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KPRX on Nasdaq

KIORA PHARMACEUTICALS INC

In its 2026 annual report the company says: “We are a clinical-stage specialty pharmaceutical company developing and commercializing therapies for the treatment of retinal diseases.”4 It is headquartered in Waltham, United States.2 Its shares trade on Nasdaq under the symbol KPRX.2

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Last updated Oct 21, 2026.

Overview

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  • TickerKPRX on Nasdaq2
  • IndustryPharmaceutical Preparations2
  • HeadquartersWaltham, United States2
  • Incorporated inDE3
  • Business address169 Saxony Rd., Suite 212, Encinitas, Ca 920243
  • Filer categoryNon-accelerated filer, Smaller reporting company3
  • Legal formCorporation2
  • LEI549300395G8DB8ZFV3652
  • StatusActive2
  • LEI statusIssued and current2
  • Registered addressc/o CORPORATION SERVICE COMPANY, 251 Little Falls Drive, 19808 Wilmington, United States2
  • Registered withDivision of Corporations, Department of State, 38738182

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We are a clinical-stage specialty pharmaceutical company developing and commercializing therapies for the treatment of retinal diseases.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

-100.0%Revenue growth, 20255
-67.2%Return on equity5
-$10.1MFree cash flow5

Financial statements

Revenue6785$0 in 2025
0$5.0M$10.0M$15.0M$20.0M2019: $2.7M$2.7M20192020: $12.1K$12.1K2020−100%2021: $0$020212023: $0$020232024: $16.0M$16.0M20242025: $0$02025
Operating income791085-$12.8M in 2025+87% since 2020
-$15.0M-$10.0M-$5.0M0$5.0M2020: -$6.9M-$6.9M20202021: -$14.2M-$14.2M2021+107%2022: -$12.3M-$12.3M2022−14%2023: -$12.6M-$12.6M2023+2%2024: $4.5M$4.5M20242025: -$12.8M-$12.8M2025
Net income6791085-$10.8M in 2025+53% since 2019
-$15.0M-$10.0M-$5.0M0$5.0M2019: -$7.1M-$7.1M20192020: -$6.9M-$6.9M2020−3%2021: -$13.8M-$13.8M2021+101%2022: -$13.6M-$13.6M2022−1%2023: -$12.5M-$12.5M2023−8%2024: $3.6M$3.6M20242025: -$10.8M-$10.8M2025

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

Period ending2025-12-312024-12-31
Collaboration Revenue$0$16.0M
Grant Revenue$0$20.0K
Total Revenue$0$16.0M
General and Administrative$5.7M$5.5M
Research and Development$10.8M$7.8M
Collaboration Credits-$7.1M-$2.9M
In-Process R&D Impairment$4.6M$2.0M
Change in Fair Value of Contingent Consideration-$1.3M-$937.5K
Total Operating Expenses$12.8M$11.5M
Operating (Loss) Income Before Other Income (Expense), Net-$12.8M$4.5M
Impairment of Intangible Assets$0-$104.2K
Loss on Disposal of Fixed Assets$0-$3.9K
Interest Income$894.0K$1.3M
Interest Expense-$20.0K-$21.4K
Other (Expense) Income, Net-$160.3K$26.1K
Total Other Income, Net$713.8K$1.1M
(Loss) Income Before Income Tax Expense-$12.1M$5.7M
Income Tax Benefit (Expense)$1.3M-$2.1M
Net (Loss) Income Attributable to Common Shareholders, basic-$10.8M$3.6M
Net (Loss) Income Attributable to Common Shareholders, diluted-$10.8M$3.6M
Net (Loss) Income per Common Share - Basic (in usd per share)-$2.60$0.93
Weighted Average Shares Outstanding - Basic (in shares)4.2M shares3.9M shares
Net (Loss) Income per Common Share - Diluted (in usd per share)-$2.64$0.87
Weighted Average Shares Outstanding - Diluted (in shares)4.1M shares4.1M shares
Net (Loss) Income-$10.8M$3.6M
Unrealized (Loss) Gain on Marketable Securities-$20.1K$29.7K
Foreign Currency Translation Adjustments$56.1K-$129.1K
Comprehensive (Loss) Income-$10.8M$3.5M

