Trevena, Inc. · OTC:TRVN
Trevena — Investor Presentation (June 2021)
50 slides from Trevena's investor presentation, Jun 16, 2021
Slide 1: Innovating for Patients
INNOVATING FOR PATIENTS Nasdaq TRVN I June 2021
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. Michael R. Dougherty Barbara Yanni SENIOR MANAGEMENT Carrie L. Bourdow President & Chief Executive Officer Scott Applebaum SVP, Chief Legal & Regulato
Slide 4: Trevena: Innovative CNS Company
IV OLINVYK: Differentiated profile NCE approved for the management of acute pain in adults Commercial launch in Q1 2021; targeting 100 formulary wins by year - end Large market, targeted launch 45M+ US hospital patients; 9M procedures is initial core focus $1.5B+ market opportunity for core focus No
Slide 5: Multiple Expected Catalysts
PRE - CLINICAL PHASE 1 PHASE 2 PHASE 3 NDA EXPECTED CATALYSTS OLINVYK® New chemical entity (mu - opioid receptor) • Commercial launch ongoing • Cleveland Clinic outcomes study TRV027 Novel AT 1 receptor selective agonist • PoC study data (ICL) • NIH ACTIV study • REMAP - CAP study TRV250 G - protein
Slide 6: OLINVYK: Differentiated Profile for Acute Pain
OLINVYK: Differentiated Profile for Acute Pain 6 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 New chemical entity Distinct from IV morphine IV opioid efficacy Hard - and sof
Slide 7: OLINVYK: Broad Indication for Acute Pain
OLINVYK: Broad Indication for Acute Pain 7 Large acute market opportunity 45M patients receive IV opioids annually to treat acute pain 1 • Unrivalled analgesic efficacy • Top surgeries: Total knee arthroplasty, colectomy, hernia repair, spine fusion, C - section 2 IV NSAIDS / acetaminophen US inject
Slide 8: Broad range of surgeries / medical procedures
8 Broad range of surgeries / medical procedures Please see Important Safety Information including BOXED WARNING at the end of presentation. Full Prescribing Information at www.OLINVYK.com . Bergese SD et al. J Pain Research, 2019. Trial modeled real - world use: usual patient care with OLINVYK inste
Slide 9: OLINVYK: Well-Characterized Safety / Tolerability
OLINVYK: Well - Characterized Safety / Tolerability 9 Please see Important Safety Information including BOXED WARNING at the end of presentation. Full Prescribing Information at www.OLINVYK.com . 1) OLINVYK Prescribing Information. N ot an adequate basis for comparison of rates between the OLINVYK t
Slide 10: OLINVYK Safety Differentiation Study w/ Cleveland Clinic
OLINVYK Safety Differentiation Study w/ Cleveland Clinic • Open - label, multi - site study led by experts at Cleveland Clinic • N = ~200 adults undergoing major non - cardiac surgery • Patient enrollment to begin in Q3 2021 10 Further characterizes potential respiratory, GI and cognitive outcomes R
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 mg 1 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 Models presented at AMCP 2021 1 and available to formulary committees 1) https://www.trevena.com/publications. 2) Oderda , GM, J Pain Palliative Care Pharm, 2019; data based on 5 surgical procedure categories including Cardiothoracic / vascular, Gen e
Slide 13: Customer Engagement Strategy
Customer Engagement Strategy 13
Slide 14: Targeted Account Launch as of Q1 2021
Targeted Account Launch as of Q1 2021 ~40 account reps / MSLs deployed Q1 2021 • OLINVYK: NCE, distinct from IV morphine • 1 - 3 min onset & no active metabolites • Safety data in complex patients / surgeries • OLINVYK published safety data vs. IV morphine • Published health economic / cost offset d
Slide 15: Hospital Formulary Review Process
