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ANNX on Nasdaq

Annexon, Inc.

In its 2026 annual report the company says: “We are a biopharmaceutical company advancing the next generation platform of targeted immunotherapies aimed at complement-mediated neuroinflammatory diseases that impact nearly 10 million people worldwide.”4 It is headquartered in Brisbane, California.1 Its shares trade on Nasdaq under the symbol ANNX.1

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Last updated Oct 21, 2026.

Overview

-$206.7MNet income, fiscal 20252

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  • TickerANNX on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersBrisbane, California1
  • Incorporated inDE3
  • Business address1400 Sierra Point Parkway, Bldg C, Suite 200, Brisbane, Ca 940053
  • Filer categoryNon-accelerated filer, Smaller reporting company3
  • Legal formCorporation

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We are a biopharmaceutical company advancing the next generation platform of targeted immunotherapies aimed at complement-mediated neuroinflammatory diseases that impact nearly 10 million people worldwide. The classical complement pathway is a core component to the body’s immune system that activates a powerful inflammatory cascade. We believe that by stopping the classical complement pathway at its start by targeting C1q, the initiating molecule of the classical complement pathway, our approach may have the potential to provide more complete protection against complement-mediated disorders of the body, brain and eye.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

-97.7%Return on equity2
-$186.5MFree cash flow2

Financial statements

Operating income567892-$216.4M in 2025+565% since 2019
-$300.0M-$200.0M-$100.0M02019: -$32.5M-$32.5M20192020: -$63.5M-$63.5M2020+95%2021: -$130.7M-$130.7M2021+106%2022: -$145.6M-$145.6M2022+11%2023: -$143.7M-$143.7M2023−1%2024: -$154.1M-$154.1M2024+7%2025: -$216.4M-$216.4M2025+40%
Net income567892-$206.7M in 2025+456% since 2019
-$300.0M-$200.0M-$100.0M02019: -$37.2M-$37.2M20192020: -$63.4M-$63.4M2020+71%2021: -$130.3M-$130.3M2021+106%2022: -$141.9M-$141.9M2022+9%2023: -$134.2M-$134.2M2023−5%2024: -$138.2M-$138.2M2024+3%2025: -$206.7M-$206.7M2025+50%

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

Period ending2025-12-312024-12-31
Research and development$184.7M$119.4M
General and administrative$31.7M$34.6M
Total operating expenses$216.4M$154.1M
Loss from operations-$216.4M-$154.1M
Interest and other income, net$9.7M$15.9M
Net loss-$206.7M-$138.2M
Deemed dividend on modification of common stock warrants-$1.9M$0
Net loss attributable to common stockholders-$208.5M-$138.2M
Net loss per share, basic-$1.34-$1.01
Net loss per share, diluted-$1.34-$1.01
Weighted-average shares used in computing net loss per share, basic155.1M shares137.4M shares
Weighted-average shares used in computing net loss per share, diluted155.1M shares137.4M shares

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Corporate structure

Annexon, 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 Annexon, Inc.

  • State Street Corporation Filed SCHEDULE 13G on Annexon, Inc., latest Aug 7, 2026
  • BlackRock Filed SCHEDULE 13G/A on Annexon, Inc., latest Jul 27, 2026 (6 filings since Feb 3, 2022)
  • FMR LLC Filed SCHEDULE 13G/A on Annexon, Inc., latest Jul 8, 2026 (8 filings since Feb 9, 2022)
  • Redmile Group, LLC Filed SCHEDULE 13G/A on Annexon, Inc., latest Jul 8, 2026 (6 filings since Feb 14, 2022)
  • BIOTECHNOLOGY VALUE FUND L P Filed SCHEDULE 13G/A on Annexon, Inc., latest May 15, 2026 (5 filings since May 26, 2022)
  • VANGUARD GROUP INC Filed SCHEDULE 13G/A on Annexon, Inc., latest Mar 26, 2026 (4 filings since Jan 31, 2025)
  • Muneer A. Satter Filed SCHEDULE 13D/A on Annexon, Inc., latest Nov 21, 2025 (3 filings since Jul 18, 2022)
  • Logos Global Management LP Filed SCHEDULE 13G/A on Annexon, Inc., latest Aug 14, 2025 (5 filings since Jun 22, 2023)
  • Point72 Asset Management, L.P. Filed SCHEDULE 13G/A on Annexon, Inc., latest May 15, 2025 (2 filings since Feb 12, 2024)
  • Bain Capital Life Sciences Fund, L.P. Filed SCHEDULE 13G/A on Annexon, Inc., latest Feb 14, 2025 (5 filings since Feb 14, 2023)
  • BB Biotech Filed SC 13G/A on Annexon, Inc., latest Nov 14, 2024 (2 filings since Apr 22, 2024)
  • PRICE T ROWE ASSOCIATES INC /MD/ Filed SC 13G/A on Annexon, Inc., latest Nov 14, 2024 (2 filings since Feb 14, 2022)
  • Annexon, Inc. Brisbane, California

Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

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

Property and equipment

ItemLatestA year beforeChange
Property and equipment, before depreciation$20.0M2 Dec 31, 2025$19.8M2 Dec 31, 2024+0.7%
Accumulated depreciation$9.3M2 Dec 31, 2025$7.2M2 Dec 31, 2024+30.2%
Property and equipment, net$10.6M2 Dec 31, 2025$12.6M2 Dec 31, 2024−16.0%
Operating-lease assets (leased space)$15.2M2 Dec 31, 2025$16.7M2 Dec 31, 2024−9.1%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$162.1M2 Dec 31, 2025$49.5M2 Dec 31, 2024+227.4%
Marketable securities, current$76.3M2 Dec 31, 2025$262.5M2 Dec 31, 2024−70.9%
Debt securities available for sale$236.3M2 Dec 31, 2025$309.4M2 Dec 31, 2024−23.6%

Properties, in its own words

Our corporate headquarters are located in Brisbane, California, where we lease approximately 65,818 square feet of office and laboratory space. The contractual term of the Brisbane lease commenced in November 2021 and will end in October 2031, with an option to extend for an additional ten years.

Item 2 of the 10-K filed Mar 30, 2026.4

Leadership

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

Chief executive

  1. Douglas Love2020–now

President

  1. Douglas Love2020–now

Chief financial officer

  1. Jennifer Lew2020–now
2025
Board members and other officers (17)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • Executive OfficerLarry C. Mattheakis, Ph.D named Jul 22, 202232
  • DirectorJung E. Choi named Jul 22, 202232

Timeline

  1. Aug 12, 20268-K Results of operations; Other events33
  2. Aug 10, 20268-K Executive or director change; Regulation FD disclosure34
  3. Aug 6, 20268-K Other events35
  4. Jul 30, 20268-K Entered a material agreement; New debt or obligation; Other events36
  5. Jun 12, 20268-K Shareholder vote37
  6. May 7, 20268-K Results of operations38
  7. Mar 30, 20268-K Results of operations39
  8. Feb 17, 20268-K Executive or director change40
  9. Jan 14, 20268-K Regulation FD disclosure41
  10. Jan 12, 20268-K Other events42
  11. Nov 14, 20258-K Entered a material agreement; Other events43
  12. Nov 10, 20258-K Results of operations44
  13. Jul 23, 2020New chief executive Douglas Love becomes CEO14

Calendar

Coming up

  1. Nov 9, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.37) a share, on Nov 10, 2025.45

When it reported results

  1. Aug 12, 2026Reported quarterly or annual results33
  2. May 7, 2026Reported quarterly or annual results38
  3. Mar 30, 2026Reported quarterly or annual results39
  4. Nov 10, 2025Reported quarterly or annual results44
  5. Aug 14, 2025Reported quarterly or annual results46
  6. May 12, 2025Reported quarterly or annual results47
  7. Mar 3, 2025Reported quarterly or annual results48
  8. Nov 14, 2024Reported quarterly or annual results49

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

Filings

402 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 63 major events, 151 insider forms, 74 large holders, 1 private raises, 93 other. The latest 20:

  1. Sep 25, 20264 EDGAR
  2. Aug 13, 2026144 EDGAR
  3. Aug 12, 20264 EDGAR
  4. Aug 12, 20263 EDGAR
  5. Aug 12, 202610-Q EDGAR
  6. Aug 12, 20268-K EDGAR
  7. Aug 10, 20268-K EDGAR
  8. Aug 7, 2026SCHEDULE 13G EDGAR
  9. Aug 6, 20268-K EDGAR
  10. Jul 30, 20268-K EDGAR
  11. Jul 27, 2026SCHEDULE 13G/A EDGAR
  12. Jul 15, 2026144 EDGAR
  13. Jul 14, 2026144 EDGAR
  14. Jul 8, 2026SCHEDULE 13G/A EDGAR
  15. Jul 8, 2026SCHEDULE 13G/A EDGAR
  16. Jun 15, 20264 EDGAR
  17. Jun 15, 20264 EDGAR
  18. Jun 15, 20264 EDGAR
  19. Jun 15, 20264 EDGAR
  20. Jun 15, 20264 EDGAR

The 402 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

78 open-market trades by officers, directors and large owners since October 2021: 31 buys and 47 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 24, 2026Love DouglasPRESIDENT AND CEOBuy26,065$3.83$99.8KForm 4
May 28, 2026Satter Muneer ADirectorBuy613,497$5.41$3.3MForm 4
May 11, 2026Carson William H.DirectorBuy8,000$5.78$46.2KForm 4
Apr 10, 2026Carson William H.DirectorBuy8,000$6.20$49.6KForm 4
Mar 10, 2026Carson William H.DirectorBuy8,000$5.67$45.4KForm 4
Mar 2, 2026ARTIS DEAN RICHARDEVP & CHIEF SCIENTIFIC OFFICERSale5,894$5.43$32.0KForm 4
Mar 2, 2026Yednock TedEVP & CHIEF INNOVATION OFFICERSale5,566$5.42$30.2KForm 4
Mar 2, 2026Overdorf MichaelEVP & CHIEF BUSINESS OFFICERSale4,339$5.42$23.5KForm 4
Mar 2, 2026Dananberg JamieCHIEF MEDICAL OFFICERSale5,820$5.43$31.6KForm 4
Mar 2, 2026Lew JenniferEVP & CHIEF FINANCIAL OFFICERSale5,565$5.42$30.2KForm 4
Feb 18, 2026ARTIS DEAN RICHARDEVP & CHIEF SCIENTIFIC OFFICERSale5,290$5.10$27.0KForm 4
Feb 18, 2026Yednock TedEVP & CHIEF INNOVATION OFFICERSale7,857$5.11$40.1KForm 4
Feb 18, 2026Overdorf MichaelEVP & CHIEF BUSINESS OFFICERSale6,225$5.10$31.7KForm 4
Feb 18, 2026Dananberg JamieCHIEF MEDICAL OFFICERSale5,290$5.10$27.0KForm 4
Feb 18, 2026Lew JenniferEVP & CHIEF FINANCIAL OFFICERSale7,851$5.11$40.1KForm 4
Dec 30, 2025Carson William H.DirectorBuy4,115$5.02$20.7KForm 4
Dec 1, 2025Carson William H.DirectorBuy4,115$4.47$18.4KForm 4
Dec 1, 2025Choi JungDirectorBuy33,000$4.19$138.3KForm 4
Nov 21, 2025Satter Muneer ADirectorBuy422,613$4.28$1.8MForm 4
Nov 20, 2025Satter Muneer ADirectorBuy400,000$4.48$1.8MForm 4

All 78 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
2025Douglas Love, Esq.President & Chief Executive Officer58$670.8K$3.6M73
2025Ted Yednock, Ph.D.Executive Vice President and Chief Innovation Officer68$497.6K$1.4M73
2025Jennifer Lew.Executive Vice President and Chief Financial Officer53$495.8K$1.3M73
2024Douglas Love, Esq.President & Chief Executive Officer58$641.1K$3.7M73
2024Ted Yednock, Ph.D.Executive Vice President and Chief Innovation Officer68$478.8K$1.6M73

Money raised

Private offerings the company reported to the SEC on Form D.

