TARA on Nasdaq

Proteon Therapeutics

Logo: proteontherapeutics.com4

American pharmaceutical company

Proteon Therapeutics, Inc. is a developer of pharmaceuticals with offices in Waltham, Massachusetts and Kansas City, Missouri.3 Its shares trade on Nasdaq under the symbol TARA.1 Wikipedia text CC BY-SA 4.0

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Last updated Oct 21, 2026.

Overview

Jan 1, 2001Founded1

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  • TickerTARA on Nasdaq1
  • Industrypharmaceutical industry1
  • HeadquartersWaltham1
  • Websitewww.proteontherapeutics.com
  • Business address345 Park Avenue South, 3Rd Floor, New York, Ny 100105
  • Filer categoryNon-accelerated filer, Smaller reporting company5
Proteon Therapeutics image from its website
Image: proteontherapeutics.com4

Proteon Therapeutics, Inc. is a developer of pharmaceuticals with offices in Waltham, Massachusetts and Kansas City, Missouri.3

Financials

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

Financial statements

Operating income8910111213-$64.5M in 2025+724% since 2019
-$80.0M-$60.0M-$40.0M-$20.0M02019: -$7.8M-$7.8M20192020: -$34.4M-$34.4M2020+340%2021: -$47.5M-$47.5M2021+38%2022: -$67.1M-$67.1M2022+41%2023: -$43.6M-$43.6M2023−35%2024: -$49.2M-$49.2M2024+13%2025: -$64.5M-$64.5M2025+31%
Net income8910111213-$57.4M in 2025+634% since 2019
-$80.0M-$60.0M-$40.0M-$20.0M02019: -$7.8M-$7.8M20192020: -$34.0M-$34.0M2020+334%2021: -$47.3M-$47.3M2021+39%2022: -$66.0M-$66.0M2022+40%2023: -$40.4M-$40.4M2023−39%2024: -$44.6M-$44.6M2024+10%2025: -$57.4M-$57.4M2025+29%

Every line of the income statement as filed: the last 2 fiscal years, latest first.13

Period ending2025-12-312024-12-31
Research and development$42.6M$31.7M
General and administrative$21.9M$17.4M
Total operating expenses$64.5M$49.2M
Income (Loss) from operations-$64.5M-$49.2M
Interest and investment income (expense)$6.4M$4.2M
Other income (expense)$730.0K$387.0K
Other income (expense), net$7.1M$4.6M
Net income (loss)-$57.4M-$44.6M
Net unrealized gain (loss) on marketable debt securities$88.0K$33.0K
Other comprehensive income (loss)$88.0K$33.0K
Comprehensive income (loss)-$57.4M-$44.6M
Net income (loss) per share attributable to common stockholders, basic (in Dollars per share)-$1.34-$2.17
Net income (loss) per share attributable to common stockholders, diluted (in Dollars per share)-$1.34-$2.17
Weighted-average shares outstanding, basic (in Shares)42.8M shares20.6M shares
Weighted-average shares outstanding, diluted (in Shares)42.8M shares20.6M shares

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Corporate structure

Proteon Therapeutics sits at the top of its group. 6 entities, 3 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Proteon Therapeutics

  • Proteon Therapeutics Waltham
    • ArTara Subsidiary, Inc. Subsidiary · Delaware, United States
    • Proteon Bermuda Limited Subsidiary · Bermuda
    • Proteon International Holdings, Inc. Subsidiary · Delaware, United States
    • Proteon Ireland Limited Subsidiary · Ireland
    • Proteon Securities Corp. Subsidiary · Massachusetts, United States

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

What it owns

What Proteon Therapeutics 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$2.2M13 Dec 31, 2025$2.1M13 Dec 31, 2024+4.4%
Accumulated depreciation$1.5M13 Dec 31, 2025$1.1M13 Dec 31, 2024+32.7%
Property and equipment, net$759.0K13 Dec 31, 2025$1.0M13 Dec 31, 2024−26.1%
Operating-lease assets (leased space)$3.2M13 Dec 31, 2025$4.3M13 Dec 31, 2024−25.4%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$49.7M13 Dec 31, 2025$162.8M13 Dec 31, 2024−69.5%
Marketable securities, current$105.9M13 Dec 31, 2025$7.5M13 Dec 31, 2024+1313.1%
Marketable securities, non-current$42.3M13 Dec 31, 2025$17.9M11 Dec 31, 2022+136.7%

Properties, in its own words

As of December 31, 2025, we leased approximately 10,000 square feet of space for our headquarters in New York, New York under an agreement that expires in May 2028. We leased approximately an additional 10,000 square feet for our development laboratory, a manufacturing facility and an additional manufacturing space, all located in North America under an agreement that expires in June 2029. We believe that our existing facilities are adequate to meet our current needs, and that suitable additional alternative spaces will be available in the future on commercially reasonable terms.

