PCVX on Nasdaq

Vaxcyte, Inc.

In its 2026 annual report the company says: “We are a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases. We are re-engineering the way highly complex vaccines are made through the XpressCF™ cell-free protein synthesis platform.”4 It is headquartered in San Carlos, United States.2 Its shares trade on Nasdaq under the symbol PCVX.2

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Last updated Oct 21, 2026.

Overview

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  • TickerPCVX on Nasdaq2
  • IndustryBiological Products, (No Diagnostic Substances)2
  • HeadquartersSan Carlos, United States2
  • Incorporated inDE3
  • Business address825 Industrial Road, Ste. 300, San Carlos, Ca 940703
  • Filer categoryLarge accelerated filer3
  • Legal formCorporation2
  • LEI254900M7NMHTGASX8D952
  • StatusActive2
  • LEI statusIssued and current2
  • Registered addressC/O THE CORPORATION TRUST COMPANY, 19801 Wilmington, United States2
  • Registered withDivision of Corporations, Department of State, 54408502

We are a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases. We are re-engineering the way highly complex vaccines are made through the XpressCF™ cell-free protein synthesis platform. Unlike conventional cell-based approaches, our system for producing difficult-to-make proteins and antigens is intended to develop and deliver high-fidelity vaccines with enhanced immunological benefits that are beyond the capabilities of conventional approaches.4 From its latest annual report

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Financial statements

Operating income56789-$923.7M in 2025+1606% since 2019
-$1.0B-$750.0M-$500.0M-$250.0M02019: -$54.2M-$54.2M20192020: -$89.6M-$89.6M2020+65%2021: -$103.7M-$103.7M2021+16%2022: -$232.3M-$232.3M2022+124%2023: -$468.0M-$468.0M2023+102%2024: -$569.5M-$569.5M2024+22%2025: -$923.7M-$923.7M2025+62%
Net income56789-$766.6M in 2025+1425% since 2019
-$800.0M-$600.0M-$400.0M-$200.0M02019: -$50.3M-$50.3M20192020: -$89.2M-$89.2M2020+77%2021: -$100.1M-$100.1M2021+12%2022: -$223.5M-$223.5M2022+123%2023: -$402.3M-$402.3M2023+80%2024: -$463.9M-$463.9M2024+15%2025: -$766.6M-$766.6M2025+65%

Every line of the income statement as filed: the last 3 fiscal years, latest first.9

Period ending2025-12-312024-12-312023-12-31
Research and development$794.3M$476.6M$332.3M
Acquired manufacturing rights$0$0$75.0M
General and administrative$129.4M$92.9M$60.7M
Total operating expenses$923.7M$569.5M$468.0M
Loss from operations-$923.7M-$569.5M-$468.0M
Interest income$119.7M$110.0M$62.9M
Other income (expense)$37.3M-$4.4M$2.9M
Total other income, net$157.0M$105.6M$65.8M
Net loss-$766.6M-$463.9M-$402.3M
Net loss per share, basic (in dollars per share)-$5.63-$3.80-$4.14
Net loss per share, diluted (in dollars per share)-$5.63-$3.80-$4.14
Weighted-average shares outstanding, basic (in shares)136.1M shares122.0M shares97.2M shares
Weighted-average shares outstanding, diluted (in shares)136.1M shares122.0M shares97.2M shares

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Corporate structure

Vaxcyte, 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 Vaxcyte, Inc.

  • Vaxcyte, Inc. San Carlos, California, United States

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

What it owns

What Vaxcyte, 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$290.1M9 Dec 31, 2025$214.3M9 Dec 31, 2024+35.4%
Accumulated depreciation$32.8M9 Dec 31, 2025$16.3M9 Dec 31, 2024+101.4%
Property and equipment, net$257.4M9 Dec 31, 2025$198.0M9 Dec 31, 2024+30.0%
Operating-lease assets (leased space)$116.0M9 Dec 31, 2025$72.1M9 Dec 31, 2024+60.9%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$174.0M9 Dec 31, 2025$387.9M9 Dec 31, 2024−55.2%
Marketable securities, current$1.4B9 Dec 31, 2025$1.4B9 Dec 31, 2024+2.0%
Debt securities available for sale$2.3B9 Dec 31, 2025$2.7B8 Dec 31, 2024−17.4%
Long-term investments$881.7M9 Dec 31, 2025$1.4B9 Dec 31, 2024−36.5%

Properties, in its own words

Our corporate headquarters is located in San Carlos, California, where we currently lease and occupy 195,633 square feet of laboratory and office space pursuant to an Amended and Restated Lease Agreement (the “Amended and Restated Lease”). Our Amended and Restated Lease premises consist of an aggregate of approximately 258,581 square feet of laboratory and office space, of which (i) 16,731 square feet we currently sublet, and (ii) 46,217 square feet of which the lease commencements will begin starting in 2026. Our Amended and Restated Lease expires on February 28, 2035. We use our corporate headquarters primarily for corporate research, development, regulatory, manufacturing and quality functions. We believe that our existing facilities are adequate to meet our current needs.

