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KALA on Nasdaq

Kala Pharmaceuticals (United States)

In its 2026 annual report the company says: “We are a biopharmaceutical company in transition, evaluating the development of a dedicated, on-premises artificial intelligence (AI) infrastructure platform for the biotechnology industry. Our current focus is leveraging our mesenchymal stem cell secretome platform to test development of a scalable AI platform-as-a-service business to deploy secure, purpose-built AI systems directly within biotech and pharmaceutical client environments.”4 It was founded in 2009.1 It is headquartered in Waltham.1 Its shares trade on Nasdaq under the symbol KALA.1

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Last updated Oct 21, 2026.

Overview

Jan 1, 2009Founded1

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  • TickerKALA on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersWaltham1
  • Websitewww.kalarx.com
  • Incorporated inDE3
  • Business address1167 Massachusetts Avenue, Arlington, Ma 024763
  • Filer categoryNon-accelerated filer, Smaller reporting company3
  • Legal formCorporation

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We are a biopharmaceutical company in transition, evaluating the development of a dedicated, on-premises artificial intelligence (AI) infrastructure platform for the biotechnology industry. Our current focus is leveraging our mesenchymal stem cell secretome (“MSC-S”) platform to test development of a scalable AI platform-as-a-service business to deploy secure, purpose-built AI systems directly within biotech and pharmaceutical client environments. We have historically been engaged in the research, development and commercialization of innovative therapies for rare and severe diseases of the front and back of the eye. Our lead product candidate was KPI-012, MSC-S, which we acquired from Combangio, Inc. (“Combangio”) on November 15, 2021. KPI-012 was in clinical development for the treatment of persistent corneal epithelial defects (“PCED”), a rare disease of impaired corneal healing. Based…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

-385.6%Return on equity5

Financial statements

Revenue6789105$0 in 2025
0$5.0M$10.0M$15.0M2019: $6.1M$6.1M20192020: $6.4M$6.4M2020+5%2021: $11.2M$11.2M2021+77%2022: $3.9M$3.9M2022−65%2023: $0$020232024: $0$020242025: $0$02025
Operating income6789105-$39.2M in 2025−56% since 2019
-$150.0M-$100.0M-$50.0M02019: -$88.2M-$88.2M20192020: -$96.2M-$96.2M2020+9%2021: -$130.2M-$130.2M2021+35%2022: -$81.7M-$81.7M2022−37%2023: -$39.7M-$39.7M2023−51%2024: -$41.0M-$41.0M2024+3%2025: -$39.2M-$39.2M2025−4%
Net income6789105-$27.0M in 2025−71% since 2019
-$150.0M-$100.0M-$50.0M02019: -$94.3M-$94.3M20192020: -$104.3M-$104.3M2020+11%2021: -$142.6M-$142.6M2021+37%2022: -$44.8M-$44.8M2022−69%2023: -$42.2M-$42.2M2023−6%2024: -$38.5M-$38.5M2024−9%2025: -$27.0M-$27.0M2025−30%

Every line of the income statement as filed: the last 3 fiscal years, latest first.5

Period ending2025-12-312024-12-312022-12-31
General and administrative$23.6M$18.3M
Research and development$18.8M$22.1M
(Gain) loss on fair value remeasurement of contingent consideration-$4.7M$549.0K
Impairment of right-of-use assets$1.4M
Total costs and expenses$39.2M$41.0M
Loss from operations-$39.2M-$41.0M
Interest income$1.1M$2.1M
Interest expense-$3.3M-$5.8M
Grant income$3.4M$6.2M
Gain on extinguishment of debt$5.8M-$2.6M
Other income (expense), net$5.1M
Total other income (expense)$12.2M$2.5M
Net loss per share attributable to common stockholders-basic (in dollar per share)-$3.31-$10.15
Net loss per share attributable to common stockholders-diluted (in dollar per share)-$3.31-$10.15
Weighted average shares outstanding-basic (in shares)8.1M shares3.8M shares
Weighted average common shares outstanding -diluted (in shares)8.1M shares3.8M shares
Net loss-$27.0M-$38.5M
Total comprehensive loss-$27.0M-$38.5M

