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TRVI on Nasdaq

Trevi Therapeutics, Inc.

American pharmaceutical preparations company based in New Haven1

In its 2026 annual report the company says: “We are a clinical-stage biopharmaceutical company focused on the development and commercialization of the investigational therapy Haduvio (oral nalbuphine ER) for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis, or IPF, non-IPF interstitial lung disease, or non-IPF ILD, and refractory chronic cough, or RCC.”3 Its shares trade on Nasdaq under the symbol TRVI.1

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Last updated Oct 21, 2026.

Overview

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  • TickerTRVI on Nasdaq1
  • IndustryPharmaceutical Preparations1
  • HeadquartersNew Haven, Connecticut1
  • Incorporated inDE2
  • Business address195 Church Street, 16Th Floor, New Haven, Ct 065102
  • Filer categoryNon-accelerated filer, Smaller reporting company2
  • Legal formCorporation

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We are a clinical-stage biopharmaceutical company focused on the development and commercialization of the investigational therapy Haduvio (oral nalbuphine ER) for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis, or IPF, non-IPF interstitial lung disease, or non-IPF ILD, and refractory chronic cough, or RCC.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 income456789-$49.3M in 2025+85% since 2019
-$60.0M-$40.0M-$20.0M02019: -$26.6M-$26.6M20192020: -$32.5M-$32.5M2020+22%2021: -$32.5M-$32.5M2021−0%2022: -$29.9M-$29.9M2022−8%2023: -$33.9M-$33.9M2023+13%2024: -$51.5M-$51.5M2024+52%2025: -$49.3M-$49.3M2025−4%
Net income456789-$42.8M in 2025+64% since 2019
-$60.0M-$40.0M-$20.0M02019: -$26.1M-$26.1M20192020: -$32.8M-$32.8M2020+26%2021: -$33.9M-$33.9M2021+4%2022: -$29.2M-$29.2M2022−14%2023: -$29.1M-$29.1M2023−0%2024: -$47.9M-$47.9M2024+65%2025: -$42.8M-$42.8M2025−11%

Every line of the income statement as filed: the last 2 fiscal years, latest first.9

Period ending2025-12-312024-12-31
Research and development$33.5M$39.4M
General and administrative$15.8M$12.1M
Total operating expenses$49.3M$51.5M
Loss from operations-$49.3M-$51.5M
Interest income, net$6.5M$3.6M
Other expense, net-$31.0K-$15.0K
Interest expense$0-$4.0K
Total other income, net$6.5M$3.6M
Loss before income taxes-$42.8M-$47.9M
Income tax benefit-$64.0K-$30.0K
Net loss-$42.8M-$47.9M
Basic net loss per common share outstanding-$0.32-$0.47
Diluted net loss per common share outstanding-$0.32-$0.47
Weighted average common shares used in net loss per share attributable to common stockholders, basic134.7M shares102.0M shares
Weighted average common shares used in net loss per share attributable to common stockholders, diluted134.7M shares102.0M shares
Net unrealized gains on available-for-sale marketable securities$87.0K$90.0K
Comprehensive loss-$42.7M-$47.8M

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Corporate structure

Trevi 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 Trevi Therapeutics, Inc.

  • Trevi Therapeutics, Inc. New Haven, Connecticut

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

What it owns

What Trevi 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.

Property and equipment

ItemLatestA year beforeChange
Property and equipment, before depreciation$537.0K9 Dec 31, 2025$385.0K9 Dec 31, 2024+39.5%
Accumulated depreciation$359.0K9 Dec 31, 2025$228.0K9 Dec 31, 2024+57.5%
Property and equipment, net$178.0K9 Dec 31, 2025$157.0K9 Dec 31, 2024+13.4%
Finance-lease assets$09 Dec 31, 2025$157.0K9 Dec 31, 2024−100.0%
Operating-lease assets (leased space)$677.0K9 Dec 31, 2025$915.0K9 Dec 31, 2024−26.0%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$18.9M9 Dec 31, 2025$34.1M9 Dec 31, 2024−44.5%
Marketable securities, current$169.3M9 Dec 31, 2025$73.5M9 Dec 31, 2024+130.3%
Debt securities available for sale$169.3M9 Dec 31, 2025$73.5M9 Dec 31, 2024+130.3%

