Trevi Therapeutics(US:TRVI)2019-11-14 21:17PART I. FINANCIAL INFORMATION Financial Statements 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 million3334 Management's Discussion and Analysis of Financial Condition and Results of Operations 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 2020139 - 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 2020140 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 disease160164 - 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 2021146179 Quantitative and Qualitative Disclosures About Market Risk This section is not required for the registrant - The company has indicated that quantitative and qualitative disclosures about market risk are not required189 Controls and Procedures 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 level190 - 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 controls191 PART II. OTHER INFORMATION Legal Proceedings The company reports that it is not currently subject to any material legal proceedings - The company is not subject to any material legal proceedings193 Risk Factors 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 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 million195 - 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 indication201202 - 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 again205 Risks Related to Development and Commercialization 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 ER207 - 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 trial212240 - The use of patient-reported outcomes and historically high placebo response rates in pruritus trials could adversely impact clinical development222223 - Nalbuphine ER could be subject to restrictive marketing, such as a REMS program, or be classified as a controlled substance by the DEA230231 Risks Related to Dependence on Third Parties 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 cGCPs274275 - The company relies on a single supplier, Mallinckrodt, for its nalbuphine hydrochloride drug substance and does not have a long-term supply agreement280 - The company has no manufacturing facilities and depends on contract manufacturers, who must comply with cGMPs for any potential product approval277282 Risks Related to Intellectual Property 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-how292 - The patent position of biopharmaceutical companies is highly uncertain, and the company's patents may be challenged, potentially resulting in loss of exclusivity299301 - The company may become involved in costly and time-consuming lawsuits to protect its patents or defend against infringement claims307310 Risks Related to Regulatory Approval and Other Legal Compliance Matters 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 more324325 - The regulatory approval process is expensive and uncertain, and there is no guarantee of approval from the FDA or foreign regulatory authorities329337 - The company is subject to numerous healthcare laws, including the federal Anti-Kickback Statute and False Claims Act, which carry significant penalties364365366 - International operations are subject to data privacy laws like the GDPR and anti-corruption laws like the FCPA373374 Risks Related to Employee Matters and Managing Growth 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 objectives384 - The company expects to significantly expand its organization and may encounter difficulties managing this growth, which could disrupt operations387 - The company is exposed to the risk of employee misconduct, including non-compliance with regulatory standards, which could result in sanctions388 Risks Related to Common Stock 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 sustainable389390 - Lock-up agreements expired on November 3, 2019, making a substantial number of shares eligible for public sale, which could reduce the stock price394395 - As of November 14, 2019, executive officers, directors, and their affiliates beneficially own approximately 72.8% of the common stock, giving them significant control398 - The company is an "emerging growth company", allowing it to rely on reduced disclosure requirements, which may make its stock less attractive401 Unregistered Sales of Equity Securities and Use of Proceeds 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, 2019412 - The May 2019 IPO generated net proceeds of approximately $48.2 million, and as of September 30, 2019, none of these proceeds had been used414416 Exhibits 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 Act418