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ACTU on Nasdaq

ACTUATE THERAPEUTICS, INC.

ACTUATE THERAPEUTICS, INC. is an American pharmaceutical preparations company based in Fort Worth.1

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Last updated Oct 21, 2026.

Overview

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  • TickerACTU on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersFort Worth, Texas1
  • Incorporated inDE2
  • Business address1751 River Run, Suite 400, Fort Worth, Tx 761072
  • Filer categoryNon-accelerated filer, Smaller reporting company, Emerging growth company2
  • Legal formCorporation

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500 patients with elraglusib as an IV injection (“Elraglusib Injection”) in Phase 1 and Phase 2 studies.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-$22.5M in 2025−10% since 2023
-$30.0M-$20.0M-$10.0M02023: -$25.0M-$25.0M20232024: -$25.2M-$25.2M2024+1%2025: -$22.5M-$22.5M2025−11%
Net income56-$22.2M in 2025−10% since 2023
-$30.0M-$20.0M-$10.0M02023: -$24.7M-$24.7M20232024: -$27.3M-$27.3M2024+10%2025: -$22.2M-$22.2M2025−19%

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$10.3M$18.7M
General and administrative$12.2M$6.5M
Total operating expenses$22.5M$25.2M
Loss from operations-$22.5M-$25.2M
Change in estimated fair value of warrant liability$0-$78.9K
Gain on settlement of warrants$0$343.2K
Loss on issuance of related party convertible notes payable at fair value$0-$400.0K
Change in estimated fair value of related party convertible notes payable$0-$2.2M
Interest expense-$20.2K-$18.7K
Interest income$287.7K$222.3K
Total other income (expense), net$267.5K-$2.1M
Net loss-$22.2M-$27.3M
Weighted-average shares of common stock outstanding, basic21.0M shares8.4M shares
Weighted-average shares of common stock outstanding, diluted21.0M shares8.4M shares
Net loss per share attributable to common stockholders, basic-$1.06-$3.26
Net loss per share attributable to common stockholders, diluted-$1.06-$3.26

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Corporate structure

ACTUATE THERAPEUTICS, INC. sits at the top of its group. 1 entity, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of ACTUATE THERAPEUTICS, INC.

  • Voss Capital, LP Filed SCHEDULE 13G/A on ACTUATE THERAPEUTICS, INC., latest Apr 22, 2026 (2 filings since Dec 17, 2025)
  • BIOS Fund I, LP Filed SCHEDULE 13D/A on ACTUATE THERAPEUTICS, INC., latest Jun 30, 2025 (3 filings since Aug 19, 2024)
  • ACTUATE THERAPEUTICS, INC. Fort Worth, Texas

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 ACTUATE THERAPEUTICS, 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.

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$13.2M6 Dec 31, 2025$8.6M5 Dec 31, 2024+52.3%

Properties, in its own words

Our principal executive offices are located in Fort Worth, Texas, whereby we rent limited office space in a shared environment on a month-to-month basis beginning December 1, 2024 at an initial rate of $4,200 per month. Rent expense for the years ended December 31, 2025 and 2024 was $51,200 and $4,200, respectively. Prior to December 1, 2024, we utilized office space made available to us by our largest investor for administrative purposes at no cost to the Company. We believe that our current arrangement is sufficient to meet our needs for the foreseeable future and that any additional space we may require will be available on commercially reasonable terms. All research and development activities are undertaken at CROs or with academic collaborators.

Item 2 of the 10-K filed Mar 26, 2026.4

Leadership

Who has led ACTUATE THERAPEUTICS, INC., and when. Pick a name to see everywhere that person has worked.

Chief executive

  1. Daniel M. Schmitt2024–now

President

  1. Daniel M. Schmitt2024–now

Chief financial officer

  1. Paul J. Lytle2024–now

Chief operating officer

  1. Andrew Paul Mazar2024–now
2025
Board members and other officers (11)

Named in SEC Form D filings

People the company listed in its private-offering notices.

