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Synta Pharmaceuticals Corp. We are a product-focused biopharmaceutical company developing novel, small-molecule drugs for inflammatory diseases, cancer, and diabetes. Our product pipeline is diverse – each of our seven clinical and preclinical small-molecule drug programs is based on a unique chemical class with a distinct mechanism of action – and our drug candidates address some of the largest pharmaceutical markets in the world. All of our drug candidates were discovered and developed using internal assets and capabilities built over the twelve-year history of Synta, our predecessor companies, and acquired research programs. We use these chemistry, biology, and pharmaceutical development capabilities to discover and develop new drugs, and to enhance and protect the value of our clinical programs. We have retained worldwide rights to all of our drug candidates in all indications. We have three drug candidates in human clinical trials and four additional programs in preclinical studies. For our two most advanced drug candidates, we are conducting six Phase 2 clinical trials across five therapeutic indications, including Crohn's disease, psoriasis, and multiple cancer types. We have enrolled over 450 patients in these Phase 2 trials at over 90 trial sites. STA-5326, an orally administered, small-molecule inhibitor of interleukin-12, or IL-12, and interleukin-23, or IL-23, is currently in Phase 2 clinical development for the treatment of Crohn's disease and psoriasis. STA-4783, a small-molecule anticancer therapeutic, is in three separate Phase 2 trials for the treatment of non-small cell lung cancer, malignant melanoma, and soft tissue sarcoma. STA-5312, a small-molecule anticancer agent we are developing initially for the treatment of chemotherapy-resistant cancers, is currently in two Phase 1 trials for the treatment of solid-tumor cancers and cancers of the blood. These programs are described in greater detail below. STA-5326 STA-5326 is a novel, orally administered, small-molecule drug candidate that selectively and potently inhibits the production of the IL-12 family of proteins, including IL-12 and IL-23. Over-production of these proteins plays a central role in chronic inflammatory diseases, driving the body's immune system to infiltrate and damage tissues and organs. In particular, IL-12 has been recognized as a key regulator of a type of immune cell known as TH1. Inflammatory diseases known to be mediated by TH1 cells include Crohn's disease, psoriasis, rheumatoid arthritis, and multiple sclerosis. A category of approved drugs, including Remicade, Enbrel, and Humira, that inhibit a protein known as tumor necrosis factor-alpha, or TNFa, has achieved significant commercial success as a treatment for certain TH1-biased diseases. However, for many patients these TNFa-antagonist drugs are ineffective or poorly tolerated. Recent results have shown that inhibiting IL-12 is a promising therapeutic strategy. Two antibody drug candidates that target IL-12 are currently in development. Data from recent clinical trials involving these antibodies have indicated significant therapeutic benefit to patients, and offer promise that inhibiting IL-12 activity may be a more advantageous therapeutic approach for the treatment of TH1-biased inflammatory diseases than inhibiting TNFa activity. We believe that STA-5326, as an orally administered, small-molecule IL-12 inhibitor, may offer additional advantages over both the TNFa-antagonists and anti-IL-12 antibodies, which require intravenous or subcutaneous injection. Our initial therapeutic focus for STA-5326 has been on the treatment of Crohn's disease and psoriasis. We have completed enrollment of a 57-patient Phase 2a clinical trial in moderate-to-severe Crohn's disease. This trial was designed as an open-label, dose-escalating study to assess the safety, pharmacokinetics, and efficacy of STA-5326. Patients were assigned to one of four dose levels of STA-5326 – 14 mg twice-a-day, 35 mg once-a-day, 28 mg twice-a-day, and 35 mg twice-a-day – and treated for four weeks. Efficacy was assessed using the Crohn's Disease Activity Index, or CDAI, which is a composite index of symptomatic and other parameters that has been the basis of pivotal studies for previously approved Crohn's disease therapies. We currently have data for the 37 patients comprising the first three dose cohorts of this Phase 2a trial. To date, STA-5326 has demonstrated an acceptable safety profile over four weeks of treatment. In addition, we observed clinical improvement at all but the lowest dose level and an onset of therapeutic benefit within two weeks of initiation of treatment. Based on these preliminary safety and efficacy results, we have added two cohorts to the Phase 2a trial to evaluate higher doses, and we expect to complete enrollment of these additional cohorts in early 2005. Assuming continued favorable results from our ongoing Phase 2a trial, we plan to initiate a Phase 2b clinical trial in Crohn's disease in the second half of 2005. In the second half of 2004, we initiated two Phase 2 trials for the treatment of chronic plaque psoriasis, the most common form of psoriasis. These trials will enroll a total of approximately 230 patients. Results from both trials are expected to be available in the second half of 2005. If the data are favorable, we expect to initiate a pivotal Phase 3 clinical trial for the treatment of chronic plaque psoriasis by the end of 2005. STA-4783 STA-4783 is a novel, small-molecule compound that we are currently evaluating in three separate Phase 2 trials for the treatment of non-small cell lung cancer, malignant melanoma, and soft tissue sarcoma, in combination with taxanes, a leading class of anticancer therapeutic agents. STA-4783 induces the expression of heat shock protein 70, or Hsp70, on the surface of tumor cells, which flags the cells for