2Cautionary Statement on Forward-Looking Information Certain information contained in this presentation, including any information as to our strategy, projects, plans or future financial or operating performance and other statements that express management's expectations or estimates of future performance, constitute "forward-looking statements”. All statements, other than statements of historical fact, are forward-looking statements. The words “believe”, "expect", "will", “anticipate”, “contemplate”, “target”, “plan”, “continue”, “budget”, “may”, “intend”, “estimate” and similar expressions identify forward-looking statements. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable by management, are inherently subject to significant business, economic and competitive uncertainties and contingencies. Immune Cell Therapy, Inc. cautions the reader that such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual financial results, performance or achievements of the company to be materially different from the company's estimated future results, performance or achievements expressed or implied by those forward-looking statements and the forward-looking statements are not guarantees of future performance. Such risks include but are not limited to: the ability to obtain financing immediately in current markets, the impact of general economic conditions, general conditions in the pharmaceutical and/or nutraceuticals industry, changes in the regulatory environment in the jurisdictions in which the Immune Cell Therapy, Inc. does business, fluctuations in costs, and changes to the competitive environment due to consolidation, achievement of forecasted burn rate, and that actual results may vary once the final and quality-controlled verification of data and analyses has been completed. Immune Cell Therapy, Inc. disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.
3About Immune Cell Therapy, Inc. (ICT) ICT possesses the exclusive Intellectual Patent Property for the utilization of Allogeneic Cell Lines (ACL) in the modification and method of use in the treatment of human cancers.Pre-clinical data provides strong evidence that the relative effects of ACL processes are highly immunogenic and efficaciousPersonalized Cellular Vaccines for Lung CancerVaccines for Breast CancerFine. But will be
4Pre-Clinical Research First Patient Cancer FREE Our ObjectiveAdjuvant to current treatment methods with proprietary DNA-based vaccine methods developed by ICT that have shown evidence to be more effective at eliminating residual cancer cells in patients who have completed conventional treatment.Pre-Clinical ResearchClinical StudiesNDAReviewSynthesis & PurificationAnimal TestingInstitutional Review BoardsPhase 1First Patient Cancer FREEIND SubmittedPhase 2NDA SubmittedReview DecisionReview DecisionPhase 3Breast Cancer Vaccine IND Ready to be FiledLung Cancer Vaccine Currently in Phase I TrialICT Plans to Complete Phase I/II Clinical Trial of immunotherapy for 37 eligible patients with pathologically documented Non-Small Cell Lung Cancer (NSCLC)
5Our Team Edward Cohen, M.D Founder & Interim CEO Mary L. (Nora) Disis, M.D.Scientific AdvisorAlice Lin-Tsing Yu, M.D., Ph.D.Scientific AdvisorThomas Gajewski, M.D., Ph.D.Scientific AdvisorSandra Gendler, Ph.D.Scientific Advisor
6Normal Cells from Unrelated Healthy Individual How It WorksDNA from the patient’s Cancer Cells is Transferred into Normal Cells from Unrelated Healthy Individual.Normal cells from an unrelated healthy individual that take up DNA express cancer antigens.Normal CellsNormal Cells from Unrelated Healthy IndividualCancer Cells
7How It WorksDendritic cells incorporate DNA from the foreign cells expressing cancer antigens. They activate killer T cells in the patient.Foreign cells expressing cancer antigens are taken up by patient’s dendritic cells.
8Leaving normal patient cells intact How It WorksActivated T cells seek out cancer cells in the patient and destroy them.Leaving normal patient cells intact
10Pre-Clinical ResultsExtended survival seen with ICT Vaccine compared to Dendritic Cell Vaccine (DC/SCC) in mice with aggressive Squamous Cell Carcinoma (SCC).DC/SCCICTVaccineAnticancer Research 26; 2006; pp
11Pre-Clinical ResultsMice with melanoma treated solely by immunization with the ICT Vaccine developed strong, long-term resistance to the growth of the tumor. In some instances, the mice survived indefinitely.ICTVaccineThe Journal of Immunology, Vol. 160, No. 6; March 15, 1998; pp
12Pre-Clinical ResultsMice with breast cancer treated by immunization with ICT Vaccine survived more than 55 days without evident disease. They rejected the breast cancer cells.ICTVaccine
13Early Phase 1 ProgressFirst lung cancer patient who received conventional therapy* followed by immunization with ICT’s DNA-based vaccine has remained disease free with no toxicity for more than two years.PathologyStage IIBPoorly diff. 6.5 cm adenocarcinoma with metastasesICT VaccinePatient is disease free and no toxicity. Make implication to tie in with disease free. Prehaps a subliminal on health. Cancer cell being distroyed*Taxotere/Cisplatin; **Case report in preparation.
