MGNX on Nasdaq

MACROGENICS INC

MACROGENICS INC is an American pharmaceutical preparations company based in Rockville.2 Its shares trade on Nasdaq under the symbol MGNX.2

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Last updated Oct 21, 2026.

Overview

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  • TickerMGNX on Nasdaq2
  • IndustryPharmaceutical Preparations2
  • HeadquartersRockville, United States2
  • Incorporated inDE3
  • Business address9704 Medical Center Drive, Rockville, Md 208503
  • Filer categoryNon-accelerated filer, Smaller reporting company3
  • Legal formCorporation2
  • LEI5493001KJQUA83L8MH792
  • StatusActive2
  • LEI statusLapsed (not renewed)2
  • Registered addressC/O The Corporation Trust Company, 19801 Wilmington, United States2
  • Registered withDivision of Corporations, Department of State, 32740052

All forward-looking statements, including, without limitation, our examination of historical operating trends, are based upon our current expectations and various assumptions. We believe there is a reasonable basis for our expectations and beliefs, but they are inherently uncertain. We may not realize our expectations, and our beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements. The following uncertainties and factors, among others (including those set forth under "Risk Factors"), could affect future performance and cause actual results to differ materially from those matters expressed in or implied by forward-looking statements:4 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

-48.7%Operating margin5
-49.9%Net margin5
-0.3%Revenue growth, 20255
-134.2%Return on equity5
-$83.0MFree cash flow5

What sells

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

Products and services

Revenue From Collaborative Agreements brought in 58% of the revenue MACROGENICS INC broke down this way in fiscal 2025.

  1. Revenue From Collaborative Agreements$87.2M558%down 27% from 2024
  2. Contract Manufacturing$52.6M535%up 303% from 2024
  3. Revenue From Royality Agreements$9.7M56%up 1627% from 2024
Products and services by year
Products and services202320242025
Revenue From Collaborative Agreements$30.5M$119.9M$87.2M
Contract Manufacturing$9.8M$13.1M$52.6M
Revenue From Royality Agreements$431.0K$561.0K$9.7M

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Research and development98¢$147.2M
  • Other costs1¢$1.7M
  • Income tax0¢$672.0K

Out of $149.5M in revenue.5 The company lost money this year.

Financial statements

Revenue67895$149.5M in 2025+133% since 2019
0$50.0M$100.0M$150.0M$200.0M2019: $64.2M$64.2M20192020: $104.9M$104.9M2020+63%2021: $77.4M$77.4M2021−26%2022: $151.9M$151.9M2022+96%2023: $58.7M$58.7M2023−61%2024: $150.0M$150.0M2024+155%2025: $149.5M$149.5M2025−0%
Operating income67895-$72.8M in 2025−59% since 2019
-$300.0M-$200.0M-$100.0M02019: -$177.2M-$177.2M20192020: -$131.1M-$131.1M2020−26%2021: -$202.8M-$202.8M2021+55%2022: -$121.4M-$121.4M2022−40%2023: -$168.2M-$168.2M2023+39%2024: -$110.6M-$110.6M2024−34%2025: -$72.8M-$72.8M2025−34%
Net income67895-$74.6M in 2025−51% since 2019
-$300.0M-$200.0M-$100.0M02019: -$151.8M-$151.8M20192020: -$129.7M-$129.7M2020−15%2021: -$202.1M-$202.1M2021+56%2022: -$119.8M-$119.8M2022−41%2023: -$9.1M-$9.1M2023−92%2024: -$67.0M-$67.0M2024+639%2025: -$74.6M-$74.6M2025+11%

Every line of the income statement as filed: the last 3 fiscal years, latest first.5

