ZBIO on Nasdaq

Zenas BioPharma, Inc.

Zenas BioPharma, Inc. is an American pharmaceutical preparations company based in Waltham.1 Its shares trade on Nasdaq under the symbol ZBIO.1

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Last updated Oct 21, 2026.

Overview

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  • TickerZBIO on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersWaltham, Massachusetts1
  • Incorporated inDE2
  • Business address852 Winter Street, Suite 250, Waltham, Ma 024512
  • Filer category, Emerging growth company2
  • Legal formCorporation

Our lead I&I product candidate, obexelimab, is a bifunctional monoclonal antibody designed to bind both CD19 and FcγRIIb, which are broadly present across B cell lineage, in order to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them. Based on existing clinical data generated to date, we believe that targeting B cell lineage via CD19 and FcγRIIb can inhibit B cells and has been shown to be well-tolerated. While anti-CD20 or other anti-CD19 targeting agents may effectively deplete B cells in systemic circulation, these agents do not fully impact B cells in relevant tissue, and the intermittent dosing regimens of these agents may not provide optimal benefits for all patients. In addition, anti-CD20 and other anti-CD19 targeting agents may cause prolonged depletion of circulating B cells for six months or longer, placing patients at higher r…3 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

-3830.6%Operating margin4
-3777.4%Net margin4
100.0%Revenue growth, 20254
-156.0%Return on equity4
0.32×Debt to equity4
-$172.4MFree cash flow4

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Research and development100¢$168.1M
  • Income tax0¢$79.0K

Out of $10.0M in revenue.4 The company lost money this year.

Financial statements

Revenue54$10.0M in 2025−80% since 2023
0$20.0M$40.0M$60.0M2023: $50.0M$50.0M20232024: $5.0M$5.0M2024−90%2025: $10.0M$10.0M2025+100%
Operating income54-$383.1M in 2025+931% since 2023
-$400.0M-$300.0M-$200.0M-$100.0M02023: -$37.1M-$37.1M20232024: -$163.9M-$163.9M2024+341%2025: -$383.1M-$383.1M2025+134%
Net income54-$377.7M in 2025+918% since 2023
-$400.0M-$300.0M-$200.0M-$100.0M02023: -$37.1M-$37.1M20232024: -$157.0M-$157.0M2024+323%2025: -$377.7M-$377.7M2025+141%

Every line of the income statement as filed: the last 2 fiscal years, latest first.4

Period ending2025-12-312024-12-31
License and collaboration revenue$10.0M$5.0M
Total revenue$10.0M$5.0M
Research and development$168.1M$139.1M
General and administrative$53.3M$29.7M
Acquired in-process research and development$171.7M
Total operating expenses$393.1M$168.9M
Loss from operations-$383.1M-$163.9M
Fair value adjustments to convertible notes-$846.0K
Interest expense on royalty obligation-$7.3M
Interest income$12.2M$8.0M
Other income, net$417.0K$202.0K
Total other income (expense), net$5.2M$7.3M
Loss before income taxes-$377.8M-$156.6M
Income tax (benefit) provision-$79.0K$429.0K
Net loss-$377.7M-$157.0M
Net loss per share - basic (in dollars per share)-$8.44-$11.89
Net loss per share - diluted (in dollars per share)-$8.44-$11.89
Weighted-average common stock outstanding - basic (in shares)44.7M shares13.2M shares
Weighted-average common stock outstanding - diluted (in shares)44.7M shares13.2M shares
Unrealized gain on investments$156.0K$31.0K
Foreign currency translation adjustment-$414.0K$126.0K
Comprehensive loss-$378.0M-$156.8M

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Corporate structure

Zenas BioPharma, 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 Zenas BioPharma, Inc.