Item 2 of the 10-K filed Feb 24, 2026.4

Leadership

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

Board members and other officers (22)

Former names

  • SutroVax, Inc.Jul 24, 2015 to Apr 3, 20203

Timeline

  1. Oct 9, 20268-K Entered a material agreement; New debt or obligation; Other events38
  2. Oct 5, 20268-K Regulation FD disclosure; Other events39
  3. Sep 3, 20268-K Executive or director change; Regulation FD disclosure40
  4. Aug 5, 20268-K Results of operations41
  5. Jul 15, 20268-K Executive or director change42
  6. Jun 23, 20268-K Executive or director change43
  7. Jun 16, 20268-K Shareholder vote44
  8. May 6, 20268-K Results of operations45
  9. Feb 24, 20268-K Results of operations46
  10. Feb 24, 20268-K Other events47
  11. Feb 2, 20268-K Other events48
  12. Dec 19, 20258-K Executive or director change49
  13. Jun 11, 2020New chief executive Grant Pickering becomes CEO13
  14. Nov 27, 2013Founded Vaxcyte, Inc. is founded2

Calendar

Coming up

  1. Nov 3, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($1.56) a share, on Nov 4, 2025.50

When it reported results

  1. Aug 5, 2026Reported quarterly or annual results41
  2. May 6, 2026Reported quarterly or annual results45
  3. Feb 24, 2026Reported quarterly or annual results46
  4. Nov 4, 2025Reported quarterly or annual results51
  5. Aug 6, 2025Reported quarterly or annual results52
  6. May 7, 2025Reported quarterly or annual results53
  7. Feb 25, 2025Reported quarterly or annual results54
  8. Nov 5, 2024Reported quarterly or annual results55

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

Filings

614 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 57 major events, 325 insider forms, 43 large holders, 169 other. The latest 20:

  1. Oct 9, 20268-K EDGAR
  2. Oct 8, 2026424B5 EDGAR
  3. Oct 8, 2026424B5 EDGAR
  4. Oct 7, 20264 EDGAR
  5. Oct 7, 20264 EDGAR
  6. Oct 7, 2026FWP EDGAR
  7. Oct 6, 2026305B2 EDGAR
  8. Oct 6, 2026424B5 EDGAR
  9. Oct 6, 2026424B5 EDGAR
  10. Oct 5, 2026144 EDGAR
  11. Oct 5, 2026144 EDGAR
  12. Oct 5, 20268-K EDGAR
  13. Oct 2, 20264 EDGAR
  14. Oct 1, 2026144 EDGAR
  15. Sep 9, 20264 EDGAR
  16. Sep 9, 20263 EDGAR
  17. Sep 9, 2026144 EDGAR
  18. Sep 9, 20264 EDGAR
  19. Sep 9, 20264 EDGAR
  20. Sep 9, 20264 EDGAR

