TRANSFORMING THE LIVES OF PATIENTS WITH AUTOIMMUNE DISEASES AND CANCER Making Cell Therapies Accessible to AllTM Corporate Presentation February 2026 © 2026 Fate Therapeutics. All rights reserved. - 1 - Q1 2026 Business Updates & Near-Term Objectives Competitively positioned to accelerate clinical stage development | | Milestones Achieved | Near Term Next Steps | | --- | --- | --- | | | ✓ 15 lupus patients enrolled with 7 initial sites, with 16 | Complete Phase 1 SLE cohort enrollment by mid-2026 | | Autoim ...

CareDx (NasdaqGM:CDNA) Q4 2025 Earnings call February 24, 2026 04:30 PM ET Company ParticipantsAndrew Cooper - VP of Equity ResearchBrandon Couillard - Managing DirectorCaroline Corner - Director of Investor RelationsJohn Hanna - President and CEOKeith Kennedy - COONathan Smith - CFOTycho Peterson - Managing DirectorConference Call ParticipantsAndrew Brackmann - Equity Research AnalystBill Bonello - Senior Research AnalystEduardo Martinez - Equity Research AnalystMason Carrico - Research AnalystVivian Cerva ...

CareDx (NasdaqGM:CDNA) Q4 2025 Earnings call February 24, 2026 04:30 PM ET Speaker9Hello, everyone. Thank you for joining us, welcome to the CareDx Q4 2025 financial results earnings call. After today's prepared remarks, we will host a question-and-answer session. If you would like to ask a question, please press star one on your telephone keypad. To withdraw your question, press star one again. I will now hand the call over to Caroline Corner, Investor Relations. Please go ahead.Speaker4Thank you, operator ...

Key Takeaways GILD will acquire Arcellx for $115 per share plus a $5 CVR, valuing the deal at $7.8 billion.The deal centers on anito-cel, a BCMA CAR-T therapy under FDA review with a December 2026 decision date.GILD expects the acquisition to be accretive from 2028 and strengthen its oncology and cell therapy portfolio.Gilead Sciences, Inc. (GILD) announced that it will acquire a clinical-stage biotechnology company, Arcellx (ACLX) , for $115 per share in cash plus a $5 contingent value right, implying an e ...

Iovance Biotherapeutics (NasdaqGM:IOVA) Q4 2025 Earnings call February 24, 2026 08:30 AM ET Company ParticipantsAndrew Tsai - Managing DirectorBrian Gastman - EVP of Transitional Medicine and ResearchCorleen Roche - CFODan Kirby - Chief Commercial OfficerDavid Dai - DirectorFrederick Vogt - Interim CEO and PresidentIgor Bilinsky - COOReni Benjamin - Managing DirectorSara Pellegrino - SVP of Investor Relations and Corporate CommunicationsNone - Company RepresentativeConference Call ParticipantsAsthika Goonew ...

Iovance Biotherapeutics (NasdaqGM:IOVA) Q4 2025 Earnings call February 24, 2026 08:30 AM ET Company ParticipantsAndrew Tsai - Managing DirectorBrian Gastman - EVP of Transitional Medicine and ResearchCorleen Roche - CFODan Kirby - Chief Commercial OfficerDavid Dai - DirectorFrederick Vogt - Interim CEO and PresidentFriedrich Finckenstein - Chief Medical OfficerIgor Bilinsky - COOReni Benjamin - Managing DirectorSara Pellegrino - SVP of Investor Relations and Corporate CommunicationsNone - Company Representa ...

Core Viewpoint - Gilead Sciences, Inc. has announced a definitive agreement to acquire Arcellx for an implied equity value of $7.8 billion, which includes $115 per share in cash and a contingent value right of $5 per share [1] Company Overview - Gilead Sciences is a biopharmaceutical company focused on innovative medicines for life-threatening diseases, including cancer, with a commitment to advancing public health [12] - Arcellx is a clinical-stage biotechnology company dedicated to developing innovative immunotherapies for cancer and other incurable diseases [11] Transaction Details - The acquisition is expected to close in the second quarter of 2026, pending customary closing conditions and regulatory approvals [7] - Gilead currently owns approximately 11.5% of Arcellx's outstanding common stock [7] - The offer price represents a 68% premium to Arcellx's 30-day volume-weighted average share price as of February 20, 2026 [8] Product Pipeline - Gilead and Arcellx are collaborating on anitocabtagene autoleucel (anito-cel), a CAR T-cell therapy for multiple myeloma, which has shown deep and durable responses in clinical studies [2][3] - The Biologics License Application (BLA) for anito-cel has been accepted by the FDA, with a Prescription Drug User Fee Act (PDUFA) action date set for December 23, 2026 [4] Strategic Importance - Gilead's CEO emphasized the potential of anito-cel to become a foundational treatment for multiple myeloma and its importance in the company's oncology and inflammation efforts [5] - Arcellx's D-Domain CAR technology platform offers proprietary target-binding domains that could enhance future CAR T-cell and bispecific therapies [5] Financial Implications - The transaction is expected to be accretive to Gilead's earnings per share in 2028 and beyond, contingent upon FDA approval of anito-cel [9]

