Atossa Therapeutics, Inc. (ATOS): Business Model Canvas [Dec-2025 Updated]

You're looking to cut through the noise and see exactly how Atossa Therapeutics, Inc. (ATOS) plans to turn its promising (Z)-endoxifen candidate into a commercial success, and honestly, that's smart analysis. As someone who's mapped out biotech models for years, I've broken down their entire operation into the nine essential blocks, showing you where the $51.8 million cash runway is being spent-like the recent $3.3 million jump in R&D for the nine months ended September 30, 2025-and what their value proposition is against older breast cancer drugs. This isn't just theory; it's the reality of a clinical-stage company betting big on a proprietary enteric oral formulation, so dive into the details below to see the key partnerships, cost structure, and customer segments driving their next regulatory milestone.

Atossa Therapeutics, Inc. (ATOS) - Canvas Business Model: Key Partnerships

You're looking at the external engine driving Atossa Therapeutics, Inc.'s (ATOS) clinical progress, which is heavily reliant on specialized external expertise to move (Z)-endoxifen through development as of late 2025. These relationships are critical for managing complex trials and regulatory navigation.

The financial commitment to these external collaborations is visible in the operating expenses. Research and Development (R&D) expenses, which cover these trial costs, increased by $1.8 million for the three months ended September 30, 2025, compared to the same period in 2024. For the nine months ended September 30, 2025, the R&D spend increase was $3.3 million over the prior year, largely due to increases in spend related to (Z)-endoxifen trials and drug development costs. Honestly, this spend reflects the heavy lifting being done by partners.

Contract Research Organizations (CROs) like PSI for clinical trial execution

Atossa Therapeutics has been actively engaging CROs to manage the execution of its clinical trials. As of the second quarter of 2025, the Company announced it was working toward selecting a specific Contract Research Organization (CRO) to execute the planned metastatic dose ranging study. This selection process was a key deliverable leading up to a targeted Investigational New Drug (IND) submission in the fourth quarter of 2025. The cost associated with this external trial execution is a component of the reported R&D increases.

Eli Lilly and Company for combination therapy trials (I-SPY 2 with Verzenio)

The collaboration with Eli Lilly and Company, centered around the I-SPY 2 Endocrine Optimization Pilot (EOP), is a major component of the current development strategy. This involves testing (Z)-endoxifen in combination with Eli Lilly's abemaciclib (VERZENIO®), a CDK 4/6 inhibitor. The combination therapy arm, evaluating 40 mg (Z)-endoxifen with abemaciclib, had 41 patients initiated as of July 29, 2025. The overall combination study, conducted across the I-SPY network, is designed to enroll approximately 80 participants across two 40-participant cohorts. Data from these arms are anticipated beginning in 2026.

Specialized regulatory and legal consultants for accelerated FDA pathway

To potentially fast-track the regulatory path for (Z)-endoxifen, Atossa Therapeutics engaged an internationally recognized FDA law firm and senior regulatory affairs experts. These consultants reviewed the Company's extensive data and published scientific literature. The Company expected to receive FDA meeting minutes in December 2025 to evaluate the implications for their timelines, following constructive written feedback received in July 2025 supporting the proposed dose optimization trial in metastatic breast cancer.

Academic institutions for collaborative platform trials like I-SPY 2 and RECAST™ DCIS

Atossa Therapeutics relies heavily on academic and collaborative structures for its platform trials. The I-SPY 2 trial is managed in partnership with the Quantum Leap Healthcare Collaborative™ (QLHC). Furthermore, the RECAST™ DCIS platform trial is sponsored by QLHC, with research support from the NIH and other industry partners. This shared-infrastructure model helps accelerate enrollment and optimize capital efficiency. The monotherapy arm of the I-SPY 2 EOP, which included 20 women, showed that 65 percent achieved a Ki-67 $\le$ 10 percent response rate at Week 3. The RECAST™ trial aims to reshape the standard of care for Ductal Carcinoma In Situ (DCIS).

