1. NEW HAVEN, Conn., Aug. 12, 2021 /PRNewswire/ -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of an investigational therapy Haduvio™ (nalbuphine ER) to treat serious neurologically mediated conditions, today announced financial results for the quarter ended June 30, 2021, as well as business updates.

    www.trevitherapeutics.com (PRNewsfoto/Trevi Therapeutics, Inc.)" alt="Trevi Therapeutics, Inc. www.trevitherapeutics.com (PRNewsfoto/Trevi Therapeutics, Inc.)">

    Pruritus in PN (PRISM) Trial 80% enrolled and top-line data readout expected in 1H 2022

    "We continue to advance both our pruritus in prurigo nodularis (PN) and chronic cough in idiopathic pulmonary fibrosis (IPF) trials," said Jennifer L. Good, President and CEO of Trevi Therapeutics. "We are particularly pleased to see recruitment and enrollment activity resume in our CANAL trial with the lifting of COVID-19 restrictions in the UK. As a result of this activity, we have announced guidance for reporting top-line data on the CANAL trial in the first half of 2022." 

    In addition, Trevi recently announced two new additions to its management team. "Trevi is pleased to have welcomed Lisa Delfini as our Chief Financial Officer and Danine Summers who joined us full time as our VP of Medical Affairs. We look forward to utilizing their deep experience as we grow the Company," added Ms. Good.

    Key Business Updates

    • Phase 2b/3 PRISM trial of Haduvio for severe pruritus in patients with PN
      • Approximately 285, or 80%, of planned subjects have enrolled
        • Enrollment expected to be completed by the end of 2021
      • Top-line data readout expected in the first half of 2022
    • Phase 2 CANAL trial of Haduvio for chronic cough in patients with IPF
      • Ongoing recruitment and screening taking place at multiple sites in the UK
      • Top-line data readout expected in the first half of 2022
    • Expanded leadership team to support the growth of the Company

    Second Quarter 2021 Financial Highlights

    Cash position: As of June 30, 2021, the Company had total cash and cash equivalents of $36.4 million, compared to $45.0 million as of December 31, 2020.

    Research and development (R&D) expenses: R&D expenses for the second quarter of 2021 were $6.5 million compared to $4.9 million in the same period in 2020. The increase was primarily due to an increase in personnel-related expenses due to increased employee headcount, increased costs associated with higher activity and enrollment in the Company's ongoing Phase 2b/3 PRISM trial, increased purchases of clinical trial supplies and an increase in consulting and professional fees. These increases were partially offset by decreased expenses relating to the Company's Phase 1b clinical trial in patients with chronic liver disease which was completed in the first half of 2020.

    General and administrative (G&A) expenses: G&A expenses for the second quarter of 2021 were $2.7 million compared to $2.5 million in the same period in 2020. The increase was primarily due to increased legal and professional fees partially offset by a reduction in personnel-related expenses.

    Net loss: For the second quarter of 2021, the Company reported a net loss of $9.8 million, compared to a net loss of $7.4 million in the same period in 2020.

    Conference Call

    To participate in the live conference call today, August 12th at 4:30 p.m. ET, please dial (888) 317-6003 (domestic) or (412) 317-6061 (international) and provide access code 0833159. A live audio webcast will be accessible from the 'Investors & News' section on the Company's website at www.trevitherapeutics.com. An archived replay of the webcast will also be available for 30 days on the Company's website following the event. 

    About Trevi Therapeutics, Inc.

    Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of the investigational therapy Haduvio to treat serious neurologically mediated conditions. Trevi is conducting a Phase 2b/3 clinical trial of Haduvio for the treatment of chronic pruritus associated with prurigo nodularis (PN) and a Phase 2 trial for chronic cough in patients with idiopathic pulmonary fibrosis (IPF). Trevi is also developing Haduvio for the treatment of levodopa-induced dyskinesia (LID) in patients with Parkinson's disease. These conditions share a common pathophysiology that is mediated through opioid receptors in the central and peripheral nervous systems.

    Founded in 2011, Trevi Therapeutics is headquartered in New Haven, CT.

    About Haduvio

    Haduvio, an investigational therapy, is an oral extended-release (ER) formulation of nalbuphine. Nalbuphine is a mixed ĸ-opioid receptor agonist and µ-opioid receptor antagonist that has been approved and marketed as an injectable for pain indications for more than 20 years in the United States and Europe. The ĸ- and µ-opioid receptors are known to be critical mediators of itch, cough and certain movement disorders. Nalbuphine's mechanism of action may also mitigate the risk of abuse associated with µ-opioid agonists because it antagonizes, or blocks, µ-opioid receptors. Parenteral nalbuphine is not currently classified as a controlled substance by the DEA in the United States and by regulatory authorities in most of Europe. Trevi intends to propose Haduvio as the trade name for nalbuphine ER. Haduvio is an investigational therapy that has been granted Fast Track designation by the FDA for the proposed indication of reduction of moderate to severe pruritus in patients with prurigo nodularis. Its safety and efficacy have not been evaluated by any regulatory authority.

    Forward-Looking Statements

    Statements contained in this press release 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 statements include, but are not limited to, statements regarding the impact of the COVID-19 pandemic on Trevi's clinical trials, business and operations; the expected timing of enrollment and for reporting top-line data from Trevi's Phase 2b/3 PRISM trial of Haduvio in patients with PN and Phase 2 CANAL trial of Haduvio for chronic cough in patients with IPF; Trevi's business plans and objectives, including future plans or expectations for Trevi's product candidates; expectations regarding Trevi's uses and sufficiency of capital; and other statements containing the words "believes," "anticipates," "plans," "expects," and similar expressions. Risks that contribute to the uncertain nature of the forward-looking statements include: uncertainties regarding the success, cost and timing of Trevi's product candidate development activities and ongoing and planned clinical trials; uncertainties regarding the scope, timing and severity of the COVID-19 pandemic, the impact of the COVID-19 pandemic on Trevi's clinical operations and actions taken in response to the pandemic; uncertainties regarding Trevi's ability to execute on its strategy; the risk that positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical trials; potential regulatory developments in the United States and foreign countries; uncertainties regarding fast track designation and the effect such status could have on the regulatory review or approval process;  uncertainties inherent in estimating Trevi's cash runway, future expenses and other financial results; including Trevi's ability to continue as a going concern and its obligations under its loan facility; as well as other risks and uncertainties set forth in the quarterly report on Form 10-Q for the quarter ended June 30, 2021 filed with the Securities and Exchange Commission and in subsequent filings with the Securities and Exchange Commission.  All forward-looking statements contained in this press release speak only as of the date on which they were made. Trevi undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Trevi Therapeutics, Inc.

    Selected Balance Sheet Data

    (unaudited)

    (amounts in thousands)







    June 30,

    2021





    December 31,

    2020



    Cash and cash equivalents



    $

    36,425





    $

    45,001



    Working capital





    29,070







    40,714



    Total assets





    39,149







    47,131



    Total debt





    14,245







    13,954



    Stockholders' equity





    17,736







    27,282



     

    Trevi Therapeutics, Inc.

    Selected Statement of Operations Data

    (unaudited)

    (amounts in thousands)





    Three Months Ended

    June 30,





    Six Months Ended

    June 30,





    2021





    2020





    2021





    2020



    Operating expenses:































    Research and development

    $

    6,498





    $

    4,921





    $

    12,087





    $

    10,940



    General and administrative



    2,669







    2,492







    5,169







    5,112



    Total operating expenses



    9,167







    7,413







    17,256







    16,052



    Loss from operations



    (9,167)







    (7,413)







    (17,256)







    (16,052)



    Other (expense) income, net



    (629)







    14







    (926)







    171



    Loss before income taxes



    (9,796)







    (7,399)







    (18,182)







    (15,881)



    Income tax benefit



    2







    15







    17







    24



    Net loss

    $

    (9,794)





    $

    (7,384)





    $

    (18,165)





    $

    (15,857)



     

    Investor Contact

    Katie McManus

    Trevi Therapeutics, Inc.

    203-304-2499

    k.mcmanus@trevitherapeutics.com

    Media Contact

    Rosalia Scampoli

    914-815-1465

    rscampoli@marketcompr.com

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    SOURCE Trevi Therapeutics, Inc.

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  2. NEW HAVEN, Conn., Aug. 9, 2021 /PRNewswire/ -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of the investigational therapy Haduvio™ (nalbuphine ER) to treat serious neurologically mediated conditions, today announced the appointment of Lisa Delfini, CPA, as Chief Financial Officer and Danine Summers, as Vice President, Medical Affairs. Ms. Delfini will lead the accounting and finance operations. Ms. Summers will be responsible for educating the medical community on Haduvio's data and development programs through publications, congresses and relationship building with key opinion leaders.

    NEW HAVEN, Conn., Aug. 9, 2021 /PRNewswire/ -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of the investigational therapy Haduvio™ (nalbuphine ER) to treat serious neurologically mediated conditions, today announced the appointment of Lisa Delfini, CPA, as Chief Financial Officer and Danine Summers, as Vice President, Medical Affairs. Ms. Delfini will lead the accounting and finance operations. Ms. Summers will be responsible for educating the medical community on Haduvio's data and development programs through publications, congresses and relationship building with key opinion leaders.

    www.trevitherapeutics.com (PRNewsfoto/Trevi Therapeutics, Inc.)" alt="Trevi Therapeutics, Inc. www.trevitherapeutics.com (PRNewsfoto/Trevi Therapeutics, Inc.)">

    New CFO and Vice President, Medical Affairs will be instrumental in Trevi's growth as lead trials move towards data

    "We are thrilled to welcome Lisa and Danine to our skilled senior leadership team," said Jennifer L. Good, President and Chief Executive Officer of Trevi. "Their knowledge and experience will be instrumental as we move towards enrollment completion and topline data in our Phase 2b/3 PRISM trial and Phase 2 CANAL trial and preparing for the next stage of growth at Trevi."

    Ms. Delfini joins Trevi with 30 years of experience in the financial sector. Her background includes helping public and private companies with finance transformation and preparing for and executing capital raising activities, acquisitions, and other complex financial and accounting matters. As a Financial Accounting and Advisory Services Partner at Marcum LLP, Ms. Delfini led a team of professionals who provided advisory services on financial activities to companies. In this role, she served as interim CFO, CAO or controller for companies in multiple sectors, including pharmaceuticals. Previously, Ms. Delfini worked at General Electric where she was the Global Controller for the GE Corporate Technical Center of Excellence (TCOE) and then became the Global Controller for GE Industrial Solutions. Ms. Delfini began her career at Deloitte & Touche LLP where she worked for 16 years and completed her time there as a Client Service Partner. She holds a B.S. in Accounting from Lehigh University and is a Certified Public Accountant in the State of Connecticut.

    Ms. Summers is an accomplished Medical Affairs executive whose success in leading medical affairs operations, key opinion leader communication and new market development spans throughout start-up, growth, turnaround, and acquisition phases.  Ms. Summers has spent the majority of her career working in dermatology-focused companies. Before joining Trevi, she held varying senior management roles in medical affairs and marketing at companies such as Anacor Pharmaceuticals, Menlo Therapeutics, Medicis Pharmaceutical, Connetics Corporation, VICOM/FCB and Roche Pharmaceuticals. Ms. Summers was instrumental in the development of Medical Affairs departments and demonstrated her ability to connect with healthcare professionals to educate them on their products' profiles. Ms. Summers holds an M.B.A. in Marketing from the Golden Gate University and a B.A. in Psychology, Business Minor from San Jose State University.

    About Trevi Therapeutics, Inc.

    Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of the investigational therapy Haduvio to treat serious neurologically mediated conditions. Trevi is conducting a Phase 2b/3 clinical trial of Haduvio for the treatment of chronic pruritus associated with prurigo nodularis (PN) and a Phase 2 trial for chronic cough in patients with idiopathic pulmonary fibrosis (IPF). Trevi is also developing Haduvio for the treatment of levodopa-induced dyskinesia (LID) in patients with Parkinson's disease. These conditions share a common pathophysiology that is mediated through opioid receptors in the central and peripheral nervous systems.

    Founded in 2011, Trevi Therapeutics is headquartered in New Haven, CT.

    About Haduvio

    Haduvio, an investigational therapy, is an oral extended-release formulation of nalbuphine. Nalbuphine is a mixed ĸ-opioid receptor agonist and µ-opioid receptor antagonist that has been approved and marketed as an injectable for pain indications for more than 20 years in the United States and Europe. The ĸ- and µ-opioid receptors are known to be critical mediators of itch, cough and certain movement disorders. Nalbuphine's mechanism of action may also mitigate the risk of abuse associated with µ-opioid agonists because it antagonizes, or blocks, µ-opioid receptors. Parenteral nalbuphine is not currently classified as a controlled substance by the DEA in the United States and by regulatory authorities in most of Europe. Trevi intends to propose Haduvio as the trade name for nalbuphine ER. Haduvio is an investigational therapy that has been granted Fast Track designation by the FDA for the proposed indication of reduction of moderate to severe pruritus in patients with PN. Its safety and efficacy have not been evaluated by any regulatory authority.

    Forward-Looking Statements

    Statements contained in this press release 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 statements include, but are not limited to, statements regarding Trevi's business plans and objectives, including future plans or expectations for Trevi's product candidates, and other statements containing the words "believes," "anticipates," "plans," "expects," and similar expressions. Risks that contribute to the uncertain nature of the forward-looking statements include: uncertainties regarding the success, cost and timing of Trevi's product candidate development activities and ongoing and planned clinical trials; uncertainties regarding the scope, timing and severity of the COVID-19 pandemic, the impact of the COVID-19 pandemic on Trevi's clinical operations and actions taken in response to the pandemic; uncertainties regarding Trevi's ability to execute on its strategy; the risk that positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical trials; potential regulatory developments in the United States and foreign countries; uncertainties regarding fast track designation and the effect such status could have on the regulatory review or approval process;  uncertainties inherent in estimating Trevi's cash runway, future expenses and other financial results, including Trevi's ability to continue as a going concern and its obligations under its loan facility; as well as other risks and uncertainties set forth in the quarterly report on Form 10-Q for the quarter ended March 31, 2021 filed with the Securities and Exchange Commission and in subsequent filings with the Securities and Exchange Commission.  All forward-looking statements contained in this press release speak only as of the date on which they were made. Trevi undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Investor Contact

    Katie McManus

    Trevi Therapeutics, Inc.

    203-304-2499

    k.mcmanus@trevitherapeutics.com

    Media Contact 

    Rosalia Scampoli

    914-815-1465

    rscampoli@marketcompr.com

     

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  3. NEW HAVEN, Conn., Aug. 5, 2021 /PRNewswire/ -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of an investigational therapy Haduvio (nalbuphine ER) to treat serious neurologically mediated conditions, today announced that management will host a conference call and live audio webcast on Thursday, August 12 at 4:30 p.m. ET, to provide a corporate update and review the Company's financial results for the quarter ended June 30, 2021.

    NEW HAVEN, Conn., Aug. 5, 2021 /PRNewswire/ -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of an investigational therapy Haduvio (nalbuphine ER) to treat serious neurologically mediated conditions, today announced that management will host a conference call and live audio webcast on Thursday, August 12 at 4:30 p.m. ET, to provide a corporate update and review the Company's financial results for the quarter ended June 30, 2021.

    www.trevitherapeutics.com (PRNewsfoto/Trevi Therapeutics, Inc.)" alt="Trevi Therapeutics, Inc. www.trevitherapeutics.com (PRNewsfoto/Trevi Therapeutics, Inc.)">

    Trevi Therapeutics Hosting Conference Call on Q2 2021 Financial Results

    To participate in the live conference call by phone, please dial (888) 317-6003 (domestic) or (412) 317-6061 (international) and provide access code 0833159. A live audio webcast will be accessible from the 'Investors & News' section on the Company's website at www.trevitherapeutics.com. An archived replay of the webcast will also be available for 30 days on the Company's website following the event.  

    About Trevi Therapeutics, Inc.

    Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of the investigational therapy Haduvio to treat serious neurologically mediated conditions. Trevi is conducting a Phase 2b/3 clinical trial of Haduvio for the treatment of chronic pruritus associated with prurigo nodularis (PN) and a Phase 2 trial for chronic cough in patients with idiopathic pulmonary fibrosis (IPF). Trevi is also developing Haduvio for the treatment of levodopa-induced dyskinesia (LID) in patients with Parkinson's disease. These conditions share a common pathophysiology that is mediated through opioid receptors in the central and peripheral nervous systems.

    Founded in 2011, Trevi Therapeutics is headquartered in New Haven, CT.

    About Haduvio

    Haduvio, an investigational therapy, is an oral extended-release formulation of nalbuphine. Nalbuphine is a mixed ĸ-opioid receptor agonist and µ-opioid receptor antagonist that has been approved and marketed as an injectable for pain indications for more than 20 years in the United States and Europe. The ĸ- and µ-opioid receptors are known to be critical mediators of itch, cough and certain movement disorders. Nalbuphine's mechanism of action may also mitigate the risk of abuse associated with µ-opioid agonists because it antagonizes, or blocks, µ-opioid receptors. Parental nalbuphine is not currently classified as a controlled substance by the DEA in the United States and by regulatory authorities in most of Europe. Trevi intends to propose Haduvio as the trade name for nalbuphine ER. Haduvio is an investigational therapy that has been granted Fast Track designation by the FDA for the proposed indication of reduction of moderate to severe pruritus in patients with prurigo nodularis. Its safety and efficacy have not been evaluated by any regulatory authority.

    Investor Contact

    Katie McManus

    Trevi Therapeutics, Inc.

    203-304-2499

    k.mcmanus@trevitherapeutics.com

    Media Contact 

    Rosalia Scampoli

    914-815-1465

    rscampoli@marketcompr.com

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/trevi-therapeutics-to-report-q2-2021-financial-results-on-august-12-301349802.html

    SOURCE Trevi Therapeutics, Inc.

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  4. NEW HAVEN, Conn., June 9, 2021 /PRNewswire/ -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of the investigational therapy Haduvio™ (nalbuphine ER) to treat serious neurologically mediated conditions, today announced that Jennifer Good, President and CEO, has been selected to deliver a company presentation at 2021 BIO Digital. For 2021, the BIO International Convention will be held virtually as BIO Digital, on June 10 and 11 and from June 14-18.

    NEW HAVEN, Conn., June 9, 2021 /PRNewswire/ -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of the investigational therapy Haduvio™ (nalbuphine ER) to treat serious neurologically mediated conditions, today announced that Jennifer Good, President and CEO, has been selected to deliver a company presentation at 2021 BIO Digital. For 2021, the BIO International Convention will be held virtually as BIO Digital, on June 10 and 11 and from June 14-18.

    www.trevitherapeutics.com (PRNewsfoto/Trevi Therapeutics, Inc.)" alt="Trevi Therapeutics, Inc. www.trevitherapeutics.com (PRNewsfoto/Trevi Therapeutics, Inc.)">

    The Company's presentation will be available to registered BIO Digital attendees from 9am ET June 10, until the end of the conference on June 18.

    An archived replay of the presentation will be available for 30 days following the conclusion of the conference by visiting 'News & Events' in the 'Investors & News' section on the Company's website at www.trevitherapeutics.com.

    About Trevi Therapeutics, Inc.

    Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of the investigational therapy Haduvio to treat serious neurologically mediated conditions. Trevi is conducting a Phase 2b/3 clinical trial of Haduvio for the treatment of chronic pruritus associated with prurigo nodularis (PN) and a Phase 2 trial for chronic cough in patients with idiopathic pulmonary fibrosis (IPF). Trevi is also developing Haduvio for the treatment of levodopa-induced dyskinesia (LID) in patients with Parkinson's disease. These conditions share a common pathophysiology that is mediated through opioid receptors in the central and peripheral nervous systems.

