7 unchanged sentences
The advancement of DehydraTECH-enabled pharmaceutical products will be subject to successful completion of multi-phase testing under significant regulatory requirements and testing protocols, such as those required by the US Food and Drug Administration (FDA) and comparable foreign regulators.
−Removed: A number of companies in the biopharmaceutical industry have suffered significant setbacks in advanced clinical trials due to lack of efficacy or adverse safety profiles, notwithstanding promising results in earlier studies.
−Removed: It is possible we could face similar setbacks.
+Added: While we have seen success in our animal studies and in many of our human pilot studies and exploratory human studies, it is possible that setbacks may occur in advanced clinical trials due to lack of efficacy or adverse safety profiles, notwithstanding promising results in such earlier studies.
The effects of such reversions could cause significant delays or abandonment of testing with negative effect to our business through financial loss, industry credibility and/or a temporary or permanent decline in valuation of our Company.
22 unchanged sentences
As a result of these factors, management cannot be certain that the Company will be able to compete against current or future competitors or that competitive pressure will not seriously harm our business.
−Removed: Any failure in protecting our intellectual property may have a negative impact adverse effect on our ability to develop and licence DehydraTECH.
+Added: Any failure in protecting our intellectual property may have a negative impact adverse effect on our ability to develop and license DehydraTECH.
Because patents involve complex legal and factual questions, the issuance, scope, validity, and enforceability of patents cannot be predicted with certainty.
−Removed: Some of our patent pending applications will not be granted as patents.
+Added: Some of our patent pending applications may not be granted as patents.
Even if patents are issued, they may not be granted with claims of sufficient breadth to protect DehydraTECH technology or may not provide us with a competitive advantage over other products or technologies.
44 unchanged sentences
It is possible that such third parties may not successfully carry out their contractual obligations, meet expected deadlines, adhere to our protocols, or comply with regulatory requirements.
−Removed: This could result in the lost revenue or program delays.
+Added: This could result in lost revenue or program delays.
Demand for our services may be adversely affected if customers lose confidence in the quality of our services or the industry’s practices.
20 unchanged sentences
Even if we are successful in any litigation, it could result in substantial costs and be a distraction to management with an adverse impact on our business.
−Removed: Risks related to the effects of COVID-19
−Removed: The outbreak of the coronavirus (COVID-19) has evolved into a global pandemic.
−Removed: The extent to which the virus impacts our business and operating results will depend on future developments that are highly uncertain and cannot be accurately predicted, including new information that may emerge concerning the virus, its variants, and the actions to contain the coronavirus or treat its impact, among others.
−Removed: With the continued spread of the virus, our business operations could be interrupted or delayed.
−Removed: It is possible that our R&D programs could be adversely affected by the restrictions imposed during the pandemic.
−Removed: Travel restrictions, lock-down quarantines or other such limitations may hamper our ability to conduct our R & D programs.
−Removed: In some of our programs, particularly our human studies, participant recruitment and enrolment, participant dosing, distribution of results, study monitoring and data analysis may be paused or delayed due to the effects that the pandemic has in different localities.
−Removed: If the virus continues to spread, some participants and clinical investigators may not be able to comply with clinical trial protocols.
−Removed: We currently utilize third parties to conduct our R&D programs and in the production of our B2B customers’ products.
−Removed: These relationships could be adversely impacted by any future covid-related restrictions.
−Removed: It is possible that our supply chain may be disrupted, limiting our ability to manufacture products for our R&D operations or for our B2B customers.
−Removed: The spread of COVID-19 and its variants has caused a broad global impact which could have a material economic effect on our business.
−Removed: While the potential economic impact brought by and the duration of the pandemic may be difficult to assess or predict, it has already caused, and is likely to result in further significant disruption of global financial markets, which may reduce our ability to access capital either on favorable terms or at all.
−Removed: Inflation and recession or other sustained adverse economic events resulting from the pandemic could materially and adversely affect our business and the market for or value of our common stock.
Risks Associated with our Financial Condition
21 unchanged sentences
Future collaborations may involve the following risks whereby collaborators may:
−Removed: not perform their obligations as expected or terminated an agreement for their convenience.
+Added: not perform their obligations as expected or terminate an agreement for their convenience.
If terminated, we could be required to raise additional capital to pursue further development or commercialization of the applicable product candidates.
21 unchanged sentences
As a result, we cannot guarantee that we will be able to submit INDs, or similar applications, within our projected timelines, if at all, or that the FDA, or similar regulatory authorities, will allow us to commence clinical trials.
−Removed: Pharmaceutical products incorporating DehydraTECH has never been approved for the treatment of disease.
+Added: Pharmaceutical products incorporating DehydraTECH have never been approved for the treatment of disease.
In order to commercialize a product that utilizes DehydraTECH for the treatment of any disease, we and/or our commercial partner must obtain regulatory product approvals for treatment of a particular indication.
16 unchanged sentences
Failure to comply with applicable regulatory requirements may result in criminal prosecution, civil penalties, recall or seizure of products, total or partial suspension of production, or an injunction preventing certain activity, as well as other regulatory action against our product candidates or our Company.
+Added: We may choose to conduct one or more of our clinical trials or a portion of our clinical trials for our product candidates outside the U.S.
+Added: The acceptance of study data from clinical trials conducted outside the U.S.
+Added: or another jurisdiction by the FDA or comparable regulatory authority may be subject to certain conditions or may not be accepted at all.
We currently have no commercial pharmaceutical products and therefore generate no revenue from pharmaceutical products and may never be able to develop marketable pharmaceutical products.
−Removed: We have no experience in filing the applications necessary to obtain approval and expect that we will need to rely on CROs and regulatory consultants to assist us with this process.
+Added: We have limited experience in filing the applications necessary to obtain approval and expect that we will need to rely on CROs and regulatory consultants to assist us with this process.
Regulatory approval also requires the submission about the product manufacturing process and the inspection of the manufacturing facilities.
44 unchanged sentences
If investors find our common shares less attractive as a result, there may be a less active trading market for our common shares and trading prices may be negatively affected.
−Removed: 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.