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VRDN on Nasdaq

Viridian Therapeutics, Inc.\DE

In its 2026 annual report the company says: “We are a biopharmaceutical company focused on discovering, developing, and commercializing potential best-in-class medicines for serious and rare diseases. We develop therapeutics through internal research and discovery, as well as through in-licensing opportunities that align with our strategic focus.”4 It is headquartered in Waltham, Massachusetts.1 Its shares trade on Nasdaq under the symbol VRDN.1

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Last updated Oct 21, 2026.

Overview

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  • TickerVRDN on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersWaltham, Massachusetts1
  • Incorporated inDE2
  • Business address221 Crescent Street, Suite 103A, Waltham, Ma 024532
  • Filer categoryLarge accelerated filer2

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We are a biopharmaceutical company focused on discovering, developing, and commercializing potential best-in-class medicines for serious and rare diseases. We target therapeutic areas in which current treatments leave room for improvements in efficacy, safety, and/or dosing convenience. We believe there is significant potential in these areas, for better medicines that address unmet needs, improve outcomes, and expand treatment options for patients. We aim to develop differentiated, potential best-in-class medicines that could lead to improved patient outcomes, reduced side effects, improved quality of life, and expanded market access.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

-512.9%Operating margin5
-483.6%Net margin5
23359.9%Revenue growth, 20255
-47.4%Return on equity5
-$276.9MFree cash flow5

What sells

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

Products and services

License brought in 99% of the revenue Viridian Therapeutics, Inc.\DE broke down this way in fiscal 2025.

  1. License$70.0M599%
  2. Collaboration$849.0K51%up 181% from 2024
Products and services by year
Products and services202320242025
License$0$0$70.0M
Collaboration$314.0K$302.0K$849.0K

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Selling, general and admin100¢$95.3M

Out of $70.8M in revenue.5 The company lost money this year.

Financial statements

Revenue67895$70.8M in 2025+1488% since 2019
0$20.0M$40.0M$60.0M$80.0M2019: $4.5M$4.5M20192020: $1.1M$1.1M2020−76%2021: $3.0M$3.0M2021+182%2022: $1.8M$1.8M2022−40%2023: $314.0K$314.0K2023−82%2024: $302.0K$302.0K2024−4%2025: $70.8M$70.8M2025+23360%
Operating income67895-$363.4M in 2025+766% since 2019
-$400.0M-$300.0M-$200.0M-$100.0M02019: -$42.0M-$42.0M20192020: -$110.4M-$110.4M2020+163%2021: -$79.7M-$79.7M2021−28%2022: -$134.3M-$134.3M2022+68%2023: -$254.4M-$254.4M2023+89%2024: -$299.0M-$299.0M2024+18%2025: -$363.4M-$363.4M2025+22%
Net income67895-$342.6M in 2025+718% since 2019
-$400.0M-$300.0M-$200.0M-$100.0M02019: -$41.9M-$41.9M20192020: -$110.7M-$110.7M2020+164%2021: -$79.4M-$79.4M2021−28%2022: -$129.9M-$129.9M2022+64%2023: -$237.7M-$237.7M2023+83%2024: -$269.9M-$269.9M2024+14%2025: -$342.6M-$342.6M2025+27%

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$70.8M$302.0K$314.0K
Research and development$338.9M$238.3M$159.8M
Selling, general and administrative$95.3M$61.1M$95.0M
Total operating expenses$434.2M$299.3M$254.8M
Loss from operations-$363.4M-$299.0M-$254.4M
Interest income$27.4M$31.6M$18.2M
Interest expense-$4.9M-$2.2M-$1.3M
Other expense, net-$1.7M-$314.0K-$193.0K
Total other income, net$20.8M$29.1M$16.7M
Net loss-$342.6M-$269.9M-$237.7M
Unrealized gain (loss) on available-for-sale securities$457.0K-$348.0K$728.0K
Total other comprehensive income (loss)$457.0K-$348.0K$728.0K
Comprehensive loss-$342.1M-$270.3M-$237.0M

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Corporate structure

Viridian Therapeutics, Inc.\DE sits at the top of its group. 4 entities, 3 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Viridian Therapeutics, Inc.\DE

  • Viridian Therapeutics, Inc.\DE Waltham, Massachusetts
    • Viridian Securities Corporation Subsidiary · Massachusetts, United States
    • Viridian Therapeutics Europe Limited Subsidiary · United Kingdom
    • Viridian Therapeutics S.á.r.l. Subsidiary · Luxembourg

