Core Insights - Atossa Therapeutics is advancing its development of (Z)-endoxifen for breast cancer, with plans for an Investigational New Drug (IND) submission and a focus on commercialization by 2026 [1][2][3] Clinical & Regulatory Developments - The company has requested a Type C meeting with the FDA to discuss regulatory strategies for (Z)-endoxifen aimed at accelerating its development for breast cancer risk reduction [3] - Atossa has streamlined its Phase 2 EVANGELINE study to prioritize activities that could enable a New Drug Application (NDA) in 2026 [3] - Janet R. Rea has been appointed as Senior Vice President of R&D to oversee (Z)-endoxifen programs, while Mark Daniel has been named CFO to lead financial strategies [3] - PSI has been selected as the Contract Research Organization (CRO) for a pivotal dose-ranging study of (Z)-endoxifen in metastatic breast cancer [3] Financial Performance - Total operating expenses for Q3 2025 were $9.3 million, an increase from $6.4 million in Q3 2024, with R&D expenses rising significantly due to increased trial activities [6][7] - Research and development expenses for the three months ended September 30, 2025, were $5.4 million, up 57% from $3.4 million in the same period in 2024 [7] - General and administrative expenses also increased to $3.9 million for Q3 2025, compared to $3.0 million in Q3 2024, primarily due to higher professional fees [9] Intellectual Property & Patent Portfolio - Atossa has made progress in its global intellectual property strategy, including the issuance of an Israeli patent for (Z)-endoxifen [8] - The company is currently facing post-grant challenges on two patents but remains confident in defending its intellectual property [8] Strategic Outlook & Upcoming Milestones - Atossa is focused on executing its breast cancer development strategy, with key upcoming deliverables including the IND submission and ongoing Phase 2 trials [6][13] - The company aims to provide updates on its regulatory path and milestones by the end of 2025 [13]

Core Insights - Olema Pharmaceuticals is set to present a trial-in-progress poster for the Phase 3 OPERA-02 trial at the 2025 San Antonio Breast Cancer Symposium, focusing on the combination of palazestrant and ribociclib for treating advanced ER+/HER2- breast cancer [1][2] Company Overview - Olema Oncology is a clinical-stage biopharmaceutical company dedicated to improving treatment standards and outcomes for breast cancer patients, with a focus on developing targeted therapies [3] - The company is advancing a pipeline that includes palazestrant (OP-1250), an orally available complete estrogen receptor antagonist and selective estrogen receptor degrader, currently in two Phase 3 clinical trials [3][4] Product Details - Palazestrant (OP-1250) is being investigated for its efficacy in recurrent, locally advanced, or metastatic ER+/HER2- breast cancer, demonstrating complete blockage of ER-driven transcriptional activity and anti-tumor efficacy [4] - The product has received FDA Fast Track designation for treating ER+/HER2- metastatic breast cancer that has progressed after endocrine therapy, with ongoing evaluations in pivotal Phase 3 trials OPERA-01 and OPERA-02 [4]

Core Insights - Processa Pharmaceuticals Inc. (NASDAQ:PCSA) shares experienced a significant increase of 37.5% to $0.50 in after-hours trading, following a 29.03% gain during the regular session, closing at $0.36 [1] - Despite the recent surge, the company has faced challenges, with shares down 71.43% over the past year and 59.09% year to date, although there has been a 50% gain over the last six months [2] Clinical Development - Processa Pharmaceuticals is conducting a Phase 2 clinical trial for next-generation capecitabine (NGC-Cap) as a treatment for advanced or metastatic breast cancer, with the first patient treated in October 2024 [3] - The trial is a global, multicenter study comparing two doses of NGC-Cap with the FDA-approved drug capecitabine, involving 60 to 90 patients [3] - Interim analysis results are expected to be announced in mid-2025, as stated by David Young, President of Research and Development [4] Market Context - Breast cancer represents a significant market opportunity, with over 2 million cases diagnosed globally in 2022 and a five-year survival rate of approximately 30% for metastatic cases [6] - For the second quarter, Processa reported a loss of $0.25 per share, which was wider than the expected loss of $0.23, and the company generated no revenue during that quarter [6] - The third-quarter earnings report is scheduled for October 29 [6] Stock Performance - Over the past year, PCSA shares have traded between $0.15 and $1.50, with an average daily trading volume of 3.95 million shares and a market capitalization of $18.06 million [7] - Current trends indicate that PCSA is experiencing long-term consolidation according to Benzinga's Edge Stock Rankings [7]

