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CING on Nasdaq

Cingulate Inc.

Cingulate Inc. is an American pharmaceutical preparations company, incorporated in Delaware.1 It is headquartered in Kansas City, Kansas.1

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Last updated Oct 21, 2026.

Overview

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  • TickerCING on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersKansas City, Kansas1
  • Incorporated inDE2
  • Business address1901 W. 47Th Place, Kansas City, Ks 662052
  • Filer category, Emerging growth company2

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These forward-looking statements include, without limitation, statements about the following:3 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 income45678-$19.9M in 2025+181% since 2020
-$30.0M-$20.0M-$10.0M02020: -$7.1M-$7.1M20202021: -$20.7M-$20.7M2021+192%2022: -$17.5M-$17.5M2022−15%2023: -$22.8M-$22.8M2023+30%2024: -$15.6M-$15.6M2024−31%2025: -$19.9M-$19.9M2025+27%
Net income45678-$22.4M in 2025+213% since 2020
-$30.0M-$20.0M-$10.0M02020: -$7.2M-$7.2M20202021: -$20.7M-$20.7M2021+188%2022: -$17.7M-$17.7M2022−15%2023: -$23.5M-$23.5M2023+33%2024: -$16.6M-$16.6M2024−30%2025: -$22.4M-$22.4M2025+36%

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$9.8M$9.4M
General and administrative$10.2M$6.2M
Operating loss-$19.9M-$15.6M
Issuance cost and change in fair value of derivative-$1.2M-$1.0M
Interest and other income (expense), net-$1.4M$99.2K
Loss before income taxes-$22.4M-$16.6M
Net loss and comprehensive loss-$22.4M-$16.6M
Net loss per share of common stock, basic-$4.44-$10.86
Net loss per share of common stock, diluted-$4.44-$10.86
Weighted average number of shares used in computing net loss per share of common stock, basic5.1M shares1.5M shares
Weighted average number of shares used in computing net loss per share of common stock, diluted5.1M shares1.5M shares

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Corporate structure

Cingulate 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 Cingulate Inc.

  • Falcon Creek Capital Advisor LLC Filed SCHEDULE 13D/A on Cingulate Inc., latest Mar 26, 2026 (2 filings since Feb 9, 2026)
  • Lind Global Fund II LP Filed SC 13G/A on Cingulate Inc., latest Nov 14, 2024 (2 filings since Feb 9, 2024)
  • Peter J. Werth Filed SC 13D/A on Cingulate Inc., latest Aug 30, 2024 (18 filings since Dec 20, 2021)
  • Shane J. Schaffer Filed SC 13D/A on Cingulate Inc., latest Jan 4, 2024 (5 filings since Dec 20, 2021)
  • Matthew Brams Filed SC 13G/A on Cingulate Inc., latest Jul 25, 2023 (3 filings since Feb 14, 2022)
  • SABBY MANAGEMENT, LLC Filed SC 13G/A on Cingulate Inc., latest Jan 10, 2023 (3 filings since Dec 14, 2021)
  • Cingulate Inc. Kansas City, Kansas

Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Cingulate 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, before depreciation$5.6M8 Dec 31, 2025$5.4M8 Dec 31, 2024+3.0%
Accumulated depreciation$3.8M8 Dec 31, 2025$3.3M8 Dec 31, 2024+16.4%
Property and equipment, net$1.7M8 Dec 31, 2025$2.1M8 Dec 31, 2024−18.0%
Operating-lease assets (leased space)$1.3M8 Dec 31, 2025$99.0K8 Dec 31, 2024+1252.5%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$11.0M8 Dec 31, 2025$12.2M8 Dec 31, 2024−10.3%

Properties, in its own words

Our corporate headquarters is located in Kansas City, Kansas, where we lease approximately 14,205 square feet of office space. Our lease expires in May 2030, with an option to extend. We executed a sub-lease of a portion of our Kansas City office space through September 1, 2027. Our manufacturing activities take place at Core Rx, Inc. (dba Bend Bioscience), our CDMO in Gainesville, Georgia. We believe our current offices, laboratories, and manufacturing spaces are sufficient to meet our needs. We may seek to negotiate new leases or evaluate additional or alternate space to accommodate operations. We believe that appropriate alternative space is readily available on commercially reasonable terms.