  • Zenas BioPharma, Inc. Waltham, Massachusetts

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

What it owns

What Zenas BioPharma, 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, net$34.0K4 Dec 31, 2025$185.0K4 Dec 31, 2024−81.6%
Operating-lease assets (leased space)$1.4M4 Dec 31, 2025$1.0M4 Dec 31, 2024+34.9%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$110.6M4 Dec 31, 2025$319.7M4 Dec 31, 2024−65.4%
Marketable securities, current$232.6M4 Dec 31, 2025$31.0M4 Dec 31, 2024+649.6%
Long-term investments$17.3M4 Dec 31, 2025

Properties, in its own words

Our headquarters are located in Waltham, Massachusetts, and consists of 30,305 square feet of leased office space. In December 2025, we extended the Waltham lease, which expires on January 31, 2027. We also lease 5,127 square feet of office space in Shanghai, PRC, which expires on September 9, 2027. To meet future needs of our business, we may lease additional or alternate space and we believe suitable additional or alternate space will be available in the future on commercially reasonable terms.

Item 2 of the 10-K filed Mar 16, 2026.3

Leadership

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

Board members and other officers (15)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • Executive OfficerTANYA Z. FISCHER named May 14, 202422
  • Executive Officer, DirectorHUA O. MU named Nov 15, 202223
  • DirectorHONGBO O. LU named Nov 15, 2022 to May 14, 202422
  • DirectorJAKE JACOB NUNN named May 14, 202422
  • DirectorTIM JACOB XIAO named May 14, 202422
  • DirectorMARIETTA O. WU named Nov 15, 202223

Former names

  • Zenas BioPharma (Cayman) LtdNov 15, 2022 to Nov 15, 20222

Timeline

  1. Oct 13, 20268-K Regulation FD disclosure24
  2. Aug 13, 20268-K Results of operations; Executive or director change25
  3. May 13, 20268-K Results of operations; Executive or director change; Shareholder vote26
  4. Mar 31, 20268-K Entered a material agreement; New debt or obligation; Other events27
  5. Mar 16, 20268-K Results of operations28
  6. Feb 13, 20268-K Executive or director change29
  7. Jan 5, 20268-K Results of operations; Regulation FD disclosure; Other events30
  8. Dec 15, 20258-K Executive or director change31
  9. Nov 12, 20258-K Results of operations32
  10. Oct 27, 20258-K Regulation FD disclosure; Other events33
  11. Oct 8, 20258-K Entered a material agreement; Results of operations; Unregistered sale of shares34
  12. Sep 2, 20258-K Entered a material agreement; Completed an acquisition or sale; New debt or obligation35
  13. Sep 12, 2024New chief executive Leon O. Moulder Jr. becomes CEO8

Calendar

Coming up

  1. Around Nov 13, 2026Next results, estimated About a quarter after its last report. The company hasn't announced the date.

When it reported results

  1. Aug 13, 2026Reported quarterly or annual results25
  2. May 13, 2026Reported quarterly or annual results26
  3. Mar 16, 2026Reported quarterly or annual results28
  4. Jan 5, 2026Reported quarterly or annual results30
  5. Nov 12, 2025Reported quarterly or annual results32
  6. Oct 8, 2025Reported quarterly or annual results34
  7. Aug 12, 2025Reported quarterly or annual results36
  8. May 15, 2025Reported quarterly or annual results37

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

Filings

189 filings to the SEC since October 2021: 2 annual reports, 6 quarterly reports, 20 major events, 84 insider forms, 25 large holders, 2 private raises, 50 other. The latest 20:

  1. Oct 13, 20268-K EDGAR
  2. Sep 11, 2026S-3ASR EDGAR
  3. Sep 11, 2026S-8 EDGAR
  4. Sep 8, 20263 EDGAR
  5. Sep 8, 2026SCHEDULE 13G/A EDGAR
  6. Sep 8, 2026SCHEDULE 13G EDGAR
  7. Sep 2, 20264 OWNERSHIP DOCUMENT EDGAR
  8. Sep 2, 20263 OWNERSHIP DOCUMENT EDGAR
  9. Aug 19, 2026144 EDGAR
  10. Aug 19, 2026SCHEDULE 13D/A EDGAR
  11. Aug 17, 2026SCHEDULE 13D/A EDGAR
  12. Aug 13, 202610-Q EDGAR
  13. Aug 13, 20268-K EDGAR
  14. Jun 17, 20264 EDGAR
  15. Jun 17, 20264 OWNERSHIP DOCUMENT EDGAR
  16. Jun 17, 20264 OWNERSHIP DOCUMENT EDGAR
  17. Jun 17, 20264 OWNERSHIP DOCUMENT EDGAR
  18. Jun 17, 20264 OWNERSHIP DOCUMENT EDGAR
  19. Jun 17, 20264 OWNERSHIP DOCUMENT EDGAR
  20. Jun 17, 20264 OWNERSHIP DOCUMENT EDGAR

The 189 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

39 open-market trades by officers, directors and large owners since October 2021: 39 buys and 0 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
May 18, 2026MOULDER LEON O JRSee RemarksBuy60,000$16.88$1.0MForm 4
Apr 29, 2026MOULDER LEON O JRSee RemarksBuy35,000$17.62$616.7KForm 4
Apr 28, 2026MOULDER LEON O JRSee RemarksBuy25,000$18.02$450.5KForm 4
Mar 31, 2026Lu HongboDirectorBuy3,768$18.63$70.2KForm 4
Mar 31, 2026Kiselak TomasDirectorBuy150,000$20.00$3.0MForm 4
Mar 31, 2026MOULDER LEON O JRSee RemarksBuy34,000$19.31$656.5KForm 4
Mar 31, 2026Lu HongboDirectorBuy75,000$20.00$1.5MForm 4
Mar 30, 2026MOULDER LEON O JRSee RemarksBuy20,000$18.23$364.6KForm 4
Feb 13, 2026Allen Patricia LDirectorBuy4,160$26.36$109.7KForm 4
Feb 12, 2026Allen Patricia LDirectorBuy15,700$24.85$390.1KForm 4
Feb 11, 2026Lu HongboDirectorBuy25,985$22.50$584.7KForm 4
Feb 2, 2026MOULDER LEON O JRSee RemarksBuy57,000$17.96$1.0MForm 4
Jan 9, 2026MOULDER LEON O JRSee RemarksBuy20,000$16.55$331.0KForm 4
Jan 8, 2026MOULDER LEON O JRSee RemarksBuy30,000$16.30$489.0KForm 4
Jan 7, 2026MOULDER LEON O JRSee RemarksBuy50,000$16.38$819.0KForm 4
Oct 9, 2025Nunn Jason RaleighDirectorBuy63,158$19.00$1.2MForm 4
Oct 9, 2025SR ONE CAPITAL MANAGEMENT, LLC10% ownerBuy126,315$19.00$2.4MForm 4
Oct 9, 2025ENRIGHT PATRICK GDirectorBuy117,255$19.19$2.3MForm 4
Oct 7, 2025MOULDER LEON O JRSee RemarksBuy36,928$20.85$769.9KForm 4
Oct 7, 2025Harwin Peter EvanDirectorBuy316,219$19.00$6.0MForm 4

All 39 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
2025Leon O. Moulder, Jr.Founder, Chief Executive Officer and Chairman68$520.0K$4.7M48
2025Lisa von Moltke, M.D. Head of Research and Development and Chief Medical Officer 67$411.7K$3.5M48
2025Joseph L. FarmerPresident and Chief Operating Officer54$520.0K$2.5M48
2024Leon O. Moulder, Jr.Founder, Chief Executive Officer and Chairman68$429.9K$20.0M48
2024Joseph L. FarmerPresident and Chief Operating Officer54$500.0K$6.0M48

