NVUS 2018 Annual Report

clinical trials of our product candidates, obtaining marketing approval for these product candidates and manufacturing, marketing and selling those products for which we obtain marketing approval. We may never succeed in these activities and, even if we do, may never generate revenues that are significant or large enough to achieve profitability. If we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to become and remain profitable would decrease the value of the Company, could impair our ability to raise capital, maintain our nonclinical and clinical development efforts, and expand our business or continue our operations and may require us to raise additional capital that may dilute the ownership interest of common stockholders. A decline in the value of the Company could also cause stockholders to lose all or part of their investment. We are early in our development efforts and have only two drug candidates, OP0102 and OP0201. If we are unable to successfully develop and commercialize any drug candidate, or if we experience significant delays in doing so, our business will be materially harmed. We currently do not have any products that have gained regulatory approval. We have invested substantially all our efforts and financial resources in product development, including funding our formulation and device development, manufacturing, nonclinical studies, and clinical studies. Our ability to generate product revenues, which we do not expect will occur for several years, if ever, will depend heavily on the successful development and eventual commercialization of one or more drug candidates. As a result, our business is substantially dependent on our ability to successfully complete the development of and obtain regulatory approval for our, or additional product candidates. We have not yet demonstrated an ability to successfully overcome many of the risks and uncertainties frequently encountered by companies in new and rapidly evolving fields, particularly in the pharmaceutical area. For example, to execute our business plan, we will need to successfully: x execute formulation, manufacturing, clinical, and nonclinical development activities; x manufacture drug product at commercial scale; x establish and confirm commercially acceptable stability (shelf-life) of our drug products; x in-license or acquire other product candidates and advance them through clinical development; x obtain required regulatory approvals for the development and commercialization of OP0201 or other product candidates; x maintain, leverage and expand our intellectual property portfolio; x build and maintain robust sales, distribution and marketing capabilities, either on our own or in collaboration with strategic partners; x gain market acceptance for any approved and marketed drug products; x obtain and maintain adequate product pricing and reimbursement; x develop and maintain any strategic relationships we elect to enter; and x manage our spending as costs and expenses increase due to product manufacturing, nonclinical development, clinical trials, regulatory approvals, post-marketing commitments, and commercialization. If we are unsuccessful in accomplishing these objectives, we may not be able to successfully develop and commercialize our or other product candidates, and our business will suffer.

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