TCRX on Nasdaq

TScan Therapeutics, Inc.

In its 2026 annual report the company says: “We are a fully integrated clinical-stage biotechnology company focused on developing a robust pipeline of T cell receptor (TCR)-engineered T cell, or TCR-T, therapies for the treatment of patients with cancer. Our lead product candidate, TSC-101, is in development for the treatment of patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) who are undergoing allogeneic hematopoietic cell transplantation (HCT).”5 It is headquartered in Waltham, Massachusetts.1 Its shares trade on Nasdaq under the symbol TCRX.1

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Last updated Oct 21, 2026.

Overview

$10.3MRevenue, fiscal 20252
-$129.8MNet income, fiscal 20252

Compare with Alpha Cognition Inc., Taysha Gene Therapies, Inc. or Caribou Biosciences, Inc., or pick any stock.

  • TickerTCRX on Nasdaq1
  • IndustryBiological Products, (No Diagnostic Substances)1
  • HeadquartersWaltham, Massachusetts1
  • Incorporated inDE3
  • Business address830 Winter Street, Waltham, Ma 024513
  • Filer category, Emerging growth company3

We are a fully integrated clinical-stage biotechnology company focused on developing a robust pipeline of T cell receptor (TCR)-engineered T cell, or TCR-T, therapies for the treatment of patients with cancer. Our lead product candidate, TSC-101, is in development for the treatment of patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) who are undergoing allogeneic hematopoietic cell transplantation (HCT). The product is designed to eliminate residual disease and promote complete donor chimerism, thereby preventing relapse. TSC-101 targets HA-2, an antigen that is present on all blood cells, malignant or benign, in patients with the HLA type A*02:01. We are currently conducting a Phase 1 clinical study of TSC-101 (the ALLOHA™ trial, NCT05473910) and during the fourth quarter of 2025, following a productive End-of-Phase meeting with the U.S. Food and Drug Adminis…5 From its latest annual report

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Key numbers, fiscal 2025

-1315.4%Operating margin2
-1256.8%Net margin2
266.7%Revenue growth, 20252
-105.4%Return on equity2
0.26×Debt to equity2
-$139.7MFree cash flow2

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Research and development98¢$114.2M
  • Interest2¢$2.8M

Out of $10.3M in revenue.2 The company lost money this year.

Financial statements

Revenue67892$10.3M in 2025+852% since 2020
0$10.0M$20.0M$30.0M2020: $1.1M$1.1M20202021: $10.1M$10.1M2021+835%2022: $13.5M$13.5M2022+33%2023: $21.0M$21.0M2023+56%2024: $2.8M$2.8M2024−87%2025: $10.3M$10.3M2025+267%
Operating income67892-$135.8M in 2025+418% since 2020
-$150.0M-$100.0M-$50.0M02020: -$26.2M-$26.2M20202021: -$48.6M-$48.6M2021+85%2022: -$66.6M-$66.6M2022+37%2023: -$93.5M-$93.5M2023+40%2024: -$134.8M-$134.8M2024+44%2025: -$135.8M-$135.8M2025+1%
Net income67892-$129.8M in 2025+397% since 2020
-$150.0M-$100.0M-$50.0M02020: -$26.1M-$26.1M20202021: -$48.6M-$48.6M2021+86%2022: -$66.2M-$66.2M2022+36%2023: -$89.2M-$89.2M2023+35%2024: -$127.5M-$127.5M2024+43%2025: -$129.8M-$129.8M2025+2%

Every line of the income statement as filed: the last 2 fiscal years, latest first.2

Period ending2025-12-312024-12-31
Collaboration and license revenue$10.3M$2.8M
Research and development$114.2M$107.3M
General and administrative$32.0M$30.3M
Total operating expenses$146.1M$137.6M
Loss from operations-$135.8M-$134.8M
Interest and other income, net$8.8M$12.1M
Interest expense-$2.8M-$3.7M
Loss on extinguishment of debt-$1.1M
Total other income$6.0M$7.3M
Net Loss-$129.8M-$127.5M
Net loss per share, basic-$1.00-$1.14
Net loss per share, diluted-$1.00-$1.14
Weighted average common shares outstanding- basic129.8M shares112.0M shares
Weighted average common shares outstanding-diluted129.8M shares112.0M shares
Unrealized gain (loss) on available-for-sale securities-$51.0K$51.0K
Comprehensive loss-$129.8M-$127.4M

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Corporate structure

TScan Therapeutics, Inc. sits at the top of its group. 2 entities, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of TScan Therapeutics, Inc.

