SCLX on Nasdaq

Scilex Holding Co

In its 2026 annual report the company says: “We are an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain. We target indications with high unmet needs and large market opportunities with non-opioid therapies for the treatment of patients with acute and chronic pain and are dedicated to advancing and improving patient outcomes.”4 It is headquartered in Palo Alto, California.1 Its shares trade on Nasdaq under the symbol SCLX.1

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Last updated Oct 21, 2026.

Overview

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  • TickerSCLX on Nasdaq1
  • IndustryBiological Products, (No Diagnostic Substances)1
  • HeadquartersPalo Alto, California1
  • Incorporated inDE2
  • Business address960 San Antonio Road, Palo Alto, Ca 943032
  • Filer category, Emerging growth company2
  • Legal formCorporation

We are an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain. We target indications with high unmet needs and large market opportunities with non-opioid therapies for the treatment of patients with acute and chronic pain and are dedicated to advancing and improving patient outcomes.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

415.8%Gross margin5
-1143.7%Operating margin5
-1236.4%Net margin5
-46.5%Revenue growth, 20255
$3.7MFree cash flow5

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue4¢$10.6M
  • Research and development7¢$20.7M
  • Selling, general and admin89¢$266.9M
  • Income tax0¢$26.0K

Out of $30.3M in revenue.5 The company lost money this year.

Where each dollar of operating cash went, fiscal 2025

  • Capital spending3¢$133.0K
  • Kept or used elsewhere97¢$3.7M

Out of $3.8M of cash from operations.5

Financial statements

Revenue6785$30.3M in 2025+28% since 2020
0$20.0M$40.0M$60.0M2020: $23.6M$23.6M20202021: $31.3M$31.3M2021+33%2022: $38.0M$38.0M2022+21%2023: $46.7M$46.7M2023+23%2024: $56.6M$56.6M2024+21%2025: $30.3M$30.3M2025−47%
Gross profit5$125.8M in 2025−25% since 2024
0$50.0M$100.0M$150.0M$200.0M2024: $167.4M$167.4M20242025: $125.8M$125.8M2025−25%
Operating income6785-$346.0M in 2025+881% since 2020
-$400.0M-$300.0M-$200.0M-$100.0M02020: -$35.3M-$35.3M20202021: -$35.8M-$35.8M2021+2%2022: -$50.6M-$50.6M2022+41%2023: -$105.4M-$105.4M2023+108%2024: -$83.4M-$83.4M2024−21%2025: -$346.0M-$346.0M2025+315%
Net income6785-$374.1M in 2025+687% since 2020
-$400.0M-$300.0M-$200.0M-$100.0M02020: -$47.5M-$47.5M20202021: -$88.4M-$88.4M2021+86%2022: -$23.4M-$23.4M2022−74%2023: -$114.3M-$114.3M2023+389%2024: -$72.8M-$72.8M2024−36%2025: -$374.1M-$374.1M2025+414%

Every line of the income statement as filed: the last 2 fiscal years, latest first.5