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Corporate structure

KIORA PHARMACEUTICALS 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 KIORA PHARMACEUTICALS INC

  • KIORA PHARMACEUTICALS INC Waltham, Massachusetts, 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 KIORA PHARMACEUTICALS 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$117.6K5 Dec 31, 2025$6.3K5 Dec 31, 2024+1779.5%
Accumulated depreciation$25.9K5 Dec 31, 2025$1.0K5 Dec 31, 2024+2430.5%
Property and equipment, net$91.7K5 Dec 31, 2025$5.2K5 Dec 31, 2024+1652.1%
Operating-lease assets (leased space)$285.8K5 Dec 31, 2025$57.2K5 Dec 31, 2024+400.0%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$8.7M5 Dec 31, 2025$3.8M5 Dec 31, 2024+129.3%
Marketable securities, current$8.4M5 Dec 31, 2025$23.0M5 Dec 31, 2024−63.5%
Debt securities available for sale$8.4M5 Dec 31, 2025$23.0M5 Dec 31, 2024−63.5%

Intangibles and goodwill

ItemLatestA year beforeChange
Intangible assets, net (excluding goodwill)$2.1M5 Dec 31, 2025$6.7M5 Dec 31, 2024−69.1%
Accumulated amortization$05 Dec 31, 2025$145.8K5 Dec 31, 2024−100.0%
Finite-lived intangibles, net$05 Dec 31, 2025$05 Dec 31, 2024

Properties, in its own words

We currently have three facilities, including our principal executive office located at 169 Saxony Rd., Suite 212, Encinitas, CA, 92024 under a lease that expires in August 2028; our office located at Level 7, 180 Flinders Street, Melbourne, Australia 3000 under a lease that expires in December 2026; and our office located at Herrengasse 5, 1010 Vienna, Austria under a lease that expires in October 2028. We also have four clinical trial sites in Adelaide, Australia, Brisbane, Australia, Perth, Australia, and Auckland, New Zealand under leases that expire in January 2027 for Brisbane and Perth and under a month-to-month lease for Adelaide; We conduct our operations using third-party manufacturing facilities and trial sites. We believe our current facilities are adequate for our needs for the foreseeable future.

Item 2 of the 10-K filed Mar 25, 2026.4

Leadership

Who has led KIORA PHARMACEUTICALS INC, and when. Pick a name to see everywhere that person has worked.

Chief executive

  1. Stephen From2015–2021
  2. Franz Obermayr2021
  3. Brian M. Strem2021–now

Chair

  1. Stephen From2021–2022

President

  1. Stephen From2015–2021
  2. Brian M. Strem2021–now

Chief financial officer

  1. Ryan Randall Brenneman2016
  2. Sarah Romano2017–2022
  3. Susan L. Drexler2022
  4. Melissa Tosca2024–now
20202025
Board members and other officers (21)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • Chief Development OfficerEric Daniels named Nov 4, 2021 to Feb 14, 202440
  • DirectorDavid Hollander named Feb 17, 2023 to Apr 21, 202641

