CAMBRIDGE, Mass., Feb. 05, 2026 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM; “Cullinan”), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, high-impact therapies in autoimmune diseases and cancer, today announced that Nadim Ahmed, Chief Executive Officer, and Jeffrey Jones, M.D., M.B.A., Chief Medical Officer, will participate in a fireside chat at the Guggenheim Emerging Outlook: Biotech Summit 2026 on Thursday, February 12, 2026, at 11:00 a.m. ET. ...

Core Insights - Cullinan Therapeutics is advancing multiple clinical programs in autoimmune diseases and cancer, with significant data readouts expected in 2026 [1][2][3] Group 1: Autoimmune Programs - The company has made progress with CLN-978, completing multiple dose cohorts in OUTRACE RA and OUTRACE SLE studies, and has initiated dosing in the Sjögren's disease study [2] - Initial data from the single target dose escalation for OUTRACE RA and OUTRACE SLE is expected in Q2 2026, focusing on safety and B cell depletion [4] - Repeat dosing data for OUTRACE RA is anticipated in Q3 2026, while initial data for OUTRACE SjD is expected in Q4 2026 [4][5] Group 2: Oncology Programs - The CLN-049 program is progressing with plans to complete dose expansion cohorts for relapsed/refractory AML and TP53m AML in Q2 2026, and to initiate a frontline combination study in Q4 2026 [3][11] - Zipalertinib's rolling NDA submission is expected to be completed in Q1 2026, with full enrollment of the REZILIENT3 frontline study anticipated in H1 2026 [1][11] Group 3: Financial Position - As of December 31, 2025, the company reported preliminary cash and investments of $439.0 million, providing a runway into 2029 under its current operating plan [1][8]

© Cullinan Therapeutics, Inc. All rights reserved. Confidential and proprietary. | 2 Agenda Introduction & Pipeline Strategy Nadim Ahmed CLN-049 Update at ASH December 8, 2025 Important notice and disclaimers This presentation contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this presentation, including express or implied statements regarding the Company's beliefs and expectat ...

Summary of Vir Biotechnology FY Conference Call - December 03, 2025 Company Overview - **Company**: Vir Biotechnology (NasdaqGS:VIR) - **Focus**: Development of innovative therapies for infectious diseases and cancer, particularly through T cell engagers and hepatitis programs Key Accomplishments in 2025 - **Clinical Programs**: Significant advancements in three clinical-stage T cell engagers and a registration program for hepatitis delta [2][4] - **Data Reporting**: First-time reporting of data on Vir-5500 (PSMA CD3 T cell engager) and Vir-5818 (HER2 CD3 T cell engager) with promising early results [2][3] - **Hepatitis Delta Program**: Achieved transformative data with 66% of patients achieving undetectable virus levels after 48 weeks of treatment [4] Clinical Development Highlights - **Vir-5500**: - Unique dual masking technology enhances safety and efficacy by preventing toxicity associated with naked PSMA T cell engagers [8][10] - Extended half-life of 8-10 days allows for less frequent dosing [10] - Early clinical data showed 58% of patients achieving a PSA reduction of 50, with only 25% experiencing any CRS (cytokine release syndrome) [15][16] - **Hepatitis Delta**: - Phase two Solstice trial demonstrated significant efficacy, with 66% of patients achieving target not detected status [4][30] - Enrollment for phase three trials (Eclipse) completed ahead of schedule, indicating strong demand for therapy [32] Differentiation and Competitive Landscape - **Masking Technology**: - Vir-5500 utilizes a dual masking approach that is distinct from single mask competitors, providing a better therapeutic index [21][22] - The Xtend mask technology has been validated in other marketed drugs, enhancing confidence in safety and efficacy [11][22] - **Market Positioning**: - Potential to position Vir-5500 in both pre- and post-Pluvicto treatment settings, aiming for a balance of efficacy and safety [26][27] Future Expectations - **Upcoming Data**: - Next data cut expected in January will focus on early readouts such as PSA levels and safety data, with a meaningful dataset anticipated [24] - **Product Presentation**: - Anticipated to be two subcutaneous injections, allowing for at-home administration or by healthcare professionals [33] Industry Insights - **Feedback from Medical Community**: - Positive reception from KOLs regarding the unmet medical need in hepatitis delta, with enthusiasm for the efficacy demonstrated in clinical trials [29][30] - **Enrollment Trends**: - Rapid enrollment in Eclipse trials reflects strong demand and interest in the hepatitis delta treatment [32] Conclusion - Vir Biotechnology has made significant strides in its clinical programs, particularly with its innovative masking technology for T cell engagers and promising results in its hepatitis delta program. The company is well-positioned to address unmet medical needs in both oncology and infectious diseases, with strong support from the medical community and a clear path forward for upcoming data releases and product development.

