TGTX on Nasdaq

TG Therapeutics

Logo: tgtherapeutics.com4

TG Therapeutics is a commercial stage biopharmaceutical company based in New York City.1 Its shares trade on Nasdaq under the symbol TGTX.1

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Last updated Oct 21, 2026.

Overview

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  • TickerTGTX on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersNew York City1
  • Websitetgtherapeutics.com
  • Incorporated inDE5
  • Business address2 Gansevoort Street, 9Th Floor, New York, Ny 100145
  • Filer categoryLarge accelerated filer5
  • Legal formCorporation3
  • LEI529900X21UKABN9NJ5293
  • StatusActive3
  • LEI statusLapsed (not renewed)3
  • Registered addressc/o The Corporation Trust Company, Corporation Trust Center 1209 Orange St, 19801 Wilmington, United States3
  • Registered withDivision of Corporations, Department of State, 23367563

Certain matters discussed in this Annual Report on Form 10-K contain forward-looking statements. All statements other than statements of historical facts may constitute forward-looking statements. We intend such forward-looking statements to be subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including Section 27A of the Securities Act of 1933, as amended (Securities Act) and Section 21E of the Securities Exchange Act of 1934, as amended (Exchange Act). Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from the future results, performance or achievements expressed or implied by such forward-looking statements. In some cases, you can identify forward-looking statements by words such as “anticipate,” “believe,” “co…6 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

20.0%Operating margin7
72.6%Net margin7
87.3%Revenue growth, 20257
69.0%Return on equity7
0.38×Debt to equity7
-$25.0MFree cash flow7

What sells

Revenue by product, business segment and region, as the company reports it to the SEC.

Products and services

Product brought in 97% of the revenue TG Therapeutics broke down this way in fiscal 2025.

  1. Product$606.9M797%up 93% from 2024
  2. License$9.4M71%down 39% from 2024
  3. Royalty$5.6M71%up 601% from 2024
  4. Other Revenue$3.6M71%up 97% from 2024
  5. License revenue$152.0K70%up 0% from 2024
Products and services by year
Products and services202320242025
Product$92.0M$313.7M$606.9M
License$141.7M$15.3M$9.4M
Royalty$0$801.0K$5.6M
Other Revenue$1.5M$1.8M$3.6M
License revenue$140.2M$152.0K$152.0K

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue8¢$100.7M
  • Research and development13¢$160.2M
  • Selling, general and admin18¢$232.0M
  • Income tax27¢$339.8M
  • Profit35¢$447.2M

Out of $616.3M in revenue.7

Financial statements

Revenue8910117$616.3M in 2025+405352% since 2019
0$200.0M$400.0M$600.0M$800.0M2019: $152.0K$152.0K20192020: $152.0K$152.0K2020+0%2021: $6.7M$6.7M2021+4301%2022: $2.8M$2.8M2022−58%2023: $233.7M$233.7M2023+8290%2024: $329.0M$329.0M2024+41%2025: $616.3M$616.3M2025+87%
Operating income8910117$123.3M in 2025
-$400.0M-$200.0M0$200.0M2019: -$169.1M-$169.1M20192020: -$273.6M-$273.6M2020+62%2021: -$344.8M-$344.8M2021+26%2022: -$218.3M-$218.3M2022−37%2023: $20.6M$20.6M20232024: $41.9M$41.9M2024+103%2025: $123.3M$123.3M2025+194%
Net income8910117$447.2M in 2025
-$400.0M-$200.0M0$200.0M$400.0M$600.0M2019: -$172.9M-$172.9M20192020: -$279.4M-$279.4M2020+62%2021: -$348.1M-$348.1M2021+25%2022: -$223.8M-$223.8M2022−36%2023: $12.7M$12.7M20232024: $23.4M$23.4M2024+85%2025: $447.2M$447.2M2025+1812%

Every line of the income statement as filed: the last 3 fiscal years, latest first.7

