As filed with the Securities and Exchange Commission on May 27, 2020

 

Registration No. 333-234292

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

 

Amendment No. 8 to

FORM F-1

 

REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933

 

 

 

BRIACELL THERAPEUTICS CORP.

(Exact name of Registrant as specified in its charter)

 

British Columbia   2834   47-1099599
(State or other jurisdiction of   (Primary Standard Industrial   (I.R.S. Employer
incorporation or organization)   Classification Code Number)   Identification Number)

 

Suite 300 – 235 15th Street

West Vancouver, BC V7T 2X1

Telephone: (604) 921-1810

(Address, including zip code, and telephone number, including area code, of Registrant’s principal executive offices)

 

Paracorp Incorporated

2804 Gateway Oaks Drive #100,

Sacramento, CA 95833

Telephone: (888) 280-6563

(Name, address, including zip code, and telephone number, including area code, of agent of service)

 

Copies to:

 

Gregory Sichenzia, Esq.

Avital Perlman, Esq.

Sichenzia Ross Ference LLP

1185 Avenue of Americas

37th Floor

New York, NY 10036

Telephone: (212) 930-9700

Facsimile: (212) 930-9725

 

Aaron Sonshine

Bennett Jones LLP

3400 One First Canadian Place

P.O. Box 130, Toronto, ON

M5X 1A4

Telephone: (416) 777-6448
Facsimile: (416) 863-1716

 

Virgil Z. Hlus
Clark Wilson LLP
Suite 900-885 West Georgia Street
Vancouver, BC,V6C 3H1
Telephone: (604) 687-5700
Facsimile: (604) 687-6314

 

Approximate date of commencement of proposed sale to the public: As soon as practicable after this Registration Statement becomes effective.

 

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box. [X]

 

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. [  ]

 

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. [  ]

 

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. [  ]

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933. Emerging growth company [X]

 

If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards† provided pursuant to Section 7(a)(2)(B) of the Securities Act. [  ]

 

† The term “new or revised financial accounting standard” refers to any update issued by the Financial Accounting Standards Board to its Accounting Standards Codification after April 5, 2012.

 

CALCULATION OF REGISTRATION FEE

 

   

Proposed

Maximum

Aggregate

Offering

Price(1)(2)

    Amount of
Registration Fee
 
Common Units (3)   $ 4,000,000.00 (4)   $ 519.20  
Common shares, no par value, included in the Common Units       (5)        
Warrants included in the Common Units (6)       (5)        
Pre-funded Units(7)       (4)        
Pre-funded Warrants included in the Pre-funded Units(8)       (9)        
Warrants included in the Pre-funded Units(6)       (9)        
Common shares underlying the Pre-funded Warrants included in the Pre-funded Units                
Common shares underlying the Warrants included in the Common Units and the Pre-funded Units   $ 5,000,000.00     $ 649.00  
Warrants to be issued to the Placement Agent       (10)        
Common shares underlying warrants to be issued to the Placement Agent     250,000.00 (11)     32.45  
Total   $ 9,250,000.00     $ 1,200.65 (12)

 

  1) Calculated pursuant to Rule 457(o) on the basis of the maximum aggregate offering price of all of the securities to be registered.
     
  2) Pursuant to Rule 416, the securities being registered hereunder include such indeterminate number of additional securities as may be issued after the date hereof as a result of stock splits, stock dividends or similar transactions.
     
  3) Each Common Unit consists of one common share and one warrant, each whole warrant exercisable for one common share.
     
  4) The proposed maximum aggregate offering price of Common Units proposed to be sold in the offering will be reduced on a dollar-for-dollar basis based on the offering price of any Pre-funded Units offered and sold in the offering, and the proposed maximum aggregate offering price of the Pre-funded Units to be sold in the offering will be reduced on a dollar-for-dollar basis based on the offering price of any Common Units sold in the offering. Accordingly, the proposed maximum aggregate offering price of the Common Units and Pre-funded Units (including the common shares issuable upon exercise of the Pre-funded warrants included in the Pre-funded Units), if any, is $4,000,000.
     
