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OSTX on NYSE

OS Therapies Inc

OS Therapies Inc is an American pharmaceutical preparations company based in Grasonville.1 Its shares trade on NYSE under the symbol OSTX.1

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Last updated Oct 21, 2026.

Overview

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  • TickerOSTX on NYSE1
  • IndustryPharmaceutical Preparations1
  • HeadquartersRockville, Maryland1
  • Incorporated inDE2
  • Business address15825 Shady Grove Road, Suite 135, Rockville, Md 208502
  • Filer category, Emerging growth company2
  • Legal formCorporation

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Medicines Agency (EMA) regarding the clinical and biomarker data for OST-HER2 in recurrent, fully resected pulmonary metastatic Osteosarcoma.4 From its latest annual report

Financials

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

Financial statements

Operating income56-$28.7M in 2025+561% since 2023
-$30.0M-$20.0M-$10.0M02023: -$4.3M-$4.3M20232024: -$6.8M-$6.8M2024+57%2025: -$28.7M-$28.7M2025+321%
Net income56-$28.8M in 2025+269% since 2023
-$30.0M-$20.0M-$10.0M02023: -$7.8M-$7.8M20232024: -$8.9M-$8.9M2024+14%2025: -$28.8M-$28.8M2025+224%

Every line of the income statement as filed: the last 2 fiscal years, latest first.6

Period ending2025-12-312024-12-31
Research and development$16.4M$2.8M
General and administrative$12.3M$4.0M
Loss from operations-$28.7M-$6.8M
Interest income$249
Interest expense-$2.1M
Non-operating income$34.0K
Non-operating expenses-$1.5M-$51.2K
Change in fair value of warrant liability$1.4M
TOTAL OTHER INCOME/EXPENSE-$48.1K-$2.1M
NET LOSS-$28.8M-$8.9M
Cumulative Series A preferred stock dividend requirement-$31.2K
NET LOSS available to common shareholders-$28.8M-$8.9M
Weighted average # of shares (in Shares)29.3M shares7.0M shares
Basic loss per common share outstanding (in Dollars per share)-$0.98-$1.28
Diluted loss per common share outstanding (in Dollars per share)-$0.98-$1.28

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Corporate structure

OS Therapies Inc sits at the top of its group. 3 entities, 2 countries on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of OS Therapies Inc

  • Shalom Auerbach Filed SCHEDULE 13D/A on OS Therapies Inc, latest Aug 18, 2025 (5 filings since Jan 17, 2025)
  • Thomas A. Satterfield Jr. Filed SCHEDULE 13G/A on OS Therapies Inc, latest Aug 13, 2025 (3 filings since Aug 28, 2024)
  • Advaxis Filed SCHEDULE 13G on OS Therapies Inc, latest Apr 16, 2025
  • OS Therapies Inc Rockville, Maryland
    • OS Animal Health Corp Subsidiary · Delaware, United States
    • OS Therapies UK LTD Subsidiary · United Kingdom

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 OS Therapies 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$2.5K6 Dec 31, 2025$5.3K6 Dec 31, 2024−52.8%

Intangibles and goodwill

ItemLatestA year beforeChange
Finite-lived intangibles, net$6.5M6 Dec 31, 2025

Properties, in its own words

Our corporate address is 115 Pullman Crossing Road, Suite 103, Grasonville, Maryland 21638. This space is the accounting office of our Chief Financial Officer and provided to us rent free. We believe that suitable additional or alternative space would be available in the future on commercially reasonable terms, if necessary. All our operations are presently conducted remotely.

Item 2 of the 10-K filed Mar 31, 2026.4

Leadership

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

Chief executive

  1. Paul A. Romness2024–now

President

  1. Paul A. Romness2024–now

Chief financial officer

  1. Christopher P. Acevedo2024–now
2025
Board members and other officers (10)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • Chief Business OfficerGerald P. Commissiong named Jan 22, 202520
  • Chief Technology OfficerJutta Wanner named Jan 11, 202321

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • OS Animal Health Corp Delaware3
  • OS Therapies UK LTD United Kingdom3

