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SONX on OTC

Sonendo (United States)

Logo: sonendo.com3

American dental equipment and supplies company based in Laguna Hills1

In its 2025 annual report the company says: “We are an early-stage company with a history of significant net losses, we expect to continue to incur operating losses for the foreseeable future and we may not be able to achieve or sustain profitability.”12 It was founded in 2006.1 Its shares trade on OTC under the symbol SONX.1

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Last updated Oct 21, 2026.

Overview

2006Founded1

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  • TickerSONX on OTC1
  • IndustryDental Equipment & Supplies1
  • HeadquartersLaguna Hills1
  • Websitesonendo.com
  • Incorporated inDE4
  • Business address26061 Merit Circle, Suite 101, Laguna Hills, Ca 926534
  • Filer categoryNon-accelerated filer, Smaller reporting company, Emerging growth company4
  • Legal formCorporation

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Financials

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

Key numbers, fiscal 2024

37.4%Gross margin6
-92.6%Operating margin6
-88.4%Net margin6
-8.4%Revenue growth, 20246
-540.0%Return on equity6
0.70×Debt to equity6
-$24.8MFree cash flow6

Where the money goes

Where each dollar of revenue went, fiscal 2024

  • Cost of revenue63¢$19.9M
  • Research and development21¢$6.8M
  • Other costs16¢$5.1M
  • Income tax0¢$2.0K

Out of $31.7M in revenue.6 The company lost money this year.

Financial statements

Revenue7896$31.7M in 2024+36% since 2020
0$20.0M$40.0M$60.0M2020: $23.4M$23.4M20202021: $33.2M$33.2M2021+42%2022: $41.7M$41.7M2022+25%2023: $34.6M$34.6M2023−17%2024: $31.7M$31.7M2024−8%
Gross profit7896$11.8M in 2024+205% since 2020
0$5.0M$10.0M$15.0M2020: $3.9M$3.9M20202021: $8.3M$8.3M2021+115%2022: $10.5M$10.5M2022+26%2023: $4.7M$4.7M2023−55%2024: $11.8M$11.8M2024+154%
Operating income7896-$29.4M in 2024−31% since 2020
-$60.0M-$40.0M-$20.0M02020: -$42.8M-$42.8M20202021: -$44.4M-$44.4M2021+4%2022: -$58.2M-$58.2M2022+31%2023: -$59.3M-$59.3M2023+2%2024: -$29.4M-$29.4M2024−50%
Net income7896-$28.0M in 2024−40% since 2020
-$80.0M-$60.0M-$40.0M-$20.0M02020: -$46.7M-$46.7M20202021: -$48.5M-$48.5M2021+4%2022: -$57.0M-$57.0M2022+18%2023: -$60.9M-$60.9M2023+7%2024: -$28.0M-$28.0M2024−54%
Fiscal year201920202021202220232024
Revenue$23.4M7$33.2M8$41.7M9$34.6M6$31.7M6
Cost of revenue$19.5M7$24.9M8$31.2M9$30.0M6$19.9M6
Gross profit$3.9M7$8.3M8$10.5M9$4.7M6$11.8M6
Research and development$20.5M7$18.6M8$16.8M9$10.4M6$6.8M6
Selling, general and admin$26.7M7$33.9M8$51.9M9$54.0M9
Operating expenses$52.7M8$68.7M9$63.9M6$41.2M6
Operating income-$42.8M7-$44.4M8-$58.2M9-$59.3M6-$29.4M6
Income before tax-$48.5M8-$57.0M9-$62.5M6-$33.5M6
Income tax$2.0K7$2.0K8$2.0K9$2.0K6$2.0K6
Net income-$46.7M7-$48.5M8-$57.0M9-$60.9M6-$28.0M6
Earnings per share-$8.528-$1.279-$129.636-$59.036
Earnings per share (diluted)-$8.528-$1.279-$129.636-$59.036
Shares (weighted, basic)5.7M shares844.9M shares9469.9K shares6474.9K shares6
Shares (weighted, diluted)5.7M shares844.9M shares9469.9K shares6474.9K shares6

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Corporate structure

Sonendo (United States) sits at the top of its group. 3 entities, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Sonendo (United States)

  • Sonendo (United States) Laguna Hills
    • Pipstek, LLC Subsidiary · Delaware, United States
    • Sonendo Acquisition Corp Subsidiary · California, United States