Hospital Formulary Review Process 15 Physician Pharmacy Department P&T Committee Approval Pharmacy Department Submits request for drug review C onducts formal assessment of the drug R eviews assessment / votes to revise formulary Updates formulary, protocols / order sets Request YE 2021 target: 100
Slide 16: Differentiated Profile For Use in Hosp Outpatient & ASCs
Differentiated Profile For Use in Hosp Outpatient & ASCs 16 ASC = ambulatory surgery center. PK = pharmacokinetic. Images: www.flaticon.com Fast onset (1 - 3 min median) No known active metabolites No dosage adjustments for renally impaired Improves patient throughput / time to discharge Streamlines
Slide 17: OLINVYK: Significant Opportunity in Acute Pain
OLINVYK: Significant Opportunity in Acute Pain 17 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 oliceridine 203
Slide 18: We Continue to Learn from and Adapt to COVID-19 Challenges
We Continue to Learn from and Adapt to COVID - 19 Challenges • No delays in regulatory timelines; approval and DEA scheduling in 2H 2020 • Commercial supply of all 3 presentations made available to customers Transitioned into commercial organization with minimal business interruption • Procedure vol
Slide 19: TRV027 NCE targeting the AT1 receptor in COVID-19
TRV027 NCE targeting the AT 1 receptor in COVID - 19 19
Slide 20: Multi-Organ Damage From Coronavirus
Multi - Organ Damage From Coronavirus 20 Elimination of ACE2 protein leads to critical hormonal imbalances ARDS = Acute Respiratory Distress Syndrome. 1) Kuba K et al., Nat Med, 2005. 2) Gibson PG et al, Med J Aust, 2020. *In patients requiring ventilation. 3) Klok FA et al, Thromb Res, 2020. SARS -
Slide 21: TRV027: New MOA for COVID-19
TRV027 β - arrestin TRV027: New MOA for COVID - 19 21 Mechanism targeted to improve lung function and prevent abnormal clotting AT 1 receptor TRV027 is the only selective AT 1 receptor agonist Safety / tolerability established in ~700 patients G protein Cell surface Cell interior Lung damage Abnorma
Slide 22: TRV027 COVID Study - Imperial College London
TRV027 COVID - 19 Study - Imperial College London • Randomized, double - blind, placebo - controlled proof - of - concept study • N = 30 COVID - 19 patients - Hospitalized, non - ventilated - ≥18 years old • IV infusion of placebo or TRV027 for 7 days (12 mg/ hr ) • Review of interim data by DMSC fo
Slide 23: TRV027 COVID Study - Vanderbilt UMC (ACTIV-4d)
TRV027 COVID - 19 Study - Vanderbilt UMC (ACTIV - 4d) • Part of NIH’s ongoing ACTIV* public - private partnership • Multi - site, multi - arm, placebo - controlled trial • ~300 COVID - 19 patients ≥18 years old treated with TRV027 23 NIH - funded trial with Vanderbilt University Medical Center as le
Slide 24: TRV027 COVID Study - REMAP-CAP
TRV027 COVID - 19 Study - REMAP - CAP • Multi - site, adaptive, Phase 2 / 3 trial in hospitalized COVID - 19 patients (≥18 years)* • 200 - 300 COVID - 19 patients treated with TRV027 • TRV027 administered (open label) in conjunction w/ACE inhibitor 24 Funded by REMAP - CAP, a global clinical trial n
Slide 25: Multiple Expected Catalysts
PRE - CLINICAL PHASE 1 PHASE 2 PHASE 3 NDA EXPECTED CATALYSTS OLINVYK® New chemical entity (mu - opioid receptor) • Commercial launch ongoing • Cleveland Clinic outcomes study TRV027 Novel AT 1 receptor selective agonist • PoC study data (ICL) • NIH ACTIV study • REMAP - CAP study TRV250 G - protein
Slide 26: TRV250: New MOA for Acute Treatment of Migraine