    Founded in 2011, Trevi Therapeutics is headquartered in New Haven, CT.

    About Haduvio

    Haduvio, an investigational therapy, is an oral extended release formulation of nalbuphine. Nalbuphine is a mixed ĸ-opioid receptor agonist and µ-opioid receptor antagonist that has been approved and marketed as an injectable for pain indications for more than 20 years in the United States and Europe. The ĸ- and µ-opioid receptors are known to be critical mediators of itch, cough and certain movement disorders. Nalbuphine's mechanism of action may also mitigate the risk of abuse associated with µ-opioid agonists because it antagonizes, or blocks, µ-opioid receptors. Nalbuphine is not currently classified as a controlled substance by the DEA in the United States and by regulatory authorities in most of Europe. Trevi intends to propose Haduvio as the trade name for nalbuphine ER. Haduvio is an investigational therapy that has been granted Fast Track designation by FDA for the proposed indication of reduction of moderate to severe pruritus in patients with prurigo nodularis. Its safety and efficacy have not been evaluated by any regulatory authority.

    Investor Contact

    Katie McManus

    Trevi Therapeutics, Inc.

    203-304-2499

    k.mcmanus@trevitherapeutics.com

    Media Contact 

    Rosalia Scampoli

    914-815-1465

    rscampoli@marketcompr.com

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/trevi-therapeutics-to-present-at-2021-bio-digital-conference-301308705.html

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  5. Geneva, Switzerland and Boston, MA – May 25, 2021 – ObsEva SA (NASDAQ:OBSV), a biopharmaceutical company developing and commercializing novel therapies to improve women's reproductive health, today announced that its Board of Directors will propose the election at the 2021 Annual General Meeting of Shareholders to be held on May 28, 2021 of Anne VanLent as member of the Board of Directors for a term of one year expiring at the closing of the 2022 Annual General Meeting of Shareholders.

    Anne VanLent is a seasoned senior life sciences executive with over 35 years of management and governance experience with emerging growth companies. Since 2008, Anne has provided strategic, financial and management consulting services to emerging growth companies

    Geneva, Switzerland and Boston, MA – May 25, 2021 – ObsEva SA (NASDAQ:OBSV), a biopharmaceutical company developing and commercializing novel therapies to improve women's reproductive health, today announced that its Board of Directors will propose the election at the 2021 Annual General Meeting of Shareholders to be held on May 28, 2021 of Anne VanLent as member of the Board of Directors for a term of one year expiring at the closing of the 2022 Annual General Meeting of Shareholders.

    Anne VanLent is a seasoned senior life sciences executive with over 35 years of management and governance experience with emerging growth companies. Since 2008, Anne has provided strategic, financial and management consulting services to emerging growth companies in the life sciences and technology arenas through her consulting company AMV Advisors. Assignments have included strategic financial funding and structuring advice, mergers and acquisitions transaction support, and interim Chief Financial Officer services. She has been a member of the board of directors of at least one public company consistently for over twenty years, serving 10 different medical device and biopharmaceutical public companies. She currently serves as a member of the board of directors and audit committee chair for Applied Genetics Technologies Corporation (NASDAQ:AGTC) and Trevi Therapeutics, Inc. (NASDAQ:TRVI).

    Prior to 2008, Anne was EVP and Chief Financial Officer for Barrier Therapeutics, Inc., a Johnson & Johnson spin-off company focused on dermatology which she helped take public in 2004. She had previously served as EVP of Ventures and Licensing for the Sarnoff Corporation (now SRI International) and as Chief Financial Officer for The Liposome Company, Inc., a publicly traded specialty pharmaceutical company, and for Neurogenics, Inc. a venture-backed biotechnology company focused on neurotrophic growth factors. She began her career in the food industry focused on operations, finance, and business line optimization.

    Anne is active in the not-for-profit world through governance and philanthropy, with a focus on global health, women's empowerment and the arts. She has been on the board of IAVI (formerly the International AIDS Vaccine Initiative), a global nonprofit scientific research organization dedicated to addressing urgent, unmet global health challenges including HIV and tuberculosis, since 2008 and currently serves as Vice Chair. She is also a Trustee of McCarter Theatre and the Princeton Area Community Foundation, and is a past-trustee and current advisor to the Princeton Symphony Orchestra, the Arts Council of Princeton, and WIL in Philadelphia, PA.

    Anne received a BA in Physics with high honors from Mount Holyoke College and studied biophysics as a Rotary Scholar at the Center for Macromolecular Research at the University of Strasbourg, France. She resides in Princeton, NJ and Old Saybrook, CT.

    Anne VanLent will replace Barbara Duncan, who will not stand for re-election at the Board of Directors.

     

    About ObsEva

    ObsEva is a biopharmaceutical company developing and commercializing novel therapies to improve women's reproductive health and pregnancy. Through strategic in-licensing and disciplined drug development, ObsEva has established a late-stage clinical pipeline with development programs focused on treating endometriosis, uterine fibroids and preterm labor. ObsEva is listed on the Nasdaq Global Select Market and is trading under the ticker symbol "OBSV" and on the SIX Swiss Exchange where it is trading under the ticker symbol "OBSN". For more information, please visit www.ObsEva.com.

     

    For further information, please contact:

    CEO Office Contact:

    Shauna Dillon

    Shauna.dillon@obseva.ch

    +41 22 552 1550

    Investor Contact:

    Joyce Allaire

    jallaire@lifesciadvisors.com

    +1 (617)-435-6602

     

     

     

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  6. NEW HAVEN, Conn., May 13, 2021 /PRNewswire/ -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of the investigational therapy Haduvio™ (nalbuphine ER) to treat serious neurologically mediated conditions, today announced financial results for the quarter ended March 31, 2021, as well as business updates.  

    www.trevitherapeutics.com (PRNewsfoto/Trevi Therapeutics, Inc.)" alt="Trevi Therapeutics, Inc. www.trevitherapeutics.com (PRNewsfoto/Trevi Therapeutics, Inc.)">

    Fast Track Designation Granted by FDA for Moderate to Severe Pruritus in Prurigo Nodularis (PN)

    "We continue to make progress in our clinical development programs for the treatment of chronic pruritus in patients with PN and chronic cough in patients with Idiopathic Pulmonary Fibrosis (IPF)," said Jennifer L. Good, President and CEO of Trevi Therapeutics. "Our PRISM trial is over 70% enrolled and we expect to complete enrollment in the second half of this year. We also recently received FDA Fast Track designation for moderate to severe pruritus in PN, evidencing the seriousness of this condition. In addition, our CANAL trial has resumed screening subjects since the COVID-19 shelter in place directive was lifted at the end of March in the UK and we are very pleased to see screening activity resume. We remain focused on completing enrollment in both trials and planning for the next steps in clinical development," concluded Ms. Good.

    Key Business Updates

    • Phase 2b/3 PRISM trial of Haduvio for severe pruritus in patients with mild to severe prurigo nodularis: The PRISM trial has enrolled approximately 255 out of the planned 360 total subjects in the trial. We expect to complete enrollment in the second half of 2021, with top-line data to be reported approximately four months after enrollment is complete.

    The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to nalbuphine ER for the proposed indication of reduction of moderate to severe pruritus in patients with prurigo nodularis. Fast Track designation is intended to facilitate development and expedite review of drugs to treat serious and life-threatening conditions so that an approved product can reach the market expeditiously.  

    • Phase 2 CANAL trial of Haduvio for chronic cough in patients with idiopathic pulmonary fibrosis: Sites for our CANAL trial have resumed screening since the UK's shelter in place order was lifted at the end of March 2021. We continue to work with the sites in the U.K. that have not yet resumed screening to fully reopen the trial.

    First Quarter 2021 Financial Highlights

    Cash position: As of March 31, 2021, the Company had total cash and cash equivalents of $41.6 million, compared to $45.0 million as of December 31, 2020. The Company expects its current cash position will fund operations into the second quarter of 2022.

    Research and development (R&D) expenses: R&D expenses for the first quarter of 2021 were $5.6 million compared to $6.0 million in the same period in 2020. The decrease was primarily due to a decrease in clinical development expenses related to decreased purchases of clinical trial supplies and decreased expenses reflecting the completion of our Phase 1b clinical trial in patients with chronic liver disease in the first half of 2020.  These decreased clinical development expenses were partially offset by increased costs associated with higher activity and enrollment in the Company's ongoing Phase 2b/3 PRISM trial, an increase in personnel-related expenses and higher consulting and professional fees.

    General and administrative (G&A) expenses: G&A expenses for the first quarter of 2021 were $2.5 million compared to $2.6 million in the same period in 2020. The decrease was primarily due to a decrease in stock-based compensation expense.

    Net loss: For the first quarter of 2021, the Company reported a net loss of $8.4 million, compared to a net loss of $8.5 million in the same period in 2020.

    Conference Call

    As previously announced, the Company will host a conference call and webcast today, Thursday, May 13, 2021 at 4:30 p.m. ET. To participate in the live conference call by phone, please dial (888) 317-6003 (domestic) or (412) 317-6061 (international) and provide access code 6116464. A live audio webcast will be accessible from the 'Investors & News' section on the Company's website at www.trevitherapeutics.com. An archived replay of the webcast will also be available for 30 days on the Company's website following the event.

    About Trevi Therapeutics, Inc.

    Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of the investigational therapy Haduvio to treat serious neurologically mediated conditions. Trevi is conducting a Phase 2b/3 clinical trial of Haduvio for the treatment of chronic pruritus associated with prurigo nodularis (PN) and a Phase 2 trial for chronic cough in patients with idiopathic pulmonary fibrosis (IPF). Trevi is also developing Haduvio for the treatment of levodopa-induced dyskinesia (LID) in patients with Parkinson's disease. These conditions share a common pathophysiology that is mediated through opioid receptors in the central and peripheral nervous systems.

    Founded in 2011, Trevi Therapeutics is headquartered in New Haven, CT.

    About Haduvio

    Haduvio, an investigational therapy, is an oral extended release formulation of nalbuphine. Nalbuphine is a mixed ĸ-opioid receptor agonist and µ-opioid receptor antagonist that has been approved and marketed as an injectable for pain indications for more than 20 years in the United States and Europe. The ĸ- and µ-opioid receptors are known to be critical mediators of itch, cough and certain movement disorders. Nalbuphine's mechanism of action may also mitigate the risk of abuse associated with µ-opioid agonists because it antagonizes, or blocks, µ-opioid receptors. Nalbuphine is not currently classified as a controlled substance by the DEA in the United States and by regulatory authorities in most of Europe. Trevi intends to propose Haduvio as the trade name for nalbuphine ER. Haduvio is an investigational therapy that has been granted Fast Track designation by FDA for the proposed indication of reduction of moderate to severe pruritus in patients with prurigo nodularis. Its safety and efficacy have not been evaluated by any regulatory authority.

    Forward-Looking Statements

    Statements contained in this press release 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 statements include, but are not limited to, statements regarding the impact of the COVID-19 pandemic on Trevi's clinical trials, business and operations; the expected timing of enrollment and for reporting top-line data from Trevi's Phase 2b/3 PRISM trial of Haduvio in patients with prurigo nodularis; Trevi's business plans and objectives, including future plans or expectations for Trevi's product candidates; expectations regarding Trevi's uses and sufficiency of capital; and other statements containing the words "believes," "anticipates," "plans,"  "expects," and similar expressions. Risks that contribute to the uncertain nature of the forward-looking statements include: uncertainties regarding the success, cost and timing of Trevi's product candidate development activities and ongoing and planned clinical trials; uncertainties regarding the scope, timing and severity of the COVID-19 pandemic, the impact of the COVID-19 pandemic on Trevi's clinical operations and actions taken in response to the pandemic; uncertainties regarding Trevi's ability to execute on its strategy; the risk that positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical trials; potential regulatory developments in the United States and foreign countries; uncertainties regarding fast track designation and the effect such status could have on the regulatory review or approval process;  uncertainties inherent in estimating Trevi's cash runway, future expenses and other financial results; as well as other risks and uncertainties set forth in the annual report on Form 10-K for the year ended December 31, 2020 filed with the Securities and Exchange Commission and in subsequent filings with the Securities and Exchange Commission.  All forward-looking statements contained in this press release speak only as of the date on which they were made. Trevi undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

     

    Trevi Therapeutics, Inc.

    Selected Balance Sheet Data

     (unaudited)

    (amounts in thousands)







    March 31,

    2021





    December 31,

    2020













    Cash and cash equivalents



    $                 41,570





    $                 45,001

    Working capital



    36,821





    40,714

    Total assets



    42,864





    47,131

    Total debt



    14,099





    13,954

    Stockholders' equity



    23,685





    27,282













     

     

    Trevi Therapeutics, Inc.

    Selected Statement of Operations Data

    (unaudited)

    (amounts in thousands)







    Three Months Ended

    March 31,





    2021





    2020













    Operating expenses:













            Research and development



    $                   5,589





    $                   6,019

            General and administrative



    2,500





    2,620

                  Total operating expenses



    8,089





    8,639

    Loss from operations



    (8,089)





    (8,639)

    Other (expense) income, net



    (297)





    157

    Loss before income tax benefit



    (8,386)





    (8,482)

    Income tax benefit



    15





    9

    Net loss



    $                 (8,371)





    $                 (8,473)















     

    Investor Contact

    Katie McManus

    Trevi Therapeutics, Inc.

    203-304-2499

    k.mcmanus@trevitherapeutics.com

    Media Contact

    Rosalia Scampoli

    914-815-1465

    rscampoli@marketcompr.com

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/trevi-therapeutics-announces-first-quarter-2021-financial-results-and-business-update-301290411.html

    SOURCE Trevi Therapeutics, Inc.

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  7. NEW HAVEN, Conn., May 6, 2021 /PRNewswire/ -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of an investigational therapy Haduvio™ (nalbuphine ER) to treat serious neurologically mediated conditions, today announced that management will host a conference call and live audio webcast on Thursday, May 13 at 4:30 p.m. ET, to provide a corporate update and review the Company's financial results for the quarter ended March 31, 2021.

    Trevi Therapeutics Hosting Conference Call on Q1 2021 Financial Results

    To participate in the live conference call by phone, please dial (888) 317-6003 (domestic) or (412) 317-6061 (international) and provide access code 6116464. A live audio webcast will be accessible from the 'Investors & News' section on the Company's website at www.trevitherapeutics.com. An archived replay of the webcast will also be available for 30 days on the Company's website following the event.  

    About Trevi Therapeutics, Inc.

    Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of an investigational therapy Haduvio to treat serious neurologically mediated conditions. Trevi is conducting a Phase 2b/3 clinical trial of Haduvio for the treatment of chronic pruritus associated with prurigo nodularis and a Phase 2 trial for chronic cough in patients with idiopathic pulmonary fibrosis (IPF). Trevi is also developing Haduvio for the treatment of levodopa-induced dyskinesia (LID) in patients with Parkinson's disease and is in the planning stages of a Phase 2 study in this indication. These conditions share a common pathophysiology that is mediated through opioid receptors in the central and peripheral nervous systems.

    Founded in 2011, Trevi Therapeutics is headquartered in New Haven, CT.

    About Haduvio

    Haduvio, an investigational therapy, is an oral extended release formulation of nalbuphine. Nalbuphine is a mixed ĸ-opioid receptor agonist and µ-opioid receptor antagonist that has been approved and marketed as an injectable for pain indications for more than 20 years in the United States and Europe. The ĸ- and µ-opioid receptors are known to be critical mediators of itch, cough and certain movement disorders. Nalbuphine's mechanism of action may also mitigate the risk of abuse associated with µ-opioid agonists because it antagonizes, or blocks, µ-opioid receptors. Nalbuphine is not currently classified as a controlled substance by the DEA in the United States and by regulatory authorities in most of Europe. Trevi intends to propose Haduvio as the trade name for the nalbuphine ER investigational therapy. Haduvio is an investigational therapy and its safety and efficacy have not been evaluated by any regulatory authority.

    Investor Contact

    Katie McManus

    Trevi Therapeutics, Inc.

    203-304-2499

    k.mcmanus@trevitherapeutics.com

    Media Contact 

    Rosalia Scampoli

    914-815-1465

    rscampoli@marketcompr.com

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/trevi-therapeutics-to-report-q1-2021-financial-results-on-may-13-301285710.html

    SOURCE Trevi Therapeutics, Inc.

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  8. NEW HAVEN, Conn., April 07, 2021 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio™ (nalbuphine ER) to treat serious neurologically mediated conditions, today announced that management will participate in a virtual fireside chat, as well as host investor meetings, at the 20th Annual Needham Virtual Healthcare Conference on April 14, 2021. Trevi's presentation is scheduled for 2:15 p.m. ET.

    A live webcast of the virtual fireside chat can be accessed by visiting ‘News & Events' in the ‘Investors & News' section on the Company's website at www.trevitherapeutics.com. An archived replay of the webcast will also be available for 30 days…

    NEW HAVEN, Conn., April 07, 2021 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio™ (nalbuphine ER) to treat serious neurologically mediated conditions, today announced that management will participate in a virtual fireside chat, as well as host investor meetings, at the 20th Annual Needham Virtual Healthcare Conference on April 14, 2021. Trevi's presentation is scheduled for 2:15 p.m. ET.

    A live webcast of the virtual fireside chat can be accessed by visiting ‘News & Events' in the ‘Investors & News' section on the Company's website at www.trevitherapeutics.com. An archived replay of the webcast will also be available for 30 days on the Company's website following the conference.

    The Company's corporate presentation is posted to its website in the ‘Investors & News' section under ‘News & Events'.

    About Trevi Therapeutics, Inc.

    Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio to treat serious neurologically mediated conditions. Trevi is conducting a Phase 2b/3 clinical trial of Haduvio for the treatment of chronic pruritus associated with prurigo nodularis and a Phase 2 trial for chronic cough in patients with idiopathic pulmonary fibrosis (IPF). Trevi is also developing Haduvio for the treatment of levodopa-induced dyskinesia (LID) in patients with Parkinson's disease and is in the planning stages of a Phase 2 study in this indication. These conditions share a common pathophysiology that is mediated through opioid receptors in the central and peripheral nervous systems.

    Founded in 2011, Trevi Therapeutics is headquartered in New Haven, CT.

    About Haduvio

    Haduvio is an oral extended release formulation of nalbuphine. Nalbuphine is a mixed ĸ-opioid receptor agonist and µ-opioid receptor antagonist that has been approved and marketed as an injectable for pain indications for more than 20 years in the United States and Europe. The ĸ- and µ-opioid receptors are known to be critical mediators of itch, cough and certain movement disorders. Nalbuphine's mechanism of action also mitigates the risk of abuse associated with µ-opioid agonists because it antagonizes, or blocks, µ-opioid receptors. Nalbuphine is currently the only opioid approved for marketing that is not classified as a controlled substance in the United States and most of Europe. Trevi intends to propose Haduvio as the trade name for the nalbuphine ER investigational product. Haduvio is an investigational drug product and its safety and efficacy have not been fully evaluated by any regulatory authority.

    Investor Contact

    Katie McManus

    Trevi Therapeutics, Inc.

    203-304-2499

    katie.mcmanus@trevitherapeutics.com

    Media Contact  

    Rosalia Scampoli

    914-815-1465

    rscampoli@marketcompr.com



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  9. Expects to Complete Enrollment and Report Top-Line Data of the Phase 2b/3 PRISM Trial in Second Half of 2021

    Cash Position Expected to Fund Operations into the Second Quarter of 2022

    NEW HAVEN, Conn., March 25, 2021 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio™ (nalbuphine ER) to treat serious neurologically mediated conditions, today announced financial results for the quarter and year ended December 31, 2020, as well as business highlights.