Money raised

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

  1. May 3, 2024Raised $200.1 million in a private offering of equity Form D: 26 investors so far Form D
  2. Nov 2, 2022Raised $183.9 million in a private offering of equity Form D: 17 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 LLC9,506,701$241.3M0.0%+424,701
SR One Capital Management, LP5,037,854$127.9M12.3%No change
NEA Management Company, LLC4,023,219$102.1M6.4%No change
Enavate Sciences Gp, LLC3,919,159$99.5M28.8%No change
Federated Hermes, Inc.3,116,805$79.1M0.1%−10,226
BlackRock, Inc.2,686,225$68.2M0.0%+648,677
Capital International Investors2,502,912$63.5M0.0%+68,912
Polar Capital Holdings Plc2,412,772$61.2M0.2%−135,672
Royalty Pharma Sub-Manager, LLC2,388,150$60.6M25.1%No change
Fairmount Funds Management LLC2,359,025$59.9M4.0%No change
State Street Corp2,055,100$52.2M0.0%+584,177
Nvp Associates, LLC1,838,482$46.7M14.2%No change
Wellington Management Group Llp1,593,819$40.5M0.0%+347,766
Vanguard Capital Management LLC1,354,864$34.4M0.0%+109,473
Bank Of America Corp /de/1,231,159$31.2M0.0%+842,812
Geode Capital Management, LLC882,654$22.4M0.0%+226,869
Alliancebernstein L.P.1,103,388$21.6M0.0%+206,067
Two Sigma Investments, LP815,150$20.7M0.0%+540,094
EcoR1 Capital, LLC789,500$20.0M1.0%No change
Millennium Management LLC660,470$16.8M0.0%+183,652
Woodline Partners LP590,539$15.0M0.0%+14
Balyasny Asset Management L.P.576,717$14.6M0.0%−90,353
ArrowMark Colorado Holdings LLC573,318$14.6M0.6%−85,591
Silverarc Capital Management, LLC509,789$12.9M1.4%−626,146
Rock Springs Capital Management LP502,077$12.7M0.6%No change

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

SEC filer profile

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

  • Name on EDGARZenas BioPharma, Inc.1
  • CIK0001953926
  • Employer ID (EIN)93-27492443
  • Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; not a shell company3
  • Incorporated inDelaware3
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address852 Winter Street, Suite 250, Waltham, MA 024511
  • Phone857-271-29541
  • Shares outstanding65,176,723 as of Jul 31, 20266
  • Public float$259.3M as of Jun 30, 20253
  • AuditorErnst & Young LLP, Boston, Massachusetts PCAOB ID 42; no auditor attestation of internal control over financial reporting3
  • On EDGAR sinceNov 15, 20221
  • Filings189 in all: 4 (62), 8-K (20), 3 (19), SCHEDULE 13D/A (7), 10-Q (6), S-8 (6), SCHEDULE 13G/A (6), DRSLTR (5)1
    All 35 form types

    UPLOAD (5), 424B5 (4), 4/A (3), CORRESP (3), DRS/A (3), FWP (3), S-3ASR (3), SC 13D (3), SC 13G (3), SCHEDULE 13D (3), SCHEDULE 13G (3), 10-K (2), ARS (2), D (2), DEF 14A (2), DEFA14A (2), SEC STAFF LETTER (2), 144 (1), 424B4 (1), 424B7 (1), 8-A12B (1), CERT (1), DRS (1), EFFECT (1), S-1 (1), S-1/A (1), S-1MEF (1)

  • Latest filingsAnnual report (10-K) Mar 16, 2026
    Quarterly report (10-Q) Aug 13, 2026
    Proxy statement (DEF 14A) Mar 16, 2026
    Latest 8-K (8-K) Oct 13, 2026

Securities registered for trading

ClassSymbolExchange
Common stock, par value $0.0001 per shareZBIONasdaq Global Select Market

From the cover page of the 10-K filed Mar 16, 2026 (Section 12(b) of the Exchange Act).3

