Trevena, Inc. · OTC:TRVN
Trevena — Investor Presentation (November 2020)
41 slides from Trevena's investor presentation, Nov 2, 2020
Slide 1: Innovating for Patients
INNOVATING FOR PATIENTS Nasdaq TRVNINovember 2020
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
Trevena’s Experienced Leadership Team
Slide 4: OLINVYK indication
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. Full Prescribing Information at www
Slide 5: Important Safety Information notice
Please see Important Safety Information including BOXED WARNING at the end of presentation. Full Prescribing Information at www.OLINVYK.com.
Slide 6: OLINVYK key attributes
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 Ease of use in clinical practice Bolus / PCA; no active metabolites Data in complex patients Elderly, obese, renal impaired Well
Slide 7: OLINVYK: Broad Indication for Acute Pain
OLINVYK: Broad Indication for Acute Pain Large acute market opportunity US injectable analgesic hospital market unit volume1 45M patients receive IV opioids annually to treat acute pain1 38% 17% 45% IV Opioids IV opioids Local anesthetics IV NSAIDS / acetaminophen Unrivalled analgesic efficacy Top s
Slide 8: New chemical entity with 2032+ patent
Morphine Hydromorphone 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 Information at www.OLINVYK.com. 8 2032 composition of matter patent expiration does not inc
Slide 9: Efficacy in hard and soft tissue models
Hard Tissue (SPID-48) Superior pain relief vs. placebo (p<0.01) Soft Tissue (SPID-24) Superior pain relief vs. placebo (p<0.02) Efficacy achieved in hard tissue & soft tissue models Rapid onset: perceptible pain relief within 2-5 minutes Rapid onset (2-5 min) & ~3 hour duration OLINVYK efficacy data
Slide 10: Adverse event comparison vs. morphine
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 Somnolence 4 6 10 Back pain 4 6 6 Hot flush 4 4 8 Pruritus ge
Slide 11: Broad range of surgeries and complex patients
s Broad range of surgeries / medical procedures Complex patients were included 32% ≥ 65 years; 46% BMI ≥ 30 Number of patients 250 200 150 100 50 0 231 Orthopedic 115 Gynecologic 115 Colorectal surgery 84 General surgery 60 Plastic surgery 44 Urologic 39 Neurologic 33 Emergency 18 Bariatric surgery
Slide 12: Dosing and pricing
n For PCA use only Bolus Dosing: 1 mg and 2 mg vials (single dose) PCA Dosing: 30 mg vial (single patient use) OLINVYK 1 mg ≈ morphine 5 mg1 No refrigeration / reconstitution 27 mg cumulative daily dose limit Single doses over 3 mg have not been evaluated WAC: 1 mg / 1mL 2 mg / 2mL $17.50$25.75$110.
Slide 13: Customer Engagement Strategy
Customer Engagement Strategy
Slide 14: Supporting commercialization and formulary uptake
Will support future commercialization and hospital formulary uptake Health Care Practitioners (HCPs) New chemical entity Fast, effective IV opioid pain relief Clinical data in complex patients / targeted surgeries Hospital Formulary Committees Published head-to-head trials vs. IV morphine Published
Slide 15: OLINVYK development program publications
Comprehensive overview of OLINVYK development program 15 publications 7 publications OLINVYK Phase 3 trials & secondary analyses OLINVYK nonclinical / Phase 1 / Phase 2 data 4 head-to-head studies vs. IV morphine IV opioid efficacy Well-characterized safety and tolerability Data in complex patients
Slide 16: Stakeholder views on replacing IV morphine
Majority of stakeholders view IV morphine as likely to be replaced by OLINVYK: ~75% of formulary stakeholders find OLINVYK’s published data clinically meaningful:2 Likely to Replace in Practice (n=100; multiple responses permitted) 66 41 23 14 13 2 IV fentanyl Ofirmev Exparel Other 020406080 Number
Slide 17: Why OLINVYK? Cost burden of adverse events
$8,826 in hospital costs per patient for nausea / vomiting1 $28,000 per critical respiratory event / sequelae2 Increased hospital length of stay: ~7 additional days2 Cost Burden of Adverse Events Compelling clinical data - - Differentiated acute pain profile Head-to-head peer-reviewed clinical evide
Slide 18: Customer-facing roles and target hospitals
40 customer-facing roles Medical Science Liaisons Hospital Account Executives Includes virtual HCP engagement Medical Education programs Physician specialties ~4 specialties Anesthesiology Orthopedic Colorectal Gynecologic ~550 hospitals ~500 ASCs Community Large regional systems Hospital outpatient
Slide 19: Partnering with Syneos Health
Partnering with Syneos Health to provide “best in class” commercial support Allows for execution speed and flexibility in deployment Full range support: source, hire, train and deploy customer-facing roles Provides infrastructure, sales operations and compliance support Ability to flex as business n
Slide 20: Communication across a full range of channels
Communication across a full range of channels to maximize reach and impact Olinvyk.com Field directed: live, virtual & email Professional societies & congresses HCP social media Virtual “on demand” Medical Education programs Customize mix across channels with targeted HCPs
Slide 21: Initial launch focus and market opportunity
