Summary of TScan Therapeutics Conference Call Company Overview - **Company**: TScan Therapeutics (NasdaqGM:TCRX) - **Focus**: Next-generation TCR-T cell therapy, primarily targeting hematologic malignancies with a lead program, TSC-101, aimed at preventing relapse in patients undergoing allogeneic hematopoietic cell transplantation [2][3][4] Industry Context - **Industry**: Hematology and Oncology - **Key Challenge**: High relapse rates in patients with Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS) post-transplantation, with approximately 40% relapsing within two years and an 80% mortality rate within two years of relapse [5][10] Core Points and Arguments 1. **TSC-101 Program**: - TSC-101 is designed to target residual cancer cells post-transplant to prevent relapse [3][5] - A pivotal study for TSC-101 is planned for launch in Q2 of the following year [3][27] 2. **Clinical Data**: - Updated data presented at the American Society of Hematology conference showed promising results from the ongoing ALOHA study, with 23 patients enrolled in the TSC-101 arm [9][10] - The median age of patients was 65, with a significant proportion (79%) classified as high-risk [10][11] - The treatment arm showed a relapse-free survival hazard ratio of 0.46, indicating a strong potential for TSC-101 to reduce relapse rates compared to the control arm [14] 3. **Safety Profile**: - TSC-101 demonstrated a benign toxicity profile, with no dose-limiting toxicities reported and manageable cases of acute graft-versus-host disease [11][12] - The treatment was well tolerated, with only minor cases of cytokine release syndrome [12] 4. **Manufacturing Process**: - Transitioning to a new commercial-ready manufacturing process that is more efficient, reducing the time from 17 days to 12 days and minimizing loss of engineered T cells [24][25] - The new process is expected to enhance product consistency and reduce costs [24][62] 5. **Market Opportunity**: - TSC-101 targets a significant market, with an estimated 6,200 AML and MDS patients undergoing allogeneic transplants annually in the U.S., of which approximately 2,100 are eligible for TSC-101 [34][35] - Projected peak annual U.S. revenues for TSC-101 are estimated to exceed $1.4 billion [35] 6. **Regulatory and Clinical Development**: - Agreement reached with the FDA on pivotal trial design, with plans to enroll additional patients using the commercial-ready process before the pivotal study [26][40] - Anticipation of filing INDs for two additional TCR-T candidates targeting other common HLA types in the next quarter [37] Additional Important Insights - **Patient Experience**: TSC-101 integrates seamlessly into existing transplant workflows, minimizing operational complexity for healthcare providers [30][32] - **Physician Enthusiasm**: There is strong interest from transplant physicians, with indications of shifting patient treatment strategies to accommodate TSC-101 [35][36] - **Global Reach**: Expansion plans include targeting additional HLA types to broaden the patient population, potentially reaching around 20,000 patients globally [37][38] This summary encapsulates the key points discussed during the conference call, highlighting TScan Therapeutics' strategic direction, clinical advancements, and market potential.

Core Insights - TScan Therapeutics, Inc. announced updated results from the ALLOHA Phase 1 trial of TSC-101, demonstrating favorable relapse-free survival and overall survival in patients with hematologic malignancies undergoing allogeneic hematopoietic cell transplantation [1][2][3] Group 1: Trial Results - The treatment arm showed a relapse-free survival (RFS) hazard ratio of 0.50 (p=0.23) and overall survival (OS) hazard ratio of 0.61 (p=0.52) compared to the control arm [1][3] - 100% of TSC-101-treated patients who reached two-year follow-up remained relapse-free, while only 25% in the control arm did [1][3] - Among the treatment arm, 21% relapsed compared to 33% in the control arm, indicating a lower relapse rate [3] Group 2: Safety and Tolerability - TSC-101 was well-tolerated with no dose-limiting toxicities observed, and adverse events were similar across both treatment and control arms [1][9] - The new commercial-ready manufacturing process reduced the manufacturing time from 17 days to 12 days, enhancing efficiency [9] Group 3: Future Plans - The company plans to initiate a pivotal study in the second quarter of 2026, focusing on enrolling remaining patients to support a fixed-dosing regimen [2][4] - TScan aims to expand its hematologic malignancies program in 2026 with additional product candidates to double the addressable patient population [2]

