Trevi Therapeutics, Inc. (NASDAQ:TRVI) Q1 2024 Earnings Conference Call May 7, 2024 4:30 PM ET Company Participants Jennifer Good - President and Chief Executive Officer Lisa Delfini - Chief Financial Officer David Clark - Chief Medical Officer Conference Call Participants Leland Gershell - Oppenheimer Jack Padovano - Stifel Nathanael Charoensook - Leerink Partners Mayank Mamtani - B. Riley Securities Operator Good afternoon, and welcome to the Trevi Therapeutics First Quarter 2024 Earnings Conference Call. ...

FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38886 TREVI THERAPEUTICS, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 45-0834299 ( State or other jurisd ...

Exhibit 99.1 Trevi Therapeutics Reports First Quarter 2024 Financial Results and Provides Business Updates Reaffirms guidance for the Phase 2a RIVER trial in refractory chronic cough and Human Abuse Potential (HAP) Study with topline data for each expected in the second half of 2024 Topline results continue to be expected in the first half of 2025 for the Phase 2b CORAL trial in chronic cough in IPF IND cleared with the FDA for planned Phase 1b trial to evaluate respiratory physiology in IPF patients with v ...

Trevi Therapeutics, Inc. (NASDAQ:TRVI) Q4 2023 Earnings Conference Call March 20, 2024 4:30 PM ET Company Participants Jennifer Good - President & CEO Lisa Delfini - CFO David Clark - Chief Medical Officer Conference Call Participants Leland Gershell - Oppenheimer Serge Belanger - Needham & Company Operator Good afternoon, and welcome to the Trevi Therapeutics Fourth Quarter and Year-End 2023 Earnings Conference Call. At this time, all participants will be in listen-only mode. [Operator Instructions] After ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-38886 TREVI THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 45-0834299 (State or other jurisdictio ...

Exhibit 99.1 Trevi Therapeutics Reports Fourth Quarter and Year End 2023 Financial Results and Provides Business Updates Reaffirms guidance for the Phase 2a RIVER trial of Haduvio in RCC patients with topline data expected in the second half of 2024 Enrollment progressing in the Phase 2b CORAL dose-ranging trial of Haduvio for the treatment of chronic cough in IPF patients Human Abuse Potential Study more than 50% enrolled Management to host a conference call and webcast today at 4:30 p.m. ET New Haven, Con ...

Trevi Therapeutics, Inc. (NASDAQ:TRVI) Q3 2023 Earnings Conference Call November 9, 2023 4:30 PM ET Company Participants Jennifer Good - President and Chief Executive Officer Lisa Delfini - Chief Financial Officer David Clark - Chief Medical Officer Conference Call Participants Annabel Samimy - Stifel Rohan Mathur - Oppenheimer Sean Kim - JonesTrading Serge Belanger - Needham & Company Mayank Mamtani - B. Riley Securities Operator Good afternoon and welcome to the Trevi Therapeutics Q3 2023 Earnings Confere ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38886 TREVI THERAPEUTICS, INC. (Exact Name of Registrant as Specified in its Charter) (State or other jurisdiction of incorpo ...

Trevi Therapeutics, Inc. (NASDAQ:TRVI) Q2 2023 Earnings Conference Call August 10, 2023 4:30 PM ET Company Participants Jennifer Good - President and Chief Executive Officer Lisa Delfini - Chief Financial Officer Conference Call Participants Annabel Samimy - Stifel Serge Belanger - Needham and Company Leland Gershell - Oppenheimer William Wood - B. Riley Securities Operator Good afternoon and welcome to the Trevi Therapeutics’ Second Quarter 2023 Earnings Conference Call. [Operator Instructions] Please note ...

