Northwest Biotherapeutics, Inc. · OTC:NWBO
Northwest Biotherapeutics — Big CEOs Investor Conference 2013
27 slides from Northwest Biotherapeutics's conference presentation, Feb 11, 2013
Slide 1: Big CEOs Investor Conference, February 11-12, 2013
al |: dil. NORTHWEST i is. BIOTHERAPEUTICS Big CEQS%iNVESTOR CONFERENCE February 11-12, 2013 The Waldorf Astoria New York
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: Company Profile
Company Profile DCVax® platform technology: activated, educated dendritic cells (master cells of the immune system – subject of 2011 Nobel Prize) 2 products at Phase III clinical trial stage • DCVax-L for GBM brain cancer, and DCVax-Prostate 3rd product approved for Phase I & II trial in all solid t
Slide 4: External Validations: Partners and Government/Regulatory Decisions
External Validations: Partners and Government/Regulatory Decisions German partner: Fraunhofer Institute (since 2010) UK partners: Kings College Hospital & Kings College London (since 2010) University College London. Queens Hospital, Birmingham. LOC. Sarah Cannon Research Institute (700 oncologists,
Slide 5: DCVax: the Future of Cancer Medicine… Now
DCVax®: the Future of Cancer Medicine… Now DCVax®: New, uncompromised dendritic cells activated and educated with signals & tumor biomarkers Active immune therapy: mobilize the whole immune system Multiple cancer targets: the full set of tumor biomarkers (including cancer stem cells) Personali
Slide 6: Dendritic Cells Mobilize the Whole Immune System
Dendritic Cells Mobilize the Whole Immune System DENDRITIC CELLS signals & biomarkers activate & educate DCs the “General” of (“marching orders”) the immune army INNATE IMMUNE SYSTEM ADAPTIVE IMMUNE SYSTEM “First-responders” (within hours/days) Follow-on defense (within week or weeks) Response is au
Slide 7: Recent Developments Supportive of DCVax Approach Using Tumor Lysate With Dendritic Cells
Recent Developments Supportive of DCVax® Approach Using Tumor Lysate With Dendritic Cells 7
Slide 8: DCVax: Simplicity Through Advanced Technologies
DCVax®: 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/distrib
Slide 9: DCVax Applicable to All Solid Tumor Cancers
DCVax® Applicable to All Solid Tumor Cancers 3 major product lines Product Composition Market Stage DCVax®-L Dendritic cells + ~All solid tumor cancers Phase III biomarkers from tumor tissue (cancers in any tissues) that sample surgically removed can be surgically removed DCVax®- Dendritic cells ~Al
Slide 10: Clinical Development Advancing for Multiple Cancers
Clinical Development Advancing for Multiple Cancers Pre- Start Start Start clinical Ph I Ph II Ph III DCVax®-L: Brain Cancer Phase III (under way) Metastatic Ovarian Phase I (completed) DCVax®-Prostate : Phase III (pending partnering) DCVax® Direct: Phase I & II All solid tumor cancers (pending) Col
Slide 11: DCVax-L & DCVax-Prostate: Striking Phase I/II Results
DCVax®-L & DCVax®-Prostate: Striking Phase I/II Results Newly Diagnosed Hormone Independent GBM Brain Cancer Non-Metastatic Prostate Cancer Course of DCVax®- Std of care DCVax®-L disease Prostate Time to Time to progression 6.9 months 2 years 28-34 weeks 59 weeks progression (recurrence) Overall 14.
