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ONCO on Nasdaq

Onconetix, Inc.

Onconetix, Inc. is an American pharmaceutical preparations company based in Cincinnati.1

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Last updated Oct 21, 2026.

Overview

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  • TickerONCO on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersCincinnati, Ohio1
  • Incorporated inDE2
  • Business address201 E. Fifth Street, Suite 1900, Cincinnati, Oh 452022
  • Filer category, Emerging growth company2
  • Legal formCorporation

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ENTADFI program, effective April 30, 2024, with such individuals to continue assisting the Company on an as-needed, consulting basis.4 From its latest annual report

Financials

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

Key numbers, fiscal 2025

77.6%Gross margin5
-2190.0%Operating margin5
-1721.0%Net margin5
-67.7%Revenue growth, 20255
-89.0%Return on equity5

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue3¢$182.5K
  • Selling, general and admin97¢$7.0M
  • Income tax0¢$525

Out of $815.4K in revenue.5 The company lost money this year.

Financial statements

Revenue65$815.4K in 2025+1295% since 2023
0$1.0M$2.0M$3.0M2023: $58.5K$58.5K20232024: $2.5M$2.5M2024+4217%2025: $815.4K$815.4K2025−68%
Gross profit65$632.9K in 2025
-$2.0M-$1.0M0$1.0M$2.0M2023: -$1.1M-$1.1M20232024: $1.1M$1.1M20242025: $632.9K$632.9K2025−40%
Operating income7865-$17.9M in 2025+423% since 2021
-$60.0M-$40.0M-$20.0M02021: -$3.4M-$3.4M20212022: -$13.5M-$13.5M2022+294%2023: -$36.0M-$36.0M2023+167%2024: -$56.5M-$56.5M2024+57%2025: -$17.9M-$17.9M2025−68%
Net income765-$14.0M in 2025+311% since 2021
-$60.0M-$40.0M-$20.0M02021: -$3.4M-$3.4M20212022: -$13.4M-$13.4M2022+293%2023: -$37.4M-$37.4M2023+179%2024: -$58.7M-$58.7M2024+57%2025: -$14.0M-$14.0M2025−76%
Fiscal year202020212022202320242025
Revenue$58.5K6$2.5M5$815.4K5
Cost of revenue$1.2M6$1.5M5$182.5K5
Gross profit-$1.1M6$1.1M5$632.9K5
Research and development$1.3M7$4.1M8$1.9M6$154.4K6
Selling, general and admin$9.4M8$14.8M6$11.2M5$7.0M5
Operating expenses$3.4M7$13.5M8$34.9M6$57.5M5$18.5M5
Operating income-$3.4M7-$13.5M8-$36.0M6-$56.5M5-$17.9M5
Interest$671.6K8
Income before tax-$13.4M8-$37.4M6-$59.7M5-$14.0M5
Income tax$675.7B7$3.2T7-$12.6K6-$1.0M5$5255
Net income-$3.4M7-$13.4M7-$37.4M6-$58.7M5-$14.0M5
Earnings per share-$1.267-$1.108-$87.456-$1,823.395-$16.565
Earnings per share (diluted)-$1.267-$1.108-$87.456-$1,823.395-$16.565
Shares (weighted, basic)3.2M shares712.3M shares8427.8K shares632.3K shares5937.7K shares5
Shares (weighted, diluted)3.2M shares712.3M shares8427.8K shares632.3K shares5937.7K shares5

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Corporate structure

Onconetix, Inc. 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 Onconetix, Inc.

