Trevena, Inc. · OTC:TRVN
Trevena — Investor Presentation (September 2023)
31 slides from Trevena's investor presentation, Sep 6, 2023
Slide 1: Innovating for Patients
INNOVATING FOR PATIENTS Nasdaq: TRVN I September 2023
Slide 2: Forward-Looking Statements
Forward - Looking Statements To the extent that statements contained in this presentation are not descriptions of historical facts regarding Trevena, Inc. (t he “Company” or “we”), they are forward - looking statements reflecting management’s current beliefs and expectations. Forward - looking state
Slide 3: Trevena's Experienced Leadership Team
BOARD OF DIRECTORS Leon O. Moulder , Jr. Chairman Marvin H. Johnson, Jr. Carrie L. Bourdow Jake R. Nunn Scott Braunstein, M.D. Anne M. Phillips, M.D. Mark Corrigan, M.D. Barbara Yanni Michael R. Dougherty SENIOR MANAGEMENT Carrie L. Bourdow President & Chief Executive Officer Mark A. Demitrack , M.D
Slide 4: Trevena: Innovative CNS Company
Trevena: Innovative CNS Company 4 *OLINVYK 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 BOXED WARNING at the end of presentation.
Slide 5: Highlights and Multiple Expected Catalysts
PRE - CLIN PHASE 1 PHASE 2 PHASE 3 NDA POST - APPR Highlights OLINVYK® New chemical entity (mu - opioid receptor) TRV045 Selective S1P receptor modulator • Data reported • Data reported • Data expected 2H 23 TRV734 G - protein selective agonist (mu - opioid receptor) Multiple Expected Catalysts 5 NI
Slide 6: Ex-US Royalty-Based Financing Highlights
Ex - US Royalty - Based Financing Highlights Blue Chip Investor R - Bridge Healthcare Fund affiliate of CBC Group (one of the largest and most active healthcare - dedicated investment firms in Asia) $40M Total Financing $15M upfront $15M on first commercial sale in China $10M on commercial or financ
Slide 7: OLINVYK Overview
WV Trevena OLINVYK Overview
Slide 8: Large Market Opportunity – Acute Pain
Large Market Opportunity – Acute Pain 8 45M patients receive IV opioids annually to treat acute pain 1 IV opioids have unrivalled analgesic efficacy Top surgeries: Total knee arthroplasty, colectomy, hernia repair, spine fusion, C - section 2 IV NSAIDS / acetaminophen US injectable analgesic hospita
Slide 9: OLINVYK: Differentiated Profile for Acute Pain
OLINVYK: Differentiated Profile for Acute Pain 9 OLINVYK 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 BOXED WARNING at the end of p
Slide 10: VOLITION Clinical Outcomes Study w/ Cleveland Clinic
VOLITION Clinical Outcomes Study w/ Cleveland Clinic • Open - label, multi - site study led by experts at Cleveland Clinic and Wake Forest Baptist Health • N = 203 adults undergoing major non - cardiac surgery treated with IV OLINVYK • Initial topline data reported 1Q 23 Further characterizes respir
Slide 11: ARTEMIS – EMR Clinical Outcomes Study
ARTEMIS – EMR Clinical Outcomes Study • 201 OLINVYK - treated patients at Cleveland Clinic and Wake Forest Baptist Health VOLITION sites • 982 matched patients undergoing similar surgical procedures, treated with other IV opioids, at same sites during VOLITION study - Based on 8 demographic/clinical
Slide 12: OLINVYK: Ease of Dosing and Administration
OLINVYK: Ease of Dosing and Administration • Bolus Dosing: 1 mg and 2 mg vials (single dose) • PCA Dosing: 30 mg vial (single patient use) • OLINVYK 1 mg ≈ morphine 5 mg 1 27 mg cumulative daily dose limit Do not administer single doses greater than 3 mg 12 3 vials allow for flexible and tailored IV
Slide 13: OLINVYK vs IV Morphine Health Economic Models
OLINVYK vs IV Morphine Health Economic Models 13 Published 1 and available to formulary committees * As stated in the label these data are not an adequate basis for comparison of rates between OLINVYK treatment group and the mo rphine treatment group. The OLINVYK and morphine dosing regimens studied
Slide 14: OLINVYK: Significant Opportunity in Acute Pain Market
OLINVYK: Significant Opportunity in Acute Pain Market 14 Please see Important Safety Information including BOXED WARNING at the end of presentation. Full Prescribing Information at www.OLINVYK.com . Source: Definitive Healthcare; American Hospital Association. *Assumes ~$100 / day price for OLINVYK
Slide 15: TRV045 S1P Receptor Modulator Novel MOA for Diabetic Neuropathic Pain
TRV045 S1P Receptor Modulator Novel MOA for Diabetic Neuropathic Pain
Slide 16: S1P Receptor – Novel Target for CNS Indications