[PART I. FINANCIAL INFORMATION](index=6&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Condensed Consolidated Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) This section presents the unaudited condensed consolidated financial statements, including balance sheets, statements of comprehensive loss, stockholders' equity, and cash flows, along with their accompanying notes, highlighting key financial movements and an improved net loss [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) **Condensed Consolidated Balance Sheets (Amounts in thousands)** | Metric | June 30, 2023 (Unaudited) | December 31, 2022 | | :--------------------------------- | :------------------------ | :------------------ | | Total Assets | $100,977 | $123,015 | | Total Liabilities | $5,904 | $15,556 | | Total Stockholders' Equity | $95,073 | $107,459 | [Condensed Consolidated Statements of Comprehensive Loss](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Loss) **Condensed Consolidated Statements of Comprehensive Loss (Amounts in thousands)** | Metric | Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $5,842 | $5,103 | $10,842 | $9,748 | | General and administrative | $2,540 | $2,717 | $5,103 | $5,097 | | Total operating expenses | $8,382 | $7,820 | $15,945 | $14,845 | | Loss from operations | $(8,382) | $(7,820) | $(15,945) | $(14,845) | | Interest income, net | $1,207 | $195 | $2,428 | $199 | | Interest expense | $(153) | $(295) | $(384) | $(597) | | Net loss | $(7,145) | $(8,052) | $(13,546) | $(15,381) | | Basic and diluted net loss per common share | $(0.07) | $(0.14) | $(0.14) | $(0.34) | [Condensed Consolidated Statements of Stockholders' Equity](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) **Condensed Consolidated Statements of Stockholders' Equity (Amounts in thousands)** | Metric | December 31, 2022 | June 30, 2023 | | :--------------------------------- | :------------------ | :------------------ | | Total Stockholders' Equity | $107,459 | $95,073 | | Stock-based compensation | — | $1,183 | | Net loss | — | $(13,546) | | Unrealized losses on available-for-sale marketable securities | $(122) | $(248) | [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) **Condensed Consolidated Statements of Cash Flows (Amounts in thousands)** | Metric | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--------------------------------- | :------------------------------- | :------------------------------- | | Net cash used in operating activities | $(18,072) | $(13,268) | | Net cash provided by (used in) investing activities | $28,601 | $(54,217) | | Net cash (used in) provided by financing activities | $(9,366) | $55,353 | | Net increase (decrease) in cash and cash equivalents | $1,163 | $(12,132) | | Cash and cash equivalents at end of period | $13,752 | $24,698 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) - Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing Haduvio (oral nalbuphine ER) for chronic cough in idiopathic pulmonary fibrosis (IPF), other chronic cough indications, and prurigo nodularis[29](index=29&type=chunk) - Haduvio is an oral extended-release formulation of nalbuphine, a mixed κ-opioid receptor agonist and μ-opioid receptor antagonist, approved as an injectable for pain for over 20 years and not scheduled as a controlled substance in the U.S[30](index=30&type=chunk) **Marketable Securities (Amounts in thousands)** | Type of Security | June 30, 2023 Fair Value | December 31, 2022 Fair Value | | :--------------------------------- | :------------------------------- | :------------------------------- | | Corporate bonds | $56,594 | $62,513 | | Commercial paper | $14,916 | $30,739 | | U.S. government agency securities | $4,939 | $2,903 | | U.S. treasury securities | $1,997 | $9,852 | | Asset backed securities | $1,954 | $1,914 | | Total marketable securities | $80,400 | $107,921 | - The company fully extinguished its SVB Term Loan on May 9, 2023, with a total payoff of **$6.5 million**, including principal, final payment fee, and accrued interest/prepayment premium[79](index=79&type=chunk)[149](index=149&type=chunk) **Stockholders' Equity - Shares Reserved for Future Issuance** | Category | June 30, 2023 | December 31, 2022 | | :--------------------------------- | :------------------ | :------------------ | | Common stock warrants and pre-funded warrants | 45,330,707 | 48,330,707 | | LPC Purchase Agreement sales | 30,000,000 | 30,000,000 | | 2019 Stock Incentive Plan | 6,528,753 | 4,553,202 | | 2019 Employee Stock Purchase Plan | 1,208,274 | 701,232 | | 2012 Stock Incentive Plan | 