to progressive worsening of symptoms including pain and reduced mobility of the affected joint, significantly impacting physical function in what is typically an otherwise healthy and young population. It has been reported that up to half of people with TGCT can be initially misdiagnosed, resulting in delays in the appropriate disease management.3 If left untreated or in recurrent cases, TGCT may result in cumulative morbidity and irreversible damage to the bone, joint and surrounding tissues.

"The results of the Phase 3 MANEUVER trial demonstrate that PIMJETMI elicits durable2 tumor response with a manageable tolerability profile," said Vinod Ravi, MD, MS, MBA, Department of Sarcoma Medical Oncology, Division of Cancer Medicine, UT MD Anderson, an investigator on the MANEUVER trial. "This combination of efficacy and safety data will potentially address the needs of people living with TGCT in a once-daily treatment option."

FDA approval is based on primary and longer-term results from the global Phase 3 MANEUVER study. PIMJETMI demonstrated a statistically significant improvement in objective response rate (ORR) at week 25 as assessed by blinded independent review committee (BIRC) based on RECIST v1.1 compared with placebo (56% vs. 3% for placebo; p<0.0001). PIMJETMI also demonstrated clinically meaningful and statistically significant improvements as compared to placebo across secondary endpoints relevant to patients’ daily lives, improving relative range of motion (p=0.0003), physical functioning (p=0.0074), and pain (p<0.0001). The MANEUVER study was presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. In the longer-term follow up (median 14.3 months for patients initially randomized to pimicotinib) presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in 2025, the median duration of response was not reached. The majority (77%) of patients with response at 25 weeks maintained clinical benefit after an additional 12 months of follow up, demonstrating the durability2 of response with PIMJETMI.

In MANEUVER, pimicotinib was well-tolerated, with no evidence of cholestatic hepatotoxicity or hair/skin hypopigmentation. During the randomized, double-blind treatment phase of the trial, treatment-emergent adverse events (TEAEs) leading to treatment discontinuation occurred in one patient (1.6%) treated with pimicotinib; TEAEs leading to dose reduction occurred in 7.9% (n=5) of pimicotinib-treated patients.

"TGCT can profoundly affect patients’ daily lives through persistent pain, swelling, and loss of joint function," said Sydney Stern, PhD, MS, TGCT Support, a Program of the Life Raft Group. "For symptomatic patients who are not likely to benefit from surgery alone, there remains need for treatment options which are tolerable and effectively address the burden of disease, shrink their TGCT, and improve pain and function."

The FDA approval of PIMJETMI builds on growing momentum for the Merck rare tumors portfolio that included two other drug approvals in the past three years including OGSIVEO, the first FDA-approved treatment for adults with progressing desmoid tumors who require systemic therapy. The PIMJETMI approval follows its approval in China by the National Medical Products Administration (NMPA) in December 2025, in Canada by Health Canada in June 2026 for the treatment of adult patients with symptomatic TGCT, as well as in Switzerland by its own independent national regulatory authority, the Swissmedic in October 2026.

The application for PIMJETMI was reviewed under Project Orbis, an international initiative of the FDA Oncology Center of Excellence. Application reviews are ongoing for partners of Project Orbis, an international framework for collaboration.

1 In the global Phase 3 MANEUVER clinical trial, the effect of pimicotinib had an early onset, with 41.3 % (26 of 63) of patients experiencing objective response to therapy after 13 weeks.

2 The majority (77%) of patients with response at 25 weeks maintained this clinical benefit after an additional 12 months of treatment.

3 Stern S, et al. Localized and diffuse tenosynovial giant cell tumor: real-world results from a patient observational registry. Future Oncol. 2025;21(12):1501-1510.

About MANEUVER

The pivotal, global, Phase 3 MANEUVER study is a three-part, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of PIMJETMI in patients with TGCT who were eligible for systemic therapy and have not received prior anti-CSF-1/CSF-1R therapy.

The ongoing study is being conducted by Abbisko Therapeutics and enrolled patients globally in USA, Canada and Europe (n=49) and China (n=45.)

In the double-blind Part 1, 94 patients were randomized 2:1 to receive either 50 mg QD of PIMJETMI (n=63) or placebo (n=31) for 24 weeks. In addition to the primary endpoint of ORR at week 25, as measured by RECIST v1.1 by BICR, secondary endpoints include tumor volume score (TVS), relative range of motion, pain by Brief Pain Inventory (BPI), and physical function measured by Patient-Reported Outcomes Measurement Information System (PROMIS-PF).

After the double-blind Part 1, all eligible patients from either arm could continue to the open-label Part 2 and receive up to 24 weeks of pimicotinib treatment. Patients who completed Part 2 could then enter the open-label extension phase (Part 3) for extended treatment and safety follow-up.

About PIMJETMI (pimicotinib)

PIMJETMI, developed by Abbisko Therapeutics, is a novel, orally administered, highly selective and potent small-molecule inhibitor of CSF-1R. PIMJETMI has been approved for the treatment of adult patients with symptomatic TGCT for which surgical resection will potentially cause functional limitation or relatively severe morbidity by China National Medical Products Administration (NMPA) and Health Canada. PIMJETMI has received priority medicine (PRIME) designation from the European Medicines Agency (EMA). Merck holds worldwide commercialization rights for PIMJETMI.

(Press release, Merck KGaA, NOV 10, 2026, View Source [SID1234674582])