[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].

Core Insights - TScan Therapeutics is advancing its T cell receptor (TCR)-engineered T cell therapies for cancer treatment, with significant milestones expected by the end of 2025 [1][2][4] Corporate Updates - The company appointed Stephen Camiolo as Senior Vice President, Market Access, bringing over 25 years of experience in the pharmaceutical and biotechnology industries [6] - TScan is on track to file an IND application for TSC-102-A0301 targeting HLA-A*03:01 in the second half of 2025 [1][7] - The company continues to develop its ImmunoBank, a collection of TCR-T therapy candidates targeting various cancer-associated antigens [5][13] Clinical Trials - TScan is enrolling patients in the PLEXI-T solid tumor trial and anticipates dosing the first patient with multiplex therapy soon, with safety and efficacy data expected later this year [2][15] - The ALLOHA Phase 1 trial is ongoing, focusing on TSC-101 for treating acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and myelodysplastic syndrome (MDS) [4][7] 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 [8] - R&D expenses rose to $29.8 million in Q1 2025 from $24.9 million in Q1 2024, driven by increased laboratory supplies and personnel costs [9] - G&A expenses increased to $8.6 million in Q1 2025 from $7.1 million in Q1 2024, mainly due to higher personnel expenses [10] - The net loss for Q1 2025 was $34.1 million, compared to $30.1 million in Q1 2024, with cash and cash equivalents totaling $251.7 million as of March 31, 2025, sufficient to fund operations into Q1 2027 [11][12]

Core Insights - TScan Therapeutics, Inc. announced the acceptance of an abstract for a poster presentation at the ASGCT 28th Annual Meeting, highlighting its focus on TCR-engineered T cell therapies for cancer treatment [1][2]. Company Overview - TScan is a clinical-stage biotechnology company specializing in 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 to prevent relapse in patients with hematologic malignancies following allogeneic hematopoietic cell transplantation, specifically through the ALLOHA™ Phase 1 heme trial [3]. - TScan is expanding its ImmunoBank, a repository of therapeutic TCRs that recognize diverse targets across multiple HLA types, to offer customized multiplex TCR-T therapies for various cancers, as seen in the PLEXI-T™ Phase 1 solid tumor trial [3]. - The company is currently enrolling patients in both clinical programs [3]. Presentation Details - The poster presentation titled "CD45 as a Universal Target for Adjuvant TCR-T Cell Therapy Following Allogeneic Hematopoietic Cell Transplantation" will take place on May 13 from 6:00 - 7:30 p.m. Central Time [2]. - The presentation will be held in the Poster Hall, Hall I2, and materials will be available on the company's website post-presentation [2].

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] Group 1: Company Participation - The company will participate in a fireside chat at the 24th Annual Needham Virtual Healthcare Conference on April 7, 2025, at 9:30 a.m. Eastern Time [1] Group 2: Webcast Information - A webcast of the fireside chat will be available on the company's website, with an archived replay accessible for 90 days post-event [2] Group 3: Company Overview - TScan's lead TCR-T therapy candidates are aimed at treating hematologic malignancies to prevent relapse after allogeneic hematopoietic cell transplantation [3] - The company is expanding its ImmunoBank, a repository of therapeutic TCRs for customized multiplex TCR-T therapies targeting various cancers [3] - TScan is currently enrolling patients in both its clinical programs, including the ALLOHA™ Phase 1 heme trial and the PLEXI-T™ Phase 1 solid tumor trial [3]

Core Insights - TScan Therapeutics, Inc. has appointed Stephen Camiolo as Senior Vice President, Market Access, bringing over 25 years of experience in market access and commercialization within the pharmaceutical and biotechnology sectors [1][2] - Camiolo's experience includes leading 16 successful product launches, including three cell therapies, which will be crucial as TScan prepares for a pivotal trial of TSC-101 targeting residual disease in patients with AML, ALL, and MDS [2] - TScan is advancing its clinical-stage pipeline, with ongoing enrollment in its ALLOHA™ Phase 1 trial for hematologic malignancies and the PLEXI-T™ Phase 1 trial for solid tumors [3] Company Overview - TScan Therapeutics focuses on developing T cell receptor (TCR)-engineered T cell (TCR-T) therapies for cancer treatment, specifically targeting hematologic malignancies and solid tumors [3] - The company is expanding its ImmunoBank, a repository of therapeutic TCRs, to provide customized multiplex TCR-T therapies for various cancers [3]