Properties, in its own words

Our headquarters is currently located in New Haven, Connecticut, and consists of approximately 12,500 square feet of leased office space under a lease that expires in February 2028 and under which we have an option to extend the lease by a five-year term. We believe that our existing facilities are adequate for our current needs; however, we may require additional space and facilities as our business expands.

Item 2 of the 10-K filed Mar 17, 2026.3

Leadership

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

Chief executive

  1. Jennifer L. Good2019–now

President

  1. Jennifer L. Good2019–now

Chief financial officer

  1. Christopher Seiter2019–2021
  2. Lisa Delfini2021–2026
  3. David C. Hastings2026–now
20202025
Board members and other officers (20)

Timeline

  1. Aug 6, 20268-K Results of operations35
  2. Jun 4, 20268-K Bylaws or fiscal year changed; Shareholder vote36
  3. May 5, 20268-K Results of operations37
  4. Apr 17, 20268-K Entered a material agreement; Results of operations; Other events38
  5. Mar 17, 20268-K Results of operations39
  6. Mar 9, 20268-K Other events40
  7. Dec 5, 20258-K Executive or director change41
  8. Nov 13, 20258-K Results of operations42
  9. Aug 20, 20258-K Executive or director change43
  10. Aug 7, 20258-K Results of operations44
  11. Jun 17, 20258-K Executive or director change; Shareholder vote45
  12. Jun 4, 20258-K Entered a material agreement; Other events46
  13. Jun 5, 2019New chief executive Jennifer L. Good becomes CEO12

Calendar

Coming up

  1. Nov 12, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.08) a share, on Nov 13, 2025.47

When it reported results

  1. Aug 6, 2026Reported quarterly or annual results35
  2. May 5, 2026Reported quarterly or annual results37
  3. Apr 17, 2026Reported quarterly or annual results38
  4. Mar 17, 2026Reported quarterly or annual results39
  5. Nov 13, 2025Reported quarterly or annual results42
  6. Aug 7, 2025Reported quarterly or annual results44
  7. May 8, 2025Reported quarterly or annual results48
  8. Mar 18, 2025Reported quarterly or annual results49

Drug trials and FDA: coming up

  1. Aug 2027Phase 3 trial readout expected Phase 3 trial of NAL ER in Idiopathic Pulmonary Fibrosis: primary completion expected Aug 2027 (ClinicalTrials.gov NCT07868419).50
  2. Sep 2027Phase 2 trial readout expected Phase 2 trial of NAL ER in Refractory Chronic Cough: primary completion expected Sep 2027 (ClinicalTrials.gov NCT07671924).51

Drug trials and FDA: recently

  1. Apr 24, 2025Phase 2 trial completed Phase 2 trial of NAL ER in Idiopathic Pulmonary Fibrosis: primary completion Apr 24, 2025, results posted Jun 26, 2026 (ClinicalTrials.gov NCT05964335).52
  2. Jan 6, 2025Phase 2 trial completed Phase 2 trial of NAL ER in Refractory Chronic Cough: primary completion Jan 6, 2025, results posted Mar 30, 2026 (ClinicalTrials.gov NCT05962151).53

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

335 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 53 major events, 142 insider forms, 54 large holders, 3 private raises, 63 other. The latest 20:

  1. Sep 17, 20264 EDGAR
  2. Sep 15, 2026144 EDGAR
  3. Aug 6, 2026S-8 EDGAR
  4. Aug 6, 202610-Q EDGAR
  5. Aug 6, 20268-K EDGAR
  6. Aug 6, 2026SCHEDULE 13G/A EDGAR
  7. Jun 4, 20264 EDGAR
  8. Jun 4, 20264 EDGAR
  9. Jun 4, 20264 EDGAR
  10. Jun 4, 20264 EDGAR
  11. Jun 4, 20264 EDGAR
  12. Jun 4, 20268-K EDGAR
  13. May 7, 2026SCHEDULE 13D/A EDGAR
  14. May 6, 2026SCHEDULE 13G/A EDGAR
  15. May 5, 202610-Q EDGAR
  16. May 5, 20268-K EDGAR
  17. Apr 21, 2026DEF 14A EDGAR
  18. Apr 21, 2026ARS EDGAR
  19. Apr 21, 2026DEFA14A EDGAR
  20. Apr 17, 2026424B5 EDGAR

The 335 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

52 open-market trades by officers, directors and large owners since October 2021: 18 buys and 34 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Sep 15, 2026Heffernan Michael ThomasDirectorSale39,473$15.09$595.8KForm 4
Mar 25, 2025SCIASCIA THOMASChief Scientific OfficerSale2,631$6.60$17.4KForm 4
Mar 21, 2025GOOD JENNIFER LPresident & CEOSale5,263$6.58$34.6KForm 4
Mar 10, 2025Simon FarrellChief Commercial OfficerSale81,313$6.75$549.1KForm 4
Sep 9, 2024GOOD JENNIFER LPresident & CEOSale1,840$3.04$5.6KForm 4
Sep 6, 2024GOOD JENNIFER LPresident & CEOSale4,219$3.03$12.8KForm 4
Sep 5, 2024GOOD JENNIFER LPresident & CEOSale40,277$3.11$125.3KForm 4
Sep 4, 2024GOOD JENNIFER LPresident & CEOSale10,981$3.02$33.2KForm 4
Sep 3, 2024GOOD JENNIFER LPresident & CEOSale3,863$3.02$11.7KForm 4
Aug 27, 2024Meeker David PDirectorSale4,555$2.93$13.3KForm 4
Aug 19, 2024SCIASCIA THOMASChief Scientific OfficerSale16,496$2.96$48.8KForm 4
Aug 16, 2024SCIASCIA THOMASChief Scientific OfficerSale18,660$2.76$51.5KForm 4
Aug 15, 2024SCIASCIA THOMASChief Scientific OfficerSale12,745$2.79$35.6KForm 4
Aug 14, 2024SCIASCIA THOMASChief Scientific OfficerSale100$2.75$275Form 4
May 29, 2024SCIASCIA THOMASChief Scientific OfficerSale53,368$2.55$136.1KForm 4
May 22, 2024Delfini LisaChief Financial OfficerSale4,350$2.64$11.5KForm 4
May 20, 2024GOOD JENNIFER LPresident & CEOSale25,037$2.86$71.6KForm 4
May 10, 2024GOOD JENNIFER LPresident & CEOSale4,578$2.90$13.3KForm 4
Oct 11, 2023Delfini LisaChief Financial OfficerSale785$2.02$1.6KForm 4
Sep 11, 2023Delfini LisaChief Financial OfficerSale711$2.20$1.6KForm 4

All 52 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
2025Jennifer Good$622.4K$3.9M69
2025James CassellaPh.D.$488.3K$1.6M69
2025Farrell SimonPharm. D.$370.1K$1.4M69
2024President and Chief Executive Officer$607.9K$2.6M69
2024Chief Development Officer$120.0K$1.4M69

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$69.8M 2021–2022
Money received by yearMoney received by year, 2021–2022: $69.8M in all. Private raises (Form D) $69.8M.$0$20M$40M$60M2021 · Private raises (Form D): $14.8M20212022 · Private raises (Form D): $55.0M2022
Figures by year
YearPrivate raises (Form D)Total
2022$55.0M$55.0M
2021$14.8M$14.8M

