What the changes say
- Astrotech faces ongoing net losses and accumulated deficits while developing early-stage business units and medical devices like the BreathTest-1000.
- Regulatory challenges, FDA compliance, and reliance on single-source suppliers heavily influence the company's risk profile.
What changed since the prior 10-K
New
- NewRisks Related to Our Business and Industry
We have incurred significant losses since inception and anticipate that we will incur continued losses for the foreseeable future
The company reported an accumulated deficit of approximately $251 million and a net loss of $13.8 million for fiscal year 2025.
Dropped
- DroppedRisks Related to Our Business and Industry
if we fail to comply with applicable FDA regulations, our premarket submissions could be adversely affected, and we could face substantial enforcement actions, including civil and criminal penalties and our business, operations and financial condition could be adversely affected
- DroppedLegal and Regulatory Risks
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
- DroppedRisks Related to Ownership of Our Common Stock
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
Reworded
- 100% rewritten
We have incurred significant losses since inception and anticipate that we will incur continued losses for the foreseeable future
Updated accumulated deficit to $251 million and net loss to $13.8 million, adding details about development-stage business units needing capital.
- 100% rewritten
A failure of a key information technology system, process, or site could have a material adverse impact on our ability to conduct business
Shifted from IT systems reliance entirely to focus on third-party suppliers, product warranties, regulatory compliance, and BreathTest-1000 delays.
- 100% rewritten
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, if any, and to produce, market and distribute those products after clearance or approval is obtained
Replaced healthcare reform and reimbursement text with specific risks regarding FDA funding shortages and agency disruptions.
- 100% rewritten
We may not be able to obtain patents, other intellectual property protection or licenses for the technologies contained in the products we develop
Expanded to include third-party IP infringement claims, international market risks, inflation, and customer concentration.
- 89% rewrittenLegal and Regulatory Risks
the manufacturing process or facilities we use may not meet applicable requirements
Retained the core FDA enforcement and product clearance warning text.
- 89% rewritten
We and our suppliers may not meet regulatory quality standards applicable to our device-manufacturing processes, which could have an adverse effect on our business, financial condition, and results of operations
Added specific warnings about 510(k) modifications, product recalls, and off-label promotion liabilities.
- 88% rewritten
Our financial performance may be adversely affected by medical device tax provisions in healthcare reform laws
Replaced medical device tax and ACA provisions entirely with risks concerning the AgLAB business, U.S. hemp/cannabis regulations, and CSA compliance.
- 66% rewrittenRisks Related to Our Business and Industry
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
Appended standard IT system failure risks to the existing contract and grant bidding cost disclosures.
- 65% rewrittenLegal and Regulatory Risks
Changes in U.S. trade policy, including changes to existing trade agreements and any resulting changes in international trade relations, may have a material adverse effect on us and our export compliance as it relates to our international customers
Was: Changes in U.S. trade policy, including changes to existing trade agreements and any resulting changes in international trade relations, may have a material adverse effect on us
- 59% rewrittenRisks Related to Our Business and Industry
the potential cost of and delays in product development as a result of any regulatory oversight that may be applicable to our products
- 53% rewrittenRisks Related to Our Business and Industry
Third parties have infringed on our intellectual property rights, and may claim in the future that we are infringing on their intellectual property rights, and we could suffer significant litigation or licensing expenses or be prevented from selling products
Was: Their 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
- 31% rewrittenRisks Related to Our Business and Industry
We may not be able to successfully develop the BreathTest-1000 or any other new products or services
- 24% rewrittenRisks Related to Our Business and Industry
We generate substantial revenue from a limited number of customers and the loss of any such customer may harm our business, results of operations and financial results
- 21% rewrittenRisks Related to Ownership of Our Common Stock
Our stock price has fluctuated in the past, has recently been volatile and may be volatile in the future, and as a result, investors in our common stock could incur substantial losses
All 49 risk factors
Headings as the filing states them, in filing order.