Period ending2025-12-312024-12-31
Net Revenue$30.3M$56.6M
Cost of revenue$10.6M$16.7M
Research and development$20.7M$9.6M
Selling, general and administrative$266.9M$119.0M
Goodwill impairment$73.4M$0
Intangible amortization$4.4M$4.0M
Legal settlements$345.0K-$9.4M
Total net operating costs and expenses$376.3M$140.0M
Loss from operations-$346.0M-$83.4M
(Gain) loss on derivative liability$22.7M-$17.4M
Change in fair value of debt and liability instruments$25.4M$4.8M
Interest expense, net$11.5M$2.0M
Loss on foreign currency exchange-$86.0K$45.0K
Unrealized loss on digital assets, net$12.2M$0
Loss on debt extinguishment, net$7.4M$0
Realized loss on digital assets, net$30.2M$0
Unrealized (gain) on equity investment, net-$2.7M$0
Realized (gain) on equity investments, net-$19.2M$0
Unrealized (gain) on equity method investments carried at fair value, net-$54.8M$0
Realized (gain) on equity method investments carried at fair value, net-$4.7M$0
Realized (gain) on securities$199.0K$0
Total other (income) expense, net$28.0M-$10.6M
Loss before income taxes-$374.0M-$72.8M
Income tax expense (benefit)$26.0K-$1.0K
Net loss-$374.1M-$72.8M
Net Loss Attributable to Common Stockholders Before Deemed Dividend-$358.7M-$72.8M
Deemed dividend-$43.8M$0
Net loss attributable to noncontrolling interests-$15.3M$0
Net Income (Loss) Available to Common Stockholders, Basic, Total-$402.5M-$72.8M
Net comprehensive loss attributable to common stockholders-$358.7M-$72.8M
Net loss per share attributable to common stockholders - basic-$36.48-$7.24
Net loss per share attributable to common stockholders - diluted-$36.48-$8.05
Weighted average number of shares during the period-basic11.0K shares10.1K shares
Weighted average number of shares, diluted11.0K shares10.1K shares
Foreign currency translation adjustment-$756.0K$0
Changes in fair value attributable to instrument-specific credit risk-$11.4M$6.3M
Total other comprehensive income-$12.1M$6.3M
Comprehensive loss attributable to common stockholders-$370.9M-$66.5M

Compare Scilex Holding Co with another company

Corporate structure

Scilex Holding Co sits at the top of its group. 12 entities, 2 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Scilex Holding Co

  • Scilex Holding Co Palo Alto, California
    • Datavault AI Inc. Stake · Beaverton, Oregon
    • Semnur Pharmaceuticals, Inc. Stake · Palo Alto, California
    • Scilex (BVI), Limited Subsidiary · British Virgin Islands
    • Scilex Bio, Inc. Subsidiary · Delaware, United States
    • Scilex Pharmaceuticals Inc. Subsidiary · Delaware, United States
    • Scilex, Inc. Subsidiary · Delaware, United States
    • SCLX DRE Holdings LLC Subsidiary · Delaware, United States
    • SCLX Stock Acquisition JV LLC Subsidiary · Texas, United States
    • Semnur (BVI), Limited Subsidiary · British Virgin Islands
    • Semnur Pharmaceuticals, Inc. Subsidiary · Delaware, United States
    • Semnur, Inc. Subsidiary · Delaware, United States

Built from subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G; stakes of 5% or more it reported on Schedules 13D and 13G (2 companies). Each entity in the chart links to its source.

What it owns

What Scilex Holding Co 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$13.9M5 Dec 31, 2025$772.0K5 Dec 31, 2024+1703.1%
Accumulated depreciation$321.0K5 Dec 31, 2025$64.0K5 Dec 31, 2024+401.6%
Property and equipment, net$13.6M5 Dec 31, 2025$708.0K5 Dec 31, 2024+1820.8%
Operating-lease assets (leased space)$14.8M5 Dec 31, 2025$2.2M5 Dec 31, 2024+566.0%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$5.0M5 Dec 31, 2025$3.3M5 Dec 31, 2024+51.4%

Intangibles and goodwill

ItemLatestA year beforeChange
Goodwill$13.5M5 Dec 31, 2025$13.5M5 Dec 31, 20240%
Intangible assets, net (excluding goodwill)$59.1M5 Dec 31, 2025$32.5M5 Dec 31, 2024+82.1%
Finite-lived intangibles, gross$91.8M5 Dec 31, 2025$60.8M5 Dec 31, 2024+51.0%
Accumulated amortization-$32.7M5 Dec 31, 2025-$28.3M5 Dec 31, 2024−15.4%
Finite-lived intangibles, net$59.1M5 Dec 31, 2025$32.5M5 Dec 31, 2024+82.1%

Inventory

ItemLatestA year beforeChange
Inventory, total$4.8M5 Dec 31, 2025$2.4M5 Dec 31, 2024+96.6%

Properties, in its own words

Our principal executive office is currently located in Palo Alto, California, and consists of approximately 12,500 square feet of leased office space. The lease term expires in September 2027. We also sublease office space in San Diego, California. We believe our facilities are adequate to meet our current needs, although we may seek to negotiate new leases or evaluate additional or alternate space for our operations. We believe appropriate additional or alternative space will be available on commercially reasonable terms.