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 Viridian Therapeutics, Inc.\DE 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$2.4M5 Dec 31, 2025$2.5M5 Dec 31, 2024−2.3%
Accumulated depreciation$1.2M5 Dec 31, 2025$1.3M5 Dec 31, 2024−3.9%
Property and equipment, net$1.2M5 Dec 31, 2025$1.2M5 Dec 31, 2024−0.6%
Operating-lease assets (leased space)$2.4M5 Dec 31, 2025$2.2M5 Dec 31, 2024+9.8%

Investments

ItemLatestA year beforeChange
Marketable securities, current$662.3M5 Dec 31, 2025$618.0M5 Dec 31, 2024+7.2%
Debt securities available for sale$662.3M5 Dec 31, 2025$618.0M5 Dec 31, 2024+7.2%

Properties, in its own words

We are party to a multi-year, non-cancelable lease agreement for our office space in Waltham, Massachusetts (as subsequently amended in July 2021, April 2022, July 2022, April 2024, September 2024 and September 2025, the “Massachusetts Lease”). In April 2024, we entered into a fourth amendment to the Massachusetts Lease (the “Fourth Amendment”). The Fourth Amendment makes certain modifications to the Massachusetts Lease, including (i) securing 10,427 sq. ft. of office space in the same building (the “New Premises”), (ii) the termination of the 10,956 sq. ft. of leased space under the Massachusetts Lease (the “Original Premises”), and (iii) the extension of the expiration date of the New Premises to July 2029. Under the Fourth Amendment, we have the option to extend the lease term for an additional period of three years upon notice to the landlord. In September 2024, we entered into a fifth amendment to the Massachusetts Lease (the “Fifth Amendment”). The Fifth Amendment makes certain modifications to both the Massachusetts Lease and the Fourth Amendment, including the addition of 2,788 sq. ft. of office space in the same building (the “September 2024 Expansion Premises”). In September 2025, we entered into the sixth amendment to the Massachusetts Lease (the “Sixth Amendment”). The Sixth amendment makes certain modifications to the Massachusetts Lease, including the addition of 5,240 sq. ft. of office space in the same building (the “September 2025 Expansion Premises”).

Additionally, we leased approximately 27,128 sq. ft. of office and laboratory space in Boulder, Colorado under a lease that expired in December 2024. In September 2024, we entered into a new, multi-year lease agreement for 7,117 sq. ft. of office and laboratory space in Boulder, Colorado that expires in December 2026. We have the option to extend the lease term for an additional period of five years upon notice to the Landlord.

Item 2 of the 10-K filed Feb 26, 2026.4

Leadership

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

Chief executive

  1. Samuel D. Riccitelli2014–2016
  2. Lee M. Rauch2020
  3. Jonathan Violin2021–2022
  4. Scott Dunseth Myers2023
  5. Stephen F. Mahoney2023–now

President

  1. Samuel D. Riccitelli2014–2016
  2. Lee M. Rauch2020
  3. Jonathan Violin2020–2021
  4. Stephen F. Mahoney2023–now

Chief financial officer

  1. Tamara A. Seymour2014–2016
  2. Jason A. Leverone2017–2021
  3. Kristian Humer2021–2023
  4. Seth Harmon2025–now

Chief operating officer

  1. Lee M. Rauch2020
  2. Jonathan Violin2020
  3. Carrie Melvin2022–2023
  4. Thomas W. Beetham2023–now
201520202025
Board members and other officers (31)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Viridian Securities Corporation Massachusetts3
  • Viridian Therapeutics Europe Limited England and Wales3
  • Viridian Therapeutics S.á.r.l. Luxembourg3

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

Former names

  • MIRAGEN THERAPEUTICS, INC.Feb 13, 2017 to Jan 15, 20212
  • SIGNAL GENETICS, INC.Dec 6, 2013 to Feb 10, 20172
  • SIGNAL GENETICS LLCNov 12, 2013 to Jul 9, 20142

