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Track 4: Company Presentations

The Company Presentations Track will feature 20 minute presentations by the hottest life sciences companies. Carefully selected by the BayBio2009 Company Presentations Advisory Board, companies will introduce the company, highlight key technologies, alliances, and where they stand with product & clinical developments.

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Company Presentations
9:45am – 11:00am

Arcxis Biotechnologies Arcxis Biotechnologies is transforming cumbersome molecular diagnostic techniques through proprietary, disruptive technologies in sample preparation, assay development and systems integration. The most significant Arcxis advancements include: Fully automated, rapid and reliable sample extraction, purification and amplification; Maximum DNA/RNA detection accuracy in minutes, rather than hours/days; Seamless integration of sample preparation and assay performance for rapid turn around and minimal operator error; Proprietary materials and microfluidics expertise for extreme cost-efficiency; True multi-plex (multiple tests, multiple detection targets-DNA/RNA, proteins) capability. Two primary technology components are prepared for immediate commercialization and will drive near-term revenue: Fully automated molecular sample preparation device (Xisyl); Dual-action molecular probes (Tentacle Probes), proven to maximize test sensitivity and specificity. Arcxis collaborations: USAMRID, CA Department of Health Services, Roche Molecular Systems, Dept. of Homeland Security and Kaiser Permanente Labs demonstrate the confidence industry-leading organizations have in the power of these novel technologies.

Tethys Tethys Bioscience is a predictive personalized medicine company developing novel tests which address the growing global healthcare challenge of chronic diseases such as diabetes. Founded in 2005, the company integrates an experienced management team, innovative research based on sound science, a CLIA-licensed clinical laboratory, and a commercialization team with extensive experience in diagnostic innovation. Tethys lead product is the PreDx™ Diabetes Risk Score, a first-of-its-kind predictive tool that delivers an accurate assessment of an individual's risk of developing Type 2 diabetes within the next five years. The blood test and resulting PreDx Score is designed to help physicians identify patients at highest risk of developing Type 2 diabetes so that they can promote lifestyle changes or initiate treatment plans to prevent or slow progression to Type 2 diabetes. Numerous studies have demonstrated that such interventions can reduce the incidence of new onset diabetes by up to 60%.

Bayhill Therapeutics Bayhill Therapeutics is a clinical-stage biopharmaceutical company at the forefront of developing novel and targeted treatment candidates for autoimmune diseases. Leveraging its proprietary therapeutic BHT-DNA™ platform, the Company’s product candidates have been designed to restore the immune system to its normal state, known as “tolerance,” by selectively eliminating specific, harmful immune responses while leaving the rest of the immune system intact. Through a targeted and selective approach, Bayhill’s product candidates have the potential to deliver superior efficacy, safety and tolerability relative to current therapies. Bayhill is in active discussions with potential pharmaceutical partners for the further advancement of two BHT-DNA™-based disease modifying product candidates that have demonstrated safety, tolerability, and preliminary efficacy in patients: BHT-3009, a treatment candidate poised to enter a Phase IIb clinical study in patients with multiple sclerosis (MS); and BHT-3021, an investigational treatment for type 1 diabetes (T1D) currently being evaluated in an ongoing Phase I/II clinical study.

Metabolex Metabolex is a privately-held biopharmaceutical company focused on the discovery and development of proprietary new medicines for the treatment of metabolic diseases, with an emphasis on type 2 diabetes. Our deep understanding of the biology of these diseases has enabled us to build a robust pipeline of proprietary product candidates. The Company’s strategy is to discover and develop promising therapies for metabolic diseases and to address significant unmet medical needs in large markets, developing them through proof-of-concept studies and then collaborating with companies through late-stage clinical trials and commercialization to maximize the value of our compounds.

Company Presentations
11:30am – 12:45pm

Eureka Therapeutics, Inc. Eureka Therapeutics, Inc. is a privately-owned, VC funded antibody technology and drug development company. Our primary technology enhances the ADCC activity of human (or humanized) antibodies to improve clinical efficacy. Eureka's core technical capability is an efficient high-throughput mammalian expression platform for antibody production, purification, and characterization in support of therapeutic antibody drug discovery and development. We are located in Emeryville, California.