  5) Included in the price of the Common Units. No separate registration fee required pursuant to Rule 457(g) under the Securities Act of 1933, as amended.
     
  6) The warrants are exercisable at a price per common share equal to 125% of the Common Unit offering price.
     
  7) Each Pre-funded Unit consists of one Pre-funded warrant to purchase one common share and one warrant to purchase one common share.
     
  8) The Pre-funded warrants are exercisable at an exercise price of $0.0001 per share.
     
  9) Included in the price of the Pre-funded Units. No separate registration fee required pursuant to Rule 457(g) under the Securities Act of 1933, as amended.
     
  10) No fee pursuant to Rule 457(g) under the Securities Act of 1933, as amended
     
  11) Estimated solely for the purpose of calculating the registration fee pursuant to Rule 457(g) under the Securities Act of 1933, as amended. We have agreed to issue to the placement agent warrants to purchase a number of common shares equal to 5% of the aggregate number of Common Units and Pre-funded Units sold in the offering. The warrants are exercisable at a per share exercise price equal to 125% of the per Common Unit public offering price for five years after the effective date of this registration statement.
     
  12) Previously paid.

 

The registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933, as amended, or until the registration statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.

 

 

 

 
 

 

The information in this prospectus is not complete and may be changed. We may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This prospectus is not an offer to sell these securities and it is not soliciting an offer to buy these securities in any state where the offer or sale is not permitted.

 

PRELIMINARY PROSPECTUS SUBJECT TO COMPLETION DATED MAY 27 , 2020

 

Up to 1,000,000 Common Units, Each Consisting of a Common Share and a Warrant to Purchase One Common Share

 

Up to 1,000,000 Pre-funded Units, Each Consisting of a Pre-funded Warrant to Purchase One Common Share and a Warrant to Purchase One Common Share

 

 

BriaCell Therapeutics Corp.

 

 

 

We are offering in a reasonable efforts offering up to 1,000,000 common units (each, a “Common Unit”), each Common Unit consisting of one common share, no par value per share, and one warrant (each a “Warrant”), at an assumed price of US$4.00 per Common Unit. Each Warrant will entitle the holder to purchase one common share at an exercise price of US$____, equal to 125% of the public offering price of one Common Unit, and expire five years from the date of issuance.

 

We are also offering to those purchasers, if any, whose purchase of Common Units in this offering would otherwise result in the purchaser, together with its affiliates and certain related parties, beneficially owning more than 4.99% (or, at the election of the purchaser, 9.99%) of our outstanding common shares immediately following the consummation of this offering, the opportunity to purchase, if the purchaser so chooses, pre-funded units (each a “Pre-funded Unit”) in lieu of Common Units that would otherwise result in the purchaser’s beneficial ownership exceeding 4.99% (or, at the election of the purchaser, 9.99%) of our outstanding common shares. We are offering a maximum of                     Pre-funded Units. Each Pre-funded Unit will consist of a pre-funded warrant to purchase one common share at an exercise price of US$0.0001 per share (each a “Pre-funded Warrant”) and a Warrant. The purchase price of each Pre-funded Unit is equal to the price per Common Unit being sold to the public in this offering, minus US$0.0001. The Pre-funded Warrants will be immediately exercisable and may be exercised at any time until all of the Pre-funded Warrants are exercised in full.

 

For each Pre-funded Unit we sell, the number of Common Units we are offering will be decreased on a one-for-one basis. Common Units and Pre-funded Units will not be certificated. The common shares or Pre-funded Warrants, as the case may be, and the Warrants included in the Common Units or the Pre-funded Units, can only be purchased together in this offering, but the securities contained in the Common Units or Pre-funded Units are immediately separable and will be issued separately.

 

The offering also includes the common shares issuable from time to time upon exercise of the Pre-Funded Warrants and Warrants. It is currently estimated that the initial public offering price per Common Unit will be between US$3.00 and US$5.00 and per Pre-funded Unit will be between US$2.9999 and US$4.9999.

