First patient dosed in Phase 3 ALLOHA-2™ study; topline readout expected mid-2028
Shared positive initial data from Cohort C of Phase 1 ALLOHA™ study, validating internal commercial-ready manufacturing process
Cash and cash equivalents fund operations into the second quarter of 2027
“This is a transformative time for TScan with our first pivotal study now enrolling at major transplant centers across the U.S.,” said
Recent Corporate Highlights
- In July, the Company announced that it has dosed the first patient in the ongoing Phase 3 ALLOHA-2™ clinical trial evaluating TSC-101 for the treatment of patients with heme malignancies undergoing allogeneic hematopoietic cell transplantation (allo-HCT). The Company anticipates completion of enrollment and reporting of topline data from this pivotal study mid-2028.
- In June, the Company reported positive initial data from Cohort C of the Phase 1 ALLOHA™ study (NCT05473910) and additional patient characteristics are described below.
- ~90% first-pass manufacturing success rate (17/19) with commercial-ready process.
- Most patients enrolled in Cohort C had poor prognostic features, with 86% of patients (12/14) being minimal residual disease (MRD)-positive prior to transplant and 86% (12/14) having mixed donor chimerism at their first assessment post-transplant.
- Despite having aggressive disease with a high risk of relapse, patients infused with TSC-101 have demonstrated meaningful clinical benefit from the product candidate. 79% of patients (11/14) achieved complete donor chimerism within ~three weeks of receiving their first infusion of TSC-101; an additional two had improving chimerism following TSC-101, which is consistent with eliminating residual cancer cells and correlates with preventing post-transplant relapse.
- TSC-101 continued to be well-tolerated, with observed safety consistent with post-HCT adverse events.
- In June, the Company announced that it has entered into an agreement with Cellares, the first integrated development and manufacturing organization (IDMO), to assess Cellares’ fully automated Cell Shuttle® and Cell Q™ platforms as a potentially scalable and cost-efficient path to commercial manufacturing.
Pipeline Progress and Upcoming Anticipated Milestones
Heme Malignancies Program: TScan’s lead TCR-T therapy candidate, TSC-101, is designed to treat residual disease and prevent relapse in patients with heme malignancies undergoing allogeneic HCT (ALLOHA-2™ trial, NCT07702578).
- Share updated data on patients treated in Cohort C of the Phase 1 ALLOHA™ study in the fourth quarter of 2026.
- Initiate Phase 1 study of TSC-102-A01 and TSC-102-A03 in the fourth quarter of 2026 with initial data in 2027.
- Share updated data, inclusive of over 1-year of follow-up time, on Cohort C patients of the ALLOHA study in the first half of 2027.
Solid Tumor Program: The Company’s strategy is to treat patients with multiple TCR-T therapy candidates to overcome tumor heterogeneity.
- Currently developing methods to engineer TCR-Ts in vivo to treat solid tumors, with initial candidates in preclinical development.
- Established a roadmap for filing an investigational new drug (IND) application by H2 2027 after recent INTERACT engagement with the
U.S. Food and Drug Administration (FDA).
Autoimmunity Program: The Company has discovered novel targets for ankylosing spondylitis and other HLA-B*27-associated autoimmune disorders and is currently developing potential treatment options.
Second Quarter 2026 Financial Results
Revenue: Revenue for the second quarter of 2026 was
R&D Expenses: Research and development (R&D) expenses for the second quarter of 2026 were
G&A Expenses: General and administrative (G&A) expenses for the second quarter of 2026 were
Net Loss: Net loss was
Cash Position: Cash and cash equivalents as of
Share Count: As of
About TScan Therapeutics, Inc.
TScan is a clinical-stage biotechnology company focused on the development of T cell receptor (TCR)-engineered T cell (TCR-T) therapies for the treatment of patients with cancer. The Company’s lead TCR-T therapy candidate, TSC-101, is in development for the treatment of patients with hematologic malignancies to prevent relapse following allogeneic hematopoietic cell transplantation (the ALLOHA-2™ Phase 3 pivotal trial). The Company is also in early stages of developing methods for in vivo engineering to treat solid tumors. In addition, the Company is applying its target discovery platform to discover novel targets in various T cell-mediated autoimmune disorders.