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

Timeline

  1. Oct 5, 20268-K Entered a material agreement; Executive or director change; Other events22
  2. Sep 10, 20268-K Other events23
  3. Sep 9, 20268-K Executive or director change; Shareholder vote24
  4. Aug 21, 20268-K Entered a material agreement25
  5. Aug 12, 20268-K Entered a material agreement; New debt or obligation; Unregistered sale of shares26
  6. Aug 6, 20268-K Entered a material agreement; New debt or obligation; Unregistered sale of shares27
  7. Jul 29, 20268-K Ended a material agreement28
  8. Jul 7, 20268-K Financial statements and exhibits29
  9. Jul 2, 20268-K Entered a material agreement; New debt or obligation; Unregistered sale of shares30
  10. Apr 30, 20268-K Regulation FD disclosure31
  11. Apr 2, 20268-K Entered a material agreement; Other events32
  12. Mar 31, 20268-K Other events33
  13. Aug 1, 2024New chief executive Paul A. Romness becomes CEO9

Calendar

Coming up

  1. Nov 13, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.21) a share, on Nov 14, 2025.34

When it reported results

  1. Aug 19, 2025Reported quarterly or annual results35
  2. May 16, 2025Reported quarterly or annual results36
  3. Mar 31, 2025Reported quarterly or annual results37
  4. Nov 15, 2024Reported quarterly or annual results38
  5. Aug 15, 2024Reported quarterly or annual results39

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

Filings

229 filings to the SEC since October 2021: 2 annual reports, 8 quarterly reports, 40 major events, 50 insider forms, 9 large holders, 9 private raises, 111 other. The latest 20:

  1. Oct 5, 20263 EDGAR
  2. Oct 5, 20263 EDGAR
  3. Oct 5, 20268-K CURRENT REPORT EDGAR
  4. Sep 21, 2026S-8 REGISTRATION STATEMENT EDGAR
  5. Sep 10, 20268-K CURRENT REPORT EDGAR
  6. Sep 10, 2026424B7 PROSPECTUS SUPPLEMENT EDGAR
  7. Sep 9, 20268-K CURRENT REPORT EDGAR
  8. Aug 25, 2026D EDGAR
  9. Aug 21, 20268-K CURRENT REPORT EDGAR
  10. Aug 21, 2026424B5 PROSPECTUS SUPPLEMENT EDGAR
  11. Aug 14, 202610-Q QUARTERLY REPORT EDGAR
  12. Aug 12, 20268-K CURRENT REPORT EDGAR
  13. Aug 6, 20268-K CURRENT REPORT EDGAR
  14. Aug 6, 2026424B5 PROSPECTUS SUPPLEMENT EDGAR
  15. Jul 29, 20268-K CURRENT REPORT EDGAR
  16. Jul 24, 2026ARS EDGAR
  17. Jul 24, 2026DEFA14A DEFINITIVE ADDITIONAL MATERIALS EDGAR
  18. Jul 24, 2026DEF 14A PROXY STATEMENT EDGAR
  19. Jul 23, 20263 EDGAR
  20. Jul 16, 2026D EDGAR

The 229 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

5 open-market trades by officers, directors and large owners since October 2021: 0 buys and 5 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
May 7, 2025Auerbach ShalomSale82,000$2.00$164.0KForm 4
Apr 10, 2025Auerbach ShalomSale10,000$1.39$13.9KForm 4
Apr 9, 2025Auerbach ShalomSale50,012$1.35$67.5KForm 4
Feb 14, 2025Einodmil LLCSale100,000$2.84$284.0KForm 4
Jan 15, 2025Auerbach ShalomSale16,720$6.74$112.7KForm 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.

  • Shalom AuerbachSCHEDULE 13D/A, 5 filings Jan 17, 2025 to Aug 18, 202540
  • Thomas A. Satterfield Jr.SCHEDULE 13G/A, 3 filings Aug 28, 2024 to Aug 13, 202541
  • AdvaxisSCHEDULE 13G, 1 filing Apr 16, 202542

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
2025Paul A. RomnessMPH$480.0K$1.9M43
2025Robert G. PetitPh.D.$420.0K$1.0M43
2025ChristopherP. Acevedo$36.0K$280.0K43
2024President and Chief Executive Officer$480.0K$1.7M43
2024Chief Medical and Scientific Officer$420.0K$912.0K43
2024Chief Financial Officer$36.0K$282.0K43

