Trevena, Inc. · OTC:TRVN
Trevena — Investor Presentation (January 2023)
22 slides from Trevena's investor presentation, Jan 9, 2023
Slide 1: Innovating for Patients
INNOVATING FOR PATIENTS Nasdaq TRVN I January 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 Overview
Trevena Overview 3 Focused on Innovative Medicines For CNS Disorders Olinvyk IV* Approved NCE for the management of acute pain in adults* Proven track record of Trevena internal discovery and development through approval S1P Modulator Program Novel S1P 1 R modulator with differentiated MOA (lead ass
Slide 4: TRV045: Innovative Clinical-Stage S1P Receptor Modulator
TRV045: Innovative Clinical - Stage S1P 1 R Modulator TRV045: Selective S1PR Modulator Large Addressable Target Indications Novel Family of S1PR Modulators Strong MOA Support Near - Term Value Drivers S1PR: Validated target for multiple blockbusters (fingolimod / siponimod / ozanimod / ponesimod ) T
Slide 5: 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 6: TRV045 MOA (1): Rapid Receptor Recycling
TRV045 MOA (1): Rapid Receptor Recycling b - arrestin2 S1P 1 receptor G b 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 ly
Slide 7: TRV045 MOA (2): S1PR Subtype-1 Selectivity
Highly expressed in key CNS / brain cells TRV045 MOA (2): S1PR Subtype - 1 Selectivity • S1P acts on 5 distinct subtypes of receptors (S1P 1 - 5 ) • TRV045 is potent and selective for S1P subtype - 1 receptor - S1P 1 R is highly expressed on astrocytes / other glial cells and implicated in brain inf
Slide 8: TRV045 MOA (3): Anti-Inflammatory Effect
• Main Findings: Net anti - inflammatory action (statistically significant) on astrocyte cytokine / chemokine release - Increased all anti - inflammatory cytokines measured 1 - Reduced all inflammatory cytokines measured 1 • Method: Primary mouse astrocytes in monolayer cell culture, incubated for 2
Slide 9: TRV045: Broad Potential Applicability
TRV045: Broad Potential Applicability Potential fields for development may include: Seizure treatment (anticonvulsant) Prevention of seizure ( epileptogenesis ) Pain (DPN, CIPN) Autoimmune (MS, RA, UC, Crohn’s Disease) Neuropsychiatric / neurodegenerative (MDD, schizophrenia, AD, PD) Potent and sele
Slide 10: TRV045 Phase 1 Data – Safety / Tolerability / PK
TRV045 Phase 1 Data – Safety / Tolerability / PK Randomized, double - blinded, placebo - controlled study 3 - parts: single dose (n=53), food effect (n=27), multiple dose (n=9) • Favorable tolerability profile with no SAEs Well Tolerated Target Exposure Attractive PK Profile • Free plasma concentrat
Slide 11: POC Study: Single-dose Target Engagement (Ph 1)
POC Study: Single - dose Target Engagement (Ph 1) Enrollment completion expected mid - 2023 Pharmacodynamic Endpoint Test and Outcome Pain Type Cold Pressor Pain detection (PDT), pain tolerance (PTT), post - test VAS Nociceptive (thermal) Electrical Pain Burst: PDT, PTT, PT - VAS Stair: PDT, PTT, PT
Slide 12: TRV045 Epilepsy and Related Indications
TRV045 Epilepsy and Related Indications
Slide 13: TRV045 Dose-Dependent Protection in Corneal-Kindled Seizure Models
TRV045 demonstrated dose - dependent protection in seizure risk in corneal - kindled seizure models Corneal - kindled Seizure Model TRV045: Dose Dependent Seizure Protection 13 Corneal kindled mouse Subcutaneous 0 20 40 60 80 100 1 2.5 5 7.5 10 % protected TRV045 mg/kg Corneal kindled mouse Oral 0 2
Slide 14: TRV045: Improves Seizure Burden / Freedom
Baseline Vehicle TRV045 0 4 8 12 16 20 Seizure Burden Score * Post - kainate rat (IP) 15 mg/kg * # 0 25 50 75 Baseline Vehicle TRV045 % Seizure Freedom Baseline Vehicle TRV045 0 4 8 12 16 20 Seizure Burden Score * Post - kainate rat (IP) 10 mg/kg ** 0 25 50 75 Baseline Vehicle TRV045 % Seizure Freed
Slide 15: TRV045: Protection from Acute Seizures
TRV045 demonstrated protection from acute seizures in three replicated experiments TRV045: Protection from Acute Seizures 15 Maximal Electroshock Model 0 5 10 15 20 25 30 35 0 20 40 60 80 TRV045 mg/kg s.c. % of rats protected Maximal electroshock Subcutaneous 0 10 20 30 40 50 60 0 10 20 30 40 TRV045
Slide 16: TRV045 Non-opioid Pain Indications
TRV045 Non - opioid Pain Indications
Slide 17: TRV045 Efficacy in Chronic Pain Models (w/ no Lymphopenia)
0 1 2 3 4 5 6 Fingolimod TRV045 No Lymphopenia TRV045 Efficacy in 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. Lymphocyte
Slide 18: TRV045: Reversed Hyperalgesia
Rat diabetic peripheral neuropathic pain (STZ) model TRV045: Reversed Hyperalgesia 18 Veh 10 30 60 gabap 0 5 10 15 20 25 Mehcanical allodynia 50% Withdrawal Threshold (g) STZ TRV045 (mg/kg, p.o.) Mechanical allodynia Thermal hyperalgesia Effective on thermal pain endpoint Effective on mechanical pai
Slide 19: TRV045: Innovative Clinical-Stage S1P Receptor Modulator
TRV045: Innovative Clinical - Stage S1P 1 R Modulator TRV045: Selective S1PR Modulator Large Addressable Target Indications Novel Family of S1PR Modulators Strong MOA Support Near - Term Value Drivers S1PR: Validated target for multiple blockbusters (fingolimod / siponimod / ozanimod / ponesimod ) T
Slide 20: Important OLINVYK Safety Information
20 JL: can will create a transition slide? IMPORTANT OLINVYK SAFETY INFORMATION
Slide 21: 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 ri
Slide 22: 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 ris