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Corporate structure

Kala Pharmaceuticals (United States) 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 Kala Pharmaceuticals (United States)

  • David E. Lazar Filed SCHEDULE 13D/A on Kala Pharmaceuticals (United States), latest Jul 2, 2026 (2 filings since Feb 6, 2026)
  • BAKER BROS. ADVISORS LP Filed SCHEDULE 13G/A on Kala Pharmaceuticals (United States), latest May 15, 2026 (8 filings since Feb 14, 2023)
  • LIFESCI CAPITAL, LLC Filed SCHEDULE 13G on Kala Pharmaceuticals (United States), latest Jan 13, 2026
  • OXFORD FINANCE LLC Filed SCHEDULE 13G on Kala Pharmaceuticals (United States), latest Dec 3, 2025
  • Cormorant Asset Management, LP Filed SCHEDULE 13G/A on Kala Pharmaceuticals (United States), latest Nov 14, 2025 (2 filings since Feb 14, 2025)
  • PERCEPTIVE ADVISORS LLC Filed SCHEDULE 13G/A on Kala Pharmaceuticals (United States), latest Nov 14, 2025 (2 filings since Sep 11, 2025)
  • Point72 Asset Management, L.P. Filed SCHEDULE 13G/A on Kala Pharmaceuticals (United States), latest Nov 14, 2025 (2 filings since Sep 11, 2025)
  • SR ONE CAPITAL MANAGEMENT, LLC Filed SCHEDULE 13D/A on Kala Pharmaceuticals (United States), latest Oct 15, 2025 (3 filings since Jul 8, 2024)
  • MILLENNIUM MANAGEMENT LLC Filed SCHEDULE 13G/A on Kala Pharmaceuticals (United States), latest May 12, 2025 (2 filings since Feb 16, 2024)
  • ADAR1 Capital Management, LLC Filed SCHEDULE 13G/A on Kala Pharmaceuticals (United States), latest Feb 14, 2025 (2 filings since Nov 14, 2024)
  • Checkpoint Capital L.P. Filed SC 13G/A on Kala Pharmaceuticals (United States), latest Feb 14, 2024 (2 filings since Jun 15, 2023)
  • INTEGRATED CORE STRATEGIES (US) LLC Filed SC 13G/A on Kala Pharmaceuticals (United States), latest Jan 29, 2024 (2 filings since Jan 17, 2023)
  • Kala Pharmaceuticals (United States) Waltham

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

What it owns

What Kala Pharmaceuticals (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$869.0K5 Dec 31, 2025$2.1M5 Dec 31, 2024−57.9%
Accumulated depreciation$869.0K5 Dec 31, 2025$1.3M5 Dec 31, 2024−33.9%
Property and equipment, net$749.0K5 Dec 31, 2024$753.0K10 Dec 31, 2023−0.5%
Operating-lease assets (leased space)$1.7M5 Dec 31, 2024$2.0M10 Dec 31, 2023−16.5%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$7.6M5 Dec 31, 2025$51.2M5 Dec 31, 2024−85.2%

Properties, in its own words

We currently lease a limited amount of office space in Arlington, Massachusetts, which serves as our corporate headquarters since 2021. The lease is short term, with approximately $3,000 monthly rent, and is renewable every six months.

In April 2023, Combangio entered into a lease agreement with Menlo Prepi I, LLC, pursuant to which Combangio leased approximately 6,135 square feet of office, laboratory and research and development space in Menlo Park, California. The term of the lease commenced on July 1, 2023. The initial term of the lease was for 62 months, unless earlier terminated. The lease provided Combangio with an option to extend the lease for an additional five-year term. During the fourth quarter of 2025, the Company terminated the lease and signed, and paid, a settlement agreement to release the Company from all obligations.