Here's a quick look at the key trial metrics and recent financial context:

Generative AI partners for drug combination discovery

Atossa Therapeutics continues to explore novel approaches for drug combination discovery. The Company has been involved in presenting research describing molecules synergistic with (Z)-endoxifen, though specific, named partnerships with Generative AI firms for combination discovery were not detailed in the latest public updates as of November 2025.

• FDA meeting minutes expected in December 2025.
• Targeting potential IND submission in Q4 2025 for the metastatic dose ranging study.
• The Q3 2025 Pretax Profit was -$8.692 Million.
• The I-SPY 2 combination study is planned to enroll approximately 80 participants.

Atossa Therapeutics, Inc. (ATOS) - Canvas Business Model: Key Activities

You're managing a clinical-stage biotech, so your key activities are all about de-risking the science and hitting regulatory milestones. For Atossa Therapeutics, Inc., this means intense focus on the (Z)-endoxifen program. The near-term goal is clearly the IND submission for the metastatic setting, which is driving a lot of the current operational spend.

Executing Phase 2 clinical trials for (Z)-endoxifen in multiple breast cancer settings

Atossa Therapeutics, Inc. is running concurrent Phase 2 studies to build a comprehensive data package for (Z)-endoxifen. The company is actively evaluating the drug in three Phase 2 studies: one in Ductal Carcinoma In Situ (DCIS) and two in ER+/HER2- breast cancer patients. Specifically, the EVANGELINE study, which targets premenopausal women with newly diagnosed early-stage ER+/HER2- breast cancer, was streamlined in October 2025. This amendment changed the design to a single-arm, open-label, non-registrational format, cutting the projected patient total from 214 down to 40-65 participants to accelerate readouts and reduce future costs. The I-SPY2 trial provided strong early signals; the low-dose monotherapy showed the median Ki-67 dropped from 10.5% to 5% by Week 3, and the MRI functional tumor volume decreased by 77.7%.

The increased clinical activity is reflected in the financials. For the three months ended September 30, 2025, clinical and non-clinical trial expenses rose by $1.8 million compared to the same period in 2024, driven by spend on (Z)-endoxifen trials and drug development costs. The operating loss for Q2 2025 was $9.0 million.

Here's a quick look at the clinical execution metrics:

Managing regulatory submissions, including the planned Q4 2025 IND filing for metastatic breast cancer

A major focus is managing the path to market for metastatic breast cancer. Atossa Therapeutics, Inc. is targeting an Investigational New Drug (IND) submission for the dose-optimization trial in metastatic breast cancer in the fourth quarter of 2025. This timeline was supported by highly constructive written feedback received from the U.S. Food and Drug Administration (FDA) in July 2025, which cleared the way for the filing. Importantly, the FDA indicated that no additional general toxicity or neurotoxicity studies are required for the monotherapy arm (Part A) of the study. The company also appointed Janet R. Rea as Senior Vice President of Research and Development to lead these late-stage clinical and regulatory programs. Topline data from the subsequent dose-ranging study is anticipated in 2026.

Developing and manufacturing the proprietary enteric oral formulation of the drug

The core of the development activity involves the proprietary enteric oral formulation of (Z)-endoxifen. Research and development (R&D) expenses are increasing due to these efforts; for the six months ended June 30, 2025, R&D expenses rose compared to 2024, driven by clinical spend and professional fees related to the (Z)-endoxifen program. The formulation itself is protected by specific patent claims focusing on purity and delivery. For instance, the Israeli patent granted in July 2025 covers oral delayed-release enteric dosage forms containing at least 90% Z-endoxifen by weight, with optional impurity limits of <2%.

