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LSTA on Nasdaq

Caladrius Biosciences

Biopharmaceutical company in New Jersey, United States

Lisata Therapeutics is an American clinical stage pharmaceutical company active in the field of oncology, specifically aimed at developing and commercializing new cancer therapies. It was formed through a merger of Cend Therapeutics and Caladrius Biosciences in September 2022. In 2019, the FDA granted their product, certepetide (also known as iRGD and CEND-1), orphan drug status in pancreatic cancer, followed by a Fast track (FDA) status in 2022.3 It is headquartered in New York City.1 Its shares trade on Nasdaq under the symbol LSTA.1 Wikipedia text CC BY-SA 4.0

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Last updated Oct 21, 2026.

Overview

2006Founded1

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  • TickerLSTA on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersNew York City1
  • Websitewww.caladrius.com
  • Legal formDelaware corporation1
  • Incorporated inDE5
  • Business address110 Allen Road, Second Floor, Basking Ridge, Nj 079205
  • Filer categoryNon-accelerated filer, Smaller reporting company5
  • LEI5493002287F62M3EGQ044
  • StatusActive4
  • LEI statusLapsed (not renewed)4
  • Registered addressC/O LEGALINC CORPORATE SERVICES INC., 19709 Middletown, United States4
  • Registered withDivision of Corporations, Department of State, 8994444

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Lisata Therapeutics is an American clinical stage pharmaceutical company active in the field of oncology, specifically aimed at developing and commercializing new cancer therapies. It was formed through a merger of Cend Therapeutics and Caladrius Biosciences in September 2022.3

Financials

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

Key numbers, fiscal 2025

-10711.2%Operating margin7
-9756.5%Net margin7
-83.0%Revenue growth, 20257
-111.7%Return on equity7
-$16.0MFree cash flow7

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Income tax100¢$962.0K

Out of $170.0K in revenue.7 The company lost money this year.

Financial statements

Revenue897$170.0K in 2025
0$250.0K$500.0K$750.0K$1.0M2022: $0$020222023: $0$020232024: $1.0M$1.0M20242025: $170.0K$170.0K2025−83%
Operating income101112897-$18.2M in 2025−9% since 2019
-$60.0M-$40.0M-$20.0M02019: -$20.1M-$20.1M20192020: -$19.1M-$19.1M2020−5%2021: -$29.1M-$29.1M2021+52%2022: -$57.6M-$57.6M2022+98%2023: -$25.7M-$25.7M2023−55%2024: -$22.4M-$22.4M2024−13%2025: -$18.2M-$18.2M2025−19%
Net income101112897-$16.6M in 2025−14% since 2019
-$60.0M-$40.0M-$20.0M02019: -$19.4M-$19.4M20192020: -$8.2M-$8.2M2020−58%2021: -$27.5M-$27.5M2021+237%2022: -$54.2M-$54.2M2022+97%2023: -$20.8M-$20.8M2023−62%2024: -$20.0M-$20.0M2024−4%2025: -$16.6M-$16.6M2025−17%

Every line of the income statement as filed: the last 2 fiscal years, latest first.7

Period ending2025-12-312024-12-31
Revenue$170.0K$1.0M
Research and development$7.9M$11.3M
General and administrative$10.4M$12.1M
Operating expenses$18.4M$23.4M
Operating loss-$18.2M-$22.4M
Investment income, net$806.0K$1.9M
Other expense, net-$145.0K-$257.0K
Total other income$661.0K$1.6M
Net loss before benefit from income taxes and noncontrolling interests-$17.5M-$20.8M
Benefit from income taxes-$962.0K-$798.0K
Net loss-$16.6M-$20.0M
Less - net income (loss) attributable to noncontrolling interests$0$0
Net loss attributable to Lisata Therapeutics, Inc. common stockholders-$16.6M-$20.0M
Lisata Therapeutics, Inc. common stockholders - basic (in dollars per share)-$1.91-$2.40
Lisata Therapeutics, Inc. common stockholders - diluted (in dollars per share)-$1.91-$2.40
Basic (in shares)8.7M shares8.3M shares
Diluted (in shares)8.7M shares8.3M shares

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Corporate structure

Caladrius Biosciences sits at the top of its group. 5 entities, 5 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Caladrius Biosciences