Item 2 of the 10-K filed Mar 18, 2026.3

Leadership

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

Chief executive

  1. Shane J. Schaffer2021–now

Chief financial officer

  1. Horn Louis G. Van2021–2023
  2. Jennifer L. Callahan2024–now

Chief operating officer

  1. Laurie Myers2021–now
2025
Board members and other officers (17)

Timeline

  1. Oct 2, 20268-K Executive or director change31
  2. Aug 13, 20268-K Results of operations32
  3. Jul 23, 20268-K Executive or director change33
  4. Jul 14, 20268-K Executive or director change; Shareholder vote34
  5. Jul 2, 20268-K Executive or director change; Regulation FD disclosure35
  6. Jun 16, 20268-K Regulation FD disclosure36
  7. Jun 2, 20268-K Regulation FD disclosure; Other events37
  8. May 19, 20268-K Executive or director change38
  9. May 14, 20268-K Results of operations39
  10. Apr 2, 20268-K Executive or director change40
  11. Mar 24, 20268-K Entered a material agreement; Shareholder vote41
  12. Mar 18, 20268-K Results of operations; Other events42
  13. Dec 7, 2021New chief executive Shane J. Schaffer becomes CEO11

Calendar

Coming up

  1. Nov 12, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($1.35) a share, on Nov 13, 2025.43

When it reported results

  1. Aug 13, 2026Reported quarterly or annual results32
  2. May 14, 2026Reported quarterly or annual results39
  3. Mar 18, 2026Reported quarterly or annual results42
  4. Nov 13, 2025Reported quarterly or annual results44
  5. Aug 19, 2025Reported quarterly or annual results45
  6. May 8, 2025Reported quarterly or annual results46
  7. Mar 26, 2025Reported quarterly or annual results47
  8. Nov 7, 2024Reported quarterly or annual results48

Drug trials and FDA: recently

  1. Feb 29, 2024Phase 3 trial completed Phase 3 trial of CTx-1301-Dexmethylphenidate 12.5 mg (titration only), CTx-1301-Dexmethylphenidate 18.75mg (randomized fixed dose) and others in ADHD: primary completion Feb 29, 2024, results posted Jan 22, 2026 (ClinicalTrials.gov NCT05286762).49
  2. Jun 13, 2023Phase 3 trial completed Phase 3 trial of CTx-1301 - Dexmethylphenidate 25mg, CTx-1301 - Dexmethylphenidate 37.5mg and others in ADHD: primary completion Jun 13, 2023, results posted Jul 2, 2026 (ClinicalTrials.gov NCT05631626).50

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). Trials from ClinicalTrials.gov, as the sponsor registered them (expected dates are the sponsor's own and often move); approvals and advisory committee meetings from the FDA. The FDA does not publish its decision (PDUFA) dates. The full markets calendar

Filings

479 filings to the SEC since October 2021: 5 annual reports, 14 quarterly reports, 99 major events, 175 insider forms, 33 large holders, 153 other. The latest 20:

  1. Oct 2, 20264 EDGAR
  2. Oct 2, 20268-K EDGAR
  3. Aug 13, 202610-Q EDGAR
  4. Aug 13, 20268-K EDGAR
  5. Jul 23, 20268-K EDGAR
  6. Jul 20, 20264 EDGAR
  7. Jul 20, 20264 EDGAR
  8. Jul 20, 20264 EDGAR
  9. Jul 20, 20264 EDGAR
  10. Jul 20, 20264 EDGAR
  11. Jul 20, 20264 EDGAR
  12. Jul 20, 20264 EDGAR
  13. Jul 20, 20264 EDGAR
  14. Jul 15, 2026S-8 EDGAR
  15. Jul 14, 20268-K EDGAR
  16. Jul 2, 20264 EDGAR
  17. Jul 2, 20268-K EDGAR
  18. Jun 16, 20268-K EDGAR
  19. Jun 8, 20264 EDGAR
  20. Jun 8, 20263 EDGAR

