[Special Note Regarding Forward-Looking Statements](index=2&type=section&id=SPECIAL%20NOTE%20REGARDING%20FORWARD-LOOKING%20STATEMENTS) This section highlights forward-looking statements, subject to substantial risks and uncertainties - This report contains forward-looking statements involving substantial risks and uncertainties, identifiable by words like 'expect,' 'plan,' 'anticipate,' or 'potential'[5](index=5&type=chunk)[6](index=6&type=chunk) - Forward-looking statements cover anticipated use of cash, product candidate characteristics, preclinical/clinical trial timing and results, regulatory approvals, commercialization plans, market size estimates, manufacturing capabilities, expenses, competition, growth strategies, personnel, partnerships, regulatory requirements, intellectual property, and economic factors[7](index=7&type=chunk) - Actual results may differ materially due to known and unknown risks, uncertainties, and assumptions, particularly those described in the 'Risk Factors' section'[8](index=8&type=chunk) [Risk Factor Summary](index=4&type=section&id=RISK%20FACTOR%20SUMMARY) This summary outlines key risks impacting the company's business and financial prospects - The company's business operations are subject to numerous risks that could materially and adversely affect its business, financial condition, results of operations, and future growth prospects[14](index=14&type=chunk) - Key risk categories include business and industry, product candidate development, manufacturing, government regulation, intellectual property, reliance on third parties, employee matters and growth management, common stock and public company status, and general risk factors[14](index=14&type=chunk)[15](index=15&type=chunk)[17](index=17&type=chunk) [PART I. FINANCIAL INFORMATION](index=6&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section presents the company's unaudited financial statements and management's financial analysis [Item 1. Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents the company's unaudited consolidated financial statements and accompanying notes [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section presents the company's condensed consolidated balance sheets, showing assets, liabilities, and equity | Category | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :-------------------------------- | :--------------------------- | :----------------------------- | | Cash and cash equivalents | $169,394 | $178,689 | | Marketable securities | $48,651 | $111,421 | | Total current assets | $221,130 | $292,722 | | Total assets | $298,561 | $371,118 | | Total current liabilities | $31,322 | $35,956 | | Total liabilities | $121,847 | $130,148 | | Total stockholders' equity | $176,714 | $240,970 | | Accumulated deficit | $(446,175) | $(375,096) | - Total assets decreased by **$72.557 million** from December 31, 2024, to June 30, 2025, primarily due to a reduction in marketable securities and cash and cash equivalents[22](index=22&type=chunk) - Total stockholders' equity decreased by **$64.256 million**, driven by an increased accumulated deficit[22](index=22&type=chunk) [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) This section presents the company's condensed consolidated statements of operations for recent interim periods | Category | Three Months Ended June 30, 2025 (in thousands) | Three Months Ended June 30, 2024 (in thousands) | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :-------------------------------- | :-------------------------------------- | :-------------------------------------- | :------------------------------------ | :------------------------------------ | | Collaboration and license revenue | $3,076 | $536 | $5,247 | $1,102 | | Research and development | $32,634 | $26,877 | $62,422 | $51,734 | | General and administrative | $9,095 | $7,773 | $17,728 | $14,855 | | Total operating expenses | $41,729 | $34,650 | $80,150 | $66,589 | | Loss from operations | $(38,653) | $(34,114) | $(74,903) | $(65,487) | | Net loss | $(36,952) | $(31,661) | $(71,079) | $(61,803) | | Net loss per share, basic and diluted | $(0.28) | $(0.28) | $(0.55) | $(0.59) | - Collaboration and license revenue increased significantly for both the three-month period (from **$536 thousand** to **$3.076 million**) and six-month period (from **$1.102 million** to **$5.247 million**) year-over-year[25](index=25&type=chunk) - Net loss increased to **($36.952) million** for the three months ended June 30, 2025, from **($31.661) million** in the prior year, and to **($71.079) million** for the six months ended June 30, 2025, from **($61.803) million** in the prior year, primarily due to increased operating expenses[25](index=25&type=chunk) [Condensed Consolidated Statements of Stockholders' Equity](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity) This section presents the company's condensed consolidated statements of stockholders' equity | Category | Balances at March 31, 2024 (in thousands) | Balances at June 30, 2024 (in thousands) | Balances at March 31, 2025 (in thousands) | Balances at June 30, 2025 (in thousands) | | :-------------------------------- | :-------------------------------------- | :------------------------------------- | :-------------------------------------- | :------------------------------------- | | Common Stock Shares | 43,628,149 | 48,656,158 | 52,314,039 | 52,471,405 | | Additional Paid-In Capital | $400,701 | $564,615 | $619,423 | $622,887 | | Accumulated Deficit | $(277,739) | $(309,400) | $(409,223) | $(446,175) | | Total Stockholders' Equity | $122,967 | $255,221 | $210,202 | $176,714 | - Total stockholders' equity decreased from **$240.970 million** at January 1, 2025, to **$176.714 million** at June 30, 2025, primarily due to a net loss of **$71.079 million**[28](index=28&type=chunk) - Additional paid-in capital increased by **$6.878 million** during the six months ended June 30, 2025, mainly from stock-based compensation expense and ESPP plan issuance[28](index=28&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section presents the company's condensed consolidated statements of cash flows | Category | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :------------------------------------------ | :------------------------------------ | :------------------------------------ | | Net cash used in operating activities | $(70,853) | $(55,492) | | Net cash provided by investing activities | $61,967 | $2,447 | | Net cash provided by (used in) financing activities | $(409) | $161,845 | | Net increase (decrease) in cash, cash equivalents and restricted cash | $(9,295) | $108,800 | | Cash, cash equivalents, and restricted cash - end of period | $174,425 | $247,190 | - Net cash used in operating activities increased to **$70.853 million** for the six months ended June 30, 2025, from **$55.492 million** in the prior year[31](index=31&type=chunk) - Net cash provided by investing activities significantly increased to **$61.967 million** in 2025 from **$2.447 million** in 2024, primarily due to marketable securities maturities[31](index=31&type=chunk) - Net cash from financing activities shifted from providing **$161.845 million** in 2024 to using **$409 thousand** in 2025, reflecting reduced equity offerings[31](index=31&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed notes to the unaudited condensed consolidated financial statements [1. Nature of Business and Basis of Presentation](index=11&type=section&id=1.%20Nature%20of%20Business%20and%20Basis%20of%20Presentation) This note describes TScan Therapeutics' business as a clinical-stage biotech and its accounting basis - TScan Therapeutics, Inc. is a clinical-stage biotechnology company developing TCR-T therapy product candidates for the treatment of cancer[34](index=34&type=chunk) - The company has incurred recurring net losses, including **$71.1 million** for the six months ended June 30, 2025, and has an accumulated deficit of **$446.2 million**[37](index=37&type=chunk) - Existing cash, cash equivalents, and marketable securities are expected to fund operations for at least the next 12 months from the date of financial statements issuance[37](index=37&type=chunk) - The company qualifies as an "emerging growth company" and has elected to use the extended transition period for complying with new or revised accounting standards[38](index=38&type=chunk) [2. Summary of Significant Accounting Policies](index=12&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) This note summarizes the company's accounting policies and evaluation of new pronouncements - The accounting policies for interim financial reporting are consistent with those in the Company's Annual Report on Form 10-K for the year ended December 31, 2024[40](index=40&type=chunk) - The company is evaluating the impact of ASU No. 2023-09, "Income Taxes (Topic 740): Improvements to Income Tax Disclosures," effective for annual periods beginning after December 15, 2024[41](index=41&type=chunk) - The company is evaluating the potential impact of ASU No. 2024-03, "Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures," effective for annual periods beginning after December 15, 2026[43](index=43&type=chunk) [3. Fair Value Measurements](index=12&type=section&id=3.