Trevena, Inc. · OTC:TRVN
Trevena — Investor Presentation (July 2022)
46 slides from Trevena's investor presentation, Jul 28, 2022
Slide 1: Innovating for Patients
INNOVATING FOR PATIENTS Nasdaq: TRVN I August 2022
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
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 Mark A. Demitrack, M.D. SVP, Chief Medical O
Slide 4: Trevena: Innovative CNS Company
Trevena: Innovative CNS Company 4 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. Please see Important Safety Information including BOXED WARNING at the end of presentation. F
Slide 5: Multiple Expected Catalysts
PRE-CLIN PHASE 1 PHASE 2 PHASE 3 NDA POST-APPR EXPECTED CATALYSTS OLINVYK® New chemical entity (mu-opioid receptor) TRV045 Selective S1P receptor modulator • Phase 1 complete 2H 22 • Epilepsy/ETSP Data 2H 22 TRV250 G-protein selective agonist (delta receptor) • IND-enabling activities (oral) TRV734
Slide 6: Ex-US Royalty-Based Financing Highlights
Ex-US Royalty-Based Financing Highlights Blue Chip Investor R-Bridge Healthcare Fund affiliate of CBC Group (one of the largest and most active healthcare-dedicated investment firms in Asia) $40M Total Financing $15M upfront (received April 2022) $10M on commercial or financing milestone $15M on fir
Slide 7: Large Market Opportunity – Acute Pain
Large Market Opportunity – Acute Pain 7 45M patients receive IV opioids annually to treat acute pain1 IV opioids have unrivalled analgesic efficacy Top surgeries: Total knee arthroplasty, colectomy, hernia repair, spine fusion, C-section2 IV NSAIDS / acetaminophen US injectable analgesic hospital ma
Slide 8: Stable IV Opioid Market Performance
Stable IV Opioid Market Performance 8 Despite the 20% decline in elective surgeries, IV opioid volume remained stable SOURCE: IQVIA DDD Data May 2022 Declines due to COVID-19 across top surgical procedures: Total knee, Total hip, Hernia repair, Hysterectomy, Bariatric Pack Units (000s) CDC reports f
Slide 9: OLINVYK: Differentiated Profile for Acute Pain
OLINVYK: Differentiated Profile for Acute Pain 9 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 Please see Important Safety Information including BOXED WARNING at the end of p
Slide 10: OLINVYK Studied in Complex Surgeries & Patients
OLINVYK Studied in Complex Surgeries & Patients 10 Broad range of surgeries / medical procedures 0 50 100 150 200 250 Orthopedic Gynecologic Colorectal surgery General surgery Plastic surgery Urologic Neurologic Emergency Bariatric surgery Cardiothoracic Medical Number of patients 11 18 18 33 39 44
Slide 11: OLINVYK: Well-Characterized Safety / Tolerability
OLINVYK: Well-Characterized Safety / Tolerability 11 Placebo (N = 162) OLINVYK ≤ 27 mg (N = 316) Morphine (N = 158) Patients with any TEAE (%) 73 86 96 Nausea 35 52 70 Vomiting 10 26 52 Headache 30 26 30 Dizziness 11 18 25 Constipation 9 14 14 Hypoxia 3 12 17 Pruritus 6 9 19 Sedation 5 7 13 Somnolen
Slide 12: Respiratory Physiology Study
Respiratory Physiology Study Assessment of Respiratory Function: • Increase inhaled CO2 to experimentally induce respiratory drive • Impact of drug measured as change in minute ventilation • Greater reductions in minute ventilation indicate more respiratory depression • Validated method to estimate
Slide 13: Respiratory Physiology Study: Elderly / Overweight Subjects
Respiratory Physiology Study: Elderly / Overweight Subjects Please see Important Safety Information including BOXED WARNING at the end of presentation. Full Prescribing Information at www.OLINVYK.com. 13 50 70 90 110 130 0 1 2 3 4 5 6 7 OLINVYK 0.5mg Morphine 2.0mg 50 70 90 110 130 0 1 2 3 4 5 6 7 O
Slide 14: Respiratory Physiology Study Observations