Item 2 of the 10-K filed Apr 15, 2026.4

Leadership

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

Chief executive

  1. Mark T. Iwicki2017–2025
  2. David E. Lazar2025–2026
  3. Avraham Minkowitz2026–now

President

  1. Charles Douglas McDermott2017

Chief financial officer

  1. Mary Reumuth2017–now

Chief operating officer

  1. Todd Bazemore2017–2021
2010201520202025
Board members and other officers (26)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • Executive Officer, DirectorAvi Minkowitz named Feb 13, 2026 to Mar 17, 202643
  • Executive OfficerKim Brazzell named Nov 29, 2021 to Dec 31, 202444
  • Executive OfficerHongming Chen named Nov 29, 202145

Former names

  • KALA BIO, Inc.Aug 2, 2023 to Sep 24, 20263
  • Kala Pharmaceuticals, Inc.Dec 23, 2009 to Jun 23, 20233

Timeline

  1. Sep 10, 20268-K Entered a material agreement46
  2. Sep 9, 20268-K Director nominations; Other events47
  3. Aug 28, 20268-K Listing notice or transfer48
  4. Jul 23, 20268-K Other events49
  5. May 7, 20268-K Change to shareholders' rights; Bylaws or fiscal year changed; Other events50
  6. Mar 4, 20268-K Entered a material agreement; Unregistered sale of shares; Regulation FD disclosure51
  7. Feb 20, 20268-K Executive or director change52
  8. Feb 9, 2026New chief executive Avraham Minkowitz becomes CEO14
  9. Feb 5, 20268-K Executive or director change53
  10. Feb 2, 20268-K Entered a material agreement; Unregistered sale of shares; Change in control54
  11. Jan 23, 20268-K Listing notice or transfer55
  12. Jan 8, 20268-K Entered a material agreement56
  13. Jan 6, 20268-K Entered a material agreement; Unregistered sale of shares; Regulation FD disclosure57
  14. Nov 26, 2025New chief executive David E. Lazar becomes CEO15
  15. Jul 19, 2017New chief executive Mark T. Iwicki becomes CEO16
  16. Jan 1, 2009Founded Founded1

Calendar

Coming up

  1. Nov 18, 2026Reports results for the quarter ending Sep/202658

When it reported results

  1. Aug 8, 2025Reported quarterly or annual results59
  2. May 14, 2025Reported quarterly or annual results60
  3. Mar 31, 2025Reported quarterly or annual results61
  4. Nov 12, 2024Reported quarterly or annual results62
  5. Aug 6, 2024Reported quarterly or annual results63
  6. May 14, 2024Reported quarterly or annual results64
  7. Mar 29, 2024Reported quarterly or annual results65
  8. Nov 13, 2023Reported quarterly or annual results66

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

Filings

372 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 75 major events, 138 insider forms, 42 large holders, 5 private raises, 92 other. The latest 20:

  1. Sep 24, 2026DEF 14A EDGAR
  2. Sep 11, 2026PRE 14A EDGAR
  3. Sep 10, 20268-K EDGAR
  4. Sep 9, 20268-K EDGAR
  5. Aug 28, 20268-K EDGAR
  6. Aug 19, 202610-Q EDGAR
  7. Aug 14, 2026NT 10-Q EDGAR
  8. Jul 23, 20268-K EDGAR
  9. Jul 22, 2026424B5 EDGAR
  10. Jul 2, 2026SCHEDULE 13D/A EDGAR
  11. Jun 25, 2026EFFECT EDGAR
  12. Jun 12, 2026S-3/A EDGAR
  13. May 15, 2026SCHEDULE 13G/A EDGAR
  14. May 15, 202610-Q EDGAR
  15. May 7, 2026S-3 EDGAR
  16. May 7, 20268-K EDGAR
  17. Apr 15, 202610-K EDGAR
  18. Mar 31, 2026NT 10-K EDGAR
  19. Mar 17, 2026144 EDGAR
  20. Mar 17, 2026D EDGAR