%20Fair%20Value%20Measurements) This note details the fair value measurements of the company's financial assets, primarily cash equivalents and marketable securities | Asset Category | June 30, 2025 (Level 1) | December 31, 2024 (Level 1) | | :----------------------------- | :---------------------- | :-------------------------- | | Cash equivalents – money market funds | $162,200 | $169,744 | | Cash equivalents - government securities | $2,993 | - | | Marketable securities – government securities | $48,651 | $111,421 | | **Total financial assets** | **$213,844** | **$281,165** | - Money market funds and government securities are valued based on quoted market prices, representing a Level 1 measurement within the fair value hierarchy[44](index=44&type=chunk) [4. Accrued Expenses and Other Current Liabilities](index=13&type=section&id=4.%20Accrued%20Expenses%20and%20Other%20Current%20Liabilities) This note explains the composition and changes in accrued expenses and other current liabilities | Category | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :------------------------------------ | :--------------------------- | :----------------------------- | | Accrued research and development | $7,054 | $6,735 | | Accrued employee compensation and benefits | $3,662 | $6,845 | | Accrued consulting and professional services | $1,534 | $1,473 | | Accrued legal services and license fee | $357 | $281 | | Other | $190 | $76 | | **Total accrued expenses and other current liabilities** | **$12,797** | **$15,410** | - Accrued employee compensation and benefits decreased by **$3.183 million** from December 31, 2024, to June 30, 2025[46](index=46&type=chunk) [5. Stockholders' Equity](index=13&type=section&id=5.%20Stockholders%27%20Equity) This note details the company's equity offerings and changes in stockholders' equity - On May 16, 2023, the company entered into an "at-the-market" (ATM) sales agreement for up to **$75.0 million** of voting common stock, with no sales to date[47](index=47&type=chunk) - On April 24, 2024, an underwritten public offering generated approximately **$161.4 million** in aggregate net proceeds from common stock and pre-funded warrants[49](index=49&type=chunk) - On December 27, 2024, a registered direct offering of pre-funded warrants generated approximately **$30.0 million** in gross proceeds[50](index=50&type=chunk) - As of June 30, 2025, no Pre-Funded Warrants have been exercised[51](index=51&type=chunk) [6. Collaboration and License Agreements](index=13&type=section&id=6.%20Collaboration%20and%20License%20Agreements) This note describes the company's collaboration and license agreements, including the Amgen agreement - On May 8, 2023, TScan Therapeutics entered a Collaboration Agreement with Amgen Inc. to identify antigens recognized by T cells in patients with Crohn's disease[52](index=52&type=chunk) - The agreement included an upfront payment of **$30.0 million**, collected in July 2023, and eligibility for over **$500.0 million** in success-based milestone payments and tiered single-digit royalties[53](index=53&type=chunk) - Revenue associated with the Amgen Agreement is recognized over the estimated three-year research term using an input method based on costs incurred[56](index=56&type=chunk) | Period | 2025 (in thousands) | 2024 (in thousands) | | :------------------- | :------------------ | :------------------ | | Three Months Ended June 30, | $3,076 | $536 | | Six Months Ended June 30, | $5,247 | $1,102 | [7. Commitments and Contingencies](index=14&type=section&id=7.%20Commitments%20and%20Contingencies) This note outlines the company's lease commitments, license agreements, and royalty obligations - The company leases office space under non-cancelable operating lease agreements, with no material changes during the period[59](index=59&type=chunk) - TScan holds a worldwide exclusive license to its foundational TargetScan technology from Brigham and Women's Hospital, which includes fees for development milestones and various royalties on future product sales[60](index=60&type=chunk) - A royalty agreement with one of its founders mandates a **1%** royalty of net sales for products covered by specific patents, payable in perpetuity for a defined period[61](index=61&type=chunk) [8. Loan and Security Agreements](index=15&type=section&id=8.%20Loan%20and%20Security%20Agreements) This note details the company's debt agreements, including the termination of K2HV and new SVB loan - On December 20, 2024, the K2HV Loan Agreement was terminated, with **$15.0 million** in remaining principal, a **$1.8 million** exit fee, and a **$0.3 million** prepayment fee repaid[63](index=63&type=chunk) - A new Loan and Security Agreement with Silicon Valley Bank (SVB) was entered into on December 20, 2024, providing up to **$52.5 million**, with a first tranche of **$32.5 million** fully funded[65](index=65&type=chunk) - The SVB term loans mature on September 1, 2029, with monthly interest-only payments until September 30, 2027, contingent on achieving certain financial and clinical milestones[66](index=66&type=chunk) | Period | Interest Expense (in thousands) | | :------------------- | :------------------------------ | | Three Months Ended June 30, 2025 | $689 | | Three Months Ended June 30, 2024 | $952 | | Six Months Ended June 30, 2025 | $1,368 | | Six Months Ended June 30, 2024 | $1,911 | | Year | Future Principal Payments (in thousands) | | :--- | :------------------------------------- | | 2027 | $4,063 | | 2028 | $16,250 | | 2029 | $12,187 | | **Total principal payments** | **$32,500** | [9. Segment Reporting](index=16&type=section&id=9.%20Segment%20Reporting) This note states the company operates as a single segment focused on TCR-T therapy development - The company manages its operations as a single segment, focused on the development of TCR-T therapy product candidates for cancer[72](index=72&type=chunk) - The Chief Operating Decision Maker (CODM) assesses performance by reviewing GAAP net loss and significant expenses by function, along with annual budget variances[73](index=73&type=chunk) [10. Net Loss Per Share](index=17&type=section&id=10.%20Net%20Loss%20Per%20Share) This note provides the calculation of basic and diluted net loss per share | Period | Net Loss Per Share (basic and diluted) | | :------------------------------------------------ | :------------------------------------- | | Three Months Ended June 30, 2025 | $(0.28) | | Three Months Ended June 30, 2024 | $(0.28) | | Six Months Ended June 30, 2025 | $(0.55) | | Six Months Ended June 30, 2024 | $(0.59) | - **73,087,945** shares of common stock issuable upon exercise of Pre-Funded Warrants are included as outstanding common stock in the calculation of basic and diluted net loss per share[76](index=76&type=chunk) | Anti-Dilutive Potential Common Shares | June 30, 2025 | June 30, 2024 | | :------------------------------------ | :------------ | :------------ | | Options to purchase common stock | 17,917,902 | 12,804,957 | | Common stock issuable upon conversion of K2HV Loan Agreement | - | 6,269,592 | | Potential shares issuable under the ESPP | 109,984 | 69,617 | | **Total** | **18,027,886** | **19,144,166** | [11. Subsequent Event](index=17&type=section&id=11.%20Subsequent%20Event) This note describes the enactment of the OBBBA tax act and its potential impact on the company - The One Big Beautiful Bill Act (OBBBA) was enacted on July 4, 2025, introducing significant changes to U.S. tax law, including mandatory research and development capitalization[78](index=78&type=chunk) - The company is currently analyzing the impact of these changes, awaiting regulations and guidance from the Department of Treasury[78](index=78&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=17&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's analysis of the company's financial condition, operations, and future outlook [Overview](index=18&type=section&id=Overview) This overview describes TScan Therapeutics' business, financial performance, and future funding needs - TScan Therapeutics is a clinical-stage biotechnology company focused on developing TCR-T therapies for hematologic and solid tumor malignancies, utilizing its ImmunoBank and proprietary platform technologies[81](index=81&type=chunk)[83](index=83&type=chunk) - The company's lead product candidate, TSC-101, is in a Phase 1 clinical study for AML, MDS, and ALL patients undergoing allogeneic HCT[82](index=82&type=chunk) - TScan reported net losses of **$71.1 million** for the six months ended June 30, 2025, and has an accumulated deficit of **$446.2 million** since inception[85](index=85&type=chunk) - The company expects to incur significant expenses and increasing operating losses, requiring substantial additional funding to advance its product candidates and build commercial capabilities[85](index=85&type=chunk)[87](index=87&type=chunk) [Results of Operations](index=19&type=section&id=Results%20of%20Operations) This section analyzes the company's financial performance, highlighting revenue and expense trends [Three months ended June 30, 2025 and 