TScan Therapeutics Conference Call Summary Company Overview - TScan Therapeutics was founded in 2018, focusing on TCR-T cell therapy to target anti-cancer T-cells and build a pipeline of therapeutic TCRs for genetically engineering patient T-cells [3][4] Key Clinical Programs Heme Malignancies - Lead program targets acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) in patients undergoing allogeneic bone marrow transplants [4] - A pivotal trial is set to begin in Q2 2026, with updated data expected at the ASH conference [4][18] - Current data shows a 50% reduction in relapse rates, with 82% of patients treated with TSC-101 remaining relapse-free compared to 64% in the control arm [11][12] Solid Tumors - The solid tumor program is shifting to an in vivo engineering platform, pausing the current phase one study due to challenges with autologous T cell therapy [25][26] - The new approach aims to provide an off-the-shelf product, leveraging recent advancements in in vivo engineering [25][26] Autoimmunity - Target discovery work is ongoing in autoimmune diseases, with early results reported in conditions like ankylosing spondylitis and ulcerative colitis [5][30] - Collaboration with Amgen focuses on Crohn's disease target discovery [5][31] Market Opportunity - Approximately 7,500 patients with AML or MDS undergo allogeneic transplants annually, with about 60% qualifying for reduced intensity conditioning [6][23] - TSC-101 targets patients with the HLA type A0201, representing around 42% of the U.S. population, leading to an addressable market of about 2,000 patients annually [23][24] - The anticipated market opportunity for TSC-101 is projected to exceed $1 billion in the U.S. [24] Regulatory and Development Updates - A productive meeting with the FDA led to a revised pivotal trial design using an internal control arm, enhancing monitoring of relapse rates [16][17] - The pivotal trial is expected to launch in Q2 2026, with a top-line readout anticipated by the end of 2028 [18] Manufacturing and Dosing Strategy - Transitioning to a fixed dosing schedule for easier implementation in commercial settings, with a new manufacturing process reducing time from 17 days to 12 days [19][20][22] - The new process aims to improve cell persistence and reduce the need for ex vivo T cell expansion [21][22] Financial Outlook - Following a reduction in force, TScan has extended its cash runway into the second half of 2027 [34] - Key upcoming milestones include presenting data on TSC-101 at ASH, launching the pivotal trial, and filing two additional INDs for other HLA types [34][35] Conclusion - TScan Therapeutics is positioned to address significant unmet needs in heme malignancies and explore opportunities in solid tumors and autoimmune diseases, with a strong focus on innovative TCR-T cell therapies and strategic regulatory engagements [5][30][34]

TScan Therapeutics, Inc. (TCRX) came out with a quarterly loss of $0.28 per share versus the Zacks Consensus Estimate of a loss of $0.35. This compares to a loss of $0.25 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of +20.00%. A quarter ago, it was expected that this company would post a loss of $0.28 per share when it actually produced a loss of $0.28, delivering no surprise.Over the last four quarters, the company has surpa ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____________________________to_____________________________________________________ Commission File Number: 001-40603 TSCAN THERAPEUTICS, INC. (Exact nam ...

TScan Therapeutics Reports Third Quarter 2025 Financial Results and Provides Corporate Update Reached agreement with FDA on pivotal study design for TSC-101 following productive end of Phase 1 meeting Data from ALLOHA™ Phase 1 heme trial to be presented at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition Made the strategic decision to prioritize clinical development of the heme program and initiate preclinical development of in vivo-engineered TCR-T for solid tumors Exhibit 99.1 U ...

Core Insights - TScan Therapeutics has reached an agreement with the FDA on the pivotal trial design for TSC-101, which is expected to begin in Q2 2026 [3][4] - The company has decided to prioritize the clinical development of its heme program while pausing enrollment in the solid tumor Phase 1 trial [5][13] - Financial results for Q3 2025 show a revenue increase to $2.5 million, up from $1.0 million in Q3 2024, primarily due to research activities with Amgen [7] FDA Agreement and Clinical Development - The FDA has approved a pivotal trial design for TSC-101 that mirrors the ALLOHA Phase 1 trial, utilizing a biologically-assigned internal control arm [3] - The pivotal trial is anticipated to facilitate efficient enrollment and streamlined assessment of study endpoints [3] - The company has implemented a commercial-ready manufacturing process that reduces manufacturing time by five days, lowering costs and the extent of ex vivo T cell expansion [3] Financial Performance - Revenue for Q3 2025 was $2.5 million, a 150% increase from $1.0 million in Q3 2024 [7] - R&D expenses rose to $31.7 million in Q3 2025 from $26.3 million in Q3 2024, driven by increased manufacturing and clinical activities [8] - General and administrative expenses increased slightly to $7.9 million in Q3 2025 from $7.4 million in Q3 2024 [9] - The net loss for Q3 2025 was $35.7 million, compared to $29.9 million in Q3 2024 [10] Cash Position and Future Plans - As of September 30, 2025, the company had cash, cash equivalents, and marketable securities of $184.5 million, expected to fund operations into the second half of 2027 [10] - Plans to submit IND applications for two additional TCR-T product candidates are set for Q4 2025 [13] - The company aims to share updated clinical data from the ALLOHA Phase 1 heme trial at the upcoming ASH Annual Meeting [4]

