Trevi Therapeutics(TRVI)

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Trevi Therapeutics(TRVI) - 2023 Q2 - Quarterly Report
2023-08-10 20:10
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, 2023 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 ...
Trevi Therapeutics(TRVI) - 2023 Q1 - Earnings Call Transcript
2023-05-11 22:42
Trevi Therapeutics, Inc. (NASDAQ:TRVI) Q1 2023 Earnings Conference Call May 11, 2023 4:30 PM ET Company Participants Jennifer Good – President and Chief Executive Officer Lisa Delfini – Chief Financial Officer Conference Call Participants Serge Belanger – Needham & Company Sean Kim – Jones Trading Annabel Samimy – Stifel Operator Good afternoon and welcome to the Trevi Therapeutics’ Q1 2023 Earnings Conference Call. [Operator Instructions] Please note this event is being recorded. Various remarks that manag ...
Trevi Therapeutics(TRVI) - 2023 Q1 - Quarterly Report
2023-05-11 20:11
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, 2023 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 ...
Trevi Therapeutics(TRVI) - 2022 Q4 - Earnings Call Transcript
2023-03-17 03:10
Trevi Therapeutics, Inc. (NASDAQ:TRVI) Q4 2022 Earnings Conference Call March 16, 2023 8:30 AM ET Company Participants Jennifer Good - President & Chief Executive Officer Lisa Delfini - Chief Financial Officer David Clark - Chief Medical Officer Conference Call Participants Leland Gershell - Oppenheimer Nat Charoensook - SVB Securities Sean Kim - Jones Trading Mayank Mamtani - B. Riley Securities Operator Good afternoon and welcome to the Trevi Therapeutics Q4 and Year-End 2022 Earnings Conference Call. [Op ...
Trevi Therapeutics(TRVI) - 2022 Q4 - Annual Report
2023-03-16 20:14
Financial Performance - The company reported an accumulated deficit of $210.1 million as of December 31, 2022, primarily due to research and development and general and administrative expenses [509]. - The company has not generated any revenue from product sales and has incurred net losses each year since its inception [509]. - Net loss for the year ended December 31, 2022, was $29.2 million, compared to a net loss of $33.9 million in 2021, reflecting an improvement of $4.8 million [533]. - Interest income increased by $1.7 million to $1.7 million in 2022, primarily due to higher cash equivalents and marketable securities balances [536]. - Other income, net for 2022 was $0.7 million, compared to other expense, net of $1.5 million in 2021, mainly due to the absence of a $0.4 million expense recorded in 2021 related to shares issued to Lincoln Park [536]. - Total operating expenses for 2022 were $29.9 million, a decrease of $2.6 million from $32.5 million in 2021 [533]. Research and Development - The Phase 2 CANAL trial for Haduvio demonstrated statistically significant results for daytime cough frequency reduction (p<0.0001) with 38 subjects enrolled [503]. - A Phase 2 clinical trial for Haduvio targeting refractory chronic cough is expected to commence in the third quarter of 2023 [505]. - The Phase 2b/3 PRISM trial for prurigo nodularis showed statistically significant results on all primary and secondary endpoints [506]. - The company expects to conduct an additional Phase 3 clinical trial to support NDA submissions for Haduvio for prurigo nodularis [507]. - The company anticipates an increase in research and development expenses as it pursues regulatory approval and prepares for a potential commercial launch of Haduvio [524]. - Research and development expenses decreased by $3.2 million, or 13.7%, to $19.8 million in 2022 from $23.0 million in 2021, primarily due to reduced clinical trial costs [534]. Funding and Cash Flow - As of December 31, 2022, the company had cash, cash equivalents, and marketable securities totaling $120.5 million [516]. - The company may need substantial additional funding to support ongoing operations and growth strategy [518]. - The company expects to incur substantial expenditures for clinical development and regulatory approval of Haduvio, impacting future funding needs [552][553]. - The company has no committed external funding sources and will need to secure additional financing through various means [558]. - The company believes existing cash and marketable securities will fund operations into 2026, excluding costs for additional clinical trials [556]. - Net cash used in operating activities was $28.2 million, a decrease from $28.9 million in 2021 [546][547]. - Net cash