Vistagen Therapeutics, Inc. · NASDAQ:VTGN
Vistagen Therapeutics — Investor Presentation (October 2019)
44 slides from Vistagen Therapeutics's investor presentation, Oct 9, 2019
Slide 1: VistaGen Therapeutics Fall 2019
Ke) VistaGeno Therapeutics i i + Nasdaq: VTGN Fall 2019
Slide 2: Forward-looking Statements
a Forward-looking VistaGens_ Statements
Slide 3: Looking Beyond Current Treatments for CNS Diseases and Disorders with High Unmet Need
Looking Beyond Current Treatments for y ) CNS Diseases and Disorders with High Unmet Need VistaGen is developing differentiated/hew generation medications for large and growing mental health and neurology markets where current treatments to meet the needs of millions of patients
Slide 4: Looking beyond current therapies for CNS diseases and disorders with high unmet need
Looking beyond current therapies for CNS diseases and disorders with high unmet need New generation MO, Fast-acting, exceptional safety H Potentially trai rmative milestones in 2H 20:
Slide 5: Our Pipeline
Slide 6: PH94B: Novel, fast-acting, non-systemic therapy
Ke) VistaGene Therapeutics Novel, fast-acting, non-systemic therapy for: + Social Anxiety Disorder * Generalized Anxiety Disorder * Peripartum Anxiety + Preoperative Anxiety + Panic Disorder + Post-Traumatic Stress Disorder
Slide 7: Social Anxiety Disorder (SAD) in the U.S.
i i t@., i Social Anxiety Disorder (SAD) in the U.S. More than Just Shyness of the most prevalent m jety/fear i ong gat conditions in the yg” socidl Und Seformanee 2tetions Affects as many as 2 ica TI aking worpresntaon 20 million thing speech Americans raaligraw scold ge BE eentenes trap ‘eating/dr
Slide 8: Current SAD Drug Treatments Fall Short
Current SAD Drug Treatments Fall Short ©. Not FDA-Approved * Prescribed Off-label * Antidepressants (2 SSRIs, 1 SNRI) Benzodiazepines & Beta Blockers Slow onset, chronic administration x Addiction risk % May worsen anxiety initially x Significant potential side effects Significant potential side eff
Slide 9: Fundamentally different from all current SAD therapies
Fundamentally different from all current SAD therapies * Successful Phase 2 completed; Phase 3 in 2020 * Fast-acting efficacy (10-15 minutes), exceptional safety * Microgram dose, non-systemic * Well-tolerated, non-sedating, non-addictive Ke) VistaGene Therapeutics
Slide 10: PH94B Mechanism of Action
} PH94B Mechanism of Action = Engages nasal chemosensory receptors, which activate neural circuits in the brain that suppress fear and anxiety = Engages nasal chemosensory receptors, which activate olfactory bulb neurons that project to the limbic amygdala = Modulates activity of the limbic-hypothal
Slide 11: Published PH94B Phase Study — Social Interaction
Published PH94B Phase 2 Study — Social Interaction (n=91) (@ VistaGen. ii 3 crraskmnt Pass) _ | PH94B Rapidly ted Reduced Anxiety in fs a 50 ston Response to Social ‘of Distress Score. Interaction Challenge (suos) “4M eee aE mL onsen Mean Difference =183 Mean Diference = 66 3) ‘Standard Deviation =
Slide 12: Published PH94B Phase Study — Public Speaking
Published PH94B Phase 2 Study — Public Speaking (n = 91) [sae eames el Foes Fad ae — aml i 2 3 4 Simin Pant is tld tat wave to gve a Sm speech without ote fo an aullence Cr Srateplayers and tan nto prepare VistaGen. PH94B Rapidly Reduced Anxiety in Response to Public Speaking Challenge ‘Active Group
Slide 13: PH94B Pilot Phase Crossover Study
| PH94B Pilot Phase 3 Crossover Study (n = 22) cross-over Phase t ase? vee iw ve vs We vat? Sewenng Racin raoede ‘Adult subjects were randomized on a 1:1 basis to PH948 or placebo for two weeks, ‘and then crossed over to the opposite treatment for an additional two weeks. VistaGen.
