Core Insights - The article highlights the background and expertise of Brendan, who has a strong foundation in organic synthesis and experience in both pharmaceutical and biotech sectors [1] Group 1: Background and Experience - Brendan completed a Ph.D. at Stanford University in organic synthesis in 2009 [1] - He worked for Merck, a major pharmaceutical company, from 2009 to 2013 [1] - Brendan has experience in biotech startups, including Theravance and Aspira, before joining Caltech [1] Group 2: Entrepreneurial Ventures - He was the first employee and co-founder of 1200 Pharma, which spun out of Caltech and secured significant investment in the 8 figures [1] - Brendan remains an avid investor, focusing on market trends, particularly in biotechnology stocks [1]

Core Insights - The article highlights the professional background of Brendan, who has extensive experience in the pharmaceutical and biotechnology sectors, including a Ph.D. from Stanford and roles at major companies like Merck and start-ups [1] Group 1: Professional Background - Brendan completed a Ph.D. in organic synthesis at Stanford University in 2009 [1] - He worked for Merck from 2009 to 2013, gaining significant experience in the pharmaceutical industry [1] - Brendan has been involved in biotech start-ups, including Theravance and Aspira, before joining Caltech [1] Group 2: Entrepreneurial Ventures - He was the first employee and co-founder of 1200 Pharma, which spun out of Caltech and secured major investments in the eight-figure range [1] - Brendan remains an active investor, focusing on market trends, particularly in biotechnology stocks [1]

Summary of Jazz Pharmaceuticals Investor Call on Zanidatamab Horizon-GEA-01 Company and Industry - **Company**: Jazz Pharmaceuticals (NasdaqGS:JAZZ) - **Industry**: Oncology, specifically focusing on HER2-positive gastroesophageal adenocarcinoma (GEA) Core Points and Arguments 1. **Clinical Trial Presentation**: Jazz Pharmaceuticals presented data from the phase III Horizon-GEA-01 Clinical Trial at the American Society of Clinical Oncology Gastrointestinal Cancer Symposium, focusing on zanidatamab in combination with chemotherapy for HER2-positive GEA patients [2][4] 2. **Efficacy of Zanidatamab**: The trial demonstrated a 35% reduction in the risk of disease progression or death, translating to over four months of improvement in median progression-free survival (PFS) compared to trastuzumab plus chemotherapy [7][24] 3. **Overall Survival Benefits**: There was a statistically significant 28% reduction in the risk of death for zanidatamab plus tislelizumab plus chemotherapy versus trastuzumab, leading to a more than seven-month improvement in median overall survival (OS) [8][24] 4. **Mechanism of Action**: Zanidatamab is a bispecific antibody targeting two extracellular domains of HER2, which differentiates it from traditional therapies and enhances its efficacy [22][23] 5. **Safety Profile**: The safety profile of zanidatamab was consistent with known profiles of the individual treatments, although there was an increase in grade three or more toxicities in zanidatamab-containing arms [18][19] 6. **Regulatory Plans**: Jazz Pharmaceuticals plans to submit a supplemental biologics license application in the first half of the year and seeks inclusion in NCCN guidelines based on the trial results [21][33] Additional Important Content 1. **Patient Demographics**: The trial included 914 patients, with approximately 50% enrolled from Asia and 80%-85% of tumors being HER2 IHC3+ [12][13] 2. **Adverse Events**: Infusion-related reactions occurred in 25% of patients receiving zanidatamab, compared to 13.2% for trastuzumab, indicating a need for careful monitoring [18] 3. **Market Opportunity**: GEA is the fifth most common cancer globally, with a significant unmet need for effective HER2-targeted therapies, as the last new option was introduced in 2010 [30][31] 4. **Commercial Strategy**: Jazz Pharmaceuticals is positioned to leverage existing infrastructure for a rapid launch of zanidatamab if approved, with a focus on the strong data supporting its efficacy [31][32] 5. **Future Development**: The company is exploring zanidatamab in various HER2-positive solid tumors, indicating a robust pipeline and potential for broader applications [29][28] This summary encapsulates the key points discussed during the investor call, highlighting the promising data for zanidatamab and its potential impact on the treatment landscape for HER2-positive GEA.

January 9, 2026 Zanidatamab: Pivotal Phase 3 HERIZON-GEA-01 Trial Results in Gastroesophageal Adenocarcinoma (GEA) Innovating to Transform the Lives of Patients and Their Families Intended for U.S. investor audiences only. Intended for U.S. investor audiences only. 2 January 9, 2026 Transforming Lives. Redefining Possibilities. Caution Concerning Forward-Looking Statements This presentation contains forward-looking statements and financial targets, including, but not limited to, statements related to: the C ...