Expanding and defending the global intellectual property portfolio (e.g., new US and Israeli patents)

Protecting the asset is paramount, and Atossa Therapeutics, Inc. has been actively expanding its intellectual property (IP) estate. As of mid-May 2025, three new U.S. patents were granted, which expanded the total patent claims related to (Z)-endoxifen formulations to more than 200 claims. One of these, U.S. Patent No. 12,281,056, specifically contains 58 claims covering enteric oral formulations. On the international front, an Israeli patent (No. 304863) was granted on July 2, 2025, covering manufacturing methods that enrich the Z-isomer and specific dosage forms. However, you should note that two existing patents (U.S. Patent Nos. 11,261,151 and 12,071,391) are currently subject to post-grant challenges.

Strategic planning to accelerate the regulatory path for breast cancer risk-reduction

Beyond the metastatic indication, Atossa Therapeutics, Inc. is strategically planning to accelerate the development timeline for low-dose (Z)-endoxifen in breast cancer risk reduction. In September 2025, the company formally requested a Type C meeting with the FDA to align on a regulatory strategy for this indication. The goal is to potentially shorten approval timelines by years and avoid tens of millions of dollars in clinical trial costs. The company had approximately $57.9 million in cash and no debt as of June 30, 2025, which supports this disciplined capital allocation toward value-creating milestones. You can expect an update on the viability of this accelerated path by the end of 2025.

• Requested FDA Type C meeting for risk reduction pathway in September 2025.
• Expects to share viability update on accelerated path by year-end 2025.
• Cash balance as of June 30, 2025, was $57.9 million.

Atossa Therapeutics, Inc. (ATOS) - Canvas Business Model: Key Resources

The Key Resources for Atossa Therapeutics, Inc. center on its proprietary drug candidate and the financial backing to advance it through clinical stages.

The lead drug candidate, (Z)-endoxifen, and its proprietary formulation is central. This is supported by a formulation designed to bypass stomach acid, which helps maintain the therapeutic integrity of the active (Z)-isomer. Over 700 subjects have received doses up to 360 mg/day without identifying a maximum tolerated dose (MTD) as of September 2025.

The financial foundation is anchored by the balance sheet. Atossa Therapeutics, Inc. reported a strong cash and cash equivalents balance of approximately $51,845 thousand, or $51.8 million, as of September 30, 2025.

Intellectual property provides a significant barrier to entry. The extensive global patent portfolio includes over 200 total claims protecting the molecule and its use. This protection is reinforced by four additional issued U.S. Patents as of November 2025, including U.S. Patent No. 12,275,684, which granted in April 2025 with 58 claims related to enteric oral formulations.

The clinical data generated from ongoing trials serve as a critical resource, validating the drug's biological activity. Atossa Therapeutics, Inc. is evaluating (Z)-endoxifen in multiple Phase 2 studies, including the EVANGELINE trial and the I-SPY 2 study.

Here are some key statistical readouts from the clinical data:

Regulatory progress is also a key asset, with the FDA providing positive feedback in July 2025, indicating no additional general toxicity or neurotoxicity studies are required for the metastatic breast cancer Investigational New Drug (IND) application, which is targeted for Q4 2025. Furthermore, the selection of PSI as the Contract Research Organization (CRO) in August 2025 operationalizes the planned pivotal dose-ranging study.

The experienced executive and clinical development team, led by Chairman and CEO Dr. Steven Quay, M.D., Ph.D., provides the necessary scientific and strategic leadership to manage these complex assets.

• (Z)-endoxifen is being evaluated in three Phase 2 studies, including one in Ductal Carcinoma In Situ (DCIS) and two in ER+/HER2- breast cancer.
• The company is concentrating resources on NDA-enabling activities planned for 2026.
• The company stated a choice not to utilize its At-The-Market (ATM) facility at recent share prices, citing undervaluation.

Atossa Therapeutics, Inc. (ATOS) - Canvas Business Model: Value Propositions

You're looking at the core reasons why a physician or patient would choose Atossa Therapeutics, Inc.'s (Z)-endoxifen over existing options. It all boils down to the molecule itself and how Atossa is delivering it.

