What the changes say
- Oramed faces significant risks from ongoing clinical trial uncertainties for its oral insulin capsule and heavy reliance on strategic investments like Alpha Tau and Scilex loans.
- The company also implemented a poison pill defense and maintains extensive operations and research activities in Israel.
What changed since the prior 10-K
New
- NewRisks Related to Our Business
We have a history of losses and may not be able to sustain profitability in the future
We have a history of ongoing financial losses and face uncertainties in obtaining FDA and foreign regulatory approvals to commercialize our product candidates.
- NewRisks Related to Our Business
Even if we succeed in commencing a new clinical trial for our oral insulin capsule, there are a variety of risks and uncertainties related to its development
Despite submitting a new Phase 3 trial protocol for our oral insulin capsule following missed endpoints, development risks and uncertainties remain.
- NewRisks Related to Our Business
We may not realize a return on the shares of DNA, Entera, Nano, Alpha Tau and Pelthos that we own
We hold shares in DNA, Entera, Nano, Alpha Tau, and Pelthos that trade at low volumes and are subject to market fluctuations and potential low returns.
- NewRisks Related to Our Business
If Alpha Tau fails to achieve positive clinical results or obtain regulatory approvals, the value of our investment could decline materially, which may adversely affect our financial results
In April 2025, we invested approximately $36.9 million in Alpha Tau, exposing us to potential clinical setbacks and market volatility that could depress its share value.
- NewRisks Related to Our Business
The value of our investment into Lifeward may decline
We acquired a 49.99% equity stake and warrants in Lifeward, exposing us to risks of declining share values and potential defaults on secured promissory notes.
- NewRisks Related to Conducting Business in Israel
Our stockholder rights plan, or “poison pill,” includes terms and conditions which could discourage a takeover or other transaction that stockholders may consider favorable
Our board adopted a poison pill stockholder rights plan on November 16, 2025, that may discourage favorable takeover offers.
Dropped
- DroppedRisks Related to Our Business
We continue, and in the future expect, to incur losses
- DroppedRisks Related to Our Business
Our success was primarily dependent on the successful commercialization of our oral insulin capsule
- DroppedRisks Related to Our Business
Clinical trials of our products conducted by third parties may encounter delays, suspensions or other problems and are outside of our control
- DroppedRisks Related to Our Business
We may not realize a return on the ordinary shares of DNA and Entera and the common stock of Scilex and BioXcel that we own
- DroppedRisks Related to Our Business
We face uncertainties related to Oravax’s oral COVID-19 vaccine
We continue, and in the future expect, to incur losses.
- DroppedRisks Related to the Notes
We may have difficulty realizing the full value of the Warrants
- DroppedRisks Related to our Common Stock
Because 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
- DroppedRisks Related to JV Agreement
The 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
- DroppedRisks Related to JV Agreement
We may not complete the transactions contemplated by the JV Agreement, as supplemented by the Supplemental Agreement
- DroppedRisks Related to JV Agreement
We may not realize the anticipated benefits from the Spin Off, and the Spin Off could harm our business
Our success was primarily dependent on the successful commercialization of our oral insulin capsule.
- DroppedRisks Related to JV Agreement
Potential 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
- DroppedRisks Related to JV Agreement
We potentially could have received better terms from unaffiliated third parties than the terms we received in our agreements with OraTech
- DroppedRisks Related to JV Agreement
Our business and assets will be less diversified following the Spin Off
- DroppedRisks Related to JV Agreement
The financial position and business operations of the OraTech could be impacted by HTIT’s ability to perform its obligations under certain contracts with us
Third-party clinical trials may encounter delays, suspensions, or other problems.
- DroppedRisks Related to JV Agreement
The Spin Off may expose us to potential liabilities arising out of state and federal fraudulent conveyance laws
Reworded
- 60% rewrittenRisks Related to Our Business
We are exposed to fluctuations in currency exchange rates
Retained currency exchange rate exposure disclosures regarding NIS and Euro expenses relative to dollars.
- 32% rewrittenRisks Related to Our Business
We may not realize the full benefit from our distribution license agreement with Medicox
Added specific background details and date of November 13, 2022, for the Medicox License Agreement for ORMD-0801 distribution in Korea.
- 30% rewrittenRisks Related to Our Business
Because 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
Updated investment holdings as of December 31, 2025, removing BioXcel and adding Nano, Pelthos, and Alpha Tau percentages and warrants.
- 28% rewrittenRisks Related to Our Business
We 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
Updated Scilex loan disclosures to include $25,000,000 under the Tranche B Note, 3,750,000 Tranche B Warrants, and a 4% royalty right.