Period ending2025-12-312024-12-312023-12-31
Revenue$616.3M$329.0M$233.7M
Cost of revenue$100.7M$38.5M$14.1M
Noncash compensation$16.6M$11.2M$13.0M
Other research and development$143.6M$83.1M$63.2M
Total research and development$160.2M$94.3M$76.2M
Noncash compensation$48.1M$31.4M$24.9M
Other selling, general and administrative$184.0M$122.9M$97.8M
Total selling, general and administrative$232.0M$154.3M$122.7M
Total costs and expenses$493.0M$287.1M$213.0M
Operating income$123.3M$41.9M$20.6M
Interest expense$26.7M$24.0M$12.6M
Other income-$10.8M-$7.7M-$5.0M
Total other expense$15.9M$16.3M$7.6M
Net income before taxes$107.4M$25.6M$13.1M
Income tax benefit (expense)$339.8M-$2.2M-$390.0K
Net income$447.2M$23.4M$12.7M
Basic (in dollars per share)$3.10$0.16$0.09
Diluted (in dollars per share)$2.77$0.15$0.09
Basic (in shares)144.3M shares145.3M shares142.0M shares
Diluted (in shares)161.4M shares160.3M shares148.5M shares

Compare TG Therapeutics with another company

Corporate structure

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

Major holders of TG Therapeutics

  • VANGUARD PORTFOLIO MANAGEMENT LLC Filed SCHEDULE 13G on TG Therapeutics, latest Apr 29, 2026
  • VANGUARD GROUP INC Filed SCHEDULE 13G/A on TG Therapeutics, latest Mar 27, 2026 (6 filings since Feb 10, 2022)
  • State Street Corporation Filed SCHEDULE 13G on TG Therapeutics, latest Nov 10, 2025 (4 filings since Feb 3, 2023)
  • BlackRock Filed SCHEDULE 13G/A on TG Therapeutics, latest Apr 30, 2025 (5 filings since Feb 1, 2022)
  • Darwin Global Management, Ltd. Filed SC 13G/A on TG Therapeutics, latest Nov 14, 2024 (3 filings since Apr 3, 2023)
  • FMR LLC Filed SC 13G/A on TG Therapeutics, latest Feb 9, 2023 (3 filings since Feb 9, 2022)
  • TG Therapeutics New York, New York, United States

Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What TG Therapeutics 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
Operating-lease assets (leased space)$6.3M7 Dec 31, 2025$7.2M7 Dec 31, 2024−12.2%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$79.1M7 Dec 31, 2025$179.9M7 Dec 31, 2024−56.0%
Marketable securities, current$62.8M7 Dec 31, 2025$131.1M7 Dec 31, 2024−52.1%
Long-term investments$59.1M7 Dec 31, 2025$808.0K7 Dec 31, 2024+7218.8%

Inventory

ItemLatestA year beforeChange
Inventory, total$125.6M7 Dec 31, 2025$110.5M7 Dec 31, 2024+13.7%
Raw materials$28.2M11 Dec 31, 2024$6.6M11 Dec 31, 2023+327.7%
Work in process$68.4M11 Dec 31, 2024$31.2M11 Dec 31, 2023+118.8%

Properties, in its own words

We maintain corporate and executive space in Morrisville, North Carolina and New York, New York. We are also currently leasing small office space in Boca Raton, Florida.

We believe that our existing facilities are adequate to meet our current requirements. We do not own any real property.

Item 2 of the 10-K filed Feb 27, 2026.6

Leadership

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

Board members and other officers (18)

Former names

  • MANHATTAN PHARMACEUTICALS INCMar 10, 2003 to Apr 27, 20125
  • ATLANTIC TECHNOLOGY VENTURES INCAug 14, 2000 to Mar 10, 20035
  • ATLANTIC PHARMACEUTICALS INCNov 7, 1996 to Feb 4, 20005

Timeline

  1. Aug 3, 20268-K Results of operations37
  2. Jun 12, 20268-K Shareholder vote38
  3. Jun 3, 20268-K Other events39
  4. May 27, 20268-K Other events40
  5. May 6, 20268-K Results of operations41
  6. Mar 20, 20268-K Entered a material agreement; New debt or obligation42
  7. Feb 26, 20268-K Results of operations43
  8. Jan 13, 20268-K Regulation FD disclosure44
  9. Nov 3, 20258-K Results of operations45
  10. Aug 4, 20258-K Results of operations46
  11. Jun 13, 20258-K Shareholder vote47
  12. May 5, 20258-K Results of operations48
  13. Jan 2, 2013New chief executive Michael S. Weiss becomes CEO15
  14. Jul 10, 2006New chief executive Douglas Abel becomes CEO16