Next-generation Selective Estrogen Receptor Modulator (SERM) with potential best-in-class efficacy

The value here is potency and mechanism. (Z)-endoxifen is a highly potent Selective Estrogen Receptor Modulator (SERM). It's designed to work even where other endocrine therapies have failed, showing activity in tumors that have developed resistance to older treatments. Plus, it hits a secondary target, protein kinase C beta 1 (PKCβ1), which is an oncogenic signaling protein, at levels achievable in the clinic. We see evidence of its potential efficacy from prior studies; for instance, in one trial, women with ER+/HER2- breast cancer who saw their Ki-67 levels drop below 10 percent after just two weeks of neoadjuvant therapy experienced a 5-year recurrence rate of only 8.4 percent, compared to 21.5 percent for those whose Ki-67 remained elevated. In that same study, median functional tumor volume decreased by 77.7 percent from baseline to surgery.

The comparison to established therapies is also key. Atossa's compound appears to offer bone-protective effects that are comparable to or even superior to those from tamoxifen.

Improved tolerability and safety profile compared to older endocrine therapies like Tamoxifen

Safety matters immensely for long-term treatment. Clinical studies have shown Atossa's (Z)-endoxifen to be well tolerated across both healthy women and those with breast cancer. Here's the quick math on safety tolerance: across over 700 subjects, doses as high as 360 mg/day have been given without identifying a maximum tolerated dose (MTD). That's a significant safety margin to explore further. In one reported safety assessment, adverse events were mostly Grade 1, with the most common being vasomotor symptoms (hot flushes) and fatigue.

Broad utility across the breast cancer spectrum: prevention to metastatic disease

(Z)-endoxifen isn't a one-trick pony; it's designed for a wide range of patient needs. Atossa is actively pursuing development across the entire spectrum: prevention, neoadjuvant, adjuvant, and metastatic settings. Right now, the compound is being evaluated in three Phase 2 trials. Specifically, there is one trial in ductal carcinoma in situ (DCIS) and two ongoing trials in ER+/HER2- breast cancer. Furthermore, the company is engaging the FDA on a regulatory strategy to potentially accelerate development for low-dose (Z)-endoxifen specifically for breast cancer risk reduction.

Optimized bioavailability via a proprietary enteric oral formulation

This is about making sure the drug gets where it needs to go effectively. Atossa developed a proprietary oral formulation that is enteric-coated, meaning it passes through stomach acid intact. This protects the active (Z)-isomer from converting into its inactive (E)-form. This delivery method is intended to provide optimal bioavailability and maintain the drug's therapeutic integrity. The speed of action is a differentiator too; direct oral (Z)-endoxifen can reach target concentrations within hours and typically achieves steady state in about one week in clinical studies. That's much faster than tamoxifen, which can take four weeks to reach plasma steady state. This innovation is protected by a strong IP portfolio, including U.S. Patent No. 12,281,056, which contains 58 claims covering these enteric oral formulations.

Addressing the high unmet need in ER+/HER2- metastatic breast cancer

The focus is sharp here because the need is urgent. Atossa is prioritizing (Z)-endoxifen for metastatic breast cancer, a space where new options are desperately needed. The company has received positive feedback from the FDA, which supports their proposed dose optimization trial for ER+/HER2- metastatic breast cancer, clearing the path for an Investigational New Drug (IND) application. Atossa is targeting an IND submission for this metastatic program in Q4 2025. The financial commitment reflects this focus; for the nine months ended September 30, 2025, Atossa reported a net loss of USD 23.83 million, up from USD 19.16 million in the prior year period, driven by increased R&D spend on trials like these.

Here's a quick look at the development focus:

• Currently being evaluated in three Phase 2 studies.
• Prioritizing development in metastatic breast cancer.
• Targeting IND submission for metastatic program in Q4 2025.
• Q3 2025 net loss was USD 8.69 million.

You need to see the details on the ongoing trials to fully grasp the scope of this value proposition.

The company's intellectual property portfolio supports this, including three recently issued U.S. patents supporting the (Z)-endoxifen program.