  1. Jul 7, 2022Raised $130.5 million in a private offering of equity Form D: 12 investors so far Form D

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 LLC19,518,496$111.5M0.0%+8,882,848
BlackRock, Inc.13,539,744$77.3M0.0%+2,601,235
Redmile Group, LLC11,869,877$67.8M4.6%−2,679,891
State Street Corp9,824,321$56.1M0.0%+2,905,066
Bvf Inc/il8,698,173$49.7M1.3%No change
Woodline Partners LP6,925,067$39.5M0.1%+4,587,930
Vanguard Capital Management LLC6,871,015$39.2M0.0%+914,426
Mak Capital One LLC5,862,180$33.5M4.7%+1,138,137
Goldman Sachs Group Inc5,825,579$33.3M0.0%+3,672,699
Siren, L.L.C.4,458,646$25.5M0.5%+500,000
Bain Capital Life Sciences Investors, LLC4,437,731$25.3M1.5%−774,943
Bellevue Group AG4,100,016$23.4M0.5%−1,057,274
Geode Capital Management, LLC4,037,193$23.1M0.0%+659,370
Mpm Bioimpact LLC3,544,354$20.2M1.2%New
Ameriprise Financial Inc3,509,623$20.0M0.0%+60,502
Adage Capital Partners Gp, L.l.c.3,500,000$20.0M0.0%−800,000
Great Point Partners LLC3,500,000$20.0M4.7%+1,000,000
Morgan Stanley3,144,453$18.0M0.0%+408,483
Palo Alto Investors LP2,948,090$16.8M2.3%No change
Balyasny Asset Management L.P.2,830,976$16.2M0.0%−1,055,933
Nuveen, LLC2,765,080$15.8M0.0%−1,481,250
Qube Research & Technologies Ltd2,749,961$15.7M0.0%−364,353
Vanguard Portfolio Management LLC2,246,800$12.8M0.0%+763,710
Opaleye Management Inc.1,714,451$9.8M0.9%−617,310
Logos Global Management LP1,500,000$8.6M0.4%New

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

SEC filer profile

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

  • Name on EDGARAnnexon, Inc.1
  • CIK0001528115
  • Employer ID (EIN)27-54144234
  • 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 address1400 Sierra Point Parkway, Bldg C, Suite 200, Brisbane, CA 940051
  • Phone(650) 822-55001
  • Shares outstanding160,474,333 Common Stock shares; 37,793,577 Prefunded Warrant shares as of Mar 25, 20264
  • Public float$244.4M as of Jun 30, 20254
  • AuditorKPMG LLP, San Francisco, CA PCAOB ID 185; no auditor attestation of internal control over financial reporting4
  • On EDGAR sinceAug 22, 20111
  • Filings521 in all: 4 (172), 8-K (74), 144 (44), SC 13G/A (37), 3 (33), SC 13G (28), 10-Q (19), SCHEDULE 13G/A (15)1
    All 42 form types

    S-8 (10), CORRESP (8), 10-K (6), 424B5 (6), DEF 14A (6), DEFA14A (6), UPLOAD (6), EFFECT (5), ARS (4), D (4), SCHEDULE 13G (4), DRS/A (3), S-3 (3), DRSLTR (2), FWP (2), S-1/A (2), S-3ASR (2), SC 13D (2), SC 13D/A (2), SEC STAFF LETTER (2), 4/A (1), 424B3 (1), 424B4 (1), 8-A12B (1), 8-K/A (1), CERT (1), DRS (1), POS AM (1), POS EX (1), POSASR (1), PRE 14A (1), S-1 (1), S-1MEF (1), SCHEDULE 13D/A (1)

  • Latest filingsAnnual report (10-K) Mar 30, 2026
    Quarterly report (10-Q) Aug 12, 2026
    Proxy statement (DEF 14A) Apr 27, 2026
    Latest 8-K (8-K) Aug 12, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.001 per shareANNXNasdaq