Item 2 of the 10-K filed Mar 10, 2026.16

The story

Proteon was founded by Dr. F. Nicholas Franano based on technology created at Johns Hopkins University. Major investors in the company include MPM Capital, Rockhill Partners, TVM Capital, Skyline Ventures, Prism VentureWorks, Vectis Life Sciences and Intersouth Partners. They have invested over $72 million in the company.

The company is led by Timothy Noyes, CEO; Steven Burke, CMO; George Eldridge, CFO; and Scott Toner, director of marketing.

On March 5, 2009, the company announced that it had raised $32 million from its existing investors plus MPM Capital and Vectis Life Sciences. Proteon also announced that it had entered into an option agreement to be acquired by Novartis for up to $550 million. The company went public in 2014.

In September 2019, Proteon Therapeutics merged with ArTara Therapeutics.

From Wikipedia’s article on Proteon Therapeutics, shared under CC BY-SA 4.0.6

Leadership

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

Board members and other officers (32)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • ArTara Subsidiary, Inc. Delaware7
  • Proteon Bermuda Limited Bermuda7
  • Proteon International Holdings, Inc. Delaware7
  • Proteon Ireland Limited Ireland7
  • Proteon Securities Corp. Massachusetts7

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

Former names

  • Protara Therapeutics, Inc.May 13, 2020 to Aug 13, 20265
  • ArTara Therapeutics, Inc.Nov 29, 2019 to Apr 23, 20205
  • PROTEON THERAPEUTICS INCApr 14, 2006 to Dec 31, 20195

Timeline

  1. Aug 11, 20268-K Results of operations51
  2. Jun 29, 20268-K Executive or director change52
  3. Jun 15, 20268-K Shareholder vote53
  4. May 13, 20268-K Results of operations54
  5. Mar 30, 20268-K Regulation FD disclosure55
  6. Mar 10, 20268-K Results of operations56
  7. Feb 24, 20268-K Regulation FD disclosure; Other events57
  8. Dec 15, 20258-K Other events58
  9. Dec 8, 20258-K Entered a material agreement59
  10. Dec 3, 20258-K Regulation FD disclosure; Other events60
  11. Nov 19, 20258-K Regulation FD disclosure; Other events61
  12. Nov 10, 20258-K Results of operations62
  13. Jan 13, 2020New chief executive Jesse Shefferman becomes CEO17
  14. Oct 21, 2014New chief executive Timothy P. Noyes becomes CEO18
  15. Jan 1, 2001Founded Founded1

Calendar

Coming up

  1. Nov 9, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.31) a share, on Nov 10, 2025.63

When it reported results

  1. Aug 11, 2026Reported quarterly or annual results51
  2. May 13, 2026Reported quarterly or annual results54
  3. Mar 10, 2026Reported quarterly or annual results56
  4. Nov 10, 2025Reported quarterly or annual results62
  5. Aug 11, 2025Reported quarterly or annual results64
  6. May 8, 2025Reported quarterly or annual results65
  7. Mar 5, 2025Reported quarterly or annual results66
  8. Nov 12, 2024Reported quarterly or annual results67

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

Filings

308 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 48 major events, 149 insider forms, 34 large holders, 57 other. The latest 20:

  1. Aug 13, 2026SCHEDULE 13G/A EDGAR
  2. Aug 11, 2026S-8 REGISTRATION STATEMENT EDGAR
  3. Aug 11, 202610-Q QUARTERLY REPORT EDGAR
  4. Aug 11, 20268-K CURRENT REPORT EDGAR
  5. Jul 7, 2026SCHEDULE 13G/A EDGAR
  6. Jul 1, 20264 PRIMARY DOCUMENT EDGAR
  7. Jun 29, 2026144 EDGAR
  8. Jun 29, 20268-K CURRENT REPORT EDGAR
  9. Jun 16, 20264 PRIMARY DOCUMENT EDGAR
  10. Jun 16, 20264 PRIMARY DOCUMENT EDGAR
  11. Jun 16, 20264 PRIMARY DOCUMENT EDGAR
  12. Jun 16, 20264 PRIMARY DOCUMENT EDGAR
  13. Jun 16, 20264 PRIMARY DOCUMENT EDGAR
  14. Jun 16, 20264 PRIMARY DOCUMENT EDGAR
  15. Jun 16, 20264 PRIMARY DOCUMENT EDGAR
  16. Jun 16, 20264 PRIMARY DOCUMENT EDGAR
  17. Jun 15, 20268-K CURRENT REPORT EDGAR
  18. Jun 3, 20264 PRIMARY DOCUMENT EDGAR
  19. May 28, 2026424B5 PROSPECTUS SUPPLEMENT EDGAR
  20. May 22, 2026EFFECT EDGAR