Atossa Therapeutics, Inc. (ATOS) - Canvas Business Model: Customer Relationships

Direct, high-stakes engagement with the U.S. Food and Drug Administration (FDA).

Atossa Therapeutics received highly constructive written feedback from the FDA in July 2025, supporting the proposed dose optimization trial for (Z)-endoxifen in ER+/HER2- metastatic breast cancer. This feedback affirmed key elements of the clinical development plan, including agreement that existing clinical and nonclinical data are sufficient to initiate the monotherapy arm (Part A) of the study, aligning with Project Optimus requirements. The Agency also confirmed that Atossa Therapeutics' cardiac safety assessment monitoring protocol is sufficient for the monotherapy portion of the trial, indicating no additional general toxicity or neurotoxicity studies are required. The Company is targeting an Investigational New Drug (IND) application submission in the fourth quarter of 2025. Furthermore, Atossa Therapeutics requested a Type C meeting with the FDA in September 2025 to discuss a regulatory strategy aimed at accelerating development of low-dose (Z)-endoxifen for breast cancer risk reduction, with an update on the outcome expected before year end 2025. This potential favorable outcome could shorten approval timelines by years and avoid tens of millions of dollars in clinical trial costs.

Close, collaborative relationships with clinical investigators and key opinion leaders.

Atossa Therapeutics maintains relationships with key figures guiding its clinical programs. Dr. Laura J. Esserman, MD, MBA, Professor of Surgery and Radiology at the University of California, San Francisco and Principal Investigator of RECAST™, was noted for speaking on the Company's collaborative work in the RECAST platform trial in October 2025. Other noted advisors include Dr. Peregrine Hall at the Karolinska Institute in Stockholm, Sweden, Dr. Matthew Galsky, MD, from the Mayo Clinic, who is the principal investigator of the EVANGELINE trial, and David Liu from Weill Cornell in New York City, studying triple negative breast cancer on Atossa Therapeutics' behalf. The compound (Z)-endoxifen is currently being evaluated in three Phase 2 studies: one in Ductal Carcinoma In Situ (DCIS) and two in ER+/HER2- breast cancer, including the EVANGELINE study and an I-SPY study.

Investor relations via quarterly reports and shareholder updates.

Atossa Therapeutics communicates progress to its investment community through regular disclosures. The Company announced it appointed CORE IR, a strategic investor relations firm, in September 2025 to enhance investor awareness and strengthen shareholder engagement. Atossa Therapeutics reported its Third Quarter 2025 financial results on November 12, 2025. As of June 30, 2025, Atossa Therapeutics had approximately $57.9 million in cash and no debt. As of November 17, 2025, the stock information showed a last price of $0.77, a trading volume of 7.4K, and a Market Capitalization of $99.9M. The Company stated it deliberately chose not to utilize its ATM facility at recent share price levels, which it believes significantly undervalue the true potential of the Company. Research and Development Expense Total increased by $3.3 million for the nine months ended September 30, 2025, compared to the same period in 2024, due to increases in spend related to (Z)-endoxifen trials.

Scientific community outreach through conference presentations (e.g., SABCS 2025).

Outreach to the scientific community is critical for validating the data package for (Z)-endoxifen. Atossa Therapeutics secured acceptance for four abstracts featuring data on (Z)-endoxifen for presentation at the San Antonio Breast Cancer Symposium (SABCS) in December 2025. These presentations cover findings across several studies:

• Initial results from RECAST DCIS platform trial.
• Low dose (Z)-endoxifen in the I-SPY2 Endocrine Optimization Pilot.
• Mechanistic data on (Z)-Endoxifen activity against ESR1 Mutants.
• The EVANGELINE randomized Phase 2 Non-Inferiority Trial.

The poster presentations were scheduled for December 11, 2025, and December 12, 2025, at the symposium held in San Antonio, TX.

Finance: draft 13-week cash view by Friday.