Timeline

  1. Aug 6, 20268-K Results of operations53
  2. Jun 29, 20268-K Regulation FD disclosure; Other events54
  3. Jun 3, 20268-K Shareholder vote55
  4. May 28, 20268-K Ended a material agreement56
  5. May 26, 20268-K Entered a material agreement57
  6. May 11, 20268-K Entered a material agreement; New debt or obligation; Other events58
  7. May 5, 20268-K Results of operations59
  8. May 5, 20268-K Regulation FD disclosure60
  9. Mar 30, 20268-K Regulation FD disclosure61
  10. Feb 26, 20268-K Results of operations62
  11. Nov 5, 20258-K Results of operations63
  12. Oct 23, 20258-K Entered a material agreement64
  13. Nov 1, 2023New chief executive Stephen F. Mahoney becomes CEO15
  14. Feb 7, 2023New chief executive Scott Dunseth Myers becomes CEO14
  15. Jan 20, 2021New chief executive Jonathan Violin becomes CEO16
  16. Sep 15, 2020New chief executive Lee M. Rauch becomes CEO17
  17. Jun 17, 2014New chief executive Samuel D. Riccitelli becomes CEO18

Calendar

Coming up

  1. Nov 4, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.34) a share, on Nov 5, 2025.65

When it reported results

  1. Aug 6, 2026Reported quarterly or annual results53
  2. May 5, 2026Reported quarterly or annual results59
  3. Feb 26, 2026Reported quarterly or annual results62
  4. Nov 5, 2025Reported quarterly or annual results63
  5. Oct 21, 2025Reported quarterly or annual results66
  6. Aug 6, 2025Reported quarterly or annual results67
  7. May 6, 2025Reported quarterly or annual results68
  8. Feb 27, 2025Reported quarterly or annual results69

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

Filings

317 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 61 major events, 103 insider forms, 69 large holders, 64 other. The latest 20:

  1. Aug 20, 20264 EDGAR
  2. Aug 20, 2026SCHEDULE 13G EDGAR
  3. Aug 19, 2026144 EDGAR
  4. Aug 18, 20264 EDGAR
  5. Aug 14, 2026SCHEDULE 13G/A EDGAR
  6. Aug 14, 2026SCHEDULE 13G/A EDGAR
  7. Aug 14, 2026SCHEDULE 13G/A EDGAR
  8. Aug 14, 2026SCHEDULE 13G EDGAR
  9. Aug 7, 2026SCHEDULE 13G EDGAR
  10. Aug 6, 202610-Q EDGAR
  11. Aug 6, 20268-K EDGAR
  12. Jul 2, 20264 EDGAR
  13. Jul 2, 20264 EDGAR
  14. Jul 2, 20264 EDGAR
  15. Jul 2, 20264 EDGAR
  16. Jul 2, 20264 EDGAR
  17. Jul 2, 20264 EDGAR
  18. Jun 29, 20268-K EDGAR
  19. Jun 26, 2026SCHEDULE 13G EDGAR
  20. Jun 3, 20268-K EDGAR

The 317 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

40 open-market trades by officers, directors and large owners since October 2021: 9 buys and 31 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Aug 19, 2026Tousignant JenniferChief Legal OfficerSale14,212$24.50$348.2KForm 4
May 11, 2026Fairmount Healthcare Fund II L.P.DirectorBuy1,176,470$17.00$20.0MForm 4
Dec 31, 2025Tousignant JenniferChief Legal OfficerSale2,272$31.16$70.8KForm 4
Oct 23, 2025Fairmount Healthcare Fund II GP LLCDirectorBuy454,545$22.00$10.0MForm 4
Sep 27, 2024Beetham Thomas W.Chief Operating OfficerBuy5,000$23.41$117.0KForm 4
Sep 27, 2024Mahoney Stephen F.President and CEOBuy21,400$23.33$499.3KForm 4
Sep 13, 2024Fairmount Healthcare Fund II L.P.DirectorBuy1,600,000$18.75$30.0MForm 4
Jan 22, 2024Fairmount Healthcare Fund II L.P.DirectorBuy476,190$21.00$10.0MForm 4
Jun 16, 2023Meisner LaraChief Legal OfficerSale27$28.35$765Form 4
Jun 15, 2023Meisner LaraChief Legal OfficerSale2,269$28.02$63.6KForm 4
Jun 6, 2023Meisner LaraChief Legal OfficerSale5,126$25.02$128.3KForm 4
Jun 5, 2023Meisner LaraChief Legal OfficerSale499$25.03$12.5KForm 4
Jun 2, 2023Meisner LaraChief Legal OfficerSale1,875$24.21$45.4KForm 4
Apr 12, 2023Myers Scott DunsethChief Executive OfficerBuy4,000$25.37$101.5KForm 4
Mar 13, 2023Myers Scott DunsethChief Executive OfficerBuy5,500$29.15$160.3KForm 4
Mar 9, 2023Meisner LaraChief Legal OfficerSale29,971$29.07$871.3KForm 4
Feb 2, 2023Violin JonathanChief Executive OfficerSale50,000$36.80$1.8MForm 4
Feb 2, 2023Violin JonathanChief Executive OfficerSale50,000$36.80$1.8MForm 4
Jan 23, 2023Meisner LaraChief Legal OfficerSale6,843$35.66$244.0KForm 4
Jan 17, 2023Katz BarrettChief Medical OfficerSale24,853$37.21$924.8KForm 4