The 308 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

47 open-market trades by officers, directors and large owners since October 2021: 23 buys and 24 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Jun 29, 2026Shefferman JesseCEO and PresidentSale215,687$4.09$882.2KForm 4
Apr 8, 2026Zummo JacquelineChief R&D OfficerSale1,134$5.40$6.1KForm 4
Apr 1, 2026Zummo JacquelineChief R&D OfficerSale22,598$5.26$118.9KForm 4
May 14, 2025Levy Richard SDirectorBuy20,000$3.19$63.8KForm 4
May 14, 2025Levy Richard SDirectorBuy20,000$3.19$63.8KForm 4
Mar 26, 2025Zummo JacquelineChief R&D OfficerSale21,224$4.53$96.1KForm 4
Sep 12, 2024Opaleye Management Inc.10% ownerSale126,301$1.71$216.0KForm 4
Sep 11, 2024Opaleye Management Inc.10% ownerSale32,600$1.71$55.7KForm 4
Sep 10, 2024Opaleye Management Inc.10% ownerSale25,500$1.77$45.1KForm 4
Sep 9, 2024Opaleye Management Inc.10% ownerSale36,492$1.89$69.0KForm 4
Jul 16, 2024Opaleye Management Inc.10% ownerSale11,396$2.44$27.8KForm 4
Jul 11, 2024Opaleye Management Inc.10% ownerSale47,993$2.40$115.2KForm 4
Jul 10, 2024Opaleye Management Inc.10% ownerSale18,061$2.31$41.7KForm 4
Jul 9, 2024Opaleye Management Inc.10% ownerSale8,497$2.21$18.8KForm 4
Jul 1, 2024Opaleye Management Inc.10% ownerSale8,288$2.12$17.6KForm 4
Jun 28, 2024Opaleye Management Inc.10% ownerSale17,994$2.07$37.2KForm 4
Jun 27, 2024Opaleye Management Inc.10% ownerSale46,574$2.26$105.3KForm 4
Jun 25, 2024Opaleye Management Inc.10% ownerSale12,725$2.26$28.8KForm 4
May 31, 2024Opaleye Management Inc.10% ownerSale5,824$2.90$16.9KForm 4
May 30, 2024Opaleye Management Inc.10% ownerSale9,230$2.94$27.1KForm 4

All 47 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
2025Jesse Shefferman54$654.9K$2.7M82
2025Leonardo NicacioM.D.$373.9K$1.4M82
2025Jacqueline ZummoPh.D.$494.0K$1.4M82
2024President, ChiefExecutive Officer and Director$632.3K$1.8M82
2024Chief R&D Officer$475.8K$1.2M82

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 100. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Jupiter Topco LLC4,696,709$17.9M0.0%New
BlackRock, Inc.3,663,499$14.0M0.0%+268,531
Millennium Management LLC3,101,166$11.8M0.0%+269,958
Velan Capital Investment Management LP2,844,652$10.9M6.7%+10,000
Vanguard Capital Management LLC2,300,133$8.8M0.0%+181,115
Blackstone Inc.2,265,514$8.7M0.0%No change
Orbimed Advisors LLC2,220,000$8.5M0.2%New
Sio Capital Management, LLC1,921,872$7.3M1.3%−47,967
Acorn Capital Advisors, LLC1,752,115$6.7M1.8%No change
Integral Health Asset Management, LLC1,500,000$5.7M0.2%−250,000
5AM Venture Management, LLC1,369,782$5.2M1.8%No change
Geode Capital Management, LLC1,326,246$5.1M0.0%+149,046
Citadel Advisors LLC1,232,365$4.7M0.0%+163,807
State Street Corp1,068,295$4.1M0.0%+63,153
Qube Research & Technologies Ltd1,045,516$4.0M0.0%+868,512
Balyasny Asset Management L.P.1,026,691$3.9M0.0%New
Baker Bros. Advisors LP971,614$3.7M0.0%No change
ADAR1 Capital Management, LLC940,512$3.6M0.2%No change
Bank Of America Corp /de/882,179$3.4M0.0%−43,739
Marshall Wace, Llp701,021$2.7M0.0%+650,290
Dimensional Fund Advisors LP683,230$2.6M0.0%+151,963
Northern Trust Corp552,306$2.1M0.0%+177,454
Point72 Asset Management, L.P.548,932$2.1M0.0%−603,782
Goldman Sachs Group Inc546,227$2.1M0.0%+148,246
Catalio Capital Management, LP520,148$2.0M0.4%−59,876

