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 ...

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, 2021 TREVI THERAPEUTICS, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 45-0834299 ( State or other jurisdiction of incorporation or organization) 195 Church Street, 14th Floor New Haven, Connecticut 06510 (Address of principal executive offices) (Zip Code) (I.R.S. Em ...

Trevi Therapeutics, Inc. (NASDAQ:TRVI) Q4 2020 Earnings Conference Call March 25, 2021 4:30 PM ET Company Participants Jennifer Good - President and CEO Chris Seiter - Chief Financial Officer Bill Forbes - Chief Development Officer Conference Call Participants Gary Nachman - BMO Capital Markets Annabel Samimy - Stifel Serge Belanger - Needham & Company Operator Good afternoon, and welcome to the Trevi Therapeutics Year End 2020 Earnings Conference Call [Operator Instructions]. As a reminder, this call may b ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) Registrant's telephone number, including area code: (203) 304-2499 \ Securities registered pursuant to Section 12(b) of the Act: ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | | Trading | | | --- | --- | --- | | Title of each class | Symbol(s) | Name of each exchange on which registered | | Common Stock, $0.001 par value per share | TRVI | The Nasdaq Stock Market LLC | For t ...

PART I. FINANCIAL INFORMATION [Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) Trevi Therapeutics, Inc. presents its unaudited condensed consolidated financial statements for the periods ended September 30, 2020, covering balance sheets, operations, equity, cash flows, and notes - The company is a clinical-stage biopharmaceutical firm developing **Haduvio** for chronic pruritus, chronic cough in IPF, and LID in Parkinson's disease[31](index=31&type=chunk) - The company has incurred recurring losses since inception, reporting a **net loss of $23.2 million** for the nine months ended September 30, 2020, and an **accumulated deficit of $137.5 million**[34](index=34&type=chunk) - Management anticipates **$53.3 million in cash and cash equivalents** as of September 30, 2020, will fund operations for at least the next 12 months from the financial statements' issuance date[34](index=34&type=chunk) [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Condensed Consolidated Balance Sheet Highlights (in thousands) | Balance Sheet Item | September 30, 2020 | December 31, 2019 | | :--- | :--- | :--- | | Cash and cash equivalents | $53,293 | $57,313 | | Total current assets | $55,209 | $59,552 | | **Total assets** | **$55,879** | **$60,001** | | Total current liabilities | $6,103 | $5,199 | | Term loan | $13,798 | $0 | | **Total liabilities** | **$20,261** | **$5,456** | | **Total stockholders' equity** | **$35,618** | **$54,545** | | **Total liabilities and stockholders' equity** | **$55,879** | **$60,001** | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Condensed Consolidated Statements of Operations (in thousands, except per share data) | Line Item | Three Months Ended Sep 30, 2020 | Three Months Ended Sep 30, 2019 | Nine Months Ended Sep 30, 2020 | Nine Months Ended Sep 30, 2019 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $4,828 | $5,650 | $15,768 | $14,516 | | General and administrative | $2,416 | $2,000 | $7,528 | $5,363 | | **Total operating expenses** | **$7,244** | **$7,650** | **$23,296** | **$19,879** | | Loss from operations | ($7,244) | ($7,650) | ($23,296) | ($19,879) | | **Net loss** | **($7,378)** | **($7,365)** | **($23,235)** | **($19,513)** | | Basic and diluted net loss per common share | ($0.41) | ($0.41) | ($1.30) | ($2.09) | [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Condensed Consolidated Statements of Cash Flows (in thousands) | Cash Flow Activity | Nine Months Ended Sep 30, 2020 | Nine Months Ended Sep 30, 2019 | | :--- | :--- | :--- | | Net cash used in operating activities | ($20,076) | ($16,891) | | Net cash used in investing activities | ($27) | ($9) | | Net cash provided by financing activities | $16,083 | $73,213 | | **Net cash increase (decrease)** | **($4,020)** | **$56,313** | | Cash and cash equivalents at end of period | $53,293 | $63,515 | - Financing activities in the first nine months of 2020 were primarily driven by **$14.0 million in term loan proceeds** and **$2.4 million from at-the-market sales**, contrasting with **$51.2 million from the 2019 IPO** and **$14.0 million from a private placement**[29](index=29&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) - In August 2020, the company secured a **$14.0 million term loan** from Silicon Valley Bank, collateralized by most assets excluding intellectual property, with interest-only payments until March 2022[55](index=55&type=chunk) - The company initiated an ATM offering in June 2020 to sell up to **$12.0 million of common stock**, having sold **466,758 shares for $2.5 million** in gross proceeds by September 30, 2020[73](index=73&type=chunk) - Licensing agreements with Endo Pharmaceuticals and Rutgers include potential future milestone payments of up to **$1.0 million to Endo** and **$331 thousand to Rutgers**, plus sales-based royalties[91](index=91&type=chunk)[97](index=97&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial condition and operational results, detailing Haduvio's clinical development, COVID-19 impacts, financial performance for the three and nine months ended September 30, 2020, and liquidity [Overview](index=22&type=section&id=Overview) - The company is conducting a Phase 2b/3 PRISM trial for Haduvio in prurigo nodularis patients, with the trial size increased from **240 to 360 subjects** after re-estimation[108](index=108&type=chunk) - PRISM trial enrollment is anticipated to complete in **Q3 2021**, with top-line data in **Q4 