Built from subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Sonendo (United States) 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$06 Dec 31, 2024$832.0K6 Dec 31, 2023−100.0%
Accumulated depreciation$06 Dec 31, 2024$168.0K6 Dec 31, 2023−100.0%
Property and equipment, net$06 Dec 31, 2024$664.0K6 Dec 31, 2023−100.0%
Operating-lease assets (leased space)$3.3M6 Dec 31, 2024$2.7M6 Dec 31, 2023+23.5%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$10.2M6 Dec 31, 2024$14.0M6 Dec 31, 2023−27.0%
Marketable securities, current$1.4M6 Dec 31, 2024$32.8M6 Dec 31, 2023−95.7%

Intangibles and goodwill

ItemLatestA year beforeChange
Goodwill$8.5M9 Dec 31, 2023$8.5M9 Dec 31, 20220%
Finite-lived intangibles, gross$3.4M9 Dec 31, 2023$4.7M9 Dec 31, 2022−28.3%
Accumulated amortization$2.7M9 Dec 31, 2023$2.4M9 Dec 31, 2022+12.2%
Finite-lived intangibles, net$661.0K9 Dec 31, 2023$2.3M9 Dec 31, 2022−71.2%

Inventory

ItemLatestA year beforeChange
Inventory, total$10.2M6 Dec 31, 2024$11.1M6 Dec 31, 2023−7.8%
Raw materials$5.2M6 Dec 31, 2024$6.5M6 Dec 31, 2023−19.1%
Work in process$148.0K6 Dec 31, 2024$278.0K6 Dec 31, 2023−46.8%
Finished goods$4.8M6 Dec 31, 2024$4.3M6 Dec 31, 2023+11.5%

Properties, in its own words

Our corporate headquarters, which includes our manufacturing facility, is located in Laguna Hills, California, where we occupy approximately 55,000 square feet of space under a series of lease agreements. The lease agreement for our corporate headquarters expires in March 2028. We believe our current facilities are sufficient to meet our current and anticipated future needs and that suitable additional space is available as needed to accommodate expansion of our operations.

Item 2 of the 10-K filed Mar 26, 2025.12

Leadership

Who has led Sonendo (United States), and when. Pick a name to see everywhere that person has worked.

Chief executive

  1. Bjarne Bergheim2021–2024

President

  1. Bjarne Bergheim2021–2024

Chief financial officer

  1. Michael Patrick Watts2021–2024
  2. Chris Guo2024
  3. John J. Bostjancic2024

Chief operating officer

  1. Andrew J. Kirkpatrick2021–2023
2010201520202025
Board members and other officers (15)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • DirectorRaj P. Pudipeddi named May 12, 202531

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Pipstek, LLC Delaware5
  • Sonendo Acquisition Corp California5

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

Former names

  • Dentatek CORPJul 20, 2007 to Dec 1, 20104

Timeline

  1. Mar 4, 20258-K Entered a material agreement; New debt or obligation32
  2. Nov 12, 20248-K Regulation FD disclosure33
  3. Nov 12, 20248-K Results of operations34
  4. Oct 22, 20248-K Change to shareholders' rights; Bylaws or fiscal year changed35
  5. Oct 10, 20248-K Results of operations36
  6. Oct 2, 20248-K Completed an acquisition or sale; Regulation FD disclosure37
  7. Sep 17, 20248-K Other events38
  8. Aug 30, 20248-K Executive or director change39
  9. Aug 16, 20248-K Change of auditor40
  10. Aug 7, 20248-K Results of operations41
  11. Jun 11, 20248-K Shareholder vote42
  12. Jun 5, 20248-K Executive or director change; Regulation FD disclosure43
  13. Oct 28, 2021New chief executive Bjarne Bergheim becomes CEO13
  14. 2006Founded Founded1

Calendar

When it reported results

  1. Nov 12, 2024Reported quarterly or annual results34
  2. Oct 10, 2024Reported quarterly or annual results36
  3. Aug 7, 2024Reported quarterly or annual results41
  4. May 8, 2024Reported quarterly or annual results44
  5. Mar 11, 2024Reported quarterly or annual results45
  6. Nov 8, 2023Reported quarterly or annual results46
  7. Oct 10, 2023Reported quarterly or annual results47
  8. Aug 9, 2023Reported quarterly or annual results48

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

Filings

349 filings to the SEC since October 2021: 4 annual reports, 10 quarterly reports, 51 major events, 185 insider forms, 27 large holders, 1 private raises, 71 other. The latest 20:

  1. Feb 11, 2026SCHEDULE 13G/A EDGAR
  2. May 12, 2025D EDGAR
  3. Mar 26, 202510-K EDGAR
  4. Mar 4, 20258-K EDGAR
  5. Feb 27, 2025EFFECT EDGAR
  6. Feb 27, 2025EFFECT EDGAR
  7. Feb 27, 202515-12G EDGAR
  8. Feb 26, 2025S-8 POS EDGAR
  9. Feb 26, 2025S-8 POS EDGAR
  10. Feb 26, 2025S-8 POS EDGAR
  11. Feb 26, 2025S-8 POS EDGAR
  12. Feb 26, 2025S-8 POS EDGAR
  13. Feb 26, 2025S-8 POS EDGAR
  14. Feb 26, 2025POS AM EDGAR
  15. Feb 26, 2025POS AM EDGAR
  16. Feb 13, 2025SCHEDULE 13G EDGAR
  17. Nov 14, 2024SC 13G/A AMENDMENT TO FORM SC 13G EDGAR
  18. Nov 14, 2024SC 13G EDGAR
  19. Nov 12, 202410-Q EDGAR
  20. Nov 12, 20248-K EDGAR

The 349 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

110 open-market trades by officers, directors and large owners since October 2021: 35 buys and 75 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Jun 21, 2024Bergheim BjarnePresident and CEOSale43,240$0.09$3.9KForm 4
Jun 20, 2024Chen Roy TChief Talent OfficerSale8,510$0.09$766Form 4
May 23, 2024McGaugh John P.Sr. VP OperationsSale10,901$0.09$981Form 4
May 22, 2024McGaugh John P.Sr. VP OperationsBuy116,500$0.10$11.7KForm 4
May 16, 2024BERGHEIM OLAVDirectorBuy520,000$0.10$52.0KForm 4
May 14, 2024Pudipeddi Vamsi Mohan RajDirectorBuy500,000$0.09$45.0KForm 4
May 6, 2024Guo ChrisInterim CFOSale492$0.10$49Form 4
May 3, 2024Bergheim BjarnePresident and CEOSale2,381$0.09$214Form 4
May 3, 2024Chen Roy TChief Talent OfficerSale774$0.09$70Form 4
Apr 15, 2024Guo ChrisInterim CFOSale481$0.08$38Form 4
Mar 26, 2024Chen Roy TChief Talent OfficerSale2,625$0.10$262Form 4
Mar 26, 2024Bergheim BjarnePresident and CEOSale11,493$0.10$1.1KForm 4
Mar 15, 2024Pudipeddi Vamsi Mohan RajDirectorBuy800,000$0.10$80.0KForm 4
Mar 15, 2024Bergheim BjarnePresident and CEOSale23,351$0.10$2.3KForm 4
Mar 15, 2024Chen Roy TChief Talent OfficerSale5,359$0.10$536Form 4
Mar 15, 2024Watts Michael PatrickChief Financial OfficerSale10,670$0.10$1.1KForm 4
Feb 5, 2024Bergheim BjarnePresident and CEOSale2,685$0.15$403Form 4
Feb 5, 2024Chen Roy TChief Talent OfficerSale740$0.15$111Form 4
Feb 5, 2024Watts Michael PatrickChief Financial OfficerSale1,614$0.15$242Form 4
Dec 25, 2023Chen Roy TChief Talent OfficerSale2,166$0.32$693Form 4

All 110 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.

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$5.0M 2025–2025
Money received by yearMoney received by year, 2025–2025: $5.0M in all. Private raises (Form D) $5.0M.$0$2M$4M$6M2025 · Private raises (Form D): $5.0M2025
Figures by year
YearPrivate raises (Form D)Total
2025$5.0M$5.0M

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. Apr 30, 2025Raised $5 million in a private offering of equity31 Form D: $15 million offered in all Form D

SEC filer profile

How Sonendo (United States) is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARSonendo, Inc.2
  • CIK0001407973
  • Employer ID (EIN)20-504171812
  • Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; not a shell company12
  • Incorporated inDelaware12
  • Fiscal year endsDecember 312
  • Industry code (SIC)3843 Dental Equipment & Supplies2
  • SEC reviewing officeOffice of Industrial Applications and Services, Division of Corporation Finance2
  • Business address26061 Merit Circle, Suite 101, Laguna Hills, CA 926532
  • Phone(949) 766-36362
  • Shares outstanding427,401 shares as of Mar 12, 202512
  • Public float$4.3M as of Jun 30, 202412
  • AuditorBDO USA, P.C., Costa Mesa, California PCAOB ID 24312
  • On EDGAR sinceJul 20, 20072
  • Filings370 in all: 4 (164), 8-K (50), 144 (20), 3 (19), D (14), SC 13G/A (13), SC 13G (12), 10-Q (10)2
    All 38 form types