  • DirectorAmy G.L. Ronneberg named Apr 10, 2025 to Jul 7, 202520
  • DirectorDaniel G.L. Zabrowski named Apr 10, 2025 to Jul 7, 202520
  • DirectorDan Zabrowski named Mar 6, 202421
  • DirectorDan Wayne Zabrowski named Dec 15, 202222

Subsidiaries and ownership

Subsidiaries (Exhibit 21)

  • Actuate Therapeutics LTD Ireland3

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

Timeline

  1. Jul 17, 20268-K Listing notice or transfer23
  2. May 22, 20268-K Shareholder vote24
  3. May 11, 20268-K Regulation FD disclosure25
  4. May 6, 20268-K Executive or director change; Other events26
  5. Jan 12, 20268-K Regulation FD disclosure27
  6. Nov 28, 20258-K Entered a material agreement28
  7. Nov 21, 20258-K Other events29
  8. Sep 10, 20258-K Entered a material agreement; Other events30
  9. Jun 26, 20258-K Entered a material agreement; Unregistered sale of shares31
  10. Jun 5, 20258-K Regulation FD disclosure32
  11. Jun 2, 20258-K Regulation FD disclosure; Other events33
  12. May 23, 20258-K Shareholder vote34
  13. Aug 12, 2024New chief executive Daniel M. Schmitt becomes CEO9

Calendar

Coming up

  1. Nov 12, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.25) a share, on Nov 13, 2025.35

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

Filings

174 filings to the SEC since October 2021: 2 annual reports, 7 quarterly reports, 19 major events, 54 insider forms, 5 large holders, 5 private raises, 82 other. The latest 20:

  1. Oct 14, 2026S-1/A FORM S-1 AMENDMENT EDGAR
  2. Oct 8, 2026FWP FREE WRITING PROSPECTUS EDGAR
  3. Oct 6, 2026S-1 REGISTRATION STATEMENT EDGAR
  4. Aug 14, 20264 EDGAR
  5. Aug 14, 202610-Q FORM 10-Q FOR JUN 2026 EDGAR
  6. Jul 17, 20268-K CURRENT REPORT EDGAR
  7. Jun 8, 2026DRS EDGAR
  8. May 22, 20268-K CURRENT REPORT EDGAR
  9. May 22, 20264 EDGAR
  10. May 22, 20264 EDGAR
  11. May 22, 20264 EDGAR
  12. May 22, 20264 EDGAR
  13. May 22, 20264 EDGAR
  14. May 22, 20264 EDGAR
  15. May 22, 20264 EDGAR
  16. May 14, 2026S-8 INITIAL REGISTRATION STATEMENT EDGAR
  17. May 14, 202610-Q FORM 10-Q FOR MAR 2026 EDGAR
  18. May 11, 20268-K EDGAR
  19. May 6, 20263 EDGAR
  20. May 6, 2026DEFA14A ADDITIONAL DEFINITIVE PROXY SOLICITING MATERIALS EDGAR

The 174 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

14 open-market trades by officers, directors and large owners since October 2021: 6 buys and 8 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Jan 5, 2026THOMSON TODD SDirectorSale280,000$5.80$1.6MForm 4
Jun 27, 2025Bios Equity COF, LPDirectorBuy71,428$7.00$500.0KForm 4
Jun 27, 2025BIOS Fund II, LPDirectorBuy71,428$7.00$500.0KForm 4
Jun 27, 2025BIOS Actuate Co-Invest I, LPDirectorBuy71,428$7.00$500.0KForm 4
Aug 14, 2024Bios Clinical Opportunity Fund, LPDirectorSale24,999$8.00$200.0KForm 4
Aug 14, 2024BIOS Capital Management, LPDirectorSale24,999$8.00$200.0KForm 4
Aug 14, 2024BIOS Fund II, LPDirectorSale24,999$8.00$200.0KForm 4
Aug 14, 2024Kairos-Actuate SPV, L.P.DirectorSale18,750$8.00$150.0KForm 4
Aug 14, 2024BP Directors, LPDirectorBuy500,000$8.00$4.0MForm 4
Aug 14, 2024BP Directors, LPDirectorSale24,999$9.00$225.0KForm 4
Aug 14, 2024BIOS Equity Partners III, LPDirectorBuy500,000$8.00$4.0MForm 4
Aug 14, 2024BIOS Equity Partners III, LPDirectorSale24,999$9.00$225.0KForm 4
Aug 14, 2024BIOS Fund II QP, LPDirectorBuy500,000$8.00$4.0MForm 4
Aug 14, 2024BIOS Fund II QP, LPDirectorSale24,999$9.00$225.0KForm 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
2025Daniel M. Schmitt64$570.0K$2.2M38
2025Andrew P. MazarPh. D.$450.0K$1.4M38
2025Paul Lytle58$435.4K$1.0M38
2024President and Chief Executive Officer$400.0K$5.6M38
2024Chief Financial Officer$210.0K$1.9M38
2024Chief Operating Officer$450.0K$675.0K38