 

Our common shares are currently quoted on the U.S. OTCQB marketplace of OTC Markets Group, or OTCQB, under the symbol “BCTXF”, on the TSX Venture Exchange, or TSXV, under the symbol “BCT.V” and on the Frankfurt Stock Exchange under the Symbol “8BTA”.

 

On January 2, 2020, we implemented a 1-for-300 consolidation, or reverse split, of our issued and outstanding common shares prior to the date that we price this offering. Except where otherwise indicated, all share and per share data in this prospectus have been retroactively restated to reflect the reverse stock split.

 

On May 26, 2020, the closing price of our common shares was US$7.21 per share, as reported on the OTCQB. We have assumed a public offering price of US$4.00 per Common Unit. The actual public offering price per Common Unit and Pre-funded Unit, as the case may be, will not be determined by any particular formula but will rather be determined through negotiations between us and the potential investors in the offering. Therefore, the assumed public offering prices used throughout this prospectus may not be indicative of the final offering price.

 

We are an “emerging growth company” as that term is used in the Jumpstart Our Business Start-ups Act of 2012 and, as such, have elected to comply with certain reduced public company reporting requirements for this prospectus and future filings.

 

Neither the Securities and Exchange Commission nor any other regulatory body has approved or disapproved of these securities or passed upon the accuracy or adequacy of this prospectus. Any representation to the contrary is a criminal offense.

 

Investing in our securities involves a high degree of risk. See “Risk Factors” on page 18 to read about factors you should consider before buying our securities.

 

    Per
Common
Unit
    Per
Pre-Funded
Unit
    Total  
Public offering price   US$                 US$                       US$             
Placement agent fees(1)   US$       US$       US$    
Proceeds to BriaCell Therapeutics Corp., before expenses   US$       US$       US$    

 

(1)

Does not include a non-accountable expense allowance equal to 1% of the initial public offering price per Common Unit and Pre-Funded Unit, as applicable, payable to the placement agent. We refer you to “Plan of Distribution” beginning on page 117 for additional information regarding the placement agent’s compensation.

 

We have retained ThinkEquity, a division of Fordham Financial Management, Inc. as our exclusive placement agent to use its reasonable efforts to solicit offers to purchase the securities in this offering. The placement agent does not have any obligation to buy any of the securities from us or to arrange for the purchase or sale of any specific number or dollar amount of the securities. Because there is no minimum offering amount required as a condition to closing in this offering, and such is being conducted on an “any or all” basis, the actual public offering amount, placement agent fees, and proceeds to us, if any, are not presently determinable and may be substantially less than the total offering amount set forth above.

 

Delivery of the securities to investors is expected to take place on or about                  , 2020.

 

ThinkEquity

​a division of Fordham Financial Management, Inc.

 

The date of this prospectus is                 , 2020

 

 
 

 

TABLE OF CONTENTS

 

  Page
Part I  
   
PROSPECTUS SUMMARY 5
   
RISK FACTORS 18
   
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS 35
   
USE OF PROCEEEDS 36
   
DILUTION 37
   
DIVIDEND POLICY 37
   
CAPITALIZATION 38
   
ENFORCEMENT OF CIVIL LIABILITIES 39
   
SELECTED CONSOLIDATED FINANCIAL DATA 40
   
MANAGEMENT’S DISCUSSION AND ANALYSIS AND RESULTS OF OPERATION 41
   
DESCRIPTION OF BUSINESS 48
   
WHERE YOU CAN GET MORE INFORMATION 82
   
LEGAL PROCEEDINGS 82
   
DIRECTORS, EXECUTIVE OFFICERS, AND SIGNIFICANT EMPLOYEES 83
   
EXECUTIVE COMPENSATION 93
   
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT 98
   
CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS 99
   
DESCRIPTION OF SECURITIES 101
   
SHARES ELIGIBLE FOR FUTURE SALE 106
   
TAXATION 107
 
PLAN OF DISTRIBUTION 117
   
MATERIAL AGREEMENTS 124
   
EXPERTS AND LEGAL MATTERS 125
   
CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE 125
   
EXPENSES OF THIS OFFERING 125
   
INDEX TO FINANCIAL STATEMENTS F-2
   
Part II II-1

 