Core Insights - Eli Lilly and Company (LLY) received marketing authorization from the European Commission for Kisunla (donanemab) to treat early symptomatic Alzheimer's disease (AD) [1][7] - Kisunla is approved for adults with mild cognitive impairment (MCI) and mild dementia stage of AD with confirmed amyloid pathology [1][9] - The approval is supported by data from two late-stage studies, TRAILBLAZER-ALZ 2 and TRAILBLAZER-ALZ 6, demonstrating significant slowing of cognitive and functional decline [2][9] Company Performance - Year to date, Eli Lilly's shares have declined by 7.4%, while the industry has seen a decrease of only 0.5% [4] Market Context - Kisunla is part of a competitive landscape in the AD treatment space, alongside Biogen/Eisai's Leqembi, which also targets early symptomatic AD [8][9] - Both drugs aim to reduce amyloid beta (Aβ) plaque accumulation, a key factor in cognitive decline associated with AD [9][10] - Kisunla has shown rapid uptake, recording sales of $70.1 million in the first half of 2025 [10]

Core Insights - Atossa Therapeutics is advancing (Z)-endoxifen into a pivotal Phase 2 dose-ranging study for metastatic breast cancer, with regulatory input from the FDA and an IND filing expected in Q4 2025, aiming for topline results in 2026 [1][3][4] Study Design and Execution - The global Phase 2 study will evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of (Z)-endoxifen monotherapy [3][4] - PSI has been selected as the contract research organization to manage the study, recognized for its efficiency in oncology trials, with 93% of its studies enrolling on time in 2024 [4][5][6] Market Opportunity - Approximately 5.6% of newly diagnosed invasive breast cancers in the U.S. are metastatic, equating to about 13,000 women annually, with an estimated 170,000 women currently living with metastatic breast cancer [7] - Current therapies often fail due to resistance, creating a significant market opportunity for (Z)-endoxifen as a potential first-in-class therapy in this multi-billion-dollar market [7] Pipeline Development - In addition to the metastatic trial, Atossa is advancing other Phase 2 studies, including (Z)-endoxifen monotherapy in early-stage breast cancer and combination therapy with abemaciclib [8] Product Profile - (Z)-endoxifen is a potent Selective Estrogen Receptor Modulator/Degrader (SERM/D) with dual mechanisms of action, showing potential for superior bone protection and a favorable safety profile compared to tamoxifen [9][10] - The proprietary formulation of (Z)-endoxifen is designed to enhance bioavailability and overcome limitations of previous formulations [10]

