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 ...

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, 2019 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 ...

PART I. FINANCIAL INFORMATION [Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) The company's net loss increased, but its financial position strengthened significantly following a $62.1 million IPO Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | Sep 30, 2019 | Dec 31, 2018 | Change | | :--- | :--- | :--- | :--- | | **Assets** | | | | | Cash and cash equivalents | $63,515 | $7,202 | +$56,313 | | Total current assets | $65,544 | $8,824 | +$56,720 | | Total assets | $66,022 | $10,526 | +$55,496 | | **Liabilities & Equity** | | | | | Total current liabilities | $5,030 | $2,676 | +$2,354 | | Redeemable convertible preferred stock | $0 | $115,742 | -$115,742 | | Total stockholders' equity (deficit) | $60,709 | $(109,494) | +$170,203 | Condensed Consolidated Statements of Operations Highlights (in thousands) | Account | Nine Months Ended Sep 30, 2019 | Nine Months Ended Sep 30, 2018 | Change | | :--- | :--- | :--- | :--- | | Research and development | $14,516 | $9,549 | +$4,967 | | General and administrative | $5,363 | $2,930 | +$2,433 | | **Loss from operations** | **$(19,879)** | **$(12,479)** | **+$7,400** | | **Net loss** | **$(19,513)** | **$(14,563)** | **+$4,950** | | Basic and diluted net loss per common share | $(2.09) | $(41.68) | N/A | Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Activity | Nine Months Ended Sep 30, 2019 | Nine Months Ended Sep 30, 2018 | | :--- | :--- | :--- | | Net cash used in operating activities | $(16,891) | $(13,557) | | Net cash used in investing activities | $(9) | $(66) | | Net cash provided by financing activities | $73,213 | $5,137 | | **Net cash increase (decrease)** | **$56,313** | **$(8,486)** | - On May 9, 2019, the company completed its IPO and a concurrent private placement, issuing 7,000,000 shares of common stock at $10.00 per share for **net proceeds of $62.1 million**[33](index=33&type=chunk)[34](index=34&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=28&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) The company's lead drug trial faces enrollment delays, operating expenses have risen, and future operations depend on additional funding - The company is conducting a Phase 2b/3 PRISM trial for nalbuphine ER, with **slower-than-expected enrollment** pushing top-line data to the second half of 2020[139](index=139&type=chunk) - A Phase 2 trial of nalbuphine ER for chronic cough in patients with IPF is underway, with top-line data also expected in the **second half of 2020**[140](index=140&type=chunk) Comparison of Operating Expenses (in thousands) | Expense Category | Three Months Ended Sep 30, 2019 | Three Months Ended Sep 30, 2018 | Nine Months Ended Sep 30, 2019 | Nine Months Ended Sep 30, 2018 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $5,650 | $3,747 | $14,516 | $9,549 | | General and administrative | $2,000 | $1,210 | $5,363 | $2,930 | | **Total operating expenses** | **$7,650** | **$4,957** | **$19,879** | **$12,479** | - The increase in R&D expenses was primarily due to **increased clinical development activities** for the Phase 2b/3 PRISM trial, the Phase 2 trial in chronic cough, and the Phase 1b trial in chronic liver disease[160](index=160&type=chunk)[164](index=164&type=chunk) - As of September 30, 2019, the company had **cash and cash equivalents of $63.5 million**, which it believes will fund operations through at least the end of Q1 2021[146](index=146&type=chunk)[179](index=179&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=36&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section is not required for the registrant - The company has indicated that quantitative and qualitative disclosures about market risk **are not required**[189](index=189&type=chunk) [Controls and Procedures](index=36&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective, with no material changes to internal controls - Management concluded that as of September 30, 2019, the company's disclosure controls and procedures **were effective** at the reasonable assurance level[190](index=190&type=chunk) - **No changes in internal control over financial reporting** occurred during the nine months ended September 30, 2019, that have materially affected, or are reasonably likely to materially affect, internal controls[191](index=191&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=37&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that it is not currently subject to any material legal proceedings - The company is **not subject to any material legal proceedings**[193](index=193&type=chunk) [Risk Factors](index=37&type=section&id=Item%201A.%20Risk%20Factors) The company faces substantial risks from its history of losses, dependence on a single product, and reliance on third parties [Risks Related to Financial Position and Need for Additional Capital](index=37&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position%20and%20Need%20for%20Additional%20Capital) The company has a history of significant net losses and requires substantial additional funding to continue as a going concern - The company has incurred significant losses since inception, with a **net loss of $19.5 million** for the nine months ended September 30, 2019, and an accumulated deficit of $107.7 million[195](index=195&type=chunk) - **Substantial additional funding is needed** to continue operations, and the company's existing cash is not sufficient to complete the development of nalbuphine ER for any indication[201](index=201&type=chunk)[202](index=202&type=chunk) - The company's independent registered public accounting firm included a **"going concern" explanatory paragraph** in its report for the year ended December 31, 2018, and may do so again[205](index=205&type=chunk) [Risks Related to Development and Commercialization](index=40&type=section&id=Risks%20Related%20to%20the%20Development%20and%20Commercialization%20of%20Nalbuphine%20ER%20and%20Any%20Future%20Product%20Candidates) The company's success depends entirely on its sole product candidate, which faces a lengthy and uncertain clinical pathway - The company is **entirely dependent on the successful