Core Insights - The Phase 3 HERIZON-GEA-01 trial results indicate that Ziihera (zanidatamab-hrii) in combination with chemotherapy, with or without tislelizumab, is positioned to become the new standard of care for HER2-positive first-line metastatic gastroesophageal adenocarcinoma (GEA) [1][2][4] Efficacy Summary - The trial achieved a median overall survival (OS) of 26.4 months for Ziihera plus tislelizumab and chemotherapy, which is the longest reported in a Phase 3 trial for this indication, showing a greater than seven-month improvement compared to the control arm [2][4][5] - Median progression-free survival (PFS) was over one year, with a 35% reduction in the risk of disease progression or death compared to trastuzumab plus chemotherapy, representing a more than four-month improvement [4][5] - The objective response rate (ORR) was 70.7% for Ziihera plus tislelizumab and chemotherapy, compared to 65.7% for the control arm [5] Safety Profile - The safety profile of Ziihera in combination with chemotherapy was consistent with known effects of HER2-directed therapy, with no new safety signals identified [6][7] - Grade 3 treatment-related adverse events (TRAEs) were reported at 71.8% for Ziihera plus tislelizumab and chemotherapy, and 59.0% for Ziihera plus chemotherapy [6] - The most common Grade 3 TRAE was diarrhea, occurring in 24.5% of patients receiving Ziihera plus tislelizumab and chemotherapy [6] Future Developments - Jazz Pharmaceuticals plans to submit Ziihera for FDA approval based on these results and is also evaluating Ziihera in other HER2-driven tumor types, including HER2-positive metastatic breast cancer [7][8] - An investor webcast is scheduled to discuss the Ziihera data presented at the ASCO GI symposium [8] Trial Details - The HERIZON-GEA-01 trial was a global, randomized, open-label study involving 914 patients across more than 30 countries, comparing Ziihera plus chemotherapy (with or without tislelizumab) to trastuzumab plus chemotherapy [9]

Core Insights - Jazz Pharmaceuticals will participate in key investor events in January 2026, including a webcast to review Phase 3 trial results for zanidatamab [1][2] Group 1: Upcoming Events - The company will host an investor webcast on January 9, 2026, at 6:30 a.m. PT / 3:30 p.m. GMT to discuss results from the Phase 3 zanidatamab HERIZON-GEA-01 trial, featuring commentary from senior management and Dr. Geoffrey Ku [1] - Jazz Pharmaceuticals will present at the 44th Annual J.P. Morgan Healthcare Conference on January 13, 2026, at 11:15 a.m. PST / 7:15 p.m. GMT, where CEO Renee Gala will provide a company strategy overview and business update [2] Group 2: Company Overview - Jazz Pharmaceuticals is a global biopharma company focused on developing innovative medicines for serious diseases, with a diverse portfolio that includes therapies for sleep disorders, epilepsy, and cancer treatments [3] - The company is headquartered in Dublin, Ireland, and has research and development laboratories, manufacturing facilities, and employees in multiple countries dedicated to serving patients worldwide [3]

Core Insights - Jazz Pharmaceuticals reported strong Q3 2025 earnings, with adjusted EPS of $8.13, surpassing estimates by 24% year over year [2][3] - Total revenues reached $1.13 billion, a 7% increase year over year, also exceeding consensus estimates [2][3] Financial Performance - Net product sales increased nearly 8% year over year to $1.06 billion, beating estimates [3] - Royalty revenues from high-sodium oxybate authorized generic decreased by 9% year over year to $53 million, missing estimates [3] - Neuroscience product sales rose 10% to $774 million, with Xywav sales up 11% to over $431 million [4][5] - Sales of Epidiolex/Epidyolex increased by 20% to about $303 million, driven by volume growth [5] - Oncology product sales rose 1% to about $288 million, with Rylaze/Enrylaze sales at $100 million, also up 1% [7][8] Cost and Guidance - Adjusted SG&A expenses rose 59% year over year to $460 million, primarily due to litigation settlements [11] - Jazz revised its 2025 revenue guidance to $4.18-$4.28 billion, indicating a 3% year-over-year increase at the midpoint [12] - Adjusted EPS guidance was significantly raised to $7.65-$8.45 from the previous $4.80-$5.60 [14] Market Outlook - The consensus estimate for Jazz has shifted upward by 8.54% in the past month, indicating positive investor sentiment [15] - Jazz holds a Zacks Rank 3 (Hold), suggesting an expectation of in-line returns in the coming months [17] Industry Comparison - Jazz is part of the Zacks Medical - Biomedical and Genetics industry, which has seen Regeneron report a slight revenue increase of 0.9% year over year [19] - Regeneron is expected to post a year-over-year EPS decline of 11.8% for the current quarter, reflecting broader industry challenges [20]