Atossa Therapeutics, Inc. (ATOS) - Canvas Business Model: Channels

You're looking at how Atossa Therapeutics, Inc. gets its drug candidates, primarily (Z)-endoxifen, from the lab bench to the prescribers and regulators. This is all about the pathways for testing, approval, and eventual market reach.

Clinical trial sites (hospitals and research centers) for drug testing and data generation

The clinical channel relies on a network of specialized medical institutions to execute the ongoing Phase 2 studies. The EVANGELINE Phase 2 study, for instance, involves a specific set of U.S. centers to gather data on (Z)-endoxifen in premenopausal women with early-stage ER+/HER2- breast cancer.

The participating U.S. centers for the EVANGELINE trial include:

• Mayo Clinic Rochester
• Mayo Clinic Arizona
• Mayo Clinic Florida
• Washington University School of Medicine
• St. Elizabeth Healthcare
• Bon Secours Cancer Institute
• Vanderbilt-Ingram Cancer Center
• Henry Ford Cancer Institute
• Fred Hutch
• Dana-Farber Cancer Institute
• Baylor University
• University of Arizona
• Northwestern University
• Avera Cancer Institute
• California Research Institute

The I-SPY 2 Endocrine Optimization Pilot, which provided data supporting the current regulatory path, involved 20 women with stage II/III ER+, HER2- breast cancer in its monotherapy arm. Atossa Therapeutics is currently advancing enrollment and data generation from these ongoing Phase 2 trials, with the EVANGELINE study now operating under an amended, non-registrational design as of October 2025.

Direct communication with the FDA for regulatory approval

Direct engagement with the U.S. Food and Drug Administration (FDA) is a critical channel for advancing (Z)-endoxifen toward market authorization. Atossa Therapeutics has been actively working with the agency to align on development strategies for both metastatic and risk-reduction indications.

Key FDA interactions and milestones as of late 2025 include:

• Received highly constructive written feedback from the FDA in July 2025 supporting the proposed dose optimization trial for metastatic breast cancer.
• The FDA agreed that existing clinical and nonclinical data are sufficient to initiate Part A (monotherapy) of the dose optimization study.
• The Agency indicated no additional general toxicity or neurotoxicity studies are required.
• The FDA confirmed the cardiac safety assessment monitoring protocol is sufficient for the monotherapy portion of the trial.
• Atossa is targeting an Investigational New Drug (IND) application submission in Q4 2025 for the metastatic program.
• In September 2025, Atossa requested a Type C meeting with the FDA to discuss accelerating the regulatory path for breast cancer risk reduction, with an update expected before year-end 2025.

The ability to fund this regulatory channel is supported by the Company's financial position; Atossa Therapeutics had approximately $57.9 million in cash and no debt as of June 30, 2025.

Scientific publications and medical conferences for data dissemination to prescribers

Disseminating clinical and mechanistic data through peer-reviewed channels and major medical meetings is essential for building prescriber confidence and establishing the scientific foundation for (Z)-endoxifen. This channel translates trial results into clinical awareness.

For the end of 2025, Atossa Therapeutics secured acceptance for four poster presentations at the San Antonio Breast Cancer Symposium (SABCS), held December 9-12, 2025. These presentations cover the RECAST DCIS trial, the I-SPY2 pilot, ESR1 mutant data, and the EVANGELINE trial. Specific poster presentation times include sessions on December 11, 2025 (12:30pm-2:00pm CT) and December 12, 2025 (7:00am-8:30am CT and 12:30pm-2:00pm CT). Furthermore, in November 2025, the Company highlighted an emerging opportunity following a peer-reviewed publication and scientific presentation.

Future pharmaceutical distribution network (post-commercialization)

While Atossa Therapeutics is currently focused on clinical development and regulatory submissions, the planning for post-approval distribution is implicitly tied to the market opportunity they are targeting. The Company is concentrating capital on data packages that can enable future regulatory submissions and potential commercialization.