  • KEYSTONE CAPITAL PARTNERS, LLC Filed SCHEDULE 13G on Onconetix, Inc., latest Jul 27, 2026
  • Altos Venture AG Filed SCHEDULE 13D/A on Onconetix, Inc., latest Jul 16, 2025 (3 filings since Dec 28, 2023)
  • Christian Bruhlmann Filed SCHEDULE 13D/A on Onconetix, Inc., latest Feb 14, 2025 (2 filings since Oct 1, 2024)
  • Ralph Schiess Filed SCHEDULE 13D/A on Onconetix, Inc., latest Feb 14, 2025 (2 filings since Oct 1, 2024)
  • American Financial Group Filed SCHEDULE 13G/A on Onconetix, Inc., latest Feb 13, 2025 (3 filings since Jan 31, 2023)
  • Kantonalbank (zurich Cantonalbank) Zurcher Filed SCHEDULE 13G/A on Onconetix, Inc., latest Feb 7, 2025 (2 filings since Nov 14, 2024)
  • Scablis AG Filed SCHEDULE 13G on Onconetix, Inc., latest Sep 27, 2024
  • New Horizon Health Ltd Filed SC 13G on Onconetix, Inc., latest Sep 26, 2024
  • Joseph Hernandez Filed SC 13G/A on Onconetix, Inc., latest Jun 10, 2024 (2 filings since Feb 14, 2023)
  • SABBY MANAGEMENT, LLC Filed SC 13G/A on Onconetix, Inc., latest Jan 2, 2024 (2 filings since Jan 4, 2023)
  • Cincinnati Cornerstone Investors BWV I, LLC Filed SC 13D on Onconetix, Inc., latest Jun 29, 2023 (5 filings since Mar 3, 2022)
  • CINCYTECH FUND IV, LLC Filed SC 13D on Onconetix, Inc., latest Mar 3, 2022
  • Onconetix, Inc. Cincinnati, Ohio
    • Proteomedix AG Subsidiary · Switzerland

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 Onconetix, Inc. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Property and equipment, net$37.1K5 Dec 31, 2025$62.9K5 Dec 31, 2024−41.0%
Operating-lease assets (leased space)$48.8K5 Dec 31, 2025$119.4K5 Dec 31, 2024−59.2%

Investments

ItemLatestA year beforeChange
Deposits held (banks)$3.5M6 Dec 31, 2024$3.5M8 Dec 31, 20230%

Intangibles and goodwill

ItemLatestA year beforeChange
Goodwill$18.5M5 Dec 31, 2025$27.0M5 Dec 31, 2024−31.4%

Inventory

ItemLatestA year beforeChange
Inventory, total$150.0K5 Dec 31, 2025$64.1K5 Dec 31, 2024+134.0%
Raw materials$103.4K5 Dec 31, 2025$57.4K5 Dec 31, 2024+80.0%
Finished goods$46.5K5 Dec 31, 2025$6.6K5 Dec 31, 2024+601.5%

Properties, in its own words

We currently lease an office located at 201 E Fifth Street, Suite 1900, Cincinnati, OH 45202, which is renewed on a monthly basis.

Additionally, Proteomedix leases office and lab space located at Wagistrasse 23, 8952 Schlieren, Switzerland. This lease expired on December 31, 2025, and was renewed for a successive two-year term, resulting in an additional right-of-use asset and lease liability of approximately $49,000. The lease, as renewed, requires payments of approximately $24,000 over the next twelve months. The lease will automatically renew for successive two-year terms, unless terminated. Either party may terminate the lease with twelve months’ written notice.

Item 2 of the 10-K filed Mar 13, 2026.4

Leadership

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

Chief executive

  1. Neil J. Campbell2023
  2. Ralph Schiess2024–now

Chief financial officer

  1. Bruce Harmon2023
  2. Karina M. Fedasz2024
2025
Board members and other officers (15)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • DirectorThomas Meier named Oct 17, 2024 to Oct 7, 202529

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Proteomedix AG Switzerland3

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

Former names

  • Blue Water Biotech, Inc.Apr 24, 2023 to Dec 18, 20232
  • Blue Water Vaccines Inc.Jul 15, 2019 to Apr 20, 20232

Timeline

  1. Sep 14, 20268-K Entered a material agreement; Regulation FD disclosure30
  2. Jul 29, 20268-K Entered a material agreement; Unregistered sale of shares31
  3. May 19, 20268-K Bylaws or fiscal year changed; Other events32
  4. May 14, 20268-K Other events33
  5. May 4, 20268-K Shareholder vote34
  6. Apr 24, 20268-K Executive or director change35
  7. Mar 27, 20268-K Bylaws or fiscal year changed; Other events36
  8. Mar 25, 20268-K Executive or director change37
  9. Mar 24, 20268-K Executive or director change38
  10. Feb 12, 20268-K Entered a material agreement; Other events39
  11. Feb 9, 20268-K Shareholder vote40
  12. Dec 10, 20258-K Entered a material agreement41
  13. Sep 26, 2024New chief executive Ralph Schiess becomes CEO11
  14. Oct 10, 2023New chief executive Neil J. Campbell becomes CEO12