    CORRESP (8), S-8 (6), S-8 POS (6), EFFECT (5), 10-K (4), DEFA14A (4), UPLOAD (4), DEF 14A (3), 4/A (2), ARS (2), D/A (2), POS AM (2), S-3 (2), S-3/A (2), 15-12G (1), 25-NSE (1), 424B3 (1), 424B4 (1), 8-A12B (1), 8-K/A (1), CERT (1), DRS (1), DRS/A (1), DRSLTR (1), PRE 14A (1), REGDEX (1), S-1 (1), S-1/A (1), SCHEDULE 13G (1), SCHEDULE 13G/A (1)

  • Latest filingsAnnual report (10-K) Mar 26, 2025
    Quarterly report (10-Q) Nov 12, 2024
    Proxy statement (DEF 14A) Apr 29, 2024
    Latest 8-K (8-K) Mar 4, 2025

Risk factors and legal proceedings

The risks Sonendo (United States) names in Item 1A of its 10-K filed Mar 26, 2025: 76 risks under these headings, as written.12

  • Risks Related to Our Limited Operating History, Financial Condition and Capital Requirements
  • We are an early-stage company with a history of significant net losses, we expect to continue to incur operating losses for the foreseeable future and we may not be able to achieve or sustain profitability.
  • Our securities are trading on the OTC Pink market, which is volatile and sporadic and could depress our securities’ market price and liquidity.
  • Our reverse stock split could further decrease our total capitalization, and may continue to increase the volatility of our stock price.
  • The sale of securities by us in any equity or debt financing could result in substantial dilution to our existing stockholders.
  • Our decision to deregister our common stock under the Exchange Act could negatively affect the liquidity and trading prices of our common stock, will result in substantially less disclosure about us, and could severely impair our ability to raise capital.
  • Our revenue is primarily generated from sales of our GentleWave Console and the accompanying single-use PIs and our business, financial condition and results of operations are therefore highly dependent on the success of our remaining offerings.
  • Our quarterly and annual operating results may fluctuate significantly and may not fully reflect the underlying performance of our business. This makes our future operating results difficult to predict and could cause our operating results to fall below expectations or any guidance we may provide.
  • As a result of the divestiture of our TDO software segment, we lost a substantial source of our revenues.
  • The divestiture of our TDO software segment may cause potential customers to be less likely to commit to purchases of GentleWave Console.
  • The recent divestiture of our TDO software segment may disrupt our business or result in costs that could have a material adverse effect on our financial condition and results of operations.
  • The terms of our Credit Agreement require us to meet certain operating and financial covenants and place restrictions on our operating and financial flexibility.
The other 64 risks
  • We will need additional funding beyond the capital resources currently available to us to finance our planned operations, and may not be able to raise capital when needed, which could force us to delay, reduce or eliminate one or more of our product development programs and future commercialization efforts.
  • We maintain cash deposits in excess of federally insured limits. Adverse developments affecting financial institutions, including bank failures, could adversely affect our liquidity and financial performance.
  • Risks Related to Our Business and Industry
  • Uncertainty of Insurance Reimbursement for the GentleWave® Procedure
  • The commercial success of our GentleWave System and the GentleWave Procedure will depend upon the degree of market acceptance of our products by dental practitioners, and failure to achieve or maintain market acceptance and/or market share could materially and adversely affect our ability to generate revenue and would have a material adverse effect on our business, financial condition and results of operations.
  • The continuing acceptance of our products depends upon maintaining strong working relationships with our existing clinician and dental customers, and if we cannot maintain strong working relationships with these professionals, the development and marketing of our products could suffer, which could harm our business, financial condition and results of operations.
  • Our future success is dependent upon our ability to increase penetration in our existing markets and expand into adjacent markets.
  • We may provide inadequate training, fail to increase our sales and marketing capabilities or fail to develop and maintain broad brand awareness in a cost-effective manner.
  • We may not be able to obtain or maintain adequate levels of third-party coverage and reimbursement, and third parties may rescind or modify their coverage or delay payments related to our products.
  • We may not be able to achieve or maintain satisfactory pricing and margins for our products.
  • We face competition from many sources, including larger companies, and we may be unable to compete successfully.
  • If we are unable to continue to innovate and improve our GentleWave System, we could lose market share.
  • New product development takes time and requires considerable resources and we may be unable to develop or commercialize products on a timely basis, or at all.
  • We have limited experience manufacturing our products in large-scale commercial quantities and we face a number of manufacturing risks that may adversely affect our manufacturing abilities, which could delay, prevent or impair our growth.
  • We depend upon third-party suppliers, including contract manufacturers and single and sole source suppliers, making us vulnerable to supply shortages and price fluctuations that could negatively affect our business, financial condition and results of operations.
  • Shipping is a critical part of our business and any changes in our shipping arrangements or damages or losses sustained during shipping could adversely affect our business, financial condition, results of operations and prospects.