595,389 | 602,231 | | Total | 83,663,123 | 84,187,372 | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=27&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) The company, a clinical-stage biopharmaceutical firm, is developing Haduvio for chronic cough in IPF and prurigo nodularis, with positive Phase 2 and Phase 2b/3 data reported, and expects existing cash to fund operations into 2026, despite ongoing net losses and the need for substantial additional funding - Trevi Therapeutics is a clinical-stage biopharmaceutical company developing Haduvio (oral nalbuphine ER) for chronic cough in idiopathic pulmonary fibrosis (IPF), other chronic cough indications, and prurigo nodularis[133](index=133&type=chunk) - Positive Phase 2 data for Haduvio in chronic cough in IPF (CANAL trial) showed a statistically significant reduction in daytime cough frequency (**p<0.0001**) and positive results for patient/clinician reported outcomes[134](index=134&type=chunk) - Positive Phase 2b/3 data for Haduvio in prurigo nodularis (PRISM trial) showed statistically significant results on primary and all three key secondary endpoints[137](index=137&type=chunk) - The Human Abuse Potential (HAP) study for oral nalbuphine ER is delayed due to a U.S. shortage of IV butorphanol, the comparator drug[140](index=140&type=chunk) **Key Financial Highlights (Amounts in thousands)** | Metric | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--------------------------------- | :------------------------------- | :------------------------------- | | Net Loss | $(13,546) | $(15,381) | | Accumulated Deficit (as of June 30, 2023 / Dec 31, 2022) | $(223,615) | $(210,069) | | Cash, Cash Equivalents & Marketable Securities (as of June 30, 2023 / Dec 31, 2022) | $94,200 | $120,510 | - The company believes existing cash, cash equivalents, and marketable securities of **$94.2 million** will fund operating expenses and capital expenditure requirements into **2026**, but substantial additional funding is needed for continued development and commercialization[149](index=149&type=chunk)[193](index=193&type=chunk) [Components of Operating Results](index=31&type=section&id=Components%20of%20Operating%20Results) - Research and development (R&D) expenses are primarily for Haduvio development, including personnel, consulting, and contract manufacturing, and are expected to increase as the company advances clinical trials and prepares for regulatory approval and commercial launch[153](index=153&type=chunk)[154](index=154&type=chunk) - General and administrative (G&A) expenses consist of personnel, professional fees (legal, consulting, accounting), rent, and other operating costs, and are anticipated to increase due to expanded infrastructure and personnel[155](index=155&type=chunk)[156](index=156&type=chunk) - Other income (expense) includes interest income from cash and marketable securities, other income (e.g., employee retention tax credit, foreign currency gains, debt extinguishment effect), and interest expense from the now-extinguished SVB Term Loan[157](index=157&type=chunk)[158](index=158&type=chunk)[159](index=159&type=chunk)[161](index=161&type=chunk) [Results of Operations](index=32&type=section&id=Results%20of%20Operations) **Operating Results Comparison (Amounts in thousands)** | Metric | 3 Months Ended June 30, 2023 | 3 Months Ended June 30, 2022 | Change | | :--------------------------------- | :------------------------------- | :------------------------------- | :------- | | Research and development | $5,842 | $5,103 | $739 | | General and administrative | $2,540 | $2,717 | $(177) | | Net loss | $(7,145) | $(8,052) | $907 | | Interest income, net | $1,207 | $195 | $1,012 | | Interest expense | $(153) | $(295) | $142 | **Operating Results Comparison (Amounts in thousands)** | Metric | 6 Months Ended June 30, 2023 | 6 Months Ended June 30, 2022 | Change | | :--------------------------------- | :------------------------------- | :------------------------------- | :------- | | Research and development | $10,842 | $9,748 | $1,094 | | General and administrative | $5,103 | $5,097 | $6 | | Net loss | $(13,546) | $(15,381) | $1,835 | | Interest income, net | $2,428 | $199 | $2,229 | | Interest expense | $(384) | $(597) | $213 | - R&D expenses increased for both periods primarily due to increased consulting and professional fees for planned chronic cough trials and higher personnel-related and stock-based compensation expenses[164](index=164&type=chunk)[169](index=169&type=chunk) [Liquidity and Capital Resources](index=34&type=section&id=Liquidity%20and%20Capital%20Resources) - The