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MNPR on Nasdaq

Monopar Therapeutics

Logo: monopartx.com4

Monopar Therapeutics is a biopharmaceutical company.1 It is headquartered in Northbrook, United States.1 Its shares trade on Nasdaq under the symbol MNPR.1

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Last updated Oct 21, 2026.

Overview

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  • TickerMNPR on Nasdaq1
  • Industrypharmaceutical industry1
  • HeadquartersNorthbrook, United States1
  • Websitewww.monopartx.com
  • Incorporated inDE5
  • Business address1000 Skokie Blvd Suite 350, Wilmette, Il 600915
  • Filer categoryNon-accelerated filer, Smaller reporting company5
  • Legal formCorporation3
  • LEI549300QJFAI7L6YHKG833
  • StatusActive3
  • LEI statusLapsed (not renewed)3
  • Registered addressC/O Corporation Trust Company, 19801 Wilmington, United States3
  • Registered withDivision of Corporations, Department of State, 56525773

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You should read the following discussion in conjunction with our financial statements as of December 31, 2025, and the notes to such financial statements included elsewhere in this Annual Report on Form 10-K.7 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

-10.0%Return on equity8

Financial statements

Revenue9108$0 in 2025
02019: $0$020192024: $0$020242025: $0$02025
Operating income11121314108-$16.7M in 2025+286% since 2019
-$20.0M-$15.0M-$10.0M-$5.0M02019: -$4.3M-$4.3M20192020: -$6.5M-$6.5M2020+51%2021: -$9.1M-$9.1M2021+40%2022: -$10.5M-$10.5M2022+15%2023: -$8.8M-$8.8M2023−16%2024: -$16.2M-$16.2M2024+83%2025: -$16.7M-$16.7M2025+3%
Net income11121314108-$13.7M in 2025+225% since 2019
-$20.0M-$15.0M-$10.0M-$5.0M02019: -$4.2M-$4.2M20192020: -$6.3M-$6.3M2020+49%2021: -$9.1M-$9.1M2021+44%2022: -$10.5M-$10.5M2022+16%2023: -$8.4M-$8.4M2023−20%2024: -$15.6M-$15.6M2024+86%2025: -$13.7M-$13.7M2025−12%

Every line of the income statement as filed: the last 2 fiscal years, latest first.8

Period ending2025-12-312024-12-31
Research and development$9.9M$13.0M
General and administrative$6.8M$3.2M
Total operating expenses$16.7M$16.2M
Loss from operations-$16.7M-$16.2M
Other income$0$171.3K
Interest income$3.0M$404.0K
Net loss-$13.7M-$15.6M
Foreign currency translation (loss) gain, net-$4.2K$1.6K
Unrealized gain on investments, net$99.6K$48.5K
Comprehensive loss-$13.6M-$15.5M
Basic and diluted (in dollars per share)-$1.85-$4.11
Basic and diluted** (in shares)7.4M shares3.8M shares

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Corporate structure

Monopar Therapeutics sits at the top of its group. 2 entities, 2 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Monopar Therapeutics

  • Adage Capital Management, L.P. Filed SCHEDULE 13G/A on Monopar Therapeutics, latest Aug 12, 2026 (3 filings since Feb 12, 2025)
  • Saturn V Capital Management LP Filed SCHEDULE 13G/A on Monopar Therapeutics, latest Aug 12, 2026 (2 filings since May 15, 2026)
  • RA CAPITAL MANAGEMENT, L.P. Filed SCHEDULE 13G/A on Monopar Therapeutics, latest Feb 17, 2026 (4 filings since Oct 31, 2024)
  • AstraZeneca Filed SCHEDULE 13G/A on Monopar Therapeutics, latest Feb 6, 2026 (2 filings since Oct 28, 2024)
  • Tactic Pharma LLC Filed SCHEDULE 13D/A on Monopar Therapeutics, latest Jan 30, 2026 (3 filings since Dec 17, 2024)
  • Janus Henderson Group Ltd. Filed SCHEDULE 13G/A on Monopar Therapeutics, latest Nov 14, 2025 (5 filings since Nov 6, 2024)
  • TANG CAPITAL MANAGEMENT LLC Filed SCHEDULE 13G/A on Monopar Therapeutics, latest Feb 14, 2025 (2 filings since Oct 24, 2024)
  • Gem Pharmaceuticals LLC Filed SCHEDULE 13D/A on Monopar Therapeutics, latest Feb 7, 2025
  • Jeffrey R. Klunzinger Filed SC 13G on Monopar Therapeutics, latest Jun 2, 2023
  • Monopar Therapeutics Northbrook, Illinois, United States
    • Monopar Therapeutics Australia Ltd Pty Subsidiary · Australia

