cytori8511216.htm

­UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

Form 8-K

Current Report 

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported):  January 12, 2016

CYTORI THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
 

Delaware
001-34375
33-0827593
(State or Other Jurisdiction of Incorporation)
(Commission File
Number)
(I.R.S. Employer Identification Number)

3020 Callan Road, San Diego, California 92121
(Address of principal executive offices, with zip code)

(858) 458-0900
(Registrant's telephone number, including area code)

n/a
(Former name or former address, if changed since last report)


Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
 
 
 □
    Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
 
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    Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
 
 □
    Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
 
 □
    Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))




Item 7.01 Regulation FD Disclosure

A copy of an investor slide presentation that Cytori Therapeutics, Inc. (the “Company”) will use during a presentation at the Biotech Showcase™ on Tuesday, January 12, 2016 at 4:30 PM Pacific Time (7:30 PM Eastern Time) in the B-Mission I room at the Parc 55 Wyndham Hotel in San Francisco, is attached to this Current Report on Form 8-K (“Current Report”) as Exhibit 99.1 and is incorporated by reference herein. Additionally, the Company has posted the slide presentation on the Company's Investor Relations website at http://ir.cytori.com.

The information contained in this Item 7.01 and Exhibit 99.1 hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by reference in such a filing.


Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

99.1 Investor Presentation Material



SIGNATURES


Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.




             
       
CYTORI THERAPEUTICS, INC.
       
January 12, 2016
     
By:
 
/s/ Jeremy Hayden
           
Name: Jeremy Hayden
           
Title: General Counsel and VP of Business Development
 

 


Exhibit Index
     
Exhibit
No.
 
 
 
Description
 
   
   
99.1
 
Investor Presentation Material.
 

 Cytori Therapeutics   NASDAQ: CYTX    Enhancing lives through novel cell therapies  Biotech Showcase I January 2016 
 

 Forward Looking Statements and Disclaimers  33%  15%  11%  22%  19%  OTHER  USA  EU  JAPAN  ASIA-PACIFIC  This presentation contains certain ‘forward-looking statements’ about Cytori Therapeutics, Inc. All statements, other than statements of historical fact, that address activities, events or developments that we intend, expect, project, believe or anticipate will or may occur in the future are forward-looking statements. Such statements are based upon certain assumptions and assessments made by our management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. The forward-looking statements included in this presentation, involve known and unknown risks that relate to future events or our future financial performance and the actual results could differ materially from those discussed in this presentation. Some of those forward-looking statements include: our commercialized and pipeline products and technologies; the timing and conduct of our clinical trials, and the associated financial, clinical and regulatory burdens; other parties’ abilities to conduct clinical trials involving Cytori Cell Therapy; the various medical indications and markets that may be addressed by Cytori Cell Therapy; the potential effectiveness of Cytori Cell Therapy, including clinical outcomes; our regulatory, reimbursement and commercial strategies and pathways; potential costs and other adverse effects of diseases targeted for treatment by our products, and; anticipated future funding and contract revenues. Some risks and uncertainties related to such forward looking statements include risks and uncertainties regarding the funding, conduct and completion of our clinical trials and other parties’ clinical trials involving Cytori Cell therapy, uncertain clinical outcomes, regulatory uncertainties, unfavorable reimbursement outcomes, inability to access sufficient capital on acceptable terms (including inability to fund, or find third party sources to fund, our proposed clinical trials or continued development of our technologies), failure to maintain our substantially reduced cash burn; our partners’ failure to launch products in China and other markets where we currently forecast sales; our abilities to service, pay and/or refinance our corporate debt; availability of future government funding and changes in government procurement priorities; the U.S. federal government’s ability to reduce, modify or terminate the BARDA contract if it determines it is in its best interests to do so, potential performance issues with our products and technologies, and other risks and uncertainties described under the "Risk Factors" section in our Securities and Exchange Commission Filings on Form 10-K and Form 10-Q. These risks and uncertainties may cause our actual results to differ materially from those discussed in this presentation. We advise reading our most recent annual report on Form 10-K and quarterly report on Form 10-Q filed with the United States Securities and Exchange Commission for a more detailed description of these risks.The forward-looking statements contained in this presentation represent our estimates and assumptions only as of the date of this presentation and we undertake no duty or obligation to update or revise publicly any forward-looking statements contained in this presentation as a result of new information, future events or changes in our expectations.DisclaimersCaution: Within the U.S., the Celution System is an investigational device limited by U.S. law to investigational use.Celase, Celution, Celution (with design), Cytori Therapeutics, and Cytori (with design) are registered trademarks of Cytori Therapeutics. Cytori Cell Therapy is a trademark of Cytori Therapeutics.  All third party trademarks are the property of their respective owners.    2  1/10/16 
 