The 372 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

72 open-market trades by officers, directors and large owners since October 2021: 1 buys and 71 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Oct 23, 2025Reumuth MaryCHIEF FINANCIAL OFFICERSale967$0.82$793Form 4
Oct 23, 2025Iwicki Mark TDirectorSale154,894$0.81$125.5KForm 4
Oct 22, 2025Kharabi DariusCHIEF BUSINESS OFFICERSale20,806$0.83$17.3KForm 4
Oct 22, 2025Reumuth MaryCHIEF FINANCIAL OFFICERSale32,230$0.83$26.8KForm 4
Oct 22, 2025Bazemore ToddDirectorSale47,768$0.83$39.6KForm 4
Oct 22, 2025Brazzell Romulus KSEE REMARKSSale46,748$0.83$38.8KForm 4
Oct 1, 2025BAKER JULIANSale513,607$1.38$708.8KForm 4
Sep 30, 2025BAKER JULIANSale216,801$1.60$346.9KForm 4
Jun 24, 2025Kharabi DariusCHIEF BUSINESS OFFICERSale4,511$4.01$18.1KForm 4
Jun 24, 2025Reumuth MaryCHIEF FINANCIAL OFFICERSale3,631$4.01$14.6KForm 4
Jun 24, 2025Bazemore ToddDirectorSale4,058$4.01$16.3KForm 4
Jun 24, 2025Brazzell Romulus KSEE REMARKSSale5,251$4.01$21.1KForm 4
Jun 24, 2025Iwicki Mark TDirectorSale13,227$4.01$53.0KForm 4
Jun 3, 2025Kharabi DariusCHIEF BUSINESS OFFICERSale730$3.74$2.7KForm 4
Jun 3, 2025Reumuth MaryCHIEF FINANCIAL OFFICERSale2,850$3.74$10.7KForm 4
Jun 3, 2025Bazemore ToddDirectorSale3,390$3.74$12.7KForm 4
Jun 3, 2025Brazzell Romulus KSEE REMARKSSale3,687$3.74$13.8KForm 4
Jun 3, 2025Iwicki Mark TDirectorSale10,866$3.74$40.6KForm 4
Jun 3, 2025Iwicki Mark TDirectorSale10,866$3.74$40.6KForm 4
Jan 6, 2025Kharabi DariusCHIEF BUSINESS OFFICERSale2,021$7.63$15.4KForm 4

All 72 trades can be filtered by person here when JavaScript is on.

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Executive pay

What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.

YearExecutiveAgeSalaryTotal pay
2025Todd Bazemore$489.1K$3.5M87
2025Kim BrazzellPh.D.$420.0K$1.4M87
2025Mary Reumuth$439.0K$1.3M87
2025Mark Iwicki$111.9K$906.6K87
2024Former ChiefExecutive Officer$709.4K$1.5M87
2024Former Interim Chief Executive OfficerPresident and Chief Operating Officer$535.6K$949.5K87
2024Former Head of Research and Development and Chief Medical Officer$520.0K$920.7K87
2024Former Chief Financial Officer$468.0K$778.3K87

Money raised

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

  1. Mar 3, 2026Raised $1.8 million in a private offering of equity Form D: 1 investor so far Form D
  2. Jan 30, 2026Raised $2.3 million in a private offering of equity Form D: $4.2 million offered in all Form D
  3. Dec 31, 2024Raised $10.7 million in a private offering of equity Form D: 6 investors so far Form D
  4. Jun 28, 2024Raised $12.5 million in a private offering of equity Form D: 5 investors so far Form D
  5. Nov 15, 2021Raised $16.1 million in a private offering of equity Form D: $36.5 million offered in all 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
Vanguard Capital Management LLC220,623$381.7K0.0%New
Geode Capital Management, LLC145,152$251.1K0.0%New
Vanguard Fiduciary Trust Co101,396$175.4K0.0%New
BlackRock, Inc.71,542$123.8K0.0%New
Northern Trust Corp41,606$72.0K0.0%New
Qube Research & Technologies Ltd11,073$19.2K0.0%New
Goldman Sachs Group Inc10,921$18.9K0.0%New
UBS Group AG9,057$15.7K0.0%New
Tower Research Capital LLC (TRC)616$1.1K0.0%New
Barclays PLC608$1.1K0.0%New
Morgan Stanley28$480.0%New
Caitong International Asset Management Co., Ltd10$170.0%New
International Assets Investment Management, LLC2$40.0%New

