Core Viewpoint - Arcellx's stock surged approximately 80% following Gilead Sciences' announcement to acquire the cancer-therapy developer for $7.8 billion in an all-cash deal, with a definitive buyout price set at $115 per share [1]. Deal Structure - Gilead will pay $115 per share in cash, plus a contingent value right (CVR) worth an additional $5 per share if Arcellx's lead therapy, anito-cel, achieves at least $6 billion in cumulative global net sales by the end of 2029 [1]. - The total offer represents a premium of about 87% over Arcellx's previous closing price, prompting immediate trading activity towards the buyout price [1]. - The transaction is structured as a tender offer followed by a second-step merger, already approved by both companies' boards [1]. Strategic Importance - Gilead is acquiring anitocabtagene autoleucel (anito-cel), a CAR-T therapy for relapsed or refractory multiple myeloma, which presents a significant commercial opportunity despite intense competition from established products like Johnson & Johnson's Carvykti [1]. - Analysts have previously noted supportive data for anito-cel's potential, with comparisons to Carvykti as the datasets have matured [1]. - The FDA is expected to make a decision on anito-cel by December 23, 2026, which positions the acquisition within a near-launch timeframe rather than a distant research phase [1]. Historical Context - Gilead and Arcellx have collaborated in cell therapy since 2022, making this acquisition a consolidation of a program that Gilead is already familiar with [1].

Core Insights - Tempest Therapeutics, Inc. is advancing its CAR-T assets post-transaction while maintaining a capital-efficient operational model [1][6] Strategic Priorities - The company will prioritize the development of its dual-targeting CD19/BCMA CAR-T program, TPST-2003, with clinical data expected from an ongoing Phase 1 trial in China and a registrational Phase 2b trial anticipated to start by the end of 2026 [2][3] - TPST-4003, an in vivo CAR-T program, aims to deliver the same dual-targeting construct without ex vivo cell manufacturing, with plans for preclinical development and potential clinical entry through a partner-funded trial [4][6] - Amezalpat is positioned for pivotal development in first-line hepatocellular carcinoma (HCC), with plans for business development discussions to advance this program [4] - The company plans to initiate a Phase 2 study of TPST-1495 in familial adenomatous polyposis (FAP), with first patient enrollment expected in Q1 2026, funded by the National Cancer Institute [5][6] Pipeline Expansion - Tempest is expanding its next-generation CAR-T pipeline, which includes additional dual-targeting CAR-T programs such as TPST-3003, TPST-2206, and TPST-3206 [6][7]

Core Insights - Tempest Therapeutics, Inc. has successfully closed an all-stock transaction to acquire dual-targeting CAR-T programs and secured financing support from Factor Bioscience Inc., enhancing its portfolio and operational runway [1][4] Group 1: Transaction Details - The transaction includes a diverse portfolio of clinical-stage product candidates and extends the operational runway to mid-2027, supporting multiple potential value-generating milestones [1][4] - The acquisition brings next-generation CAR-T assets, including TPST-2003, a dual-targeting CD-19/BCMA CAR-T, with a biologics license application (BLA) filing in China planned for 2027 [4][5] - The transaction was finalized following stockholder approval of share issuance at the 2025 Annual Meeting on January 27, 2026 [4] Group 2: Leadership Changes - Dr. Matt Angel has joined Tempest as President and CEO, expressing excitement about developing the innovative pipeline for treating solid tumors and hematologic malignancies [2][4] - Stephen Brady, Chair of the Board, acknowledged the contributions of outgoing board members and emphasized the importance of the transaction for the company's financial stability and future milestones [2][3] Group 3: Pipeline Developments - Amezalpat (TPST-1120) is ready for Phase 3 trials in first-line liver cancer, supported by global regulatory agreement and positive Phase 2 data [5] - TPST-2003 has completed Phase 1 trials in patients with relapsed/refractory multiple myeloma, with data expected in 2026 and a BLA in China planned for 2027 [5] - Tempest plans to initiate a Phase 2 study of TPST-1495 in familial adenomatous polyposis (FAP) in Q1 2026, funded by the National Cancer Institute [5][11]

