Astrotech (ASTC)

Risks

• We have incurred significant losses since inception and anticipate that we will incur continued losses for the foreseeable future.
• Our business units are in development stage. They have earned limited revenues and it is uncertain whether they will earn any revenues in the future or whether any of them will ultimately be profitable.
• We may not be able to successfully develop the BreathTest-1000 or any other new products or services.
• We face various risks related to health epidemics, pandemics and similar outbreaks, which may have material adverse effects on our business, financial position, results of operations, and/or cash flows.
• Our success depends significantly on the establishment and maintenance of successful relationships with our customers.
• Third parties may claim we are infringing their intellectual property rights, and we could suffer significant litigation or licensing expenses or be prevented from selling products.
• Our ongoing success is dependent upon the continued availability of certain key employees.
• Our operating results may be adversely affected by increased competition.
• Our insurance coverage may be inadequate to cover all significant risk exposures.
• Increased cybersecurity requirements, vulnerabilities, threats, and more sophisticated and targeted computer crime could pose a risk to our systems, networks, products, services, and data.
• Our facilities located in Austin are susceptible to damage caused by hurricanes or other natural disasters.
• If we are unable to anticipate technological advances and customer requirements in the commercial and governmental markets, our business and financial condition may be adversely affected.
• Significant safety concerns could arise for our BreathTest-1000 product, which could have a material adverse effect on our future revenues and financial condition.
• We incur substantial upfront, non-reimbursable costs in preparing proposals to bid on contracts or to receive research and development grants that we may not be awarded.
• A failure of a key information technology system, process, or site could have a material adverse impact on our ability to conduct business.
• A sale of a substantial number of shares of the common stock may cause the price of our common stock to decline.
• We are a smaller reporting company and, as a result of the reduced disclosure and governance requirements applicable to such companies, our common stock may be less attractive to investors.
• We are required to evaluate the effectiveness of our internal control over financial reporting on an annual basis and publicly disclose any material weaknesses in our controls. Any adverse results from such evaluation could result in a loss of investor confidence in our financial reports and significant expense to remediate, and ultimately could have an adverse effect on our stock price.
• We can sell additional shares of common stock without consulting shareholders and without offering shares to existing shareholders, which would result in dilution of shareholders’ interests in the Company and could depress our stock price.
• Our products and operations are subject to extensive governmental regulation, and failure to comply with applicable requirements could cause our business to suffer.
• Failure to obtain clearance or authorization for the BreathTest-1000, or other delays in the development of the BreathTest-1000, would adversely affect our ability to grow our business.
• FDA’s policy with respect to Emergency Use Authorizations is evolving and may limit the ability for medical products, including the BreathTest-1000, to be eligible for commercialization under an Emergency Use Authorization.
• Modifications to our products may require new 510(k) clearances, de novo submissions, or pre‑market approvals, or may require us to cease marketing or recall the modified products until clearances are obtained.
• If we or our third‑party suppliers fail to comply with the FDA’s good manufacturing practice regulations or fail to adequately, timely, or sufficiently respond to an FDA Form 483 or subsequent Warning Letter, this could impair our ability to market our products in a cost‑effective and timely manner and could result in FDA enforcement action.
• A recall of our product, or the discovery of serious safety issues with our product, could have a significant adverse impact on us.
• We may be liable if the FDA or other U.S. enforcement agencies determine we have engaged in the off‑label promotion of our products or have disseminated false or misleading labeling or promotional materials.
• Legislative or regulatory healthcare reforms may make it more difficult and costly for us to obtain reimbursement for our products or regulatory clearance or approval of our future products, and to produce, market and distribute those products after clearance or approval is obtained.