Item 2 of the 10-K filed Apr 10, 2026.4

Leadership

Who has led Scilex Holding Co, and when. Pick a name to see everywhere that person has worked.

Board members and other officers (17)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • Executive Officer, DirectorStephen Ma named Oct 5, 2023 to Oct 14, 202527
  • Executive Officer, DirectorJaisim Shah named Oct 5, 202328

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • SCLX DRE Holdings LLC Delaware3
  • SCLX Stock Acquisition JV LLC Texas3
  • Scilex (BVI), Limited British Virgin Islands3
  • Scilex Bio, Inc. Delaware3
  • Scilex Pharmaceuticals Inc. Delaware3
  • Scilex, Inc. Delaware3
  • Semnur (BVI), Limited British Virgin Islands3
  • Semnur Pharmaceuticals, Inc. Delaware3
  • Semnur, Inc. Delaware3

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

Former names

  • Scilex Holding Company/DEJun 9, 2022 to Nov 30, 20222
  • Vickers Vantage Corp. IAug 19, 2020 to Nov 15, 20222

Timeline

  1. Sep 29, 20268-K Entered a material agreement29
  2. Aug 12, 20268-K Entered a material agreement30
  3. Jul 22, 20268-K Entered a material agreement; Completed an acquisition or sale31
  4. Jul 6, 20268-K Entered a material agreement; Unregistered sale of shares; Regulation FD disclosure32
  5. Jun 29, 20268-K Entered a material agreement; Unregistered sale of shares33
  6. Jun 24, 20268-K Shareholder vote34
  7. May 11, 20268-K Other events35
  8. May 5, 20268-K Entered a material agreement; Regulation FD disclosure36
  9. Apr 28, 20268-K Entered a material agreement37
  10. Mar 13, 20268-K Regulation FD disclosure38
  11. Mar 13, 20268-K Regulation FD disclosure39
  12. Feb 20, 20268-K Entered a material agreement; Unregistered sale of shares40
  13. Oct 9, 2025New chief executive Henry Ji becomes CEO12

Calendar

Coming up

  1. Nov 13, 2026Reports results for the quarter ending Sep/202641

When it reported results

  1. Oct 8, 2024Reported quarterly or annual results42
  2. Aug 1, 2024Reported quarterly or annual results43
  3. Jul 1, 2024Reported quarterly or annual results44
  4. Apr 16, 2024Reported quarterly or annual results45
  5. Mar 5, 2024Reported quarterly or annual results46
  6. Jan 2, 2024Reported quarterly or annual results47
  7. Dec 1, 2023Reported quarterly or annual results48
  8. Nov 1, 2023Reported 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

697 filings to the SEC since October 2021: 6 annual reports, 16 quarterly reports, 144 major events, 80 insider forms, 27 large holders, 2 private raises, 422 other. The latest 20:

  1. Sep 29, 20268-K EDGAR
  2. Aug 14, 202610-Q EDGAR
  3. Aug 12, 20268-K EDGAR
  4. Jul 22, 20268-K EDGAR
  5. Jul 7, 2026SCHEDULE 13D/A EDGAR
  6. Jul 7, 20264 EDGAR
  7. Jul 6, 20268-K EDGAR
  8. Jun 30, 2026S-8 EDGAR
  9. Jun 29, 20268-K EDGAR
  10. Jun 24, 20268-K EDGAR
  11. Jun 11, 2026EFFECT EDGAR
  12. Jun 9, 2026CORRESP EDGAR
  13. Jun 9, 2026UPLOAD EDGAR
  14. Jun 2, 2026S-3 EDGAR
  15. May 22, 2026EFFECT EDGAR
  16. May 20, 2026CORRESP EDGAR
  17. May 20, 202610-Q EDGAR
  18. May 15, 2026NT 10-Q EDGAR
  19. May 11, 20268-K EDGAR
  20. May 5, 2026DEFA14A EDGAR