Core Insights - AstraZeneca has agreed to acquire AbelZeta's 50% share of the China development and commercialization rights to C-CAR031, granting AstraZeneca sole rights to develop, manufacture, and commercialize C-CAR031 globally, with potential payments to AbelZeta totaling up to $630 million [1][2] Group 1: Company Overview - AbelZeta Pharma, Inc. is a global clinical-stage biopharmaceutical company focused on developing innovative cell-based therapeutic products, with operations in Rockville, Maryland, and Shanghai, China [6] - The company is dedicated to creating bespoke treatments that utilize the body's immune system to combat hematological malignancies, inflammatory and immunological diseases, and solid tumors [6] Group 2: Product Information - C-CAR031 is an autologous CAR-T therapy targeting Glypican 3 (GPC3), currently under investigation for treating Hepatocellular carcinoma (HCC) and other solid tumors [4] - The therapy is designed using AstraZeneca's armoring platform, which enhances its efficacy against solid tumors with high unmet medical needs [3] Group 3: Market Context - Hepatocellular carcinoma (HCC) is the most common form of primary liver cancer, accounting for approximately 75% of all cases, with a poor prognosis for advanced-stage patients [5] - The incidence of HCC in China is projected to reach around 344,500 cases by 2024, indicating a growing market for effective treatments [5]

As filed with the U.S. Securities and Exchange Commission on January 16, 2026 Registration No. 333-292331 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 1 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ____________________________ ESTRELLA IMMUNOPHARMA, INC. (Exact Name of Registrants as Specified in its Charter) ____________________________ | Delaware | 6770 | 86-1314502 | | --- | --- | --- | | (State or other jurisdiction of | (Primary Standard I ...

Summary of Allogene Therapeutics FY Conference Call Company Overview - **Company**: Allogene Therapeutics (NasdaqGS:ALLO) - **Focus**: Allogeneic cell therapy, specifically targeting large B-cell lymphoma and autoimmune diseases Key Points on Allogeneic Cell Therapy - **Lead Program**: CD19-directed CAR-T therapy called cema-cel, focusing on relapsed refractory large B-cell lymphoma [4][5] - **Objective**: Democratize cell therapy by simplifying logistics and reducing manufacturing costs, allowing treatment in community-based cancer centers [4] - **Current Study**: Alpha-3 study, targeting MRD positive patients post-R-CHOP treatment to assess the efficacy of cema-cel [6][9] Study Design and Expectations - **Study Design**: Patients completing R-CHOP will be tested for MRD; MRD positive patients will be randomized to receive either cema-cel or standard care [5][6] - **Interim Analysis**: Expected in the first half of 2026, focusing on MRD conversion rates and safety [6][9] - **Primary Endpoint**: Event-free survival (EFS), with a target differential of 30% between treatment arms to predict clinical outcomes [9][10] Market Dynamics and Adoption Challenges - **Market Adoption**: Expected to be data-driven; successful outcomes could lead to high adoption rates in community settings [17][18] - **MRD Testing**: Increasing trend in hematology; adoption of MRD testing is crucial for the success of the therapy [17][18] - **Patient Population**: Approximately one-third of patients treated with R-CHOP are expected to be MRD positive [14] Autoimmune Program: ALLO-329 - **Program Overview**: ALLO-329 is a dual CAR targeting CD19 and CD70, designed to address autoimmune disorders by depleting autoreactive B-cells and activated T-cells [31][32] - **Current Study**: Conducting a basket study for conditions like lupus and inflammatory myositis, with a focus on lymphodepletion strategies [31][32] - **Expected Data**: Initial data on CAR-T cell expansion and disease-specific biomarkers anticipated in the first half of 2026 [32][33] Competitive Landscape - **In Vivo CAR-T vs. Allogeneic CAR-T**: Allogeneic CAR-T is seen as more advanced due to established manufacturing processes and clinical data, while in vivo CAR-T is still in development [43][44] - **Cost of Goods**: Allogeneic CAR-T is projected to have a cost advantage due to efficient manufacturing capabilities [46] Conclusion - Allogene Therapeutics is positioned to make significant advancements in both oncology and autoimmune therapies through its innovative allogeneic CAR-T approaches, with key data releases expected in 2026 that could shape market adoption and clinical outcomes [47][48]