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 Monopar 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
Operating-lease assets (leased space)$254.9K8 Dec 31, 2025$08 Dec 31, 2024

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$61.8M8 Dec 31, 2025$45.8M8 Dec 31, 2024+35.0%
Marketable securities, current$60.9M8 Dec 31, 2025$45.5M8 Dec 31, 2024+33.7%
Debt securities held to maturity$78.6M8 Dec 31, 2025$14.4M8 Dec 31, 2024+445.7%

Properties, in its own words

We entered into a 36-month lease that commenced on April 1, 2025, for our executive headquarters at 1000 Skokie Blvd in the Village of Wilmette, Illinois, at a monthly rate of $3,580. On November 1, 2025, we entered into an additional 36-month lease at the same location at a monthly rate of $5,002, which replaced a previous month-to-month arrangement for that space. Additionally, on January 16, 2025, we entered into a one-year lease for a small wet laboratory space and certain equipment at the Helix 51 Bioscience Incubator at The Rosalind Franklin University of Medicine and Science in North Chicago, Illinois, at a rate of $1,000 per month, which was cancellable after six months with 30 days’ advance written notice. Since the expiration of the initial one-year term, we have continued to occupy this space on a month-to-month basis.

Item 2 of the 10-K filed Mar 27, 2026.7

Leadership

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

Chief executive

  1. Andrew Paul Mazar2018–2021
  2. Chandler Robinson2018–now

Chief financial officer

  1. Kim R. Tsuchimoto2018–2024
  2. Karthik Radhakrishnan2024
  3. Quan Anh Vu2025–now

Chief operating officer

  1. Andrew Cittadine2021–now
20202025
Board members and other officers (12)

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Monopar Therapeutics Australia Ltd Pty Australia6
  • Monopar Therapeutics, SARL France6

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

Timeline

  1. Aug 12, 20268-K Results of operations32
  2. Jul 22, 20268-K Regulation FD disclosure33
  3. Jun 30, 20268-K Regulation FD disclosure34
  4. Jun 26, 20268-K Regulation FD disclosure35
  5. Jun 23, 20268-K Shareholder vote36
  6. May 29, 20268-K Regulation FD disclosure37
  7. May 19, 20268-K Regulation FD disclosure38
  8. May 14, 20268-K Results of operations39
  9. Apr 20, 20268-K Regulation FD disclosure40
  10. Mar 27, 20268-K Results of operations41
  11. Mar 2, 20268-K Regulation FD disclosure42
  12. Nov 13, 20258-K Results of operations43
  13. Jan 8, 2018New chief executive Chandler Robinson becomes CEO18
  14. Jan 8, 2018New chief executive Andrew Paul Mazar becomes CEO17

Calendar

Coming up

  1. Nov 12, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.48) a share, on Nov 13, 2025.44

When it reported results

  1. Aug 12, 2026Reported quarterly or annual results32
  2. May 14, 2026Reported quarterly or annual results39
  3. Mar 27, 2026Reported quarterly or annual results41
  4. Nov 13, 2025Reported quarterly or annual results43
  5. Aug 12, 2025Reported quarterly or annual results45
  6. May 13, 2025Reported quarterly or annual results46
  7. Mar 31, 2025Reported quarterly or annual results47
  8. Nov 8, 2024Reported quarterly or annual results48