The 697 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

19 open-market trades by officers, directors and large owners since October 2021: 15 buys and 4 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Dec 30, 2025Scilex Holding Co10% ownerSale9,657,300$0.54$5.2MForm 4
Dec 29, 2025Scilex Holding Co10% ownerSale7,310,984$0.66$4.8MForm 4
Dec 26, 2025Scilex Holding Co10% ownerSale3,689,016$0.75$2.8MForm 4
Dec 18, 2024SHAH JAISIMSee RemarksBuy30,000$0.46$13.8KForm 4
Oct 31, 2024Ji HenryExec Chair, CEO and PresidentBuy8,888$0.94$8.4KForm 4
Oct 29, 2024SHAH JAISIMSee RemarksBuy32,000$0.99$31.7KForm 4
Oct 18, 2024Followwill DormanDirectorBuy1,000$0.99$990Form 4
Oct 18, 2024Chun JayDirectorBuy5,000$0.95$4.8KForm 4
Oct 17, 2024Wu Yue AlexanderDirectorBuy20,000$0.95$19.0KForm 4
Oct 17, 2024Lemus DavidDirectorBuy2,000$0.90$1.8KForm 4
Oct 17, 2024Ji HenryExec Chair, CEO and PresidentBuy10,000$0.97$9.7KForm 4
Oct 16, 2024SHAH JAISIMSee RemarksBuy30,000$0.99$29.7KForm 4
Oct 16, 2024Ma Stephen HoiCFO, COO and SecretaryBuy6,700$0.97$6.5KForm 4
May 17, 2024Ji HenryExec Chair, CEO and PresidentBuy50,000$0.88$44.0KForm 4
May 17, 2024Chun JayDirectorBuy57,500$0.90$51.8KForm 4
May 17, 2024SHAH JAISIMSee RemarksBuy56,939$0.92$52.4KForm 4
May 17, 2024Ma Stephen HoiCFO, COO and SecretaryBuy14,140$0.88$12.4KForm 4
May 16, 2024SHAH JAISIMSee RemarksBuy83,061$0.84$69.8KForm 4
Sep 21, 2023Sorrento Therapeutics, Inc.10% ownerSale60,068,585Form 4

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.

Stakes it holds

Scilex Holding Co has told the SEC it owns more than 5% of 2 companies, latest first (Schedules 13D and 13G).

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
2025Henry JiPh.D.$1.6M$3.1M62
2025Stephen Ma53$696.5K$1.5M62
2025Jaisim Shah$1.2M$1.3M62
2024Former Chief Executive OfficerPresident and Director$1.2M$1.3M62
2024Chief Executive OfficerPresident and Executive Chairperson$1.2M$1.3M62
2024Chief Financial OfficerChief Operating Officer, Senior Vice President and Secretary$600.0K$613.8K62

Funding

Where the company's money came from, by calendar year: private offerings filed with the SEC, federal grants, loans, contracts and other assistance from USAspending.gov, and PPP loans from the SBA. Each bar links to the records below.

Money received by year$104.6M 2023–2025
Money received by yearMoney received by year, 2023–2025: $104.6M in all. Private raises (Form D) $104.6M.$0$50M$100M$150M2023 · Private raises (Form D): $101.9M202320242025 · Private raises (Form D): $2.7M2025
Figures by year
YearPrivate raises (Form D)Total
2025$2.7M$2.7M
2023$101.9M$101.9M

Private raises

Private offerings the company reported to the SEC on Form D. The amount is what the latest filing says was sold so far, charted in the year of the first sale. Covers filings since Oct 1, 2021.