2021**, subject to COVID-19 pandemic uncertainties that previously halted patient screening[108](index=108&type=chunk) - The Phase 2 trial for chronic cough in IPF patients was impacted by COVID-19, with enrollment halted and resumed, as the company prioritizes completing both the PRISM and this Phase 2 trial[109](index=109&type=chunk)[113](index=113&type=chunk) [Results of Operations](index=26&type=section&id=Results%20of%20Operations) Comparison of Operating Results for the Three Months Ended September 30 (in thousands) | Line Item | 2020 | 2019 | Change | | :--- | :--- | :--- | :--- | | Research and development | $4,828 | $5,650 | ($822) | | General and administrative | $2,416 | $2,000 | $416 | | **Total operating expenses** | **$7,244** | **$7,650** | **($406)** | | **Net loss** | **($7,378)** | **($7,365)** | **($13)** | - For the three months ended September 30, 2020, **R&D expenses decreased by $0.8 million**, mainly due to Phase 1b trial completion and paused Phase 2 IPF trial enrollment, partially offset by increased PRISM trial activity[132](index=132&type=chunk) Comparison of Operating Results for the Nine Months Ended September 30 (in thousands) | Line Item | 2020 | 2019 | Change | | :--- | :--- | :--- | :--- | | Research and development | $15,768 | $14,516 | $1,252 | | General and administrative | $7,528 | $5,363 | $2,165 | | **Total operating expenses** | **$23,296** | **$19,879** | **$3,417** | | **Net loss** | **($23,235)** | **($19,513)** | **($3,722)** | - For the nine months ended September 30, 2020, **R&D expenses increased by $1.3 million** due to PRISM trial activity and clinical trial supply purchases, while **G&A expenses rose by $2.2 million** from public company costs and higher stock-based compensation[136](index=136&type=chunk)[137](index=137&type=chunk) [Liquidity and Capital Resources](index=28&type=section&id=Liquidity%20and%20Capital%20Resources) - As of September 30, 2020, the company held **$53.3 million in cash and cash equivalents**[141](index=141&type=chunk) - The company expects its current cash and cash equivalents to fund operations and capital expenditures into the **first half of 2022**[118](index=118&type=chunk)[153](index=153&type=chunk) - Recent financing includes a **$14.0 million term loan from SVB** in August 2020 and **$2.5 million in gross proceeds** from an ATM sales agreement by September 30, 2020[142](index=142&type=chunk)[143](index=143&type=chunk) - Substantial additional funding will be required for ongoing operations, including completing the PRISM trial, conducting an additional Phase 3 trial, and potential commercial launch activities[120](index=120&type=chunk)[151](index=151&type=chunk)[152](index=152&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=32&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Trevi Therapeutics, Inc. is exempt from providing disclosures on quantitative and qualitative market risk - Disclosure for this item is not required for smaller reporting companies[162](index=162&type=chunk) [Controls and Procedures](index=32&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, concluded the company's disclosure controls and procedures were effective as of September 30, 2020, with no material changes to internal control over financial reporting - The CEO and CFO concluded the company's disclosure controls and procedures were effective at a reasonable assurance level as of September 30, 2020[163](index=163&type=chunk) - No material changes to internal control over financial reporting occurred during the nine months ended September 30, 2020[164](index=164&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=33&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently subject to any material legal proceedings - The company is not subject to any material legal proceedings[166](index=166&type=chunk) [Risk Factors](index=33&type=section&id=Item%201A.%20Risk%20Factors) This section details numerous risks, including COVID-19 impacts on trials, significant losses, capital needs, dependence on Haduvio, reliance on third parties for manufacturing and trials, and intellectual property and regulatory challenges - The COVID-19 pandemic has delayed clinical trials, including the Phase 2b/3 PRISM trial, by halting patient enrollment and may cause further operational and supply chain disruptions[168](index=168&type=chunk)[170](index=170&type=chunk) - The company has a history of significant losses, with a **$137.5 million accumulated deficit** as of September 30, 2020, requiring substantial additional funding for Haduvio's development and commercialization[173](index=173&type=chunk)[179](index=179&type=chunk) - The business is entirely dependent on the successful development and commercialization of its sole product candidate, **Haduvio**[189](index=189&type=chunk) - The company relies on a single supplier, Mallinckrodt, for Haduvio's active ingredient, and Mallinckrodt's October 2020 bankruptcy filing creates future supply uncertainty[260](index=260&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) The company reports no unregistered equity sales in Q3 2020 and details the use of approximately **$11.0 million** from its May 2019 IPO for Haduvio's development and general corporate purposes - There were no unregistered sales of equity securities during the three months ended September 30, 2020[398](index=398&type=chunk) - From the May 2019 IPO's **$48.2 million net proceeds**, approximately **$11.0 million** has been used by September 30, 2020, for Haduvio's development and general corporate purposes[400](index=400&type=chunk)[402](index=402&type=chunk) [Exhibits](index=82&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including the Loan and Security Agreement with Silicon Valley Bank, officer certifications, and XBRL data files

