Core Viewpoint - Atossa Therapeutics has received positive feedback from the FDA regarding its proposed dose optimization trial for (Z)-endoxifen, aimed at treating ER+/HER2- metastatic breast cancer, which is a significant milestone for the company [1][2][3] FDA Feedback and Clinical Development - The FDA's constructive responses affirm key elements of Atossa's clinical development plan, eliminating the need for a virtual pre-IND meeting and facilitating a potential IND submission by Q4 2025 [2][3] - The FDA supports Atossa's dose optimization strategy and agrees with the existing clinical and nonclinical data, allowing the initiation of Part A (monotherapy) of the proposed study [7] Strategic Momentum and Future Plans - Atossa is positioned to maintain strategic momentum and meet regulatory milestones, aiming to deliver (Z)-endoxifen to patients and enhance shareholder value [5] - The company plans to announce details regarding the target patient population, combination therapies, and overall trial design for the upcoming dose-ranging study in the coming weeks [7] Project Optimus and Dose Exploration - The FDA's Project Optimus initiative emphasizes data-driven dose exploration to maximize benefits and minimize toxicity, which aligns with Atossa's upcoming clinical study plans [6] - Atossa will explore multiple dose levels in its study to define the optimal dose for combination therapy while ensuring a balance between efficacy and patient safety [6] (Z)-Endoxifen Overview - (Z)-endoxifen is a potent Selective Estrogen Receptor Modulator (SERM) that inhibits and potentially degrades estrogen receptors, showing activity in tumors resistant to other therapies [8] - The compound is being developed in a proprietary oral formulation that is enteric-coated to ensure optimal bioavailability and therapeutic integrity [9] Clinical Trials and Intellectual Property - Atossa is prioritizing (Z)-endoxifen for metastatic breast cancer, currently evaluating it in three Phase 2 trials [10] - The program is supported by a growing global intellectual property portfolio, including recently issued U.S. patents and pending applications worldwide [10]

Core Viewpoint - Atossa Therapeutics has received positive feedback from the FDA regarding its proposed dose optimization trial for (Z)-endoxifen, aimed at treating ER+/HER2- metastatic breast cancer, which is a significant milestone for the company [1][2][3] FDA Feedback and Clinical Development - The FDA's constructive responses affirm key elements of Atossa's clinical development plan, eliminating the need for a virtual pre-IND meeting and facilitating a potential IND submission by Q4 2025 [2][3] - The FDA supports Atossa's dose optimization strategy and agrees with the existing nonclinical data package, enhancing confidence in the company's regulatory approach [3][7] Dose Optimization Strategy - The FDA has confirmed that existing clinical and nonclinical data are sufficient to initiate Part A (monotherapy) of the proposed dose optimization study, providing guidance on study design enhancements [7] - Atossa plans to explore multiple dose levels in its upcoming clinical study to define the optimal dose for combination therapy, aligning with the FDA's Project Optimus initiative [6][7] Combination Study Support - The FDA agrees with the scientific rationale for combining (Z)-endoxifen with standard-of-care therapies for breast cancer, which helps narrow the strategic approach for the potential IND [7] Cardiac Safety and Nonclinical Data - The FDA has confirmed that Atossa's cardiac safety assessment plan, including ECGs and QT interval monitoring, is sufficient for the monotherapy portion of the trial [7] - The existing nonclinical safety data package is deemed adequate, allowing Atossa to proceed without additional toxicity studies [7] Next Steps and Strategic Momentum - Atossa will announce plans for the target patient population, combination backbone, and overall trial design for the upcoming dose-ranging study in the coming weeks [7] - The company is positioned to maintain strategic momentum and meet regulatory milestones, aiming to deliver (Z)-endoxifen to patients and enhance shareholder value [5][10] About (Z)-Endoxifen - (Z)-endoxifen is a potent Selective Estrogen Receptor Modulator (SERM) that inhibits and potentially degrades estrogen receptors, showing activity in tumors resistant to other therapies [8][10] - Atossa is developing an oral formulation of (Z)-endoxifen that is enteric-coated to ensure optimal bioavailability and therapeutic integrity [9] Clinical Trials and Intellectual Property - Atossa is prioritizing (Z)-endoxifen for metastatic breast cancer, currently evaluating it in three Phase 2 trials [10] - The program is supported by a growing global intellectual property portfolio, including recently issued U.S. patents [10]