Calendar

Coming up

  1. Nov 2, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported $2.43 a share, on Nov 3, 2025.49

When it reported results

  1. Aug 3, 2026Reported quarterly or annual results37
  2. May 6, 2026Reported quarterly or annual results41
  3. Feb 26, 2026Reported quarterly or annual results43
  4. Nov 3, 2025Reported quarterly or annual results45
  5. Aug 4, 2025Reported quarterly or annual results46
  6. May 5, 2025Reported quarterly or annual results48
  7. Mar 3, 2025Reported quarterly or annual results50
  8. Nov 4, 2024Reported quarterly or annual results51

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

Filings

175 filings to the SEC since October 2021: 6 annual reports, 15 quarterly reports, 35 major events, 58 insider forms, 22 large holders, 39 other. The latest 20:

  1. Sep 14, 20264 EDGAR
  2. Sep 10, 2026144 EDGAR
  3. Aug 7, 20264 EDGAR
  4. Aug 5, 202610-Q EDGAR
  5. Aug 3, 20268-K EDGAR
  6. Jun 15, 20264 EDGAR
  7. Jun 15, 20264 EDGAR
  8. Jun 15, 20264 EDGAR
  9. Jun 15, 20264 EDGAR
  10. Jun 15, 20264 EDGAR
  11. Jun 12, 20268-K EDGAR
  12. Jun 3, 20268-K EDGAR
  13. May 27, 20268-K EDGAR
  14. May 6, 202610-Q EDGAR
  15. May 6, 20268-K EDGAR
  16. Apr 30, 2026DEF 14A EDGAR
  17. Apr 29, 2026SCHEDULE 13G EDGAR
  18. Mar 27, 2026SCHEDULE 13G/A EDGAR
  19. Mar 20, 20268-K EDGAR
  20. Feb 27, 202610-K EDGAR

The 175 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

24 open-market trades by officers, directors and large owners since October 2021: 2 buys and 22 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 10, 2026Charney Laurence NDirectorSale5,000$54.96$274.8KForm 4
Nov 24, 2025Echelard YannDirectorSale5,000$32.57$162.8KForm 4
Sep 11, 2025Lonial SagarDirectorSale20,852$32.24$672.3KForm 4
Jun 13, 2025Echelard YannDirectorSale10,000$36.94$369.4KForm 4
Jan 6, 2025Power Sean ACFOSale10,021$28.53$285.9KForm 4
Jan 3, 2025Power Sean ACFOSale11,337$30.29$343.4KForm 4
Nov 11, 2024Lonial SagarDirectorSale5,000$30.44$152.2KForm 4
Nov 11, 2024Charney Laurence NDirectorSale25,000$30.20$755.0KForm 4
Nov 5, 2024Echelard YannDirectorSale20,000$24.48$489.6KForm 4
Jun 20, 2024Lonial SagarDirectorSale16,348$16.87$275.8KForm 4
Jun 17, 2024Lonial SagarDirectorSale9,585$16.39$157.1KForm 4
Mar 13, 2024Lonial SagarDirectorSale5,000$15.94$79.7KForm 4
Mar 12, 2024Charney Laurence NDirectorSale22,000$15.97$351.3KForm 4
Jan 5, 2024Charney Laurence NDirectorSale17,500$19.03$333.0KForm 4
Jan 3, 2024Power Sean ACFOSale47,867$16.91$809.4KForm 4
Aug 11, 2023WEISS MICHAEL SCEOBuy100,000$10.13$1.0MForm 4
Jun 23, 2023Lonial SagarDirectorSale34,854$23.37$814.5KForm 4
Jun 2, 2023Power Sean ACFOSale73,647$26.70$2.0MForm 4
Jan 6, 2023Echelard YannDirectorBuy9,000$10.64$95.8KForm 4
Jan 4, 2023Charney Laurence NDirectorSale30,000$11.10$333.0KForm 4

All 24 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
2025Michael S. Weiss60$875.0K$25.6M58
2025Sean A. Power44$500.0K$3.8M58
2024Chief Executive$875.0K$18.8M58
2024Chief Financial OfficerTreasurer$480.0K$2.3M58
2023Officer and President$875.0K$18.5M58
2023and Corporate Secretary$445.6K$1.9M58

