1. CHESTERBROOK, Pa., Jan. 07, 2021 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced that management will participate in two upcoming virtual investor conferences, with additional details below.

      LifeSci Partners 10th Annual Healthcare Corporate Access Event
     Date:Friday, January 8th, 2021
     Time:2:00 p.m. ET
     Format:Panel Discussion - Executing a Successful Product Launch During a Pandemic
     Attendees:Carrie Bourdow, President & CEO
     Webcast:https://wsw.com/webcast/lifesci/panel14/2387307
       
      H.C. Wainwright BioConnect Conference
     Date:Monday, January 11th, 2021
     Time: 6:00 a.m. ET

    CHESTERBROOK, Pa., Jan. 07, 2021 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced that management will participate in two upcoming virtual investor conferences, with additional details below.

      LifeSci Partners 10th Annual Healthcare Corporate Access Event
     Date:Friday, January 8th, 2021
     Time:2:00 p.m. ET
     Format:Panel Discussion - Executing a Successful Product Launch During a Pandemic
     Attendees:Carrie Bourdow, President & CEO
     Webcast:https://wsw.com/webcast/lifesci/panel14/2387307
       
      H.C. Wainwright BioConnect Conference
     Date:Monday, January 11th, 2021
     Time: 6:00 a.m. ET (webcast available)
     Format:Fireside Chat
     Attendees:Carrie Bourdow, President & CEO
      Bob Yoder, Senior Vice President & Chief Commercial Officer
     Webcast:https://journey.ct.events/view/940f6f19-b43a-471d-8bab-6aa4e8e612e0

    Links to the webcasts will be available on the Events page of the Investors section on the Company's website at www.trevena.com/investors/events-presentations/ir-calendar.

    About Trevena

    Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with CNS disorders. The Company has one approved product in the U.S., OLINVYK™ (oliceridine) injection, indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. The Company also has four novel and differentiated investigational drug candidates: TRV250 for the acute treatment of migraine, TRV734 for maintenance treatment of opioid use disorder, and TRV027 for acute lung injury / abnormal blood clotting in COVID-19 patients. The Company has also identified TRV045, a novel S1P receptor modulator that may offer a new, non-opioid approach to treating a variety of CNS disorders.

    For more information, please visit www.Trevena.com.

    Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development and trials of its therapeutic candidates, plans for potential future product candidates, commercialization of approved drug products and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "might," "plan," "objective," "predict," "project," "suggest," "target," "potential," "will," "would," "could," "should," "continue," "ongoing," or the negative of these terms or similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the commercialization of any approved drug product, the status, timing, costs, results and interpretation of the Company's clinical trials or any future trials of any of the Company's investigational drug candidates; the uncertainties inherent in conducting clinical trials; expectations for regulatory interactions, submissions and approvals, including the Company's assessment of the discussions with the FDA or other regulatory agencies about any and all of its programs; uncertainties related to the commercialization of OLINVYK; available funding; uncertainties related to the Company's intellectual property; uncertainties related to the ongoing COVID-19 pandemic, other matters that could affect the availability or commercial potential of the Company's therapeutic candidates; and other factors discussed in the Risk Factors set forth in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.

    For more information, please contact:

    Investor Contact:

    Dan Ferry

    Managing Director

    LifeSci Advisors, LLC



    (617) 430-7576

    Company Contact:

    Bob Yoder

    SVP and Chief Commercial Officer

    Trevena, Inc.

    (610) 354-8840



    Primary Logo

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  2. --

    Build-out of customer-facing team on track for this quarter

    OLINVYK comprehensive product dossier / health economic model now available to facilitate formulary reviews

    --

    CHESTERBROOK, Pa., Jan. 06, 2021 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today provided an update on the U.S. commercial launch for OLINVYK (oliceridine) injection and announced anticipated milestones for 2021.

    "We enter 2021 focused on building upon the foundation we laid in 2020 to deliver a successful launch for OLINVYK. I'm pleased by the early interest we've received from hospital physicians and institutions…

    --

    Build-out of customer-facing team on track for this quarter

    OLINVYK comprehensive product dossier / health economic model now available to facilitate formulary reviews

    --

    CHESTERBROOK, Pa., Jan. 06, 2021 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today provided an update on the U.S. commercial launch for OLINVYK (oliceridine) injection and announced anticipated milestones for 2021.

    "We enter 2021 focused on building upon the foundation we laid in 2020 to deliver a successful launch for OLINVYK. I'm pleased by the early interest we've received from hospital physicians and institutions across the country," said Carrie Bourdow, President and Chief Executive Officer of Trevena, Inc. "Additionally, we continue to make exciting progress across our pipeline, with several upcoming catalysts this year."

    OLINVYK Commercial Launch

    • OLINVYK commercially available. The Company has contracted with the three major wholesalers covering the majority of the acute care business. All three vial presentations of OLINVYK (1 mg/1 mL and 2 mg/2 mL single-dose vials; 30 mg/30 mL single-patient-use vials for patient-controlled analgesia) are now available for ordering.
    • Ramp-up of customer engagement activities underway. Since the approval of OLINVYK, the Company has received inbound interest from a diverse set of institutions and engaged with a number of key opinion leaders who participated in the Phase 3 OLINVYK "real-world" multi-site safety study. Physicians continue to reinforce the value proposition of OLINVYK as a compelling new analgesic option for acute pain patients in the hospital and other controlled clinical settings.



      The comprehensive product dossier and detailed health economic model for OLINVYK are now complete and accessible to healthcare decision makers to facilitate formulary inclusion. The health economic model, which highlights OLINVYK versus IV morphine cost information, is expected to be published in 1H 2021.



      In addition, the "Now Available" marketing campaign for OLINVYK has launched, which includes early digital engagement, launch emails to targeted healthcare professionals, and an updated website which provides product ordering and reimbursement information.
    • Build-out of customer-facing team on track for deployment this quarter. The Company has completed hiring of its medical science liaisons (MSLs) and sales manager team, and it remains on track to complete hiring, training and deployment of its field commercial team this quarter. The Company today announced that it will be targeting 100 formulary acceptances in 2021. In response to the ongoing COVID-19 pandemic, the Company is employing analytics on a local and regional basis to monitor the impact on hospitals and ambulatory surgical centers, and to inform the safe and effective deployment of its customer-facing teams.
    • All required CMS reimbursement submissions and registrations complete. The Company today announced that all submissions for permanent J- and C-Codes have been submitted to the Centers for Medicare and Medicaid Services (CMS) for OLINVYK. In the interim, as is customary for all new products, customers will use the miscellaneous J- and C-codes for reimbursement. This ensures that OLINVYK can be reimbursed in both the inpatient and outpatient setting until permanent codes are established. Market access resources are now available to customers which support reimbursement of OLINVYK at 95% of Average Wholesale Price (AWP) in advance of pass-through status being decided.

    Pipeline Updates

    • COVID-19 trial for TRV027 on track to report topline data this quarter. TRV027 is being evaluated in a 60-person trial as a potential treatment for acute lung damage / abnormal blood clotting associated with COVID-19. Imperial College London is sponsoring and funding the study, with additional support through the British Heart Foundation Centre for Research Excellence Award.
    • IND filing for TRV045 on track for 1H 2021. In December 2020, the Company presented nonclinical data supporting the potential utility of TRV045 to treat a variety of CNS disorders, including epilepsy, chemotherapy-induced peripheral neuropathy, and diabetic peripheral neuropathy. The Company is currently collaborating with the National Institutes of Health (NIH) to evaluate TRV045 in their screening programs for epilepsy and non-addictive treatment of pain.

    About OLINVYK™ (oliceridine) injection

    OLINVYK is a new chemical entity approved by the FDA in August 2020. OLINVYK contains oliceridine, a Schedule II controlled substance with a high potential for abuse similar to other opioids. It is indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. OLINVYK is available in 1 mg/1 mL and 2 mg/2 mL single-dose vials, and a 30 mg/30 mL single-patient-use vial for patient-controlled analgesia (PCA). Approved PCA doses are 0.35 mg and 0.5 mg and single bolus doses greater than 3 mg should not be administered. The cumulative daily dose should not exceed 27 mg. Please see Important Safety Information, including the BOXED WARNING, and full prescribing information at www.OLINVYK.com.

    About Trevena

    Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with CNS disorders. The Company has one approved product in the United States, OLINVYK™ (oliceridine) injection, indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. The Company also has four novel and differentiated investigational drug candidates: TRV250 for the acute treatment of migraine, TRV734 for maintenance treatment of opioid use disorder, and TRV027 for acute lung injury / abnormal blood clotting in COVID-19 patients. The Company has also identified TRV045, a novel S1P receptor modulator that may offer a new, non-opioid approach to treating a variety of CNS disorders.

    For more information, please visit www.Trevena.com 

    Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development and trials of its therapeutic candidates, plans for potential future product candidates, commercialization of approved drug products and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "might," "plan," "objective," "predict," "project," "suggest," "target," "potential," "will," "would," "could," "should," "continue," "ongoing," or the negative of these terms or similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the commercialization of any approved drug product, the status, timing, costs, results and interpretation of the Company's clinical trials or any future trials of any of the Company's investigational drug candidates; the uncertainties inherent in conducting clinical trials; expectations for regulatory interactions, submissions and approvals, including the Company's assessment of the discussions with the FDA or other regulatory agencies about any and all of its programs; uncertainties related to the commercialization of OLINVYK; available funding; uncertainties related to the Company's intellectual property; uncertainties related to the ongoing COVID-19 pandemic, other matters that could affect the availability or commercial potential of the Company's therapeutic candidates; and other factors discussed in the Risk Factors set forth in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.

    For more information, please contact:

    Investor Contact:

    Dan Ferry

    Managing Director

    LifeSci Advisors, LLC



    (617) 430-7576

    Company Contact:

    Bob Yoder

    SVP and Chief Commercial Officer

    Trevena, Inc.

    (610) 354-8840



    Primary Logo

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  3. --

    Presentations highlight efficacy of TRV045 in animal models of neuropathic pain and epilepsy

    TRV045 selectively targets the S1P1 receptor without associated lymphopenia

    IND filing on track for 1H 2021

    --

    CHESTERBROOK, Pa., Dec. 10, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced two presentations at the 59th Annual Meeting for the American College of Neuropsychopharmacology (ACNP). The conference was held virtually from December 6th to 9th, 2020.

    The presentations included two posters, both of which discussed the potential utility of TRV045 to treat a variety…

    --

    Presentations highlight efficacy of TRV045 in animal models of neuropathic pain and epilepsy

    TRV045 selectively targets the S1P1 receptor without associated lymphopenia

    IND filing on track for 1H 2021

    --

    CHESTERBROOK, Pa., Dec. 10, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced two presentations at the 59th Annual Meeting for the American College of Neuropsychopharmacology (ACNP). The conference was held virtually from December 6th to 9th, 2020.

    The presentations included two posters, both of which discussed the potential utility of TRV045 to treat a variety of CNS disorders, including epilepsy, chemotherapy-induced peripheral neuropathy (CIPN), and diabetic peripheral neuropathy (DPN). The Company is currently collaborating with the National Institutes of Health (NIH) to evaluate TRV045 in their screening programs for epilepsy and non-addictive treatment of pain.

    "These are compelling nonclinical findings for TRV045 and support its potential application in the treatment of epilepsy and neuropathic pain. We look forward to continuing to investigate the potential of TRV045 as a treatment for these debilitating disorders," said Mark Demitrack, M.D., Senior Vice President and Chief Medical Officer of Trevena, Inc.

    Poster Details

    1. "TRV045, a novel, selective S1PR1 modulator, is efficacious in reversing neuropathic pain without affecting lymphocyte trafficking" (Poster #T125)



      • TRV045 demonstrated efficacy comparable to fingolimod, an approved S1P receptor modulator, in a mouse CIPN model. Unlike fingolimod, TRV045 did not cause lymphopenia at therapeutic doses.
      • TRV045 demonstrated efficacy comparable to gabapentin, an approved anticonvulsant medication sometimes used to treat diabetic neuropathy, in a rat diabetic peripheral neuropathy model. The Company believes this is the first time that modulation of the S1P1 receptor has been shown to have potential therapeutic benefit in reversing diabetic neuropathic pain.
    2. "TRV045, a novel, selective S1P1 receptor modulator that is not an immunosuppressant, is efficacious in rodent models of epilepsy" (Poster #W105)



      • TRV045 was evaluated as a potential anti-epileptic treatment in four well-established rodent seizure models, as part of the NIH's Epilepsy Therapy Screening Program (ETSP).
      • TRV045 demonstrated a dose-dependent seizure prevention response in three of the models.
      • TRV045 does not cause lymphopenia at therapeutic doses, suggesting it may offer unique therapeutic benefits in a variety of CNS indications, including epilepsy, where immunosuppression is not desirable. Notably, fingolimod has also shown efficacy in rodent epilepsy models, but with substantial immunosuppression.

    All posters can be found at https://www.trevena.com/publications.

    About TRV045

    Trevena is currently developing a novel sphingosine-1-phosphate (S1P) receptor modulator, TRV045, as a non-opioid treatment for various CNS disorders. S1P receptors are located throughout the body, including the central nervous system, where they are believed to play a role in modulating neurotransmission and membrane excitability. TRV045 is a preclinical, investigational drug candidate that engages the S1P receptor in a more selective manner that does not produce immunosuppression or alter lymphocyte trafficking. In a preclinical model of neuropathic pain, TRV045 demonstrated activity with no lymphopenia at therapeutic doses. The National Institutes of Health are currently evaluating TRV045 as a potential treatment for epilepsy and as a potential non-addictive treatment for acute / chronic pain.

    About Trevena

    Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with CNS disorders. The Company has one approved product in the United States, OLINVYK™ (oliceridine) injection, indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. The Company also has four novel and differentiated investigational drug candidates: TRV250 for the acute treatment of migraine, TRV734 for maintenance treatment of opioid use disorder, and TRV027 for acute lung injury / abnormal blood clotting in COVID-19 patients. The Company has also identified TRV045, a novel S1P receptor modulator that may offer a new, non-opioid approach to treating a variety of CNS disorders.

    For more information, please visit www.Trevena.com 

    Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development and trials of its therapeutic candidates, plans for potential future product candidates, commercialization of approved drug products and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "might," "plan," "objective," "predict," "project," "suggest," "target," "potential," "will," "would," "could," "should," "continue," "ongoing," or the negative of these terms or similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the commercialization of any approved drug product, the status, timing, costs, results and interpretation of the Company's clinical trials or any future trials of any of the Company's investigational drug candidates; the uncertainties inherent in conducting clinical trials; expectations for regulatory interactions, submissions and approvals, including the Company's assessment of the discussions with the FDA or other regulatory agencies about any and all of its programs; uncertainties related to the commercialization of OLINVYK; available funding; uncertainties related to the Company's intellectual property; uncertainties related to the ongoing COVID-19 pandemic, other matters that could affect the availability or commercial potential of the Company's therapeutic candidates; and other factors discussed in the Risk Factors set forth in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.

    This press release is not sanctioned by the ACNP.

    For more information, please contact:

    Investor Contact:

    Dan Ferry

    Managing Director

    LifeSci Advisors, LLC



    (617) 430-7576

    Company Contact:

    Bob Yoder

    SVP and Chief Commercial Officer

    Trevena, Inc.

    (610) 354-8840



    Primary Logo

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  4. --

    OLINVYK significantly reduced risk of vomiting and rescue antiemetic use compared to IV morphine in a retrospective analysis

    --

    CHESTERBROOK, Pa., Nov. 20, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced a publication, titled "Oliceridine is Associated with Reduced Risk of Vomiting and Need for Rescue Antiemetics Compared to Morphine: Exploratory Analysis from Two Phase 3 Randomized Placebo and Active Controlled Trials," with lead author Tim Beard, M.D., Chair of the Department of Surgery at Summit Medical Group (DOI: https://doi.org/10.1007/s40122-020-00216-x

    --

    OLINVYK significantly reduced risk of vomiting and rescue antiemetic use compared to IV morphine in a retrospective analysis

    --

    CHESTERBROOK, Pa., Nov. 20, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced a publication, titled "Oliceridine is Associated with Reduced Risk of Vomiting and Need for Rescue Antiemetics Compared to Morphine: Exploratory Analysis from Two Phase 3 Randomized Placebo and Active Controlled Trials," with lead author Tim Beard, M.D., Chair of the Department of Surgery at Summit Medical Group (DOI: https://doi.org/10.1007/s40122-020-00216-x).

    The results of this analysis highlight an improved gastrointestinal (GI) tolerability profile, with OLINVYK demonstrating a ~2-3x likelihood of achieving a "complete GI response" compared to IV morphine under equianalgesic conditions. A complete GI response is defined as the proportion of patients who complete the study without vomiting and without using any antiemetics.

    "There are multiple types of procedures where post-operative nausea or vomiting can disrupt the integrity of a surgery, posing a significant challenge to a patient's recovery," said Tim Beard, M.D. "Based on the results of this analysis, OLINVYK has the potential to greatly reduce the risk of nausea and vomiting following surgery, compared to IV morphine. These are compelling findings that suggest the clinical advantages OLINVYK may offer in the post-operative acute care setting."

    Publication Key Points:

    • Orthopedic surgery-bunionectomy study: A higher proportion of patients achieved ‘complete GI response' with all OLINVYK treatment regimens (0.1 mg: 76.3%; 0.35 mg: 53.2%; 0.5 mg: 49.4%) compared to IV morphine (32.9%; p < 0.05 for all 3 OLINVYK dose regimens).
    • Plastic surgery-abdominoplasty study: A higher proportion of patients achieved ‘complete GI response' with all OLINVYK treatment regimens (0.1 mg: 59.7%; 0.35 mg: 39.2%; 0.5 mg: 29.9%) compared to IV morphine (28.8%; p ≤ 0.0001 for OLINVYK 0.1 mg).
    • Pooled data from both trials: There was a statistically significantly higher rate of ‘complete GI response' associated with OLINVYK 0.1 mg (68%) and 0.35 mg (46.2%) compared to IV morphine (30.8%; p ≤ 0.005).
    • Under equianalgesic conditions: Where analgesia as measured by Sum of Pain Intensity Difference (SPID) scores was held constant, patients were 3.1x more likely to achieve a ‘complete GI response' with OLINVYK than IV morphine in the orthopedic surgery-bunionectomy study (95% CI: 1.78, 5.56; p <0.0001), and 1.9x more likely in the plastic-surgery abdominoplasty study (95% CI: 1.09, 3.36; p = 0.024).

    About OLINVYK™ (oliceridine) injection

    OLINVYK is a new chemical entity approved by the FDA in August 2020. OLINVYK contains oliceridine, a Schedule II controlled substance with a high potential for abuse similar to other opioids. It is indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. OLINVYK is available in 1 mg/1 mL and 2 mg/2 mL single-dose vials, and a 30 mg/30 mL single-patient-use vial for patient-controlled analgesia (PCA). Approved PCA doses are 0.35 mg and 0.5 mg and single bolus doses greater than 3 mg have not been evaluated. The cumulative daily dose should not exceed 27 mg. Please see Important Safety Information, including the BOXED WARNING, and full prescribing information at www.OLINVYK.com.

    About Trevena

    Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with CNS disorders. The Company has one approved product in the United States, OLINVYK™ (oliceridine) injection, indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. The Company also has four novel and differentiated investigational drug candidates: TRV250 for the acute treatment of migraine, TRV734 for maintenance treatment of opioid use disorder, and TRV027 for acute lung injury / abnormal blood clotting in COVID-19 patients. The Company has also identified TRV045, a novel S1P receptor modulator that may offer a new, non-opioid approach to treating a variety of CNS disorders.

    For more information, please visit www.Trevena.com 

    Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development and trials of its therapeutic candidates, plans for potential future product candidates, commercialization of approved drug products and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "might," "plan," "objective," "predict," "project," "suggest," "target," "potential," "will," "would," "could," "should," "continue," "ongoing," or the negative of these terms or similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the commercialization of any approved drug product, the status, timing, costs, results and interpretation of the Company's clinical trials or any future trials of any of the Company's investigational drug candidates; the uncertainties inherent in conducting clinical trials; expectations for regulatory interactions, submissions and approvals, including the Company's assessment of the discussions with the FDA or other regulatory agencies about any and all of its programs; uncertainties related to the commercialization of OLINVYK; available funding; uncertainties related to the Company's intellectual property; uncertainties related to the ongoing COVID-19 pandemic, other matters that could affect the availability or commercial potential of the Company's therapeutic candidates; and other factors discussed in the Risk Factors set forth in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.

    For more information, please contact:

    Investor Contact:

    Dan Ferry

    Managing Director

    LifeSci Advisors, LLC



    (617) 430-7576

    Company Contact:

    Bob Yoder

    SVP and Chief Business Officer

    Trevena, Inc.

    (610) 354-8840



    Primary Logo

    View Full Article Hide Full Article
  5. --

    Guggenheim Healthcare Talks - 2nd Annual Neuro/Immunology Day Conference
    November 16th

    Stifel Virtual Healthcare Conference
    November 18th

    --

    CHESTERBROOK, Pa., Nov. 09, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced that management will participate in the following conferences in the month of November and invites investors to participate by webcast. Please see additional details below:

    Guggenheim Healthcare Talks - 2nd Annual Neuro/Immunology Day   
     Date:Monday, November 16th, 2020
     Format:One-on-One meetings with Trevena Management &
      Analyst-moderated panels
     Attendees:

    --

    Guggenheim Healthcare Talks - 2nd Annual Neuro/Immunology Day Conference

    November 16th



    Stifel Virtual Healthcare Conference

    November 18th

    --

    CHESTERBROOK, Pa., Nov. 09, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced that management will participate in the following conferences in the month of November and invites investors to participate by webcast. Please see additional details below:

    Guggenheim Healthcare Talks - 2nd Annual Neuro/Immunology Day   
     Date:Monday, November 16th, 2020
     Format:One-on-One meetings with Trevena Management &
      Analyst-moderated panels
     Attendees:Carrie Bourdow, President & CEO
      Barry Shin, Senior Vice President & Chief Financial Officer
       
    Stifel Virtual Healthcare Conference 
     Date:Wednesday, November 18th, 2020
     Format:Corporate Presentation
     Time:4:40 - 5:10 pm Eastern Time
     Attendees:Carrie Bourdow, President & CEO
      Barry Shin, Senior Vice President & Chief Financial Officer
      Mark A. Demitrack, MD, Senior Vice President & Chief Medical Officer

    Any replay or webcast will be made available when possible, via the Events page of the Investors section on the Company's website at www.Trevena.com.

