Clinical Trial Centers Alliance

1. Clinical Trial Centers Alliance offering  specialized expertise to fit the unique needs of  each client Bobbie Theodore Alliance Director clinicaltrials@btheodore.com www.clinicaltrialscenters.com

2. Executive Summary • Our Alliance of experienced research sites and services can address portfolio clinical research needs in one bundled package. We propose flexible options to serve your clinical development needs as follows: • A menu of services under one liaison and contract • Expertise across a range of therapeutic areas, phase I through post-marketing • Integrated services including protocol development, study conduct, data analysis, monitoring – any or all to meet clinical program needs OR site-only services

3. Independent (Non-SMO) entities in California, Texas and Florida comprise the Alliance • Combined 1,000+ clinical trials conducted, phases I-IV • Central IRB • Large patient databases, affiliated medical practices and proven recruitment methods

4. Alliance Facilities - California • 60 Bed Clinical Pharmacology Unit – healthy subjects, and CNS, general medical, bioequivalence and ethno-bridging patient population trials • 20 Bed Psychiatric Health Facility – licensed psychiatric health care unit, private and semi-private rooms - inpatient acute psychiatric population trials • Outpatient Offices – neurology, pain, and general medical population trials • CNS, LLC • Long Beach, CA – Dedicated 80 Bed specialty Phase I Unit / Inpatient / Outpatient • Principal Investigators: David Walling, PhD, CEO, Mark Leibowitz, MD, Medical Director, Armen Goenjian, MD, Omid Omidvar, MD, Nirav Patel, MD, Steven Reynolds, DO • Garden Grove, CA – Outpatient psychiatry offices – Principal Investigator: David Walling, PhD • Torrance, CA – Outpatient psychiatry - Principal Investigator: Armen Goenjian, MD

5. Alliance Facilities - California • Pacific Research Partners, LLC San Francisco area, CA – Principal Investigator: Ira Glick, MD • Inpatient - psychiatry (10 beds with flexible capacity) patient population trials • Outpatient Offices – psychiatry, cognition, MCI, pain population trials

6. Alliance Facilities - Texas • FutureSearch Trials, LP Austin, TX – Principal Investigators: Donald Garcia, Jr., MD, President, and John Hudson, MD • Inpatient and Outpatient - psychiatry (30 beds) including phase I special population trials • Inpatient -6 bed sleep lab for PSG and sleep trials • Outpatient Offices – sleep, neurology, Alzheimer’s and pain population trials Dallas, TX – Principal Investigator: Michael Downing, MD • Inpatient - psychiatry (10 beds with flex capacity) population trials • Outpatient Offices – psychiatry, Alzheimer's disease, cognitive dysfunction, pain, and insomnia population trials

7. Alliance Facilities - Florida • Florida Clinical Research Center, LLC • Bradenton, FL – Principal Investigators: Andrew Cutler, MD, CEO, and Jose Zaglul, MD • Inpatient - psychiatry, pediatric - adult (10 beds with flexible capacity) including phase I population trials • Outpatient Offices – psychiatry, cognitive dysfunction, insomnia, and pain population trials • Maitland, FL – Principal Investigators: Martin Kane, MD, Richard Knapp, DO, and Joanne Northcutt, PhD • Inpatient - psychiatry, pediatric – adult (30 beds with flex capacity) population trials • Outpatient Offices – psychiatry, pediatric – adults, cognitive dysfunction, insomnia, and pain population trials

8. Staff Highlights • Each Research Site Has Fulltime Dedicated and Highly Experienced Staff • Investigators Board Certified in Psychiatry, Neurology, Sleep Medicine, Internal Medicine, Family Practice, and Licensed Clinical Psychologists • Protocol consultants to sponsors and CROs in psychiatry, neurology, sleep indications and phase I study designs • Fulltime certified psychometric clinical raters – M.D., Ph.D. and M.A.-level with up to 20+ years rating experience • Multiple fulltime study coordinators including CCRCs, RNs, and LVNs • Dedicated recruitment and outreach specialists with established referral networks in their communities • Regulatory, QA, training and IT personnel

9. Specialized Capabilities and Experience • Dedicated 80 bed Clinical Pharmacology Unit (CPU) in Long Beach, CA • Healthy subjects, and special patient populations • Cardiac, telemetry and holter monitoring • QTc and Thorough QTc • EEG and qEEG • Evoked potentials • Serial PK and ECG • 1.5 and 3T MRI, fMRI bold and 64-Slice PET/CT system imaging • Lumbar puncture and CSF collection • PSG (polysomnography) • Infusion, oral, device, and transdermal patch delivery systems

