CNS, LLC CLINICAL PHARMACOLOGY UNIT 2600 Redondo Avenue, Suite 500 Long Beach, CA 90806

1. CNS, LLCCLINICAL PHARMACOLOGY UNIT2600 Redondo Avenue, Suite 500Long Beach, CA 90806 Annie Speno Operations Manager annie@btheodore.com Bobbie Theodore Alliance Director clinicaltrials@btheodore.com • www.clinicaltrialcenters.com

2. State-of-the-Art Clinical Pharmacology Unit • Facility • 60+ bed CPU dedicated and designed specifically for early phase clinical research • Targeted healthy normal volunteers, stable psychiatric, CNS, medical and ethno-bridging special patient population trials • Additional 20 beds in separate PHF unit (Psychiatric Health Facility) licensed by the state of California for acute psychiatric patient population trials • Private and semi-private rooms for double occupancy to accommodate caregiver or significant other • Located within a medical HMO building with a 7 day/week urgent care; acute hospital within 5 miles • Number of offices to accommodate monitors/CRA’s with internet access and copy/fax services • Building has video surveillance that can be monitored in all nurses stations • Secure offsite automatic data back up • Easy access to regional Long Beach airport for monitors and visitors • Reverse airflow room for smoking breaks, or if protocol allows, patients are accompanied outside of facility for smoking break • Contracted with trained pharmacist in compounding procedures; capabilities include encapsulating powder

3. Staff • Full Time Experienced Staff • Principal and Sub-Investigators Board Certified in Psychiatry, Neurology, Internal Medicine and Family Practice, and Licensed Clinical Psychologists • Multiple certified doctorate-level raters with comprehensive cognitive rating scales experience • 24 hour staffing includes licensed ACLS certified nurse’s (RNs, LVNs) on all shifts • Director of nursing, charge nurse and director of social services • Multiple dedicated early phase experienced CCRCs and research assistants • Lab technicians IATA certified • Dedicated medication dispensary with a Pharm.D. supervisor • Dedicated outreach and recruitment specialists • Recreational therapist • Operations manager provides continuous staff training on GCP, SOPs • Dedicated internal QA staff conducts internal audits • Caterer provides daily meals, and dietician for special meals or protocol mandated dietary requests

4. Experience • Healthy normal volunteers (HNV) • First in human (FIM) patient populations – Alzheimer’s, schizophrenia • SAD/MAD, single, and multiple dose escalation • TQT, Qtc, single and continuous ECG • Telemetry, holter and ambulatory cardiac monitoring • EEG/qEEG, evoked potentials • Drug-drug interaction (DDI), food effect, fed and fasted • Serial PK, 24 to 36 hour draws, on the hour and or ½ hour • Imaging, fMRI , 1.5 and 3T, Arterial Spin Labeling (ASL), and PET imaging • CSF collection (conducted by Neurologists and Internists on site. Additional access to anesthesiologists that perform and monitor the setting of spinal catheters) • Proof-of-concept (POC), pilot, pivotal and crossover designs • Large cohorts, and competitive enrollments • Up to 8 week inpatient stays • Delivery system methods – oral, IV infusion, intravenous, injectable, device, patch • Bioequivalence

5. Therapeutic Areas • Psychiatric special patient populations - Addictions (smoking cessation, alcohol dependence, eating disorders, opioid dependence), ADHD, bipolar disorders, cognitive dysfunction, MCI, depression, schizophrenia, stable and acute • Non-psychiatric CNS and medical special patient populations - Alzheimer's, pain disorders (headache, migraine, diabetic neuropathy, chronic, PHN, fibromyalgia, osteoarthritis), Parkinson's, type 2 diabetes, hypertension, high cholesterol, women’s health, asthma, multiple sclerosis, OIC, asthma, and IBS • Bioequivalence and biosimilar • Ethno-bridging