Core Insights - Atossa Therapeutics has received positive feedback from the FDA regarding its (Z)-endoxifen program for metastatic breast cancer, indicating no additional toxicity studies are required and supporting the company's planned IND submission [3][4][6] - The company reported strong results from the I-SPY2 trial, demonstrating the efficacy of (Z)-endoxifen as a monotherapy, with significant reductions in Ki-67 levels, a key biomarker for cancer cell proliferation [4][11] - Atossa is strategically focused on advancing its clinical programs while maintaining a strong balance sheet, avoiding the use of its ATM facility at current undervalued share prices [2][6] Clinical & Regulatory Developments - The FDA's feedback supports Atossa's proposed dose optimization trial in ER+/HER2- metastatic breast cancer, allowing the initiation of the monotherapy arm and combination therapy arms [3] - Atossa plans to file an IND application in Q4 2025, aligning with FDA's Project Optimus initiative [3][6] Clinical Trial Readouts & Scientific Validation - In the I-SPY2 trial, 95% of subjects completed at least 75% of planned dosing, with a median Ki-67 reduction from 10.5% to 5% by Week 3 [4] - The median functional tumor volume decreased by 77.7% from baseline to surgery, indicating significant tumor response [4] Financial Overview - Total operating expenses for Q2 2025 were $9.0 million, an increase from $7.1 million in Q2 2024, driven by higher R&D costs related to (Z)-endoxifen trials [6][20] - Research and development expenses rose to $5.5 million for Q2 2025, up from $3.6 million in Q2 2024, reflecting increased spending on clinical trials [7][20] Intellectual Property & Patent Portfolio - Atossa holds a robust intellectual property portfolio, including recent patents related to (Z)-endoxifen formulations, which provide substantial protection for its lead program [15] - The company is currently facing post-grant challenges on two patents but remains confident in defending its intellectual property [7][15] Strategic Outlook & Upcoming Milestones - Key upcoming milestones include the IND submission for (Z)-endoxifen and advancing enrollment in ongoing Phase 2 trials [6][15] - Atossa is also exploring regulatory strategies for additional breast cancer indications beyond metastatic cases [6][15]

Core Insights - Novartis anticipates Kisqali to become a blockbuster drug, shifting focus from Entresto [1] - Kisqali sales increased by 64% globally in Q2, with 100% growth in the U.S. [1] - The company reported a 56% increase in Kisqali sales in Q1 [2] Industry Trends - Global breast cancer diagnoses and deaths are expected to rise significantly by 2050, with 1 in 20 women projected to be diagnosed [2] - This could lead to 3.2 million new cases and 1.1 million deaths annually by 2050, compared to 2.3 million new cases and 670,000 deaths in 2022 [3] Company Pipeline - Novartis has a strong pipeline with other potential blockbusters like Pluvicto for prostate cancer and Scemblix for chronic myeloid leukemia [3] - The company is focused on driving performance for Kisqali, Pluvicto, and Scemblix, indicating a strategy to replace reliance on older therapies [3]

(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]

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]

Core Insights - Atossa Therapeutics is advancing (Z)-endoxifen as a next-generation therapy for metastatic breast cancer, emphasizing its potential to address unmet medical needs in this area [3][11] - The company has enhanced its intellectual property portfolio with three new U.S. patents, bringing the total to over 200 patent claims related to (Z)-endoxifen [1][6] - Atossa ended Q1 2025 with $65.1 million in cash and cash equivalents, maintaining a debt-free status [1] Financial Performance - For Q1 2025, Atossa reported total operating expenses of $7.4 million, an increase of $0.4 million from $7.0 million in Q1 2024 [5][14] - Research and Development (R&D) expenses totaled $4.2 million for Q1 2025, up from $3.7 million in Q1 2024, reflecting an increase of 11% [7][10] - General and Administrative (G&A) expenses were $3.3 million for Q1 2025, slightly up from $3.2 million in Q1 2024, indicating a 1% increase [8][14] Research and Development Focus - Atossa is prioritizing (Z)-endoxifen for metastatic breast cancer, with ongoing clinical trials demonstrating strong tolerability and therapeutic versatility [3][11] - The company is currently evaluating (Z)-endoxifen in three Phase 2 trials targeting different breast cancer types, including ductal carcinoma in situ and estrogen receptor-positive breast cancer [11][12] - The recent patent grants cover various formulations and applications of (Z)-endoxifen, enhancing its market position [6][9] Market Position and Strategy - The strategic focus on metastatic breast cancer reflects Atossa's commitment to addressing significant treatment gaps and the potential for a streamlined regulatory pathway [6][11] - (Z)-endoxifen is positioned as a potentially safer and more effective endocrine therapy, with advantages over current standard-of-care treatments [9][12] - The company aims to unlock the full potential of (Z)-endoxifen while delivering value to shareholders through its robust intellectual property and clinical research programs [3][12]