EX-99.1 2 ex99_1.htm EXHIBIT 99.1
Exhibit 99.1
 
 Advancing Medicines for Neglected and Rare Diseases Through Innovative Business Models  OTC: KBIO www.kalobios.com  | Corporate Overview - October 14, 2016   1 
 

 Forward-Looking Statements  | Corporate Overview   2  This presentation contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management’s current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct, and actual results could differ materially from the forward-looking statements.Words such as “will,” “expect,” “intend,” “plan,” “predict,” “potential,” “possible,” and similar expressions identify forward-looking statements, including, without limitation, statements related to the scope, progress, expansion, and costs of developing and commercializing our product candidates, anticipated regulatory incentives for product candidates, and anticipated expenses related to development activities, clinical trials and the development and potential commercialization of product candidates.Forward-looking statements are subject to risks and uncertainties including, but not limited to, the Company’s ability to execute its revised strategy and business plan; the ability of the Company to list its common stock on a national securities exchange; the Company’s access to limited cash reserves and its ability to obtain additional capital, including the additional capital which will be necessary to complete the clinical trials that the Company has initiated or plans to initiate; the potential timing and outcomes of clinical studies of benznidazole, lenzilumab, ifabotuzumab or any other product candidates; the commercial viability of the Company’s proposed drug pricing program; the ability of the Company to timely source adequate supply of its development products from third-party manufacturers on whom the Company depends; the potential, if any, for future development of any of its present or future products; the Company's ability to successfully progress, partner or complete further development of its programs; the ability of the Company to identify and develop additional products; the uncertainties inherent in clinical testing; the timing, cost and uncertainty of obtaining regulatory approvals and reaching other development milestones; the Company’s ability to apply or receive Priority Review Vouchers; the Company's ability to protect the Company's intellectual property; competition; and changes in the regulatory landscape or the imposition of regulations that affect the Company's products; and the various risks described in the "Risk Factors" and elsewhere in the Company's periodic and other filings with the Securities and Exchange Commission.You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. The company has no obligation, and expressly disclaims any obligation to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise.  
 

 Turnaround focused on high-value neglected and rare diseases, including pediatricPipeline of products with multiple potential near- and longer-term catalystsBenznidazole: anticipated streamlined US approval process relying on existing data; potentially eligible for Priority Review Voucher (PRV) that may be able to be sold for significant returnLenzilumab (recombinant mAb) initially directed toward pediatric and orphan blood cancers; potential regulatory/development incentives, including possible eligibility for PRVIfabotuzumab (recombinant mAb) targeting pediatric brain cancers; ready for partneringExperienced, focused new management with track record of efficient execution, commitment to leadership in responsible, transparent pricing  Compelling Investment Opportunity  | Corporate Overview   3             
 

 Two-Pronged Value Model: a Unique Approach To Near-Term Return Propelling Long-Term Value Creation  | Corporate Overview   4                      Smart Investment in underappreciated assets  Leverage FDA incentives for better efficiency  Value Options From multiple FDA catalysts like PRV  Value Creation Potential robust commercial return  HuntLate-stage, neglected, rare/orphan assets                                                                      NEAR-TERM  LONG-TERM 
 

 Leadership  Cameron Durrant, MD, MBAChairman and CEOSenior pharmaceutical and biotech exec, turnaround specialistSenior exec roles at Pharmacia/Pfizer, J+J in US, Merck, GSK in Europe; experience as Exec Chairman, CEO and CFO; CEO roles at three specialty pharma groupsExpertise in anti-infectives, pediatrics, oncologyMorgan LamChief Scientific OfficerExtensive industry experience in clinical researchHead of Clinical Operations and Development KaloBiosExecutive Director, Medical Affairs, GeronDave Tousley, MBA, CPAInterim Chief Financial Officer More than 35 years experience in biotech, spec pharma, big pharmaSenior exec roles, President, COO, CFOPasteur, Merieux, Connaught, AVAX, airPharma, PediaMed, DARA Biosciences  Tariq Arshad, MD, MBAConsultant focused on medical affairsExtensive industry experience in clinical developmentExperienced in orphan, pediatrics, oncology, pediatric oncology, immunologyPharmacia/Pfizer, Genentech, XomaNiv Caviar, MBAConsultant focused on corporate/business developmentSenior functional roles in marketing, business development, strategic planningSenior exec roles, CEO, EVP-CBO, CFO, VP Bus DevLa Jolla Pharma, Allergan, Suneva, SpineOvations, Affymetrix, AccentureChristopher BoweConsultant focused on corporate affairsDeep experience advising CEOs on articulating, executing strategy through corporate affairsFormer Strategic Affairs advisor at Schering-PloughIndustry thought leader, prior award-winning writer Financial Times Steve Pal, MBAConsultant focused on commercialGlobal pharma and consumer healthcare product commercialisationFormer Corporate VP Global Strategic Marketing, Health Outcomes, Strategy and Research, Global Medical Affairs, Allergan  | Corporate Overview   5 
 