Core Insights - TScan Therapeutics, Inc. will host a virtual key opinion leader event to discuss updated data from the ALLOHA Phase 1 trial and future market opportunities for its heme program [1][2] - The event will include a review of two-year relapse data from the ongoing ALLOHA Phase 1 trial evaluating TSC-101 in patients with hematologic malignancies [2] - The company has implemented an improved commercial-ready manufacturing process for the ALLOHA Phase 1 trial, which will be utilized in the upcoming pivotal trial set to begin in Q2 2026 [2] Company Overview - TScan Therapeutics is a clinical-stage biotechnology company focused on developing T cell receptor-engineered T cell therapies for cancer treatment [4] - The lead therapy candidate is aimed at preventing relapse in patients with hematologic malignancies following allogeneic hematopoietic cell transplantation [4] - The company is also developing multiple TCR-T therapy candidates for solid tumors and exploring novel targets in T cell-mediated autoimmune disorders through its TargetScan platform [4]

Core Insights - Several biotech and therapeutics companies experienced significant gains in after-hours trading on December 2, 2025, driven by corporate updates, investor anticipation, and scientific disclosures [1] Company Updates - Clene Inc. (CLNN) shares surged 8.53% to $10.05 after a regular session close of $9.26, following the announcement of an upcoming update on its CNM-Au8 program for ALS, which is expected to boost investor optimism [2] - Werewolf Therapeutics, Inc. (HOWL) advanced 6.12% to $0.91, recovering from a decline, as investors reacted to the company's presentation at the Society for Immunotherapy of Cancer's Annual Meeting and its narrower Q3 net loss of $16.4 million compared to the previous year [3] - Biomea Fusion, Inc. (BMEA) gained 7.31% to $1.03 after announcing its selection for an oral presentation at the 23rd World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease, showcasing advancements in metabolic disease research [4] - Denali Therapeutics Inc. (DNLI) rose 3.14% to $18.40 despite no new news, indicating steady investor interest in the neurodegenerative disease sector [5] - TScan Therapeutics, Inc. (TCRX) added 3.97% to $0.99, recovering from a drop, with Q3 revenue growth reported at $2.5 million, up from $1.0 million a year earlier, despite widening net losses to $35.7 million [6] - Nyxoah SA (NYXH) climbed 4.03% to $4.90, following an increase in insider voting rights to 10.14%, reflecting growing insider ownership [7] - Dyne Therapeutics, Inc. (DYN) rose 4.80% to $20.95, despite widening net losses to $108.0 million in Q3, compared to $97.1 million a year earlier, as it advances its muscle disease therapy pipeline [8] - Outlook Therapeutics, Inc. (OTLK) gained 3.83% to $1.90, with no new updates but reflecting investor positioning ahead of regulatory milestones for its ophthalmic drug candidate [9]

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]

Company Performance - TScan Therapeutics, Inc. reported a quarterly loss of $0.28 per share, which was better than the Zacks Consensus Estimate of a loss of $0.35, representing an earnings surprise of +20.00% [1] - The company posted revenues of $2.51 million for the quarter ended September 2025, missing the Zacks Consensus Estimate by 21.61%, compared to revenues of $1.05 million in the same quarter last year [2] - Over the last four quarters, TScan Therapeutics has surpassed consensus EPS estimates two times and topped consensus revenue estimates two times [2] Stock Performance - TScan Therapeutics shares have declined approximately 59.9% since the beginning of the year, contrasting with the S&P 500's gain of 16.4% [3] - The stock's immediate price movement will largely depend on management's commentary during the earnings call [3] Future Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.35 on revenues of $3.38 million, and for the current fiscal year, it is -$1.32 on revenues of $11.83 million [7] - The estimate revisions trend for TScan Therapeutics was favorable ahead of the earnings release, resulting in a Zacks Rank 2 (Buy) for the stock, indicating expected outperformance in the near future [6] Industry Context - The Medical - Biomedical and Genetics industry, to which TScan Therapeutics belongs, is currently in the top 34% of over 250 Zacks industries, suggesting a favorable outlook for stocks within this sector [8]