The potential market size for the risk-reduction indication, where (Z)-endoxifen could compete with tamoxifen, is substantial. An estimated 1.6 to 2.1 million tamoxifen prescriptions are filled annually in the United States for breast cancer risk reduction settings.

Atossa Therapeutics, Inc. (ATOS) - Canvas Business Model: Customer Segments

You're looking at the specific patient populations Atossa Therapeutics, Inc. (ATOS) is targeting with its (Z)-endoxifen platform, which spans the entire breast cancer paradigm. This isn't just one group; it's several distinct, large markets where endocrine therapy is central.

The overall landscape is substantial. In 2025, an estimated 316,950 women are projected to be diagnosed with invasive breast cancer in the U.S.. Furthermore, roughly 70% of all breast cancers are estrogen receptor-positive (ER+), which is the primary focus for Atossa Therapeutics, Inc. (ATOS)'s molecule.

Here is a breakdown of the key patient groups Atossa Therapeutics, Inc. (ATOS) is pursuing:

• Women with newly diagnosed ER+/HER2- breast cancer (neoadjuvant/adjuvant).
• Women with metastatic breast cancer (mBC) who need novel endocrine therapy.
• Patients with Ductal Carcinoma In Situ (DCIS).
• High-risk women seeking breast cancer risk-reduction/prevention therapy.
• Oncologists and breast cancer specialists (the key prescribers).

The market for risk reduction and adjuvant therapy alone is large. As of January 1, 2025, approximately 4.3 million U.S. women are living with a history of breast cancer. Of those, about 1 million women are currently taking adjuvant endocrine therapy. For primary risk-reduction, 2010 NHIS data estimated roughly 120,000 U.S. women were using preventive SERM therapy. Atossa Therapeutics, Inc. (ATOS) sees a market opportunity for low-dose (Z)-endoxifen estimated at 1.6 to 2.1 million tamoxifen prescriptions filled annually across all risk-reduction settings.

For the DCIS segment, 59,080 new cases are estimated for 2025. DCIS alone is estimated to account for up to 80,000 women on therapy (SERMs or AIs) at any given time for risk-reduction post-surgery.

The metastatic setting also represents a significant need, with about 30,000 women diagnosed with metastatic disease in the U.S. each year.

The prescribers are a defined group. As of October 2025, the U.S. tracking shows more than 28,000 oncologists in total. The key prescribers for these endocrine therapies fall within the medical and hematology/oncology specialties, which together account for 11,937 and 4,778 physicians tracked, respectively.

Here's a quick look at the patient population scale Atossa Therapeutics, Inc. (ATOS) is targeting:

Atossa Therapeutics, Inc. (ATOS) is positioning (Z)-endoxifen to address this multi-billion dollar market opportunity across the ER+ spectrum. The company reported having approximately $57.9 million in cash and no debt as of June 30, 2025, supporting the execution against these segments.

Atossa Therapeutics, Inc. (ATOS) - Canvas Business Model: Cost Structure

You're looking at the core spending areas for Atossa Therapeutics, Inc. as they push their (Z)-endoxifen program forward. For a clinical-stage biotech, the cost structure is almost entirely driven by the science and the regulatory hurdles.

Research and Development (R&D) is the single largest cost driver. For the nine months ended September 30, 2025, total R&D expenses reached $15.0 million, representing a 40% increase compared to the same period in 2024. The overall operating expenses for the nine months ended September 30, 2025, were $25.7 million, up from $20.5 million in the prior year period.

The heavy investment in R&D is directly tied to advancing the lead candidate. Specifically, clinical and non-clinical trial expenses, which cover things like Contract Research Organization (CRO) fees and drug development costs, increased by $3.3 million for the nine months ended September 30, 2025, over the prior year. This increase reflects the spend related to the (Z)-endoxifen trials.

Here's a quick look at how the operating expenses broke down for the nine months ended September 30, 2025, compared to the prior year:

General and Administrative (G&A) expenses also saw an increase, totaling $10.7 million year-to-date September 30, 2025, which is a 9% rise. This covers the corporate overhead necessary to support the clinical operations.