  • If we receive a significant number of warranty claims or our GentleWave Systems require significant amounts of service after sale, our operating expenses may substantially increase and our business and financial results will be adversely affected.
  • We need to ensure strong product performance and reliability to maintain and grow our business, otherwise our business, financial condition and results of operations will suffer.
  • We may encounter difficulties in managing our growth, which could disrupt our operations.
  • Our results of operations will be materially harmed if we are unable to accurately forecast demand for, and utilization of, our GentleWave System and manage our inventory.
  • Our internal computer systems or those used by our contractors or consultants, may fail or suffer security breaches, and such failure could negatively affect our business, financial condition and results of operations.
  • Natural or man-made disasters and other similar events may significantly disrupt our business, including by causing delays in production or an increase in costs, and negatively impact our business, financial condition and results of operations.
  • The sizes of the addressable markets for our GentleWave System have not been established with precision and our potential market opportunity may be smaller than we estimate and may decline.
  • If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit or halt the marketing and sale of our products. The expense and potential unavailability of insurance coverage for liabilities resulting from our products could harm us and our ability to sell our products.
  • Our insurance policies are expensive and protect us only from some business risks, which leaves us exposed to significant uninsured liabilities.
  • We may seek strategic alliances, joint ventures or collaborations, or enter into licensing or partnership arrangements in the future and may not be successful in doing so, and even if we are, we may not realize the benefits or costs of such relationships.
  • As international expansion of our business occurs in future years, it will expose us to market, regulatory, political, operational, financial and economic risks associated with doing business outside of the United States.
  • We are highly dependent on our senior management team and key personnel, and our business could be harmed if we are unable to attract and retain personnel necessary for our success.
  • We could be adversely affected by violations of the FCPA and similar worldwide anti-bribery laws, as well as violations of export or import controls or economic sanctions laws and regulations. Any investigation, and the outcome of any investigation, by government agencies of possible violations by us of such laws and regulations could have a material adverse effect on our business.
  • Changes in tax laws or regulations that are applied adversely to us or our customers may seriously harm our business.
  • Our ability to utilize our net operating loss carryforwards and research and development credit carryforwards may be limited.
  • We may acquire other companies or technologies, which could fail to result in a commercial product or net sales, divert our management’s attention, result in additional dilution to our stockholders and otherwise disrupt our business.
  • Risks Related to Governmental Regulation
  • Healthcare reform measures could hinder or prevent the commercial success of our GentleWave System.
  • We must comply with anti-kickback, fraud and abuse, false claims, transparency, and other healthcare laws and regulations.
  • If we fail to obtain and maintain necessary clearances, approvals or certifications from the FDA, other applicable foreign regulatory authorities and notified bodies, if clearances, approvals or certifications for future products, product modifications or enhancements, and indications are delayed or not issued, or if there are state, federal or international level regulatory changes, our commercial operations could be harmed.
  • Our future success depends on our ability to develop, receive regulatory clearance or approval for, and introduce new products that will be accepted by the market in a timely manner. There is no guarantee that the FDA will grant 510(k) clearance or PMA approval of our future products on a timely basis, if at all, and failure to obtain necessary clearances or approvals for our future products would adversely affect our ability to grow our business.
  • New legislation and regulations and legislative and regulatory reforms may make it more difficult and costly for us to obtain regulatory clearance or approval of our new and modified products, or to manufacture, market and distribute our products after clearance or approval is obtained.
  • Modifications to our products may require new clearances, premarket approvals or new or amended certifications, and may require us to cease marketing or recall the modified products until clearances, approvals or the relevant certifications are obtained.
  • Clinical trials may be necessary to support a 510(k) clearance, comparable marketing authorization, or certification. Such trials may require the enrollment of large numbers of patients and suitable patients may be difficult to identify and recruit. Delays or failures in our clinical trials may prevent us from commercializing modified or new products and may adversely affect our business, financial condition and results of operations.
  • The safety and efficacy of some of our products are not yet supported by long-term clinical data, which could limit sales, and our products might therefore prove to be less safe or effective than initially thought.
