• obtain, maintain, expand, protect and enforce our intellectual property and other proprietary rights and obtain licenses
to third-party intellectual property;
• add clinical, regulatory, scientific, operational, financial, legal, intellectual property, compliance and management
information systems and personnel, including personnel to support our product development and potential future
commercialization efforts; and
• experience any delays or encounter any issues relating to any of the above, including failed studies, ambiguous trial
results, safety issues, other regulatory challenges or third party supply or manufacturing issues.
Since our inception in 2004, we have invested most of our resources in developing our product candidates, building our
intellectual property portfolio, developing our supply chain, conducting business planning, raising capital and providing
general and administrative support for these operations. We do not currently have any approved products and have never
generated any revenue from product sales.
To become profitable, we must succeed in developing and eventually commercializing products that generate significant
revenue. This will require us or our licensees to be successful in a range of challenging activities, including completing
preclinical testing and clinical trials of our product candidates, discovering and developing additional product candidates,
obtaining regulatory approval for any product candidates that successfully complete clinical trials, establishing
manufacturing and marketing capabilities and ultimately selling any products for which we may obtain regulatory
approval. We are only in the preliminary stages of most of these activities. We may never succeed in these activities and,
even if we do, may never generate revenue that is significant enough to sustain or increase profitability on a quarterly or
annual basis. Our failure to become profitable would decrease the value of our company and could impair our ability to
raise capital, maintain our research and development efforts, expand our business or continue our operations.
If we are required by the U.S. Food and Drug Administration, or FDA, the European Medicines Agency, or EMA, or other
comparable foreign authorities to perform studies in addition to those we currently anticipate, or if there are any delays in
completing our clinical trials or the development of any of our product candidates, our expenses could increase and revenue
could be further delayed.
Even if we do generate product royalties or product sales, we may never sustain profitability on a quarterly or annual basis.
Our failure to sustain profitability would depress the market price of the ADSs and could impair our ability to raise capital,
expand our business, diversify our product offerings or continue our operations. A decline in the market price of the ADSs
also could cause you to lose all or a part of your investment.
We may need substantial additional funding in order to complete the development and commercialization of our product
candidates. Failure to obtain this necessary capital when needed may force us to delay, limit or terminate certain of our
product development or research operations.
To date, we have funded our operations through public and private placements of equity securities, upfront, milestone,
option exercise, reservation fee, expense reimbursement, sponsored research payments received from our collaborators,
recharging of third party costs and interest income from the investment of our cash, cash equivalents and financial assets.
We expect to require additional funding in the future to sufficiently finance our operations and advance development of our
product candidates. On July 1, 2022, we entered into a sales agreement with Leerink Partners LLC (previously known as
SVB Securities LLC), or the Sales Agreement, to sell ordinary shares from time to time at our discretion under an “at the
market” program, with aggregate gross sales proceeds of up to $100.0 million.
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