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

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

Financial Position - The company has an accumulated deficit of $172.4 million as of September 30, 2021, primarily due to research and development and general and administrative expenses [132]. - As of September 30, 2021, the company had cash and cash equivalents of $29.3 million, which may not be sufficient to fund operations for the next 12 months [137]. - The company reported a net loss of $25.4 million for the nine months ended September 30, 2021, with non-cash charges of $2.8 million primarily from stock-based compensation [171]. - The company believes existing cash and equivalents will fund operations into Q4 2022, barring any failure to meet Milestone Conditions set by the SVB Loan Agreement [179]. - The company has no committed external source of funds and will need to obtain further funding through public or private equity offerings, debt financings, collaborations, or licensing arrangements to complete the clinical development and commercialization of Haduvio [182]. Clinical Trials - The Phase 2b/3 PRISM trial for Haduvio has increased its enrollment target from 240 to 360 subjects to maintain statistical power, with approximately 90% of subjects already enrolled [128]. - The company expects to report top-line data from the Phase 2b/3 PRISM trial in the first half of 2022, subject to uncertainties related to the COVID-19 pandemic [128]. - The ongoing Phase 2 CANAL trial for chronic cough in patients with IPF aims to enroll approximately 60 subjects, with a goal of having 44 study completers [129]. - The ongoing Phase 2b/3 PRISM trial and Phase 2 CANAL trial for Haduvio are critical to the company's future product development [27]. - The company expects some clinical trial sites may take longer to resume activities due to disruptions caused by the COVID-19 pandemic [141]. Expenses and Financial Performance - Research and development expenses for Q3 2021 decreased to $4.7 million from $4.8 million in Q3 2020, primarily due to decreased purchases of clinical trial supplies [155]. - General and administrative expenses for Q3 2021 decreased to $2.2 million from $2.4 million in Q3 2020, mainly due to lower market research costs and stock-based compensation [156]. - Total operating expenses for the nine months ended September 30, 2021, increased to $24.2 million from $23.3 million in 2020, reflecting a rise in research and development expenses [158]. - Research and development expenses for the nine months ended September 30, 2021, increased to $16.8 million from $15.8 million in 2020, driven by higher personnel-related expenses and consulting fees [159]. - The company anticipates an increase in research and development expenses over the next few years as it pursues regulatory approval and prepares for a possible commercial launch of Haduvio [145]. Funding and Capital Needs - The company anticipates needing substantial additional funding to support operations and growth strategies, relying on equity offerings, debt financings, and collaborations [178]. - The company has raised an aggregate of $102.2 million from preferred stock and convertible notes, and borrowed $15.0 million under the Solar Term Loan prior to its IPO [162]. - The company issued 4,225,053 shares and warrants in private placements in October 2021, generating approximately $14.8 million in gross proceeds [167]. - If the company raises additional funds by issuing equity securities, stockholders may experience dilution, and any debt financing may involve restrictive covenants that could adversely impact business operations [182]. - The company may be required to delay, reduce, or abandon product development programs or commercialization efforts if sufficient capital is not raised [183]. Impact of COVID-19 - The COVID-19 pandemic has significantly impacted clinical trial activities, causing delays and interruptions in subject enrollment and data monitoring [140]. - The impact of the COVID-19 pandemic on clinical trials and product development remains a concern for the company [27]. Accounting and Financial Reporting - The company has not engaged in any off-balance sheet arrangements since inception, indicating a straightforward financial structure [186]. - The adoption of new accounting standards on January 1, 2021, did not materially affect the company's financial statements [187]. - The company’s critical accounting policies include research and development expenses and stock-based compensation, which are essential for understanding financial results [185].