Core Insights - TScan Therapeutics (TCRX) is highlighted as a significant biotech company to monitor in the upcoming year due to its development of T-Cell Receptor engineered T-cells (TCR-T) aimed at treating residual disease [2]. Company Overview - TScan Therapeutics is engaged in the innovative field of T-cell therapy, focusing on engineered T-cells to address unmet medical needs in oncology [2]. Market Position - The company is part of a broader biotech landscape that includes a library of over 600 biotech investing articles and a model portfolio of small and mid-cap stocks, indicating a robust analytical framework for investors [2].

分组1 - TScan Therapeutics reported a quarterly loss of $0.29 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.27, and compared to a loss of $0.21 per share a year ago, indicating a negative earnings surprise of -7.41% [1] - The company posted revenues of $0.67 million for the quarter ended December 2024, missing the Zacks Consensus Estimate by 53.59%, and this represents a significant decline from year-ago revenues of $7.21 million [2] - TScan Therapeutics shares have declined approximately 33.6% since the beginning of the year, contrasting with the S&P 500's decline of -1.8% [3] 分组2 - The earnings outlook for TScan Therapeutics is mixed, with the current consensus EPS estimate for the coming quarter at -$0.28 on revenues of $1.62 million, and for the current fiscal year at -$1.14 on revenues of $10.97 million [7] - The Medical - Biomedical and Genetics industry, to which TScan Therapeutics belongs, is currently ranked in the top 30% of over 250 Zacks industries, suggesting a favorable industry outlook [8] - Another company in the same industry, Voyager Therapeutics, is expected to report a quarterly loss of $0.35 per share, reflecting a year-over-year change of -128%, with revenues anticipated to be $20.13 million, down 77.7% from the previous year [9][10]

Financial Performance - For the years ended December 31, 2024, 2023, and 2022, the company reported net losses of $127.5 million, $89.2 million, and $66.2 million, respectively, with an accumulated deficit of $375.1 million as of December 31, 2024[268]. - The company anticipates significant increases in expenses as product candidates advance through preclinical studies and clinical trials, necessitating substantial additional funding for development and commercialization efforts[280]. - The company expects its financial condition and operating results to fluctuate significantly from quarter to quarter and year to year due to various uncontrollable factors[276]. - Global economic uncertainty and financial market volatility may adversely affect the company's ability to access financing and could impact business operations[286]. - The company may need to raise additional capital through various means, including equity or debt financing, which could dilute existing stockholder ownership[284]. - Future capital requirements will depend on various factors, including the scope and progress of drug discovery and clinical development activities[282]. Research and Development - The company has incurred significant research and development expenses and continues to do so, with no products licensed for commercial sale to date[267]. - The success of the company's proprietary platform is critical for discovering and developing product candidates, which require significant investment and regulatory approval[270]. - The company acknowledges the inherent risks in biotechnology R&D and may not successfully develop a pipeline of commercially viable product candidates[347]. - The company faces significant risks in biotechnology product development, including the potential failure to demonstrate adequate efficacy or safety profiles for its product candidates[350]. - The company has limited experience in conducting clinical trials and managing manufacturing facilities, which may lead to delays[304]. Clinical Trials and Regulatory Approval - The company has initiated clinical trials for several product candidates, but revenue generation is not expected for many years[302]. - There is no guarantee that any product candidates will achieve regulatory approval, as the process is lengthy and fraught with challenges[306]. - The company may need to conduct additional clinical trials to obtain regulatory approval for its product candidates, which could delay commercialization[353]. - The FDA has cleared the T-Plex IND application, allowing the company to combine product candidates in multiplex TCR-T therapy, but safety data for each candidate is still required[331]. - Delays in obtaining regulatory approval could materially adversely impact the company's business and prospects[404]. Manufacturing and Supply Chain - Manufacturing difficulties may arise from limited experience, resource constraints, or geopolitical tensions, particularly with suppliers in China[321]. - The company relies on third-party contract manufacturers for clinical product supplies, which may affect compliance with regulatory requirements[320]. - The manufacturing process is susceptible to product loss or failure due to various logistical and operational issues, which could adversely affect patient outcomes[382]. - The company has expanded its existing cell manufacturing facility but lacks direct experience in managing such expansions, which may lead to delays in clinical trials and product quality issues[305]. Market and Competitive Landscape - The biotechnology industry is characterized by intense competition, and the company may face challenges from larger competitors with greater resources[371]. - The market opportunities for the company's product candidates may be relatively small, and estimates of the prevalence of target patient populations may be inaccurate[353]. - The company currently has no marketing and sales organization and lacks experience in marketing products, which may hinder its ability to generate product revenue[358]. Compliance and Regulatory Risks - The company must comply with extensive regulatory requirements, including safety monitoring and quality control, which could impact operational costs[420]. - The company faces ongoing regulatory obligations post-approval, which may lead to significant additional expenses and potential penalties for non-compliance[420]. - The company is subject to stringent data privacy laws, such as the California Consumer Privacy Act (CCPA), which imposes new obligations and potential penalties for noncompliance[447]. - Non-compliance with environmental, health, and safety regulations could result in fines or penalties, adversely affecting business success[456]. Cybersecurity and Data Privacy - The company has not experienced any material system failures or cybersecurity incidents, but potential disruptions could significantly impact development programs and business operations[373]. - Unauthorized disclosure of sensitive data could lead to negative publicity, legal liability, and damage to the company's reputation[374]. - The company must invest significant resources to protect against cybersecurity incidents and data breaches, which could have material adverse effects on its business[376]. Funding and Financial Strategy - The company has a loan agreement with Silicon Valley Bank for up to $52.5 million, with $32.5 million fully funded and a second tranche of $20 million available at SVB's discretion[295]. - The company may need to pursue equity or debt financing to meet capital needs, which could lead to significant dilution for existing stockholders[289]. - The company may seek orphan drug status for product candidates, which could provide financial incentives but may not guarantee market exclusivity[405]. Pricing and Reimbursement - Coverage and adequate reimbursement from government programs and private insurers are critical for the successful commercialization of products[459]. - The uncertainty surrounding third-party payer reimbursement could limit the company's ability to market its products and generate revenue[422]. - The company anticipates that adverse publicity related to engineered T cell therapies could negatively impact market acceptance of its product candidates[364].

