Relmada Therapeutics, Inc. · NASDAQ:RLMD
Relmada Therapeutics — Investor Presentation (April 2018)
32 slides from Relmada Therapeutics's investor presentation, Apr 5, 2018
Slide 1: Innovations in Central Nervous System Diseases
Ticker Symbol OTCQB:RLMD Innovations in Central Nervous System Diseases April 4, 2018 Targeting Major Advances in Treatment of CNS Disorders Ticker Symbol OTCQB:RLMD
Slide 2: Forward Looking Statements
Forward Looking Statements Certain statements contained in this presentation or in other documents of Relmada Therapeutics (the “Company”), along with certain statements that may be made by management of the Company orally in presenting this material, may contain “forward - looking statements . ” Th
Slide 3: Unlocking the Potential of Dextromethadone
• Relmada is a global leader in advancing dextromethadone (REL - 1017) as a rapid - acting oral treatment for depression, CNS and ophthalmological disorders. • Demonstrated NMDA receptor binding activity in preclinical studies • Mechanism of Action ( MoA ) shows potential to repair damaged brain cel
Slide 4: Development Timeline REL-1017
4 Development Timeline REL - 1017 Indication 2018 2019 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Majo r Depressive Disorder Rett Syndrome Ophthalmology Mitochondrial diseases / ALS Rel - 1017 Ph2a Preclinical preclinical clinical Preclinical Formulation & preclinical * Depends on preclinical results, FDA feedback and
Slide 5: Dextromethadone as a Treatment for Major Depressive Disorder
Ticker Symbol OTCQB:RLMD Dextromethadone (REL - 1017) as a Treatment for Major Depressive Disorder
Slide 6: Expanding Focus on NMDA Role in Treatment of Depression
Expanding Focus on NMDA Role in Treatment of Depression 6 6 Johnson & Johnson Is Reinventing the Party Drug Ketamine to Treat Depression
Slide 7: Dextromethadone: Significant Potential Advantages in the Treatment of Depression
Dextromethadone: Significant Potential Advantages in the Treatment of Depression 7 Source : Am J Psychiatry. 2006 Nov;163(11):1905 - 17. Novel MOA Novel Mechanism of Action Dextromethadone and other NMDA antagonists represent new approach to treating depression with MOA markedly different from curre
Slide 8: The Potential for Faster Antidepressive Activity
The Potential for Faster Antidepressive Activity 8 Source: Signaling pathways underlying the pathophysiology and treatment of depression: novel mechanisms for rapid - acting agents. Duman, Ronald S. et al. Trends in Neurosciences, Volume 35, Issue 1, 47 - 56 NMDA Traditional antidepressants work slo
Slide 9: The Potential to Set a New Standard in Risk/Benefit
The Potential to Set a New Standard in Risk/Benefit • NMDAR antagonist ketamine is clinically effective but with side - effects that limit clinical utility. 1 • Dextromethadone is a non - competitive antagonist that antagonizes signaling only when the NMDA receptor is activated. • Presents opportuni
Slide 10: Strong Evidence of Efficacy in Three Depression Models
0 5 10 15 20 25 30 35 40 45 50 Strong Evidence of Efficacy in Three Depression Models 10 Frequency of Behavior Immobility depression indicator Climbing Swimming anti - depression indicators Placebo/Saline (SC) Ketamine (10mg/kg, IP) Dextromethadone (10mg/kg, SC) Dextromethadone (20mg/kg, SC) Dextrom
Slide 11: Strong Evidence of Efficacy in Three Depression Models
Novelty Suppressed Feeding * * Strong Evidence of Efficacy in Three Depression Models 11 * Female Urine Smell Test * Female Urine Smell Test Novelty Suppressed Feeding = p<0.05 compared to placebo group *
Slide 12: Phase 1 Studies Established Maximum Tolerated Dose with No Severe AEs
Phase 1 Studies Established Maximum Tolerated Dose of Dextromethadone with No Severe AEs 12 Single Ascending Dose (SAD) Study Design • Parallel group, double - blind, placebo controlled Objectives : • Establish PK, PD and safety of single dose administration Treatment Administration: • Cohorts 5, 20
Slide 13: Phase 1 Studies Established Maximum Tolerated Dose with No Severe AEs
Phase 1 Studies Established Maximum Tolerated Dose of Dextromethadone with No Severe AEs 13 Source: Relmada study report - Table 14.3.1.1 SAE = serious adverse event, TEAE = treatment - emergent adverse event a A related TEAE is one assessed as “possible” or “probable” for relationship to study drug
Slide 14: Phase 2a Study for Major Depressive Disorder
Phase 2a Multicenter, Randomized, Double - Blind, Placebo - Controlled Study for Major Depressive Disorder 14 SAFER interview done by CTNI - MGH Screening Period Days - 30 to - 2 Dosing Period Days 1 to 7 Observation Period Days 8 to 14 Follow - Up Days 15 to 21 CRU Inpatient Days - 1 to 9 All Patie
Slide 15: REL-1017-202 Phase 2 Study
• Treatment in non - responding MDD patients. • Randomized, double - blind, placebo - controlled study of 7 - day dosing at 25 mg and 50 mg QD as adjunctive therapy. • Dose selection based on effect measured in pre - clinical studies. • ~60 eligible subjects randomized to three arms: placebo, 25 mg,
