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]

Core Insights - Roche, in collaboration with the Breast International Group (BIG) and other partners, announced significant overall survival results from the phase III APHINITY study for HER2-positive early-stage breast cancer, showing a 17% reduction in the risk of death after ten years for patients treated with a Perjeta-based regimen compared to those receiving Herceptin and chemotherapy [1][2][6]. Study Results - The APHINITY study demonstrated that 91.6% of patients treated with the Perjeta-based regimen were alive at ten years, compared to 89.8% for the control group, with a hazard ratio of 0.83 [6]. - A 21% reduction in the risk of death was observed in the subgroup of patients with lymph node-positive disease, with a hazard ratio of 0.79 [6][5]. - The previously reported invasive disease-free survival benefit was maintained, reinforcing earlier analyses [6][5]. Treatment Implications - The results validate the Perjeta-based regimen as a standard-of-care treatment for high-risk HER2-positive breast cancer patients, particularly those with lymph node-positive disease [2][4]. - Roche's commitment to improving outcomes for HER2-positive breast cancer patients is evident through the development of targeted therapies like Herceptin and Perjeta, which have transformed survival rates [11][10]. Future Presentations - Full results from the APHINITY study will be presented as a late-breaking abstract at the 2025 European Society for Medical Oncology Breast Cancer Congress [3].

Core Insights - Roche, in collaboration with Breast International Group (BIG) and other partners, announced significant overall survival results from the phase III APHINITY study for HER2-positive early-stage breast cancer, showing a 17% reduction in the risk of death after ten years for patients treated with a Perjeta-based regimen compared to standard treatment [1][5][6] Group 1: Study Results - The APHINITY study demonstrated that after ten years, 91.6% of patients treated with the Perjeta-based regimen were alive, compared to 89.8% of those receiving standard treatment, with a hazard ratio of 0.83 [6] - A 21% reduction in the risk of death was observed in the subgroup of patients with lymph node-positive disease, with a hazard ratio of 0.79 [6] - The previously reported invasive disease-free survival benefit was maintained, reinforcing earlier analyses [6] Group 2: Treatment Implications - The results validate the Perjeta-based regimen as a standard-of-care treatment for early-stage HER2-positive breast cancer, particularly for high-risk patients [1][3] - Roche's commitment to improving outcomes for HER2-positive breast cancer patients is evident through the development of targeted therapies like Herceptin and Perjeta, which have transformed survival rates [8][9] Group 3: Future Directions - Full results from the APHINITY study will be presented at the 2025 European Society for Medical Oncology Breast Cancer Congress, indicating ongoing research and collaboration in the field [2][5] - The collaborative efforts in the APHINITY study have led to pivotal trials that continue to enhance understanding and treatment of HER2-positive breast cancer [3][4]

Core Insights - Er-Kim has signed an agreement with Puma Biotechnology to commercialize NERLYNX in select Eastern European and Central Asian countries [1][2] - NERLYNX is a treatment for HER2-positive breast cancer, approved for both early-stage and metastatic cases [3][7] - Breast cancer is the most common cancer among women globally, with 2.3 million new cases and 670,000 deaths reported in 2022 [4] Company Overview - Er-Kim, established in 1981, partners with over 40 global leaders and has revenues exceeding EUR 260 million, reaching over 600 million patients [6] - Puma Biotechnology focuses on developing innovative cancer care products and has successfully commercialized NERLYNX since its FDA approval in 2017 [7] Market Context - The agreement aims to improve access to NERLYNX in Russia and the Commonwealth of Independent States, addressing the disparity in treatment availability for breast cancer [5] - The burden of breast cancer varies significantly across different regions, highlighting the need for targeted treatment solutions [4][5]

Basel, 30 April 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending an update to the European Union (EU) label for Phesgo®, a subcutaneous (SC) fixed-dose combination of Perjeta® (pertuzumab) and Herceptin® (trastuzumab), for human epidermal growth factor receptor 2 (HER2)-positive breast cancer. If approved, administration of Phesgo outside of a clinical setting (such ...