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

SEC filer profile

How Kala Pharmaceuticals (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 EDGARKALA BIO, Inc.2
  • CIK0001479419
  • Employer ID (EIN)27-06045954
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company4
  • Incorporated inDelaware4
  • Fiscal year endsDecember 312
  • Industry code (SIC)2834 Pharmaceutical Preparations2
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance2
  • Business address1167 Massachusetts Avenue, Arlington, MA 024762
  • Phone781-996-52522
  • Shares outstanding19,339,786 as of Aug 14, 202612
  • Public float$24.6M as of Jun 30, 20254
  • AuditorHTL International, LLC, Houston, Texas PCAOB ID 7000; no auditor attestation of internal control over financial reporting4
  • On EDGAR sinceDec 23, 20092
  • Filings673 in all: 4 (242), 8-K (122), 3 (40), 10-Q (28), 144 (24), SC 13G/A (15), SC 13G (13), CORRESP (12)2
    All 45 form types

    D (12), DEFA14A (12), DEF 14A (11), S-8 (11), UPLOAD (11), SC 13D/A (10), 10-K (9), 424B5 (9), EFFECT (9), S-3 (8), SC 13D (7), SCHEDULE 13G/A (7), CT ORDER (6), SCHEDULE 13G (6), SCHEDULE 13D/A (5), 4/A (4), 424B3 (4), DRS/A (4), PRE 14A (4), 8-K/A (3), S-3/A (3), 3/A (2), 424B2 (2), ARS (2), DRSLTR (2), NT 10-Q (2), SC TO-I/A (2), 424B4 (1), 8-A12B (1), 8-A12G (1), DRS (1), NT 10-K (1), PRER14A (1), S-1 (1), S-1/A (1), SC TO-I (1), SCHEDULE 13D (1)

  • Latest filingsAnnual report (10-K) Apr 15, 2026
    Quarterly report (10-Q) Aug 19, 2026
    Proxy statement (DEF 14A) Sep 24, 2026
    Latest 8-K (8-K) Sep 10, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, $0.001 par value per shareKALANasdaq

From the cover page of the 10-K filed Apr 15, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks Kala Pharmaceuticals (United States) names in Item 1A of its 10-K filed Apr 15, 2026: 71 risks under these headings, as written.4