    "We made significant progress in the PRISM trial this year, despite the impact of COVID-19 which slowed recruitment activities worldwide through the latter part of…

    Expects to Complete Enrollment and Report Top-Line Data of the Phase 2b/3 PRISM Trial in Second Half of 2021

    Cash Position Expected to Fund Operations into the Second Quarter of 2022

    NEW HAVEN, Conn., March 25, 2021 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio™ (nalbuphine ER) to treat serious neurologically mediated conditions, today announced financial results for the quarter and year ended December 31, 2020, as well as business highlights.

    "We made significant progress in the PRISM trial this year, despite the impact of COVID-19 which slowed recruitment activities worldwide through the latter part of 2020 and early 2021. Recruiting for this trial has accelerated this month and we expect to complete enrollment in the third quarter of this year and report top-line results in the fourth quarter of 2021," said Jennifer L. Good, President and CEO of Trevi Therapeutics. "Throughout this past year, we have added to our key talent as we progress through the clinical development of Haduvio in two important indications and prepare for the next phase of development."

    Key Business Updates

    • Phase 2b/3 PRISM trial of Haduvio for severe pruritus in patients with prurigo nodularis (PN): To date, the Company has enrolled approximately 240 of the 360 planned total subjects in the trial and reaffirms expectations that enrollment will be completed in the third quarter of 2021 and top-line data will be reported in the fourth quarter of 2021.
    • Phase 2 CANAL trial of Haduvio for chronic cough in patients with idiopathic pulmonary fibrosis (IPF): This trial is currently being conducted in the United Kingdom, which resumed its shelter in place directive due to COVID-19 in early December 2020 through the end of March 2021. The restrictions paused enrollment for this at-risk patient group during the related time period. We expect to resume recruiting subjects for the trial in the second quarter of 2021. Trevi is also seeking regulatory and ethics board approvals to add study sites in Germany.

    Fourth Quarter 2020 Financial Highlights

    Research and development (R&D) expenses: R&D expenses for the fourth quarter of 2020 were $6.6 million compared to $4.8 million in the same period in 2019. The increase was primarily due to increased activity in the Company's Phase 2b/3 PRISM clinical trial as well as expenses associated with the purchase of clinical trial supplies.

    General and administrative (G&A) expenses: G&A expenses for the fourth quarter of 2020 were $2.6 million compared to $1.9 million in the same period in 2019. The increase was primarily due to an increase in consulting fees and stock-based compensation expenses.

    Net loss: For the fourth quarter of 2020, the Company reported a net loss of $9.5 million, compared to a net loss of $6.5 million in the same period in 2019.

    Year End 2020 Financial Highlights

    Cash position: As of December 31, 2020, total cash and cash equivalents were $45.0 million compared to $57.3 million as of December 31, 2019. Trevi believes its current cash position will be sufficient to fund operations into the second quarter of 2022.

    R&D expenses: R&D expenses for the year ended December 31, 2020 were $22.3 million compared to $19.3 million for the year ended December 31, 2019. The increase was primarily due to an increase in clinical development expenses, primarily related to increased activity and enrollment in the Phase 2b/3 PRISM trial as well as an increase in expenses related to the purchase of clinical trial supplies.

    G&A expenses: G&A expenses for the year ended December 31, 2020 were $10.2 million compared to $7.3 million for the year ended December 31, 2019. The increase was primarily due to an increase in stock-based compensation expenses attributable to the issuance of new stock option grants in connection with the IPO and in the first quarter of 2020, increased consulting fees as well as increased expenses related to being a public company.

    Net loss: For the year ended December 31, 2020, Trevi reported a net loss of $32.8 million compared to a net loss of $26.1 million for the year ended December 31, 2019.

    Conference Call

    As previously announced, the Company will host a conference call and webcast today, March 25, 2021 at 4:30 p.m. ET. To participate in the live conference call by phone, please dial (866) 360-5746 (domestic) or (602) 563-8605 (international) and provide access code 8599904. A live audio webcast will be accessible from the ‘Investors & News' section on the Company's website at www.trevitherapeutics.com. An archived replay of the webcast will also be available for 30 days on the Company's website following the event.

    About Trevi Therapeutics, Inc.

    Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio to treat serious neurologically mediated conditions. Trevi is conducting a Phase 2b/3 clinical trial of Haduvio for the treatment of chronic pruritus associated with prurigo nodularis and a Phase 2 trial for chronic cough in patients with idiopathic pulmonary fibrosis (IPF). Trevi is also developing Haduvio for the treatment of levodopa-induced dyskinesia (LID) in patients with Parkinson's disease and is in the planning stages of a Phase 2 study in this indication. These conditions share a common pathophysiology that is mediated through opioid receptors in the central and peripheral nervous systems.

    Founded in 2011, Trevi Therapeutics is headquartered in New Haven, CT.

    About HADUVIO

    Haduvio is an oral extended release formulation of nalbuphine. Nalbuphine is a mixed ĸ-opioid receptor agonist and µ-opioid receptor antagonist that has been approved and marketed as an injectable for pain indications for more than 20 years in the United States and Europe. The ĸ- and µ-opioid receptors are known to be critical mediators of itch, cough and certain movement disorders. Nalbuphine's mechanism of action also mitigates the risk of abuse associated with µ-opioid agonists because it antagonizes, or blocks, µ-opioid receptors. Nalbuphine is currently the only opioid approved for marketing that is not classified as a controlled substance in the United States and most of Europe. Trevi intends to propose Haduvio as the trade name for the nalbuphine ER investigational product. Haduvio is an investigational drug product and its safety and efficacy have not been fully evaluated by any regulatory authority.

    Forward-Looking Statements

    Statements contained in this press release 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 statements include, but are not limited to, statements regarding the impact of the COVID-19 pandemic on Trevi's clinical trials, business and operations; the expected timing of enrollment and for reporting top-line data from Trevi's Phase 2b/3 PRISM trial of Haduvio in patients with prurigo nodularis; Trevi's business plans and objectives, including future plans or expectations for Trevi's product candidates; expectations regarding Trevi's uses and sufficiency of capital; and other statements containing the words "believes," "anticipates," "plans," "expects," and similar expressions. Risks that contribute to the uncertain nature of the forward-looking statements include: uncertainties regarding the success, cost and timing of Trevi's product candidate development activities and ongoing and planned clinical trials; uncertainties regarding the scope, timing and severity of the COVID-19 pandemic, the impact of the COVID-19 pandemic on Trevi's clinical operations and actions taken in response to the pandemic; uncertainties regarding Trevi's ability to execute on its strategy; the risk that positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical trials; potential regulatory developments in the United States and foreign countries; uncertainties inherent in estimating Trevi's cash runway, future expenses and other financial results; as well as other risks and uncertainties set forth in the quarterly report on Form 10-Q for the quarter ended September 30, 2020 filed with the Securities and Exchange Commission and in subsequent filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Trevi undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Trevi Therapeutics, Inc.

    Selected Balance Sheet Data

    (unaudited)

    (amounts in thousands)

     December 31,

    2020
     December 31,

    2019
        
    Cash and cash equivalents$45,001  $57,313 
    Working capital 40,714   54,353 
    Total assets 47,131   60,001 
    Total debt 13,954   ── 
    Stockholders' equity 27,282   54,545 



    Trevi Therapeutics, Inc.

    Selected Statement of Operations Data

    (unaudited)

    (amounts in thousands)

     Three Months Ended

    December 31,
     Year Ended

    December 31,
      2020   2019   2020   2019 
    Operating expenses:                
    Research and development$6,560  $4,823  $22,328  $19,339 
    General and administrative 2,633   1,943   10,161   7,306 
    Total operating expenses 9,193   6,766   32,489   26,645 
    Loss from operations (9,193)  (6,766)  (32,489)  (26,645)
    Other income (expense), net (313)  225   (287)  577 
    Loss before income tax benefit (9,506)  (6,541)  (32,776)  (26,068)
    Income tax benefit (expense) (17)  4   18   18 
    Net loss$(9,523) $(6,537) $(32,758) $(26,050)



    Investor Contact

    Eric Ribner

    LifeSci Advisors

    917 592 0932

    Eric@lifesciadvisors.com

    Media Contact

    Rosalia Scampoli

    914-815-1465

    rscampoli@marketcompr.com



    Primary Logo

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  10. NEW HAVEN, Conn., March 18, 2021 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio™ (nalbuphine ER) to treat serious neurologically mediated conditions, today announced that management will host a conference call and live audio webcast at 4:30 p.m. ET on March 25, 2021, to provide a corporate update and review the Company's financial results for the quarter and year ended December 31, 2020.

    To participate in the live conference call by phone, please dial (866) 360-5746 (domestic) or (602) 563-8605 (international) and provide access code 8599904. A live audio webcast will be accessible from the ‘Investors & News' section on the…

    NEW HAVEN, Conn., March 18, 2021 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio™ (nalbuphine ER) to treat serious neurologically mediated conditions, today announced that management will host a conference call and live audio webcast at 4:30 p.m. ET on March 25, 2021, to provide a corporate update and review the Company's financial results for the quarter and year ended December 31, 2020.

    To participate in the live conference call by phone, please dial (866) 360-5746 (domestic) or (602) 563-8605 (international) and provide access code 8599904. A live audio webcast will be accessible from the ‘Investors & News' section on the Company's website at www.trevitherapeutics.com. An archived replay of the webcast will also be available for 30 days on the Company's website following the event.

    About Trevi Therapeutics, Inc.

    Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio to treat serious neurologically mediated conditions. Trevi is conducting a Phase 2b/3 clinical trial of Haduvio for the treatment of chronic pruritus associated with prurigo nodularis and a Phase 2 trial for chronic cough in patients with idiopathic pulmonary fibrosis (IPF). Trevi is also developing Haduvio for the treatment of levodopa-induced dyskinesia (LID) in patients with Parkinson's disease and is in the planning stages of a Phase 2 study in this indication. These conditions share a common pathophysiology that is mediated through opioid receptors in the central and peripheral nervous systems.

    Founded in 2011, Trevi Therapeutics is headquartered in New Haven, CT.

    About HADUVIO

    Haduvio is an oral extended release formulation of nalbuphine. Nalbuphine is a mixed ĸ-opioid receptor agonist and µ-opioid receptor antagonist that has been approved and marketed as an injectable for pain indications for more than 20 years in the United States and Europe. The ĸ- and µ-opioid receptors are known to be critical mediators of itch, cough and certain movement disorders. Nalbuphine's mechanism of action also mitigates the risk of abuse associated with µ-opioid agonists because it antagonizes, or blocks, µ-opioid receptors. Nalbuphine is currently the only opioid approved for marketing that is not classified as a controlled substance in the United States and most of Europe. Trevi intends to propose Haduvio as the trade name for the nalbuphine ER investigational product. Haduvio is an investigational drug product and its safety and efficacy have not been fully evaluated by any regulatory authority.

    Investor Contact

    Eric Ribner

    LifeSci Advisors

    917 592 0932

    Eric@lifesciadvisors.com

    Media Contact  

    Rosalia Scampoli

    914-815-1465

    rscampoli@marketcompr.com



    Primary Logo

    View Full Article Hide Full Article
  11. NEW HAVEN, Conn., Feb. 18, 2021 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio™ (nalbuphine ER) to treat serious neurologically mediated conditions, today announced that management will participate in a virtual fireside chat, as well as host virtual investor meetings, at the 10th Annual SVB Leerink Global Healthcare Conference on February 25, 2021.

    Presentation Time: 4:20 p.m. ET

    A live webcast of the virtual fireside chat can be accessed by visiting ‘News & Events' in the ‘Investors & News' section on the Company's website at www.trevitherapeutics.com. An archived replay of the webcast will also be available for 30…

    NEW HAVEN, Conn., Feb. 18, 2021 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio™ (nalbuphine ER) to treat serious neurologically mediated conditions, today announced that management will participate in a virtual fireside chat, as well as host virtual investor meetings, at the 10th Annual SVB Leerink Global Healthcare Conference on February 25, 2021.

    Presentation Time: 4:20 p.m. ET

    A live webcast of the virtual fireside chat can be accessed by visiting ‘News & Events' in the ‘Investors & News' section on the Company's website at www.trevitherapeutics.com. An archived replay of the webcast will also be available for 30 days on the Company's website following the conference.

    The Company's corporate presentation is posted to its website in the ‘Investors & News' section under ‘News & Events'.

    About Trevi Therapeutics, Inc.

    Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio to treat serious neurologically mediated conditions. Trevi is currently developing Haduvio for the treatment of chronic pruritus, chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and levodopa-induced dyskinesia (LID) in patients with Parkinson's disease. These conditions share a common pathophysiology that is mediated through opioid receptors in the central and peripheral nervous systems. Trevi is currently conducting a Phase 2b/3 clinical trial of Haduvio, referred to as the PRISM trial, in patients with severe pruritus associated with prurigo nodularis and a Phase 2 trial for chronic cough in patients with IPF.

    Founded in 2011, Trevi Therapeutics is headquartered in New Haven, CT.

    About HADUVIO

    Haduvio is an oral extended release formulation of nalbuphine. Nalbuphine is a mixed ĸ-opioid receptor agonist and µ-opioid receptor antagonist that has been approved and marketed as an injectable for pain indications for more than 20 years in the United States and Europe. The ĸ- and µ-opioid receptors are known to be critical mediators of itch, cough and certain movement disorders. Nalbuphine's mechanism of action also mitigates the risk of abuse associated with µ-opioid agonists because it antagonizes, or blocks, µ-opioid receptors. Nalbuphine is currently the only opioid approved for marketing that is not classified as a controlled substance in the United States and most of Europe. Trevi intends to propose Haduvio as the trade name for the nalbuphine ER investigational product. Haduvio is an investigational drug product and its safety and efficacy have not been fully evaluated by any regulatory authority.

    Investor Contact

    Chris Seiter, Chief Financial Officer

    Trevi Therapeutics, Inc.

    203-304-2499

    chris.seiter@trevitherapeutics.com

    Media Contact

    Rosalia Scampoli

    914-815-1465

    rscampoli@marketcompr.com



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  12. Industry Veteran to Lead the Clinical Development of Haduvio™ in Multiple Indications

    NEW HAVEN, Conn., Feb. 01, 2021 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio™ (nalbuphine ER) to treat serious neurologically mediated conditions, today announced the appointment of William Forbes, Pharm.D., as Chief Development Officer. Dr. Forbes will join Trevi's senior management team and be responsible for leading the clinical development of Haduvio which is in late-stage clinical trials in its two lead indications.

    "I am happy to welcome Bill to our executive leadership team," said Jennifer L. Good, President and Chief Executive Officer…

    Industry Veteran to Lead the Clinical Development of Haduvio™ in Multiple Indications

    NEW HAVEN, Conn., Feb. 01, 2021 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio™ (nalbuphine ER) to treat serious neurologically mediated conditions, today announced the appointment of William Forbes, Pharm.D., as Chief Development Officer. Dr. Forbes will join Trevi's senior management team and be responsible for leading the clinical development of Haduvio which is in late-stage clinical trials in its two lead indications.

    "I am happy to welcome Bill to our executive leadership team," said Jennifer L. Good, President and Chief Executive Officer of Trevi. "Bill has a proven track record of success in developing and managing highly effective product development teams and progressing products through all phases of clinical development and regulatory milestones, including multiple approvals. Bill's extensive experience in pharmaceutical product development will be extremely valuable as we complete enrollment and report top-line data from our Phase 2b/3 trial for chronic pruritus in patients with prurigo nodularis and our Phase 2 trial for chronic cough in patients with IPF and prepare for the next steps in development for both of these programs."

    Dr. Forbes joins Trevi with over 30 years of experience in pharmaceutical product development. Before joining Trevi, he served as Founder, President and CEO of Vivelix Pharmaceuticals. Prior to Vivelix, Dr. Forbes held multiple senior leadership positions throughout his career, including Chief Development Officer for Salix Pharmaceuticals where he was responsible for the development of Xifaxan (rifaximin) in multiple indications. Dr. Forbes' contributions at Salix were instrumental in guiding 12 FDA approvals. He holds a Pharm.D. from Creighton University.

    "This is an exciting time to join Trevi with two late-stage development programs of Haduvio ongoing which could help to meet the needs' of patients suffering from serious conditions with no approved therapies," said Dr. Forbes. "I am impressed with Trevi's highly skilled professionals and look forward to working with the team to achieve key near-term product development goals this year."

    About Trevi Therapeutics, Inc.

    Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio to treat serious neurologically mediated conditions. Trevi is currently developing Haduvio for the treatment of chronic pruritus, chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and levodopa-induced dyskinesia (LID) in patients with Parkinson's disease. These conditions share a common pathophysiology that is mediated through opioid receptors in the central and peripheral nervous systems. Trevi is currently conducting a Phase 2b/3 clinical trial of Haduvio, referred to as the PRISM trial, in patients with severe pruritus associated with prurigo nodularis and a Phase 2 trial for chronic cough in patients with IPF.

    Founded in 2011, Trevi Therapeutics is headquartered in New Haven, CT.

    About HADUVIO

    Haduvio is an oral extended release formulation of nalbuphine. Nalbuphine is a mixed ĸ-opioid receptor agonist and µ-opioid receptor antagonist that has been approved and marketed as an injectable for pain indications for more than 20 years in the United States and Europe. The ĸ- and µ-opioid receptors are known to be critical mediators of itch, cough and certain movement disorders. Nalbuphine's mechanism of action also mitigates the risk of abuse associated with µ-opioid agonists because it antagonizes, or blocks, µ-opioid receptors. Nalbuphine is currently the only opioid approved for marketing that is not classified as a controlled substance in the United States and most of Europe. Trevi intends to propose Haduvio as the trade name for the nalbuphine ER investigational product. Haduvio is an investigational drug product and its safety and efficacy have not been fully evaluated by any regulatory authority.

    Forward-Looking Statements

    Statements contained in this press release 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 statements include, but are not limited to, statements regarding the expected timing of enrollment and for reporting top-line data from, Trevi's Phase 2b/3 PRISM trial of Haduvio in patients with prurigo nodularis; Trevi's business plans and objectives, including future plans or expectations for Trevi's product candidates; and other statements containing the words "believes," "anticipates," "plans," "expects," and similar expressions. Risks that contribute to the uncertain nature of the forward-looking statements include: uncertainties regarding the success, cost and timing of Trevi's product candidate development activities and ongoing and planned clinical trials; uncertainties regarding the scope, timing and severity of the COVID-19 pandemic, the impact of the COVID-19 pandemic on Trevi's clinical operations and actions taken in response to the pandemic; uncertainties regarding Trevi's ability to execute on its strategy; the risk that positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical trials; potential regulatory developments in the United States and foreign countries; uncertainties inherent in estimating Trevi's cash runway, future expenses and other financial results; as well as other risks and uncertainties set forth in the quarterly report on Form 10-Q for the quarter ended June 30, 2020 filed with the Securities and Exchange Commission and in subsequent filings with the Securities and Exchange Commission.  All forward-looking statements contained in this press release speak only as of the date on which they were made. Trevi undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Investor Contact

    Chris Seiter, Chief Financial Officer

    Trevi Therapeutics, Inc.

    203-304-2499

    chris.seiter@trevitherapeutics.com

    Media Contact

    Rosalia Scampoli

    914-815-1465

    rscampoli@marketcompr.com



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  13. PRISM Trial of Haduvio™ for Severe Pruritus in Patients with Prurigo Nodularis 

    Exceeds Halfway Enrollment Milestone

    Phase 2 Chronic Cough Trial in Patients with IPF Enrolled First New Subject Post-COVID-19 Restrictions

    Cash Position Expected to Fund Operations into the First Half of 2022

    NEW HAVEN, Conn., Nov. 11, 2020 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio™ (nalbuphine ER) to treat serious neurologically mediated conditions, today announced financial results for the quarter ended September 30, 2020, as well as business updates.

