Micromet, AG JP Morgan Healthcare Conference January 10, 2006 |
Micromet AG - CancerVax Corporation Merger Announcement |
Forward Looking Statements This presentation may include certain forward-looking statements that involve risks and uncertainties that could cause Micromet's or CancerVax's actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding the proposed transaction, the efficacy, safety, and intended utilization of the companies' respective product candidates, the conduct and results of future clinical trials, and plans regarding regulatory filings, future research and clinical trials and plans regarding partnering activities. Factors that may cause actual results to differ materially include the risk that CancerVax and Micromet may not be able to complete the proposed transaction, the risk that product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger- scale or later clinical trials, the risk that CancerVax and Micromet will not obtain approval to market their respective products, the risks associated with reliance on outside financing to meet capital requirements, and the risks associated with reliance on collaborative partners for further clinical trials, development and commercialization of product candidates. You are urged to consider statements that include the words "may," "will," "would," "could," "should," "believes," "estimates," "projects," "potential," "expects," "plans," "anticipates," "intends," "continues," "forecast," "designed," "goal," or the negative of those words or other comparable words to be uncertain and forward-looking. The transaction is subject to customary closing conditions, including approval of CancerVax's and Micromet's stockholders. These factors and others are more fully discussed in CancerVax's periodic reports and other filings with the SEC. Any forward-looking statements are made pursuant to Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and, as such, speak only as of the date made. CancerVax undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise. |
Micromet AG Micromet AG, private, Munich, Germany Scientific roots at Institute for Immunology of Munich University Focus on antibody-based therapeutics Private equity raised from institutional investors to date 75M ($87M), first round raised in 1996 Investor base: 3i, Abingworth, Advent Ventures, BioMedical TrendsHealth, DG Lux Lacuna, HBM Bioventures, IBT, Omega, Permira, SVLSF, Wellcome Trust |
CancerVax CancerVax Corporation (NASDAQ: CNVX) Mission: To build a fully integrated biotechnology company focused on the treatment and control of cancer - $60 M cash as of September 30, 2005 Experienced management team Anticipate IND filing in Q106 for D93, a humanized antibody designed to block angiogenesis and the formation of neovasculature Actively seeking sublicensing opportunities for 3 product candidates targeting the EGFR signaling pathway |
Merger Rationale Creation of a transatlantic biopharmaceutical company with access to both U.S. and European markets Access to U.S. capital markets to accelerate development of product portfolio Highly differentiated drug development pipeline focused on antibody-based therapeutics in oncology, autoimmune, inflammatory diseases Significant experience in drug discovery and development Expanded management base with strong U.S. experience |
Merger Details Definitive merger agreement announced on January 9, 2006 Pro forma ownership of combined company: approx. 67.5% Micromet shareholders and 32.5% CancerVax shareholders S-4 and related proxy statement /prospectus to be filed with the SEC in the next several weeks Completion of merger contingent on stockholder approvals and satisfaction of other, customary closing conditions Stockolder votes anticipated to occur in Q206 New entity to be named Micromet Inc.; anticipated Nasdaq ticker symbol: MITI |
Combined Company - Anticipated Highlights Two clinical-stage product candidates in three major cancer indications Five pre-clinical product candidates in cancer and inflammatory diseases Proprietary drug development platforms: BiTE? and SCA Collaborations with MedImmune and Serono Research & development center in E.U. Initial U.S. operations will cover finance, legal and business development Experienced team with a total of 95 FTEs |
Combined Company's Expected Executive Management Christian Itin, CEO & President William R. LaRue, CFO Patrick Baeuerle, CSO Gregor Mirow, COO Hazel M. Aker, General Counsel Carsten Reinhard, CMO Jens Hennecke, Business Development |
Combined Company's Anticipated Board of Directors David F. Hale, Chairman Christian Itin, CEO Phillip M. Schneider, former CFO of Idec Pharmaceuticals, Inc. Barclay Phillips, Managing Director of Vector Fund Management Dr. Michael G. Carter, former Commercial Director of Zeneca Jerry Benjamin, Advent Venture Partners, London Otello Stampacchia, Omega Fund, Geneva John Berriman, former Business Director of Celltech (now UCB Pharma) One additional board member will be designated by Micromet shareholders |
Combined Company's Product Candidates Antibodies and BiTEs |
Combined Company's Pipeline Preclinical Phase I Phase II BiTE ? MT110 Antibody MT201 Prostate Cancer Antibody MT201 Metastatic Breast Cancer (MBC) Antibody MT204 BiTE? MT103 B-Cell Lymphoma Antibody D93 BiTE ? I BiTE ? II Antibody MT201 MBC Taxotere(r) Combo Antibody MT203 Research Collaboration Serono Serono Serono MedImmune MedImmune MedImmune |