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$27.0M 2022–2025
Money received by yearMoney received by year, 2022–2025: $27.0M in all. Private raises (Form D) $27.0M.$0$5M$10M$15M$20M2022 · Private raises (Form D): $19.3M202220232024 · Private raises (Form D): $3.0M20242025 · Private raises (Form D): $4.7M2025
Figures by year
YearPrivate raises (Form D)Total
2025$4.7M$4.7M
2024$3.0M$3.0M
2022$19.3M$19.3M

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. Jun 27, 2025Raised $4.7 million in a private offering of equity20 Form D: $9.3 million offered in all Form D
  2. Apr 10, 2025Filed a private offering of equity39 Form D: $50 million offered in all Form D
  3. Feb 20, 2024Raised $3 million in a private offering of debt21 Form D: $5 million offered in all Form D
  4. Sep 30, 2022Raised $19.3 million in a private offering of equity22 Form D: $50 million offered in all 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 64. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
BIOS Capital Management, LP10,049,996$15.4M36.9%No change
Voss Capital, LP1,725,000$2.6M0.1%No change
Vanguard Capital Management LLC393,433$602.0K0.0%−7,096
Aqr Capital Management LLC127,493$195.1K0.0%+100,384
Geode Capital Management, LLC112,554$172.2K0.0%−115,777
Texas Capital Bank Wealth Management Services Inc102,612$157.0K0.0%+8,020
Palogic Value Management, L.P.100,000$153.0K0.1%No change
Millennium Management LLC96,684$147.9K0.0%New
BlackRock, Inc.90,035$137.8K0.0%−337,118
ABS Investment Management LLC73,186$112.0K0.1%New
ABS Direct Equity Fund LLC73,186$112.0K0.1%+23,186
Vanguard Fiduciary Trust Co54,497$83.4K0.0%−8,095
Rock Creek Group LLC39,263$60.1K0.0%No change
Jane Street Group, LLC39,132$59.9K0.0%New
HighTower Advisors, LLC36,461$55.8K0.0%New
Goldman Sachs Group Inc35,498$54.3K0.0%+23,090
Sfmg, LLC33,000$50.5K0.0%No change
Susquehanna International Group, Llp28,182$43.1K0.0%New
Bridgeway Capital Management, LLC23,482$35.9K0.0%−7,500
State Street Corp21,850$33.4K0.0%−44,180
Northern Trust Corp21,220$32.5K0.0%−76,631
Mariner, LLC21,082$32.3K0.0%New
Gleason Group, Inc.19,028$29.1K0.0%No change
Northwestern Mutual Wealth Management Co18,518$28.3K0.0%−12,878
Qube Research & Technologies Ltd15,256$23.3K0.0%New

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

SEC filer profile

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

  • Name on EDGARACTUATE THERAPEUTICS, INC.1
  • CIK0001652935
  • Employer ID (EIN)47-30447854
  • Filer statusNon-accelerated filer4
  • Incorporated inDelaware4
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address1751 River Run, Suite 400, Fort Worth, TX 761071
  • Phone847-986-41901
  • Shares outstanding24,014,202 as of Aug 13, 20268
  • Public float$42.1M as of Jun 30, 20254
  • AuditorCrowe LLP, Costa Mesa, California PCAOB ID 173; no auditor attestation of internal control over financial reporting4
  • On EDGAR sinceOct 8, 20151
  • Filings182 in all: 4 (38), CORRESP (21), 8-K (19), 3 (13), D (11), UPLOAD (9), 10-Q (7), S-1/A (6)1
    All 35 form types

    FWP (5), DRSLTR (4), EFFECT (4), S-1 (4), 4/A (3), 424B5 (3), DEFA14A (3), DRS (3), DRS/A (3), S-8 (3), 10-K (2), 424B3 (2), D/A (2), DEF 14A (2), SCHEDULE 13D/A (2), SEC STAFF LETTER (2), 144 (1), 424B4 (1), 8-A12B (1), 8-A12B/A (1), ARS (1), CERT (1), POS EX (1), S-3 (1), SC 13D (1), SCHEDULE 13G (1), SCHEDULE 13G/A (1)

  • Latest filingsAnnual report (10-K) Mar 26, 2026
    Quarterly report (10-Q) Aug 14, 2026
    Proxy statement (DEF 14A) Apr 6, 2026
    Latest 8-K (8-K) Jul 17, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.000001 per shareACTUNasdaq

From the cover page of the 10-K filed Mar 26, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks ACTUATE THERAPEUTICS, INC. names in Item 1A of its 10-K filed Mar 26, 2026: 57 risks under these headings, as written.4