The 614 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

181 open-market trades by officers, directors and large owners since October 2021: 0 buys and 181 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 9, 2026Wassil JimEVP, Chief Scientific Ofc, COOSale1,334$59.52$79.4KForm 4
Sep 4, 2026Wassil JimEVP, Chief Scientific Ofc, COOSale1,381$61.16$84.5KForm 4
Sep 1, 2026Wassil JimEVP, Chief Scientific Ofc, COOSale3,477$61.08$212.4KForm 4
Aug 5, 2026Dhaliwal Harpreet S.Chief Technical Ops OfficerSale17,000$55.00$935.0KForm 4
Aug 3, 2026Wassil JimEVP, Chief Scientific Ofc, COOSale2,250$53.86$121.2KForm 4
Aug 3, 2026GUGGENHIME ANDREWPRESIDENT AND CFOSale10,000$53.89$538.9KForm 4
Jul 27, 2026PICKERING GRANTCHIEF EXECUTIVE OFFICERSale18,198$55.63$1.0MForm 4
Jul 6, 2026GUGGENHIME ANDREWPRESIDENT AND CFOSale10,000$57.29$572.9KForm 4
Jul 1, 2026Wassil JimEVP, Chief Scientific Ofc, COOSale2,250$56.33$126.7KForm 4
Jun 26, 2026PICKERING GRANTCHIEF EXECUTIVE OFFICERSale24,237$55.22$1.3MForm 4
Jun 18, 2026PICKERING GRANTCHIEF EXECUTIVE OFFICERSale24,461$52.50$1.3MForm 4
Jun 18, 2026GUGGENHIME ANDREWPRESIDENT AND CFOSale10,000$53.00$530.0KForm 4
Jun 1, 2026Wassil JimEVP, Chief Scientific Ofc, COOSale2,250$49.52$111.4KForm 4
May 1, 2026Wassil JimEVP, Chief Scientific Ofc, COOSale2,250$56.83$127.9KForm 4
Apr 7, 2026Cowan ElviaSVP, Finance & CAOSale3,000$60.00$180.0KForm 4
Apr 1, 2026Wassil JimEVP, Chief Scientific Ofc, COOSale2,250$58.43$131.5KForm 4
Mar 17, 2026Cowan ElviaSVP, Finance & CAOSale1,892$55.58$105.2KForm 4
Mar 11, 2026Cowan ElviaSVP, Finance & CAOSale2,500$58.59$146.5KForm 4
Mar 10, 2026Wassil JimEVP, Chief Scientific Ofc, COOSale7,395$58.88$435.4KForm 4
Dec 31, 2025Dhaliwal Harpreet S.Chief Technical Ops OfficerSale9,743$46.69$454.9KForm 4

All 181 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
2025Grant E. Pickering58$800.0K$14.5M68
2025Andrew Guggenhime57$620.0K$6.1M68
2025Jim Wassil56$600.0K$5.8M68
2025Mikhail Eydelman$501.0K$4.0M68
2025Harp Dhaliwal53$495.0K$3.8M68
2024Chief Executive Officer$700.0K$39.6M68
2024President and Chief Financial Officer$556.0K$17.9M68
2024Executive VicePresident and Chief Operating Officer$550.0K$17.9M68
2024Senior Vice PresidentGeneral Counsel and Corporate Secretary$477.0K$5.7M68
2023Chief Executive Officer$640.0K$12.1M68
2023President and Chief Financial Officer$517.0K$5.4M68
2023Executive VicePresident and Chief Operating Officer$508.0K$5.4M68
2023Senior Vice PresidentGeneral Counsel and Corporate Secretary$448.1K$3.5M68

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 LLC20,852,907$1.2B0.1%+4,360,046
Jupiter Topco LLC17,965,847$1.0B0.4%New
BlackRock, Inc.12,068,129$701.5M0.0%+1,096,313
Ra Capital Management, L.P.11,474,599$667.0M5.8%No change
Wellington Management Group Llp7,001,565$407.0M0.1%+1,386,968
Vanguard Portfolio Management LLC6,593,551$383.3M0.0%+314,006
Vanguard Capital Management LLC6,348,679$369.0M0.0%+81,978
State Street Corp5,351,698$311.1M0.0%+911,179
Deep Track Capital, LP4,300,000$250.0M3.7%No change
Geode Capital Management, LLC3,459,363$201.1M0.0%+258,080
Kynam Capital Management, LP2,922,335$169.9M9.4%No change
Westfield Capital Management Co LP2,472,428$143.7M0.5%−1,173,710
Caligan Partners LP2,188,636$127.2M6.1%+127,917
Paradigm Biocapital Advisors LP2,127,852$123.7M2.3%−2,665,168
Bellevue Group AG1,971,935$114.6M2.4%+781,238
D. E. Shaw & Co., Inc.1,901,872$110.6M0.1%−963,446
Maverick Capital Ltd1,613,242$93.8M0.8%+235,504
Charles Schwab Investment Management Inc1,464,812$85.1M0.0%+60,864
Pivotal bioVenture Partners Investment Advisor LLC1,425,470$82.9M26.9%+53,045
Eventide Asset Management, LLC1,380,219$80.2M1.1%+5,927
Goldman Sachs Group Inc1,350,760$78.5M0.0%+75,724
Northern Trust Corp1,280,172$74.4M0.0%+135,703
Norges Bank1,245,805$72.4M0.0%New
Jpmorgan Chase & Co1,227,346$71.2M0.0%+219,032
Dimensional Fund Advisors LP1,194,754$69.4M0.0%+818,982

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

Members of Congress who traded it

9 trades disclosed by members of Congress. “Vs S&P since” is the stock’s change since the trade minus the S&P 500’s.