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. Apr 11, 2022Raised $55 million in a private offering of equity70 Form D: 12 investors so far Form D
  2. Oct 18, 2021Raised $3 million in a private offering of equity71 Form D: 1 investor so far Form D
  3. Oct 5, 2021Raised $11.8 million in a private offering of equity72 Form D: 1 investor 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 100. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
NEA Management Company, LLC13,222,228$246.6M15.5%No change
Fmr LLC12,562,839$234.3M0.0%+4,524,778
BlackRock, Inc.11,155,026$208.0M0.0%+914,840
Frazier Life Sciences Management, L.P.9,939,447$185.4M4.0%−100
Wellington Management Group Llp5,684,592$106.0M0.0%+495,504
Vanguard Capital Management LLC5,530,675$103.1M0.0%+552,108
Vivo Capital, LLC5,094,668$95.0M8.7%No change
Woodline Partners LP4,081,333$76.1M0.2%+3,080,551
Vestal Point Capital, LP3,100,000$57.8M1.4%+933,496
Mpm Bioimpact LLC3,073,577$57.3M3.5%−224,853
Frontier Capital Management Co LLC3,070,740$57.3M0.5%+1,076,448
Assenagon Asset Management S.A.3,050,628$56.9M0.0%New
State Street Corp3,027,315$56.5M0.0%+362,002
Geode Capital Management, LLC2,928,068$54.6M0.0%+149,837
Marshall Wace, Llp2,674,137$49.9M0.0%−1,291,882
Eventide Asset Management, LLC2,660,000$49.6M0.7%+37,694
Rubric Capital Management LP2,504,513$46.7M0.4%−1,207,860
Artia Global Partners LP2,210,852$41.2M7.8%+197,250
Acorn Capital Advisors, LLC2,144,844$40.0M10.9%No change
First Light Asset Management, LLC2,097,215$39.1M2.4%New
Pictet Asset Management Holding SA2,013,786$37.6M0.0%+307,738
Logos Global Management LP1,880,000$35.1M1.5%−520,000
Affinity Asset Advisors, LLC1,800,172$33.6M1.7%−200,000
Emerald Advisers, LLC1,797,611$33.5M0.8%−41,955
Siren, L.L.C.1,786,867$33.3M0.7%No change

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

SEC filer profile

How Trevi 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 EDGARTrevi Therapeutics, Inc.1
  • CIK0001563880
  • Employer ID (EIN)45-08342993
  • Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not 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 address195 Church Street, 16Th Floor, New Haven, CT 065101
  • Phone203-304-24991
  • Shares outstanding142,475,841 as of Jul 31, 202611
  • Public float$588.4M as of Jun 30, 20253
  • AuditorErnst & Young LLP, New York, New York PCAOB ID 42; no auditor attestation of internal control over financial reporting3
  • On EDGAR sinceDec 18, 20121
  • Filings536 in all: 4 (198), 8-K (80), 3 (43), 10-Q (23), SC 13G/A (19), SCHEDULE 13G/A (14), 144 (13), SC 13G (12)1
    All 41 form types

    CORRESP (10), S-8 (9), UPLOAD (9), 4/A (8), 424B5 (8), 5 (8), DEFA14A (8), 10-K (7), DEF 14A (7), EFFECT (7), D (5), S-3 (5), SC 13D/A (5), ARS (4), SCHEDULE 13D/A (4), SCHEDULE 13G (4), S-1 (3), S-1/A (3), 424B3 (2), DRS/A (2), DRSLTR (2), PRE 14A (2), SC 13D (2), 144/A (1), 424B4 (1), 8-A12B (1), CERT (1), D/A (1), DRS (1), FWP (1), RW (1), S-3/A (1), S-3ASR (1)

  • Latest filingsAnnual report (10-K) Mar 17, 2026
    Quarterly report (10-Q) Aug 6, 2026
    Proxy statement (DEF 14A) Apr 21, 2026
    Latest 8-K (8-K) Aug 6, 2026

