All-stock acquisition includes clinical-stage CD19/BCMA Dual-CAR T programAcquisition will expand existing advanced clinical-stage pipeline of amezalpat (PPAR⍺ Antagonist, Phase 3-ready) and TPST-1495 (Dual Ep2/4 Antagonist, Phase 2 start expected near term)The anticipated preclosing equity financing and an investment commitment from Factor Bioscience is expected to extend Tempest’s runway to mid 2027 and through potentially significant milestonesPlan to proceed with execution of globally approved protocol ...

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]

Core Insights - AbbVie has completed the acquisition of Capstan Therapeutics, enhancing its capabilities in developing innovative therapies for B cell-mediated autoimmune diseases [1][3] Company Overview - AbbVie aims to discover and deliver innovative medicines addressing serious health issues across key therapeutic areas including immunology, oncology, neuroscience, and eye care [4] Acquisition Details - Capstan's lead asset, CPTX2309, is currently in Phase 1 trials and utilizes a targeted lipid nanoparticle (tLNP) platform to generate CD19-specific, CD8+ in vivo CAR-T cells, which are designed for rapid and deep B cell depletion [2][3] - The acquisition strengthens AbbVie's ability to deliver new treatments that can reset the immune system and allows broader application of Capstan's proprietary technology for in vivo cell programming [3]

Financial Data and Key Metrics Changes - Cash, cash equivalents, and marketable securities at year-end 2024 totaled $588 million, up from $239 million at the end of 2023, primarily due to a collaboration with BioNTech and equity financing [27][28] - Loss from operations for the year ending December 31, 2024, was $241.4 million, compared to $179.7 million for 2023 [28] - Net loss was $220.7 million for the year-end December 31, 2024, compared to $208.4 million for the same period in 2023 [30] Business Line Data and Key Metrics Changes - Cost of sales totaled $11.4 million following the BLA approval for obe-cel, representing costs associated with commercially available plant capacity [28] - Research and development expenses increased to $138.4 million for the year ending December 31, 2024, compared to $130.5 million in 2023, driven by increases in employee salaries and manufacturing costs [29] - Selling, general, and administrative expenses increased to $101.1 million for the year, compared to $46.7 million for the same period in 2023, primarily due to increased headcount for commercialization activities [29] Market Data and Key Metrics Changes - As of March 19, 2025, 33 centers were authorized to deliver AUCATZYL, expected to reach approximately 60% of the target patient population in the U.S. [13][21] - The company aims to have approximately 60 centers ready to deliver AUCATZYL by the end of the year [14] Company Strategy and Development Direction - The primary objective for 2025 is to execute a successful commercial launch for AUCATZYL and explore additional indications for obe-cel [8][10] - The company is planning an R&D event on April 23, 2025, to outline future growth opportunities [9] - The company is also moving through regulatory steps in the UK and Europe, with expected decisions in the second half of 2025 [14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the product's safety profile and its potential for outpatient administration, depending on physician experience and patient suitability [41][42] - The company noted a strong interest from centers to activate and deliver the product, indicating a positive dynamic in the launch [39] - Management highlighted the importance of ongoing experience with the product to build confidence among physicians [42] Other Important Information - The company received a $30 million milestone payment from Blackstone following FDA approval and made a regulatory milestone payment of GBP10 million [31][32] - The manufacturing facility is operational and is expected to reliably deliver products to centers [23] Q&A Session Summary Question: Initial demand and outpatient administration for AUCATZYL - Management noted a positive dynamic around center activation and interest in outpatient administration based on safety data [39][41] Question: Ramp-up of authorized centers and impact of tariffs - Management expects a steady ramp-up of centers, driven by individual center capabilities, and noted uncertainty regarding potential tariffs [48][53] Question: Time from site activation to first patient treatment - The time varies significantly, with some centers quickly treating patients while others may experience delays [60] Question: Manufacturing success rate and BioNTech's decision on AUTO6NG - Initial production experience mirrors clinical studies, and BioNTech's option on AUTO6NG will be exercised after pivotal study results [71][72] Question: SLE data context and resource allocation for launch - Upcoming SLE data will focus on product properties, safety, and B-cell depletion, with resources primarily directed towards service support for centers [78][85] Question: Treatment adoption among centers and sales guidance - Both experienced and new centers are adopting the treatment, and the company will not provide sales guidance due to multiple variables affecting sales trajectories [91][110]