Northwest Biotherapeutics, Inc. · OTC:NWBO
Northwest Biotherapeutics — Investor Presentation (January 2013)
29 slides from Northwest Biotherapeutics's investor presentation, January 2013
Slide 1: Company Overview
Company Overview January, 2013
Slide 2: Disclaimer
Disclaimer Certain statements made in this presentation are “forward-looking statements” of NWBT as defined by the Securities and Exchange Commission (“SEC”). All statements, other than statements of historical fact, included in this presentation that address activities, events or developments that
Slide 3: DCVax -- the Future of Cancer Medicine....Now
DCVax® -- the Future of Cancer Medicine….Now Immune therapies Multiple cancer targets Personalized medicine 3
Slide 4: Multiple Products Advancing: Robust Development Pipeline
Multiple Products Advancing: Robust Development Pipeline Pre- Start Start Start clinical Ph I Ph II Ph III DCVax®-L: Brain Cancer Phase III (under way) Future potential applications: Ovarian (Phase I/II already completed) Non-metastatic colon Triple negative breast DCVax®-Prostate : Phase III (pendi
Slide 5: DCVax Products Can Address Most Cancers
DCVax® Products Can Address Most Cancers 3 major product lines based on DCVax® platform technology Product Composition Market Stage DCVax®-L Patient’s activated dendritic ~All solid tumor cancers Phase III cells + biomarkers from (cancers in any tissues) that patient’s tumor tissue can be surgically
Slide 6: Dendritic Cells Direct the Whole Immune System
Dendritic Cells Direct the Whole Immune System DCVax® gives 2 signals: DENDRITIC CELLS “marching orders” the “General” of the immune army shift into what to attack mode & attack INNATE IMMUNE SYSTEM ADAPTIVE IMMUNE SYSTEM “First-responders” (within hours/days) Follow-on defense (within week or weeks
Slide 7: Simplicity Through Advanced Technologies
Simplicity Through Advanced Technologies Front end Advanced technologies Back end simplicity behind the scenes simplicity Batch manufacturing Automation (TFF and other) Collection of Cryopreservation, banking tumor tissue (in kit) Simple intra-dermal instead of throwing away Shipping/distribution in
Slide 8: After Decade of Development, DCVax-L In Phase III Trial
After Decade of Development, DCVax®-L In Phase III Trial First Phase I/II trial in GBM brain cancer Second Phase 2000-02 I/II trial in GBM Non- Blinded, randomized, controlled brain cancer blinded, 2003-06 random Phase II Phase III -ized trial in trial in Phase II GBM Trial GBM 2008-2012 2012— 2007
Slide 9: Impressive Clinical Trial Results to Date With DCVax-L
Impressive Clinical Trial Results to Date With DCVax-L® Newly diagnosed GBM brain cancer patients Standard of DCVax®-L care1 Time to progression (recurrence of 6.9 months 2 years tumor) Overall survival 14.6 months 3 years 1 Stupp data from 573 patients -- the “gold standard” benchmark for GBM brain
Slide 10: Newly Diagnosed GBM: Progression Free Survival
Newly Diagnosed GBM: Progression Free Survival 1.0 0.9 “P value” = 0.00001 (i.e., 1 in 100,000 probability that 0.8 these trial results were random) Proportion not progressed 0.7 0.6 Patients 0.5 treated with 0.4 DCVax®-L 0.3 Matched patients 0.2 treated at same hospital, with Standard of Care 0.1 8
Slide 11: Newly Diagnosed GBM: Overall Survival
Newly Diagnosed GBM: Overall Survival 1.0 P value = 0.0003 0.9 (i.e., 3 in 10,000 probability that these trial results were random) 0.8 Proportion surviving 0.7 0.6 0.5 Patients 0.4 treated with DCVax®-L 0.3 0.2 Matched patients 0.1 treated at same hospital, 17 36.4 with Standard of Care 0.0 0 20 40
Slide 12: Phase III GBM Brain Cancer Trial Currently Under Way
Phase III GBM Brain Cancer Trial Currently Under Way • Treating patients who have newly diagnosed GBM • 300-patient, randomized (2:1), double blind, placebo controlled Phase III trial: the “gold standard” in clinical trial design • Primary endpoint: PFS (progression free survival) Endpoint will be s
Slide 13: DCVax-L for Brain Cancer Offers Large Market Potential
DCVax®-L for Brain Cancer Offers Large Market Potential Metastatic Brain Cancers: 500,000 1/3 US, 1/3 Europe, 1/3 RoW Market Potential of just GBM… US & Europe… 50% market share: 12,000 patients/year x $110K/patient = $1.32 billion Comparison: Temodar -- adds 10 weeks survival, has ~100% market shar
Slide 14: Prostate Cancer Course of Disease
Prostate Cancer Course of Disease Early Stage Hormone Hormone Dependent independent 30-40% fail in 5 yrs All fail in 5 yrs Period w/o Metastasis Diagnosis Metastasis (occurs immediately in No metastasis Death (85-90% of patients) 10-15% of patients) No metastasis 36 mos. 18 mos. First Line Therapy M
Slide 15: DCVax-Prostate -- Unparalleled Clinical Benefits
DCVax®-Prostate -- Unparalleled Clinical Benefits Hormone independent (late stage) prostate cancer: § Group A: Patients with no metastases (85% of market) § Currently no approved treatments/standard of care for these patients Natural course of DCVax®-Prostate disease1 Median time to 28-34 weeks 59 w