Neugenesis Neugenesis Corporation is a privately held biotechnology company which has generated a proven and diverse set of technology platforms and products for the biotechnology and biopharmaceutical industry. The Company holds strong intellectual property positions in the areas of production of recombinant monoclonal antibodies, production of multivalent vaccines for infectious diseases, cell based gene directed evolution and cell based combinatorial biology. Neugenesis has the additional capability of expression and improvement of enzymes useful in biofuels manufacturing. The Company is currently in the second year of a DARPA contract for Bio-Defense. The contract supports the Company’s basic technology platforms which are applicable to all product areas.

Vaxart, Inc. Vaxart has created the first oral vaccine platform, with a modular approach that substantially cuts vaccine development time and cost. The technology solves two major problems: overcoming pre-existing vector immunity, and generating strong selective response against the target. Our non-replicating adenovirus vector expresses the target antigen as well as a TLR3 adjuvant (dsRNA). The final product is a tablet that can be distributed without cold chain, and does not require trained medical personnel to administer. Further, oral delivery may outperform injected vaccines by eliciting mucosal immunity. Vaxart's approach has been validated by collaboration with a large vaccine firm, and NIH grants. Large animal efficacy was demonstrated by using Vaxart's oral avian flu vaccine to protect against lethal H5N1 challenge. The company plans to initiate a definitive Phase I trial on our lead program within a year; data from the trial will validate the platform approach for follow-on indications.

Mendel Biotechnology During the next 20 years, with an expanding global population, improved diets and rapidly growing energy demands, society will need to produce plants enhanced for food, feed, fiber, energy and aesthetic benefit without large increases in production acreage. With the growth of energy production from agricultural feedstocks, agricultural and energy supply chains serving the needs of a growing carbohydrate economy are expected to become integrated. Mendel Biotechnology's vision is that our knowledge about regulation of plant gene and pathway function will enable accelerated improvement in plant varieties, and the delivery of associated services, to meet global agricultural and energy production needs. Mendel is dedicated to being a premier biotechnology company serving large agricultural companies with new genetic and chemical solutions and to becoming the leading seed and feedstock company serving the emerging bioenergy industry.

Company Presentations
2:15pm – 3:30pm

KAI Pharmaceuticals KAI Pharmaceuticals is a drug discovery and development company with multiple, novel clinical-stage programs in cardiovascular disease and pain. KAI’s lead product candidate, KAI-9803, is partnered with Bristol-Myers Squibb and has demonstrated efficacy in reducing damage to heart muscle and improving cardiac function in patients with myocardial infarction (MI) who undergo balloon angioplasty. KAI’s second clinical program, KAI-1678, is a promising first-in-class drug candidate that may address both the inflammatory and neuropathic pain markets. KAI’s expertise is in the selective modulation of intracellular protein: protein interactions via delivery of peptide drugs into the cell. The Company has applied its core technology to discover highly potent and selective inhibitors and activators for validated members of the protein kinase C (PKC) family of isozymes.

Acologix Acologix is a biopharmaceutical company focusing on development of novel therapeutic products in osteo-renal (hard tissues and kidney) area. While patient population with hard tissue damage and chronic kidney disease is growing rapidly, available therapy is limited. The most advanced program in the renal field is AC-820 for urmic pruritus, severe systemic itch which a majority of dialysis patients suffer from with no available therapies other than kidney transplantation. It is in Phase 3 in the U.S. and approved in Japan. In the hard tissue area, the most advanced compound is AC-100, which promotes regrowth and repair of cartilage, bone, and dentin. A Phase 2 for dentin repair has been successful. Acologix currently plans for Phase 2 studies for cartilage and bone repairs in osteoarthritis, rheumatoid arthritis, and trauma patients. All compounds at Acologix are protected by broad patents. Our corporate goal is to enhance patients' lives through revolutionary therapies.

Accera, Inc. Accera is a privately-held, development and commercialization biotechnology company focused on the discovery and development of novel drugs for neurodegenerative diseases. Our primary focus is memory and cognition disorders such as Alzheimer's disease (AD) and related dementia where we have applied our proprietary technology for the treatment of neuronal energy metabolism dysfunction, a condition underlying many neurodegenerative diseases. Accera has successfully completed 3 human clinical trials and a pioneering clinical study in canines that demonstrate the efficacy of our marketed compound, Axona(tm) for Alzheimer's disease. The company has built a sales force and has launched Axona in the US as a prescription-only product. Accera has small molecule drugs in preclinical development for Parkinson's and Huntington's diseases and TBI.