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

Filings

349 filings to the SEC since October 2021: 6 annual reports, 15 quarterly reports, 78 major events, 169 insider forms, 23 large holders, 58 other. The latest 20:

  1. Oct 5, 20264 EDGAR
  2. Oct 2, 20264 EDGAR
  3. Oct 2, 20264 EDGAR
  4. Oct 2, 20264 EDGAR
  5. Oct 1, 2026144 EDGAR
  6. Sep 28, 20264 EDGAR
  7. Sep 24, 2026144 EDGAR
  8. Aug 28, 20264/A EDGAR
  9. Aug 28, 20264/A EDGAR
  10. Aug 27, 20264 EDGAR
  11. Aug 27, 20264 EDGAR
  12. Aug 27, 20264 EDGAR
  13. Aug 26, 2026144 EDGAR
  14. Aug 26, 2026144 EDGAR
  15. Aug 25, 2026144 EDGAR
  16. Aug 12, 2026SCHEDULE 13G/A EDGAR
  17. Aug 12, 20268-K EDGAR
  18. Aug 12, 202610-Q EDGAR
  19. Aug 12, 2026SCHEDULE 13G/A EDGAR
  20. Jul 22, 2026S-8 POS EDGAR

The 349 filings since October 2021 can be filtered by form type and year here when JavaScript is on.

Every filing from the last five years, summarized. The full record is on SEC EDGAR.

Insider trades

26 open-market trades by officers, directors and large owners since October 2021: 14 buys and 12 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 24, 2026Robinson ChandlerChief Executive OfficerSale29,056$88.00$2.6MForm 4
Aug 26, 2026Tsuchimoto Kim RDirectorSale4,090$111.39$455.6KForm 4
Aug 26, 2026RIOUX PATRICESale1$111.26$111Form 4
Aug 26, 2026Tsuchimoto Kim RDirectorSale4,090$111.39$455.6KForm 4
Aug 25, 2026Anderson RaymondDirectorSale3,142$111.98$351.8KForm 4
Aug 25, 2026Anderson RaymondDirectorSale3,142$111.77$351.2KForm 4
Dec 26, 2025Vu Quan AnhChief Financial OfficerBuy1,500$69.95$104.9KForm 4
Dec 18, 2025KLAUSNER ARTHUR JDirectorSale5,121$67.15$343.9KForm 4
Sep 24, 2025Tactic Pharma LLCChief Executive OfficerSale550,229$63.61$35.0MForm 4
Jul 14, 2025Tsuchimoto Kim RDirectorSale8,904$40.00$356.2KForm 4
Jul 14, 2025STARR CHRISTOPHER MDirectorSale16,800$40.00$672.0KForm 4
Jul 14, 2025Robinson ChandlerChief Executive OfficerSale16,800$40.00$672.0KForm 4
Apr 2, 2025Brown Michael JSale33,334$35.00$1.2MForm 4
Oct 28, 2024Radhakrishnan KarthikChief Financial OfficerBuy1,550$16.25$25.2KForm 4
Jun 20, 2024Cittadine AndrewChief Operating OfficerBuy20,508$0.74$15.2KForm 4
Jun 18, 2024Cittadine AndrewChief Operating OfficerBuy12,000$0.86$10.3KForm 4
Jun 17, 2024Cittadine AndrewChief Operating OfficerBuy12,000$0.90$10.8KForm 4
Jun 14, 2024Cittadine AndrewChief Operating OfficerBuy12,000$0.93$11.2KForm 4
Jun 13, 2024Cittadine AndrewChief Operating OfficerBuy12,000$0.91$10.9KForm 4
Jun 4, 2024Cittadine AndrewChief Operating OfficerBuy12,000$0.78$9.4KForm 4