Former names

  • EYEGATE PHARMACEUTICALS INCAug 9, 2006 to Nov 4, 20213

Timeline

  1. Sep 8, 20268-K Executive or director change; Regulation FD disclosure42
  2. Aug 19, 20268-K Entered a material agreement; Regulation FD disclosure43
  3. Aug 7, 20268-K Results of operations44
  4. Jun 18, 20268-K Regulation FD disclosure45
  5. Jun 11, 20268-K Executive or director change; Shareholder vote46
  6. May 8, 20268-K Results of operations47
  7. Apr 7, 20268-K Entered a material agreement; Unregistered sale of shares; Regulation FD disclosure48
  8. Apr 2, 20268-K Executive or director change; Regulation FD disclosure49
  9. Mar 25, 20268-K Results of operations50
  10. Nov 7, 20258-K Results of operations51
  11. Aug 13, 20258-K Regulation FD disclosure52
  12. Aug 8, 20258-K Results of operations53
  13. Aug 2, 2021New chief executive Brian M. Strem becomes CEO14
  14. Feb 3, 2021New chief executive Franz Obermayr becomes CEO13
  15. Feb 12, 2015New chief executive Stephen From becomes CEO15
  16. Dec 28, 2004Founded KIORA PHARMACEUTICALS INC is founded2

Calendar

Coming up

  1. Nov 6, 2026Reports results for the quarter ending Sep/202654

When it reported results

  1. Aug 7, 2026Reported quarterly or annual results44
  2. May 8, 2026Reported quarterly or annual results47
  3. Mar 25, 2026Reported quarterly or annual results50
  4. Nov 7, 2025Reported quarterly or annual results51
  5. Aug 8, 2025Reported quarterly or annual results53
  6. May 9, 2025Reported quarterly or annual results55
  7. Mar 25, 2025Reported quarterly or annual results56
  8. Nov 8, 2024Reported quarterly or annual results57

Drug trials and FDA: coming up

  1. Nov 2026Phase 2 trial readout expected Phase 2 trial of KIO-104 in Macular Edema: primary completion expected Nov 2026 (ClinicalTrials.gov NCT06825702).58
  2. Aug 2027Phase 2 trial readout expected Phase 2 trial of 100 μg KIO-301 and 50 μg KIO-301 in Retinitis Pigmentosa: primary completion expected Aug 2027 (ClinicalTrials.gov NCT06628947).59

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). Trials from ClinicalTrials.gov, as the sponsor registered them (expected dates are the sponsor's own and often move); approvals and advisory committee meetings from the FDA. The FDA does not publish its decision (PDUFA) dates. The full markets calendar

Filings

306 filings to the SEC since October 2021: 6 annual reports, 15 quarterly reports, 71 major events, 96 insider forms, 42 large holders, 5 private raises, 71 other. The latest 20:

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

The 306 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

10 open-market trades by officers, directors and large owners since October 2021: 10 buys and 0 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 11, 2024Stengone Carmine N.DirectorBuy1,250$3.68$4.6KForm 4
Sep 10, 2024Shapiro AronDirectorBuy3,000$3.60$10.8KForm 4
Aug 19, 2024Walters-Hoffert LisaDirectorBuy1,250$3.86$4.8KForm 4
Aug 19, 2024TYLE PRAVEENDirectorBuy5,000$3.96$19.8KForm 4
Aug 14, 2024Tosca MelissaCFOBuy2,000$3.21$6.4KForm 4
Jun 14, 2024Tosca MelissaCFOBuy100$5.25$525Form 4
Jun 14, 2024Daniels Eric JosephChief Development OfficerBuy1,431$5.29$7.6KForm 4
Jun 13, 2024Parsons ErinDirectorBuy5,260$4.88$25.7KForm 4
Jun 13, 2024Strem Brian M.President and CEOBuy3,000$5.00$15.0KForm 4
Nov 18, 2021Strem Brian M.President and CEOBuy17,853$1.41$25.2KForm 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.

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
2025Brian M. StremPh.D$582.1K$971.7K77
2025Eric J. DanielsMD, MBA$452.7K$957.5K77
2025Melissa Tosca$344.8K$516.7K77
2024President and Chief Executive Officer5$489.6K$954.9K77
2024Former Chief Development Officer6$388.2K$674.1K77
2024Chief Financial Officer7$323.6K$534.2K77