company's primary funding sources have been private placements of preferred stock and convertible notes, IPO proceeds, at-the-market (ATM) sales agreements, and private placements of common stock and warrants[172](index=172&type=chunk)[173](index=173&type=chunk)[174](index=174&type=chunk)[175](index=175&type=chunk)[176](index=176&type=chunk) **Cash, Cash Equivalents & Marketable Securities (Amounts in thousands)** | Metric | June 30, 2023 | | :--------------------------------- | :------------------ | | Cash, Cash Equivalents & Marketable Securities | $94,200 | - The company expects its current cash, cash equivalents, and marketable securities to fund operating expenses and capital expenditure requirements into **2026**[193](index=193&type=chunk) - Substantial additional funding will be required for future operations, including advancing Haduvio through clinical development, regulatory approval, and commercial launch activities, as well as for operating as a public company[190](index=190&type=chunk)[191](index=191&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=38&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section states that the company does not have material market risks requiring quantitative or qualitative disclosure beyond what is already presented in the financial statements - The company has no material quantitative or qualitative disclosures about market risk to report[201](index=201&type=chunk) [Item 4. Controls and Procedures](index=38&type=section&id=Item%204.%20Controls%20and%20Procedures) As of June 30, 2023, management, with the participation of the CEO and CFO, concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level, with no material changes in internal control over financial reporting during the quarter - As of June 30, 2023, the company's disclosure controls and procedures were deemed effective at the reasonable assurance level by management, including the CEO and CFO[202](index=202&type=chunk) - No material changes in internal control over financial reporting occurred during the three months ended June 30, 2023[203](index=203&type=chunk) [PART II. OTHER INFORMATION](index=38&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=38&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings - The company is not subject to any material legal proceedings[204](index=204&type=chunk) [Item 1A. Risk Factors](index=38&type=section&id=Item%201A.%20Risk%20Factors) This section outlines numerous significant risks that could materially and adversely affect the company's business, financial condition, results of operations, and future growth prospects, spanning financial stability, product development, third-party reliance, intellectual property, regulatory compliance, employee matters, and common stock volatility [Risks Related to Our Financial Position and Need for Additional Capital](index=39&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position%20and%20Need%20for%20Additional%20Capital) - The company has incurred significant net losses since inception, with an accumulated deficit of **$223.6 million** as of June 30, 2023, and expects to continue incurring substantial losses, potentially never achieving profitability[206](index=206&type=chunk)[207](index=207&type=chunk)[208](index=208&type=chunk) - Substantial additional funding is required to complete Haduvio's development and commercialization, and failure to raise capital on acceptable terms could force delays, reductions, or abandonment of product development programs[212](index=212&type=chunk)[214](index=214&type=chunk) - Existing cash, cash equivalents, and marketable securities are projected to fund operations into **2026**, but this estimate is subject to change, and additional financing may be needed sooner[215](index=215&type=chunk)[216](index=216&type=chunk)[217](index=217&type=chunk) [Risks Related to the Development and Commercialization of Haduvio and Any Future Product Candidates](index=42&type=section&id=Risks%20Related%20to%20the%20Development%20and%20Commercialization%20of%20Haduvio%20and%20Any%20Future%20Product%20Candidates) - The company's prospects are highly dependent on the successful development and commercialization of Haduvio, its sole product candidate, for chronic cough in IPF, other chronic cough indications, and prurigo nodularis[221](index=221&type=chunk)[222](index=222&type=chunk) - Clinical drug development is a lengthy, expensive, and uncertain process, with risks including unfavorable or inconclusive trial results, regulatory requirements for additional trials, and