Respiratory Physiology Study Observations • Study population comprised elderly individuals (56 to 87 years, mean = 71.2) with BMI ranging from 20 to 34 (mean = 26.3) • Both OLINVYK and IV morphine achieved comparable levels of pain relief. A statistically significant reduced impact on respiratory fu
Slide 15: Top Line Data: OLINVYK vs IV Morphine Cognitive Function Study
Top Line Data: OLINVYK vs IV Morphine Cognitive Function Study 15 Clinical assessment of OLINVYK’s potential impact on cognitive function vs. IV morphine • Randomized, double-blind, placebo-controlled, crossover study • N = 23 subjects, 19-53 years old (median age 26), 13 females & 10 males • Toplin
Slide 16: OLINVYK Showed Evidence of Reduced Impact on Neurocognitive Function
50 70 90 110 130 0 1 2 3 4 5 6 7 OLINVYK 2.0mg Morphine 8.0mg OLINVYK Showed Evidence of Reduced Impact on Neurocognitive Function Compared to IV Morphine 16 Please see Important Safety Information including BOXED WARNING at the end of presentation. Full Prescribing Information at www.OLINVYK.com. O
Slide 17: Secondary Endpoint Results
Secondary Endpoint Results • Reaction Time. Reduced impact on saccadic eye movement reaction time -Main effect, P=0.0201 OLINVYK vs IV morphine, P=0.0273 • Postural Stability (Motor Function). Reduced body sway, a measure of motor function -Main effect, P=0.0314 OLINVYK vs IV morphine, P=0.0951 • Ey
Slide 18: OLINVYK Safety Outcomes Study w/ Cleveland Clinic
OLINVYK Safety Outcomes Study w/ Cleveland Clinic • Open-label, multi-site study led by experts at Cleveland Clinic and Wake Forest Baptist Health • N = ~200 adults undergoing major non-cardiac surgery • Topline data expected in 2H 2022 18 Further characterizes potential respiratory, GI and cognitiv
Slide 19: 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 mg1 27 mg cumulative daily dose limit Do not administer single doses greater than 3 mg 19 3 vials allow for flexible and tailored IV
Slide 20: OLINVYK vs IV Morphine Health Economic Models
OLINVYK vs IV Morphine Health Economic Models 20 Published1 and available to formulary committees * As stated in the lable, these data are not an adequate basis for comparison of rates between OLINVYK treatment group and the morphine treatment group. The OLINVYK and morphine dosing regimens studied
Slide 21: Customer Engagement Strategy
Customer Engagement Strategy
Slide 22: Targeted Account Launch
Targeted Account Launch 22 Health Care Practitioners (HCPs) Anesthesiology, Colorectal, Critical Care physicians Targeted Accounts Over 50% of IV opioid volume covered by customer facing team Please see Important Safety Information including BOXED WARNING at the end of presentation. Full Prescribing
Slide 23: Expanded Targets: ~150 Burn Center Accounts
Expanded Targets: ~150 Burn Center Accounts Targeted market opportunity • ~40k burn-related hospitalizations each year across 150 burn centers in US • Longer average in-patient stay: 8-9 days • Burn guidelines recommend use of IV opioids 23 Critical care / burn patients experience severe pain and ar
Slide 24: OLINVYK: Significant Opportunity in Acute Pain Market
OLINVYK: Significant Opportunity in Acute Pain Market 24 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 OLINVYK 2
Slide 25: TRV045 S1P Receptor Modulator Novel MOA for Diabetic Neuropathic Pain
TRV045 S1P Receptor Modulator Novel MOA for Diabetic Neuropathic Pain
Slide 26: TRV045: Novel MOA for Diabetic Neuropathic Pain
TRV045: Novel MOA for Diabetic Neuropathic Pain 26 Selective S1PR with no lymphopenia – Expected Completion of Phase 1 2H 2022 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 Pha
Slide 27: TRV045 for Diabetic Neuropathic Pain
