Serina Therapeutics, Inc. · AMEX:SER

Serina Therapeutics — Investor Presentation (April 2014)

18 slides from Serina Therapeutics's investor presentation, April 2014

  1. Slide 1: Serina Therapeutics: SER-214 POZ-Rotigotine

    Serina Therapeutics Randall Moreadith, MD, PhD President and CEO SER-214 POZ-Rotigotine A Once-per-week SC Injection that Provides Continuous Drug Delivery 1

  2. Slide 2: Parkinson's Disease

    Parkinson’s Disease “Do you think you could use your polymer technology to develop a drug to treat Parkinson’s disease ?” Serina shareholder and patient with Parkinson’s disease Non-Confidential 2

  3. Slide 3: Parkinson's Disease

    Parkinson’s Disease Of the current drugs for Parkinson’s disease the dopamine agonists had some attractive features for a POZ conjugate approach … Non-Confidential 3

  4. Slide 4: The Therapeutic Window For Treatment of Parkinson's Disease

    The “Therapeutic Window” For Treatment of Parkinson’s Disease Current Drugs – “wearing off” and dyskinesia Adapted from: Stocchi F, et al. Eur Neurol, 1996. Non-Confidential 4

  5. Slide 5: None of the approved drugs for PD deliver CDS

    None of the approved drugs for PD deliver CDS … but would it work ? Non-Confidential 5

  6. Slide 6: Summary

    Summary  Study Design  Double-blind, double-dummy trial of levo-dopa gel infusion (37 patients) versus levo-dopa sustained release capsules (34 patients) *  Endpoint was reduction in “off” time and corresponding increase in “on” time (without troublesome dyskinesia) during 12 weeks of administrat

  7. Slide 7: SER-214 Product Concept

    SER-214 Product Concept  Target Product Profile  Subcutaneous delivery once a week in a standard insulin or tuberculin syringe (injectate ~ 0.5-1 cc)  Prompt onset of dopaminergic “tone” (within 20-30 min)  Steady-state levels of dopamine agonist within a relatively narrow therapeutic window  S

  8. Slide 8: SER-214

    SER-214 20 kDa POZ polymer with 10 rotigotine molecules Non-Confidential 8

  9. Slide 9: PK Profiles in Plasma

    PK Profiles in Plasma SER-214 “slow release” SER-214 showed a marked difference in release rates, with a half-life of ~ 11 hours in the rat and > 3 days in monkey and human (the same linker:drug attached to PEG or polydextrans releases completely in < 10 minutes) Non-Confidential 9

  10. Slide 10: MPTP Monkey Model

    MPTP Monkey Model Study Design  The study is a twelve week PK and PD study to assess the efficacy and safety of a weekly SC injection of SER-214 versus a twice daily oral dose of L-DOPA versus polymer alone  Adult monkeys (6-7 YOA) were treated with daily MPTP for several months  MPTP is a mitoch

  11. Slide 11: Preliminary Results: PK Profiles

    Preliminary Results PK Profiles Plasma Rotigotine levels following four SC injections of SER-214 to Monkeys (n=3;  SD) 1000 Plasma concentration (ng/mL) 100 Total Rotigotine (Pro-drug levels) 10 A weekly SC injection of SER-214 delivers a 1 steady-state level of rotigotine upon repeat 0.1 dosing Fr

  12. Slide 12: Preliminary Results (Week Two)

    Preliminary Results (Week Two) vehicle N=3 L-DOPA (15 mg/kg, b.i.d.) N=3 SER-214 (1 mg/kg equiv. 1/ weekly) N=2 activity (0-360 min, % post-MPTP) 300 # A single SC injection ** of SER-214 promotes 200 * prompt and sustained * locomotor activity 100 0 1 4 7 1 4 7 1 4 7 study day Non-Confidential 12

  13. Slide 13: Preliminary Results

    Preliminary Results  SER-214 appears to be safe – no adverse events reported in the monkeys to date  Polymer control is safe, and shows no evidence of efficacy  L-DOPA twice daily promotes prompt, but non-sustained locomotor activity (as expected for this model)  Monkeys in the L-DOPA group have

  14. Slide 14: Formulation

    Formulation Non-Confidential 14

  15. Slide 15: Development Milestones And Timelines

    Development Milestones And Timelines  IND-enabling Toxicology  In vitro Metabolite Profiles (GLP) – Complete  Rat single dose MTD and PK (GLP) - Complete  Dog single dose MTD and PK (GLP) - Complete  Rat 6 week and 12 week PK (non-GLP) - Complete  Rat Chronic Dose 3 Month Study (GLP) - Complet

  16. Slide 16: Strong IP Position

    Strong IP Position Issued on SER-214  US 8,383,093 B1 – Issued February 26, 2013  US 8,597,633 B2 – Issued December 3, 2013  Subcutaneous delivery of poly(oxazoline) conjugates  “… a heterofunctional POZ of a general formula containing a dopamine agonist (all dopamine agonists)”  Composition of

  17. Slide 17: Summary

    Summary  SER-214  Target Product Profile achieved  Parkinson’s disease models (rat and monkey)  At least as efficacious as levo-dopa in MPTP monkey model (Week 2)  All monkeys in levo-dopa:carbidopa cohort have developed dyskinesias  None of the monkeys in the SER-214 cohort have developed dys

  18. Slide 18: Acknowledgements

    Acknowledgements The Serina Team Our Shareholders Dr. David Standaert Chairman, Division of Neurology, UAB Dr. Warren Olanow Chairman Emeritus, Mt Sinai Medical Center The Atuka Team Montreal, Canada Non-Confidential 18

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