Core Viewpoint - Tempest Therapeutics, Inc. has announced an all-stock acquisition of dual-targeting CAR-T programs from Factor Bioscience, aimed at expanding its clinical pipeline and extending its operational runway to mid-2027 [1][2][4] Group 1: Acquisition Details - The acquisition includes the first clinical-stage CD19/BCMA dual-CAR T program, TPST-2003, designed for patients with extramedullary disease [2][3] - Tempest will issue 8,268,495 shares of common stock to Factor, representing 65% of the outstanding shares post-transaction [9] - The transaction is expected to close in early 2026, pending stockholder approval and other customary conditions [12] Group 2: Pipeline Expansion - The acquisition will diversify Tempest's pipeline, which includes amezalpat (Phase 3-ready) and TPST-1495 (Phase 2 expected to start soon) [3][4] - TPST-2003 has completed Phase 1 trials in patients with relapsed multiple myeloma, with data expected in 2026 and a biologics license application planned for 2027 in China [4] - Tempest plans to continue developing additional preclinical and research-stage programs, including TPST-2206 and TPST-3003 [4] Group 3: Financial and Operational Outlook - Existing cash and an investment commitment from Factor are expected to support operations through mid-2027, including key development milestones [2][9] - The company plans to pursue business development discussions or additional financing to advance the pivotal development of amezalpat in first-line liver cancer [4] - The anticipated preclosing equity financing is expected to extend Tempest's runway and support significant milestones [3][4] Group 4: Leadership Changes - Upon closing, Matt Angel, Ph.D., will become the President and CEO, while Stephen Brady will transition to Chairman of the board [3][9] - Dr. Angel has extensive experience in biotechnology and cell therapy, having previously led Factor Bioscience and other cell therapy companies [8][10]

Core Insights - Anixa Biosciences has received approval from the WHO for the non-proprietary name "liraltagene autoleucel" for its CAR-T therapy targeting recurrent ovarian cancer, marking a significant milestone in its development and potential commercialization [1][2][3] Company Overview - Anixa Biosciences is a clinical-stage biotechnology company focused on cancer treatment and prevention, with a therapeutic portfolio that includes an ovarian cancer immunotherapy program developed in collaboration with Moffitt Cancer Center [4] - The company utilizes a novel CAR-T technology known as chimeric endocrine receptor-T cell (CER-T) therapy, which targets the follicle stimulating hormone receptor (FSHR) expressed on ovarian cells and certain cancer cells [3][4] Clinical Development - The ongoing Phase 1 trial of liraltagene autoleucel is designed to evaluate safety, identify the maximum tolerated dose, and monitor clinical activity in adult women with recurrent ovarian cancer who have progressed after at least two prior therapies [3][4] - The trial is being conducted in partnership with Moffitt Cancer Center, a leader in cancer immunotherapy [2][4] Future Directions - The approval of the non-proprietary name allows Anixa to establish a universally recognized name for its CAR-T therapy, facilitating clearer identification and safe prescription of the drug [2][3] - The company plans to transition to using the name liraltagene autoleucel, or lira-cel, in future communications [2]