Forward-Looking Statements
This release contains 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 TScan’s plans, progress, expectations, and timing relating to the ALLOHA™ and ALLOHA-2™ clinical trials, including presentation of data and the implications of such results, enrollment and dosing of patients, and clinical trial design; plans, progress, expectations, and timing relating to TScan’s TSC-102-A01 and TSC-102-A03 Phase 1 study; the evaluation of Cellares’s fully automated manufacturing platforms being indicative of Cellares’s successful manufacturing support of TScan’s programs, including scalability and cost-effectiveness; TScan’s plans, progress, and timing relating to TScan’s solid tumor program, including preclinical development and submission of an IND application; TScan’s plans, process, and timing relating TScan’s autoimmunity program; the potential benefits of any of TScan’s proprietary platforms or current or future product candidates in treating patients; TScan’s ability to fund its operating plan into the second quarter of 2027 with its existing cash resources; and TScan’s goals and strategy. TScan intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as, but not limited to, “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “anticipate,” “project,” “target,” “design,” “estimate,” “predict,” “potential,” “plan,” “on track,” or similar expressions or the negative of those terms. Such forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions, and uncertainties. The express or implied forward-looking statements included in this release are only predictions and are subject to a number of risks, uncertainties and assumptions, including, without limitation: the beneficial characteristics, safety, efficacy, therapeutic effects and potential advantages of TScan’s TCR-T therapy product candidates; TScan’s expectations regarding its preclinical studies or clinical trials being predictive of future clinical trial results; TScan’s cleared INDs being indicative or predictive of bringing TScan closer to its goal of providing customized TCR-T therapies to treat patients with cancer; the timing of the launch, initiation, progress, expected results and announcements of TScan’s preclinical studies, clinical trials and its research and development programs; TScan’s ability to enroll patients for its clinical trials within its expected timeline; TScan’s plans relating to developing and commercializing its TCR-T therapy product candidates, if approved, including sales strategy; estimates of the size of the addressable market for TScan’s TCR-T therapy product candidates; TScan’s manufacturing capabilities and the scalable nature of its manufacturing process; TScan’s estimates regarding expenses, future milestone payments and revenue, capital requirements and needs for additional financing; TScan’s expectations regarding competition; TScan’s anticipated growth strategies; TScan’s ability to attract or retain key personnel; TScan’s ability to establish and maintain development partnerships and collaborations; TScan’s expectations regarding federal, state and foreign regulatory requirements; TScan’s ability to obtain and maintain intellectual property protection for its proprietary platform technology and our product candidates; the sufficiency of TScan’s existing capital resources to fund its future operating expenses and capital expenditure requirements; and other factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of TScan’s most recent Annual Report on Form 10-K and any other filings that TScan has made or may make with the SEC in the future. Any forward-looking statements contained in this release represent TScan’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Except as required by law, TScan explicitly disclaims any obligation to update any forward-looking statements.
Investor and Media Contact
Caileigh Dougherty
AVP, Head of Corporate Communications & Investor Relations
857-399-9890
cdougherty@tscan.com
| Condensed Consolidated Balance Sheet Data | |||||||
| (unaudited, in thousands, except share amount) | |||||||
| Assets | |||||||
| Cash and cash equivalents | $ | 100,156 | $ | 152,406 | |||
| Other assets | 71,296 | 76,383 | |||||
| Total assets | $ | 171,452 | $ | 228,789 | |||
| Liabilities and Stockholders' Equity | |||||||
| Total liabilities | $ | 102,433 | $ | 105,666 | |||
| Total stockholders' equity | 69,019 | 123,123 | |||||
| Total liabilities and stockholders' deficit | $ | 171,452 | $ | 228,789 | |||
| Common stock and pre-funded warrants outstanding(1) | 130,025,962 | 129,913,390 | |||||
| (1)Includes at | |||||||
| Condensed Consolidated Statements of Operations | |||||||||
| (unaudited, in thousands, except share and per share amounts) | |||||||||
| Three Months Ended | |||||||||
| 2026 | 2025 | ||||||||
| Revenue: | |||||||||
| Collaboration and license revenue | $ | 1,051 | $ | 3,076 | |||||
| Operating expenses: | |||||||||
| Research and development | 23,402 | 32,634 | |||||||
| General and administrative | 8,142 | 9,095 | |||||||
| Total operating expenses | 31,544 | 41,729 | |||||||
| Loss from operations | (30,493 | ) | (38,653 | ) | |||||
| Interest and other income, net | 833 | 2,390 | |||||||
| Interest expense | (699 | ) | (689 | ) | |||||
| Net loss | $ | (30,359 | ) | $ | (36,952 | ) | |||
| Net loss per share, basic and diluted | $ | (0.23 | ) | $ | (0.28 | ) | |||
| Weighted average common shares outstanding—basic and diluted(2) | 129,948,878 | 129,730,451 | |||||||
| (2)For the three months ended | |||||||||