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

SEC filer profile

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

  • Name on EDGARProtara Therapeutics, Inc.2
  • CIK0001359931
  • Employer ID (EIN)20-458052516
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company16
  • Incorporated inDelaware16
  • Fiscal year endsDecember 312
  • Industry code (SIC)2836 Biological Products, (No Diagnostic Substances)2
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance2
  • Business address345 Park Avenue South, 3Rd Floor, New York, NY 100102
  • Phone646-844-03372
  • Shares outstanding59,095,488 as of Aug 7, 202615
  • Public float$112.3M as of Jun 30, 202516
  • AuditorErnst & Young LLP, New York PCAOB ID 42; no auditor attestation of internal control over financial reporting16
  • On EDGAR sinceApr 14, 20062
  • Filings809 in all: 4 (318), 8-K (128), 3 (45), 10-Q (36), SC 13G (20), SC 13G/A (20), CORRESP (18), SCHEDULE 13G/A (16)2
    All 50 form types

    144 (13), 4/A (13), S-8 (13), SC 13D/A (13), UPLOAD (13), 10-K (12), DEF 14A (12), EFFECT (11), 424B5 (9), DEFA14A (9), S-3 (9), 424B3 (6), 425 (5), SC 13D (5), SCHEDULE 13G (5), 3/A (4), 424B7 (4), ARS (4), CT ORDER (4), D (4), DRSLTR (4), SEC STAFF LETTER (4), REGDEX (3), S-4/A (3), 10-K/A (2), 5 (2), 8-K/A (2), DRS/A (2), PRE 14A (2), REGDEX/A (2), S-1 (2), S-3/A (2), 10-Q/A (1), 424B4 (1), 8-A12B (1), CERTNAS (1), DRS (1), RW (1), S-1/A (1), S-1MEF (1), S-3MEF (1), S-4 (1)

  • Latest filingsAnnual report (10-K) Mar 10, 2026
    Quarterly report (10-Q) Aug 11, 2026
    Proxy statement (DEF 14A) Apr 28, 2026
    Latest 8-K (8-K) Aug 11, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.001 per shareTARAThe Nasdaq Global Market

From the cover page of the 10-K filed Mar 10, 2026 (Section 12(b) of the Exchange Act).16

Risk factors and legal proceedings

The risks Proteon Therapeutics names in Item 1A of its 10-K filed Mar 10, 2026: 61 risks under these headings, as written.16

