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Business Description We are a biopharmaceutical company focused on developing therapeutic products for cancer and infectious diseases based on our proprietary Tarmogen® platform. Tarmogens activate the immune system by stimulating a subset of white blood cells called T cells that destroy infected or malignant cells in contrast to traditional vaccines, which predominately stimulate antibody production. We have four Tarmogen product candidates in five ongoing clinical trials. Our lead cancer product candidate, GI-4000, is being evaluated in combination with gemcitabine in a fully-enrolled, placebo-controlled Phase 2b trial in resected pancreas cancer. Our lead infectious disease product candidate, GI-5005, has completed a randomized, active-control Phase 2b trial in chronic hepatitis C virus, or HCV, infection. Collaborations with biopharmaceutical companies and research institutions have allowed us to advance the development of our Tarmogen product candidates while managing our own investment in these product candidates. We have two strategic collaborations, one with Celgene Corporation for all oncology product candidates and one with Gilead Sciences, Inc. for chronic hepatitis B virus, or HBV, infection. We currently have no products approved for commercial sale. Our Tarmogen platform technology has characteristics that we believe will enable us, in collaboration with our strategic collaborators and independently, to develop and commercialize a portfolio of Tarmogen products. Highlights of our Tarmogen technology include: • Tarmogens activate the cellular immune response : Each Tarmogen consists of intact, heat-inactivated yeast containing the target protein. The cellular immune system has evolved to protect against yeast and fungal infections, among other threats. As a result, we believe our data demonstrate that immunization with a Tarmogen primarily results in cellular immune responses against the target protein and reduction in the number of abnormal cells containing the same target protein. • Broad applicability : We have evaluated Tarmogens in both oncology and infectious diseases in randomized, controlled Phase 2 clinical trials. We have successfully created Tarmogens to express over 100 different proteins. In eight Phase 1 and 2 clinical trials, we have treated more than 300 patients, including some who have received monthly dosing for over four years, with a tolerability profile that we believe will allow the Tarmogens to be added to other therapeutic regimens without leading to additional toxicity. • Proven preclinical development capability : We have advanced seven Tarmogens from concept into human clinical trials in approximately 6 to 18 months. • Efficient manufacturing : We manufacture Tarmogens through a process that yields a stable, off-the-shelf product that is disease- or protein- specific. We believe that the productivity of our manufacturing process compares favorably to the productivity reported by other biotechnology companies for their manufacturing processes. We have an approximately 22,000 square foot manufacturing facility that we believe has the capacity and equipment for commercial-scale production of Tarmogens. Tarmogens target the molecular profile that distinguishes a diseased cell from a normal cell. We have designed Tarmogens to target specific antigens that play a role in oncology and infectious diseases that represent unmet medical needs. • GI-4000 targets cancers with Ras mutations. We estimate that Ras mutations are found in approximately 180,000 new cancer cases each year in the United States across a spectrum of tumor types, including pancreas, non-small cell lung cancer, or NSCLC, colorectal, endometrial and ovarian cancers, as well as melanoma and multiple myeloma. The mutated Ras protein causes a normal cell to become malignant by altering cell division pathways, resulting in uncontrolled proliferation of malignant cells. Studies have shown that tumors with Ras mutations are generally less responsive than tumors with normal Ras to conventional chemotherapy as well as approved targeted agents. However, there are no approved products that are specifically directed towards Ras mutations. We are conducting a Phase 2b clinical trial for GI-4000 in resected pancreas cancer patients in collaboration with Celgene. We also plan to initiate a Phase 2/3 adaptive clinical trial in resected pancreas cancer patients by the end of the second quarter of 2013, also in collaboration with Celgene. We are also evaluating GI-4000 in two investigator- sponsored Phase 2a clinical trials in NSCLC and colorectal cancer. • GI-6207 targets carcinoembryonic antigen, or CEA, a protein that is over -expressed in a large number of epithelial cancers, which we estimate represent approximately 500,000 new cancer cases in the United States each year. The National Cancer Institute, or NCI, has completed a Phase 1 clinical trial of GI-6207 and we plan to initiate in collaboration with the NCI a Phase 2 clinical trial in patients with medullary thyroid cancer tumors, or MTC, expressing human carcinoembryonic antigen by the end of 2012. • GI-6301 targets cancers expressing the brachyury protein, which plays a role in metastatic progression of certain cancers. The NCI is currently conducting a dose escalation Phase 1 trial of GI-6301 in patients with advanced cancer, which we expect to be completed by the end of 2013. • GI-5005 contains a fusion of two hepatitis C proteins, NS3 and Core, which are highly conserved across HCV genotypes and are recognized by T cells. The World Health Organization estimates that up to 170 million people globally are infected with HCV, with three to four million new infections each year. We believe that GI-5005 is the first therapeutic vaccine to demonstrate a clinically meaningful