Calendar

Coming up

  1. Nov 12, 2026Reports results for the quarter ending Sep/202642

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

Filings

386 filings to the SEC since October 2021: 5 annual reports, 14 quarterly reports, 125 major events, 69 insider forms, 25 large holders, 2 private raises, 146 other. The latest 20:

  1. Oct 7, 2026DEF 14A DEFINITIVE PROXY STATEMENT EDGAR
  2. Sep 17, 2026PRE 14A PRELIMINARY PROXY STATEMENT EDGAR
  3. Sep 14, 2026DEFA14A CURRENT REPORT EDGAR
  4. Sep 14, 20268-K CURRENT REPORT EDGAR
  5. Sep 14, 2026425 EDGAR
  6. Sep 8, 2026424B3 PROSPECTUS EDGAR
  7. Sep 3, 2026EFFECT EDGAR
  8. Sep 3, 2026425 EDGAR
  9. Aug 31, 2026S-1/A AMENDMENT NO. 1 TO FORM S-1 EDGAR
  10. Aug 13, 202610-Q QUARTERLY REPORT EDGAR
  11. Aug 12, 2026S-1 REGISTRATION STATEMENT EDGAR
  12. Aug 6, 2026425 EDGAR
  13. Jul 29, 20268-K CURRENT REPORT EDGAR
  14. Jul 27, 2026SCHEDULE 13G EDGAR
  15. Jul 7, 2026425 EDGAR
  16. Jun 24, 2026425 EDGAR
  17. Jun 17, 2026424B3 PROSPECTUS EDGAR
  18. Jun 16, 2026EFFECT EDGAR
  19. Jun 15, 2026CORRESP EDGAR
  20. Jun 12, 2026UPLOAD EDGAR

The 386 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

11 open-market trades by officers, directors and large owners since October 2021: 3 buys and 8 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Apr 21, 2026HRT FINANCIAL LP10% ownerSale49,710$0.69$34.3KForm 4
Apr 20, 2026HRT FINANCIAL LP10% ownerSale94,462$0.75$70.8KForm 4
Apr 17, 2026HRT FINANCIAL LP10% ownerBuy34,636$0.73$25.3KForm 4
Apr 16, 2026HRT FINANCIAL LP10% ownerSale53,867$0.73$39.3KForm 4
Apr 15, 2026HRT FINANCIAL LP10% ownerBuy92,554$0.76$70.3KForm 4
Apr 14, 2026HRT FINANCIAL LP10% ownerBuy74,350$0.77$57.2KForm 4
Aug 22, 2022Hernandez JosephCEOSale30,269$4.10$124.1KForm 4
Aug 19, 2022Shaw AllanDirectorSale29,636$3.94$116.8KForm 4
Aug 19, 2022Hernandez JosephCEOSale76,841$4.21$323.5KForm 4
Aug 19, 2022Henderson ErinChief Business OfficerSale4,834$3.97$19.2KForm 4
Aug 18, 2022Hernandez JosephCEOSale442,539$4.96$2.2MForm 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
2025Karina Fedasz;53$307.1K$352.1K55
2025Ralph Schiess;$163.9K55
2024Former ChiefExecutive Officer and Former Chief Science Officer$265.2K$305.2K55
2024Interim Chief Financial Officer and Former Interim Chief Executive Officer$197.1K55

Funding

Where the company's money came from, by calendar year: private offerings filed with the SEC, federal grants, loans, contracts and other assistance from USAspending.gov, and PPP loans from the SBA. Each bar links to the records below.

Money received by year$15.0M 2024–2025
Money received by yearMoney received by year, 2024–2025: $15.0M in all. Private raises (Form D) $15.0M.$0$5M$10M$15M2024 · Private raises (Form D): $2.0M20242025 · Private raises (Form D): $13.0M2025
Figures by year
YearPrivate raises (Form D)Total
2025$13.0M$13.0M
2024$2.0M$2.0M

Private raises

Private offerings the company reported to the SEC on Form D. The amount is what the latest filing says was sold so far, charted in the year of the first sale. Covers filings since Oct 1, 2021.