 Summary  Unique cell therapy platform- clear commercial model, late-stage lead indication and growing development pipeline Completed corporate restructuring- better positioned to achieve key milestones 2016Substantial clinical data- indicates Cytori Cell Therapy provides symptomatic benefit, improved quality of life and may impact disease progressionScleroderma product introduction- 2016 EU managed access program and anticipated US product launch 2018Product & contract revenue growth- increasingly offset burn through 2018    3  1/10/16 
 

                         Enrolling2  Cytori Cell Therapy: Late-Stage Clinical Pipeline  ECCI-50  Enrollment Complete  ECCO-50  Preclinical3  DCCT-10  Enrolling  ECCS-50  Enrolling1  ECCS-50        Pre-Clinical  Phase I/II  Phase III  Market (Estimate)  >$1B  >$500M  >$3B  >$75M  >$50M  1 Cytori-funded, Investigator-initiated trial2 Japan Govt Sponsorship3 Funded by BARBA (US Govt.)    Scleroderma Associated Hand Dysfunction    Knee Osteoarthritis    Urinary Incontinence    Cutaneous Radiation & Thermal Injury  Therapeutic Agent    4                    1/10/16 
 

 Cytori 3-Step Bedside Process  TIME   30 Min    120 Min  5 - 30 Min  PROCESS  HARVESTSmall Volume Liposuction(100-360 mL)  PROCESSCelution® SystemTissue Processing, Cell Isolation & Dose Preparation  DELIVERCytori® Cell TherapyTM Delivery      Bedside Manufactureproprietary consumables,software, and reagents  Adipose Tissue  Non-Viable Cellular Debris, Waste & Enzymes  Adipose Derived Regenerative Cells(ADRCs)  Hand Scleroderma  Knee Osteoarthritis    5  1/10/16  1  2  3 
 

 Cytori Cell Therapy: Cellular Composition  Cells sourced from autologous adipose tissueTherapeutic manufactured in bedside GMP processProcess yields a diverse, unique cell populationAll consumables are clinical grade  Stem & Stromal Cells  Leukocytes  Tissue Macrophages  Endothelial  VascularSMCs  A clinical grade, heterogeneous cell population highly-enriched for adipose-derived stem, stromal, vascular, and immunoregulatory cell types    6  1/10/16 
 

 Cytori Cell Therapy: Mechanism of Action  Cytori Cell Therapy beneficially modulates multiple key pathologic processes leading to anticipated sustained reduction in pain and disability and improved quality of life  Promotes angiogenesisNormalization of vessel architectureImproved vasomotor function1-5  Reduces development of fibrosisRemodels existing fibrosis2,10,11  Modulates expression of pro- and anti-inflammatory factorsModulates the function of pro- and anti-inflammatory cells3, 6-9,   1. Foubert et al (2015); 2. Koh et al (2011); 3. Premaratne (2011); 4. Morris et al (2015); 5. Eguchi et al (2015); 6. Feng et al (2010); 7. Hao et al (2014); 8. Dong et al (2013); 9. Data on file (Cytori); 10. Serratrice et al (2014); 11. Data on file (Cytori)  Inflammation  Fibrosis/Wound Remodeling  Angiogenesis/Vasculopathy    7  1/10/16 
 

