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related topics |
{product, candidate, development} |
{product, liability, claim} |
{property, intellectual, protect} |
{cost, regulation, environmental} |
{stock, price, operating} |
{interest, director, officer} |
{provision, law, control} |
{personnel, key, retain} |
{control, financial, internal} |
{capital, credit, financial} |
{competitive, industry, competition} |
{cost, contract, operation} |
{stock, price, share} |
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Our product development programs are inherently risky.
We have granted to Wyeth the exclusive rights to develop and commercialize MNTX, our lead product candidate, and our resulting dependence on Wyeth exposes us to significant risks.
If testing does not yield successful results, our products will not be approved.
A setback in our clinical development programs could adversely affect us.
We have a history of operating losses, and we may never be profitable.
We are likely to need additional financing, but our access to capital funding is uncertain.
Our clinical trials could take longer than we expect.
We are subject to extensive regulation, which can be costly and time consuming and can subject us to unanticipated fines and delays.
Our products do not yet have, and may never obtain, the regulatory approvals needed for marketing.
Even if our products obtain marketing approval, they might not be accepted in the marketplace.
Marketplace acceptance will depend in part on competition in our industry, which is intense.
One or more competitors developing an opioid antagonist may reach the market ahead of us and adversely affect the market potential for MNTX.
Disputes with Cytogen could delay or halt our PSMA programs.
If we are unable to negotiate collaborative agreements, our cash burn rate could increase and our rate of product development could decrease.
If we do not remedy our failure to achieve milestones or satisfy conditions regarding some of our product candidates, we may not maintain our rights under our licenses relating to these product candidates.
We have limited manufacturing capabilities, which could adversely impact our ability to commercialize products.
We are dependent on our patents and other intellectual property rights. The validity, enforceability and commercial value of these rights are highly uncertain.
If we infringe third-party patent or other intellectual property rights, we may need to alter or terminate a product development program.
We are dependent upon third parties for a variety of functions. These arrangements may not provide us with the benefits we expect.
We lack sales and marketing experience, which will make us dependent on third parties for their expertise in this area.
If we lose key management and scientific personnel on whom we depend, our business could suffer.
If we are unable to obtain sufficient quantities of the raw and bulk materials needed to make our products, our product development and commercialization could be slowed or stopped.
A substantial portion of our funding comes from federal government grants and research contracts. We cannot rely on these grants or contracts as a continuing source of funds.
If health care reform measures are enacted, our operating results and our ability to commercialize products could be adversely affected.
We are exposed to product liability claims, and in the future we may not be able to obtain insurance against these claims at a reasonable cost or at all.
We handle hazardous materials and must comply with environmental laws and regulations, which can be expensive and restrict how we do business. If we are involved in a hazardous waste spill or other accident, we could be liable for damages, penalties or other forms of censure.
Our stock price has a history of volatility. You should consider an investment in our stock as risky and invest only if you can withstand a significant loss.
Our principal stockholders are able to exert significant influence over matters submitted to stockholders for approval.
Anti-takeover provisions may make the removal of our Board of Directors or management more difficult and discourage hostile bids for control of our company that may be beneficial to our stockholders.
If there are substantial sales of our common stock, the market price of our common stock could decline.
Full 10-K form ▸
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