 Board of Directors  Cameron Durrant, MD, MBAChairman  | Corporate Overview   6  Ronald Barliant, JDOf Counsel at Goldberg Kohn, extensive experience representing debtors and creditors in complex bankruptcy casesUnited States bankruptcy judge for the Northern District of Illinois 1988 to 2002Dale Chappell, MD, MBAManaging member of Black Horse Capital Management, LLCPreviously associate at Chilton Investment Company specializing in healthcareTimothy Morris, CPACFO AcelRx Pharmaceuticals; also Head of Business DevelopmentCFO, SVP Finance and Global Corporate Development VIVUS, Inc.Ezra FriedbergFounder and general partner of Multiplier Capital, LP>20 years investing experience across public and private companies 
 

   KaloBios Turnaround Momentum Builds: Rising from the Ashes  | Corporate Overview   7  Funding dead-end, winding down Oct 2015  Martin Shkreli investment late Nov 2015  Shkreli arrest, indictment Dec 2015  Chapter 11 filing Dec 2015  Delisted by Nasdaq Jan 2016  Two new board members Jan 2016  New CEO Mar 2016  Announced Responsible Pricing Model April 2016  Exit from Chapter 11 bankruptcy June 30, 2016  Lenzilumab Phase 1 start July 2016  Shkreli governance agreement July 2016  Shkreli stake extinguished Aug 2016  Current with SEC filings Sept 2016    San Francisco R&D company, mAb platform   
 

     Neglected and Rare Disease Assets with Promise to Deliver  | Corporate Overview   8  BENZNIDAZOLEPotential value generator near-term if approvedOral monotherapy with extensive history treating life-threatening infection with 60-day course Preferred treatment for Chagas disease, a neglected tropical diseaseNever been approved in US, eligible for PRVLENZILUMABPotential value commercially, may be eligible for PRVRecombinant monoclonal antibody from our Humaneered® technologyFirst-in-class therapeutic for rare hematologic malignanciesTargeting both chronic myelomonocytic leukemia (CMML) and juvenile myelomonocytic leukemia (JMML), a rare pediatric diseaseClinical safety data from prior studies in other conditionsMechanism of action has multiple orphan/rare pediatric opportunitiesIFABOTUZUMABPartnering or development potential  ✔  Treat neglected or rare disease  ✔  Powerful scientific rationale  Potential FDA incentives  ✔  ✔  Few, or no, competitors  ✔  Unique market space             
 

 Current Pipeline  | Corporate Overview   9    Pre-clin  Phase I  Phase II  Phase III  Target NDA/BLA              Benznidazole (potential PRV)Chagas diseaseAnti-infective                        LenzilumabCMML Anti-GM-CSF mAb            Lenzilumab (potential PRV)JMML (peds) – dependent on interim data in CMMLAnti-GM-CSF mAb                        Ifabotuzumab (potential PRV)Solid (peds) tumorsAnti-EphA3 mAb               2018        Partnering potential    Intend to seek approval pursuant to 505(b)(2) pathway 
 

     Anticipated KaloBios Milestones*  Potential FDA Meeting Minutes  IND SubmissionPotential Orphan Designation  Bioavailability Results  CMML P1 interim dataCMML Orphan designationJMML FDA meeting Other potential FDA designations  JMML Orphan/RPD designationOther potential FDA designationsJMML P1 first patient dosedCMML Phase 1b/2 Start  CMML P1 final data  | Corporate Overview   10  * Does not include potential outlicensing, other deals, or development timelines for ifabotuzumab    Pre-IND FDA Meeting  Q42016  Q12017  Q22017  Q32017  Q42017      Benznidazole  Lenzilumab 
 