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$29.9M 2022–2026
Money received by yearMoney received by year, 2022–2026: $29.9M in all. Private raises (Form D) $29.9M.$0$5M$10M$15M2022 · Private raises (Form D): $2.0M20222023 · Private raises (Form D): $700.0K20232024 · Private raises (Form D): $7.1M20242025 · Private raises (Form D): $8.0M20252026 · Private raises (Form D): $12.1M2026
Figures by year
YearPrivate raises (Form D)Total
2026$12.1M$12.1M
2025$8.0M$8.0M
2024$7.1M$7.1M
2023$700.0K$700.0K
2022$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. Aug 10, 2026Raised $5 million in a private offering of securities44 Form D: $10 million offered in all Form D
  2. Jun 30, 2026Raised $1.6 million in a private offering of debt45 Form D: $9.2 million offered in all Form D
  3. Mar 4, 2026Raised $2 million in a private offering of debt46 Form D: 9 investors so far Form D
  4. Jan 14, 2026Raised $3.5 million in a private offering of equity47 Form D: $7.5 million offered in all Form D
  5. Sep 2, 2025Raised $3.8 million in a private offering of equity48 Form D: 10 investors so far Form D
  6. Jun 23, 2025Raised $4.2 million in a private offering of equity49 Form D: 27 investors so far Form D
  7. Dec 31, 2024Raised $7.1 million in a private offering of equity20 Form D: $10 million offered in all Form D
  8. Dec 8, 2023Raised $700,000 in a private offering of securities50 Form D: $2 million offered in all Form D
  9. Nov 16, 2022Raised $2 million in a private offering of equity21 Form D: 11 investors so far Form D

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 29. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Vanguard Capital Management LLC777,651$1.5M0.0%+308,184
CM Management, LLC400,000$760.0K0.5%No change
Geode Capital Management, LLC301,794$573.4K0.0%+21,749
Howard Financial Services, Ltd.248,001$471.2K0.0%+2,565
BlackRock, Inc.242,479$460.7K0.0%+177,707
Vanguard Fiduciary Trust Co174,132$330.9K0.0%+57,469
State Street Corp120,100$228.2K0.0%+28,900
Marshall Wace, Llp100,640$191.2K0.0%New
HighTower Advisors, LLC85,550$162.5K0.0%+70,350
Northern Trust Corp70,817$134.6K0.0%+4,763
Beacon Pointe Advisors, LLC62,507$118.8K0.0%No change
Bridgeway Capital Management, LLC45,000$85.5K0.0%+20,000
Two Sigma Investments, LP30,414$57.8K0.0%+4,034
Stifel Financial Corp27,900$53.0K0.0%+12,900
Jane Street Group, LLC26,999$51.3K0.0%−13,317
Axq Capital, LP24,623$46.8K0.0%New
Vanguard Global Advisers, LLC20,958$39.8K0.0%No change
Stratos Wealth Advisors, LLC19,314$36.7K0.0%+5,497
Quadrature Capital Ltd15,662$29.8K0.0%New
Jones Financial Companies Lllp14,501$27.3K0.0%+1,580
Susquehanna International Group, Llp13,532$25.7K0.0%−435,205
Morgan Stanley13,000$24.7K0.0%+3,510
UBS Group AG8,813$16.7K0.0%−339,865
Rockefeller Capital Management L.P.7,500$14.2K0.0%New
Steward Partners Investment Advisory, LLC5,681$10.8K0.0%New

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

SEC filer profile

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

  • Name on EDGAROS Therapies Inc1
  • CIK0001795091
  • Employer ID (EIN)82-51183684
  • 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 address15825 Shady Grove Road, Suite 135, Rockville, MD 208501
  • Phone410-297-77931
  • Shares outstanding46,125,825 as of Aug 12, 20268
  • Public float$49.6M as of Jun 30, 20254
  • AuditorMaloneBailey, LLP, Houston, Texas PCAOB ID 206; no auditor attestation of internal control over financial reporting4
  • On EDGAR sinceDec 5, 20191
  • Filings232 in all: 8-K (39), CORRESP (31), 4 (26), 3 (14), D (12), UPLOAD (10), EFFECT (9), S-1/A (9)1
    All 43 form types