Other
- 01We have incurred significant losses since inception and anticipate that we will incur continued losses for the foreseeable future100% rewritten
- 02We may not be able to obtain patents, other intellectual property protection or licenses for the technologies contained in the products we develop100% rewritten
- 03A failure of a key information technology system, process, or site could have a material adverse impact on our ability to conduct business100% rewritten
- 04We and our suppliers may not meet regulatory quality standards applicable to our device-manufacturing processes, which could have an adverse effect on our business, financial condition, and results of operations89% rewritten
- 05Legislative 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, if any, and to produce, market and distribute those products after clearance or approval is obtained100% rewritten
- 06Our financial performance may be adversely affected by medical device tax provisions in healthcare reform laws88% rewritten
Risks Related to Our Business and Industry
- 07We have incurred significant losses since inception and anticipate that we will incur continued losses for the foreseeable futureNew
- 08Our business units are in the 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
- 09We may need to raise additional capital to fund the operations of our business units and commercialize our products
- 10finance capital expenditures and general and administrative expenses
- 11the potential cost of and delays in product development as a result of any regulatory oversight that may be applicable to our products59% rewritten
- 12Third parties have infringed on our intellectual property rights, and may claim in the future that we are infringing on their intellectual property rights, and we could suffer significant litigation or licensing expenses or be prevented from selling products53% rewritten
- 13We may not be able to successfully develop the BreathTest-1000 or any other new products or services31% rewritten
- 14Our sales and operations in international markets expose us to operational, financial and regulatory risks
- 15Our business, financial condition and results of operations may be adversely impacted by the effects of inflation
- 16We generate substantial revenue from a limited number of customers and the loss of any such customer may harm our business, results of operations and financial results24% rewritten
- 17Our success depends significantly on the establishment and maintenance of successful relationships with our customers
- 18Third 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
- 19Our ongoing success is dependent upon the continued availability of certain key employees
- 20Our operating results may be adversely affected by increased competition
- 21Our facilities located in Austin are susceptible to damage caused by hurricanes or other natural disasters
- 22If 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
- 23We 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 awarded66% rewritten
- 24Our manufacturing operations are mostly dependent upon third party suppliers, including single source suppliers, making us vulnerable to external factors such as supply shortages and price fluctuations, which could harm our business
- 25fluctuation in delivery by our suppliers due to changes in demand from us or their other customers
- 26Repair or replacement costs due to warranties we provide on our products could have a material adverse effect on our business, financial condition and results of operations
Legal and Regulatory Risks
- 27Our products and operations are subject to extensive governmental regulation, and failure to comply with applicable requirements could cause our business to suffer
- 28recalls and field‑safety corrective actions
- 29the manufacturing process or facilities we use may not meet applicable requirements89% rewritten
- 30Although we do not grow, sell or distribute cannabis products, our products are closely tied to the hemp and cannabis industry and could subject us to regulatory, financial, operational and reputational risks and challenges
- 31Evolving federal and state laws and regulations pertaining to the use or cultivation of hemp and cannabis, as well active enforcement by federal or state authorities of the laws and regulations governing the use and cultivation of hemp and cannabis may indirectly affect our business, our revenues and our profits
- 32As the possession and use of marijuana is illegal under the CSA, it is possible that our manufacture and sale of equipment that is used to cultivate marijuana or marijuana products may be deemed to be aiding and abetting illegal activities
- 33We may become subject to FDA or ATF regulation with respect to our AgLab business
- 34The hemp and cannabis industry could face strong opposition from other industries
- 35There may be difficulty enforcing certain of our commercial agreements and contracts
- 36A drop in the retail price of hemp and cannabis products may negatively impact our business
- 37We may be subject to constraints on and differences in marketing our products under varying state laws
- 38We are subject to differing tax rates in several jurisdictions in which we operate, which may adversely affect our business, financial condition, results of operations and prospects
- 39Changes in U.S. trade policy, including changes to existing trade agreements and any resulting changes in international trade relations, may have a material adverse effect on us and our export compliance as it relates to our international customers65% rewritten
Risks Related to Ownership of Our Common Stock
- 40Our stock price has fluctuated in the past, has recently been volatile and may be volatile in the future, and as a result, investors in our common stock could incur substantial losses21% rewritten
- 41general economic, industry and market conditions; and
- 42We 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
- 43Our Certificate of Incorporation provides that the Court of Chancery of the State of Delaware will be the sole and exclusive forum for any disputes between us and our stockholders, which could limit stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors or officers
- 44A sale of a substantial number of shares of the common stock may cause the price of our common stock to decline
- 45We 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
- 46Our failure to maintain compliance with Nasdaq’s continued listing requirements could result in the delisting of our Common Stock
- 47Increased cybersecurity requirements, vulnerabilities, threats, and more sophisticated and targeted computer crime could pose a risk to our systems, networks, products, services, and data
- 48Increased costs associated with corporate governance compliance may significantly impact our results of operations
- 49Our insurance coverage may be inadequate to cover all significant risk exposures
Other Astrotech 10-Ks
- FY2026 10-K risk factors56 risks7 new9 reworded
Lunar Initiatives now dominate risk disclosure, with unproven technology, funding dependence, acquisitions, competition, and execution uncertainty.
Filed Sep 25, 2026 - FY2024 10-K risk factors51 risks
Astrotech relies on two affiliated customers without long-term contracts and faces early-stage development risks for products like the BreathTest-1000. The company has an accumulated deficit of $237 million and needs additional capital to fund operations. Its equipment sales are tied to the federally illegal hemp and cannabis industry.
Filed Sep 20, 2024
About this page
The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.