Trevena, Inc. · OTC:TRVN
Trevena — Investor Presentation (January 2024)
31 slides from Trevena's investor presentation, January 2024
Slide 1: Innovating for Patients
INNOVATING FOR PATIENTS Nasdaq: TRVN I January 2024
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 Chair, 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. Yo
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® New chemical entity Cleveland Clinic / Wake
Slide 6: OLINVYK Overview
WéTrevena OLINVYK Overview
Slide 7: 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 8: 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 9: 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 10: 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 For PCA use only 27 mg cumulative daily dose
Slide 11: TRV045: S1P Receptor Modulator
TRV045 S1P Receptor Modulator Novel MOA for Diabetic Neuropathic Pain
Slide 12: 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 Epilepsy Neuropathic pain • Neuroprotective effects3 • Inhibits pain sensation1 • Modulates B
Slide 13: TRV045 MOA (1): Rapid Receptor Recycling
TRV045 MOA (1): 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 Recepto
Slide 14: TRV045 MOA (2): S1PR Subtype-1 Selectivity
TRV045 MOA (2): S1PR Subtype-1 Selectivity Subtype-1 is broadly expressed in the CNS and may avoid effects associated with other subtypes • S1P acts on 5 distinct subtypes of receptors (S1P1-5) Highly expressed in key • TRV045 is potent and selective for S1P subtype-1 receptor CNS / brain cells - S1
Slide 15: TRV045 MOA (3): Anti-Inflammatory Effect (nonclinical)
TRV045 MOA (3): Anti-Inflammatory Effect (nonclinical) Anti-inflammatory actions (cytokines / chemokines) on astrocytes in cell culture • Main Findings: Net anti-inflammatory action (statistically Anti-inflammatory significant) on astrocyte cytokine / chemokine release markers IL-10 - Increased all
Slide 16: TRV045 Proof-of-Concept Study Program – Highlights
TRV045 Proof-of-Concept Study Program – Highlights Preliminary data* • 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 inc
Slide 17: Target Engagement (PainCart) POC Study Design
Target Engagement (PainCart®) POC Study Design • Design: Randomized, double-blind, placebo-controlled, single dose, four-way cross-over (N=25 subjects; 8F/17M, mean age 37.6 years, range 18-53) - Placebo or TRV045 (50/150/300mg) • Pharmacodynamic Endpoints: - Mechanical allodynia (Von Frey hair test
Slide 18: TRV045 Significantly Reduced Mechanical Allodynia
TRV045 Significantly Reduced Mechanical Allodynia 1% capsaicin-treated dominant volar forearm – Von Frey filament allodynic area (CFB, mm 2) 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 To
Slide 19: Effect Size Comparison: TRV045 v Other Analgesics
Effect Size Comparison: TRV045 v Other Analgesics Hedges' g -2.0 -1.5 -1.0 -0.5 0.0 0.5 1.0 1.5 2.0 Favors Placebo Favors Active Mechanical Hedges' g Allodynia -2.0 -1.5 -1.0 -0.5 0.0 0.5 1.0 1.5 2.0 TRV045 (300mg) Cold Pressor Pain Test Mechanical Allodynia TRV045 (300mg) Cold Pressor Pain Test Pre
Slide 20: Target Engagement (PainCart) Study
Target Engagement (PainCart®) Study PainCart observations • Statistically significant, dose-dependent, treatment effect in model of capsaicin-induced mechanical allodynia provides evidence of the therapeutic potential of TRV045 in neuropathic pain - Recognized and validated study index of central pa
Slide 21: TMS POC Study Design
TMS POC Study Design • Design: Randomized, double-blind, placebo-controlled, multiple dose, two-way cross-over (n=25 male subjects; mean age 31.5 years, range 21-55) - Placebo or TRV045 (250mg) for 4 days; post-dose assessments performed at 4 hours • TMS-EEG Pharmacodynamic endpoints: - Resting qEEG
Slide 22: EEG Shifts in Alpha, Beta, Gamma, Delta Power Spectra
EEG Shifts in Alpha, Beta, Gamma, Delta Power Spectra 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 5 * * +21.3% 5 -15.2% * 0 * 0 * -5 -5 Delta Theta Alpha Beta Gamma Delta Theta Alpha Beta G
Slide 23: TRV045 Effect on Cortical Excitability vs AEDs
TRV045 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 differen
Slide 24: Safety and Tolerability Summary
Safety and Tolerability Summary POC data generally consistent with FIH study • No AEs assessed as probably / definitely related to study drug; no AEs reported as severe; no SAEs - 98% of AEs (102 of 104) in PainCart® study reported as mild - 99% of AEs (79 of 80) in TMS study reported as mild • Scre
Slide 25: Safety and Tolerability Summary
Safety and Tolerability Summary Generally well tolerated and consistent with FIH study • AEs with incidence of ≥10% for any TRV045 dose shown below (none deemed drug related) Placebo TRV045 50mg TRV045 150mg TRV045 300mg PainCart Study N (%) Events N (%) Events N (%) Events N (%) Events General Diso
Slide 26: Overall Conclusions
Overall 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, dose-dependent
Slide 27: TRV045: Broad Potential Applicability
TRV045: Broad Potential Applicability Unique MOA Produces Compelling Profile Potent and selective S1P1R target engagement anti-inflammatory and nociceptive effects No lymphopenia (in FIH study) potentially limits other S1PR modulators May avoid AEs associated with approved S1PR drugs cardiac / pulmo
Slide 28: 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 29: Important Safety Information
IMPORTANT SAFETY INFORMATION 29
Slide 30: Boxed Warning: Addiction, Abuse, and Misuse
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 31: 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