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 100. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
BlackRock, Inc.22,050,045$1.2B0.0%−202,885
Vanguard Portfolio Management LLC7,963,266$437.5M0.0%−310,713
State Street Corp7,786,471$427.8M0.0%−863,295
Vanguard Capital Management LLC6,149,403$337.8M0.0%−453,855
Geode Capital Management, LLC3,642,216$200.1M0.0%+142,300
D. E. Shaw & Co., Inc.3,400,808$186.8M0.1%+2,810,761
Soleus Capital Management, L.P.2,927,895$160.9M5.5%−1,101,424
Clearbridge Investments, LLC2,650,192$145.6M0.1%−560,738
Congress Asset Management Co2,600,123$142.9M0.9%+432,042
Two Sigma Investments, LP2,468,971$135.6M0.1%+926,659
Goldman Sachs Group Inc2,314,279$127.1M0.0%+26,591
Pictet Asset Management Holding SA1,785,951$98.1M0.1%+38,578
Jane Street Group, LLC1,752,646$96.3M0.1%−289,023
Nuveen, LLC1,625,876$89.3M0.0%+178,798
Morgan Stanley1,601,714$88.0M0.0%+193,544
Hood River Capital Management LLC1,600,510$87.9M0.6%+31,339
Northern Trust Corp1,537,059$84.4M0.0%+94,480
Charles Schwab Investment Management Inc1,313,103$72.1M0.0%+18,048
Bank Of America Corp /de/1,309,788$72.0M0.0%−151,514
Dimensional Fund Advisors LP1,210,578$66.5M0.0%+125,723
Fmr LLC1,018,814$56.0M0.0%+738,368
Vanguard Fiduciary Trust Co961,750$52.8M0.0%−6,916
Barclays PLC957,848$52.6M0.0%+841,191
Bank of New York Mellon Corp900,482$49.5M0.0%+13,177
Bnp Paribas Financial Markets860,500$47.3M0.0%−96,526

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

SEC filer profile

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

  • Name on EDGARTG THERAPEUTICS, INC.2
  • CIK0001001316
  • Employer ID (EIN)36-38982696
  • Filer statusLarge accelerated filer not an emerging growth company; not a smaller reporting company; not a shell company6
  • Incorporated inDelaware6
  • Fiscal year endsDecember 312
  • Industry code (SIC)2834 Pharmaceutical Preparations2
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance2
  • Business address2 Gansevoort Street, 9Th Floor, New York, NY 100142
  • Phone(212) 554-44842
  • Shares outstanding153,069,053 as of Aug 3, 202613
  • Public float$2.5B as of Jun 30, 20256
  • AuditorKPMG LLP, New York, NY PCAOB ID 185; it also attests to the company’s internal control over financial reporting6
  • On EDGAR sinceJul 3, 19962
  • Filings1,148 in all: 4 (296), 8-K (245), 10-Q (61), SC 13G/A (58), 424B3 (34), 10QSB (30), SC 13G (30), 3 (29)2
    All 67 form types

    DEF 14A (29), 5 (20), 10-K (19), 144 (18), UPLOAD (18), PRE 14A (17), CORRESP (16), 424B5 (15), S-3 (14), 10KSB (11), 8-K/A (11), EFFECT (11), NT 10-Q (10), S-8 (10), 10QSB/A (9), CT ORDER (9), DEFA14A (8), S-3/A (8), SC 13D/A (8), REGDEX (7), SB-2/A (6), 4/A (5), 10-K/A (4), 10-Q/A (4), POS AM (4), PREC14A (4), PX14A6G (4), S-1 (4), SC 13D (4), 424B1 (3), 8-A12B (3), PRRN14A (3), REGDEX/A (3), RW (3), S-3ASR (3), SB-2 (3), SCHEDULE 13G (3), SCHEDULE 13G/A (3), 10KSB/A (2), 3/A (2), ARS (2), D (2), D/A (2), DEF 14C (2), DEFR14A (2), NT 10-K (2), PRE 14C (2), S-1/A (2), 144/A (1), 25 (1), 25/A (1), 5/A (1), CERTAMX (1), CERTNAS (1), DEFC14A (1), DEFS14A (1), POS462B (1), PRER14A (1), PRER14C (1)