Slide 14: PH94B Pilot Phase Crossover Study: Peak SUDS
remileogencom PH94B Pilot Phase 3 Crossover Study Peak Suds at Baseline and Weeks 14 * Early suggestions of drug/placebo differences were seen in Week 1 and 2 SUDS scores: average change in SUDS at week 1 was 16.1 for PH94B versus 3.4 for placebo (t=1.86, p=.078, £5.79), and at week 2, the average c
Slide 15: PH94B Pilot Phase Crossover Study: LSAS
eemiteagencom PH94B Pilot Phase 3 Crossover Study SAS at Baseline and Weeks 4 VistaGen. + After the first 2 weeks of treatment, subjects who received PH94B dropped an average of 23.2 points on the LSAS, while those who received placebo dropped only 8.2 points, showing a trend difference (t=1.9, 7) w
Slide 16: PH94B Pilot Phase Crossover Study: Predicting LSAS Change
i H | PH94B Pilot Phase 3 Crossover Study i i i Predicting Change in LSAS from Change in SUDS During Week 1 VistaGen. Changes in total LSAS scores were closely associated with change in SUDS peak anxiety scores at Week 1 (R- sq (adj) 45.256) and at Week 2 (R-sq (adj) 34.95%). Looking at LSAS subscal
Slide 17: PH94B Phase Development Plan for SAD
Initial Phase 3 Study PH94B Phase 3 Development Plan for SAD wears, Principal Investigator: Dr. Michael Liebowitz, Columbia University, New York * Randomized, double-blind, placebo-controlled, monotherapy study * 3.2 jig of PH94B or placebo for 4 weeks + Multi-center, ca. 15 sites in North America +
Slide 18: AV-101: Novel oral NMDA receptor GlyB antagonist
Ke) VistaGene kynurenine Novel oral NMDA receptor GlyB antagonist for: Therapeutics + Major Depressive Disorder * Suicidal Ideation * Neuropathic Pain * Levodopa-Induced Dyskinesia associated with Parkinson’s Therapy * Epilepsy
Slide 19: Major Depressive Disorder in the U.S.
VistaGen. Major Depressive Disorder in the U.S. | © 1in4 women 1in6men 1in8 ae | oh RG eo ae RAR > REDD TTTT diagnosed with depressive disorders age 12 and over takes an antidepressant* LARGE ADDRI 11.6M 7.3M 5.1M Drug-treated patients with Inadequate response Treatment-resistant after Major Depress
Slide 20: FDA-Approved MDD Treatments Fall Short
VistaGen. FDA-Approved MDD Treatments Fall Short Current Oral Antidepressants Atypical Antipsychotics * Often do not work; slow to work * Often do not work —Initial ADT effective in 1 of 3 patients —Only ca. 20% of patients respond to — May take 4 to 6 weeks or more for ‘augmentation antidepressant
Slide 21: Ketamine Therapy for Treatment-Resistant Depression
reetngenson Ketamine Therapy for Treatment-Resistant Depres: Intravenous ketamine Intranasal ketamine s& CNBC “48's new ketamine-like depression drug Spravato off to ‘very, very strong start, company says” “Ketamine offers lifeline for people with severe depression, suicidal thoughts”
Slide 22: Ketamine therapy offers new hope, but is it a long-term solution?