  • TScan Therapeutics, Inc. Waltham, Massachusetts
    • TScan Securities Corporation Subsidiary · Massachusetts, United States

Built from subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What TScan Therapeutics, Inc. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Property and equipment, before depreciation$30.3M2 Dec 31, 2025$25.9M2 Dec 31, 2024+16.7%
Accumulated depreciation$21.6M2 Dec 31, 2025$18.7M2 Dec 31, 2024+15.3%
Property and equipment, net$8.7M2 Dec 31, 2025$7.2M2 Dec 31, 2024+20.2%
Operating-lease assets (leased space)$57.7M2 Dec 31, 2025$64.4M2 Dec 31, 2024−10.3%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$152.4M2 Dec 31, 2025$178.7M2 Dec 31, 2024−14.7%
Marketable securities, current$111.4M2 Dec 31, 2024$58.7M9 Dec 31, 2023+89.9%

Properties, in its own words

Our corporate headquarters is located at 830 Winter Street in Waltham, Massachusetts. The facility at 830 Winter Street is 51,100 square feet of laboratory space, with a lease expiration of October 2029. We also lease a facility at 880 Winter Street which is 113,487 square feet of office and laboratory space with a lease termination date of December 2032. We believe our facilities are sufficient to meet our current needs for the foreseeable future.

Item 2 of the 10-K filed Mar 4, 2026.5

Leadership

Who has led TScan Therapeutics, Inc., and when. Pick a name to see everywhere that person has worked.

Board members and other officers (21)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • TScan Securities Corporation Massachusetts4

The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.

Timeline

  1. Sep 30, 20268-K Executive or director change35
  2. Sep 11, 20268-K Executive or director change36
  3. Sep 2, 20268-K Exit or restructuring costs; Listing notice or transfer; Executive or director change37
  4. Aug 18, 20268-K Ended a material agreement38
  5. Aug 12, 20268-K Results of operations39
  6. Jun 22, 20268-K Regulation FD disclosure; Other events40
  7. May 22, 20268-K Bylaws or fiscal year changed; Shareholder vote41
  8. May 6, 20268-K Results of operations42
  9. Apr 2, 20268-K Executive or director change43
  10. Mar 4, 20268-K Results of operations44
  11. Jan 12, 20268-K Regulation FD disclosure45
  12. Nov 26, 20258-K Executive or director change46
  13. Jun 15, 2023New chief executive Gavin Macbeath becomes CEO14
  14. Jul 15, 2021New chief executive David P. Southwell becomes CEO15

Calendar

Coming up

  1. Nov 11, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.28) a share, on Nov 12, 2025.47

When it reported results

  1. Aug 12, 2026Reported quarterly or annual results39
  2. May 6, 2026Reported quarterly or annual results42
  3. Mar 4, 2026Reported quarterly or annual results44
  4. Nov 12, 2025Reported quarterly or annual results48
  5. Aug 12, 2025Reported quarterly or annual results49
  6. May 6, 2025Reported quarterly or annual results50
  7. Mar 5, 2025Reported quarterly or annual results51
  8. Nov 12, 2024Reported quarterly or annual results52

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar

Filings

272 filings to the SEC since October 2021: 6 annual reports, 15 quarterly reports, 62 major events, 94 insider forms, 41 large holders, 54 other. The latest 20:

  1. Oct 2, 20264 EDGAR
  2. Oct 2, 20264 EDGAR
  3. Sep 30, 20268-K EDGAR
  4. Sep 25, 2026SCHEDULE 13G EDGAR
  5. Sep 11, 20268-K EDGAR
  6. Sep 2, 20268-K EDGAR
  7. Aug 18, 20268-K EDGAR
  8. Aug 14, 2026SCHEDULE 13G/A EDGAR
  9. Aug 14, 2026SCHEDULE 13G/A EDGAR
  10. Aug 12, 202610-Q EDGAR
  11. Aug 12, 20268-K EDGAR
  12. Jun 22, 20268-K EDGAR
  13. May 22, 20264 EDGAR
  14. May 22, 20268-K EDGAR
  15. May 22, 20264 EDGAR
  16. May 22, 20264 EDGAR
  17. May 22, 20264 EDGAR
  18. May 22, 20264 EDGAR
  19. May 22, 20264 EDGAR
  20. May 15, 2026SCHEDULE 13G/A EDGAR

The 272 filings since October 2021 can be filtered by form type and year here when JavaScript is on.

Every filing from the last five years, summarized. The full record is on SEC EDGAR.

Insider trades

23 open-market trades by officers, directors and large owners since October 2021: 21 buys and 2 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Dec 23, 2025Lynx1 Capital Management LP10% ownerBuy6,232$0.90$5.6KForm 4
Dec 22, 2025Lynx1 Capital Management LP10% ownerBuy75,500$0.90$68.0KForm 4
Dec 19, 2025Lynx1 Capital Management LP10% ownerBuy80,069$0.90$72.1KForm 4
May 20, 2025Lynx1 Capital Management LP10% ownerBuy1,200,000$1.20$1.4MForm 4
May 19, 2025Lynx1 Capital Management LP10% ownerBuy1,388,794$1.20$1.7MForm 4
Dec 13, 2024Nichols Weston10% ownerBuy100,000$2.90$290.0KForm 4
Dec 12, 2024Nichols Weston10% ownerBuy31,800$3.01$95.7KForm 4
Nov 15, 2024Nichols Weston10% ownerBuy947$4.34$4.1KForm 4
Sep 23, 2024Klencke BarbaraDirectorBuy5,000$5.29$26.4KForm 4
Aug 26, 2024Klencke BarbaraDirectorBuy5,000$5.53$27.6KForm 4
Aug 23, 2024Klencke BarbaraDirectorBuy5,000$5.69$28.4KForm 4
Aug 23, 2024ZDRAVESKI ZORANSee RemarksSale164,686$5.78$951.9KForm 4
Dec 19, 2023BARBERICH TIMOTHY JDirectorBuy317$4.97$1.6KForm 4
Dec 18, 2023BARBERICH TIMOTHY JDirectorBuy28,830$4.89$141.0KForm 4
Dec 14, 2023Klencke BarbaraDirectorBuy5,000$5.08$25.4KForm 4
Jun 2, 2023BARBERICH TIMOTHY JDirectorBuy37,880$2.63$99.6KForm 4
May 31, 2023Lynx1 Capital Management LP10% ownerSale25,400$2.52$63.9KForm 4
Dec 28, 2022Silver Brian M.Chief Financial OfficerBuy3,158$1.56$4.9KForm 4
Dec 27, 2022Silver Brian M.Chief Financial OfficerBuy2,842$1.50$4.3KForm 4
May 18, 2022SOUTHWELL DAVID PChief Executive OfficerBuy25,000$3.59$89.8KForm 4

All 23 trades can be filtered by person here when JavaScript is on.

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Executive pay

What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.

YearExecutiveAgeSalaryTotal pay
2025Gavin MacBeathPh.D.$665.0K$2.8M69
2025Chrystal LouisM.D., M.P.H.50$530.0K$1.6M69
2025Jason A. Amello57$520.0K$1.3M69
2024Chief Financial Officer and Treasurer$463.5K$3.7M69
2024Chief Medical Officer$343.1K$3.0M69
2024Chief Executive Officer and Director$620.0K$1.8M69

