TRVI Trevi Therapeutics Inc.

1.9
-0.01  -1%
Previous Close 1.91
Open 1.9
52 Week Low 1.78
52 Week High 8.5
Market Cap $40,978,543
Shares 21,567,654
Float 4,078,867
Enterprise Value $13,737,542
Volume 22,731
Av. Daily Volume 81,438
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Upcoming Catalysts

Drug Stage Catalyst Date
Haduvio - PRISM
Prurigo Nodularis
Phase 2/3
Phase 2/3
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Drug Pipeline

Drug Stage Notes
Nalbuphine ER
Chronic cough - Idiopathic pulmonary fibrosis (IPF)
Phase 2
Phase 2
Phase 2 trial has restarted following halt due to COVID-19 - October 21, 2020.

Latest News

  1. 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

    Media Contact 

    Rosalia Scampoli

    914-815-1465

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

    SOURCE Trevi Therapeutics, Inc.

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  2. 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

    +41 22 552 1550

    Investor Contact:

    Joyce Allaire

    +1 (617)-435-6602

     

     

     

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  3. 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

    Media Contact

    Rosalia Scampoli

    914-815-1465

    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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  4. 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

    Media Contact 

    Rosalia Scampoli

    914-815-1465

    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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  5. 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

    Media Contact  

    Rosalia Scampoli

    914-815-1465



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