All 40 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
2025Stephen MahoneyChief Executive Officer55$700.0K$6.8M100
2025Dr. Radhika Tripuraneni46$430.6K$4.1M100
2025Thomas BeethamChief Operating Officer56$545.0K$3.8M100
2025Seth HarmonChief Financial Officer46$480.0K$2.6M100
2025Jennifer TousignantChief Legal Officer54$469.9K$2.4M100
2024Jennifer TousignantChief Legal Officer54$400.6K$4.9M100
2024Stephen MahoneyChief Executive Officer55$650.0K$1.1M100
2024Thomas BeethamChief Operating Officer56$500.0K$809.5K100
2024Seth HarmonChief Financial Officer46$419.6K$770.7K100
2023Stephen MahoneyChief Executive Officer55$112.8K$12.5M100
2023Seth HarmonChief Financial Officer46$241.4K$6.5M100
2023Thomas BeethamChief Operating Officer56$86.8K$4.8M100

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
Fmr LLC16,604,740$305.0M0.0%+1,225,363
BlackRock, Inc.8,551,488$157.1M0.0%+720,013
Bellevue Group AG6,731,909$123.7M2.6%+5,765
Paradigm Biocapital Advisors LP6,723,788$123.5M2.3%+3,574,895
Kynam Capital Management, LP6,453,877$118.6M6.6%+4,112,225
State Street Corp6,124,976$112.5M0.0%+1,452,091
Fairmount Funds Management LLC5,090,928$93.5M6.2%+1,176,470
Vanguard Capital Management LLC4,576,860$84.1M0.0%+409,659
Deep Track Capital, LP3,592,740$66.0M1.0%+2,198,796
Venrock Adviser, LLC3,257,917$59.8M1.8%−624,792
Wellington Management Group Llp3,128,362$57.5M0.0%+49,808
Vanguard Portfolio Management LLC2,752,827$50.6M0.0%+1,111,350
Geode Capital Management, LLC2,501,869$46.0M0.0%+168,656
Avoro Capital Advisors LLC2,500,000$45.9M0.4%+1,000,000
Baker Bros. Advisors LP2,383,025$43.8M0.2%+411,347
Point72 Asset Management, L.P.2,343,208$43.0M0.1%+2,020,372
Caligan Partners LP2,193,981$40.3M1.9%New
Novo Holdings A/s2,135,000$39.2M2.3%+135,000
Tang Capital Management LLC1,792,626$32.9M1.5%No change
Fisher Asset Management, LLC1,750,850$32.2M0.0%−17,445
Candriam S.C.A.1,707,698$31.3M0.1%+995,959
Goldman Sachs Group Inc1,691,304$31.1M0.0%+99,359
First Turn Management, LLC1,670,000$30.7M3.3%+758,663
Dimensional Fund Advisors LP1,611,521$29.6M0.0%+1,081,758
Alliancebernstein L.P.1,391,639$27.2M0.0%−433

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

SEC filer profile

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

  • Name on EDGARViridian Therapeutics, Inc.\DE1
  • CIK0001590750
  • Employer ID (EIN)47-11872614
  • Filer statusLarge accelerated filer not an emerging growth company; not 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 address221 Crescent Street, Suite 103A, Waltham, MA 024531
  • Phone617.272.46001
  • Shares outstanding113,292,269 as of Aug 3, 202611
  • Public float$943.0M as of Jun 30, 20254
  • AuditorKPMG LLP, Boston, Massachusetts PCAOB ID 185; it also attests to the company’s internal control over financial reporting4
  • On EDGAR sinceNov 12, 20131
  • Filings815 in all: 4 (207), 8-K (173), 3 (48), SC 13G/A (48), 10-Q (37), SC 13G (37), 424B5 (24), CORRESP (18)1
    All 51 form types

