21 unchanged sentences
Our business is to research and develop new therapies to treat unmet needs in women’s health focusing on oncology and urology.
−Removed: Our current product pipeline includes novel treatments for oncology and we are also developing novel delivery technologies to allow targeted delivery of existing drugs for a faster time-to-market.
+Added: Our current product pipeline includes novel treatments for oncology and we also intend to develop novel delivery technologies to allow targeted delivery of existing drugs for a faster time-to-market.
We will require substantial additional funds to complete our research and development activities, and if such funds are not available we may need to significantly curtail or cease our operations.
1 unchanged sentence
Based on our current cash levels, we do not have sufficient cash to meet our planned day-to-day operating needs through January 2018, including our planned research and development activities.
−Removed: We raised $240,000 through private placements during the year ended January 31, 2016.
+Added: We raised $379,718 through private placement of convertible debentures during the year ended January 31, 2017.
Based on our planned research and development activities, we anticipate that we will require additional funds of approximately $1.5 million to meet our planned day-to-day operating needs for the next 12 months.
7 unchanged sentences
Our inability to complete our research and development projects in a timely manner could have a material adverse effect of our results of operations, financial condition and cash flows.
−Removed: If our research and development projects are not completed in a timely fashion, our company could experience:
−Removed: substantial additional cost for re-application to obtain clinical trial approvals;
−Removed: additional competition as other groups may enter the area of use of anti-inflammatory application to treat neurocognitive impairment;
−Removed: up to six months delay in obtaining approvals;
+Added: If our research and development (R&D) projects are not completed in a timely fashion, our company could experience:
+Added: substantial additional cost for the conduct of IND supporting R&D activities;
+Added: additional competition in the oncology indications affecting women’s health;
+Added: additional delay in obtaining requisite regulatory approvals;
delay in obtaining future inflow of cash from financial or partnership activities, any of which could have a material adverse effect of our results of operations, financial condition and cash flows.
Any products that we may develop will be required to undergo a time-consuming, costly and burdensome pre-market approval process, and if we are unable to obtain regulatory approval for our products we may never become profitable.
−Removed: Any products that we may develop will be subject to extensive governmental regulations relating to development, clinical trials, manufacturing and commercialization.
+Added: Any products that we may develop will be subject to extensive governmental regulations relating to development activities, conduct of clinical trials, manufacturing and commercialization.
In the United States, for example, the prospective therapeutic products that we intend to develop and market are regulated by the FDA under its new drug development and review process.
16 unchanged sentences
If we cannot show that our product candidates are both safe and effective in clinical trials, we may be forced to abandon our business plan.
−Removed: We rely on third parties to conduct our pre-clinical and clinical trials.
+Added: We will rely on third parties to conduct our formulation development, chemistry activities, as well as pre-clinical and clinical trials.
If these third parties do not perform as contractually required or otherwise expected we may not be able to obtain regulatory approval for our product candidates, which may prevent us from becoming profitable.
38 unchanged sentences
As a result, they may be able to:
−Removed: develop product candidates and market products that are less expensive, safer, more effective or involve more convenient treatment procedures than our future products;
+Added: develop product candidates and market products that are faster to market and thus less expensive, potentially safer, and/or more effective or involve more convenient treatment procedures than our future products;
commercialize competing products before we can launch any of our product candidates;
9 unchanged sentences
Consequently, the costs associated with any such action could cause our business to suffer and prevent us from achieving our goals or becoming profitable.
−Removed: Since our place of business and several of our officers, directors and business assets are also located in Canada, you may be limited in your ability to enforce U.S.
+Added: Since one of our place of business and some of our officers, directors and business assets are also located in Canada, you may be limited in your ability to enforce U.S.
civil actions against them for damages to the value of your investment.
10 unchanged sentences
The ability of our licensors, collaborators and suppliers to maintain their patent rights against third-party challenges to their validity, scope or enforceability will also play an important role in determining our future.
−Removed: In addition, our commercial success will depend, in part, on maintaining patent rights we have licensed or plan to license related to products we may market in the future.
+Added: In addition, our commercial success will depend, in part, on maintaining patent rights we have licensed and plan to license in the future, related to products we may market in the future.
Since we will not fully control the patent prosecution of any licensed patent applications, it is possible that our licensors will not devote the same resources or attention to the prosecution of the licensed patent applications as we would if we controlled the prosecution of the applications ourselves.
21 unchanged sentences
However, depending on the ongoing results and requirements of pre-clinical or clinical trials, which may unexpectedly vary from our anticipated plan of development, we may be required to seek additional third-party licenses at later stages of product development.
−Removed: We may be required to pay license fees or royalties or both to obtain such licenses, and there is no guarantee that such licenses will be available on acceptable terms, if at all.
−Removed: Even if we are able to successfully obtain a license, the rights may be non-exclusive, and this would give our competitors access to the same intellectual property as us, which could ultimately prevent us from commercializing a product.
+Added: We will also be required to pay license fees, certain milestones or royalties or both to obtain such licenses, and there is no guarantee that such licenses will be available on acceptable terms, if at all.
+Added: Even if we are able to successfully obtain a license, certain rights may be non- or co-exclusive, and this would give our competitors access to some of the intellectual property as us, which could ultimately prevent us from commercializing a product.
Upon obtaining a license, our business prospects will depend, in part, on the ability of our licensors to obtain, maintain and enforce patent protection on our licensed intellectual property.
2 unchanged sentences
If the FDA grants one of our competitors an orphan drug designation for a drug and indication combination that is similar to the drug and indication combination used and targeted by one of our products, we will face significant competition in marketing our product during the seven year exclusivity period.
−Removed: The FDA may grant an orphan drug designation to a drug intended to treat a rare disease or condition that affects fewer than 200,000 individuals in the United States.
+Added: The FDA grants an orphan drug designation to a drug intended to treat a rare disease or condition that affects fewer than 200,000 individuals in the United States.
An orphan drug designation must be requested before a sponsor submits a New Drug Application to the FDA, and if the FDA grants such a designation the generic identity of the therapeutic agent and its potential orphan use are disclosed publicly by the FDA.
6 unchanged sentences
Trading on the OTC Bulletin Board may be volatile and sporadic, which could depress the market price of our common stock and make it difficult for our stockholders to resell their shares.
−Removed: Our common stock is quoted on the OTC Bulletin Board service of the Financial Industry Regulatory Authority.
+Added: Our common stock is quoted on the OTCQB service of the Financial Industry Regulatory Authority.
Trading in stock quoted on the OTC Bulletin Board is often thin and characterized by wide fluctuations in trading prices, due to many factors that may have little to do with our operations or business prospects.
52 unchanged sentences
We also maintain a dedicated mailing address and telephone reception service located at 1275 West 6th Avenue, Vancouver, British Columbia, Canada V6H 1A6.
−Removed: We also have access to office and meeting space at that location for a nominal fee, on an as-used basis.
+Added: We also have access to office and meeting space for a nominal fee, on an as-used basis.
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.