2024](index=20&type=section&id=Three%20months%20ended%20June%2030%2C%202025%20and%202024) This section compares financial results for the three months ended June 30, 2025 and 2024 | Category | June 30, 2025 (in thousands) | June 30, 2024 (in thousands) | Change (in thousands) | | :-------------------------------- | :--------------------------- | :--------------------------- | :-------------------- | | Collaboration and license revenue | $3,076 | $536 | $2,540 | | Research and development | $32,634 | $26,877 | $5,757 | | General and administrative | $9,095 | $7,773 | $1,322 | | Total operating expenses | $41,729 | $34,650 | $7,079 | | Loss from operations | $(38,653) | $(34,114) | $(4,539) | | Net loss | $(36,952) | $(31,661) | $(5,291) | - Research and development expenses increased by **$5.8 million**, primarily due to a **$3.8 million** increase in laboratory supplies, research materials, and studies, and a **$1.7 million** increase in facility-related expenses[92](index=92&type=chunk) - General and administrative expenses increased by **$1.3 million**, mainly due to a **$0.7 million** increase in personnel expenses from additional headcount[94](index=94&type=chunk) [Six months ended June 30, 2025 and 2024](index=21&type=section&id=Six%20months%20ended%20June%2030%2C%202025%20and%202024) This section compares financial results for the six months ended June 30, 2025 and 2024 | Category | June 30, 2025 (in thousands) | June 30, 2024 (in thousands) | Change (in thousands) | | :-------------------------------- | :--------------------------- | :--------------------------- | :-------------------- | | Collaboration and license revenue | $5,247 | $1,102 | $4,145 | | Research and development | $62,422 | $51,734 | $10,688 | | General and administrative | $17,728 | $14,855 | $2,873 | | Total operating expenses | $80,150 | $66,589 | $13,561 | | Loss from operations | $(74,903) | $(65,487) | $(9,416) | | Net loss | $(71,079) | $(61,803) | $(9,276) | - Research and development expenses increased by **$10.7 million**, primarily due to a **$6.0 million** increase in laboratory supplies, research materials, and studies, and a **$3.4 million** increase in facility-related expenses[99](index=99&type=chunk) - General and administrative expenses increased by **$2.9 million**, mainly due to a **$1.1 million** increase in personnel expenses and a **$0.3 million** increase in legal and professional fees[100](index=100&type=chunk) [Liquidity and Capital Resources](index=22&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's funding sources, capital requirements, and cash flow activities [Sources of Liquidity](index=22&type=section&id=Sources%20of%20Liquidity) This section details the company's sources of liquidity, including equity offerings and collaboration agreements - The company received a **$30.0 million** upfront payment in July 2023 from the Amgen Collaboration Agreement[102](index=102&type=chunk) - An underwritten public offering in April 2024 generated approximately **$161.4 million** in net proceeds from common stock and pre-funded warrants[105](index=105&type=chunk) - A registered direct offering in December 2024 generated approximately **$30.0 million** in gross proceeds from pre-funded warrants[107](index=107&type=chunk) - As of June 30, 2025, the company had **$218.0 million** in cash, cash equivalents, and marketable securities (excluding **$5.0 million** restricted cash)[108](index=108&type=chunk) [Funding requirements](index=23&type=section&id=Funding%20requirements) This section outlines the company's anticipated funding needs for R&D, clinical trials, and commercialization efforts - The company expects expenses to increase substantially for research and development, preclinical/clinical development, manufacturing, regulatory approvals, and commercialization[109](index=109&type=chunk) - Existing cash, cash equivalents, and marketable securities are believed to fund the current operating plan into the first quarter of 2027[110](index=110&type=chunk) - Substantial additional funding will be required through equity offerings, debt financings, collaborations, or other arrangements, which may dilute ownership or impose restrictions[111](index=111&type=chunk) - Failure to raise additional funds could lead to delays, reductions, or termination of research, product development, or commercialization efforts[111](index=111&type=chunk) [Cash Flows](index=25&type=section&id=Cash%20Flows) This section summarizes the company's cash flow activities from operations, investing, and financing | Category | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :------------------------------------------ | :------------------------------------ | :------------------------------------ | | Net cash used in operating activities | $(70,853) | $(55,492) | | Net cash provided by investing activities | $61,967 | $2,447 | | Net cash provided by (used in) financing activities | $(409) | $161,845 | | **Net increase (decrease) in cash, cash equivalents and restricted cash** | **$(9,295)** | **$108,800** | - Net cash used in operating activities for the six months ended June 30, 2025, was **$70.9 million**, primarily driven by the net loss of **$71.1 million**[118](index=118&type=chunk) - Net cash provided by investing activities was **$62.0 million** for the six months ended June 30, 2025, mainly from maturities of marketable securities[120](index=120&type=chunk) - Net cash used in financing activities was **$0.4 million** for the six months ended June 30, 2025, compared to **$161.8 million** provided in the prior year, reflecting reduced equity proceeds[121](index=121&type=chunk)[122](index=122&type=chunk) [Critical Accounting Policies and Estimates](index=25&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) This section confirms no material changes to the company's critical accounting policies and estimates - There have been no material changes to the company's critical accounting policies and estimates from those disclosed in its Annual Report on Form 10-K filed on March 5, 2025[125](index=125&type=chunk) [Emerging Growth Company and Smaller Reporting Company Status](index=26&type=section&id=Emerging%20Growth%20Company%20and%20Smaller%20Reporting%20Company%20Status) This section explains the company's status as an emerging growth and smaller reporting company - The company qualifies as an "emerging growth company" under the JOBS Act and has elected the extended transition period for complying with new or revised accounting standards[126](index=126&type=chunk) - The company is also a "smaller reporting company," which allows for reduced disclosure obligations, including auditor attestation requirements and executive compensation details[127](index=127&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=25&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, TScan Therapeutics is not required to provide market risk disclosures - As a "smaller reporting company," TScan Therapeutics is not required to provide quantitative and qualitative disclosures about market risk[128](index=128&type=chunk) [Item 4. Controls and Procedures](index=25&type=section&id=Item%204.%20Controls%20and%20Procedures) This section details management's evaluation of disclosure controls and internal control over financial reporting [Evaluation of Disclosure Controls and Procedures](index=26&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) Management evaluated the effectiveness of disclosure controls and procedures, concluding they were effective - Management, under the supervision of the Principal Executive Officer and Principal Financial Officer, evaluated the effectiveness of disclosure controls and procedures as of June 30, 2025[129](index=129&type=chunk) - Based on the evaluation, disclosure controls and procedures were concluded to be effective at the reasonable assurance level[129](index=129&type=chunk) [Changes in Internal Control over Financial Reporting](index=27&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) No material changes in internal control over financial reporting occurred during the period - No change in internal control over financial reporting occurred during the period ended June 30, 2025, that materially affected, or is reasonably likely to materially affect, internal control over financial reporting[131](index=131&type=chunk) [PART II. OTHER INFORMATION](index=27&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section covers legal proceedings, risk factors, equity sales, and other miscellaneous information [Item 1. Legal Proceedings](index=27&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings - The company is not currently a party to any material legal proceedings[133](index=133&type=chunk) - Involvement in legal proceedings, even in the ordinary course of business, can have an adverse impact due to defense and settlement costs, diversion of management resources, negative publicity, and reputational harm[133](index=133&type=chunk) [Item 1A. Risk Factors](index=28&type=section&id=Item%201A.