20 unchanged sentences
If we fail to generate sufficient revenues to operate profitability, or if we are unable to fund our continuing losses, you could lose all or part of your investment.
−Removed: Our business is to research and develop new applications of existing therapeutic drugs and enhancements to those drugs, and if we are unable to market our new applications and enhancements we may never generate revenues.
−Removed: We have concentrated our efforts on developing new, proprietary substances, methods and processes intended to enhance the therapeutic effects of existing anti-inflammatory drugs in the treatment of diseases mediated by acute and chronic inflammatory conditions.
−Removed: The existing drugs that form the basis of our efforts to develop our new substances, methods and processes are relatively new, and any scientific evidence that may exist to support the feasibility of our goals is not conclusive.
−Removed: If we are not successful in developing and marketing any new applications or enhancements for these existing drugs we may never generate revenues and our business may fail.
+Added: Our business is to research and develop new therapies to treat unmet needs in women's health focusing on oncology and urology.
+Added: 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.
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 2017, including our planned research and development activities.
−Removed: We raised $nil through private placements during the year ended January 31, 2015 and $9,500 from the issuance of convertible debentures.
−Removed: Based on our planned research and development activities, we anticipate that we will require additional funds of approximately $40,000 to meet our planned day-to-day operating needs for the next 12 months.
+Added: We raised $240,000 through private placements during the year ended January 31, 2016.
+Added: 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.
If we do not raise sufficient funds, our plan of operation will be delayed until such time as we raise sufficient funds, provided we are able to do so.
6 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 (by the end of December 2015), our company could experience:
+Added: If our research and development projects are not completed in a timely fashion, our company could experience:
substantial additional cost for re-application to obtain clinical trial approvals;
14 unchanged sentences
If we successfully complete any clinical study of our own, the commercial value of any such study will significantly depend upon our choice of indication and our patient population selection for that indication.
−Removed: We plan to employ existing drugs for new indications, and these drugs may have the ability to treat different kinds of indications.
−Removed: As a result, we may incorrectly assess the market opportunities of an indication or may incorrectly estimate or fail to fully appreciate the scientific and technological difficulties associated with treating an indication.
−Removed: In addition, the quality and robustness of the results and data of any clinical study that we may conduct will depend upon our selection of a patient population for clinical testing, and if we select a patient population that is not representative of our intended target market, or rely on pre-existing clinical results and data that do not reflect our intended target market or selected patient population, we may be forced to complete supplemental pre-clinical and/or clinical testing of our product candidates or terminate our research and development activities related to those candidates.
−Removed: The utility of any clinical results and data produced by third parties that we may apply to our own research will also depend upon the similarity between the patient population studied to obtain those results and data and the patient population that we select for our own clinical testing.
−Removed: Our inability to commence clinical testing or our choice of clinical strategy could therefore compromise our business prospects and prevent us from achieving revenues.
−Removed: Our clinical trials may fail to adequately demonstrate the safety and efficacy of our product candidates, which could force us to abandon our business plan.
+Added: Our clinical trials for each drug may fail to adequately demonstrate the safety and efficacy of that candidate, which could force us to abandon our product development plans for that drug candidate.
Before obtaining regulatory approval for the commercial sale of any of our product candidates, we must demonstrate through lengthy, complex and expensive pre-clinical testing and clinical trials that each product is both safe and effective for use in each target indication.
8 unchanged sentences
If we are unable to establish a sales, marketing and distribution infrastructure or enter into collaborations with partners to perform these functions, we may not be successful in commercializing our product candidates.
−Removed: This could cause us to cease our operations.
In order to successfully commercialize any of our product candidates, we must either develop a satisfactory sales, marketing and distribution infrastructure or enter into collaborations with partners to perform these services for us.
15 unchanged sentences
If these parties fail to meet our manufacturing requirements and applicable regulatory requirements, our product development and commercialization efforts could suffer and we may never realize a profit.
−Removed: If we obtain the necessary regulatory approvals to market our products, we will rely on contract manufacturers as single source suppliers for the components of our product candidates.