  1. Sep 30, 2025Raised $2.7 million in a private offering of securities27 Form D: 2 investors so far Form D
  2. Sep 21, 2023Raised $101.9 million in a private offering of debt28 Form D: 1 investor 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 70. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Vanguard Capital Management LLC301,292$2.4M0.0%+37,242
BlackRock, Inc.109,417$853.5K0.0%+6,621
Vanguard Fiduciary Trust Co45,822$357.4K0.0%+6,164
Jacobs Levy Equity Management, Inc41,163$321.1K0.0%New
State Street Corp35,376$275.9K0.0%No change
UBS Group AG33,376$260.3K0.0%+26,908
Renaissance Technologies LLC33,064$257.9K0.0%−3,800
Citadel Advisors LLC27,497$214.5K0.0%New
Ashton Thomas Private Wealth, LLC18,482$144.2K0.0%+493
Northern Trust Corp15,047$117.4K0.0%+14
Morgan Stanley4,032$31.5K0.0%−7,941
Vanguard Global Advisers, LLC2,937$22.9K0.0%No change
Osaic Holdings, Inc.2,339$18.2K0.0%+2,241
Creative Financial Designs Inc /adv1,853$14.5K0.0%No change
Royal Bank Of Canada1,745$14.0K0.0%+149
Jones Financial Companies Lllp1,755$12.5K0.0%+1,003
Larson Financial Group LLC1,419$11.1K0.0%+1,377
MetLife Investment Management, LLC1,090$8.5K0.0%No change
Deutsche Bank Ag\800$6.2K0.0%No change
Versant Capital Management, Inc761$5.9K0.0%No change
IFP Advisors, Inc576$4.5K0.0%No change
MCF Advisors LLC474$3.7K0.0%No change
Activest Wealth Management302$2.4K0.0%No change
Klp Kapitalforvaltning As290$2.3K0.0%No change
Integrated Wealth Concepts LLC149$1.2K0.0%New

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

SEC filer profile

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

  • Name on EDGARScilex Holding Co1
  • CIK0001820190
  • Employer ID (EIN)92-10625424
  • Filer statusNon-accelerated filer an emerging growth company; 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 address960 San Antonio Road, Palo Alto, CA 943031
  • Phone(650) 516-43101
  • Shares outstanding8,493,000 as of Aug 10, 202610
  • Public float$32.4M as of Jun 30, 20254
  • AuditorBPM LLP, Walnut Creek, California PCAOB ID 207; no auditor attestation of internal control over financial reporting4
  • On EDGAR sinceAug 19, 20201
  • Filings742 in all: 424B3 (248), 8-K (144), 4 (70), CORRESP (27), 425 (26), EFFECT (23), 3 (21), UPLOAD (19)1
    All 48 form types

    10-Q (17), POS AM (11), S-1/A (10), S-1 (9), SCHEDULE 13D/A (9), S-4/A (8), DEF 14A (7), S-8 (7), SC 13D/A (7), 10-K (6), 424B5 (6), SC 13G (6), SC 13G/A (5), ARS (4), DEFA14A (4), NT 10-Q (4), S-3 (4), SCHEDULE 13G/A (4), 8-K/A (3), PRE 14A (3), SC 13D (3), SCHEDULE 13D (3), SEC STAFF LETTER (3), 10-Q/A (2), D (2), DRS (2), RW (2), 10-K/A (1), 25-NSE (1), 3/A (1), 4/A (1), 424B4 (1), 8-A12B (1), CERT (1), NT 10-K (1), PRER14A (1), S-1MEF (1), S-3/A (1), S-4 (1), SCHEDULE 13G (1)