3

 

 

You should rely only on the information contained in this prospectus, any amendment or supplement to this prospectus or any free writing prospectus prepared by or on our behalf. Neither we, nor the placement agent, has authorized any other person to provide you with different or additional information. Neither we, nor the placement agent, take responsibility for, nor can we provide assurance as to the reliability of, any other information that others may provide. The placement agent is not making an offer to sell these securities in any jurisdiction where the offer or sale is not permitted. The information contained in this prospectus is accurate only as of the date of this prospectus or such other date stated in this prospectus, and our business, financial condition, results of operations and/or prospects may have changed since those dates.

 

Except as otherwise set forth in this prospectus, neither we nor the placement agent has taken any action to permit a public offering of these securities outside the United States and Canada or to permit the possession or distribution of this prospectus outside the United States. Persons outside the United States who come into possession of this prospectus must inform themselves about and observe any restrictions relating to the offering of these securities and the distribution of this prospectus outside the United States.

 

Unless the context otherwise requires, in this prospectus, the term(s) “we”, “us”, “our”, “Company”, “our company”, “BriaCell,” and “our business” refer to BriaCell Therapeutics Corp. and our subsidiaries.

 

MARKET, INDUSTRY AND OTHER DATA

 

This prospectus contains estimates, projections and other information concerning our industry, our business, and the markets for our products. Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties, and actual events or circumstances may differ materially from events and circumstances that are assumed in this information. Unless otherwise expressly stated, we obtained this industry, business, market and other data from our own internal estimates and research as well as from reports, research surveys, studies and similar data prepared by market research firms and other third parties, industry, medical and general publications, government data, and similar sources.

 

In addition, assumptions and estimates of our and our industry’s future performance are necessarily subject to a high degree of uncertainty and risk due to a variety of factors, including those described in “Risk Factors.” These and other factors could cause our future performance to differ materially from our assumptions and estimates. See “Cautionary Statement Regarding Forward-Looking Statements.”

 

CURRENCY AND EXCHANGE RATES

 

All dollar amounts in this prospectus are expressed in Canadian dollars unless otherwise indicated. The Company’s accounts are maintained in Canadian dollars and the Company’s financial statements are prepared in accordance with International Financial Reporting Standards as issued by the International Accounting Standards Board. All reference to “U.S. dollars”, “USD”, or to “US$” are to United States dollars.

 

The following table sets forth the rate of exchange for the Canadian dollar, expressed in United States dollars in effect at the end of the periods indicated, the average of exchange rates in effect during such periods, and the high and low exchange rates during such periods based on the noon rate of exchange as reported by the Bank of Canada for conversion of Canadian dollars into United States dollars.

 

On May 27, 2020, the exchange rate was US$1.00 = CAD$1.3782.

 

Canada Dollar per U.S. Dollar Noon Buying Rate      
    Average     High     Low     Period-End  
Year ended July, 31,                                
2019     1.3234       1.3642       1.2803       1.3148  
2018     1.2738       1.3310       1.2128       1.3017  
Most recent six months                                
November 2019     1.3239       1.3307       1.3148       1.3289  
December 2019     1.3172       1.3302       1.2988       1.2988  
January 2020     1.3087       1.3233       1.2970       1.3233  
February 2020     1.3286       1.3429       1.3224       1.3429  

March 2020

   

1.3953

     

1.4496

     

1.3356

     

1.4187

 

April 2020

   

1.4058

     

1.4217

     

1.3904

     

1.3910

 

 

4

 

 

PROSPECTUS SUMMARY

 

This summary highlights selected information contained elsewhere in this prospectus and does not contain all of the information that you should consider in making your investment decision. Before deciding to invest in our common shares, you should read this entire prospectus carefully, including the sections of this prospectus entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our consolidated financial statements and the related notes included elsewhere in this prospectus. All share and per share data in this prospectus reflects a 1-for-300 reverse stock split of our common shares issued and outstanding (including adjustments for fractional shares), which will be effected prior to the date we price this offering.