  • You should consider carefully the following information about the risks described below, together with the other information contained in this Annual Report on Form 10-K and in our other public filings, in evaluating our business. If any of the following risks actually occurs, our business, financial condition, results of operations, and future growth prospects would likely be materially and adversely affected. In these circumstances, the market price of our common stock would likely decline.
  • Risks Related to Our Financial Condition
  • We have a limited operating history and have never generated any revenues.
  • We expect to incur significant expenses and significant losses for the foreseeable future and may never generate revenue or achieve or maintain profitability.
  • We will need to raise additional financing in the future to fund our operations, which may not be available to us on favorable terms or at all.
  • Our ability to use our net operating loss carryforwards and certain other tax attributes to offset future taxable income or taxes may be limited.
  • The April 2024 Common Warrants are speculative in nature.
  • Risks Related to Drug/Biologics Development and Commercialization
  • Our business depends on the successful preclinical and clinical development, regulatory approval and commercialization of our product candidates, including TARA-002 and IV Choline Chloride.
  • We have never completed a registrational clinical trial or made a BLA or NDA submission and may be unable to successfully do so for TARA-002 or IV Choline Chloride.
  • Even if a product candidate obtains regulatory approval, it may fail to achieve the broad degree of adoption and use necessary for commercial success.
  • Preclinical and clinical development involves lengthy and expensive processes with uncertain outcomes. We may incur additional expenses or experience delays in completing, or ultimately be unable to complete, the development of our current product candidates or any future product candidates.
The other 51 risks
  • We rely, and expect to continue to rely, on third-party CROs and other third parties to conduct and oversee our clinical trials. If these third parties do not meet our requirements or otherwise conduct the clinical trials as required, we may not be able to satisfy our contractual obligations or obtain regulatory approval for, or commercialize, our product candidates.
  • Interim, topline and preliminary data from our clinical trials may change as more patient data become available, and are subject to audit and verification procedures that could result in material changes in the final data.
  • The clinical development of our product candidates has included and may continue to include clinical trial sites outside the U.S., and the FDA and applicable foreign regulatory authorities may not accept data from such sites.
  • TARA-002 is an immunopotentiator, and one indication that we are pursuing is the treatment of LMs. There are no FDA-approved therapies for the treatment of LMs and it is difficult to predict the timing and costs of clinical development for TARA-002 for LMs.
  • Certain disorders we seek to treat have low incidence and prevalence, and it may be difficult to identify patients with these disorders, which may lead to delays in enrollment for our clinical trials or slower commercial revenue if approved.
  • Our product candidates may cause undesirable or unforeseen side effects or have other unexpected properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved label, or result in post-approval regulatory action.
  • A Fast Track Designation by the FDA may not lead to a faster development or regulatory review or approval process.
  • An Orphan Drug Designation by the FDA or European Commission does not increase the likelihood that our product candidates will receive marketing exclusivity.
  • A Breakthrough Therapy Designation by the FDA may not lead to a faster development or regulatory review or approval process.
  • Although the FDA has granted Rare Pediatric Disease Designation for TARA-002 for the treatment of LMs, a BLA for TARA-002, if approved, may not meet the eligibility criteria for a PRV.
  • Any adverse developments that occur in patients undergoing treatment with OK-432 / Picibanil or in patients participating in clinical trials conducted by third parties may affect our ability to obtain regulatory approval or commercialize TARA-002.
  • We may choose to delay or discontinue developing or commercializing any of our product candidates at any time during development or after approval, which would reduce or eliminate the potential return on investment for those product candidates.
  • Other Risks Related to Our Business
  • Our product candidates, if approved, will face significant competition and their failure to compete effectively may prevent them from achieving significant market penetration.
  • We currently have limited marketing capabilities and no sales organization. If we are unable to grow our sales and marketing capabilities on our own or through third parties, we will be unable to successfully commercialize our product candidates, if approved, or generate product revenue.
  • TARA-002 and any future product candidates for which we intend to seek approval as biologic products may face competition sooner than anticipated.
  • We have only received the exclusive rights to the materials required to commercialize TARA-002 in territories other than Japan and Taiwan until June 17, 2030, or an earlier date if Chugai Pharmaceutical terminates the agreement with us for any number of reasons, following which such rights become non-exclusive.
  • Even if we obtain regulatory approval to begin commercializing any of our products, we would remain subject to ongoing regulatory review, which could subsequently result in a suspension or termination of sale of these products, limitations on the approved indication or additional warnings, or, if we fail to comply with regulatory requirements, other penalties.
  • We face product liability exposure, and if successful claims are brought against us, we may incur substantial liability if our insurance coverage for those claims is inadequate.
  • Our employees, independent contractors, principal investigators, other clinical trial staff, consultants, vendors, CROs and any partners with whom we may collaborate may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements.
  • We may be subject to risks related to off-label use of our product candidates, if approved.
  • If we or any partners with which we may collaborate are unable to achieve and maintain coverage and adequate levels of reimbursement for TARA-002 or IV Choline Chloride following regulatory approval, their commercial success may be hindered severely.
  • Healthcare reform measures could hinder or prevent the commercial success of our product candidates.
  • We are subject to strict healthcare laws, regulation and enforcement, and our failure to comply with those laws could adversely affect our business, operations and financial condition.