Compensation expenses are a key component within both buckets. You can see the impact of headcount growth:

• R&D compensation expenses increased by $0.5 million for the nine months ended September 30, 2025, compared to the same period in 2024, directly tied to an increase in R&D headcount.
• G&A compensation expenses increased by $0.8 million for the nine months ended September 30, 2025, over the prior year, primarily due to increases in non-cash stock-based compensation expense of $0.6 million.

Costs for patent prosecution, maintenance, and defense fall under the broader G&A and professional fees line items, though specific figures for patent defense aren't separately itemized in the high-level reporting. However, R&D professional fees and other costs, which would include regulatory consulting fees related to the (Z)-endoxifen program, increased by $0.6 million for the nine months ended September 30, 2025, compared to 2024.

Finance: draft 13-week cash view by Friday.

Atossa Therapeutics, Inc. (ATOS) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Atossa Therapeutics, Inc. (ATOS) as of late 2025. Honestly, for a clinical-stage biopharma company, the current revenue picture is exactly what you'd expect: it's all about the balance sheet and pipeline progress, not product sales.

Zero revenue from product sales, consistent with being a clinical-stage company in 2025.

Atossa Therapeutics, Inc. is firmly in the pre-revenue phase. For the three months ended September 30, 2025 (Q3 2025), the company reported no revenue. This aligns perfectly with their status; they are advancing their lead candidate, (Z)-endoxifen, through clinical trials, not commercializing a product yet. The consensus revenue forecast for the fourth quarter of 2025 (2025Q4) is also $0.00. This means the current focus for funding operations is entirely on their existing cash reserves.

Minimal interest income generated from cash and investment balances.

While they aren't selling drugs, the cash they hold from previous financing activities does generate a small, non-operating income stream. This interest income is minimal, but it helps offset the operating burn a tiny bit. Here's a look at the recent figures:

The interest income has actually been declining, which is typical when a company is actively spending down its cash balance on R&D, as seen by the drop from $1.1 million in the prior year period to $0.7 million for the three months ended March 31, 2025. You see, the cash balance itself is shrinking as they fund the advancement of (Z)-endoxifen.

Future potential revenue from commercial sales of (Z)-endoxifen post-FDA approval.

This is the big one. The entire revenue model hinges on the successful commercialization of (Z)-endoxifen. The company is prioritizing the metastatic breast cancer indication, aiming for a potentially more streamlined regulatory path. They received positive FDA feedback in July 2025, which supports their path to filing an Investigational New Drug (IND) application in the fourth quarter of 2025 for this indication. If approved, revenue would shift to product sales, likely starting with the US market, as they are focusing on the FDA first.

The intellectual property underpinning this future revenue is quite robust, with Atossa Therapeutics holding over 200 patent claims related to (Z)-endoxifen formulations and their clinical applications, with patent protection extending until at least November 17, 2038.

Potential future milestone payments or royalties from out-licensing agreements.

While the primary focus is internal development, out-licensing is a classic revenue stream for clinical-stage biotechs, especially for drugs with broad potential like (Z)-endoxifen across different indications (metastatic, DCIS, risk reduction). The search results indicate Atossa is exploring potential collaborations to bolster its portfolio in oncology. Any out-licensing deal for ex-U.S. rights or specific indications would immediately inject non-dilutive capital via upfront payments and subsequent milestone payments or royalties on net sales. The current strategy involves advancing the metastatic program, and they expect to share more about the viability of an accelerated path for other indications by the end of 2025. These potential deals represent contingent revenue streams that would materialize upon achieving specific clinical or regulatory targets set with a partner.

• Potential for upfront payments upon signing a collaboration agreement.
• Earn-outs from milestone payments tied to clinical success (e.g., Phase 3 completion, NDA filing).
• Royalty streams on future net sales post-commercialization.

Finance: draft 13-week cash view by Friday.