 

Overview of the Company

 

BriaCell is an immuno-oncology focused biotechnology company developing targeted and safe approaches for the management of cancer, with a focus on advanced breast cancer. BriaCell has completed positive proof-of-concept studies of Bria-IMT™, a whole cell targeted immunotherapy, in patients with advanced breast cancer.

 

BriaCell has been conducting a Phase I/IIa clinical trial of Bria-IMT™, BriaCell’s lead candidate, in a Combination Study with immune checkpoint inhibitors and has initiated combination therapy with the Incyte drugs INCMGA00012 (an anti-PD-1 antibody) and epacadostat, an orally bioavailable small-molecule inhibitor of indoleamine 2,3-dioxygenase 1 (IDO1).

 

BriaCell and Incyte Corporation have formed a non-exclusive clinical trial collaboration to evaluate the effects of combinations of novel clinical candidates. Under the agreement, Incyte and BriaCell will be evaluating novel combinations of compounds from Incyte’s development portfolio with Bria-IMT™ in advanced breast cancer patients.

 

Pending consummation of the offering, Bria-IMT™ will also be evaluated in an investigator-initiated Phase I/IIa study in combination with pembrolizumab (Keytruda) by Dr. Saveri Bhattacharya, Principal Investigator, in women with advanced breast cancer at Thomas Jefferson University. Dr. Bhattacharya has been selected to receive a grant from the Merck Investigator Studies Program for this study. Merck will provide Keytruda to Thomas Jefferson University and Dr. Bhattacharya for use in the combination study. The Company does not have an agreement with Merck for the supply of Keytruda. The Company has entered into a study agreement with Thomas Jefferson University providing for the investigator-initiated Phase I/IIa study by Dr. Bhattacharya and the Company’s supply of Bria-IMT™ to Thomas Jefferson University and Dr. Bhattacharya (the “Study Agreement”). Pursuant to the Study Agreement, the Company shall pay Thomas Jefferson University a total budget of $3,049,322.50. The FDA and Thomas Jefferson University’s internal review board have approved the clinical protocol. Patients with advanced breast cancer who have at least one human leukocyte antigen (“HLA”) that matches with Bria-IMT™ will be eligible for the trial. Pending consummation of the offering, the study is expected to commence in June 2020 with safety and efficacy data to be released during 2021 and 2022.

 

BriaCell is also developing Bria-OTS™, an off-the-shelf personalized immunotherapy, for advanced breast cancer. Bria-OTS™ immunotherapy treatments are personalized to match the patient without the need for personalized manufacturing. Bria-OTS™ are a set of biologic drugs similar to Bria-IMT™, differing by a set of HLAs. The Bria-OTS™ cell lines will be pre-manufactured and stored frozen and ready to ship once a patient’s HLA type is known, making them “off-the-shelf.” HLA molecules are polymorphic in that they are different in some people and shared by some people with the different HLA molecules referred to as “HLA alleles” or “HLA types”. Patients will be treated with the Bria-OTS™ drugs most closely matching their HLA type, making their treatment “personalized”. Bria-OTS™, which is expected to cover over 99 percent of the patient population, is designed to produce a potent and selective immune response against the cancer of each patient while eliminating the time, expense and complex manufacturing logistics associated with other personalized immunotherapies.

 

BriaCell’s pipeline also includes other immunotherapy cell lines in development for other cancers (including lung, prostate and melanoma), the development of other immunotherapy approaches for cancer and infectious diseases, including multi-specific binding reagents similar to Bi-specific T-cell engagers, and small molecule inhibitors of protein kinase C delta which are postulated to be effective in cancers caused by mutations in the RAS oncogene.