DateMemberTradeAmountVs S&P sinceFiling
Jul 16, 2026Gilbert Ray Cisneros, Jr.Democratic, HouseBuy$1,001 - $15,000+13.7%Report
May 13, 2026Gilbert Ray Cisneros, Jr.Democratic, HouseBuy$1,001 - $15,000+16.3%Report
May 12, 2026Gilbert Ray Cisneros, Jr.Democratic, HouseBuy$1,001 - $15,000+16.3%Report
Apr 28, 2025Gilbert Ray Cisneros, Jr.Democratic, HouseBuy$1,001 - $15,000+58.3%Report
Apr 15, 2025Gilbert Ray Cisneros, Jr.Democratic, HouseBuy$1,001 - $15,000+72.4%Report
Apr 14, 2025Gilbert Ray Cisneros, Jr.Democratic, HouseBuy$1,001 - $15,000+60.6%Report
Mar 5, 2025Jefferson ShreveRepublican, HouseSale$15,001 - $50,000+44.0%Report
Dec 12, 2022Christopher L. Jacobs, HouseSale$1,001 - $15,000+45.7%Report
Nov 8, 2022Christopher L. Jacobs, HouseBuy$1,001 - $15,000−56.3%Report

Members report amounts as ranges, not exact figures. Returns are price-only (no dividends).

SEC filer profile

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

  • Name on EDGARVaxcyte, Inc.1
  • CIK0001649094
  • Employer ID (EIN)46-42333854
  • 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)2836 Biological Products, (No Diagnostic Substances)1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address825 Industrial Road, Ste. 300, San Carlos, CA 940701
  • Phone650-837-01111
  • Shares outstanding148,805,278 as of Aug 3, 202611
  • Public float$3.7B as of Jun 30, 20254
  • AuditorDeloitte & Touche LLP, San Francisco, California PCAOB ID 34; it also attests to the company’s internal control over financial reporting4
  • On EDGAR sinceJul 24, 20151
  • Filings761 in all: 4 (383), 144 (122), 8-K (68), 3 (32), SC 13G/A (25), 10-Q (19), 424B5 (18), SCHEDULE 13G/A (17)1
    All 34 form types

    SC 13G (10), S-8 (7), 10-K (6), DEF 14A (6), DEFA14A (6), UPLOAD (5), ARS (4), CORRESP (4), D (4), 4/A (3), S-3ASR (3), 144/A (2), DRS/A (2), DRSLTR (2), SCHEDULE 13G (2), 305B2 (1), 424B4 (1), 8-A12B (1), CERT (1), DRS (1), EFFECT (1), FWP (1), PRE 14A (1), S-1 (1), S-1/A (1), S-1MEF (1)

  • Latest filingsAnnual report (10-K) Feb 24, 2026
    Quarterly report (10-Q) Aug 5, 2026
    Proxy statement (DEF 14A) Apr 23, 2026
    Latest 8-K (8-K) Oct 9, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, $0.001 par value per sharePCVXThe Nasdaq Stock Market

From the cover page of the 10-K filed Feb 24, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks Vaxcyte, Inc. names in Item 1A of its 10-K filed Feb 24, 2026: 70 risks under these headings, as written.4

