results, levels of activity, performance and achievements may be materially different from what we expect. These forward-looking statements speak only as of the date of this Annual Report on Form 10-K. Except as required by applicable law, we undertake no obligation to publicly update or revise any forward-looking statements contained in this Annual Report on Form 10-K, whether as a result of any new information, future events or otherwise.
TRADEMARKS
Solely for convenience, our trademarks and trade names in this report are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that we will not assert, to the fullest extent under applicable law, our rights thereto.
SUMMARY RISK FACTORS
Our business is subject to numerous risks and uncertainties, including those described in Part I, Item 1A. “Risk Factors” in this Annual Report on Form 10-K. You should carefully consider these risks and uncertainties when investing in our Class A common stock. The principal risks and uncertainties affecting our business include the following:
| ● | We have incurred significant losses since inception, we expect to incur losses in the future and we may not be able to generate sufficient revenue to achieve and maintain profitability; |
| ● | Our limited operating history makes it difficult to evaluate our future prospects and the risks and challenges we may encounter; |
| ● | Our success depends on the success of our Growth Direct platform, which may not be achieved or maintained. |
| ● | Our operating results have fluctuated significantly in the past and will fluctuate significantly in the future, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations. |
| ● | Our revenue has been primarily generated from sales of our Growth Direct system, proprietary consumables and laboratory information management system, or LIMS, connection software, which require a substantial period of time to generate recurring revenue; |
| ● | If we cannot maintain the level of sales of our Growth Direct systems or the sales of our consumables and service contracts to existing customers declines, our future operating results would be adversely affected; |
| ● | We may need to raise additional capital to fund our existing operations, improve our platform or develop and commercialize new products or expand our operations; |
| ● | The COVID-19 pandemic has impacted, and may continue to impact, our operations and may materially and adversely affect our business and financial results; |
| ● | The continued success of our business relies heavily on establishing and maintaining our position in the market as a leading provider of automated microbial quality control, or MQC, testing; |
| ● | It may be difficult for us to implement our strategies for improving growth; |
| ● | We may not successfully implement our strategy to expand our Growth Direct platform to customers who manufacture cell and gene therapies; |
| ● | The size of the markets and forecasts of market growth for automated MQC testing and other of our key performance indicators are based on a number of complex assumptions and estimates, and may be inaccurate; |
| ● | New product development involves a lengthy and complex process and we may be unable to develop or commercialize products on a timely basis, or at all; |
| ● | Our customers use our Growth Direct platform as part of their quality-control workflow, which is subject to regulation by the U.S. Food and Drug Administration, or FDA, and other comparable regulatory authorities; |
| ● | If we are unable to support demand for the Growth Direct platform, and for our future product offerings, including ensuring that we have adequate capacity to meet increased demand, our business could suffer; |