(Z)-endoxifen's Potential & Differentiation - (Z)-endoxifen is a novel, next-generation anti-estrogen with best-in-class potential across the breast cancer treatment paradigm[8] - (Z)-endoxifen is potentially a superior ER antagonist, being 100-fold more potent vs other SERMs, and demonstrates superior antitumor efficacy in preclinical and clinical studies[7] - (Z)-endoxifen inhibits clinically relevant ESR1 mutants, an acquired resistance mechanism to aromatase inhibitors[7] - (Z)-endoxifen has the potential to avoid current negative "on target off tissue" effects, potentially improving safety & tolerability and adherence[7] Clinical Trial Results & Regulatory Path - In a Phase II trial, CDK4/6 inhibitor-naïve patients had improved Progression-Free Survival (PFS) with (Z)-endoxifen compared to tamoxifen, with median PFS of 7.2 months versus 2.4 months, HR=0.42 (95% CI 0.22-0.80), Log rank test P=0.002[12] - The KARISMA trial showed a 17.3 percentage point reduction (p<0.01) in mammographic breast density with 1 mg of (Z)-endoxifen compared to a minimal change in the placebo group of 0.27 percentage points[13] - In an ongoing neoadjuvant clinical study, (Z)-endoxifen has demonstrated promising early efficacy with 1 CR and multiple PRs[14] Financials - The company's research and development expenses were $14.117 million in 2024, compared to $17.334 million in 2023[21] - The company's general and administrative expenses were $13.504 million in 2024, compared to $14.043 million in 2023[21] - The company's net loss was $(25.504) million in 2024, compared to $(30.094) million in 2023[21]

Atossa Therapeutics Conference Summary Company Overview - Atossa Therapeutics (NASDAQ: ATOS) focuses on breast cancer and oncology, addressing a multi-billion dollar opportunity in estrogen receptor positive breast cancer with its lead molecule, Z endoxifen [3][52]. Key Points and Arguments - **Market Opportunity**: Atossa is targeting a significant market in estrogen receptor positive breast cancer, with Z endoxifen showing potential from prevention to metastatic treatment [3][52]. - **Intellectual Property**: The company boasts a robust and growing intellectual property portfolio, with 92 patents held by the CEO, indicating strong future value for shareholders [4][52]. - **Financial Position**: Atossa is in a strong financial position, with over $65 million in cash as of March 31, providing approximately two years of operational runway and no debt [5][50][51]. - **Leadership Team**: The company has an experienced leadership team and advisory group, including experts from renowned institutions like the Mayo Clinic and UCSF [6][52]. Product Differentiation - **Z endoxifen's Unique Properties**: - It has superior estrogen receptor antagonism, which is crucial as 75% of breast cancers are driven by estrogen receptors [16][52]. - It triggers apoptosis, a unique mechanism that differentiates it from other endocrine therapies [10][18][52]. - Improved adherence due to a favorable side effect profile compared to existing treatments like tamoxifen and aromatase inhibitors [11][20][52]. Clinical Insights - **Unmet Needs**: Approximately 40-50% of patients stop taking current treatments due to adverse events, highlighting the need for better-tolerated therapies [7][8][52]. - **Efficacy Data**: Clinical trials have shown significant reductions in tumor size and improved patient outcomes with Z endoxifen compared to traditional therapies [33][45][52]. - **Combination Therapies**: Ongoing research indicates that Z endoxifen may work synergistically with CDK4/6 inhibitors, enhancing treatment efficacy [21][36][52]. Regulatory Strategy - **FDA Engagement**: Atossa is actively engaging with the FDA to expedite the approval process for Z endoxifen, focusing on the metastatic setting as the first target for approval [29][48][52]. - **Upcoming Trials**: The company aims to initiate its first patient in an FDA-approved registration trial by the end of 2025, with ongoing trials in prevention and neoadjuvant settings [50][52]. Conclusion - Atossa Therapeutics is positioned strongly within the breast cancer treatment landscape, with a promising drug candidate, a solid financial foundation, and a strategic approach to regulatory approval and market entry [52].