 Lead Indication: Scleroderma 
 

 Scleroderma  Pathophysiology  Scleroderma or Systemic SclerosisRare autoimmune conditionAffects Women: Men, 4:1US Prevalence: 50,000 patients>90% of patients have hand disabilityFibrosis, pain, and edema result in diminished mobility and hand function even with standard medical careSevere vasomotor symptoms  Cytori Cell TherapyPreclinical and in vitro studies report modulation of perivascular inflammation, improved endothelial function, and reduction of extracellular matrix (fibrosis)   Images reproduced with permission of the nonprofit International Scleroderma Network at sclero.orgImage on left by D Niklas, https://commons.wikimedia.org/wiki/File:Raynaud-Syndrom.JPG used under CC licenseImage on right reproduced with permission of the nonprofit International Scleroderma Network at sclero.org  Raynaud’s Phenomenon  Ulceration and Edema    9  1/10/16 
 

   Scleroderma: Market Overview  Current Standard of CareNo therapies approved for treatment of hand dysfunction in scleroderma patientsExisting 1st and 2nd line treatments for treatment of Raynaud’s Phenomenon or other aspects of scleroderma are often inadequate and poorly toleratedExisting 3rd line treatments are costly ($30-$100k) and often very poorly tolerated  DiagnosisAverage age: 30’s-50’s  1st/2nd Line TherapiesInadequately effective or poorly tolerated in ~50% of patients1,2Calcium channel blockers (eg: nifedipine)PDE5 inhibitors (eg: sildenafil)Topical nitratesSide effects: headache, dizziness, flushing, tachycardia, and edema   3rd Line TherapiesExpensive, often poorly-tolerated;doses titrated to tolerance rather than to symptom reliefIntravenous (IV) prostaglandin (PG) analog (eg: Iloprost)Endothelin-1 receptor antagonist (eg: Bosentan)Surgical sympathectomyPain due to severe ischemia may require the use of narcotic analgesicsImmunosuppressive agents (eg: methotrexate, cyclophosphamide)  1. Thompson et al Arthritis Rheum. 2001;44(8):1841-72. Herrick (2008) BMJ Clin Evidence 09:1125     10  1/10/16 
 

 Scleroderma: Treatment Approach  AmbulatoryProcedure roomLocal or mild conscious sedationSingle administration ECCS-500.5cc injection to each NVBNo bandage  \  11  1/10/16 
 

 Pilot/Phase I SCLERADEC I Trial    SCLERADEC I  Study size  12  Randomization  Open label  Administration  Single administration (~4m cells/finger)  Sites  Single site (IIS) - Marseille, France  Endpoints  Cochin Hand Function ScaleRaynaud’s Condition ScoreScleroderma Health Assessment QuestionnairePain Modified Rodnan Skin ScoreCapillaroscopy Adverse eventsOther  Follow-Up   24 months  Status  Complete  Six and 12 month data published1,224 month data to be presented at Systemic Sclerosis World Congress in Lisbon, Portugal, February 19, 2016  1. Granel et al (2014); Ann Rheum Dis Aug 11: doi: 10.1136/annrheumdis-2014-2056812. Guillaume-Jugnot et al (2015) Rheumatol. 10.1093/rheumatology/kev323    12  1/10/16 
 

 ECCS-50 Treatment led to improvement in hand function, Raynaud’s phenomenon, and pain  SCLERADEC I Improved PROs over 24 months  Granel et al. Ann Rheum Dis 2014; Guillaume-Jugnot et al. Rheumatology 2015mean ± std err  Key Observation:Concordant reduction (~50% ) in four key symptomatic patient reported outcomesTopline data show efficacy sustained to two years following a single treatment   p<0.001  p<0.001  p<0.001  p<0.052  p<0.002    13  1/10/16 
 

 SCLERADEC I- Other Endpoints  Granel et al. Ann Rheum Dis 2014; Guillaume-Jugnot et al. Rheumatology 2015All data presented as mean ± std err  Sustained improvement in hand strength & skin stiffness  130% improvement in pinch strength30% improvement in grip strength  p=0.014  23% improvement in mRSS of the hand    14  p=0.038  1/10/16 
 