  1. Sep 22, 2025Raised $13 million in a private offering of securities29 Form D: 11 investors so far Form D
  2. Oct 2, 2024Raised $2 million in a private offering of securities56 Form D: 5 investors so far Form D

Held by these funds

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

FundSharesValueShare of the fundChange
XTX Topco Ltd13,548$15.3K0.0%New
SBI Securities Co., Ltd.252$2850.0%New
Tower Research Capital LLC (TRC)145$1640.0%New
Hollencrest Capital Management100$1130.0%New
Hrt Financial LP51,398$580.0%New
Morgan Stanley21$240.0%New

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

SEC filer profile

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

  • Name on EDGAROnconetix, Inc.1
  • CIK0001782107
  • Employer ID (EIN)81-22628164
  • Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; not a shell company4
  • Incorporated inDelaware4
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address201 E. Fifth Street, Suite 1900, Cincinnati, OH 452021
  • Phone513-620-41011
  • Shares outstanding3,949,107 as of Aug 13, 202610
  • Public float$3.6M as of Jun 30, 20254
  • AuditorMaloneBailey, LLP, Houston, Texas PCAOB ID 206; no auditor attestation of internal control over financial reporting4
  • On EDGAR sinceJul 15, 20191
  • Filings389 in all: 8-K (118), 4 (43), 3 (25), CORRESP (21), S-1/A (18), UPLOAD (15), 10-Q (14), EFFECT (14)1
    All 39 form types

    S-1 (12), 424B3 (10), 425 (10), SC 13D (9), DEF 14A (8), 8-K/A (7), PRE 14A (6), SC 13G (6), 10-K (5), NT 10-Q (5), 424B4 (4), PRER14A (4), S-8 (4), D (3), SC 13G/A (3), SCHEDULE 13D/A (3), DEFA14A (2), FWP (2), NT 10-K (2), POS AM (2), SCHEDULE 13G (2), SCHEDULE 13G/A (2), SEC STAFF LETTER (2), 3/A (1), 424B5 (1), 8-A12B (1), CERT (1), DEF 14C (1), DRS (1), PRE 14C (1), S-3 (1)

  • Latest filingsAnnual report (10-K) Mar 13, 2026
    Quarterly report (10-Q) Aug 13, 2026
    Proxy statement (DEF 14A) Oct 7, 2026
    Latest 8-K (8-K) Sep 14, 2026

Securities registered for trading

ClassSymbolExchange
Common stock, $0.00001 par valueONCONasdaq

From the cover page of the 10-K filed Mar 13, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks Onconetix, Inc. names in Item 1A of its 10-K filed Mar 13, 2026: 74 risks under these headings, as written.4