 Priority Review Vouchers (PRVs) Create Options For Significant Potential Return   existing PRV programs  | Corporate Overview   11  Highest disclosed sale price so far for PRV is $350MM      Rare Pediatric Diseases (RPD)  Neglected Tropical Diseases (NTD)  FDA can award a PRV for eligible products upon approvalMost recent PRV issued was for RPD on September 19, Sarepta’s eteplirsen for DMDIncentivizes companies to bring medicines through FDA approval to U.S. patients for overlooked diseasesHolder of PRV can receive a priority review for any drug/biologic application with FDAPRV can be sold to another company seeking a competitive jump      2 
 

 Two-Year Outlook  We Expect PRV Policy to Remain Generally Stable   Zika virus highlights importance of NTD incentives Post-election, congressional gridlock expected to continueFocus likely on big issues: Medicare Part D, Affordable Care Act May be less political will to change small issuesAdditional PRV programs for medical countermeasures and generics proposed  | Corporate Overview   12  Immediate Outlook      Rare Pediatric Diseases (RPD)  Neglected Tropical Diseases (NTD)      NTD PRVNo pending or expected change to policy  RPD PRVCongress extended law through 2016Longer reauthorization anticipated 
 

 Benznidazole  a potential treatment for Chagas disease  | Corporate Overview   13 
 

            On FDA list of NTDs eligible for PRVNeglected tropical disease presenting in the US and other nations Currently no FDA-approved treatmentsImmediate need for reliable benznidazole supply in US and abroad  CHAGAS disease  | Corporate Overview   14  Insect carries the parasite called Trypanosoma cruzi  Infected individuals in US*  Can also affect swallowing, digestion and cause neurological complications  300,000  * Source: CDC  A chronic, potentially life-threatening infectious disease spread by contact with feces of an infected triatomine insect, called “kissing bugs”                                                                                          KEY TAKEAWAYS                      Significant portion of chronic patients progress to serious heart illness                                                       
 

 Benznidazole: the Preferred Treatment Globally for Chagas  | Corporate Overview   15  40 years of clinical experience, primarily in Latin AmericaUsed in tens of thousands of patients Believed to work by inducing free radicals causing DNA damage within the T. cruzi parasite Efficacy ~60% or more in children and can be higher in young children, according to published studiesBetter tolerated in children; side effect profile extremely well knownPotential for streamlined development through FDA 505(b)(2) approval pathwayOnly available in US via special protocol with CDC Drug supply believed to be sporadic, product difficult to obtain          N  N  HN  N           
 

       Benznidazole Has Potential for 505(b)(2) New Drug Application  | Corporate Overview   16  Less complexity in overall dossierOur manufacturing validation will be similar to that for a new drug – a competitive advantage  505(b)(2)    Hybrid between an ANDA and full NDATo demonstrate efficacy & safety, some data will be drawn from studies done by othersNeed to file non-clinical & manufacturing packages  505(j)  Abbreviated NDA (ANDA)Primarily for drugs that are the same as approved products (i.e. generics) Clinical studies to demonstrate equivalence onlyDo not need to repeat studies demonstrating efficacy & safety Usually do not require any non-clinical studies  505(b)(1)  Full ApplicationFor drugs that have not been previously approved by the FDATo demonstrate efficacy & safety, data predominantly obtained from studies conducted by the sponsor to demonstrate efficacy & safetyNeed to file complete non-clinical and manufacturing packages 
 

 Benznidazole Strategy Is to Be First to US Approval  | Corporate Overview   17                            SPEEDUtilizing a combination of published literature and existing studies to demonstrate efficacy and safety of benznidazole  SAFETYDemonstrating comparable bioavailability and/or bioequivalence with a reference benznidazole comparator by conducting a study in healthy volunteers  QUALITYManufacturing benznidazole under GMP to produce a New Chemical Entity to current FDA standard  TRUSTSubmitting a robust Non-Clinical Data Package to include toxicology and metabolic studies to current FDA standardNever conducted when benznidazole was approved in South America                                             
 