The 479 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

40 open-market trades by officers, directors and large owners since October 2021: 38 buys and 2 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Feb 13, 2026Hargroves Thomas JeffreyDirectorBuy97,276$5.04$490.3KForm 4
Feb 6, 2026Werth Peter J.DirectorBuy19,455$5.04$98.1KForm 4
Feb 6, 2026Callahan Jennifer L.EVP and CFOBuy4,864$5.04$24.5KForm 4
Feb 6, 2026Schaffer Shane J.Chief Executive OfficerBuy6,809$5.04$34.3KForm 4
Feb 6, 2026Brams MatthewEVP and Chief Medical OfficerBuy1,946$5.04$9.8KForm 4
Aug 15, 2024Myers LaurieEVP and COOSale202$4.17$842Form 4
Sep 15, 2023Callahan Jennifer L.EVP and CFOBuy5,000$0.67$3.4KForm 4
Aug 11, 2023Werth Peter J.DirectorBuy1,823,155$0.55$1.0MForm 4
May 15, 2023Callahan Jennifer L.EVP and CFOBuy2,000$1.01$2.0KForm 4
May 12, 2023Callahan Jennifer L.EVP and CFOBuy4,000$1.08$4.3KForm 4
Dec 16, 2022Schaffer Shane J.Chief Executive OfficerBuy10,000$1.02$10.2KForm 4
Dec 14, 2022Schaffer Shane J.Chief Executive OfficerBuy13,267$1.01$13.4KForm 4
Dec 14, 2022Callahan Jennifer L.EVP and CFOBuy7,548$0.99$7.5KForm 4
Dec 13, 2022Schaffer Shane J.Chief Executive OfficerBuy1,733$1.01$1.8KForm 4
Dec 13, 2022Werth Peter J.DirectorBuy28,934$0.98$28.4KForm 4
Nov 29, 2022Callahan Jennifer L.EVP and CFOBuy1,530$0.98$1.5KForm 4
Nov 28, 2022Callahan Jennifer L.EVP and CFOBuy3,487$0.98$3.4KForm 4
Nov 23, 2022Myers LaurieEVP and COOBuy1,111$0.90$1.0KForm 4
Nov 23, 2022Gilgallon Craig S.EVP and General CounselBuy3,575$0.84$3.0KForm 4
Nov 22, 2022GIVENS GREGG WMDirectorBuy85,000$0.88$74.8KForm 4

All 40 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
2025Shane J. Schaffer,51$479.5K$1.9M57
2025Jennifer L. Callahan55$373.0K$968.9K57
2025Laurie A. Myers$263.2K$608.0K57
2025EVP and CMO$165.0K$492.5K57
2025EVPCLO and CCO$230.5K$404.6K57
2024CEO$319.3K$770.3K57
2024Former EVP and COO$282.7K$458.2K57
2024EVP and CFO$254.0K$446.1K57

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 32. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Vanguard Capital Management LLC570,873$3.1M0.0%+261,906
Raymond James Financial Inc166,898$912.9K0.0%New
Chicago Partners Investment Group LLC188,429$912.0K0.0%+169,679
Kestra Advisory Services, LLC151,500$828.7K0.0%+11,500
Geode Capital Management, LLC144,636$791.4K0.0%+43,263
Renaissance Technologies LLC127,500$697.4K0.0%+95,612
Vanguard Fiduciary Trust Co79,160$433.0K0.0%+29,086
BlackRock, Inc.53,130$290.6K0.0%+29,861
BCV Asset Management Inc.51,200$272.9K0.0%No change
State Street Corp47,888$261.9K0.0%+20,300
Northern Trust Corp35,121$192.1K0.0%+12,849
Quantum Private Wealth, LLC30,000$164.1K0.0%+20,000
Prospera Financial Services Inc29,900$163.6K0.0%+8,100
Jane Street Group, LLC28,878$158.0K0.0%−61,989
UBS Group AG25,947$141.9K0.0%+14,914
Mariner, LLC21,281$116.4K0.0%+8,351
XTX Topco Ltd20,818$113.9K0.0%−32,685
Jump Financial, LLC14,638$80.1K0.0%New
PKS Advisory Services, LLC11,500$62.9K0.0%New
Vanguard Global Advisers, LLC4,743$25.9K0.0%No change
Morgan Stanley4,263$23.3K0.0%+1,863
Osaic Holdings, Inc.2,292$12.5K0.0%+2,250
IFP Advisors, Inc2,000$10.9K0.0%New
Jones Financial Companies Lllp2,000$9.9K0.0%New
Barclays PLC1,566$8.6K0.0%New