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$20.3M 2021–2026
Money received by yearMoney received by year, 2021–2026: $20.3M in all. Private raises (Form D) $20.3M.$0$5M$10M$15M2021 · Private raises (Form D): $67.3K20212023 · Private raises (Form D): $200.0K20232024 · Private raises (Form D): $15.0M20252026 · Private raises (Form D): $5.0M2026
Figures by year
YearPrivate raises (Form D)Total
2026$5.0M$5.0M
2024$15.0M$15.0M
2023$200.0K$200.0K
2021$67.3K$67.3K

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 6, 2026Raised $5 million in a private offering of equity41 Form D: 3 investors so far Form D
  2. Feb 5, 2024Raised $15 million in a private offering of equity40 Form D: 13 investors so far Form D
  3. Feb 17, 2023Filed a private offering of equity78 Form D: $10 million offered in all Form D
  4. Feb 3, 2023Raised $200,000 in a private offering of equity79 Form D: 1 investor so far Form D
  5. Oct 21, 2021Raised $67,258 in a private offering of equity80 Form D: 6 investors so far Form D

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Perceptive Advisors LLC438,471$1.2M0.0%New
ADAR1 Capital Management, LLC167,941$441.7K0.0%No change
Citadel Advisors LLC116,011$305.1K0.0%+66,478
Two Sigma Investments, LP88,792$233.5K0.0%New
Millennium Management LLC74,202$195.2K0.0%New
Renaissance Technologies LLC29,824$78.4K0.0%New
Geode Capital Management, LLC26,717$70.3K0.0%−21,133
Vanguard Capital Management LLC19,861$52.2K0.0%No change
Scientech Research LLC18,746$49.3K0.0%New
Vanguard Fiduciary Trust Co13,030$34.3K0.0%No change
LPL Financial LLC12,500$32.9K0.0%New
Dimensional Fund Advisors LP12,138$31.9K0.0%New
Northern Trust Corp11,767$30.9K0.0%New
Jane Street Group, LLC10,615$27.9K0.0%New
UBS Group AG1,961$5.2K0.0%+660
Caitong International Asset Management Co., Ltd1,813$4.8K0.0%+1,807
Morgan Stanley1,408$3.7K0.0%No change
Tower Research Capital LLC (TRC)837$2.2K0.0%−158
SBI Securities Co., Ltd.256$6730.0%No change
Hrt Financial LP58,612$1540.0%New
BlackRock, Inc.58$1530.0%No change
Activest Wealth Management2$50.0%No change

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

SEC filer profile

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

  • Name on EDGARKIORA PHARMACEUTICALS INC1
  • CIK0001372514
  • Employer ID (EIN)98-04432844
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company4
  • Incorporated inDelaware4
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address169 Saxony Rd., Suite 212, Encinitas, CA 920241
  • Phone858-224-96001
  • Shares outstanding4,424,387 as of Aug 5, 202612
  • Public float$10.5M as of Jun 30, 20254
  • AuditorHASKELL & WHITE LLP, Irvine, California PCAOB ID 200; no auditor attestation of internal control over financial reporting4
  • On EDGAR sinceAug 9, 20061
  • Filings925 in all: 4 (370), 8-K (154), CORRESP (40), 10-Q (35), 3 (33), SC 13G (24), UPLOAD (22), S-1/A (21)1
    All 49 form types

    SC 13G/A (20), D (17), EFFECT (15), SC 13D/A (14), DEF 14A (13), SCHEDULE 13G/A (13), 10-K (12), S-8 (12), 424B3 (9), FWP (9), DEFA14A (8), PRE 14A (8), S-1 (8), S-3 (8), 424B5 (6), SCHEDULE 13G (5), 424B4 (4), CERTNAS (4), CT ORDER (4), REGDEX (4), S-3/A (4), SC 13D (4), 4/A (3), 424B1 (2), 8-A12B (2), 8-K/A (2), POS EX (2), 10-K/A (1), 10-Q/A (1), 144 (1), 25-NSE (1), 8-A12B/A (1), 8-A12G (1), ARS (1), DRS (1), DRS/A (1), DRSLTR (1), NT 10-K (1), NT 10-Q (1), RW (1), S-1MEF (1)

