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 March 31, 2022 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 ...

Corporate Presentation March 2022 Forward Looking Statement Disclaimer Statements contained in this presentation and oral statements made regarding the subject of this presentation regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties and actual results may differ materially from those expressed or implied by such forward-looking statements. Such state ...

Trevi Therapeutics, Inc. (NASDAQ:TRVI) Q4 2021 Earnings Conference Call March 17, 2022 4:30 PM ET Company Participants Jennifer Good - President and Chief Executive Officer William Forbes - Chief Development Officer Lisa Delfini - Chief Financial Officer Conference Call Participants Annabel Samimy - Stifel Nathan Weinstein - Aegis Capital Operator Good afternoon, and welcome to the Trevi Therapeutics Q4 and Year End 2021 Earnings Conference Call. At this time, all participants will be in listen-only mode. [ ...

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, 2021 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 | | --- | --- | | ( Sta ...

Corporate Presentation March 2022 Forward Looking Statement Disclaimer Statements contained in this presentation and oral statements made regarding the subject of this presentation regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties and actual results may differ materially from those expressed or implied by such forward-looking statements. Such state ...

Trevi Therapeutics, Inc. (NASDAQ:TRVI) Q3 2021 Earnings Conference Call November 10, 2021 4:30 PM ET Company Participants Jennifer Good - President and CEO Bill Forbes - Chief Development Officer Lisa Delfini - CFO Conference Call Participants Nick Rubino - Stifel Rohit Bhasin - Needham & Company Operator Good afternoon, and welcome to the Trevi Therapeutics Third Quarter 2021 Earnings Conference Call. At this time, all participants will be in listen-only mode. [Operator Instructions] Please note this event ...

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, 2021 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 ju ...

Trevi Therapeutics, Inc. (NASDAQ:TRVI) Q2 2021 Earnings Conference Call August 12, 2021 4:30 PM ET Company Participants Jennifer Good - President and Chief Executive Officer Bill Forbes - Chief Development Officer Conference Call Participants Serge Belanger - Needham & Company Operator Good afternoon and welcome to the Trevi Therapeutics Q2 2021 Earnings Conference Call. At this time, all participants will be in listen-only mode. [Operator Instructions] After today's presentation, there will be an opportuni ...