Securities registered for trading

ClassSymbolExchange
Common Stock, $0.001 par value per shareTRVIThe Nasdaq Stock Market LLC

From the cover page of the 10-K filed Mar 17, 2026 (Section 12(b) of the Exchange Act).3

Risk factors and legal proceedings

The risks Trevi Therapeutics, Inc. names in Item 1A of its 10-K filed Mar 17, 2026: 73 risks under these headings, as written.3

  • Risks Related to Our Financial Position and Need for Additional Capital
  • We have incurred significant losses since inception, expect to incur significant and increasing losses for the foreseeable future and may never achieve or maintain profitability.
  • We have no products approved for commercial sale, which may make it difficult to evaluate the prospects for our future success and viability.
  • We will need substantial additional funding and if we are unable to raise sufficient capital when needed on acceptable terms or at all, we could be forced to delay, reduce or abandon our product development programs or commercialization efforts.
  • Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our product candidates.
  • Risks Related to the Development and Commercialization of Haduvio and Any Future Product Candidates
  • We are dependent on the successful development and commercialization of Haduvio, our sole product candidate. If we are unable to complete the clinical development of, obtain marketing approval for or successfully commercialize Haduvio or if we experience significant delays in doing so, our business would be substantially harmed.
  • Our approach to the development and commercialization of Haduvio to treat chronic cough is unproven.
  • Clinical drug development involves a lengthy and expensive process with an uncertain outcome.
  • Our clinical trials may fail to demonstrate adequately the safety and efficacy of Haduvio or any future product candidates, which would likely prevent or delay regulatory approval and commercialization.
  • Use of patient-reported outcome assessments, or PROs, in our clinical trials and high placebo response rates may delay or impair the development of Haduvio or adversely impact our clinical trials.
  • If we experience delays or difficulties in the enrollment of patients in clinical trials, our receipt of necessary regulatory approvals could be delayed or prevented.
The other 62 risks
  • Adverse events or undesirable side effects caused by, or other unexpected properties of, Haduvio or any future product candidate may be identified during development and could delay or prevent the marketing approval or limit the use of Haduvio or any future product candidate.
  • The drug label for nalbuphine, the active ingredient in Haduvio, carries an opioid class label warning for serious, life-threatening or fatal respiratory depression and Haduvio, if approved for marketing in any indication, will likely carry a similar opioid class label.
  • Many currently approved mu-opioid receptor agonist products are subject to restrictive marketing and distribution regulations which, if applied to Haduvio, could potentially restrict its use and harm our ability to generate profits.
  • Results of preclinical studies and clinical trials may not be predictive of results of later clinical trials.
  • Even if Haduvio or any future product candidate receives marketing approval, we or others may later discover that the product is less effective than previously believed or that it causes undesirable side effects that were not previously identified, which could compromise our ability to market the product.
  • Even if Haduvio or any future product candidate receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success, in which case the market opportunity for Haduvio may be smaller than we estimate and we may not generate significant revenues or become profitable.
  • 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.
  • If we are unable to establish sales, marketing and distribution capabilities or enter into sales, marketing and distribution arrangements with third parties, we may not be successful in commercializing Haduvio or any future product candidates if and when they are approved.
  • We face competition, which may result in others developing or commercializing products before or more successfully than we do.
  • Even if we are able to commercialize a product candidate, the product may become subject to unfavorable pricing regulations, third-party payor reimbursement practices or healthcare reform initiatives, any of which could harm our business.
  • Product liability lawsuits could divert our resources, cause us to incur substantial liabilities and limit commercialization of any products that we may develop or in-license.
  • Risks Related to Our Dependence on Third Parties
  • We rely on third parties to conduct our clinical trials. If they do not perform satisfactorily, our business could be harmed.
  • We contract with third parties for the manufacture, storage, packaging and distribution of Haduvio and other drug product for clinical trials, including a single supplier for the active ingredient in Haduvio and expect to continue to rely on third parties for these services in connection with our future development and commercialization efforts for Haduvio and any future product candidates.
  • We may seek to establish collaborations and, if we are not able to establish them on commercially reasonable terms, we may have to alter our development and commercialization plans.
