Trevena, Inc. · OTC:TRVN
Trevena — Investor Presentation (April 2024)
32 slides from Trevena's investor presentation, Apr 1, 2024
Slide 1: Innovating for Patients
INNOVATING FOR PATIENTS Nasdaq: TRVN I April 2024
Slide 2: Forward-Looking Statements
Forward - Looking Statements Any statements in this press release about future expectations, plans and prospects for the Company, including statements abo ut the Company’s strategy, future operations, clinical development and trials of its therapeutic candidates, plans for potential future product c
Slide 3: Trevena's Experienced Leadership Team
BOARD OF DIRECTORS Carrie L. Bourdow Jake R. Nunn Scott Braunstein, M.D. Lead Independent Director Anne M. Phillips, M.D. Mark Corrigan, M.D. Barbara Yanni Marvin H. Johnson, Jr. SENIOR MANAGEMENT Carrie L. Bourdow Chair, President & Chief Executive Officer Mark A. Demitrack , M.D . SVP, Chief Medic
Slide 4: Trevena: Innovative CNS Company
*OLINVYK is indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and fo r whom alternative treatments are inadequate. Please see Important Safety Information including BOXED WARNING at the end of presentation. Full Prescribing Information at w
Slide 5: Multiple Expected Catalysts
*OLINVYK is indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and fo r whom alternative treatments are inadequate. Please see Important Safety Information including BOXED WARNING at the end of presentation. Full Prescribing Information at w
Slide 6: OLINVYK Overview
WV Trevena OLINVYK Overview
Slide 7: OLINVYK: Differentiated Profile for Acute Pain
OLINVYK: Differentiated Profile for Acute Pain 7 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 8: 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 Further characterizes respiratory, GI and cognitive outcomes Cogni
Slide 9: ARTEMIS EMR-Based Clinical Outcomes Study
ARTEMIS EMR - Based Clinical Outcomes Study • 201 OLINVYK - treated patients at Cleveland Clinic and Wake Forest Baptist Health VOLITION sites • 982 matched patients undergoing similar surgical procedures, treated with other IV opioids, at same sites during VOLITION study 9 Statistically significant
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: TRV045 Overview
WV Trevena TRV045 Overview
Slide 12: 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 13: TRV045 MOA (1): Rapid Receptor Recycling
TRV045 MOA (1): Rapid Receptor Recycling b - arrestin2 S1P 1 receptor G GRK Internalization ↑ I K Ach ligand G a i ↓cAMP ↓ Ca++ (via IcaL ) Reduces surface receptor, which leads to lymphopenia ( Gilenya , etc ) Receptor R ecycling Maintains surface receptor and avoids lymphopenia, allowing free lymp
Slide 14: TRV045 MOA (2): S1PR Subtype-1 Selectivity
Highly expressed in key CNS / brain cells TRV045 MOA (2): S1PR Subtype - 1 Selectivity • S1P acts on 5 distinct subtypes of receptors (S1P 1 - 5 ) • TRV045 is potent and selective for S1P subtype - 1 receptor - S1P 1 R is highly expressed on astrocytes / other glial cells - May play role in central
Slide 15: TRV045 MOA (3): Anti-Inflammatory Effect (nonclinical)
1) P<0.05 v vehicle 2) Full cytokine / chemokine panel studied: (Inflammatory markers) – TNFa , IL - 6, IL - 1b, IL - 17, IL - 23, IL - 33, CCL1, CCL2, CCL20, CXCL5, CXCL12, CX3CL1, IFNg , Csf2, Substance P; (Anti - inflammatory markers) – IL - 10, IL - 4. (Trevena, Inc., data on file) TRV045 MOA (3
Slide 16: TRV045 Proof-of-Concept Study Program – Highlights
TRV045 Proof - of - Concept Study Program – Highlights • Target Engagement. Demonstrated CNS penetration and target engagement • Neuropathic Pain. Statistically significant, dose - dependent effect in validated model of neuropathic pain • EEG Spectral Power. Statistically significant increases in br
Slide 17: Target Engagement (PainCart) POC Study Design
Target Engagement ( PainCart ®) POC Study Design • Pharmacodynamic Endpoints : - Mechanical allodynia (Von Frey hair testing on capsaicin - treated skin), pressure pain, heat pain (capsaicin - treated, UVB - exposed, and unexposed skin), cold pain (CPT), electrical pain (stair, burst conditions), co
Slide 18: TRV045 Significantly Reduced Mechanical Allodynia
TRV045 Significantly Reduced Mechanical Allodynia 18 1% capsaicin - treated dominant volar forearm – Von Frey filament allodynic area (CFB, mm 2 ) Change from Baseline (mm 2) -1200 -1000 -800 -600 -400 -200 0 200 400 600 Baseline Hr 1 Hr 2 Hr 4 Hr 6 Hr 8 Hr 10 Total Allodynic Area Placebo 50mg 150mg