  • Caladrius Biosciences Basking Ridge, New Jersey, United States
    • Lisata Therapeutics (U.K.) Limited Subsidiary · United Kingdom
    • Lisata Therapeutics Australia Pty Ltd Subsidiary · Australia
    • Lisata Therapeutics Ireland Limited Subsidiary · Ireland
    • Lisata Therapeutics KK Subsidiary · Japan

Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); 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 Caladrius Biosciences 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$494.0K7 Dec 31, 2025$661.0K7 Dec 31, 2024−25.3%
Accumulated depreciation$476.0K7 Dec 31, 2025$589.0K7 Dec 31, 2024−19.2%
Property and equipment, net$18.0K7 Dec 31, 2025$72.0K7 Dec 31, 2024−75.0%
Operating-lease assets (leased space)$07 Dec 31, 2025$138.0K7 Dec 31, 2024−100.0%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$16.0M7 Dec 31, 2025$16.2M7 Dec 31, 2024−1.6%
Debt securities available for sale$11.6M7 Dec 31, 2025$25.6M7 Dec 31, 2024−54.6%

Intangibles and goodwill

ItemLatestA year beforeChange
Intangible assets, net (excluding goodwill)$400.0K7 Dec 31, 2025$400.0K9 Dec 31, 20240%
Finite-lived intangibles, net$07 Dec 31, 2025$192.0K7 Dec 31, 2024−100.0%

Properties, in its own words

Our corporate headquarters are in Basking Ridge, New Jersey and although our lease expired on September 30, 2025 we, based on prior understanding with the building’s management, continue to occupy a portion of office space in the building. We are seeking a new corporate space as a result of the building recently falling into receivership (and pending sale).

Item 2 of the 10-K filed Mar 12, 2026.15

Leadership

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

Chief executive

  1. David J. Mazzo2015–now

President

  1. Mark Weinreb2006–2009
  2. Robert S. Vaters2015
  3. David W. Slack2022–2023
  4. David J. Mazzo2024–2026
  5. Joshua Lehrer-Graiwer2026–now

Chief financial officer

  1. Robert S. Vaters2015
  2. Joseph Talamo2016–2020

Chief operating officer

  1. Joshua Lehrer-Graiwer2026–now
2010201520202025
Board members and other officers (47)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Lisata Therapeutics (U.K.) Limited United Kingdom6
  • Lisata Therapeutics Australia Pty Ltd Australia6
  • Lisata Therapeutics Ireland Limited Ireland6
  • Lisata Therapeutics KK Japan6

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

Former names

  • Caladrius Biosciences, Inc.Aug 10, 2017 to Sep 15, 20225
  • NeoStem, Inc.Sep 6, 2006 to Jun 5, 20155
  • PHASE III MEDICAL INC/DESep 9, 2003 to Sep 1, 20065
  • CORNICHE GROUP INC /DENov 24, 1995 to Aug 14, 20035

Timeline

  1. Oct 14, 20268-K Executive or director change65
  2. Sep 17, 20268-K Entered a material agreement; Completed an acquisition or sale; Unregistered sale of shares66
  3. Aug 4, 20268-K Exit or restructuring costs; Executive or director change; Other events67
  4. Jul 24, 20268-K Ended a material agreement; Other events68
  5. Jul 17, 20268-K Entered a material agreement69
  6. Jun 9, 20268-K Entered a material agreement70
  7. Jun 1, 20268-K Other events71
  8. May 29, 20268-K Entered a material agreement72
  9. May 4, 20268-K Entered a material agreement73
  10. Apr 15, 20268-K Other events74
  11. Apr 3, 20268-K Other events75
  12. Mar 9, 20268-K Entered a material agreement; Regulation FD disclosure76
  13. Jan 5, 2015New chief executive David J. Mazzo becomes CEO16
  14. 2006Founded Founded1

Calendar

Coming up

  1. Nov 5, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.49) a share, on Nov 6, 2025.77

When it reported results

  1. Nov 6, 2025Reported quarterly or annual results78
  2. Aug 7, 2025Reported quarterly or annual results79
  3. Jun 17, 2025Reported quarterly or annual results80
  4. May 8, 2025Reported quarterly or annual results81
  5. Feb 27, 2025Reported quarterly or annual results82
  6. Nov 12, 2024Reported quarterly or annual results83
  7. Aug 12, 2024Reported quarterly or annual results84
  8. Jun 27, 2024Reported quarterly or annual results85