  • Latest filingsAnnual report (10-K) Mar 25, 2026
    Quarterly report (10-Q) Aug 7, 2026
    Proxy statement (DEF 14A) Apr 30, 2026
    Latest 8-K (8-K) Sep 8, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, $0.01 par valueKPRXNASDAQ

From the cover page of the 10-K filed Mar 25, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks KIORA PHARMACEUTICALS INC names in Item 1A of its 10-K filed Mar 25, 2026: 52 risks under these headings, as written.4

  • Risks Related to Our Financial Position and Need for Additional Capital
  • We have incurred significant operating losses since our inception. We expect to incur losses for the foreseeable future and may never achieve or maintain profitability.
  • We will need substantial additional funding. If we are unable to raise capital when needed, we could be forced to delay, reduce, or eliminate our product development programs or commercialization efforts.
  • Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
  • Our limited operating history may make it difficult for investors to evaluate the success of our business to date and to assess our future viability.
  • Taxing authorities could reallocate our taxable income among our subsidiaries, which could increase our overall tax liability.
  • Foreign currency exchange rate fluctuations may have a negative impact on our financial results.
  • Risks Related to the Discovery and Development of Our Product Candidates
  • We depend heavily on the success of KIO-104 and KIO-301. If we are unable to successfully obtain marketing approval for KIO-104 and KIO-301, or experience significant delays in doing so, or if after obtaining marketing approvals, we fail to commercialize KIO-104 and KIO-301, our business will be materially harmed.
  • If clinical trials of KIO-104, KIO-301, or any other product candidate that we may develop fail to demonstrate safety and efficacy to the satisfaction of the FDA or foreign regulatory authorities or do not otherwise produce favorable results, we may incur additional costs or experience delays in completing, or ultimately be delayed or unable to complete, the development and commercialization of KIO-104, KIO-301, or any other product candidate.
  • If we experience any of a number of possible unforeseen events in connection with our clinical trials, potential marketing approval or commercialization of our product candidates could be delayed or prevented.
  • If we experience delays or difficulties in the enrollment of patients in clinical trials, our receipt of necessary regulatory approvals could be delayed or prevented.
The other 42 risks
  • If serious adverse or unacceptable side effects are identified during the development of our product candidates, we may need to abandon or limit our development of such product candidates.
  • We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
  • Risks Related to the Commercialization of Our Product Candidates
  • Even if KIO-104, KIO-301, or any other product candidate that we may develop receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors, and others in the medical community necessary for commercial success and the market opportunity for our product candidates may be smaller than we estimate.
  • If we are unable to establish sales, marketing and distribution capabilities, we may not be successful in KIO-104, KIO-301, or any other product candidates that we may develop if and when they are approved.
  • We face substantial competition, which may result in others discovering, developing, or commercializing products before or more successfully than we do.
  • Even if we are able to commercialize KIO-104, KIO-301, or any other product candidate that we may develop, the products may become subject to unfavorable pricing regulations, third-party coverage or reimbursement practices, or healthcare reform initiatives, which could harm our business.
  • Our strategy of obtaining rights to product candidates and approved products through in-licenses and acquisitions may not be successful.
  • Product liability lawsuits against us could cause us to incur substantial liabilities and limit commercialization of any products that we develop.
  • Risks Related to Our Dependence on Third Parties
  • We may enter into collaborations with other third parties for the development or commercialization of our product candidates. If our collaborations are not successful, we may not be able to capitalize on the market potential of these product candidates.
  • We are dependent on TOI for the successful co-development and commercialization of KIO-301. If TOI does not devote sufficient resources to the co-development and commercialization of KIO-301, are unsuccessful in their efforts, or chooses to terminate their agreement with us, the potential revenue may not materialize.
  • If we are not able to establish additional collaborations, we may have to alter our development and commercialization plans and our business could be adversely affected.
  • We rely, and expect to continue to rely, on third parties to conduct our clinical trials, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials.
  • We contract with third parties for the manufacture of KIO-104 and KIO-301 for clinical trials and expect to continue to do so in connection with the commercialization of KIO-104, KIO-301, and for clinical trials and commercialization of any other product candidates that we may develop. This reliance on third parties increases the risk that we will not have sufficient quantities of our product candidates or products or such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.