    S-8 (17), CT ORDER (13), DEF 14A (13), UPLOAD (13), 10-K (12), 144 (12), DEFA14A (11), EFFECT (11), SC 13D/A (9), 4/A (8), S-1/A (8), SCHEDULE 13G (8), SCHEDULE 13G/A (8), 425 (7), FWP (7), S-3 (6), 8-K/A (4), ARS (4), PRE 14A (4), S-3ASR (4), SEC STAFF LETTER (4), 10-Q/A (3), 424B3 (3), D (3), DRSLTR (3), SC 13D (3), 10-K/A (2), 424B4 (2), DRS/A (2), POS AM (2), S-1 (2), S-4/A (2), S-8 POS (2), SCHEDULE 13D/A (2), 305B2 (1), 5 (1), 8-A12B (1), CERTNAS (1), D/A (1), DRS (1), PRER14A (1), S-1MEF (1), S-4 (1)

  • Latest filingsAnnual report (10-K) Feb 26, 2026
    Quarterly report (10-Q) Aug 6, 2026
    Proxy statement (DEF 14A) Apr 17, 2026
    Latest 8-K (8-K) Aug 6, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, $0.01 par value per shareVRDNThe Nasdaq Stock Market LLC

From the cover page of the 10-K filed Feb 26, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks Viridian Therapeutics, Inc.\DE names in Item 1A of its 10-K filed Feb 26, 2026: 72 risks under these headings, as written.4