Financial Data and Key Metrics Changes - For Q3 2020, the company reported a net loss of $7.4 million, unchanged from the same quarter in 2019 [21] - R&D expenses decreased to $4.8 million from $5.7 million in Q3 2019, primarily due to reduced activity in the Phase 2 trial for chronic cough due to COVID-19 [22] - G&A expenses increased to $2.4 million from $2 million in Q3 2019, attributed to higher stock-based compensation and consulting fees [22] - Cash and cash equivalents totaled $53.3 million as of September 30, 2020, down from $57.3 million at the end of 2019 [23] Business Line Data and Key Metrics Changes - The company is focused on developing Haduvio for severe pruritus in prurigo nodularis, with approximately 250,000 patients in the U.S. and 430,000 globally [8] - The PRISM trial for prurigo nodularis has randomized approximately 190 subjects, with over 95% opting to continue into the open-label extension [11][46] - The Phase 2 trial for chronic cough in idiopathic pulmonary fibrosis (IPF) was paused due to COVID-19 but has resumed with an amended protocol [18] Market Data and Key Metrics Changes - The company is conducting trials in both the U.S. and Europe, with over 60 sites activated for the PRISM trial [9] - The company is exploring potential study sites in Germany to enhance enrollment for the IPF cough study [19] Company Strategy and Development Direction - The company aims to complete enrollment in the PRISM trial by Q3 2021 and report top-line data in Q4 2021 [15] - The focus remains on optimizing development execution and resource allocation for both pruritus and cough programs [20] - The company is considering starting a second trial for prurigo nodularis before receiving results from the first trial, depending on resource availability [56] Management's Comments on Operating Environment and Future Outlook - Management noted that enrollment for the PRISM trial has been strong post-COVID, with a good pace of recruitment [28] - The company is optimistic about the competitive landscape, particularly in the IPF cough space, following the failure of a competitor's drug [33] - Management expressed confidence in the ability to adapt to ongoing COVID-19 challenges while maintaining trial progress [60] Other Important Information - The company has implemented funding strategies, including a $14 million term loan and $2.5 million from common stock sales, to extend its cash runway into the first half of 2022 [24] Q&A Session Summary Question: Enrollment progress for PRISM trial - Management indicated that enrollment has been strong, averaging 15 to 20 patients per month, with a target of 360 total participants [28] Question: Chronic cough trial details - The target for the chronic cough trial has been increased to 60 patients, with the same number of completers expected [30] Question: Dropout rates and adverse events - Dropout rates are within expected ranges, and adverse events reported are typical, including dizziness and nausea [38] Question: Moving forward with IPF cough program - Management stated that resources are adequate to support both trials, with a focus on recruitment and enrollment [40] Question: Starting a second trial for PN - Management is considering starting a second trial in parallel but prefers to wait for data from the first trial to optimize the protocol [56] Question: Competitive landscape and comfort level - Management expressed confidence in their competitive position, particularly against a competitor that recently failed in the cough space [57] Question: Impact of lockdowns on enrollment - Current lockdown procedures do not restrict patient visits as previously, allowing for continued enrollment [60]

Trevi Therapeutics, Inc. (NASDAQ:TRVI) Q2 2020 Earnings Conference Call August 13, 2020 4:30 PM ET Company Participants Jennifer Good - President and CEO Chris Seiter - CFO Conference Call Participants Gary Nachman - BMO Capital Ami Fabia - SVB Leerink Annabel Sami - Stifel Serge Belanger - Needham & Co Operator Good afternoon and welcome to the Trevi Therapeutics Second Quarter Earnings Conference Call. At this time all participants are in listen-only mode. Later we will conduct a question-and-answer sessi ...

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 June 30, 2020 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 jurisdi ...

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, 2020 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 ...