Item 8.01. Other Events
Forward Looking Statements
Statements contained under this Item 8.01 regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements about the initiation, timing, progress, results, 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 and related preparatory work, the period during which the results of the trials will become available, and our research and development programs; our ability to successfully manufacture our drug substances and product candidates for preclinical use, for clinical trials and on a larger scale for commercial use, if approved; the ability and willingness of our third-party strategic collaborators to continue research and development activities relating to our development candidates and product candidates; our ability to obtain funding for our operations necessary to complete further development and commercialization of our product candidates; our ability to obtain and maintain regulatory approval of our product candidates; the size and growth potential of the markets for our product candidates, and our ability to serve those markets; our financial performance; the effect of the COVID-19 pandemic, including mitigation efforts and economic effects, on any of the foregoing or other aspects of our business operations, including but not limited to our preclinical studies and clinical trials and any future studies or trials; our ability to commercialize our products, if approved; and the implementation of our business model, and strategic plans for our business and product candidates.
Any forward-looking statements are neither promises nor guarantees, and
investors should not place undue reliance on these forward-looking statements
because they involve known and unknown risks, uncertainties, and other factors,
many of which are beyond the Company's control and which could cause actual
results to differ materially from those expressed or implied by these
forward-looking statements, including, without limitation, an improved quality
of life of patients after treatment with belzupacap sarotalocan; a potential
paradigm shift in the approach to the treatment of choroidal melanoma; the
urgent need for a vision preserving targeted therapy; the potential of
belzupacap sarotalocan compared to the existing standard of care for patients
with choroidal melanoma; uncertainties inherent in clinical trials and in the
availability and timing of data from ongoing clinical trials; the expected
timing for submissions for regulatory approval or review by governmental
authorities; the risk that the results of the Company's clinical trials may not
be predictive of future results in connection with future clinical trials; the
risk that interim data from ongoing clinical trials may not be predictive of
final data from completed clinical trials; whether the Company will receive
regulatory approvals to conduct trials or to market products; whether the
Company's cash resources will be sufficient to fund its foreseeable and
unforeseeable operating expenses and capital expenditure requirements; risks,
assumptions and uncertainties regarding the impact of the continuing COVID-19
pandemic on the Company's business, operations, strategy, goals and anticipated
timelines; the Company's ongoing and planned pre-clinical activities; and the
Company's ability to initiate, enroll, conduct or complete ongoing and planned
clinical trials. These risks, uncertainties, and other factors include those
risks and uncertainties described under the heading "Risk Factors" in the
Company's most recent Annual Report on Form 10-K and Quarterly Report on Form
10-Q filed with the
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Item 9.01. Financial Statements and Exhibits.
(d) Exhibits. Exhibit No. Description 99.1 Corporate presentation of the Company 104 Cover Page Interactive Data (embedded within the Inline XBRL document)
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