Slide 16: DCVax-Prostate: Unparalleled Clinical Benefits
DCVax®-Prostate: Unparalleled Clinical Benefits Hormone independent (late stage) prostate cancer: § Group B: Patients with metastases (15% of market) § Currently only 2 approved drugs Std. of care DCVax®- (Taxotere) Dendreon3 Prostate4 Median survival 18.9 months 25.9 months 38.7 months Overall surv
Slide 17: NWBT's DCVax Prostate vs. Dendreon's Provenge
NWBT’s DCVax® Prostate vs. Dendreon’s Provenge® DCVax® Prostate Provenge® Target PSMA-Attractive PAP-Problematic High Concentration Low Concentration Active Drug >80% Active Ingredient ≤ 15% Active Ingredient Intra-dermal IV Infusion Delivery Similar to flu shot Invasive, cumbersome 1 Mfg Run = 1 Mo
Slide 18: Recent Events Building Toward Inflection
Recent Events Building Toward Inflection Momentum built during 2011-2012… • Clinical/Regulatory FDA approval -- upgrade of DCVax®-L brain cancer trial to Phase III trial Phase III trial expansion -- 41 sites across US UK regulatory approval -- brain cancer Phase III trial Phase III trial exp
Slide 19: Potential Value Milestones In Multiple Programs Over Next 16-18 Months
Potential Value Milestones In Multiple Programs Over Next 16-18 Months DCVax®-L Program: • Potential German regulatory approval for Phase III brain cancer trial • Potential German regulatory approval for compassionate use program • Potential German reimbursement decision • Launch German sites/enroll
Slide 20: Potential Value Milestones (cont'd)
Potential Value Milestones In Multiple Programs Over Next 16-18 Months (cont’d) DCVax®-Direct program: • Announce partner institutions for this program • 36-patient Phase I/II trial for all solid tumor cancers Use to obtain rapid demonstration of efficacy in multiple cancers Endpoint -- tumor regr
Slide 21: Cost-Effective, Rapid Batch Manufacturing
Cost-Effective, Rapid Batch Manufacturing •DAY 1: Tumor tissue & blood at manufacturing facility. •DAY 2: Precursors of dendritic cells isolated. •DAY 2-7: Precursors differentiated into dendritic cells. •DAY 7: Dendritic cells “educated” by exposure to biomarkers from tumor tissue. •DAY 8: “Educate
Slide 22: Manufacturing Established In Both US and Europe
Manufacturing Established In Both US and Europe More than 2 years’ work completed Manufacturing established in US for to effect technology transfer and more than 8 years. obtain all regulatory & institutional approvals for manufacturing in Europe. 22
Slide 23: Manufacturing Located At Major Air Hubs in US & Europe
Manufacturing Located At Major Air Hubs in US & Europe US manufacturing in Memphis, TN: worldwide air hub of both FedEx & UPS German manufacturing in Leipzig, Germany: European and international logistics hub (DHL & other) 23
Slide 24: Exceptional Partners: Fraunhofer Institute
Exceptional Partners: Fraunhofer Institute Fraunhofer is a world renowned leader in new technologies • Leader in Cell/Immune Therapies (unlike big pharma, who have not yet developed cell therapy capabilities) • $2.3 billion annual revenue • 18,000 Scientists, Engineers and Business Personnel NWBT’s
Slide 25: Experienced Management Team
Experienced Management Team • CEO: Ms. Linda Powers Over 10 years’ experience building biotech companies, developing cell therapy products. Over 15 years’ experience in corporate finance, M&A, joint ventures, and intellectual property. Largest shareholder of NW: >$20 million invested. • COO: Dr. Ant
Slide 26: Solid Intellectual Property Coverage: DCVax Product and Platform
Solid Intellectual Property Coverage: DCVax Product and Platform Over 130 patents issued and pending, worldwide DCVax®-L for brain cancer: § orphan status granted in US (allows 7 years market exclusivity) § orphan status granted in EU (allows 10 years market exclusivity) DCVax®-Prostate and DCVax®-D
Slide 27: Financial Profile
Financial Profile Outstanding shares: 26 million (including over $35 million in debt conversions and recent $13.8M raise) Share price (at close on 1-4-13): $3.27 Market Cap: $85 million Cash balance as of 12-12-12: $12.6 million Additional funding available for use: $5.5 million (matching grant awar
Slide 28: Buyout Comparisons
Buyout Comparisons Stage at Company Acquirer Deal Size Lead Products Acquisition Zytiga: Cougar Phase III J&J $970M Hormone Independent Clinical Trials Biotechnology Prostate Cancer OncoVEX: Phase II/III Biovex Amgen $1B Melanoma Clinical Trials Head and Neck Cancer Blinatumomab: Leukemia Phase I &
Slide 29: NWBT Summary
NWBT Summary • Immune therapies for cancer: right time, right place. • DCVax® platform technology. Multiple chances to win. • 3 product lines: 2 products at Phase III stage, 1 product at Phase I/II • 2 products applicable to all solid tumor cancers (cancers in any tissues) • Phase III trial and manu
Northwest Biotherapeutics — Investor Presentation (January 2013) on 6ix