  • Our business, financial condition, and operating results may be affected by a number of factors, whether currently known or unknown, including but not limited to those described below. Any one or more of such factors could directly or indirectly cause our actual results of operations and financial condition to vary materially from past or anticipated future results of operations
  • and financial condition. Any of these factors, in whole or in part, could materially and adversely affect our business, financial condition, results of operations, and stock price. The following information should be read in conjunction with Part II, Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and the consolidated financial statements and related notes in Part II, Item 8, “Financial Statements and Supplementary Data” of this Annual Report.
  • Risks Related to Our Financial Condition and Capital Requirements
  • We have historically incurred losses, have a limited operating history on which to assess our business, and anticipate that we will continue to incur significant losses for the foreseeable future.
  • If we are unable to raise capital when needed, we would be forced to delay, reduce, or eliminate our research and product development programs or future commercialization efforts.
  • We have never generated any revenue from product sales and may never be profitable.
  • Raising additional capital may cause dilution to our stockholders, restrict our operations, or require us to relinquish rights.
  • Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses.
  • We may not be entitled to obtain additional milestone payments under the DRI Purchase and Sale Agreement.
  • Risks Related to the Discovery and Development of Our Product Candidates
  • Clinical trials are costly, time consuming, and inherently risky, and we may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities.
  • Even if we obtain regulatory approval for a product candidate, we will remain subject to ongoing regulatory requirements.
The other 62 risks
  • Regulatory approval processes are lengthy, time-consuming and inherently unpredictable. Failure to obtain regulatory approval for our product candidates would have a material adverse effect upon our business and business prospects.
  • There is substantial uncertainty as to the potential impacts of a prolonged U.S. federal government shutdown and as to whether and to what extent measures implemented by the current presidential administration in the U.S. will impact the FDA. Our business could be negatively impacted by disruptions at the FDA or other government agencies.
  • Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial viability of approved labeling, or result in significant negative consequences following marketing approval, if any.
  • Additional time may be required to obtain marketing authorizations for certain of our product candidates because they are, or are anticipated to be, combination products.
  • Product development involves a lengthy and expensive process with an uncertain outcome, and results of earlier nonclinical studies and clinical trials may not be predictive of future clinical trial results.
  • Preliminary data from our clinical trials that we announce or publish are subject to audit and verification procedures that could result in material changes in the final data.
  • We may use our financial and human resources to pursue a particular research program or product candidate and fail to capitalize on programs or product candidates that may be more profitable or for which there is a greater likelihood of success.
  • Risks Related to Commercialization of Our Product Candidates
  • Our business operations and market access arrangements will be subject to applicable healthcare regulatory laws, which, if not properly adhered to, could expose us to penalties.
  • If we are unable to establish commercial manufacturing, sales and marketing capabilities or enter into agreements with third parties to commercially manufacture, market and sell our product candidates, we may be unable to generate any revenue.
  • We may attempt to form collaborations in the future with respect to our product candidates, but we may not be able to do so, which may cause us to alter our development and commercialization plans. Even where we have entered into a collaboration, they may not be successful.
  • We face substantial competition, and our competitors may discover, develop, or commercialize products faster or more successfully than us.
  • Our products may not be widely adopted by patients, payors or healthcare providers, which would adversely impact our potential profitability and future business prospects.
  • Failure to obtain or maintain adequate pricing, reimbursement or insurance coverage for our products, if any, could limit our ability to market those products and decrease our ability to generate revenue.
  • If we are unable to successfully further develop and maintain internal commercialization capabilities, sales of our future products may be negatively impacted.
  • The size of the potential market for our product candidates is difficult to estimate and, if any of our assumptions are inaccurate, the actual markets for our product candidates may be different than our estimates. If the market opportunities for any product candidates we develop are smaller than we believe they are, our potential revenues may be adversely affected, and our business may suffer.
  • Risks Related to Our Reliance on Third Parties
  • We rely on third parties to conduct our nonclinical development activities and clinical trials, manufacture our product candidates, and perform other services. If these third parties do not successfully perform and comply with regulatory requirements, we may not be able to successfully complete clinical development, obtain regulatory approval, or commercialize our product candidates and our business could be substantially harmed.
  • Our manufacturing processes are complex, and we may encounter difficulties in production, which would delay or prevent our ability to provide a sufficient clinical or commercial supply of our product candidates or products.
  • We may be unable to realize the potential benefits of any collaboration.
  • Risks Related to Our Intellectual Property
  • We rely on patent rights, trade secret protections and confidentiality agreements to protect the intellectual property related to our product candidates and any future product candidates. If we are unable to obtain or maintain exclusivity from the combination of these approaches, we may not be able to compete effectively in our markets.
  • We may not have sufficient patent term protections for our product candidates to effectively protect our business.
  • Changes in patent laws in the U.S. and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products, and recent patent reform legislation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents.
  • If we are unable to maintain effective proprietary rights for our product candidates or any future product candidates, we may not be able to compete effectively in our proposed markets.
  • Third-party claims of intellectual property infringement may prevent or delay our development and commercialization efforts.
  • We are dependent on intellectual property licensed from third parties. We may not be successful in meeting our obligations under our existing license agreements necessary to maintain our product candidate licenses in effect. In addition, if required in order to commercialize our product candidates, we may be unsuccessful in obtaining or maintaining necessary rights to our product candidates through acquisitions and in-licenses.
  • The patent protection and patent prosecution for some of our product candidates are dependent on third parties.
  • Obtaining and maintaining our 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 fail to comply with obligations in the agreements under which we license intellectual property and other rights from third parties or otherwise experience disruptions to our business relationships with our licensors, we could lose license rights that are important to our business, which would harm our business.