    10-Q (8), 5 (7), S-1 (6), 424B5 (4), DEFA14A (4), NT 10-Q (4), SCHEDULE 13D/A (4), 424B7 (3), DEF 14A (3), POS AM (3), RW (3), S-8 (3), 10-K (2), ARS (2), DRS/A (2), DRSLTR (2), PRE 14A (2), SCHEDULE 13G/A (2), SEC STAFF LETTER (2), 144 (1), 3/A (1), 4/A (1), 424B3 (1), 424B4 (1), 5/A (1), 8-A12B (1), 8-K/A (1), CERT (1), DRS (1), NT 10-K (1), S-3 (1), SC 13G (1), SCHEDULE 13D (1), SCHEDULE 13G (1), SP 15D2 (1)

  • Latest filingsAnnual report (10-K) Mar 31, 2026
    Quarterly report (10-Q) Aug 14, 2026
    Proxy statement (DEF 14A) Jul 24, 2026
    Latest 8-K (8-K) Oct 5, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.001 per shareOSTXNYSE

From the cover page of the 10-K filed Mar 31, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks OS Therapies Inc names in Item 1A of its 10-K filed Mar 31, 2026: 64 risks under these headings, as written.4

  • In addition to the other information contained in this Form 10-K, the following risk factors should be considered carefully in evaluating our company’s business. Our business, financial condition or results of operations could be materially and adversely affected by any of these risks. Additional risks not presently known to us or that we currently deem immaterial may also adversely affect our business, financial condition or results of operations.
  • Risks Related to Our Financial Position and Need for Additional Capital
  • Risks Related to Drug Development and Regulatory Approval
  • Risks Related to Intellectual Property
  • Risks Related to Management and Our Operations
  • We are a clinical stage biopharmaceutical company and have not generated any revenue to date from drug sales, and may never become profitable.
  • We have incurred significant operating losses in recent periods and anticipate that we will incur continued losses for the foreseeable future.
  • If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, scale back or discontinue some of our product candidate development programs or commercialization efforts.
  • Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
  • Our independent registered public accounting firm has expressed substantial doubt about our ability to continue as a going concern.
  • Our ability to utilize our net operating loss carryforwards and certain other tax attributes in the future may be limited.
  • We depend heavily on the success of our lead product candidates, OST-HER2 and OST-tADC. We may not be able to obtain regulatory approval for, or successfully commercialize, any of our current or future product candidates.
The other 56 risks
  • Delays or difficulties in enrolling patients in clinical trials could prevent or delay regulatory approval and increase development costs.
  • If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals for both our current or future product candidates, we will not be able to commercialize, or will be delayed in commercializing, our current or future product candidates, and our ability to generate revenue will be materially impaired.
  • Our current or future product candidates may cause adverse or other undesirable side effects that could delay or prevent their regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences following marketing approval, if any.
  • A breakthrough therapy designation by the FDA for our current or future product candidate does not convey any advantage in, or shorten the duration of, the regulatory review or approval process, and it does not increase the likelihood that our current or future product candidates will receive marketing approval.
  • A fast track designation by the FDA does not convey any advantage in, or shorten the duration of, the regulatory review regulatory review or approval process.
  • We may not be able to obtain or maintain orphan drug designation or exclusivity for any product candidates and, even if we do, that exclusivity may not prevent the FDA, EMA or other regulatory authorities from approving other competing products.
  • Although we have obtained rare pediatric disease designation for OST-HER2 for Osteosarcoma patients, we may not be eligible to receive a priority review voucher in the event that FDA approval does not occur within the timeframe required by the applicable statutory provisions or if future law changes eliminate or further modify the PRV Program.
  • Even if we receive regulatory approval for any of our current or future product candidates, we will be subject to ongoing obligations and continued regulatory review, which may result in significant additional expense. Additionally, our current or future product candidates, if approved, could be subject to labeling and other restrictions and market withdrawal and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our drugs.
  • Positive results from early preclinical studies and clinical trials of our current or future product candidates are not necessarily predictive of the results of later preclinical studies and clinical trials of our current or future product candidates. If we cannot replicate the positive results from our earlier preclinical studies and clinical trials of our current or future product candidates in our later preclinical studies and clinical trials, we may be unable to successfully develop, obtain regulatory approval for and commercialize our current or future product candidates.
  • Manufacturing our current or future product candidates is complex and we may encounter difficulties in production. If we encounter such difficulties, our ability to provide our current or future product candidates for preclinical studies and clinical trials or for commercial purposes could be delayed or stopped.
