Trevena, Inc. · OTC:TRVN
Trevena — Investor Presentation (May 2023)
39 slides from Trevena's investor presentation, May 15, 2023
Slide 1: Innovating for Patients
INNOVATING FOR PATIENTS Nasdaq: TRVN I May 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'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 Medica
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.
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 • Topline data expected 3Q 23 • Topline data expected 3Q 23 TRV250 G - protein selective agonist (delta receptor) • IND - enabling activit
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 $15M on first commercial sale in China $10M on commercial or financ
Slide 7: Large Market Opportunity – Acute Pain
Large Market Opportunity – Acute Pain 7 45M patients receive IV opioids annually to treat acute pain 1 IV opioids have unrivalled analgesic efficacy Top surgeries: Total knee arthroplasty, colectomy, hernia repair, spine fusion, C - section 2 IV NSAIDS / acetaminophen US injectable analgesic hospita
Slide 8: OLINVYK: Differentiated Profile for Acute Pain
OLINVYK: Differentiated Profile for Acute Pain 8 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 9: OLINVYK Studied in Complex Surgeries & Patients
OLINVYK Studied in Complex Surgeries & Patients 9 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 6
Slide 10: OLINVYK: Well-Characterized Safety / Tolerability
OLINVYK: Well - Characterized Safety / Tolerability 10 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 Somnol
Slide 11: VOLITION Clinical Outcomes Study w/ Cleveland Clinic
VOLITION Clinical Outcomes Study w/ Cleveland Clinic • 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 • Initial topline data reported 1Q 23 Further characterizes respir
Slide 12: ARTEMIS – EMR Clinical Outcomes Study
ARTEMIS – EMR Clinical Outcomes Study • 96 OLINVYK - treated patients at Wake Forest Baptist Health VOLITION site • 457 matched patients undergoing similar surgical procedures, treated with other IV opioids, at same site during VOLITION study - Based on 8 demographic/clinical characteristics (age, s
Slide 13: 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 14: 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 . 14 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
Slide 15: 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 16: Top Line Data: OLINVYK vs IV Morphine Cognitive Function Study
Top Line Data: OLINVYK vs IV Morphine Cognitive Function Study 16 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 •
Slide 17: OLINVYK Showed Evidence of Reduced Impact on Neurocognitive Function
OLINVYK Showed Evidence of Reduced Impact on Neurocognitive Function Compared to IV Morphine 17 Please see Important Safety Information including BOXED WARNING at the end of presentation. Full Prescribing Information at www.OLINVYK.com . OLINVYK showed a statistically significant reduction in sedati
Slide 18: Secondary Endpoint Results
Secondary Endpoint Results • Reaction Time. Reduced impact on saccadic eye movement reaction time - M ain effect, P=0.0201 OLINVYK vs IV morphine, P=0.0273 • Postural Stability (Motor Function). Reduced body sway, a measure of motor function - M ain effect, P=0.0314 OLINVYK vs IV morphine, P=0.0951
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 mg 1 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 Published 1 and available to formulary committees * As stated in the label these data are not an adequate basis for comparison of rates between OLINVYK treatment group and the mo rphine 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 Ambulatory Surgical Centers & Hospitals OLINVYK: NCE, distinct from IV morphine 1 - 3 min onset & 1 - 3 hour duration N o active metabolites OLINVYK published safety dat
Slide 23: OLINVYK: Significant Opportunity in Acute Pain Market
OLINVYK: Significant Opportunity in Acute Pain Market 23 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
Slide 24: TRV045 S1P Receptor Modulator Novel MOA for Diabetic Neuropathic Pain
TRV045 S1P Receptor Modulator Novel MOA for Diabetic Neuropathic Pain
Slide 25: 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 26: TRV045: Novel MOA, Selective S1PR
Avoids Lymphopenia TRV045: Novel MOA, Selective S1PR 26 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. Lymphocytes measured after 3 days of dosing. Data are mean “
Slide 27: TRV045 Phase 1 Study – Safety / Tolerability / PK
TRV045 Phase 1 Study – Safety / Tolerability / PK Randomized, double - blinded, placebo - controlled study 3 - parts: single dose (n=53), food effect (n=27), multiple dose (n=9) 27 • Favorable tolerability profile with no SAEs Well Tolerated Target Exposure Attractive PK Profile • Calculated free pl
Slide 28: POC Study: Single-dose Target Engagement (Ph 1)
POC Study: Single - dose Target Engagement (Ph 1) Topline data expected 3Q 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 - VAS Nocic
Slide 29: POC Study: Repeat-dose TMS study (Ph 1)
• Design: Randomized, double - blind, placebo - controlled, multiple dose, two - way cross - over study (n~24) - Placebo or TRV045 (250mg) for 4 days Pharmacodynamic Endpoint Test and Outcome Resting Motor Threshold % maximal machine output MEP Amplitude Peak - to - peak amplitude (P - PA) Short Int
Slide 30: Effect of TRV045 on Cytokine / Chemokine Release
Effect of TRV045 on Cytokine / Chemokine Release • Methods: • Primary mouse astrocytes in monolayer cell culture; incubated for 24 hrs w/ 5 m M TRV045 • Panel of 17 cytokines / chemokines * assessed by ELISA • Main Findings: • Net anti - inflammatory action on astrocyte cytokine / chemokine release
Slide 31: TRV045 Demonstrates Efficacy in Nonclinical Epilepsy Models
TRV045 Demonstrates Efficacy in Nonclinical Epilepsy Models • NIH - supported Epilepsy Therapy Screening Program • Acute seizure protection in max. electroshock model - Replicated in 3 independent experiments using either subcutaneous or oral administration • Efficacy demonstrated in two different p
Slide 32: TRV250 Acute Migraine; TRV734 Opioid Use Disorder
TRV250: New MOA for Acute Treatment of Migraine TRV734: Maintenance Therapy for Opioid Use Disorder
Slide 33: TRV250: New MOA for Acute Treatment of Migraine
TRV250: New MOA for Acute Treatment of Migraine 33 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 34: 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 n
Slide 35: TRV734: Maintenance Therapy for Opioid Use Disorder
TRV734: Maintenance Therapy for Opioid Use Disorder 35 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 36: Trevena: Innovative CNS Company
Trevena: Innovative CNS Company 36 *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 37: Important Safety Information
37 JL: can will create a transition slide? IMPORTANT SAFETY INFORMATION
Slide 38: Boxed Warning: Addiction, Abuse, 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 39: 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