Financial Data and Key Metrics Changes - In Q3 2025, net product revenue was $21.1 million, slightly up from $20.9 million in Q2 2025 [29] - Deferred revenue at the end of Q3 was $7.6 million, compared to $2.1 million in Q2 2025, indicating a healthy backlog of products ready for infusion [29] - The net loss for Q3 2025 was $79.1 million, reduced from a loss of $82.1 million in Q3 2024 [31] Business Line Data and Key Metrics Changes - AUCATZYL achieved $21.1 million in net sales for Q3 2025, with total sales of $51 million for the first nine months of the year [8][29] - The manufacturing success rate exceeded 90%, and patient access was achieved for over 90% of U.S. covered lives [9] Market Data and Key Metrics Changes - The CAR-T market share for the treatment of relapsed refractory B-ALL was approximately 15% before AUCATZYL's commercialization, increasing to around 20% within the 60 treatment centers currently active [10] Company Strategy and Development Direction - The company aims to drive market share in adult ALL, improve margins, and expand beyond ALL into pediatric ALL and other indications [8][33] - The focus is on optimizing operations and leveraging investments in infrastructure to enhance efficiencies [7][17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing commercial launch of AUCATZYL, highlighting positive feedback from physicians and the potential for growth in the CAR-T market [5][10] - The company is preparing for upcoming data presentations at ASH and expects to initiate pivotal studies in lupus nephritis and pediatric ALL [33] Other Important Information - The company has made key leadership changes to strengthen its operational capabilities, including the appointment of a new Chief Technology Officer and Chief Commercial Officer [12][13] Q&A Session Summary Question: Can you talk about the patient flow and anticipated patient flow going forward? - Management noted a good proportion of patients were not initially considered for CAR-T therapy, indicating an expansion of market penetration [35][37] Question: What is the competitive positioning for obe-cel in pediatric patients? - The focus is on high-risk pediatric patients who currently have limited options, with a strong safety and efficacy profile for obe-cel [39][41] Question: Can you provide insights on the Q3 performance and expectations for Q4? - Management indicated that Q3 performance was impacted by CMS reimbursement policy changes, but they expect a healthy amount of deferred revenue for Q4 [46][50] Question: What are the growth opportunities in the CAR-T market? - The majority of patients are not yet receiving CAR-T therapy, presenting significant growth opportunities within existing treatment centers [58][60] Question: What data is expected at ASH? - Key data points will include pediatric ALL study results and expanded data from the CARLYSLE study, focusing on safety and efficacy [68][70]

Financial Data and Key Metrics Changes - In Q3 2025, net product revenue was $21.1 million, slightly up from $20.9 million in Q2 2025, with deferred revenue increasing to $7.6 million from $2.1 million in Q2 2025 [28][29] - Cost of sales for Q3 2025 totaled $28.6 million, while research and development expenses decreased to $27.9 million from $40.3 million in the same period of 2024 [29][30] - Selling, general, and administrative expenses rose to $36.3 million from $27.3 million in Q3 2024, resulting in a loss from operations of $71.6 million compared to $67.9 million in Q3 2024 [30][31] - The net loss for Q3 2025 was $79.1 million, reduced from $82.1 million in Q3 2024 [31] Business Line Data and Key Metrics Changes - The launch of AUCATZYL in the U.S. achieved $21.1 million in net sales for Q3 2025, with total sales of $51 million for the first nine months of 2025 [8][28] - The manufacturing success rate exceeded 90%, and patient access was achieved for over 90% of U.S. covered lives [9][10] Market Data and Key Metrics Changes - The CAR-T market share for the treatment of relapsed refractory B-cell ALL was approximately 20% within the 60 treatment centers currently active, indicating substantial growth potential [10][56] - The company aims to expand its geographic footprint and minimize travel distances for patients to access therapy [9] Company Strategy and Development Direction - The company is focusing on driving market share in ALL, improving margins, and expanding beyond ALL into pediatric ALL, lupus nephritis, and progressive multiple sclerosis [8][19] - The management is optimizing operations and leveraging investments made in infrastructure to drive efficiencies [7][17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing commercial launch of AUCATZYL, highlighting positive feedback from physicians and interest in investigator-sponsored trials [5][6] - The company anticipates significant growth opportunities in the CAR-T market and is preparing for upcoming data presentations at ASH [10][32] Other Important Information - The company has made key leadership changes to enhance its operational capabilities, including the appointment of a new Chief Technology Officer and Chief Commercial Officer [12][13] - The company is well-capitalized with $367.4 million in cash and marketable securities as of September 30, 2025, to support its commercialization efforts [31] Q&A Session Summary Question: Can you talk about the patient flow and anticipated patient flow going forward? - Management noted a good proportion of patients were not initially considered for CAR-T therapy, indicating an expansion of market penetration [34][35] Question: What is the competitive positioning for OB/Cell in pediatric patients? - The focus is on high-risk pediatric patients who are not eligible for CAR-T therapy, emphasizing the product's good safety and efficacy profile [37][38] Question: Can you provide insights on the Q3 performance and expected trends for Q4? - Management indicated that the Q3 performance was impacted by CMS reimbursement policy changes, but a healthy amount of deferred revenue suggests a positive outlook for Q4 [44][46] Question: What are the expected data presentations at ASH? - Key data points from the pediatric ALL study and the Carlyle study will be presented, focusing on safety, efficacy, and long-term outcomes [66][68]