    About Trevena

    Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with CNS disorders. The Company has one approved product in the U.S., OLINVYK™ (oliceridine) injection, indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. The Company also has four novel and differentiated investigational drug candidates: TRV250 for the acute treatment of migraine, TRV734 for maintenance treatment of opioid use disorder, and TRV027 for acute lung injury / abnormal blood clotting in COVID-19 patients. The Company has also identified TRV045, a novel S1P receptor modulator that may offer a new, non-opioid approach to treating a variety of CNS disorders.

    For more information, please visit www.Trevena.com.

    Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development and trials of its therapeutic candidates, plans for potential future product candidates, commercialization of approved drug products and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "might," "plan," "objective," "predict," "project," "suggest," "target," "potential," "will," "would," "could," "should," "continue," "ongoing," or the negative of these terms or similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the commercialization of any approved drug product, the status, timing, costs, results and interpretation of the Company's clinical trials or any future trials of any of the Company's investigational drug candidates; the uncertainties inherent in conducting clinical trials; expectations for regulatory interactions, submissions and approvals, including the Company's assessment of the discussions with the FDA or other regulatory agencies about any and all of its programs; uncertainties related to the commercialization of OLINVYK; available funding; uncertainties related to the Company's intellectual property; uncertainties related to the ongoing COVID-19 pandemic, other matters that could affect the availability or commercial potential of the Company's therapeutic candidates; and other factors discussed in the Risk Factors set forth in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.

    For more information, please contact:

    Investor Contact:

    Dan Ferry

    Managing Director

    LifeSci Advisors, LLC

     

    (617) 430-7576

    Company Contact:

    Bob Yoder

    SVP and Chief Business Officer

    Trevena, Inc.

    (610) 354-8840

    Primary Logo

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  6. --

    OLINVYK commercial supply on track and available in November

    Company funded through Q4 2022, including OLINVYK commercialization

    --

    Company to host conference call at 8:30 a.m. ET on Monday, November 2nd, 2020

    --

    CHESTERBROOK, Pa., Oct. 30, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced that oliceridine has been classified as a Schedule II controlled substance by the U.S. Drug Enforcement Administration (DEA). With DEA scheduling now complete, the Company expects to make OLINVYK available for distribution in November.

    "I am pleased that OLINVYK is now an…

    --

    OLINVYK commercial supply on track and available in November

    Company funded through Q4 2022, including OLINVYK commercialization

    --

    Company to host conference call at 8:30 a.m. ET on Monday, November 2nd, 2020

    --

    CHESTERBROOK, Pa., Oct. 30, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced that oliceridine has been classified as a Schedule II controlled substance by the U.S. Drug Enforcement Administration (DEA). With DEA scheduling now complete, the Company expects to make OLINVYK available for distribution in November.

    "I am pleased that OLINVYK is now an FDA approved and scheduled product – two major milestones achieved in 2020," said Carrie Bourdow, President and Chief Executive Officer of Trevena, Inc. "We made the decision earlier this year to begin manufacturing commercial product, so that physicians could have access to OLINVYK for their hospitalized acute pain patients as soon as possible upon approval and DEA scheduling. We look forward to making OLINVYK available for ordering in November."

    Each year, approximately 45 million hospital patients in the United States receive drugs like IV morphine to treat their acute pain. OLINVYK is an IV opioid that is the first new chemical entity in this drug class in decades and is distinct from drugs like IV morphine. OLINVYK has no active metabolites and requires no dosage adjustment in renal-impaired patients, a large patient population with significant medical complications. In addition, OLINVYK delivers IV opioid efficacy with a rapid 2-5 minute onset of action.

    OLINVYK was studied in over 1,500 patients, including medically complex patients such as the elderly and obese, and across a variety of surgical procedures.

    As a new chemical entity, OLINVYK was required to be scheduled by the DEA following its approval by FDA in August 2020. A Schedule II assignment applies to drugs that should only be administered by a healthcare professional in controlled clinical settings. All current IV opioids used in the hospital setting are classified as Schedule II substances.

    The Company also today announced cash and cash equivalents of $112.7 million as of September 30, 2020, which the Company expects will be sufficient to fund operating expenses, including the commercialization of OLINVYK, through year-end 2022.

    Conference Call and Webcast Information

    The Company will host a conference call and webcast with the investment community on Monday, November 2nd, 2020, at 8:30 a.m. Eastern Time featuring remarks by Carrie Bourdow, President and Chief Executive Officer, Robert Yoder, Chief Commercial Officer, Mark Demitrack, M.D., Chief Medical Officer, and Barry Shin, Chief Financial Officer.

    Title:Conference Call to Provide Update on Commercial Launch Activities for OLINVYK
    Date:Monday, November 2nd, 2020
    Time:8:30 a.m. ET
    Conference

    Call Details:
    Toll-Free: 1-877-451-6152

    International: 1-201-389-0879

    Conference ID: 13712808
    Webcast:https://www.trevena.com/investors/events-presentations/ir-calendar

    About OLINVYK™ (oliceridine) injection

    OLINVYK is a new chemical entity approved by the FDA in August 2020. OLINVYK contains oliceridine, a Schedule II controlled substance with a high potential for abuse similar to other opioids including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone, and tapentadol. It is indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. Please see Important Safety Information, including the BOXED WARNING, and full prescribing information at www.OLINVYK.com.

    About Trevena

    Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with CNS disorders. The Company has one approved product in the United States, OLINVYK™ (oliceridine) injection, indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. The Company also has four novel and differentiated investigational drug candidates: TRV250 for the acute treatment of migraine, TRV734 for maintenance treatment of opioid use disorder, and TRV027 for acute lung injury / abnormal blood clotting in COVID-19 patients. The Company has also identified TRV045, a novel S1P receptor modulator that may offer a new, non-opioid approach to treating a variety of CNS disorders.

    For more information, please visit www.Trevena.com 

    Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development and trials of its therapeutic candidates, plans for potential future product candidates, commercialization of approved drug products and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "might," "plan," "objective," "predict," "project," "suggest," "target," "potential," "will," "would," "could," "should," "continue," "ongoing," or the negative of these terms or similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the commercialization of any approved drug product, the status, timing, costs, results and interpretation of the Company's clinical trials or any future trials of any of the Company's investigational drug candidates; the uncertainties inherent in conducting clinical trials; expectations for regulatory interactions, submissions and approvals, including the Company's assessment of the discussions with the FDA or other regulatory agencies about any and all of its programs; uncertainties related to the commercialization of OLINVYK; available funding; uncertainties related to the Company's intellectual property; uncertainties related to the ongoing COVID-19 pandemic, other matters that could affect the availability or commercial potential of the Company's therapeutic candidates; and other factors discussed in the Risk Factors set forth in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.

    For more information, please contact:

    Investor Contact:

    Dan Ferry

    Managing Director

    LifeSci Advisors, LLC



    (617) 430-7576

    Company Contact:

    Bob Yoder

    SVP and Chief Commercial Officer

    Trevena, Inc.

    (610) 354-8840

     

    Primary Logo

    View Full Article Hide Full Article
  7. --

    Posters highlight improvements in respiratory safety and gastrointestinal tolerability associated with OLINVYK (oliceridine) injection vs. IV morphine

    --

    CHESTERBROOK, Pa., Oct. 05, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced three presentations at ANESTHESIOLOGY® 2020, the national conference for the American Society of Anesthesiologists (ASA). The conference was held virtually from October 2nd to 7th, 2020. The presentations included three posters, all of which discussed new analyses of data from the OLINVYK Phase 3 program.

    "Throughout its clinical development…

    --

    Posters highlight improvements in respiratory safety and gastrointestinal tolerability associated with OLINVYK (oliceridine) injection vs. IV morphine

    --

    CHESTERBROOK, Pa., Oct. 05, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced three presentations at ANESTHESIOLOGY® 2020, the national conference for the American Society of Anesthesiologists (ASA). The conference was held virtually from October 2nd to 7th, 2020. The presentations included three posters, all of which discussed new analyses of data from the OLINVYK Phase 3 program.

    "Throughout its clinical development, OLINVYK has demonstrated a consistently favorable side effect profile," said Mark Demitrack, M.D., Senior Vice President and Chief Medical Officer of Trevena, Inc. "I am pleased that we are still gaining valuable clinical insights into its differentiated profile as we continue to examine the robust Phase 3 data, which is clearly of great interest to clinicians looking for alternative treatment options for the treatment of acute pain."

    Poster Details

    1. (Poster #A4280) "Evaluating Predictive Value Of Postoperative O2 Saturation Levels To Rate Of Respiratory Safety Events In Oliceridine Trials," with lead author Sabry Ayad, M.D., Department of Anesthesiology at Cleveland Clinic.

    • OLINVYK demonstrated an overall lower incidence of respiratory safety events (RSEs) (12.8% - 13.8%) compared with IV morphine (22.8% - 23.4%) in Phase 3 randomized controlled trials (RCTS) in orthopedic and plastic surgeries.
    • In these OLINVYK Phase 3 RCTs, respiratory safety was assessed using a predefined RSE measure. An analysis was conducted to determine the correlation between RSEs and oxygen saturation (SpO2) < 90%, a known independent risk factor of early postoperative respiratory complications and resource utilization.
    • The analysis showed that SpO2 < 90% was predictive of an RSE and may serve as a valuable objective measure within a health economic model for OLINVYK.

    2. (Poster #A4281) "Improved Tolerability With Oliceridine Compared To Morphine At Equianalgesic Doses," with lead author Gregory Hammer, M.D., Professor of Anesthesiology, Perioperative and Pain Medicine, and of Pediatrics at Stanford University. 

    A secondary analysis was conducted on the data from the OLINVYK Phase 3 pivotal RCTs in order to evaluate the safety of OLINVYK, compared to IV morphine, when adjusted for equal levels of analgesia. A composite safety endpoint was defined using the adverse events (AEs) that occurred in ≥ 10% of patients who received either OLINVYK or IV morphine (nausea, vomiting, sedation, dizziness, pruritus, and hypoxia). The incidence of the individual AEs was also assessed.

    • Following orthopedic surgery, OLINVYK demonstrated a significantly lower odds ratio (p < 0.05) for rates of nausea, vomiting, and pruritus, compared to IV morphine.
    • Following plastic surgery, OLINVYK demonstrated a significantly lower odds ratio (p < 0.05) for rates of nausea, vomiting, and sedation compared to IV morphine.
    • At equianalgesic levels, OLINVYK's odds ratio for the composite safety endpoint was approximately half of that associated with IV morphine. The findings were consistent across both studies.

    3. (Poster #A4284) "Reduced Incidence Of Postoperative Vomiting With Oliceridine Than Morphine At Equianalgesic Doses," with lead author Tim Beard, M.D., Chair of the Department of Surgery at Summit Medical Group. 



    A retrospective analysis was conducted on the gastrointestinal (GI) tolerability data from the OLINVYK Phase 3 RCTs, using a ‘complete GI response' endpoint. A ‘complete GI response' is defined as the proportion of patients who complete the study without vomiting and without using any anti-emetics.

    • In both studies, OLINVYK 0.1 mg and 0.35 mg were associated with a significantly higher rate of ‘complete GI response' compared with IV morphine.
    • Under equianalgesic conditions, where analgesia as measured by Sum of Pain Intensity Difference (SPID) scores was held constant, the odds ratio for ‘complete GI response' was higher with OLINVYK than IV morphine.

    All posters can be found at https://www.trevena.com/publications.

    About OLINVYK™ (oliceridine) injection

    OLINVYK is a new chemical entity approved by the FDA in August 2020. It is indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. OLINVYK will not be available for distribution until the United States Drug Enforcement Administration assigns it to its schedule of controlled substances. Please see Important Safety Information, including the BOXED WARNING, and full prescribing information at www.OLINVYK.com.

    About Trevena

    Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with CNS disorders. The Company has one approved product in the United States, OLINVYK™ (oliceridine) injection, indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. The Company also has four novel and differentiated investigational drug candidates: TRV250 for the acute treatment of migraine, TRV734 for maintenance treatment of opioid use disorder, and TRV027 for acute lung injury / abnormal blood clotting in COVID-19 patients. The Company has also identified TRV045, a novel S1P receptor modulator that may offer a new, non-opioid approach to treating a variety of CNS disorders.

    For more information, please visit www.Trevena.com 

    Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development and trials of its therapeutic candidates, plans for potential future product candidates, commercialization of approved drug products and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "might," "plan," "objective," "predict," "project," "suggest," "target," "potential," "will," "would," "could," "should," "continue," "ongoing," or the negative of these terms or similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the commercialization of any approved drug product, the status, timing, costs, results and interpretation of the Company's clinical trials or any future trials of any of the Company's investigational drug candidates; the uncertainties inherent in conducting clinical trials; expectations for regulatory interactions, submissions and approvals, including the Company's assessment of the discussions with the FDA or other regulatory agencies about any and all of its programs; uncertainties related to the commercialization of OLINVYK; available funding; uncertainties related to the Company's intellectual property; uncertainties related to the ongoing COVID-19 pandemic, other matters that could affect the availability or commercial potential of the Company's therapeutic candidates; and other factors discussed in the Risk Factors set forth in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.

    For more information, please contact:

    Investor Contact:

    Dan Ferry

    Managing Director

    LifeSci Advisors, LLC



    (617) 430-7576

    Company Contact:

    Bob Yoder

    SVP and Chief Business Officer

    Trevena, Inc.

    (610) 354-8840

     

    Primary Logo

    View Full Article Hide Full Article
  8. --

    Live presentation highlighting TRV027 as a potential treatment for COVID-19 acute respiratory distress syndrome (ARDS) / abnormal clotting

    Posters on OLINVYK benefit-risk profile and TRV250 Phase 1 pharmacokinetics

    --

    CHESTERBROOK, Pa., Sept. 21, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced three presentations at the virtual 2020 American College of Clinical Pharmacology (ACCP) Annual Meeting, taking place from September 21st to 23rd, 2020.

    The Company will give a live presentation on TRV027, its AT1 receptor selective agonist being studied as a potential…

    --

    Live presentation highlighting TRV027 as a potential treatment for COVID-19 acute respiratory distress syndrome (ARDS) / abnormal clotting

    Posters on OLINVYK benefit-risk profile and TRV250 Phase 1 pharmacokinetics

    --

    CHESTERBROOK, Pa., Sept. 21, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced three presentations at the virtual 2020 American College of Clinical Pharmacology (ACCP) Annual Meeting, taking place from September 21st to 23rd, 2020.

    The Company will give a live presentation on TRV027, its AT1 receptor selective agonist being studied as a potential treatment for ARDS / abnormal clotting in COVID-19. Additionally, the Company will present two posters highlighting previously published data for OLINVYK, which is approved in the U.S. for the management of acute pain, and TRV250, its delta receptor selective agonist being developed for the acute treatment of migraine.

    "I am pleased at this opportunity to present compelling data from three of our programs. The interest from ACCP highlights the diversity of our novel pipeline, with multiple exciting catalysts over the next few months," said Mark A. Demitrack, M.D., Senior Vice President and Chief Medical Officer of Trevena, Inc.

    Poster Presentation Details

    Live presentation: "The Use of Simulation in the Re-purposing of Drugs for COVID-19: The Example of TRV027" (8:00-9:30 a.m. ET, September 21st, 2020)

    • In a COVID-19 infection, the SARS-coronavirus-2 binds to and removes the ACE2 protein in the lungs and other organs, resulting in a hormonal imbalance of angiotensin 2 within the RAAS pathway, converging at the AT1 receptor.
    • There is significant interest in the potential utility of TRV027 in COVID-19 patients, given its unique mechanism of action at the AT1 receptor, which is known to mediate the effects of angiotensin 2 on lung damage and abnormal coagulation.
    • Simulations were conducted to determine potential therapeutic doses, which informed a proof-of-concept trial recently initiated by Imperial College London. The study will enroll 60 hospitalized, non-ventilated patients aged 18 or older with a confirmed COVID-19 infection. The primary objective of the study is to evaluate whether TRV027 reduces abnormal clotting associated with COVID-19.

    Poster presentation (#009): "Improved Safety of Opioid Analgesic Oliceridine Compared to Morphine Assessed by Utility Function Analysis" (4:00-6:00 p.m. ET, September 21st and 22nd, 2020)

    • OLINVYK was associated with a higher probability of analgesia than respiratory depression, while the reverse was true for morphine.
    • The clinical utility function model predicted there would be a lower probability of a respiratory event occurring with OLINVYK versus morphine.
    • Over the clinically relevant concentration range, OLINVYK had a higher probability of providing analgesia than producing respiratory depression, while morphine had a higher probability of producing respiratory depression than providing analgesia.

    Poster presentation (#022): "A Phase 1 Healthy Volunteer Study of the Safety, Tolerability and Pharmacokinetics of TRV250, a G Protein-Selective Delta Receptor Agonist" (4:00-6:00 p.m. ET, September 21st and 22nd, 2020)

    • TRV250 was well-tolerated up to 30 mg, with a PK profile appropriate for an acute migraine therapy.
    • There were no serious adverse events and no clinically significant changes in EEG, ECG, or other safety parameters.

    About OLINVYK™ (oliceridine) injection

    OLINVYK is a new chemical entity approved by the FDA in August 2020. It is indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. OLINVYK will not be available for distribution until the United States Drug Enforcement Administration assigns it to its schedule of controlled substances. Please see Important Safety Information, including the BOXED WARNING, and full prescribing information at www.OLINVYK.com.

    About TRV027

    TRV027 is a novel AT1 receptor selective agonist that has previously been studied in 691 individuals. It has demonstrated efficacy, potency, and selectivity at the AT1 receptor in nonclinical studies and has a well-characterized pharmacokinetic profile. In previous clinical trials, there was a low dropout rate associated with TRV027, and no significant safety issues were reported. In April 2020, the Company filed a provisional patent application with the United States Patent and Trademark Office covering the use of TRV027 to treat ARDS and the prevention or treatment of abnormal clotting in COVID-19 patients.

    About TRV250

    TRV250 is a G-protein selective agonist targeting the delta receptor, with potential to be a first-in-class, non-narcotic mechanism for the treatment of migraine. TRV250 also may have utility in a range of other central nervous system indications. As a selective delta receptor modulator, TRV250 is not expected to have the abuse and addiction liability of medications targeting the mu opioid receptor. TRV250 is an investigational product and has not been approved by FDA for distribution in the US.

    About Trevena

    Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with CNS disorders. The Company has one approved product in the United States, OLINVYK™ (oliceridine) injection, indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. The Company also has four novel and differentiated investigational drug candidates: TRV250 for the acute treatment of migraine, TRV734 for maintenance treatment of opioid use disorder, and TRV027 for acute lung injury / abnormal blood clotting in COVID-19 patients. The Company has also identified TRV045, a novel S1P receptor modulator that may offer a new, non-opioid approach to treating a variety of CNS disorders.

    For more information, please visit www.Trevena.com 

    Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development and trials of its therapeutic candidates, plans for potential future product candidates, commercialization of approved drug products and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "might," "plan," "objective," "predict," "project," "suggest," "target," "potential," "will," "would," "could," "should," "continue," "ongoing," or the negative of these terms or similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the commercialization of any approved drug product, the status, timing, costs, results and interpretation of the Company's clinical trials or any future trials of any of the Company's investigational drug candidates; the uncertainties inherent in conducting clinical trials; expectations for regulatory interactions, submissions and approvals, including the Company's assessment of the discussions with the FDA or other regulatory agencies about any and all of its programs; uncertainties related to the commercialization of OLINVYK; available funding; uncertainties related to the Company's intellectual property; uncertainties related to the ongoing COVID-19 pandemic, other matters that could affect the availability or commercial potential of the Company's therapeutic candidates; and other factors discussed in the Risk Factors set forth in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.

    For more information, please contact:

    Investor Contact:

    Dan Ferry

    Managing Director

    LifeSci Advisors, LLC



    (617) 430-7576

    Company Contact:

    Bob Yoder

    SVP and Chief Business Officer

    Trevena, Inc.

    (610) 354-8840

     

    Primary Logo

    View Full Article Hide Full Article
  9. - H.C. Wainwright: 22nd Annual Global Investment Conference -
    September 14th

    - Cantor Fitzgerald Virtual Global Healthcare Conference -
    September 17th

    -Oppenheimer Fall Healthcare Life Sciences & MedTech Summit -
    September 23rd

    CHESTERBROOK, Pa., Sept. 02, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced that management will participate in the following conferences in the month of September and invites investors to participate by webcast. Please see additional details below:

    H.C. Wainwright: 22nd Annual Global Investment Conference
    Title:Trevena (TRVN) Fireside

    - H.C. Wainwright: 22nd Annual Global Investment Conference -

    September 14th

    - Cantor Fitzgerald Virtual Global Healthcare Conference -

    September 17th

    -Oppenheimer Fall Healthcare Life Sciences & MedTech Summit -

    September 23rd

    CHESTERBROOK, Pa., Sept. 02, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced that management will participate in the following conferences in the month of September and invites investors to participate by webcast. Please see additional details below:

    H.C. Wainwright: 22nd Annual Global Investment Conference
    Title:Trevena (TRVN) Fireside Chat 
    Date:Monday, September 14th, 2020
    Time:2:00 – 2:20 p.m. Eastern Time
    Presenters:Carrie Bourdow, President & Chief Executive Officer
     Mark Demitrack, M.D., SVP & Chief Medical Officer
      
    Cantor Fitzgerald Virtual Global Healthcare Conference
    Title:Trevena (TRVN) Fireside Chat
    Date:Thursday, September 17th, 2020
    Time:2:00 – 2:30 p.m. Eastern Time
    Presenter:Carrie Bourdow, President & Chief Executive Officer
      
    Oppenheimer Fall Healthcare Life Sciences & MedTech Summit
    Title:Trevena (TRVN) Virtual Presentation
    Date:Wednesday, September 23rd, 2020
    Time:11:40 a.m. – 12:20 p.m. Eastern Time
    Presenter:Bob Yoder, SVP & Chief Business Officer

    Webcast Links:

    A replay of the webcast will be accessible on the Events page of the Investors section on the Company's website at https://www.trevena.com/investors/events-presentations/ir-calendar.

    About Trevena

    Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with CNS disorders. The Company has one approved product in the United States, OLINVYK™ (oliceridine) injection, indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. The Company also has four novel and differentiated investigational drug candidates: TRV250 for the acute treatment of migraine, TRV734 for maintenance treatment of opioid use disorder, and TRV027 for acute lung injury / abnormal blood clotting in COVID-19 patients. The Company has also identified TRV045, a novel S1P receptor modulator that may offer a new, non-opioid approach to treating a variety of CNS disorders.