i Ketamine therapy offers new hope to millions, but is it VistaGen- i _ along-term solution? “In the clinical trials, the most common side effects of SPRAVATO™ when used along with an antidepressant taken by mouth included: dissociation, dizziness, nausea, sedation, spinning sensation, reduced sense
Slide 23: AV-101 for MDD: Transformative Potential
reiteagencom AV-101 for MDD: Transformative Potential VistaGen- Rapid-onset Potential, Exceptional Safety * Oral prodrug of 7-Cl-KYNA = NMDA receptor glycine site antagonist (a full antagonist) = Rapid-onset antidepressant effects and neurogenesis in preclinical studies = Well-tolerated in all clini
Slide 24: AV-101's Mechanism of Action
remileogencom _ AV-101’s Mechanism of Action 4-CI-KYN (prodrug) + 7-Cl-KYNA (active metabolite) NMDA Receptor Pharmacology ‘asic cRanne locking antagonists
Slide 25: AV-101 Inhibits NMDA Receptor Activity
VistaGen. AV-101 Inhibits NMDA Receptor Activity heecant | I AV-101's active metabolite (7-CI-KYNA) does ine completely blocks the ion channel of the NMDA receptor
Slide 26: AV-101 vs. Ketamine in Published Preclinical Studies
I AV-101 vs. Ketamine in Published Preclinical Studies vores. | Ketamine-Like Antidepressant Effects, without Ketamine’s Side Effects | Antidepressant-like Effects av-t01 Ketamine Foreed-swim —lu La | Tollsuspension =u Learned: helplessness i Novelty-suppressed feeding eo=—lu Side Effects AV-101 Ket
Slide 27: AV-101 Published Phase 1 Clinical Trials
AV-101 Published Phase 1 Clinical Trials VistaGen: AV-101 is Very Well Tolerated and Orally Bioavailable Plasma levels of AV-101 in normal volunteers following single oral dosing Plasma half-life is about 2 hr Dosed up to 1440 mg daily for 2 weeks ‘Adverse events were placebo-like except for some fe
Slide 28: Initial Objective for AV-101 in MDD
Initial Objective for AV-101 in MDD vores. Displace atypical antipsychotics in current MDD treatment paradigm i 1 SSRI/SNRI SSRI/SNRI SSRI/SNRI | LITT L/ sees asspends //////
Slide 29: AV-101 for MDD - The ELEVATE Study
ease AV-101 for MDD - The ELEVATE Study VistaGen- Phase 2 Clinical Study of AV-101 as an Adjunctive Treatment for MDD Principal Investigator: Dr. Maurizio Fava, Harvard Medical School + Multi-center U.S. Phase 2 clinical study * Evaluation of efficacy and safety of AV-101 as an adjunctive treatment
Slide 30: The ELEVATE Study: Sequential Parallel Comparison Design
é } AV-101 for MDD — The ELEVATE Study E) sequential Parallel Comparison Design (SPCD) ‘Only groups within grey highlight are analyzed for efficacy - weighted 50:50 —* sie, — aie, Le sme —! + Compares drug vs. placebo only in placebo non-responders + Drug vs. placebo differences are expected to be g
Slide 31: PH10: Novel, safe, fast-acting therapy for depression
: Ke) {| ViStaGeno Therapeutics Novel, safe, fast-acting therapy for: * Major Depressive Disorder Treatment-Resistant Depression = Peripartum Depression * Suicidal Ideation
Slide 32: PH10 Neuroactive Nasal Spray
PH10 Neuroactive Nasal Spray Rapid-Onset, Exceptional Safety Fundamentally different from all current depression therapies ‘Successful Phase 2a completed Rapid-onset antidepressant efficacy demonstrated in Phase 2a Microgram dose, non-systemic Well-tolerated, minimal side effects Stand-alone and adj
Slide 33: PH10 Mechanism of Action
i @) | PH10 Mechanism of Action = Engages nasal chemosensory receptors, which activate neural circuits in the brain leading to antidepressant effects = Engages nasal chemosensory receptors, which activate olfactory bulb neurons that project to the limbic amygdala = OB neurons stimulate neurons in th