      2016                        2017                           H1            H2            H1            H2                                                                                       Manufacturing (CMC)                                                                          Analytical methods development                                                                          Drug substance                                                                          Drug product                                                                           Stability studies                                                                                                                                                     Non-Clinical (Non-Human)                                                                           Metabolism / PK                                                                          Toxicity assessment                                                                          T.cruzi biology                                                                          Environmental assessment                                                                                                                                                     Clinical                                                                          Summary of relevant clinical studies                                                                          Right of Reference & data extraction for studies                                                                          Human bioavailability (BA) Study                                                                                                                                                     Regulatory                                                                          Pre-IND meeting & open IND                                                                          Orphan drug status application                                                                          Pediatric plan                                                                          Pre-NDA meeting                                                                          Assembly of NDA & NDA filing                                                                                  Benznidazole Target Approval Plan  | Corporate Overview   18  Pre-IND meeting  IND submission              NDA filing 2018   
 

 Benznidazole Clinical Profile Treating Chagas Is Well Known  | Corporate Overview   19  Source  Study Design  Age  Follow Up  Sample Size  Treatment Groups  Primary Endpoint  Sosa Estani et al 1998  Randomized, double-blind  6-12  48 mo.  106  BNZ 5 mg/kg/d x 60 days (n=55)vs.Placebo (n=51)  Negative Serology  De Andrade et al 1996  Randomized, double-blind  7-12  36 mo.  129  BNZ 7.5 mg/kg/d x 60 days (n=64)vs.Placebo (n=65)  Negative Serology  Streiger et al 2004  Prospective cohort, longitudinal  1-14  4-24 yrs.  88  BNZ: 5 mg/kg/d x 30 days (n=64)vs.Not treated (n=24)  Negative Serology  Coura et al 1997  Randomized, not double-blinded  Adults  n/a  77  BNZ 5 mg/kg/d X 30 days (n=26)vs.Nifurtimox 5mg/kg/d (n=27)vs.Placebo (n=24)  Post-treatment Xenodiagnosis Positive  Viotti et al2006  Nonrandomized, unblinded: alternative assignment to BNZ or no treatment (NT)  Mean age 39.4  9.8 yrs.  566  BNZ 5 mg/kg/d x 30 days (n=283)vs.No treatment (n=283)  Disease Progression: Mortality:  BNZ  Placebo  BNZ  Placebo  BNZ  Nifurtimox  Placebo  BNZ  NT  BNZ  NT  BNZ  NT  *BNZ = benznidazole 
 

 Lenzilumab  a potential pipeline in a product  | Corporate Overview   20 
 

 KaloBios Humaneered® Platform  Murine segments replaced by human sequences from human donor libraryNew segments have amino acid identity very near to human germ-line segments  | Corporate Overview   21  THERAPEUTIC GOALS  Proprietary and patented technology platform to engineer antibodies, typically murine, into high-affinity human antibodies for therapies                    ENGINEERING PROCESS      Designed to eliminate immunogenicity that may arise from chimeric or conventionally humanized antibodiesClinically tested in more than 200 subjects with no evidence of serious immunogenicityDesigned to bind better and to be prone to less rejection     
 

            High unmet needPatients typically unsuitable for stem cell transplant40-90% patients show hypersensitivity to GM-CSF  CMML overview  | Corporate Overview   22  Recently classified as separate disease with distinct natural history*  Median overall survival rate in months  Newly diagnosed US patients per year  Age at diagnosis  ~1,100                                * Formerly classified as subtype of the myelodysplastic syndromes (MDS)       60+  a rare hematologic cancer                                                                                          20  KEY TAKEAWAYS           
 

            No FDA-approved treatmentClear unmet needPotential for a rare pediatric disease PRVGM-CSF hypersensitivity is hallmarkPediatric oncology largely ignored in clinical development  JMML overview  | Corporate Overview   23  Event-free survival rate at 5 years (with bone marrow transplant)  New US cases per year  Age of majority of patients at diagnosis is 4 years or younger  ~420  very rare, frequently lethal pediatric leukemia                                                            ~52%  KEY TAKEAWAYS       
 

 Neutralization of GM-CSF inhibits JAK-STAT and RAS signaling pathways in leukemic cells  Mutations Affect GM-CSF Signaling, Confers Hypersensitivity in Leukemias  | Corporate Overview   24  Inactivation of the NF1 tumor suppressor gene or oncogenic mutations in NRAS, KRAS2, CBL, or PTPN11. The values in parentheses are the percentages of individual genetic abnormalities among patients with JMML or CMML. Source: Adapted from Koike 2008, Loh 2009. 
 