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 60. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Lynx1 Capital Management LP8,019,148$7.9M0.9%No change
Bvf Inc/il5,564,290$5.5M0.1%No change
Baker Bros. Advisors LP2,784,792$2.7M0.0%No change
Vanguard Capital Management LLC2,158,831$2.1M0.0%+4,575
Two Sigma Investments, LP1,949,604$1.9M0.0%+740,595
Renaissance Technologies LLC1,326,799$1.3M0.0%−37,984
Deer Management Co. LLC1,245,504$1.2M0.2%No change
Millennium Management LLC1,163,611$1.1M0.0%−296,674
Jacobs Levy Equity Management, Inc1,049,806$1.0M0.0%+241,450
Citadel Advisors LLC1,009,107$989.0K0.0%+690,696
BlackRock, Inc.994,654$974.9K0.0%−846,298
Kalehua Capital Management LLC909,752$891.6K0.3%New
Boothbay Fund Management, LLC772,241$756.9K0.0%New
Marshall Wace, Llp687,364$673.6K0.0%+450,018
DC Funds, LP630,000$617.5K49.3%No change
Geode Capital Management, LLC584,811$573.4K0.0%−32,141
D. E. Shaw & Co., Inc.548,402$537.5K0.0%+228,815
Vanguard Fiduciary Trust Co363,954$356.7K0.0%+58,182
Jane Street Group, LLC241,493$236.7K0.0%+97,072
Verdad Advisers, LP232,759$228.1K0.2%+98,758
State Street Corp207,313$203.2K0.0%No change
Mizuho Securities Usa LLC205,600$201.5K0.0%New
Morgan Stanley197,891$194.0K0.0%+24,248
XTX Topco Ltd149,467$146.5K0.0%+88,747
Brown Brothers Harriman & Co143,051$140.2K0.0%No change

13F reports cover disclosed long positions in U.S. stocks only.

SEC filer profile

How TScan Therapeutics, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARTScan Therapeutics, Inc.1
  • CIK0001783328
  • Employer ID (EIN)82-52820755
  • Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; not a shell company5
  • Incorporated inDelaware5
  • Fiscal year endsDecember 311
  • Industry code (SIC)2836 Biological Products, (No Diagnostic Substances)1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address830 Winter Street, Waltham, MA 024511
  • Phone857-399-95001
  • Shares outstanding52,625,035 Voting Common Stock shares; 4,276,588 Nonvoting Common Stock shares as of Feb 27, 20265
  • Public float$56.9M as of Jun 30, 20255
  • AuditorDeloitte & Touche LLP, Boston, Massachusetts PCAOB ID 34; no auditor attestation of internal control over financial reporting5
  • On EDGAR sinceJul 26, 20191
  • Filings331 in all: 4 (97), 8-K (64), 3 (22), 10-Q (16), SC 13G (15), CORRESP (13), SCHEDULE 13G/A (12), SC 13G/A (11)1
    All 35 form types

    S-8 (8), UPLOAD (8), 424B5 (6), 10-K (5), DEF 14A (5), DEFA14A (5), EFFECT (5), ARS (4), S-1/A (4), S-3 (4), FWP (3), S-3/A (3), SC 13D/A (3), SEC STAFF LETTER (3), 144 (2), D (2), 10-K/A (1), 424B4 (1), 8-A12B (1), AW (1), CERT (1), DRS (1), PRE 14A (1), S-1 (1), S-1MEF (1), SC 13D (1), SCHEDULE 13G (1)

  • Latest filingsAnnual report (10-K) Mar 4, 2026
    Quarterly report (10-Q) Aug 12, 2026
    Proxy statement (DEF 14A) Apr 17, 2026
    Latest 8-K (8-K) Sep 30, 2026

Securities registered for trading

ClassSymbolExchange
Voting Common Stock, $0.0001 par value per shareTCRXThe Nasdaq Global Market, LLC

From the cover page of the 10-K filed Mar 4, 2026 (Section 12(b) of the Exchange Act).5

Risk factors and legal proceedings

The risks TScan Therapeutics, Inc. names in Item 1A of its 10-K filed Mar 4, 2026: 75 risks under these headings, as written.5