Slide 12: DCVax-L in Newly Diagnosed GBM: Progression Free Survival
DCVax®-L in Newly Diagnosed GBM: Progression Free Survival in Phase I/II Trials 1.0 0.9 “P value” of this comparison = 0.00001 (i.e., 1 in 100,000 probability that 0.8 the trial results were random) Proportion not progressed 0.7 0.6 20 patients 0.5 treated with DCVax®-L 0.4 0.3 119 matched patients
Slide 13: DCVax-L in Newly Diagnosed GBM: Overall Survival
DCVax®-L in Newly Diagnosed GBM: Overall Survival in Phase I/II Trials 1.0 0.9 “P value” of this comparison = 0.0003 (i.e., 3 in 10,000 probability that 0.8 the trial results were random) Proportion surviving 0.7 0.6 0.5 20 patients 0.4 treated with DCVax®-L 0.3 0.2 119 matched patients 0.1 treated
Slide 14: Phase III GBM Brain Cancer Trial Under Way
Phase III GBM Brain Cancer Trial Under Way • Newly diagnosed GBM brain cancer • 312 patient, randomized (2:1), double blind, placebo controlled Phase III trial: the “gold standard” in clinical trial design o Primary endpoint: PFS (progression free survival) o Secondary endpoints include OS (overall
Slide 15: GBM Trial Size and Enrollment
GBM Trial Size and Enrollment Company TOTAL Enrollment trial size Period IMUC enrolled Celldex 440 patients Q4 2011 – Q4 2015 ?? 124 patients (not 278) Ph III (162 sites) [data collection for primary endpoint thru Q4 2016] in ~7 quarters. NWBT 312 patients H1 2008 [then stopped] If NWBT enrolls its
Slide 16: DCVax-Direct: Novel Technology for Inoperable Tumors
DCVax®-Direct: Novel Technology for Inoperable Tumors Immature DCs will effectively take up antigens (biomarkers) in situ in tumors, but will not activate T cells. Also, immature DCs are highly susceptible to suppression by the tumor. Mature DCs will not effectively take up antigens in situ in t
Slide 17: DCVax-Direct: Striking Pre-Clinical Results
DCVax®-Direct: Striking Pre-Clinical Results Tumor clearance on same side of body after direct injection in animal studies 250 250 Tumor Size (mm2) Tumor Size (mm2) 200 200 + chemo 150 150 partially only 100 100 activated 50 50 DCs 0 0 0 7 14 21 28 35 42 0 7 14 21 28 35 42 Day Post Tumor Inoculation
Slide 18: DCVax-Direct: Striking Pre-Clinical Results
DCVax®-Direct: Striking Pre-Clinical Results Tumor clearance on opposite side of body after direct injection in animal studies 250 250 200 + Tumor Size (mm2) 200 chemo 150 partially Tumor Size (mm2) only 150 100 activated 100 DCs 50 50 0 0 7 14 21 28 35 42 0 0 7 14 21 28 35 42 Day Day 250 250 200 +
Slide 19: DCVax-Direct Phase I & II Trials In Process
DCVax®-Direct Phase I & II Trials In Process Key endpoints: safety, tumor regression 1. Proof of Concept Trial : “All Comers” in Multiple Cancers Approved by FDA for ALL solid tumor cancers Phase I: 36 patients – dose-escalation and confirmation (colon, liver, pancreas, melanoma & misc.) Phase I
Slide 20: Company Plans and Anticipated Milestones: H1 2013
Company Plans and Anticipated Milestones: H1 2013 DCVax-L: DCVax-Direct: • International CRO for trial in Europe All Comers Trial: • UK IRB renewal and site contracts • Amendment to increase patient #s • Begin UK enrollment • IRB approvals and site contracts • UK NIHR decision on “adoption” of • CRO
Slide 21: DCVax-L: Cost-Effective, Rapid Batch Manufacturing
DCVax®-L: 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 22: DCVax-Direct Manufacturing
DCVax®-Direct Manufacturing 22
Slide 23: 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. 23
Slide 24: 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) 24
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
Solid Intellectual Property Coverage 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®-Direct: § composition and met
Slide 27: Financial Profile
Financial Profile Outstanding shares: 26.4 million (including over $36 million in debt conversions and recent $13.8M raise) Share price (at close on 2-9-13): $3.19 Market Cap (as of 2-9-13): $84 million Funding, Dec. 2012: $12.6 million Additional funding available for use: $5.5 million (grant) Inve
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