PART I. FINANCIAL INFORMATION [Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Financial%20Statements%20%28Unaudited%29) This section presents unaudited financial statements, highlighting growing net losses, decreased cash, and management's substantial doubt about the company's ability to continue as a going concern Condensed Consolidated Balance Sheet Data (in thousands of US dollars) | | June 30, 2021 | December 31, 2020 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $36,425 | $45,001 | | Total current assets | $38,480 | $46,269 | | Total assets | $39,149 | $47,131 | | **Liabilities and Stockholders' Equity** | | | | Total current liabilities | $9,410 | $5,555 | | Total liabilities | $21,413 | $19,849 | | Accumulated deficit | $(165,142) | $(146,977) | | Total stockholders' equity | $17,736 | $27,282 | Condensed Consolidated Statements of Operations Data (in thousands of US dollars) | | Three Months Ended June 30, | Six Months Ended June 30, | | :--- | :--- | :--- | | | **2021** | **2020** | **2021** | **2020** | | Research and development | $6,498 | $4,921 | $12,087 | $10,940 | | General and administrative | $2,669 | $2,492 | $5,169 | $5,112 | | Loss from operations | $(9,167) | $(7,413) | $(17,256) | $(16,052) | | Net loss | $(9,794) | $(7,384) | $(18,165) | $(15,857) | | Basic and diluted net loss per common share | $(0.49) | $(0.41) | $(0.92) | $(0.89) | - The company has incurred recurring losses and negative cash flows since inception, with an accumulated deficit of **$165.1 million** as of June 30, 2021, and expects continued losses[30](index=30&type=chunk) - Management concluded substantial doubt exists about the company's ability to continue as a going concern, with **$36.4 million** cash insufficient for 12 months of operations[31](index=31&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section details Haduvio's clinical trial progress, increasing operating losses, significant liquidity challenges, and recent financing efforts [Overview](index=23&type=section&id=Overview) - The company is a clinical-stage biopharmaceutical firm developing Haduvio (nalbuphine ER) for neurologically mediated conditions like chronic pruritus and cough[122](index=122&type=chunk) - The Phase 2b/3 PRISM trial for prurigo nodularis increased enrollment to **360 subjects**, with top-line data expected in H1 2022, similar to the COVID-19 delayed CANAL trial for chronic cough in IPF[124](index=124&type=chunk)[125](index=125&type=chunk) - The company has a history of net losses, with an accumulated deficit of **$165.1 million** as of June 30, 2021, and anticipates no revenue until Haduvio's approval[128](index=128&type=chunk) - Management concluded substantial doubt exists about the company's ability to continue as a going concern due to insufficient cash for the next 12 months of operations[133](index=133&type=chunk) [Results of Operations](index=27&type=section&id=Results%20of%20Operations) Comparison of Operating Results (in thousands of US dollars) | | Three Months Ended June 30, | Six Months Ended June 30, | | :--- | :--- | :--- | | | **2021** | **2020** | **2021** | **2020** | | Research and development | $6,498 | $4,921 | $12,087 | $10,940 | | General and administrative | $2,669 | $2,492 | $5,169 | $5,112 | | Net loss | $(9,794) | $(7,384) | $(18,165) | $(15,857) | - For the three months ended June 30, 2021, R&D expenses increased by **$1.6 million**, driven by higher personnel costs and increased PRISM trial activity[148](index=148&type=chunk) - For the six months ended June 30, 2021, R&D expenses increased by **$1.1 million** due to higher personnel, stock-based compensation, and consulting fees[152](index=152&type=chunk) [Liquidity and Capital Resources](index=29&type=section&id=Liquidity%20and%20Capital%20Resources) Cash Flow Summary (in thousands of US dollars) | | Six Months Ended June 30, | | :--- | :--- | | | **2021** | **2020** | | Net cash used in operating activities | $(15,476) | $(13,109) | | Net cash provided by (used in) financing activities | $6,900 | $(12) | | Net decrease in cash and cash equivalents | $(8,576) | $(13,133) | - As of June 30, 2021, the company held **$36.4 million** in cash and cash equivalents[168](index=168&type=chunk) - The company secured a **$14.0 million** term loan with SVB in August 2020, with a July 2021 amendment requiring **$15.0 million** in net equity proceeds by October 31, 2021, to avoid loan collateralization[158](index=158&type=chunk)[159](index=159&type=chunk) - In June 2021, the company entered a common stock purchase agreement with Lincoln Park Capital Fund, LLC, allowing the sale of up to **$15.0 million** in common stock over 24 months[160](index=160&type=chunk) - Existing cash is projected to fund operations into Q2 2022, excluding potential cash collateralization under the SVB loan if milestones are unmet[179](index=179&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=33&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, the company is exempt from providing quantitative and qualitative market risk disclosures - As a smaller reporting company, Trevi Therapeutics is not required to provide quantitative and qualitative disclosures about market risk[188](index=188&type=chunk) [Controls and Procedures](index=33&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls were effective as of June 30, 2021, with no material changes to internal financial reporting controls - Management, including the CEO, concluded the company's disclosure controls and procedures were effective at a reasonable assurance level as of June 30, 2021[189](index=189&type=chunk) - No material changes occurred in the company's internal control over financial reporting during the quarter ended June 30, 2021[190](index=190&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=34&type=section&id=Item%201.%20Legal%20Proceedings) The company reports no current exposure to any material legal proceedings - The company reports it is not subject to any material legal proceedings[192](index=192&type=chunk) [Risk Factors](index=34&type=section&id=Item%201A.