Risk factors and legal proceedings

The risks Zenas BioPharma, Inc. names in Item 1A of its 10-K filed Mar 16, 2026: 71 risks under these headings, as written.3

  • Risks Related to Our Financial Position and Need for Capital
  • We are a clinical stage biopharma company with a limited operating history and no products approved for commercial sale; we have incurred substantial losses since our inception, and we anticipate incurring substantial and increasing losses for the foreseeable future.
  • We will require substantial additional financing to achieve our goals, and failure to obtain additional capital when needed, or on acceptable terms, would cause us to delay, limit, reduce or terminate our product development efforts.
  • Our independent registered public accounting firm has expressed substantial doubt about our ability to continue as a going concern.
  • Raising additional capital may cause dilution to our stockholders, impose restrictions on our operations or require us to relinquish rights to our product candidates.
  • Risks Related to Product Candidate Development and Commercialization
  • Clinical development is lengthy and expensive, characterized by uncertain outcomes, with results of earlier studies and trials often failing to predict future trial results or results in other indications of a product candidate. We may incur additional costs or experience delays in completing, or fail to complete, the development and commercialization of our current product candidates or any future product candidates.
  • Delays or difficulties in the enrollment and dosing of patients in clinical trials, delay or prevent receipt of necessary regulatory approvals.
  • Any significant adverse events or undesirable side effects caused by our product candidates may delay or prevent regulatory approval or market acceptance of our product candidates, or result in significant negative consequences following marketing approval, if any.
  • Risks associated with the in-licensing or acquisition of product candidates could cause substantial delays in the preclinical and clinical development of our product candidates.
  • We face potential competition from different sources that have made substantial investments into the rapid development of novel treatments for immunological indications, including large and specialty pharmaceutical and biotechnology companies, many of which already have approved therapies in our current indications and have achieved commercial success or may be more successful than our product candidates.
  • Interim, initial, “top-line” and preliminary data from our clinical trials that we announce or publish from time to time are subject to audit and verification procedures and may differ materially from final data as more patient data become available.
The other 61 risks
  • Our clinical trials of our product candidates, even if successfully completed, may not be sufficient for marketing approval for the applicable indication.
  • We may not realize the benefits of our current or future collaborations or licensing arrangements and may be unsuccessful in consummating future partnerships.
  • Even if we complete the necessary clinical trials, we cannot predict when, or if, we will obtain regulatory approval to commercialize any product candidate in the U.S. or any other jurisdiction, and any such approval may be for a more narrow indication than we seek.
  • We may expend our limited resources to pursue a particular product candidate in specific indications and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
  • We are currently conducting, and may in the future conduct, clinical trials for current or future product candidates outside the U.S., and the FDA and comparable foreign regulatory authorities may not accept data from such trials.
  • Even if we receive marketing approval for our current or future product candidates in the U.S., we may never receive regulatory approval to market outside of the U.S.
  • The successful commercialization of our product candidates, if approved, will depend in part on the extent to which governmental authorities and other third party payors establish broad coverage, adequate reimbursement levels and favorable pricing for our products. Failure to obtain or maintain such coverage, reimbursement and pricing for any approved products could limit our ability to market those products and would decrease our ability to generate revenue.
  • We may not be able to obtain or maintain orphan drug designations for certain of our product candidates, and we may be unable to maintain the benefits associated with orphan drug designation, including the potential for market exclusivity.
  • We may seek fast track designation, breakthrough therapy designation and/or priority review designation from the FDA or similar designations from comparable foreign regulatory authorities for one or more of our product candidates. Even if one or more of our product candidates receive these designations, we may be unable to obtain or maintain the benefits associated with such designation.
  • We may seek accelerated approval for some of our product candidates but may not be able to obtain it as the sufficiency of our clinical trial results for accelerated approval are subject to the FDA’s discretion.
  • Risks Related to Our Business and Operations
  • Our business depends entirely on the success of our product candidates, and we may fail to successfully develop, receive regulatory approval for, or successfully commercialize any or all of our product candidates.