%20Risk%20Factors) This section details significant risks that could materially affect the company's business and prospects [Risks Related to Our Business and Industry](index=29&type=section&id=Risks%20Related%20to%20Our%20Business%20and%20Industry) This section outlines risks related to the company's business model, operating history, and economic factors - The company has incurred significant net losses (**$71.1 million** for H1 2025, **$446.2 million** accumulated deficit) and expects increasing losses, requiring substantial additional funding[138](index=138&type=chunk)[149](index=149&type=chunk) - Business success depends on the proprietary platform for discovering and developing TCR-T therapy product candidates, which is a novel approach to cancer treatment[140](index=140&type=chunk)[172](index=172&type=chunk) - Limited operating history makes it difficult to assess future viability and successful transition from R&D to commercial activities[143](index=143&type=chunk)[144](index=144&type=chunk) - Global economic uncertainty, financial market volatility, and changes in federal policies (e.g., tax laws like OBBBA) could adversely affect financing access and business operations[156](index=156&type=chunk)[159](index=159&type=chunk)[160](index=160&type=chunk) [Risks Related to the Development of Our Product Candidates](index=35&type=section&id=Risks%20Related%20to%20the%20Development%20of%20Our%20Product%20Candidates) This section details risks associated with developing novel TCR-T therapy product candidates - Developing TCR-T therapy product candidates is a novel approach with significant challenges, including educating medical personnel, sourcing supplies, manufacturing efficiently, and managing adverse side effects[172](index=172&type=chunk)[173](index=173&type=chunk) - Preclinical studies and clinical trials may fail to adequately demonstrate safety, potency, and purity, leading to delays or prevention of regulatory approval and commercialization[184](index=184&type=chunk)[187](index=187&type=chunk) - Product candidates may cause undesirable side effects (e.g., GvHD, autoimmunity, immunogenicity) that could halt clinical development, require trial expansion, or limit commercial potential[207](index=207&type=chunk)[208](index=208&type=chunk)[210](index=210&type=chunk)[212](index=212&type=chunk) - Difficulties in enrolling patients in clinical trials, due to strict eligibility criteria, competition, or patient drop-out, could delay or adversely affect clinical development activities[218](index=218&type=chunk)[219](index=219&type=chunk)[220](index=220&type=chunk) - Product candidates may target healthy cells expressing target antigens, leading to serious and potentially fatal adverse effects, or exhibit cross-reactivity to unrelated peptides[215](index=215&type=chunk)[216](index=216&type=chunk) [Risks Related to Manufacturing](index=48&type=section&id=Risks%20Related%20to%20Manufacturing) This section outlines manufacturing risks, including complexity, third-party reliance, and scaling challenges - The manufacturing and administration process for product candidates is complex and highly regulated, susceptible to product loss or failure due to logistical issues, manufacturing interruptions, contamination, and equipment failure[258](index=258&type=chunk)[260](index=260&type=chunk) - The company relies on third parties for non-viral vectors and other components, and is reliant on single manufacturers/suppliers for critical raw materials and reagents, posing supply disruption risks[259](index=259&type=chunk)[427](index=427&type=chunk)[430](index=430&type=chunk) - Limited company experience in managing manufacturing facilities and scaling production could lead to cost-overruns, delays, and difficulties in maintaining quality control and regulatory compliance[264](index=264&type=chunk)[265](index=265&type=chunk) - Challenges in validating the manufacturing process due to the heterogeneity of patient starting material could impact the ability to manufacture product candidates for clinical or commercial distribution[267](index=267&type=chunk)[268](index=268&type=chunk) [Risks Related to Government Regulation](index=49&type=section&id=Risks%20Related%20to%20Government%20Regulation) This section details regulatory risks, including approval processes, pricing, and data privacy laws - The regulatory approval pathway for novel product candidates is uncertain, complex, expensive, and lengthy, with no guarantee of licensure[269](index=269&type=chunk) - Delays in clinical trials can occur due to regulatory disagreements, patient enrollment difficulties, or unforeseen safety issues, harming commercial prospects and increasing costs[271](index=271&type=chunk)[189](index=189&type=chunk) - Failure to obtain or maintain adequate coverage and reimbursement from governmental and private payors could limit market access and revenue generation for approved products[302](index=302&type=chunk)[306](index=306&type=chunk) - The company is subject to evolving data privacy laws (e.g., GDPR, CCPA, U.S. state laws) and regulations, with non-compliance potentially leading to significant fines, litigation, and reputational harm[327](index=327&type=chunk)[328](index=328&type=chunk)[332](index=332&type=chunk)[334](index=334&type=chunk) - Inadequate funding for regulatory agencies (FDA, SEC) or changes in leadership/policy could delay product review and approval, negatively impacting the business[315](index=315&type=chunk)[317](index=317&type=chunk) [Risks Related to Our Intellectual Property](index=62&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) This section outlines risks concerning patent protection, licensing, and potential infringement claims - Success depends on obtaining and maintaining patent protection for technology and product candidates, but meaningful coverage is uncertain and competitors may design around patents[344](index=344&type=chunk)[345](index=345&type=chunk)[347](index=347&type=chunk) - Patent prosecution is complex, expensive, and inconsistent across jurisdictions, with risks of failing to identify patentable aspects or timely filing applications[350](index=350&type=chunk) - Issued patents may be challenged, narrowed, or invalidated by third parties through litigation or administrative proceedings, reducing protection or allowing competitors to commercialize similar products[351](index=351&type=chunk)[352](index=352&type=chunk)[396](index=396&type=chunk) - Failure to comply with obligations under license agreements could lead to termination, loss of valuable rights, and impairment of product development[356](index=356&type=chunk)[357](index=357&type=chunk) - Limited foreign intellectual property rights and differing legal protections in other countries may hinder the ability to prevent infringement or marketing of competing products globally[399](index=399&type=chunk)[400](index=400&type=chunk) [Risks Related to Our Reliance on Third Parties](index=74&type=section&id=Risks%20Related%20to%20Our%20Reliance%20on%20Third%20Parties) This section details risks from relying on third parties for clinical trials, manufacturing, and collaborations - Reliance on third parties (independent investigators, CROs, CDMOs) for clinical trials means less direct control over conduct, timing, and data quality, potentially leading to delays or termination[410](index=410&type=chunk)[411](index=411&type=chunk) - Collaborations and strategic alliances carry risks, including partners not performing as expected, diverting resources, or developing competing products, potentially delaying or terminating development[417](index=417&type=chunk) - Reliance on a limited number of third-party manufacturers for product candidates exposes the company to risks of manufacturing difficulties, quality issues, and supply disruptions[422](index=422&type=chunk)[423](index=423&type=chunk) - The company's product candidates require specialty materials, some from single or limited suppliers, posing risks of unavailability or delays that could harm clinical or commercial manufacturing[427](index=427&type=chunk)[430](index=430&type=chunk) [Risks Related to Employee Matters and Managing Growth](index=79&type=section&id=Risks%20Related%20to%20Employee%20Matters%20and%20Managing%20Growth) This section outlines risks related to personnel, organizational growth, and product liability - The company is highly dependent on attracting and retaining qualified managerial, scientific, and medical personnel in a competitive biotechnology market[433](index=433&type=chunk)[434](index=434&type=chunk) - Future growth will require additional managerial, operational, sales, marketing, financial, and other personnel, as well as facilities, imposing significant added responsibilities on management[437](index=437&type=chunk) - The company faces an inherent risk of product liability from clinical testing and potential commercialization, which could result in substantial liabilities, decreased demand, and reputational harm[440](index=440&type=chunk)[442](index=442&type=chunk) [Risks Related to Our Common Stock and Our Status as a Public Company](index=81&type=section&id=Risks%20Related%20to%20Our%20Common%20Stock%20and%20Our%20Status%20as%20a%20Public%20Company) This section details risks concerning stock price volatility, ownership concentration, and public company status - The company's stock price is volatile and fluctuates substantially, influenced by factors such