    "We are pleased with the continued progress of our clinical development programs," said Jennifer…

    PRISM Trial of Haduvio™ for Severe Pruritus in Patients with Prurigo Nodularis 

    Exceeds Halfway Enrollment Milestone

    Phase 2 Chronic Cough Trial in Patients with IPF Enrolled First New Subject Post-COVID-19 Restrictions

    Cash Position Expected to Fund Operations into the First Half of 2022

    NEW HAVEN, Conn., Nov. 11, 2020 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio™ (nalbuphine ER) to treat serious neurologically mediated conditions, today announced financial results for the quarter ended September 30, 2020, as well as business updates.

    "We are pleased with the continued progress of our clinical development programs," said Jennifer L. Good, President and CEO of Trevi Therapeutics. "We recently announced significant developments in both of our ongoing clinical trials by surpassing halfway enrollment in our PRISM trial and enrolling the first new subject in our chronic cough trial in IPF since the study resumed after pausing due to COVID restrictions. We are focused on completing enrollment in both trials and preparing for the next steps in the development of Haduvio."

    Key Business Updates

    • Phase 2b/3 PRISM trial of Haduvio for severe pruritus in patients with prurigo nodularis: The Company has enrolled approximately 190 subjects in the trial and reaffirms its guidance that it expects to complete enrollment in the third quarter of 2021 and to report top-line data in the fourth quarter of 2021.



    • Phase 2 trial of Haduvio for chronic cough in patients with idiopathic pulmonary fibrosis (IPF): The Company resumed screening and enrolling patients in the trial following the pause in the trial due to COVID-19. The Company amended the study protocol to require fewer in-person visits by subjects as well as fewer procedures in order to facilitate the completion of the trial in an at-risk patient population for COVID-19. Additionally, the Company is assessing additional study sites in Germany which could potentially accelerate enrollment and reduce the risks inherent with single-country recruitment during the COVID-19 pandemic.

    Third Quarter 2020 Financial Highlights

    Cash position: As of September 30, 2020, the Company had total cash and cash equivalents of $53.3 million, compared to $57.3 million as of December 31, 2019. During the third quarter of 2020, the Company received $14.0 million in proceeds from a term loan with Silicon Valley Bank and sold approximately $2.5 million of common stock under the Company's ATM program. The Company expects its cash position will fund operations into the first half of 2022.

    Research and development (R&D) expenses: R&D expenses for the third quarter of 2020 were $4.8 million compared to $5.7 million in the same period in 2019. The decrease was primarily due to decreased activity in the Company's Phase 2 trial in chronic cough in patients with IPF due to the pausing of enrollment and treatment of patients as a result of the COVID-19 pandemic as well as decreased activity with the completion of the Company's Phase 1b trial in patients with chronic liver disease.

    General and administrative (G&A) expenses: G&A expenses for the third quarter of 2020 were $2.4 million compared to $2.0 million in the same period in 2019. The increase was primarily due to an increase in stock-based compensation expenses and an increase in consulting fees.

    Net loss: For the third quarter of 2020, the Company reported a net loss of $7.4 million, compared to a net loss of $7.4 million in the same period in 2019.

    Conference Call

    As previously announced, the Company will host a conference call and webcast today, November 11, 2020 at 4:30 p.m. ET. To participate in the live conference call by phone, please dial (866) 360-5746 (domestic) or (602) 563-8605 (international) and provide access code 9375955. A live audio webcast will be accessible from the ‘Investors & News' section on the Company's website at www.trevitherapeutics.com. An archived replay of the webcast will also be available for 30 days on the Company's website following the event.         

    About Trevi Therapeutics, Inc.

    Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio to treat serious neurologically mediated conditions. Trevi is currently developing Haduvio for the treatment of chronic pruritus, chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and levodopa-induced dyskinesia (LID) in patients with Parkinson's disease. These conditions share a common pathophysiology that is mediated through opioid receptors in the central and peripheral nervous systems. Trevi is currently conducting a Phase 2b/3 clinical trial of Haduvio, referred to as the PRISM trial, in patients with severe pruritus associated with prurigo nodularis.

    Founded in 2011, Trevi Therapeutics is headquartered in New Haven, CT.

    About HADUVIO

    Haduvio is an oral extended release formulation of nalbuphine. Nalbuphine is a mixed ĸ-opioid receptor agonist and µ-opioid receptor antagonist that has been approved and marketed as an injectable for pain indications for more than 20 years in the United States and Europe. The ĸ- and µ-opioid receptors are known to be critical mediators of itch, cough and certain movement disorders. Nalbuphine's mechanism of action also mitigates the risk of abuse associated with µ-opioid agonists because it antagonizes, or blocks, µ-opioid receptors. Nalbuphine is currently the only opioid approved for marketing that is not classified as a controlled substance in the United States and most of Europe. Trevi intends to propose Haduvio as the trade name for the nalbuphine ER investigational product. Haduvio is an investigational drug product and its safety and efficacy have not been fully evaluated by any regulatory authority.

    Forward-Looking Statements

    Statements contained in this press release 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 statements include, but are not limited to, statements regarding the impact of the COVID-19 pandemic on Trevi's clinical trials, business and operations; the expected timing of enrollment and for reporting top-line data from, Trevi's Phase 2b/3 PRISM trial of Haduvio in patients with prurigo nodularis; Trevi's business plans and objectives, including future plans or expectations for Trevi's product candidates and expectations regarding Trevi's uses and sufficiency of capital; and other statements containing the words "believes," "anticipates," "plans," "expects," and similar expressions. Risks that contribute to the uncertain nature of the forward-looking statements include: uncertainties regarding the success, cost and timing of Trevi's product candidate development activities and ongoing and planned clinical trials; uncertainties regarding the scope, timing and severity of the COVID-19 pandemic, the impact of the COVID-19 pandemic on Trevi's clinical operations and actions taken in response to the pandemic; uncertainties regarding Trevi's ability to execute on its strategy; the risk that positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical trials; potential regulatory developments in the United States and foreign countries; uncertainties inherent in estimating Trevi's cash runway, future expenses and other financial results; as well as other risks and uncertainties set forth in the quarterly report on Form 10-Q for the quarter ended June 30, 2020 filed with the Securities and Exchange Commission and in subsequent filings with the Securities and Exchange Commission.  All forward-looking statements contained in this press release speak only as of the date on which they were made. Trevi undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Trevi Therapeutics, Inc.

    Selected Balance Sheet Data

    (unaudited)

    (amounts in thousands)

     September 30,

    2020
     December 31,

    2019
        
    Cash and cash equivalents$53,293 $57,313
    Working capital 49,106 54,353
    Total assets 55,879 60,001
    Total debt 13,798 ──
    Stockholders' equity 35,618 54,545

    Trevi Therapeutics, Inc.

    Selected Statement of Operations Data

    (unaudited)

    (amounts in thousands)

     Three Months Ended

    September 30,
     Nine Months Ended

    September 30,
     2020 2019 2020 2019
            
    Operating expenses:       
    Research and development$4,828  $5,650  $15,768  $14,516 
    General and administrative 2,416   2,000   7,528   5,363 
    Total operating expenses 7,244   7,650   23,296   19,879 
    Loss from operations (7,244)  (7,650)  (23,296)  (19,879)
    Other income (expense), net (145)  280   26   352 
    Loss before income tax benefit (7,389)  (7,370)  (23,270)  (19,527)
    Income tax benefit 11   5   35   14 
    Net loss$(7,378) $(7,365) $(23,235) $(19,513)

    Investor Contact

    Chris Seiter, Chief Financial Officer

    Trevi Therapeutics, Inc.

    203-304-2499

    chris.seiter@trevitherapeutics.com

    Media Contact  

    Rosalia Scampoli

    914-815-1465

    rscampoli@marketcompr.com

    Primary Logo

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  14. NEW HAVEN, Conn., Nov. 10, 2020 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio™ (nalbuphine ER) to treat serious neurologically mediated conditions, today announced that management will present a Company overview, as well as host virtual investor meetings, at the Stifel 2020 Virtual Healthcare Conference on November 17, 2020.

    Presentation Time: 10:00 a.m. ET

    A live webcast of the presentation can be accessed by visiting ‘News & Events' in the ‘Investors & News' section on the Company's website at www.trevitherapeutics.com. An archived replay of the webcast will also be available for 30 days on the Company's website following…

    NEW HAVEN, Conn., Nov. 10, 2020 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio™ (nalbuphine ER) to treat serious neurologically mediated conditions, today announced that management will present a Company overview, as well as host virtual investor meetings, at the Stifel 2020 Virtual Healthcare Conference on November 17, 2020.

    Presentation Time: 10:00 a.m. ET

    A live webcast of the presentation can be accessed by visiting ‘News & Events' in the ‘Investors & News' section on the Company's website at www.trevitherapeutics.com. An archived replay of the webcast will also be available for 30 days on the Company's website following the conference.

    The Company's corporate presentation is posted to its website in the ‘Investors & News' section under ‘News & Events'.

    About Trevi Therapeutics, Inc.

    Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio to treat serious neurologically mediated conditions. Trevi is currently developing Haduvio for the treatment of chronic pruritus, chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and levodopa-induced dyskinesia (LID) in patients with Parkinson's disease. These conditions share a common pathophysiology that is mediated through opioid receptors in the central and peripheral nervous systems. Trevi is currently conducting a Phase 2b/3 clinical trial of Haduvio, referred to as the PRISM trial, in patients with severe pruritus associated with prurigo nodularis.

    Founded in 2011, Trevi Therapeutics is headquartered in New Haven, CT.

    About HADUVIO

    Haduvio is an oral extended release formulation of nalbuphine. Nalbuphine is a mixed ĸ-opioid receptor agonist and µ-opioid receptor antagonist that has been approved and marketed as an injectable for pain indications for more than 20 years in the United States and Europe. The ĸ- and µ-opioid receptors are known to be critical mediators of itch, cough and certain movement disorders. Nalbuphine's mechanism of action also mitigates the risk of abuse associated with µ-opioid agonists because it antagonizes, or blocks, µ-opioid receptors. Nalbuphine is currently the only opioid approved for marketing that is not classified as a controlled substance in the United States and most of Europe. Trevi intends to propose Haduvio as the trade name for the nalbuphine ER investigational product. Haduvio is an investigational drug product and its safety and efficacy have not been fully evaluated by any regulatory authority.

    Investor Contact

    Chris Seiter, Chief Financial Officer

    Trevi Therapeutics, Inc.

    203-304-2499

    chris.seiter@trevitherapeutics.com

    Media Contact  

    Rosalia Scampoli

    914-815-1465

    rscampoli@marketcompr.com

    Primary Logo

    View Full Article Hide Full Article
  15. NEW HAVEN, Conn., Nov. 04, 2020 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio™ (nalbuphine ER) to treat serious neurologically mediated conditions, today announced that management will host a conference call and live audio webcast at 4:30 p.m. ET on November 11, 2020, to provide a corporate update and review the Company's financial results for the third quarter ended September 30, 2020.

    To participate in the live conference call by phone, please dial (866) 360-5746 (domestic) or (602) 563-8605 (international) and provide access code 9375955. A live audio webcast will be accessible from the ‘Investors & News' section on the…

    NEW HAVEN, Conn., Nov. 04, 2020 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio™ (nalbuphine ER) to treat serious neurologically mediated conditions, today announced that management will host a conference call and live audio webcast at 4:30 p.m. ET on November 11, 2020, to provide a corporate update and review the Company's financial results for the third quarter ended September 30, 2020.

    To participate in the live conference call by phone, please dial (866) 360-5746 (domestic) or (602) 563-8605 (international) and provide access code 9375955. A live audio webcast will be accessible from the ‘Investors & News' section on the Company's website at www.trevitherapeutics.com. An archived replay of the webcast will also be available for 30 days on the Company's website following the event.

    About Trevi Therapeutics, Inc.

    Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio to treat serious neurologically mediated conditions. Trevi is currently developing Haduvio for the treatment of chronic pruritus, chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and levodopa-induced dyskinesia (LID) in patients with Parkinson's disease. These conditions share a common pathophysiology that is mediated through opioid receptors in the central and peripheral nervous systems. Trevi is currently conducting a Phase 2b/3 clinical trial of Haduvio, referred to as the PRISM trial, in patients with severe pruritus associated with prurigo nodularis.

    Founded in 2011, Trevi Therapeutics is headquartered in New Haven, CT.

    About HADUVIO

    Haduvio is an oral extended release formulation of nalbuphine. Nalbuphine is a mixed ĸ-opioid receptor agonist and µ-opioid receptor antagonist that has been approved and marketed as an injectable for pain indications for more than 20 years in the United States and Europe. The ĸ- and µ-opioid receptors are known to be critical mediators of itch, cough and certain movement disorders. Nalbuphine's mechanism of action also mitigates the risk of abuse associated with µ-opioid agonists because it antagonizes, or blocks, µ-opioid receptors. Nalbuphine is currently the only opioid approved for marketing that is not classified as a controlled substance in the United States and most of Europe. Trevi intends to propose Haduvio as the trade name for the nalbuphine ER investigational product. Haduvio is an investigational drug product and its safety and efficacy have not been fully evaluated by any regulatory authority.

    Investor Contact

    Chris Seiter, Chief Financial Officer

    Trevi Therapeutics, Inc.

    203-304-2499

    chris.seiter@trevitherapeutics.com

    Media Contact  

    Rosalia Scampoli

    914-815-1465

    rscampoli@marketcompr.com        

    Primary Logo

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  16. Restart of Phase 2 Clinical Trial of Haduvio for Chronic Cough in Patients with IPF

    Phase 2b/3 PRISM Trial of Haduvio for Severe Pruritus in Patients with Prurigo Nodularis Reaches 50% Enrollment Milestone

    NEW HAVEN, Conn., Oct. 21, 2020 (GLOBE NEWSWIRE) --  Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio™ (nalbuphine ER) to treat serious neurologically mediated conditions, today, announced updates to their ongoing clinical trials of Haduvio. Patient screening has resumed for the Phase 2 trial of Haduvio for chronic cough in patients with idiopathic pulmonary fibrosis (IPF), a trial that was paused due to IPF patients being an at-risk population…

    Restart of Phase 2 Clinical Trial of Haduvio for Chronic Cough in Patients with IPF

    Phase 2b/3 PRISM Trial of Haduvio for Severe Pruritus in Patients with Prurigo Nodularis Reaches 50% Enrollment Milestone

    NEW HAVEN, Conn., Oct. 21, 2020 (GLOBE NEWSWIRE) --  Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio™ (nalbuphine ER) to treat serious neurologically mediated conditions, today, announced updates to their ongoing clinical trials of Haduvio. Patient screening has resumed for the Phase 2 trial of Haduvio for chronic cough in patients with idiopathic pulmonary fibrosis (IPF), a trial that was paused due to IPF patients being an at-risk population for COVID-19. In addition, the Phase 2b/3 PRISM trial of Haduvio for severe pruritus in patients with prurigo nodularis, randomized its 180th subject, officially reaching 50% enrollment.

    Phase 2 trial of Haduvio for chronic cough in patients with idiopathic pulmonary fibrosis (IPF): The Phase 2 clinical trial is a randomized, double-blind, placebo controlled, two-treatment, two-period, crossover study designed to evaluate the efficacy, safety, tolerability and dosing of nalbuphine ER for chronic cough in patients with IPF that is being conducted in the United Kingdom (UK). The study is designed to enroll approximately 60 subjects with a goal to have 44 study completers. The primary endpoint for the study is the mean percent change in daytime cough frequency as measured by a cough monitor. The study will also examine various secondary endpoints.

    Professor Toby Maher, based at the Royal Brompton Hospital and the lead investigator for this Phase 2 trial, said, "I am pleased to see Trevi's trial for chronic cough in IPF patients restart screening after pausing due to the COVID-19 pandemic. IPF is a debilitating disease, with chronic cough being a significant contributor to a patient's reduced quality of life. Nalbuphine ER is of particular interest for the clinical treatment of chronic cough due to the potential of its mixed agonist/antagonist mechanism of action."

    "The Company has worked with Dr. Maher to amend the protocol to require fewer in-person visits by the subjects as well as fewer procedures," said Dr. Thomas Sciascia, Trevi's Chief Medical Officer. "We believe this better protects the overall safety of these patients during the time of the pandemic."

    The amended protocol was recently approved by the Medicines and Healthcare products Regulatory Agency (MHRA) of the UK and patient screening has restarted at certain sites in the UK. Additionally, Trevi is analyzing the possible addition of study sites in Germany to potentially accelerate enrollment and mitigate the COVID-related risks inherent to recruitment from a single-country.

    Phase 2b/3 PRISM trial of Haduvio for severe pruritus in patients with prurigo nodularis:

    During October, the PRISM trial randomized its 180th subject into the study, reaching 50% enrollment of the expanded trial size following the sample size re-estimation completed in July. We expect to complete enrollment in the PRISM trial in the third quarter of 2021 and report top-line data in the fourth quarter of 2021.

    "We are pleased with the continued progress of our clinical development programs in these two severe conditions," said Jennifer L. Good, President and CEO of Trevi Therapeutics. "We have seen continued momentum in the enrollment in the PN trial and look forward to helping the remaining clinical sites for cough in IPF get restarted."

    About Trevi Therapeutics, Inc.

    Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio to treat serious neurologically mediated conditions. Trevi is currently developing Haduvio for the treatment of chronic pruritus, chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and levodopa-induced dyskinesia (LID) in patients with Parkinson's disease. These conditions share a common pathophysiology that is mediated through opioid receptors in the central and peripheral nervous systems. Trevi is currently conducting a Phase 2b/3 clinical trial of Haduvio, referred to as the PRISM trial, in patients with severe pruritus associated with prurigo nodularis.

    Founded in 2011, Trevi Therapeutics is headquartered in New Haven, CT.

    About HADUVIO

    Haduvio is an oral extended release formulation of nalbuphine. Nalbuphine is a mixed ĸ-opioid receptor agonist and µ-opioid receptor antagonist that has been approved and marketed as an injectable for pain indications for more than 20 years in the United States and Europe. The ĸ- and µ-opioid receptors are known to be critical mediators of itch, cough and certain movement disorders. Nalbuphine's mechanism of action also mitigates the risk of abuse associated with µ-opioid agonists because it antagonizes, or blocks, µ-opioid receptors. Nalbuphine is currently the only opioid approved for marketing that is not classified as a controlled substance in the United States and most of Europe. Trevi intends to propose Haduvio as the trade name for the nalbuphine ER investigational product. Haduvio is an investigational drug product and its safety and efficacy have not been fully evaluated by any regulatory authority.

    Forward-Looking Statements

    Statements contained in this press release 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 statements include, but are not limited to, statements regarding the impact of the COVID-19 pandemic on our clinical trials, business and operations, the expected timing of enrollment and for reporting top-line data from, Trevi's Phase 2b/3 PRISM trial of Haduvio in patients with prurigo nodularis; the expected timing of milestones for the Company's other ongoing and planned clinical trials; Trevi's business plans and objectives, including future plans or expectations for Trevi's product candidates and expectations regarding Trevi's uses and sufficiency of capital; and other statements containing the words "believes," "anticipates," "plans," "expects," and similar expressions. Risks that contribute to the uncertain nature of the forward-looking statements include: uncertainties regarding the success, cost and timing of Trevi's product candidate development activities and ongoing and planned clinical trials; uncertainties regarding the scope, timing and severity of the COVID-19 pandemic, the impact of the COVID-19 pandemic on Trevi's clinical operations and actions taken in response to the pandemic; uncertainties regarding Trevi's ability to execute on its strategy, including to enroll patients in the anticipated timeframes; the risk that positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical trials; potential regulatory developments in the United States and foreign countries; uncertainties inherent in estimating our cash runway, future expenses and other financial results; as well as other risks and uncertainties set forth in the Company's quarterly report on Form 10-Q for the quarter ended June 30, 2020 filed with the Securities and Exchange Commission and in subsequent filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Trevi undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Investor Contact

    Chris Seiter, Chief Financial Officer

    Trevi Therapeutics, Inc.