From the cover page of the 10-K filed Mar 30, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks Annexon, Inc. names in Item 1A of its 10-K filed Mar 30, 2026: 70 risks under these headings, as written.4

  • Risks Related to Our Limited Operating History, Financial Condition and Capital Requirements
  • We are a clinical-stage biopharmaceutical company with a limited operating history and no products approved for commercial sale. We have incurred significant losses since our inception, and we anticipate that we will continue to incur significant losses for the foreseeable future, which, together with our limited operating history, makes it difficult to assess our future viability.
  • We will require substantial additional financing to achieve our goals, and a failure to obtain this necessary capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our product development programs, commercialization efforts or other operations.
  • Due to the significant resources required for the development of our product candidates, we must prioritize development of certain product candidates and/or certain disease indications. We may expend our limited resources on candidates or indications that do not yield a successful product and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
  • Conducting a global Phase 3 program for vonaprument in patients with dry AMD with GA will be expensive and time consuming, and we may need additional capital to complete the Phase 3 clinical program and even if favorable, the FDA and comparable foreign regulatory authorities may not accept data from our Phase 3 program.
  • Our results of operations may fluctuate significantly, which makes our future results of operations difficult to predict and could cause our results of operations to fall below expectations.
  • Risks Related to Our Business
  • Our business is heavily dependent on the successful development, regulatory approval and commercialization of our product candidates, some of which are in early stages of clinical development.
  • Public health crises such as pandemics or similar outbreaks have, and could in the future, materially and adversely affect our preclinical and clinical trials, business, financial condition and results of operations.
  • Research and development of biopharmaceutical products is inherently risky. We cannot give any assurance that any of our product candidates will receive regulatory approval, which is necessary before they can be commercialized.
  • We may encounter substantial delays in our clinical trials or may not be able to conduct or complete our clinical trials on the timelines we expect, if at all.
  • If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
The other 59 risks
  • Adverse events or undesirable side effects caused by, or other unexpected properties of, any of our product candidates could halt their clinical development, delay or prevent their regulatory approval, limit their commercial potential or result in significant negative consequences.
  • Interim, “top-line” and preliminary data from studies or trials that we announce or publish from time to time may change as more data become available and are subject to audit and verification procedures that could result in material changes in the final data.
  • Even if our current or future product candidates obtain regulatory approval, they may fail to achieve the broad degree of physician and patient adoption and use necessary for commercial success.
  • We have received Orphan Drug designation for tanruprubart for the treatment of GBS and HD in the United States and for GBS in Europe, and we may seek Orphan Drug designation for certain future product candidates. We may be unable to obtain such designations or to maintain the benefits associated with Orphan Drug designation, including market exclusivity, which may cause any revenue from product sales to be reduced.
  • A Breakthrough Therapy designation by the FDA, even if granted for any of our product candidates, may not lead to a faster development or regulatory review or approval process, and it does not increase the likelihood that our product candidates will receive marketing approval.
  • A Fast Track designation by the FDA or PRIME designation by the EMA, even if granted for any of our product candidates, may not lead to a faster development or regulatory review or approval process, and does not increase the likelihood that our product candidates will receive marketing approval.
  • Disruptions at the FDA and other government agencies or foreign regulatory authorities caused by funding shortages or global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved or commercialized in a timely manner or at all, which could negatively impact our business.
  • We conduct, and in the future plan to conduct, clinical trials for product candidates outside the United States, and the FDA and comparable foreign regulatory authorities may not accept data from such trials.
  • If the product candidates that we develop receive regulatory approval in the United States or another jurisdiction, they may never receive approval in other jurisdictions, which would limit market opportunities for our product candidates and adversely affect our business.
  • Any product candidates for which we intend to seek approval as biologic products may face competition sooner than anticipated.
  • We rely on third-party suppliers to manufacture our product candidates, and we intend to rely on third parties to produce commercial supplies of any approved product. The loss of these suppliers, or their failure to comply with applicable regulatory requirements or to provide us with sufficient quantities at acceptable quality levels or prices, or at all, would materially and adversely affect our business.