  • 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, our competitors could develop and commercialize technology and products similar or identical to ours, and our ability to successfully commercialize our technology and products may be impaired.
  • We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time consuming, and unsuccessful.
  • Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on the success of our business.
  • If we fail to comply with our obligations in our intellectual property licenses and funding arrangements with third parties, we could lose rights that are important to our business.
  • We may be subject to claims by third parties asserting that our employees or we have misappropriated their intellectual property or claiming ownership of what we regard as our own intellectual property.
  • Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • Risks Related to Regulatory Approval of Our Product Candidates and Other Legal Compliance Matters
  • If we are not able to obtain required regulatory approvals, we will not be able to commercialize KIO-104, KIO-301, or any other product candidate that we may develop, and our ability to generate revenue will be materially impaired. The marketing approval process is expensive, time-consuming, and uncertain. As a result, we cannot predict when or if we, or any collaborators we may have in the future, will obtain marketing approval to commercialize KIO-104, KIO-301, or any other product candidate.
  • Failure to obtain marketing approval in international jurisdictions would prevent our product candidates from being marketed abroad.
  • Even if we, or any collaborators that we have now or may have in the future, obtain marketing approvals for KIO-104, KIO-301, or our other product candidates, the terms of those approvals, ongoing regulations and post-marketing restrictions may limit how we, or they, manufacture and market our products, which could materially impair our ability to generate revenue.
  • We may be subject to substantial penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our products.
  • Our relationships with customers and third-party payors may be subject, directly or indirectly, to applicable anti-kickback, fraud and abuse, false claims, transparency, health information privacy and security, and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm, administrative burdens, and diminished profits and future earnings.
  • Previously enacted and future legislation may affect our ability to commercialize and the prices we obtain for any products that are approved in the U.S. or foreign jurisdictions.
  • If we or our third-party manufacturers fail to comply with environmental, health, and safety laws and regulations, we could become subject to fines or penalties or incur significant costs.
  • Risks Related to Employee Matters and Managing Growth
  • Our future success depends on our ability to retain key executives and to attract, retain, and motivate qualified personnel.
  • We expect to expand our development capabilities and potentially implement sales, marketing, and distribution capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.
  • We may fail to realize any benefits and incur losses related to any acquisition.
  • Risks Related to Our Common Stock
  • Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, will be your sole source of gain.
  • The price of our common stock may be volatile and fluctuate substantially, which could result in substantial losses for purchasers of our common stock.
  • If we fail to comply with the continued listing requirements of the Nasdaq Capital Market, our common stock may be delisted and the price of our common stock and our ability to access the capital markets could be negatively impacted.
  • General Risk Factors
  • Laws and regulations governing international operations may preclude us from developing, manufacturing, and selling certain products outside of the U.S. and require us to develop and implement costly compliance programs.
  • Our business and operations would suffer in the event of system failures.
  • Provisions in our corporate charter documents and under Delaware law could make an acquisition of our company, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management.
  • Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.
  • Sales of a substantial number of shares of our common stock by our existing stockholders in the public market could cause our stock price to fall.
  • We are a smaller reporting company and the reduced disclosure requirements applicable to smaller reporting companies may make our common stock less attractive to investors.
  • We incur increasing costs as a result of operating as a public company, and our management is required to devote substantial time to new compliance initiatives and corporate governance practices.
  • A material amount of our assets represents intangible assets, and our net income would be reduced if our intangible assets become impaired.

Legal proceedings

We are not currently a party to any legal proceedings, however, from time to time we may be a party to a variety of legal proceedings that arise in the normal course of our business.

The opening of Item 3, Legal Proceedings.4

Sources

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