Protagenic Therapeutics, Inc. · OTC:PTIX
Protagenic Therapeutics — Investor Presentation (August 2021)
28 slides from Protagenic Therapeutics's investor presentation, August 2021
Slide 1: Breakthrough Therapeutics for Stress-Related Neuropsychiatric Disorders
Breakthrough Therapeutics for Stress-Related Neuropsychiatric Disorders Corporate Overview August 2021
Slide 2: Cautionary Statements
Cautionary Statements This presentation has been prepared by Protagenic Therapeutics, Inc. (the “Company”) solely for informational purposes based on its own information, as well as information from public sources. This presentation has been prepared to assist interested parties in making their own
Slide 3: Corporate Highlights
Corporate Highlights ü Phase I/IIa clinical study to be underway in early 2022 by Dr. Maurizio Fava (Psychiatrist-in-Chief at MGH) ü Potential for Breakthrough Designation by the FDA for accelerated approval pathway for COVID smell/taste trials as well as differentiated safety/efficacy profile in ma
Slide 4: Stress Related Disorders are a Major Unmet Need
Stress Related Disorders are a Major Unmet Need Current therapies are suboptimal Depression Anxiety PTSD Drug & Alcohol Addiction 19 Million 9 Million 11 Million 20 Million Americans Americans Americans Americans 50% 43% Only 2 approved Only Available drugs treated treated3 drugs target opioid recep
Slide 5: The Stress Feedback Loop
The Stress Feedback Loop • A person with past trauma or a history of substance abuse is more prone or sensitive to stress, which commences a vicious cycle STRESS PSYCHOLOGICAL & LEVEL PHYSIOLOGICAL HARM • When met with a stressor, this causes brain impairment, and physical & emotional harm • This st
Slide 6: TCAP is the body's natural regulator of stress response
TCAP is the body’s natural regulator of stress response, breaking the vicious cycle of stress overdrive TCAP restores stress response in the brain to healthy levels Taps into a biological system that has evolved over millions Works on a newly-discovered receptor system in the brain of years across s
Slide 7: Stress Signaling and TCAP's Mechanism of Action
Stress Signaling and TCAP’s Mechanism of Action • TCAP acts as a “brake” in this stress 1 A stress signal increases levels of brain 1 response system, dampening the hormones CRF and AVP, these hormones signaling of CRF and AVP are associated with increased anxiety, disrupted sleep, overall dysphoria
Slide 8: TCAP Reverses or Prevents Stress-Induced Disorders in Relevant Models
TCAP Reverses or Prevents Stress-Induced Disorders in Relevant Models Extensive Pharmacological Experiments with PT00114 Corroborate its Activity • TCAP leads to increases in activity of the neuronal circuitry implicated in depression, demonstrated by increases in the utilization of glucose, a surro
Slide 9: TCAP as a platform technology in Neuronal Health
TCAP as a platform technology in Neuronal Health TCAP has the potential to preserve, protect, and repair nerve circuits, making it a possible treatment for not only neuropsychiatric disorders but also neurodegenerative diseases • TCAP has been shown to be active in the regulation of cell proliferati
Slide 10: PT00114 Has Demonstrated Profound Efficacy and Safety in Extensive Preclinical Models
PT00114 Has Demonstrated Profound Efficacy and Safety in Extensive Preclinical Models of Stress-Related Disorders Efficacy Safety • Multiple preclinical animal studies conducted in a range of stress- • Preclinical safety data for PT00114 induced behavioral distortions using objective behavioral and
Slide 11: Saelens Test: Significant Reduction in Opioid Withdrawal Symptoms
Saelens Test: Significant Reduction in Opioid Withdrawal Symptoms and Harmful Behavioral Response With Subcu-Administered PT00114 • The Saelens Test is a standard animal model of Drug Withdrawal Response, whereby mice are addicted to an opioid (Morphine in this experiment), and after several days, w
Slide 12: PT00114 - Advantages
PT00114 - Advantages Pharmacology and Mechanism of Action • Naturally crosses the blood brain barrier • Rapid onset of action in animal anxiety and depression models as compared with other TRD drugs • Effects are long-lasting and potent (single 1-10 nmole/kg lasts up to one week) • Rapidly cleared;
Slide 13: Phase I/II Trial in 1H 2022 Advancing with Clinical and Operational Leaders
Phase I/II Trial in 1H 2022 Advancing with Clinical and Operational Leaders Double-Blind Study of PT00114 In Major Indications Sequential dose escalation with cohort replication for dose & biologic activity in: 1. Major Depressive Disorder (MDD) who have suboptimal response to or poorly tolerated tw
Slide 14: Phase I/II Trial Cohort 1: Normal Volunteers (NV)