Summary of Atosa Therapeutics Webinar Company Overview - **Company**: Atosa Therapeutics - **Ticker**: ATOS (NASDAQ) - **Market Focus**: Estrogen receptor positive breast cancer, addressing a multibillion dollar market opportunity [5][39] Key Points and Arguments Product Development - **Drug**: Z endoxifen, a prodrug of tamoxifen, is being developed for various stages of breast cancer treatment including prevention, neoadjuvant, adjuvant, and metastatic settings [5][11][39] - **Market Potential**: The market for estrogen receptor positive breast cancer is projected to reach $42 billion by 2030 [25] - **Clinical Utility**: Z endoxifen shows broad clinical utility and aims to address significant unmet needs in breast cancer treatment, particularly in improving efficacy and reducing resistance to therapy [8][9][39] Clinical Insights - **Efficacy**: Approximately 50% of patients discontinue adjuvant endocrine therapy due to side effects, and nearly 60% do not respond to second-line therapies [8][9] - **Unique Mechanism**: Z endoxifen not only blocks estrogen receptor binding but also induces apoptosis, which is a critical mechanism lacking in current therapies [10][15] - **Resistance**: Z endoxifen remains effective even in cases of estrogen receptor mutations, which occur in over 50% of long-term endocrine therapy patients [16][17] Safety and Tolerability - **Adverse Events**: Z endoxifen has a low adverse event profile, enhancing patient adherence to treatment [18][32] - **Combination Therapy**: The drug is positioned as a promising backbone for combination therapies, showing compatibility with existing treatments [19][30] Regulatory Strategy - **FDA Approval Pathway**: The company is prioritizing the metastatic setting for FDA approval, which is expected to provide the fastest path to market [24][36] - **Ongoing Discussions**: Atosa is actively engaging with the FDA to align on registrational endpoints and accelerated approval pathways [47] Financial Position - **Cash Reserves**: Atosa has approximately $65 million in cash with nearly two years of runway and zero debt [37][39] - **Market Capitalization**: As of May, the company's market cap was $140 million, with a stock price of $1.06 [39] Additional Important Information - **Intellectual Property**: Atosa has a robust and growing IP portfolio providing protection in the US and globally [6][39] - **Leadership Team**: The company boasts an experienced leadership team with a history of successful drug development [6][40] - **Clinical Trials**: Ongoing trials include the EVANGELINE trial for grade one and two estrogen receptor breast cancers in the neoadjuvant setting [32][34] Conclusion Atosa Therapeutics is positioned to make significant advancements in the treatment of estrogen receptor positive breast cancer with its lead product Z endoxifen, backed by a strong financial position and a clear regulatory strategy aimed at addressing a substantial market need.

Core Insights - Atossa Therapeutics has reported promising results from the Phase 2 Endocrine Optimization Pilot sub-study, demonstrating the bioactivity of low-dose (Z)-endoxifen in treating stage II/III ER+/HER2- breast cancer [1][4] Group 1: Study Results - No participants achieved a pathologic complete response (pCR), with residual cancer burden (RCB) classes indicating moderate to extensive disease [3] - The study showed a median Ki-67 suppression from 10.5% at baseline to 5% by Week 3, with 65% of patients achieving Ki-67 ≤ 10% [6] - Median functional tumor volume decreased by 77.7% from baseline to surgery, with the longest tumor diameter reduced by 36.8% [6] Group 2: Drug Profile - (Z)-endoxifen is a potent Selective Estrogen Receptor Modulator (SERM) that can inhibit and potentially degrade estrogen receptors, showing activity in resistant tumors [5] - The drug targets PKCβ1, an oncogenic signaling protein, at clinically achievable blood levels, and offers comparable or superior bone protection compared to tamoxifen [5] Group 3: Future Directions - Atossa is enrolling participants in an additional I-SPY2 cohort testing (Z)-endoxifen at a 40 mg daily dose, with top-line data expected in 2026 [4] - The company is focused on developing (Z)-endoxifen for metastatic breast cancer, supported by a growing intellectual property portfolio [8]

Drug Development - The company is developing (Z)-endoxifen for breast cancer treatment, with a focus on metastatic breast cancer, aiming for a streamlined regulatory pathway[85] - The FDA has authorized the Investigational New Drug (IND) application for (Z)-endoxifen, with a Phase 2 study enrolling approximately 190 patients planned[98] - The ongoing Phase 2 DCIS study aims to evaluate (Z)-endoxifen's suitability for long-term active surveillance in women with ductal carcinoma in situ, with approximately 100 patients expected to be treated[96] - The treatment cohort for the neoadjuvant study of (Z)-endoxifen was initiated in April 2025, comparing it to exemestane plus OFS[100] - The company plans to conduct additional studies to assess (Z)-endoxifen's correlation with breast cancer risk reduction, as advised by the FDA[94] - (Z)-endoxifen achieved a primary endpoint with 95% of patients receiving over 75% of planned treatment, showing a 69% reduction in Ki-67 and a 30.4% reduction in functional tumor volume after three weeks[102] - The company has completed four Phase 1 and two Phase 2 clinical studies for (Z)-endoxifen, demonstrating its potential in treating breast cancer and reducing breast density[89] Financial Performance - Total operating expenses increased to $7.4 million for the three months ended March 31, 2025, up from $7.0 million in the same period in 2024, reflecting a $0.4 million increase[110] - Research and Development (R&D) expenses totaled $4.2 million for the three months ended March 31, 2025, an 11% increase from $3.7 million in 2024[111] - Compensation expenses within R&D rose by 41% to $0.9 million, while professional fees increased by 123% to $0.5 million for the same period[111] - Interest income decreased to $0.7 million for the three months ended March 31, 2025, down from $1.1 million in 2024, due to a lower balance in the money market account[112] - Net cash used in operating activities was $5.96 million for the three months ended March 31, 2025, compared to $4.70 million in 2024, reflecting a $1.3 million increase[115] - As of March 31, 2025, the company had $65.1 million in cash and cash equivalents, sufficient to fund projected operating requirements for at least the next 12 months[115] - The company has an estimated non-cancellable commitment of $9.4 million for clinical trial service providers as of March 31, 2025[122] - The company is not currently generating revenue and does not anticipate doing so until pharmaceutical programs are developed and launched[104] Intellectual Property - The company has been granted six U.S. and ten international patents for (Z)-endoxifen, with protection extending through at least November 17, 2038[83] Corporate Strategy - The company aims to opportunistically add programs in areas of high unmet medical need through acquisition or collaboration[84] - The company is focused on advancing its clinical studies and successfully commercializing new therapeutics[82] Compliance and Regulatory Issues - The company received a letter from Nasdaq regarding non-compliance with the minimum bid price requirement, with a deadline to regain compliance by August 20, 2025[121]