  • We are dependent on the services of our senior management and other clinical and scientific personnel, and if we are not able to retain these individuals or recruit additional management or clinical and scientific personnel, our business will suffer.
  • We will need to grow our organization, and we may experience difficulties in managing our growth and expanding our operations, which could adversely affect our business.
  • The manufacturing of our product candidates is complex, and our third-party manufacturers may encounter difficulties in production. If our third-party manufacturers encounter such difficulties, our ability to provide supply of our product candidates for clinical trials, to obtain marketing approval, or to provide commercial supply of our products, if approved, could be delayed or halted.
  • Revenue from our product candidates, if approved, will be limited if the product does not achieve broad market acceptance.
  • Misconduct or other improper actions, including noncompliance with regulatory standards and requirements, by our employees, independent contractors, consultants, commercial partners and vendors exposes us to potential noncompliance with regulatory standards and requirements.
  • Commercial opportunities for product candidates and forecasts of market growth may prove to be smaller than we believe, and even if the markets in which we compete achieve the forecasted growth, our business may not grow at similar rates, or at all.
  • Our future growth may depend, in part, on our ability to operate in foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties.
  • Strategic transactions could impact our liquidity, increase our expenses and present significant distractions to our management.
  • If our internal information technology systems, or those used by our CROs, CMOs, clinical sites or other contractors or consultants, are or were compromised, become unavailable or suffer security incidents, loss or leakage of data or other disruptions, we could suffer material adverse consequences, including operational or service interruption, harm to our reputation, litigation, fines, penalties, compromise of sensitive information related our business and other adverse consequences.
  • Our business entails a significant risk of product liability and our ability to obtain sufficient insurance coverage could adversely affect our business, financial condition, results of operations and prospects.
  • Public opinion and scrutiny of I&I treatments may impact public perception of our company and product candidates, or may adversely affect our ability to conduct our business and our business plans.
  • Risks Related to Our Intellectual Property
  • If we are unable to obtain and maintain sufficient intellectual property protection for our product candidates or any future product candidates we may develop, or if the scope of the intellectual property protection obtained is not sufficiently broad, our competitors or other third parties could develop and commercialize products similar or identical to ours, and our ability to successfully develop and commercialize our product candidates may be adversely impacted.
  • We have in-licensed patent portfolios, but have no solely owned issued patents relating to our product candidates.
  • We may not obtain or maintain necessary rights to our product candidates through acquisitions and in-licenses.
  • Patent rights relating to inventions described and claimed in our or our licensors’ pending patent applications may not issue and patents based on our or our licensors’ patent applications could be challenged and rendered invalid and/or unenforceable.
  • We may not be able to protect our intellectual property rights throughout the world.
  • Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
  • We may be involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time consuming and unsuccessful.
  • Changes in patent law in the U.S. and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.
  • We may become subject to claims challenging the inventorship or ownership of our or our licensors’ patents and other intellectual property.
  • Patent terms may be inadequate to protect our competitive position on products or product candidates for an adequate amount of time.
  • Obtaining and maintaining patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated as a result of noncompliance with these requirements.
  • If we do not obtain patent term extension for our product candidates, our business may be materially harmed.
  • If approved, our product candidates may face competition from biosimilar or generic products approved through abbreviated regulatory pathways.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • 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 be subject to claims asserting that our employees, consultants or advisors have wrongfully used or disclosed alleged trade secrets of their current or former employers or claims asserting ownership of what we regard as our own intellectual property.
  • Risks Related to Government Regulation
  • The regulatory approval process is highly uncertain, and we may be unable to obtain, or may be delayed in obtaining, U.S. or foreign regulatory approval and, as a result, unable to commercialize our product candidates or any future product candidates. Even if we believe our current, or planned clinical trials are successful, regulatory authorities may not agree that they provide adequate data on safety or efficacy.