TRV250: New MOA for Acute Treatment of Migraine 26 Delta receptor: Untapped potential in CNS space Migraine represents a large market opportunity; total migraine drug market = ~$3.5B 1) Data from Decision Resources, Pharmacor migraine market landscape and forecast 2018. 2) Moven et al., J Neurol Neu
Slide 27: TRV250: Well-Tolerated in Ph1 Healthy Volunteer PK Study
TRV250: Well - Tolerated in Ph1 Healthy Volunteer PK Study • Well tolerated, with no SAEs across broad range of doses • Predictable PK: dose - proportional between 0.1 mg to 30 mg SC • Half - life consistent across all doses • No EEG findings observed in any subject Subcutaneous doses up to 30 mg st
Slide 28: TRV734: Maintenance Therapy for Opioid Use Disorder
TRV734: Maintenance Therapy for Opioid Use Disorder 28 Selective agonism at µ receptor: Potential for 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. suffer fro
Slide 29: TRV045: Selective S1PR With No Lymphopenia
TRV045: Selective S1PR With No Lymphopenia 29 Uniquely selective for S1P - subtype 1 receptor 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
Slide 30: TRV045: Novel MOA for Diabetic Neuropathic Pain
Avoids Lymphopenia Reverses Pain Response TRV045: Novel MOA for Diabetic Neuropathic Pain 0 20 40 60 80 100 Fingolimod TRV045 30 1) Rosenberger et al., Journal of Neural Transmission, 2020 and CDC National Diabetes Statistics Report, 2020. 2) Shillo et al., Current Diabetes Reports, 2019. 3) America
Slide 31: Trevena: Innovative CNS Company
IV OLINVYK: Differentiated profile NCE approved for the management of acute pain in adults Commercial launch in Q1 2021; targeting 100 formulary wins by year - end Large market, targeted launch 45M+ US hospital patients; 9M procedures is initial core focus $1.5B+ market opportunity for core focus No
Slide 32: Appendix
APPENDIX 32
Slide 33: OLINVYK: Distinct From IV Morphine / Hydromorphone
Studied in >1,900 individuals IV morphine included as active comparator NCE with 2032+ COM patent 1 Hydromorphone OLINVYK: Distinct From IV Morphine / Hydromorphone Morphine 33 OLINVYK Please see Important Safety Information including BOXED WARNING at the end of presentation. Full Prescribing Inform
Slide 34: Robust Clinical Development Program
• No dosage adjustments for elderly / renally impaired • No known active metabolites Robust Clinical Development Program 34 Please see Important Safety Information including BOXED WARNING at the end of presentation. Full Prescribing Information at www.OLINVYK.com . # subjects exposed to OLINVYK in P
Slide 35: OLINVYK: IV Opioid Efficacy and Rapid Onset
Superior pain relief vs. placebo (p<0.02) Soft Tissue (SPID - 24) OLINVYK: IV Opioid Efficacy and Rapid Onset 35 • Efficacy achieved in hard tissue & soft tissue models • Rapid onset: perceptible pain relief within 1 - 3 minutes (median onset of action) • OLINVYK efficacy data in peer - reviewed jou
Slide 36: Analgesic responder rates in Phase 3 trials
36 Please see Important Safety Information including BOXED WARNING at the end of presentation. Full Prescribing Information at www.OLINVYK.com . These analyses were the prespecified primary endpoints for both studies. Section 14 of the Prescribing Information includes t he SPID - 24 and SPID - 48 ef
Slide 37: OLINVYK: IV Opioid Efficacy in 2 Phase 3 RCTs
0 1 2 3 4 5 6 7 8 9 10 0 4 8 12 16 20 24 28 32 36 40 44 48 0 1 2 3 4 5 6 7 8 9 10 0 4 8 12 16 20 24 Time (hours) Average NRS Pain Score OLINVYK: IV Opioid Efficacy in 2 Phase 3 RCTs Study 1 (Orthopedic – Hard Tissue) 3 PCA regimens studied (0.1, 0.35, 0.5 mg) vs. placebo; all doses P<0.01 vs. placeb
Slide 38: Robust Assessment of Respiratory Safety in Phase 3 RCTs