 Reduction in digital ulcers, improved microvascular architecture  All data presented as mean ± std errGranel et al. Ann Rheum Dis 2014; Guillaume-Jugnot et al. Rheumatology 2015Image at top reproduced with permission of the nonprofit International Scleroderma Network at sclero.org  SCLERADEC I- Other Endpoints  30-35% improvement in vascular suppression score  40% improvement in number of ulcers    Baseline  12 Months  p<0.001    15  1/10/16 
 

 Scleroderma: Ongoing Clinical Trials    STAR (Phase III)  SCLERADEC II (Phase III)  Study size  80  40  Randomization  1:1, active: placebo  1:1 (dose from Pilot, placebo)  Crossover  Placebo, crossover at 48 weeks  Placebo, crossover at 24 weeks (cryo)  Sites  Up to 20 in USA  6 France  Primary Endpoint  Cochin Hand Function Score (CHFS) at 6 months  Cochin Hand Function Score at 3 months  Secondary Endpoints  CHFS, Raynaud’s Condition Score, Scleroderma Health Assessment Questionnaire, Pain, Modified Rodnan Skin Score, Hand Mobility in Scleroderma Test, Adverse events  CHFS, Raynaud’s Condition Score, Scleroderma Health Assessment Questionnaire, Pain, Modified Rodnan Skin Score, Capillaroscopy, Adverse events  Follow-Up   48 weeks  24 weeks  Status  Enrolling  Enrolling  Clinical/Regulatory StrategyEU SCLERADEC I trial data used to support US FDA STAR trial approvalUS FDA STAR trial for US PMA approvalUS STAR trial ± SCLERADEC II to obtain EU Conditional Marketing Authorization/Normal Marketing Authorization    16  1/10/16 
 

 Scleroderma: Anticipated Development Timeline  2015    2016        2017        2018        2019        3  4  1  2  3  4  1  2  3  4  1  2  3  4  1  2  3  4                                        STAR Enrollment, 12 Month Follow-Up & Data Analysis     FDA Original PMA Submission & Panel Approval    Reimbursement    Scleradec II Enrollment,6 Month Follow-Up & Data Analysis     Reimbursement    EMA MAA Submission for Full Marketing Authorization(based on SCLERADEC I/II and STAR)  Approval  Phase III Data  Reimbursement  Conditional Approval  EU Phase III Data  Reimbursement  Full Approval    EMA Conditional MAA Submission for(based on SCLERADEC I/II)    17  Device (PMA)  Drug (ATMP)  1/10/16 
 

 Managed Access Program Overview  SituationScleroderma rare disease, orphan designationSCLERADEC-I results show positive ECCS-50 risk-benefit ratioTwo pivotal trials enrollingClear unmet patient needs and verified broad EMEA demand for ECCS-50OpportunityProvide ECCS-50 access to patients unable to participate in clinical trialsFulfill company missionPartnerIDIS– global market leader with headquarters in UK, NJ22 years of Managed Access Program experience> 200 total Programs executed (>74 orphan/rare disease)    18  1/10/16 
 

 Managed Access Program Objectives  ❶ Provide ethical and compliant access to Cytori Cell TherapyTM, ECCS-50, for hand scleroderma patients prior to EMA marketing authorization ❷ Increase awareness of and facilitate a positive experience with Cytori Cell TherapyTM among healthcare providers in advance of commercial launch❸ Track and collect key program data and documentation providing valuable insight regarding the demand for and use of Cytori Cell TherapyTM ❹ Implement a chargeable program in EMEA countries where regulations allow❺ Launch the program in Q1 and begin treating patients in Y1 and close the program once reimbursement is attained in each EMEA country    19  1/10/16 
 