  • Even if we receive regulatory approval for any of our product candidates, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense. Additionally, our product candidates, if approved, could be subject to labeling and other restrictions and market withdrawal. We may also be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our product candidates.
  • Disruptions at the FDA or comparable 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 products from being developed, approved or commercialized in a timely manner or otherwise prevent those authorities from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
  • Recently enacted legislation, future legislation and other healthcare reform measures may increase the difficulty and cost for us to obtain marketing approval for and commercialize our product candidates and may affect the prices we may set.
  • If we fail to comply with healthcare and other regulations, we could face substantial penalties and our business, operations and financial condition could be adversely affected.
  • Governments outside the U.S. tend to impose strict price controls, which may adversely affect our revenue, if any.
  • We are subject to stringent and evolving U.S. and foreign laws, regulations, rules, contractual obligations, and policies related to data privacy and security. Our actual or perceived failure to comply with such obligations could lead 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 business consequences.
  • 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.
  • Significant political, trade, regulatory developments, including changes in relations between the U.S. and China, and other circumstances beyond our control, may adversely impact our business, financial condition, and results of operations.
  • Risks Related to Our Reliance on Third Parties
  • We have relied and expect to continue to rely on third parties to conduct our preclinical studies and clinical trials. If those third parties do not perform as contractually required, fail to satisfy legal or regulatory requirements, miss deadlines or terminate the relationship, our development programs could be delayed, more costly or unsuccessful, and we may never be able to seek or obtain regulatory approval for or commercialize our product candidates.
  • We may have conflicts with our current or future licensors or collaborators that could delay or prevent the development or commercialization of our product candidates.
  • Our rights to develop and commercialize our product candidates are subject, in large part, to the terms and conditions of licenses granted to us by others, such as Xencor and InnoCare. If we fail to comply with our obligations in the agreements under which we in-license or acquire development or commercialization rights to product candidates, or data from third parties, we could lose such rights that are important to our business.
  • The operations of our suppliers, many of which are located outside of the U.S., including our current sole CMO for drug substance and drug product, WuXi Biologics, and our collaboration partner, InnoCare, both of which are located in China, are subject to additional risks that are beyond our control and that could harm our business, financial condition, results of operations and prospects.
  • Risks Related to Ownership of Our Common Stock
  • An active and liquid trading market for our common stock may not be sustained.
  • The market price of our common stock may be volatile, which could result in substantial losses for investors.
  • A significant portion of our total outstanding shares may be sold into the market, which could cause the market price of our common stock to decline significantly, even if our business is doing well.
  • Insiders have substantial influence over us, which could limit other stockholders’ ability to affect the outcome of key transactions, including a change of control.
  • Because we do not anticipate paying any cash dividends on our common stock in the foreseeable future, capital appreciation, if any, will be investors’ sole source of gain.
  • We are an “emerging growth company,” and the reduced disclosure requirements applicable to emerging growth companies may make our common stock less attractive to investors.
  • Provisions in our Second Restated Certificate of Incorporation (our “Restated Charter”), our Amended and Restated Bylaws (our “Restated Bylaws”) and Delaware law may have anti-takeover effects that could discourage an acquisition of us by others, even if an acquisition would be beneficial to our stockholders, and may prevent attempts by our stockholders to replace or remove our current management.
  • Our Restated Charter designates specific courts as the sole and exclusive forum for certain claims or causes of action that may be brought by our stockholders, which could discourage lawsuits against us and our directors and officers.
  • Risks Related to Our Indebtedness
  • Our indebtedness resulting from our Loan Agreement or future indebtedness could adversely affect our financial condition or restrict our future operations.
  • Servicing our Loan Agreement requires a significant amount of cash, and we may not have sufficient cash flow to pay our debt.
  • General Risk Factors

Legal proceedings

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

The opening of Item 3, Legal Proceedings.3

Sources

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