6. Emergency Capabilities, Lab and Data Collection • Emergency Capabilities and Training • Each unit has an emergency cart which includes an AED and emergency medications checked at every shift • Staff ACLS certified and qualified in use of emergency crash cart, CPR, AED, oxygen tank • Automatic defibrillators on site tested and calibrated annually • 8AM-8PM Urgent Care on site (1st floor) • ER ½ mile away • Admitting privileges at Pacific Hospital (2 miles) • Clinical/Analytical Specimens and Laboratory • Relationship with local laboratory for services • 24/7 Pick-up • STAT capabilities analyze within 1-2 hours • Electronic transmission capabilities • Refrigerated and ambient centrifuges • Alarmed refrigerators/freezers (-20, -70 and -80 degrees) • CLIA waivered lab • Diesel generator provides 24-hour battery back up • Data Collection • All data collected by experienced licensed staff, with strict adherence to the protocol, timely and accurately • Data entry between 24-48 hours

7. Phase I Trials • Phase I: (includes Dr. Mark Leibowitz’ trial experience) • 70+ healthy normal subject trials, 40+ FIM, 200+ bioequivalence and ethno-bridging • 50+ patient populations – Alzheimer’s, depression, diabetes, epilepsy, gastrointestinal disorders, hypertension, insomnia, migraine, multiple sclerosis, obesity, Parkinson’s, and schizophrenia • Cognition: • 20+ targeting cognitive primary endpoints • Cognitive dysfunction in schizophrenia, depression, MCI and Alzheimer’s • CANTAB administered over 300+ times in 3 yrs (additional rating scale experience on slide 18)

8. Phase II – III Trials • Psychiatry: 300+ studies, inpatient and outpatient • 200+ Schizophrenia and schizoaffective disorders - acute, negative symptoms, stable, cognition • 50+ Depression – MDD, refractory/treatment resistant, depression with sexual dysfunction • 20+ Bipolar mania and mixed • 5+ Other indications – ADHD, anxiety, PTSD, chemical dependency • Neurology: 80+ studies, inpatient and outpatient, broad range of indications • 30+ Alzheimer’s - MCI, mild-to-moderate, severe • 25+ Pain studies - migraine, diabetic neuropathy, OA, chronic back/knee pain, fibromyalgia • 15+ Parkinson’s trials - early stage and advanced • 8+ Epilepsy - adjunctive therapy and monotherapy • 8+ MS – relapsing remitting • 5+ Sleep disorders – insomnia, restless legs syndrome • Dr. Mark Leibowitz: • 20+ patient populations • 200+ Bioequivalence • 15+ Japanese bridging • General Medical: • 10+ across broad range of indications – type 2 diabetes, NOH, hypercholesterolemia, OIC, IBS, asthma, crohn’s, women’s health

9. Phase I Sample Metrics

10. Phase I Sample Metrics (cont'd)

11. Phase I Sample Metrics (cont'd)

12. Phase I Sample Metrics (cont'd)

13. Phase IIa Sample Metrics

14. Recruitment • Located within three large metropolitan areas, strategically situated to recruit from a very diverse ethnic population of over 15 million people (Los Angeles County – 9MM, Orange County – 3M, and Riverside/San Bernardino Counties – 3M). There are also several major universities and community colleges nearby for healthy normal volunteer recruitment • Partnered with PIs that are part of large psychiatric mental health facilities (serving 5,000 schizophrenia patients), group neurology practice of over 4,000 patients, and a 15 physician family practice with access to thousands of patients • Extensive site and practice databases of over 40,000 subjects across a variety of therapeutic areas, established over 13+ years of clinical research • Dedicated, 15+ recruitment specialists including field-based outreach staff with established community relationships that visit referring physicians, residential facilities and senior communities, provide free seminars, lunch and learns, distribute flyers and attend community events • Established relationships with media buyers; discounted print and radio ad pricing and preferred placements • Recruitment plans tailored to each study, consistently meet or exceeds enrollment goals in a timely and efficient manner • Ads contain number that directs callers straight to our internal call center staff of trained specialists who conduct prescreening over the phone • Ability to pre-qualify patients via IRB-approved pre-screen consent form