Slide 34: PH10 Phase 1 Safety and Tolerability Study
eretagenson VistaGen. PH10 Phase 1 Safety and Tolerability Study — PH10 found to be safe to use in clinical studies Study Design + Open, prospective, multiple flexible doses, controlled with placebo in 12 healthy volunteers + Dose range: 0.8 ug to 6.4 He + Self-administered intranasally in escalatin
Slide 35: PH10 Phase 2a MDD Monotherapy Study
eretagenson PH10 Phase 2a MDD Monotherapy Study (n = 22) Hamilton Depression (HAM D) Score Reduction From Baseline Microgram doses of PH10 neuroactive nasal spray improved MDD symptoms with rapid-onset efficacy
Slide 36: PH10 Phase 2b Development Plan for MDD
VistaGen- PH10 Phase 2b Development Plan for MDD — Principal Investigator: Dr. Michael Liebowitz, Columbia University, New York + Randomized, double-blind, placebo-controlled, multi-center monotherapy study * MDD patients with zero or 1 prior failure on a standard antidepressant * Twice a day admini
Slide 37: AV-101 for Suicidal Ideation
US. Department AV-101 for Suicidal Ideation == Baylor / VA Phase 1b Clinical Study (ongoing) + Sponsored by U.S. Department of Veteran’s Affairs (VA) * First-step target engagement study * Double-blind, placebo-controlled, crossover design * Two single doses of AV-101 (720 mg and 1440 mg) and placeb
Slide 38: AV-101 for Neuropathic Pain in Preclinical Studies
eretagenson VistaGen. AV-101 for Neuropathic Pain in Preclinical Studies — Significant dose-response with similar efficacy in a rat model of a mononeuropathy as compared to gabapentin (Neurontin) and pregabalin (Lyrica) Robust analgesic effects, similar to gabapentin and pregabalin, but fewer side e
Slide 39: AV-101 for Levodopa-induced Dyskinesia in Preclinical Studies
AV-101 for Levodopa-induced Dyskinesia Associated with “nt Parkinson’s Therapy in Preclinical Studies eretagenson + Antidyskinetic effects in the MPTP primate model similar to those generally observed with amantadine therapy, but without adverse effects experienced with amantadine + Significantly (p
Slide 40: Distinguished Clinical and Regulatory Advisors
emiteageton HARVARD. Maurizio Fava, M.O. Professrof Psychiatry, Harvard Medal School, Decor, Orion of Cea Research, Massachusetts General Hoxptal GH) Reseach inte xeeutve Decor, MGM Clint re etwork a nstte Michael Liebowitz, M.D. Profesor of Clea Pyehistey, Columba Univers: Managing recor and Founde
Slide 41: Experienced Team
. Ke Experienced Team } Leading Execution Shawn K. Singh Chief Executive Oficer += 2s years of experience with opharmaceutal companies 2 healthcare ‘entre eaptal frm and. grftable CRO «hres Neurosence,Silone Pharmaceutialy; Cato aVentures; Cato 2B years of experienc ins + ProentorUnebergee Co Jerrol
Slide 42: Board of Directors
Board of Directors Jerry Gin, Ph.D., MBA + 4S years of healthcare industry experience; Co-Founder of Ocues (acquired by Alergan for $230m) + Cofounder President and CEO of Nuvora ‘Shawn Singh, JD, CEO + 25 years of experience with biopharmaceutial ‘companies, a venture capital frm and a profitable C
Slide 43: Looking beyond current therapies for CNS diseases and disorders with high unmet need
Looking beyond current therapies for CNS diseases and disorders with high unmet need New generation MO, Fast-acting, exceptional safety H Potentially trai rmative milestones in 2H 20:
Slide 44: Looking Beyond Current Treatments for CNS Diseases and Disorders
Ke) VistaGeno Therapeutics LOOKING BEYOND CURRENT TREATMENTS FOR CNS DISEASES AND DISORDERS WITH HIGH UNMET NEED i rd Nasdaq:VTGN
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