  • Risks Related to Our Limited Operating History, Financial Condition and Capital Requirements
  • We have a limited operating history, have incurred significant operating losses since our inception and expect to incur significant operating losses for the foreseeable future. We may never generate revenue or achieve profitability, and if we do achieve profitability, it may not be sustained.
  • We will require substantial additional capital to finance our operations, and a failure to obtain this necessary capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our development programs, commercialization efforts or our operations.
  • Raising additional capital or acquiring or licensing assets by issuing equity or debt securities may cause dilution to our stockholders, and raising funds through lending and licensing arrangements may restrict our operations or require us to relinquish proprietary rights.
  • Risks Related to the Development and Commercialization of Our Product Candidates
  • We currently depend entirely on the success of elraglusib, which is our only product candidate. If we are unable to advance elraglusib in clinical development, obtain regulatory approval and ultimately commercialize elraglusib in a timely manner, our business will be materially harmed.
  • We do not have and may never have any approved products on the market. Our business is highly dependent upon receiving approvals from various governmental agencies and will be severely harmed if we are not granted approval to manufacture and sell our product candidates.
  • Clinical and preclinical drug development involves a lengthy and expensive process with uncertain timelines and outcomes, and the results of preclinical studies and early clinical trials are not necessarily predictive of future results. Elraglusib or any future product candidates may not achieve favorable results or receive regulatory approval on a timely basis, if at all.
  • We may not be successful in our efforts to advance elraglusib in additional indications. We may expend our limited resources to pursue a new product candidate or a particular indication for elraglusib and fail to capitalize on more profitable or successful alternatives.
  • If we experience delays or difficulties enrolling subjects to our clinical trials, our receipt of necessary regulatory approvals could be delayed or otherwise adversely affected.
  • As a company, we have not yet initiated nor completed a Phase 3 clinical trial and have limited experience in completing regulatory filings, and any delays in regulatory filings could materially affect our financial condition.
  • Interim, topline, and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
The other 46 risks
  • We anticipate that many of our product candidates may be tested and, if approved, used in combination with third-party drugs and/or devices, some of which may still be in development, and we have limited or no control over the supply, regulatory status or regulatory approval of such drugs and/or devices.
  • We may seek additional Orphan Drug, Fast Track (“FTD”), Breakthrough (“BTD”) or orphan and priority (“PRIME”) designations for one or more of our current and future product candidates, but we might not receive any such designation, and even if we do, such designation may not actually lead to a faster development or regulatory review or approval process.
  • We, or any future collaborators, may not be able to obtain and maintain orphan drug exclusivity for our product candidates in the United States and Europe.
  • 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 may be adversely affected and our business may suffer.
  • Our product development efforts are at an early stage. 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.
  • We currently have no marketing and sales organization and have no experience as a company in commercializing products, and we may need to invest significant resources to develop these capabilities. If we are unable to establish marketing and sales capabilities or enter into agreements with third parties to market, sell and distribute our products, we may not be able to generate product revenue.
  • 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.
  • The successful commercialization of elraglusib or any future product candidates, if approved, will depend in part on the extent to which governmental authorities and health insurers establish coverage, adequate reimbursement levels and favorable pricing policies. Failure to obtain or maintain coverage and adequate reimbursement for our products could limit our ability to market those products and decrease our ability to generate revenue.
  • Risks Related to Our Reliance on Third Parties
  • The termination of third-party licenses could adversely affect our rights to important technologies.
  • Our current drug substance (“DS”) manufacturer of elraglusib is in China, and it is unknown how current or future geopolitical relationships with China may affect our ability to obtain DS, increase our costs, delay clinical trials and potential regulatory approval, and adversely impact our financial condition.
  • We rely on third parties for the manufacture and shipping of elraglusib for clinical development and expect to continue to do so for the foreseeable future. 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/or meet demand for our products and lose time to market and potential revenues.
  • We depend on a third-party manufacturer for certain drug substances, drug products, raw materials, samples, components, and other materials used in our product candidates. We obtain our supplies on a purchase order basis and do not have any long-term supply agreements in place. If we are unable to source these supplies on a timely basis, or establish longer-term contracts with suppliers, we will not be able to complete our clinical trials or studies on time and the development of our product candidates may be delayed.
  • We rely on third parties to conduct our non-clinical studies and clinical trials. If these parties do not successfully carry out their duties or meet deadlines, we may be unable to obtain regulatory approval for or commercialize our product candidates and adversely affect our financial condition.
  • Our reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor or other third party will discover them or that our trade secrets will be misappropriated or disclosed.