All 26 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
2025Chandler D. RobinsonMD$700.0K$10.6M58
2025Andrew Cittadine54$440.0K$4.7M58
2025Quan Vu54$305.0K$2.1M58
2024Chief Executive Officer and Director$603.2K$1.1M58
2024Chief Operating Officer$384.8K$554.8K58

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 96. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Jupiter Topco LLC1,312,129$121.7M0.0%New
Ra Capital Management, L.P.667,207$61.8M0.5%No change
BlackRock, Inc.348,819$32.3M0.0%+32,252
Deerfield Management Company, L.P.323,745$30.0M0.4%No change
Saturn V Capital Management LP311,976$28.9M4.1%−33,650
Siren, L.L.C.270,118$25.0M0.5%No change
ADAR1 Capital Management, LLC217,595$20.1M1.0%−46,683
Polar Capital Holdings Plc214,469$19.9M0.1%−12,057
Vanguard Capital Management LLC209,711$19.4M0.0%−8,752
Adage Capital Partners Gp, L.l.c.209,195$19.4M0.0%−100,000
TCG Crossover Management, LLC203,327$18.8M0.5%+71,224
Wellington Management Group Llp158,437$14.7M0.0%−15,905
Orbimed Advisors LLC157,423$14.6M0.3%New
Candriam S.C.A.143,339$13.3M0.1%New
Balyasny Asset Management L.P.134,543$12.5M0.0%−1,900
Geode Capital Management, LLC112,578$10.4M0.0%+12,660
Alyeska Investment Group, L.P.100,000$9.3M0.0%No change
State Street Corp92,551$8.6M0.0%+4,196
Vivo Capital, LLC90,500$8.4M0.8%No change
Driehaus Capital Management LLC84,040$7.8M0.0%+50,884
Bank of New York Mellon Corp76,942$7.1M0.0%−1,676
Vestal Point Capital, LP75,727$7.0M0.2%+10,309
Longaeva Partners L.P.55,834$5.2M0.1%New
Neuberger Berman Group LLC55,194$5.1M0.0%+12,760
Millennium Management LLC50,311$4.7M0.0%−2,640

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

SEC filer profile

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

  • Name on EDGARMonopar Therapeutics2
  • CIK0001645469
  • Employer ID (EIN)32-04637817
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company7
  • Incorporated inDelaware7
  • Fiscal year endsDecember 312
  • Industry code (SIC)2834 Pharmaceutical Preparations2
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance2
  • Business address1000 Skokie Blvd Suite 350, Wilmette, IL 600912
  • Phone84738803492
  • Shares outstanding6,712,172 as of Jul 31, 202616
  • Public float$155.5M as of Jun 30, 20257
  • AuditorBPM LLP, Santa Rosa, California PCAOB ID 207; no auditor attestation of internal control over financial reporting7
  • On EDGAR sinceJun 18, 20152
  • Filings532 in all: 4 (221), 8-K (118), 10-Q (26), 3 (19), CORRESP (14), SCHEDULE 13G/A (12), 144 (11), UPLOAD (11)2
    All 40 form types

    10-K (9), 424B5 (7), DEF 14A (7), DEFA14A (6), EFFECT (6), S-1/A (6), S-3 (5), S-8 (5), SC 13G (5), ARS (4), D (4), S-8 POS (4), 10-Q/A (3), 4/A (3), SCHEDULE 13D/A (3), 10-12G/A (2), 10-K/A (2), 424B3 (2), DEF 14C (2), SC 13D (2), SCHEDULE 13G (2), 10-12G (1), 144/A (1), 3/A (1), 424B4 (1), 8-A12B (1), CERT (1), CT ORDER (1), FWP (1), PRE 14A (1), S-1 (1), SC 13D/A (1)

  • Latest filingsAnnual report (10-K) Mar 27, 2026
    Quarterly report (10-Q) Aug 12, 2026
    Proxy statement (DEF 14A) Apr 30, 2026
    Latest 8-K (8-K) Aug 12, 2026