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

Filings

202 filings to the SEC since October 2021: 7 annual reports, 15 quarterly reports, 58 major events, 66 insider forms, 5 large holders, 1 private raises, 50 other. The latest 20:

  1. Oct 15, 20263 EDGAR
  2. Oct 14, 20268-K EDGAR
  3. Oct 7, 2026PRE 14A EDGAR
  4. Oct 2, 2026D EDGAR
  5. Sep 28, 20263 EDGAR
  6. Sep 28, 20263 EDGAR
  7. Sep 17, 20268-K EDGAR
  8. Aug 26, 2026SCHEDULE 13G EDGAR
  9. Aug 6, 202610-Q EDGAR
  10. Aug 4, 20268-K EDGAR
  11. Jul 28, 2026SC TO-T/A EDGAR
  12. Jul 24, 20268-K EDGAR
  13. Jul 21, 2026SC 14D9/A EDGAR
  14. Jul 17, 20268-K EDGAR
  15. Jul 17, 2026SC 14D9/A EDGAR
  16. Jul 17, 2026SC TO-T/A EDGAR
  17. Jul 13, 2026SC 14D9/A EDGAR
  18. Jul 10, 2026SC TO-T/A SCHEDULE TO-T/A EDGAR
  19. Jul 2, 2026SC 14D9/A EDGAR
  20. Jun 10, 2026SC 14D9 EDGAR

The 202 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

1 open-market trades by officers, directors and large owners since October 2021: 1 buys and 0 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Dec 8, 2021MYERS STEVEN SDirectorBuy33,785$0.89$30.1KForm 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
2024David J. MazzoPresident and Chief Executive Officer$703.0K$1.7M91
2024Kristen K. Buck, M.DExecutive Vice President of Research & Development and Chief Medical Officer51$597.4K$1.1M91
2024James NiscoSenior Vice President, Finance and Treasury and Chief Accounting Officer54$341.9K$516.2K91
2023David J. MazzoPresident and Chief Executive Officer$675.9K$1.4M91
2023Kristen K. Buck, M.DExecutive Vice President of Research & Development and Chief Medical Officer51$574.4K$969.8K91
2023James NiscoSenior Vice President, Finance and Treasury and Chief Accounting Officer54$307.5K$438.6K91

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 32. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Vanguard Capital Management LLC278,837$948.0K0.0%+7,022
Yakira Capital Management, Inc.138,561$471.1K0.1%New
Css Llc/il110,422$375.4K0.0%+48,524
Deltec Asset Management LLC83,197$282.9K0.0%−6,803
Rangeley Capital, LLC81,000$275.4K0.3%+6,000
Geode Capital Management, LLC72,632$247.0K0.0%+1,745
BlackRock, Inc.54,857$186.5K0.0%No change
Vanguard Fiduciary Trust Co48,964$166.5K0.0%+14,047
Gts Securities LLC30,200$102.7K0.0%−1,196
State Street Corp25,348$86.2K0.0%No change
Jane Street Group, LLC18,741$63.7K0.0%New
Citadel Advisors LLC15,541$52.8K0.0%−7,125
Northern Trust Corp15,534$52.8K0.0%+5,266
JBF Capital, Inc.14,347$48.8K0.0%+1,113
Cerity Partners LLC12,183$41.4K0.0%No change
Bank Of America Corp /de/10,353$35.2K0.0%No change
HighTower Advisors, LLC10,042$34.1K0.0%No change
International Assets Investment Management, LLC5,000$16.8K0.0%No change
Founders Capital Management1,667$5.7K0.0%No change
Vanguard Global Advisers, LLC1,033$3.5K0.0%No change
Connective Capital Management, LLC1,016$3.5K0.0%No change
Tower Research Capital LLC (TRC)726$2.5K0.0%−59
Osaic Holdings, Inc.200$6800.0%No change
Caitong International Asset Management Co., Ltd90$3060.0%+68
Morgan Stanley75$2550.0%No change

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

SEC filer profile

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

  • Name on EDGARLISATA THERAPEUTICS, INC.2
  • CIK0000320017
  • Employer ID (EIN)22-234356815
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company15
  • Incorporated inDelaware15
  • Fiscal year endsDecember 312
  • Industry code (SIC)2834 Pharmaceutical Preparations2
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance2
  • Business address110 Allen Road, Second Floor, Basking Ridge, NJ 079202
  • Phone908-229-25902
  • Shares outstanding9,010,937 as of Aug 6, 202614
  • Public float$23.6M as of Jun 30, 202515
  • AuditorGRANT THORNTON LLP, New York, New York PCAOB ID 248; no auditor attestation of internal control over financial reporting15
  • On EDGAR sinceNov 24, 19952
  • Filings1,578 in all: 4 (580), 8-K (338), 10-Q (91), 3 (59), CORRESP (36), 424B5 (31), 10-K (28), EFFECT (28)2
    All 66 form types

