−Removed: Risks Related to Our Business and Industry
There is substantial doubt as to whether we will continue operations.
1 unchanged sentence
Our financial statements have been prepared on the going concern basis, which assumes that we will be able to realize our assets and discharge our liabilities in the normal course of business.
−Removed: However, as at January 31, 2017, we have not earned any revenues and had a deficit of $20,597,753.
+Added: However, as at January 31, 2018, we have not earned any revenues and had an accumulated deficit of $20,718,935.
We anticipate that we will incur increased expenses without realizing sufficient revenues (if any) to offset those expenses and we therefore expect to incur significant losses for the foreseeable future.
Our ability to continue our operations is dependent on obtaining additional financing and generating future revenues, and no assurance can be given that we will successfully be able to do so.
−Removed: Accordingly, our auditor has indicated in our financial statements that these factors raise substantial doubt about our ability to continue as a going concern.
+Added: Accordingly, our financial statements contain disclosure of management’s determination that these factors raise substantial doubt about our ability to continue as a going concern.
Importantly, the inclusion in our financial statements of a going concern opinion may negatively impact our ability to raise future financing and achieve future revenue.
4 unchanged sentences
We have incurred operating losses in each year since our inception and expect to continue to incur substantial and increasing losses for the foreseeable future.
−Removed: If we cannot generate sufficient revenues to operate profitably, we may suspend or cease our operations.
+Added: We also have negative capital cash flows from operating activities.
+Added: If we cannot generate sufficient revenues to operate profitably or with positive cash flow from operating activities, we may suspend or cease our operations.
We have not generated any revenue since our inception on June 10, 2002 and we have incurred operating and net losses in each year of our existence.
1 unchanged sentence
We expect to incur substantial and increasing losses for the foreseeable future as we develop, seek regulatory approval for and commercialize our product candidates and pursue our other research and development activities.
−Removed: If our products are not successful in clinical trials, does not gain regulatory approval or does not achieve market acceptance, we may never generate any revenue.
+Added: If our products are not successful in research and development or in clinical trials, does not gain regulatory approval or does not achieve market acceptance, we may never generate any revenue.
We also cannot assure you that we will be profitable even if we successfully commercialize our products.
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 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 also intend to develop novel delivery technologies to allow targeted delivery of existing drugs for a faster time-to-market.
−Removed: 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.
+Added: We will require substantial additional funds to complete our research and development activities and proposed acquisition, and if such funds are not available we may need to significantly curtail or cease our operations.
We will require substantial funds to research, develop, test and protect our product candidates, and to manufacture and market any such candidates that may be approved for commercial sale.
−Removed: 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 $379,718 through private placement of convertible debentures during the year ended January 31, 2017.
−Removed: 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.
+Added: Based on our planned research and development and commercialization activities, we anticipate that we will require funds of approximately $24.45 million to proceed with completing the development and commercialization of our products.
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 (R&D) projects are not completed in a timely fashion, our company could experience:
+Added: If our R&D projects are not completed in a timely fashion, our Company could experience:
substantial additional cost for the conduct of IND supporting R&D activities;
−Removed: additional competition in the oncology indications affecting women’s health;
+Added: additional competition in the pharmaceutical and nutraceutical indications in our pipeline;
additional delay in obtaining requisite regulatory approvals;
43 unchanged sentences
For example, a contract manufacturer working on our behalf may violate the intellectual property rights of a third party in manufacturing a component of one of our products, and if such a violation occurs without our knowledge, we may be held vicariously liable for the acts of our contractor, incur related costs and court mandated damages, or become enjoined from selling products which violate those third-party intellectual property rights.
−Removed: Similarly, if a contract manufacturer working on our behalf is found to be in violation of FDA or other national regulatory standards regarding the manufacture, packaging or labeling of any of our products, we could face any of a number of adverse consequences including costly regulatory investigations and fines, interruptions in the flow of our products or materials, product recalls, or liability to consumers regarding any of our products that do not meet such regulatory requirements.
+Added: Similarly, if a contract manufacturer working on our behalf is found to be in violation of FDA or other national regulatory standards regarding the manufacture, packaging or labeling of any of our products, we could face any number of adverse consequences including costly regulatory investigations and fines, interruptions in the flow of our products or materials, product recalls, or liability to consumers regarding any of our products that do not meet such regulatory requirements.
If any of these events occurs, if our relationship with any of our potential contract manufacturers terminates, or if any such manufacturer is unable fulfill its obligations to us for any reason, our product development and commercialization efforts could suffer and we may never realize a profit.
27 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 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.
−Removed: civil actions against them for damages to the value of your investment.
+Added: Since our directors are located outside of Canada, you may be limited in your ability to enforce Canadian civil actions against them for damages to the value of your investment.
We plan to indemnify our directors and officers against liability to us and our security holders, and such indemnification could increase our operating costs.
1 unchanged sentence
Our Articles also allow us to reimburse them for the costs of certain legal defenses.
−Removed: Insofar as indemnification for liabilities arising under the Securities Act of 1933 (the “Securities Act”) may be permitted to our directors, officers or control persons, we have been advised by the SEC that such indemnification is against public policy and is therefore unenforceable.