  • If we enter into collaborations with third parties for the development or commercialization of Haduvio or any future product candidate, our prospects with respect to those product candidates will depend in significant part on the success of those collaborations.
  • Risks Related to Our Intellectual Property
  • If we fail to comply with our obligations under our existing and any future intellectual property licenses with third parties, we could lose license rights that are critical to our business or owe damages to the licensor of such intellectual property.
  • If we are unable to obtain and maintain sufficient patent protection for Haduvio or any future product candidate and the disease indications for which we are developing or may in the future develop, Haduvio or if the scope of the patent protection is not sufficiently broad, competitors could develop and commercialize products similar or identical to such product candidate and our ability to successfully commercialize such product candidate may be adversely affected.
  • If we are unable to protect the confidentiality of our trade secrets, the value of our products could be negatively impacted and our business would be harmed.
  • We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time-consuming and unsuccessful.
  • If we are sued for infringing intellectual property rights of third parties, such litigation could be costly and time-consuming, its outcome would be uncertain and it could prevent or delay us from developing or commercializing Haduvio or any future product candidate.
  • Changes to the patent law in the U.S. and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.
  • We may not be able to enforce our intellectual property rights throughout the world.
  • 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.
  • Obtaining and maintaining 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 unable to obtain licenses from third parties on commercially reasonable terms, our business could be harmed.
  • Risks Related to Regulatory Approval and Other Legal Compliance Matters
  • If the FDA does not conclude that Haduvio for the treatment of chronic cough in patients with IPF, non-IPF ILD, or RCC, or any other development program satisfies the requirements under Section 505(b)(2) of the FDCA or if the requirements for such programs are not as we expect, the approval pathway for these programs will likely take significantly longer, cost significantly more and entail significantly greater complications and risks than anticipated and in any case may not be successful.
  • Even if we complete the necessary nonclinical studies and clinical trials, the regulatory approval process is expensive, time-consuming and uncertain and may prevent us from obtaining approvals for the commercialization of Haduvio or any future product candidate on a timely basis or at all. As a result, we cannot predict when or if and in which territories, we will obtain marketing approval to commercialize a product candidate.
  • We have conducted, are conducting and intend in the future to conduct clinical trials for Haduvio and may conduct clinical trials for any future product candidates, at sites outside the U.S. The FDA may not accept data from trials conducted in such locations and the conduct of trials outside the U.S. could subject us to additional delays and expense.
  • Failure to obtain marketing approval in foreign jurisdictions would prevent Haduvio or any future product candidate from being marketed in other countries. Any marketing approval we are granted in the U.S. would not assure marketing approval in foreign jurisdictions.
  • A Fast Track designation, grant of Priority Review status or Breakthrough Therapy status by the FDA or the receipt of a priority voucher from the FDA is not assured and, in any event, may not actually lead to a faster development or regulatory review or approval process and, moreover, would not assure FDA approval of Haduvio or any future product candidate.
  • We may seek PRIME Designation in the E.U. for Haduvio but we might not receive such designations and, even if we do, such designations may not lead to a faster development or regulatory review or approval process.
  • Any regulatory approval to market Haduvio in the U.S. will be limited by indication. If we fail to comply or are found to be in violation of FDA regulations restricting the promotion of Haduvio for unapproved uses, we could be subject to criminal penalties, substantial fines or other sanctions and damage awards.
  • Any product for which we obtain marketing approval in the future could be subject to post-marketing restrictions or withdrawal from the market and we may be subject to substantial penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with any such product following approval.
  • Disruptions at the FDA and other government agencies from funding cuts, personnel losses, regulatory reform, government shutdowns and other developments could hinder our ability to obtain guidance from the FDA regarding our clinical development program, progress development efficiently, and secure approval of our product candidates in a timely manner, which would negatively impact our business.
  • Current and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize Haduvio or any future product candidate and may affect the prices we may obtain.