Revenue Performance - Revenue for Q4 2024 was $0.7 million, down 90.3% from $7.2 million in Q4 2023; full-year revenue decreased to $2.8 million from $21.0 million in 2023[6]. - Collaboration and license revenue for the three months ended December 31, 2024, was $665 million, compared to $7,211 million for the same period in 2023[21]. Expenses and Losses - R&D expenses increased to $29.4 million in Q4 2024, up 31.3% from $22.4 million in Q4 2023; full-year R&D expenses rose to $107.4 million from $88.2 million[9]. - Total operating expenses increased to $37,377 million for the three months ended December 31, 2024, from $28,568 million in the prior year, representing a 30.5% increase[21]. - The net loss for Q4 2024 was $35.8 million, compared to $19.6 million in Q4 2023; full-year net loss increased to $127.5 million from $89.2 million[11]. - The net loss for the three months ended December 31, 2024, was $35,809 million, compared to a net loss of $19,613 million for the same period in 2023, indicating an increase of 82.4%[21]. - Total operating expenses for the twelve months ended December 31, 2024, were $137,637 million, up from $114,507 million in 2023, marking a 20.2% increase[21]. - The loss from operations for the twelve months ended December 31, 2024, was $134,821 million, compared to $93,458 million in 2023, indicating a significant increase of 44.3%[21]. - The company reported a net loss of $127,499 million for the twelve months ended December 31, 2024, compared to a net loss of $89,218 million in 2023, reflecting an increase of 43%[21]. Cash Position - Cash, cash equivalents, and marketable securities as of December 31, 2024, were $290.1 million, sufficient to fund operations into Q1 2027[12]. - The company closed a $30 million registered direct offering at a 37% premium, extending its cash runway[6]. Clinical Development - Seven TCR-Ts are now cleared for clinical development in the PLEXI-T Phase 1 trial, including the recently added MAGE-A4 TCR-T[7]. - TScan plans to initiate a registration trial for TSC-101 in the second half of 2025, pending regulatory feedback[7]. - The company aims to present additional data from the Phase 1 trial by the end of 2025, including two-year relapse data[7]. Recognition - TScan has been recognized as one of the Top Places to Work in Massachusetts for the third consecutive year[6].