  • Latest filingsAnnual report (10-K) Feb 27, 2026
    Quarterly report (10-Q) Aug 5, 2026
    Proxy statement (DEF 14A) Apr 30, 2026
    Latest 8-K (8-K) Aug 3, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.001TGTXNasdaq

From the cover page of the 10-K filed Feb 27, 2026 (Section 12(b) of the Exchange Act).6

Risk factors and legal proceedings

The risks TG Therapeutics names in Item 1A of its 10-K filed Feb 27, 2026: 74 risks under these headings, as written.6

  • Risks Related to Commercialization
  • If we obtain marketing approval from the U.S. Food and Drug Administration (FDA) or any comparable regulatory authority outside of the U.S. for a product candidate and do not achieve broad market acceptance among physicians, patients, healthcare payors, and the medical community, the revenues that we generate from product sales will be limited.
  • We may be subject to limitations on the indicated uses or requirements to fulfill certain post-marketing requirements or commitments to the satisfaction of regulatory authorities or may be unable to maintain marketing approval for BRIUMVI or future products that we may bring to market.
  • BRIUMVI, and any of our product candidates for which we in the future obtain marketing approval, may, after approval, be found to cause undesirable side effects that could result in significant negative consequences following commercialization.
  • The incidence and prevalence for target patient populations of BRIUMVI and our other product candidates have not been established with precision. If the market opportunities for BRIUMVI and our product candidates are smaller than we estimate or if any approval that we obtain is based on a narrower definition of the patient population, our revenue and ability to achieve profitability will be adversely affected.
  • We face substantial competition, which may result in others commercializing drugs before or more successfully than we do, resulting in the reduction or elimination of our commercial opportunity.
  • BRIUMVI, as well as any products that we are able to commercialize in the future, may become subject to unfavorable pricing regulations or third-party payor coverage and reimbursement policies, which would harm our business.
  • If we are unable to expand our commercialization operations, we may not be successful in commercializing BRIUMVI or any product candidate, if and when such product candidates are approved, and we may not be able to generate revenue.
  • Product liability lawsuits against us could cause us to incur substantial liabilities and could limit commercialization of any drug candidates that we may develop.
  • Any contracts that we enter into with government entities may involve future funding and compliance risks.
  • Risks Related to Our Financial Position and Need for Additional Capital
  • We have incurred substantial operating losses since our inception, and we may incur losses in the future.
The other 64 risks
  • While we do not expect to need to raise additional capital, we may need to do so. If we are unable to raise capital, if needed, we may be required to delay, limit, reduce or eliminate some of our drug development programs or commercialization efforts.
  • Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or drug candidates and occupy valuable management time and resources.
  • Due to limited resources, we may fail to capitalize on programs or product candidates that may present a greater commercial opportunity or for which there is a greater likelihood of success.
  • Our level of indebtedness and debt service obligations could adversely affect our financial condition and may make it more difficult for us to fund our operations.
  • We may not have cash available in an amount sufficient to enable us to make interest or principal payments on our indebtedness when due.
  • Our cash and cash equivalents could be adversely affected if the financial institutions in which we hold our cash and cash equivalents fail.
  • Risks Related to Drug Development and Regulatory Approval
  • If we are unable to maintain or obtain regulatory approval for our product or product candidates and ultimately cannot successfully commercialize our product or product candidates, or experience significant delays in doing so, our business will be materially harmed.
  • Because results of preclinical studies and early clinical trials are not necessarily predictive of future results, any product candidate we advance may not have favorable results in later clinical trials or receive regulatory approval. Moreover, interim, “top-line,” and preliminary data from our clinical trials that we announce or publish may change, or the perceived product profile may be negatively impacted, as more patient data or additional endpoints (including efficacy and safety) are analyzed.
  • Clinical drug development involves a lengthy and expensive process, with an uncertain outcome. We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.
  • Biologics carry unique risks and uncertainties, which could have a negative impact on our business.
  • Our product or product candidates may cause undesirable side effects or adverse events that could delay or prevent their regulatory approval or impact their availability and commercial potential after approval.
  • Any products or product candidates we may advance through clinical development are subject to extensive regulation, which can be costly and time consuming, cause unanticipated delays or prevent the receipt of the required approvals.
  • A Breakthrough Therapy or Fast Track designation by the FDA may not actually lead to a faster development or regulatory review or approval process.
  • We may seek orphan drug designation for some of our drug candidates. However, we may be unsuccessful in obtaining or may be unable to maintain the benefits associated with orphan drug designation, including the potential for market exclusivity.