Period ending2025-12-312024-12-312023-12-31
Total revenues$149.5M$150.0M$58.7M
Cost of product sales$0$847.0K$619.0K
Cost of manufacturing services$36.0M$11.5M$7.6M
Research and development$147.2M$177.2M$166.6M
Selling, general and administrative$39.2M$71.0M$52.2M
Total costs and expenses$222.3M$260.5M$227.0M
Loss from operations-$72.8M-$110.6M-$168.2M
Gain on royalty monetization arrangement$0$0$150.9M
Gain on sale of MARGENZA$0$36.2M$0
Interest and other income$6.1M$9.4M$9.7M
Interest and other expense-$8.5M-$1.1M-$1.4M
Loss before income taxes-$75.3M-$66.0M-$9.1M
Income tax (benefit) expense-$672.0K$944.0K$0
Net loss-$74.6M-$67.0M-$9.1M
Unrealized gain (loss) on investments$28.0K$10.0K-$1.0K
Comprehensive loss-$74.6M-$67.0M-$9.1M
Basic and diluted net loss per common share, basic (in dollars per share)-$1.18-$1.07-$0.15
Basic and diluted net loss per common share, diluted (in dollars per share)-$1.18-$1.07-$0.15
Basic weighted average number of common shares outstanding (in shares)63.2M shares62.6M shares61.9M shares
Diluted weighted average number of common shares outstanding (in shares)63.2M shares62.6M shares61.9M shares

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Corporate structure

MACROGENICS INC 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 MACROGENICS INC

  • ARMISTICE CAPITAL, LLC Filed SCHEDULE 13G/A on MACROGENICS INC, latest Aug 14, 2026 (9 filings since Feb 14, 2023)
  • Bank of America Filed SCHEDULE 13G/A on MACROGENICS INC, latest Aug 3, 2026 (2 filings since May 14, 2026)
  • BlackRock Filed SCHEDULE 13G on MACROGENICS INC, latest Jul 29, 2026 (7 filings since Feb 3, 2022)
  • MILLENNIUM MANAGEMENT LLC Filed SCHEDULE 13G/A on MACROGENICS INC, latest Jul 20, 2026 (8 filings since Sep 2, 2022)
  • VANGUARD GROUP INC Filed SCHEDULE 13G/A on MACROGENICS INC, latest Mar 27, 2026 (4 filings since Feb 10, 2022)
  • Frazier Life Sciences Public Fund, L.P. Filed SCHEDULE 13G/A on MACROGENICS INC, latest Feb 13, 2026 (3 filings since Nov 20, 2024)
  • Bellevue Group Filed SCHEDULE 13G/A on MACROGENICS INC, latest Jan 6, 2026 (2 filings since Jul 7, 2025)
  • WASATCH ADVISORS LP Filed SCHEDULE 13G/A on MACROGENICS INC, latest Nov 12, 2025 (4 filings since Feb 11, 2022)
  • BB Biotech Filed SCHEDULE 13G/A on MACROGENICS INC, latest Jun 13, 2025 (5 filings since Feb 11, 2022)
  • RA CAPITAL MANAGEMENT, L.P. Filed SCHEDULE 13G/A on MACROGENICS INC, latest Feb 14, 2025 (5 filings since Feb 14, 2022)
  • T. Rowe Price Investment Management, Inc. Filed SC 13G on MACROGENICS INC, latest Feb 14, 2024
  • RTW INVESTMENTS, LP Filed SC 13G/A on MACROGENICS INC, latest Feb 14, 2023 (2 filings since Feb 14, 2022)
  • MACROGENICS INC Rockville, Maryland, 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 MACROGENICS 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
Construction in progress$371.0K5 Dec 31, 2025$1.2M5 Dec 31, 2024−69.5%
Property and equipment, before depreciation$108.4M5 Dec 31, 2025$106.8M5 Dec 31, 2024+1.5%
Accumulated depreciation$95.8M5 Dec 31, 2025$88.7M5 Dec 31, 2024+8.0%
Property and equipment, net$12.6M5 Dec 31, 2025$18.1M5 Dec 31, 2024−30.2%
Operating-lease assets (leased space)$22.9M5 Dec 31, 2025$24.5M5 Dec 31, 2024−6.6%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$57.2M5 Dec 31, 2025$182.8M5 Dec 31, 2024−68.7%
Debt securities available for sale$132.7M5 Dec 31, 2025$18.8M5 Dec 31, 2024+604.8%

Inventory

ItemLatestA year beforeChange
Inventory, total$7.9M5 Dec 31, 2025$05 Dec 31, 2024

Properties, in its own words

We lease a total of approximately 190,000 square feet of manufacturing, office, laboratory and warehouse space in Maryland. Our headquarters building in Rockville, Maryland currently houses laboratory, office and manufacturing operations to support clinical and commercial quantities and scale. This location is occupied under a lease that expires in 2035. Our leases each have one or more five-year options to renew. We believe that our properties are generally in good condition, well maintained, suitable and adequate to carry on our business. We believe our capital resources are sufficient to lease any additional facilities required to meet our expected growth needs.

