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Important notice and disclaimer
This presentation contains forward-looking statements and information. All statements other than statements of historical fact contained in this Presentation, including statements regarding our strategy, future financial condition, future operations, projected costs, prospects, plans, management objectives and expected market growth, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” ” estimate,” “target,” “seek,” “anticipate,” “potential,” “continue,” or the negative of these terms or other similar terminology. Although we believe that the expectations expressed in these forward-looking statements are reasonable, these statements refer to our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans, management objectives and expected market growth, and include known and unknown risks, uncertainties and other factors that may cause our actual results, activity levels, performance or achievements will be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements.The forward-looking statements in this presentation include, but are not about limited to, statements about: the success, cost and timing of our clinical development of our product candidates, including zipalertinib, CLN-619 and CLN-049; the initiation, timing, progress, results and costs of our research and development programs and our current and future preclinical and clinical studies, including statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which trial results will become available; and our research and development programs; our ability to initiate, recruit and enroll patients in and conduct our clinical trials at the pace we plan; our ability to obtain and maintain regulatory approval for our product candidates, and any related restrictions, limitations or warnings on the label of any of our product candidates, if approved; our ability to compete with companies that currently market or are engaged in the development of treatments for which our product candidates are designed; our reliance on third parties to conduct our clinical trials and manufacture drug substances for use in our clinical trials; the size and growth potential of the oncology and immuno-oncology markets and any of our current product candidates or other product candidates we may identify and pursue, and our ability to serve those markets; our ability to identify and advance through clinical development any additional product candidates; the commercialization of our current product candidates and any other product candidates that we may identify and pursue, if approved, including our ability to successfully build a dedicated sales force and commercial infrastructure to market our current product candidates and any other product candidates that we can identify and track; our ability to identify research priorities and implement a risk mitigation strategy to effectively discover and develop product candidates; our ability to retain and employ key personnel; our ability to obtain and maintain appropriate intellectual property rights; our expectations regarding government and third-party coverage and reimbursement; our estimates of our costs, current losses, capital requirements and our need or ability to obtain additional financing; express or implied statements regarding our beliefs and expectations regarding significant payments we may receive from Taiho; expected development and commercialization of zipalertinib; development of our commercial infrastructure; potential investments in our plan and potential for such product candidates; and our cash runway; the potential benefits of strategic collaboration agreements, our ability to enter into strategic collaborations or arrangements and our ability to attract collaborators with development, regulatory and commercialization expertise; our financial performance; developments and projections relating to our competitors or our industry; the effect of the COVID-19 pandemic, including mitigation efforts and economic effects, on any of the foregoing or other aspects of our business, including but not limited to our preclinical studies and future clinical trials. The Recipient is cautioned not to place undue reliance on the forward-looking statements contained in this presentation. The forward-looking statements in this presentation speak only as of the date hereof, and we undertake no obligation to update or revise any of these statements. Our business is subject to significant risks and uncertainties, including those listed above.
These forward-looking statements involve known and unknown risks and uncertainties that could cause our actual results, performance or achievements to be materially different from any expressed or implied in the forward-looking statements. These risks include, but are not limited to, the following: uncertainty regarding the results of regulatory filings, including our ability to agree with the FDA on an acceptable trial design for CLN-049; the success of our clinical trials and preclinical studies; risks related to the manufacturing, supply and distribution of our therapeutic candidates; and the success of any collaboration, partnership, license or similar agreement. These and other important risks and uncertainties are discussed in our filings with the Securities and Exchange Commission or the SEC, including under the heading “Risk Factors” in our January 7, 2021 prospectus filed with the SEC on January 11, 2021 and subsequent filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this presentation. Although we may choose to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date after the date of this presentation.
Certain information contained in this Presentation relates to or is based on studies, publications, surveys and other data obtained from third-party sources and the Company’s own internal assessments and research. Although the Company believes these third-party sources to be reliable as of the date of this Presentation, it has not independently verified, and makes no representations about the adequacy, fairness, accuracy or completeness, of any information obtained from third-party sources. In addition, any market data included in this Presentation involves numerous assumptions and limitations, and there can be no guarantee as to the accuracy or reliability of such assumptions. Finally, while we believe our internal research is reliable, such research has not been verified by any independent source.
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