    UPLOAD (26), DEFA14A (25), DEF 14A (22), S-8 (21), SC 13D/A (21), S-3 (19), SC 13G (17), 10-K/A (16), 425 (16), 424B3 (14), NT 10-Q (13), SC 13G/A (13), 8-K/A (11), PRE 14A (11), D (9), SC 13D (9), SC14D9C (9), 10-Q/A (7), 424B2 (7), NT 10-K (6), REGDEX (6), S-4/A (6), S-8 POS (6), S-1 (5), S-1/A (5), 3/A (4), 4/A (4), S-4 (4), SB-2/A (4), SC 14D9/A (4), 10QSB (3), S-3/A (3), SC TO-C (3), SC TO-T/A (3), 10-K405 (2), 25-NSE (2), 424B1 (2), 8-A12B (2), CT ORDER (2), POS AM (2), PRER14A (2), REGDEX/A (2), RW (2), SB-2 (2), SC TO-T (2), 10-KT (1), 25 (1), 5 (1), ARS (1), AW (1), CERTAMX (1), CERTNAS (1), DEFM14A (1), FWP (1), PREM14A (1), RW WD (1), SC 14D9 (1), SCHEDULE 13G (1)

  • Latest filingsAnnual report (10-K) Mar 12, 2026
    Quarterly report (10-Q) Aug 6, 2026
    Proxy statement (DEF 14A) Apr 25, 2025
    Latest 8-K (8-K) Oct 14, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.001 per shareLSTANasdaq

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

Risk factors and legal proceedings

The risks Caladrius Biosciences names in Item 1A of its 10-K filed Mar 12, 2026: 71 risks under these headings, as written.15