  • Risks Related to Our Financial Position and Capital Needs
  • We are in the clinical or preclinical stages of vaccine development and have a limited operating history and no products approved for commercial sale, which may make it difficult for you to evaluate the success of our business to date and to assess our future viability.
  • We have incurred significant net losses since inception and anticipate that we will continue to incur substantial net losses for the foreseeable future. We currently have no source of product revenue and may never achieve profitability. Our stock is a highly speculative investment.
  • We will require substantial additional funding to finance our operations, which may not be available to us on acceptable terms, or at all. If we are unable to raise additional capital when needed, we could be forced to delay, reduce or terminate certain of our development programs or other operations.
  • Due to the significant resources required for the development of our vaccine candidates, and depending on our ability to access capital, we must prioritize development of certain vaccine candidates. Moreover, we may expend our limited resources on vaccine candidates that do not yield a successful vaccine and fail to capitalize on vaccine candidates that may be more profitable or for which there is a greater likelihood of success.
  • Risks Related to Our Business and Industry
  • Our approach to the discovery and development of our vaccine candidates is based on novel technologies that are unproven, which may expose us to unforeseen risks, require us to modify processes, and make it difficult to predict the time and cost of vaccine candidate development and the timing to apply for and obtain regulatory approvals.
  • Our vaccine candidates are in clinical or preclinical stages of development and may fail in development or suffer delays that materially and adversely affect their commercial viability. If we are unable to complete development of or commercialize our vaccine candidates or experience significant delays in doing so, our business would be materially harmed.
  • Our business is highly dependent on the success of our PCV candidates. If we are unable to successfully develop, obtain approval for and effectively commercialize our PCV candidates, our business would be significantly harmed.
  • Our primary competitors have significantly greater resources and experience than we do, which may make it difficult for us to successfully develop and commercialize our vaccine candidates, or may result in others discovering, developing or commercializing products before or more successfully than us.
  • We and our contract manufacturers may face difficulty satisfying CMC requirements imposed by the FDA and comparable foreign regulatory authorities. To date, no product developed using a cell-free manufacturing platform has received approval from the FDA or been commercialized.
  • Even if we obtain regulatory approval of our vaccine candidates, the products may not gain market acceptance among regulators, advisory boards, physicians, patients, third-party payors and others in the medical community necessary for commercial success.
The other 60 risks
  • We may not be successful in our efforts to use our cell-free protein synthesis platform to expand our pipeline of vaccine candidates and develop marketable products.
  • Our vaccine candidates may cause undesirable side effects or have other properties, including interactions with existing vaccine regimens, that could halt their clinical development, prevent their regulatory approval, limit their commercial potential or result in significant negative consequences.
  • Negative developments and negative public opinion of vaccines or new technologies on which we rely may damage public perception of our vaccine candidates or adversely affect our ability to conduct our business or obtain regulatory approvals for our vaccine candidates.
  • We may not be able to file IND applications to commence clinical trials on the timelines we expect, and even if we are able to, the FDA may not permit us to proceed.
  • We may encounter substantial delays in our clinical trials or may not be able to conduct our trials on the timelines we expect.
  • If we encounter difficulties enrolling subjects in any clinical trials we may conduct, including any field efficacy trials that may be required, our clinical development activities could be delayed or otherwise adversely affected.
  • Interim topline and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
  • We have in the past and may in the future seek breakthrough therapy designation ("BTD") or Fast Track designation by the FDA for one or more of our vaccine candidates, but we may not receive the designations we seek, and even if we do, such designation may not lead to a faster development or regulatory review or approval process and it does not increase the likelihood that our vaccine candidates will receive marketing approval.
  • We currently have no marketing and sales organization, and as an organization have no experience in marketing products. If we are unable to establish marketing and sales capabilities or enter into agreements with third parties to market and sell our vaccine candidates, we may not be able to generate product revenue.
  • A variety of risks associated with our current and potential international operations and collaborations could materially adversely affect our business.
  • We are highly dependent on our key personnel, and if we are not able to retain these members of our management team or recruit and retain highly qualified personnel, we may not be able to successfully implement our business strategy.
  • We have grown rapidly and will need to continue to grow the size of our organization, and we may experience difficulties in managing this growth.
  • Obtaining and maintaining regulatory approval of our vaccine candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our vaccine candidates in other jurisdictions.
  • We may form or seek strategic alliances or enter into additional licensing arrangements in the future, and we may not realize the benefits of such alliances or licensing arrangements.
  • Revenue from any “catch up” opportunity may decline over time as more of the patient population is vaccinated.
  • If our information technology systems or those of the third parties upon which we rely, are or were compromised, we could experience adverse consequences resulting from such compromise, including, but not limited to, significant fines
  • or other liability; regulatory investigations or actions; disruptions of our development programs or business operations; harms to our reputation; and other adverse consequences.
  • Use of artificial intelligence in our operations could result in reputational or competitive harm and legal or regulatory liability.
  • Natural or man-made disasters or business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses.
  • If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our vaccine candidates.
  • Our employees, principal investigators, consultants and commercial partners may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements and insider trading.
  • Changes in tax laws or tax rulings could affect our financial position.
