Northwest Biotherapeutics, Inc. · OTC:NWBO
Northwest Biotherapeutics — IPO Roadshow (November 2012)
31 slides from Northwest Biotherapeutics's IPO roadshow presentation, Nov 2, 2012
Slide 1: Company Overview November 2012
Company Overview November 2012
Slide 2: Disclaimer
2 Disclaimer 2 This communication is neither an offer to sell nor a solicitation of an offer to buy any securities mentioned herein. This publication is confidential for the information of the addressee only and may not be reproduced in whole or in part; copies circulated, or disclosed to another pa
Slide 3: Offering Summary
3 Offering Summary Issuer Northwest Biotherapeutics , Inc. Listing/Ticker OTCBB: NWBO Applied to list on the NasdaqCM : NWBO Offering Size $25 million (15% over - allotment) Securities Offered Common Stock Use of Proceeds Phase III trial with DCVax - L for GBM brain cancer Phase I/II trial with DCVa
Slide 4: The Future of Cancer Medicine….Now
4 DCVax ® -- the Future of Cancer Medicine….Now » Immune therapies » M ultiple cancer targets » Personalized medicine
Slide 5: NWBT Overview
5 NWBT Overview • 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 a
Slide 6: NWBT Management Team
6 NWBT 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. Anthony
Slide 7: Exceptional Partners: Fraunhofer Institute
Exceptional Partners: Fraunhofer Institute • 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 7 NWBT’s partnership with Fraunhofer provides key benefits that
Slide 8: Major product lines based on DCVax platform technology
8 3 major product lines based on DCVax ® platform technology DCVax ® Products Can Address Most Cancers Product Composition Market Stage DCVax ® - L Patient’s activated dendritic cells + biomarkers from patient’s tumor tissue ~All solid tumor cancers (cancers in any tissues) that can be surgically re
Slide 9: Advancing: Robust Development Pipeline
Pre - clinical Start Ph I Start Ph II Start Ph III 9 Multiple Products Advancing: Robust Development Pipeline DCVax ® Direct: Phase I/II DCVax ® - Prostate : Phase III (pending partnering) Brain Cancer Phase III (under way) All solid tumor cancers (in process) Colon cancer metastases (in process) Fu
Slide 10: Buyout Comparisons
10 Buyout Comparisons Company Acquirer Deal Size Lead Products Stage at Acquisition Cougar Biotechnology J&J $970M Zytiga : Hormone Independent Prostate Cancer Phase III Clinical Trials Biovex Amgen $1B OncoVEX : Melanoma Head and Neck Cancer Phase II/III Clinical Trials Micromet Amgen $1.16B Blinat
Slide 11: Recent Events Building Toward Inflection
Recent Events Building Toward Inflection • 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 expansion -- 4 leading UK medical c
Slide 12: Potential Value Milestones Over Next 16-18 Months
12 Potential Value Milestones In Multiple Programs Over Next 16 - 18 Months • Corporate partnering • Potential German regulatory approval for Phase III brain cancer trial • Potential German regulatory approval for compassionate use program • Launch German sites/enrollment for DCVax ® - L brain cance
Slide 13: Potential Value Milestones (cont'd)
13 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 --
Slide 14: Dendritic Cells Direct the Whole Immune System
14 Dendritic Cells Direct the Whole Immune System 14 INNATE IMMUNE SYSTEM ADAPTIVE IMMUNE SYSTEM “First - responders” (within hours/days) Response is automatic Response is non - specific (not tailored to each particular threat ) Follow - on defense (within week or weeks) Response is triggered by exp
Slide 15: Simplicity Through Advanced Technologies
15 Simplicity Through Advanced Technologies Front end simplicity Back end simplicity Advanced technologies behind the scenes Batch manufacturing Immune monitoring, timing Information technologies Proteomics profiles of tumor proteins (biomarkers) (future) Simple intra - dermal injection, similar to
Slide 16: After Decade of Development, DCVax-L In Phase III Trial
16 After Decade of Development, DCVax ® - L In Phase III Trial 99 2000 01 02 03 04 05 06 07 08 09 10 11 12 First Phase I/II trial in GBM brain cancer Second Phase I/II trial in GBM brain cancer Phase III trial in GBM Phase II trial in GBM Phase I/II trial in ovarian cancer FDA grants Orphan Drug sta
Slide 17: Impressive Clinical Trial Results to Date With DCVax-L