  • Risks Related to our Financial Position and Need for Capital
  • We have incurred significant net losses since inception, have only generated minimal revenue, and anticipate that we will continue to incur substantial net losses for the foreseeable future and may never achieve profitability. Our stock is a highly speculative investment.
  • There is substantial doubt about our ability to continue as a “going concern,” and we will require substantial additional funding to finance our long-term operations. If we are unable to raise additional capital when needed, we could be forced to delay, reduce or terminate our product or other operations.
  • Our current liabilities are significant, and if those to whom we owe accounts payable, were to demand payment, we would be unable to pay.
  • Risks Related to the Commercialization of our Product
  • The marketing approval processes in the United States are lengthy, time-consuming and inherently unpredictable, and if we are ultimately unable to obtain marketing approval for Proclarix, our business may be harmed.
  • We depend entirely on the success of a single product. If we do not successfully commercialize our product or we experience significant delays in doing so, this product may not be profitable.
  • Obtaining and maintaining regulatory approval of our product in one jurisdiction does not mean that we will be successful in obtaining regulatory approval in other jurisdictions.
  • Even if we are able to commercialize our product, it may become subject to unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives, which would harm our business.
  • Our product could be subject to marketing restrictions or withdrawal from the market, and we may be subject to penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our product.
  • Failure to obtain regulatory approvals in foreign jurisdictions will prevent us from marketing our product and product candidates internationally.
  • Company shareholders may not realize a benefit from the Proteomedix acquisitions commensurate with the ownership dilution they have experienced in connection with the transactions.
The other 64 risks
  • Disruptions to or significantly increased costs associated with transportation and other distribution channels for Proclarix may adversely affect our margins and profitability.
  • We are dependent on third parties, including LabCorp, to develop, market, distribute and sell our product.
  • We may not be able to gain and retain market acceptance for our product.
  • Proclarix is subject to competition from other prostate cancer diagnostics and larger, well-established companies with substantially greater resources than us.
  • The commercial success of our in-development and future diagnostic tests and services and our revenue growth depend upon attaining significant market acceptance among payers, providers, clinics, patients, and biopharmaceutical companies.
  • If we fail to increase our sales and marketing capabilities or develop broad awareness of our diagnostic tests in a cost-effective manner, we may not be able to generate revenue growth.
  • If we cannot maintain our current relationships, or enter into new relationships, with CROs, universities, clinics, laboratories or tissue sample banks, our revenue prospects could be reduced.
  • We need to ensure strong product performance and quality to maintain and grow our business.
  • The sizes of the markets for our diagnostic tests and services and any future diagnostic tests and services may be smaller than we estimate and may decline.
  • We have a significant customer concentration, with a limited number of customers accounting for a large portion or all of our revenues.
  • Our results of operations will be materially harmed if we are unable to accurately forecast customer demand for, and utilization of, our diagnostic tests and manage our inventory.
  • The timing of our new product offerings is uncertain.
  • Our access to samples may hinder our ability to research, develop, and commercialize future products.
  • Adherence to complex test protocols is required.
  • Risks Related to our Business and Industry
  • Our reliance on third parties heightens the risks faced by our business.
  • We are dependent on third parties to market, distribute and sell our product.
  • We have no experience manufacturing our product on a commercial scale and are dependent on third parties for the manufacture of our product. If we experience problems with any of these third parties, they could delay our ability to sell our product.
  • Manufacturing risks may adversely affect our ability to manufacture our product and could reduce our gross margin and profitability.
  • We maintain single supply relationships for certain key components, and our business and operating results could be harmed if supply is restricted or ends or the price of raw materials used in its manufacturing process increases.
  • We may not be able to manage our manufacturing and supply chain effectively, which would harm our results of operations.
  • We may in the future have conflicts with our current or future partners or third-party providers that could delay or prevent the commercialization of our current product.
  • Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of our product.
  • We may engage in acquisitions that could disrupt our business, cause dilution to our stockholders or reduce our financial resources.
  • Security threats to our information technology infrastructure and/or our physical buildings could expose us to liability and damage our reputation and business.
  • We will need to grow the size of our organization in the future, and we may experience difficulties in managing this growth.
  • Our future success depends on our ability to retain our executive officers and to attract, retain and motivate qualified personnel.
  • Members of our management team and board of directors have significant experience as founders, board members, officers, or executives of other companies. As a result, certain of those people have been and may become involved in proceedings, investigations and litigation relating to the business affairs of the companies with which they were, are, or may in the future be, affiliated. This may have an adverse effect on us, could damage our reputation and business.
  • 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 review of regulatory submissions 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.
  • We may be adversely affected by natural disasters, pandemics and other catastrophic events, and by man-made problems such as terrorism and acts of war, that could disrupt our business operations and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.
  • Our employees, independent contractors, principal investigators, consultants, and vendors and engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
  • Macroeconomic pressures in the markets in which we operate, including, but not limited to, the current conflicts in Ukraine and the Middle East may alter the ways in which we conduct our business operations and manage our financial capacities.
  • Economic uncertainty may adversely affect our access to capital, cost of capital and ability to execute our business plan as scheduled.
  • Conditions in the global economy may adversely affect our business, financial condition and results of operations.
  • Misconduct and errors by our current and former employees and our third-party service providers could cause a material adverse effect on our business and reputation.