Phase I/II Trial Cohort 1: Normal Volunteers (NV) Screening Baseline V1 V2 V3 V4 V5 V6 V7 Day -21 to -1 Day 0 Day 1 Day 7 Day 8 Day 14 Day 15 Day 21 48 hour in-patient stay 48 hour in-patient stay 48 hour in-patient stay 2 Placebo 2 Placebo 2 Placebo Same subjects Same subjects One week One week One
Slide 15: Phase I/II Trial Cohorts 2 – 5: MDD, GAD, and PTSD
Phase I/II Trial Cohorts 2 – 5: MDD, GAD, and PTSD Cohort 2 Cohort 3 H H H H H MDD-(3:1) P Play the winner H H H H H P A-(5:1) Play the winner Low Cohort 2 Cohort 2 and 3 H H H GAD-(3:1) P H H H P B-(3:1) dose Mid dose L L L P PTSD-(3:1) M P C-(1:1) Each subject 28 days treatment Each subject 28 day
Slide 16: Worldwide Exclusive Rights to Commercialize TCAP; Patent Estate
Worldwide Exclusive Rights to Commercialize TCAP; Patent Estate Across Six Families of COM & Methods of Use Patents Patent Family Title Initial Patent Term Teneurin C-Terminal Associated Peptides (TCAP) and Methods 1 May 2, 2023 and Uses Thereof 2 A Method of Regulating Neurite Growth May 2, 2023 Me
Slide 17: PTIX's Management Team Has Decades of Combined Experience
PTIX’s Management Team Has Decades of Combined Experience Building Biopharma Companies From Discovery Through Development Garo H. Armen, Ph.D., Andrew Slee, Ph.D., Co-Founder, Executive Chairman Chief Operating Officer • Founder • Joined in 2016 and over 37 years in the pharmaceutical industry, take
Slide 18: Key Strategic and Tactical Goals Over the Next Eight Quarters
Key Strategic and Tactical Goals Over the Next Eight Quarters Transitioning Into a Clinical-stage Company • Rapidly advance PT00114 through clinical trials in TRD, GAD, PTSD, and substance use disorder • Explore efficacy in additional stress-related neuropsychiatric and mood disorders beyond initial
Slide 19: Multiple Clinical Development-Related Catalysts Over the Next 12 Months
Multiple Clinical Development-Related Catalysts Over the Next 12 Months Milestone Date* IND Filing Q4 2021 Initiation of Phase I/II study January 2022 Presentation at CNS conference 1H 2022 Initial Readout of Phase I/II study 1H 2022 Final Readout of Phase I/II study Q3 2022 Plans for subsequent con
Slide 20: Public Comparable Companies – Neuropsychiatric / Neurodegenerative
Public Comparable Companies – Neuropsychiatric / Neurodegenerative Logo N am e M a r k e t C a p ($ M ) L e ad C an d i d ate Ph as e A C Im m u n e S A (N asd aq G M :A C IU ) 6 1 4 .7 C re n e zu m ab 2 A d am as Ph arm ac e u tic als, In c . (N asd aq G M :A D M S ) 1 6 7 .4 A D S -5 1 0 2 3 A n
Slide 21: TCAP is a Platform With Potential to Deliver Therapeutic Impact
TCAP is a Platform With Potential to Deliver Therapeutic Impact to Millions of Patients With Unmet Need Acts through the body’s intrinsic mechanism to regulate stress • Compelling preclinical data in animal models of Depression, PTSD, Anxiety, and Addiction • Powerfully addresses voids in treatment
Slide 22: Thank You
Thank You Corporate Overview 22
Slide 23: Appendix
Appendix Corporate Overview 23
Slide 24: PT00114 Alleviates Physical and Emotional Impacts of Addiction, PTSD, and Depression
PT00114 Alleviates Physical and Emotional Impacts of Addiction, PTSD, and Depression in Animal Models Observed substantial reduction in behavioral and biochemical impacts of disease with no impact to motor function Saelens Test (standard animal model of Drug Withdrawal Response) • Mice are addicted
Slide 25: Saelens Test: Significant Reduction in Opioid Withdrawal Symptoms
Saelens Test: Significant Reduction in Opioid Withdrawal Symptoms and Harmful Behavioral Response With Subcu-Administered PT00114 severe withdrawal symptoms in untreated mouse Maximal response seen with Pfizer’s failed CRF-R1 antagonist PT00114 treated mice jumped 3x less than the untreated mice Con
Slide 26: Open Field Test: Substantial Reduction in Stress-Related, Anxious Behavior
Open Field Test: Substantial Reduction in Stress-Related, Anxious Behavior With No Impact to Motor Function Motion Traces of Tube Stressed Mice, Day 8 Cortisol Level in Blood PT00114 treated mice Cortisol levels of moved freely stressed, untreated mice through field, are almost double that exhibitin
Slide 27: TCAP's Novel Mechanism of Action in the Brain's Stress Response Cascade
TCAP’s Novel Mechanism of Action Suggests its Central Role in Counterbalancing Stress Within the Brain’s Stress Response Cascade CRISPR-Based gene knockdown experiment confirms that PT00114 acts through Latrophilin receptors TCAP interacts with Latrophilins via The Latrophilin 1 (Lat-1) receptor was
Slide 28: Integrated Development Plan
Integrated Development Plan Corporate Overview 28 Timeline is illustrative and subject to change
Protagenic Therapeutics — Investor Presentation (August 2021) on 6ix