delays in patient enrollment due to competition or off-label treatments[227](index=227&type=chunk)[228](index=228&type=chunk)[230](index=230&type=chunk)[243](index=243&type=chunk)[245](index=245&type=chunk)[246](index=246&type=chunk) - Haduvio, as a mixed κ-opioid receptor agonist and μ-opioid receptor antagonist, may be susceptible to psychiatric side effects, withdrawal effects, respiratory depression, and potential cardiac/endocrine risks, and its label will likely carry an opioid class warning for serious respiratory depression[250](index=250&type=chunk)[253](index=253&type=chunk) - There is a risk that Haduvio could be classified as a controlled substance by the DEA, or require a Risk Evaluation and Mitigation Strategy (REMS), which would impose restrictive marketing and distribution regulations, increasing costs and potentially limiting its use[254](index=254&type=chunk)[255](index=255&type=chunk)[257](index=257&type=chunk) [Risks Related to Our Dependence on Third Parties](index=54&type=section&id=Risks%20Related%20to%20Our%20Dependence%20on%20Third%20Parties) - The company relies on third parties (CROs, medical institutions, clinical investigators) to conduct clinical trials, limiting control over these activities and posing risks if they do not perform satisfactorily or comply with cGCPs[287](index=287&type=chunk)[288](index=288&type=chunk)[289](index=289&type=chunk)[290](index=290&type=chunk) - The company depends on third-party contract manufacturers for Haduvio's drug substance and product, including a single supplier (Mallinckrodt) for nalbuphine hydrochloride, creating risks of manufacturing delays, supply shortages, and non-compliance with cGMPs[291](index=291&type=chunk)[293](index=293&type=chunk)[294](index=294&type=chunk)[296](index=296&type=chunk)[297](index=297&type=chunk) - Seeking collaborations for Haduvio's development and commercialization, especially for larger indications or international markets, involves risks such as collaborators not dedicating sufficient resources, potential disagreements, or termination of agreements[299](index=299&type=chunk)[300](index=300&type=chunk)[301](index=301&type=chunk)[304](index=304&type=chunk) [Risks Related to Our Intellectual Property](index=58&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) - The company's success relies on obtaining and maintaining patent protection for Haduvio, which is uncertain due to the expensive, time-consuming, and complex patent application and approval process, and the risk of challenges to patent validity or enforceability[309](index=309&type=chunk)[312](index=312&type=chunk)[314](index=314&type=chunk) - Disputes over licensed intellectual property, including scope of rights or diligence obligations, could lead to loss of critical license rights or damages, materially impacting the business[307](index=307&type=chunk)[308](index=308&type=chunk) - The company faces risks of lawsuits for infringing third-party intellectual property rights, which could be costly, time-consuming, and prevent or delay Haduvio's development or commercialization, or require obtaining licenses on unfavorable terms[321](index=321&type=chunk)[323](index=323&type=chunk)[324](index=324&type=chunk) - Changes in patent laws (e.g., America Invents Act, E.U. unitary patent system) or their interpretation, and difficulties in enforcing intellectual property rights globally, could diminish the value of patents and competitive advantage[325](index=325&type=chunk)[328](index=328&type=chunk)[329](index=329&type=chunk)[330](index=330&type=chunk) [Risks Related to Regulatory Approval and Other Legal Compliance Matters](index=63&type=section&id=Risks%20Related%20to%20Regulatory%20Approval%20and%20Other%20Legal%20Compliance%20Matters) - The regulatory approval process for Haduvio is expensive, lengthy, and uncertain, with no guarantee of approval or that the company will qualify for the Section 505(b)(2) pathway, which could significantly delay and increase the cost of development[339](index=339&type=chunk)[340](index=340&type=chunk)[344](index=344&type=chunk)[345](index=345&type=chunk) - Post-marketing, Haduvio will be subject to ongoing stringent regulations, including restrictions on promotion for unapproved uses, compliance with cGMPs, and potential post-marketing studies or withdrawal from the market, with non-compliance leading to substantial penalties[357](index=357&type=chunk)[360](index=360&type=chunk)[361](index=361&type=chunk)[365](index=365&type=chunk)[366](index=366&type=chunk)[367](index=367&type=chunk) - Inadequate funding for regulatory