  • Latest filingsAnnual report (10-K) Apr 10, 2026
    Quarterly report (10-Q) Aug 14, 2026
    Proxy statement (DEF 14A) Apr 30, 2026
    Latest 8-K (8-K) Sep 29, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.0001 per shareSCLXNasdaq

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

Risk factors and legal proceedings

The risks Scilex Holding Co names in Item 1A of its 10-K filed Apr 10, 2026: 74 risks under these headings, as written.4

  • Risks Related to our Limited Operating History, Financial Condition and Capital Requirements
  • Risks Related to our Commercial Operations and Product Development
  • Risks Related to our Business and Operations
  • Risks Related to our Intellectual Property
  • Risks Related to Government Regulations
  • Risks Related to Ownership of our Common Stock
  • Risks Related to Cryptocurrency
  • We currently have three commercial products, ZTlido, ELYXYB and GLOPERBA; but we are currently heavily dependent on the commercial success of ZTlido, as ELYXYB and GLOPERBA are in the initial stages of commercialization, and we may be unable to generate sufficient revenue to support our operations.
  • We have a limited operating history and have incurred significant losses since our inception. We anticipate that we will incur continued losses for the foreseeable future.
  • The terms of the Oramed Note and the Tranche B Notes impose certain operating and financial covenants that restrict our operating and financial flexibility. and any failure to comply with such covenants could result in an event of default that could adversely affect our business, financial condition and results of operations.
  • The Oramed Note and Tranche B Notes impose certain operating and financial covenants and any failure to comply with such covenants could result in an event of default that could adversely affect our business, financial condition and results of operations.
  • We may not have the ability to raise the funds necessary to settle the Oramed Note or the Tranche B Notes in cash upon a change of control or other event of default, and any future debt may contain limitations on our ability to pay cash upon conversion of the Tranche B Notes.
The other 68 risks
  • We may be unable to comply with the covenants of our debt agreements with The St. James Bank.
  • We may be required to make milestone payments to the former stockholders of Semnur in connection with our development and commercialization of SEMDEXA, which could adversely affect the overall profitability of SEMDEXA, if approved.
  • We will require substantial additional funding, which may not be available to us on acceptable terms, or at all.
  • We may not be able to generate sufficient cash to service our indebtedness and other liquidity needs.
  • Our recurring losses from operations, negative cash flows and substantial cumulative net losses raise substantial doubt about our ability to continue as a going concern.
  • We have previously identified material weaknesses in our internal control over financial reporting. If we experience additional 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 timely and accurately report our financial results, and such material weaknesses may result in a material misstatement of our consolidated financial statements.
  • We obtain, or historically have obtained, our commercial supply of certain of our products, the clinical supply of our product candidates and certain of the raw materials used in our product candidates from sole or single source suppliers and manufacturers. In the event of a loss of one of these suppliers or manufacturers, or a failure by any such supplier or manufacturer to comply with FDA regulations, we may not be able to find an alternative source on commercially reasonable terms, or at all.
  • We rely on a single third-party logistics distribution provider for ZTlido, ELYXYB and GLOPERBA.
  • If we fail to achieve certain milestones in our Product Development Agreement with Itochu and Oishi, we could lose rights that are important to our business.
  • We rely on third parties to conduct our clinical trials and intend to rely on third parties to conduct all of our future 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.
  • We may in the future enter into collaborations, in-licensing arrangements, joint ventures, or strategic alliances with third parties that may not result in the development of commercially viable products or the generation of significant future revenues.
  • Delays in clinical trials could result in increased costs for us and delay our ability to obtain commercial approval and generate additional revenue.
  • Our business could be adversely affected by the effects of health pandemics or other health crises, which could cause significant disruptions in our operations and those of our CMOs, CROs and other third parties upon whom we rely.
  • Even if we complete the necessary clinical trials, we cannot predict when, or if, we will obtain regulatory approval for our product candidates, and the approval may be for a more narrow indication than we seek.
  • We may find it difficult to enroll or maintain patients in our clinical trials, which could delay or prevent us from proceeding with clinical trials of our product candidates.
