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 ...

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 ...