    203-304-2499

    chris.seiter@trevitherapeutics.com

    Media Contact  

    Rosalia Scampoli

    914-815-1465

    rscampoli@marketcompr.com        

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  17. NEW HAVEN, Conn., Oct. 13, 2020 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio™ (nalbuphine ER) to treat serious neurologically mediated conditions, today announced the appointment of Shashank Rohatagi, Ph.D., as Vice President, Pharmacology and Clinical Pharmacokinetics, Farrell Simon, Pharm.D., as Vice President, Head of U.S. Marketing, and Katherine S. Takaki, Ph.D., as Vice President, Global Regulatory Affairs. Dr. Rohatagi will be responsible for managing the supportive studies required to seek regulatory approvals as well as all CMC-related activities, and joins Trevi after senior roles at Metrum Research, Otsuka Pharmaceuticals…

    NEW HAVEN, Conn., Oct. 13, 2020 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio™ (nalbuphine ER) to treat serious neurologically mediated conditions, today announced the appointment of Shashank Rohatagi, Ph.D., as Vice President, Pharmacology and Clinical Pharmacokinetics, Farrell Simon, Pharm.D., as Vice President, Head of U.S. Marketing, and Katherine S. Takaki, Ph.D., as Vice President, Global Regulatory Affairs. Dr. Rohatagi will be responsible for managing the supportive studies required to seek regulatory approvals as well as all CMC-related activities, and joins Trevi after senior roles at Metrum Research, Otsuka Pharmaceuticals and Daiichi Sankyo. Dr. Simon will lead the development and implementation of the commercial strategy for Haduvio, and joins Trevi from Pfizer. Dr. Takaki will oversee Trevi's global regulatory strategies including interactions with key regulatory authorities and leading any registration efforts for Haduvio, and joins the Company after working at Iterum Therapeutics and Bristol Myers Squibb.

    "We are pleased to welcome Shashank, Farrell, and Kathy to our management team as we move forward with Haduvio," said Jennifer L. Good, President and Chief Executive Officer. "Their extensive backgrounds in various areas of the biopharmaceutical industry should be invaluable to the success of Trevi as we continue to advance Haduvio. We look forward to their insight as we work towards providing treatment to those suffering from serious conditions, such as chronic pruritus in patients with prurigo nodularis and chronic cough in idiopathic pulmonary fibrosis which currently have no approved therapies."

    Dr. Rohatagi brings his diverse experience in the pharmaceutical industry and drug development to the Trevi team. As Senior Principal Scientist for Clinical Pharmacology at Metrum Research Group, he was responsible for providing strategic and operational support for clinical pharmacology and regulatory issues across therapeutic areas for various stages of drug development. Prior to that, Dr. Rohatagi was Vice President of Data Sciences at Otsuka managing the group that supported data analytics for all phases of development and regulatory submissions. Dr. Rohatagi holds a Ph.D. from the University of Florida in Pharmacokinetics/Pharmacodynamics and an M.B.A from St. Joseph's University.

    Dr. Simon has a diverse set of experiences he brings to Trevi to develop and execute commercialization plans for Haduvio. His career spans both U.S. and global roles, where he has developed and implemented numerous marketing and sales campaigns to increase internal and external engagement. He is an experienced general manager who has successfully led operating plans for brands of varying size and worked across the lifecycle of products from in-line brands to early commercial development assets. Prior to joining Trevi, Dr. Simon most recently served as Chief of Staff to the Group President of Biopharma at Pfizer and was a member of the leadership team. In this role he led operations across seven innovative business units, as well as led pan-business unit strategic initiatives. He began his career at Procter & Gamble and holds both an M.B.A. and a Pharm.D. from the University of Florida.

    Dr. Takaki joins Trevi with extensive pharmaceutical industry experience in regulatory strategy, global project and team management, and drug discovery. Before becoming part of Trevi, she served as Vice President, Global Regulatory Affairs at Iterum Therapeutics where she helped build out the regulatory group to support the company's regulatory strategy and operations. Prior to that, Dr. Takaki held leadership positions at Bristol Myers Squibb supporting multiple therapeutic areas. She was the global project manager for the team that developed Baraclude for the treatment of hepatitis B and launched it in markets worldwide. Her most recent role at Bristol Myers was Group Director, Head of Regulatory Strategy Marketed Products. She holds a Ph.D. in Organic Chemistry from the Massachusetts Institute of Technology and a B.S. in Chemistry from the University of Hawaii at Manoa.

    About Trevi Therapeutics, Inc.

    Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio to treat serious neurologically mediated conditions. Trevi is currently developing Haduvio for the treatment of chronic pruritus, chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and levodopa-induced dyskinesia (LID) in patients with Parkinson's disease. These conditions share a common pathophysiology that is mediated through opioid receptors in the central and peripheral nervous systems. Trevi is currently conducting a Phase 2b/3 clinical trial of Haduvio, referred to as the PRISM trial, in patients with severe pruritus associated with prurigo nodularis.

    Founded in 2011, Trevi Therapeutics is headquartered in New Haven, CT.

    About HADUVIO

    Haduvio is an oral extended release formulation of nalbuphine. Nalbuphine is a mixed ĸ-opioid receptor agonist and µ-opioid receptor antagonist that has been approved and marketed as an injectable for pain indications for more than 20 years in the United States and Europe. The ĸ- and µ-opioid receptors are known to be critical mediators of itch, cough and certain movement disorders. Nalbuphine's mechanism of action also mitigates the risk of abuse associated with µ-opioid agonists because it antagonizes, or blocks, µ-opioid receptors. Nalbuphine is currently the only opioid approved for marketing that is not classified as a controlled substance in the United States and most of Europe. Trevi intends to propose Haduvio as the trade name for the nalbuphine ER investigational product. Haduvio is an investigational drug product and its safety and efficacy have not been fully evaluated by any regulatory authority.

    Forward-Looking Statements

    Statements contained in this press release 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 statements include, but are not limited to, Trevi's business plans and objectives, including future plans or expectations for Trevi's product candidates and expectations regarding potential regulatory submissions; and other statements containing the words "believes," "anticipates," "plans," "expects," and similar expressions. Risks that contribute to the uncertain nature of the forward-looking statements include: uncertainties regarding the success, cost and timing of Trevi's product candidate development activities and ongoing and planned clinical trials; uncertainties regarding the scope, timing and severity of the COVID-19 pandemic, the impact of the COVID-19 pandemic on Trevi's clinical operations and actions taken in response to the pandemic; uncertainties regarding Trevi's ability to execute on its strategy; the risk that positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical trials; potential regulatory developments in the United States and foreign countries; uncertainties inherent in estimating our cash runway, future expenses and other financial results; as well as other risks and uncertainties set forth in the Company's quarterly report on Form 10-Q for the quarter ended June 30, 2020 filed with the Securities and Exchange Commission and in subsequent filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Trevi undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Investor Contact

    Chris Seiter, Chief Financial Officer

    Trevi Therapeutics, Inc.

    203-304-2499

    chris.seiter@trevitherapeutics.com

    Media Contact

    Rosalia Scampoli

    914-815-1465

    rscampoli@marketcompr.com        

     

    Primary Logo

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  18. NEW HAVEN, Conn., Sept. 09, 2020 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio™ (nalbuphine ER) to treat serious neurologically mediated conditions, today announced that management will present a Company overview, as well as host virtual investor meetings, at the 2020 H.C. Wainwright Global Investment Conference on September 16, 2020:

    Presentation Time: 3:00 p.m. ET

    A live webcast of the presentation can be accessed by visiting ‘News & Events' in the ‘Investors & News' section on the Company's website at www.trevitherapeutics.com. An archived replay of the webcast will also be available for 30 days on the Company's website…

    NEW HAVEN, Conn., Sept. 09, 2020 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio™ (nalbuphine ER) to treat serious neurologically mediated conditions, today announced that management will present a Company overview, as well as host virtual investor meetings, at the 2020 H.C. Wainwright Global Investment Conference on September 16, 2020:

    Presentation Time: 3:00 p.m. ET

    A live webcast of the presentation can be accessed by visiting ‘News & Events' in the ‘Investors & News' section on the Company's website at www.trevitherapeutics.com. An archived replay of the webcast will also be available for 30 days on the Company's website following the conference.

    The Company's corporate presentation is posted to its website in the ‘Investors & News' section under ‘News & Events'.

    About Trevi Therapeutics, Inc.

    Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio to treat serious neurologically mediated conditions. Trevi is currently developing Haduvio for the treatment of chronic pruritus, chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and levodopa-induced dyskinesia (LID) in patients with Parkinson's disease. These conditions share a common pathophysiology that is mediated through opioid receptors in the central and peripheral nervous systems. Trevi is currently conducting a Phase 2b/3 clinical trial of Haduvio, referred to as the PRISM trial, in patients with severe pruritus associated with prurigo nodularis.

    Founded in 2011, Trevi Therapeutics is headquartered in New Haven, CT.

    About HADUVIO

    Haduvio is an oral extended release formulation of nalbuphine. Nalbuphine is a mixed ĸ-opioid receptor agonist and µ-opioid receptor antagonist that has been approved and marketed as an injectable for pain indications for more than 20 years in the United States and Europe. The ĸ- and µ-opioid receptors are known to be critical mediators of itch, cough and certain movement disorders. Nalbuphine's mechanism of action also mitigates the risk of abuse associated with µ-opioid agonists because it antagonizes, or blocks, µ-opioid receptors. Nalbuphine is currently the only opioid approved for marketing that is not classified as a controlled substance in the United States and most of Europe. Trevi intends to propose Haduvio as the trade name for the nalbuphine ER investigational product and will therefore use that name in Company materials going forward. Haduvio is an investigational drug product and its safety and efficacy have not been fully evaluated by any regulatory authority.

    Investor Contact

    Chris Seiter, Chief Financial Officer

    Trevi Therapeutics, Inc.

    chris.seiter@trevitherapeutics.com

    203-304-2499

    Media Contact

    Rosalia Scampoli

    rscampoli@marketcompr.com

    914-815-1465

    Primary Logo

    View Full Article Hide Full Article
  19. Announced Positive Outcome of Sample Size Re-Estimation Analysis for PRISM Trial

    Strong Enrollment in PRISM Trial After Lifting of COVID-19 Restrictions

    Announces $14 Million Term Loan - Cash Position Expected to Fund Operations into the First Half of 2022 

    NEW HAVEN, Conn., Aug. 13, 2020 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio™ (nalbuphine ER) to treat serious neurologically mediated conditions, today announced financial results for the quarter ended June 30, 2020, as well as recent business updates.

    "We are pleased with how the Trevi team was able to manage the continued execution of the PRISM trial in the face…

    Announced Positive Outcome of Sample Size Re-Estimation Analysis for PRISM Trial

    Strong Enrollment in PRISM Trial After Lifting of COVID-19 Restrictions

    Announces $14 Million Term Loan - Cash Position Expected to Fund Operations into the First Half of 2022 

    NEW HAVEN, Conn., Aug. 13, 2020 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio™ (nalbuphine ER) to treat serious neurologically mediated conditions, today announced financial results for the quarter ended June 30, 2020, as well as recent business updates.

    "We are pleased with how the Trevi team was able to manage the continued execution of the PRISM trial in the face of the COVID-19 pandemic restrictions. The Company announced the positive outcome of the sample size re-estimation analysis and continued to activate clinical sites virtually," said Jennifer L. Good, President and CEO of Trevi Therapeutics. "Once the screening and enrollment restrictions were lifted in the PRISM trial, we were able to rapidly restart screening and enrollment in most of our sites. We now have approximately 80% of our sites screening patients and have had our strongest two months of enrollment thus far in the trial. In addition, we are pleased to announce the execution of a non-dilutive $14 million term loan which we expect will extend our cash runway into the first half of 2022, past the anticipated top-line results from the PRISM trial which are expected in the fourth quarter of 2021."

    Key Business Updates

    • Phase 2b/3 PRISM trial of Haduvio for severe pruritus in patients with prurigo nodularis: The Company completed the pre-specified sample size re-estimation (SSRE) analysis in July and based on the recommendation of the independent Data Monitoring Committee, we increased the trial size from the initial target enrollment of 240 to 360 subjects to maintain statistical power for the primary endpoint. The pace of enrollment has accelerated since the removal of most COVID-19 screening and enrollment restrictions and approximately 155 subjects have been enrolled in the study. We expect to complete enrollment in the third quarter of 2021 and report top-line data in the fourth quarter of 2021.
    • Phase 2 trial of Haduvio for chronic cough in patients with idiopathic pulmonary fibrosis (IPF):  The Company is amending the study protocol to reduce the number of in-person visits to facilitate this study being completed in an at-risk patient population for COVID-19.  The Company is planning for a restart of this trial in the second half of 2020.
    • Entered into $14 million term loan with Silicon Valley Bank: The Company entered into a $14 million term loan with Silicon Valley Bank on August 13, 2020 which will bolster our balance sheet and extends our cash runway into the first half of 2022. The term loan requires monthly interest-only payments through February 28, 2022, followed by monthly payments of principal and interest until February 1, 2024. Interest on the term loan initially accrues at a floating per annum rate of the greater of (i) the prime rate plus 1.0% and (ii) 4.25%. Other material terms related to the term loan can be found in the Company's Form 10-Q.

    Second Quarter 2020 Financial Highlights

    Cash position: As of June 30, 2020, the Company had total cash and cash equivalents of $44.2 million, compared to $57.3 million as of December 31, 2019.

    Research and development (R&D) expenses: R&D expenses for the second quarter of 2020 were $4.9 million compared to $5.5 million in the same period in 2019. The decrease was primarily due to decreased activity in our Phase 2 trial in chronic cough in patients with IPF due to the halting of enrollment and treatment of patients as a result of the COVID-19 pandemic.   

    General and administrative (G&A) expenses: G&A expenses for the second quarter of 2020 were $2.5 million compared to $1.9 million in the same period in 2019. The increase was primarily due to an increase in stock-based compensation expenses and an increase in expenses related to being a public company.

    Net loss: For the second quarter of 2020, the Company reported a net loss of $7.4 million, compared to a net loss of $7.3 million in the same period in 2019.

    Conference Call

    As previously announced, the Company will host a conference call and webcast today, August 13, 2020 at 4:30 p.m. ET. To participate in the live conference call by phone, please dial 866-360-5746 (domestic) or 270-833-1418 (international) and provide access code 8162375. A live audio webcast will be accessible from the ‘Investors & News' section on the Company's website at www.trevitherapeutics.com. An archived replay of the webcast will also be available for 30 days on the Company's website following the event.

    About Trevi Therapeutics, Inc.

    Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio to treat serious neurologically mediated conditions. Trevi is currently developing Haduvio for the treatment of chronic pruritus, chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and levodopa-induced dyskinesia (LID) in patients with Parkinson's disease. These conditions share a common pathophysiology that is mediated through opioid receptors in the central and peripheral nervous systems. Trevi is currently conducting a Phase 2b/3 clinical trial of Haduvio, referred to as the PRISM trial, in patients with severe pruritus associated with prurigo nodularis.

    Founded in 2011, Trevi Therapeutics is headquartered in New Haven, CT.

    About HADUVIO

    Haduvio is an oral extended release formulation of nalbuphine. Nalbuphine is a mixed ĸ-opioid receptor agonist and µ-opioid receptor antagonist that has been approved and marketed as an injectable for pain indications for more than 20 years in the United States and Europe. The ĸ- and µ-opioid receptors are known to be critical mediators of itch, cough and certain movement disorders. Nalbuphine's mechanism of action also mitigates the risk of abuse associated with µ-opioid agonists because it antagonizes, or blocks, µ-opioid receptors. Nalbuphine is currently the only opioid approved for marketing that is not classified as a controlled substance in the United States and most of Europe. Trevi intends to propose Haduvio as the trade name for the nalbuphine ER investigational product. Haduvio is an investigational drug product and its safety and efficacy have not been fully evaluated by any regulatory authority.

    Forward-Looking Statements

    Statements contained in this press release 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 statements include, but are not limited to, statements regarding the impact of the COVID-19 pandemic on our clinical trials, business and operations, the expected timing of enrollment and for reporting top-line data from, Trevi's Phase 2b/3 PRISM trial of Haduvio in patients with prurigo nodularis;  the expected timing of milestones for the Company's other ongoing and planned clinical trials; Trevi's business plans and objectives, including future plans or expectations for Trevi's product candidates and expectations regarding Trevi's uses and sufficiency of capital; and other statements containing the words "believes," "anticipates," "plans," "expects," and similar expressions. Risks that contribute to the uncertain nature of the forward-looking statements include: uncertainties regarding the success, cost and timing of Trevi's product candidate development activities and ongoing and planned clinical trials; uncertainties regarding the scope, timing and severity of the COVID-19 pandemic, the impact of the COVID-19 pandemic on Trevi's clinical operations and actions taken in response to the pandemic; uncertainties regarding Trevi's ability to execute on its strategy; the risk that positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical trials; potential regulatory developments in the United States and foreign countries; uncertainties inherent in estimating our cash runway, future expenses and other financial results; as well as other risks and uncertainties set forth in the annual report on Form 10-Q for the quarter ended March 31, 2020 filed with the Securities and Exchange Commission and in subsequent filings with the Securities and Exchange Commission.  All forward-looking statements contained in this press release speak only as of the date on which they were made. Trevi undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Trevi Therapeutics, Inc.

    Selected Balance Sheet Data

    (unaudited)

    (amounts in thousands)

     June 30,

    2020
     December 31,

    2019
        
    Cash and cash equivalents$44,180 $57,313
    Working capital 39,573 54,353
    Total assets 47,009 60,001
    Stockholders' equity 40,037 54,545
         

    Trevi Therapeutics, Inc.

    Selected Statement of Operations Data

    (unaudited)

    (amounts in thousands)

     Three Months Ended

    June 30,
     Six Months Ended

    June 30,
     2020 2019 2020 2019
            
    Operating expenses:       
    Research and development$4,921 $5,528 $10,940 $8,866
    General and administrative2,492 1,889 5,112 3,363
    Total operating expenses7,413 7,417 16,052 12,229
    Loss from operations(7,413) (7,417) (16,052) (12,229)
    Other income (expense), net14 66 171 72
    Loss before income tax benefit(7,399) (7,351) (15,881) (12,157)
    Income tax benefit15 5 24 9
    Net loss$(7,384) $(7,346) $(15,857) $(12,148)
            

    Investor Contact

    Chris Seiter, Chief Financial Officer

    Trevi Therapeutics, Inc.

    chris.seiter@trevitherapeutics.com

    203-304-2499

    Media Contact

    Rosalia Scampoli

    rscampoli@marketcompr.com

    914-815-1465

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  20. NEW HAVEN, Conn., Aug. 06, 2020 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio™ (nalbuphine ER) to treat serious neurologically mediated conditions, today announced that management will host a conference call and live audio webcast at 4:30 p.m. ET on August 13, 2020, to provide a corporate update and review the Company's financial results for the second quarter ended June 30, 2020.

