Oramed Pharmaceuticals (ORMP) risk factors, FY2024 10-K

Risks Related to Our Business

1. 01Our strategic review process may not be successful or timely
2. 02If we are successful in completing a strategic transaction, we may be exposed to other operational and financial risks
3. 03Our ability to consummate a strategic transaction depends on our ability to retain our employees required to consummate such transaction
4. 04We may become involved in securities and stockholder litigation that could divert management’s attention and harm the Company’s business, and insurance coverage may not be sufficient to cover all costs and damages
5. 05We continue, and in the future expect, to incur losses
6. 06We may need substantial additional capital in order to satisfy our business objectives
7. 07We have a history of losses and can provide no assurance as to our future operating results
8. 08We rely upon patents to protect our technology
9. 09We may be unable to protect our intellectual property rights and we may be liable for infringing the intellectual property rights of others
10. 10Our success was primarily dependent on the successful commercialization of our oral insulin capsule
11. 11We have limited experience in conducting clinical trials
12. 12Our clinical trials may encounter delays, suspensions or other problems
13. 13Initial success in the completed and ongoing early-stage clinical trials does not ensure success in later stage trials, regulatory approval or commercial viability of a product
14. 14Clinical trials of our products conducted by third parties may encounter delays, suspensions or other problems and are outside of our control
15. 15We can provide no assurance that our products will obtain regulatory approval or that the results of clinical trials will be favorable
16. 16We are dependent upon third party suppliers of our raw materials and for other services
17. 17We may not realize a return on the ordinary shares of DNA and Entera and the common stock of Scilex and BioXcel that we own
18. 18Because we may from time to time maintain a significant percentage of our assets in cash and/or securities, we may in the future be deemed to be an investment company under the Investment Company Act of 1940 resulting in additional costs and regulatory burdens
19. 19We may not realize the full benefit from our distribution license agreement with Medicox
20. 20We are highly dependent upon our ability to enter into agreements with collaborative partners to develop, commercialize and market our products
21. 21The biotechnology and biopharmaceutical industries are characterized by rapid technological developments and a high degree of competition. We may be unable to compete with more substantial enterprises
22. 22Our financial position or results could be negatively affected by product liability claims
23. 23We have limited senior management resources and may be required to obtain more resources to manage our growth
24. 24We depend upon our senior management and skilled personnel and their loss or unavailability could put us at a competitive disadvantage
25. 25We are currently party to certain joint ventures, and we may in the future sell or contribute additional assets or acquire, develop or recapitalize assets to or in these joint ventures or other joint ventures that we may enter
26. 26Healthcare policy changes, including pending legislation recently adopted and further proposals still pending to reform the U.S. healthcare system, may harm our future business
27. 27We are exposed to fluctuations in currency exchange rates
28. 28We face uncertainties related to Oravax’s oral COVID-19 vaccine

Risks Related to the Notes

1. 29We have lent a substantial amount of funds to Scilex. In the event that Scilex is unable to service its obligations under the Note and defaults on such Note, it could have a material adverse effect on our business
2. 30We may have difficulty realizing the full value of the Warrants

Risks Related to our Common Stock

1. 31Future sales of our common stock by our existing stockholders could adversely affect our stock price
2. 32Our issuance of warrants, options and RSUs to investors, employees and consultants may have a negative effect on the trading prices of our common stock as well as a dilutive effect
3. 33Because we will not pay cash dividends in the foreseeable future, investors may have to sell shares of our common stock in order to realize their investment
4. 34Our failure to maintain compliance with the Nasdaq Capital Market’s continued listing requirements could result in the delisting of our common stock
5. 35As the market price of our common stock may fluctuate significantly, this may make it difficult for you to sell your shares of common stock when you want or at prices you find attractive
6. 36Future sales of common stock or the issuance of securities senior to our common stock or convertible into, or exchangeable or exercisable for, our common stock could materially adversely affect the trading price of our common stock, and our ability to raise funds in new equity offerings
7. 37Our stockholders may experience significant dilution as a result of any additional financing using our equity securities

Risks Related to JV Agreement

1. 38The consummation of the transactions contemplated by the JV Agreement, as supplemented by the Supplemental Agreement, is subject to the satisfaction or waiver of certain other closing conditions
2. 39We may not complete the transactions contemplated by the JV Agreement, as supplemented by the Supplemental Agreement
3. 40We may not realize the anticipated benefits from the Spin Off, and the Spin Off could harm our business
4. 41Potential indemnification liabilities to HTIT pursuant to the JV Agreement, as supplemented by the Supplemental Agreement could materially and adversely affect our financial condition, results of operations, and cash flows
5. 42We potentially could have received better terms from unaffiliated third parties than the terms we received in our agreements with OraTech
6. 43Our business and assets will be less diversified following the Spin Off
7. 44The financial position and business operations of the OraTech could be impacted by HTIT’s ability to perform its obligations under certain contracts with us
8. 45The Spin Off may expose us to potential liabilities arising out of state and federal fraudulent conveyance laws

Risks Related to Conducting Business in Israel

1. 46We are affected by the political, economic and military risks of having operations in Israel
2. 47Changes to tax laws could have a negative effect on us or our stockholders
3. 48Our business and operations would suffer in the event of computer system failures, cyber-attacks or deficiencies in our cyber-security
4. 49Our management will have significant flexibility in using the net proceeds of any offering of securities
5. 50Delaware law could discourage a change in control, or an acquisition of us by a third party, even if the acquisition would be favorable to you, and thereby adversely affect existing stockholders