  • Our future growth may depend, in part, on our ability to penetrate foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties that could materially adversely affect our business.
  • We may in the future conduct clinical trials for current or future product candidates outside the United States, and the FDA and comparable foreign regulatory authorities may not accept data from such trials.
  • We may not be successful in our efforts to identify or discover additional product candidates or we may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
  • Although a larger number of Osteosarcoma patients reside outside the United States, our ability to generate meaningful revenues in those jurisdictions may be limited due to pricing controls, reimbursement limitations, and other market access challenges.
  • Risks Related to Commercialization
  • Even if we receive marketing approval for our current or future product candidates, our current or future product candidates may not achieve broad market acceptance, which would limit the revenue that we generate from their sales.
  • We face substantial competition, which may result in others discovering, developing or commercializing drugs before or more successfully than we do.
  • Product liability lawsuits against us could cause us to incur substantial liabilities and could limit commercialization of any current or future product candidates that we may develop.
  • Even if we are able to commercialize any current or future product candidates, such drugs may become subject to unfavorable pricing regulations or third-party coverage and reimbursement policies, which would harm our business.
  • Healthcare reform measures may have a material adverse effect on our business and results of operations.
  • If, in the future, we are unable to establish sales and marketing and patient support capabilities or enter into agreements with third parties to sell and market our current or future product candidates, we may not be successful in commercializing our current or future product candidates if and when they are approved, and we may not be able to generate any revenue.
  • Our relationships with prescribers, customers and third-party payors will be subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose us to significant penalties and adversely affect our business.
  • We may face potential liability and increased regulatory scrutiny if we obtain, use or fail to adequately protect identifiable patient health information in connection with our clinical trials and operations.
  • If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business.
  • If the market opportunities for OST-HER2 and our other current and future product candidates are smaller than we believe they are, our revenue may be adversely affected and our business may suffer. Moreover, because the target patient populations we are seeking to treat are small, we must be able to successfully identify patients and capture a significant market share to achieve profitability and growth.
  • Risks Related to Our Dependence on Third Parties
  • We rely, and expect to continue to rely, on third parties to conduct our ongoing and planned clinical trials for our current and future product candidates. If these third parties do not successfully carry out their contractual duties, comply with regulatory requirements or meet expected deadlines, we may not be able to obtain marketing approval for or commercialize our current and potential future product candidates and our business could be substantially harmed.
  • The third parties upon whom we rely for the supply of the active pharmaceutical ingredient, or API, drug product and drug substance used in our core product candidates are limited in number, and the loss of any of these suppliers could significantly harm our business.
  • Our success is dependent on our executive management team’s ability to successfully pursue business development, strategic partnerships and investment opportunities as our company matures. We may also form or seek strategic alliances or acquisitions or enter into additional collaboration and licensing arrangements in the future, and we may not realize the benefits of such collaborations, alliances, acquisitions or licensing arrangements.
  • Our manufacturing process needs to comply with FDA 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.
  • If we and the third parties from whom we in-license intellectual property are unable to obtain, maintain, protect, or enforce patent and other intellectual property rights for our technology and product candidates, or if the scope of such protection is not sufficiently broad, our competitors could develop and commercialize similar or identical technologies and products, and our ability to successfully commercialize our product candidates may be impaired.
  • If our trademarks and trade names for our products or company name are not adequately protected in one or more countries where we intend to market our products, we may delay the launch of product brand names, use different trademarks or tradenames in different countries, or face other potentially adverse consequences to building our product brand recognition.
  • If we are unable to adequately protect and enforce our trade secrets, our business and competitive position would be harmed.
  • We may initiate, become a defendant in, or otherwise become party to lawsuits to protect or enforce our intellectual property rights, which could be expensive, time-consuming and unsuccessful.