Item 2 of the 10-K filed Mar 9, 2026.4

Leadership

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

Board members and other officers (27)

Timeline

  1. Sep 3, 20268-K Financial statements and exhibits42
  2. Aug 13, 20268-K Results of operations43
  3. Jul 23, 20268-K Other events44
  4. Jul 8, 20268-K Executive or director change45
  5. Jul 7, 20268-K Completed an acquisition or sale; Regulation FD disclosure46
  6. May 20, 20268-K Shareholder vote47
  7. May 13, 20268-K Results of operations48
  8. May 12, 20268-K Entered a material agreement; Regulation FD disclosure49
  9. May 4, 20268-K Entered a material agreement; Other events50
  10. Apr 8, 20268-K Other events51
  11. Mar 9, 20268-K Results of operations52
  12. Mar 2, 20268-K Other events53
  13. Aug 15, 2025New chief executive Eric Blasius Risser becomes CEO13
  14. Oct 9, 2013New chief executive Scott Koenig becomes CEO14
  15. Aug 14, 2000Founded MACROGENICS INC is founded2

Calendar

Coming up

  1. Nov 11, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported $0.27 a share, on Nov 12, 2025.54

When it reported results

  1. Aug 13, 2026Reported quarterly or annual results43
  2. May 13, 2026Reported quarterly or annual results48
  3. Mar 9, 2026Reported quarterly or annual results52
  4. Nov 12, 2025Reported quarterly or annual results55
  5. Aug 14, 2025Reported quarterly or annual results56
  6. May 13, 2025Reported quarterly or annual results57
  7. Mar 20, 2025Reported quarterly or annual results58
  8. Nov 5, 2024Reported quarterly or annual results59

Drug trials and FDA: coming up

  1. Jul 2027Phase 2 trial readout expected Phase 2 trial of Lorigerlimab in Platinum-resistant Ovarian Cancer: primary completion expected Jul 2027 (ClinicalTrials.gov NCT06730347).60

Drug trials and FDA: recently

  1. Feb 19, 2026Phase 2 trial completed Phase 2 trial of lorigerlimab, docetaxel and others in Androgen-Independent Prostatic Cancer: primary completion Feb 19, 2026, no results posted yet (ClinicalTrials.gov NCT05848011).61

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). Trials from ClinicalTrials.gov, as the sponsor registered them (expected dates are the sponsor's own and often move); approvals and advisory committee meetings from the FDA. The FDA does not publish its decision (PDUFA) dates. The full markets calendar

Filings

345 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 58 major events, 166 insider forms, 55 large holders, 46 other. The latest 20:

  1. Oct 7, 20264 EDGAR
  2. Sep 21, 2026144 EDGAR
  3. Sep 3, 2026S-8 EDGAR
  4. Sep 3, 20268-K/A EDGAR
  5. Aug 20, 20264 EDGAR
  6. Aug 19, 2026144 EDGAR
  7. Aug 18, 20264 EDGAR
  8. Aug 17, 2026144 EDGAR
  9. Aug 14, 2026SCHEDULE 13G/A EDGAR
  10. Aug 14, 202610-Q EDGAR
  11. Aug 13, 20268-K EDGAR
  12. Aug 3, 2026144 EDGAR
  13. Aug 3, 2026SCHEDULE 13G/A EDGAR
  14. Jul 29, 2026SCHEDULE 13G EDGAR
  15. Jul 23, 20268-K EDGAR
  16. Jul 20, 2026SCHEDULE 13G/A EDGAR
  17. Jul 13, 2026144 EDGAR
  18. Jul 8, 20268-K EDGAR
  19. Jul 7, 20268-K EDGAR
  20. Jun 5, 2026SCHEDULE 13G EDGAR