10. Phase I-IV Trial Experience • Psychiatry • Addictions – smoking cessation, alcohol dependence, binge eating • ADHD – adult and child, including classroom ADHD • Anxiety – GAD, PTSD • Bipolar – bipolar depression, mania, mixed • Cognition – in schizophrenia, mild cognitive impairment • Depression – MDD, refractory/treatment resistant, depression with sexual dysfunction • Schizophrenia and schizoaffective disorders – acute, cognitive dysfunction, negative symptoms, stable • Pediatric psychiatry • Neurology • Alzheimer’s – MCI, prodromal, mild, moderate, and severe • Parkinson’s – early stage to advanced • Post-stroke • Multiple Sclerosis – relapsing remitting • Sleep disorders – insomnia, narcolepsy, restless legs syndrome, shift worker, sleep apnea • Pain • Chronic pain, diabetic neuropathy, fibromyalgia, migraine, osteoarthritis, post herpetic neuralgia • General Medical • COPD, asthma, hypercholesterolemia, hypertension, obesity, OIC, type 2 diabetes, women’s health

11. Recruitment and Retention • Recruitment • Full time dedicated recruitment and outreach specialists on staff • Large databases accumulated over 13+ years of research across all indications • Affiliated PI physician private and group practice databases • Established relationships with network of physicians for additional patient referrals • Outreach to and established relationships with residential facilities, board and cares, senior communities • Participation in community events and support groups – provide free seminars, lunch and learns • History of successful print, web, radio, and television advertising – recruitment departments have established relationships with media buyers for discounted advertising rates and preferred placement • Ability to pre-qualify patients via IRB-approved pre-screen consent form • Retention • Inpatient facilities have private rooms, double occupancy for caregivers or loved ones as needed • Site-provided patient transportation as needed • Fulltime dedicated staff for regular communication with patient and family, reminder and follow-up phone calls • Many of the study patients are treated in the Investigator’s practices allowing for ease in transition, follow up, and retention

12. Affiliated Practices • Affiliated Medical Practices • CNS, CAis aligned with Drs. Goenjian, Omidvar, Patel and Reynolds large psychiatry, neurology and family group practices respectively in the LA and Orange County regions. • Pacific Research Partners, CA has exclusive relationship with the largest mental health clinics in the San Francisco Bay Area Counties. • FutureSearch Trials, Austin, TXis aligned with Dr. Hudson’s sleep medicine/neurology practice and sleep lab on premises of research facility. • FutureSearch Trials, Dallas, TXis aligned with Dr. Downing‘s psychiatry practice. Both Austin and Dallas sites have established community referral relationships with several residential facilities and mental health agencies. • Florida Clinical Research Center, FLis aligned with Dr. Zaglul’s large child and adult mental health agency and residential facilities.

13. Alliance Advantages and Expertise • Menu of site and study management services based on sponsor need • Responsiveness and ease of single point of contact with sponsor relations team • Dedicated regulatory/budget/contract staff for quick turnaround times including use of Central IRB • Best clinical and operational practices shared across sites • Thought leaders in CNS and Phase I indications with multiple publications, and advisory board memberships • Clinical, budget, and protocol feedback during development process, if needed • Established vendor relationships for seamless execution

14. Psychiatry Sample Metrics

15. Phase I Sample Metrics

16. Neurology Sample Metrics

17. Pain Sample Metrics

18. Curriculum Vitae • Click on PI names to view CVs: • David P. Walling, Ph.D. CEO and PI – CNS, LLC • Armen K. Goenjian, M.D., D.F.A.P.A., F.A.C.G.S. PI and Partner – CNS, LLC • Omid Omidvar, M.D. PI – CNS, LLC • Nirav S. Patel, M.D. PI – CNS, LLC • Steven Reynolds, D.O. PI – CNS, LLC • Mark Leibowitz, M.D. – PI – CNS, LLC • Ira D. Glick, M.D.PI – Pacific Research Partners, LLC • Donald J. Garcia, M.D. President and PI – FutureSearch Clinical Trials, LP • John Douglas Hudson, M.D. PI– FutureSearch Trials of Neurology, LP • Michael Downing, M.D. PI– FutureSearch Trials of Dallas, LP • Andrew J. Cutler, M.D. CEO and PI – Florida Clinical Research Center, LLC • Jose T. Zaglul, M.D. PI – Florida Clinical Research Center, LLC • Richard D. Knapp, D.O. PI – Florida Clinical Research Center, LLC • Joanne Northcutt, Ph.D. PI – Florida Clinical Research Center, LLC • Martin Kane, M.D. PI – Florida Clinical Research Center, LLC

19. Conclusion For further information on Alliance services contact: Bobbie Theodore (916) 939-6696 clinicaltrials@btheodore.com www.clinicaltrialcenters.com