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related topics |
{product, candidate, development} |
{product, liability, claim} |
{property, intellectual, protect} |
{stock, price, share} |
{personnel, key, retain} |
{cost, regulation, environmental} |
{product, market, service} |
{acquisition, growth, future} |
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We are heavily dependent on the success of our lead product candidate Onrigin tm
which is still under development. If Onrigin tm
is not successful in clinical trials or we do not obtain FDA approval of Onrigin
, or if FDA delays approval or narrows the indications for which we may market Onrigin
, our business will be materially adversely affected.
Even though we have filed an NDA, Onrigin tm continues to be evaluated in clinical trials. If these trials are delayed or achieve unfavorable results, we might not be able to obtain regulatory approval for Onrigin tm or our efforts to expand the product label for Onrigin tm could be delayed.
If we fail to obtain the capital necessary to fund our operations, we will be unable to continue or complete our product development, regulatory approval or commercialization efforts.
If the testing or use of our product candidates harms people, we could be subject to costly and damaging product liability claims.
The commercial success of Onrigin tm will depend upon the degree of market acceptance by physicians, patients, third party payors and others in the medical community.
If we are unable to obtain adequate reimbursement from governments or third party payors for Onrigin tm or if we are unable to obtain an acceptable price for Onrigin tm , our prospects for generating revenue and achieving profitability will suffer.
If we are found to be infringing on patents or trade secrets owned by others, we may be forced to cease or alter our drug development efforts, obtain a license to continue the development or sale of our products, and/or pay damages.
We rely on confidentiality agreements to protect our trade secrets. If these agreements are breached by our employees or other parties, our trade secrets may become known to our competitors.
A substantial portion of our technology is subject to limited retained rights of our licensors, and we may not be able to prevent the grant of similar rights to third parties.
Our proprietary rights may not adequately protect our technologies.
If we fail to recruit and retain key personnel, our research and development programs may be delayed.
We face intense competition in the market for anticancer products, and if we are unable to compete successfully, our business will suffer.
If our corporate partners, licensors, licensees, collaborators at research institutions and others do not conduct activities in accordance with our arrangements, our research and development efforts may be delayed.
If Yale does not conduct research relating to products we would like to pursue, we may never realize any benefits from our funding provided to Yale.
If we are unable to establish sales, marketing and distribution capabilities, or to enter into agreements with third parties to do so, we will be unable to successfully market and sell future drug products.
We rely on third-party manufacturers to manufacture our product candidates. If these third-party manufacturers fail to manufacture product candidates of satisfactory quality, in a timely manner, in sufficient quantities or at acceptable costs, development and commercialization of our products could be delayed.
The conduct of our operations may subject us to liabilities under environmental laws, and we may face large capital expenditures in order to comply with such laws.
We may expand our business through new acquisitions that could disrupt our business, harm our financial condition and may also dilute current stockholders ownership interests in our company.
The terms of our outstanding notes and warrants, as well as any additional funding we raise in the future could cause extreme dilution to our stockholders. Further, the large number of our shares that may be held in the market may depress the market price of our stock.
Our common stock has been delisted from the Nasdaq Capital Market . Among other things, delisting from the Nasdaq Capital Market may make it more difficult for investors to trade in our securities and may make it more difficult for us to raise additional capital.
Full 10-K form ▸
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