    To participate in the live conference call by phone, please dial 866-360-5746 (domestic) or 270-833-1418 (international) and provide access code 8162375. A live audio webcast will be accessible from the ‘Investors & News' section on the Company's…

    NEW HAVEN, Conn., Aug. 06, 2020 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio™ (nalbuphine ER) to treat serious neurologically mediated conditions, today announced that management will host a conference call and live audio webcast at 4:30 p.m. ET on August 13, 2020, to provide a corporate update and review the Company's financial results for the second quarter ended June 30, 2020.

    To participate in the live conference call by phone, please dial 866-360-5746 (domestic) or 270-833-1418 (international) and provide access code 8162375. A live audio webcast will be accessible from the ‘Investors & News' section on the Company's website at www.trevitherapeutics.com. An archived replay of the webcast will also be available for 30 days on the Company's website following the event.

    About Trevi Therapeutics, Inc.

    Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio to treat serious neurologically mediated conditions. Trevi is currently developing Haduvio for the treatment of chronic pruritus, chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and levodopa-induced dyskinesia (LID) in patients with Parkinson's disease. These conditions share a common pathophysiology that is mediated through opioid receptors in the central and peripheral nervous systems. Trevi is currently conducting a Phase 2b/3 clinical trial of Haduvio, referred to as the PRISM trial, in patients with severe pruritus associated with prurigo nodularis.

    Founded in 2011, Trevi Therapeutics is headquartered in New Haven, CT.

    About HADUVIO

    Haduvio is an oral extended release formulation of nalbuphine. Nalbuphine is a mixed ĸ-opioid receptor agonist and µ-opioid receptor antagonist that has been approved and marketed as an injectable for pain indications for more than 20 years in the United States and Europe. The ĸ- and µ-opioid receptors are known to be critical mediators of itch, cough and certain movement disorders. Nalbuphine's mechanism of action also mitigates the risk of abuse associated with µ-opioid agonists because it antagonizes, or blocks, µ-opioid receptors. Nalbuphine is currently the only opioid approved for marketing that is not classified as a controlled substance in the United States and most of Europe. Trevi intends to propose Haduvio as the trade name for the nalbuphine ER investigational product. Haduvio is an investigational drug product and its safety and efficacy have not been fully evaluated by any regulatory authority.

    Investor Contact

    Chris Seiter, Chief Financial Officer

    Trevi Therapeutics, Inc.

    chris.seiter@trevitherapeutics.com

    203-304-2499

    Media Contact

    Rosalia Scampoli

    rscampoli@marketcompr.com

    914-815-1465

    Primary Logo

    View Full Article Hide Full Article
  21. NEW HAVEN, Conn., Aug. 05, 2020 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio™ (nalbuphine ER) to treat serious neurologically mediated conditions, today announced that management will participate in a virtual fireside chat, as well as host virtual investor meetings, at the 2020 BTIG Biotechnology Conference on August 10, 2020:

    Presentation Time: 11:00 a.m. ET

    A live webcast of the virtual fireside chat can be accessed by visiting ‘News & Events' in the ‘Investors & News' section on the Company's website at www.trevitherapeutics.com. An archived replay of the webcast will also be available for 30 days on the Company's website…

    NEW HAVEN, Conn., Aug. 05, 2020 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio™ (nalbuphine ER) to treat serious neurologically mediated conditions, today announced that management will participate in a virtual fireside chat, as well as host virtual investor meetings, at the 2020 BTIG Biotechnology Conference on August 10, 2020:

    Presentation Time: 11:00 a.m. ET

    A live webcast of the virtual fireside chat can be accessed by visiting ‘News & Events' in the ‘Investors & News' section on the Company's website at www.trevitherapeutics.com. An archived replay of the webcast will also be available for 30 days on the Company's website following the conference.

    The Company's corporate presentation is posted to its website in the ‘Investors & News' section under ‘News & Events'.

    About Trevi Therapeutics, Inc.

    Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of nalbuphine ER to treat serious neurologically mediated conditions. Trevi is currently developing nalbuphine ER for the treatment of chronic pruritus, chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and levodopa-induced dyskinesia (LID) in patients with Parkinson's disease. These conditions share a common pathophysiology that is mediated through opioid receptors in the central and peripheral nervous systems. Trevi is currently conducting a Phase 2b/3 clinical trial of nalbuphine ER, referred to as the PRISM trial, in patients with severe pruritus associated with prurigo nodularis.

    Founded in 2011, Trevi Therapeutics is headquartered in New Haven, CT.

    About HADUVIO

    Haduvio is an oral extended release formulation of nalbuphine. Nalbuphine is a mixed ĸ-opioid receptor agonist and µ-opioid receptor antagonist that has been approved and marketed as an injectable for pain indications for more than 20 years in the United States and Europe. The ĸ- and µ-opioid receptors are known to be critical mediators of itch, cough and certain movement disorders. Nalbuphine's mechanism of action also mitigates the risk of abuse associated with µ-opioid agonists because it antagonizes, or blocks, µ-opioid receptors. Nalbuphine is currently the only opioid approved for marketing that is not classified as a controlled substance in the United States and most of Europe. Trevi intends to propose Haduvio as the trade name for the nalbuphine ER investigational product and will therefore use that name in Company materials going forward. Haduvio is an investigational drug product and its safety and efficacy have not been fully evaluated by any regulatory authority.

    Investor Contact

    Chris Seiter, Chief Financial Officer

    Trevi Therapeutics, Inc.

    chris.seiter@trevitherapeutics.com

    203-304-2499

    Media Contact

    Rosalia Scampoli

    rscampoli@marketcompr.com

    914-815-1465

    Primary Logo

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  22. Independent Data Monitoring Committee Recommends Continuation of PRISM Trial with Expansion to 360 Subjects per the Adaptive Design

    Enrollment Expected to be Complete by Third Quarter 2021

    Introducing HADUVIO™ as Proposed Trade Name for Nalbuphine ER  

    NEW HAVEN, Conn., July 13, 2020 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio (nalbuphine ER) to treat serious neurologically mediated conditions, today announced the completion of the pre-specified sample size re-estimation (SSRE) analysis for the ongoing PRISM Phase 2b/3 trial of Haduvio for severe pruritus in patients with prurigo nodularis (PN).

    Based on the SSRE analysis…

    Independent Data Monitoring Committee Recommends Continuation of PRISM Trial with Expansion to 360 Subjects per the Adaptive Design

    Enrollment Expected to be Complete by Third Quarter 2021

    Introducing HADUVIO™ as Proposed Trade Name for Nalbuphine ER  

    NEW HAVEN, Conn., July 13, 2020 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio (nalbuphine ER) to treat serious neurologically mediated conditions, today announced the completion of the pre-specified sample size re-estimation (SSRE) analysis for the ongoing PRISM Phase 2b/3 trial of Haduvio for severe pruritus in patients with prurigo nodularis (PN).

    Based on the SSRE analysis the independent Data Monitoring Committee (DMC) recommended that the PRISM trial should continue and that the trial size should increase from an initial enrollment target of 240 to 360 subjects which maintains the statistical power for the primary endpoint. The DMC's recommendation was based on a pre-specified interim conditional power assessment conducted after approximately 45% of the initial targeted number of patients were evaluable for the primary endpoint of the trial. Based on the DMC's recommendation, the Company plans to increase the size of the trial to 360 subjects. 

    "Severe pruritus in prurigo nodularis is a very serious and difficult-to-treat condition. We are pleased with the re-estimation results midway through the trial which inform the sample size and further reinforces our view that Haduvio may be an effective treatment option for patients with PN," said Jennifer L. Good, President and CEO of Trevi Therapeutics. "Enrollment in the PRISM trial has been picking up nicely since the removal of most COVID-19 screening and enrollment restrictions. We have increased the number of active sites to more than 60 globally and approximately 140 subjects have enrolled in the study. Based on the increased sample size, and considering COVID-19 related restrictions, we expect to complete enrollment in the third quarter of 2021 and report top-line data in the fourth quarter of 2021."

    PRISM Phase 2b/3 Trial Design

    The PRISM trial is a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Haduvio for severe pruritus in patients with prurigo nodularis. In this trial, subjects are randomized equally across two treatment groups (Haduvio 162 mg or placebo, twice daily including an initial 2-week blinded titration period). The primary endpoint of the trial is the proportion of patients achieving a greater than or equal to 4-point improvement in the weekly mean Worst Itch Numerical Rating Scale (WI-NRS) score at Week 14, after which all participants rollover to an open-label extension.

    About Trevi Therapeutics, Inc.

    Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of Haduvio to treat serious neurologically mediated conditions. Trevi is currently developing Haduvio for the treatment of chronic pruritus, chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and levodopa-induced dyskinesia (LID) in patients with Parkinson's disease. These conditions share a common pathophysiology that is mediated through opioid receptors in the central and peripheral nervous systems. Trevi is currently conducting a Phase 2b/3 clinical trial of Haduvio, referred to as the PRISM trial, in patients with severe pruritus associated with prurigo nodularis (PN).

    Founded in 2011, Trevi Therapeutics is headquartered in New Haven, CT.

    About HADUVIO

    Haduvio is an oral extended release formulation of nalbuphine. Nalbuphine is a mixed ĸ-opioid receptor agonist and µ-opioid receptor antagonist that has been approved and marketed as an injectable for pain indications for more than 20 years in the United States and Europe. The ĸ- and µ-opioid receptors are known to be critical mediators of itch, cough and certain movement disorders. Nalbuphine's mechanism of action also mitigates the risk of abuse associated with µ-opioid agonists because it antagonizes, or blocks, µ-opioid receptors. Nalbuphine is currently the only opioid approved for marketing that is not classified as a controlled substance in the United States and most of Europe. Trevi intends to propose Haduvio as the trade name for the nalbuphine ER investigational product and will therefore use that name in Company materials going forward. Haduvio is an investigational drug product and its safety and efficacy have not been fully evaluated by any regulatory authority.

    Forward-Looking Statements

    Statements contained in this press release 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 statements include, but are not limited to, statements regarding the impact of the COVID-19 pandemic on our clinical trials, business and operations; the expected timing of enrollment, and for reporting top-line data from, Trevi's Phase 2b/3 PRISM trial of Haduvio in patients with prurigo nodularis;  Trevi's business plans and objectives, including future plans or expectations for Trevi's product candidates; and other statements containing the words "believes," "anticipates," "plans," "expects," and similar expressions. Risks that contribute to the uncertain nature of the forward-looking statements include: uncertainties regarding the success, cost, and timing of Trevi's product candidate development activities and ongoing and planned clinical trials; uncertainties regarding the scope, timing and severity of the COVID-19 pandemic, the impact of the COVID-19 pandemic on Trevi's clinical operations and actions taken in response to the pandemic; uncertainties regarding Trevi's ability to execute on its strategy; the risk that positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical trials; potential regulatory developments in the United States and foreign countries; uncertainties inherent in estimating future expenses, capital requirements and other financial results; as well as other risks and uncertainties set forth in the quarterly report on Form 10-Q for the quarter ended March 31, 2020 filed with the Securities and Exchange Commission and in subsequent filings with the Securities and Exchange Commission.  All forward-looking statements contained in this press release speak only as of the date on which they were made. Trevi undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Investor Contact

    Chris Seiter, Chief Financial Officer

    Trevi Therapeutics, Inc.

    chris.seiter@trevitherapeutics.com

    203-304-2499

    Media Contact

    Rosalia Scampoli

    rscampoli@marketcompr.com

    914-815-1465

    Primary Logo

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  23. NEW HAVEN, Conn., June 30, 2020 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. ("Trevi"), a clinical-stage biopharmaceutical company focused on the development and commercialization of nalbuphine ER to treat serious neurologically mediated conditions, today announced the election of Dominick C. Colangelo to Trevi's Board of Directors.

    Mr. Colangelo joins Trevi's Board with more than twenty years of executive management and corporate development experience in the biopharmaceutical industry, including nearly a decade with Eli Lilly and Company. He has served as President and Chief Executive Officer of Vericel since 2013. During his career, he has held a variety of executive positions of increasing responsibility in product development, pharmaceutical…

    NEW HAVEN, Conn., June 30, 2020 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. ("Trevi"), a clinical-stage biopharmaceutical company focused on the development and commercialization of nalbuphine ER to treat serious neurologically mediated conditions, today announced the election of Dominick C. Colangelo to Trevi's Board of Directors.

    Mr. Colangelo joins Trevi's Board with more than twenty years of executive management and corporate development experience in the biopharmaceutical industry, including nearly a decade with Eli Lilly and Company. He has served as President and Chief Executive Officer of Vericel since 2013. During his career, he has held a variety of executive positions of increasing responsibility in product development, pharmaceutical operations, sales and marketing, and corporate development. He has extensive experience in the acquisition, development, and commercialization of products across a variety of therapeutic areas. During his tenure at Eli Lilly and Company, Nick held positions as Director of Strategy and Business Development for Lilly's Diabetes Product Group and also served as a founding Managing Director of Lilly Ventures. Nick received his B.S.B.A. in Accounting, Magna Cum Laude, from the State University of New York at Buffalo and a J.D. degree, with Honors, from the Duke University School of Law.    

    "Nick brings extensive executive leadership and corporate development experience which will be valuable skills for the Trevi Board as we execute our business plans and strategy moving forward," said Jennifer L. Good, President and Chief Executive Officer.

    "I am excited to join Trevi's Board of Directors, and look forward to leveraging my experience building and growing companies and working with the Company's highly-experienced Board and strong leadership team at a very exciting time for the Company," said Mr. Colangelo.

    About Trevi Therapeutics, Inc.

    Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of nalbuphine ER to treat serious neurologically mediated conditions. Trevi is currently developing nalbuphine ER for the treatment of chronic pruritus, chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and levodopa-induced dyskinesia (LID) in patients with Parkinson's disease. These conditions share a common pathophysiology that is mediated through opioid receptors in the central and peripheral nervous systems. Trevi is currently conducting a Phase 2b/3 clinical trial of nalbuphine ER, referred to as the PRISM trial, in patients with severe pruritus associated with prurigo nodularis.

    Founded in 2011, Trevi Therapeutics is headquartered in New Haven, CT.

    About Nalbuphine ER

    Nalbuphine ER is an oral extended release formulation of nalbuphine. Nalbuphine is a mixed ĸ-opioid receptor agonist and µ-opioid receptor antagonist that has been approved and marketed as an injectable for pain indications for more than 20 years in the United States and Europe. The ĸ- and µ-opioid receptors are known to be critical mediators of itch, cough and certain movement disorders. Nalbuphine's mechanism of action also mitigates the risk of abuse associated with µ-opioid agonists because it antagonizes, or blocks, µ-opioid receptors. Nalbuphine is currently the only opioid approved for marketing that is not classified as a controlled substance in the United States and most of Europe.

    Investor Contact

    Chris Seiter, Chief Financial Officer

    Trevi Therapeutics, Inc.

    203-304-2499

    chris.seiter@trevitherapeutics.com

    Media contact 

    Rosalia Scampoli

    914-815-1465

    rscampoli@marketcompr.com      

    Primary Logo

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  24. NEW HAVEN, Conn., June 17, 2020 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of nalbuphine ER to treat serious neurologically mediated conditions, today announced that management will present via a virtual fireside chat, as well as host virtual investor meetings, at the 2020 BMO Capital Markets Prescriptions for Success Healthcare Conference on June 23, 2020:

    Presentation Time: 11:30 a.m. ET

    A live webcast of the virtual fireside chat can be accessed by visiting ‘News & Events' in the ‘Investors & News' section on the Company's website at www.trevitherapeutics.com. An archived replay of the webcast will also be available for 30…

    NEW HAVEN, Conn., June 17, 2020 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of nalbuphine ER to treat serious neurologically mediated conditions, today announced that management will present via a virtual fireside chat, as well as host virtual investor meetings, at the 2020 BMO Capital Markets Prescriptions for Success Healthcare Conference on June 23, 2020:

    Presentation Time: 11:30 a.m. ET

    A live webcast of the virtual fireside chat can be accessed by visiting ‘News & Events' in the ‘Investors & News' section on the Company's website at www.trevitherapeutics.com. An archived replay of the webcast will also be available for 30 days on the Company's website following the conference.

    The Company's corporate presentation is posted to its website in the ‘Investors & News' section under ‘News & Events'.

    About Trevi Therapeutics, Inc.

    Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of nalbuphine ER to treat serious neurologically mediated conditions. Trevi is currently developing nalbuphine ER for the treatment of chronic pruritus, chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and levodopa-induced dyskinesia (LID) in patients with Parkinson's disease. These conditions share a common pathophysiology that is mediated through opioid receptors in the central and peripheral nervous systems. Trevi is currently conducting a Phase 2b/3 clinical trial of nalbuphine ER, referred to as the PRISM trial, in patients with severe pruritus associated with prurigo nodularis.

    Founded in 2011, Trevi Therapeutics is headquartered in New Haven, CT.

    About Nalbuphine ER

    Nalbuphine ER is an oral extended release formulation of nalbuphine. Nalbuphine is a mixed ĸ-opioid receptor agonist and µ-opioid receptor antagonist that has been approved and marketed as an injectable for pain indications for more than 20 years in the United States and Europe. The ĸ- and µ-opioid receptors are known to be critical mediators of itch, cough and certain movement disorders. Nalbuphine's mechanism of action also mitigates the risk of abuse associated with µ-opioid agonists because it antagonizes, or blocks, µ-opioid receptors. Nalbuphine is currently the only opioid approved for marketing that is not classified as a controlled substance in the United States and most of Europe.

    Investor Contact

    Chris Seiter, Chief Financial Officer

    Trevi Therapeutics, Inc.

    chris.seiter@trevitherapeutics.com

    203-304-2499

    Media Contact

    Rosalia Scampoli

    rscampoli@marketcompr.com

    914-815-1465

    Primary Logo

    View Full Article Hide Full Article
  25. NEW HAVEN, Conn., May 29, 2020 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of nalbuphine ER to treat serious neurologically mediated conditions, today announced that, due to the public health impact of the novel coronavirus (COVID-19) outbreak and governmental restrictions limiting the number of people who may gather together, and to support the health and well-being of its stockholders, employees and community, it has switched its 2020 Annual Meeting of Stockholders from an in-person meeting to a virtual meeting. The Annual Meeting will be held on Thursday, June 11, 2020 at 9:30 a.m. Eastern time, as previously announced. Stockholders…

    NEW HAVEN, Conn., May 29, 2020 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of nalbuphine ER to treat serious neurologically mediated conditions, today announced that, due to the public health impact of the novel coronavirus (COVID-19) outbreak and governmental restrictions limiting the number of people who may gather together, and to support the health and well-being of its stockholders, employees and community, it has switched its 2020 Annual Meeting of Stockholders from an in-person meeting to a virtual meeting. The Annual Meeting will be held on Thursday, June 11, 2020 at 9:30 a.m. Eastern time, as previously announced. Stockholders will be able to participate in this year's Annual Meeting only via the virtual meeting.

    Stockholders are entitled to attend and vote at the Annual Meeting if they were a stockholder as of the close of business on April 16, 2020, the record date, or hold a legal proxy for the meeting provided by their bank, broker or nominee as of such record date. To access, participate in, and vote at the Annual Meeting at http://www.meetingcenter.io/250238243 (the "Annual Meeting Website"), you must enter the password and control number found on your proxy card, voting instruction form or notice you previously received.  Stockholders may submit questions prior to and during the Annual Meeting through the virtual meeting platform. Additional information regarding the virtual meeting is included in a proxy supplement that the company has filed today with the Securities and Exchange Commission.