The 345 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

30 open-market trades by officers, directors and large owners since October 2021: 16 buys and 14 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Aug 19, 2026Peters Jeffrey StuartSenior VP, GC, and SecretarySale31,105$4.15$129.1KForm 4
Aug 20, 2025HEIDEN WILLIAM KDirectorBuy49,500$1.49$73.8KForm 4
Aug 19, 2025HEIDEN WILLIAM KDirectorBuy50,500$1.52$76.8KForm 4
Feb 15, 2025Smith Beth AnnVP, Controller & TreasurerSale423$2.56$1.1KForm 4
Apr 4, 2024Peters Jeffrey StuartSenior VP, GC, and SecretarySale51,395$15.55$799.1KForm 4
Mar 6, 2024Peters Jeffrey StuartSenior VP, GC, and SecretarySale19,625$21.50$421.9KForm 4
Mar 4, 2024Risser Eric BlasiusPresident and CEOSale41,159$19.76$813.5KForm 4
Mar 4, 2024Spitznagel ThomasSr VP, Technical OpsSale10,000$20.00$200.0KForm 4
Mar 4, 2024Karrels JamesSVP and CFOSale30,000$20.50$615.0KForm 4
Feb 26, 2024Peters Jeffrey StuartSenior VP, GC, and SecretarySale16,124$17.22$277.7KForm 4
Feb 7, 2024Bonvini EzioSr VP, Research & CSOSale3,334$18.00$60.0KForm 4
Feb 5, 2024Peters Jeffrey StuartSenior VP, GC, and SecretarySale76,251$16.50$1.3MForm 4
Feb 1, 2024Bonvini EzioSr VP, Research & CSOSale13,316$15.00$199.7KForm 4
Jan 19, 2024Bonvini EzioSr VP, Research & CSOSale13,316$12.00$159.8KForm 4
Dec 20, 2023Bonvini EzioSr VP, Research & CSOSale18,880$10.08$190.3KForm 4
Oct 2, 2023BB BIOTECH AG10% ownerBuy150,000$4.46$669.0KForm 4
Sep 7, 2023BIOTECH TARGET N V10% ownerBuy200,000$5.26$1.1MForm 4
Aug 30, 2023HURWITZ EDWARDDirectorBuy15,000$4.91$73.7KForm 4
Mar 10, 2023Peters Jeffrey StuartSenior VP, GC, and SecretarySale5,372$6.03$32.4KForm 4
Feb 14, 2023BB BIOTECH AG10% ownerBuy500,000$5.07$2.5MForm 4

All 30 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
2025Eric Risser53$561.6K$2.1M76
2025Ezio Bonvini72$533.2K$1.2M76
2025James Karrels59$506.5K$1.1M76
2025Scott KoenigM.D., Ph.D.$477.1K$953.0K76
2024Former ChiefExecutive Officer and current Director$734.0K$6.4M76
2024Senior VicePresident and Chief Financial Officer$491.1K$2.4M76

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
Armistice Capital, LLC5,006,752$23.1M0.6%−1,005,248
BlackRock, Inc.4,679,229$21.6M0.0%+3,516,083
Vanguard Capital Management LLC2,656,010$12.3M0.0%+2,157
Renaissance Technologies LLC2,632,750$12.2M0.0%−330,809
Bank Of America Corp /de/2,488,252$11.5M0.0%+86,438
Two Sigma Investments, LP2,465,699$11.4M0.0%−62,130
Millennium Management LLC2,374,296$11.0M0.0%−420,061
Wasatch Advisors LP2,018,881$9.3M0.1%+459,180
Ra Capital Management, L.P.1,864,176$8.6M0.1%No change
Vanguard Portfolio Management LLC1,820,231$8.4M0.0%+611,456
Mackenzie Financial Corp1,642,626$7.6M0.0%+1,045,184
Marshall Wace, Llp1,616,220$7.5M0.0%−409,306
Geode Capital Management, LLC1,576,549$7.3M0.0%+879,228
Affinity Asset Advisors, LLC1,216,606$5.6M0.3%+716,606
D. E. Shaw & Co., Inc.1,062,991$4.9M0.0%+4,567
Jacobs Levy Equity Management, Inc1,002,274$4.6M0.0%+561,131
Connor, Clark & Lunn Investment Management Ltd.1,000,412$4.6M0.0%+133,163
State Street Corp863,663$4.0M0.0%+569,976
Goldman Sachs Group Inc558,001$2.6M0.0%+284,523
Northern Trust Corp516,129$2.4M0.0%+363,847
Vanguard Fiduciary Trust Co420,106$1.9M0.0%+80,017
Nomura Asset Management International Inc.420,000$1.9M0.0%No change
Walleye Capital LLC408,150$1.9M0.0%+72,885
Dimensional Fund Advisors LP379,335$1.8M0.0%+127,532
Diadema Partners LP374,403$1.7M0.7%−225,597

