Trevena, Inc. · OTC:TRVN
Trevena — Investor Presentation (October 2023)
30 slides from Trevena's investor presentation, October 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
Trevena’s Experienced Leadership Team SENIOR MANAGEMENT Carrie L. Bourdow President & Chief Executive Officer Mark A. Demitrack, M.D. SVP, Chief Medical Officer Patricia Drake SVP, Chief Commercial Officer Barry Shin SVP, Chief Financial Officer SVP, Chief Business Officer & Head Robert T. Yoder of
Slide 4: Trevena: Innovative CNS Company
Trevena: Innovative CNS Company IV OLINVYK: NCE approved for the management of acute pain in adults* Differentiated profile Significant cost savings / differentiation shown in ‘real world’ post-approval studies TRV045: S1PR: Validated target for blockbusters (fingolimod / siponimod / ozanimod / pone
Slide 5: Multiple Expected Catalysts
Multiple Expected Catalysts PRE-CLIN PHASE 1 PHASE 2 PHASE 3 NDA POST-APPR Highlights IV acute pain* APPROVED • Commercial launch ongoing Cleveland Clinic / Wake Forest Baptist Health collab. VOLITION clinical outcomes • Real world differentiation OLINVYK® Cleveland Clinic / Wake Forest Baptist Heal
Slide 6: OLINVYK Overview
VW Trevena OLINVYK Overview
Slide 7: Large Market Opportunity – Acute Pain
Large Market Opportunity – Acute Pain US injectable analgesic hospital market unit volume1 45M patients receive IV opioids annually to treat acute pain1 IV opioids 38% 45% Local anesthetics IV opioids have unrivalled analgesic efficacy IV Opioids IV NSAIDS / acetaminophen Top surgeries: 17% Total kn
Slide 8: OLINVYK: Differentiated Profile for Acute Pain
OLINVYK: Differentiated Profile for Acute Pain 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 Data in complex patients New chemical entity Elderly / obese, multiple comorbidit
Slide 9: VOLITION Clinical Outcomes Study w/ Cleveland Clinic
VOLITION Clinical Outcomes Study w/ Cleveland Clinic Further characterizes respiratory, GI and cognitive outcomes • 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 GI Tolerabi
Slide 10: ARTEMIS EMR-Based Clinical Outcomes Study
ARTEMIS EMR-Based Clinical Outcomes Study Statistically significant differentiation on a range of meaningful endpoints • 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
Slide 11: OLINVYK: Ease of Dosing and Administration
OLINVYK: Ease of Dosing and Administration 3 vials allow for flexible and tailored IV dosing No refrigeration / reconstitution • 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 1 mg / 1mL
Slide 12: OLINVYK vs IV Morphine Health Economic Models
OLINVYK vs IV Morphine Health Economic Models Published1 and available to formulary committees Representative Inputs: Key Outputs: Ph3 trials Placebo OLINVYK ≤ 27 mg Morphine Vomiting (N = 162) (N = 316) (N = 158) 73 86 96 35 52 70 AE rates* Somnolence / sedation 10 26 52 30 26 30 HECON 11 18 25 >10
Slide 13: OLINVYK: Significant Opportunity in Acute Pain Market
OLINVYK: Significant Opportunity in Acute Pain Market ~15M days of therapy (initial focus) = ~45M $1.5B+ market opportunity* patients Core focus Specialty Targets Expanded areas of focus: • Ambulatory surgical centers (28M) • Hospitals Initial core focus: Expanded areas of focus (9M) • New cognitive
Slide 14: TRV045: S1P Receptor Modulator
TRV045 S1P Receptor Modulator Novel MOA for Diabetic Neuropathic Pain
Slide 15: S1P1 Receptor – Novel Target for CNS Indications
S1P1 Receptor – Novel Target for CNS Indications S1P1 receptors are highly expressed on key CNS cells involved in neuroinflammation Potential therapeutic role in seizures, epileptogenesis and pain signaling Neuropathic pain Epilepsy • Inhibits pain sensation1 • Neuroprotective effects3 • Inhibits ex
Slide 16: TRV045 MOA: Rapid Receptor Recycling
TRV045 MOA: Rapid Receptor Recycling Maintained (rather than degraded) S1P receptors on cell surface ligand S1P1 receptor Gβγ GRK No lymphopenia Gαi β-arrestin2 reported in prior Phase 1 FIH study ↓cAMP ↑IKAch ↓ Ca++ Internalization (via IcaL) Other S1PR Drugs TRV045 Receptor Degradation Receptor Re