Core Viewpoint - Atossa Therapeutics has been granted a new patent for (Z)-endoxifen formulations, enhancing its intellectual property portfolio and supporting its mission to advance breast cancer treatment [1][2][3] Group 1: Patent and Intellectual Property - The newly granted patent (U.S. Patent No. 12,281,056) includes 58 claims related to (Z)-endoxifen formulations, focusing on purity, stability, and therapeutic methods [2] - Atossa's patent estate now encompasses over 200 claims related to (Z)-endoxifen formulations and their clinical applications, reinforcing the company's leadership in targeted therapies for hormone receptor-positive breast cancer [3] Group 2: Product Development and Efficacy - (Z)-endoxifen is a potent Selective Estrogen Receptor Modulator (SERM) that may cause estrogen receptor degradation and has shown efficacy in patients resistant to other hormonal treatments [4] - The company is developing an oral formulation of (Z)-endoxifen designed to bypass the stomach, which converts a significant portion of the drug to an inactive form [5] - Clinical studies indicate that (Z)-endoxifen is well tolerated in women with and without breast cancer, and it is being studied for both treatment and prevention of breast cancer, including a program for metastatic breast cancer [5] Group 3: Company Mission and Vision - Atossa is dedicated to transforming breast cancer treatment through innovative science and patient-focused solutions, aiming to improve the lives of millions of women while generating substantial value for shareholders [3][6]

Core Viewpoint - Atossa Therapeutics has been granted a new patent for enteric oral formulations of (Z)-endoxifen, enhancing its intellectual property portfolio and supporting its mission to develop innovative treatments for breast cancer [1][2][3]. Intellectual Property - The newly granted U.S. Patent No. 12,275,684 covers enteric oral formulations of (Z)-endoxifen and methods for treating hormone-dependent breast and reproductive tract disorders [2]. - Atossa's patent estate now includes multiple U.S. patents with over 100 claims related to (Z)-endoxifen formulations and their clinical applications, reinforcing the company's leadership in targeted therapies for hormone receptor-positive breast cancer [3]. Product Development - (Z)-endoxifen is a potent Selective Estrogen Receptor Modulator (SERM) that may cause estrogen receptor degradation and has shown efficacy in patients resistant to other hormonal treatments [4]. - Atossa is developing a proprietary oral formulation of (Z)-endoxifen designed to bypass the stomach, as acidic conditions convert a significant portion of (Z)-endoxifen to the inactive (E)-endoxifen [5]. - Clinical studies indicate that (Z)-endoxifen is well tolerated in women with and without breast cancer, and it is currently being studied for both treatment and prevention of breast cancer, including a program in metastatic breast cancer [5]. Company Overview - Atossa Therapeutics is a clinical-stage biopharmaceutical company focused on transforming breast cancer treatment through innovative science and patient-centered solutions [6]. - The company's lead product candidate, (Z)-endoxifen, is designed for use across the breast cancer spectrum, including prevention, neoadjuvant, adjuvant, and metastatic settings [6].

Atossa Genetics Inc. (ATOS) could be a solid choice for investors given its recent upgrade to a Zacks Rank #2 (Buy). This rating change essentially reflects an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices.A company's changing earnings picture is at the core of the Zacks rating. The system tracks the Zacks Consensus Estimate -- the consensus measure of EPS estimates from the sell-side analysts covering the stock -- for the current and following years.The power ...