    Please note that the proxy card included with the proxy materials previously distributed will not be updated to reflect the change in location and may continue to be used to vote your shares in connection with the Annual Meeting.

    All stockholders - whether attending the Annual Meeting or not - are encouraged to vote and submit their proxies in advance of the meeting by one of the methods described in the proxy materials. Stockholders may also vote online during the Annual Meeting by following the instructions available on the Annual Meeting Website.

    About Trevi Therapeutics, Inc.
    Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of nalbuphine ER to treat serious neurologically mediated conditions. Trevi is currently developing nalbuphine ER for the treatment of chronic pruritus, chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and levodopa-induced dyskinesia (LID) in patients with Parkinson's disease. These conditions share a common pathophysiology that is mediated through opioid receptors in the central and peripheral nervous systems. Trevi is currently conducting a Phase 2b/3 clinical trial of nalbuphine ER, referred to as the PRISM trial, in patients with severe pruritus associated with prurigo nodularis (PN).

    Founded in 2011, Trevi Therapeutics is headquartered in New Haven, CT.

    About Nalbuphine ER
    Nalbuphine ER is an oral extended release formulation of nalbuphine. Nalbuphine is a mixed ĸ-opioid receptor agonist and µ-opioid receptor antagonist that has been approved and marketed as an injectable for pain indications for more than 20 years in the United States and Europe. The ĸ- and µ-opioid receptors are known to be critical mediators of itch, cough and certain movement disorders. Nalbuphine's mechanism of action also mitigates the risk of abuse associated with µ-opioid agonists because it antagonizes, or blocks, µ-opioid receptors. Nalbuphine is currently the only opioid approved for marketing that is not classified as a controlled substance in the United States and most of Europe. 

    Investor Contact
    Chris Seiter, Chief Financial Officer
    Trevi Therapeutics, Inc.
    chris.seiter@trevitherapeutics.com 
    203-304-2499

    Media Contact
    Rosalia Scampoli
    rscampoli@marketcompr.com
    914-815-1465

    Primary Logo

    View Full Article Hide Full Article
  26. Sample Size Re-Estimation Analysis for PRISM Trial Expected in Mid-2020

    New Patient Screening Re-Starting at PRISM Sites in the US and Europe

    Cash Position of $52.6 Million Expected to Fund Operations into the Fourth Quarter of 2021

    NEW HAVEN, Conn., May 07, 2020 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of nalbuphine ER to treat serious neurologically mediated conditions, today announced financial results for the quarter ended March 31, 2020, as well as recent business highlights.

    "We are pleased to announce that we have completed enrollment of the patients necessary to conduct the sample size re-estimation analysis in our PRISM trial…

    Sample Size Re-Estimation Analysis for PRISM Trial Expected in Mid-2020

    New Patient Screening Re-Starting at PRISM Sites in the US and Europe

    Cash Position of $52.6 Million Expected to Fund Operations into the Fourth Quarter of 2021

    NEW HAVEN, Conn., May 07, 2020 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of nalbuphine ER to treat serious neurologically mediated conditions, today announced financial results for the quarter ended March 31, 2020, as well as recent business highlights.

    "We are pleased to announce that we have completed enrollment of the patients necessary to conduct the sample size re-estimation analysis in our PRISM trial and expect to announce the results of this analysis in mid-2020," said Jennifer L. Good, President and CEO of Trevi Therapeutics. "With the ongoing COVID-19 pandemic, we have experienced some disruption to new patient screening and enrollment in the PRISM trial, however, our clinical sites are beginning to screen new patients and we expect most of our sites will begin to screen and enroll new patients in May and June. Importantly, we have not had any patient discontinuations in the blinded portion of the trial related to COVID-19 and substantially all patients on treatment were able to complete their required visits. We plan to provide guidance on the expected timing of top-line results from the PRISM trial when we announce the results from the sample size re-estimation analysis in mid-2020."

    Key Product Pipeline Updates

    • Phase 2b/3 PRISM trial of nalbuphine ER for severe pruritus in patients with prurigo nodularis: The pace of enrollment in the PRISM trial has been impacted by the COVID-19 pandemic with new patient screening and most patient enrollment temporarily halted. Patient screening restrictions have been lifted in the United States and are in the process of being lifted in Europe.  We expect many of our sites will restart patient screening and enrollment throughout May and June 2020. The protocol for the PRISM trial provides for a sample size re-estimation (SSRE) analysis once approximately 50% of the patients in the trial are evaluable for the primary endpoint. In light of the pandemic-related delays, we have decided to conduct the SSRE analysis once approximately 45% of the patients in the trial are evaluable for the primary endpoint.  We have enrolled all the patients that will be included in the SSRE and will conduct the SSRE analysis once the last of these patients has completed the 14-week blinded treatment period. We expect the SSRE analysis will occur in mid-2020. We plan to provide guidance on our expected timing to report top-line data from the 14-week blinded treatment period of the PRISM trial when we report the results of the SSRE analysis in mid-2020 based on the results of the SSRE analysis and our progress in restarting patient screening and enrollment related to COVID-19.
    • Phase 2 trial of nalbuphine ER for chronic cough in patients with idiopathic pulmonary fibrosis (IPF):  Due to the COVID-19 pandemic, and the specific at-risk nature of IPF patients, our clinical sites halted their enrollment and treatment of patients in this trial. We believe that enrollment may restart in the second half of 2020 and plan to provide guidance on the expected timing of top-line data from the trial in the second half of 2020.

    First Quarter 2020 Financial Highlights

    Cash position: As of March 31, 2020, Trevi reported total cash and cash equivalents of $52.6 million, compared to $57.3 million as of December 31, 2019. Trevi believes this cash position will be sufficient to fund operations into the fourth quarter of 2021.

    Research and development (R&D) expenses: R&D expenses for the first quarter of 2020 were $6.0 million compared to $3.3 million in the same period in 2019. The increase was primarily due to increased activity in our Phase 2b/3 PRISM trial and our Phase 2 trial in chronic cough in patients with IPF as well as an increase in expenses related to the purchase of clinical trial supplies.   

    General and administrative (G&A) expenses: G&A expenses for the first quarter of 2020 were $2.6 million compared to $1.5 million in the same period in 2019. The increase was primarily due to an increase in stock-based compensation expenses and an increase in expenses related to being a public company.

    Net loss: For the first quarter of 2020, Trevi reported a net loss of $8.5 million, compared to a net loss of $4.8 million in the same period in 2019.

    About Trevi Therapeutics, Inc.
    Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of nalbuphine ER to treat serious neurologically mediated conditions. Trevi is currently developing nalbuphine ER for the treatment of chronic pruritus, chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and levodopa-induced dyskinesia (LID) in patients with Parkinson's disease. These conditions share a common pathophysiology that is mediated through opioid receptors in the central and peripheral nervous systems. Trevi is currently conducting a Phase 2b/3 clinical trial of nalbuphine ER, referred to as the PRISM trial, in patients with severe pruritus associated with prurigo nodularis (PN).

    Founded in 2011, Trevi Therapeutics is headquartered in New Haven, CT.

    About Nalbuphine ER
    Nalbuphine ER is an oral extended release formulation of nalbuphine. Nalbuphine is a mixed ĸ-opioid receptor agonist and µ-opioid receptor antagonist that has been approved and marketed as an injectable for pain indications for more than 20 years in the United States and Europe. The ĸ- and µ-opioid receptors are known to be critical mediators of itch, cough and certain movement disorders. Nalbuphine's mechanism of action also mitigates the risk of abuse associated with µ-opioid agonists because it antagonizes, or blocks, µ-opioid receptors. Nalbuphine is currently the only opioid approved for marketing that is not classified as a controlled substance in the United States and most of Europe.

    Forward-Looking Statements
    Statements contained in this press release 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 statements include, but are not limited to, statements regarding the impact of the COVID-19 pandemic on our clinical trials, business and operations, the expected timing of enrollment and the sample size re-estimation analysis for, and for reporting top-line data from, Trevi's Phase 2b/3 PRISM trial of nalbuphine ER in patients with prurigo nodularis;  the expected timing of milestones for the Company's other ongoing and planned clinical trials; Trevi's business plans and objectives, including future plans or expectations for Trevi's product candidates and expectations regarding Trevi's uses and sufficiency of capital; and other statements containing the words "believes," "anticipates," "plans," "expects," and similar expressions. Risks that contribute to the uncertain nature of the forward-looking statements include: uncertainties regarding the success, cost, and timing of Trevi's product candidate development activities and ongoing and planned clinical trials; uncertainties regarding the scope, timing and severity of the COVID-19 pandemic and actions taken in response to the pandemic; uncertainties regarding Trevi's ability to execute on its strategy; the risk that positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical trials; potential regulatory developments in the United States and foreign countries; uncertainties inherent in estimating future expenses, capital requirements and other financial results; as well as other risks and uncertainties set forth in the annual report on Form 10-K for the year ended December 31, 2019 filed with the Securities and Exchange Commission and in subsequent filings with the Securities and Exchange Commission.  All forward-looking statements contained in this press release speak only as of the date on which they were made. Trevi undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.


    Trevi Therapeutics, Inc.

    Selected Balance Sheet Data

    (unaudited)

    (amounts in thousands)

      March 31,
    2020
        December 31,
    2019
             
    Cash and cash equivalents $   52,640     $   57,313
    Working capital     46,614     54,353
    Total assets     54,238       60,001
    Stockholders' equity     46,802       54,545

    Trevi Therapeutics, Inc.

    Selected Statement of Operations Data

    (unaudited)

    (amounts in thousands)

        Three Months Ended
    March 31,
          2020       2019  
    Operating expenses:        
    Research and development   $   6,019     $   3,338  
    General and administrative       2,620         1,474  
    Total operating expenses       8,639         4,812  
    Loss from operations       (8,639 )       (4,812 )
    Other income (expense), net:       157         6  
    Loss before income tax benefit       (8,482 )       (4,806 )
    Income tax benefit       9         4  
    Net loss   $    (8,473 )   $    (4,802 )

    Investor Contact
    Chris Seiter, Chief Financial Officer
    Trevi Therapeutics, Inc.
    chris.seiter@trevitherapeutics.com
    203-304-2499

    Media Contact
    Rosalia Scampoli
    rscampoli@marketcompr.com
    914-815-1465

    Primary Logo

    View Full Article Hide Full Article
  27. NEW HAVEN, Conn., April 08, 2020 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of nalbuphine ER to treat serious neurologically mediated conditions, today announced that management will present a Company overview, as well as host virtual investor meetings, at the 2020 Needham Healthcare Conference:

    Date: Tuesday, April 14, 2020
    Presentation Time: 10:00 a.m. ET

    A live webcast of the presentation can be accessed by visiting ‘News & Events' in the ‘Investors & News' section on the Company's website at www.trevitherapeutics.com. An archived replay of the webcast will also be available for 90 days on the Company's website following the conference…

    NEW HAVEN, Conn., April 08, 2020 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of nalbuphine ER to treat serious neurologically mediated conditions, today announced that management will present a Company overview, as well as host virtual investor meetings, at the 2020 Needham Healthcare Conference:

    Date: Tuesday, April 14, 2020
    Presentation Time: 10:00 a.m. ET

    A live webcast of the presentation can be accessed by visiting ‘News & Events' in the ‘Investors & News' section on the Company's website at www.trevitherapeutics.com. An archived replay of the webcast will also be available for 90 days on the Company's website following the conference.

    The Company's corporate presentation is posted to its website in the ‘Investors & News' section under ‘News & Events'.

    About Trevi Therapeutics, Inc.
    Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of nalbuphine ER to treat serious neurologically mediated conditions. Trevi is currently developing nalbuphine ER for the treatment of chronic pruritus, chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and levodopa-induced dyskinesia (LID) in patients with Parkinson's disease. These conditions share a common pathophysiology that is mediated through opioid receptors in the central and peripheral nervous systems. Trevi is currently conducting a Phase 2b/3 clinical trial of nalbuphine ER, referred to as the PRISM trial, in patients with severe pruritus associated with prurigo nodularis.

    Founded in 2011, Trevi Therapeutics is headquartered in New Haven, CT.

    About Nalbuphine ER
    Nalbuphine ER is an oral extended release formulation of nalbuphine. Nalbuphine is a mixed ĸ-opioid receptor agonist and µ-opioid receptor antagonist that has been approved and marketed as an injectable for pain indications for more than 20 years in the United States and Europe. The ĸ- and µ-opioid receptors are known to be critical mediators of itch, cough and certain movement disorders. Nalbuphine's mechanism of action also mitigates the risk of abuse associated with µ-opioid agonists because it antagonizes, or blocks, µ-opioid receptors. Nalbuphine is currently the only opioid approved for marketing that is not classified as a controlled substance in the United States and most of Europe.

    Investor Contact
    Chris Seiter, Chief Financial Officer
    Trevi Therapeutics, Inc.
    chris.seiter@trevitherapeutics.com 
    203-304-2499

    Media Contact
    Rosalia Scampoli
    rscampoli@marketcompr.com
    212-537-5177 ext. 7

    Primary Logo

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  28. Enrollment in PRISM Study Progressing - Sample Size Re-estimation Planned for mid-2020

    Expect to Report Top-Line Data in both PN and IPF-Cough Trials in Second Half of 2020

    Cash Position of $57.3 Million Expected to Fund Operations into the Third Quarter of 2021

    NEW HAVEN, Conn., March 16, 2020 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of nalbuphine ER to treat serious neurologically mediated conditions, today announced financial results for the quarter and year ended December 31, 2019, as well as recent business highlights.

    "We made substantial progress in 2019 advancing the development of nalbuphine ER across our clinical indications…

    Enrollment in PRISM Study Progressing - Sample Size Re-estimation Planned for mid-2020

    Expect to Report Top-Line Data in both PN and IPF-Cough Trials in Second Half of 2020

    Cash Position of $57.3 Million Expected to Fund Operations into the Third Quarter of 2021

    NEW HAVEN, Conn., March 16, 2020 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of nalbuphine ER to treat serious neurologically mediated conditions, today announced financial results for the quarter and year ended December 31, 2019, as well as recent business highlights.

    "We made substantial progress in 2019 advancing the development of nalbuphine ER across our clinical indications and expect 2020 to be an important year for Trevi with clinical data expected in our two lead indications. We continued to progress our lead development program in prurigo nodularis, and expect to achieve 50% enrollment in the PRISM study in the second quarter of 2020 with the sample size re-estimation in mid-2020 and top-line data from this study in the second half of 2020," said Jennifer L. Good, President and CEO of Trevi Therapeutics. "We are also actively enrolling the cough study in idiopathic pulmonary fibrosis patients in the UK and expect to report top-line data in the second half of 2020 as well."

    Key Product Pipeline Updates

    • Phase 2b/3 PRISM trial of nalbuphine ER for severe pruritus in patients with prurigo nodularis (PN): The ongoing PRISM trial is a randomized, double-blind, placebo controlled, two-arm treatment study that is designed to evaluate the safety and anti-pruritic efficacy of nalbuphine ER in approximately 240 patients with severe pruritus from PN in approximately 60 centers in the U.S. and Europe. To date, the Company has enrolled approximately 45% of the targeted number of patients in the study. The Company expects to report top-line data from the PRISM trial in the second half of 2020.  Additionally, the protocol for the PRISM trial provides for a sample size re-estimation analysis once 50% of the patients in the trial are evaluable for the primary endpoint.  Trevi expects to reach 50% patient enrollment during the second quarter of 2020 and that the re-estimation analysis will occur in mid-2020.
    • Phase 2 trial of nalbuphine ER for chronic cough in patients with idiopathic pulmonary fibrosis (IPF):  The ongoing Phase 2 clinical trial is a randomized, double-blind, placebo controlled, two-treatment, two-period, crossover study designed to evaluate the efficacy, safety, tolerability and dosing of nalbuphine ER for chronic cough in up to 56 patients with IPF.  Patient enrollment is underway and Trevi expects to report top-line data in the second half of 2020.   

    Fourth Quarter 2019 Financial Highlights

    Research and development (R&D) expenses: R&D expenses for the fourth quarter of 2019 were $4.8 million compared to $4.5 million in the same period in 2018. The increase was primarily due to increased activities in several clinical trials including the Phase 2b/3 PRISM trial and the Phase 2 trial in chronic cough in patients with IPF.   

    General and administrative (G&A) expenses: G&A expenses for the fourth quarter of 2019 were $1.9 million compared to $1.4 million in the same period in 2018. The increase was primarily due to an increase in personnel and stock-based compensation expense as well as expenses related to being a public company.

    Net loss: For the fourth quarter of 2019, Trevi reported a net loss of $6.5 million compared to a net loss of $6.0 million in the same period in 2018.

    Year End 2019 Financial Highlights

    Cash position: As of December 31, 2019, total cash and cash equivalents were $57.3 million compared to $7.2 million as of December 31, 2018. Trevi believes this cash position will be sufficient to fund operations into the third quarter of 2021.

    R&D expenses: R&D expenses for the year ended December 31, 2019 were $19.3 million compared to $14.1 million for the year ended December 31, 2018. The increase was primarily due to increased activities in several clinical trials including the Phase 2b/3 PRISM trial, the Phase 2 trial in chronic cough in patients with IPF and the Phase 1b trial in patients with chronic liver disease.   

    G&A expenses: G&A expenses for the year ended December 31, 2019 were $7.3 million compared to $4.3 million for the year ended December 31, 2018. The increase was primarily due to an increase in personnel and stock-based compensation expense as well as expenses related to being a public company.

    Net loss: For the year ended December 31, 2019, Trevi reported a net loss of $26.1 million compared to a net loss of $20.5 million for the year ended December 31, 2018.

    About Trevi Therapeutics, Inc.
    Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of nalbuphine ER to treat serious neurologically mediated conditions. Trevi is currently developing nalbuphine ER for the treatment of chronic pruritus, chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and levodopa-induced dyskinesia (LID) in patients with Parkinson's disease. These conditions share a common pathophysiology that is mediated through opioid receptors in the central and peripheral nervous systems. Trevi is currently conducting a Phase 2b/3 clinical trial of nalbuphine ER, referred to as the PRISM trial, in patients with severe pruritus associated with prurigo nodularis (PN).

    Founded in 2011, Trevi Therapeutics is headquartered in New Haven, CT.

    About Nalbuphine ER
    Nalbuphine ER is an oral extended release formulation of nalbuphine. Nalbuphine is a mixed ĸ-opioid receptor agonist and µ-opioid receptor antagonist that has been approved and marketed as an injectable for pain indications for more than 20 years in the United States and Europe. The ĸ- and µ-opioid receptors are known to be critical mediators of itch, cough and certain movement disorders. Nalbuphine's mechanism of action also mitigates the risk of abuse associated with µ-opioid agonists because it antagonizes, or blocks, µ-opioid receptors. Nalbuphine is currently the only opioid approved for marketing that is not classified as a controlled substance in the United States and most of Europe.