Securities registered for trading

ClassSymbolExchange
Common stock, $0.001 par valueMNPRNasdaq

From the cover page of the 10-K filed Mar 27, 2026 (Section 12(b) of the Exchange Act).7

Risk factors and legal proceedings

The risks Monopar Therapeutics names in Item 1A of its 10-K filed Mar 27, 2026: 73 risks under these headings, as written.7

  • Risks Related to Our Financial Condition and Capital Requirements
  • We have a limited operating history, expect to incur significant operating losses, and have a high risk of never being profitable.
  • We may need to raise additional funding or find one or more suitable pharmaceutical partners to continue to advance our clinical programs; finance our regulatory, pre-commercial and commercial activities; and support our preclinical studies.
  • If we continue to incur operating losses and fail to obtain the capital necessary to fund our operations, we will be unable to advance our development programs, complete our clinical trials, or bring products to market, or may be forced to reduce or cease operations entirely. In addition, any capital obtained by us may be obtained on terms that are unfavorable to us, our investors, or both.
  • Market variables, such as inflation of product costs, labor rates and fuel, freight and energy costs, tariffs, as well as geopolitical events could likely cause us to suffer significant increases in our operating and administrative expenses.
  • Unstable market and economic conditions may have serious adverse consequences on our ability to raise funds, which may cause us to delay, restructure or cease our operations.
  • Our operations and financial results could be adversely impacted by resurgences of COVID-19 or any future pandemics, which may negatively impact our ability to manufacture our product candidates for our clinical trials, our ability to accrue and conduct our clinical trials, and may delay regulatory agency responses. Any such impact will negatively impact our financial condition and could require us to delay our clinical development programs.
  • Risks Related to Clinical Development and Regulatory Approval
  • There are risks and uncertainties associated with our recently acquired ALXN1840 program which could result in delays in development or in gaining marketing approval, if at all, and such delays will negatively impact our financial condition.
  • Radiopharmaceuticals are a relatively novel approach to cancer imaging and treatment, which may create significant and potentially unpredictable challenges for them.
  • We do not have and may never have any approved products on the market. Our business is highly dependent upon receiving approvals from various U.S., Australian, and international governmental agencies and will be severely harmed if we are not granted approval to manufacture and sell our product candidates.
  • Even if we complete the clinical trials we discussed with the FDA or TGA, there is no guarantee that at the time of submission the FDA or TGA will accept our NDA or BLA based on the trials discussed.
The other 63 risks
  • As a company, we have never completed a clinical trial and have limited experience in completing regulatory filings and any delays in regulatory filings could materially affect our financial condition.
  • We, or any future collaborators, may not be able to obtain and maintain orphan drug exclusivity for our product candidates in the U.S. and Europe.
  • If serious adverse or undesirable side effects are identified during the development of our product candidates, we may abandon or limit our development or commercialization of such product candidates.
  • If we experience delays or difficulties in the enrollment of subjects to our clinical trials, our receipt of necessary regulatory approvals could be delayed or prevented, which could materially affect our financial condition.
  • If we or our licensees, development collaborators, or suppliers are unable to manufacture our products in sufficient quantities or at defined quality specifications, or are unable to obtain regulatory approvals for the manufacturing facility, we may be unable to develop and to meet the demand for our products and lose time to market and potential revenues.
  • It is uncertain whether product liability insurance will be adequate to address product liability claims, or that insurance against such claims will be affordable or available on acceptable terms in the future.
  • If the market opportunities for our current and potential future drug candidates are smaller than we believe they are, our ability to generate product revenues will be adversely affected and our business may suffer.
  • Risks Related to Our Reliance on Third Parties
  • We rely on third-party contract manufacturers for all our required raw materials, active pharmaceutical ingredients (“API”) and biologic drug substances, and finished drug products for ALXN1840 and MNPR-101 radiopharmaceutical programs, exposing us to potential delays and compliance inadequacies.
  • Corporate, non-profit, and academic collaborators may take actions (including lack of effective actions) to delay, prevent, or undermine the success of our products.
  • The termination of third-party licenses could adversely affect our rights to important compounds or technologies.
  • Data provided by collaborators and other parties upon which we rely have not been independently verified and could turn out to be inaccurate, misleading, or incomplete.