    For more information, please visit www.Trevena.com 

    Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development and trials of its therapeutic candidates, plans for potential future product candidates, commercialization of approved drug products and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "might," "plan," "objective," "predict," "project," "suggest," "target," "potential," "will," "would," "could," "should," "continue," "ongoing," or the negative of these terms or similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the commercialization of any approved drug product, the status, timing, costs, results and interpretation of the Company's clinical trials or any future trials of any of the Company's investigational drug candidates; the uncertainties inherent in conducting clinical trials; expectations for regulatory interactions, submissions and approvals, including the Company's assessment of the discussions with the FDA or other regulatory agencies about any and all of its programs; uncertainties related to the commercialization of OLINVYK; available funding; uncertainties related to the Company's intellectual property; uncertainties related to the ongoing COVID-19 pandemic, other matters that could affect the availability or commercial potential of the Company's therapeutic candidates; and other factors discussed in the Risk Factors set forth in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.

    For more information, please contact:

    Investor Contact:

    Dan Ferry

    Managing Director

    LifeSci Advisors, LLC



    (617) 430-7576

    Company Contact:

    Bob Yoder

    SVP and Chief Business Officer

    Trevena, Inc.

    (610) 354-8840 

    Primary Logo

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  10. --

    Publication in Anesthesiology: Favorable benefit-risk profile for OLINVYK (oliceridine) injection as measured by clinical utility function analysis

    Publication in Clinical Drug Investigation: Lower incidence of respiratory depression associated with OLINVYK as measured by frequency / duration of dosing interruption

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    CHESTERBROOK, Pa., Aug. 26, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced two publications of the respiratory safety data from the OLINVYK development program. Both publications highlight data showing an improved respiratory safety profile for…

    --

    Publication in Anesthesiology: Favorable benefit-risk profile for OLINVYK (oliceridine) injection as measured by clinical utility function analysis

    Publication in Clinical Drug Investigation: Lower incidence of respiratory depression associated with OLINVYK as measured by frequency / duration of dosing interruption

    --

    CHESTERBROOK, Pa., Aug. 26, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced two publications of the respiratory safety data from the OLINVYK development program. Both publications highlight data showing an improved respiratory safety profile for OLINVYK compared to IV morphine.

    "These two publications add to the comprehensive safety database of peer-reviewed published literature for OLINVYK," said Mark Demitrack, M.D., Senior Vice President and Chief Medical Officer of Trevena, Inc. "We believe these data will provide important information to clinicians and other healthcare decision-makers in managing acute pain patients in the hospital setting."

    1.) Benefit and Risk Evaluation of Biased μ-Receptor Agonist Oliceridine versus Morphine, by lead author Albert Dahan, M.D., Ph.D., Professor of Anesthesiology, Leiden University Medical Center.

    (https://doi.org/10.1097/ALN.0000000000003441)

    Study Summary and Key Findings:

    • A clinical utility function analysis was conducted on the ventilatory response to hypercapnia (VRH) data from the OLINVYK Phase 1 study. VRH is a validated measure of respiratory function, and opioid medications are known to interfere with the body's normal respiratory drive in response to elevated CO2 levels (hypercapnia). Clinical utility function analysis integrates the relative probability of analgesia and respiratory depression over the therapeutic plasma concentration range of a medication.

        
    • OLINVYK was associated with a higher probability of analgesia than respiratory depression, while the reverse was true for morphine.



    • The clinical utility function model predicted there would be a lower probability of a respiratory event occurring with OLINVYK versus morphine.



    • Over the clinically relevant concentration range, OLINVYK had a higher probability of providing analgesia than producing respiratory depression, while morphine had a higher probability of producing respiratory depression than providing analgesia.

    2.) Evaluating the Incidence of Opioid-Induced Respiratory Depression Associated with Oliceridine and Morphine as Measured by the Frequency and Average Cumulative Duration of Dosing Interruption in Patients Treated for Acute Postoperative Pain, by lead author Sabry Ayad, M.D., Department of Anesthesiology at Cleveland Clinic.

    (https://link.springer.com/article/10.1007%2Fs40261-020-00936-0)

    Study Summary and Key Findings:

    • In a secondary analysis of two Phase 3 randomized controlled trials using PCA dosing in orthopedic and plastic surgeries, the rate of dosing interruptions due to a respiratory safety event and average cumulative duration of interruptions was reported for both OLINVYK and IV morphine.



    • In both studies, the proportion of patients with dosing interruptions was higher with morphine 1 mg (17.1% in orthopedic surgery and 25.6% in plastic surgery) compared to OLINVYK 0.35 mg (7.6% in orthopedic surgery, 20.3% in plastic surgery) and 0.5 mg (11.4% in orthopedic surgery, 18.8% in plastic surgery).



    • A higher proportion of patients with dosing interruptions was also observed with morphine compared to OLINVYK when the two studies were pooled (morphine 1 mg: 21.5%, OLINVYK 0.35 mg: 13.9%, OLINVYK 0.5 mg: 15.1%).



    • The average cumulative duration of interruptions was also lower for all OLINVYK demand doses in both Phase 3 studies compared to morphine.



    • Using dosing interruptions as a potential surrogate for opioid-induced respiratory depression suggests improved respiratory safety with OLINVYK versus morphine.

    About OLINVYK™ (oliceridine) injection

    OLINVYK is a new chemical entity approved by the FDA in August 2020. It is indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. OLINVYK will not be available for distribution until the United States Drug Enforcement Administration assigns it to its schedule of controlled substances. Please see Important Safety Information, including the BOXED WARNING, and full prescribing information at www.OLINVYK.com.

    About Trevena

    Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with CNS disorders. The Company has one approved product in the U.S., OLINVYK™ (oliceridine) injection, indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. The Company also has four novel and differentiated investigational drug candidates: TRV250 for the acute treatment of migraine, TRV734 for maintenance treatment of opioid use disorder, and TRV027 for acute lung injury / abnormal blood clotting in COVID-19 patients. The Company has also identified TRV045, a novel S1P receptor modulator that may offer a new, non-opioid approach to treating a variety of CNS disorders.

    Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development and trials of its therapeutic candidates, plans for potential future product candidates, commercialization of approved drug products and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "might," "plan," "objective," "predict," "project," "suggest," "target," "potential," "will," "would," "could," "should," "continue," "ongoing," or the negative of these terms or similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the commercialization of any approved drug product, the status, timing, costs, results and interpretation of the Company's clinical trials or any future trials of any of the Company's investigational drug candidates; the uncertainties inherent in conducting clinical trials; expectations for regulatory interactions, submissions and approvals, including the Company's assessment of the discussions with the FDA or other regulatory agencies about any and all of its programs; uncertainties related to the commercialization of OLINVYK; available funding; uncertainties related to the Company's intellectual property; uncertainties related to the ongoing COVID-19 pandemic, other matters that could affect the availability or commercial potential of the Company's therapeutic candidates; and other factors discussed in the Risk Factors set forth in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.

    For more information, please contact:

    Investor Contact:

    Dan Ferry

    Managing Director

    LifeSci Advisors, LLC



    (617) 430-7576

    Company Contact:

    Bob Yoder

    SVP and Chief Business Officer

    Trevena, Inc.

    (610) 354-8840

     

    Primary Logo

    View Full Article Hide Full Article
  11. --

    TRV027 is a novel AT1 receptor selective agonist with the potential to treat acute lung damage / abnormal blood clotting associated with COVID-19

    The Company expects to report topline data in Q1 2021

    --

    CHESTERBROOK, Pa., Aug. 24, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced Imperial College London (ICL) has initiated a proof-of-concept study for TRV027 in COVID-19 patients. Through an ongoing collaboration with ICL, the Company is evaluating the potential of TRV027 to treat acute lung damage / abnormal blood clotting associated with COVID-19. ICL is sponsoring…

    --

    TRV027 is a novel AT1 receptor selective agonist with the potential to treat acute lung damage / abnormal blood clotting associated with COVID-19

    The Company expects to report topline data in Q1 2021

    --

    CHESTERBROOK, Pa., Aug. 24, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced Imperial College London (ICL) has initiated a proof-of-concept study for TRV027 in COVID-19 patients. Through an ongoing collaboration with ICL, the Company is evaluating the potential of TRV027 to treat acute lung damage / abnormal blood clotting associated with COVID-19. ICL is sponsoring and funding the study, with additional support through the British Heart Foundation Centre for Research Excellence Award.

    "I am very pleased that Imperial College London has reached this important milestone of trial initiation," said Carrie Bourdow, President and Chief Executive Officer of Trevena, Inc. "As the global search for solutions to combat the COVID-19 pandemic continues, there remains an urgent need for new therapies that can prevent the severe multi-organ damage caused by the virus. TRV027 represents a uniquely targeted approach to potentially treating some of the serious and deadly complications associated with COVID-19."

    In a COVID-19 infection, the SARS-coronavirus-2 binds to and removes the ACE2 protein in the lungs and other organs, resulting in a hormonal imbalance at the AT1 receptor. This results in acute lung damage, which often progresses to acute respiratory distress syndrome (ARDS), as well as abnormal blood clotting throughout the body. TRV027 specifically binds to and rebalances AT1 receptor activation, blocking the damaging pathway that leads to ARDS and abnormal blood clotting conditions such as stroke. Additionally, the unique mechanism of action of TRV027 selectively targets the reparative pathway that improves lung function and promotes anti-inflammatory effects.

    This is a randomized, double-blind, placebo-controlled study that will enroll approximately 60 hospitalized, non-ventilated patients aged 18 or older with a confirmed COVID-19 infection. The primary objective of the study is to evaluate whether TRV027 reduces abnormal clotting associated with COVID-19. The study will also assess the effect of TRV027 on lung function and other clinical outcomes. The Company currently expects to report topline data in Q1 2021.

    About TRV027

    TRV027 is a novel AT1 receptor selective agonist that has previously been studied in 691 individuals. It has demonstrated efficacy, potency, and selectivity at the AT1 receptor in nonclinical studies and has a well-characterized pharmacokinetic profile. In previous clinical trials, there was a low dropout rate associated with TRV027, and no significant safety issues were reported. In April 2020, the Company filed a provisional patent application with the United States Patent and Trademark Office covering the use of TRV027 to treat ARDS and the prevention or treatment of abnormal clotting in COVID-19 patients.

    About Trevena

    Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with CNS disorders. The Company has one approved product in the U.S., OLINVYK™ (oliceridine) injection, indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. The Company also has four novel and differentiated investigational drug candidates: TRV250 for the acute treatment of migraine, TRV734 for maintenance treatment of opioid use disorder, and TRV027 for acute lung injury / abnormal blood clotting in COVID-19 patients. The Company has also identified TRV045, a novel S1P receptor modulator that may offer a new, non-opioid approach to treating a variety of CNS disorders.

    Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development and trials of its therapeutic candidates, plans for potential future product candidates, commercialization of approved drug products and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "might," "plan," "objective," "predict," "project," "suggest," "target," "potential," "will," "would," "could," "should," "continue," "ongoing," or the negative of these terms or similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the commercialization of any approved drug product, the status, timing, costs, results and interpretation of the Company's clinical trials or any future trials of any of the Company's investigational drug candidates; the uncertainties inherent in conducting clinical trials; expectations for regulatory interactions, submissions and approvals, including the Company's assessment of the discussions with the FDA or other regulatory agencies about any and all of its programs; uncertainties related to the commercialization of OLINVYK; available funding; uncertainties related to the Company's intellectual property; uncertainties related to the ongoing COVID-19 pandemic, other matters that could affect the availability or commercial potential of the Company's therapeutic candidates; and other factors discussed in the Risk Factors set forth in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.

    For more information, please contact:

    Investor Contact:

    Dan Ferry

    Managing Director

    LifeSci Advisors, LLC



    (617) 430-7576

    Company Contact:

    Bob Yoder

    SVP and Chief Business Officer

    Trevena, Inc.

    (610) 354-8840

    Primary Logo

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  12. --

    $3 million milestone payment for U.S. approval of OLINVYK™ (oliceridine) injection

    Additional approval and commercialization milestone payments expected as well as 10% royalties on net sales in China

    --

    CHESTERBROOK, Pa., Aug. 20, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced it has a received a $3 million milestone payment from its partner in China for the U.S. approval of OLINVYK. Nhwa holds an exclusive license agreement to develop, manufacture, and commercialize OLINVYK in China.

    "With U.S. approval of OLINVYK now in hand, I am pleased that our ex-U.S…

    --

    $3 million milestone payment for U.S. approval of OLINVYK™ (oliceridine) injection

    Additional approval and commercialization milestone payments expected as well as 10% royalties on net sales in China

    --

    CHESTERBROOK, Pa., Aug. 20, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced it has a received a $3 million milestone payment from its partner in China for the U.S. approval of OLINVYK. Nhwa holds an exclusive license agreement to develop, manufacture, and commercialize OLINVYK in China.

    "With U.S. approval of OLINVYK now in hand, I am pleased that our ex-U.S. partnerships also continue to make meaningful progress," said Carrie Bourdow, President and Chief Executive Officer of Trevena, Inc. "We look forward to supporting Nhwa as they continue to advance OLINVYK towards regulatory approval in China."

    In June 2020, the Company announced that Nhwa had been approved by the Chinese National Medical Products Administration (NMPA) to initiate clinical trials. The Company expects to receive future milestone payments, as well as a 10% royalty on net sales of OLINVYK in China.

    About OLINVYK™ (oliceridine) injection

    OLINVYK is a new chemical entity approved by the FDA in August 2020. It is indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. OLINVYK will not be available for distribution until the United States Drug Enforcement Administration assigns it to its schedule of controlled substances. For more information, please visit www.OLINVYK.com.

    About Trevena

    Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with CNS disorders. The Company has one approved product in the U.S., OLINVYK™ (oliceridine) injection, indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. The Company also has four novel and differentiated investigational drug candidates: TRV250 for the acute treatment of migraine, TRV734 for maintenance treatment of opioid use disorder, and TRV027 for acute lung injury / abnormal blood clotting in COVID-19 patients. The Company has also identified TRV045, a novel S1P receptor modulator that may offer a new, non-opioid approach to treating a variety of CNS disorders.

    Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development and trials of its therapeutic candidates, plans for potential future product candidates, commercialization of approved drug products and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "might," "plan," "objective," "predict," "project," "suggest," "target," "potential," "will," "would," "could," "should," "continue," "ongoing," or the negative of these terms or similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the commercialization of any approved drug product, the status, timing, costs, results and interpretation of the Company's clinical trials or any future trials of any of the Company's investigational drug candidates; the uncertainties inherent in conducting clinical trials; expectations for regulatory interactions, submissions and approvals, including the Company's assessment of the discussions with the FDA or other regulatory agencies about any and all of its programs; uncertainties related to the commercialization of OLINVYK; available funding; uncertainties related to the Company's intellectual property; uncertainties related to the ongoing COVID-19 pandemic, other matters that could affect the availability or commercial potential of the Company's therapeutic candidates; and other factors discussed in the Risk Factors set forth in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.

    For more information, please contact:

    Investor Contact:

    Dan Ferry

    Managing Director

    LifeSci Advisors, LLC



    (617) 430-7576

    Company Contact:

    Bob Yoder

    SVP and Chief Business Officer

    Trevena, Inc.

    (610) 354-8840 

    Primary Logo

    View Full Article Hide Full Article
  13. CHESTERBROOK, Pa., Aug. 14, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced that Carrie Bourdow, President and Chief Executive Officer, will participate in a fireside chat at the JMP Securities CNS Forum, being held virtually on August 19 - 20, 2020.

    Presentation Details

    Date: Thursday, August 20, 2020
    Time:  12:30 p.m. Eastern Time
    Webcast: https://www.trevena.com/investors/events-presentations/ir-calendar


    About Trevena

    Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with CNS disorders. The Company…

    CHESTERBROOK, Pa., Aug. 14, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced that Carrie Bourdow, President and Chief Executive Officer, will participate in a fireside chat at the JMP Securities CNS Forum, being held virtually on August 19 - 20, 2020.

    Presentation Details

    Date: Thursday, August 20, 2020
    Time:  12:30 p.m. Eastern Time
    Webcast: https://www.trevena.com/investors/events-presentations/ir-calendar



    About Trevena


    Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with CNS disorders. The Company has one approved product in the U.S., OLINVYK™ (oliceridine) injection, indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate.   The Company also has four novel and differentiated investigational drug candidates: TRV250 for the acute treatment of migraine, TRV734 for maintenance treatment of opioid use disorder, and TRV027 for acute lung injury / abnormal blood clotting in COVID-19 patients. The Company has also identified TRV045, a novel S1P receptor modulator that may offer a new, non-opioid approach to treating a variety of CNS disorders.

    For more information, please contact:

    Investor Contact:

    Daniel Ferry

    Managing Director

    LifeSci Advisors, LLC

     

    (617) 430-7576

    Company Contact:

    Bob Yoder

    SVP and Chief Business Officer

    Trevena, Inc.

    (610) 354-8840

    Primary Logo

    View Full Article Hide Full Article
  14. CHESTERBROOK, Pa., Aug. 12, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN) ("Trevena" or the "Company"), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system ("CNS") disorders, announced today the pricing of its previously announced underwritten public offering of 21,739,131 shares of its common stock at a public offering price of $2.30 per share. Trevena has also granted the underwriters a 30-day option to purchase up to 3,260,869 additional shares of common stock, at the public offering price, less underwriting discounts and commissions. The gross proceeds of the offering are expected to be approximately $50 million, before deducting the underwriting…

    CHESTERBROOK, Pa., Aug. 12, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN) ("Trevena" or the "Company"), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system ("CNS") disorders, announced today the pricing of its previously announced underwritten public offering of 21,739,131 shares of its common stock at a public offering price of $2.30 per share. Trevena has also granted the underwriters a 30-day option to purchase up to 3,260,869 additional shares of common stock, at the public offering price, less underwriting discounts and commissions. The gross proceeds of the offering are expected to be approximately $50 million, before deducting the underwriting discounts and commissions and other offering expenses. The closing of the offering is expected to occur on or about August 14, 2020, subject to the satisfaction of customary closing conditions.

    Guggenheim Securities, LLC is acting as lead book-running manager for the offering. Cantor Fitzgerald & Co. is also acting as book-running manager for the offering. JMP Securities LLC and Oppenheimer & Co. Inc. are acting as co-lead managers for the offering. H.C. Wainwright & Co., LLC is also acting as co-manager for the offering.

    Trevena intends to use the net proceeds from the offering primarily to fund the commercialization of OLINVYK, to support the clinical development of its pipelines assets and for working capital and general corporate purposes.

    The offering is being conducted by Trevena pursuant to a shelf registration statement on Form S-3 (File No. 333-225685) previously filed with and subsequently declared effective by the Securities and Exchange Commission (the "SEC") on June 15, 2018 and a preliminary prospectus supplement filed with the SEC on August 11, 2020. A final prospectus supplement and an accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC's website located at http://www.sec.gov. When available, copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained from Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017 or by telephone at (212) 518-9544, or by email at .

    Before investing in the offering, you should read the prospectus supplement and the accompanying prospectus, and the other documents that Trevena has filed with the SEC that are incorporated by reference in the prospectus supplement and the accompanying prospectus, in their entirety, which provide more information about Trevena and the offering.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction. The offering will be made only by means of a prospectus supplement and the accompanying prospectus that forms a part of the registration statement.

    About Trevena

    Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with CNS disorders. The Company has one approved product in the U.S., OLINVYK™ (oliceridine) injection, indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. The Company also has four novel and differentiated investigational drug candidates: TRV250 for the acute treatment of migraine, TRV734 for maintenance treatment of opioid use disorder, and TRV027 for acute lung injury / abnormal blood clotting in COVID-19 patients. The Company has also identified TRV045, a novel S1P receptor modulator that may offer a new, non-opioid approach to treating a variety of CNS disorders.

    Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements regarding the Company's expectations on the completion, timing and size of the proposed public offering and the anticipated use of proceeds therefrom, and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "might," "plan," "objective," "predict," "project," "suggest," "target," "potential," "will," "would," "could," "should," "continue," "ongoing," or the negative of these terms or similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the commercialization of any approved drug product, the status, timing, costs, results and interpretation of the Company's clinical trials or any future trials of any of the Company's investigational drug candidates; the uncertainties inherent in conducting clinical trials; expectations for regulatory interactions, submissions and approvals, including the Company's assessment of the discussions with the FDA or other regulatory agencies about any and all of its programs; uncertainties related to the commercialization of OLINVYK; available funding; uncertainties related to the Company's intellectual property; uncertainties related to the ongoing COVID-19 pandemic, other matters that could affect the availability or commercial potential of the Company's therapeutic candidates; and other factors discussed in the Risk Factors set forth in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.

    For more information, please contact:

    Investor Contact:

    Dan Ferry

    Managing Director

    LifeSci Advisors, LLC



    (617) 430-7576

    Company Contact:

    Bob Yoder

    SVP and Chief Business Officer

    Trevena, Inc.

    (610) 354-8840

    Primary Logo

    View Full Article Hide Full Article
  15. CHESTERBROOK, Pa., Aug. 11, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system ("CNS") disorders, announced today that it intends to offer and sell shares of its common stock in an underwritten public offering. In addition, Trevena intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of its common stock offered in the public offering. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. 

    Guggenheim Securities, LLC is acting as lead…

    CHESTERBROOK, Pa., Aug. 11, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system ("CNS") disorders, announced today that it intends to offer and sell shares of its common stock in an underwritten public offering. In addition, Trevena intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of its common stock offered in the public offering. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. 

    Guggenheim Securities, LLC is acting as lead book-running manager for the offering.  Cantor Fitzgerald & Co. is also acting as a book-running manager for the offering.

    The securities described above are being offered by Trevena pursuant to a registration statement previously filed with, and declared effective by, the Securities and Exchange Commission (the "SEC"). A preliminary prospectus supplement and accompanying prospectus relating to this offering will be filed with the SEC. When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may be obtained from Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017 or by telephone at (212) 518-9544, or by email at . Electronic copies of the preliminary prospectus supplement and accompanying prospectus will also be available on the website of the SEC at www.sec.gov. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

    About Trevena

    Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with CNS disorders. The Company has one approved product in the U.S., OLINVYK™ (oliceridine) injection, indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. The Company also has four novel and differentiated investigational drug candidates: TRV250 for the acute treatment of migraine, TRV734 for maintenance treatment of opioid use disorder, and TRV027 for acute lung injury / abnormal blood clotting in COVID-19 patients. The Company has also identified TRV045, a novel S1P receptor modulator that may offer a new, non-opioid approach to treating a variety of CNS disorders.

    Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements regarding the Company's expectations on the completion, timing and size of the proposed public offering and the anticipated use of proceeds therefrom, and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "might," "plan," "objective," "predict," "project," "suggest," "target," "potential," "will," "would," "could," "should," "continue," "ongoing," or the negative of these terms or similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the commercialization of any approved drug product, the status, timing, costs, results and interpretation of the Company's clinical trials or any future trials of any of the Company's investigational drug candidates; the uncertainties inherent in conducting clinical trials; expectations for regulatory interactions, submissions and approvals, including the Company's assessment of the discussions with the FDA or other regulatory agencies about any and all of its programs; uncertainties related to the commercialization of OLINVYK; available funding; uncertainties related to the Company's intellectual property; uncertainties related to the ongoing COVID-19 pandemic, other matters that could affect the availability or commercial potential of the Company's therapeutic candidates; and other factors discussed in the Risk Factors set forth in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.