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

SEC filer profile

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

  • Name on EDGARCingulate Inc.1
  • CIK0001862150
  • Employer ID (EIN)86-38255353
  • Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; a shell company3
  • Incorporated inDelaware3
  • Fiscal year endsDecember 311
  • Industry code (SIC)2834 Pharmaceutical Preparations1
  • SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
  • Business address1901 W. 47Th Place, Kansas City, KS 662051
  • Phone(913) 942-23001
  • Shares outstanding14,541,826 as of Aug 12, 202610
  • Public float$19.4M as of Jun 30, 20253
  • AuditorKPMG LLP, Kansas City, MO PCAOB ID 185; no auditor attestation of internal control over financial reporting3
  • On EDGAR sinceMay 24, 20211
  • Filings493 in all: 4 (152), 8-K (99), CORRESP (26), 3 (23), SC 13D/A (21), EFFECT (16), UPLOAD (16), 10-Q (14)1
    All 37 form types

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

  • Latest filingsAnnual report (10-K) Mar 18, 2026
    Quarterly report (10-Q) Aug 13, 2026
    Proxy statement (DEF 14A) May 29, 2026
    Latest 8-K (8-K) Oct 2, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, par value $0.0001 per shareCINGThe Nasdaq Stock Market LLC
Warrants, exercisable for common stockCINGWThe Nasdaq Stock Market LLC

From the cover page of the 10-K filed Mar 18, 2026 (Section 12(b) of the Exchange Act).3

Risk factors and legal proceedings

The risks Cingulate Inc. names in Item 1A of its 10-K filed Mar 18, 2026: 73 risks under these headings, as written.3