Syntaxin Ltd. Syntaxin Ltd was founded in 2005 and is based in Abingdon, Oxfordshire, UK with a staff of approx 45. Syntaxin’s technology selectively shuts down stimulated vesicular secretion in a cell that causes disease with novel recombinant proteins developed through the genetic engineering process of its novel proprietary technology. The potential advantages of this technology include the combination of high potency, broad safety and improved efficacy together with a long duration of action providing infrequent dosing requirements. With over ten years’ experience of engineering bacterial protein therapeutics that can target specific cell types, Syntaxin is leading its field. Cell secretion plays an important role in the development of numerous diseases including endocrine, inflammatory, respiratory and metabolic disorders, certain cancers, as well as chronic pain. Syntaxin has an exclusive alliance with Allergan who filed an IND for the most advanced drug candidate, which is now in Phase I clinical trials.

Company Presentations
3:45pm – 5:00pm


BiPar Sciences, Inc. BiPar Sciences is a clinical-stage biopharmaceutical company focused on DNA repair using Poly ADP-Ribose Polymerase (PARP) inhibitors. PARP inhibitors represent a new, targeted approach to treating many types of cancers. By preventing cancer cells from repairing their own DNA, PARP inhibitors ultimately cause cancer cell death. Like other targeted therapies, PARP inhibitors target a specific aspect of cancer cells and may not be toxic to healthy, non-cancerous cells. BiPar's lead product candidate, BSI-201, is a potential first-in-class and best-in-class PARP inhibitor and the furthest along in clinical trials evaluating this class of novel therapeutics. BSI-201 is currently being studied in a randomized Phase 2 clinical trial of patients with metastatic triple negative breast cancer.

Target Discovery Target Discovery is developing the next generation of clinical diagnostics, offering higher value molecular insights for disease management and diagnosis. Accessing protein modification states (the “missing link” in biomarkers), the company creates protein isoform diagnostics (Isonostics™) that better guide therapeutic choices for cancer and lower overall treatment costs. We engage in funded collaborations with partners, for application of unique isoform-level technologies in other disease areas and in theranostic applications. Traditional immunodiagnostic assays measure protein families, typically combining all isoforms into one result (causing loss of specificity and sensitivity). Molecular diagnostics (DNA/RNA level) offer insights into single nucleotide polymorphisms (SNPs) and splice variants, accounting for only a small portion of all protein isoforms. Isonostic™ assays capture SNPs and splice variants, but ALSO quantify the enormous variety of post-translational modifications (PTMs) not differentiated by existing clinical diagnostics, but which are typically the critical determinants of disease conditions and treatment optimization.

Sunesis Pharmaceuticals Sunesis is a clinical-stage biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the treatment of solid and hematologic cancers. Sunesis has built a highly experienced cancer drug development organization committed to advancing its lead product candidate, voreloxin, in multiple indications to improve the lives of people with cancer. Voreloxin is currently being evaluated as a single agent in a Phase 2 clinical trial in platinum-resistant ovarian cancer, in a Phase 2 clinical trial (known as the REVEAL-1 trial) in previously untreated elderly acute myeoloid leukemia (AML) patients, and in a Phase 1b/2 clinical trial combining voreloxin with cytarabine for the treatment of patients with relapsed/refractory AML. In clinical trials conducted to date, voreloxin has been generally well tolerated and has shown objective responses in both solid and hematologic tumor types.

Jennerex Biotherapeutics, Inc. KaloBios Pharmaceuticals, Inc., a U.S. based, private monoclonal company, uses its biologic capabilities and its proprietary platform technology to develop first-in-class human antibody therapeutics. The company has multiple programs that were in seven Phase 1 or 2 clinical trials in 2008: KB001 is an anti-infective for Pseudomonas aeruginosa infections being tested in cystic fibrosis and in intensive care patients on a ventilator, and KB002 and KB003 are being evaluated in inflammatory conditions, such as rheumatoid arthritis and asthma. KB004 is in preclinical development for oncology. The company’s Humaneering™ technology offers advantages over other methods of human antibody creation in terms of immunogenicity, potency, and manufacturing yields. The company is focusing on partnering its clinical-stage programs in 2009 and may grant limited access to its Humaneering™ technology platform to select partners.

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