    For more information, please contact:

    Investor Contact:

    Dan Ferry

    Managing Director

    LifeSci Advisors, LLC



    (617) 430-7576

    Company Contact:

    Bob Yoder

    SVP and Chief Business Officer

    Trevena, Inc.

    (610) 354-8840

    Primary Logo

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  16. OLINVYK is a new chemical entity approved in adults for the management of acute pain severe enough to require an IV opioid analgesic

    OLINVYK product availability expected in fourth quarter of 2020

    Company funded through year-end 2021, including OLINVYK commercialization

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    Company to host conference call at 8:30 a.m., today, August 10, 2020

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    CHESTERBROOK, Pa., Aug. 10, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has approved OLINVYK in adults for the management of acute pain severe enough to require an intravenous…

    OLINVYK is a new chemical entity approved in adults for the management of acute pain severe enough to require an IV opioid analgesic

    OLINVYK product availability expected in fourth quarter of 2020

    Company funded through year-end 2021, including OLINVYK commercialization

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    Company to host conference call at 8:30 a.m., today, August 10, 2020

    --

    CHESTERBROOK, Pa., Aug. 10, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has approved OLINVYK in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. OLINVYK will be commercially available when the U.S. Drug Enforcement Administration (DEA) issues its controlled substance schedule in approximately 90 days.

    "The approval of OLINVYK marks an exciting step forward in Trevena's mission of translating cutting-edge scientific discovery into therapeutic benefit for patients in need. I would like to thank all of the patients, investigators, and our employees who helped us achieve this important milestone," said Carrie L. Bourdow, President and Chief Executive Officer. "We will work quickly to bring this novel IV analgesic to patients and healthcare providers in need of alternative treatment options."

    Each year, approximately 45 million hospital patients in the United States receive an IV opioid to treat their acute pain. Many of these patients are complex and difficult to treat, such as the elderly, obese, or renally-impaired. Current hospital trends suggest that the number of these complex patients is growing, representing an increasing burden on the healthcare system.

    OLINVYK is an opioid agonist that is the first new chemical entity in this IV drug class in decades and offers a differentiated profile that addresses a significant unmet need in the acute pain management landscape. OLINVYK delivers IV opioid efficacy with a rapid 2-5 minute onset of action. In addition, OLINVYK requires no dosage adjustments in patients with renal impairment, a large patient population with significant medical complications.

    The FDA approval of OLINVYK was based on results from the Phase 3 development program, which evaluated OLINVYK in over 1,500 patients with moderate to severe acute pain. In two pivotal efficacy studies in hard- and soft-tissue surgical models, OLINVYK demonstrated rapid analgesic efficacy statistically significant vs. placebo. In a large, open-label, "real world" safety study, OLINVYK was safe and well-tolerated in a medically complex patient population, including the elderly, obese, and patients with comorbid conditions such as diabetes and sleep apnea.

    "Complex patients present unique challenges in the management of their postoperative acute pain, due to the presence of medical comorbidities that can complicate dosing," said Gregory Hammer, M.D., Professor of Anesthesiology, Perioperative and Pain Medicine, and of Pediatrics at Stanford University. "OLINVYK represents a new alternative for clinicians, due to its rapid onset of action, effective pain relief, and unique profile."

    The Company expects to make OLINVYK available in the fourth quarter of 2020 following scheduling by the DEA, which may take up to 90 days. The Company is committed to an ethical and responsible marketing campaign for OLINVYK and will have safeguards in place to monitor for and mitigate the risk of non-medical uses of OLINVYK.

    The Company also today announced $54.8 million in cash and cash equivalents as of June 30, 2020, which the Company expects will be sufficient to fund operating expenses, including the commercialization of OLINVYK, through year-end 2021.

    Conference Call and Webcast Information

    The Company will host a conference call and webcast with the investment community on August 10, 2020, at 8:30 a.m. Eastern Time featuring remarks by Carrie Bourdow, President and Chief Executive Officer, Mark Demitrack, M.D., Chief Medical Officer, Robert Yoder, Chief Business Officer, and Barry Shin, Chief Financial Officer.

    Title: Conference Call to Provide Update Following Recent FDA Approval of OLINVYK
    Date: Monday, August 10, 2020
    Time: 8:30 a.m. ET
    Conference Call Details: Toll-Free: 855-465-0180

    International: 484-756-4313

    Conference ID: 4976734
    Webcast: https://www.trevena.com/investors/events-presentations/ir-calendar

    OLINVYK Efficacy and Safety Data

    The efficacy of OLINVYK was established in two randomized, double-blind, placebo- and morphine-controlled studies which enrolled 790 patients with moderate to severe acute pain (pain intensity of ≥4 on a 0-10 numeric rating scale) after orthopedic surgery-bunionectomy or plastic surgery-abdominoplasty.

    In each study, patients were randomized to one of three OLINVYK treatment regimens, a placebo-control regimen, or a morphine-control regimen. The loading dose for all OLINVYK treatment regimens was 1.5 mg; demand doses were 0.1, 0.35, or 0.5 mg, according to the assigned treatment group; supplemental doses were 0.75 mg. A lockout interval of 6 minutes was used for all PCA regimens. Etodolac 200 mg was available as rescue medication. Patients using the approved OLINVYK doses of 0.35 and 0.5 mg had a statistically significantly greater SPID-48/24 than patients using placebo.

    The most common adverse reactions (≥10%) in these controlled trials were nausea, vomiting, dizziness, headache, constipation, pruritus, and hypoxia. When stratified by the 27 mg daily dosing limit, discontinuation of OLINVYK due to adverse reactions occurred in 4% of patients who received a daily dose ≤27 mg, and less than 1% of patients who received a daily dose >27 mg.

    In an open-label safety study of patients with moderate to severe acute pain following a surgical procedure or due to a medical condition, a total of 768 patients received at least one dose of OLINVYK. OLINVYK was administered via clinician-administered bolus dosing, PCA, or a combination of the two. Bolus dosing was initiated at 1 to 2 mg, with supplemental doses of 1 to 3 mg every 1 to 3 hours, as needed, based on individual patient need and previous response to OLINVYK. If OLINVYK was administered via PCA, the loading dose was 1.5 mg, the demand dose was 0.5 mg, and the lockout interval was 6 minutes. Supplemental doses of 1 mg were given as needed, taking into account the patient's utilization of PCA demand doses, individual patient need, and previous response to OLINVYK.

    The most frequent condition treated in the open-label safety study was postsurgical acute pain, and  included (in order of decreasing frequency): orthopedic, gynecologic, colorectal, general, plastic, urologic, neurologic (including spinal), bariatric, and cardiothoracic surgical procedures. Of the 768 patients treated with OLINVYK, 32% were age 65 years or older and 78% had a Body Mass Index ≥ 25 kg/m2. OLINVYK was administered as needed; 55% of patients received OLINVYK via clinician bolus administration only, and 45% of patients received OLINVYK via PCA self-administration or a combination of clinician bolus- and PCA self-administration. Discontinuation of OLINVYK in this study due to adverse drug reactions occurred in 3% of patients who received a daily dose ≤27 mg and 1% of patients who received a daily dose >27 mg.

    Full Prescribing Information, including the Boxed Warning, is available at www.OLINVYK.com.

    IMPORTANT SAFETY INFORMATION

    WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CENTRAL NERVOUS SYSTEM (CNS) DEPRESSANTS

    Addiction, Abuse, and Misuse

    OLINVYK exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk before prescribing OLINVYK, and monitor all patients regularly for the development of behaviors or conditions.

    Life-Threatening Respiratory Depression

    Serious, life-threatening, or fatal respiratory depression may occur with use of OLINVYK.  Monitor for respiratory depression, especially during initiation of OLINVYK or following a dose increase.

    Neonatal Opioid Withdrawal Syndrome

    Prolonged use of OLINVYK during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. 

    Risk From Concomitant Use With Benzodiazepines or Other CNS Depressants

    Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation.

    INDICATIONS AND USAGE

    OLINVYK is a new chemical entity indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate.

    Limitations of Use

    Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve OLINVYK for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:

    • Have not been tolerated, or are not expected to be tolerated
    • Have not provided adequate analgesia, or are not expected to provide adequate analgesia.

    The cumulative total daily dose should not exceed 27 mg, as total daily doses greater than 27 mg may increase the risk for QTc interval prolongation.

    CONTRAINDICATIONS

    OLINVYK is contraindicated in patients with:

    • Significant respiratory depression
    • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
    • Known or suspected gastrointestinal obstruction, including paralytic ileus
    • Known hypersensitivity to oliceridine (e.g., anaphylaxis)

    WARNINGS AND PRECAUTIONS

    • OLINVYK contains oliceridine, a Schedule [controlled substance schedule pending], that exposes users to the risks of addiction, abuse, and misuse. Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed OLINVYK. Assess risk, counsel, and monitor all patients receiving opioids.
    • Serious, life-threatening respiratory depression has been reported with the use of opioids, even when used as recommended, especially in patients with chronic pulmonary disease, or in elderly, cachectic and debilitated patients. The risk is greatest during initiation of OLINVYK therapy, following a dose increase, or when used with other drugs that depress respiration. Proper dosing of OLINVYK is essential, especially when converting patients from another opioid product to avoid overdose. Management of respiratory depression may include close observation, supportive measures, and use of opioid antagonists, depending on the patient's clinical status.
    • Opioids can cause sleep-related breathing disorders including central sleep apnea (CSA) and sleep-related hypoxemia with risk increasing in a dose-dependent fashion.  In patients who present with CSA, consider decreasing the dose of opioid using best practices for opioid taper.
    • Prolonged use of opioids during pregnancy can result in withdrawal in the neonate that can be life‑threatening. Observe newborns for signs of neonatal opioid withdrawal syndrome and manage accordingly. Advise pregnant women using OLINVYK for a prolonged period of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
    • Profound sedation, respiratory depression, coma, and death may result from the concomitant use of OLINVYK with benzodiazepines or other CNS depressants (e.g., non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, or alcohol). Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate, prescribe the lowest effective dose, and minimize the duration.
    • OLINVYK was shown to have mild QTc interval prolongation in thorough QT studies where patients were dosed up to 27 mg. Total cumulative daily doses exceeding 27 mg per day were not studied and may increase the risk for QTc interval prolongation. Therefore, the cumulative total daily dose of OLINVYK should not exceed 27 mg.
    • Increased plasma concentrations of OLINVYK may occur in patients with decreased Cytochrome P450 (CYP) 2D6 function or normal metabolizers taking moderate or strong CYP2D6 inhibitors; also in patients taking a moderate or strong CYP3A4 inhibitor, in patients with decreased CYP2D6 function who are also receiving a moderate or strong CYP3A4 inhibitor, or with discontinuation of a CYP3A4 inducer. These patients may require less frequent dosing and should be closely monitored for respiratory depression and sedation at frequent intervals. Concomitant use of OLINVYK with CYP3A4 inducers or discontinuation of a moderate or strong CYP3A4 inhibitor can lower the expected concentration, which may decrease efficacy, and may require supplemental doses.
    • Cases of adrenal insufficiency have been reported with opioid use (usually greater than one month). Presentation and symptoms may be nonspecific and include nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. If confirmed, treat with physiologic replacement doses of corticosteroids and wean patient from the opioid.
    • OLINVYK may cause severe hypotension, including orthostatic hypotension and syncope in ambulatory patients. There is increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs (e.g., phenothiazines or general anesthetics).   Monitor these patients for signs of hypotension.  In patients with circulatory shock, avoid the use of OLINVYK as it may cause vasodilation that can further reduce cardiac output and blood pressure. 
    • Avoid the use of OLINVYK in patients with impaired consciousness or coma.  OLINVYK should be used with caution in patients who may be susceptible to the intracranial effects of CO2 retention, such as those with evidence of increased intracranial pressure or brain tumors, as a reduction in respiratory drive and the resultant CO2 retention can further increase intracranial pressure. Monitor such patients for signs of sedation and respiratory depression, particularly when initiating therapy.
    • As with all opioids, OLINVYK may cause spasm of the sphincter of Oddi, and may cause increases in serum amylase. Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms.
    • OLINVYK may increase the frequency of seizures in patients with seizure disorders and may increase the risk of seizures in vulnerable patients.  Monitor patients with a history of seizure disorders for worsened seizure control.
    • Do not abruptly discontinue OLINVYK in a patient physically dependent on opioids.  Gradually taper the dosage to avoid a withdrawal syndrome and return of pain. Avoid the use of mixed agonist/antagonist (e.g., pentazocine, nalbuphine, and butorphanol) or partial agonist (e.g., buprenorphine) analgesics in patients who are receiving OLINVYK, as they may reduce the analgesic effect and/or precipitate withdrawal symptoms.
    • OLINVYK may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery.
    • Although self-administration of opioids by patient-controlled analgesia (PCA) may allow each patient to individually titrate to an acceptable level of analgesia, PCA administration has resulted in adverse outcomes and episodes of respiratory depression. Health care providers and family members monitoring patients receiving PCA analgesia should be instructed in the need for appropriate monitoring for excessive sedation, respiratory depression, or other adverse effects of opioid medications.

    ADVERSE REACTIONS

    Adverse reactions are described in greater detail in the Prescribing Information.

    The most common (incidence ≥10%) adverse reactions in Phase 3 controlled clinical trials were nausea, vomiting, dizziness, headache, constipation, pruritus, and hypoxia.

    About OLINVYK™ (oliceridine) injection

    OLINVYK is a new chemical entity approved by the FDA in August 2020. It is indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. OLINVYK will not be available for distribution until the United States Drug Enforcement Administration assigns it to its schedule of controlled substances. For more information, please visit www.OLINVYK.com.

    About Trevena

    Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with CNS disorders. The Company has one approved product in the U.S., OLINVYK™ (oliceridine) injection, indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. The Company also has four novel and differentiated investigational drug candidates: TRV250 for the acute treatment of migraine, TRV734 for maintenance treatment of opioid use disorder, and TRV027 for acute lung injury / abnormal blood clotting in COVID-19 patients. The Company has also identified TRV045, a novel S1P receptor modulator that may offer a new, non-opioid approach to treating a variety of CNS disorders.

    Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development and trials of its therapeutic candidates, plans for potential future product candidates, commercialization of approved drug products and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "might," "plan," "objective," "predict," "project," "suggest," "target," "potential," "will," "would," "could," "should," "continue," "ongoing," or the negative of these terms or similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the commercialization of any approved drug product, the status, timing, costs, results and interpretation of the Company's clinical trials or any future trials of any of the Company's investigational drug candidates; the uncertainties inherent in conducting clinical trials; expectations for regulatory interactions, submissions and approvals, including the Company's assessment of the discussions with the FDA or other regulatory agencies about any and all of its programs; uncertainties related to the commercialization of OLINVYK; available funding; uncertainties related to the Company's intellectual property; uncertainties related to the ongoing COVID-19 pandemic, other matters that could affect the availability or commercial potential of the Company's therapeutic candidates; and other factors discussed in the Risk Factors set forth in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.

    For more information, please contact:

    Investor Contact:

    Dan Ferry

    Managing Director

    LifeSci Advisors, LLC



    (617) 430-7576

    Company Contact:

    Bob Yoder

    SVP and Chief Business Officer

    Trevena, Inc.

    (610) 354-8840

     

    Primary Logo

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  17. CHESTERBROOK, Pa., June 03, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced the Company's partner in China has been approved by the Chinese National Medical Products Administration (NMPA) to initiate clinical trials for IV oliceridine, Trevena's lead investigational asset for the management of moderate-to-severe acute pain. Jiangsu Nhwa holds an exclusive license agreement for the development and commercialization of oliceridine in China.

    "I am pleased to have reached this important regulatory milestone for IV oliceridine ," said Carrie Bourdow, President and Chief Executive…

    CHESTERBROOK, Pa., June 03, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced the Company's partner in China has been approved by the Chinese National Medical Products Administration (NMPA) to initiate clinical trials for IV oliceridine, Trevena's lead investigational asset for the management of moderate-to-severe acute pain. Jiangsu Nhwa holds an exclusive license agreement for the development and commercialization of oliceridine in China.

    "I am pleased to have reached this important regulatory milestone for IV oliceridine ," said Carrie Bourdow, President and Chief Executive Officer of Trevena, Inc. "As we work towards our August 7th PDUFA date for potential approval in the U.S., we also continue to support our ex-U.S. partnerships, as part of our mission to deliver novel treatment options to patients with moderate-to-severe acute pain."

    The Company expects to receive future milestone payments, as well as a 10% royalty on net sales of oliceridine in China.

    About Oliceridine
    Oliceridine is a G protein-selective mu-opioid receptor agonist in development for the management of moderate-to-severe acute pain in hospitals or other controlled clinical settings where intravenous therapy is warranted. It is a new chemical entity with a novel mechanism of action that enables more selective targeting of newly discovered pathways with the potential for fewer side effects. Oliceridine is an investigational product and has not been approved by FDA or any other regulatory agency. If approved, the Company expects that oliceridine will be classified as a Schedule II controlled substance.

    About Trevena
    Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with CNS disorders. The Company has five novel and differentiated investigational drug candidates, including IV oliceridine, for the management of moderate to severe acute pain in hospitals, TRV250 for the acute treatment of migraine, TRV734 for maintenance treatment of opioid use disorder, and TRV027 for acute lung injury in COVID-19 patients. The Company has also identified TRV045, a novel S1P receptor modulator that may offer a new, non-opioid approach to treating a variety of CNS disorders.

    Forward-Looking Statements
    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development and trials of its therapeutic candidates, plans for potential future product candidates and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "suggest," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the status, timing, costs, results and interpretation of the Company's clinical trials or any future trials of any of the Company's investigational drug candidates; the uncertainties inherent in conducting clinical trials; expectations for regulatory interactions, submissions and approvals, including the Company's assessment of the discussions with FDA, the timing of FDA's decision on the oliceridine NDA; available funding ; uncertainties related to the Company's intellectual property; uncertainties related to the ongoing COVID-19 pandemic, other matters that could affect the availability or commercial potential of the Company's therapeutic candidates; and other factors discussed in the Risk Factors set forth in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.

    For more information, please contact:

    Investor Contact:
    Dan Ferry
    Managing Director
    LifeSci Advisors, LLC

    (617) 430-7576

    Company Contact:
    Bob Yoder
    SVP and Chief Business Officer
    Trevena, Inc.
    (610) 354-8840

    Primary Logo

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  18. --

    TRV027 is a novel AT1 receptor selective agonist with the potential to treat acute lung injury and ARDS

    Robust clinical development history with well-characterized PK and demonstrated safety in ~700 individuals

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    CHESTERBROOK, Pa., June 02, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced it has entered into a collaboration with Imperial College London to evaluate the potential of TRV027, a novel AT1 receptor selective agonist, to treat acute lung injury contributing to acute respiratory distress syndrome (ARDS) in COVID-19 patients. ARDS is a major complication leading…

    --

    TRV027 is a novel AT1 receptor selective agonist with the potential to treat acute lung injury and ARDS

    Robust clinical development history with well-characterized PK and demonstrated safety in ~700 individuals

    --

    CHESTERBROOK, Pa., June 02, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced it has entered into a collaboration with Imperial College London to evaluate the potential of TRV027, a novel AT1 receptor selective agonist, to treat acute lung injury contributing to acute respiratory distress syndrome (ARDS) in COVID-19 patients. ARDS is a major complication leading to mortality associated with COVID-19. Imperial College London will be sponsoring and funding this study, with additional support through the British Heart Foundation Centre for Research Excellence Award.

    "It is a great privilege to be working with Imperial College London, a global thought leader in this pandemic, as we join the urgent fight to deliver treatments to healthcare providers and COVID-19 patients in dire need," said Carrie Bourdow, President and Chief Executive Officer of Trevena, Inc. "TRV027 may offer a new and innovative approach to treating acute lung injury, which poses a grave threat to patients' lives."

    "We are very pleased to be partnering with Trevena in our endeavor to combat the global threat posed by this pandemic," said David Owen, M.D., Ph.D., Faculty of Medicine, Imperial College London and Head of Clinical Studies, Imperial Clinical Research Facility. "I am excited for this opportunity to study the potential utility of TRV027 in treating COVID-19 patients."

    In a COVID-19 infection, the SARS-coronavirus-2 binds to and removes the ACE2 protein in the lungs, causing elevated levels of angiotensin II. This drives overactivation of the AT1 receptor, which results in downstream acute lung injury. This often develops into ARDS, which can ultimately lead to mortality. TRV027 potentially counteracts the disproportionate levels of angiotensin II, by competitively binding to and rebalancing AT1 receptor activation. Additionally, its unique mechanism of action preferentially engages the signaling pathway to promote reparative effects on lung tissue.

    TRV027 is an investigational new drug that has previously been studied in 691 individuals. It has demonstrated efficacy, potency, and selectivity at the AT1 receptor in nonclinical studies and has a well-characterized pharmacokinetic profile. In previous clinical trials, there was a low dropout rate associated with TRV027, and no significant safety issues were reported. In April 2020, the Company filed a provisional patent application with the United States Patent and Trademark Office covering the use of TRV027 to treat ARDS in COVID-19 patients.

    About the Imperial College London COVID-19 Study
    This will be a randomized, double-blind, placebo-controlled Phase 1b proof-of-concept study in approximately 60 hospitalized, non-ventilated patients aged 65 or older with a confirmed or suspected COVID-19 infection. The study will determine whether TRV027, a novel AT1 receptor selective agonist, modulates pathways that contribute to COVID-19 pathology. The primary endpoint is a coagulation cascade biomarker, which serves as a surrogate for measuring the effect of TRV027 on adverse health outcomes associated with increased mortality in COVID-19 infections. Imperial College London will be sponsoring and funding this study, with additional support through the British Heart Foundation Centre for Research Excellence Award.

    About TRV027
    TRV027 is a novel AT1 receptor selective agonist. It is an investigational new drug that was studied through a Phase 2b trial for acute heart failure. TRV027 is currently being investigated as a potential treatment for acute lung injury contributing to ARDS in COVID-19 patients. TRV027 may counteract overactivation of the AT1 receptor caused by SARS-coronavirus-2, while simultaneously promoting reparative effects on lung tissue. The use of TRV027 in COVID-19 patients has been proposed by Nobel Laureate Robert J. Lefkowitz, M.D., and Howard A. Rockman, M.D., both Professors of Medicine at Duke University and scientific co-founders of the Company, along with two of their colleagues, Laura M. Wingler, Ph.D., Duke University and Aashish Manglik, M.D., Ph.D., University of California San Francisco.
                 