used in investing activities for 2022 was $107.4 million, primarily for marketable securities [549]. - Net cash provided by financing activities in 2022 was $111.3 million, significantly up from $20.8 million in 2021 [550][551]. Debt and Obligations - The SVB Term Loan requires interest-only payments until March 2022, with full repayment due by February 1, 2024 [532]. - The SVB Term Loan was originally $14.0 million with an interest rate of either the prime rate plus 1.00% or 4.25% [542]. - The SVB Loan Agreement includes restrictive covenants that may limit the company's operational flexibility [559]. - Failure to raise sufficient capital could lead to delays or abandonment of product development programs [559]. Accounting and Financial Reporting - Financial statements prepared in accordance with U.S. GAAP, requiring estimates and assumptions affecting reported amounts of assets and liabilities [560]. - Research and development expenses are expensed as incurred, with nonrefundable advance payments deferred and capitalized [562]. - Stock-based compensation expense recognized using fair value-based method, influenced by stock price and various complex variables [564]. - Fair value estimates of financial instruments made at a specific point in time, with cash and cash equivalents considered representative of fair value [576]. - No new accounting pronouncements adopted during the year ended December 31, 2022, materially impacting consolidated financial statements [580]. - Company has elected not to avail itself of the JOBS Act exemption, subjecting it to the same new or revised accounting standards as other public companies [579]. - Research and development accruals estimated based on service levels performed and study progress, included in accrued expenses [563]. - Fair value measurements categorized into three levels, with Level 1 being quoted prices in active markets and Level 3 involving unobservable inputs [578]. - Company assesses uncertain tax positions based on sustainability and measures at the largest amount of benefit greater than fifty percent likely to be realized [573]. - Stock options' expected term estimated using the "simplified method," averaging the vesting term and original contractual term [567].
Trevi Therapeutics(TRVI) - 2022 Q3 - Earnings Call Transcript
2022-11-14 00:41
Trevi Therapeutics, Inc. (NASDAQ:TRVI) Q3 2022 Earnings Conference Call November 10, 2022 4:30 PM ET Company Participants Jennifer Good - President and CEO Lisa Delfini - CFO Conference Call Participants Annabel Samimy - Stifel Serge Belanger - Needham & Company Operator Good afternoon, and welcome to the Trevi Therapeutics Q3 2022 Earnings Conference Call. [Operator Instructions] Please note, today's event is being recorded. Various remarks that management makes during this conference call about the compan ...
Trevi Therapeutics(TRVI) - 2022 Q3 - Quarterly Report
2022-11-10 21:11
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 September 30, 2022 Commission File Number: 001-38886 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 ex ...
Trevi Therapeutics(TRVI) - 2022 Q2 - Earnings Call Transcript
2022-08-14 12:20
Trevi Therapeutics, Inc. (NASDAQ:TRVI) Q2 2022 Earnings Conference Call August 11, 2022 4:30 PM ET Company Participants Jennifer Good – President and Chief Executive Officer Lisa Delfini – Chief Financial Officer Bill Forbes – Chief Development Officer Conference Call Participants Annabel Samimy – Stifel Serge Belanger – Needham & Company Leland Gershell – Oppenheimer Nathan Weinstein – Aegis Operator Good afternoon, and welcome to the Trevi Therapeutics Second Quarter 2022 Earnings Conference Call. [Operat ...
Trevi Therapeutics(TRVI) - 2022 Q2 - Quarterly Report
2022-08-11 20:35
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, 2022 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 ...
Trevi Therapeutics(TRVI) - 2022 Q1 - Earnings Call Transcript
2022-05-14 06:40
Trevi Therapeutics, Inc. (NASDAQ:TRVI) Q1 2022 Earnings Conference Call May 12, 2022 4:30 PM ET Company Participants Jennifer Good – President and Chief Executive Officer Lisa Delfini – Chief Financial Officer Bill Forbes – Chief Development Officer Conference Call Participants Serge Belanger – Needham & Company Annabel Samimy – Stifel Nathan Weinstein – Aegis Capital Operator Good afternoon, and welcome to the Trevi Therapeutics First Quarter 2022 Earnings Conference Call. [Operator Instructions] Please no ...