  • We may in-license and acquire product candidates and may engage in other strategic transactions, which could impact our liquidity, increase our expenses and present significant distractions to our management.
  • Our failure to successfully in-license, acquire, develop and market additional product candidates or approved products would impair our ability to grow our business.
  • We expect to rely on agreements with third parties for the successful development and commercialization of our product candidates.
  • We rely completely on third-party contractors to supply, manufacture and distribute clinical drug supplies for our product candidates, which may include sole-source suppliers and manufacturers; we intend to rely on third parties for commercial supply, manufacturing and distribution if any of our product candidates receive regulatory approval; and we expect to rely on third parties for supply, manufacturing and distribution of preclinical, non-clinical, clinical and commercial supplies of any future product candidates.
  • The manufacturing of biologics is complex and our third-party manufacturers may encounter difficulties in production. If our CDMO encounters such difficulties, the ability to provide supply of TARA-002 for clinical trials, our ability to obtain marketing approval, or our ability to obtain commercial supply of TARA-002, if approved, could be delayed or stopped.
  • Our CDMOs and suppliers use biological materials and may use hazardous materials, and any claims relating to improper handling, storage or disposal of these materials could be time-consuming or costly.
  • Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay.
  • If we fail to attract and retain management and other key personnel, we may be unable to continue to successfully develop or commercialize our product candidates or otherwise implement our business plan.
  • We or the third parties upon which we depend may be adversely affected by natural disasters and other catastrophic events and by man-made problems such as terrorism and war that could disrupt our business operations, and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.
  • The effects of epidemics and pandemics and their corresponding macroeconomic impacts could materially and adversely impact our business, including our clinical development plans and non-clinical research.
  • Risks Related to Our Common Stock
  • We expect our stock price to be highly volatile.
  • We incur costs and demands upon management as a result of complying with the laws and regulations affecting public companies.
  • If we fail to maintain proper and effective internal controls, our ability to produce accurate financial statements on a timely basis could be impaired, investors may lose confidence in our financial reporting and the trading price of our common stock may decline.
  • We are able to take advantage of reduced disclosure and governance requirements applicable to smaller reporting companies, which could result in our common stock being less attractive to investors.
  • We do not anticipate paying any dividends in the foreseeable future.
  • If equity research analysts do not publish research or reports, or publish unfavorable research or reports, about us, our business or our market, our stock price and trading volume could decline.
  • We will not receive a significant amount, or potentially any, additional funds upon the exercise of our April 2024 Pre-Funded Warrants and December 2024 Pre-Funded Warrants; however, any exercise would increase the number of shares eligible for future resale in the public market and result in substantial dilution to our stockholders.
  • Risk Related to Our Ownership Structure and Governance
  • Certain stockholders have the ability to control or significantly influence certain matters submitted to our stockholders for approval.
  • Anti-takeover provisions in our charter documents and under Delaware law could make an acquisition of our business more difficult and may prevent attempts by our stockholders to replace or remove management.
  • Our certificate of incorporation provides that the Court of Chancery of the State of Delaware is the exclusive forum for certain disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or other employees.
  • Risks Related to Intellectual Property Rights
  • We may not be able to obtain, maintain or enforce global patent rights or other intellectual property rights that cover our product candidates and technologies that are of sufficient breadth to prevent third parties from competing against us.
  • We may not be able to protect our intellectual property rights throughout the world.
  • 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.
  • If we fail to comply with our obligations under our intellectual property license agreements, we could lose license rights that are important to our business. Additionally, these agreements may be subject to disagreement over contract interpretation, which could narrow the scope of our rights to the relevant intellectual property or technology or increase our financial or other obligations to our licensors.
  • If we are sued for infringing intellectual property rights of third parties, such litigation could be costly and time consuming and could prevent or delay us from developing or commercializing our product candidates.
  • We may be subject to claims that our officers, directors, employees, consultants or independent contractors have wrongfully used or disclosed to us alleged trade secrets of their former employers or their former or current customers.
  • General Risk Factors
  • Pharmaceutical companies are subject to stringent and changing obligations related to data privacy and security. Our actual or perceived failure to comply with such obligations could lead to regulatory investigations or actions; litigation; fines and penalties; a disruption of our business operations, including our clinical trials; harm to our reputation; and other adverse effects on our business or prospects.
  • If our information technology systems or data, or those of third parties upon which we rely, are or were compromised, we could experience adverse consequences resulting from such compromise, including, but not limited to, regulatory investigations or actions; litigation; fines and penalties; disruptions of our business operations; loss of revenue or profits; interruptions to our operations such as our clinical trials; harm to our reputation; loss of customers or sales; and other adverse consequences.

Legal proceedings

From time to time, we may be subject to various legal proceedings and claims that arise in the ordinary course of our business activities. We are not currently a party to any legal proceedings that, in the opinion of our management, are likely to have a material adverse effect on our business. Regardless of outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources and other factors.

The opening of Item 3, Legal Proceedings.16

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