    About Trevena
    Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with CNS disorders. The Company has five novel and differentiated investigational drug candidates, including IV oliceridine, for the management of moderate to severe acute pain in hospitals, TRV250 for the acute treatment of migraine, TRV734 for maintenance treatment of opioid use disorder, and TRV027 for acute lung injury in COVID-19 patients. The Company has also identified TRV045, a novel S1P receptor modulator that may offer a new, non-opioid approach to treating a variety of CNS disorders.

    Forward-Looking Statements
    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development and trials of its therapeutic candidates, plans for potential future product candidates and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "suggest," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the status, timing, costs, results and interpretation of the Company's clinical trials or any future trials of any of the Company's investigational drug candidates; the uncertainties inherent in conducting clinical trials; expectations for regulatory interactions, submissions and approvals, including the Company's assessment of the discussions with FDA, the timing of FDA's decision on the oliceridine NDA; available funding ; uncertainties related to the Company's intellectual property; uncertainties related to the ongoing COVID-19 pandemic, other matters that could affect the availability or commercial potential of the Company's therapeutic candidates; and other factors discussed in the Risk Factors set forth in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.

    For more information, please contact:

    Investor Contact:
    Dan Ferry
    Managing Director
    LifeSci Advisors, LLC

    (617) 430-7576

    Company Contact:
    Bob Yoder
    SVP and Chief Business Officer
    Trevena, Inc.
    (610) 354-8840

     

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  19. Trevena Reports First Quarter 2020 Results

    FDA review of oliceridine NDA ongoing; PDUFA date August 7, 2020

    IND filing for novel S1P modulator (TRV045) in 1H 2021; ongoing collaboration with NIH to evaluate for epilepsy and pain

    --

    Company to host conference call today, May 7, 2020, at 8:00 a.m. ET

    CHESTERBROOK, Pa., May 07, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today reported its financial results for the first quarter ended March 31, 2020, and provided an overview of its recent operational highlights.

    "In the first quarter, we reached a significant milestone for the oliceridine…

    Trevena Reports First Quarter 2020 Results

    FDA review of oliceridine NDA ongoing; PDUFA date August 7, 2020

    IND filing for novel S1P modulator (TRV045) in 1H 2021; ongoing collaboration with NIH to evaluate for epilepsy and pain

    --

    Company to host conference call today, May 7, 2020, at 8:00 a.m. ET

    CHESTERBROOK, Pa., May 07, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today reported its financial results for the first quarter ended March 31, 2020, and provided an overview of its recent operational highlights.

    "In the first quarter, we reached a significant milestone for the oliceridine program, with our resubmission and FDA's acceptance of the NDA. I am very pleased with FDA's engagement in the review process, and we look forward to receiving their decision in August," said Carrie Bourdow, President and Chief Executive Officer of Trevena, Inc.

    First Quarter 2020 and Recent Corporate Highlights:

    •  Resubmitted NDA for oliceridine, with FDA review ongoing. In March 2020, the Company announced that the U.S. Food and Drug Administration (FDA) had set a Prescription Drug User Fee Act (PDUFA) goal date of August 7, 2020 for oliceridine, and the Agency considered the resubmitted New Drug Application (NDA) to be a complete response to their 2018 action letter.

      FDA's review of the NDA resubmission is ongoing, and the Company continues to expect a decision from the Agency by August 7.             
    • Further expanded body of peer-reviewed literature. The Company recently announced the publication of a comprehensive review of the nonclinical and clinical data for oliceridine. The monograph provides an overview of the data the Company has published over the past 18 months, including head-to-head data versus IV morphine in hard- and soft-tissue surgical models and safety / tolerability data in high-risk patients from an open-label, "real world" safety study. These high-risk patients –  elderly, obese, renally impaired and / or co-morbid – make up the initial target market for oliceridine.
       
    • Initiated collaboration with NIH to evaluate TRV045 for epilepsy and non-addictive treatment for pain. In March 2020, the Company announced it had entered into a collaboration with NIH to evaluate the potential of TRV045, the lead candidate for its novel S1P receptor modulator program, as a treatment for epilepsy. NIH has initiated the first round of assays for TRV045 within its Epilepsy Treatment Screening Program.

      The Company today announced that NIH is also investigating TRV045 as a potential non-addictive treatment for various acute and chronic pain conditions, including inflammatory and neuropathic pain, within its Preclinical Screening Platform for Pain.
       
    • Advanced IND-enabling activities for TRV045. The Company today announced it plans to file an Investigational New Drug (IND) application for TRV045 in 1H 2021. IND-enabling activities are currently ongoing.             

    Financial Results for First Quarter 2020

    For the first quarter of 2020, the Company reported a net loss attributable to common stockholders of $5.7 million, or $0.06 per share, compared to $5.2 million, or $0.06 per share, for the first quarter of 2019. This increase in net loss is primarily due to higher research and development expenses associated with the TRV250 acute migraine proof-of-concept study and activities to support the NDA resubmission for oliceridine.

    Cash and cash equivalents were $28.1 million at March 31, 2020, which the Company believes to be sufficient to fund the Company's operating expenses and capital expenditure requirements into the first quarter of 2021.

    Conference Call and Webcast Information

    The Company will host a conference call and webcast with the investment community on May 7, 2020, at 8:00 a.m. Eastern Time featuring remarks by Carrie Bourdow, President and Chief Executive Officer, Robert Yoder, Chief Business Officer, Mark Demitrack, M.D., Chief Medical Officer, and Barry Shin, Chief Financial Officer.

    Title: Trevena First Quarter 2020 Conference Call and Webcast
    Date: Thursday, May 7, 2020
    Time: 8:00 a.m. ET
    Conference
    Call Details:
    Toll-Free: 855-465-0180
    International: 484-756-4313
    Conference ID: 5469527
    Webcast: https://www.trevena.com/investors/events-presentations/ir-calendar

    About Oliceridine
    Oliceridine is a G protein-selective mu-opioid receptor agonist in development for the management of moderate-to-severe acute pain in hospitals or other controlled clinical settings where intravenous therapy is warranted. It is a new chemical entity with a novel mechanism of action that enables more selective targeting of newly discovered pathways with the potential for fewer side effects. Oliceridine is an investigational product and has not been approved by FDA or any other regulatory agency. If approved, the Company expects that oliceridine will be classified as a Schedule II controlled substance.

    About Trevena
    Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with CNS disorders. The Company has four novel and differentiated investigational drug candidates, including IV oliceridine, for the management of moderate to severe acute pain in hospitals, TRV250 for the acute treatment of migraine, and TRV734 for maintenance treatment of opioid use disorder. The Company has also identified TRV045, a novel S1P receptor modulator that may offer a new, non-opioid approach to treating a variety of CNS disorders.

    Forward-Looking Statements
    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development and trials of its therapeutic candidates, plans for potential future product candidates and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "suggest," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the status, timing, costs, results and interpretation of the Company's clinical trials or any future trials of any of the Company's investigational drug candidates; the uncertainties inherent in conducting clinical trials; expectations for regulatory interactions, submissions and approvals, including the Company's assessment of the discussions with FDA, the timing of FDA's decision on the oliceridine NDA; available funding ; uncertainties related to the Company's intellectual property; uncertainties related to the ongoing COVID-19 pandemic, other matters that could affect the availability or commercial potential of the Company's therapeutic candidates; and other factors discussed in the Risk Factors set forth in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.

    For more information, please contact:

    Investor Contact:
    Dan Ferry
    Managing Director
    LifeSci Advisors, LLC

    (617) 430-7576

    Company Contact:
    Bob Yoder
    SVP and Chief Business Officer
    Trevena, Inc.
    (610) 354-8840

    TREVENA, INC.
    Condensed Statements of Operations
    (Unaudited, in thousands except share and per share data)
             
        Three Months Ended March 31,
          2020       2019  
             
    Revenue   $ -     $ -  
             
    Operating expenses:        
    General and administrative     3,632       3,060  
    Research and development     2,191       2,154  
    Total operating expenses     5,823       5,214  
    Loss from operations     (5,823 )     (5,214 )
    Other income     98       45  
    Loss before income tax expense     (5,725 )     (5,169 )
    Income tax expense     -       -  
    Net loss   $ (5,725 )   $ (5,169 )
             
    Per share information:        
    Net loss per share of common stock, basic and diluted   ($0.06 )   ($0.06 )
    Weighted average shares outstanding, basic and diluted   96,332,324       88,897,292  
             



    TREVENA, INC.      
    Condensed Balance Sheets      
    (Unaudited, in thousands)      
                   
        March 31, 2020   December 31, 2019  
    Assets              
    Current assets:              
    Cash and cash equivalents   $ 28,090     $ 32,305        
    Marketable securities     -       3,500        
    Prepaid expenses and other current assets     1,666       1,683        
    Total current assets     29,756       37,488        
    Restricted cash     1,310       1,309        
    Property and equipment, net     2,577       2,705        
    Right-of-use lease assets     5,389       5,472        
    Other assets     18       20.00        
    Total assets   $ 39,050     $ 46,994        
                   
    Liabilities and stockholders' equity              
    Current liabilities:              
    Accounts payable   $ 698     $ 1,047        
    Accrued expenses and other current liabilities     1,277       2,403        
    Current portion of loans payable, net     -       5,037        
    Current portion of lease liabilities     642       620        
    Total current liabilities     2,617       9,107        
    Leases, net of current portion     7,636       7,804        
    Warrant liability     2       5        
    Total liabilities     10,255       16,916        
                   
    Common stock     99       94        
    Additional paid-in capital     447,566       443,129        
    Accumulated deficit     (418,870 )     (413,145 )      
    Total stockholders' equity     28,795       30,078        
    Total liabilities and stockholders' equity   $ 39,050     $ 46,994        
                   

     


     

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  20. CHESTERBROOK, Pa., May 01, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced that it will release its financial results for the first quarter ended March 31, 2020, prior to the market open on Thursday, May 7, 2020.

    Company management will host a conference call and webcast to discuss its financial results and provide a general business update at 8:00 a.m. (ET) on the same day, featuring remarks by Carrie Bourdow, President and Chief Executive Officer, Bob Yoder, SVP and Chief Business Officer, Mark Demitrack, SVP and Chief Medical Officer, and Barry Shin, SVP and Chief…

    CHESTERBROOK, Pa., May 01, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced that it will release its financial results for the first quarter ended March 31, 2020, prior to the market open on Thursday, May 7, 2020.

    Company management will host a conference call and webcast to discuss its financial results and provide a general business update at 8:00 a.m. (ET) on the same day, featuring remarks by Carrie Bourdow, President and Chief Executive Officer, Bob Yoder, SVP and Chief Business Officer, Mark Demitrack, SVP and Chief Medical Officer, and Barry Shin, SVP and Chief Financial Officer.  

       
    Title: Trevena First Quarter 2020 Financial Results Conference Call & Webcast
       
    Date: Thursday, May 7, 2020
       
    Time: 8:00 a.m. ET
       
    Conference 
    Call Details:
    Toll-Free: 855-465-0180
    International: 484-756-4313
    Conference ID: 5469527
     
     
    The conference call will be webcast live from the company's website and will be available via the following links:
     
     
      https://www.trevena.com/investors/events-presentations/ir-calendar
    Webcast:  
      https://edge.media-server.com/mmc/p/r7x9zckv
       

    The webcast should be accessed 15 minutes prior to the conference call start time. A replay of the webcast will be available following the conclusion of the live broadcast and will be accessible on the company's website.

    About Trevena
    Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with CNS disorders. The Company has four novel and differentiated investigational drug candidates, including IV oliceridine, for the management of moderate to severe acute pain in hospitals, TRV250 for the acute treatment of migraine, and TRV734 for maintenance treatment of opioid use disorder. The Company has also identified TRV045, a novel S1P receptor modulator that may offer a new, non-opioid approach to treating a variety of CNS disorders.

    For more information, please contact:

    Investor Contact:
    Dan Ferry - Managing Director
    LifeSci Advisors, LLC

    (617) 430-7576

    Company Contact:
    Bob Yoder
    SVP and Chief Business Officer
    Trevena, Inc.
    (610) 354-8840 

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  21. Overview of clinical and nonclinical data to date for oliceridine; includes efficacy data in hard- and soft- tissue surgeries, safety / tolerability data in high-risk patients

    CHESTERBROOK, Pa., April 23, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced the publication of a review of the clinical and nonclinical data for oliceridine in Drugs of Today.

    The publication is titled "Oliceridine, a G protein-selective ligand at the μ-opioid receptor, for the management of moderate to severe acute pain", with lead author Tong J. Gan, M.D., Department of Anesthesiology at Stony…

    Overview of clinical and nonclinical data to date for oliceridine; includes efficacy data in hard- and soft- tissue surgeries, safety / tolerability data in high-risk patients

    CHESTERBROOK, Pa., April 23, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced the publication of a review of the clinical and nonclinical data for oliceridine in Drugs of Today.

    The publication is titled "Oliceridine, a G protein-selective ligand at the μ-opioid receptor, for the management of moderate to severe acute pain", with lead author Tong J. Gan, M.D., Department of Anesthesiology at Stony Brook Medicine (DOI: 10.1358/dot.2020.56.4.3107707).

    "I am pleased to have the opportunity to provide a comprehensive overview of the data we have amassed over the entire oliceridine development program from over 1,800 individuals," said Mark A. Demitrack, M.D., Senior Vice President and Chief Medical Officer of Trevena, Inc. "This monograph is the latest addition to the compelling body of peer-reviewed published literature for oliceridine, and summarizes the novel characteristics that make it a potentially differentiated treatment option for moderate-to-severe acute pain in hospital settings."

    Monograph Key Points:

    • Novel, biased mechanism of action; robust efficacy in animal models with less associated constipation, gastrointestinal (GI) dysfunction, and respiratory depression.

    • Novel pharmacology with a half-life that allows for adequate drug concentrations to provide efficacy without drug accumulation or development of active metabolites. No dosage adjustments needed when administering oliceridine to patients with renal impairment, mild to moderate hepatic impairment, or the elderly.

    • Rapid analgesia in hard- and soft-tissue surgeries in patients with moderate-to-severe acute pain. Safe and well-tolerated in a large, open-label, "real world" safety study, including in high-risk patients with advanced age, obesity, and diabetes and across a variety of surgical procedures and settings of care.

    About Oliceridine
    Oliceridine is a G protein-selective mu-opioid receptor agonist in development for the management of moderate-to-severe acute pain in hospitals or other controlled clinical settings where intravenous therapy is warranted. It is a new chemical entity with a novel mechanism of action that enables more selective targeting of newly discovered pathways with the potential for fewer side effects. Oliceridine is an investigational product and has not been approved by FDA or any other regulatory agency. If approved, the Company expects that oliceridine will be classified as a Schedule II controlled substance.

    About Trevena
    Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with CNS disorders. The Company has four novel and differentiated investigational drug candidates, including IV oliceridine, for the management of moderate to severe acute pain in hospitals, TRV250 for the acute treatment of migraine, and TRV734 for maintenance treatment of opioid use disorder. The Company has also identified TRV045, a novel S1P receptor modulator that may offer a new, non-opioid approach to treating a variety of CNS disorders.

    Forward-Looking Statements
    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development and trials of its therapeutic candidates, plans for potential future product candidates and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "suggest," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the status, timing, costs, results and interpretation of the Company's clinical trials or any future trials of any of the Company's investigational drug candidates; the uncertainties inherent in conducting clinical trials; expectations for regulatory interactions, submissions and approvals, including the Company's assessment of the discussions with FDA, the timing of FDA's decision on the oliceridine NDA; available funding ; uncertainties related to the Company's intellectual property; other matters that could affect the availability or commercial potential of the Company's therapeutic candidates; and other factors discussed in the Risk Factors set forth in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.

    For more information, please contact:

    Investor Contact:
    Dan Ferry
    Managing Director
    LifeSci Advisors, LLC

    (617) 430-7576

    Company Contact:
    Bob Yoder
    SVP and Chief Business Officer
    Trevena, Inc.
    (610) 354-8840

     

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  22. PDUFA date of August 7, 2020 for IV oliceridine; FDA considers NDA resubmission complete

    Initiated proof-of-concept studies for acute migraine (TRV250) and opioid use disorder (TRV734)

    Announces NIH collaboration to evaluate TRV045 for epilepsy

    Updated guidance on extended cash runway, funding operations into Q1 2021

    --

    Company to host conference call today, March 12, 2020, at 8:00 a.m. ET

    CHESTERBROOK, Pa., March 12, 2020 (GLOBE NEWSWIRE) --  Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today reported its financial results for the fourth quarter and full year ended December 31, 2019, and provided an overview…

    PDUFA date of August 7, 2020 for IV oliceridine; FDA considers NDA resubmission complete

    Initiated proof-of-concept studies for acute migraine (TRV250) and opioid use disorder (TRV734)

    Announces NIH collaboration to evaluate TRV045 for epilepsy

    Updated guidance on extended cash runway, funding operations into Q1 2021

    --

    Company to host conference call today, March 12, 2020, at 8:00 a.m. ET

    CHESTERBROOK, Pa., March 12, 2020 (GLOBE NEWSWIRE) --  Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today reported its financial results for the fourth quarter and full year ended December 31, 2019, and provided an overview of its 2019 and 2020 year-to-date operational highlights.

    "In 2019, we delivered on our plan to establish Trevena as a leading innovator in the treatment of CNS disorders. We completed a significant amount of work to thoroughly address the FDA complete response letter for oliceridine, which positioned us to successfully resubmit the NDA earlier this year. Additionally, we advanced our pipeline, initiating two proof-of-concept studies for acute migraine and opioid use disorder, as well as a collaboration with NIH to evaluate TRV045 for epilepsy," said Carrie Bourdow, President and Chief Executive Officer of Trevena. "We enter 2020 with the same focus and commitment, preparing for the expected approval of oliceridine in the second half of the year, as well as advancing our pipeline assets."

    2019 and 2020 YTD Corporate Highlights:

    IV Oliceridine Milestones

    • Resubmitted NDA and received PDUFA goal date of August 7, 2020. In February 2020, the Company resubmitted the NDA for oliceridine to the FDA, after successfully completing all activities requested in the complete response letter, including a multi-dose healthy volunteer QT study, nonclinical work to confirm levels of an inactive metabolite, and drug product validation reports.
                   
      In March 2020, the Company announced that FDA had acknowledged receipt of the resubmitted NDA. In their acknowledgement letter, FDA stated that the Company's resubmission was a complete, Class 2 response to the Agency's action letter. A PDUFA goal date has been set for August 7, 2020.

    • Continued to expand body of published peer-reviewed literature. In 2019, the Company announced the publication of data from both pivotal Phase 3 trials and the Phase 3 "real world" open-label safety study. These data will serve as a critical element of the oliceridine launch.             

    CNS Pipeline Milestones

    • Initiated TRV250 acute migraine PoC study. In November 2019, the Company initiated a proof-of-concept (PoC) study evaluating TRV250 for the treatment of acute migraine and associated anxiety. This randomized, double-blind, single-dose, placebo-controlled study will enroll approximately 120 migraine patients in a validated nitroglycerin (NTG) human migraine provocation model.
                   
      The primary endpoint of the study is reduction of sustained NTG-induced headaches; secondary outcomes include overall safety measures and reduction of symptomatic anxiety. The Company continues to expect reporting topline data in 2H 2020.

    • Initiated TRV734 opioid use disorder PoC study sponsored and funded by NIDA. In December 2019, the Company announced the initiation of a PoC study evaluating TRV734 as a potential maintenance therapy for opioid use disorder. This randomized, double-blind, four-period, placebo- and positive-controlled study will enroll approximately 50 opioid-dependent patients.

      The primary endpoint of the study is reduction of acute opioid craving symptoms. The study will also evaluate suppression of withdrawal signs, neurocognitive changes, and overall safety.

    • Announced collaboration with NIH to evaluate TRV045 for epilepsy. In March 2019, the Company announced its identification of TRV045 as the lead candidate for its novel S1P receptor modulator program. TRV045 has a unique mechanism of action that holds potential as a treatment for a variety of CNS disorders.

      The Company today announced it entered into a collaboration with the U.S. National Institutes of Health (NIH) to evaluate the potential of TRV045 as a treatment for epilepsy. NIH is assessing TRV045 within its Epilepsy Therapy Screening Program.

    Financial and Corporate Milestones

    • Updated guidance on cash runway, into Q1 2021. The Company today announced $35.8 million in cash, cash equivalents, and marketable securities as of December 31, 2019, which it believes to be sufficient to fund the Company's operating expenses and capital expenditure requirements into Q1 2021.
       
    • Strengthened leadership team. In February 2020, the Company announced the appointment of Scott Applebaum as Chief Legal and Compliance Officer and Senior Vice President of Regulatory Affairs. Mr. Applebaum brings over 20 years of experience in a variety of senior leadership roles at both large and small companies at various stages of development and commercialization in the biopharmaceuticals sector.

      In July 2019, the Company announced the appointment of Barry Shin as Senior Vice President and Chief Financial Officer. Mr. Shin brings over 17 years of investment banking and corporate advisory experience, focused on the biopharmaceutical sector.            

    Financial Results for Fourth Quarter and Full Year 2019

    For the fourth quarter of 2019, the Company reported a net loss attributable to common stockholders of $6.4 million, or $0.07 per share, compared to $8.0 million, or $0.10 per share, for the fourth quarter of 2018.  For the full year ended December 31, 2019, net loss attributable to common stockholders was $24.9 million, or $0.27 per share, compared to $30.8 million, or $0.42 per share, for the year ended December 31, 2018. This decrease is primarily due to a reduction in headcount associated with the 2018 restructuring and reduction in force, as well as a decrease in research and development expenses from the completion of the Phase 1 clinical trial for TRV250.

    Cash, cash equivalents, and marketable securities were $35.8 million at December 31, 2019. The Company believes that its cash and cash equivalents and marketable securities as of December 31, 2019, together with interest thereon, to be sufficient to fund the Company's operating expenses and capital expenditure requirements into the first quarter of 2021.

    Conference Call and Webcast Information

    The Company will host a conference call and webcast with the investment community on March 12, 2020, at 8:00 a.m. Eastern Time featuring remarks by Carrie Bourdow, President and Chief Executive Officer, Mark Demitrack, SVP and Chief Medical Officer, Barry Shin, SVP and Chief Financial Officer, and Timothy Beard, M.D., Chair of the Department of Surgery at Summit Medical Group.