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

SEC filer profile

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

  • Name on EDGARMACROGENICS INC1
  • CIK0001125345
  • Employer ID (EIN)06-15916134
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company4
  • Incorporated inDelaware4
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address9704 Medical Center Drive, Rockville, MD 208501
  • Phone301-251-51721
  • Shares outstanding63,700,187 as of Aug 8, 202611
  • Public float$73.9M as of Jun 30, 20254
  • AuditorErnst & Young LLP, Tysons, Virginia PCAOB ID 42; it also attests to the company’s internal control over financial reporting4
  • On EDGAR sinceNov 12, 20031
  • Filings937 in all: 4 (433), 8-K (146), SC 13G/A (64), 10-Q (39), 3 (32), SC 13G (30), SCHEDULE 13G/A (18), 144 (16)1
    All 38 form types

    S-8 (15), 10-K (13), DEF 14A (13), UPLOAD (13), CORRESP (11), CT ORDER (11), DEFA14A (11), 424B5 (10), 4/A (9), 5 (6), EFFECT (6), S-1/A (6), SCHEDULE 13G (6), REGDEX (5), S-3 (3), 10-K/A (2), 424B4 (2), 8-K/A (2), ARS (2), S-1 (2), S-3ASR (2), 424B3 (1), 8-A12B (1), CERTNAS (1), D (1), DRS (1), POS AM (1), POSASR (1), PRE 14A (1), S-1MEF (1)

  • Latest filingsAnnual report (10-K) Mar 9, 2026
    Quarterly report (10-Q) Aug 14, 2026
    Proxy statement (DEF 14A) Apr 8, 2026
    Latest 8-K (8-K) Aug 13, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.01 per shareMGNXNasdaq Global Select Market

From the cover page of the 10-K filed Mar 9, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks MACROGENICS INC names in Item 1A of its 10-K filed Mar 9, 2026: 51 risks under these headings, as written.4