as clinical trial results, regulatory actions, and overall market conditions[446](index=446&type=chunk)[448](index=448&type=chunk) - Substantial sales of common stock by directors, executive officers, and significant stockholders could lead to a decline in the stock price[451](index=451&type=chunk)[454](index=454&type=chunk) - The concentration of stock ownership (approximately **25%** by executive officers, directors, and affiliates) limits other stockholders' ability to influence corporate matters[455](index=455&type=chunk) - As an "emerging growth company" and "smaller reporting company," the company benefits from reduced reporting requirements, but this status may make its common stock less attractive to some investors[456](index=456&type=chunk)[459](index=459&type=chunk) - Requirements associated with being a public company significantly increase costs and divert management attention, especially after ceasing to be an "emerging growth company"[461](index=461&type=chunk) - Delaware law and provisions in the company's amended and restated certificate of incorporation and bylaws could make mergers, tender offers, or proxy contests difficult, potentially depressing the stock price[469](index=469&type=chunk)[472](index=472&type=chunk)[473](index=473&type=chunk) [General Risk Factors](index=86&type=section&id=General%20Risk%20Factors) This section covers general risks including tax changes, inflation, litigation, and business disruptions - Changes in tax legislation (federal, state, local, and non-U.S.) could adversely affect the business and financial condition[475](index=475&type=chunk) - Rising inflation rates may result in increased operating costs, reduced liquidity, and limitations on the ability to access credit[478](index=478&type=chunk) - The company could be subject to securities class action litigation, which would result in substantial costs and a diversion of management's attention and resources[479](index=479&type=chunk) - Business disruptions from natural or man-made disasters (e.g., earthquakes, power shortages, medical epidemics) could seriously harm future revenue and financial condition[480](index=480&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=87&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section reports no unregistered equity sales and details IPO proceeds use - No unregistered sales of equity securities occurred during the period[482](index=482&type=chunk) - The July 2021 IPO generated aggregate net cash proceeds of **$89.6 million**, and there has been no material change in the planned use of these proceeds[482](index=482&type=chunk) [Item 3. Defaults Upon Senior Securities](index=87&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is marked as 'Not Applicable', indicating no defaults upon senior securities - This item is marked as "Not Applicable," indicating no defaults upon senior securities[483](index=483&type=chunk) [Item 4. Mine Safety Disclosures](index=87&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is marked as 'Not Applicable', indicating no mine safety disclosures - This item is marked as "Not Applicable," indicating no mine safety disclosures[483](index=483&type=chunk) [Item 5. Other Information](index=87&type=section&id=Item%205.%20Other%20Information) This section confirms no Rule 10b5-1 trading arrangements were adopted, modified, or terminated by directors or officers - None of the company's directors or officers adopted, modified, or terminated a Rule 10b5-1 trading arrangement or non-Rule 10b5-1 trading arrangement during the three months ended June 30, 2025[483](index=483&type=chunk) [Item 6. Exhibits](index=87&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including key corporate documents and certifications - Exhibits include the Amended and Restated Certificate of Incorporation and Bylaws, certifications of the Principal Executive Officer and Principal Financial Officer, and Inline XBRL documents[484](index=484&type=chunk) [Signatures](index=88&type=section&id=Signatures) The report is duly signed by the Chief Executive Officer and Chief Financial Officer - The report was signed by Gavin MacBeath, Chief Executive Officer, and Jason A. Amello, Chief Financial Officer, on August 12, 2025[486](index=486&type=chunk)

[Corporate Update and Highlights](index=1&type=section&id=Corporate%20Update%20and%20Highlights) TScan Therapeutics provided a Q2 2025 corporate update, highlighting ALLOHA heme trial data, solid tumor patient dosing, and cash runway into Q1 2027 - Two-year relapse data from ALLOHA™ Phase 1 heme trial to be presented by **year-end**[1](index=1&type=chunk) - Expects to dose first solid tumor patients with multiplex TCR-T in the **third quarter of 2025**[1](index=1&type=chunk)[2](index=2&type=chunk) - Cash, cash equivalents, and marketable securities continue to fund operations into the **first quarter of 2027**[1](index=1&type=chunk) - Plans to share safety and preliminary response data from PLEXI-T trial in the **first quarter of 2026**[2](index=2&type=chunk) - Finalizing commercial-ready process for heme program, resulting in shorter manufacturing times and substantially lower cost of goods[2](index=2&type=chunk) [Pipeline Updates and Anticipated Milestones](index=1&type=section&id=Upcoming%20Anticipated%20Milestones) TScan provided detailed updates on its Heme Malignancies and Solid Tumor programs, outlining key clinical and regulatory milestones [Heme Malignancies Program](index=1&type=section&id=Heme%20Malignancies%20Program) TScan's lead candidate, TSC-101, treats residual disease and prevents relapse in AML, ALL, or MDS patients post-HCT - TSC-101 is designed to treat residual disease and prevent relapse in patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), or myelodysplastic syndrome (MDS) undergoing allogeneic hematopoietic cell transplantation (HCT)[3](index=3&type=chunk) - Plans to initiate a registrational trial for TSC-101, pending further regulatory feedback, in the **second half of 2025**[3](index=3&type=chunk) - Expects to file an investigational new drug (IND) application for TSC-102-A0301 in the **second half of 2025**[3](index=3&type=chunk) - Plans to present additional data from the ALLOHA Phase 1 trial, including two-year relapse data on initial patients treated with TSC-101, by the **end of the year**[3](index=3&type=chunk) [Solid Tumor Program](index=2&type=section&id=Solid%20Tumor%20Program) The Solid Tumor Program develops ImmunoBank TCR-T therapy candidates to overcome tumor heterogeneity and resistance in the PLEXI-T trial - TScan continues to develop the ImmunoBank, a collection of TCR-T therapy candidates that target different cancer-associated antigens presented on diverse HLA types[4](index=4&type=chunk) - Strategy is to treat patients with multiple TCR-T therapy candidates to overcome tumor heterogeneity and resistance that may arise from either target or HLA loss (the PLEXI-T trial)[4](index=4&type=chunk) [Second Quarter 2025 Financial Performance](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Results) TScan Therapeutics reported increased Q2 2025 revenue from collaboration activities, higher operating expenses, and an increased net loss, while maintaining a strong cash position [Revenue](index=2&type=section&id=Revenue) Revenue for Q2 2025 significantly increased to $3.1 million from $0.5 million in Q2 2024, primarily due to collaboration activities | Metric | Q2 2025 (in millions) | Q2 2024 (in millions) | Change | | :----- | :-------------------- | :-------------------- | :----- | | Revenue | $3.1 | $0.5 | +$2.6 (+520%) | [Operating Expenses](index=2&type=section&id=Operating%20Expenses) Total operating expenses increased to $41.7 million in Q2 2025 from $34.7 million in Q2 2024, driven by higher R&D and G&A costs | Metric | Q2 2025 (in millions) | Q2 2024 (in millions) | Change | | :----- | :-------------------- | :-------------------- | :----- | | Total Operating Expenses | $41.7 | $34.7 | +$7.0 (+20.2%) | [Research and Development (R&D) Expenses](index=2&type=section&id=R%26D%20Expenses) R&D expenses rose to $32.6 million in Q2 2025 from $26.9 million in Q2 2024, mainly due to increased laboratory supplies, research materials, and facility/personnel expenses for expanding internal manufacturing capabilities | Metric | Q2 2025 (in millions) | Q2 2024 (in millions) | Change | | :----- | :-------------------- | :-------------------- | :----- | | R&D Expenses | $32.6 | $26.9 | +$5.8 (+21.6%) | | Non-cash stock compensation | $1.7 | $1.2 | +$0.5 (+41.7%) | [General and Administrative (G&A) Expenses](index=2&type=section&id=G%26A%20Expenses) G&A expenses increased to $9.1 million in Q2 2025 from $7.8 million in Q2 2024, primarily due to higher personnel expenses from increased headcount | Metric | Q2 2025 (in millions) | Q2 2024 (in millions) | Change | | :----- | :-------------------- | :-------------------- | :----- | | G&A Expenses | $9.1 | $7.8 | +$1.3 (+16.7%) | | Non-cash stock compensation | $1.6 | $1.1 | +$0.5 (+45.5%) | [Net Loss and Cash Position](index=2&type=section&id=Net%20Loss) The net loss for Q2 2025 was $37.0 million, an increase from $31.7 million in Q2 2024, with a cash position of $218.0 million funding