- 28% rewrittenRisks Related to Our Business
Our strategic review process may not be successful or timely
Added a warning that our strategic review process may not result in any transaction or be completed on attractive terms.
- 26% rewrittenRisks Related to our Common Stock
Our 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
Updated figures for outstanding RSUs to 1,707,383 shares and options weighted average exercise price to $7.1 as of March 26, 2026.
- 25% rewrittenRisks Related to Conducting Business in Israel
We are affected by the political, economic and military risks of having operations in Israel
Retained general political, economic, and military risk disclosures regarding operations in Israel.
- 23% rewrittenRisks Related to Our Business
Our clinical trials may encounter delays, suspensions or other problems
Retained clinical trial delay risks citing the South African COVID-19 vaccine trial enrollment challenges.
- 23% rewrittenRisks Related to Our Business
We have a history of losses and can provide no assurance as to our future operating results
All 41 risk factors
Headings as the filing states them, in filing order.
Risks Related to Our Business
- 01Our strategic review process may not be successful or timely28% rewritten
- 02If we are successful in completing a strategic transaction, we may be exposed to other operational and financial risks
- 03Our ability to consummate a strategic transaction depends on our ability to retain our employees required to consummate such transaction
- 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
- 05We have a history of losses and may not be able to sustain profitability in the futureNew
- 06We may need substantial additional capital in order to satisfy our business objectives
- 07We have a history of losses and can provide no assurance as to our future operating results23% rewritten
- 08We rely upon patents to protect our technology
- 09We may be unable to protect our intellectual property rights and we may be liable for infringing the intellectual property rights of others
- 10Even if we succeed in commencing a new clinical trial for our oral insulin capsule, there are a variety of risks and uncertainties related to its developmentNew
- 11We have limited experience in conducting clinical trials
- 12Our clinical trials may encounter delays, suspensions or other problems23% rewritten
- 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
- 14We can provide no assurance that our products will obtain regulatory approval or that the results of clinical trials will be favorable
- 15We are dependent upon third party suppliers of our raw materials and for other services
- 16We may not realize a return on the shares of DNA, Entera, Nano, Alpha Tau and Pelthos that we ownNew
- 17Because 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 burdens30% rewritten
- 18We may not realize the full benefit from our distribution license agreement with Medicox32% rewritten
- 19We are highly dependent upon our ability to enter into agreements with collaborative partners to develop, commercialize and market our products
- 20The 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
- 21Our financial position or results could be negatively affected by product liability claims
- 22We have limited senior management resources and may be required to obtain more resources to manage our growth
- 23We depend upon our senior management and skilled personnel and their loss or unavailability could put us at a competitive disadvantage
- 24We 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
- 25Healthcare policy changes, including pending legislation recently adopted and further proposals still pending to reform the U.S. healthcare system, may harm our future business
- 26We are exposed to fluctuations in currency exchange rates60% rewritten
- 27If Alpha Tau fails to achieve positive clinical results or obtain regulatory approvals, the value of our investment could decline materially, which may adversely affect our financial resultsNew
- 28We 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 business28% rewritten
- 29The value of our investment into Lifeward may declineNew
Risks Related to our Common Stock
- 30Future sales of our common stock by our existing stockholders could adversely affect our stock price
- 31Our 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 effect26% rewritten
- 32Our failure to maintain compliance with the Nasdaq Capital Market’s continued listing requirements could result in the delisting of our common stock
- 33As 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
- 34Future 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
- 35Our stockholders may experience significant dilution as a result of any additional financing using our equity securities
Risks Related to Conducting Business in Israel
- 36We are affected by the political, economic and military risks of having operations in Israel25% rewritten
- 37Changes to tax laws could have a negative effect on us or our stockholders
- 38Our business and operations would suffer in the event of computer system failures, cyber-attacks or deficiencies in our cyber-security
- 39Our management will have significant flexibility in using the net proceeds of any offering of securities
- 40Our stockholder rights plan, or “poison pill,” includes terms and conditions which could discourage a takeover or other transaction that stockholders may consider favorableNew
- 41Delaware 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
Other Oramed Pharmaceuticals 10-Ks
- FY2024 10-K risk factors50 risks
Oramed faces critical risks from the failed Phase 3 oral insulin trial and ongoing strategic transaction evaluations. Financial stability heavily depends on the Scilex note repayment and maintaining Nasdaq compliance. The company navigates joint ventures, vaccine development uncertainties, and potential equity dilution.
Filed Mar 27, 2025
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.