12 unchanged sentences
We may never achieve or sustain profitability.
−Removed: The COVID-19 pandemic could continue to adversely impact our business, including clinical trials.
Our product candidates will subject us to liability exposure.
3 unchanged sentences
Even if our product candidates are cleared or approved by regulatory authorities, if we or our suppliers fail to comply with ongoing FDA or other foreign regulatory authority requirements, or if we experience unanticipated problems with our product candidates, these product candidates could be subject to restrictions or withdrawal from the market.
−Removed: General market conditions, including the effects of the ongoing war between Russia and Ukraine and attendant economic sanctions, high inflation, governmental, monetary and fiscal policies including tariffs and rising interest rates as well as the effects of laws and regulations on foreign investment in the United States under the jurisdiction of the Committee on Foreign Investment in the United States (CFIUS), and other agencies and related regulations, including the Foreign Investment Risk Review Modernization Act (FIRRMA), adopted in August 2018, may make it difficult for us to seek financing from the capital markets.
+Added: General market conditions, including the effects of the ongoing war between Russia and Ukraine as well as the military conflict in the Middle East and attendant economic sanctions, high inflation, governmental, monetary and fiscal policies including tariffs and rising interest rates as well as the effects of laws and regulations on foreign investment in the United States under the jurisdiction of the Committee on Foreign Investment in the United States (CFIUS), and other agencies and related regulations, including the Foreign Investment Risk Review Modernization Act (FIRRMA), adopted in August 2018, may make it difficult for us to seek financing from the capital markets.
Our principal stockholders hold a significant percentage of our voting power and will be able to exert significant control over us.
15 unchanged sentences
We will need additional funds in the near future and our operations will be adversely affected if we are unable to obtain needed funding.
−Removed: We ended the year 2024 with approximately $2.5 million of operating cash on-hand and will need to raise additional capital in the second quarter and beyond to fund operations.
+Added: We ended the year 2025 with approximately $1.4 million of operating cash on-hand and will need to raise additional capital before or during the second quarter of 2026 and beyond to fund operations.
If we do not raise additional capital from outside sources before or during the second quarter of 2026, we may be forced to further curtail or cease our operations.
7 unchanged sentences
We may not be able to obtain additional financing on terms favorable to us, if at all.
−Removed: In addition, general market conditions, including the effects of the ongoing war between Russia and Ukraine and attendant economic sanctions, high inflation, governmental, monetary and fiscal policies including tariffs and rising interest rates on financial markets, as well as the effects of laws and regulations on foreign investment in the United States under the jurisdiction of the Committee on Foreign Investment in the United States (CFIUS), and other agencies and related regulations, including the Foreign Investment Risk Review Modernization Act (FIRRMA), adopted in August 2018, may make it difficult for us to seek financing from the capital markets.
+Added: In addition, general market conditions, including the effects of the ongoing war between Russia and Ukraine as well as the military conflict in the Middle East and attendant economic sanctions, high inflation, governmental, monetary and fiscal policies including tariffs and rising interest rates on financial markets, as well as the effects of laws and regulations on foreign investment in the United States under the jurisdiction of the Committee on Foreign Investment in the United States (CFIUS), and other agencies and related regulations, including the Foreign Investment Risk Review Modernization Act (FIRRMA), adopted in August 2018, may make it difficult for us to seek financing from the capital markets.
Any additional equity financings could result in significant dilution to our stockholders and possible restrictions on subsequent financings.
212 unchanged sentences
It is also possible that patients enrolled in clinical trials will experience adverse side effects that are not currently part of the product candidate’s profile.
−Removed: Regulatory approval delays due to COVID-19
−Removed: COVID-19 may impede clinical trials and slow down regulatory actions.
−Removed: It could adversely affect the entire clinical trial spectrum from enrollment to data analysis.
−Removed: Assuming patients enroll, clinical trials may face disruptions to protocol schedules for treatment and follow-up visits.
−Removed: Reports from Europe have noted overwhelmed facilities where all non-critical visits have been postponed or canceled.
−Removed: hospitals have followed suit to limit exposure and allow for care of COVID-19 patients.
−Removed: Deviations from trial protocols could present challenges when it comes time to analyze the related data set.
−Removed: Some clinics may stop allowing clinical trial monitors on site.
−Removed: Without reconciling the data, we may be unable to “lock” the trial database, an essential step that precedes the analysis of the data.
−Removed: We rely on regular interaction and guidance from the FDA and other regional/country regulatory authorities/agencies to plan research and development activities across all stages.
−Removed: Due to the COVID-19 pandemic, the FDA and worldwide regulatory authorities have a great deal of resources dedicated to COVID-19 related matters, resulting in disruption in their ability to fully support the regulatory clearance/approval processes.
−Removed: As resources continue to be diverted, regulatory clearances/approvals may continue to be delayed, until the pandemic is under control.
−Removed: Therefore, delays with approvals, clearances, inspections, and meetings that are currently being experienced may continue for the foreseeable future.
−Removed: Postponement of these interactions could delay us from bringing our product candidates to market.
Clinical trials necessary to support a biological product license or other marketing authorization for our product candidates will be expensive and will require the enrollment of sufficient patients to adequately demonstrate safety and efficacy for the product ’ s target populations.
86 unchanged sentences
Economic, political and other risks associated with our international operations could adversely affect our revenues and international growth prospects.
−Removed: The Company started selling consumer health supplements through Consumer Health Products in the third quarter of 2023.
+Added: The Company sells consumer health supplements through Consumer Health Products.
These products are commercially marketed to the general public and initially targeted at consumers in Asia through eCommerce (online sales).
87 unchanged sentences
The rights of the holders of common stock may be adversely affected by the rights of future holders of preferred stock.
−Removed: We have in the past issued, and we may at any time in the future issue additional shares of authorized preferred stock.
−Removed: For example, in our December 2017 private placement transaction, we authorized 12,000 shares of Series D convertible preferred stock, of which we issued 3,108 shares, all of which have been converted into shares of common stock, and in June 2022 we also issued 4,000 shares of Series E convertible preferred stock, and additional 257 shares of Series E convertible preferred stock thereafter in relation to dividends on such Series E convertible preferred stock.
−Removed: All shares of Series E convertible preferred stock have been converted into shares of common stock as of December 31, 2023.
We do not intend to pay cash dividends on our common stock.
122 unchanged sentences
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.