  • Risks Related to Our Financial Position and Need for Additional Capital
  • The Company’s predecessor auditor noted substantial doubt about our ability to continue as a going concern.
  • We have incurred significant losses from operations and negative cash flows from operations since our inception. We expect to incur additional losses 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 efforts or cease operations.
  • Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
  • The milestone consideration we are eligible to receive in connection with the sale of our Commercial Business to Alcon is subject to various risks and uncertainties.
  • If our estimates or judgments relating to our critical accounting policies, or any of our projections, prove to be inaccurate or financial reporting standards or interpretations change, our results of operations could be adversely affected.
  • Our limited operating history and our limited experience in developing AI technology or biologics may make it difficult to evaluate the success of our business to date and to assess our future viability.
  • Risks Related to Product Development and Monetization of our Biologics Assets
  • Our ability to monetize our biologics asset portfolio is subject to significant uncertainty, and we may be unable to enter into any licensing, collaboration, sale, or other strategic arrangement with respect to our KPI-012 or KPI-014 product candidates or related intellectual property on acceptable terms, or at all.
  • If we were to resume research and development activities with respect to KPI-012, KPI-014 or any other product candidate, such activities would be subject to all of the risks inherent in the development of biologics and other pharmaceutical products, including the risk of clinical trial failure, regulatory rejection, manufacturing challenges, and the absence of adequate financing.
  • We are shifting our business to focus on developing an AI infrastructure platform for the biotech industry that may present risks to our business. We may not be successful in driving the global deployment and customer adoption of digital offerings, including AI-enabled software solutions.
The other 61 risks
  • We have invested and expect to continue to invest in research and development efforts that further enhance our computational platform. Such investments may affect our operating results, and, if the return on these investments is lower or develops more slowly than we expect, our revenue and operating results may suffer
  • Risks Related to Our Dependence on Third Parties
  • The involvement of third-party vendors and partners in developing and delivering our AI platform services introduces risks to quality control that could result in service failures, reputational harm, or liability.
  • If we resume research and development activities and enter into arrangements with third-party manufacturers for the production of any of our product candidates, we will be exposed to risks associated with reliance on third-party manufacturers, including risks related to regulatory compliance, supply chain disruptions, manufacturing quality, and our ability to secure adequate quantities at acceptable cost.
  • If we continue to pursue development of our MSC-S platform, we may enter into collaborations with third parties for the development or commercialization of our clinical product candidates. If our collaborations are not successful, we may not be able to capitalize on the market potential of these product candidates.
  • If we are not able to establish collaborations or strategic partnerships relating to our AI platform, we may have to alter our development and commercialization plans and our business could be adversely affected.
  • Risks Related to Our AI Platform Business
  • We are at an early stage of development of our AI platform business and may be unable to successfully develop, commercialize, or generate revenue from Researgency.
  • Our Researgency business depends on an exclusive license for the Researgency platform, and the termination, modification, or invalidity of that license could materially harm our business.
  • Issues relating to the use of artificial intelligence and machine learning in our offerings could adversely affect our business and operating results.
  • Regulatory and legislative developments related to the use of AI could adversely affect our use of such technologies in our products, services, and business.
  • The market for AI platforms serving the biotechnology and pharmaceutical industries is intensely competitive, rapidly evolving, and may develop in ways that are adverse to our business.
  • Our Researgency business model depends on market acceptance of on-premises AI deployment architectures by biotechnology and pharmaceutical companies, and there is no assurance that sufficient market demand will develop.
  • We may not be able to protect our proprietary AI platform technology, and third parties may be able to develop competing products that use similar methods.
  • Our use of artificial intelligence and machine learning in our AI platform business may be subject to methodological and processing limitations that could expose us to regulatory, legal, and reputational risks.
  • Data security and privacy risks are heightened in our Researgency business given that our platform may process proprietary biological and clinical data of our customers.
  • Our plans to use our KPI-012 clinical development dataset as a proof-of-concept for Researgency may not generate the commercial benefits we expect, and may expose us to additional risks.
  • Risks Related to Our Intellectual Property
  • We may be unable to obtain and maintain patent protection for our technology or product candidates, or the scope of the patent protection obtained may not be sufficiently broad or enforceable, such that our competitors could develop and commercialize technology, products and product candidates similar or identical to ours, and our ability to successfully commercialize our technology and product candidates may be impaired.
  • If we are not able to obtain patent term extension in the United States under the Hatch-Waxman Act and in foreign countries under similar legislation, thereby potentially extending the term of our marketing exclusivity for our product candidates, our business may be materially harmed.
  • We may become involved in lawsuits to protect or enforce our patents or other intellectual property rights, which could be expensive, time-consuming and unsuccessful.
  • Third parties may initiate legal proceedings alleging that we are infringing, misappropriating or otherwise violating their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on the success of our business.
  • Obtaining and maintaining 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.
  • KPI-012 is protected by patent rights exclusively licensed from other companies or institutions. If these third parties terminate their agreements with us or fail to maintain or enforce the underlying patents, or we otherwise lose our rights to these patents, our competitive position and our market share in the markets for any of our products, if any when approved, will be harmed.
