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the initiation, cost, timing, progress and results of our research and development activities, preclinical and nonclinical studies and future clinical trials; |
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our ability to obtain and maintain regulatory approval of our future product candidates, and any related restrictions, limitations and/or warnings in the label of an approved product candidate; |
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our ability to obtain funding for our operations; |
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our plans to research, develop and commercialize our future product candidates; |
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our ability to attract collaborators with development, regulatory and/or commercialization expertise; |
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our ability to obtain and maintain intellectual property protection for our current and future product candidates; |
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the size and growth potential of the markets for our future product candidates, and our ability to serve those markets; |
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our ability to successfully commercialize our product candidates; |
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the rate and degree of market acceptance of our product candidates; |
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our ability to develop sales and marketing capabilities, whether alone or with potential future collaborators; |
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regulatory developments in the United States and foreign countries; |
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the performance of our third-party suppliers and manufacturers; |
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the success of competing therapies that are or become available; |
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our ability to retain key scientific or management personnel; |
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our expectations regarding the time during which we will be an emerging growth company under the JOBS Act; and |
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the accuracy of our estimates regarding expenses, future revenues, capital requirements and need for additional financing. |
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Advance our lead product candidate, MRX34, through clinical development. MRX34 is potentially the first in a new class of promising cancer drugs. Mirna is the first to establish clinical proof‑of‑concept for a microRNA‑based replacement therapy for cancer. In our Phase 1 clinical trial we have achieved confirmed partial responses by Response Evaluation Criteria in Solid Tumors (RECIST) in a patient with metastasized hepatocellular carcinoma, a patient with advanced acral melanoma and a patient with advanced RCC. We have also observed a number of patients with long term stable disease during MRX34 |