17 Impressive Clinical Trial Results to Date With DCVax - L® 17 Newly diagnosed GBM brain cancer patients Standard of care 1 DCVax ® - L Time to progression (recurrence of tumor) 6.9 months 2 years Overall survival 14.6 months 3 years 1 Stupp data from 573 patients -- the “gold standard” benchmark f
Slide 18: Newly Diagnosed GBM: Progression Free Survival
18 Months 0 20 40 60 80 Proportion not progressed 0.0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0 8.1 26.4 Newly Diagnosed GBM: Progression Free Survival “ P value” = 0.00001 (i.e., 1 in 100,000 p robability that these trial results were random) Patients treated with DCVax ® - L Matched patients treated
Slide 19: Newly Diagnosed GBM: Overall Survival
19 Months 0 20 40 60 80 100 120 Proportion surviving 0.0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0 17 36.4 Newly Diagnosed GBM: Overall Survival P value = 0.0003 (i.e., 3 in 10,000 p robability that these trial results were random) Patients treated with DCVax ® - L Matched patients treated at same hos
Slide 20: Phase III GBM Brain Cancer Trial Currently Under Way
20 Phase III GBM Brain Cancer Trial Currently Under Way • 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) • Secondary endpoints include OS ( overall survival) • Cross
Slide 21: DCVax-L for Brain Cancer Offers Large Market Potential
21 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 DCVax ® - L for Brain Cancer Offers Large Market Potential Comparison: Temodar -- adds 10 weeks survival -- market satura
Slide 22: Prostate Cancer Course of Disease
22 Prostate Cancer Course of Disease 22 Early Stage 30 - 40% fail in 5 yrs No metastasis First Line Therapy • Surgery • Radiation • Branchytherapy Hormone Dependent All fail in 5 yrs No metastasis Second Line Therapy • Anti - androgen hormone therapy Hormone independent Diagnosis Death Period w/o Me
Slide 23: Prostate -- Unparalleled Clinical Benefits (Group A)
23 DCVax ® - Prostate -- Unparalleled Clinical Benefits 23 § Group A: Patients with no metastases (85% of market) § Currently no approved treatments/standard of care for these patients Natural course of disease 1 DCVax ® - Prostate Median time to disease progression 28 - 34 weeks 59 weeks Median sur
Slide 24: Prostate: Unparalleled Clinical Benefits (Group B)
24 DCVax ® - Prostate: Unparalleled Clinical Benefits 24 § Group B: Patients with metastases (15% of market) § Currently only 2 approved drugs Std. of care (Taxotere) Dendreon 3 DCVax ® - Prostate4 Median survival 18.9 months 25.9 months 38.7 months Overall survival at 3 years 11% 33% 64% 1 Petrylat
Slide 25: NWBT's DCVax Prostate vs. Dendreon's Provenge
NWBT’s DCVax ® Prostate vs. Dendreon’s Provenge ® DCVax ® Prostate Provenge ® Target PSMA - Attractive PAP - Problematic Active Drug High Concentration >80% Active Ingredient Low Concentration ≤ 15% Active Ingredient Delivery Intra - dermal Similar to flu shot IV Infusion Invasive, cumbersome Econom
Slide 26: 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:
Slide 27: Manufacturing Established In Both US and Europe
27 Manufacturing Established In Both US and Europe More than 2 years’ work completed to effect technology transfer and obtain all regulatory & institutional approvals for manufacturing in Europe. Manufacturing established in US for more than 8 years.
Slide 28: Manufacturing Located At Major Air Hubs in US & Europe
28 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)
Slide 29: Solid Intellectual Property Coverage
29 Solid Intellectual Property Coverage: DCVax Product and Platform DCVax - Brain: § orphan status granted in US (allows 7 years market exclusivity) § orphan status granted in EU (allows 10 years market exclusivity ) DCVax - Prostate: § composition and methods coverage issued Other platform coverage
Slide 30: Financial Profile
30 Financial Profile Outstanding shares: 21 million (including debt conversions) Share price (at close on 10 - 26 - 12): $5.75 Offering: $25 million Use of proceeds: ~85% Phase III trial with DCVax - L & company ops ~15% Phase I/II trial with DCVax - Direct Additional funding: $5.5 million grant awa
Slide 31: NWBT Overview
31 NWBT Overview • 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
Northwest Biotherapeutics — IPO Roadshow (November 2012) on 6ix