operations into Q1 2027 | Metric | Q2 2025 (in millions) | Q2 2024 (in millions) | Change | | :----- | :-------------------- | :-------------------- | :----- | | Net Loss | $(37.0) | $(31.7) | $(5.3) (-16.7%) | | Net Interest Income | $1.7 | $2.5 | $(0.8) (-32.0%) | - Cash, cash equivalents, and marketable securities as of June 30, 2025, were **$218.0 million**, excluding $5.0 million of restricted cash[8](index=8&type=chunk) - The Company believes that its existing cash resources will be sufficient to fund its current operating plan into the **first quarter of 2027**[8](index=8&type=chunk) [Share Count](index=2&type=section&id=Share%20Count) As of June 30, 2025, TScan had 56.7 million common shares outstanding and 73.1 million pre-funded warrants, totaling 129.8 million pro forma shares | Metric | As of June 30, 2025 | As of Dec 31, 2024 | | :----- | :------------------ | :----------------- | | Common Stock Outstanding | 56,747,993 | N/A | | Pre-funded Warrants Outstanding | 73,087,945 | 73,087,945 | | Pro Forma Outstanding Shares (incl. warrants) | 129,835,938 | 129,678,572 | [About TScan Therapeutics, Inc.](index=2&type=section&id=About%20TScan%20Therapeutics%2C%20Inc.) TScan Therapeutics is a clinical-stage biotechnology company developing TCR-T therapies for cancer, including the ALLOHA™ Phase 1 heme trial and the ImmunoBank for solid tumors - 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[12](index=12&type=chunk) - The Company's lead TCR-T therapy candidates are in development for the treatment of patients with hematologic malignancies to prevent relapse following allogeneic hematopoietic cell transplantation (the ALLOHA™ Phase 1 heme trial)[12](index=12&type=chunk) - The Company has developed and continues to expand its ImmunoBank, a repository of therapeutic TCRs, to provide customized multiplex TCR-T therapies for patients with a variety of cancers (the PLEXI-T™ Phase 1 solid tumor trial)[12](index=12&type=chunk) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This section outlines the forward-looking nature of statements regarding TScan's clinical programs, financial expectations, and business strategies, highlighting inherent risks - The release contains forward-looking statements regarding the Company's plans, progress, expectations, and timing relating to its hematologic malignancies program and solid tumor program, including clinical updates, data presentations, IND filings, and initiation of trials[13](index=13&type=chunk) - Statements also cover the Company's ability to fund its operating plan, the potential benefits of its proprietary platforms or product candidates, and anticipated financial performance[13](index=13&type=chunk) - Such forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions, and uncertainties, and should not be relied upon as representing views as of any subsequent date[13](index=13&type=chunk)[14](index=14&type=chunk) [Contacts](index=4&type=section&id=Contacts) Contact information for investor relations and media inquiries is provided - Investor Relations contact: **Heather Savelle, VP, Investor Relations, TScan Therapeutics**[15](index=15&type=chunk) - Media/Investor contact: **Melissa Forst, Argot Partners**[15](index=15&type=chunk) [Condensed Consolidated Financial Data](index=5&type=section&id=Condensed%20Consolidated%20Financial%20Data) This section presents TScan Therapeutics' unaudited condensed consolidated balance sheet and statements of operations, detailing financial position and performance [Condensed Consolidated Balance Sheet Data](index=

Core Insights - TScan Therapeutics, Inc. is focused on developing T cell receptor-engineered T cell therapies for cancer treatment, with significant updates on their clinical trials and financial performance [11] Financial Performance - Revenue for Q2 2025 was $3.1 million, a substantial increase from $0.5 million in Q2 2024, primarily due to research activities related to a collaboration with Amgen [5] - Research and development expenses for Q2 2025 were $32.6 million, up from $26.9 million in Q2 2024, driven by increased laboratory supplies and personnel costs [6] - General and administrative expenses for Q2 2025 were $9.1 million, compared to $7.8 million in Q2 2024, mainly due to higher personnel expenses [7] - The net loss for Q2 2025 was $37.0 million, compared to $31.7 million in Q2 2024, with net interest income of $1.7 million in 2025 and $2.5 million in 2024 [9] - As of June 30, 2025, the company had cash, cash equivalents, and marketable securities totaling $218.0 million, expected to fund operations into Q1 2027 [9] Clinical Development Updates - The company plans to dose its first solid tumor patients with multiplex TCR-T in Q3 2025 and share safety and preliminary response data in Q1 2026 [2][8] - TScan's lead TCR-T therapy candidate, TSC-101, is designed to treat residual disease in patients with hematologic malignancies undergoing allogeneic hematopoietic cell transplantation [3] - The ImmunoBank is being developed to provide multiple TCR-T therapy candidates targeting various cancer-associated antigens to address tumor heterogeneity [4] Upcoming Milestones - TScan plans to present two-year relapse data from the ALLOHA Phase 1 trial by the end of 2025 [8] - The company expects to initiate a registrational trial for TSC-101 in the second half of 2025, pending regulatory feedback [8] - An investigational new drug (IND) application for TSC-102-A0301 is anticipated to be filed in the second half of 2025 [8]

Summary of TScan Therapeutics (TCRX) 2025 Conference Call Company Overview - TScan Therapeutics is a clinical-stage company focused on next-generation TCR T cell therapy, founded in 2018 [2][3] - The company has two main clinical programs: one for hematologic malignancies (AML, MDS, ALL) and another for solid tumors [3][4] Hematologic Malignancies Program - Promising data reported at ASH in December, showing only 8% relapse rate in treated patients compared to 33% in the control arm [4][24] - The pivotal trial for the heme program is set to launch this year, with multiple clinical catalysts expected [5][25] - The program targets patients undergoing allogeneic bone marrow transplants, aiming to improve outcomes and reduce relapse rates [9][10] - The treatment involves engineering donor T cells to target residual cancer cells post-transplant, minimizing side effects [13][15] - The study design includes a synthetic control arm using data from the CIBMTR database, aiming for a hazard ratio of 0.6 with 85% power [28][29] - The addressable patient population in the U.S. is approximately 7,350 annually, with an estimated 1,000 patients meeting the trial criteria [31][32] - Potential market opportunity estimated in the multibillion-dollar range, with pricing for TCR therapies around $727,000 [34][35] Solid Tumors Program - The solid tumors strategy focuses on addressing tumor heterogeneity through multiplex therapy, using multiple TCRs simultaneously [38][39] - The company has seven TCRs cleared by the FDA, currently in a phase one clinical trial called the Plexity study [41][42] - The first patient is expected to be treated with multiplex therapy in the first half of this year, with safety and efficacy data to be reported by year-end [46][51] - The focus will be on HPV-positive cancers (head and neck, cervical, anal) and HPV-negative cancers (non-small cell lung cancer, sarcoma) [48][50] - A significant percentage of patients in these indications qualify for multiplex therapy, indicating a substantial addressable market [50] Key Data and Findings - In the heme program, 100% donor chimerism was achieved in treated patients, significantly reducing relapse risk compared to the control group [22][24] - The treatment arm showed a much lower probability of relapse (8%) compared to the control arm [24] - The company plans to expand its therapy to other HLA types, potentially doubling the addressable patient population [36][37] Future Milestones - Launch of the pivotal study for the heme program in the second half of the year [52] - Filing of an IND for expanded HLA TCRs by year-end [52] - Continued updates on safety and efficacy data for both heme and solid tumor programs throughout the year [52]

Core Viewpoint - TScan Therapeutics, Inc. is set to present at the Jefferies Global Healthcare Conference on June 4, 2025, highlighting its focus on T cell receptor-engineered therapies for cancer treatment [1]. Company Overview - TScan Therapeutics is a clinical-stage biotechnology company dedicated to developing T cell receptor (TCR)-engineered T cell (TCR-T) therapies aimed at treating cancer patients [3]. - The company's lead TCR-T therapy candidates are designed for patients with hematologic malignancies, specifically to prevent relapse after allogeneic hematopoietic cell transplantation, as part of the ALLOHA Phase 1 heme trial [3]. - TScan is expanding its ImmunoBank, a repository of therapeutic TCRs that target diverse antigens and are compatible with multiple HLA types, to create customized multiplex TCR-T therapies for various cancers, including the PLEXI-T Phase 1 solid tumor trial [3]. - The company is currently enrolling patients in both clinical programs [3].