    Title: Trevena Fourth Quarter 2019 & Full Year 2019 Financial Results
    Conference Call and Webcast
    Date: Thursday, March 12, 2020
    Time: 8:00 a.m. ET
    Conference Call Details: Toll-Free: 877-451-6152
    International: 201-389-0879
    Conference ID: 13699727
    Webcast: https://www.trevena.com/investors/events-presentations/ir-calendar

    http://public.viavid.com/index.php?id=138309

    About Oliceridine
    Oliceridine is a G protein-selective mu-opioid receptor agonist in development for the management of moderate-to-severe acute pain in hospitals or other controlled clinical settings where intravenous therapy is warranted. It is a new chemical entity with a novel mechanism of action that enables more selective targeting of newly discovered pathways with the potential for fewer side effects. Oliceridine is an investigational product and has not been approved by FDA or any other regulatory agency. If approved, the Company expects that oliceridine will be classified as a Schedule II controlled substance.

    About Trevena
    Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with CNS disorders. The Company has four novel and differentiated investigational drug candidates, including IV oliceridine, for the management of moderate to severe acute pain in hospitals, TRV250 for the acute treatment of migraine, and TRV734 for maintenance treatment of opioid use disorder. The Company has also identified TRV045, a novel S1P receptor modulator that may offer a new, non-opioid approach to treating a variety of CNS disorders.

    Forward-Looking Statements
    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development and trials of its therapeutic candidates, plans for potential future product candidates and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "suggest," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the status, timing, costs, results and interpretation of the Company's clinical trials or any future trials of any of the Company's investigational drug candidates; the uncertainties inherent in conducting clinical trials; expectations for regulatory interactions, submissions and approvals, including the Company's assessment of the discussions with FDA, the timing of FDA's decision on the oliceridine NDA; available funding ; uncertainties related to the Company's intellectual property; other matters that could affect the availability or commercial potential of the Company's therapeutic candidates; and other factors discussed in the Risk Factors set forth in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.

    For more information, please contact:

    Investor Contact:
    Dan Ferry
    Managing Director
    LifeSci Advisors, LLC

    (617) 430-7576

    Company Contact:
    Bob Yoder
    SVP and Chief Business Officer
    Trevena, Inc.
    (610) 354-8840



    TREVENA, INC.  
    Condensed Statements of Operations  
    (Unaudited, in thousands except share and per share data)  
                       
        Three Months Ended December 31,   Year Ended December 31,  
          2019       2018       2019       2018    
                       
    License and related revenue   $ 31     $ 232     $ 31     $ 5,732    
                       
    Operating expenses:                  
    General and administrative     3,640       4,073       13,212       18,979    
    Research and development     2,861       2,747       13,291       15,824    
    Restructuring charges     -       1,363       -       1,427    
    Impairment of property and equipment     -       -       108       -    
    Total operating expenses     6,501       8,183       26,611       36,230    
    Loss from operations     (6,470 )     (7,951 )     (26,580 )     (30,498 )  
    Other income (expense)     25       (25 )     1,709       459    
    Loss before income tax expense     (6,445 )     (7,976 )     (24,871 )     (30,039 )  
    Foreign income tax expense     -       -       -       (745 )  
    Net loss   $ (6,445 )   $ (7,976 )   $ (24,871 )   $ (30,784 )  
                       
    Per share information:                  
    Net loss per share of common stock, basic and diluted   ($ 0.07 )   ($ 0.10 )   ($ 0.27 )   ($ 0.42 )  
    Weighted average shares outstanding, basic and diluted   92,777,480       82,323,393       91,677,963       73,558,548    
                       



    TREVENA, INC.      
    Condensed Balance Sheets      
    (Unaudited, in thousands)      
                   
        December 31, 2019 December 31, 2018  
    Assets              
    Current assets:              
    Cash and cash equivalents   $ 32,305     $ 32,892        
    Marketable securities     3,500       28,590        
    Prepaid expenses and other current assets     1,683       607        
    Total current assets     37,488       62,089        
    Restricted cash     1,309       1,303        
    Property and equipment, net     2,705       3,387        
    Right-of-use lease assets     5,472       -        
    Other assets     20       -        
    Total assets   $ 46,994     $ 66,779        
                   
    Liabilities and stockholders' equity              
    Current liabilities:              
    Accounts payable, net   $ 1,047     $ 1,416        
    Accrued expenses and other current liabilities     2,403       3,295        
    Current portion of loans payable, net     5,037       12,562        
    Current portion of lease liabilities     620       10        
    Deferred rent     -       207        
    Total current liabilities     9,107       17,490        
    Loans payable, net     -       4,811        
    Leases, net of current portion     7,804       20        
    Deferred rent, net of current portion     -       2,931        
    Warrant liability     5       1        
    Total liabilities     16,916       25,253        
                   
    Common stock     94       82        
    Additional paid-in capital     443,129       429,727        
    Accumulated deficit     (413,145 )     (388,274 )      
    Accumulated other comprehensive income (loss)     -       (9 )      
    Total stockholders' equity     30,078       41,526        
    Total liabilities and stockholders' equity   $ 46,994     $ 66,779        
                   

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  23. CHESTERBROOK, Pa., March 05, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced that it will release its financial results for the fourth quarter and full year ended December 31, 2019, prior to the market open on Thursday, March 12, 2020.

    The Company will host a conference call and webcast with the investment community on March 12, 2020, at 8:00 a.m. Eastern Time featuring remarks by Carrie Bourdow, President and Chief Executive Officer, Mark Demitrack, SVP and Chief Medical Officer, and Barry Shin, SVP and Chief Financial Officer, providing an overview of its 2019 results…

    CHESTERBROOK, Pa., March 05, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced that it will release its financial results for the fourth quarter and full year ended December 31, 2019, prior to the market open on Thursday, March 12, 2020.

    The Company will host a conference call and webcast with the investment community on March 12, 2020, at 8:00 a.m. Eastern Time featuring remarks by Carrie Bourdow, President and Chief Executive Officer, Mark Demitrack, SVP and Chief Medical Officer, and Barry Shin, SVP and Chief Financial Officer, providing an overview of its 2019 results and 2020 year-to-date operational highlights. Additionally, Dr. Timothy Beard, Chair of the Department of Surgery at Summit Medical Group, will be providing additional remarks around post-operative acute pain management in the hospital and ambulatory surgical center (ASC) settings and where within the clinical paradigm a technology such as IV oliceridine would be advantageous for surgeons.

    Title:   Trevena Fourth Quarter 2019 & Full Year 2019 Financial Results Conference Call and Webcast
         
    Date:   Thursday, March 12, 2020
         
    Time:   8:00 a.m. ET
         
    Conference Call Details:   Toll-Free: 877-451-6152
    International: 201-389-0879
    Conference ID: 13699727
         
    Webcast:   https://www.trevena.com/investors/events-presentations/ir-calendar

    http://public.viavid.com/index.php?id=138309

    About Trevena
    Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with CNS disorders. The Company has four novel and differentiated investigational drug candidates, including IV oliceridine, for the management of moderate to severe acute pain in hospitals, TRV250 for the acute treatment of migraine, and TRV734 for maintenance treatment of opioid use disorder. The Company has also identified TRV045, a novel S1P receptor modulator that may offer a new, non-opioid approach to treating a variety of CNS disorders.

    For more information, please contact:

    Investor Contact:
    Dan Ferry - Managing Director
    LifeSci Advisors, LLC
     
    (617) 430-7576

    Company Contact:
    Bob Yoder
    SVP and Chief Business Officer
    Trevena, Inc.
    (610) 354-8840

     

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  24. FDA considers NDA resubmission a complete Class 2 response

    Updated guidance on extended cash runway, funding operations into Q1 2021

    CHESTERBROOK, Pa., March 05, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the resubmitted New Drug Application (NDA) for IV oliceridine, the Company's lead investigational asset for the management of moderate-to-severe acute pain.

    "I am pleased that FDA considers our resubmission to be a complete response to the Agency's 2018 letter. This represents the crucial…

    FDA considers NDA resubmission a complete Class 2 response

    Updated guidance on extended cash runway, funding operations into Q1 2021

    CHESTERBROOK, Pa., March 05, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the resubmitted New Drug Application (NDA) for IV oliceridine, the Company's lead investigational asset for the management of moderate-to-severe acute pain.

    "I am pleased that FDA considers our resubmission to be a complete response to the Agency's 2018 letter. This represents the crucial next step to bringing oliceridine to patients," said Carrie Bourdow, President and Chief Executive Officer of Trevena. "There remains a significant clinical need in the hospital setting for an effective and well-tolerated IV analgesic to help manage patients' moderate-to-severe pain. We are committed to delivering oliceridine to these patients and their healthcare providers, and we look forward to supporting the Agency's review of our application."

    In their acknowledgement letter, FDA stated that the Company's resubmission is a complete, Class 2 response to the Agency's action letter dated November 2, 2018. A Prescription Drug User Fee Act (PDUFA) goal date has been set for August 7, 2020.

    In addition, the Company today announced that it is updating and extending its cash runway guidance.  Cash, cash equivalents, and marketable securities were approximately $35.8 million as of December 31, 2019, which the Company believes will be sufficient to fund the Company's operating expenses, debt service, and capital expenditure requirements into the first quarter of 2021.

    The information above related to the Company's expected operating results for the year ended and as of December 31, 2019, including revenue and cash, cash equivalents, and marketable securities, is preliminary, has not been audited and is subject to change upon completion of the audit of the Company's financial statements as of and for the year ended December 31, 2019.

    About Oliceridine
    Oliceridine is a G protein-selective mu-opioid receptor agonist in development for the management of moderate-to-severe acute pain in hospitals or other controlled clinical settings where intravenous therapy is warranted. It is a new chemical entity with a novel mechanism of action that enables more selective targeting of newly discovered pathways with the potential for fewer side effects. Oliceridine is an investigational product and has not been approved by FDA or any other regulatory agency. If approved, the Company expects that oliceridine will be classified as a Schedule II controlled substance.

    About Trevena
    Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with CNS disorders. The Company has four novel and differentiated investigational drug candidates, including IV oliceridine, for the management of moderate to severe acute pain in hospitals, TRV250 for the acute treatment of migraine, and TRV734 for maintenance treatment of opioid use disorder. The Company has also identified TRV045, a novel S1P receptor modulator that may offer a new, non-opioid approach to treating a variety of CNS disorders.

    Forward-Looking Statements
    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development and trials of its therapeutic candidates, plans for potential future product candidates and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "suggest," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the status, timing, costs, results and interpretation of the Company's clinical trials or any future trials of any of the Company's investigational drug candidates; the uncertainties inherent in conducting clinical trials; expectations for regulatory interactions, submissions and approvals, including the Company's assessment of the discussions with FDA, FDA's acknowledgement of the submitted NDA for oliceridine and the timing of FDA's decision on the oliceridine NDA; available funding; uncertainties related to the Company's intellectual property; other matters that could affect the availability or commercial potential of the Company's therapeutic candidates; and other factors discussed in the Risk Factors set forth in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.

    For more information, please contact:

    Investor Contact:
    Dan Ferry
    Managing Director
    LifeSci Advisors, LLC

    (617) 430-7576

    Company Contact:
    Bob Yoder
    SVP and Chief Business Officer
    Trevena, Inc.
    (610) 354-8840

     

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  25. CHESTERBROOK, Pa., Feb. 13, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced the appointment of Scott Applebaum as Chief Legal and Compliance Officer and Senior Vice President of Regulatory Affairs. Mr. Applebaum comes to the Company with over 20 years of experience in a variety of senior leadership roles at both large and small companies at various stages of development and commercialization in the biopharmaceuticals sector.

    "We are very pleased that Scott is joining the Trevena team at this important stage in our progress," said Carrie Bourdow, President and Chief Executive…

    CHESTERBROOK, Pa., Feb. 13, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced the appointment of Scott Applebaum as Chief Legal and Compliance Officer and Senior Vice President of Regulatory Affairs. Mr. Applebaum comes to the Company with over 20 years of experience in a variety of senior leadership roles at both large and small companies at various stages of development and commercialization in the biopharmaceuticals sector.

    "We are very pleased that Scott is joining the Trevena team at this important stage in our progress," said Carrie Bourdow, President and Chief Executive Officer of Trevena, Inc. "We recently achieved a significant milestone with the resubmission of the NDA for oliceridine. We have several important catalysts ahead this year, including proof-of-concept data for TRV250 in acute migraine and associated anxiety; and, of course, potential approval and launch of oliceridine. Scott's breadth of strategic, legal and regulatory experience will be invaluable as we prepare for the commercialization of oliceridine and continue to advance our innovative pipeline."

    "I am excited to join the Trevena team," said Scott Applebaum. "I look forward to helping the company grow and continue in its mission of ‘Innovating for Patients' and developing and commercializing important new therapeutic options for patients in need."

    Mr. Applebaum joins Trevena with extensive experience providing legal counsel and regulatory guidance to biopharmaceutical companies in a variety of roles across several organizations. He began his biopharmaceutical career over two decades ago at Bristol-Myers Squibb, where he served in various legal and compliance roles. He subsequently joined Shire Pharmaceuticals as Senior Vice President, where he held leadership roles in multiple functions, including SVP of Legal, SVP of Global Regulatory Affairs & Quality Assurance and SVP of the Global Neuroscience Business Unit where he led the successful launch of Shire's flagship and market-leading ADHD product in multiple countries. Mr. Applebaum's experience with high growth biopharmaceutical companies includes his role as General Counsel and Corporate Secretary of Vitae Pharmaceuticals where he played a key role in the sale of Vitae to Allergan plc, as well as Chief Legal Officer of Medgenics. Most recently, Mr. Applebaum was President of Context Therapeutics, a privately held biopharma company dedicated to discovering novel compounds for the treatment of hormone responsive cancers. Mr. Applebaum received a B.S.E. in Finance and Accounting from the Wharton School of the University of Pennsylvania and a J.D. from the Stanford Law School.

    About Trevena
    Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with CNS disorders. The Company has four novel and differentiated investigational drug candidates, including IV oliceridine, for the management of moderate to severe acute pain in hospitals, TRV250 for the acute treatment of migraine, and TRV734 for maintenance treatment of opioid use disorder. The Company has also identified TRV045, a novel S1P receptor modulator that may offer a new, non-opioid approach to treating a variety of CNS disorders.

    Forward-Looking Statements
    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development of its therapeutic candidates, plans for potential future product candidates and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "suggest," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the status, timing, costs, results and interpretation of the Company's clinical trials; the uncertainties inherent in conducting clinical trials; expectations for regulatory approvals, including for oliceridine; availability of funding sufficient for the Company's foreseeable and unforeseeable operating expenses and capital expenditure requirements; uncertainties related to the Company's intellectual property; other matters that could affect the availability or commercial potential of the Company's therapeutic candidates; and other factors discussed in the Risk Factors set forth in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.

    For more information, please contact:

    Investor Contact:
    Daniel Ferry
    LifeSci Advisors
    Phone: 617-430-7576
    Email:

    Company Contact:
    Bob Yoder, SVP and Chief Business Officer
    Trevena, Inc.
    Phone: 610-354-8840

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  26. CHESTERBROOK, Pa., Feb. 10, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced that it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for IV oliceridine, the Company's lead investigational product for the management of moderate-to-severe acute pain. The Company anticipates a six-month review period by FDA.

    The NDA for oliceridine was resubmitted based on the outcome and final minutes of a Type A meeting with FDA, which was conducted to obtain clarity on their Complete Response Letter (CRL). The resubmission package included…

    CHESTERBROOK, Pa., Feb. 10, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced that it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for IV oliceridine, the Company's lead investigational product for the management of moderate-to-severe acute pain. The Company anticipates a six-month review period by FDA.

    The NDA for oliceridine was resubmitted based on the outcome and final minutes of a Type A meeting with FDA, which was conducted to obtain clarity on their Complete Response Letter (CRL). The resubmission package included data from the multi-dose healthy volunteer QT study, nonclinical data that confirmed levels of an inactive metabolite, and drug product validation reports. The resubmission package also specified a maximum daily dose of 27 mg, as previously acknowledged by FDA in the Type A meeting minutes. No efficacy data or additional comparative data versus IV morphine were requested as part of the CRL.

    "The resubmission of the oliceridine NDA represents a significant milestone for the program and an important achievement for the company. I am thankful for the team's commitment and diligent work to bring us to this exciting point," said Carrie Bourdow, President and Chief Executive Officer of Trevena. "We appreciate FDA's guidance through the resubmission process and look forward to continuing to work closely with the Agency as they review our application."

    About Oliceridine
    Oliceridine is a G protein-selective mu-opioid receptor agonist in development for the management of moderate-to-severe acute pain in hospitals or other controlled clinical settings where intravenous therapy is warranted. It is a new chemical entity with a novel mechanism of action that enables more selective targeting of newly discovered pathways with the potential for fewer side effects. Oliceridine is an investigational product and has not been approved by FDA or any other regulatory agency. If approved, the Company expects that oliceridine will be classified as a Schedule II controlled substance.

    About Trevena
    Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with CNS disorders. The Company has four novel and differentiated investigational drug candidates, including IV oliceridine, for the management of moderate to severe acute pain in hospitals, TRV250 for the acute treatment of migraine, and TRV734 for maintenance treatment of opioid use disorder. The Company has also identified TRV045, a novel S1P receptor modulator that may offer a new, non-opioid approach to treating a variety of CNS disorders.

    Forward-Looking Statements
    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development and trials of its therapeutic candidates, plans for potential future product candidates and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "suggest," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the status, timing, costs, results and interpretation of the Company's clinical trials or any future trials of any of the Company's investigational drug candidates; the uncertainties inherent in conducting clinical trials; expectations for regulatory interactions, submissions and approvals, including the Company's assessment of the discussions with FDA, FDA's acknowledgement of the submitted NDA for oliceridine and the timing of FDA's decision on the oliceridine NDA; available funding ; uncertainties related to the Company's intellectual property; other matters that could affect the availability or commercial potential of the Company's therapeutic candidates; and other factors discussed in the Risk Factors set forth in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.

    For more information, please contact:

    Investor Contact:
    Dan Ferry
    Managing Director
    LifeSci Advisors, LLC

    (617) 430-7576

    Company Contact:
    Bob Yoder
    SVP and Chief Business Officer
    Trevena, Inc.
    (610) 354-8840

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  27. CHESTERBROOK, Pa., Feb. 05, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced that Carrie Bourdow, President and Chief Executive Officer, will present a corporate overview at the BIO CEO & Investor Conference, being held at the Marriott Marquis Times Square on February 10th-11th, 2020, in New York City.

    Trevena presentation details are listed below:

    Date: Tuesday, February 11th, 2020
    Time: 9:30 a.m. ET
    Location: Wilder Room

    A live audio webcast and archived replay of the presentation will be available on Trevena's investor relations website at https://investors.trevena.com/

    CHESTERBROOK, Pa., Feb. 05, 2020 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced that Carrie Bourdow, President and Chief Executive Officer, will present a corporate overview at the BIO CEO & Investor Conference, being held at the Marriott Marquis Times Square on February 10th-11th, 2020, in New York City.

    Trevena presentation details are listed below:

    Date: Tuesday, February 11th, 2020
    Time: 9:30 a.m. ET
    Location: Wilder Room

    A live audio webcast and archived replay of the presentation will be available on Trevena's investor relations website at https://investors.trevena.com/. Following the conclusion of the presentation, the webcast will be available for replay for 30 days.

    About Trevena
    Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with CNS disorders. The Company has four novel and differentiated investigational drug candidates, including IV oliceridine, for the management of moderate to severe acute pain in hospitals, TRV250 for the acute treatment of migraine, and TRV734 for maintenance treatment of opioid use disorder. The Company has also identified TRV045, a novel S1P receptor modulator that may offer a new, non-opioid approach to treating a variety of CNS disorders.

    For more information, please contact:

    Investor Contact:
    Dan Ferry
    Managing Director
    LifeSci Advisors, LLC

    (617) 430-7576

    Company Contact:
    Bob Yoder
    SVP and Chief Business Officer
    Trevena, Inc.
    (610) 354-8840

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  28. CHESTERBROOK, Pa., Dec. 23, 2019 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced the initiation of a proof-of-concept study for TRV734, the Company's novel mu-opioid receptor selective agonist. TRV734 is currently being evaluated as a potential maintenance therapy for opioid use disorder.

    The study is funded by the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health. Trevena is providing TRV734 to NIDA Intramural Research Program scientists who are conducting the study.

    "The opioid crisis remains a crippling public health issue, and multiple…

    CHESTERBROOK, Pa., Dec. 23, 2019 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced the initiation of a proof-of-concept study for TRV734, the Company's novel mu-opioid receptor selective agonist. TRV734 is currently being evaluated as a potential maintenance therapy for opioid use disorder.

    The study is funded by the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health. Trevena is providing TRV734 to NIDA Intramural Research Program scientists who are conducting the study.

    "The opioid crisis remains a crippling public health issue, and multiple solutions are needed to tackle this urgent problem," said Carrie Bourdow, President and Chief Executive Officer of Trevena, Inc. "A novel mu-opioid receptor selective agonist such as TRV734 may have value as an alternative or complement to current treatments for opioid addiction, which are effective in some but not all people with opioid use disorder. We are excited to be working with NIDA to initiate this important proof-of-concept study."

    This is a randomized, double-blind, four-period, placebo- and positive-controlled study that will enroll approximately 50 opioid-dependent patients undergoing stable methadone maintenance therapy. The primary objective of the study is to assess the ability of TRV734 to reduce acute opioid craving symptoms, as measured by the Subjective Opioid Withdrawal Scale. The study will also evaluate whether TRV734 suppresses withdrawal signs using the Clinical Opioid Withdrawal Scale. Secondary outcomes will include assessments of safety and measures of neurocognitive changes.

    About TRV734
    TRV734 is a new chemical entity (NCE) targeting the same novel mechanism of action as Trevena's intravenous (IV) NCE, oliceridine, which selectively stimulates G-protein signaling at the mu-opioid receptor with low beta-arrestin recruitment. TRV734 was designed to be orally available, and its mechanism of action suggests it may offer valuable benefits for two distinct areas of important unmet medical need: pain and management of opioid dependence associated with opioid use disorder. Trevena is collaborating with NIDA to further evaluate TRV734 as a potential maintenance therapy for opioid use disorder. TRV734 is an investigational product not approved by FDA for distribution in the US.

    About Trevena
    Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with Central Nervous System disorders. The Company has four novel and differentiated investigational drug candidates, including IV oliceridine, for the management of moderate to severe acute pain in hospitals, TRV250 for the acute treatment of migraine, and TRV734 for maintenance treatment of opioid use disorder. The Company has also identified TRV045, a novel S1P receptor modulator that may offer a new, non-opioid approach to managing chronic pain.