$0 $7,000 $14,000 $21,000 $28,000 $35,000 Diabetes only Diabetes with DNP TRV045 for Diabetic Neuropathic Pain 27 Diabetic neuropathic pain (DNP) represents a large market opportunity 1) IDF, www.diabetesatlas.org 2) Economic Costs of Diabetes in the U.S. in 2017, Diabetes Care 2018;41:917–928. 3) S
Slide 28: Avoids Lymphopenia
Avoids Lymphopenia TRV045: Novel MOA for Diabetic Neuropathic Pain 28 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) American Diabetes Association. 4) FDA product labels for Lyrica, L
Slide 29: TRV250 and TRV734
TRV250: New MOA for Acute Treatment of Migraine TRV734: Maintenance Therapy for Opioid Use Disorder
Slide 30: TRV250: New MOA for Acute Treatment of Migraine
TRV250: New MOA for Acute Treatment of Migraine 30 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 31: 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 IND-enabling activities initiated for new oral
Slide 32: TRV734: Maintenance Therapy for Opioid Use Disorder
TRV734: Maintenance Therapy for Opioid Use Disorder 32 Selective agonism at µ receptor: nonclinical evidence of 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.
Slide 33: Trevena: Innovative CNS Company
Trevena: Innovative CNS Company 33 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. Please see Important Safety Information including BOXED WARNING at the end of presentation.
Slide 34: Appendix
34 JL: can will create a transition slide? Appendix
Slide 35: OLINVYK: Distinct From IV Morphine / Hydromorphone
Studied in >1,900 individuals Hydromorphone OLINVYK: Distinct From IV Morphine / Hydromorphone Morphine 35 OLINVYK IV morphine included as active comparator NCE with 2032+ COM patent1 Please see Important Safety Information including BOXED WARNING at the end of presentation. Full Prescribing Informa
Slide 36: OLINVYK: IV Opioid Efficacy and Rapid Onset
OLINVYK: IV Opioid Efficacy and Rapid Onset 36 • Efficacy achieved in hard tissue & soft tissue models • Rapid onset: perceptible pain relief within 1-3 minutes • OLINVYK efficacy data in peer-reviewed journals The Journal of Pain Research1 and Pain Practice2 Soft Tissue (SPID-24) Rapid onset (2-5 m
Slide 37: Primary Efficacy Endpoint Achieved in Two Pivotal Studies
37 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 the SPID-24 and SPID-48 efficacy
Slide 38: 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 39: Robust Assessment of Respiratory Safety in Phase 3 RCTs
Robust Assessment of Respiratory Safety in Phase 3 RCTs 39 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 Evidence Dossier for Formulary Consideration. • Prespecifie
Slide 40: Robust Assessment of GI Tolerability in Phase 3 RCTs
Robust Assessment of GI Tolerability in Phase 3 RCTs 40 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 Consideration. 3
Slide 41: Positive Feedback from Formulary Stakeholders
Positive Feedback from Formulary Stakeholders1 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 respirator
Slide 42: Omni-channel Approach for HCP Engagement
Omni-channel Approach for HCP Engagement 42 Communication across a full range of channels to maximize reach and impact Field directed: live, virtual & email HCP social media Professional Society Meetings & Congresses Olinvyk.com Virtual “on demand” Medical Education programs Please see Important Saf
Slide 43: 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 ΔΔQTcI (msec) [90% CI] No Accumulation Despite Repeated Dosing 43 Multi-Dose tQT Study Please see Important Safety Information including BOXED WARNING at the end of presentation. Full Prescribing Information at www.OLINVYK.com. 3 subject
Slide 44: Important Safety Information
44 JL: can will create a transition slide? IMPORTANT SAFETY INFORMATION
Slide 45: 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 risk
Slide 46: 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