Slide 17: TRV045 Efficacy in Nonclinical Chronic Pain Models
TRV045 Efficacy in Nonclinical Chronic Pain Models (w/ no Lymphopenia) Mouse chemotherapy-induced peripheral neuropathy (CIPN) model Reversed Pain Response 100 ** 80 * % non-response to pain stimulus 60 40 Paclitaxel- induced hyperalgesia Reversed neuropathic pain… 20 0 Fingolimod TRV045 0.03 mg/kg
Slide 18: TRV045 Demonstrates Efficacy in Nonclinical Epilepsy Models
TRV045 Demonstrates Efficacy in Nonclinical Epilepsy Models Corneal kindled mouse Corneal kindled mouse Subcutaneous Oral • NIH-supported Epilepsy Therapy Screening Program 100 100 80 80 % protected % protected 60 60 • Acute seizure protection in max. electroshock model 40 40 - Replicated in 3 indep
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) Well Tolerated • Favorable tolerability profile with no SAEs Target • Calculated free plasma concentrations exceeded targeted ef
Slide 20: POC Studies: Target Engagement / TMS
POC Studies: Target Engagement / TMS Target Engagement Study TMS Study Randomized, double-blind, placebo- Randomized, double-blind, placebo- controlled, 4x cross-over controlled, multiple dose, 2x cross-over (n=25 subjects) (n=25 subjects) Placebo or TRV045 Placebo or TRV045 (50/150/300mg) (250mg /
Slide 21: TE Study: Significantly Reduced Mechanical Allodynia
TE Study: Significantly Reduced Mechanical Allodynia 1% capsaicin-treated dominant volar forearm – Von Frey filament allodynic area (CFB, mm2) 300mg TRV045 v Placebo; P=0.0023 300mg TRV045 v Placebo; P=0.0001 150mg TRV045 v Placebo; P=0.0022 150mg TRV045 v Placebo; P=0.0002 Secondary Allodynic Area
Slide 22: TMS Study: Effect on Brain Wave Activity
TMS Study: Effect on Brain Wave Activity Resting qEEG Power Spectral Analysis – Eyes Open, Day 4 TRV045 v Placebo All Bands Frontal* Right Parietal* 10 +40.7% +26.6% +23.1% 10 * (µV2) CFB (µV2) CFB * +21.3% -15.2% 5 * * 5 * 0 0 -5 -5 Delta Theta Alpha Beta Gamma Delta Theta Alpha Beta Gamma TRV045 P
Slide 23: TMS Study: Effect on Cortical Excitability vs AEDs
TMS Study: Effect on Cortical Excitability vs AEDs* Mean change from baseline in motor-evoked potential (MEP) measured by peak-to-peak amplitude 1000 Pre-dose 900 859.0 840.1 4h post-dose Mean Peak Amplitude (µV) 782.0 800 700 605.4 600 500 400 300 200 100 0 Placebo Day 1 TRV045 Day 1 Estimated diff
Slide 24: Overall TRV045 POC Study Conclusions
Overall TRV045 POC Study Conclusions TRV045 Proof-of-Concept Study Program Taken together, these two POC studies provide strong support and direction for future development of TRV045 • Target Engagement. Demonstrated CNS penetration and target engagement • Neuropathic Pain. Statistically significant
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 Selective agonism at µ receptor: nonclinical evidence of improved tolerability Ongoing collaboration with National Institute on Drug Abuse (NIDA) NIDA study demonstrated reduced drug-seeking behavior in animal model of relapse2 >2.5M NIDA-funded pr
Slide 27: Trevena: Innovative CNS Company
Trevena: Innovative CNS Company IV OLINVYK: NCE approved for the management of acute pain in adults* Differentiated profile Significant cost savings / differentiation shown in ‘real world’ post-approval studies TRV045: S1PR: Validated target for blockbusters (fingolimod / siponimod / ozanimod / pone
Slide 28: Important Safety Information
IMPORTANT SAFETY INFORMATION 28
Slide 29: Boxed Warning: Addiction, Abuse, and Misuse; Respiratory Depression
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY Limitations of Use DEPRESSION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve OLINVYK CONCOMITANT USE WITH BENZODIAZEPINES OR
Slide 30: Warnings and Precautions
WARNINGS AND PRECAUTIONS serum amylase. Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms. • 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 w