Clinical Candidate MT201 - Adecatumumab Human antibody binding to Ep-CAM, a pan-carcinoma target Addresses major solid tumor indications (breast, prostate, colon, lung, gastric, ovarian) Phase I demonstrated excellent tolerability in humans Phase II programs in metastatic breast cancer and prostate cancer, with data expected in 2006 Phase I combination trial with Taxotere(r) (docetaxel) Manufacturing agreement with Boehringer Ingelheim Collaboration for co-development and commercialization with Serono |
Clinical Candidate MT103 First representative of a new class of drugs - BiTE? MT103 is a BiTE? molecule targeting CD19 on B cell tumors Phase I program in NHL Orphan drug designation in MCL and CLL in EU Collaboration with MedImmune for North America Novel mode of action and differentiated target antigen support positioning of MT103 in NHL |
Unpartnered Pre-Clinical Candidates MT110: BiTE? molecule against pan-carcinoma target Novel treatment approach for solid tumors based on new mode of action Targets high medical need indications and growth markets D93: Humanized antibody designed to block angiogenesis and tumor neovasculature by unique mode of action MT203 and MT204: Human or humanized antibodies neutralizing key pro-inflammatory cytokines for treatment of a range of inflammatory diseases |
Micromet's Drug Development Platforms BiTE? & SCA |
Specific T Cell Only Specific TCR & Co-Stimuli Patient's T Cell Pool Natural T Cell Directed Attack of Tumors - Only One in a Million Sees the Tumor |
Just BiTE? BiTE(tm)-directed T Cell Attack on Tumors - Each T Cell Sees the Tumor Any T Cell Patient's T Cell Pool |
T Cells Deliver Kiss of Death by a Synapse (Source: Stinchcombe et al. 2001, Immunity) Secretion Signalling Adhesion Stainings: Granzyme B Lck LFA1 (CD11a) Confocal Microscopy T Cell |
Synapse Formation: Natural vs. BiTE(tm)- Induced T Cell Tumor Cell T Cell Tumor Cell BiTE(tm) |
BiTE(tm) Synapse Natural Synapse Stainings: Granzyme B Lck LFA1 (CD11a) No Difference Detected Between BiTE(tm)-induced and Natural Synapse |
Peaceful Coexistance of Tumor and T Cells in the Absence of BiTETM |
BiTETM Trigger Attack of T Cells |
BiTETM Trigger Serial Killing by T Cells |
BiTE?: Unique Drug Development Platform Novel therapeutic modality Extremely potent (100-10,000 fold higher efficacy relative to other bispecific antibodies or IgG1 monoclonal antibodies) Strictly target cell dependent Development platform, applicable to address various indications Potential for both monotherapy and combination therapy strategies in major markets |
BiTETMs: Unique Bispecific Format ?-Tumor Antibody ?-CD3 Antibody BiTE(tm) |
Single-chain Antibodies (SCA) Full targeting ability of an antibody but at a fraction of its size Versatile for protein engineering Micromet leverages the potential of SCAs for design of novel therapeutics: Example BiTE?, a novel class of SCA-based therapeutics Broad patent estate in this field through cross-licence agreement with Enzon, Inc. Micromet exclusively markets SCA patents to third parties, revenues are shared with Enzon, Inc. SCA |
Micromet's Business Model |
Micromet's Business Strategy Focus on highly differentiated products Leverage pipeline-generating capabilities to drive innovative collaborations Balance investments with revenues from collaborations Retain option to continue investments in partnered programs |
Micromet / Serono Alliance on MT201 Serono receives worldwide exclusive rights to MT201 Micromet completes the ongoing Phase II program Micromet receives: USD $10 million upfront up to USD $138 million milestone payments if MT201 is successfully developed and approved for commercializedation in three or more indications Micromet receives undisclosed royalties on future sales Serono bears all development costs for ongoing program, but Micromet retains option to participate in further development and co-promotion |
Micromet / MedImmune Alliance on MT103 MedImmune to develop and commercialize in North America Micromet to develop and commercialize outside North America Clinical data will be shared MedImmune responsible for development of commercial scale manufacturing process (responsible for full cost) MedImmune to supply MT103 for the world market Investment of MedImmune Ventures in Micromet |
Micromet / MedImmune Alliance on New BiTE(tm)s Up to 6 new BiTE(tm) molecules Micromet obtains milestone payments, royalties and certain product rights for Europe MedImmune to fund all activities until start of phase II Micromet to create all BiTE(tm) molecules and to participate in preclinical development First program achieved proof-of-concept milestone in Nov 05 Second program initiated in Nov 2005 |
Micromet may elect to share in the development and commercialization of MT201 in the US and EU in exchange for a share of profits Focus on ex-US/CA/MX development of MT103 Continue to progress development of MT110, D93*, MT203, MT204 Outlook |
Key Anticipated Events in 2006 Completion of merger in Q2 Phase 2 results for MT201 - metastatic breast cancer & prostate cancer Phase 1 results for MT103 - NHL IND filing for D93 Continue to pursue partnering opportunities |