Robust Assessment of Respiratory Safety in Phase 3 RCTs 38 Data included in AMCP dossier used in formulary review 1) Figure 2 - 8, Section 2.2, OLINVYK Evidence Dossier for Formulary Consideration. 2) Figures 3 - 4 and 3 - 8, Section 3.1, OLINVYK E vidence Dossier for Formulary Consideration. • Pres
Slide 39: Robust Assessment of GI Tolerability in Phase 3 RCTs
Robust Assessment of GI Tolerability in Phase 3 RCTs 39 Data included in AMCP dossier used in formulary review P < 0.05 vs. morphine.1) Figure 2 - 10, Section 2.2, OLINVYK Evidence Dossier for Formulary Consideration. 2) Figure 2 - 11, Section 2.2, OLINVYK Evidence Dossier for Formulary Consideratio
Slide 40: Customer Facing Organization
Customer Facing Organization • Allows for execution speed and flexibility in deployment • Full range support: source, hire, train and deploy customer - facing roles • Ability to flex as business needs evolve 40 Partnering with Syneos Health to provide “best in class” commercial support • Sales : Ins
Slide 41: Launch Team: Top Talent with Hospital Experience
Launch Team: Top Talent with Hospital Experience CONFIDENTIAL Role Highlights Medical Science Liaisons 100% with Advanced degrees 100% with Health Econ background 100% with hospital and launch experience Regional Sales Managers 20+ Years experience Buy & Bill Hospital & ASC experience Key Account Ma
Slide 42: Robust Set of Peer-Reviewed Publications
Robust Set of Peer - Reviewed Publications 42 Comprehensive overview of OLINVYK development program • 4 head - to - head studies vs. IV morphine - IV opioid efficacy - Well - characterized safety and tolerability • Data in complex patients / surgery types • Respiratory safety data in elderly / obese
Slide 43: Positive Feedback from Formulary Stakeholders
Positive Feedback from Formulary Stakeholders 1 43 Please see Important Safety Information including BOXED WARNING at the end of presentation. Full Prescribing Information at www.OLINVYK.com . 1) Qualitative Pricing research, Charles River Associates, April 2020. 2) “Are the improvements in respirat
Slide 44: Omni-Channel Approach for HCP Engagement
Olinvyk.com Virtual “on demand” Medical Education programs HCP social media Professional Society Meetings & Congresses Field directed: live, virtual & email Omni - channel Approach for HCP Engagement 44 Communication across a full range of channels to maximize reach and impact Customize mix across c
Slide 45: No Accumulation Despite Repeated Dosing
-15 -10 -5 0 5 10 15 20 0 2 4 6 8 10 12 14 16 18 20 22 24 Mean ΔΔ QTcI ( msec ) [90% CI] No Accumulation Despite Repeated Dosing 45 Multi - Dose tQT Study Please see Important Safety Information including BOXED WARNING at the end of presentation. Full Prescribing Information at w ww. OLINVYK.com. 3
Slide 46: Interaction Between the AT1 Receptor and ACE2 in COVID-19
Interaction Between the AT 1 Receptor and ACE2 in COVID - 19 • Coronavirus binds to and downregulates angiotensin converting enzyme 2 (ACE2) 1 • Decrease in ACE2 elevates angiotensin II levels - Angiotensin II activates AT 1 receptor - No breakdown of angiotensin II into Ang(1 - 7) o Normally, Ang(1
Slide 47: Delta Receptor Agonists Have Unique Benefits
Delta Receptor Agonists Have Unique Benefits Triptans / Ditans • Target: serotonin receptors mediate vascular excitability (a ssociated CV risk) 1 • Migraine - specific treatment CGRPs • Target: CGRP receptors regulate neuronal structures involved in pain signaling 2 • Migraine - specific treatment
Slide 48: Important Safety Information
IMPORTANT SAFETY INFORMATION 48
Slide 49: 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 50: 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