  • We may be involved in lawsuits or post-grant review proceedings to defend, protect, or enforce our patents or the patents of our licensors, which could be expensive, time consuming, and unsuccessful.
  • We may be subject to claims that our employees, consultants, or independent contractors are failing to comply with obligations to former employers or other third parties, including having wrongfully used or disclosed confidential information of former employers or third parties, that our employees have wrongfully used or disclosed alleged trade secrets of their former employers or third parties, or in connection with claims that our employees, consultants, or independent contractors are soliciting employees or business from prior employers.
  • We may be subject to claims challenging the inventorship of our patents and other intellectual property.
  • We may not be able to protect our intellectual property rights throughout the world.
  • Risks Related to Regulatory Approval of Our Product Candidates and Other Legal Compliance Matters
  • We expect the product candidates we develop will be regulated as biologics, and they may be subject to competition from biosimilar and interchangeable biological products.
  • We may seek orphan drug designation for our product candidates, but we might not receive such designation.
  • We may seek Fast Track, Breakthrough Therapy, and/or Priority Review designations for one or more of our product candidates, but we might not receive such designation(s), and even if we do, such designation(s) may not actually lead to a faster development or regulatory review or approval process.
  • Any product candidates for which we may obtain approval would be subject to extensive and ongoing regulatory oversight. If we fail to comply with continuing U.S. and foreign requirements, any approvals we may receive for our product candidates could be limited or withdrawn, we could be subject to other penalties, and in any such case our business would be seriously harmed.
  • Healthcare legislative reform measures may have a material adverse effect on our business, financial condition, or results of operations, and current and future legislation may increase the difficulty and cost for us, and any collaborators, to obtain marketing approval of and commercialize our drug candidates and affect the prices we, or they, may obtain.
  • We may be subject, directly or indirectly, to a wide range of domestic and foreign healthcare and other laws. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties, sanctions, or other liability.
  • If we fail to comply with our obligations under the Medicaid Drug Rebate program, other governmental pricing or reporting programs, including state pricing reporting requirements, we could be subject to penalties and sanctions, which could have a material adverse effect on our business, financial condition, results of operations, and future prospects.
  • 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 our business, financial condition, or results of operations.
  • Non-compliance with existing or future laws and regulations related to privacy or data security could lead to government enforcement actions (which could include civil or criminal fines or penalties), private litigation, other liabilities, and/or adverse publicity. Compliance or non-compliance with such laws could increase the costs of our products and services, could limit their use or adoption, and could otherwise negatively affect our operating results and business.
  • Our use of artificial intelligence (AI) or other emerging technologies could adversely impact our business and financial results.
  • Risks Related to Our Business Operations
  • Our future success depends in part on our ability to attract, retain, and motivate qualified personnel. If we lose key personnel, or if we fail to recruit additional highly skilled personnel, our ability to develop our product candidates will be impaired and our business may be harmed.
  • We will need to expand our organization and we may experience difficulties in managing this growth, which could disrupt our operations.
  • Unstable market and economic conditions, inflation, increases in interest rates, tariffs and trade disputes with other countries, natural disasters, public health crises, political crises, geopolitical events, or other macroeconomic conditions, may have serious adverse consequences on our business and financial condition.
  • The Hercules Loan and Security Agreement contains certain covenants that could adversely affect our operations and, if an event of default were to occur, we could be forced to repay any outstanding indebtedness sooner than planned and possibly at a time when we do not have sufficient capital to meet this obligation.
  • Failure in our information technology and storage systems, or those of third parties upon whom we rely, could significantly disrupt the operation of our business and adversely impact our financial condition.
  • A data breach, security incident, or other unauthorized network intrusion or access may allow unauthorized access to our network or data, which could result in a material disruption of our clinical trials, harm our reputation, harm our business, create additional liability and adversely impact our financial results or operational results.
  • Our ability to use net operating loss carryforwards and certain other tax attributes to offset future taxable income or taxes may be limited.
  • Changes in tax laws or regulations that are applied adversely to us or our customers may have a material adverse effect on our business, cash flow, financial condition, or results of operations.
  • Our effective tax rate may fluctuate, and we may incur obligations in tax jurisdictions in excess of accrued amounts.
  • Risks Related to Ownership of our Common Stock
  • Anti-takeover provisions in our charter documents and under Delaware law and the terms of some of our contracts could make an acquisition of us more difficult and may prevent attempts by our stockholders to replace or remove our management.
  • Our Bylaws provide that the Court of Chancery of the State of Delaware is the exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers, or other employees.
  • We do not anticipate that we will pay any cash dividends in the foreseeable future.
  • Future sales of shares by existing stockholders could cause our stock price to decline.
  • Future sales and issuances of equity and debt could result in additional dilution to our stockholders.
  • Our principal stockholders own a significant percentage of our stock and will be able to exert significant control over matters subject to stockholder approval.
  • General Risk Factors
  • The market price of our common stock has historically been volatile, and the market price of our common stock may drop in the future.
  • We may be subject to risks related to litigation and other legal proceedings that may materially adversely affect our business, operating results or financial condition.
  • We incur costs and demands upon management as a result of complying with the laws and regulations affecting public companies.
  • If equity research analysts do not publish research or reports, or publish unfavorable research or reports, about us, our business, or our market, our stock price and trading volume could decline.
  • If we fail to maintain proper and effective internal controls, our ability to produce accurate financial statements on a timely basis could be impaired, investors may lose confidence in the accuracy and completeness of our financial reports and the market price of our common stock may be negatively affected.

Legal proceedings

From time to time, we may be involved in legal proceedings in the ordinary course of business. We are currently not a party to any legal proceedings that we believe would have a material adverse effect on our business, financial condition, or results of operations.

The opening of Item 3, Legal Proceedings.4

Sources

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