  • 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 may also rely on certain third-party vendors located in China or who are owned by or are associated with certain Chinese companies to assist in non-clinical or clinical trials or provide laboratory services. It is unknown how current or future geopolitical relationships with China or specific Chinese-owned or associated vendors may affect our ability to complete our non-clinical or clinical trials.
  • Risks Related to Our Intellectual Property
  • We may not be able to enforce our intellectual property rights throughout the world.
  • If we and our third-party licensors do not obtain and preserve protection for key intellectual property rights, our competitors may be able to take advantage of our (and our licensors’) development efforts.
  • The patent protection we obtain and preserve for our product candidates may not be sufficient to provide us with any competitive advantage.
  • Intellectual property disputes could require us to spend time and money to address such disputes and could limit our intellectual property rights.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • Changes to the patent law in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.
  • Patent terms may be inadequate to protect the competitive position of elraglusib or any future product candidates for an adequate amount of time.
  • We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property.
  • 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.
  • We may be subject to claims that our employees, consultants, or advisors have wrongfully used or disclosed alleged trade secrets of their current or former employers or claims asserting ownership of what we regard as our own intellectual property.
  • Some intellectual property which we own or have licensed, or which may acquire or license in the future, may have been, or may be, discovered through government funded programs and thus may be subject to federal regulations such as “march-in” rights, certain reporting requirements, and a preference for United States industry. Compliance with such regulations may limit our exclusive rights, subject us to expenditure of resources with respect to reporting requirements and limit our ability to contract with non-U.S. manufacturers.
  • Risks Related to Our Business Operations and Industry
  • We may be subject to various U.S. federal, state and foreign healthcare laws and regulations, which could increase compliance costs, and our failure to comply with these laws and regulations could harm our reputation, subject us to significant fines and liability or otherwise adversely affect our business.
  • The U.S. Congress, the Trump administration, or any new administration may make substantial changes to fiscal, tax, and other federal policies that may adversely affect our business.
  • We may engage in strategic transactions that could impact our liquidity, increase our expenses and present significant distractions to our management.
  • Our information technology systems, or those of any of our service providers, may fail or suffer security incidents and other disruptions, which could result in a material disruption of our development programs, compromise sensitive information related to our business or prevent us from accessing critical information, potentially exposing us to liability or otherwise adversely affecting our business.
  • Failure to comply with health privacy and other 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.
  • Disruptions at the FDA and other government agencies caused by funding shortages, changes in personnel, or global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved or commercialized in a timely manner or at all, which could negatively impact our business.
  • Effective collaboration with the FDA’s Center for Drug Evaluation and Research (“CDER”) for the approval of drug candidates is a highly demanding process which can result in increased time and expense to gain approvals.
  • Risks Related to our Common Stock
  • Concentration of ownership by our principal stockholders limits the ability of others to influence the outcome of director elections and other transactions requiring stockholder approval, creates the potential for conflicts of interest, may negatively impact our stock price and may deter or prevent efforts by others to acquire us, preventing our stockholders from realizing a control premium.
  • There was no public market for our common stock prior to the IPO in August 2024. An active, liquid and orderly market for our common stock may not be sustained, or we may in the future fail to satisfy the continued listing requirements of Nasdaq, and you may not be able to resell your shares at or above your purchase price or at all.
  • The trading price of the shares of our common stock could be highly volatile regardless of our operating performance, and purchasers of our common stock could incur substantial losses.
  • We do not intend to pay dividends in the foreseeable future and, as a result, your ability to achieve a return on your investment will depend on appreciation in the price of our common stock.
  • Delaware law and provisions in our amended and restated bylaws could make a merger, tender offer or proxy contest difficult, thereby depressing the potential trading price of our common stock.
  • Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware will be the exclusive forum for substantially all disputes between us and our stockholders and that the federal district courts shall be the exclusive forum for the resolution of any complaint asserting a cause of action arising under the Securities Act, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees or the underwriters of any offering giving rise to such claim.
  • General Risk Factors
  • Unstable market and economic conditions may have serious adverse consequences on our ability to raise funds, which may cause us to cease or delay our operations.
  • If securities or industry analysts do not publish research or reports or publish unfavorable research or reports about our business, our stock price and trading volume could decline.
  • If we fail to maintain proper and effective internal control over financial reporting, our ability to produce accurate and timely financial statements could be impaired, investors may lose confidence in our financial reporting and the trading price of our common stock may decline.

Legal proceedings

Information pertaining to legal proceedings is provided in Note 6 - Commitments and Contingencies, to the consolidated financial statements included in this Report and is incorporated herein by reference.

The opening of Item 3, Legal Proceedings.4

Sources

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    SEC EDGAROther events
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