  • In certain cases, we may need to rely on a single supplier for a particular manufacturing material or service, and any interruption in or termination of service by such supplier could delay or disrupt the commercialization of our products.
  • We rely on a limited number of contracted manufacturing plants. If we need to enlist new or different contract manufacturers, it will delay our ALXN1840 and MNPR-101 radiopharmaceutical programs and may increase the costs of our clinical trials and/or regulatory efforts.
  • We rely on third parties to conduct our non-clinical studies and our clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may be unable to obtain regulatory approval for or commercialize our current product candidates or any future products, on a timely and efficient basis or at all, and our financial condition will be adversely affected.
  • Risks Related to Commercialization of Our Product Candidates
  • We have no experience as a company in commercializing any product. If we fail to obtain commercial expertise, upon product approval by regulatory agencies, our product launch and revenues could be delayed.
  • We have not yet undertaken any marketing efforts, and there can be no assurance that future anticipated market testing and analyses will validate our marketing strategy. We may need to modify the products, or we may not be successful in either developing or marketing those products.
  • If we are unable to establish relationships with licensees or collaborators to carry out sales, marketing, and distribution functions or to create effective marketing, sales, and distribution capabilities, we will be unable to market our products successfully.
  • Commercial success of our product candidates will depend on the acceptance of these products by physicians, payers and patients.
  • Our products may not be accepted for reimbursement or adequately reimbursed by third-party payers.
  • The effects of economic and political pressure to lower pharmaceutical prices are a major threat to the economic viability of new research-based pharmaceutical products, and any significant decrease in drug prices could materially and adversely affect our prospects.
  • If we obtain FDA approval for any of our product candidates, we will be subject to various federal and state fraud and abuse laws; these laws may impact, among other things, our proposed sales, marketing and education programs. Fraud and abuse laws are expected to increase in breadth and in detail, which will likely increase our operating costs and the complexity of our programs to ensure compliance with such enhanced laws.
  • If our operations are found to be in violation of any of the federal and state fraud and abuse laws or any other governmental regulations that apply to us, we may be subject to criminal actions and significant civil monetary penalties, which would adversely affect our ability to operate our business and our results of operations.
  • Negotiated prices for our products covered by a Part D prescription drug plan and other government programs will be lower than the prices we might otherwise obtain.
  • Risks Related to Our Intellectual Property
  • If we and our third-party licensors do not obtain and preserve protection for our respective intellectual property rights, our competitors may be able to take advantage of our (and our licensors’) development efforts to develop competing drugs.
  • The patent protection we obtain and preserve for our product candidates may not be sufficient to provide us with any material competitive advantage.
  • Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time. If this occurs, our competitive position, business, financial condition, results of operations, and prospects would be materially harmed.
  • Intellectual property disputes could require us to spend time and money to address such disputes and could limit our intellectual property rights.
  • We may not be able to enforce our intellectual property rights throughout the world.
  • Changes to the patent law in the U.S. and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.
  • Obtaining and maintaining our 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 any license, collaboration or other intellectual property-related agreements, we may be required to pay damages and could lose intellectual property rights that may be necessary for developing, commercializing and protecting our current or future technologies or drug candidates or we could lose certain rights to grant sublicenses.
  • 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 impact on the success of our business.
  • Intellectual property rights of third parties could adversely affect our ability to commercialize our current or future technologies or drug candidates, and we might be required to litigate or obtain licenses from third parties to develop or market our current or future technologies or drug candidates, which may not be available on commercially reasonable terms, or at all.
  • Risks Related to Our Business Operations and Industry
  • We have a limited operating history.
  • If we lose key management leadership, and/or scientific personnel, and if we cannot recruit qualified employees, managers, directors, officers, or other significant personnel, it is highly likely that we will experience program delays and increases in compensation costs, and our business will be materially disrupted.
