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related topics |
{product, candidate, development} |
{stock, price, share} |
{product, liability, claim} |
{cost, regulation, environmental} |
{personnel, key, retain} |
{financial, litigation, operation} |
{property, intellectual, protect} |
{interest, director, officer} |
{control, financial, internal} |
{acquisition, growth, future} |
{stock, price, operating} |
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Risks Related to Our Business
If we fail to obtain the capital necessary to fund our operations, we may be forced to reduce or wind-down operations
We have had a history of losses, and expect to continue to incur losses and may not achieve or maintain profitability
We are not in compliance with Nasdaq listing requirements, our stock could be delisted, and the trading price, volume and marketability of our stock could be adversely affected
We are not in compliance with Nasdaq listing requirements due to the resignation of William Whelan, Jr. from the Board of Directors of Point and Chairman of Point s Audit Committee.
Our lead product candidate, talabostat, is in human clinical development, and its safety and effectiveness are still being determined
Our lead product candidate, talabostat, is in human clinical development, and we may not be able to design or implement an effective clinical development plan which will result in timely FDA approval for the selected therapeutic applications
Whether or not we raise sufficient additional capital, we may be forced to reduce the size and scope of one or both of our Phase 3 trials
If talabostat is not a successful drug candidate, we will be adversely affected
If we fail to obtain regulatory approval for talabostat in a timely manner, our operating results and business may be adversely affected
Because we rely on third parties to conduct human clinical studies, we may encounter delays or experience increased costs in product development and commercialization
If Tufts University School of Medicine terminates our license, we could experience delays or be unable to complete the development and commercialization of our potential products
We may fail to adequately protect or enforce our intellectual property rights, and our products and processes may infringe the intellectual property rights of others
If our competitors reach the market sooner or develop products and technologies that are more effective, less costly, or have reduced side effects, our commercial opportunity will be reduced or eliminated
Our manufacturing strategy presents a number of risks
Our ability to generate revenues will be diminished if talabostat is not accepted in the marketplace, if we fail to obtain acceptable prices or if adequate reimbursement is not available for talabostat from third-party payors
We have used hazardous chemicals and radioactive and biological materials in our business; any disputes relating to improper use, handling, storage or disposal of these materials could be time-consuming and costly
We may be sued for product or operational liability
If we cannot attract or retain key personnel, we may be unable to develop talabostat or achieve our commercialization objectives
We have contingent liabilities relating to our historical discontinued operations that could give rise to liability risks in the future
The subsequent sale of a substantial number of shares of our common stock could cause our stock price to decline and cause our stockholders to experience substantial dilution
Our stock price could be volatile and our trading volume may fluctuate substantially
Full 10-K form ▸
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