  • We are conducting clinical trials and anticipate conducting additional clinical trials for our product and product candidates at sites outside the United States, and trials conducted in such locations or clinical trial activities in such locations may be impacted by political conditions, including international conflict.
  • The FDA and other comparable regulatory authorities outside of the U.S. may not accept data from trials conducted in locations outside of their respective jurisdictions.
  • Approval of one of our product candidates in the United States would not assure approval of that candidate in jurisdictions outside of the U.S.
  • We have product candidates still under development and are also engaging manufacturing partners in commercial manufacturing activities, and as such clinical and commercial manufacturing site additions and process improvements implemented in the production of our product and product candidates may affect their timely delivery or quality.
  • We may be unable to successfully develop, obtain regulatory approval for, or commercialize a subcutaneous formulation of our approved intravenous product, which could limit our ability to expand our market opportunity and patient reach.
  • Risks Related to Governmental Regulation of Pharmaceutical Industry and Legal Compliance Matters
  • We are subject to new legislation, regulatory proposals and third-party payor initiatives that may increase our costs of compliance and adversely affect our ability to market our products, obtain collaborators and raise capital.
  • Inadequate funding, government shutdowns, workforce reductions or other policy changes affecting the FDA, the SEC or other government agencies could hinder their ability to hire and retain key leadership and other personnel, 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.
  • Some of our relationships with customers and third-party payors are subject to applicable fraud and abuse laws, false claims laws, transparency and disclosure laws, health information and security laws, and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, exclusion from government healthcare programs, contractual damages, reputational harm and diminished profits and future earnings.
  • If we violate applicable data privacy and security laws, we may be subject to penalties, including civil and criminal penalties, damages, fines, reputation harm and the curtailment or restructuring of our operations.
  • We, directly or through our third-party service providers, may adopt, use or incorporate artificial intelligence (AI) technology and capabilities into the information technology systems or software that we use in our business and operations. Defects in such AI technology or related security breaches, loss of data and other disruptions as well as changes in implementation standards and enforcement practices under a rapidly evolving regulatory framework for AI technology may adversely affect our business and operations and potentially expose us to increasing liability.
  • If we fail to adequately understand and comply with the local laws and customs as we expand into new international markets, these operations may incur losses or otherwise adversely affect our business and results of operations.
  • Any product for which we obtain marketing approval, including BRIUMVI, could be subject to restrictions or withdrawal from the market and we may be subject to penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our products.
  • If we or any of our contract manufacturers and suppliers fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could seriously harm our business.
  • Our research and development activities could be affected or delayed as a result of shortages in animal availability or possible restrictions on animal testing. Compliance with governmental regulations regarding the treatment of animals used in research could increase our operating costs, which would adversely affect the commercialization of our products.
  • Risks Related to Our Dependence on Third Parties
  • We rely on third parties to generate clinical, preclinical and other data necessary to support the regulatory applications needed to conduct clinical trials and submit for marketing approval. We rely on third parties to help conduct our planned clinical trials. If these third parties do not perform their services as required, we may not be able to obtain regulatory approval for or commercialize our product or product candidates when expected or at all.
  • We contract with third parties for the manufacture and testing of BRIUMVI for clinical and commercial supply, as well as for all development activities and clinical product supply for high concentration ublituximab and azer-cel, and we expect to continue to do so. This reliance on third parties increases the risk that we will not have sufficient quantities of our products or product candidates or such quantities at an acceptable cost or quality, which could delay, prevent or impair our development or commercialization efforts.
  • The third parties upon whom we rely for the supply of starting materials, intermediates, active pharmaceutical ingredient (API)/drug substance, drug product, and other materials used in our drug candidates are our sole source of supply, and the loss or disruption of any of these suppliers could significantly harm our business.
  • Because we have in-licensed BRIUMVI and our product candidates from third parties, any dispute with or non-performance by our licensors will adversely affect our ability to develop and commercialize the applicable product or product candidate.
  • If conflicts arise between us and our future collaborators or strategic partners, these parties may act in a manner adverse to us and could limit our ability to implement our strategies.
  • We may seek to establish additional collaborations, and if we are not able to establish them on commercially reasonable terms, we may have to alter our development and commercialization plans.