  • RISKS RELATED TO THE PROPOSED ACQUISITION BY KUVA
  • The proposed acquisition by Kuva is subject to a number of conditions beyond our control. Failure to complete the proposed acquisition within the expected time frame, or at all, could have a material adverse effect on our business, operating results, financial condition and our stock price.
  • RISKS RELATED TO OUR FINANCIAL CONDITION AND CAPITAL REQUIREMENTS
  • We have incurred substantial losses and negative cash flow from operations in the past and expect to continue to incur losses and negative cash flow for the foreseeable future.
  • We anticipate that we will need substantial additional financing to continue our operations; if we are unable to raise additional capital, we may be forced to delay, reduce or eliminate some or all of our product development programs, and our business will be materially harmed.
  • There is substantial doubt regarding our ability to continue as a going concern.
  • We have never generated any revenue from product sales and our ability to generate revenue from product sales and become profitable depends significantly on our success in a number of factors.
  • If our status as a smaller reporting company changes, Section 404(b) of the Sarbanes-Oxley Act of 2002 may require an independent registered public accounting firm to report on the effectiveness of our internal control over financial reporting. Any delays or difficulty in satisfying these requirements could adversely affect our future results of operations and our stock price.
  • Our ability to utilize our net operating loss carryforwards and tax credit carryforwards may be subject to limitations.
  • RISKS RELATED TO OUR PRODUCT DEVELOPMENT EFFORTS
  • We are substantially dependent on our investigational product candidate, certepetide. If we are unable to advance certepetide or any of our future product candidates through clinical development, obtain regulatory approval and ultimately commercialize certepetide or any of our other product candidates, or experience significant delays in doing so, our business will be materially harmed.
  • Our future success may be dependent on the timely and successful continued development and commercialization of our product candidates and if we encounter delays or difficulties in the development of these product candidates, our business prospects could be materially harmed.
The other 62 risks
  • Even if we are able to successfully complete our clinical development programs for our product candidates and receive regulatory approval to market one or more of the products, if the commercial opportunities are smaller than we anticipate, our future revenues will be adversely affected, and our business may suffer.
  • We may experience delays in enrolling patients in our clinical trials, which would delay or prevent the receipt of necessary regulatory approvals.
  • We may not be able to file INDs or IND amendments to commence additional clinical trials on the timelines we expect, and even if we are able to, the regulators may not permit us to proceed.
  • Results from a clinical trial, once completed, may be less clear than expected, which may hinder our efforts to obtain regulatory approval for our product candidates.
  • We and our partners are conducting clinical trials for product candidates in many countries outside of the United States, and the FDA and comparable foreign regulatory authorities may not accept data from such trials where the preponderance of data are generated in a foreign jurisdiction.
  • We may be unable to manage multiple late-stage clinical trials for a variety of product candidates simultaneously.
  • Any disruption to our access to the reagents, devices, materials or equipment we are using in the clinical development of our product candidates would adversely affect our ability to perform clinical trials and seek future regulatory submissions.
  • The initiation of pivotal Phase 3 clinical trials for our product candidates requires the validation and establishment of manufacturing controls that may delay product development timelines.
  • Product candidates that appear promising in research and development may be delayed or may fail to reach later stages of clinical development.
  • If serious or unacceptable side effects are identified during the development of any of our product candidates, we may need to abandon or limit our development of that product candidate.
  • A breakthrough therapy designation by the FDA, even if granted for any of our product candidates, is no guarantee of a faster development or regulatory review or approval process and it does not increase the likelihood that our product candidates will receive marketing approval.
  • A Fast Track designation by the FDA and other similar regulatory designations is no guarantee of a faster development, regulatory review or approval process.
  • Accelerated or provisional approval by the FDA or other relevant regulatory authority, even if granted for certepetide or future product candidates, is no guarantee of faster market introduction and it does not increase the likelihood that our product candidates will receive full marketing approval.
  • Our clinical trials may fail to demonstrate adequately the safety and efficacy of our product candidates, which would prevent or delay regulatory approval and commercialization.
  • We presently rely on contract manufacturing organizations to produce our product candidates at development and commercial scale quantities and have not yet qualified an alternate manufacturing supply, which could negatively impact our ability to meet any future demand for the products.
  • The commercial potential and profitability of our product candidates are unknown and subject to significant risk and uncertainty.
  • We may enter into collaborations, strategic alliances, additional licensing arrangements, acquisitions, business combinations or other strategic transactions in the future, any of which could require us to incur significant expenses or issue securities that could significantly dilute the shares of our existing stockholders, and we may not realize the benefits of such alliances or licensing arrangements, acquisitions, business combinations or strategic transactions.
  • If competitors develop and market products that are more effective, safer, and/or less expensive than our product candidates or offer other advantages, our commercial prospects will be limited or eliminated.
  • We conduct significant operations through our wholly-owned Australian subsidiary. If we lose our ability to operate in Australia, or if the subsidiary is unable to receive the research and development tax credit allowed by Australian regulations, our business and results of operations will suffer.
  • We may be subject to significant product liability claims and litigation, including potential exposure from the use of our product candidates in human subjects, and our insurance may be inadequate to cover claims that may arise.
  • We may be unable to retain key officers or employees or hire new key officers or employees needed to implement our business strategy and develop our products and businesses.
  • Our internal computer systems, or those used by our clinical investigators, clinical research organizations or other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of development programs for our product candidates.
  • The increasing use of social media platforms presents new risks and challenges including but not limited to the dissemination of disinformation, false or misleading accusations, incorrect statements and/or inaccurate statements or data generated by individuals or through use of artificial intelligence.