  • The incidence and prevalence for target patient populations of our product candidates are based on estimates and third-party sources. If the market opportunities for our product candidates are smaller than we estimate or if any approval that we obtain is based on a narrower definition of the patient population, our revenue and ability to achieve profitability might be materially and adversely affected.
  • We face significant competition and our competitors may discover, develop or commercialize products faster or more successfully than us.
  • The third-party payor coverage and reimbursement status of newly approved products is uncertain. Failure to obtain or maintain coverage and adequate reimbursement for ZTlido, GLOPERBA, ELYXYB or our product candidates, if approved, could decrease our ability to generate product revenue.
  • Because we have multiple programs and product candidates in our development pipeline and are pursuing a variety of target indications and treatment approaches, we may expend our limited resources to pursue a particular product candidate and fail to capitalize on development opportunities or product candidates that may be more profitable or for which there is a greater likelihood of success.
  • Drug development involves a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results.
  • Interim “top-line” 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.
  • Our clinical trials may fail to demonstrate substantial evidence of the safety and efficacy of product candidates that we may identify and pursue for their intended uses, which would prevent, delay or limit the scope of regulatory approval and commercialization.
  • Even if we obtain FDA approval for any of our product candidates in the United States, we may never obtain approval for or commercialize any of them in any other jurisdiction, which would limit our ability to realize their full market potential.
  • Our business may suffer reputational harm due to failures of our product candidates.
  • ZTlido, GLOPERBA and ELYXYB may have undesirable properties that could result in significant negative consequences, and our product candidates may cause undesirable side effects that could delay or prevent their regulatory approval.
  • ZTlido, GLOPERBA, ELYXYB and our product candidates are complex and difficult to manufacture. We could experience delays in satisfying regulatory authorities or manufacturing problems that result in delays in our development or commercialization programs, limit the supply of our product candidates, or otherwise harm our business.
  • If we are unable to retain our key executives, it may delay our development efforts and harm our business, financial condition and results of operations.
  • We may need to increase the size of our company and may not effectively manage our growth.
  • There is no assurance that the Semnur Business Combination will actually maximize the value of Legacy Semnur and/or the SP-102 asset for us or our stockholders.
  • Our insurance policies are expensive and protect us only from some business risks, which leaves us exposed to significant uninsured liabilities.
  • If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our product candidates.
  • Any disruption in our research and development facilities could adversely affect our business, financial condition and results of operations.
  • We may seek to grow our business through acquisitions and may fail to realize the anticipated benefits of any acquisition, and acquisitions can be costly and dilutive.
  • International components of our business expose us to business, legal, regulatory, political, operational, financial and economic risks associated with conducting business outside of the United States.
  • The increasing use of social media platforms presents new risks and challenges.
  • Our business and operations would suffer in the event of a system failure.
  • Unstable market and economic conditions may have serious adverse consequences on our business, financial condition and results of operations.
  • We are substantially dependent on the intellectual property we in-license from Oishi and Itochu, and if we lose the right to license such intellectual property or if the Product Development Agreement is terminated for any reason, our ability to commercialize ZTlido and develop and commercialize SP-103 would be harmed.
  • We are party to the Romeg License Agreement for the in-licensing of certain intellectual property rights from Romeg with respect to the commercialization of GLOPERBA, and if we lose the right to license such intellectual property or if the Romeg License Agreement is terminated for any reason, our ability to commercialize GLOPERBA would be harmed.
  • There can be no assurance that we will successfully develop or commercialize the technology in-licensed pursuant to the Datavault License Agreement or the Vivasor-Datavault License Agreement.
  • Potential disputes over intellectual property rights that we have licensed may prevent or impair our ability to maintain our current licensing arrangements on acceptable terms.
  • If we are unable to maintain patent protection for ZTlido, GLOPERBA, ELYXYB and our product candidates, or if the scope of the patent protection obtained is not sufficiently broad, we may not be able to compete effectively in our markets.
  • We may not be successful in obtaining or maintaining necessary rights to product components and processes and brands for our development pipeline through acquisitions and in-licenses.