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

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

Financial Data and Key Metrics Changes - For Q1 2021, the company reported a net loss of $8.4 million, slightly improved from a net loss of $8.5 million in Q1 2020 [19] - R&D expenses decreased to $5.6 million from $6 million in the same period of 2020, primarily due to reduced clinical trial supply purchases [20] - G&A expenses were $2.5 million, down from $2.6 million in Q1 2020, mainly due to a decrease in stock-based compensation [21] - As of March 31, 2021, cash and cash equivalents totaled $41.6 million, down from $45 million at the end of 2020, expected to fund operations into Q2 2022 [21] Business Line Data and Key Metrics Changes - The company is conducting a Phase 2b/3 trial for pruritus in prurigo nodularis (PN), with over 60 sites activated and approximately 255 of the planned 360 subjects randomized, representing over 70% enrollment [8][9] - The Phase 2 trial for chronic cough in idiopathic pulmonary fibrosis (IPF) is facing challenges due to COVID-19 restrictions, but sites are beginning to reopen and screening is resuming [15][17] Market Data and Key Metrics Changes - The global prevalence of PN is estimated at 730,000 patients, with 300,000 in the U.S. and 430,000 in the rest of the world [7] - Approximately 130,000 patients in the U.S. and an equal number in Europe suffer from IPF, with over 1 million patients worldwide [13][14] Company Strategy and Development Direction - The company aims to complete enrollment for the PRISM trial in the second half of 2021, adjusting guidance due to potential summer slowdowns [11][19] - The company received Fast Track designation from the FDA for the PN indication, facilitating expedited development and review [12] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about enrollment momentum in the PRISM trial despite potential summer slowdowns, with ongoing engagement from study staff and investigators [42][45] - The company is focusing efforts on the UK for the IPF trial, pivoting away from Germany due to estimated timelines and costs [18][54] Other Important Information - The company is the only non-biologic oral candidate in late-phase development for PN, which may provide a competitive advantage [7] - Management highlighted the importance of understanding the variability in itch populations and the challenges in recruiting a homogeneous patient population for the PN study [32][34] Q&A Session Summary Question: Inquiry about the opioid approach and itch population variability - Management discussed the safety and efficacy of their oral formulation, emphasizing its well-characterized profile and dose response in different populations [26][28] Question: Update on enrollment pace and strategies to accelerate it - Management acknowledged a slight slowdown in enrollment but expressed confidence in the engagement of study sites and ongoing recruitment initiatives [42][45] Question: Progress on IPF trial and site reopening - Management confirmed that about a third of the sites are engaged in screening, with plans to add more sites in the UK as needed [53][54] Question: Updates on patients rolling over into the extension study and insights from recent studies - Management reported over 95% of patients rolling over into the extension study, with discontinuation rates in line with expectations [59][61]

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 ...

Financial Data and Key Metrics Changes - For Q4 2020, the company reported a net loss of $9.5 million, compared to a net loss of $6.5 million in Q4 2019, indicating a deterioration in financial performance [15] - R&D expenses increased to $6.6 million in Q4 2020 from $4.8 million in Q4 2019, primarily due to heightened activity in the Phase IIb/III PRISM trial [15] - For the full year 2020, the net loss was $32.8 million, up from $26.1 million in 2019, reflecting increased operational costs [17] - Cash and cash equivalents as of December 31, 2020, totaled $45 million, down from $57.3 million a year earlier, but sufficient to fund operations into Q2 2022 [17] Business Line Data and Key Metrics Changes - The PRISM trial for prurigo nodularis is currently in Phase IIb/III, with 240 of the planned 360 subjects randomized, despite COVID-19 impacting enrollment [7][9] - The chronic cough trial in idiopathic pulmonary fibrosis (IPF) is facing challenges due to COVID-19 restrictions, but enrollment is expected to resume in Q2 2021 [12] Market Data and Key Metrics Changes - The global prevalence of prurigo nodularis is estimated at 730,000 patients, with 300,000 in the US and 430,000 in the rest of the world [7] - The estimated prevalence of IPF exceeds 1 million patients worldwide, with approximately 130,000 patients in the US and an equal number in Europe [11] Company Strategy and Development Direction - The company is focused on completing enrollment in both clinical trials this year and reporting data, as both conditions have no approved therapies [13] - There is an ongoing strategy to add high-quality centers for the PRISM study to enhance enrollment rates [23] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the challenges posed by COVID-19 but expressed optimism about resuming enrollment and achieving timelines for the PRISM trial [9][22] - The company has not provided formal guidance for the chronic cough trial but is striving to complete enrollment by year-end [24][31] Other Important Information - Chris Seiter, the Chief Financial Officer, will be leaving the company in April for a new opportunity [13] - The company plans to participate in various dermatology meetings to present clinical evidence related to their trials [10] Q&A Session Summary Question: Will additional sites be needed for the PRISM study to meet timelines? - Management confirmed that they are in the process of adding a few high-quality centers to the PRISM study to enhance enrollment [23] Question: How are the discontinuation rates and adverse events in the study? - Management indicated that the strategies to manage discontinuation rates are working, and adverse events reported are consistent with previous studies [27][28] Question: Can the chronic cough trial data still be expected by year-end despite challenges? - Management has not reinstated formal guidance but is internally striving to complete enrollment by year-end [24][31] Question: Is there a plan to expand the IPF trial to sites outside of Europe? - Currently, the focus remains on completing the trial in Europe due to existing expertise, with no immediate plans to expand to the US [27]

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