  • Risks Related to Our Financial Position and Need for Capital
  • We are a biopharmaceutical company with a limited operating history.
  • We have incurred a history of operating losses and expect to continue to incur substantial costs for the foreseeable future. We are not currently profitable, and we may never achieve or sustain profitability.
  • We depend heavily on the success of CTx-1301. If we are unable to secure approval of CTx-1301, we will never be able to generate revenues from CTx-1301, and our ability to create stockholder value will be severely limited.
  • We will need to raise significant additional capital to continue operations. If we are unable to raise capital, we could be required to seek bankruptcy protection or other alternatives that would likely result in our securityholders losing some or all of their investment in us.
  • The note purchase agreement and note issued by us in November 2025 contain restrictive covenants and adjustments in the event we default on the Note that may limit our operating flexibility and impact our operations.
  • Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our product candidates.
  • Changes in tax laws may materially adversely affect our business, financial condition, results of operations and cash flows.
  • Our ability to use our net operating losses to offset future taxable income may be subject to certain limitations .
  • The report of our independent registered public accounting firm for the fiscal years ended December 31, 2025 and 2024 contains an explanatory paragraph regarding substantial doubt about our ability to continue as a going concern.
  • Risks Related to Development, Clinical Testing, Manufacturing and Regulatory Approval
  • We are dependent primarily on the successful development and commercialization of our product candidates, CTx-1301 and CTx-1302 for the treatment of ADHD and CTx-2103 for the treatment of anxiety, which are either in product/early clinical development (CTx-2103), late development (CTx-1301) or planned for future product development (CTx-1302) and are not yet approved. We cannot give any assurance that we will receive regulatory approval for such product candidates or any other product candidates, which is necessary before they can be commercialized.
The other 63 risks
  • Premarket review of our product candidates by the FDA or other regulatory authorities is a lengthy and uncertain process and approval may be delayed, limited or denied, any of which would adversely affect our ability to generate operating revenues.
  • We must ensure our CDMO complies with cGMP, and regulatory inspections or findings could interrupt supply and delay development.
  • Disruptions at the FDA and other government agencies caused by funding shortages or otherwise could hinder their ability to hire and retain key leadership and other personnel, or otherwise review and process regulatory submissions in a timely manner, which could negatively impact our business.
  • Clinical testing is expensive, difficult to design and implement, can take many years to complete and is outcome uncertain. We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the commercialization of our product candidates.
  • Obtaining regulatory approval for clinical trials of CTx-1301 and CTx-1302 in children and adolescents may require additional studies and/or longer duration of studies since the requirements for regulatory approval for the pediatric populations are more stringent.
  • Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay.
  • Our product candidates CTx-1301 and CTx-1302 contain controlled substances, the manufacture, use, sale, importation, exportation, prescribing and distribution of which are subject to regulation by the DEA.
  • If we experience delays or difficulties in the enrollment of subjects in clinical trials, our receipt of necessary regulatory approvals could be delayed or prevented.
  • Our clinical trials may fail to demonstrate the safety and efficacy of our product candidates, or serious adverse or unacceptable side effects may be identified during the development of our product candidates, which could prevent or delay regulatory approval and commercialization, increase our costs or necessitate the abandonment or limitation of the development of some or all of our product candidates.
  • Our product candidates may cause adverse effects or have other properties that could delay or prevent their regulatory approval or limit the scope of any approved label or market acceptance, or result in significant negative consequences following marketing approval, if any.
  • If the FDA does not conclude that our product candidates are sufficiently bioequivalent, or have comparable bioavailability, to approved reference drugs, or if the FDA does not allow us to pursue the 505(b)(2) NDA pathway as anticipated, the approval pathway for our product candidates will likely take significantly longer, cost significantly more and entail significantly greater complications and risks than anticipated, and the FDA may not ultimately approve our product candidates.
  • Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our product candidates in other jurisdictions.
  • We may be unable to successfully complete Phase 3 clinical trials for our product candidates.
  • Even if we obtain regulatory approval for our product candidates, such approval may be limited, and we will be subject to stringent, ongoing government regulation.
  • Our employees, independent contractors, principal investigators, consultants, vendors, CROs, CDMOs and any partners with which we may collaborate may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
  • We may be required to modify our business practices, pay fines and significant expenses or experience other losses due to governmental investigations or other enforcement activities.
  • We or our current and prospective partners may be subject to product recalls in the future that could harm our brand and reputation and could negatively affect our business.
  • We will need to obtain FDA approval of any proposed names for our product candidates that gain marketing approval, and any failure or delay associated with such naming approval may adversely impact our business.
  • Government initiatives such as the Make America Healthy Again Commission could affect the development and approval of our product candidates
  • Our future growth depends, in part, on our ability to penetrate foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties.
  • A pandemic, epidemic, or outbreak of an infectious disease could cause a disruption to the development of our product candidates.
  • Risks Related to Commercialization
  • The commercial success of our product candidates, if approved, depends partially upon attaining market acceptance by physicians, patients, third-party payors, and the medical community.
  • Recently enacted and future policies and legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates and may affect the reimbursement made for any product candidate for which we receive marketing approval.
  • Unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives could harm our business in the future.
  • 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.
  • We may face significant competition from other pharmaceutical companies, and our operating results will suffer if we fail to compete effectively.
  • Social issues around the abuse of opioids and stimulants, including law enforcement concerns over diversion and regulatory efforts to combat abuse, could decrease the potential market for our product candidates.
  • Risks Related to Our Dependence on Third Parties