  • RISKS RELATED TO MANUFACTURING OUR DEVELOPMENT PRODUCT CANDIDATES
  • Contract development and manufacturing organizations have a finite manufacturing capacity, which could inhibit the long-term growth prospects of our business.
  • We will need to improve manufacturing efficiency at our contract manufacturers in order to establish cost of goods levels that will permit approved products to succeed commercially.
  • We will rely on third parties to manufacture our clinical product supplies, and we may rely on third parties to produce and process our products, if approved.
  • RISKS RELATED TO SALES, MARKETING, AND COMPETITION
  • We currently have no marketing and sales organization and have no experience in marketing products. If we are unable to establish marketing and sales capabilities or enter into agreements with third parties to market and sell our product candidates, if approved, we may not be able to generate product revenue.
  • A variety of risks associated with marketing our product candidates internationally could materially adversely affect our business.
  • Even if we obtain regulatory approval of our product candidates, our products may not gain market acceptance among physicians, patients, hospitals, cancer treatment centers and others in the medical community.
  • We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do.
  • Product candidates that we successfully develop and commercialize may compete with existing therapies and new therapies that may become available in the future.
  • RISKS RELATED TO GOVERNMENT REGULATION
  • The development and commercialization of our product candidates are subject to extensive regulation by the FDA and other regulatory agencies in the United States and abroad, respectively, and the failure to receive regulatory approvals for our product candidates would likely have a material and adverse effect on our business and prospects.
  • Even if we receive regulatory approval of our product candidates, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense, and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems.
  • The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses.
  • We may be unsuccessful in our efforts to comply with applicable federal, state and international laws and regulations, which could result in government enforcement actions or impact our ability to secure regulatory approval of our product candidates.
  • We may be subject to numerous and varying privacy and security laws, and our failure to comply could result in penalties and reputational damage.
  • Our employees, independent contractors, consultants, commercial partners, and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
  • Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not mean that it will be successful in obtaining regulatory approval of our product candidates in other jurisdictions.
  • Healthcare companies have been the subject of federal and state investigations, and we could become subject to such investigations in the future.
  • It is uncertain to what extent government, private health insurers, and third-party payors will approve coverage or provide reimbursement for the therapies and products to which our research and development relate. Availability for such reimbursement may be further limited by an increasing uninsured population and reductions in Medicare and Medicaid funding in the United States.
  • Legislation and legislative and regulatory proposals intended to contain healthcare costs may adversely affect our business.
  • Governments outside the United States tend to impose strict price controls, which may adversely affect our revenues, if any.
  • Inadequate funding for the FDA, the SEC and other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
  • A variety of risks associated with operating our business internationally could materially adversely affect our business.
  • RISKS RELATED TO OUR INTELLECTUAL PROPERTY
  • We may be unable to obtain or maintain patent protection for our products and product candidates, which could have a material adverse effect on our business.
  • Litigation relating to intellectual property is expensive, time-consuming and uncertain, and we may be unsuccessful in our efforts to protect against infringement by third parties or defend ourselves against claims of infringement.
  • If we are unable to maintain our licenses, patents or other intellectual property we could lose important protections that are material to continuing our operations and our future prospects.
  • If we fail to comply with our obligations in any future agreements under which we may license intellectual property rights from third parties or otherwise experience disruptions to our business relationships with future licensors, we could lose license rights that are important to our business.
  • We may not be successful in obtaining necessary additional rights to our product candidates through acquisitions and in-licenses.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • We may be subject to claims asserting that our employees, consultants or advisors have wrongfully used or disclosed alleged trade secrets of their current or former employers or claims asserting ownership of what we regard as our own intellectual property.
  • We may not be successful in obtaining or maintaining necessary rights to product components and processes for our development pipeline through acquisitions and in-licenses.
  • If we do not obtain patent term extension and data exclusivity for any of our current or future product candidates we may develop, our business may be materially harmed.
  • If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our marks of interest and our business may be adversely affected.
  • If we are unable to protect the confidentiality of trade secrets, our competitive position could be impaired.
  • In certain countries, patent holders may be required to grant compulsory licenses, which would likely have a significant and detrimental effect on any future revenues in such country.
  • Changes to U.S. patent law may have a material adverse effect on our intellectual property rights.
  • Third-party claims of intellectual property infringement may prevent or delay our development and commercialization efforts.
  • RISKS RELATED TO OUR RELIANCE ON THIRD PARTIES
  • We may form or seek collaborations or strategic alliances or enter into additional licensing arrangements in the future, and we may not realize the benefits of such collaborations, alliances, or licensing arrangements.
  • Our manufacturing process needs to comply with regulatory authority regulations relating to the quality and reliability of such processes. Any failure to comply with relevant regulations could result in delays in or termination of our clinical programs and suspension or withdrawal of any regulatory approvals.
  • If our third-party manufacturers use hazardous and biological materials in a manner that causes injury or violates applicable law, we may be liable for damages.
  • RISKS RELATED TO MANAGING GROWTH AND EMPLOYEE MATTERS
  • We may need to grow the size or change the structure of our organization, and may experience difficulties in managing this growth or change.

Legal proceedings

From time to time, we are subject to legal proceedings and claims, either asserted or unasserted, that arise in the ordinary course of business. While the outcome of pending claims cannot be predicted with certainty, we do not believe that the outcome of any pending claims will have a material adverse effect on our financial condition or operating results.

The opening of Item 3, Legal Proceedings.15

Sources

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