S1P 1 Receptor – Novel Target for CNS Indications 1) Sim - Selley et al., Journal of Pharmacology & Experimental Therapeutics, 2018. 2) Sim - Selley et al, Journal of Neurochemistry, 2008. 3) Gol et al., European Journal of Pharmaceutical Sciences, 2017. 4) Leo et al, CNS & Neurological Disorders -
Slide 17: TRV045 MOA: Rapid Receptor Recycling
TRV045 MOA: Rapid Receptor Recycling b - arrestin2 S1P 1 receptor G GRK Internalization ↑ I K Ach ligand G a i cAMP Ca++ (via IcaL ) Reduces surface receptor, which leads to lymphopenia ( Gilenya , etc ) Receptor R ecycling Maintains surface receptor and avoids lymphopenia, allowing free lymphocyte
Slide 18: TRV045 Efficacy in Nonclinical Chronic Pain Models
0 1 2 3 4 5 6 Fingolimod TRV045 No Lymphopenia TRV045 Efficacy in Nonclinical Chronic Pain Models (w/ no Lymphopenia) 1) CIPN mouse model: Paclitaxel 6 mg/kg, i.p. on Days 1, 3, 5, 7. Hyperalgesia measured as % non - response to 0.4 g Von Frey filament vs. baseline, tested 30’ after dosing on Day 13
Slide 19: TRV045 Demonstrates Efficacy in Nonclinical Epilepsy Models
TRV045 Demonstrates Efficacy in Nonclinical Epilepsy Models • NIH - supported Epilepsy Therapy Screening Program • Acute seizure protection in max. electroshock model - Replicated in 3 independent experiments using either subcutaneous or oral administration • Efficacy demonstrated in two different p
Slide 20: TRV045 Phase 1 Study – Safety / Tolerability / PK
TRV045 Phase 1 Study – Safety / Tolerability / PK Randomized, double - blinded, placebo - controlled study 3 - parts: single dose (n=53), food effect (n=27), multiple dose (n=9) 20 • Favorable tolerability profile with no SAEs Well Tolerated Target Exposure Attractive PK Profile • Calculated free pl
Slide 21: POC Studies: Target Engagement / TMS
Studies were conducted outside the United States and not under the IND for TRV045 POC Studies: Target Engagement / TMS 21 Results confirm activity of central action and support advancement for neuropathic pain and other CNS indications Target Engagem ent Study Randomized, double - blind, placebo - c
Slide 22: TE Study: Significantly Reduced Mechanical Allodynia
TE Study: Significantly Reduced Mechanical Allodynia 22 1% capsaicin - treated dominant volar forearm – Von Frey filament allodynic area (CFB, mm 2 ) Change from Baseline (mm 2) -1200 -1000 -800 -600 -400 -200 0 200 400 600 Baseline Hr 1 Hr 2 Hr 4 Hr 6 Hr 8 Hr 10 Total Allodynic Area Placebo 50mg 15
Slide 23: TMS Study: Effect on Brain Wave Activity
TMS Study: Effect on Brain Wave Activity -5 0 5 10 Delta Theta Alpha Beta Gamma TRV045 Placebo 23 Resting qEEG Power Spectral Analysis – Eyes Open, Day 4 TRV045 v Placebo All Bands -5 0 5 10 Delta Theta Alpha Beta Gamma TRV045 Placebo -5 0 5 10 Delta Theta Alpha Beta Gamma TRV045 Placebo * * * * * *
Slide 24: TMS Study: Effect on Cortical Excitability vs AEDs
TMS Study: Effect on Cortical Excitability vs AEDs* Mean change from baseline in MEP on Day 1 with TRV045 comparable in magnitude to MEP reductions seen with known AEDs, including levetiracetam, valproic acid, and lorazepam, performed in the same laboratory 24 Mean change from baseline in motor - ev
Slide 25: Overall TRV045 POC Study Conclusions
Overall TRV045 POC Study Conclusions • Target Engagement. Demonstrated CNS penetration and target engagement • Neuropathic Pain. Statistically significant, dose - dependent effect in validated model of neuropathic pain • EEG Spectral Power. Statistically significant increases in brain waves (alpha,
Slide 26: TRV734: Maintenance Therapy for Opioid Use Disorder
TRV734: Maintenance Therapy for Opioid Use Disorder
Slide 27: TRV734: Maintenance Therapy for Opioid Use Disorder
TRV734: Maintenance Therapy for Opioid Use Disorder 27 Selective agonism at µ receptor: nonclinical evidence of improved tolerability 1) Center for Behavioral Health Statistics and Quality. 2) NIDA data on file. Ongoing collaboration with National Institute on Drug Abuse (NIDA) >2.5M people in U.S.
Slide 28: Trevena: Innovative CNS Company
Trevena: Innovative CNS Company 28 *OLINVYK 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 BOXED WARNING at the end of presentation.
Slide 29: Important Safety Information
29 IMPORTANT SAFETY INFORMATION
Slide 30: Boxed Warning: Addiction, Abuse, and Misuse
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 ri
Slide 31: Warnings and Precautions
WARNINGS AND PRECAUTIONS Prolonged use of opioids during pregnancy can result in withdrawal in the neonate that may 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