−Removed: Our product candidates are based (either entirely, as with NK-001, P-001, P-002 and P-003, or partially, as with NK-002) upon existing generic drugs and therefore we do not anticipate having to obtain those products from their original developers.
−Removed: However, we will rely on manufacturers with expertise in producing certain generic drugs and other components and we do not plan to enter into long-term supply agreements with any of these manufacturers.
−Removed: As a result, any of them could terminate their relationship with us at any time and for any reason.
+Added: If we obtain the necessary regulatory approvals to market our products, we will rely on contract manufacturers as single source suppliers for our product candidates.
Because of our planned reliance on contract manufacturers, we may also be exposed to additional risks, including those related to intellectual property and the failure of such manufacturers to comply with strictly-enforced regulatory requirements, manufacture components to our specifications, or deliver sufficient component quantities to us in a timely manner.
3 unchanged sentences
We face potential product liability exposure, and any claim brought against us may cause us to divert resources from our normal operations or terminate selling, distributing and marketing any product for which we have received regulatory approval.
−Removed: This may cause us to cease our operations.
+Added: This may cause us to cease our operations as it relates to that product.
The use of our product candidates in clinical trials and the sale of any products for which we obtain regulatory approval may expose us to product liability claims from consumers, health care providers, pharmaceutical companies or other entities.
Although we plan to obtain product liability insurance coverage for our clinical trials with limits that we hope will be customary and adequate to provide us with coverage for foreseeable risks associated with our product development efforts, our insurance coverage may be insufficient to reimburse us for the actual expenses or losses we may suffer.
−Removed: To date, we have received a comfort letter from the insurer Marsh Inc.
−Removed: stating that our planned clinical trials of NK-001 are eligible for customary insurance subject to the approval of our clinical trial protocol by the requisite health authorities.
If we obtain sufficient financing to proceed with our planned clinical trials, we intend to purchase insurance in amounts customary for trials comparable to our own.
22 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 located in Canada, you may be limited in your ability to enforce U.S.
+Added: 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.
civil actions against them for damages to the value of your investment.
−Removed: We may indemnify our directors and officers against liability to us and our security holders, and such indemnification could increase our operating costs.
+Added: We plan to indemnify our directors and officers against liability to us and our security holders, and such indemnification could increase our operating costs.
Our Articles allow us to indemnify our directors and officers against claims associated with carrying out the duties of their offices.
29 unchanged sentences
If we cannot obtain those licenses or if third-party owners do not properly maintain or enforce the patents underlying such licenses, we may not be able to market or sell our planned products.
−Removed: Although we are not currently dependent on any third-party intellectual property rights to execute our research and development activities, we plan to license patent-protected technologies and other intellectual property if we believe it is necessary or useful to use third-party intellectual property to develop our products, or if our product development threatens to infringe upon the intellectual property rights of third parties.
+Added: We have licensed patent-protected technologies and novel anticancer drug candidates through the IndUS acquisition and we may also license other intellectual property from other third parties, if we believe it is necessary or useful to use additional third-party intellectual property to develop our products.
Typically, we would seek to negotiate and obtain any required third party licenses immediately following the completion of preliminary research to establish a concept and plan of development for a new product candidate.
2 unchanged sentences
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.
−Removed: Should we succeed in 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.
+Added: 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.
Our licensors may terminate our license, may not pursue and successfully prosecute any potential patent infringement claim, may fail to maintain their patent applications, or may pursue any litigation less aggressively than we would.
Without protection for the intellectual property that we license, other companies may be able to offer substantially similar products for sale, and we may not be able to market or sell our planned products or generate any revenues.
−Removed: If the FDA grants one of our competitors an orphan drug designation for a drug and indication combination that is identical to the drug and indication combination used and targeted by one of our products, we will prevented from marketing that product for seven years.
+Added: 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.
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.
60 unchanged sentences
As a "smaller reporting company", we are not required to provide the information required by this Item.
+Added: We currently lease an office space at 25 Olympia Avenue, Suite K-300, Woburn, MA 01801, USA.
+Added: We also maintain a dedicated mailing address and telephone reception service located at 1275 West 6th Avenue, Vancouver, British Columbia, Canada V6H 1A6.
+Added: We also have access to office and meeting space at that location 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.