  • Risks Related to Our Business and Industry
  • We have incurred significant losses since inception, and we expect to incur losses over the next several years and may not be able to achieve or sustain revenues or profitability in the future.
  • Our business depends upon the success of our proprietary platform.
  • Our limited operating history may make it difficult to evaluate the success of our business to date and to assess our future viability.
  • We have never generated any revenue from sales of our TCR-T therapy product candidates and our ability to generate revenue from product sales and become profitable depends significantly on our success in a number of areas.
  • We will need to obtain substantial additional funding to complete the development and any commercialization of our product candidates, if approved. If we are unable to raise this necessary capital when needed, we could be forced to delay, reduce or eliminate our product development programs, commercialization efforts or other operations.
  • Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to our intellectual property or product candidates on unfavorable terms to us.
  • Global economic uncertainty and financial market volatility caused by political instability, changes in international trade relationships and conflicts could make it more difficult for us to access financing and could adversely affect our business and operations.
  • The U.S. Congress and the Trump administration have made and may make substantial changes to fiscal, tax, and other federal policies that may adversely affect our business.
  • Recent volatility in capital markets and lower market prices for many securities may affect our ability to access new capital through sales of shares of our common stock or issuance of indebtedness, which may impact our liquidity, limit our ability to
  • grow our business, pursue acquisitions or improve our operating infrastructure and restrict our ability to compete in our markets.
  • Adverse developments affecting the financial services industry, such as actual events or concerns involving liquidity, defaults or non-performance by financial institutions or transactional counterparties, could adversely affect our current and projected business operations and its financial condition and results of operations.
The other 64 risks
  • The terms of our loan agreement place restrictions on our operating and financial flexibility. If we raise additional capital through debt financing, the terms of any new debt could further restrict our operating and financial flexibility.
  • We have recently reduced the size of our organization, and we may encounter difficulties in managing this development and our strategic prioritization, which could disrupt our operations. In addition, we may not achieve the anticipated benefits and savings from the workforce reduction.
  • Risks Related to the Development of Our Product Candidates
  • Our approach to the discovery and development of product candidates based on our proprietary platform represents a novel approach to cancer treatment, which creates significant challenges for us.
  • We are early in our development efforts. If we are unable to advance our product candidates through clinical development, obtain regulatory approval and ultimately commercialize our product candidates, or experience significant delays in doing so, our business will be materially harmed.
  • Although many of our personnel have extensive experience in clinical development and manufacturing at other companies, we have limited direct experience as a company in conducting clinical trials and managing a manufacturing facility for our product candidates.
  • Our business is highly dependent on our current product candidates, and we must complete IND-enabling studies and clinical testing before we can seek regulatory approval and begin commercialization of any of our product candidates.
  • Our preclinical studies and clinical trials may fail to demonstrate adequately the safety, potency and purity of any of our product candidates, which would prevent or delay development, regulatory approval and commercialization.
  • Clinical development involves a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future clinical trial results. If our preclinical studies and clinical trials are not sufficient to support regulatory approval of any of our product candidates, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development of such product candidate.
  • Our business could be adversely affected by the effects of health epidemics in regions where we, our partners or other third parties on which we rely have significant manufacturing facilities, concentrations of potential clinical trial sites or other business operations.
  • We may rely on third parties to manufacture our clinical product supplies, and we may rely on third parties to produce and process our product candidates, if licensed.
  • We cannot guarantee that our product candidates will show any functionality in the solid tumor microenvironment.
  • Since the number of patients that we plan to dose in our initial clinical trials may be small, the results from such clinical trial, once completed, may be less reliable than results achieved in larger clinical trials, which may hinder our efforts to obtain regulatory approval for our product candidates.
  • Allogeneic HCT is a high-risk procedure that may result in complications or adverse events for patients in our clinical trials including those unrelated to the use of our product candidates.
  • We may not be able to file IND applications or IND amendments to commence additional clinical trials on the timelines we expect, and even if we are able to, the FDA may not permit us to proceed.
  • Our product candidates may cause undesirable side effects or have other properties that could halt their clinical development, prevent their regulatory approval, require expansion of the trial size, limit their commercial potential, or result in other significant negative consequences.