Initial core focus (9M) Broad indication & dosing / admin IV opioid efficacy & fast onset Complex patients: elderly, obese, renal ~15M days of therapy (initial core focus) = $1.5B+ market opportunity* Initial launch focus Initial core focus (9M) Expanded areas of focus (28M) ~45M patients Expanded a
Slide 22: TRV027: NCE targeting the AT1 receptor in COVID-19
TRV027 NCE targeting the AT1 receptor in COVID-19
Slide 23: ACE2 elimination leads to hormonal imbalances
Elimination of ACE2 protein leads to critical hormonal imbalances SARS-CoV-2 ACE2 Leads to accumulation of angiotensin II: Acute lung injury and abnormal blood clots Can lead to ARDS / pulmonary embolism / stroke 66% - 94% mortality rate for COVID-19 related ARDS2* ~1/3 of hospitalized COVID-19 pati
Slide 24: TRV027 is the only selective AT1 receptor agonist
TRV027 is the only selective AT1 receptor agonist Safety / tolerability established in ~700 patients Mechanism targeted to improve lung function and prevent abnormal clotting TRV027 AT1 receptor Cell surface Cell interior G protein β-arrestin Lung damage Abnormal blood clots Lung repair Anti-inflamm
Slide 25: TRV027 proof-of-concept study in COVID-19
Investigate effect of TRV027 on blood clotting, lung function, and other clinical outcomes 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) Stud
Slide 26: Pipeline and upcoming milestones
OLINVYK™Q4 20: Product available New chemical entityAcute painIVAPPROVEDQ1 21: Commercial launch (mu-opioid receptor) TRV027 ARDS / abnormal clottingCollaboration with Novel AT1 receptor(COVID-19)IVImperial College LondonQ1 21: Topline data (ICL) selective agonist Please see Important Safety Informa
Slide 27: Delta receptor: untapped potential in CNS space
Delta receptor: Untapped potential in CNS space Migraine represents a large market opportunity; total migraine drug market = ~$3.5B Delta receptors have unique distribution throughout the brain Play important role in regulation of pain, mood, and anxiety Every year in the US1: 650M migraines treated
Slide 28: TRV250 single dose pharmacokinetics
Subcutaneous doses up to 30 mg studied; no SAEs observed Single dose pharmacokinetics of TRV250 given by SC injection 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 i
Slide 29: TRV734: selective mu receptor agonism
Selective agonism at µ receptor: Potential for improved tolerability >2.5M people in U.S. suffer from opioid use disorder1 Nonclinical evidence of improved tolerability with TRV734 NIDA study demonstrated reduced drug-seeking behavior in animal model of relapse2 Current therapies not well tolerated,
Slide 30: TRV045: Next-Generation S1P Modulator for CNS Disorders
TRV045: Next-Generation S1P Modulator for CNS Disorders Reverses Pain Response S1P receptors in the CNS play unique role in modulating neurotransmission / membrane excitability In animals, TRV045 reversed paclitaxel-induced hyperalgesia without immune-suppressing activity 100 % With Non-Response to
Slide 31: Trevena: Innovative CNS Company
Trevena: Innovative CNS Company 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. Ful
Slide 32: Appendix
APPENDIX ae -
Slide 33: OLINVYK studied in >1,900 individuals
OLINVYK studied in > 1,900 individuals Phase 1 Phase 2 Phase 3 No dosage adjustments for elderly / renally impaired No known active metabolites 4 head-to-head trials vs. IV morphine: IV opioid efficacy Rapid onset of action Well-characterized respiratory safety / GI tolerability Low rates of vomitin
Slide 34: OLINVYK achieved IV opioid efficacy
OLINVYK achieved IV opioid efficacy P < 0.0001 # * * * P = 0.0004 P = 0.029 * * * * * * 8 0 A n a lg e s ic r e s p o n d e r r a t e ( % ) Published in Pain Practice Published in The Journal of Pain Research 2 02 0 0 (1 mg) Oliceridine 0 P la c e b o0 . 10 . 3 50 . 5M o r p h in e O l in v o R e g
Slide 35: Average NRS pain scores in Phase 3 studies
10 9 8 Average NRS Pain Score 6 5 4 3 2 1 0 048 12 16 20 24 28 32 36 40 44 48 Placebo (n=79) OLINVYK 0.1mg (n=76) OLINVYK 0.35mg (n=79) OLINVYK 0.5mg (n=79) Study 1 (Orthopedic – Hard Tissue) 3 PCA regimens studied (0.1, 0.35, 0.5 mg) vs. placebo; all doses P<0.01 vs. placebo 10 9 8 7 6 5 4 3 2 1 0
Slide 36: Multi-Dose tQT Study key results
Multi-Dose tQT Study Key results 24 10121416182022 Time (hours) 02468 -15 N = 68 healthy volunteers 15 10 Mean ΔΔQTcI 5 (msec) [90% CI] 0 -5 -10 Moxifloxacin 400mg (positive control) Oliceridine x 2 or 3mg every 2hrs (27mg max) 20 Mean QTcI <10ms at 22 of 24 points No categorical QTc outliers ∆ >60
Slide 37: Interaction between the AT1 receptor and ACE2 in COVID-19
Interaction Between the AT1 Receptor and ACE2 in COVID-19 Downregulation of ACE2 by coronavirus indirectly promotes activation of the AT1 receptor SARS-CoV-2 ACE2 Viral entry and ACE2 downregulation Decrease in ACE2 elevates angiotensin II levels Angiotensin II activates AT1 receptor No breakdown of
Slide 38: Delta receptor agonists have unique benefits
Delta Receptor Agonists Have Unique Benefits Potential utility for a variety of CNS indications Triptans / Ditans Target: serotonin receptors → mediate vascular excitability (associated CV risk)1 Migraine-specific treatment CGRPs Target: CGRP receptors → regulate neuronal structures involved in pain
Slide 39: Important Safety Information
IMPORTANT SAFETY INFORMATION
Slide 40: Boxed warning
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 41: 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 of