Summary of T SCAN Therapeutics Conference Call Company Overview - The conference featured T SCAN Therapeutics, represented by CEO Gavin Macbeth, at BofA's 2025 health care conference [1] Core Insights and Arguments - T SCAN is developing a program called Orca 21, which aims to combine IL-23 and IL-17 therapies for psoriasis treatment. The strategy involves using IL-17 for rapid skin clearance followed by IL-23 for maintenance [3][4] - The company is currently in Phase 1 clinical trials for the Orca 1 program, with results expected in the second half of the year. A Phase 2 study will also commence in the same timeframe, with psoriasis data anticipated next year [5][6] - T SCAN has raised over $475 million last year, providing sufficient funding for ongoing clinical trials and a runway for an additional year without needing further capital [6] Key Upcoming Events - Key milestones include: - Phase 1 readout for Orca 1 in the second half of this year - Phase 2 study initiation for psoriasis in the second half of this year - Pharmacokinetic (PK) data expected in the first half of next year [5][6] Important Metrics - The company aims for a 50-day half-life for the molecule to enable six-month dosing and a 75-day half-life for annual dosing, which would be a significant advancement in treatment options [9][10] Additional Considerations - The combination therapy approach has garnered excitement from physicians, indicating potential market interest and acceptance [4] - The reproducibility of psoriasis data across trials is highlighted as a critical factor for the company's future success [5]

Company Performance - TScan Therapeutics reported a quarterly loss of $0.26 per share, better than the Zacks Consensus Estimate of a loss of $0.28, and an improvement from a loss of $0.32 per share a year ago, representing an earnings surprise of 7.14% [1] - The company posted revenues of $2.17 million for the quarter ended March 2025, exceeding the Zacks Consensus Estimate by 34.43%, compared to revenues of $0.57 million in the same quarter last year [2] - Over the last four quarters, TScan Therapeutics has surpassed consensus EPS estimates three times [2] Stock Performance - TScan Therapeutics shares have declined approximately 50.7% since the beginning of the year, while the S&P 500 has decreased by 3.9% [3] - The current consensus EPS estimate for the upcoming quarter is -$0.29 on revenues of $1.62 million, and for the current fiscal year, it is -$1.15 on revenues of $10.97 million [7] Industry Outlook - The Medical - Biomedical and Genetics industry, to which TScan Therapeutics belongs, is currently ranked in the top 31% of over 250 Zacks industries, indicating a favorable outlook [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact TScan's stock performance [5]

Financial Status and Future Plans - TScan's cash reserves of $290.1 million as of December 31, 2024, are expected to fund operations into Q1 2027[7,100] - TScan plans to launch a pivotal trial with topline readout in 2H27, targeting a >$1 billion addressable market across the US & EU[7,100] - TScan expects multiple clinical catalysts by the end of 2025, including launching a pivotal study and presenting two-year relapse data for the HEME program, and presenting safety and response data for multiplex therapy in solid tumors[5,8,98,101] HEME Program (ALLOHA Trial) - In the ALLOHA Phase 1 trial, 2 out of 26 (8%) treatment-arm subjects relapsed, compared to 4 out of 12 (33%) control-arm subjects[48] - Event-free survival strongly favors the treatment arm with a hazard ratio (HR) of 0.30[48] - Almost all subjects infused to date [19/22 (86.3%)] qualified for treatment with TSC-101[52] Solid Tumor Program (PLEXI-T Trial) - T-Plex enrollment will focus on five key indications with high unmet need: NSCLC (~63K potential U S patients), Sarcoma (~3K), Head & Neck (~15K), Anal & Genital (~4K), and Cervical (~7K)[88,89] - 15-60% of patients are currently eligible for multiplex TCR-T cell therapy with the 7 TCRs in the current PLEXI-T study[93]

[PART I. FINANCIAL INFORMATION](index=7&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements (Unaudited)](index=7&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents TScan Therapeutics, Inc.'s unaudited condensed consolidated financial statements as of March 31, 2025, highlighting a net loss of $34.1 million and $251.7 million in cash and equivalents [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2025, total assets decreased to $332.7 million from $371.1 million, primarily due to reduced cash, while liabilities and equity also declined Condensed Consolidated Balance Sheets (in thousands) | | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $154,108 | $178,689 | | Marketable securities | $97,581 | $111,421 | | Total current assets | $254,836 | $292,722 | | Total assets | $332,709 | $371,118 | | **Liabilities and Stockholders' Equity** | | | | Total current liabilities | $29,816 | $35,956 | | Total liabilities | $122,507 | $130,148 | | Total stockholders' equity | $210,202 | $240,970 | | Total liabilities and stockholders' equity | $332,709 | $371,118 | [Condensed Consolidated Statements of Operations](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Collaboration and license revenue increased to $2.2 million, but rising operating expenses led to a wider net loss of $34.1 million for the three months ended March 31, 2025 Condensed Consolidated Statements of Operations (in thousands) | | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Collaboration and license revenue | $2,171 | $566 | | Research and development | $29,788 | $24,857 | | General and administrative | $8,633 | $7,082 | | **Total operating expenses** | **$38,421** | **$31,939** | | Loss from operations | ($36,250) | ($31,373) | | **Net loss** | **($34,127)** | **($30,142)** | | Net loss per share, basic and diluted | ($0.26) | ($0.32) | [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased to $37.6 million in Q1 2025, partially offset by $13.5 million from investing activities, resulting in a net cash decrease Condensed Consolidated Statements of Cash Flows (in thousands) | | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($37,586) | ($29,267) | | Net cash provided by investing activities | $13,530 | $36,163 | | Net cash provided by (used in) financing activities | ($525) | $258 | | **Net (decrease) increase in cash, cash equivalents and restricted cash** | **($24,581)** | **$7,154** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) These notes detail the company's business, accounting policies, recurring losses, and significant financial activities including the Amgen collaboration and a new SVB loan agreement - The company has incurred recurring losses, including a net loss of **$34.1 million** for the three months ended March 31, 2025, and had an accumulated deficit of **$409.2 million**. Management asserts that cash, cash equivalents, and marketable securities are sufficient to fund operations for at least the next 12 months[37](index=37&type=chunk) - Under the Amgen Collaboration Agreement, the company received a **$30 million** upfront payment and is eligible for over **$500 million** in milestones. In Q1 2025, **$2.2 million** was recognized as revenue from this agreement[52](index=52&type=chunk)[53](index=53&type=chunk)[58](index=58&type=chunk) - In December 2024, the company entered into a new Loan and Security Agreement with Silicon Valley Bank (SVB) for up to **$52.5 million**, with an initial tranche of **$32.5 million** funded. This replaced the previous K2HV loan agreement[65](index=65&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=18&type=section&id=Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's TCR-T therapy development, significant operating losses, and liquidity, projecting existing cash to fund operations into Q1 2027 [Overview](index=18&type=section&id=Overview) TScan is a clinical-stage biotechnology company developing TCR-T therapies for cancer, with lead candidates in Phase 1 trials and a history of significant operating losses - The company is advancing lead product candidates **TSC-100** and **TSC-101** in a Phase 1 trial for heme malignancies (AML, MDS, ALL) in patients undergoing allogeneic HCT[80](index=80&type=chunk) - For solid tumors, the company is developing a multiplex TCR-T therapy (T-Plex) and has seven IND applications cleared by the FDA, with a Phase 1 trial (PLEXI-T™) underway[81](index=81&type=chunk) - The company has incurred significant operating losses since inception, with a net loss of **$34.1 million** for Q1 2025 and an accumulated deficit of **$409.2 million** as of March 31, 2025[84](index=84&type=chunk) [Results of Operations](index=20&type=section&id=Results%20of%20Operations) Collaboration revenue increased, but higher R&D and G&A expenses led to a wider loss from operations of $36.3 million for Q1 2025 compared to Q1 2024 Comparison of Results of Operations (in thousands) | | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | Change | | :--- | :--- | :--- | :--- | | Collaboration and license revenue | $2,171 | $566 | $1,605 | | Research and development | $29,788 | $24,857 | $4,931 | | General and administrative | $8,633 | $7,082 | $1,551 | | **Loss from operations** | **($36,250)** | **($31,373)** | **($4,877)** | - The **$4.9 million** increase in R&D expenses was primarily driven by a **$2.2 million** increase in laboratory supplies and studies related to start-up activities with a global CDMO, and a **$1.6 million** increase in facility-related expenses[91](index=91&type=chunk) - The **$1.6 million** increase in G&A expenses was mainly due to a **$0.4 million** increase in personnel costs from additional headcount and a **$0.3 million** increase in legal and professional fees[92](index=92&type=chunk) [Liquidity and Capital Resources](index=21&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2025, the company held $251.7 million in cash and equivalents, projected to fund operations into Q1 2027, with recent funding from equity offerings and a new debt facility - The company believes its existing cash, cash equivalents, and marketable securities of **$251.7 million** (as of March 31, 2025) will fund its operating plan into the **first quarter of 2027**[88](index=88&type=chunk)[99](index=99&type=chunk)[100](index=100&type=chunk) - Recent funding includes net proceeds of **$134.7 million** from a June 2023 public offering, **$161.4 million** from an April 2024 offering, and **$30.0 million** from a December 2024 