outcome in patients with a chronic infectious disease. We are evaluating the potential role of GI-5005 in difficult-to-treat chronic HCV patients. • GI-13020 is our Tarmogen being evaluated for the treatment of chronic HBV infection. HBV is the most common liver infection and the major cause of liver cancer worldwide. Globally, 350 million people have chronic HBV infection. While approved anti-viral drugs can suppress the virus, they rarely result in cures and must be taken indefinitely. Our development strategy will be to combine GI-13020 with Gilead’s Viread, an approved antiviral drug, to determine if the combination can reduce or eliminate HBV infection. We plan to initiate a Phase 1a clinical trial of GI-13020 for HBV infection in the first quarter of 2013 and report the results from the trial in the second half of 2013. We expect that Gilead will commence a Phase 1b/2a trial in HBV patients during the second half of 2013. We have generated clinical data in two randomized, controlled clinical trials with Tarmogen product candidates. GI-4000-02 is a fully-enrolled, Phase 2b randomized double-blind, active- control multi-center study of 176 subjects with resected pancreas cancer. A clinical trial is considered to have an active control when both groups in the clinical trial receive the same standard medical treatment (usually a drug) in addition to one group receiving the product candidate being studied. Thirty- nine of these subjects had microscopic residual disease after surgery, or R1 subjects, and were randomized separately from the subjects with no microscopic residual disease after surgery, or R0 subjects. Of the 39 R1 subjects, the 19 who were assigned to the GI-4000 plus gemcitabine group had a 2.6 month advantage in median overall survival compared to the 20 R1 subjects assigned to the placebo plus gemcitabine group (17.2 vs. 14.6 months). Further, in the 15 R1 subjects in the GI-4000 plus gemcitabine group who we were able to test for an immune response, seven were identified as immune responders to mutated Ras and had a 5.0 month advantage in median survival compared to the 20 R1 subjects in the placebo plus gemcitabine group (19.6 vs. 14.6 months). Of the 12 placebo-treated subjects who we were able to test for an immune response, only 1 of 12 was identified as having an immune response to mutated Ras. The study is also designed to assess GI-4000 in R0 subjects. In this trial, we observed a safety profile for GI-4000 treated subjects consistent with the safety profile that is generally observed in patients with early stage resected pancreas cancer treated with gemcitabine alone, as determined by the Data Safety Monitoring Board. This study was not intended to have enough subjects to achieve statistical significance and the differences observed in survival and occurrence were not statistically significant. We continue to monitor the recurrence and mortality events in the 137 R0 subjects, and plan to conduct a complete unblinded analysis in the R0 subgroup when sufficient deaths have occurred to allow us to make meaningful conclusions, which we expect to occur by the second quarter of 2013. We plan to initiate a Phase 2/3 adaptive clinical trial evaluating GI-4000 plus gemcitabine versus gemcitabine alone in R1 and R0 subjects with resected pancreas cancer with Ras mutations by the end of the second quarter of 2013 after conducting a meeting with the FDA regarding the design of the trial in the first quarter of 2013. In the Phase 2 portion of this trial, we plan to enroll approximately 100 subjects in order to evaluate the predictive value of proteomic testing and the potential treatment effect for recurrence free survival at one year. Proteomic analysis is a testing method intended to measure the levels of specific proteins in blood or other body fluid. If the results from the initial group of subjects are supportive, an expansion to a Phase 3 trial scale could be initiated based on pre-specified criteria for potential registration and approval. The number of patients and parameters of the Phase 3 portion of the trial will be determined by the results from the Phase 2 portion of the trial and discussions with applicable regulatory authorities. In HCV, we have conducted a randomized, active-control 140-patient Phase 2b clinical trial with GI-5005 plus pegylated-interferon and ribavirin, or pegIFN/ribavirin, in patients with genotype 1 HCV, the most common type of HCV in the United States. In 96 subjects who had not previously been treated, GI- 5005 demonstrated a 21% relative advantage in sustained virologic response at 24 weeks following completion of therapy; 58% of subjects who received GI-5005 plus pegIFN/ribavirin compared to 48% of subjects who received pegIFN/ribavirin alone. Sustained virologic response is the inability to detect HCV in a patient’s blood 24 weeks after discontinuation of therapy, or SVR24. The trial also demonstrated a three-fold advantage in SVR24 in 37 subjects who previously had received, but not responded to, interferon plus ribavirin therapy; 17% for subjects who received GI-5005 plus pegIFN/ribavirin compared to 5% for subjects who only received pegIFN/ribavirin. In this trial, we observed a safety profile for GI-5005 treated subjects consistent with the safety profile that is generally observed in patients with chronic HCV treated with pegIFN/ribavirin, as determined by the Data Safety Monitoring Board. The trend observed in SVR24 did not achieve statistical significance. We expect to report additional data from this trial in the fourth quarter of 2012 and the first quarter of 2013. We believe that the GI-5005 HCV data demonstrate the potential value of the Tarmogen platform for other chronic infectious diseases. In May 2009, we entered into a worldwide strategic collaboration with Celgene focused on the discovery, development