Revenue and Financial Performance - Revenue for Q3 2025 was $2.5 million, up from $1.0 million in Q3 2024, primarily due to research activities under the collaboration agreement with Amgen[96]. - For the nine months ended September 30, 2025, revenue increased to $7.8 million from $2.2 million in the same period in 2024, also driven by the Amgen collaboration[101]. - Net loss for Q3 2025 was $35.7 million, compared to a net loss of $29.9 million in Q3 2024, reflecting an increase in operating expenses[96]. - The company reported a net loss of $106.8 million for the nine months ended September 30, 2025, compared to a net loss of $91.7 million for the same period in 2024[89]. - Net cash used in operating activities was $103.3 million for the nine months ended September 30, 2025, compared to $83.4 million in 2024, reflecting a net loss of $106.8 million[123]. Operating Expenses - Total operating expenses for Q3 2025 were $39.6 million, up from $33.7 million in Q3 2024, with research and development expenses increasing by $5.4 million[96]. - Research and development expenses for Q3 2025 totaled $31.7 million, an increase of $5.4 million from $26.3 million in Q3 2024, driven by higher laboratory supplies and clinical study costs[97]. - General and administrative expenses for Q3 2025 were $7.9 million, up from $7.4 million in Q3 2024, primarily due to increased personnel expenses[98]. - Research and development expenses increased by $16.1 million to $94.1 million for the nine months ended September 30, 2025, compared to $78.0 million in 2024, primarily due to a $8.0 million increase in laboratory supplies and a $4.3 million increase in personnel expenses[102]. - General and administrative expenses rose by $3.3 million to $25.6 million for the nine months ended September 30, 2025, from $22.3 million in 2024, mainly driven by a $1.6 million increase in personnel expenses[104]. Cash and Funding - The company had cash, cash equivalents, and marketable securities of $184.5 million as of September 30, 2025, expected to fund operations into the second half of 2027[113]. - The company completed a public offering in June 2023, raising approximately $134.7 million in net proceeds from the sale of 23,287,134 shares at $2.00 per share[107]. - A subsequent public offering in April 2024 generated approximately $161.4 million in net proceeds from the sale of 4,958,068 shares at $7.13 per share[108]. - The company believes its existing cash and marketable securities will fund operations into the second half of 2027, but may need additional funding to support growth strategies[94]. - The company anticipates needing to raise substantial additional capital to fund operations and product development in the future[119]. Workforce and Strategic Plans - The company implemented a workforce reduction of approximately 30%, or 66 roles, to prioritize clinical development of its heme program[112]. - The company plans to expand its heme program with additional TCRs targeting other HLA types, including TSC-102-A0301 and TSC-102-A0101[84]. - The company expects to incur significant losses for the foreseeable future as it ramps up preclinical and clinical development programs[117]. Accounting and Reporting - The company qualifies as an "emerging growth company" under the JOBS Act, allowing it to take advantage of an extended transition period for new accounting standards[131]. - The market value of the company's stock held by non-affiliates is less than $700 million, qualifying it as a "smaller reporting company"[133]. - The company has not reported any material changes to its critical accounting policies and estimates since its last annual report[130]. - The company’s actual results may differ from estimates based on historical experience and known trends[129]. - The company has opted to adopt new or revised accounting standards at the same time as private companies, unless it elects to opt out[132].

Financial Performance - Revenue for Q3 2025 was $2.5 million, a 150% increase from $1.0 million in Q3 2024, primarily due to research activities under a collaboration agreement with Amgen[9] - R&D expenses for Q3 2025 were $31.7 million, up from $26.3 million in Q3 2024, driven by increased manufacturing and clinical activities[10] - G&A expenses for Q3 2025 were $7.9 million, compared to $7.4 million in Q3 2024, mainly due to personnel costs[11] - Net loss for Q3 2025 was $35.7 million, compared to $29.9 million in Q3 2024, including net interest income of $1.3 million[12] - Cash, cash equivalents, and marketable securities as of September 30, 2025, were $184.5 million, expected to fund operations into the second half of 2027[12] Clinical Development - The pivotal trial for TSC-101 is expected to begin in Q2 2026, following an agreement with the FDA on the trial design[3] - The company plans to present updated clinical data from the ALLOHA Phase 1 heme trial at the ASH Annual Meeting on December 6, 2025[5] - The company has paused enrollment in the PLEXI-T trial to focus on preclinical development for solid tumors[15] Manufacturing and Product Development - A commercial-ready manufacturing process has been implemented, reducing manufacturing time by five days and lowering costs[4] - Plans to submit IND applications for two additional TCR-T product candidates in Q4 2025 to expand HLA coverage of the heme program[7]

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]