  • We incur costs as a result of operating as a public company, and our management is required to devote substantial time to investor relations, information and communication to the public, and related compliance initiatives and corporate governance practices.
  • Despite ongoing compliance training and periodic education, our employees and consultants may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could result in delays or terminations of our development programs and adversely affect our business.
  • We are a smaller reporting company and we cannot be certain if the reduced disclosure requirements applicable to smaller reporting companies will make our common stock less attractive to investors.
  • Competition and technological change may make our product candidates less competitive or obsolete.
  • We face significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we fail to compete effectively.
  • We may engage in strategic transactions that could impact our liquidity, increase our expenses and present significant distractions to our management.
  • Our business and operations are vulnerable to computer system failures, cyber-attacks or deficiencies in our cybersecurity, which could increase our expenses, divert the attention of our management and key personnel away from our business operations and adversely affect our results of operations.
  • Failure to comply with health and data protection laws and regulations could lead to government enforcement actions (which could include civil or criminal penalties), private litigation or adverse publicity and could negatively affect our operating results and business.
  • If we, our contract research organizations (“CROs”) or our information technology (“IT”) vendors experience security or data privacy breaches or other unauthorized or improper access to, use of, or destruction of personal data, we may face costs, significant liabilities, harm to our brand and business disruption.
  • If we do not comply with laws regulating the protection of the environment and health and human safety, our business could be adversely affected.
  • We have limited the liability of and indemnified our directors and officers.
  • Future legislation or executive or private sector actions may increase the difficulty and cost for us to commercialize our products and adversely affect the prices obtained for such products.
  • Even if we are able to commercialize any drug candidate, such drug candidate may become subject to unfavorable pricing regulations or third-party coverage and reimbursement policies, which would harm our business.
  • Politically divided governmental actions and related political actions outside of government can impact the FDA’s role in the timely and effective review of new pharmaceutical products in the U.S. and our business may be adversely impacted.
  • Effective collaboration with the FDA for the approval of drug candidates is a highly demanding process which can result in increased time and expense to gain approvals.
  • Future tax reform measures may negatively impact our financial position.
  • Foreign currency exchange rates may adversely affect our consolidated financial statements.
  • Our anticipated operating expenses and capital expenditures over the next year are based upon our management’s estimates of possible future events. Actual amounts and the cost of new conditions could differ materially from those estimated by our management.
  • The financial and operational projections that we may make from time to time are subject to inherent risks.
  • Our present and potential future international operations may expose us to business, political, operational, and financial risks associated with doing business outside of the U.S.
  • The ongoing trade tensions resulting from tariff discussions/impositions can materially and adversely impact our business.
  • We are subject to U.S. and foreign anti-corruption and anti-money laundering laws with respect to our operations, and non-compliance with such laws can subject us to criminal or civil liability and harm our business.
  • Risks Associated with our Common Stock
  • Existing and new investors will experience dilution as a result of future sales or issuances of our common stock, future exercises of the pre-funded warrants, and future option exercises under our 2016 Stock Incentive Plan and any amendments to the plan.
  • The stock price of our common stock may be volatile or may decline regardless of our operating performance.
  • We may become involved in securities class action litigation that could divert management’s attention and harm our business.
  • Substantial amounts of our outstanding shares may be sold into the market. If there are substantial sales of shares of our common stock or exercises of the pre-funded warrants, the price of our common stock could decline.
  • Our ability to use our net operating loss (“NOL”) carryforwards and certain other tax attributes may be limited.
  • If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our stock price and trading volume could decline.

Legal proceedings

We are currently not, and to date have never been, a party to any adverse material legal proceedings.

The opening of Item 3, Legal Proceedings.7

Sources

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