  • Intellectual property litigation and administrative patent office patent validity challenges in one or more countries could cause us to spend substantial resources and distract our personnel from their normal responsibilities.
  • We may be unable to obtain patent or other intellectual property protection for our current or future product candidates or our future products, if any, in all jurisdictions throughout the world, and we may not be able to adequately enforce our intellectual property rights even in the jurisdictions where we seek protection.
  • We may not obtain or grant licenses or sublicenses to intellectual property rights in all markets on equally or sufficiently favorable terms with third parties.
  • If we fail to comply with our obligations in any agreements under which we may license intellectual property rights from third parties or otherwise experience disruptions to our business relationships with our licensors, we could lose license rights that are important to our business.
  • Changes in patent law could diminish the value of patents in general, thereby impairing our ability to protect our current or future product candidates.
  • Intellectual property rights do not guarantee commercial success of current or future product candidates or other business activities. Numerous factors may limit any potential competitive advantage provided by our intellectual property rights.
  • Risks Related to Employee Matters, Managing Growth and Other Risks Related to Our Business
  • Our current operations are located in Maryland; and we or the third parties upon whom we depend may be adversely affected by natural disasters and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.
  • Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel.
  • We will need to develop and expand our company, and we may encounter difficulties in managing this development and expansion, which could disrupt our operations.
  • Failure to maintain effective internal controls in accordance with Section 404 of the Sarbanes-Oxley Act could have a material adverse effect on our business, results of operation or financial condition. In addition, current and potential stockholders could lose confidence in our financial reporting, which could have a material adverse effect on the price of the common stock.
  • Unstable market and economic conditions may have serious adverse consequences on our business, financial condition and stock price.
  • Our internal computer systems, or those of our third-party CROs or other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of our current or future product candidates’ development programs.
  • We may be unable to adequately protect our information systems from cyberattacks, which could result in the disclosure of confidential or proprietary information, including personal data, damage our reputation, and subject us to significant financial and legal exposure.
  • Our employees, principal investigators, CROs and consultants may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading.
  • Use of artificial intelligence, machine learning and algorithmic tools involves risks that could materially and adversely affect our business, results of operations and development timelines.
  • Geopolitical events, trade restrictions, sanctions and export controls could adversely affect our clinical operations, supply chain, data flows and financial transactions.
  • Risks Related to Our Common Stock
  • A significant number of additional shares of our common stock may be issued pursuant to outstanding preferred stock, warrants, stock options and convertible securities, which issuances could substantially dilute existing stockholders and may depress the market price of our common stock.
  • Sales of a substantial number of shares of our common stock, including those issued pursuant to the Sales Agreement, could cause the market price of our common stock to decline.
  • It is not possible to predict the aggregate proceeds resulting from sales made under the Sales Agreement.
  • The common stock offered pursuant to the Sales Agreement will be sold in “at the market offerings,” and investors who buy shares at different times will likely pay different prices.
  • Paul A. Romness, MPH, and our other executive officers, directors and their affiliates exercise significant influence over our company, which will limit your ability to influence corporate matters and could delay or prevent a change in corporate control.
  • We are incurring increased costs as a result of operating as a public company, and our management is required to devote substantial time to new compliance initiatives.
  • We have not paid, and do not intend to pay, dividends on our shares of common stock and, therefore, unless our common stock appreciates in value, our investors may not benefit from holding our shares.

Legal proceedings

The information contained in Note 6 to our consolidated financial statements included in this Form 10-K is incorporated herein by reference.

The opening of Item 3, Legal Proceedings.4

Sources

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  18. 18
  19. 19
  20. 20
  21. 21
  22. 22
  23. 23
    SEC EDGAROther events
  24. 24
  25. 25
  26. 26
  27. 27
  28. 28
  29. 29
  30. 30
  31. 31
  32. 32
  33. 33
    SEC EDGAROther events
  34. 34
  35. 35
  36. 36
  37. 37
  38. 38
  39. 39
  40. 40
  41. 41
  42. 42
  43. 43
  44. 44
  45. 45
  46. 46
  47. 47
  48. 48
  49. 49
  50. 50