  • Risks Related to Our Intellectual Property
  • Our success depends upon our ability to obtain and protect our intellectual property and proprietary technologies. If the scope of our patent protection obtained is not sufficiently broad, our competitors could develop and commercialize technology and drugs similar or identical to ours, and our ability to successfully commercialize our technology and drugs may be impaired. At the same time, if the scope of our patent protection is too broad, our competitors may challenge the validity and enforceability of our patents.
  • Obtaining and maintaining patent protection depends on compliance with various procedural, document submission, fee payment 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 do not obtain patent term extensions under the Hatch-Waxman Act and similar foreign legislation extending the terms of our licensed patents and any future patents we may own, our business may be materially harmed.
  • We may not be able to enforce our intellectual property rights throughout the world.
  • We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time consuming and unsuccessful.
  • If we or our partners are sued for infringing intellectual property rights of third parties, it will be costly and time consuming, and an unfavorable outcome in that litigation would have a material adverse effect on our business.
  • We may need to license certain intellectual property from third parties, and such licenses may not be available or may not be available on commercially reasonable terms.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position may be harmed.
  • We may be subject to damages resulting from claims that we or our employees have wrongfully used or disclosed alleged trade secrets of our competitors or are in breach of non-competition or non-solicitation agreements with our competitors.
  • Risks Related to Our Business Organization and Governance, Strategy, Employees and Growth Management
  • If we fail to attract and keep key management, commercial, and clinical development personnel, we may be unable to successfully develop or commercialize our product and product candidates.
  • We will need to develop and expand our business, and we may encounter difficulties in managing this development and expansion, which could disrupt our operations.
  • Certain anti-takeover provisions in our governing documents and Delaware law could make a third-party acquisition of us difficult. This could limit the price investors might be willing to pay in the future for our common stock.
  • Our ability to utilize our net operating loss (NOL) carryforwards and certain other tax attributes may be limited.
  • Certain of our executive officers, directors, principal stockholders and their affiliates maintain the ability to exercise significant influence over our company and all matters submitted to stockholders for approval.
  • Our internal information technology systems, or those of our third-party CROs, CMOs, or other contractors, vendors, or consultants, are vulnerable to failures or security breaches, which could result in a material disruption of our drug candidates’ development programs and our commercialization of any products for which we receive regulatory approval.
  • Unfavorable global economic conditions and changes in government regulations could adversely affect our business, financial condition or results of operations.
  • Our employees, principal investigators, CROs, CMOs and consultants may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading, which could have a material adverse effect on our business.
  • We may acquire businesses or drugs, or form strategic alliances, in the future, and we may not realize the benefits of such acquisitions.
  • We may be subject to adverse legislative or regulatory tax changes that could negatively impact our financial condition.
  • Risks Related to Our Common Stock and Being a Publicly Traded Company
  • Our stock price is, and we expect it to remain, volatile, which could limit investors’ ability to sell our stock at a profit.
  • We are subject to risks related to corporate social responsibility and reputational matters.
  • Climate change or legal, regulatory or market measures to address climate change may negatively affect our business, supply chain, results of operations, financial condition and growth prospects.
  • Our ability to pay dividends, if any, are limited, and our stockholders may not receive any return on investment unless they sell their common stock.
  • An active trading market for our common stock may not be sustained, and investors may not be able to resell their shares at or above the price they paid.
  • If equity research analysts do not publish research or reports about our business or if they publish negative evaluations of or downgrade our common stock, the price of our common stock could decline.
  • We incur significant increased costs as a result of operating as a public company, and our management is required to devote substantial time to compliance initiatives.
  • Volatility in the price of our common stock may subject us to securities and shareholder derivative litigation, which could cause us to incur substantial costs and divert management’s attention, financial resources and other company assets.
  • Future sales of our common stock, including by us or our directors and executive officers or shares issued upon the exercise of currently outstanding options, could cause our stock price to decline.

Legal proceedings

We, and our subsidiaries, are not a party to, and our property is not the subject of, any material pending legal proceedings.

The opening of Item 3, Legal Proceedings.6

Sources

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    SEC EDGAROther events
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