Core Insights - CareDx (CDNA) announced clinical validation data for AlloHeme, a blood-based monitoring test aimed at predicting relapses in acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) post-allogeneic hematopoietic cell transplant (HCT) [1][4] Group 1: AlloHeme Test Details - AlloHeme utilizes next-generation sequencing and artificial intelligence to enhance sensitivity in detecting early relapse signals compared to traditional methods [2][4] - The ACROBAT clinical study demonstrated that AlloHeme achieved 85% sensitivity and 92% specificity, detecting relapses a median of 41 days earlier than standard clinical diagnosis [9][12] - The assay's performance metrics indicate a 95% negative predictive value and a 79% positive predictive value, with an area under the curve of 0.89 [11] Group 2: Commercialization and Market Strategy - CareDx plans to roll out AlloHeme in the U.S. starting with CLIA readiness in 2026, followed by commercialization in 2027 and expected payer coverage by 2028 [3][9] - The company aims to expand its Transplant+ strategy into cell therapy and hematologic oncology, addressing unmet needs in AML and MDS monitoring [3][6] - The integrated offering will combine diagnostics, digital tools, and patient support solutions tailored for the cell therapy ecosystem [4][7] Group 3: Market Performance and Growth Potential - Following the announcement, CDNA shares increased by 2.8%, with a 65.6% rise over the past six months, significantly outperforming the industry and S&P 500 [5] - The clinical validation of AlloHeme is seen as a significant growth catalyst, enhancing CareDx's position in the cell therapy and hematologic oncology markets [6][7] - The cell therapy market is projected to reach $9.13 billion by 2026, with a compound annual growth rate (CAGR) of 22.9% through 2034, driven by advancements in technology and increasing disease prevalence [14][15]

CareDx Investor Webinar Call Summary Company Overview - **Company**: CareDx - **Focus**: Development of AlloHeme, an AI-enabled solution for relapse monitoring in Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS) post-cell therapy, aiming to lead in precision medicine for cell therapy [2][9] Key Points Industry Context - **Market Growth**: Solid organ transplantation is a growing market, driven by federal policies and technological advances, with CareDx capturing over 70% of the serviced market [9] - **Cell Therapy Market**: The cell therapy market is expanding rapidly, with allogeneic hematopoietic cell transplants (HCT) and CAR T-cell therapies being primary focuses. The market is expected to grow at a 9% CAGR for HCT and 30% for CAR T-cell therapies from 2024 to 2028 [14][15] AlloHeme Development - **Target Population**: AlloHeme is designed for high-risk patients with hematologic malignancies, particularly those undergoing allogeneic HCT and CAR T-cell therapies [10][12] - **Monitoring Solution**: AlloHeme utilizes next-generation sequencing to analyze micro changes in cell populations from peripheral blood samples, providing a non-invasive method for relapse prediction [17][18] - **Clinical Validation**: The ACROBAT trial demonstrated AlloHeme's high sensitivity (85%) and specificity (92%) for detecting relapse, with a median lead time of 41 days before clinical relapse [41][45] Market Opportunity - **Total Addressable Market (TAM)**: Estimated at approximately $1 billion, driven by an increasing patient population eligible for HCT, with 70% for AML and 45% for MDS [57] - **Commercialization Timeline**: CareDx plans to launch AlloHeme in early 2027, following the publication of the ACROBAT study and completion of CLIA readiness activities [60] Competitive Landscape - **Current Monitoring Tools**: Existing tools for relapse monitoring, such as chimerism testing and MRD approaches, have limitations in sensitivity and require invasive procedures like bone marrow biopsies. AlloHeme aims to fill this gap with a more sensitive, non-invasive alternative [23][24][49] Future Directions - **Standardization Goal**: CareDx aims for AlloHeme to become a standardized tool for monitoring relapse in post-allogeneic HCT patients, addressing the variability in current monitoring practices [63][64] - **Clinical Utility Evidence**: Future studies will focus on demonstrating the clinical utility of AlloHeme in improving health outcomes through earlier detection and intervention [64][66] Additional Insights - **Patient Journey**: The patient journey post-transplant involves intensive monitoring for relapse, with a significant gap in current practices due to the infrequency of sensitive assessments like bone marrow biopsies [21][22] - **Regulatory Considerations**: CareDx anticipates that coverage decisions for AlloHeme will begin in 2028, which will be crucial for market adoption [60] This summary encapsulates the key points discussed during the CareDx Investor Webinar Call, highlighting the company's strategic focus on AlloHeme and its potential impact on the cell therapy market.

Core Insights - Ryoncil has demonstrated high survival rates in patients with steroid-refractory acute graft-versus-host disease, highlighting the necessity for earlier intervention [1][5] Group 1: Ryoncil's Efficacy - Ryoncil (remestemcel-L-rknd) achieved high survival outcomes in both children and adults with steroid-refractory acute graft-versus-host disease, regardless of treatment line or patient resistance status [2] - In a study involving 53 patients with SR-aGvHD who received Ryoncil as a third-line treatment, 15% died before completing the treatment course, compared to only 2% in the Phase 3 trial when used as a second-line treatment [4] - The results underscore the importance of administering Ryoncil as early as possible after steroid resistance to maximize survival rates [5] Group 2: Regulatory Approval - Ryoncil is the first mesenchymal stromal cell product approved by the U.S. FDA for any indication and is the only product approved for children under age 12 with steroid-refractory acute graft-versus-host disease [3] Group 3: Market Performance - The stock is currently trading 1.8% above its 20-day simple moving average but 2.3% below its 50-day simple moving average, indicating short-term strength but medium-term resistance [6] - Over the past 12 months, shares have decreased by 1.29% and are closer to their 52-week highs than lows [6] - The RSI is at 54.28, indicating neutral territory, while the MACD is above its signal line, suggesting bullish momentum [7] Group 4: Price Action - Mesoblast shares were down 3.06% at $17.73 during premarket trading, with key resistance at $19.50 and key support at $17.50 [8]