registered direct offering[95](index=95&type=chunk)[96](index=96&type=chunk)[98](index=98&type=chunk) - The company secured a new debt facility with SVB in December 2024 for up to **$52.5 million**, drawing an initial **$32.5 million** and terminating its prior K2HV loan agreement[97](index=97&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=25&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a "smaller reporting company," TScan is exempt from providing quantitative and qualitative disclosures about market risk - As a "smaller reporting company," TScan is not required to provide quantitative and qualitative disclosures about market risk[120](index=120&type=chunk) [Item 4. Controls and Procedures](index=25&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal control over financial reporting during the quarter - Based on an evaluation as of March 31, 2025, the Principal Executive Officer and Principal Financial Officer concluded that the company's disclosure controls and procedures were effective[121](index=121&type=chunk) - No changes in internal control over financial reporting occurred during the quarter ended March 31, 2025, that have materially affected, or are reasonably likely to materially affect, internal controls[122](index=122&type=chunk) [PART II. OTHER INFORMATION](index=26&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=26&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings, though future involvement in ordinary course legal matters is possible - The company is not currently a party to any material legal proceedings[124](index=124&type=chunk) [Item 1A. Risk Factors](index=27&type=section&id=Item%201A.%20Risk%20Factors) This section details numerous risks, including financial losses, dependence on novel TCR-T therapy, clinical development challenges, manufacturing complexities, regulatory uncertainty, intellectual property issues, and reliance on third parties [Risks Related to Our Business and Industry](index=27&type=section&id=Risks%20Related%20to%20Our%20Business%20and%20Industry) This subsection outlines fundamental business risks, including a history of significant losses, dependence on the TCR-T platform, limited operating history, and the need for substantial additional funding - The company has a history of significant losses, reporting a net loss of **$34.1 million** for Q1 2025, and expects to incur substantial losses for the foreseeable future[129](index=129&type=chunk) - The business is highly dependent on the success of its proprietary platform to discover and develop TCR-T therapy product candidates, which is a novel approach with significant challenges[131](index=131&type=chunk)[162](index=162&type=chunk) - Substantial additional funding is required to complete development and commercialization. Existing cash is projected to fund operations into Q1 2027, but the company will need to raise more capital, which may not be available on favorable terms[140](index=140&type=chunk)[141](index=141&type=chunk) [Risks Related to the Development of Our Product Candidates](index=33&type=section&id=Risks%20Related%20to%20the%20Development%20of%20Our%20Product%20Candidates) This subsection details risks in product candidate development, including the novelty of TCR-T therapy, potential for undesirable side effects, and the uncertainty of preclinical results predicting clinical success - The company's novel approach to cancer treatment with TCR-T therapy creates significant challenges, including educating medical personnel, managing potential side effects (GvHD, neurotoxicity), and scaling manufacturing[162](index=162&type=chunk)[163](index=163&type=chunk) - Product candidates are in early development, and there is a high risk of failure. Preclinical and early clinical results may not be predictive of later-stage trial success[165](index=165&type=chunk)[174](index=174&type=chunk) - Product candidates may cause undesirable side effects, such as GvHD, autoimmunity, or off-tumor toxicity, which could halt clinical development, prevent regulatory approval, or limit commercial potential[196](index=196&type=chunk)[197](index=197&type=chunk)[198](index=198&type=chunk) [Risks Related to Manufacturing](index=47&type=section&id=Risks%20Related%20to%20Manufacturing) This subsection details manufacturing risks, including the complexity of TCR-T therapy production, reliance on third parties, and challenges in validating processes for diverse patient materials - The manufacturing process for TCR-T therapies is complex, costly, and highly regulated, with risks of product loss or failure due to logistical issues, contamination, or operator error[249](index=249&type=chunk)[251](index=251&type=chunk) - The company has limited experience managing a manufacturing facility and relies on third-party suppliers for critical components, creating risks related to quality control, supply continuity, and scaling up production[250](index=250&type=chunk)[255](index=255&type=chunk) - Difficulties may arise in validating the manufacturing process due to the heterogeneity of patient starting materials, which could impact the ability to produce consistent products for clinical or commercial use[258](index=258&type=chunk)[259](index=259&type=chunk) [Risks Related to Government Regulation](index=48&type=section&id=Risks%20Related%20to%20Government%20Regulation) This subsection covers extensive regulatory risks, including lengthy approval processes, uncertain pricing and reimbursement, and compliance with complex healthcare and data privacy laws - The regulatory approval process for novel product candidates is lengthy, time-consuming, and uncertain, and the company may experience significant delays or may not obtain approval at all[260](index=260&type=chunk)[265](index=265&type=chunk) - Even if approved, the company's products face uncertain and potentially unfavorable pricing, coverage, and reimbursement from government and private payers, which could limit commercial success[291](index=291&type=chunk)[293](index=293&type=chunk) - The company is subject to complex federal, state, and foreign laws regarding healthcare fraud and abuse, as well as data privacy (e.g., GDPR, CCPA), with non-compliance carrying risks of significant fines and penalties[311](index=311&type=chunk)[318](index=318&type=chunk)[321](index=321&type=chunk) [Risks Related to Our Intellectual Property](index=60&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) This subsection details intellectual property risks, including challenges in obtaining and maintaining patent protection, potential infringement claims, and compliance with in-licensed IP agreements - The company's success depends on obtaining and maintaining patent protection, but there is no guarantee that its pending applications will issue as patents with a scope sufficient to protect its product candidates[331](index=331&type=chunk)[334](index=334&type=chunk)[335](index=335&type=chunk) - The company may face costly litigation from third-party claims of IP infringement, which could result in substantial damages or block the commercialization of its products[374](index=374&type=chunk)[375](index=375&type=chunk) - The company relies on licenses from third parties (e.g., BWH) and could lose significant rights if it fails to comply with its obligations under these agreements[346](index=346&type=chunk) [Risks Related to Our Reliance on Third Parties](index=73&type=section&id=Risks%20Related%20to%20Our%20Reliance%20on%20Third%20Parties) This subsection outlines risks from reliance on third parties for clinical trials and manufacturing, including potential delays, quality issues, and challenges in securing future strategic collaborations - The company depends on third parties like CROs and clinical investigators to conduct trials, and their failure to perform their duties properly could delay or compromise clinical development[403](index=403&type=chunk)[404](index=404&type=chunk) - Future strategic collaborations are important for development and commercialization, but the company faces significant competition in seeking partners and may not realize the benefits of such arrangements[406](index=406&type=chunk)[407](index=407&type=chunk) - Reliance on third-party manufacturers for clinical supply exposes the company to risks of production delays, quality control failures, and inability to meet demand, which could halt clinical trials[414](index=414&type=chunk)[415](index=415&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=86&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities occurred, and the planned use of $89.6 million net proceeds from the July 2021 IPO remains materially unchanged - There has been no material change in the planned use of proceeds from the company's July 2021 IPO, which generated net proceeds of **$89.6 million**[472](index=472&type=chunk) [Item 5. Other Information](index=86&type=section&id=Item%205.%20Other%20Information) No director or officer adopted, modified, or terminated a Rule 10b5-1 or non-Rule 10b5-1 trading arrangement during Q1 2025 - No director or officer adopted, modified, or terminated a Rule 10b5-1 trading plan or other trading arrangement during the first quarter of 2025[473](index=473&type=chunk)

Financial Performance - Revenue for Q1 2025 was $2.2 million, a significant increase from $0.6 million in Q1 2024, primarily due to research activities under a collaboration agreement with Amgen[7]. - R&D expenses for Q1 2025 were $29.8 million, up from $24.9 million in Q1 2024, driven by increased laboratory supplies and personnel expenses[8]. - G&A expenses for Q1 2025 were $8.6 million, compared to $7.1 million in Q1 2024, mainly due to higher personnel costs[9]. - Net loss for Q1 2025 was $34.1 million, compared to a net loss of $30.1 million in Q1 2024, including net interest income of $2.1 million[10]. - Cash, cash equivalents, and marketable securities as of March 31, 2025, were $251.7 million, expected to fund operations into Q1 2027[12]. - As of March 31, 2025, the company had 129,678,572 shares outstanding, including pre-funded warrants[13]. Research and Development - The company plans to file an IND application for TSC-102-A0301 in the second half of 2025[11]. - TScan is on track to initiate a registrational trial for TSC-101 in the latter half of 2025[11]. - The first patient for multiplex TCR-T therapy is expected to be dosed in the first half of 2025[11]. - The company continues to develop the ImmunoBank for diverse TCR-T therapy candidates targeting various cancer-associated antigens[6].