  • Our biologics product candidates, including KPI-012 and KPI-014, are protected by patent rights exclusively licensed from other companies or institutions. Our AI platform operates under an exclusive license. If any licensor terminates their agreement with us, fails to maintain or enforce the underlying patents, or if we otherwise lose our rights under these licenses, our ability to monetize our biologics assets or to operate our Researgency business could be materially harmed.
  • Some intellectual property which we own or have licensed may have been discovered through government funded programs and thus may be subject to federal regulations such as “march-in” rights, certain reporting requirements, and a preference for United States industry. Compliance with such regulations may limit our exclusive rights, subject us to expenditure of resources with respect to reporting requirements, and limit our ability to contract with non-U.S. manufacturers.
  • If we fail to comply with our obligations under our intellectual property licenses and funding arrangements with third parties, we could lose rights that are important to our business.
  • We may not be able to protect our intellectual property and proprietary rights throughout the world.
  • 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 or other legal proceedings relating to intellectual property 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.
  • Patent reform legislation under Leahy-Smith America Invents Act could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents.
  • Risks Related to Regulatory Approval of Our Product Candidates and Other Legal Compliance Matters
  • Failure to obtain marketing approval in foreign jurisdictions would prevent our product candidates from being marketed abroad. We may be subject to additional risks in commercializing any of our product candidates that receive marketing approval in foreign jurisdictions.
  • Even if our product candidates receive regulatory approval, they will be subject to significant post-marketing regulatory requirements and oversight.
  • We may seek certain designations for our product candidates, including Breakthrough Therapy, Fast Track and Priority Review designations in the United States, and PRIME Designation in the European Union, but we might not receive such designations, and even if we do, such designations may not lead to a faster development or regulatory review or approval process.
  • If approved, our products regulated as biologics may face competition from biosimilars approved through an abbreviated regulatory pathway.
  • 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.
  • Existing and future legislation may affect our ability to commercialize our products, if and when approved, and increase the difficulty and cost for us to obtain reimbursement for our products, if and when approved.
  • Current and future legislation designed to reduce prescription drug costs may affect the prices we and any collaborators may obtain for our product candidates.
  • Disruptions at the FDA and other government agencies caused by funding shortages or global health concerns personnel losses, or regulatory reform 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.
  • If we or any third-party manufacturers we engage or may engage in the future fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur significant costs.
  • We are subject to anti-corruption laws, as well as export control laws, customs laws, sanctions laws and other laws governing our operations. If we fail to comply with these laws, we could be subject to civil or criminal penalties, other remedial measures and legal expenses, be precluded from developing, manufacturing and selling certain products outside the United States or be required to develop and implement costly compliance programs, which could adversely affect our business, results of operations and financial condition.
  • We are subject to stringent privacy laws, information security laws, regulations, policies and contractual obligations related to data privacy and security and changes in such laws, regulations, policies, contractual obligations and failure to comply with such requirements could subject us to significant fines and penalties, which may have a material adverse effect on our business, financial condition or results of operations.
  • We might not be able to utilize a significant portion of our net operating loss carryforwards and research and development tax credit carryforwards.
  • Risks Related to Employee Matters
  • We have recently undertaken a cost reduction plan and may do so again in the future. The assumptions underlying these activities may prove to be inaccurate, or we may fail to achieve the expected benefits therefrom.
  • Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel.
  • A partially or fully remote workplace could negatively impact our business.
  • We are substantially dependent on our remaining employees and consultants, along with any other advisors and consultants we may engage, to facilitate pursuit of strategic options and additional financing.
  • Risks Related to Evaluation of Strategic Options and Bankruptcy Proceedings
  • Our pursuit of strategic options with respect to our biologics asset portfolio and the development of our AI platform business may not be successful, and there can be no assurance that either strategy will generate value for our stockholders.
  • Our board of directors may elect to commence bankruptcy or insolvency proceedings.
  • We may become involved in securities class action litigation that could divert management’s attention and harm our business, and insurance coverage may not be sufficient to cover all costs and damages.
  • Risks Related to 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.
  • 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.
  • An active trading market for our Common Stock may not be sustained.
  • The price of our Common Stock is volatile and fluctuates substantially, which could result in substantial losses for purchasers of our Common Stock.
  • Sales of a substantial number of shares of our Common Stock could cause the market price of our Common Stock to drop significantly, even if our business is doing well.
  • Certain existing stockholders will experience dilution upon any future conversion of the outstanding shares of our preferred stock into shares of our Common Stock.
  • 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 have incurred and will continue to incur increased costs as a result of operating as a public company, and our management is required to devote substantial time to compliance initiatives and corporate governance practices.
  • Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, will be the sole source of gain for our stockholders.
  • Our Certificate of Incorporation designates the state courts in the State of Delaware as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by our stockholders, which could discourage lawsuits against the company and our directors, officers and employees.
  • General Risk Factors
  • Our internal computer systems, or those of our vendors, contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of our product development programs.
  • Cybersecurity risks are heightened for our AI platform business, which is designed to be deployed within customer IT environments and may process sensitive biological and clinical data.

Legal proceedings

We are not currently subject to any material legal proceedings.

The opening of Item 3, Legal Proceedings.4

Sources

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