15. Retention • Investigators treat research patients in their practices which promotes retention, and allows for ease in transition and follow up • Units designed specifically for research, with patient comfort and safety in mind • Private rooms for caregiver accommodations as needed • 32” LCD flat screen TVs with cable in every room, and in lounge areas • Wireless internet for personal lab tops and community computers allows patients to keep in touch • Board games, and video systems for video games and movies (DVDs) • Recreation Therapist provides ongoing activities for longer inpatient stays • Lounge, break room, dining room with full kitchen • Fulltime caterer and dietician provide meals and protocol mandated special dietary requests • Site owned vans and town car service provides patient transportation to and from visits, including to and from the imaging facility, as needed • Dedicated staff for regular contact with patient and family

16. Advantages • Swift start up – Central IRB • CNS and healthy subject expertise – thought leaders provide clinical feedback, vendor vetting, and CRO recommendations during development process if needed • Ability to recruit quality patients for low drop out/high retention • Proven study metrics • Proven placebo separation results • Participation in many pharmaceutical and CRO preferred site programs • 13+ years experienced staff, low turnover

17. Cognitive Research CorporationCRO Services • Collaborative, non-exclusive, affiliation with Cognitive Research Corporation (CRC) evolved from our expanded phase I and II capabilities • Sponsors requested a streamlined solution to meet CRO+site deliverables under one contract • RFP flexibility of site and CRO services as stand alone, or bundled together from program development to final analysis based on sponsor’s preference • CRC is a boutique CRO with decades of clinical trial experience with unique depth of expertise in CNS populations as well as healthy subject protocols • Collaboration affords competitive pricing, ease of contracting, and single point of contact • Services offered include early drug development (Phase I, healthy subjects, and specialty populations), trial design, clinical trial management , data management, biostatistics, medical writing, regulatory affairs, quality assurance, expertise in neuro-cognitive testing

18. Rating Scale Experience: Certified, experienced raters, including M.D., Ph.D. and M.A.-level

19. Curriculum Vitae • Click on names to view CVs: • David P. Walling, Ph.D. – CEO and PI • Mark Leibowitz, M.D. - PI • Armen K. Goenjian, M.D., D.F.A.P.A., F.A.C.G.S. – PI • Omid Omidvar, M.D. – PI • Nirav S. Patel, M.D. – PI • Steven H. Reynolds, D.O. – PI • Seanglong Te, M.D.– Sub-I • Kim Lorine, Ph.D. – Rater • Sara Deering, Ph.D. – Rater • Thanh Ho, Ph.D. – Rater • Christopher Webb, MA – Rater • Denise Stephens, L.M.F.T. – Rater and Clinical Director • Dalia R. Botros, M.B.B.S. – Director of Operations • Anne Cabral, M.A. – Study Coordinator Supervisor • Geraldine Lucas, RN, CCRC – Study Coordinator • Hanna Voltattorni, B.S. – Study Coordinator • Marilou Dichoso– Study Coordinator Additional investigators, raters, and coordinators CVs upon request

20. Sponsor Relations Team Expedited feasibility and budget/contract negotiation handled by single point of contact with Sponsor Relations Team. Our team is responsible for handling the business development needs of the group, sponsor and CRO relations, facilitating the site selection process (CDAs, feasibility questionnaires, CVs, site capabilities information), budgets and contracts, keeping in regular contact for feedback and garnering new study opportunities so the site personnel can focus on their studies in process. There is no charge to sponsors or CROs for these services. • Jeanette Caruso • Finance Manager Bobbie Theodore Alliance Director Annie Speno Operations Manager

21. Contact Information Bobbie Theodore Alliance Director (916) 939-6696 clinicaltrials@btheodore.com For Inquiries contact: Annie Speno Operations Manager (916) 934-0569 annie@btheodore.com