  • Our industry is subject to rapid change, which could make our solutions and the diagnostic tests we develop and services we offer, obsolete. If we are unable to continue to innovate and improve our diagnostic tests and services, we could lose customers or market share.
  • We face competition from many sources, including larger companies, and we may be unable to compete successfully.
  • Performance issues, service interruptions or price increases by our shipping carriers and warehousing providers could adversely affect our business and harm our reputation and ability to provide our services on a timely basis.
  • Cost-containment efforts of our customers, purchasing groups and governmental purchasing organizations could have a material adverse effect on our future sales and profitability.
  • We are highly dependent on our senior management team and key personnel, and our business could be harmed if we are unable to attract and retain the personnel necessary for our success.
  • We depend on our information technology systems and any failure of these systems could harm our business.
  • Risks Related to Our Intellectual Property
  • It is difficult and costly to protect our proprietary rights, and we may not be able to ensure their protection. If our patent position does not adequately protect our product and/or product candidates, others could compete against us more directly, which would harm our business, possibly materially.
  • We are dependent on licensed intellectual property. If we were to lose our rights to licensed intellectual property, we may not be able to continue developing or commercializing our product and/or product candidates, if approved. If we breach any of the agreements under which we license the use, development, and commercialization rights to our product and/or product candidates or technology from third parties or, in certain cases, we fail to meet certain development deadlines, we could lose license rights that are important to our business.
  • Some of the intellectual property owned by Proteomedix and/or covered by our licenses concerns patent applications and provisional applications. We cannot assure investors that any of the currently pending or future patent applications will result in granted patents, nor can we predict how long it will take for such patents to be granted.
  • Even if patents are issued based on patent applications to which we have been granted a license or owned by Proteomedix, because the patent positions of diagnostic methods and/or pharmaceutical and biotechnology products are complex and uncertain, we cannot predict the scope and extent of patent protection for our product and/or product candidates.
  • Obtaining and maintaining patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and patent protection could be reduced or eliminated for noncompliance with these requirements.
  • The life of patent protection is limited, and third parties could develop and commercialize methods, products, and technologies similar or identical to ours and compete directly with us after the patent licensed to us expires, which could materially and adversely affect our ability to commercialize our product and technologies.
  • We may need to license intellectual property from third parties, and such licenses may not be available or may not be available on commercially reasonable terms or at all.
  • We may infringe the intellectual property rights of others, which may prevent or delay our method and/or product development efforts and stop us from commercializing or increase the costs of commercializing our methods and/or product and/or product candidates.
  • We may become involved in lawsuits to protect or enforce our intellectual property, which could be expensive, time consuming and unsuccessful.
  • If we are not able to adequately prevent disclosure of trade secrets and other proprietary information, the value of our technology and product could be significantly diminished.
  • We may be subject to claims that our employees or consultants have wrongfully used or disclosed alleged trade secrets.
  • Our intellectual property may not be sufficient to protect our methods and/or product and/or product candidates from competition, which may negatively affect our business as well as limit our partnership or acquisition appeal.
  • Intellectual property rights do not necessarily address all potential threats to our competitive advantage and changes in patent laws or patent jurisprudence could diminish the value of patents in general, thereby impairing our ability to protect our product.
  • Risks Related to Healthcare Compliance and Other Regulations
  • If we fail to comply with healthcare regulations, we could face substantial enforcement actions, including administrative, civil, and criminal penalties and our business, operations and financial condition could be adversely affected.
  • Healthcare reform in the United States has been implemented in the past, and we expect further changes to be proposed in the future, leading to potential uncertainty in the healthcare industry. Violations of healthcare laws can have an adverse impact on our ability to advance our product and our operating results.
  • We may rely on government funding and collaboration with government entities for our product development, which adds uncertainty to our research and development efforts and may impose requirements that increase the costs of development, commercialization and production of any programs developed under those government-funded programs.
  • We are subject to U.S. and certain foreign export and import controls, sanctions, embargoes, anti-corruption laws and anti-money laundering laws and regulations. Compliance with these legal standards could impair our ability to compete in domestic and international markets. We can face criminal liability and other serious consequences for violations, which can harm our business.
  • Risks Related to Owning our Common Stock
  • The market price of our common stock has been extremely volatile and may continue to be highly volatile due to numerous circumstances beyond our control, and stockholders could lose all or part of their investment.
  • We may be subject to securities litigation, which is expensive and could divert our management’s attention.
  • If we fail to maintain proper and effective internal controls, our ability to produce accurate financial statements on a timely basis could be impaired. We have identified weaknesses in our internal controls, and we cannot provide assurances that these weaknesses will be effectively remediated, or that additional material weaknesses will not occur in the future.
  • An active trading market for our common stock may not develop or be sustained.
  • Our principal stockholders and management own a significant percentage of our capital stock and will be able to exert a controlling influence over our business affairs and matters submitted to stockholders for approval.
  • There can be no assurance that we will be able to comply with the continued listing standards of Nasdaq.
  • If our shares become subject to the penny stock rules, it would become more difficult to trade our shares.

Legal proceedings

From time to time, we may be involved in various disputes and litigation matters that arise in the ordinary course of business. We are currently not a party to any material legal proceedings.

The opening of Item 3, Legal Proceedings.4

Sources

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