Z Squared (ZSQR) risk factors, FY2024 10-K

Risks Related to the Development and Regulatory Approval of Our Product Candidates

1. 01If clinical trials for our product candidates are prolonged, delayed or stopped, we may be unable to obtain regulatory approval and commercialize our product candidates on a timely basis, or at all, which would require us to incur additional costs and delay our receipt of any product revenue
2. 02The design or our execution of clinical trials may not support regulatory approval
3. 03We may find it difficult to enroll patients in our clinical trials given the limited number of patients who have the diseases for which our product candidates are being studied which could delay or prevent the start of clinical trials for our product candidates

General Risks

1. 04There is a substantial doubt about our ability to continue as a going concern
2. 05We have incurred significant losses in prior periods, and losses in the future could cause the quoted price of our Common Stock to decline or have a material adverse effect on our financial condition, our ability to pay its debts as they become due, and on its cash flows
3. 06If we are unable to manage future expansion effectively, our business may be adversely impacted
4. 07The Company’s ability to be successful will depend upon the efforts of the Company’s Board and our key personnel and the loss of such persons could negatively impact the operations and profitability of the Company’s business
5. 08If we are unable to recruit and retain key personnel, our business may be harmed
6. 09Our business plan is not based on independent market studies
7. 10Our Board of Directors may change our policies without shareholder approval
8. 11We need to obtain financing in order to continue our operations and pursue strategic transactions
9. 12We currently do not have sufficient cash to fully implement our business plan
10. 13We have a limited operating history and a history of operating losses, and expect to incur significant additional operating losses
11. 14The drug development and approval process is uncertain, time-consuming and expensive
12. 15We will be required to sustain and further build our intellectual property rights
13. 16We will be required to comply with our obligations in our intellectual property licenses and other agreements with third parties
14. 17Patent litigation or other litigation in connection with our intellectual property rights may lead to publicity that may harm our reputation and the value of our common stock may decline
15. 18Protecting and defending against intellectual property claims may have a material adverse effect on our business
16. 19Our competitors and potential competitors may develop products and technologies that make ours less attractive or obsolete
17. 20Competition in the biotechnology and pharmaceutical industries may result in competing products, superior marketing of other products and lower revenues or profits for us
18. 21The Company’s business and operations could be negatively affected if it becomes subject to any securities litigation or shareholder activism, which could cause the Company to incur significant expense, hinder execution of business and growth strategy and impact its stock price

Risk Related to Regulation

1. 22The regulatory approval process is costly and lengthy, and we may not be able to successfully obtain all required regulatory approvals
2. 23Even if we receive regulatory approvals for marketing our product candidates, if we fail to comply with continuing regulatory requirements, we could lose our regulatory approvals, and our business would be adversely affected
3. 24Even if we are able to obtain regulatory approvals for any of our product candidates, if they exhibit harmful side effects after approval, our regulatory approvals could be revoked or otherwise negatively impacted, and we could be subject to costly and damaging product liability claims
4. 25Healthcare reform measures could adversely affect our business
5. 26Federal legislation may increase the pressure to reduce prices of pharmaceutical products paid for by Medicare, which could adversely affect our revenues, if any
6. 27Federal laws or regulations on drug importation could make lower cost versions of our future products available, which could adversely affect our revenues, if any
7. 28Failure to obtain regulatory and pricing approvals in foreign jurisdictions could delay or prevent commercialization of our products abroad

Risks Related to Our Organization and Structure

1. 29Our holding company structure makes us dependent on our subsidiaries for our cash flow and could serve to subordinate the rights of our shareholders to the rights of creditors of our subsidiaries, in the event of an insolvency or liquidation of any such subsidiary
2. 30Delaware law and the Amended and Restated Certificate of Incorporation and Bylaws contain certain provisions, including anti-takeover provisions that limit the ability of stockholders to take certain actions and could delay or discourage takeover attempts that stockholders may consider favorable
3. 31In addition, as a Delaware corporation, the Company will generally be subject to provisions of Delaware law, including Section 203 of the DGCL

Risks Related to Our Capital Requirements and Capital Structure

1. 32Nasdaq may delist the Company’s securities from trading on its exchange, which could limit investors’ ability to make transactions in the Company’s securities and subject the Company to additional trading restrictions
2. 33If securities or industry analysts do not publish research or reports about our business or publish negative reports about our business or our industry, the trading price and volume of our securities could decline
3. 34We are an “emerging growth company” and the reduced disclosure requirements applicable to emerging growth companies may make our securities less attractive to investors