 Lenzilumab Has Strong Potential as an Inhibitor of GM-CSF  | Corporate Overview   25  Potently decreases effect of GM-CSF, shows potential to kill leukemia cells in pre-clinical studies Encouraging safety profile in multiple studies with >90 patientsPotential FDA Breakthrough Therapy and Rare Pediatric Disease designationsKey patent does not expire until at least 2029  WHAT IS IT? Lenzilumab is a Humaneered® monoclonal antibodyHOW DOES IT WORK?Lenzilumab is an antagonist of GM-CSF, a cytokine driving CMML/JMML and potentially many other conditions                                     
 

 pSTAT5 Heat Map showing GM-CSF responsive populations  Kotecha et al 2008  Strong Correlation Between GM-CSF Sensitivity, CMML / JMML  | Corporate Overview   26               
 

       Lenzilumab is a Potent Inhibitor of GM-CSF Function In Vitro  | Corporate Overview   27  Inhibits GM-CSF-dependent Proliferation of Human TF-1 Leukemia Cells  Blocks GM-CSF-induced STAT5 Phosphorylation in Human TF-1 Leukemia Cells  Source: KaloBios laboratory notebook      STAT5 phosphorylation detection in TF-1 Cells by Flow Cytometry  Inhibition of STAT5 phosphorylation by lenzilumab in TF-1 Cells (+ 2 ng/mL GM-CSF)    0.001  0.01  0.1  1  10  Lenzilumab (µg/mL)  25  20  15  10  0  5              40  30  20  10  0  MFI  0.01  0.1  1  10  100  GM-CSF (ng/mL)              Lenzilumab        0.1  1  10  100  1000  lgG (pM)  100  50  0                                        Lenzilumab  Control antibody                % Growth  Source: KaloBios pre-clinical study  MFI = mean fluorescence intensity 
 

 Lenzilumab Has an Established Safety Profile in 94 Patients  | Corporate Overview   28  Study*  Population  Objectives  Enrollment/Dose   Safety Results            Phase 1          Single-dose, dose-escalation  Healthy adult volunteers  Safety/tolerabilityPKImmunogenicity  (n=12)3 / 1 mg/kg3 / 3 mg/kg3 / 10 mg/kg3 / placebo  Clean safety profileNo drug related SAEsNon-immunogenic            Phase 2          Dose at weeks 0, 2, 4, 8, 12  Rheumatoid arthritis  EfficacySafety/tolerabilityPKImmunogenicity  (n=9)7 / 600 mg2 / placebo  Clean safety profileNo drug related SAEsNon-immunogenic  Dose at weeks 0, 2, 4, 8, 12, 16, 20  Severe asthma  EfficacySafety/tolerabilityPKImmunogenicity  (n=160)78 / 400 mg82 / placebo  Clean safety profileNo drug related SAEsNon-immunogenic  * All studies are randomized double-blind placebo-controlled, intravenous administration           
 

 Lenzilumab Holds Niche in GM-CSF  | Corporate Overview   29    Source: Wicks, I. P. & Roberts, A. W. (2015) Targeting GM‑CSF in inflammatory diseases. Nat. Rev. Rheumatol. doi:10.1038/nrrheum.2015.161      GM-CSF  Lenzilumab  Humanized monoclonal antibody  Asthma (moderate to severe)  Lenzilumab (400mg) or placebo  Phase II (Completed)  GM-CSF  Lenzilumab  Humanized monoclonal antibody  CMML  Lenzilumab  Phase I (active enrollment) 
 

   Lenzilumab Phase 1 Clinical Evaluation Builds and Transitions from CMML to JMML   PRIMARY OBJECTIVE: Maximum tolerated dose or recommended phase 2 dose; safety and tolerabilitySECONDARY OBJECTIVES: Preliminary efficacy, PK/PD biomarkers  Expect consortium or cooperative group-led study of 10-15 sites* Dependent on adequate interim data in CMML  | Corporate Overview   30    PHASE 1-2 DOSE ESCALATION AND EXPANSIONInitial dose finding (phase 1) in ~15 subjectsEnrollment period: 12 – 18 monthsPhase 2 expansion upon level of activity observedExpand to ~30-40 total subjects   CMML  JMML*     PHASE 1 DOSE ESCALATION STUDY:n = up to 18      Cohort 1200 mg3-6 evaluable  Cohort 2400 mg3-6 evaluable  Cohort 3600 mg6 evaluable 
 