 Scleroderma Anticipated Managed Access Program Timeline  2015    2016        2017        2018        2019        2020        2021    3  4  1  2  3  4  1  2  3  4  1  2  3  4  1  2  3  4  1  2  3  4  1  2                                                    SCLERADEC-II French Clinical Study    EMA Conditional MAA Submission(based on SCLERADEC-II)    Reimbursement Applications    EMA Full MAA Submission (based on SCLERADEC-II and STAR)  Conditional EMA Approval  6 Month Data    Full EMA Approval  12 Month Data    STARU.S. Clinical Study      Country-by-Country Reimbursement Approval    1st Patient Treated  ProgramDesign & Set UpPricing Strategy    Access & Billing in Most EMEA Countries  Country Expansion    Peak Adoption  Access & Billing in CRO, CZE, GER, HUN, ITA, KSA, POL, RUS, SAU, TUR(based on Conditional EU Approval)  DEVELOPMENT  MAP    Close Program  Transition to Commercial Launch    20  1/10/16 
 

 Pipeline IndicationsKnee OsteoarthritisUrinary IncontinenceRadiation/Nuclear Burn 
 

 Knee Osteoarthritis  OsteoarthritisProgressive loss of joint functionImbalance between anabolic (cartilage-forming) and catabolic (cartilage-destroying) processes driven by synovial inflammation  EpidemiologyOA is the most common form of arthritis13.9% of adults >25 years33.6% (12.4 million) >65 yearsEstimated 26.9 million US adults (2005)  Pathophysiology  Cytori Cell TherapyPreclinical, veterinary, and in vitro studies report modulation of inflammation and promotion of improved balance between anabolic and catabolic processes within the extracellular matrix of the cartilage    22  1/10/16 
 

 Knee Osteoarthritis: Market Overview      2014E Market Size: $2B      Knee OA Treatment Modality  AAOS Guideline  US  Japan  ROW  Hyaluronic Acid (HA) Injection *  Not recommended  $900M  $700M  $400M  Situation: OA affects 10% of global population and clear unmet need Few non-surgical treatments recommended by AAOSTreatment spectrum from oral analgesics/anti-inflammatory meds to total knee replacementHealth systems are paying for expensive and inadequate treatments that are not recommended by professional bodiesOpportunity: Biologic/Cell Therapy to better address gap between oral analgesics and surgical managementReduce use of NSAIDs with anticipated reduction in CV/Renal/GI side effectsImproved pain relief and functionDelay total knee arthroplasty   *Canaccord Genuity 34th Annual Growth Conference Aug 2014  Example:    23  1/10/16 
 

 Rationale for use of Cytori Cell Therapy in OA  The pathophysiology of osteoarthritis (persistent synovial inflammation leading to cartilage destruction) overlaps with other clinical indications in which Cytori Cell Therapy shown to have impactCombination of veterinary, preclinical, in vitro, and pilot clinical data indicate significant potential for symptomatic improvement and perhaps disease modificationClinical feasibility proven      24  1/10/16 
 

 ACT-OA Enrolled Phase II Trial    Phase II (ACT-OA)  Study Size  94  Randomization  1:1:1 (low dose, high dose, placebo)  Crossover  None  Sites  12 US  Primary Endpoint  KOOS - pain on walking  Secondary Endpoints  KOOS, pain/function questionnaires, pain meds, SF-36, MRI  Follow-Up   48 weeks  Status  Enrolled24 wk data Q1/1548 week data Q4/15  Clinical/Regulatory StrategyUS FDA phase II to investigate safety and potential efficacy in key endpoints of single intrarticular administrationIf positive- possible additional phase II, development, or proceed to phase III    25  1/10/16 
 

 Osteoarthritis Potential Development Path  *Pending 48 week data, funding, and FDA approval    26  2015    2016        2017        2018        2019        2020        3  4  1  2  3  4  1  2  3  4  1  2  3  4  1  2  3  4  1  2  3  4                                                        ACT-OA Follow-Up & Data Analysis   *ACT-OA II Enrollment, 12 Month Follow-Up& Data Analysis     FDA Original PMA Submission & Panel Approval    Reimbursement     Approval  Phase II/III Data  Reimbursement  Interim Phase II Data  48 wk Phase II Data  1/10/16 
 