+Added: Insofar as indemnification for liabilities arising under relevant securities legislation may be permitted to our directors, officers or control persons, certain securities regulations may deem that such indemnification is against public policy and is therefore unenforceable in that jurisdiction.
Since our officers and directors are aware that they may be indemnified for carrying out the duties of their offices, they may be less motivated to meet the standards required by law to properly carry out such duties, which could increase our operating costs.
Further, if our officers and directors file a claim against us for indemnification, the associated expenses could also increase our operating costs.
+Added: Not all jurisdictions allow for the medicinal use of cannabis and those jurisdictions which allow it could reverse their position.
+Added: Certain jurisdictions currently allow the medicinal use of cannabis.
+Added: Many other jurisdictions do not.
+Added: There can be no assurance that additional jurisdictions will allow the medicinal use of cannabis or that those jurisdictions which currently allow it will continue to do so.
+Added: If either of these events occur, then not only will our growth prospects in this field be materially impacted, we may experience a declining market for our products.
Risks Related to Our Intellectual Property
24 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: 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.
+Added: We have licensed patent-protected technologies with Altum Pharmaceuticals Inc.
+Added: 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.
14 unchanged sentences
Risks Associated with Our Securities
−Removed: 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 OTCQB service of the Financial Industry Regulatory Authority.
−Removed: 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.
+Added: Trading on the OTC Bulletin Board and the Canadian Securities Exchange (the “CSE”) 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.
+Added: Our common stock is quoted on the OTCQB service of the Financial Industry Regulatory Authority and is traded on the CSE.
+Added: Trading in stock quoted on the OTC Bulletin Board or listed on the CSE 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.
This volatility could depress the market price of our common stock for reasons unrelated to operating performance.
4 unchanged sentences
Our stock is a penny stock.
−Removed: The Securities and Exchange Commission has adopted Rule 15g-9 which generally defines “penny stock” to be any equity security that has a market price (as defined) less than $5.00 per share or an exercise price of less than $5.00 per share, subject to certain exceptions.
+Added: The Securities and Exchange Commission in the United States (the “SEC”) has adopted Rule 15g-9 which generally defines “penny stock” to be any equity security that has a market price (as defined) less than $5.00 per share or an exercise price of less than $5.00 per share, subject to certain exceptions.
Our securities are covered by the penny stock rules, which impose additional sales practice requirements on broker-dealers who sell to persons other than established customers and “accredited investors”.
12 unchanged sentences
You will experience dilution or subordinated stockholder rights, privileges and preferences as a result of our financing efforts.
−Removed: We must raise additional capital from external sources to carry out our business plan over the next 12 months.
+Added: We must raise additional capital from external sources to carry out our business plan over the next two years.
To do so, we may issue debt securities, equity securities or a combination of these securities;
9 unchanged sentences
There is also no guarantee that your investment will appreciate.
−Removed: You may face significant restrictions on the resale of your shares due to state “blue sky” laws.
−Removed: Each state has its own securities laws, often called “blue sky” laws, which (1) limit sales of securities to a state’s residents unless the securities are registered in that state or qualify for an exemption from registration, and (2) govern the reporting requirements for broker-dealers doing business directly or indirectly in the state.
−Removed: Before a security is sold in a state, there must be a registration in place to cover the transaction, or it must be exempt from registration.
−Removed: The applicable broker-dealer must also be registered in that state.
−Removed: We do not know whether our securities will be registered or exempt from registration under the laws of any state.
−Removed: A determination regarding registration will be made by those broker-dealers, if any, who agree to serve as market makers for our common stock.
−Removed: There may be significant state blue sky law restrictions on the ability of investors to sell, and on purchasers to buy, our securities.
−Removed: You should therefore consider the resale market for our common stock to be limited, as you may be unable to resell your shares without the significant expense of state registration or qualification.
−Removed: Because some of our officers and directors are located in non-U.S.
−Removed: jurisdictions, you may have no effective recourse against the non U.S.
−Removed: officers and directors for misconduct and may not be able to enforce judgment and civil liabilities against our officers, directors, experts and agents.
−Removed: Some of our directors and officers are nationals and/or residents of countries other than the United States, specifically Canada and Germany, and all or a substantial portion of such persons’ assets are located outside the United States.
−Removed: As a result, it may be difficult for investors to enforce within the United States any judgments obtained against our officers or directors, including judgments predicated upon the civil liability provisions of the securities laws of the United States or any state thereof.
+Added: Because one of our directors is located in jurisdictions other than Canada, you may have no effective recourse against the director not located in Canada for misconduct and may not be able to enforce judgment and civil liabilities against this director.
+Added: One of our directors is a national and/or resident of a country other than Canada, specifically the Germany.
+Added: As a result, it may be difficult for investors to enforce within Canada any judgments obtained against our director, including judgments predicated upon the civil liability provisions of the securities laws of Canada.
Trends, Risks and Uncertainties
3 unchanged sentences
As a “smaller reporting company”, we are not required to provide the information required by this Item.
−Removed: We currently lease an office space at 25 Olympia Avenue, Suite K-300, Woburn, MA 01801, USA.
−Removed: 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 maintain a dedicated mailing address and telephone reception service located at 1275 West 6th Avenue, Vancouver, British Columbia, Canada V6H 1A6.
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.