Slide 19: Effect Size Comparison: TRV045 v Other Analgesics
Effect Size Comparison: TRV045 v Other Analgesics 19 Favors Placebo Favors Active • Studies for comparators conducted at same lab (CHDR) conducting TRV045 studies • Single highest result for each comparator provided (cold pressor) from a battery of CHDR tests conducted - Mechanical allodynia test wa
Slide 20: Target Engagement (PainCart) Study
Source: Trevena data on file Target Engagement ( PainCart ®) Study • Statistically significant, dose - dependent, treatment effect in model of capsaicin - induced mechanical allodynia provides evidence of the therapeutic potential of TRV045 in neuropathic pain - Recognized and validated study index
Slide 21: TMS POC Study Design
TMS POC Study Design • TMS - EEG Pharmacodynamic endpoints: - Resting qEEG power spectral analysis (eyes open/eyes closed): Alpha, Beta, Delta, Gamma, Theta bands - TMS - evoked EEG response (single and paired - pulse TMS) • TMS - EMG Pharmacodynamic endpoints: - Motor - evoked potential (MEP), rest
Slide 22: EEG Shifts in Alpha, Beta, Gamma, Delta Power Spectra
EEG Shifts in Alpha, Beta, Gamma, Delta Power Spectra -5 0 5 10 Delta Theta Alpha Beta Gamma TRV045 Placebo 22 Resting qEEG Power Spectral Analysis – Eyes Open, Day 4 TRV045 v Placebo All Bands -5 0 5 10 Delta Theta Alpha Beta Gamma TRV045 Placebo -5 0 5 10 Delta Theta Alpha Beta Gamma TRV045 Placeb
Slide 23: TRV045 Effect on Cortical Excitability vs AEDs
TRV045 Effect on Cortical Excitability vs AEDs* Mean change from baseline in MEP on Day 1 with TRV045 comparable in magnitude to MEP reductions seen with known AEDs, including levetiracetam, valproic acid, and lorazepam, performed in the same laboratory 23 Mean change from baseline in motor - evoked
Slide 24: Safety and Tolerability Summary
Safety and Tolerability Summary • No AEs assessed as probably / definitely related to study drug; no AEs reported as severe; no SAEs - 98% of AEs (102 of 104) in PainCart ® study reported as mild - 99% of AEs (79 of 80) in TMS study reported as mild • Screening / follow - up physical exams (includin
Slide 25: Safety and Tolerability Summary
Safety and Tolerability Summary • AEs with incidence of ≥10% for any TRV045 dose shown below (none deemed drug related) • No clinically signficant difference (vs placebo) in any AEs including: Sedation Balance Disorders Attention Disturbances Nausea Dry Mouth Blurred Vision • 25 Generally well toler
Slide 26: Overall Conclusions
Overall Conclusions • Target Engagement. Demonstrated CNS penetration and target engagement • Neuropathic Pain. Statistically significant, dose - dependent effect in validated model of neuropathic pain • Epilepsy. Promising evidence of early reduction in cortical excitability Statistically significa
Slide 27: TRV045: Broad Potential Applicability
TRV045: Broad Potential Applicability Potential fields for development may include: Seizure treatment (anticonvulsant) Prevention of seizure ( epileptogenesis ) Pain (DPN, CIPN) Autoimmune (MS, RA, UC, Crohn’s Disease) Neuropsychiatric / neurodegenerative (MDD, schizophrenia, AD, PD) Potent and sele
Slide 28: Trevena: Innovative CNS Company
*OLINVYK is indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and fo r whom alternative treatments are inadequate. Please see Important Safety Information including BOXED WARNING at the end of presentation. Full Prescribing Information at w
Slide 29: Important Safety Information
29 IMPORTANT SAFETY INFORMATION
Slide 30: Important Safety Information: Boxed Warning
30 IMPORTANT SAFETY INFORMATION WARNING: SERIOUS AND LIFE - THREATENING RISKS FROM USE OF OLINVYK Addiction, Abuse, and Misuse Because the use of OLINVYK exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient’s
Slide 31: Warnings and Precautions
31 WARNINGS AND PRECAUTIONS OLINVYK contains oliceridine, a Schedule II controlled substance, that exposes users to the risks of addiction, abuse, and misuse. Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed OLINVYK. Assess risk, counsel,
Slide 32: Warnings and Precautions
32 WARNINGS AND PRECAUTIONS Cases of adrenal insufficiency have been reported with opioid use (usually greater than one month) . Presentation and symptoms may be nonspecific and include nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure . If confirmed, treat with physio