Summary of Context Therapeutics FY Conference Call Company Overview - **Company**: Context Therapeutics (NasdaqCM:CNTX) - **Focus**: Development of T cell engagers for solid tumors, specifically targeting Claudin-6, Mesothelin, and Nectin-4 [3][4] Core Points and Arguments T Cell Engagers - Context Therapeutics specializes in T cell engagers, a class of antibodies designed to bind tumor antigens and activate immune responses [3] - The company utilizes high affinity CD3 as the immune activator, which has been successful in all approved T cell engagers [3][4] - The company does not conduct in-house research; all programs are externally sourced [3] Claudin-6 Program (CTIM-76) - Claudin-6 is considered a compelling target due to its restricted expression in tumors, allowing for targeted therapy without affecting normal cells [5][6] - The company aims to treat ADC resistance and has a lower cutoff for Claudin-6 expression, allowing for broader patient eligibility compared to existing therapies [9][10] - Early clinical data shows promise, with a patient achieving a confirmed partial response after prior treatments [12] Management of Cytokine Release Syndrome (CRS) - CRS is a concern due to the overlap of Claudin-6 with Claudin-3 and 4, which are found in the liver [14] - The company employs strategies such as step dosing and prophylactic steroids to manage CRS effectively [15][16] Mesothelin Program (CT-95) - Mesothelin is a target found in 30% of all cancers, but previous attempts to develop therapies have faced challenges [23] - The company’s approach involves a unique antibody design that binds to a stable portion of mesothelin, minimizing side effects [24][25] - Enrollment is focused on pancreatic, ovarian, and mesothelioma cancers, with a low bar for clinical expectations due to the historical challenges in this space [27][29] Nectin-4 Program (CT202) - Nectin-4 is seen as a significant opportunity due to its expression in various cancers, but it has been dominated by ADCs [31] - The company believes T cell engagers can provide a more potent alternative, especially in combination with existing therapies [32][33] - The antibody design is pH-dependent, which may reduce skin-related side effects commonly associated with Nectin-4 therapies [34] Additional Important Insights - The company plans to provide more comprehensive data updates in Q2 2026, including insights on dosing and patient enrollment [12][18] - There is a clear market need for therapies targeting Claudin-6 and Nectin-4, particularly in ovarian and bladder cancers [21][36] - The company is exploring partnerships for indications like cervical cancer, which may require expertise in specific geographies [36] Conclusion Context Therapeutics is strategically positioned in the oncology space with a focus on T cell engagers, targeting specific tumor antigens. The company is advancing its clinical programs with promising early data and a clear strategy for managing safety concerns, while also exploring potential partnerships to expand its reach in underserved cancer markets.

Core Insights - Cullinan Therapeutics is focusing on high-conviction clinical stage programs, particularly CLN-049 and CLN-978, with promising data expected to be presented at upcoming conferences [2][3] - The company has discontinued the CLN-619 and CLN-617 programs based on emerging clinical data, streamlining its pipeline towards T cell engagers [3] - As of September 30, 2025, Cullinan reported cash and investments totaling $475.5 million, providing a financial runway into 2029 [1][12] Clinical Programs - CLN-049, a FLT3xCD3 bispecific T cell engager, demonstrated a ~30% complete response rate in heavily pretreated patients with relapsed/refractory acute myeloid leukemia (AML) [1][12] - Initial data for CLN-978, targeting systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA), is expected to be shared in the first half of 2026 [1][6] - The Phase 1 OUTRACE Program for CLN-978 is currently enrolling patients across multiple studies [6] Financial Performance - Research and development expenses for Q3 2025 were $42.0 million, up from $35.5 million in Q3 2024 [12][15] - General and administrative expenses were $13.6 million for Q3 2025, slightly higher than $13.3 million in Q3 2024 [12][15] - The net loss attributable to Cullinan for Q3 2025 was $50.6 million, compared to $40.6 million for the same period in 2024 [12][16] Strategic Focus - The company is strategically concentrating resources on T cell engagers, which are seen as having transformative potential in immunology and oncology [3][2] - A positive pre-NDA meeting with the FDA has set the stage for a rolling submission of an NDA for zipalertinib in relapsed EGFR ex20ins non-small cell lung cancer (NSCLC) by year-end 2025 [3][7]