  • Risks Related to Our Financial Position and Need for Additional Capital
  • We will require substantial additional funding, which may not be available to us on acceptable terms, or at all, and, if not available, may require us to delay, scale back, or cease our product development programs or operations.
  • We have incurred significant losses since inception and anticipate continuing to incur losses for the foreseeable future. We may never achieve or sustain profitability.
  • Our business could be adversely affected by economic downturns, inflation, increases in interest rates, disruption in global supply chains, natural disasters, political crises, geopolitical events, or other macroeconomic conditions, which have in the past and may in the future negatively impact our business and financial performance.
  • Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish substantial rights.
  • Our ability to use our net operating loss carryforwards and other tax attributes may be limited.
  • Risks Related to Our Business and the Development and Commercialization of Our Product Candidates
  • We depend substantially on the success of the clinical development of our product candidates, through our own efforts or those of our collaborators. If we or our collaborators are unable to successfully complete clinical development, obtain additional regulatory approvals and commercialize our product candidates, or experience significant delays in doing so, our business will be materially harmed and we may not be able to generate sufficient revenues and cash flows to continue our operations.
  • Drug development involves a lengthy and expensive process, with a highly uncertain outcome. We expect to incur significant additional costs related to the development of our product candidates and may experience delays in completing, or ultimately be unable to complete, the development and commercialization of our other product candidates.
  • If clinical trials for our product candidates are prolonged, delayed or stopped, for any reason, we may be unable to obtain regulatory approval and commercialize our product candidates on a timely basis, which would require us to incur additional costs and delay our receipt of any product revenue.
  • The results of previous clinical trials may not be predictive of future results, and interim or top line data may be subject to change or qualification, based on several factors, including a complete analysis of data, or in the case of interim analysis,
  • the continued or ongoing accrual of data. In addition, the results of our current and planned clinical trials may not satisfy the requirements of the FDA or non-U.S. regulatory authorities for product approval.
The other 40 risks
  • Certain of our antibody-drug conjugate, or ADC, product candidates incorporate technology developed by our collaboration partners. To date, no ADC product candidates incorporating any such technology have been approved by the FDA.
  • We may not be successful in our efforts to use and expand our technology platforms to build a pipeline of product candidates. We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
  • Our product candidates, if approved, may fail to achieve or maintain market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.
  • Our product candidates may have undesirable side effects, including fatalities. These side effects may delay or prevent further clinical development or marketing approval, or, if approval is received, require them to be taken off the market, require them to include safety warnings or otherwise limit their sales.
  • Our manufacturing facility is subject to significant government regulations and approvals, which are often costly and could result in adverse consequences to our business if we fail to comply with the regulations or maintain the approvals.
  • Our manufacturing facility is not currently being primarily utilized for the production of our own product candidates, and we may not be able to efficiently and effectively offset the costs of maintaining the facility through contract manufacturing services for third parties in the future.
  • We face significant competition and if our competitors continue to develop and market products that are more effective, safer or less expensive than our product candidates or if they are ahead of us in development, our current or future commercial opportunities may be negatively impacted.
  • The manufacture of products or product candidates, for ourselves and our collaborators, is complex, and we may encounter difficulties in production. There can be no assurance that we will be able to effectively manufacture clinical quantities of our product candidates in the future. Further, we have limited experience in large-scale commercial manufacturing, and there can be no assurance that we will be able to effectively manufacture commercial quantities of products or product candidates for ourselves or our collaborators, if and when approved.
  • We have limited experience in launching and marketing approved products. If our products achieve regulatory approval and we are unable to further develop marketing and sales capabilities or enter into agreements with third parties to market and sell our products we may not be able to generate substantial product sales revenue.
  • Actual or anticipated changes to the laws and regulations governing the health care system may have a negative impact on cost and access to health insurance coverage and reimbursement of healthcare items and services.
  • Reimbursement decisions by third-party payors may have an adverse effect on pricing and market acceptance. If there is not sufficient reimbursement for our products, it is less likely that our products will be widely used.
  • If any product liability lawsuits are successfully brought against us or any of our collaborators, we may incur substantial liabilities and may be required to limit commercialization of our products or product candidates.
  • Even if we and our collaborators obtain regulatory approvals to market our current and any future approved products, we and our collaborators will remain subject to extensive ongoing regulatory obligations and oversight, including post-approval requirements, that could result in significant additional expense and could negatively impact our and our collaborators' ability to commercialize our current and any future approved products.
  • We and/or our collaboration partners may never obtain approval or commercialize our products outside of the United States, which would limit our ability to realize their full market potential.
  • Inadequate funding or government efficiency initiatives for the FDA and other government agencies could reduce agency staffing or hinder agency 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.
  • Changes in U.S. tax law may have a material adverse effect on our business, financial condition and results of operations, and changes in international trade relations may have a material adverse effect on the commercialization of some or all of our product candidates.
  • Public health crises such as pandemics or similar outbreaks may have a significant negative impact on our clinical trials, nonclinical studies, development, manufacturing and commercialization of our product candidates and other aspects of our business, staff, and operations.
  • Risks Related to Our Dependence on Third Parties
  • Our existing therapeutic collaborations are important to our business, and future collaborations may also be important to us. If we are unable to maintain any of these collaborations, or if these collaborations are not successful, our business could be adversely affected.
  • We contract with, and may in the future contract with, third parties for components of the manufacturing of our product candidates, including our antibody drug conjugate candidates. Failure of third-party contractors to successfully perform their obligations could harm our ability to develop or commercialize our product or product candidates.
  • Failure to successfully develop and commercialize companion diagnostics with third party contractors for use with our product candidates could harm our ability to commercialize our product candidates.
  • Independent clinical investigators and CROs that we engage to conduct our clinical trials may not devote sufficient time or attention to our clinical trials or be able to repeat their past success.
  • Commercialization collaborations will be important to our business. If we are unable to maintain commercialization collaborations, or if commercialization collaborations are not successful, our business could be adversely affected.
  • If our information technology systems, or those third parties with whom we work, are or were compromised, we could experience adverse consequences resulting from such compromise, including but not limited to regulatory investigations or actions; litigation; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; loss of customers or sales; and other adverse consequences.
  • Risks Related to Our Intellectual Property
  • Our success depends significantly on our ability to operate without infringing the valid patents and other proprietary rights of third parties.
  • If we are unable to obtain and enforce patent protection for our products and our product candidates and related technology, our business could be materially harmed.
  • We may become involved in lawsuits to protect or enforce our patents, which could be expensive, time consuming and unsuccessful.
  • If we fail to comply with our obligations under our intellectual property licenses with third parties, we could lose license rights that are important to our business.
  • If we are unable to protect the confidentiality of our proprietary information, the value of our technology and products could be adversely affected.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, documentary, 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 protection under the Hatch-Waxman Amendments and similar foreign legislation for extending the term of patents covering each of our product candidates, our business may be materially harmed.
  • Risks Related to Legal Compliance Matters
  • We are subject to the U.S. Foreign Corrupt Practices Act and other anti-corruption laws. If we fail to comply with these laws, we could be subject to civil or criminal penalties, other remedial measures, and legal expenses, which could adversely affect our business, results of operations and financial condition.
  • If we do not comply with laws regulating the protection of the environment and health and human safety, our business could be adversely affected.
  • We and our collaborators are subject to various healthcare laws, and our failure, or the failure of our collaborators, to comply with those laws could result in significant penalties and adversely affect our business, operations and financial condition.
  • We and the third parties with whom we work are subject to stringent and evolving U.S. and foreign laws, regulations, and rules, contractual obligations, industry standards, policies and other obligations related to data privacy and security. Our actual or perceived failure to comply with such obligations could lead to regulatory investigations or actions; litigation (including class claims) and mass arbitration demands; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; loss of customers; and other adverse business consequences.
  • Our employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements and insider trading.
  • Risks Related to Employee Matters and Human Capital Management
  • Our future success depends on our ability to attract or retain key executives and to attract, retain and motivate qualified personnel.
  • We may undertake internal restructuring activities, including associated workforce reductions, that could result in disruptions to our business or otherwise materially harm our results of operations or financial condition.
  • We may need to grow or contract our organization, and we may experience difficulties in managing this growth or contraction, which could disrupt our operations.
  • Risks Related to Our Common Stock
  • We have been and may in the future be subject to securities litigation, which is expensive and could divert management attention and adversely impact our business.
  • Provisions of our charter, bylaws, third-party agreements and Delaware law may make an acquisition of us or a change in our management more difficult.

