Trevena, Inc. · OTC:TRVN
Trevena — Investor Presentation (October 2023)
30 slides from Trevena's investor presentation, Oct 2, 2023
Slide 1: Innovating for Patients
INNOVATING FOR PATIENTS Nasdaq: TRVN I October 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. (the “Company” or “we”), they are forward-looking statements reflecting management’s current beliefs and expectations. Forward-looking statements a
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 SENIOR MANAGEMENT Carrie L. Bourdow President & Chief Executive Officer Mark A. Demitrack, M.D. SVP, Chief Medical Of
Slide 4: Trevena: Innovative CNS Company
*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. Full Prescribing Information at ww
Slide 5: Multiple Expected Catalysts
*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. Full Prescribing Information at ww
Slide 6: OLINVYK Overview
WE Trevena OLINVYK Overview
Slide 7: Large Market Opportunity – Acute Pain
Large Market Opportunity – Acute Pain 7 45M patients receive IV opioids annually to treat acute pain1 IV opioids have unrivalled analgesic efficacy Top surgeries: Total knee arthroplasty, colectomy, hernia repair, spine fusion, C-section2 IV NSAIDS / acetaminophen US injectable analgesic hospital ma
Slide 8: OLINVYK: Differentiated Profile for Acute Pain
OLINVYK: Differentiated Profile for Acute Pain 8 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 9: 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 Further characterizes respiratory, GI and cognitive outcomes Cognitive F
Slide 10: ARTEMIS EMR-Based Clinical Outcomes Study
ARTEMIS EMR-Based 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 10 Statistically significant di
Slide 11: 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 mg1 27 mg cumulative daily dose limit Do not administer single doses greater than 3 mg 11 3 vials allow for flexible and tailored IV
Slide 12: OLINVYK vs IV Morphine Health Economic Models
OLINVYK vs IV Morphine Health Economic Models 12 Published1 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 morphine treatment group. The OLINVYK and morphine dosing regimens studied a
Slide 13: OLINVYK: Significant Opportunity in Acute Pain Market
OLINVYK: Significant Opportunity in Acute Pain Market 13 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 2
Slide 14: TRV045 S1P Receptor Modulator: Novel MOA for Diabetic Neuropathic Pain
TRV045 S1P Receptor Modulator Novel MOA for Diabetic Neuropathic Pain
Slide 15: S1P1 Receptor – Novel Target for CNS Indications
Epilepsy • Neuroprotective effects3 • Modulates BBB permeability, anti-inflammatory effects4,5 Neuropathic pain • Inhibits pain sensation1 • Inhibits excitatory neuronal signaling2 S1P1 Receptor – Novel Target for CNS Indications 1) Sim-Selley et al., Journal of Pharmacology & Experimental Therapeut
Slide 16: TRV045 MOA: Rapid Receptor Recycling
TRV045 MOA: Rapid Receptor Recycling β-arrestin2 S1P1 receptor Gβγ GRK ↑I Internalization KAch ligand Gαi ↓cAMP ↓ Ca++ (via IcaL) Reduces surface receptor, which leads to lymphopenia (Gilenya, etc) Receptor Recycling Maintains surface receptor and avoids lymphopenia, allowing free lymphocyte egress
Slide 17: 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 18: 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 pre
Slide 19: 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) 19 Well Tolerated • Favorable tolerability profile with no SAEs Target Exposure Attractive PK Profile • Calculated free plasma c
Slide 20: POC Studies: Target Engagement / TMS
Studies were conducted outside the United States and not under the IND for TRV045 POC Studies: Target Engagement / TMS 20 Results confirm activity of central action and support advancement for neuropathic pain and other CNS indications Target Engagement Study Randomized, double-blind, placebo-contro
Slide 21: TE Study: Significantly Reduced Mechanical Allodynia
TE Study: Significantly Reduced Mechanical Allodynia 21 1% capsaicin-treated dominant volar forearm – Von Frey filament allodynic area (CFB, mm2) Change from Baseline (mm2) -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 150mg 3
Slide 22: 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 22 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 23: 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 23 Mean change from baseline in motor-evok
Slide 24: 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, be
Slide 25: TRV734: Maintenance Therapy for Opioid Use Disorder
TRV734: Maintenance Therapy for Opioid Use Disorder
Slide 26: TRV734: Maintenance Therapy for Opioid Use Disorder
TRV734: Maintenance Therapy for Opioid Use Disorder 26 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 27: Trevena: Innovative CNS Company
*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. Full Prescribing Information at ww
Slide 28: Important Safety Information
28 IMPORTANT SAFETY INFORMATION
Slide 29: Boxed Warning: Addiction, Abuse, and Misuse; Respiratory Depression
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 risk
Slide 30: 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