agencies (FDA, SEC) or government shutdowns could delay product reviews and approvals, adversely impacting the business[369](index=369&type=chunk)[370](index=370&type=chunk)[372](index=372&type=chunk) - Current and future healthcare legislation (e.g., ACA, IRA) and pricing reforms may limit product prices, reduce reimbursement, and increase compliance costs, negatively impacting revenue and profitability[373](index=373&type=chunk)[374](index=374&type=chunk)[375](index=375&type=chunk)[378](index=378&type=chunk)[379](index=379&type=chunk)[383](index=383&type=chunk)[384](index=384&type=chunk) - Relationships with healthcare providers and third-party payors are subject to complex anti-kickback, fraud and abuse, and privacy laws (e.g., HIPAA, GDPR, CCPA), with non-compliance risking criminal sanctions, civil penalties, and reputational harm[389](index=389&type=chunk)[390](index=390&type=chunk)[391](index=391&type=chunk)[392](index=392&type=chunk)[393](index=393&type=chunk)[394](index=394&type=chunk)[398](index=398&type=chunk)[400](index=400&type=chunk)[401](index=401&type=chunk)[404](index=404&type=chunk) [Risks Related to Employee Matters and Managing our Growth](index=77&type=section&id=Risks%20Related%20to%20Employee%20Matters%20and%20Managing%20our%20Growth) - The company's success is highly dependent on retaining key executive, scientific, clinical, manufacturing, and sales/marketing personnel, and competition for such talent is intense[418](index=418&type=chunk)[420](index=420&type=chunk)[421](index=421&type=chunk) - Expanding the organization, particularly for commercialization, poses management challenges, including potential infrastructure weaknesses, operational mistakes, and diversion of financial resources[422](index=422&type=chunk) - The company is exposed to risks of fraud or misconduct by employees, independent contractors, and consultants, including non-compliance with regulatory standards, which could lead to significant liability and reputational harm[423](index=423&type=chunk) [Risks Related to Our Common Stock](index=77&type=section&id=Risks%20Related%20to%20Our%20Common%20Stock) - An active trading market for the company's common stock may not be sustainable, and its trading price is highly volatile, influenced by factors such as clinical trial results, regulatory actions, and general market conditions[424](index=424&type=chunk)[430](index=430&type=chunk)[431](index=431&type=chunk)[432](index=432&type=chunk) - Failure to comply with Nasdaq's continued listing requirements, such as the minimum bid price, could lead to delisting, reducing liquidity and negatively impacting the stock price and access to capital markets[425](index=425&type=chunk)[429](index=429&type=chunk) - Future sales of common stock by the company (e.g., through shelf registration, ATM sales) or by significant stockholders (e.g., private placement investors, warrant exercises) could dilute existing ownership and depress the market price of the stock[435](index=435&type=chunk)[439](index=439&type=chunk)[445](index=445&type=chunk) - The significant number of shares underlying outstanding warrants could negatively affect the common stock's market price and make future equity offerings more difficult, and in a sale of the company, warrant holders might receive disproportionately higher consideration[446](index=446&type=chunk)[448](index=448&type=chunk)[449](index=449&type=chunk) - Ownership of common stock is concentrated among executive officers and directors (approximately **35.6%**), potentially limiting new investors' influence over significant corporate decisions[450](index=450&type=chunk) [Item 6. Exhibits](index=85&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including the restated certificate of incorporation, amended and restated bylaws, certifications of principal executive and financial officers, and various Inline XBRL documents - The exhibits include the Restated Certificate of Incorporation, Amended and Restated Bylaws, certifications of principal executive and financial officers (pursuant to Sarbanes-Oxley Act sections 302 and 906), and Inline XBRL documents[466](index=466&type=chunk)[467](index=467&type=chunk) [Signatures](index=88&type=section&id=Signatures) The report is signed by Jennifer L. Good, President and Chief Executive Officer, and Lisa Delfini, Chief Financial Officer, on behalf of Trevi Therapeutics, Inc. as of August 10, 2023 - The report is signed by Jennifer L. Good, President and Chief Executive Officer, and Lisa Delfini, Chief Financial Officer, on August 10, 2023[471](index=471&type=chunk)