Core Viewpoint - Roche's Phesgo® has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for an update to its EU label, allowing for at-home administration by healthcare professionals for HER2-positive breast cancer treatment, pending final approval from the European Commission [1][3]. Group 1: Product and Treatment Impact - Phesgo is a subcutaneous fixed-dose combination of Perjeta® (pertuzumab) and Herceptin® (trastuzumab) for treating HER2-positive breast cancer, already approved in over 120 countries [4][5]. - The treatment can reduce administration costs by up to 80% in Western Europe, with 85% of patients preferring subcutaneous (SC) administration over intravenous (IV) [4][7]. - At-home treatment aligns with patient preferences, as 91% favor this method over in-clinic administration, potentially improving quality of life and reducing healthcare system burdens [3][7]. Group 2: Socioeconomic Burden and Future Projections - The socioeconomic burden of HER2-positive breast cancer in ten major economies was nearly $590 billion from 2017 to 2023, projected to rise to nearly $1,000 billion by 2032 [3]. - Roche's HER2-positive breast cancer medicines contributed a cumulative $8.2 billion to economic growth across ten major economies between 2017 and 2023 [9]. Group 3: Clinical Evidence and Safety - The CHMP's positive opinion is supported by clinical, real-world, and bioequivalence data, demonstrating the feasibility and safety of Phesgo's at-home administration [3][7]. - Clinical studies indicate that Phesgo can be administered in approximately eight minutes, significantly faster than standard IV administration, which can take hours [6].

Breast cancer cryoablation was a major focus at ECIO 2025 with a dedicated scientific session Independent studies of ProSense® featured in scientific sessions and abstracts including data from the THERMAC trial stating 95% of patients said they would choose thermal ablation over breast conserving surgery In-booth expert exchange session on breast cancer cryoablation from the perspective of both breast surgeons and interventional oncologists by Sophie Wooldrik, MD & Prof. Tomas Vogl, MD respectively Three h ...

Financial Performance - Atossa Therapeutics ended 2024 with $71.1 million in cash and cash equivalents and no debt [1] - Total operating expenses decreased to $27.6 million in 2024 from $31.4 million in 2023, a reduction of $3.8 million [7] - The net loss for 2024 was $25.5 million, compared to a net loss of $30.1 million in 2023, indicating an improvement in financial performance [21] Research and Development - Atossa plans to advance its lead program, (Z)-endoxifen, targeting metastatic breast cancer, which is seen as a critical unmet need [3][5] - The Phase 2 EVANGELINE trial showed substantial tumor suppression with (Z)-endoxifen, achieving a 4-week Ki-67 ≤ 10 percent response rate above 85% across dosing levels [5] - The Phase 2 KARISMA-Endoxifen study demonstrated that a 1 mg dose of (Z)-endoxifen reduced mammographic breast density by 17.3 percentage points, while a 2 mg dose achieved a 23.5 percentage-point reduction [5] Strategic Focus - The company is pursuing an initial approval for (Z)-endoxifen in metastatic breast cancer to expedite availability for patients [3][5] - Atossa is also engaging with the FDA to explore additional indications for (Z)-endoxifen, including breast cancer prevention and neoadjuvant therapy [5] Operating Expenses Breakdown - Research and development expenses totaled $14.1 million in 2024, down from $17.3 million in 2023, primarily due to decreased spending on (Z)-endoxifen trials [8] - General and administrative expenses decreased to $13.5 million in 2024 from $14.0 million in 2023, with a notable reduction in compensation expenses [10][11] Cash Flow and Investments - Interest income for 2024 was $4.1 million, a decrease of $0.2 million from the previous year, attributed to reduced funds in the money market account [12] - The company recorded an impairment charge on investment in equity securities of $1.7 million in 2024, down from $3.0 million in 2023 [12]

Cardiff Oncology (CRDF) Q4 2024 Earnings Call February 27, 2025 04:30 PM ET Company Participants Kiki Patel - PrincipalMark Erlander - CEOJames Levine - Chief Financial OfficerAlexander Kelly - Biotech Equity Research Associate Conference Call Participants Joseph Catanzaro - Director & Senior Equity AnalystAndy Hsieh - Research AnalystRobert Burns - MD & Senior Healthcare AnalystAlbert Lowe - Senior Research Analyst Operator Welcome to the Cardiff Oncology Fourth Quarter twenty twenty four Financial Results ...