  • We may become subject to claims challenging the inventorship or ownership of our patents and other intellectual property.
  • Claims that we infringe, misappropriate, or violate the intellectual property rights of third parties may give rise to costly and lengthy litigation, and we could be prevented from selling products, forced to pay damages, and defend against litigation.
  • We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time-consuming and unsuccessful.
  • If our intellectual property rights are invalidated or circumvented, our business, financial condition and results of operations will be adversely affected.
  • If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition and our business, financial condition and results of operations may be adversely affected.
  • Changes in patent laws or patent jurisprudence could diminish the value of patents in general, thereby impairing our ability to protect our product 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 non-compliance with these requirements.
  • Confidentiality agreements with employees may not adequately prevent disclosure of our trade secrets and other proprietary information and may not adequately protect our intellectual property, which could limit our ability to compete.
  • 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.
  • Our position as a relatively small company may cause us to be at a significant disadvantage in defending our intellectual property rights and in defending against infringement claims by third parties.
  • Third-party claims of intellectual property infringement may prevent or delay our drug discovery and development efforts.
  • If we do not obtain patent term extension and data exclusivity for any of our product candidates we are developing or may develop, our business may be materially harmed.
  • We may be subject to claims that we have wrongfully hired an employee from a competitor or that we or our employees have wrongfully used or disclosed alleged confidential information or trade secrets of their former employers.
  • We may not be able to protect our intellectual property rights throughout the world.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • Our reliance on third parties may require us to share our trade secrets, which increases the possibility that our trade secrets will be misappropriated or disclosed.
  • Intellectual property rights and regulatory exclusivity rights do not necessarily address all potential threats to our competitive advantage.
  • The regulatory approval processes of the FDA and comparable non-U.S. regulatory authorities are lengthy, time-consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for our product candidates, our business, financial condition and results of operations will be substantially harmed. Moreover, gaining approval for a product candidate in one country or jurisdiction does not guarantee that we will be able to obtain approval for or commercialize it in any other jurisdiction, which would limit our ability to realize our full market potential.
  • If the FDA does not conclude that certain of our product candidates satisfy the requirements for the Section 505(b)(2) regulatory approval pathway, or if the requirements for such product candidates under Section 505(b)(2) are not as we expect, the approval pathway for those product candidates will likely take significantly longer, cost significantly more and entail significantly greater complications and risks than anticipated, and in either case may not be successful.
  • Any approved product candidate will be subject to ongoing and continued regulatory requirements, which may result in significant expense and limit our ability to commercialize such products.
  • A fast-track product designation or other designation to facilitate product candidate development may not lead to faster development or regulatory review or approval process, and it does not increase the likelihood that our product candidates will receive marketing approval.
  • Changes in funding for the FDA could hinder its ability to hire and retain key leadership and other personnel or otherwise prevent new products and services from being developed or commercialized in a timely manner, which could negatively impact our business, financial condition and results of operations.
  • Failure to comply with health and data protection laws and regulations could lead to government enforcement actions and civil or criminal penalties, private litigation or adverse publicity and could negatively affect our operating results and business.
  • Our business may be impacted by actions of the current U.S. administration, including executive orders, policies, new legislation and judicial decisions.
  • Our business involves the use of hazardous materials and we and third parties with whom we contract must comply with environmental laws and regulations, which can be expensive and restrict how we do business.

Legal proceedings

The information required by this Item is incorporated by reference to Note 13 titled “Commitments and Contingencies” and Note 16 titled “Subsequent Events” of the Notes to our consolidated financial statements appearing elsewhere in this Annual Report on Form 10-K.

The opening of Item 3, Legal Proceedings.4

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