 Stress Urinary Incontinence Program: Japan  ‘ADRESU’ Trial ObjectivesApproved, reimbursed therapy for SUI in men following radical prostatectomySignificant unmet need for patients whose symptoms are not responding to conservative methods  SupportIIS with support from Cytori and substantial funding via grant from the Japanese Ministry of Health, Labour and Welfare  Progress/DataPilot clinical trial data published 1,2Increase in mean maximum urethral closing pressureReduction in mean 24-hour pad weightIncreased blood flowOngoing 45 pt. Multicenter Pivotal TrialEnrollment started Q3/20152 years to enroll  Development PlanOngoing pivotal trial anticipated as combined approval and reimbursement trialAssuming positive data, seek approval and reimbursement based on 12 month assessmentSeeking commercial partnership with Japanese company  1. Gotoh et al. (2014) Int J Urology 21 (3) 294-3002. Yamamoto et al. (2012) Int J Urology 19 (7) 652-9     27  1/10/16 
 

 Radiation/Nuclear Burn Program: USA  ObjectivesDevelopment medical countermeasure for mass casualty event involving thermal burn ± radiation exposure Develop proof of concept clinical data for use of Cytori Cell Therapy in wound healing  SupportFunded by $106MM contract from Biomedical Advanced Research and Development Authority (BARDA)Part of the Dept. of Health & Human Services$18.7MM of funding allocated through September 2016  Progress/ Preclinical DataImprovement in multiple tissue repair parameters following administration of Cytori Cell Therapy1,2Effective via multiple routes of administration1,2Efficacy sustained following substantial exposure to radiation dose3  Development PlanSubmit IDE application in 2016 for a first-in-man clinical trialAdditional $8.3 funding preapproved pending receipt of IDE approval for clinical trial  1. Foubert et al. (2015) Burns doi:10.1016/j.burns.2015.05.0042. Foubert et al. (2015) Adv Wound Care doi:10.1089/wound.2015.06723. Foubert et al (manuscript in preparation)    28  1/10/16 
 

 Corporate Information   
 

 Over 80 patents issued worldwide; over 55 applications pending  Cytori Cell Therapy: Global Patent Estate  Goal: Protect Cytori’s proprietary methods and devices for manufacturing Cytori Cell Therapy, as well as methods of using Cytori Cell Therapy in the treatment of scleroderma, osteoarthritis, SUI and several other pipeline indications  33%  15%  11%  22%  19%  OTHER  USA  EU  JAPAN  ASIA-PACIFIC    30  1/10/16 
 

 Capitalization Summary  Select Data – as of 12/31/15    Cash  ~ $19MM*  Senior term loan  ~ $17.7MM  Common Shares outstanding  ~ 195MM  Outstanding options, RSAs and warrants  ~ 13MM  Fully dilutive share count  ~ 208MM  Market capitalization  ~ $35MM    31  * As of September 30, 2015   1/10/16  Q2 2014- Corporate & management restructuring Change focus, eliminated/lowered outstanding liabilities and recapitalization 
 

 Financial & Operational Performance  * Based on revised guidance of $22 million in operating cash burn for 2015** Based on annualized figures from YTD September 30, 2015 financials    32  1/10/16 
 

 Summary  Unique cell therapy platform- clear commercial model, late-stage lead indication and growing development pipeline Completed corporate restructuring- better positioned to achieve key milestones 2016Substantial clinical data- indicates Cytori Cell Therapy provides symptomatic benefit, improved quality of life and may impact disease progressionScleroderma product introduction- 2016 EU managed access program and anticipated US product launch 2018Product & contract revenue growth- increasingly offset burn through 2018    33  1/10/16 
 

 Review Cytori Corporate Milestones  2016 Milestones    1st Half  EU MAP program launch24 WK ACT-OA interim data evaluation2 YR follow up data SD-I presentedFull STAR enrollmentFull SD-II enrollment  2nd Half  48 WK ACT-OA data evaluationJapan & MAP progress reportedSD-II data evaluation    34  2017 Milestones      1 YR follow up STAR evaluationFile US FDA PMA approval sclerodermaFile EMEA approval sclerodermaUS Phase I Burn enrollmentFull ADRESU enrollment 
 

 Thank You