Table of Contents
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PART I |
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Item 1. |
1 |
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Item 1A. |
40 |
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Item 1B. |
83 |
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Item 2. |
83 |
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Item 3. |
83 |
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Item 4. |
83 |
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PART II |
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Item 5. |
84 |
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Item 6. |
85 |
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Item 7. |
86 |
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Item 7A. |
101 |
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Item 8. |
101 |
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Item 9. |
101 |
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Item 9A. |
101 |
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Item 9B. |
102 |
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PART III |
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Item 10. |
103 |
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Item 11. |
103 |
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Item 12. |
103 |
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Item 13. |
103 |
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Item 14. |
103 |
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PART IV |
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Item 15. |
104 |
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Item 16 |
106 |
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report on Form 10-K, or Form 10-K, including the section entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” contains express or implied forward-looking statements that are based on our management’s belief and assumptions and on information currently available to our management. Although we believe that the expectations reflected in these forward-looking statements are reasonable, these statements relate to future events or our future operational or financial performance, and involve known and unknown risks, uncertainties, and other factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by these forward-looking statements. Forward-looking statements in this Form 10-K include, but are not limited to, statements about:
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the initiation, timing, progress, results, safety and efficacy, and cost of our research and development programs and our current and future preclinical studies and clinical trials, including statements regarding the timing of initiation and completion of studies or trials, the period during which the results of the trials will become available, and our research and development programs; |
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the ultimate impact of the current novel coronavirus pandemic, or the COVID-19 pandemic, or any other health epidemic, on our business, manufacturing, clinical trials, research programs, supply chain, regulatory review, healthcare systems or the global economy as a whole; |
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risks related to the direct or indirect impact of the COVID-19 pandemic or any future large-scale adverse health event, such as the scope and duration of the outbreak, government actions and restrictive measures implemented in response, material delays in diagnoses, initiation or continuation of treatment for diseases that may be addressed by our development candidates and investigational medicines, or in patient enrollment in clinical trials, potential clinical trials, regulatory review or supply chain disruptions, and other potential impacts to our business, the effectiveness or timeliness of steps taken by us to mitigate the impact of the pandemic, and our ability to execute business continuity plans to address disruptions caused by the COVID-19 pandemic or future large-scale adverse health event; |
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our ability to obtain funding for our operations necessary to complete further development, manufacturing and commercialization of our product candidates; |
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our ability to obtain and maintain regulatory approval for any of our current or future product candidates; |
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the period of time over which we anticipate our existing cash and cash equivalents and short-term investments will be sufficient to fund our operating expenses and capital expenditure requirements; |
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our ability to identify and develop product candidates for treatment of additional disease indications; |
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the potential attributes and benefits of our product candidates; |
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the rate and degree of market acceptance and clinical utility for any product candidates we may develop; |
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the pricing and reimbursement of our product candidates, if approved; |
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the effects of competition with respect to any of our current or future product candidates, as well as innovations by current and future competitors in our industry; |
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the implementation of our strategic plans for our business, any product candidates we may develop and our TORPEDO platform; |
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the ability and willingness of our third-party strategic collaborators to continue research, development and manufacturing activities relating to our product candidates, including our ability to advance programs under our existing collaboration agreements with F. Hoffman-La Roche Ltd. and Hoffman-LaRoche Inc., or Roche, Biogen MA, Inc., or Biogen, and Calico Life Sciences LLC, or Calico, or other new collaboration agreements; |
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the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates; |
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estimates of our future expenses, revenues, capital requirements, and our needs for additional financing; |
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future agreements with third parties in connection with the manufacturing and commercialization of our product candidates, if approved; |
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the size and growth potential of the markets for our product candidates and our ability to serve those markets; |