  • Our facilities and those of our suppliers and contract manufacturers are subject to regulation under the FDCA and FDA implementing regulations as well as potential inspections by foreign regulatory authorities and audits.
  • Even after clearance, approval or certification for our products is obtained, we and our contract manufacturers are subject to extensive post-market regulation by the FDA and foreign regulatory authorities and the notified body. Our failure to meet strict regulatory requirements could result in our being required to stop sales of our products, conduct voluntary or mandatory product recalls, pay fines, incur other costs or even close our facilities.
  • If the third parties on which we rely to conduct our clinical trials and to assist us with pre-clinical development do not perform as contractually required or expected, we may not be able to obtain regulatory clearance, approval, or other required regulatory authorizations or certifications to commercialize our products.
  • Disruptions at the FDA and foreign regulatory agencies caused by funding shortages or unexpected personnel overhaul could hinder their 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.
  • The FDA and other regulatory enforcement agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses. If we are found to have improperly promoted off-label uses, we may become subject to significant liability.
  • Actual or perceived failure to comply with data protection, privacy and security laws, regulations, standards and other requirements could negatively affect our business, financial condition or results of operations.
  • Our employees, collaborators, independent contractors and consultants may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
  • We must comply with environmental and occupational safety laws.
  • Risks Related to Our Intellectual Property
  • If we are unable to obtain and maintain patent or other intellectual property protection for any products we develop or for our technology, or if the scope of the patent and other intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize products and technology similar or identical to ours, and our ability to successfully commercialize any products we may develop, and our technology, may be harmed.
  • We may, from time to time, be a party to intellectual property litigation or administrative proceedings that are very costly and time-consuming and could interfere with our ability to sell and market our products.
  • Obtaining and maintaining intellectual property, including patent protection, depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental agencies, and our intellectual property, including patent protection, could be reduced or eliminated for non-compliance with these requirements.
  • Patent terms may be inadequate to protect our competitive position on our products for an adequate amount of time.
  • Changes in patent law or its interpretation could diminish the value of patents in general, thereby impairing our ability to protect our existing and future products.
  • Our patent rights and other intellectual property may be subject to priority, ownership or inventorship disputes, interferences, and similar proceedings.
  • We may be subject to claims that our employees, consultants, advisors, or contractors have misappropriated the intellectual property of a third party, including trade secrets or know-how, or are in breach of a non-competition or non-solicitation agreement with our competitors, and third parties may claim an ownership interest in intellectual property we regard as our own. Such claims could harm our business, financial condition, and results of operations.
  • If we fail to validly execute invention assignment agreements with our employees and contractors involved in the development of intellectual property or are unable to protect the confidentiality of our trade secrets and other proprietary information, the value of our products our business and competitive position may be harmed.
  • We may not be able to enforce our intellectual property rights throughout the world.
  • 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.
  • If we are unable to obtain licenses from third parties on commercially reasonable terms or fail to comply with our obligations under such agreements, our business could be harmed.
  • If our third-party manufacturers do not respect our intellectual property and trade secrets and produce or sell competitive products using our designs or intellectual property, our business, financial condition and results of operation would be harmed.
  • Intellectual property rights do not necessarily address all potential threats, and limitations in intellectual property rights could harm our business, financial condition, and results of operations.
  • Risks Related to Ownership of Our Common Stock
  • The market price of our common stock may be volatile or may decline steeply or suddenly regardless of our operating performance, which could result in substantial losses for purchasers of our common stock, and we may not be able to meet investor or analyst expectations.
  • An active trading market for our common stock may never develop or be sustained, and you may not be able to resell your shares at or above your purchase price.
  • Future sales of shares by existing stockholders could cause our stock price to decline.
  • We do not intend to pay dividends for the foreseeable future and, as a result, your ability to achieve a return on your investment will depend on appreciation in the price of our common stock.

Legal proceedings

From time to time, we may become involved in various claims and legal proceedings. Regardless of outcome, litigation and other legal and administrative proceedings can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors. We are not currently a party to any material legal proceeding.

The opening of Item 3, Legal Proceedings.12

Sources

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