  • Our product candidates may target healthy cells expressing target antigens leading to potentially fatal adverse effects.
  • Our product candidates may have serious and potentially fatal cross-reactivity to other peptides or protein sequences within the body.
  • The vectors used to manufacture our TCR-T therapy product candidates may incorrectly modify the genetic material of a patient’s T cells, potentially triggering the development of a new cancer or other adverse events.
  • If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
  • The market opportunities for our product candidates may be relatively small. In addition, our estimates of the prevalence of our target patient populations may be inaccurate.
  • Our product candidates rely on the use of protein binding domains, or binders, to target specific cancers, which we may develop, or which may be developed by third parties. We are limited in our ability to apply our product candidates to a wider range of potential target cancers by our ability to develop, partner for or acquire these binders on commercially reasonable terms.
  • We currently have no marketing and sales organization and have no experience as a company in marketing products. If we are unable to establish marketing and sales capabilities or to enter into agreements with third parties to market and sell our product candidates, if licensed, we may not be able to generate product revenue.
  • Even if we obtain regulatory approval of our product candidates, the products may not gain market acceptance among physicians, patients, hospitals, cancer treatment centers and others in the medical community.
  • A variety of risks associated with marketing our product candidates internationally could materially adversely affect our business.
  • We face significant competition, and our operating results will suffer if we fail to compete effectively.
  • Our internal computer systems, or those used by our third-party CROs, our clinical sites, or other contractors or consultants, may fail or suffer cybersecurity incidents, data breaches or other unauthorized or improper access, which could result in a material disruption of the development programs of our product candidates.
  • Cybersecurity incidents, loss of data or modification of information, and other disruptions could compromise information related to our business or prevent us from accessing critical information, result in a significant disruption of our activities and expose us to liability, which could adversely affect our business and our reputation.
  • Risks Related to Manufacturing
  • Manufacturing and administering our product candidates is complex and we may encounter difficulties in production, particularly with respect to process development or scaling up of our manufacturing capabilities. If we encounter such difficulties, our ability to provide supply of our TCR-T therapy product candidates for clinical trials or, if approved, for commercial purposes, could be delayed or stopped.
  • Although many of our personnel have experience in clinical manufacturing at other companies, we have limited experience as a company managing manufacturing for our product candidates, which will be costly, time-consuming, and which may not be successful.
  • We may have difficulty validating our manufacturing process as we manufacture TCR-T therapy product candidates from an increasingly diverse patient population for our clinical trials.
  • Risks Related to Government Regulation
  • The regulatory approval process is lengthy and time-consuming, and we may experience significant delays in the clinical development and regulatory approval of our product candidates.
  • We may be unable to obtain regulatory approval for our product candidates under applicable regulatory requirements. The denial or delay of any such approval would delay commercialization of our product candidates and adversely impact our potential to generate revenue, our business and our results of operations.
  • We may seek orphan drug status for some of our current or future product candidates, but we may be unable to obtain such designations or to maintain the benefits associated with orphan drug status, including market exclusivity, which may cause our revenue, if any, to be reduced.
  • A Breakthrough Therapy designation by the FDA, even if granted for any of our product candidates, may not lead to a faster development or regulatory review or approval process and it does not increase the likelihood that our product candidates will receive marketing approval.
  • A Fast Track designation by the FDA, even if granted for any of our current or future product candidates, may not lead to a faster development or regulatory review or approval process, and does not increase the likelihood that our product candidates will receive marketing approval.
  • We may seek Accelerated Approval from the FDA for any of our current or future product candidates. Accelerated Approval, even if granted, for any of our current or future product candidates, may not lead to a faster development, or regulatory review or approval process, and it does not increase the likelihood that our product candidates will receive marketing approval.
  • A Regenerative Medicine Advanced Therapy (RMAT) designation by the FDA, even if granted for any of our product candidates, may not lead to a faster development or regulatory review or approval process, and does not increase the likelihood that our product candidates will receive marketing approval and we may be unable to obtain or maintain the benefits associated with such designation.
  • We may seek designation for our target discovery platform as a designated platform technology, but we might not receive such designation, and even if we do, such designation may not lead to a faster regulatory review or approval process.
  • Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our product candidates in other jurisdictions.