 Lenzilumab CMML/JMML Planned Clinical Trial Execution Matrix  | Corporate Overview   31    2016    2017        2018        2019      Q3  Q4  Q1  Q2  Q3  Q4  Q1  Q2  Q3  Q4  2019                              CMML  Phase 1 Dose Escalation Study                                  Phase 1b/2 Expand Single Arm + Combination Study                First patient dosed                          Preliminary safety/activity data                          Interim analysis                          ASH abstract                                                    JMML          Phase 1 Dose Escalation Study        Phase 2 Expansion        JMML scientific advisory meeting                          Protocol design                          FDA meeting on JMML Phase 1                          First patent dosed                         
 

                       Lenzilumab: a Pipeline in a Drug Opportunity  | Corporate Overview   32  JMML  ALPS / RALD  Cytokine Release Syndrome  AMML  RASopathies (e.g. CFC syndrome, Costello syndrome)  Noonan Syndrome with PTPN11  CMML  CML  Plexiform Neurofibroma  Pediatric Multiple Sclerosis  US ADDRESSABLE POPULATION  325  350  500  600  700  800  1,900  5,800  24,000  40,000                           
 

 Ifabotuzumab  significant potential for partnering and development  | Corporate Overview   33 
 

 Ifabotuzumab: Several Mechanisms to Lead to Tumor Cell Killing, Disruption  | Corporate Overview   34  Brain cancer is now #1 killer pediatric cancer, according to CDCPotential in solid tumors, including rare pediatric tumors; PRV potentialEvaluating phase 0/I bio-distribution study in rare solid tumors such as glioblastoma in children Also evaluating rare hematologic cancer potentialPrior clinical experience: n=>50 Phase 1 study in hematologic malignanciesKey patent does not expire until at least 2030  WHAT IS IT? Ifabotuzumab (formerly KB004) is a Humaneered® monoclonal antibody for Ephrin type-A receptor 3 (EphA3)                                     
 

                                                                                                                                                                                                                                       Ifabotuzumab Target Affects Cell Positioning, Survival, Tumor Growth  EphA3Receptor tyrosine kinaseImportant in fetal developmentNot on normal adult tissuesRe-expressed on cancer and certain non-malignant diseasesUpregulated by some chemotherapeutic agents (HMAs, HDACs) and hypoxiaTarget accessible to antibodies in vivo in hematologic malignancies and solid tumors   35  | Corporate Overview   EphA3 Receptor  ifabotuzumab  INTRACELLULAR  Inhibition of cell positioning, survival and tumor growth                                                 
 

 1  2  3  4  Ifabotuzumab Has Four Postulated Mechanisms of Action  | Corporate Overview   36  ADCC Mediated Killing of Tumor Cells  Direct Apoptosis of Tumor Cells  Disruption of Tumor Vasculature through Cell Rounding  Anti-fibrotic Effect          Ifabotuzumab          Ifabotuzumab            Ifabotuzumab          Ifabotuzumab 
 

 Capitalization Summary as of 10/4/16  | Corporate Overview   37  Debt  $1.2 million      Common Shares Outstanding  14.9 million      Stock Options (WAEP $5.82)  2.0 million      Warrants (WAEP $14.24)  0.3 million      Fully Diluted Shares Outstanding  17.3 million 
 

 Demonstrated History of Swift Execution in Challenging Circumstances  | Corporate Overview   38  JUN  JUL  AUG  SEP  OCT        Emerge in six months from complex Chapter 11 bankruptcy        Lenzilumab Phase 1 trial started         Extinguished Martin Shkreli’s stake in the company        Current with Securities and Exchange Commission periodic reporting requirementsAssembled and filed three 10-Qs and a 10-K within three months        Market cap ~$48MM versus <$4MM preceding bankruptcy  30  24  29  23  4  2016 
 

       Summary  Unique near-term/long-term potential value creation opportunity Thoughtful business strategy that leverages existing U.S. regulatory and development incentivesAttractive asset portfolio with multiple potential milestones and partnering prospectsDeeply committed and focused new management team with an unwavering commitment to success    | Corporate Overview   39