    Forward-Looking Statements
    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development and trials of its therapeutic candidates, plans for potential future product candidates and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "suggest," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the status, timing, costs, results and interpretation of the Company's clinical trials or any future trials of any of the Company's investigational drug candidates; the uncertainties inherent in conducting clinical trials; expectations for regulatory interactions, submissions and approvals, including the Company's assessment of the discussions with FDA; available funding ; uncertainties related to the Company's intellectual property; other matters that could affect the availability or commercial potential of the Company's therapeutic candidates; and other factors discussed in the Risk Factors set forth in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.

    For more information, please contact:

    Investor Contact:
    Dan Ferry
    Managing Director
    LifeSci Advisors, LLC

    (617) 430-7576

    Company Contact:
    Bob Yoder
    SVP and Chief Business Officer
    Trevena, Inc.
    (610) 354-8840

    Primary Logo

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  29. Safety, tolerability, and PK profile support potential utility as a novel acute migraine treatment option

    CHESTERBROOK, Pa., Dec. 12, 2019 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced a poster presentation at the 58th Annual Meeting of the American College of Neuropsychopharmacology (ACNP), in Orlando, FL. The poster presentation featured results from a Phase 1 first-in-human study that evaluated the safety, tolerability, and pharmacokinetics (PK) of TRV250, the Company's novel G protein-selective delta-receptor agonist being developed for the acute treatment of migraine…

    Safety, tolerability, and PK profile support potential utility as a novel acute migraine treatment option

    CHESTERBROOK, Pa., Dec. 12, 2019 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced a poster presentation at the 58th Annual Meeting of the American College of Neuropsychopharmacology (ACNP), in Orlando, FL. The poster presentation featured results from a Phase 1 first-in-human study that evaluated the safety, tolerability, and pharmacokinetics (PK) of TRV250, the Company's novel G protein-selective delta-receptor agonist being developed for the acute treatment of migraine.

    TRV250 was well-tolerated up to 30 mg, with a PK profile appropriate for an acute migraine therapy. There were no serious adverse events and no clinically significant changes in EEG, ECG, or other safety parameters.

    "We are excited to be pursuing TRV250 as a potential new therapeutic option for migraine sufferers, many of whom struggle to achieve relief with currently available options," said Mark A. Demitrack, M.D., Senior Vice President and Chief Medical Officer of Trevena, Inc. "The positive data from this Phase 1 study informed our recently initiated proof-of-concept study, with topline data anticipated in the second half of next year."

    Poster Presentation Details

    • Poster presentation (#142): "A Phase 1 Healthy Volunteer Study of the Safety, Tolerability and Pharmacokinetics of TRV250, a G Protein-Selective Delta Receptor Agonist", Wednesday, Dec. 11th, 5:00-7:00 p.m. EDT 

    About TRV250

    TRV250 is a G protein biased ligand targeting the delta receptor, with potential to be a first-in-class, non-narcotic mechanism for the treatment of migraine. TRV250 also may have utility in a range of other central nervous system indications. As a selective delta receptor modulator, TRV250 is not expected to have the abuse and addiction liability of medications targeting the mu opioid receptor. TRV250 is an investigational product and has not been approved by FDA for distribution in the US.

    About Trevena

    Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with CNS disorders. The Company has four novel and differentiated investigational drug candidates, including IV oliceridine, for the management of moderate to severe acute pain in hospitals, TRV250 for the acute treatment of migraine, and TRV734 for maintenance treatment of opioid use disorder. The Company has also identified TRV045, a novel S1P receptor modulator that may offer a new, non-opioid approach to managing chronic pain.

    Cautionary note on forward looking statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development of its therapeutic candidates, plans for potential future product candidates and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "suggest," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995.

    Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the status, timing, costs, results and interpretation of the Company's clinical trials; the uncertainties inherent in conducting clinical trials; expectations for regulatory approvals; availability of funding sufficient for the Company's foreseeable and unforeseeable operating expenses and capital expenditure requirements; uncertainties related to the Company's intellectual property; other matters that could affect the availability or commercial potential of the Company's therapeutic candidates; and other factors discussed in the Risk Factors set forth in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time-to-time.

    In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.

    This press release is not sanctioned by ACNP.

    For more information, please contact:

    Bob Yoder, SVP and Chief Business Officer
    Trevena, Inc.
    Phone: 610-354-8840

    Primary Logo

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  30. Former CEO of NPS Pharmaceuticals brings broad expertise to support Moderna's progress towards late-stage development and commercialization

    Moderna, Inc., (NASDAQ:MRNA) a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that François Nader, M.D., M.B.A. has joined its Board of Directors. Dr. Nader is an experienced biopharmaceutical executive and director with broad expertise across development, regulatory affairs and commercial at NPS Pharmaceuticals (acquired by Shire Plc, now part of Takeda (NYSE: TAK)), as well as Aventis-Pharma and the Pasteur Vaccines division of Rhone-Poulenc, now both part of Sanofi (NASDAQ…

    Former CEO of NPS Pharmaceuticals brings broad expertise to support Moderna's progress towards late-stage development and commercialization

    Moderna, Inc., (NASDAQ:MRNA) a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that François Nader, M.D., M.B.A. has joined its Board of Directors. Dr. Nader is an experienced biopharmaceutical executive and director with broad expertise across development, regulatory affairs and commercial at NPS Pharmaceuticals (acquired by Shire Plc, now part of Takeda (NYSE: TAK)), as well as Aventis-Pharma and the Pasteur Vaccines division of Rhone-Poulenc, now both part of Sanofi (NASDAQ:SNY).

    Concurrently with Dr. Nader's appointment, Peter Barton Hutt, LL.M. has elected to step down after seven years of service to Moderna. Mr. Hutt will remain as a consultant and advisor to the Company.

    "We are focused on continuing to add leaders to our board who understand the complexity of pioneering breakthrough innovations to support the next phase of Moderna's growth," said Noubar Afeyan, Ph.D., Co-Founder and Chairman of Moderna, and CEO of Flagship Pioneering. "François is a value builder with deep experience in vaccine and rare disease therapeutic development and expertise in leading companies from early to late-stage development. As we welcome François, I would like to thank Peter Hutt for the invaluable strategic and regulatory guidance he provided while serving on the board over the last seven years."

    "I am energized by Moderna's culture, science and the impact I believe mRNA medicines will make for patients across a range of therapeutic areas," said Dr. Nader. "I look forward to working with my fellow directors and applying learnings to support Moderna as the team continues generating new clinical data, prepares for pivotal trials and scales to ensure it is ready for commercialization."

    "As Moderna prepares for late-stage development and commercialization of our CMV vaccine, we sought a director with diverse experience across clinical development, regulatory affairs and commercial. François' success in leading late-stage companies as well as his deep experience in infectious and rare diseases make him an important addition to the board as we continue to advance our pipeline," said Stéphane Bancel, Chief Executive Officer of Moderna. "François has an impressive track record of leadership and value creation in the biopharmaceutical sector and I know we will benefit from his perspective. It has been a pleasure to work closely with Peter Hutt during his seven years on the board and I would like to thank him for his contributions to the Company's success."

    Dr. Nader served as President, Chief Executive Officer and Executive Director of NPS Pharmaceuticals from 2008 until 2015, when the company was acquired by Shire. During his tenure as CEO, Dr. Nader transformed NPS Pharma into a leading global biotechnology company focused on delivering innovative therapies to patients with rare diseases. Prior to NPS, Dr. Nader was a venture partner at Care Capital, a venture capital firm. He previously served on Aventis Pharma's North America Leadership Team, holding a number of executive positions in integrated healthcare markets and medical and regulatory affairs. Dr. Nader previously led global commercial operations at the Pasteur Vaccines division of Rhone-Poulenc.

    In addition to serving on the Moderna board of directors, Dr. Nader currently serves as Chairman of the board of directors of Acceleron Pharma (NASDAQ:XLRN), Prevail Therapeutics (NASDAQ:PRVL) and Talaris Therapeutics. He also serves on the Board of Directors of Alexion Pharmaceuticals (NASDAQ:ALXN) and advisor for SVB-Leerink. Dr. Nader is the past Chairman of BioNJ, New Jersey's biotechnology trade organization, and previously served on the board of the Biotechnology Industry Organization (BIO), NPS Pharma (NASDAQ:NPSP), Advanced Accelerator Applications (NASDAQ:AAAP), Baxalta (NYSE:BXLT), Clementia Pharmaceuticals (NASDAQ:CMTA), Trevena (NASDAQ:TRVN) and Noven (NASDAQ:NOVN). In 2013, he was recognized as the Ernst and Young National Life Science Entrepreneur of the Year.

    Dr. Nader earned his French doctorate in medicine from St. Joseph University in Lebanon and a physician executive MBA from the University of Tennessee.

    About Moderna

    Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body's cells to produce intracellular, membrane or secreted proteins that have a therapeutic or preventive benefit with the potential to address a broad spectrum of diseases. Moderna's platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing the Company the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and cardiovascular diseases, independently and with strategic collaborators.

    Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca, Plc. (NASDAQ:AZN) and Merck, Inc. (NASDAQ:MRK), as well as the Defense Advanced Research Projects Agency (NASDAQ:DARPA), an agency of the U.S. Department of Defense and the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). Moderna has been named a top biopharmaceutical employer by Science for the past five years. To learn more, visit www.modernatx.com.

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  31. No dose adjustments required for patients with renal impairment or patients with mild / moderate hepatic impairment

    CHESTERBROOK, Pa., Nov. 20, 2019 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced publication of results from two Phase 1 pharmacokinetic (PK) studies of IV oliceridine, one in patients with end-stage renal disease and one in patients with hepatic impairment, in Clinical Pharmacology in Drug Development. The results demonstrate that no dose adjustments are needed in patients with renal impairment or in patients with mild / moderate hepatic impairment.

    The publication…

    No dose adjustments required for patients with renal impairment or patients with mild / moderate hepatic impairment

    CHESTERBROOK, Pa., Nov. 20, 2019 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced publication of results from two Phase 1 pharmacokinetic (PK) studies of IV oliceridine, one in patients with end-stage renal disease and one in patients with hepatic impairment, in Clinical Pharmacology in Drug Development. The results demonstrate that no dose adjustments are needed in patients with renal impairment or in patients with mild / moderate hepatic impairment.

    The publication, "The Influence of Renal or Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of Oliceridine" with lead author Anne Nafziger, M.D., Department of Medicine at St. Peter's Hospital, Albany, NY, is available online at https://accp1.onlinelibrary.wiley.com/doi/10.1002/cpdd.750.

    "Due to the accumulation of active metabolites, conventional IV opioids often require dosage adjustments when administered to patients with renal or hepatic impairment. The results of these two studies demonstrate that there is no clinically relevant difference in oliceridine clearance in patients with renal or hepatic dysfunction," said Mark A. Demitrack, M.D., Senior Vice President and Chief Medical Officer of Trevena, Inc. "These findings suggest that oliceridine may provide a new IV analgesic treatment option with clinical advantages for these at-risk patient populations."

    Study Summary and Key Findings:

    • A Phase 1, multi-center, open-label study evaluated oliceridine PK, safety, and tolerability in 17 subjects with end-stage kidney disease. In these subjects with severe renal impairment, there was no clinically relevant change in oliceridine total clearance (>50% difference) or other PK parameters compared with healthy age- and sex-matched controls.
    • A Phase 1, multi-center, open-label study evaluated oliceridine PK, safety, and tolerability in 34 subjects with mild, moderate, and severe hepatic impairment. In subjects with mild, moderate, and severe hepatic impairment, there were no clinically relevant differences in oliceridine total clearance compared with healthy subjects. Additional PK findings suggest that initial dose reduction in individuals with severe hepatic impairment should be considered, as they may require fewer doses of oliceridine compared to healthy individuals.
    • The most commonly reported adverse events (AEs) were nausea, fatigue, and euphoria. All treatment-emergent AEs in both studies were of mild intensity.

    About Oliceridine

    Oliceridine is a G protein biased (selective) mu-opioid receptor ligand in development for the management of moderate to severe acute pain in hospitals or other controlled clinical settings where intravenous therapy is warranted. It is a new chemical entity with a novel mechanism of action that enables more selective targeting of newly discovered pathways with the potential for fewer side effects. Oliceridine is an investigational product and has not been approved by the FDA or any other regulatory agency. If approved, the Company expects that oliceridine will be classified as a Schedule II controlled substance.

    About Trevena

    Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with CNS disorders. The Company has four novel and differentiated investigational drug candidates, including IV oliceridine, for the management of moderate to severe acute pain in hospitals, TRV250 for the acute treatment of migraine, and TRV734 for maintenance treatment of opioid use disorder. The Company has also identified TRV045, a novel S1P receptor modulator that may offer a new, non-opioid approach to managing chronic pain.

    Cautionary note on forward looking statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development of its therapeutic candidates, plans for potential future product candidates and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "suggest," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995.

    Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the status, timing, costs, results and interpretation of the Company's clinical trials; the uncertainties inherent in conducting clinical trials; expectations for regulatory approvals; availability of funding sufficient for the Company's foreseeable and unforeseeable operating expenses and capital expenditure requirements; uncertainties related to the Company's intellectual property; other matters that could affect the availability or commercial potential of the Company's therapeutic candidates, including whether IV opioids remain a necessary medication for many hospital patients and whether oliceridine might become a new option or clinically important alternative to help hospitals and healthcare providers better manage their patients' pain; and other factors discussed in the Risk Factors set forth in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time-to-time.

    In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.

    For more information, please contact:

    Investor Contact:
    Valter Pinto / Allison Soss
    KCSA Strategic Communications
    Phone: 212-896-1254 / 212-896-1267
    Email:  

    Company Contact:
    Bob Yoder, SVP and Chief Business Officer
    Trevena, Inc.
    Phone: 610-354-8840

    Primary Logo

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  32. Safety and tolerability demonstrated in diverse patient populations and surgeries

    CHESTERBROOK, Pa., Nov. 20, 2019 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced publication of results from the Phase 3 open-label safety study (ATHENA) for IV oliceridine in The Journal of Pain Research. The results highlight the safety and tolerability of oliceridine in the management of moderate-to-severe acute pain in a variety of surgical / medical settings and patient populations.

    The publication, "ATHENA: A Phase 3, Open Label Study of the Safety and Effectiveness of Oliceridine (TRV130…

    Safety and tolerability demonstrated in diverse patient populations and surgeries

    CHESTERBROOK, Pa., Nov. 20, 2019 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced publication of results from the Phase 3 open-label safety study (ATHENA) for IV oliceridine in The Journal of Pain Research. The results highlight the safety and tolerability of oliceridine in the management of moderate-to-severe acute pain in a variety of surgical / medical settings and patient populations.

    The publication, "ATHENA: A Phase 3, Open Label Study of the Safety and Effectiveness of Oliceridine (TRV130), a G-Protein Selective Agonist at the µ-Opioid Receptor, in Patients with Moderate to Severe Acute Pain Requiring Parenteral Opioid Therapy" with investigator and lead author, Sergio Bergese, M.D., Department of Anesthesiology, School of Medicine, Stony Brook University, is available online on Dove Medical Press.

    "The results of this study show that oliceridine was generally safe and well-tolerated in a variety of surgical and medical conditions with acute pain. Additionally, oliceridine performed consistently in the patient population studied, including elderly and obese patients, who are at greater risk for developing opioid-related adverse effects," said Dr. Bergese. "These findings suggest that oliceridine may represent a potential new treatment option for the management of moderate-to-severe acute pain where IV opioid therapy is warranted."

    Study Summary and Key Findings:

    • This was a Phase 3, multi-center, open-label study that evaluated the safety of oliceridine in 768 patients with moderate-to-severe acute pain. It was conducted in 41 sites in the United States, including ambulatory surgical centers, hospital-based outpatient and inpatient settings, and emergency departments.

    • In order to study oliceridine in a broad, "real world" context where IV analgesics are typically used, the protocol was designed with broader patient eligibility criteria, concomitant treatment allowances, and mode of administration (both clinician-directed bolus and patient-controlled analgesia were permitted as clinically indicated).

    • The average age of patients in this study was 54 years. 32% of patients were 65 years or older, and 46% were considered obese with a body mass index (BMI) of 30 kg/m2 or higher. The study included patients with a range of co-morbidities, including diabetes, chronic / cancer pain and obstructive sleep apnea. 

    • Patients with post-surgical acute pain comprised the majority of the study population (94%). The most common procedure types were orthopedic (30%), colorectal (15%) and gynecological (15%).

    • AEs were mostly of mild or moderate severity, and only 2% of patients discontinued treatment due to an AE. The most commonly reported adverse events (AEs) were nausea, vomiting, and constipation.

    About Oliceridine

    Oliceridine is a G protein biased (selective) mu-opioid receptor ligand in development for the management of moderate to severe acute pain in hospitals or other controlled clinical settings where intravenous therapy is warranted. It is a new chemical entity with a novel mechanism of action that enables more selective targeting of newly discovered pathways with the potential for fewer side effects. Oliceridine is an investigational product and has not been approved by the FDA or any other regulatory agency. If approved, the Company expects that oliceridine will be classified as a Schedule II controlled substance.

    About Trevena

    Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with CNS disorders. The Company has four novel and differentiated investigational drug candidates, including IV oliceridine, for the management of moderate to severe acute pain in hospitals, TRV250 for the acute treatment of migraine, and TRV734 for maintenance treatment of opioid use disorder. The Company has also identified TRV045, a novel S1P receptor modulator that may offer a new, non-opioid approach to managing chronic pain.

    Cautionary note on forward looking statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development of its therapeutic candidates, plans for potential future product candidates and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "suggest," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995.

    Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the status, timing, costs, results and interpretation of the Company's clinical trials; the uncertainties inherent in conducting clinical trials; expectations for regulatory approvals; availability of funding sufficient for the Company's foreseeable and unforeseeable operating expenses and capital expenditure requirements; uncertainties related to the Company's intellectual property; other matters that could affect the availability or commercial potential of the Company's therapeutic candidates, including whether IV opioids remain a necessary medication for many hospital patients and whether oliceridine might become a new option or clinically important alternative to help hospitals and healthcare providers better manage their patients' pain; and other factors discussed in the Risk Factors set forth in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time-to-time.

    In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.

    For more information, please contact:

    Investor Contact:
    Valter Pinto / Allison Soss
    KCSA Strategic Communications
    Phone: 212-896-1254 / 212-896-1267
    Email:  

    Company Contact:
    Bob Yoder, SVP and Chief Business Officer
    Trevena, Inc.
    Phone: 610-354-8840

    Primary Logo

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  33. CHESTERBROOK, Pa., Nov. 18, 2019 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced that Mark Demitrack, M.D., Senior Vice President and Chief Medical Officer, will present at the Stifel 2019 Healthcare Conference, sponsored by Stifel, to be held at the Lotte New York Palace Hotel in New York City on Wednesday, November 20, 2019 at 8:35 a.m. EST.

    A live audio webcast and archived replay of the presentation will be available on Trevena's investor relations website at https://investors.trevena.com/. Following the conclusion of the presentation, the webcast will be available for…

    CHESTERBROOK, Pa., Nov. 18, 2019 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced that Mark Demitrack, M.D., Senior Vice President and Chief Medical Officer, will present at the Stifel 2019 Healthcare Conference, sponsored by Stifel, to be held at the Lotte New York Palace Hotel in New York City on Wednesday, November 20, 2019 at 8:35 a.m. EST.

    A live audio webcast and archived replay of the presentation will be available on Trevena's investor relations website at https://investors.trevena.com/. Following the conclusion of the presentation, the webcast will be available for replay for 30 days.

    For more information about the conferences, or to schedule a one-on-one meeting with Trevena's management, please contact KCSA Strategic Communications at , or send an email to (Stifel).

    About Trevena
    Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with CNS disorders. The Company has four novel and differentiated investigational drug candidates, including IV oliceridine, for the management of moderate-to-severe acute pain in hospitals, TRV250 for the acute treatment of migraine, and TRV734 for maintenance treatment of opioid use disorder. The Company has also identified TRV045, a novel S1P receptor modulator that may offer a new, non-opioid approach to managing chronic pain.

    For more information, please contact:

    Investor Contact:
    Valter Pinto / Allison Soss
    KCSA Strategic Communications
    Phone: 212-896-1254 / 212-896-1267
    Email:  

    Company Contact:
    Bob Yoder, SVP and Chief Business Officer
    Trevena, Inc.
    Phone: 610-354-8840

    Primary Logo

    View Full Article Hide Full Article
  34. Company expects to resubmit NDA for oliceridine in Q1 2020 

    Acute migraine proof-of-concept study for TRV250 initiated 

    Company to host conference call at 8:30 a.m. EST

    CHESTERBROOK, Pa., Nov. 04, 2019 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced topline results from its multi-dose QT study for IV oliceridine, reported its financial results for the third quarter ended September 30, 2019, and provided an overview of its recent operational highlights.

    "We believe the information provided from the multi-dose QT study thoroughly addresses the questions FDA posed to us. The…

    Company expects to resubmit NDA for oliceridine in Q1 2020 

    Acute migraine proof-of-concept study for TRV250 initiated 

    Company to host conference call at 8:30 a.m. EST

    CHESTERBROOK, Pa., Nov. 04, 2019 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced topline results from its multi-dose QT study for IV oliceridine, reported its financial results for the third quarter ended September 30, 2019, and provided an overview of its recent operational highlights.

    "We believe the information provided from the multi-dose QT study thoroughly addresses the questions FDA posed to us. The results show no evidence of an accumulating effect of oliceridine on the QT interval, when administered in repeated doses to the 27 mg proposed maximum daily dose over 24 hours," said Mark Demitrack, M.D., SVP and Chief Medical Officer. "These data, alongside the cardiac safety data submitted in the original NDA, provide a comprehensive assessment of the safety and tolerability of oliceridine, and will allow us to move ahead with plans for NDA resubmission in the first quarter of next year."

    Recent Corporate Highlights:

    • Completed multi-dose QT study for oliceridine. No accumulation of effect was observed on the QT interval. A small, transient effect, consistent with that observed in the single-dose QT study, began dissipating after 12 hours and was absent at the end of the 24-hour study period despite repeated dosing of oliceridine.

      Oliceridine was well tolerated, with 59 subjects receiving the 27 mg maximum daily dose. There were no serious adverse events.

      In addition to this data, the Company previously announced that it has completed the work to address the other items requested by FDA in their complete response letter (CRL) for oliceridine. The Company expects to resubmit the NDA for oliceridine in the first quarter of 2020.

    • Initiated TRV250 acute migraine proof-of-concept study. This is a single-dose, double-blind, placebo-controlled study with an enrollment target of approximately 120 migraine patients in a validated nitroglycerin (NTG) provocation migraine model. Patients will be randomized before receiving a continuous NTG infusion, followed by administration of a 20 mg subcutaneous dose of TRV250 or placebo.

      The primary objective of the study is to determine target engagement, which will be measured as a reduction of sustained NTG-induced headaches. This study will also evaluate the overall safety of TRV250 and its ability to reduce symptomatic anxiety. The Company anticipates reporting topline data from this study in the second half of 2020.

