RISK FACTORS 4 • initiating additional preclinical studies, clinical trials or other We may never succeed in any or all of these activities and, even studies of GS011 and our other product candidates; if we do, we may never generate revenues that are significant • identifying and validating new product candidates that combine or large enough to achieve profitability. Even if we do achieve gene therapy approaches with our key platform technologies; profitability, we may not be able to sustain or increase profitability on an annual basis and may need to obtain additional funding to • preparing our biologic license application, or BLA, and European continue operations. Our failure to become and remain profitable Union centralized marketing authorization application, or MAA, would decrease the value of our Company and could impair our for GS010 and GS030, and seeking marketing approvals for ability to raise capital, maintain our research and development any of our other product candidates that successfully complete efforts, expand our business, diversify our product pipeline or clinical trials; continue our operations. A decline in the value of our Company • completing and submitting applications to, and obtaining could also cause investors to lose all or part of their investment. regulatory approval from, other regulatory authorities; Moreover, our operating results may fluctuate significantly from year • launching and commercializing product candidates for which to year, such that a period-to-period comparison of our results of we obtain marketing approval by establishing a sales force, operations may not be a good indication of our future performance. marketing and distribution infrastructure or, in regions where In any particular period or periods, our operating results could be we choose to do so, col laborating with a commercialization below the expectations of securities analysts or investors, which partner; could cause the price of the ordinary shares to decline. • setting a commercially viable price for any products for which we may receive approval; Our limited operating history may make it difficult for you to • obtaining and maintaining adequate coverage and evaluate our business to date and to assess our future viability. reimbursement from government and third-party payors for We began our operations in April 2012. Our operations to date our product candidates; have been limited to organizing and staffing our Company, business • maintaining and enhancing a sustainable, scalable, reproducible planning, raising capital, acquiring our technology, identifying and transferable manufacturing process for our product potential product candidates, undertaking preclinical studies candidates; and clinical trials of our most advanced product candidates, and • establishing and maintaining supply and manufacturing establishing collaborations. We have not yet demonstrated the relationships with third parties that can provide adequate, in ability to complete Phase I I I trials of our product candidates, both amount and quality, products and services to support obtain marketing approvals, manufacture a commercial-scale clinical supply and the market demand for our product product or conduct sales and marketing activities necessary for candidates, if approved; successful commercialization. Consequently, any predictions you make about our future success or viability may not be as accurate • obtaining market acceptance of our product candidates, if as they could be if we had a longer operating history. approved, as a viable treatment option and satisfying any post- marketing requirements; In addition, as a development-stage business, we may encounter • addressing any competing technological and market unforeseen expenses, difficulties, complications, delays and other developments; known and unknown factors. We will need to transition from a company with a research focus to a company that is also capable • implementing additional internal systems and infrastructure, of supporting commercial activities. We may not be successful in as needed; such a transition. • negotiating favorable terms in any collaboration, licensing or We may need to raise additional capital in the future, which may other arrangements into which we may enter and performing not be available on acceptable terms, or at all, and failure to obtain our obligations in such collaborations; this necessary capital when needed may force us to delay, limit or • acquiring or in-licensing other product candidates and terminate our product development efforts or other operations. technologies; • maintaining, protecting and expanding our portfolio of Our operations have consumed significant cash since inception. intellectual property rights, including patents, trade secrets To date, we have financed our activities primarily through private and know-how; placements of our ordinary shares and preferred shares, funding received from Bpifrance Financement, research tax credits • avoiding and defending against third-party interference or (crédit d’impôt recherche), or CIR, and a sale of our ordinary shares infringement claims; and in connection with our July 2016 initial public offering on the • attracting, hiring and retaining qualified personnel. regulated market of Euronext Paris, or Euronext Paris. 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