    Forward-Looking Statements
    Statements contained in this press release 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, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the expected timing of enrollment and the re-estimation analysis for, and for reporting top-line data from, Trevi's Phase 2b/3 PRISM trial of nalbuphine ER in patients with prurigo nodularis;  the expected timing of milestones for the Company's other ongoing and planned clinical trials; Trevi's business plans and objectives, including future plans or expectations for Trevi's product candidates and expectations regarding Trevi's uses and sufficiency of capital; and other statements containing the words "believes," "anticipates," "plans," "expects," and similar expressions. Risks that contribute to the uncertain nature of the forward-looking statements include: uncertainties regarding the success, cost, and timing of the Trevi's product candidate development activities and ongoing and planned clinical trials; uncertainties regarding Trevi's ability to execute on its strategy; the risk that positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical trials; potential regulatory developments in the United States and foreign countries; uncertainties inherent in estimating future expenses, capital requirements and other financial results; as well as other risks and uncertainties set forth in the quarterly report on Form 10-Q for the quarter ended September 30, 2019 filed with the Securities and Exchange Commission and in subsequent filings with the Securities and Exchange Commission.  All forward-looking statements contained in this press release speak only as of the date on which they were made. Trevi undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

     
    Trevi Therapeutics, Inc.
    Selected Balance Sheet Data
    (unaudited)
    (amounts in thousands)
     
      December 31,
    2019
        December 31,
    2018
             
    Cash and cash equivalents $   57,313     $   7,202  
    Working capital     54,353       6,148  
    Total assets     60,001       10,526  
    Stockholders' equity (deficit)     54,545       (109,494 )
                 


     
    Trevi Therapeutics, Inc.
    Selected Statement of Operations Data
    (unaudited)
    (amounts in thousands)
     
      Three Months Ended
    December 31,
      Year Ended
    December 31,
        2019       2018       2019       2018  
    Operating expenses:                              
    Research and development $ 4,823     $ 4,523     $ 19,339     $ 14,072  
    General and administrative   1,943       1,406       7,306       4,336  
    Total operating expenses   6,766       5,929       26,645       18,408  
    Loss from operations   (6,766 )     (5,929 )     (26,645 )     (18,408 )
    Other income (expense), net   225       (102 )     577       (2,261 )
    Loss before income tax benefit   (6,541 )     (6,031 )     (26,068 )     (20,669 )
    Income tax benefit   4       49       18       124  
    Net loss $ (6,537 )   $ (5,982 )   $ (26,050 )   $ (20,545 )
                                   

    Investor Contact
    Chris Seiter, Chief Financial Officer
    Trevi Therapeutics, Inc.
    chris.seiter@trevitherapeutics.com 
    203-304-2499

    Media Contact
    Rosalia Scampoli
    rscampoli@marketcompr.com
    212-537-5177 ext. 7

    Primary Logo

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  29. NEW HAVEN, Conn., Feb. 20, 2020 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of nalbuphine ER to treat serious neurologically mediated conditions, today announced that management will present a Company overview, as well as host investor meetings, at the SVB Leerink 2020 Healthcare Conference:

    Date: Tuesday, February 25, 2020
    Presentation Time: 3:30 p.m. ET
    Place: Lotte New York Palace Hotel, New York

    A live webcast of the presentation can be accessed by visiting ‘News & Events' in the ‘Investors & News' section on the Company's website at www.trevitherapeutics.com. An archived replay of the webcast will also be available for 90 days on…

    NEW HAVEN, Conn., Feb. 20, 2020 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of nalbuphine ER to treat serious neurologically mediated conditions, today announced that management will present a Company overview, as well as host investor meetings, at the SVB Leerink 2020 Healthcare Conference:

    Date: Tuesday, February 25, 2020
    Presentation Time: 3:30 p.m. ET
    Place: Lotte New York Palace Hotel, New York

    A live webcast of the presentation can be accessed by visiting ‘News & Events' in the ‘Investors & News' section on the Company's website at www.trevitherapeutics.com. An archived replay of the webcast will also be available for 90 days on the Company's website following the conference.

    The Company's corporate presentation is posted to its website under ‘Investors & News'.

    About Trevi Therapeutics, Inc.
    Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of nalbuphine ER to treat serious neurologically mediated conditions. Trevi is currently developing nalbuphine ER for the treatment of chronic pruritus, chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and levodopa-induced dyskinesia (LID) in patients with Parkinson's disease. These conditions share a common pathophysiology that is mediated through opioid receptors in the central and peripheral nervous systems. Trevi is currently conducting a Phase 2b/3 clinical trial of nalbuphine ER, referred to as the PRISM trial, in patients with severe pruritus associated with prurigo nodularis.

    Founded in 2011, Trevi Therapeutics is headquartered in New Haven, CT.

    About Nalbuphine ER
    Nalbuphine ER is an oral extended release formulation of nalbuphine. Nalbuphine is a mixed ĸ-opioid receptor agonist and µ-opioid receptor antagonist that has been approved and marketed as an injectable for pain indications for more than 20 years in the United States and Europe. The ĸ- and µ-opioid receptors are known to be critical mediators of itch, cough and certain movement disorders. Nalbuphine's mechanism of action also mitigates the risk of abuse associated with µ-opioid agonists because it antagonizes, or blocks, µ-opioid receptors. Nalbuphine is currently the only opioid approved for marketing that is not classified as a controlled substance in the United States and most of Europe.

    Investor Contact
    Chris Seiter, Chief Financial Officer
    Trevi Therapeutics, Inc.
    chris.seiter@trevitherapeutics.com
    203-304-2499

    Media Contact
    Rosalia Scampoli
    rscampoli@marketcompr.com
    212-537-5177 ext. 7

    Primary Logo

    View Full Article Hide Full Article
  30. NEW HAVEN, Conn., Feb. 18, 2020 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. ("Trevi"), a clinical-stage biopharmaceutical company focused on the development and commercialization of nalbuphine ER to treat serious neurologically mediated conditions, today announced the election of James V. Cassella, Ph.D. to Trevi's Board of Directors.

    Dr. Cassella joins Trevi's Board with over 30 years of drug development experience working with emerging growth biopharmaceutical companies. He has served as Chief Development Officer of Concert Pharmaceuticals since 2015, and prior to that held senior executive and leadership roles with Alexza Pharmaceuticals, Inc. and Neurogen Corporation. Before joining the biopharmaceutical industry, Dr. Cassella was Assistant…

    NEW HAVEN, Conn., Feb. 18, 2020 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. ("Trevi"), a clinical-stage biopharmaceutical company focused on the development and commercialization of nalbuphine ER to treat serious neurologically mediated conditions, today announced the election of James V. Cassella, Ph.D. to Trevi's Board of Directors.

    Dr. Cassella joins Trevi's Board with over 30 years of drug development experience working with emerging growth biopharmaceutical companies. He has served as Chief Development Officer of Concert Pharmaceuticals since 2015, and prior to that held senior executive and leadership roles with Alexza Pharmaceuticals, Inc. and Neurogen Corporation. Before joining the biopharmaceutical industry, Dr. Cassella was Assistant Professor of Neurosciences at Oberlin College. Dr. Cassella received his Ph.D. in Physiological Psychology from Dartmouth College, completed a postdoctoral fellowship in the Department of Psychiatry at the Yale University School of Medicine and received a B.A. in Psychology from the University of New Haven.    

    "Jim brings extensive scientific and clinical development experience which will be valuable assets for the Trevi Board as we execute against our business plans and strategy moving forward," said Jennifer L. Good, President and Chief Executive Officer.

    "I am very excited to join the Trevi Board and look forward to lending my extensive drug development experience and expertise to the Company's already deep and knowledgeable Board and strong leadership team at such an exciting time for the Company," said Dr. Cassella.

    About Trevi Therapeutics, Inc.
    Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of nalbuphine ER to treat serious neurologically mediated conditions. Trevi is currently developing nalbuphine ER for the treatment of chronic pruritus, chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and levodopa- induced dyskinesia (LID) in patients with Parkinson's disease. These conditions share a common pathophysiology that is mediated through opioid receptors in the central and peripheral nervous systems. Trevi is currently conducting a Phase 2b/3 clinical trial of nalbuphine ER, referred to as the PRISM trial, in patients with severe pruritus associated with prurigo nodularis.

    Founded in 2011, Trevi Therapeutics is headquartered in New Haven, CT.

    About Nalbuphine ER
    Nalbuphine ER is an oral extended release formulation of nalbuphine. Nalbuphine is a mixed ĸ-opioid receptor agonist and µ-opioid receptor antagonist that has been approved and marketed as an injectable for pain indications for more than 20 years in the United States and Europe. The ĸ- and µ-opioid receptors are known to be critical mediators of itch, cough and certain movement disorders. Nalbuphine's mechanism of action also mitigates the risk of abuse associated with µ-opioid agonists because it antagonizes, or blocks, µ-opioid receptors. Nalbuphine is currently the only opioid approved for marketing that is not classified as a controlled substance in the United States and most of Europe.

    Investor Contact
    Chris Seiter, Chief Financial Officer
    Trevi Therapeutics, Inc.
    203-304-2499
    chris.seiter@trevitherapeutics.com

    Media contact 
    Rosalia Scampoli
    212-537-5177 ext. 7
    rscampoli@marketcompr.com

    Primary Logo

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  31. Advancement of Nalbuphine ER in Clinical Development for Three Indications

    Cash Position of $63.5 Million Expected to Fund Operations Through At Least Q1 2021

    NEW HAVEN, Conn., Nov. 14, 2019 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of nalbuphine ER to treat serious neurologically mediated conditions, today announced financial results for the quarter ended September 30, 2019, as well as recent business highlights.

    "We have made substantial progress this year advancing the development of nalbuphine ER across all of our clinical indications.  We continued to progress our lead development program in prurigo nodularis during the third…

    Advancement of Nalbuphine ER in Clinical Development for Three Indications

    Cash Position of $63.5 Million Expected to Fund Operations Through At Least Q1 2021

    NEW HAVEN, Conn., Nov. 14, 2019 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of nalbuphine ER to treat serious neurologically mediated conditions, today announced financial results for the quarter ended September 30, 2019, as well as recent business highlights.

    "We have made substantial progress this year advancing the development of nalbuphine ER across all of our clinical indications.  We continued to progress our lead development program in prurigo nodularis during the third quarter with further enrollment and continued site initiations in Europe and the US.  We have had 100% of the patients that completed the blinded 14-week dosing continue into the open label extension portion of the study," said Jennifer L. Good, President and CEO of Trevi Therapeutics. "We are also actively enrolling the cough study in idiopathic pulmonary fibrosis patients in the UK and have completed dosing of subjects with mild to moderate liver impairment in our Phase 1b study in patients with chronic liver disease.  While the pace of enrollment in our PN trial has been slower than originally planned, our team remains focused on completing this trial, as well as those in our other clinical indications, each of which represents a significant unmet medical need."

    Product Pipeline Updates

    • Phase 2b/3 PRISM trial: The ongoing PRISM trial is a randomized, double-blind, placebo controlled, two-arm treatment study that is designed to evaluate the safety and anti-pruritic efficacy of nalbuphine ER in approximately 240 patients with severe pruritus from PN in approximately 50 centers in the U.S. and Europe.  To date, the Company has enrolled approximately 30% of the targeted number of patients in the study.  The pace of enrollment has been slower than anticipated primarily due to competition from other clinical trials and slower than planned site start-ups in Europe. As a result, the Company expects to report top-line data from the PRISM trial in the second half of 2020.  Additionally, the protocol for the PRISM trial provides for a sample size re-estimation analysis once 50% of the patients in the trial are evaluable for the primary endpoint.  Trevi expects the re-estimation analysis will occur in mid-2020.
    • Phase 2 trial of nalbuphine ER for chronic cough in patients with idiopathic pulmonary fibrosis (IPF):  The Phase 2 clinical trial is a randomized, double-blind, placebo controlled, two-treatment, two-period, crossover study designed to evaluate the efficacy, safety, tolerability and dosing of nalbuphine ER for chronic cough in up to 56 patients with IPF.  Patient enrollment is underway and Trevi expects to activate all remaining clinical sites by the end of 2019.  Trevi expects to complete enrollment in this trial in the first half of 2020 and report top-line data in the second half of 2020.
    • Phase 1b trial in patients with chronic liver disease: Trevi completed the Phase 1b single ascending dose segment of the hepatic impairment study in subjects with mild and moderate liver impairment.  There were no serious adverse events reported and based on the safety and PK profile observed in the study, planning is underway for a Phase 2 trial of nalbuphine ER in patients with pruritus associated with primary biliary cholangitis (PBC).  In addition, Trevi intends to use data from the hepatic impairment study to support a submission of a New Drug Application (NDA) for nalbuphine ER for pruritus in PN.
    • Phase 2 trial of levodopa-induced dyskinesia (LID) in patients with Parkinson's disease:  Trevi has written the protocol for a Phase 2 trial for LID in patients with Parkinson's disease and plans to submit an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) in the upcoming months.

    Third Quarter 2019 Financial Highlights

    Cash position: As of September 30, 2019, Trevi reported total cash and cash equivalents of $63.5 million compared to $7.2 million as of December 31, 2018. Trevi believes this cash position will be sufficient to fund operations through at least the end of the first quarter of 2021.

    Research and development (R&D) expenses: R&D expenses for the third quarter of 2019 were $5.6 million compared to $3.7 million in the same period in 2018. The increase was primarily due to increased activities in several clinical trials including the Phase 2b/3 PRISM trial, the Phase 2 trial in chronic cough in patients with IPF and the Phase 1b trial in patients with chronic liver disease.   

    General and administrative (G&A) expenses: G&A expenses for the third quarter of 2019 were $2.0 million compared to $1.2 million in the same period in 2018. The increase was primarily due to an increase in personnel and stock-based compensation expense as well as expenses related to being a public company.

    Net loss: For the third quarter of 2019, Trevi reported a net loss of $7.4 million compared to a net loss of $5.7 million in the same period in 2018.

    About Trevi Therapeutics, Inc.
    Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of nalbuphine ER to treat serious neurologically mediated conditions. Trevi is currently developing nalbuphine ER for the treatment of chronic pruritus, chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and levodopa-induced dyskinesia (LID) in patients with Parkinson's disease. These conditions share a common pathophysiology that is mediated through opioid receptors in the central and peripheral nervous systems. Trevi is currently conducting a Phase 2b/3 clinical trial of nalbuphine ER, referred to as the PRISM trial, in patients with severe pruritus associated with prurigo nodularis (PN).

    Founded in 2011, Trevi Therapeutics is headquartered in New Haven, CT.

    About Nalbuphine ER
    Nalbuphine ER is an oral extended release formulation of nalbuphine. Nalbuphine is a mixed ĸ-opioid receptor agonist and µ-opioid receptor antagonist that has been approved and marketed as an injectable for pain indications for more than 20 years in the United States and Europe. The ĸ- and µ-opioid receptors are known to be critical mediators of itch, cough and certain movement disorders. Nalbuphine's mechanism of action also mitigates the risk of abuse associated with µ-opioid agonists because it antagonizes, or blocks, µ-opioid receptors. Nalbuphine is currently the only opioid approved for marketing that is not classified as a controlled substance in the United States and most of Europe.

    Forward-Looking Statements
    Statements contained in this press release 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, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the expected timing of the re-estimation analysis for, and for reporting top-line data from, Trevi's Phase 2b/3 PRISM trial of nalbuphine ER in patients with prurigo nodularis;  the expected timing of milestones for the Company's other ongoing and planned clinical trials; Trevi's business plans and objectives, including future plans or expectations for Trevi's product candidates and expectations regarding Trevi's uses and sufficiency of capital; and other statements containing the words "believes," "anticipates," "plans," "expects," and similar expressions. Risks that contribute to the uncertain nature of the forward-looking statements include: uncertainties regarding the success, cost, and timing of the Trevi's product candidate development activities and planned clinical trials; uncertainties regarding Trevi's ability to execute on its strategy; the risk that positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical trials; potential regulatory developments in the United States and foreign countries; uncertainties inherent in estimating future expenses, capital requirements and other financial results; as well as other risks and uncertainties set forth in the quarterly report on Form 10-Q for the quarter ended June 30, 2019 filed with the Securities and Exchange Commission and in subsequent filings with the Securities and Exchange Commission.  All forward-looking statements contained in this press release speak only as of the date on which they were made. Trevi undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Trevi Therapeutics, Inc.
    Selected Balance Sheet Data
    (unaudited)
    (amounts in thousands)

      September 30,
    2019
        December 31,
    2018
             
    Cash and cash equivalents $ 63,515     $ 7,202  
    Working capital   60,514     6,148  
    Total assets   66,022     10,526  
    Stockholders' equity (deficit)   60,709     (109,494 )
                 

    Trevi Therapeutics, Inc.
    Selected Statement of Operations Data
    (unaudited)
    (amounts in thousands)

      Three Months Ended
    September 30,
      Nine Months Ended
    September 30,
        2019       2018       2019       2018  
    Operating expenses:                              
    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  
    Loss from operations   (7,650 )     (4,957 )     (19,879 )     (12,479 )
    Other income (expense), net   280       (722 )     352       (2,159 )
    Loss before income tax benefit   (7,370 )     (5,679 )     (19,527 )     (14,638 )
    Income tax benefit   5       25       14       75  
    Net loss $ (7,365 )   $ (5,654 )   $ (19,513 )   $ (14,563 )
                                   

    Investor Contact
    Peter Vozzo
    Westwicke
    peter.vozzo@westwicke.com
    443-213-0505

    Media Contact
    Rosalia Scampoli
    rscampoli@marketcompr.com
    212-537-5177 ext. 7

    Primary Logo

    View Full Article Hide Full Article
  32. NEW HAVEN, Conn., Nov. 13, 2019 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of nalbuphine ER to treat serious neurologically mediated conditions, today announced that management will present a Company overview, as well as host investor meetings, at the Stifel 2019 Healthcare Conference:

    Date: November 19, 2019
    Presentation Time: 9:10 a.m. ET
    Place: Lotte New York Palace Hotel, New York

    A live webcast of the presentation can be accessed by visiting ‘News & Events' in the Investor & News section on the Company's website at www.trevitherapeutics.com. An archived replay of the webcast will be available for 90 days on the Company's website…

    NEW HAVEN, Conn., Nov. 13, 2019 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company focused on the development and commercialization of nalbuphine ER to treat serious neurologically mediated conditions, today announced that management will present a Company overview, as well as host investor meetings, at the Stifel 2019 Healthcare Conference:

    Date: November 19, 2019
    Presentation Time: 9:10 a.m. ET
    Place: Lotte New York Palace Hotel, New York

    A live webcast of the presentation can be accessed by visiting ‘News & Events' in the Investor & News section on the Company's website at www.trevitherapeutics.com. An archived replay of the webcast will be available for 90 days on the Company's website following the conference.

    The corporate presentation that the Company intends to present with and at the time of the live webcast will be posted to its website under ‘Investor & News'.

    About Trevi Therapeutics, Inc.
    Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of nalbuphine ER to treat serious neurologically mediated conditions. Trevi is currently developing nalbuphine ER for the treatment of chronic pruritus, chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and levodopa-induced dyskinesia (LID) in patients with Parkinson's disease. These conditions share a common pathophysiology that is mediated through opioid receptors in the central and peripheral nervous systems. Trevi is currently conducting a Phase 2b/3 clinical trial of nalbuphine ER, referred to as the PRISM trial, in patients with severe pruritus associated with prurigo nodularis.

    Founded in 2011, Trevi Therapeutics is headquartered in New Haven, CT.

    About Nalbuphine ER
    Nalbuphine ER is an oral extended release formulation of nalbuphine. Nalbuphine is a mixed ĸ-opioid receptor agonist and µ-opioid receptor antagonist that has been approved and marketed as an injectable for pain indications for more than 20 years in the United States and Europe. The ĸ- and µ-opioid receptors are known to be critical mediators of itch, cough and certain movement disorders. Nalbuphine's mechanism of action also mitigates the risk of abuse associated with µ-opioid agonists because it antagonizes, or blocks, µ-opioid receptors. Nalbuphine is currently the only opioid approved for marketing that is not classified as a controlled substance in the United States and most of Europe.

    Investor Contact
    Peter Vozzo
    Westwicke
    peter.vozzo@westwicke.com 
    443-213-0505

    Media Contact
    Rosalia Scampoli
    rscampoli@marketcompr.com
    212-537-5177 ext. 7

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