CYTOKINETICS INC
For the period ended Dec 31, 2023. Filed Feb 28, 2024.
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A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2023 · Filed Feb 28, 2024
Contents
Forward Looking Statements Private Securities Litigation Reform Act of 1995
FORWARD LOOKING STATEMENTS
PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
This report contains forward-looking statements indicating expectations about future performance and other forward-looking statements within the meaning of Section 27A of the Securities Act, Section 21E of the Exchange Act, and the Private Securities Litigation Reform Act of 1995, that involve risks and uncertainties. We intend that such statements be protected by the safe harbor created thereby. Forward-looking statements involve risks and uncertainties and our actual results and the timing of events may differ significantly from the results discussed in the forward-looking statements. Examples of such forward-looking statements include, but are not limited to, statements about or relating to:
the timing of submissions and potential approvals of marketing authorization applications to FDA, EMA and other foreign regulatory authorities;
the initiation, design, conduct, enrollment, progress, timing and scope of clinical trials and development activities for our drug candidates conducted by ourselves or our partners, including the anticipated timing for completion and announcement of results of our clinical trials, and anticipated rates of enrollment for clinical trials;
guidance concerning revenues and net cash use for 2024;
the sufficiency of existing resources to fund our operations for at least the next 12 months;
our capital requirements and needs for additional financing;
the results from the clinical trials, the non-clinical studies and chemistry, manufacturing, and controls activities of our drug candidates and other compounds, and the significance and utility of such results; anticipated interactions with regulatory authorities;
our ability to ensure commercial availability of an antibody-based immunoassay for the dose optimization of omecamtiv mecarbil;
our and our partners’ plans or ability to conduct the continued research and development of our drug candidates and other compounds;
our expected roles in research, development or commercialization under our strategic alliances with our partners and collaborators;
the properties and potential benefits of, and the potential market opportunities for, our drug candidates and other compounds, including the potential indications for which they may be developed or commercialized;
the sufficiency of the clinical trials conducted with our drug candidates to demonstrate that they are safe and efficacious;
our receipt of milestone payments, royalties, reimbursements and other funds from current or future partners under strategic alliances;
our ability to continue to identify additional potential drug candidates that may be suitable for clinical development;
market acceptance and commercial viability of our drugs;
changes in third party healthcare coverage and reimbursement policies;
our plans or ability to commercialize drugs, with or without a partner, including our intention to develop sales and marketing capabilities and execute on commercial plans;
the focus, scope and size of our research and development activities and programs;
the utility of our focus on the biology of muscle function, and our ability to leverage our experience in muscle contractility to the research and development of drug candidates directed to other areas of muscle biology and muscle functions;
our ability to protect our intellectual property and to avoid infringing the intellectual property rights of others;
future payments and other obligations under loan, lease, and revenue interest agreements and the Convertible Notes;
potential competitors and competitive products;
retaining key personnel and recruiting additional key personnel; and
the potential impact of recent accounting pronouncements on our financial position or results of operations.
Such forward-looking statements involve risks and uncertainties, including, but not limited to:
decisions by Ji Xing with respect to the timing, design and conduct of development and commercialization activities for aficamten or omecamtiv mecarbil in China and Taiwan;
our ability to meet any of the conditions for disbursement and our receipt of any loan disbursements under the RP Loan Agreement;
our ability to enroll patients in our clinical trials by any particular date;
our ability to complete our clinical trials by any particular date;
our ability to enter into strategic partnership agreements for any of our programs on acceptable terms and conditions or in accordance with our planned timelines;
our ability to obtain additional financing on acceptable terms, if at all;
our receipt of funds and access to other resources under our current or future strategic alliances, in the development, testing, manufacturing or commercialization of our drug candidates or slower than anticipated patient enrollment, in our or partners’ clinical trials, or in the manufacture and supply of clinical trial materials;
failure by our contract research organizations, contract manufacturing organizations and other vendors to properly fulfill their obligations or otherwise perform as expected;
results from non-clinical studies that may adversely impact the timing or the further development or regulatory approvals of our drug candidates and other compounds;
the possibility the FDA or foreign regulatory agencies may delay or limit our or our partners’ ability to conduct clinical trials or may delay or withhold approvals for the manufacture and sale of our drug candidates;
changing standards of care and the introduction of products by competitors or alternative therapies for the treatment of indications we target that may limit the commercial potential of our drug candidates;
difficulties or delays in achieving market access, reimbursement and favorable drug pricing for our products and the potential impacts of health care reform;
changes in laws and regulations applicable to drug development, commercialization, pricing or reimbursement;
the uncertainty of protection for our intellectual property, whether in the form of patents, trade secrets or otherwise;
potential infringement or misuse by us of the intellectual property rights of third parties;
activities and decisions of, and market conditions affecting, current and future strategic partners;
accrual information provided by and performance of our contract research organizations, contract manufacturing organizations, and other vendors;
potential ownership changes under Internal Revenue Code Section 382; and
the timeliness and accuracy of information filed with the U.S. Securities and Exchange Commission by third parties.
In addition, such statements are subject to the risks and uncertainties discussed in the “Risk Factors” section and elsewhere in this document. Such statements speak only as of the date on which they are made, and, except as required by law, we undertake no obligation to update any forward-looking statement to reflect events or circumstances after the date on which the statement is made or to reflect the occurrence of unanticipated events. New factors emerge from time to time, and it is not possible for us to predict which factors will arise. In addition, we cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.