  • Current and future legislative efforts may limit the prices for our products, if and when they are licensed for marketing and that could materially impact our ability to generate revenues.
  • Any relationships we may have with customers, healthcare providers and professionals and third-party payors, among others, will be subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose us to penalties, including criminal sanctions, civil penalties, contractual damages, reputational harm, fines, disgorgement, exclusion from participation in government healthcare programs, curtailment or restricting of our operations and diminished profits and future earnings.
  • Analogous State and Foreign Laws.
  • Compliance with global privacy and data security requirements could result in additional costs and liabilities to us or inhibit our ability to collect and process data globally and the failure to comply with such requirements could have a material adverse effect on our business, financial condition or results of operations.
  • Laws and regulations governing any international operations we may have in the future may preclude us from developing, manufacturing and selling certain products outside of the U.S. and require us to develop and implement costly compliance programs.
  • 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 harm our business.
  • Our business and operations would suffer in the event of system failures.
  • If the FDA or comparable foreign regulatory authorities approve generic versions of any of our future products that receive marketing approval through the NDA pathway, or such authorities do not grant such future products appropriate periods of data exclusivity before approving generic versions of our products, our sales could be adversely affected.
  • Artificial intelligence presents risks and challenges that can impact our business including by posing security risks to our confidential information, proprietary information and personal data.
  • Risks Related to Employee Matters and Managing our Growth
  • Our future success depends on our ability to retain our executive team and to attract, retain and motivate qualified personnel.
  • If we expand our organization, we may encounter difficulties in managing our growth, which could disrupt our operations.
  • Our employees, independent contractors and consultants may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements, which could cause significant liability for us and harm our reputation.
  • Risks Related to Our Common Stock
  • The trading price of our common stock is highly volatile, which could result in substantial losses for purchasers of our common stock.
  • Changes in and uncertainty surrounding U.S. and international trade policies may adversely impact on our business, financial condition and results of operations.
  • We could be subject to securities class action litigation.
  • If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, the trading price and volume of our shares could decline.
  • Future sales of shares of our common stock, including by us, employees and significant stockholders, could negatively affect our stock price.
  • Ownership of our common stock is concentrated among our executive officers and directors and their affiliates, who have significant influence over our business, which may prevent new investors from influencing significant corporate decisions.
  • We do not anticipate paying any cash dividends on our capital stock in the foreseeable future. Accordingly, stockholders must rely on appreciation in the price of our common stock, if any, for any return on their investment.
  • We are a “smaller reporting company” and the reduced disclosure requirements applicable to us may make our common stock less attractive to investors.
  • We incur increased costs as a result of operating as a public company and our management is required to devote substantial time to compliance initiatives and corporate governance practices.
  • If we fail to maintain proper and effective internal controls, our ability to produce accurate financial statements on a timely basis could be impaired.
  • We might not be able to utilize a significant portion of our net operating loss carryforwards and research and development tax credit carryforwards.
  • Changes in tax laws or in their implementation or interpretation may adversely affect our business and financial condition.
  • Provisions in our organizational documents and under Delaware law may prevent or frustrate attempts by our stockholders to change our management or hinder efforts to acquire a controlling interest in us.
  • Our 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 of the U.S. are the sole and exclusive forum for the resolution of any complaint asserting a cause of action arising under the Securities Act. These choice of forum provisions could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
  • If we fail to comply with the continued listing requirements of Nasdaq, our common stock may be delisted and the price of our common stock and our ability to access the capital markets could be negatively impacted.

Legal proceedings

We are not subject to any material legal proceedings.

The opening of Item 3, Legal Proceedings.3

Sources

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