  • Even if we receive regulatory approval of our product candidates, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our product candidates.
  • The third-party payer or insurance coverage and reimbursement status of newly-approved products are uncertain. Our product candidates may become subject to unfavorable pricing regulations, third-party coverage and reimbursement practices, or healthcare reform initiatives, which would harm our business. Failure to obtain or maintain adequate coverage and reimbursement for new or current products could limit our ability to market those products and decrease our ability to generate revenue.
  • The impact of recent healthcare reform legislation and other changes in the healthcare industry and in healthcare spending on us is currently unknown and may adversely affect our business model.
  • Regulatory requirements in the U.S. and abroad governing cell therapy products have changed frequently and may continue to change in the future, which could negatively impact our ability to complete clinical trials and commercialize our product candidates in a timely manner, if at all.
  • Inadequate funding for the FDA, the SEC and other government agencies could hinder their ability to hire and retain key personnel, and substantial changes in leadership, personnel, organizational structure, and policy could prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
  • Our employees, independent contractors, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
  • We are currently subject to, and may in the future become subject to additional, federal, state and foreign laws and regulations, industry guidelines, and contractual requirements, imposing obligations on how we collect, store, use and process personal information. Our actual or perceived failure to comply with such obligations could harm our business.
  • If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business.
  • Even if we are able to commercialize any product candidates, the products may become subject to unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives, which would harm our business.
  • Risks Related to Our Intellectual Property
  • If we are unable to obtain and maintain patent protection for any product candidates we develop and for our technology, or if the scope of the patent protection obtained is not sufficiently broad, our competitors could develop and commercialize products, product candidates and technology similar or identical to ours, and our ability to successfully commercialize any product candidates we may develop, and our technology may be adversely affected.
  • We could be unsuccessful in obtaining meaningful patent protection on one or more components of our platform technology.
  • If we fail to comply with any of our obligations under existing or future agreements pursuant to which we license intellectual property rights or technology, if the licenses are terminated or if disputes regarding these licenses arise, we could lose significant rights or technology that are material to our business and could interfere with our ability to operate our business.
  • We are currently, and expect in the future to be, party to material license or collaboration agreements, which may impose numerous obligations and restrictions on us.
  • Our proprietary position may depend upon patents that are manufacturing, formulation or method-of-use patents, which may not prevent a competitor or other third party from using the same product candidate for another use.
  • If our efforts to protect the proprietary nature of the intellectual property related to our technologies are not adequate, we may not be able to compete effectively in our market.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • Third-party claims of intellectual property infringement, misappropriation or other violations may prevent or delay our product candidate discovery and development efforts.
  • We may not be successful in obtaining or maintaining necessary rights to product components and processes for our development pipeline through acquisitions and in-licenses.
  • We may eventually become involved in lawsuits to protect or enforce our intellectual property and proprietary rights, including any patents that we or our licensors may obtain in the future, which could be expensive, time-consuming and unsuccessful.
  • Obtaining and maintaining our patent protection depends on compliance with various procedures, document submission, fee payments and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • If we obtain any patents covering our product candidates, they could nonetheless be found invalid or unenforceable if challenged in court or the USPTO.
  • Changes to patent law and its interpretation in the U.S. and in foreign jurisdictions could diminish the value of patents in general and may impact the validity, scope or enforceability of our patent rights, thereby impairing our ability to protect our product candidates and technologies.
  • We have limited foreign intellectual property rights and may not be able to protect our intellectual property rights throughout the world.
  • We may be subject to claims challenging the inventorship or ownership of our patent rights and other intellectual property.
  • We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed trade secrets or other confidential information of their former employers or other third parties or claims asserting ownership of what we regard as our own intellectual property.

Legal proceedings

We are not currently a party to any material legal proceedings. From time to time, we may become involved in legal proceedings arising in the ordinary course of our business. Regardless of outcome, litigation can have an adverse impact on us due to defense and settlement costs, diversion of management resources, negative publicity, reputational harm and other factors.

The opening of Item 3, Legal Proceedings.5

Sources

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