    "With the completion of the multi-dose QT study, we have concluded all the necessary activities to address FDA's questions in the CRL for oliceridine. We remain on track to resubmit the NDA for oliceridine in the first quarter of next year," said Carrie Bourdow, President and Chief Executive Officer. "I am also very pleased that we continue to advance our pipeline with initiation of the acute migraine proof-of-concept study for TRV250."

    Financial Results for Third Quarter 2019

    For the third quarter of 2019, the Company reported a net loss attributable to common stockholders of $8.6 million, or $0.09 per share, compared to $4.5 million, or $0.06 per share, for the third quarter of 2018. This increase is primarily due to increased research and development expenditures in connection with our healthy volunteer QT study.

    Cash, cash equivalents, and marketable securities were $44.7 million as of September 30, 2019. The Company believes its cash, cash equivalents, and marketable securities as of September 30, 2019, together with interest thereon, to be sufficient to fund the Company's operating expenses, debt service, and capital expenditure requirements into the third quarter of 2020.

    Conference Call and Webcast Information

    The Company will host a conference call and webcast with the investment community on November 4th, 2019 at 8:30 a.m. Eastern Time featuring remarks by Carrie Bourdow, President and Chief Executive Officer, Barry Shin, SVP and Chief Financial Officer, and Mark Demitrack, SVP and Chief Medical Officer.

    Live Call: Toll-Free: (855) 465-0180
    International: (484) 756-4313
       
    Webcast:
    investors.trevena.com
       
    Replay:

     
    Toll-Free: (855) 859-2056 
    International: (404) 537-3406 
    Conference ID: 5249124
    (Available approximately one hour after the completion of the live call until 11:59 p.m. ET on November 11, 2019)

    About the Oliceridine Multi-Dose QT Study

    This was a randomized, single-site, placebo- and positive-controlled three-period crossover study conducted in 68 healthy volunteers, with 59 subjects receiving the maximum daily dose of 27 mg of IV oliceridine. The protocol and statistical analysis plan were developed based on review and feedback from FDA. The goal of the study was to collect the additional QT interval data requested by FDA for the resubmission of the NDA for oliceridine.

    Subjects were randomly sequenced through all three study periods: IV oliceridine, placebo, and a single oral 400 mg moxifloxacin dose as a positive control. For the oliceridine and placebo arms, 2 or 3 mg of study drug or volume-matched placebo was administered by IV bolus every two hours over a 24-hour period. Electrocardiograms for all subjects were obtained at hourly timepoints using continuous Holter monitoring.

    Oliceridine was well tolerated; adverse events were generally mild to moderate in severity and consistent with adverse events observed in the prior safety database. There were no serious adverse events.

    The primary endpoint was the placebo-corrected change from baseline in the individual rate-corrected QT interval (∆∆QTcI) measured hourly at each of the 24 time points in the study. On this outcome, the mean ∆∆QTcI was less than 10 msec at 22 of the 24 time points. The peak mean ∆∆QTcI was observed at 9 hours and was 11.7 msec, with a 90% two-sided confidence interval upper bound of 14.7 msec at this time point. At 18 of the 24 measured timepoints, the upper bound of the 90% confidence intervals for the mean ∆∆QTcI was less than 10 msec.   

    Secondary endpoints included the 24-hour time-weighted average ∆∆QTcI and categorical analyses of clinically significant individual outliers. The 24-hour time-weighted average ∆∆QTcI for oliceridine was 4.0 msec (90% two-sided CI=2.29, 5.78). There were no individual outliers with a rate-corrected change from baseline >60 msec or an absolute QT interval >500 msec.

    About Oliceridine

    Oliceridine is a G protein biased (selective) mu-opioid receptor ligand in development for the management of moderate-to-severe acute pain in hospitals or other controlled clinical settings where intravenous therapy is warranted. It is a new chemical entity with a novel mechanism of action that enables more selective targeting of newly discovered pathways with the potential for fewer side effects. Oliceridine is an investigational product and has not been approved by the FDA or any other regulatory agency. If approved, the Company expects that oliceridine will be classified as a Schedule II controlled substance.

    About Trevena

    Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with CNS disorders. The Company has four novel and differentiated investigational drug candidates, including IV oliceridine, for the management of moderate to severe acute pain in hospitals, TRV250 for the acute treatment of migraine, and TRV734 for maintenance treatment of opioid use disorder. The Company has also identified TRV045, a novel S1P receptor modulator that may offer a new, non-opioid approach to managing chronic pain.

    Forward-Looking Statements

    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development of its therapeutic candidates, plans for potential future product candidates and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "suggest," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the status, timing, costs, results and interpretation of the Company's clinical trials or any future trials, including with respect to any future clinical study of oliceridine; the uncertainties inherent in conducting clinical trials; expectations for regulatory interactions, submissions and approvals, including the Company's assessment of the discussions with FDA, and whether there is a path to resubmit the oliceridine NDA; availability of funding sufficient for the Company's foreseeable and unforeseeable operating expenses and capital expenditure requirements and whether cash, cash equivalents, and marketable securities as of September 30, 2019 will be sufficient to fund operating expenses and capital expenditure requirements into the third quarter of 2020; uncertainties related to the Company's intellectual property; other matters that could affect the availability or commercial potential of the Company's therapeutic candidates; and other factors discussed in the Risk Factors set forth in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.

    For more information, please contact:

    Investor Contact:
    Valter Pinto / Allison Soss
    KCSA Strategic Communications
    Phone: 212-896-1254 / 212-896-1267
    Email:  

    Company Contact:
    Bob Yoder, SVP and Chief Business Officer
    Trevena, Inc.
    Phone: 610-354-8840

    TREVENA, INC.
    Condensed Statements of Operations
    (Unaudited, in thousands except share and per share data)
                   
      Three Months Ended September 30,   Nine Months Ended September 30,
        2019       2018       2019       2018  
                   
    Revenue $ -     $ 3,000     $ -     $ 5,500  
                   
    Operating expenses:              
    General and administrative   3,201       3,908       9,572       14,906  
    Research and development   5,554       3,350       10,430       13,076  
    Restructuring charges   -       -       -       64  
    Impairment of property and equipment   -       -       108       -  
    Total operating expenses   8,755       7,258       20,110       28,046  
    Loss from operations   (8,755 )     (4,258 )     (20,110 )     (22,546 )
    Other income   189       (225 )     1,684       483  
    Loss before income tax expense   (8,566 )     (4,483 )     (18,426 )     (22,063 )
    Foreign income tax expense   -       -       -       (745 )
    Net loss $ (8,566 )   $ (4,483 )   $ (18,426 )   $ (22,808 )
                   
    Per share information:              
    Net loss per share of common stock, basic and diluted   ($0.09 )     ($0.06 )     ($0.20 )     ($0.32 )
    Weighted average shares outstanding, basic and diluted   92,569,993       77,445,675       91,307,429       70,604,827  


    TREVENA, INC.
    Condensed Balance Sheets
    (Unaudited, in thousands)
           
      September 30, 2019
        December 31, 2018
     
    Assets      
    Current assets:      
    Cash and cash equivalents $ 29,255     $ 32,892  
    Marketable securities   15,461       28,590  
    Prepaid expenses and other current assets   2,329       607  
    Total current assets   47,045       62,089  
    Restricted cash   1,308       1,303  
    Property and equipment, net   2,848       3,387  
    Right-of-use lease assets   5,552       -  
    Other assets   18       -  
    Total assets $ 56,771     $ 66,779  
           
    Liabilities and stockholders' equity      
    Current liabilities:      
    Accounts payable $ 3,075     $ 1,416  
    Accrued expenses and other current liabilities   2,380       3,295  
    Current portion of loans payable, net   8,158       12,562  
    Current portion of lease liabilities   600       10  
    Deferred rent   -       207  
    Total current liabilities   14,213       17,490  
    Loans payable, net   -       4,811  
    Leases, net of current portion   7,968       20  
    Deferred rent, net of current portion   -       2,931  
    Warrant liability   6       1  
    Total liabilities   22,187       25,253  
           
    Common stock   92       82  
    Additional paid-in capital   441,187       429,727  
    Accumulated deficit   (406,700 )     (388,274 )
    Accumulated other comprehensive income (loss)   5       (9 )
    Total stockholders' equity   34,584       41,526  
    Total liabilities and stockholders' equity $ 56,771     $ 66,779  

     

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  35. CHESTERBROOK, Pa., Oct. 21, 2019 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) conditions, today announced four presentations at ANESTHESIOLOGY® 2019, the national conference for the American Society of Anesthesiologists, held at the Orange County Convention Center in Orlando, Florida, October 19-23.  The presentations included one oral presentation and three posters, all of which discussed the safety profile of oliceridine.

    "IV opioids remain an effective treatment option for physicians in managing moderate-to-severe acute pain following surgery. However, opioid-related adverse effects – most notably…

    CHESTERBROOK, Pa., Oct. 21, 2019 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) conditions, today announced four presentations at ANESTHESIOLOGY® 2019, the national conference for the American Society of Anesthesiologists, held at the Orange County Convention Center in Orlando, Florida, October 19-23.  The presentations included one oral presentation and three posters, all of which discussed the safety profile of oliceridine.

    "IV opioids remain an effective treatment option for physicians in managing moderate-to-severe acute pain following surgery. However, opioid-related adverse effects – most notably respiratory depression – can interfere with a drug's analgesic efficacy and complicate a patient's recovery," said Albert Dahan, M.D., Professor of Anesthesiology at the Leiden University Medical Center.  "Because there are no generally agreed standard definitions for respiratory depression, our group has devoted attention to improving the quantitative assessment of respiratory depression in controlled clinical settings for various opioid medications.  We applied this technique, called clinical utility function analysis, to available data for oliceridine, and I was pleased to present the intriguing results of that analysis at this year's conference."

    Dr. Dahan presented the findings from a clinical utility function analysis of the ventilatory response to hypercapnia data from the Phase 1 proof-of-concept study comparing oliceridine to IV morphine in healthy human volunteers.  The oral presentation, titled "Improved safety of opioid analgesic Oliceridine compared to Morphine assessed by utility function analysis," was part of the Best of Abstracts: Clinical Science featured session.

    In addition, three poster presentations featured safety and tolerability data from the Phase 3 pivotal trials (APOLLO 1 / APOLLO 2) and "real-world use" open-label safety study (ATHENA) for oliceridine:

    1. Low Incidence Of Opioid-induced Respiratory Depression Observed With Oliceridine Regardless Of Age Or Body Mass Index (Brzezinski, M. et al) (e-poster, abstract #2228)
    2. Lower Incidence Of Postoperative Opioid-induced Respiratory Depression With Oliceridine Compared To Morphine: A Retrospective Analysis (Bergese, S. et al) (e-poster, abstract #2232)
    3. Oliceridine (TRV130) Demonstrates Less Opioid-induced Respiratory Depression Than Morphine (M) As Measured By The Average Cumulative Duration Of Dosing Interruption In Patients Being Treated For Acute Post-surgical Pain (Ayad, S. et al) (e-poster, abstract #3069)

    About Oliceridine
    Oliceridine is a G protein biased (selective) mu-opioid receptor (MOR) ligand in development for the management of moderate-to-severe acute pain in hospitals or other controlled clinical settings where intravenous (IV) therapy is warranted. It is a new chemical entity with a novel mechanism of action that enables more selective targeting of newly discovered pathways with the potential for fewer side effects. Oliceridine is an investigational product and has not been approved by the FDA or any other regulatory agency. If approved, the Company expects that oliceridine will be classified as a Schedule II controlled substance.

    About Trevena
    Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with CNS conditions.  The Company has four novel and differentiated investigational drug candidates, including IV oliceridine, for the management of moderate to severe acute pain in hospitals, TRV250 for the acute treatment of migraine, and TRV734 for maintenance treatment of opioid use disorder.  The Company has also identified TRV045, a novel S1P receptor modulator that may offer a new, non-opioid approach to managing chronic pain.

    Forward Looking Statements
    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development of its therapeutic candidates, plans for potential future product candidates and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "suggest," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the status, timing, costs, results and interpretation of the Company's clinical trials, nonclinical studies, or any future trials, including with respect to any future clinical study of oliceridine; the uncertainties inherent in conducting clinical trials; expectations for regulatory interactions, submissions and approvals, including the Company's assessment of the discussions with FDA, and whether there is a path to resubmit the oliceridine NDA; uncertainties related to the Company's intellectual property; other matters that could affect the availability or commercial potential of the Company's therapeutic candidates; and other factors discussed in the Risk Factors set forth in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.

    For more information, please contact:

    Investor Contact:
    Valter Pinto / Allison Soss
    KCSA Strategic Communications
    Phone: 212-896-1254 / 212-896-1267
    Email:  

    Company Contact:
    Bob Yoder, SVP and Chief Business Officer
    Trevena, Inc.
    Phone: 610-354-8840

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  36. CHESTERBROOK, Pa., Sept. 27, 2019 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with Central Nervous System (CNS) conditions, today announced that its management team will present at the 2019 Cantor Global Healthcare Conference sponsored by Cantor Fitzgerald, to be held at the InterContinental New York Barclay Hotel in New York City on Friday, October 4, 2019 at 8:20 a.m. EST.

    A live audio webcast and archived replay of the presentation will be available on the Company's investor relations website at https://investors.trevena.com/.  Following the conclusion of the presentation, the webcast will be available for replay for 30 days…

    CHESTERBROOK, Pa., Sept. 27, 2019 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with Central Nervous System (CNS) conditions, today announced that its management team will present at the 2019 Cantor Global Healthcare Conference sponsored by Cantor Fitzgerald, to be held at the InterContinental New York Barclay Hotel in New York City on Friday, October 4, 2019 at 8:20 a.m. EST.

    A live audio webcast and archived replay of the presentation will be available on the Company's investor relations website at https://investors.trevena.com/.  Following the conclusion of the presentation, the webcast will be available for replay for 30 days.

    For more information about the conference, or to schedule a one-on-one meeting with the Company's management, please contact KCSA Strategic Communications at , or send an email to (Cantor Fitzgerald).

    About Trevena

    Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with Central Nervous System conditions.  The Company has four novel and differentiated investigational drug candidates, including IV oliceridine, for the management of moderate-to-severe acute pain in hospitals, TRV250 for the acute treatment of migraine, and TRV734 for maintenance treatment of opioid use disorder. The Company has also identified TRV045, a novel S1P receptor modulator that may offer a new, non-opioid approach to managing chronic pain.

    For more information, please contact:

    Investor Contact:
    Valter Pinto / Allison Soss
    KCSA Strategic Communications
    Phone: 212-896-1254 / 212-896-1267
    Email:  

    Company Contact:
    Bob Yoder, SVP and Chief Business Officer
    Trevena, Inc.
    Phone: 610-354-8840

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  37. CHESTERBROOK, Pa., Sept. 03, 2019 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with Central Nervous System (CNS) conditions, today announced that its management team will participate in two upcoming conferences:

    • H.C. Wainwright 21st Annual Global Investment Conference, sponsored by H.C. Wainwright, to be held at the Lotte New York Palace Hotel in New York City on Tuesday, September 10, 2019 at 9:35am ET. 

      Live audio webcast and archived replay of the presentation will be available on Trevena's investor relations website at https://investors.trevena.com/. Following the conclusion of the presentation, the webcast will be available…

    CHESTERBROOK, Pa., Sept. 03, 2019 (GLOBE NEWSWIRE) -- Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with Central Nervous System (CNS) conditions, today announced that its management team will participate in two upcoming conferences:

    • H.C. Wainwright 21st Annual Global Investment Conference, sponsored by H.C. Wainwright, to be held at the Lotte New York Palace Hotel in New York City on Tuesday, September 10, 2019 at 9:35am ET. 

      Live audio webcast and archived replay of the presentation will be available on Trevena's investor relations website at https://investors.trevena.com/. Following the conclusion of the presentation, the webcast will be available for replay for 30 days. 

    • Oppenheimer Fall Summit Focused on Specialty Pharma & Rare Disease Companies, sponsored by Oppenheimer & Co., to be held at the  Parker New York Hotel in New York City on Wednesday, September 23 and Thursday, September 24, 2019.

    For more information about the conferences, or to schedule a one-on-one meeting with Trevena's management, please contact KCSA Strategic Communications at , or send an email to (H.C. Wainright), or (Oppenheimer & Co.).

    About Trevena
    Trevena, Inc.  is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with Central Nervous System conditions.  The Company has four novel and differentiated investigational drug candidates, including IV oliceridine, for the management of moderate to severe acute pain in hospitals, TRV250 for the acute treatment of migraine, and TRV734 for maintenance treatment of opioid use disorder. The Company has also identified TRV045, a novel S1P receptor modulator that may offer a new, non-opioid approach to managing chronic pain.

    For more information, please contact:

    Investor Contact:
    Valter Pinto / Allison Soss
    KCSA Strategic Communications
    Phone: 212-896-1254 / 212-896-1267
    Email:  

    Company Contact:
    Bob Yoder, SVP and Chief Business Officer
    Trevena, Inc.
    Phone: 610-354-8840

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  38. Former Attorney General of Louisiana, Charles C. Foti, Jr., Esq., a partner at the law firm of Kahn Swick & Foti, LLC ("KSF"), announces that KSF has commenced an investigation into Trevena, Inc. (NASDAQ:TRVN).

    On November 7, 2017, the Company reported that it had submitted a New Drug Application ("NDA") for Oliceridine, its lead product candidate. On November 2, 2018, the Company disclosed that it received a response from the Food and Drug Administration ("FDA") denying the NDA for Oliceridine due to inadequate data to support approval. However, documents released prior to the Company's disclosure containing details of the FDA's communications with the Company revealed that the FDA had informed the Company during a March 29, 2016 meeting…

    Former Attorney General of Louisiana, Charles C. Foti, Jr., Esq., a partner at the law firm of Kahn Swick & Foti, LLC ("KSF"), announces that KSF has commenced an investigation into Trevena, Inc. (NASDAQ:TRVN).

    On November 7, 2017, the Company reported that it had submitted a New Drug Application ("NDA") for Oliceridine, its lead product candidate. On November 2, 2018, the Company disclosed that it received a response from the Food and Drug Administration ("FDA") denying the NDA for Oliceridine due to inadequate data to support approval. However, documents released prior to the Company's disclosure containing details of the FDA's communications with the Company revealed that the FDA had informed the Company during a March 29, 2016 meeting that it did not agree with many aspects of the clinical trials and the NDA.

    Thereafter, the Company and certain of its executives were sued in a securities class action lawsuit, charging them with failing to disclose material information during the Class Period, which is ongoing.

    KSF's investigation is focusing on whether Trevena's officers and/or directors breached their fiduciary duties to Trevena's shareholders or otherwise violated state or federal laws.

    If you have information that would assist KSF in its investigation, or have been a long-term holder of Trevena shares and would like to discuss your legal rights, you may, without obligation or cost to you, call toll-free at 1-877-515-1850 or email KSF Managing Partner Lewis Kahn (), or visit https://www.ksfcounsel.com/cases/nasdaqgs-trvn/ to learn more.

    About Kahn Swick & Foti, LLC

    KSF, whose partners include the Former Louisiana Attorney General Charles C. Foti, Jr., is a law firm focused on securities, antitrust and consumer class actions, along with merger & acquisition and breach of fiduciary litigation against publicly traded companies on behalf of shareholders. The firm has offices in New York, California and Louisiana.

    To learn more about KSF, you may visit www.ksfcounsel.com.

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  39. Completed enrollment in healthy volunteer QT study, topline data expected in Q4 2019

    Completed characterization of inactive metabolite

    — Remains on track to resubmit NDA in Q1 2020 —

    CHESTERBROOK, Pa., Aug. 28, 2019 (GLOBE NEWSWIRE) --  Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with Central Nervous System (CNS) conditions, today provided an update on the activities to support resubmission of the New Drug Application (NDA) for oliceridine.

    The Company has completed enrollment for the ongoing healthy volunteer QT study and remains on track to support topline data readout in the fourth quarter of 2019.  

    In addition, the Company has completed…

    Completed enrollment in healthy volunteer QT study, topline data expected in Q4 2019

    Completed characterization of inactive metabolite

    — Remains on track to resubmit NDA in Q1 2020 —

    CHESTERBROOK, Pa., Aug. 28, 2019 (GLOBE NEWSWIRE) --  Trevena, Inc. (NASDAQ:TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with Central Nervous System (CNS) conditions, today provided an update on the activities to support resubmission of the New Drug Application (NDA) for oliceridine.

    The Company has completed enrollment for the ongoing healthy volunteer QT study and remains on track to support topline data readout in the fourth quarter of 2019.  

    In addition, the Company has completed the necessary nonclinical work to further characterize the 9662 inactive metabolite.  As agreed to with FDA, the Company has generated reproducible pharmacokinetic data using validated bioanalytical methods that demonstrate acceptable levels of exposure to the metabolite in nonclinical species. 

    Lastly, the Company has finished the outstanding drug product validation reports identified in the Complete Response Letter (CRL), which will be included in the NDA resubmission package. 

     "We continue to make steady progress on all fronts to gather the information needed to resubmit the NDA for oliceridine," said Carrie Bourdow, President and Chief Executive Officer.  "I am pleased that we have finished the work to address three of the four items outlined in the CRL.  Once we receive topline data for the healthy volunteer QT study, which we are on schedule to report next quarter, we look forward to resubmitting the NDA as early as possible in the first quarter of next year."

    About Trevena
    Trevena, Inc.  is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with Central Nervous System conditions.  The Company has four novel and differentiated investigational drug candidates, including IV oliceridine, for the management of moderate to severe acute pain in hospitals, TRV250 for the acute treatment of migraine, and TRV734 for maintenance treatment of opioid use disorder. The Company has also identified TRV045, a novel S1P receptor modulator that may offer a new, non-opioid approach to managing chronic pain.

    Forward-Looking Statements
    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development of its therapeutic candidates, plans for potential future product candidates and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "suggest," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the status, timing, costs, results and interpretation of the Company's clinical trials, nonclinical studies, or any future trials, including with respect to any future clinical study of oliceridine; the uncertainties inherent in conducting clinical trials; expectations for regulatory interactions, submissions and approvals, including the Company's assessment of the discussions with FDA, and whether there is a path to resubmit the oliceridine NDA; uncertainties related to the Company's intellectual property; other matters that could affect the availability or commercial potential of the Company's therapeutic candidates; and other factors discussed in the Risk Factors set forth in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.

    For more information, please contact:

    Investor Contact:
    Valter Pinto / Allison Soss
    KCSA Strategic Communications
    Phone: 212-896-1254 / 212-896-1267
    Email:  

    Company Contact:
    Bob Yoder, SVP and Chief Business Officer
    Trevena, Inc.
    Phone: 610-354-8840

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