Core Insights - Cullinan Therapeutics is presenting new preclinical data for CLN-978, a bispecific T cell engager targeting autoimmune diseases, at the ACR Convergence 2025 [1][5] - CLN-978 has shown robust B cell depletion and T cell activation in patients with autoimmune diseases [2] - The drug demonstrated dose-dependent B cell depletion in nonhuman primates, indicating potential for significant clinical efficacy [3] - In murine models, CLN-978 treatment resulted in reduced circulating B cells and disease-modifying effects in systemic lupus erythematosus [4] Company Overview - Cullinan Therapeutics is focused on developing first- or best-in-class therapies for autoimmune diseases and cancer, leveraging expertise in T cell engagers [7] - The company is advancing global clinical programs for CLN-978 in rheumatoid arthritis, Sjögren's disease, and systemic lupus erythematosus, with active trials in multiple countries [5][6] - CLN-978 is designed for high affinity binding to CD19, allowing it to target B cells effectively, including those with low CD19 levels [6]

Summary of the Conference Call Company and Industry - **Company**: Moderna - **Industry**: Oncology and mRNA-based therapeutics Key Points and Arguments 1. **Oncology Portfolio Overview**: Moderna is advancing a diverse oncology portfolio utilizing multiple therapeutic approaches and platform technologies to address various cancer types and stages [5][27] 2. **Individualized Neoantigen Therapy (INT)**: INT is a personalized therapy that identifies patient-specific neoantigens from tumor samples, showing promising results in combination with Keytruda, reducing recurrence risk by 49% and distant metastasis risk by 62% [6][7] 3. **Phase Three Study**: A phase three study in adjuvant melanoma combining INT with Keytruda has completed enrollment, with data expected in 2026 [9] 4. **Expansion of INT Development**: INT is being tested across multiple tumor types, including non-small cell lung cancer and bladder cancer, with various combinations [10] 5. **Off-the-Shelf Cancer Antigen Therapies**: Moderna is developing off-the-shelf therapies like mRNA-4359, which targets shared antigens in cancer cells, aiming for broader applicability across different cancer types [11][12] 6. **T Cell Engagers**: The company is developing T cell engagers that guide immune responses towards cancer cells, addressing tumor heterogeneity and immune dysfunction in advanced cancers [18][19] 7. **Cell Therapy Enhancers**: Moderna is exploring in vivo cell therapies to enhance the efficacy of existing CAR-T therapies, potentially improving outcomes in solid tumors [25][26] 8. **Partnerships**: Moderna has a 50/50 partnership with Merck for INT and collaborates with Immatics for T cell receptor development, leveraging external expertise to enhance their capabilities [60][61] 9. **Future Catalysts**: Key upcoming data releases include the five-year follow-up for INT in 2026 and additional data from ongoing studies in various cancer types [39][40] 10. **Competitive Landscape**: Moderna is monitoring competitors like BioNTech and IO Biotech, assessing their data to inform and de-risk its own development strategies [51][52] Other Important Content 1. **Safety and Tolerability**: The safety profiles of INT and other therapies are encouraging, with low-grade adverse events reported [7][14] 2. **Translational Data Importance**: Translational data from early studies will guide future development and inform the potential clinical benefits of therapies [64] 3. **Diverse Therapeutic Approaches**: Moderna's strategy involves a toolkit approach, tailoring therapies based on cancer stage and patient needs, from preventive to advanced settings [30][31] 4. **Market Opportunities**: The company sees potential in both solid and liquid tumors, with a focus on enhancing immune responses in challenging environments [36][44] 5. **Long-term Vision**: Moderna aims to significantly impact patient lives through its diverse oncology portfolio, leveraging its mRNA platform technology [67]

