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. 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 clinical site conduct, with or without bundled CRO services such as protocol development, trial management, data management, statistical analysis, monitoring – any or all to meet your clinical program needs

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 • CNS, LLC • Long Beach, CA – 25,000 sqftClinical Pharmacology Unit and Licensed Psychiatric Hospital • PI’s: David Walling, PhD, CEO, Mark Leibowitz, MD, Early Phase Medical Director, Armen Goenjian, MD, Medical Director, Omid Omidvar, MD, Nirav Patel, MD, Steven Reynolds, DO • Dedicated 60+ Bed Phase I Unit – stable psychiatric, CNS, targeted healthy normal volunteers, medical and ethno-bridging special patient population trials • Dedicated 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 • Garden Grove, CA – Outpatient psychiatry offices – PI: David Walling, PhD • Torrance, CA – Outpatient psychiatry - PI: Armen Goenjian, MD

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

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

7. Alliance Facilities - Florida • Florida Clinical Research Center, LLC • Bradenton, FL – PI’s: Andrew Cutler, MD, CEO, and Jose Zaglul, MD • Inpatient - psychiatry, including targeted special phase I population trials, pediatric - adult • Outpatient – psychiatry, cognitive dysfunction, insomnia, and pain population trials • Maitland, FL – PI’s: Martin Kane, MD, Richard Knapp, DO, and Joanne Northcutt, PhD • Inpatient– psychiatry population trials, pediatric - adult • Outpatient – psychiatry, cognitive dysfunction, insomnia, and pain population trials, pediatric - adult

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 Clinical Pharmacology Unit (CPU) in Long Beach, CA • Healthy subjects, and special patient populations • Cardiac, telemetry and holter monitoring • QTc and TQTc • 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, injection, 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. Testimonials • CNS Sponsor • Bobbie, we will likely initiate additional clinical trials early next year. Your team of investigators tops our list! (Their performance on our last protocol was outstanding on all levels.) Thank you! • Depression Study Sponsor • Dr. [Andrew] Cutler and Patricia, [Florida Clinical Research Center]  YOU are NUMBER 1.  My sincere appreciation and my congratulations to you for screening the first subject in the XXX depression study.  The ice is broken and the ship has now sailed.  Thank You. • Depression Study Sponsor • Dr. [Donald] Garcia’s [FutureSearch Clinical Trials] site consistently came out excellent on rater performance as monitored by our vendor. They have also helped us get ahead of schedule on enrollment. • Phase I Schizophrenia Study Sponsor • We have been extremely pleased with Dr. [David] Walling’s [CNS] sites performance as a “rescue” site for our phase I schizophrenia study. We will use you again for any new early phase opportunities we have. • Schizophrenia Study Sponsor • Dr. [David] Walling’s[CNS] site has been selected for our new schizophrenia trial because they do excellent work, and they were specifically selected for a high-profile schizophrenia trial based on a detailed statistical analysis by the study team of past placebo response rates.

15. Testimonials • Alzheimer’s Study Sponsor • Good afternoon Dr. [Omid] Omidvar, [CNS], I am writing to invite you to participate in a Phase IIb Alzheimer’s trial. You and your team were one of the top enrolling sites for the XXX Elderly MRD trial and we think that you and your team could be perfect for the trial. • ADHD Study Sponsor • Dr. [Andrew] Cutler, Patti, and Florida Clinical Research Center staff have been wonderful throughout their work on our studies. The team exceeded their enrollment goal and closed the study with a remarkably low screen failure and early discontinuation rate. In addition, and the quality of their work on both studies has been exceptional – their source and CRF data have been clean resulting in cost and time savings for our monitoring and data management activities. Dr. Cutler has also been incredibly helpful by collaborating with our team on patient recruitment strategies, the appropriate use of our study diagnostic tool, and sharing his thoughts about future development work with the compound. • ADHD Study Sponsor • I wanted to let you know what a nice job Dr. [Donald] Garcia’s [FutureSearch Clinical Trial] site has done in our adult ADHD trial. He is our highest recruiter by far! Very knowledgeable and good work. He will be on our upcoming studies as you are aware. • Multiple Sclerosis Study CRO • Dr. [Omid] Omidvar, [CNS], your pace of screening and randomizing patients over the last couple months is impressive. We need to clone your site J. Thank you.

16. Testimonials • Multiple Sclerosis Study Sponsor • Hi all, XXX  (Senior Director of Clinical Operations with XXX) came by to meet with Dr. [Nirav] Patel, Anne Cabral, and the [CNS] team to acknowledge the outstanding job we all did on the XXX (MS) spasticity study!  According to some of his internal metrics, we were performing at 300+% compared to other sites. That is amazing!  • Migraine Study Sponsor • Dr. [Eduard] Gfeller [Florida Clinical Research Center] and Dr. [Omid] Omidvar [CNS] have received Elite enrollment site acknowledgement (Elite Enroller Badge) for their participation in the XXX adult migraine study. • Pain Study Sponsor • Please pass my gratitude on to Dr. [John] Hudson and [FutureSearch Trials of Neurology] staff as they have really knocked a good many missing pages out (before deadline), I am very impressed. Other sites were not close to meeting this deadline. Please share my gratitude with Dr. Hudson next time you speak to him. I know Adam put a lot of time into this and it should not go unsung. Thank you. • Insomnia Sleep Sponsor • Dear Dr. [John] Hudson, [FutureSearch Trials of Neurology], I hope you are doing well. I was reviewing the XXX-sponsored trial enrollment numbers in my region, and was impressed with your enrollment numbers in the PSG study. I just wanted to say thank you so much for all of the hard work by you and your staff!

17. Psychiatry Sample Metrics

18. Phase I Sample Metrics

19. Neurology Sample Metrics

20. Pain Sample Metrics

21. 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

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