Core Insights - TScan Therapeutics, Inc. is a clinical-stage biotechnology company focused on T cell receptor (TCR)-engineered T cell therapies for cancer treatment [3] - The company will participate in a fireside chat at the Guggenheim 2 Annual Healthcare Innovation Conference on November 12, 2025 [1] - A webcast of the event will be available on the company's website, with an archived replay accessible for 90 days post-event [2] Company Overview - TScan Therapeutics is developing TCR-T therapies aimed at treating patients with hematologic malignancies and preventing relapse after allogeneic hematopoietic cell transplantation [3] - The company has multiple TCR-T therapy candidates for solid tumors and is working on in vivo engineering methods [3] - TScan is utilizing its TargetScan platform to identify novel targets in T cell-mediated autoimmune diseases [3]

Summary of TScan Therapeutics Conference Call Company Overview - **Company**: TScan Therapeutics (NasdaqGM:TCRX) - **Focus**: Development of engineered T cell therapies, particularly for hematologic malignancies and solid tumors Key Points Industry and Product Development - **Pivotal Study Preparation**: A fourth dose level was introduced in the phase one study to implement fixed dosing rather than weight-based dosing, with patients receiving approximately 800 million cells in the first infusion and 1.6 billion cells in the second infusion [1] - **Manufacturing Process Improvement**: The new commercial-ready manufacturing process has decreased the cost of goods and is five days shorter than the previous phase one process, making it operationally more straightforward [2] - **Durable Responses**: Initial patients treated with TSC-101 showed durable responses, with three patients treated for over two years and prolonged persistence of engineered T cells [2] Clinical Data and Efficacy - **Relapse-Free Survival**: Patients receiving TSC-101 showed improved relapse-free survival compared to the control arm, with a hazard ratio of 0.48 as of the July 18 data cut [3] - **Chimerism and Relapse**: Some patients experienced delays in achieving complete donor chimerism, which may be associated with high levels of ex vivo T cell expansion during the manufacturing process [3][4] - **In Vivo Engineering**: The company is transitioning to in vivo engineering of T cells, which could address challenges associated with ex vivo manufacturing, such as extended time from patient identification to infusion [6][7] Strategic Decisions - **Focus on HEME Program**: The company has decided to pause further enrollment in solid tumor trials to concentrate on the HEME program, which addresses unmet needs in hematologic malignancies [6][8] - **Reduction in Force**: A strategic restructuring will result in a 30% reduction in workforce to support the pivotal trial for TSC-101 and extend the company's financial runway into the second half of 2027 [9] Market Opportunity - **Allogeneic Transplant Market**: Approximately 9,000 patients undergo allogeneic transplants annually in the U.S., primarily for AML and MDS, with a concentrated market of about 120 centers [10] - **Potential Market Expansion**: The introduction of additional TCRs targeting CD45 could potentially double the addressable market, making it a multibillion-dollar opportunity [12] Clinical Development Plans - **IND Filings**: Plans to file INDs for TCRs targeting epitopes derived from CD45, with the potential to initiate a phase one study in the second half of next year [12][18] - **Quality Control Measures**: The company will utilize a commercial-ready process while gathering additional data to ensure the product's quality for the pivotal study [26][27] Challenges and Considerations - **T Cell Expansion Risks**: High levels of T cell expansion may lead to exhaustion, impacting their ability to engraft and function effectively in patients [31] - **In Vivo vs. Ex Vivo**: The company believes in vivo engineering is a promising approach despite concerns about the quality of T cells from patients who have undergone multiple therapies [36] Additional Insights - **Market Access Work**: The company has conducted extensive market access work with physicians and payers, anticipating rapid market penetration with competitive pricing [11] - **Patient Tolerance**: The product is well tolerated and could be administered in an outpatient setting, making it suitable for cell therapy [12] This summary encapsulates the critical aspects of TScan Therapeutics' conference call, highlighting the company's strategic direction, clinical developments, and market opportunities.

TScan Therapeutics, Investor Call November 3, 2025 Investor call November 3, 2025 Disclaimers and forward-looking statements This presentation and accompanying discussion contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, express or implied statements regarding the Company's plans, progress, expectations, and timing relating to the Company's hematologic malignancies program, including updated manufacturing process res ...

Core Insights - The company has reached a positive agreement with the FDA on the pivotal study design for TSC-101, focusing on hematologic malignancies such as AML and MDS [3][5] - A strategic prioritization has led to a workforce reduction of approximately 30%, or 66 employees, to concentrate on the heme program and preclinical development for solid tumors [3][8] - The company expects to extend its cash runway into the second half of 2027, with anticipated annual cost savings of approximately $45 million in 2026 and 2027 [4][11] Hematologic Malignancies Program - The pivotal trial for TSC-101 will mirror the ongoing Phase 1 ALLOHA trial, utilizing a biologically assigned internal control arm to support relapse-free survival as the primary endpoint [3][5] - The company has developed a commercial-ready manufacturing process that shortens manufacturing time by five days, resulting in lower costs and reduced T cell expansion needs [4][9] - Plans to submit IND applications for two additional TCR-T product candidates are scheduled for Q4 2025, aiming to initiate Phase 1 development in H2 2026 [6][16] Solid Tumor Program - The company has dosed its first two patients with multiplex TCR-T therapy in the PLEXI-T trial but has paused further enrollment to focus on preclinical development of in vivo-engineered TCR-Ts for solid tumors [10] - Initial safety and efficacy data from the PLEXI-T trial is expected to be shared in Q1 2026 [10] Autoimmunity - The company continues to identify novel targets in autoimmune diseases, including ankylosing spondylitis and ulcerative colitis, and is collaborating with Amgen for Crohn's disease target discovery [10] Financial Updates - The company anticipates a one-time charge of up to approximately $2.3 million in Q4 2025 for severance-related benefits and other costs due to the workforce reduction [11] - The strategic prioritization is expected to preserve capital while enhancing shareholder value [4][8]

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