development** and commercialization of its sole product candidate, nalbuphine ER[207](index=207&type=chunk) - Clinical drug development is a lengthy and expensive process with an uncertain outcome, and the company has experienced **slower-than-anticipated patient enrollment** in its PRISM trial[212](index=212&type=chunk)[240](index=240&type=chunk) - The use of patient-reported outcomes and historically **high placebo response rates** in pruritus trials could adversely impact clinical development[222](index=222&type=chunk)[223](index=223&type=chunk) - Nalbuphine ER could be subject to restrictive marketing, such as a **REMS program**, or be classified as a controlled substance by the DEA[230](index=230&type=chunk)[231](index=231&type=chunk) [Risks Related to Dependence on Third Parties](index=53&type=section&id=Risks%20Related%20to%20Our%20Dependence%20on%20Third%20Parties) The company relies heavily on third parties for clinical trials and manufacturing, including a single supplier for its active ingredient - The company relies on third parties, such as CROs, to conduct its clinical trials and remains responsible for ensuring **compliance with cGCPs**[274](index=274&type=chunk)[275](index=275&type=chunk) - The company relies on a **single supplier, Mallinckrodt**, for its nalbuphine hydrochloride drug substance and does not have a long-term supply agreement[280](index=280&type=chunk) - The company has no manufacturing facilities and **depends on contract manufacturers**, who must comply with cGMPs for any potential product approval[277](index=277&type=chunk)[282](index=282&type=chunk) [Risks Related to Intellectual Property](index=56&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) The company's success depends on maintaining intellectual property rights, much of which is licensed from third parties - The company is party to **exclusive license agreements** with Endo Pharmaceuticals and Rutgers University for critical patent rights and know-how[292](index=292&type=chunk) - The patent position of biopharmaceutical companies is **highly uncertain**, and the company's patents may be challenged, potentially resulting in loss of exclusivity[299](index=299&type=chunk)[301](index=301&type=chunk) - The company may become involved in **costly and time-consuming lawsuits** to protect its patents or defend against infringement claims[307](index=307&type=chunk)[310](index=310&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 company faces an uncertain regulatory pathway and must comply with complex healthcare and data privacy laws - The company intends to use the **Section 505(b)(2) regulatory pathway**, but if the FDA does not permit this, the approval process will likely take longer and cost more[324](index=324&type=chunk)[325](index=325&type=chunk) - The **regulatory approval process is expensive and uncertain**, and there is no guarantee of approval from the FDA or foreign regulatory authorities[329](index=329&type=chunk)[337](index=337&type=chunk) - The company is subject to numerous healthcare laws, including the federal **Anti-Kickback Statute and False Claims Act**, which carry significant penalties[364](index=364&type=chunk)[365](index=365&type=chunk)[366](index=366&type=chunk) - International operations are subject to data privacy laws like the **GDPR** and anti-corruption laws like the **FCPA**[373](index=373&type=chunk)[374](index=374&type=chunk) [Risks Related to Employee Matters and Managing Growth](index=73&type=section&id=Risks%20Related%20to%20Employee%20Matters%20and%20Managing%20our%20Growth) The company is highly dependent on its executive team and faces challenges in managing organizational growth and employee conduct - The company is **highly dependent on its executive team**, including CEO Jennifer Good, and the loss of their services could impede objectives[384](index=384&type=chunk) - The company expects to significantly expand its organization and may encounter **difficulties managing this growth**, which could disrupt operations[387](index=387&type=chunk) - The company is exposed to the risk of **employee misconduct**, including non-compliance with regulatory standards, which could result in sanctions[388](index=388&type=chunk) [Risks Related to Common Stock](index=74&type=section&id=Risks%20Related%20to%20Our%20Common%20Stock) The company's common stock is subject to high volatility, concentrated ownership, and reduced disclosure requirements - The trading price of the common stock is **highly volatile**, and an active trading market may not be sustainable[389](index=389&type=chunk)[390](index=390&type=chunk) - Lock-up agreements expired on November 3, 2019, making a **substantial number of shares eligible for public sale**, which could reduce the stock price[394](index=394&type=chunk)[395](index=395&type=chunk) - As of November 14, 2019, executive officers, directors, and their affiliates beneficially own approximately **72.8% of the common stock**, giving them significant control[398](index=398&type=chunk) - The company is an **"emerging growth company"**, allowing it to rely on reduced disclosure requirements, which may make its stock less attractive[401](index=401&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=80&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered securities were sold in Q3 2019, and IPO proceeds of $48.2 million remained unused as of September 30, 2019 - The company **did not sell or issue any unregistered equity securities** during the three months ended September 30, 2019[412](index=412&type=chunk) - The May 2019 IPO generated net proceeds of approximately $48.2 million, and as of September 30, 2019, **none of these proceeds had been used**[414](index=414&type=chunk)[416](index=416&type=chunk) [Exhibits](index=81&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including officer certifications and compensation plans - The report includes several exhibits, such as executive compensation plans and **officer certifications required by the Sarbanes-Oxley Act**[418](index=418&type=chunk)

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, 2019 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 ...

Corporate Presentation JUNE 2019 CONFIDENTIAL Forward-Looking Statements 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 statemen ...