and commercialization of product candidates for the treatment of cancer and we received an initial $30 million fee. Celgene also made a $10 million equity investment. We are responsible for initial development of product candidates. Celgene has the option to license each product candidate at specific development milestones and continue to either fund our development or assume development responsibility. In July 2012, we entered into an amendment to the Celgene collaboration pursuant to which we agreed to extend Celgene’s right to exercise its program option for GI-4000 until after we deliver a report that includes specified data from the Phase 2 portion of a planned Phase 2/3 trial, including one year recurrence free survival and the results of proteomic testing that we believe may identify patients who will respond more favorably to GI-4000. In consideration for our agreement to extend Celgene’s program option for GI-4000, Celgene agreed to increase the future royalty rates to be paid to us on potential net product sales. Celgene also agreed that in order for such amendment to be effective, it must purchase $4.9 million of our equity securities by March 31, 2013. Celgene has indicated an interest in purchasing an aggregate of approximately $4.9 million of shares of our common stock in this offering at the initial public offering price in satisfaction of this requirement. Because indications of interest are not binding agreements or commitments to purchase, the underwriters may determine to sell more, less or no shares to Celgene in this offering, or Celgene may determine to purchase more, less or no shares in this offering. If certain development and regulatory milestones are achieved, we would be eligible to receive up to $441 million in milestone payments, and if products are commercialized, up to an additional $60 million of milestone payments plus tiered royalties based on net sales of each licensed product candidate. In October 2011, we entered into a worldwide strategic collaboration with Gilead to develop GI-13000 product candidates for chronic HBV infection under which we received a $10 million upfront payment and Gilead also agreed to fund a Phase 1a clinical trial of GI-13020. Gilead is responsible for all clinical development beyond the Phase 1a clinical trial. We are eligible to receive additional proceeds of up to $135 million in development and regulatory milestones, and if products are commercialized, tiered royalties and up to $40 million of sales milestone payments based on net sales of the licensed product candidates. We are party to a Restated Intellectual Property License Agreement, or the CU Agreement, with The Regents of the University of Colorado, or CU. The CU Agreement granted to us an exclusive, worldwide, sublicenseable license under specified CU patent rights relating to yeast-based immunotherapy, to make, use and sell products and processes that are covered by such patent rights. The CU Agreement also granted to us an option to obtain rights to any future inventions or discoveries created or developed at CU by one or more of the original inventors of the licensed CU patents. We also are obligated to pay CU royalties on net revenues from our and our sublicensee’s sale of any commercialized licensed product or process, and certain other payments. We are party to a Field-of-Use Non-Exclusive License Agreement, or the WRF Agreement, with Washington Research Foundation, or WRF. The WRF Agreement granted to us a non-exclusive license in the U.S. and certain other countries relating to WRF’s recombinant yeast expression technology. In consideration of such license grant, we are obligated to pay to WRF specified license fees, annual license maintenance fees, annual sublicense fees, a milestone payment if a certain development milestone is met, and royalties as a percentage of net sales of a licensed product by us, an affiliate or a sublicensee. We are party to a Cooperative Research and Development Agreement, or CRADA, with NCI. Under the CRADA, the parties will jointly develop products intended to treat a variety of cancers, through collaborative research and development activities set forth in a research plan. We will utilize our proprietary Tarmogen technology to develop multiple immunotherapy products expressing various cancer antigens provided by the NCI, and the NCI will conduct and fund preclinical and early clinical development of the product candidates. We are party to a Patent License Agreement, or the PHS Agreement, with the U.S. Public Health Service, or PHS. Under the PHS Agreement, we are granted a worldwide exclusive license under certain PHS patent rights to develop and commercialize licensed products and licensed processes for oncology indications related to over-expressed CEA. In consideration of our license under the PHS Agreement, we have agreed to pay to PHS certain royalties, including as a percentage of net sales of any licensed products or licensed processes. We are also party to three other Patent License Agreements, or the Additional PHS Agreements, with PHS. Under the Additional PHS Agreements, we are granted worldwide exclusive licenses under certain PHS patent rights covering “subject inventions” that arose under the CRADA between us and NCI. In consideration of our licenses under the Additional PHS Agreements, we have agreed to pay to PHS certain royalties, including as a percentage of net sales of any licensed products or licensed processes. ------ We were incorporated as Ceres Pharmaceuticals, Ltd. in Colorado on February 10, 1995. We changed our name to GlobeImmune, Inc. on May 26, 2001, and reincorporated in Delaware on June 5, 2002. Our principal executive offices are located at 1450 Infinite Drive, Louisville, CO 80027, and our telephone number is (303) 625-2700. Our website address is www.globeimmune.com.