Core Insights - Jazz Pharmaceuticals announced the presentation of eight abstracts, including four late-breaking ones, at the American Epilepsy Society (AES) 2025 Annual Meeting, focusing on the efficacy of Epidiolex (cannabidiol) in treating rare forms of epilepsy [1][2][3] Group 1: EpiCom Trial Results - The EpiCom trial, a Phase 3b/4 study, showed promising reductions in behavioral problems associated with tuberous sclerosis complex (TSC) after 26 weeks of Epidiolex treatment, as indicated by improvements in TAND-SQ and ABC subscale scores [2][3] - The trial utilized novel endpoints that focused on individualized outcomes, addressing the specific problematic behaviors identified by caregivers and clinicians [3] Group 2: Additional Highlights from AES 2025 - A late-breaking poster presented results from a Phase 1 study that found no pharmacokinetic interactions between Epidiolex and cenobamate when administered together [4] - Preclinical data demonstrated a novel synergistic pharmacodynamic interaction between Epidiolex and cenobamate in a mouse model of seizures [4] - Real-world effectiveness data indicated that initiating Epidiolex in CBD-naïve patients with Dravet Syndrome, Lennox-Gastaut Syndrome, or TSC led to reduced polypharmacy and healthcare resource utilization after 12 months [4] - A post-hoc analysis from the Expanded Access Program showed that Epidiolex treatment was associated with reductions in seizure frequency in patients with developmental and epileptic encephalopathies [4] Group 3: Company Overview - Jazz Pharmaceuticals is a global biopharma company focused on developing innovative medicines for serious diseases, including epilepsy, with a commitment to addressing the needs of patients with limited therapeutic options [21]

Core Viewpoint - The content emphasizes the importance of conducting personal due diligence and consulting with competent advisors before making any financial decisions, particularly in the context of complex financial instruments like cryptocurrencies and CFDs [1]. Group 1 - The website provides general news, personal analysis, and third-party materials intended for educational and research purposes [1]. - It explicitly states that the information does not constitute a recommendation or advice for investment actions [1]. - Users are encouraged to understand the risks involved with financial instruments before making investment decisions [1]. Group 2 - The website highlights that cryptocurrencies and CFDs are complex instruments with a high risk of losing money [1]. - It advises users to carefully consider their understanding of these instruments and their financial capacity to absorb potential losses [1]. - The content may not be provided in real-time and is not guaranteed to be accurate, indicating a need for users to verify information independently [1].

Core Insights - Jazz Pharmaceuticals announced the acceptance of two abstracts featuring key data for Ziihera at the ASCO GI Symposium, highlighting its expanding clinical profile in HER2-driven gastrointestinal cancers [1][2] Group 1: HERIZON-GEA-01 Trial Results - The Phase 3 HERIZON-GEA-01 trial results for Ziihera in first-line HER2-positive locally advanced or metastatic gastroesophageal adenocarcinoma (GEA) were accepted as a late-breaking presentation [1] - Ziihera plus chemotherapy and Ziihera plus tislelizumab demonstrated statistically significant improvements in progression-free survival (PFS) compared to the control arm [2] - Ziihera plus tislelizumab also showed significant improvements in overall survival (OS), while Ziihera plus chemotherapy indicated a strong trend toward statistical significance for OS [2] Group 2: Upcoming Webcast and Presentations - Jazz Pharmaceuticals will host an investor webcast on January 9, 2026, to review the Ziihera data presented at ASCO GI [3] - The webcast will feature commentary from senior management and a physician from Memorial Sloan Kettering Cancer Center [3] Group 3: Background on GEA and BTC - Gastroesophageal adenocarcinoma (GEA) is the fifth most common cancer globally, with a poor prognosis and a five-year survival rate of less than 30% for gastric cancer [8] - Biliary tract cancer (BTC) is rare but aggressive, with HER2 overexpression observed in approximately 26% of patients, leading to worse prognosis [11][9] Group 4: Ziihera Overview - Ziihera (zanidatamab-hrii) is a bispecific HER2-directed antibody that reduces HER2 expression on tumor cells, inducing tumor growth inhibition [12] - The FDA granted accelerated approval for Ziihera for previously treated HER2-positive BTC based on overall response rate and duration of response [14]