Legal proceedings

Securities Litigation

In July 2024, a putative securities class action suit, entitled Crain v. MacroGenics, Inc. (Case No. 24-cv-02184), was filed in the U.S. District Court for the District of Maryland against the Company and Scott Koenig, M.D., Ph.D., the Company’s former President and Chief Executive Officer and a current member of the Company’s Board of Directors, alleging violations of securities laws during 2024. The suit asserted certain claims under Section 10 and Rule 10b-5 of the Securities and Exchange Act of 1934 based on alleged misstatements or omissions concerning the Company's TAMARACK Phase 2 study of vobramitamab duocarmazine in patients with metastatic castration-resistant prostate cancer. On December 20, 2024, the District Court issued an Order dismissing the case, without prejudice.

On December 9, 2024, a shareholder derivative suit, entitled Gregora v. Heiden et al. (Case No. 24-cv-03546), was filed in the U.S. District Court for the District of Maryland against certain of the Company’s officers and directors and naming the Company as a nominal defendant. The suit asserts certain claims under Section 10(b) and Rule 10b-5 of the Securities and Exchange Act of 1934 and for breach of fiduciary duty, aiding and abetting breach of fiduciary duty, unjust enrichment, and waste of corporate assets based on the same facts as the Securities Class Action. On March 10, 2025, the plaintiff filed a notice of voluntary dismissal. On March 11, 2025, the Court entered an Order dismissing the case without prejudice.

The opening of Item 3, Legal Proceedings.4

Sources

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