14Why Immune Cell Therapy? ICT addresses key issues in Cancer ImmunotherapyProblemICT SolutionVaccines usually antigen specifice.g. ProvengeIs patient-specific-Immune response isdirected toward the unique characteristicsof each patient’s cancer (all antigens)Dendritic cell based vaccinescostly/difficult to prepareCan be readily prepared and administeredat low cost to patientsLeukapheresis requiredCan be prepared from minute amountsof tumor tissue enabling treatment atearly stage of the diseaseRequires large amounts of tissueOther Cancer Vaccines requirenovel delivery methods to administerNo foreign delivery technology requiredImmune system naturally incorporatesforeign cells/processes antigens
15Benefits Only small quantity of tumor tissue required Vaccine is conveniently and readily prepared at relatively low cost. Leukapheresis is not requiredVaccine specifies a broad array of tumor antigens and is personalized to patients tumorNon-ToxicMore Efficacious and Immunogenic than other Vaccine Approaches (Preclinical Head to Head Models)Recipient cell line can be modified in advance to augment its inherent immunogenic properties (e.g., cytokine-secretion)Number of vaccine cells can be expanded as required for multiple immunizationsAdded text. Modify with graphics
16MilestonesExtensive patent portfolio protects technology (4 issued patents (US/Europe Coverage) and 2 PendingIn Excess of $2 Million in Grant and Venture Funding to dateCompany-sponsored phase 1 clinical trial is ongoing.Collaboration established with University of Pittsburgh Cancer Institute to conduct the trial.IRB (Institutional Review Board) approval obtained for phase I Lung Cancer StudyFDA-approved human cells/facilities to prepare vaccine are on-handIND (Investigational New Drug) issued for Lung Cancer VaccinePhase I/II toxicity/efficacy study.Permission granted to treat up to 37 lung cancer patients.Only Lung Cancer Vaccine in clinical trials that targets multiple epitopes unique to the patient’s tumor (Lucanix in Phase 3 development in lung cancer targets only TGF-Beta.Extensive Preclinical In Vitro and In Vivo research validates technology and efficacyPut in timeline framework.2006 to Present
17Patents UIC IP Id Title Status Country Application Number Patent NumberCM10/NPAImmunotherapeutic Strategies for the Treatment of CancerIssued08/242,4055,759,535CP54/NPACancer Immunotherapy with Semi-Allogeneic Cells09/016,5286,187,307 CP54/DIV09/522,7167,402,306 CP54/DIV212/115,8687,670,611CP/54/GBCP54/FRCP54/DECX005/PCT/USCancer Vaccines and Therapeutic MethodsPending11/909,251 N/ADB079/PCT/USTherapeutic Cancer Antigens12/922,581DB079/PCT/EPEP
19Market Technology Market Size Potential Customers Competitors Competitive AdvantagePersonalized Lung Cancer Vaccine Using Tumor DNA (ICT 1001)$2.3 billion - $13 billion per yearAll Lung Cancer patientsNo other company is utilizing ICT’s Allogeneic Based DNA ApproachesPersonalized to the patient’s tumor tissue antigenic DNA profilePersonalized Breast Cancer Vaccine (ICT 1002)$660 million - $4 billionper yearAll Breast Cancer PatientsCancer Antigen Discovery Platform$200 thousand - $2 million per yearCompanies that need to purchase cancer antigens for research purposesThere are existing vendors selling cancer antigens. Could be 5-10 companies worldwideThe method to produce cancer antigen has been used; ICT’s approach is simple and specificModified to reflect better languageCombine in table with next two slides.Rows: Lung Cancer Vaccine using tumor DNA, Breast Cancer Vaccine using 1 or more breast cancer antigens (ICT 1002), Cancer Antigen Discovery PlatformColumns: Market Size, Potential Customers, Competitors, Competitive AdvantageUse range when identifying Market Size, condense text in other columns
20MILESTONES/INFLECTION POINTS BEING MET Future GrowthMILESTONES/INFLECTION POINTS BEING MET20122013201420152016Launch$3.5MM Series AEXIT WINDOWBuild Company & Exit$10M Series BTransform Company & Exit$30M Series B If Needed
21Use of Funds $500,000 to complete and expand Intellectual Property $250,000 to Complete IND Filing for Breast Cancer Vaccine$2.0 Million for Salaries, Hiring New Staff, Facilities, R&D on Novel Antigen Discovery (Est. 2 Yrs)$750,000 to Complete Phase 1b Breast Cancer StudyMake room and create a pie chart for the combined amounts.Group similar items together in the same color, differentiate with different shade:Complete ICT Vaccine Phase 1B & Complete Phase 1B Breast Cancer StudyComplete IND Filing for Breast Cancer Vaccine, Complete Technology Transfer Licensing…, and Additional patent filingsSalariesShow valuation$750,000 to Complete ICT Vaccine Phase 1b NSCLC Lung Cancer (37 Patients)
22Conservative valuation of ICT at USD $17.5 Million Liquidity EventConservative valuation of ICT at USD $17.5 MillionContemporary Vaccine companies with single compound leads at Phase 2 with inferior DC technology and valuations in excess of $100MMStrong Patent-Portfolio of Issued PatentsPhase 1b Trial that has commenced in NSCLCPositive Phase 1 Proof of Concept to increase valuation of Company and provide ROI- 1 year outIND Trial that is ready to be filed in Breast CancerAntigen Discovery Proprietary Technology (that has identified 20 New Cancer Immunotherapy Antigens to Date)Post Phase 1 Strategy- Acquisition or Partnership or Public OfferingClient to provide. Show valuation