%20Risk%20Factors) This section outlines substantial risks, including financial instability, dependence on Haduvio, clinical trial uncertainties, and reliance on third parties [Risks Related to Financial Position and Need for Additional Capital](index=35&type=section&id=Risks%20Related%20to%20Financial%20Position%20and%20Need%20for%20Additional%20Capital) - The company has a history of significant losses, with an accumulated deficit of **$165.1 million** as of June 30, 2021, and anticipates increasing future losses[200](index=200&type=chunk) - Substantial doubt exists about the company's ability to continue as a going concern, with existing cash funding operations only into Q2 2022[206](index=206&type=chunk)[210](index=210&type=chunk) - The company requires substantial additional funding; the SVB Term Loan mandates raising at least **$15.0 million** in net equity proceeds by October 31, 2021, to avoid loan collateralization[207](index=207&type=chunk)[214](index=214&type=chunk) [Risks Related to the Development and Commercialization of Haduvio](index=39&type=section&id=Risks%20Related%20to%20the%20Development%20and%20Commercialization%20of%20Haduvio) - The company is entirely dependent on the successful development and commercialization of Haduvio, its sole product candidate[220](index=220&type=chunk) - Clinical development is lengthy and uncertain; Haduvio's Phase 2 trial for prurigo nodularis failed its primary endpoint, with FDA noting unreliable findings due to small size and high discontinuation[226](index=226&type=chunk)[232](index=232&type=chunk)[257](index=257&type=chunk) - The company experienced clinical trial enrollment delays, including the Phase 2b/3 PRISM trial, impacted by COVID-19 and an increased target from **240 to 360 subjects**[238](index=238&type=chunk)[240](index=240&type=chunk) - Haduvio, a mixed opioid receptor agonist/antagonist, may cause psychiatric effects, respiratory depression, and abuse potential, possibly leading to a restrictive label or controlled substance classification[244](index=244&type=chunk)[251](index=251&type=chunk)[252](index=252&type=chunk) [Risks Related to Dependence on Third Parties](index=52&type=section&id=Risks%20Related%20to%20Dependence%20on%20Third%20Parties) - The company relies on third parties, including CROs, for clinical trials, with limited control over their performance[292](index=292&type=chunk) - The company relies on contract manufacturers for Haduvio, including single supplier Mallinckrodt for active drug substance, whose October 2020 bankruptcy filing creates supply uncertainty[296](index=296&type=chunk)[299](index=299&type=chunk) [Risks Related to Our Intellectual Property](index=56&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) - The company's business relies on licenses from Endo Pharmaceuticals and Rutgers University; non-compliance could lead to loss of critical Haduvio development and commercialization rights[311](index=311&type=chunk)[312](index=312&type=chunk) - The company's ability to secure and maintain Haduvio patent protection is uncertain, as competitors may develop similar products or challenge existing patents[315](index=315&type=chunk)[322](index=322&type=chunk) [Risks Related to Regulatory Approval and Other Legal Compliance Matters](index=61&type=section&id=Risks%20Related%20to%20Regulatory%20Approval%20and%20Other%20Legal%20Compliance%20Matters) - The company plans to use the Section 505(b)(2) regulatory pathway, but FDA approval is not guaranteed, potentially leading to longer and costlier development[343](index=343&type=chunk)[345](index=345&type=chunk) - The regulatory approval process is expensive, time-consuming, and uncertain, with authorities having discretion to require additional trials or deny approval[348](index=348&type=chunk)[350](index=350&type=chunk) - The company is subject to complex healthcare laws, including anti-kickback, false claims, and data privacy laws like GDPR and CCPA, with potential for significant penalties for violations[382](index=382&type=chunk)[391](index=391&type=chunk)[393](index=393&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=81&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section details no unregistered equity sales in Q2 2021, except for Lincoln Park, and updates on IPO proceeds use for Haduvio development - Except for shares issued to Lincoln Park Capital Fund, LLC, the company did not sell or issue any unregistered equity securities during the three months ended June 30, 2021[441](index=441&type=chunk) - As of June 30, 2021, the company used approximately **$35.5 million** of its May 2019 IPO net proceeds for Haduvio development and general corporate purposes[445](index=445&type=chunk) [Exhibits](index=82&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including agreements with Lincoln Park Capital and SVB, and officer certifications Filed Exhibits | Exhibit No. | Description | | :--- | :--- | | 10.1 | Purchase Agreement with Lincoln Park Capital Fund, LLC | | 10.2 | Registration Rights Agreement with Lincoln Park Capital Fund, LLC | | 10.3 | First Amendment to Loan and Security Agreement with Silicon Valley Bank | | 10.4 | First Amendment to Exclusive License Agreement with Rutgers | | 31.1 | Certification of Principal Executive Officer and Principal Financial Officer (Sec. 302) | | 32.1 | Certification of Principal Executive Officer and Principal Financial Officer (Sec. 906) | [Signatures](index=83&type=section&id=Signatures) - The report was signed on August 12, 2021, by Jennifer L Good, President and CEO, and Christopher Galletta, Controller and Treasurer[449](index=449&type=chunk)[451](index=451&type=chunk)

Trevi Therapeutics, Inc. (NASDAQ:TRVI) Q1 2021 Earnings Conference Call May 13, 2021 4:30 PM ET Company Participants Jennifer Good – President and Chief Executive Officer Bill Forbes – Chief Development Officer Conference Call Participants Annabel Samimy – Stifel Gary Nachman – BMO Capital Markets Serge Belanger – Needham & Company Operator Good afternoon, and welcome to the Trevi Therapeutics First Quarter 2021 Earnings Conference Call. At this time, all participants will be in listen-only mode. [Operator ...