Trevena, Inc. · OTC:TRVN
Trevena — Investor Presentation (March 2021)
49 slides from Trevena's investor presentation, Mar 9, 2021
Slide 1: Innovating for Patients
INNOVATING FOR PATIENTS Nasdaq TRVN I March 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 Carrie L. Bourdow Julie H. McHugh Scott Braunstein, M.D. Jake R. Nunn Michael R. Dougherty Anne M. Phillips, M.D. Maxine Gowen, Ph.D. Barbara Yanni SENIOR MANAGEMENT Carrie L. Bourdow President & Chief Executive Officer Scott Applebaum SVP, Chief Leg
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 ΠNew chemical entity (mu - opioid receptor) Q1 21: Commercial launch TRV027 Novel AT 1 receptor selective agonist 1H 21: Primary completion date (ICL) TRV250 G - protein selective agonist (delta receptor) 1H 21: IND - enabling ac
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: OLINVYK: Well-Characterized Safety / Tolerability
OLINVYK: Well - Characterized Safety / Tolerability 8 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 9: Broad range of surgeries / medical procedures
9 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 10: 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 10 3 vials allow for flexible and tailored IV
Slide 11: Customer Engagement Strategy
Customer Engagement Strategy 11
Slide 12: Targeted Account Launch
Inpatient & hospital outpatient Targeted Account Launch 12 Initial focus: complex patients in 3 key surgical areas ASCs = ambulatory surgical centers ~550 hospitals ~500 ASCs Community Large regional systems Hospital outpatient Ambulatory surgical centers Physician specialties ~4 specialties Anesthe
Slide 13: Targeted Messaging and Resources
Targeted Messaging and Resources Key OLINVYK attributes focused on key customers • OLINVYK: NCE, distinct from IV morphine • Fast pain relief & no active metabolites • Safety data in complex patients / surgeries • OLINVYK published safety data vs. IV morphine • Published health economic / cost offse
Slide 14: Robust Set of Peer-Reviewed Publications
Robust Set of Peer - Reviewed Publications 14 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 15: HECON Model Driven by Compelling Clinical Data
HECON Model Driven by Compelling Clinical Data 15 Publication of base and high - risk patient models expected 1H 2021 1) Oderda , GM, J Pain Palliative Care Pharm, 2019; data based on 5 surgical procedure categories including Cardiothoracic / vascular, Gen eral / Colorectal, Ob / Gyn, Orthopedic, an
Slide 16: Hospital Formulary Review Process
Hospital Formulary Review Process 16 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 17: Differentiated Profile For Use in Hosp Outpatient & ASCs
Differentiated Profile For Use in Hosp Outpatient & ASCs 17 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 18: We Continue to Learn from and Adapt to COVID 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: OLINVYK: Significant Opportunity in Acute Pain
OLINVYK : Significant Opportunity in Acute Pain 19 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 Sp
Slide 20: TRV027 NCE targeting the AT1 receptor in COVID-19
TRV027 NCE targeting the AT 1 receptor in COVID - 19 20
Slide 21: Multi-Organ Damage From Coronavirus
Multi - Organ Damage From Coronavirus 21 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 22: TRV027: New MOA for COVID-19
TRV027 β - arrestin TRV027: New MOA for COVID - 19 22 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 23: TRV027 COVID-19 Study - Imperial College London
TRV027 COVID - 19 Study - Imperial College London • Randomized, double - blind, placebo - controlled proof - of - concept study • N = ~60 (30 per arm) COVID - 19 patients - Hospitalized, non - ventilated - ≥18 years old • IV infusion of placebo or TRV027 for 7 days (12 mg/ hr ) • Study currently ong
Slide 24: Multiple Expected Catalysts
PRE - CLINICAL PHASE 1 PHASE 2 PHASE 3 NDA EXPECTED CATALYSTS OLINVYK ΠNew chemical entity (mu - opioid receptor) Q1 21: Commercial launch TRV027 Novel AT 1 receptor selective agonist 1H 21: Primary completion date (ICL) TRV250 G - protein selective agonist (delta receptor) 1H 21: IND - enabling ac
Slide 25: TRV250: New MOA for Acute Treatment of Migraine
TRV250: New MOA for Acute Treatment of Migraine 25 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 26: 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 27: TRV734: Maintenance Therapy for Opioid Use Disorder
TRV734: Maintenance Therapy for Opioid Use Disorder 27 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 28: TRV045: Selective S1PR With No Lymphopenia
TRV045: Selective S1PR With No Lymphopenia 28 Uniquely selective for S1P - subtype 1 receptor 1) Gol et al., European Journal of Pharmaceutical Sciences, 2017. 2) Leo et al., CNS & Neurological Disorders - Drug Targets, 20 17. 3) Sim - Selley et al., Journal of Pharmacology & Experimental Therapeuti
Slide 29: TRV045: Engages S1PR Without Lymphopenia in CIPN Model
Avoids Lymphopenia Reverses Pain Response TRV045: Engages S1PR Without Lymphopenia in CIPN Model 0 20 40 60 80 100 Fingolimod TRV045 29 S1P receptor activation conventionally associated with lymphopenia / immunosuppression CIPN mouse model: Paclitaxel 6 mg/kg, i.p. on Days 1, 3, 5, 7. Hyperalgesia m
Slide 30: 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 31: Appendix
APPENDIX revena
Slide 32: 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 32 OLINVYK Please see Important Safety Information including BOXED WARNING at the end of presentation. Full Prescribing Inform
Slide 33: Robust Clinical Development Program
• No dosage adjustments for elderly / renally impaired • No known active metabolites Robust Clinical Development Program 33 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 34: 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 34 • Efficacy achieved in hard tissue & soft tissue models • Rapid onset: perceptible pain relief within 2 - 5 minutes • OLINVYK efficacy data in peer - reviewed journals The Journal of Pain
Slide 35: Please see Important Safety Information including BOXED WARNING at the end of presentation. Full
35 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 36: 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 37: Robust Assessment of Respiratory Safety in Phase 3 RCTs
Robust Assessment of Respiratory Safety in Phase 3 RCTs 37 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 38: Robust Assessment of GI Tolerability in Phase 3 RCTs
Robust Assessment of GI Tolerability in Phase 3 RCTs 38 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 39: 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 39 Partnering with Syneos Health to provide “best in class” commercial support • Sales : Ins
Slide 40: 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 41: Positive Feedback from Formulary Stakeholders
Positive Feedback from Formulary Stakeholders 1 41 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 42: 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 42 Communication across a full range of channels to maximize reach and impact Customize mix across c
Slide 43: "Now Available" Campaign
“Now Available” Campaign “Now Available” Website • Order/Reimbursement/Dosing Guides • Connect with Medical Affairs and/or Sales Rep “Now Available” Drivers • Programmatic Banner Ads - Banner ad messaging to connect HCPs through digital journey • Journal Ads - Ads will run in American Journal of Hea
Slide 44: 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 44 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 45: 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 46: 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 47: Important Safety Information
IMPORTANT SAFETY INFORMATION 47
Slide 48: Boxed Warning: Addiction, Abuse, and Misuse
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 49: 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