  • We rely on third parties in the conduct of all of our preclinical studies and clinical trials. If these third parties do not successfully carry out their contractual duties, fail to comply with applicable regulatory requirements or meet expected deadlines, we may be unable to obtain regulatory approval for our product candidates.
  • If we are not successful in identifying, developing and commercializing additional product candidates, our ability to expand our business and achieve our strategic objectives would be impaired.
  • We face significant competition in an environment of rapid technological and scientific change, and our product candidates, if approved, will face significant competition, which may prevent us from achieving significant market penetration. Most of our competitors have significantly greater resources than we do, and we may not be able to successfully compete.
  • The successful commercialization of our product candidates will depend in part on the extent to which governmental authorities and health insurers establish adequate coverage, reimbursement levels and pricing policies. Failure to obtain or maintain coverage and adequate reimbursement for our product candidates, if approved, could limit our ability to market those products and decrease our ability to generate revenue.
  • We currently have no sales organization. If we are unable to establish sales capabilities on our own or through third parties, we may not be able to market and sell our product candidates, if approved, effectively in the United States and foreign jurisdictions or generate product revenue.
  • We will need to increase the size of our organization, and we may experience difficulties in managing growth.
  • If we fail to attract and retain senior management and key scientific personnel, our business may be materially and adversely affected.
  • If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our current or future product candidates.
  • Any collaboration arrangements that we may enter into in the future may not be successful, which could adversely affect our ability to develop and commercialize our product candidates.
  • Unfavorable global and macroeconomic or political conditions could adversely affect our business, financial condition or results of operations.
  • International trade policies, including tariffs, sanctions and trade barriers may adversely affect our business, financial condition, results of operations and growth prospects.
  • We or the third parties upon whom we depend on may be adversely affected by earthquakes or other natural disasters, and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.
  • Our employees and independent contractors, including principal investigators, consultants, any future commercial collaborators, service providers and other vendors, may engage in misconduct or other improper activities,
  • including noncompliance with regulatory standards and requirements, which could have an adverse effect on our results of operations.
  • Our business involves the use of hazardous materials, and we and our third-party manufacturers and suppliers must comply with environmental laws and regulations, which can be expensive and restrict how we do business.
  • Risks Related to Intellectual Property
  • Our current and any future product candidates or products could be alleged to infringe patent rights and other proprietary rights of third parties, which may require costly litigation and, if we are not successful, could cause us to pay substantial damages and/or limit our ability to commercialize our products.
  • If we are unable to obtain, maintain and enforce intellectual property protection directed to our current and any future technologies that we develop, others may be able to make, use or sell products substantially the same as ours, which could adversely affect our ability to compete in the market.
  • If we are unable to prevent disclosure of our trade secrets or other confidential information to third parties, our competitive position may be impaired.
  • We license patent rights from third-party owners. Such licenses may be subject to early termination if we fail to comply with our obligations in our licenses with third parties, which could result in the loss of rights or technology that are material to our business.
  • Our intellectual property agreements with third parties may be subject to disagreements over contract interpretation, which could narrow the scope of our rights to the relevant intellectual property or technology or increase our financial or other obligations to our licensors.
  • We may wish to form collaborations in the future with respect to our product candidates, but may not be able to do so or to realize the potential benefits of such transactions, which may cause us to alter or delay our development and commercialization plans.
  • We jointly own certain patent rights with third parties. Our ability to out-license these patent rights, or to prevent the third party from out-licensing these patent rights, may be limited in certain countries.
  • We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property.
  • If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.
  • We may not be able to protect our intellectual property rights throughout the world.
  • Risks Related to Government Regulation
  • Even if we obtain regulatory approval for a product candidate, our products will remain subject to regulatory scrutiny.
  • Enacted and future healthcare legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates and may affect the prices we may set.
  • If we develop a small molecule product candidate that obtains regulatory approval, additional competitors could enter the market with generic versions of such drugs, which may result in a material decline in sales of affected products.
