What changed in this filing

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Item 1A. Risk Factors

2020-07-28 compared with 2019-07-29 · 28 added, 12 removed, 187 unchanged (18% of the section changed)

3 unchanged sentences

We historically incurred losses from operating activities, may require significant capital and may never achieve sustained profitability.

For the years ended April 30, 2019 and 2018 , the Company had net income of approximately $128,000 and a net loss of approximately $1.5 million , respectively.

For the years ended April 30, 2020 and 2019 , the Company had a net loss of approximately $2.0 million and net income of approximately $128,000 , respectively.

As of April 30, 2020 , the Company has an accumulated deficit of approximately $72.7 million .

As of April 30, 2019 , we had a working capital deficit of $103,000 and cash and cash equivalents of $3.2 million .

We believe that our cash and cash equivalents on hand, together with continued improved cash flows from operations, are adequate to fund our operations through at least August 2020.

As of April 30, 2020 , we had working capital of $1.4 million and cash of $8.3 million .

We believe that our cash on hand, together with continued improved cash flows from operations, are adequate to fund our operations through at least August 2021.

The amount of our losses and liquidity requirements may vary significantly from year-to-year and quarter-to-quarter and will depend on, among other factors:

8 unchanged sentences

Currently, the Company derives revenue from TOS products and POS products, while pursuing efforts to further develop bioinformatics from its TumorBank and its TumorGraft Technology Platform.

In addition, we are building our sales and marketing operations to grow the sales of our TOS products.

Our POS products are not the focus of our growth moving forward.

In addition, we are building our sales and marketing operations to further grow the sales of our TOS products.

Our POS products have not been the focus of our growth since fiscal 2016.

To become sustainably profitable, we will need to generate revenues to offset our operating costs, including our research and development and general and administrative expenses.

We may not achieve or, if achieved, sustain our revenue or profit objectives.

Our losses may increase in the future, and, ultimately, we may have to cease operations.

If our losses increase in the future and we are unable to obtain sufficient capital either from operations or externals sources, ultimately, we may have to cease operations.

In order to grow revenues, we must invest capital to implement our sales and marketing efforts and to successfully develop our bioinformatics from our TumorBank and our TumorGraft Technology Platform.

23 unchanged sentences

The framework would be phased in over many years.

If this framework is implemented, these initiatives may lead to an increased regulatory burden on our Company, which may result in a requirement for FDA review and clearance or approval of our POS services.

In January 2017, FDA summarized comments it had received on the 2014 draft guidance in a discussion paper which noted that it would not be issuing a final guidance on oversight of LDTs for the time being.

Final guidance on the framework has not since been issued by FDA although various legislative approaches to regulation over LDTs remain in discussion.

If this framework or one similar to it is implemented, these initiatives may lead to an increased regulatory burden on our Company, which may result in a requirement for FDA review and clearance or approval of our POS services.

Any increased regulatory burdens would probably result in an increase in the cost of our POS services and could keep us from selling POS services until such time as any required FDA clearance or approval is obtained.

1 unchanged sentence

Any POS services that we provide in other countries may be similarly subject to regulation by foreign regulatory agencies, which would also increase our costs.

These matters could hurt our business and our financial results.

These matters could hurt our business and our financial results of business.

Our laboratories are subject to regulation and licensure requirements, and the healthcare industry is highly regulated;

23 unchanged sentences

Our success, currently, is dependent upon the efforts of several full-time key employees, the loss of the services of one or more of which would have a material adverse effect on our business and financial condition.

We intend to continue to develop our management team and attract and retain qualified personnel in all functional areas to expand and grow our business.

We intend to continue to develop our

management team and attract and retain qualified personnel in all functional areas to expand and grow our business.

This may be difficult in the healthcare industry where competition for skilled personnel is intense.

77 unchanged sentences

Additionally, the sale of a substantial number of shares of our common stock or other equity securities to any new investors, or the anticipation of such sales, could cause the trading price of our common stock to fall.

The exercise of outstanding options and warrants may dilute current shareholders.

As of July 15, 2019, there were warrants and options outstanding to purchase an aggregate of 4,095,066 shares of our common stock, of which 2,151,107 were vested.

The exercise of a substantial number of these outstanding warrants and options could adversely affect our share price and dilute current shareholders.

Our stock price is volatile and therefore investors may not be able to sell their common stock at or above the price they paid for it.

35 unchanged sentences

If any analyst who may cover us was to cease coverage of our company or fail to regularly publish reports on us, we could lose visibility in the financial markets, which in turn could cause the price of our common stock or trading volume to decline.

A pandemic, epidemic, or outbreak of an infectious disease in the United States or elsewhere may adversely affect our business.

In December 2019, a novel strain of coronavirus, COVID-19, was first identified in Wuhan, China.

This virus continues to spread globally and, as of July 2020, has spread to over 200 countries, including the United States.

The spread of COVID-19 from China to other countries has resulted in the World Health Organization declaring the outbreak of COVID-19 as a “pandemic,” or a worldwide spread of a new disease, on March 11, 2020.

Many countries around the world have imposed quarantines and restrictions on travel and mass gatherings to slow the spread of the virus.

Employers are also required to increase, as much as possible, the capacity and arrangement for employees to work remotely.

In addition, on March 11, 2020, the President of the United States issued a proclamation to restrict travel to the United States from foreign nationals who have recently been in certain European and Latin American countries.

Although, to date, these restrictions have not impacted our operations, the effect on our business, from the spread of COVID-19 and the actions implemented by the governments of the United States and elsewhere across the globe, may worsen over time.

Any outbreak of contagious diseases, or other adverse public health developments, could have a material and adverse effect on our business operations.

These could include disruptions or restrictions on our ability to travel, pursue partnerships and other business transactions, receive shipments of biologic materials, as well as be impacted by the temporary closure of the facilities of suppliers.

The spread of an infectious disease, including COVID-19, may also result in the inability of our suppliers to deliver supplies to us on a timely basis.

In addition, health professionals may reduce staffing and reduce or postpone meetings with clients in response to the spread of an infectious disease.

Though we have not yet experienced such events, if they would occur, they could result in a period of business disruption, and in reduced operations, any of which could materially affect our business, financial condition and results of operations.

However, as of the date of this Annual Report on Form 10-K, we have not experienced a material adverse effect on our business nor the need for reduction in our work force;

and, currently, we do not expect any material impact on our long-term activity.

The extent to which COVID-19 impacts our business will depend on future developments which are highly uncertain and cannot be predicted, including, but not limited to, new information which may emerge concerning the increased severity of COVID-19, the actions to contain COVID-19, or treat its impact.

Unresolved Staff Comments

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1A. Risk Factors