Summary of Cullinan Therapeutics Conference Call Company Overview - **Company**: Cullinan Therapeutics (NasdaqGS:CGEM) - **Focus**: Development of best-in-class molecules for oncology and autoimmune diseases, with a portfolio centered around high-priority programs including CLN-978 for autoimmune diseases and zipalertinib for oncology [2][4] Key Programs and Developments - **Lead Program**: CLN-978, a CD19 x CD3 bispecific T cell engager, is currently in phase 1 clinical studies for systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and Sjogren's disease, with initial clinical data expected in the first half of 2026 [3][4] - **Oncology Program**: Zipalertinib TKI for EGFR exon 20 non-small cell lung cancer is planned for regulatory filing by the end of 2025 [4] Clinical Data and Study Design - **SLE and RA Studies**: Initial clinical data for SLE and RA has been shifted to the first half of 2026, with ongoing patient enrollment in global sites [3][25] - **Study Design**: The SLE study includes a modified single ascending dose study to identify a deeply B cell depleting dose while maintaining a therapeutic index [14][15] - **Eligibility Criteria Update**: Adjustments made to broaden patient eligibility, allowing those who have only received small molecule immune suppressants to participate [20][22] Therapeutic Benefits and Differentiation - **T Cell Engagers**: The potential for T cell engagers to provide therapeutic benefits without ongoing immune suppression is highlighted, with a focus on achieving durable responses [6][10] - **Differentiation of CLN-978**: High affinity binding to CD19 and a favorable cytokine window are key differentiators from other CD19 T cell engagers [8][9] Evidence and Market Potential - **RA Evidence**: Previous studies indicate that T cell engagers can provide clinical benefits through B cell depletion in RA, supporting the rationale for further development [28][30] - **Sjogren's Disease**: While evidence for T cell engagers in Sjogren's is limited, the disease's B cell-centric nature suggests potential therapeutic benefits from B cell-targeting therapies [32][33] Financial Position - **Cash Reserves**: As of the end of Q2, the company reported over $500 million in cash reserves, providing a runway into 2028 [39][41] Regulatory Pathway - **Collaboration with Genrex Bio**: Ongoing studies in China are expected to facilitate regulatory ambitions outside of China, with data generation in autoimmune disease patients aiding in the development of Cullinan's own studies [36][38] Conclusion - Cullinan Therapeutics is positioned to advance its innovative therapies in both oncology and autoimmune diseases, with a strong financial foundation and promising clinical programs aimed at addressing significant unmet medical needs in these areas [41]

Core Insights - Cullinan Therapeutics is advancing its CLN-978 program across three active Phase 1 studies targeting systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and Sjögren's disease, while also in-licensing the BCMA-directed bispecific T cell engager velinotamig from Genrix Bio [1][2][4] - The company reported a net loss of $70.1 million for Q2 2025, compared to a net loss of $42.0 million for the same period in 2024, indicating increased operational expenses [9][13] - Cullinan has a strong cash position of $510.9 million as of June 30, 2025, providing a runway into 2028 for ongoing and future projects [9][10] Immunology Updates - The global Phase 1 study for CLN-978 in moderate to severe SLE is currently enrolling in the U.S., Europe, and Australia, with initial safety and B cell depletion data expected in Q4 2025 [4] - The Phase 1 study for active, difficult-to-treat RA is enrolling in Europe, with initial data anticipated in the first half of 2026 [4] - The Phase 1 study for moderate to severe Sjögren's disease is also enrolling in the U.S. and Europe following regulatory approval [4] Oncology Developments - Results from the pivotal Phase 2b portion of the REZILIENT1 study of zipalertinib were shared at the 2025 ASCO Annual Meeting, with further data expected at upcoming medical conferences [3][8] - Taiho Oncology plans to submit a New Drug Application (NDA) for zipalertinib in relapsed EGFR ex20ins NSCLC by the end of 2025, with enrollment for the pivotal REZILIENT3 study expected to complete in the first half of 2026 [3][8] - Clinical data for CLN-049, targeting relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), is set to be shared in Q4 2025 [8] Corporate Governance - The company appointed Dr. Mittie Doyle and Dr. Andrew Allen to its Board of Directors, effective August 7, 2025, bringing significant expertise in immunology and oncology [6] - Drs. Anne-Marie Martin and David Ryan will resign from the Board effective the same date [6] Financial Overview - Research and development expenses for Q2 2025 were $61.0 million, up from $36.3 million in Q2 2024, reflecting increased investment in clinical programs [9][13] - General and administrative expenses rose to $14.8 million in Q2 2025 from $13.8 million in the same period last year [13] - The total operating expenses for Q2 2025 were $75.8 million, compared to $50.0 million in Q2 2024 [13]