Slide 16: REL-1017-202 Trial Protocol Advantages
• 20 subjects/arm designed to show clinically relevant difference between dextromethadone and placebo • Efficacy endpoints cover all major depression symptoms and will provide information on totality of antidepressant effect • Study will inform the design of pivotal studies REL - 1017 - 202 Trial Pr
Slide 17: Potential Competitive Advantages of Dextromethadone
Potential Competitive Advantages of Dextromethadone 17 Compound (Company) Mechanism of Action Delivery Current Clinical Stage Dosing Regimen Notes Dextromethadone (Relmada) Non - competitive NMDA channel blocker Oral Phase II ready Once Daily Completed Phase I single and ascending dose studies have
Slide 18: The Unmet Need in Treatment of Major Depression (TRD)
The Unmet Need in Treatment of Major Depression (TRD) 18 ~10M TRD US patients in the previous year 2,3 ~32M US with MDD in the previous year 1 US 12 - month prevalence = 13.4% ~65M US population with at least 1 lifetime episode 1 US lifetime prevalence = 20.6% 1. Hasin DS, et al. Epidemiology of Adu
Slide 19: Dextromethadone as a Treatment for Rett Syndrome
Ticker Symbol OTCQB:RLMD Dextromethadone (REL - 1017) as a Treatment for Rett Syndrome
Slide 20: Rett Syndrome
• X - linked neurodevelopmental disorder with high unmet need • Caused by Mecp2 gene mutation – Loss of Mecp2 disrupts synaptic function & structure and neuronal networks – Short period of developmental stagnation, then rapid regression in language and motor skills, followed by long - term stability
Slide 21: NMDARs Have Shown Potential Efficacy in Treatment of Rett Syndrome
• Studies of ketamine in Rett Syndrome mouse models show that: – Low - dose ketamine acutely reverses multiple disease manifestations – Chronic administration of ketamine improves Rett Syndrome progression • Mecp2 mouse models recapitulate salient clinical manifestations allowing for translatability
Slide 22: Development Timeline REL-1017 in Rett
22 Development Timeline REL - 1017 in Rett 2018 2019 2020 2021 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Phase 1/2, n=50 Preclinical * Depends on preclinical results, FDA feedback and available capital resources. Phase 2/3, n=250 preclinical clinical IND
Slide 23: Dextromethadone: Targeting Additional Potential Indications
Ticker Symbol OTCQB:RLMD Dextromethadone (REL - 1017): Targeting Additional Potential Indications
Slide 24: MOA Shows Potential in Ophthalmologic, Mitochondrial Indications and ALS
• Ophthalmology – Formulation work underway – Animal studies planned H2 2018 – Potential for multiple indications – Partnering candidate • Mitochondrial – Animal studies underway • Amyotrophic lateral sclerosis (ALS) MOA Shows Potential in Ophthalmologic, Mitochondrial Indications and ALS 24
Slide 25: Additional Relmada Assets
Ticker Symbol OTCQB:RLMD Additional Relmada Assets
Slide 26: REL-1015 Levocap ER
• Extended release, abuse deterrent, proprietary formulation of the opioid analgesic levorphanol – strong opioid with greater potency than morphine. – demonstrated broad spectrum of analgesic activity against many different types of pain including neuropathic pain, post - surgical pain, and chronic
Slide 27: REL-1028 BuTab
• Novel oral formulation of modified release buprenorphine for chronic pain and opioid dependence indications – Overcomes buprenorphine first pass metabolism in the upper gastrointestinal tract to allow for oral administration in traditional capsule or tablet form • REL - 1028 is – Potentially the f
Slide 28: REL-1021 MepiGel
• Novel version of local anesthetic mepivacaine for treatment of painful peripheral neuropathies – Potential treatment for diabetic neuropathy, postherpetic neuralgia and HIV - associated neuropathy • Blocks the nerve impulses that send pain signals to the brain • REL - 1021: – Has received FDA orph
Slide 29: Corporate Information
Ticker Symbol OTCQB:RLMD Corporate Information
Slide 30: Overview of Company Finances
Overview of Company Finances Ticker RLMD ( OTCQB ) Cash & Equivalents (as of 12/31/17) $5.9 million Common Shares Outstanding (as of 12/31/17) ~12.5 million 52 - Week Stock Price Range (3/1/2017 - 2/28/2018) $0.69 to $1.23 30
Slide 31: Relmada: Positioned for Success
• Strong clinical evidence supporting continued development of dextromethadone (REL - 1017) in multiple indications. • Clinical programs with clear regulatory pathways. • Established network of clinical researchers to support development program. • Strong IP with protection to the mid - 2030s. • Tar
Slide 32: Contact Information
750 Third Avenue, 9 th Floor New York, NY 10017 www.relmada.com Email: info@relmada.com Targeting Major Advances in Treatment of CNS Disorders Ticker Symbol OTCQB:RLMD
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