destruction and elimination by the immune system. STA-4783 also disrupts the function of the centrosome, a critical component of cellular infrastructure. Preclinical studies demonstrated that the combination of STA-4783 with a taxane achieved superior antitumor activity compared to the taxane alone, with minimal or no increase in toxicity. Based on the positive results we have seen during the initial stages of the ongoing Phase 2 trials, we have begun the second-stage, randomized portion of each of the non-small cell lung cancer and malignant melanoma trials. In January 2005, we completed enrollment of 87 patients in the second stage of the non-small cell lung cancer trial. We expect to report data from our Phase 2 cancer trials in the second half of 2005. If supported by continued favorable clinical data, we expect to initiate a pivotal Phase 3 clinical trial of STA-4783 for the treatment of one of these cancer types by the end of 2005. STA-5312 STA-5312 is a novel, small-molecule anticancer agent that we are initially developing for the treatment of chemotherapy-resistant cancers. STA-5312 inhibits the assembly of microtubules, fibers inside cells which play an essential role in cell division. By inhibiting microtubule assembly, STA-5312 disrupts the process of cell division, thereby causing cell death. This inhibition is more pronounced in rapidly dividing cells, such as cancer cells. In preclinical studies, STA-5312 has been shown to have considerably higher anticancer activity in chemotherapy-resistant cancer cells than standard treatments and to significantly increase animal survival in chemotherapy-resistant cancer models. We have initiated two dose-escalating Phase 1 trials of STA-5312 for the treatment of solid-tumor cancers and cancers of the blood. Results from these trials are expected by the end of 2005. Our Business Strategy Our mission is to extend and enhance the lives of patients by discovering, developing, and commercializing novel pharmaceutical products for treating severe medical conditions. To achieve this objective, we intend to continue to: • Focus on novel therapies for severe diseases with large market potential. Our clinical and discovery programs are focused on severe or life-threatening diseases, including Crohn's disease, psoriasis, and cancer, each of which represents a large therapeutic market and an attractive commercial opportunity. • Use our drug discovery capabilities to maximize the value of our ongoing clinical-stage programs. We apply our discovery capabilities to improve, expand, and protect the value of our ongoing clinical programs. • Expand our pipeline of unique drug candidates, with a focus on inflammatory diseases and cancer. Applying our discovery capabilities to rapidly and efficiently develop new drug candidates enhances the value of our pipeline through increased market potential and through diversification of our product, regulatory, and market risks. • Maximize the retained value of our drug candidates. At present, we own worldwide rights to all of our drug candidates in development. Based on our strong financial position, we intend to independently develop and commercialize certain drug candidates, and for other candidates, to develop them to a more advanced clinical stage before entering into development and commercial agreements. We believe this approach will allow us to retain a higher share of product value. • Maintain our focus on small-molecule drug development. We discover and develop small-molecule drug candidates, not large molecule biologic agents such as proteins or antibodies. Small-molecule drugs have the potential for development into orally administered drugs, thereby offering patients greater convenience. They also typically require lower infrastructure investment, face fewer manufacturing constraints, and may enable us to realize greater potential profit margins. • Build on the strength of our intellectual property estate. We are continuing to strengthen our intellectual property estate, which provides us with the ability to maximize the value of our internal discoveries and to protect these discoveries from competition. As of January 10, 2005, we had a total of 237 issued patents and pending patent applications worldwide, including issued U.S. composition-of-matter patents for our drug candidates in Phase 2 clinical development. Risks Associated with Our Business Our business is subject to numerous risks, as more fully described in the section entitled "Risk Factors" immediately following this prospectus summary. We have a limited operating history and have incurred substantial net losses. We expect to continue to incur substantial losses for the foreseeable future. All of our drug candidates are undergoing clinical trials or are in early stages of development, and failure is common and can occur at any stage of development. Our ability to generate product revenue in the future will depend heavily on the successful development and commercialization of these drug candidates, particularly our clinical drug candidates, STA-5326, STA-4783, and STA-5312. Even if we succeed in developing and commercializing one or more of our drug candidates, we may never generate sufficient revenue to achieve and then sustain profitability. Company History and Information We commenced operations in July 2001. In September 2002, we acquired Principia Associates, Inc., which had previously acquired Shionogi BioResearch Corp., a U.S.-based research company created by the Japanese pharmaceutical company, Shionogi & Co., Ltd. Through the acquisition of Principia, we acquired a unique chemical compound library, an integrated set of drug discovery capabilities, and a pipeline of preclinical and research drug candidates. To date, we have raised approximately $196 million from private investors to support our growth strategy. .... | ||||||||||||||
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