  • Our ability to utilize our net operating loss ("NOL") carryforwards and certain other tax attributes may be limited.
  • Our insurance policies may be inadequate and potentially expose us to unrecoverable risks.
  • Risks Related to Our Reliance on Third Parties
  • We rely and will continue to rely on third parties to conduct our preclinical studies and clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval of or commercialize our vaccine candidates.
  • We rely on third parties to supply raw materials and manufacture our preclinical and clinical product supplies of our vaccine candidates, and expect to rely on third parties to supply raw materials and produce and process our vaccine candidates, if approved. The loss of these suppliers or their failure to comply with applicable regulatory requirements or provide us with sufficient quantities at acceptable quality levels or prices, or at all, would materially and adversely affect our business.
  • If we or our third-party suppliers use hazardous, non-hazardous, biological or other materials in a manner that causes injury or violates applicable law, we may be liable for damages.
  • Risks Related to Government Regulation
  • The FDA regulatory approval process is lengthy and time-consuming, and we may experience significant delays in the clinical development and regulatory approval of our vaccine candidates.
  • The FDA may disagree with our regulatory plan, and we may fail to obtain regulatory approval of our vaccine candidates.
  • Even if we receive regulatory approval of our vaccine candidates, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense, and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our vaccine candidates.
  • We expect the vaccine candidates we develop will be regulated as biological products, or biologics, and therefore they may be subject to competition sooner than anticipated.
  • Our relationships with customers, physicians and third-party payors are subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, health information privacy and security laws and other healthcare laws and regulations. If we or our employees, independent contractors, consultants, commercial partners and vendors violate these laws, we could face substantial penalties.
  • Coverage and reimbursement may be limited or unavailable in certain market segments for our vaccine candidates, which could make it difficult for us to sell our vaccine candidates, if approved, profitably.
  • Healthcare legislative reform measures may have a negative impact on our business, financial condition, results of operations and prospects.
  • The development, review and approval of our product candidates are subject to the operational capacity, processes and resource levels of regulatory authorities, which may fluctuate over time and could delay or adversely affect our business.
  • Risks Related to Our Intellectual Property
  • If we are unable to obtain and maintain patent protection for our technology and products, or if the scope of the patent protection obtained is not sufficiently broad, we may not be able to compete effectively in our markets.
  • If we fail to comply with our obligations under any license, collaboration or other agreements, we may be required to pay damages and could lose intellectual property rights that are necessary for developing and protecting our vaccine candidates.
  • 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 noncompliance with these requirements.
  • Third-party claims or litigation alleging infringement of patents or other proprietary rights, or seeking to invalidate our patents or other proprietary rights, may delay or prevent the development, manufacturing and commercialization of our PCV candidates and any future vaccine candidate.
  • We may become involved in lawsuits to protect or enforce our patents, the patents of our licensors or our other intellectual property rights, which could be expensive, time consuming and unsuccessful.
  • Changes in U.S. patent law or the patent law of other countries or jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.
  • Any trademarks we may obtain may be infringed or successfully challenged, resulting in harm to our business.
  • We may not be able to protect our intellectual property rights throughout the world, which could impair our business.
  • Our reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed.
  • We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of their former employers or other third parties.
  • Risks Related to Ownership of Our Common Stock
  • The price of our stock has been and may continue to be volatile, and the value of our common stock has and may continue to decline, any of which could result in substantial losses for investors.
  • We do not intend to pay dividends on our common stock so any returns will be limited to the value of our stock.
  • Expectations relating to environmental, social and governance programs may impose additional costs and expose us to new risks.
  • Future sales of a substantial number of shares of our common stock, or the perception that such sales could occur, could cause our stock price to fall.
  • Provisions in our corporate charter documents and under Delaware law could make an acquisition of us, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current 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 provides that the Court of Chancery of the State of Delaware will, to the fullest extent permitted by applicable law, be 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 employees.
  • General Risk Factors
  • Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or vaccine candidates.
  • Unstable market and economic conditions may have serious adverse consequences on our business, financial condition and stock price.
  • Significant changes and volatility in trade policies could materially affect our business, financial condition, liquidity and results of operations, and stock price.
  • Our financial condition and results of operations may fluctuate from quarter to quarter and year to year, which makes them difficult to predict.
  • If we fail to maintain proper and effective internal control over financial reporting, our ability to produce accurate and timely consolidated financial statements could be impaired, investors may lose confidence in our financial reporting and the trading price of our common stock may decline.
  • Our reported financial results may be adversely affected by changes in accounting principles generally accepted in the United States.
  • Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.
  • If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our stock price and trading volume could decline.

Legal proceedings

From time to time we may become involved in legal proceedings or be subject to claims arising in the ordinary course of our business. We are not presently a party to any legal proceedings that in the opinion of our management, if determined unfavorably to us, would have a material adverse effect on our business, financial condition, operating results or cash flows. Regardless of the outcome, litigation can, among other things, be time consuming and expensive to resolve and divert management resources.

The opening of Item 3, Legal Proceedings.4

Sources

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