  • Our business operations and current and future relationships with investigators, healthcare professionals, consultants, third-party payors, patient organizations and customers will be subject to applicable healthcare regulatory laws, which could expose us to penalties.
  • Risks Related to Our Common Stock
  • Our stock price has been volatile, and could in the future be volatile, and you may not be able to resell shares of our common stock at or above the price you paid.
  • We are a “smaller reporting company,” and as a result of the reduced disclosure and governance requirements applicable to smaller reporting companies, our common stock may be less attractive to investors.
  • We incur significant costs as a result of operating as a public company, and our management needs to devote substantial time to compliance initiatives. We may fail to comply with the rules that apply to public companies, which could result in sanctions or other penalties that could materially and adversely affect our business, financial condition, results of operations and prospects.
  • If we experience material weaknesses in the future or otherwise fail to maintain an effective system of internal controls in the future, we may not be able to accurately report our financial condition or results of operations which may adversely affect investor confidence in us and, as a result, the value of our common stock.
  • Our principal stockholders and management own a significant percentage of our stock and will be able to exert significant control over matters subject to stockholder approval.
  • Our current shares outstanding and resulting market valuation do not reflect shares of our common stock issuable upon the exercise of pre-funded warrants and common warrants that are exercisable at the discretion of the holders of such warrants. If we sell shares of our common stock in the future, stockholders may experience immediate dilution. Stockholders may be unable to compute the dilutive impact of future financings.
  • Sales of a substantial number of shares of our common stock in the public market could cause our stock price to fall.
  • Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.
  • Provisions in our charter documents and under Delaware law could discourage a takeover that stockholders may consider favorable and may lead to entrenchment of management.
  • Claims for indemnification by our directors and officers may reduce our available funds to satisfy successful third-party claims against us and may reduce the amount of money available to us.
  • Our amended and restated certificate of incorporation and amended and restated bylaws provide that the Court of Chancery of the State of Delaware is the exclusive forum for certain 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 employees.
  • We do not currently intend to pay dividends on our common stock, and, consequently, your ability to achieve a return on your investment will depend on appreciation in the price of our common stock.
  • General Risk Factors
  • Changes in tax laws and regulations may have a material adverse effect on our business, financial condition and results of operations.
  • We are subject to U.S. and certain foreign export and import controls, sanctions, embargoes, anti-corruption laws, and anti-money laundering laws and regulations. Compliance with these legal standards could impair our ability to compete in domestic and international markets. We can face criminal liability and other serious consequences for violations, which can harm our business.
  • Cybersecurity risks and the failure to maintain the security, confidentiality, integrity, or availability of our information technology systems or data, and those maintained on our behalf, could lead to adverse consequences that materially adversely affect our business, including, without limitation, regulatory investigations or actions, a
  • material interruption to our operations, including clinical trials, damage to our reputation and/or subject us to costs, fines and penalties or lawsuits.
  • Actual or perceived failure to comply with applicable data protection laws, regulations, standards, contractual obligations and other requirements related to data privacy and security could lead to government enforcement actions as well as civil and criminal penalties, private litigation (including class actions), adverse publicity and otherwise could negatively affect our results of operations and business.
  • If securities or industry analysts do not publish research or reports about our business, or if they issue an adverse or misleading opinion regarding our stock, our stock price and trading volume could decline.
  • We may be subject to securities litigation, which is expensive and could divert our management’s attention.

Legal proceedings

We are not currently a party to any material legal proceedings. We may, however, in the ordinary course of business face various claims brought by third parties, and we may, from time to time, make claims or take legal actions to assert our rights, including intellectual property rights as well as claims relating to employment matters and the safety or efficacy of our products. Any of these claims could subject us to costly litigation, and, while we generally believe that we have adequate insurance to cover many different types of liabilities, our insurance carriers may deny coverage, may be inadequately capitalized to pay on valid claims, or our policy limits may be inadequate to fully satisfy any damage awards or settlements. If this were to happen, the payment of any such awards could have a material adverse effect on our business, results of operations and financial condition. Additionally, any such claims, whether or not successful, could damage our reputation and business.

The opening of Item 3, Legal Proceedings.4

Sources

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