  • If we fail to produce our product or product candidates in the volumes that are required on a timely basis, or fail to comply with stringent regulations applicable to pharmaceutical drug manufacturers, we may face regulatory penalties and delays in the development, approval and/or commercialization of our product candidates.
  • We rely and expect to continue to rely completely on third parties to formulate and manufacture our preclinical, clinical trial and commercial drug supplies. The development and commercialization of any of our drug candidates could be stopped, delayed or made less profitable if those third parties fail to provide us with sufficient quantities of such drug supplies or fail to do so at acceptable quality levels, including in accordance with applicable regulatory requirements or contractual obligations, and our operations could be harmed as a result.
  • Our product candidates and any drugs that we may develop may compete with other product candidates and drugs for access to manufacturing facilities, and we may be unable to obtain access to these facilities on favorable terms.
  • We expect to rely on third parties to conduct our clinical trials and our regulatory submissions for our product candidates, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials and/or regulatory submissions.
  • We depend on collaborations with third parties for the development and commercialization of our product candidates. If those collaborations are not successful, we may not be able to capitalize on the market potential of these product candidates.
  • If we are not able to maintain or establish partnerships or collaborations, we may have to alter our development and commercialization plans.
  • We rely on third parties to perform many essential services for any products that we commercialize, including distribution, customer service, accounts receivable management, cash collection and adverse event reporting. If these third parties fail to perform as expected or to comply with legal and regulatory requirements, our ability to commercialize CTx-1301 and other product candidates will be significantly impacted and we may be subject to regulatory sanctions.
  • If we are unable to achieve and maintain adequate levels of coverage and reimbursement for our product candidates, if approved, their commercial success may be severely hindered.
  • Third-party payors may not adequately cover or reimburse consumers for the purchase of our products.
  • If we are unable to support demand for our product candidates, including ensuring that we have adequate capacity to meet increased demand, or we are unable to successfully manage the evolution of our drug delivery technology platform, our business could suffer.
  • Our relationships with customers and third-party payors are subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.
  • Product liability lawsuits could divert our resources, result in substantial liabilities and reduce the commercial potential of our product candidates.
  • Our product liability insurance coverage may not be adequate to cover any and all liabilities that we may incur.
  • 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.
  • Risks Related to Managing Our Growth, Our Employees, and Our Operations
  • We will need to further increase the size and complexity of our organization in the future, and we may experience difficulties in executing our growth strategy and managing any growth.
  • If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to market and/or sell our product candidates, we may be unable to generate any revenue.
  • If we fail to attract and retain management and other key personnel, we may be unable to continue to successfully develop or commercialize our product candidates or otherwise implement our business plan.
  • Our research and development is focused on discovering and developing product candidates but these product candidates may not make it to the market.
  • Our operating results may fluctuate significantly, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations.
  • Our operating results and liquidity needs could be negatively affected by market fluctuations and economic downturn.
  • Our business and operations would suffer in the event of failures in our internal computer systems.
  • We are increasingly dependent on information technology, and our systems and infrastructure face certain risks, including cybersecurity and data leakage risks.
  • The regulatory framework for use of AI technologies in our business is rapidly evolving and any failure or perceived failure by us or our employees, representatives, contractors, consultants, CDMO, collaborators, or other third parties to comply with such requirements or adequately address privacy and security concerns, even if unfounded, could result in additional cost and liability to us, damage our reputation, and adversely affect our business and results of operations.
  • Risks Related to Our Intellectual Property
  • If our intellectual property related to our products or product candidates is not adequate, we may not be able to compete effectively in our market.
  • We may not seek to protect our intellectual property rights 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.
  • 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 are sued for infringing intellectual property rights of third parties, it will be costly and time consuming, and an unfavorable outcome in that litigation would have a material adverse effect on our business.
  • Our drug development strategy relies heavily upon the 505(b)(2) regulatory approval pathway, which requires us to certify that we do not infringe upon third-party patents covering approved drugs. Such certifications routinely result in third-party claims of intellectual property infringement, the defense of which would be costly and time consuming, and an unfavorable outcome in any litigation may prevent or delay our development and commercialization efforts which would harm our business.
  • We may be unable to adequately prevent disclosure of trade secrets and other proprietary information.
  • We may be subject to claims by third parties asserting that our employees or we have misappropriated their intellectual property or claiming ownership of what we regard as our own intellectual property.
  • Our decision to seek approval of CTx-1301 and our other product candidates under 505(b)(2) may increase the risk that patent infringement suits are filed against us, which would delay the FDA’s approval of such product candidates.
  • Risks Related to the Securities Markets and Ownership of Our Securities
  • Our failure to maintain compliance with Nasdaq’s continued listing requirements could result in the delisting of our securities from Nasdaq, and the price of our common stock and/or warrants and our ability to access the capital markets could be negatively impacted.
  • An active trading market for our common stock or warrants may not be sustained.
  • The prices of our securities may be volatile, which could subject us to securities class action litigation and our stockholders could incur substantial losses.
  • We are an “emerging growth company,” and will be able take advantage of reduced disclosure requirements applicable to “emerging growth companies,” which could make our securities less attractive to investors.
  • If we are not able to maintain an effective system of internal control over financial reporting, the reliability of our financial reporting, investor confidence in us and the value of our common stock could be adversely affected.

Legal proceedings

See Part II-Item 8, Notes to Consolidated Financial Statements and Note 6 – Contingencies, of this annual report.

The opening of Item 3, Legal Proceedings.3

Sources

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