 

Products/Pipeline

 

Bria-IMT™

 

Bria-IMT™, BriaCell’s lead candidate, is a whole-cell immunotherapy undergoing clinical testing in patients with metastatic breast cancer who have failed at least two prior lines of therapy. BriaCell has been conducting a Phase I/IIa clinical trial of Bria-IMT™ in combination with immune checkpoint inhibitors. The combination study is being conducted at 3 clinical sites: St. Joseph Heritage Healthcare, Santa Rosa, California, United States; University of Miami/Sylvester at Plantation, Plantation, Florida, USA; Cancer Center of Kansas (CCK), Wichita, Kansas, USA; Subsequent to the establishment of a collaboration with Incyte Corporation, this study has been modified to evaluate the combination of Bria-IMT™ with INCMGA00012 (a PD-1 inhibitor) and epacadostat (an indoleamine dioxygenase (IDO) inhibitor).

 

BriaCell has achieved proof of concept based on data from a Phase I/IIa study of Bria-IMT™ in advanced breast cancer patients. In essence, BriaCell obtained evidence that patients with certain HLA molecules also present in Bria-IMT™ have a higher likelihood of responding to the Bria-IMT™ regimen with tumor shrinkage, which is consistent with results from a molecular analysis of Bria-IMT™ conducted by BriaCell. BriaCell has also obtained evidence that patients with well-differentiated (grade I) or moderately differentiated (grade II) tumors are more likely to respond. Our proof of concept data is preliminary and we will need to complete the Phase I/IIa study and additional clinical studies before the Food and Drug Administration, or FDA, assesses the efficacy, safety and tolerability of this product candidate and determines whether it will be approved for commercial sale. Specifically, BriaCell plans to continue the Phase I/IIa study of the combination of Bria-IMT™ with INCMGA00012 and epacadostat. Once sufficient data is available from this study (anticipated to include data on at least 30 patients), BriaCell will determine the design of a Phase II registration study. BriaCell will negotiate with the FDA to obtain a “Special Protocol Assessment” (SPA) of the registration study. Under the SPA, the FDA would agree with the design and endpoints of the registration study and if these endpoints are met, would agree to grant marketing approval of the drug. Completion of the Phase II registration study will permit BriaCell to submit a Biologics License Application for Bria-IMT.

 

About Bria-IMT™

 

Developed and characterized by a team of dedicated scientists and clinicians, Bria-IMT™ (SV-BR-1-GM) is a targeted immunotherapy being developed for the treatment of breast cancer. Bria-IMT™ is a genetically engineered human breast cancer cell line with features of immune cells and clinically applied as a targeted immunotherapy.

 

In short, Bria-IMT™ immunotherapy is a genetically engineered human breast cancer cell line which activates the immune system to attack and destroy breast cancer tumors.

 

Mechanism of Action of Bria-IMT™: The mechanism of action of Bria-IMT™ is currently under investigation. It is likely that the expression of certain breast cancer antigens (proteins expressed in breast cancer cells) in Bria-IMT™ generates strong T cell and potentially antibody responses resulting in recognition and destruction of cancerous cells.

 

5

 

 

Bria-IMT™ is designed to secrete granulocyte/macrophage-colony stimulating factor (GM-CSF), a factor that stimulates components of the immune system. Specifically, GM-CSF activates dendritic cells, the cells that start immune responses. These activated dendritic cells then activate T cells, a key component of the immune system, to recognize the tumor cells as foreign, and eliminate them. To amplify this action, we have combined Bria-IMT™ with other immune system activators including cyclophosphamide (used in low doses to reduce immune suppression), and interferon-α, a cytokine. We believe this approach of simultaneous activation of the immune system via different pathways will improve the immune system response to attack and destroy cancer cells.

 

Using BriaCell’s novel technology platform and our strong R&D capabilities, we plan to develop Bria-OTS™, a personalized off-the-shelf immunotherapy for breast cancer, and similar immunotherapy cell lines for other cancer indications.

 

Bria-OTS™ is under development as an off-the-shelf personalized immunotherapy for advanced breast cancer.
   
The concept for Bria-OTS™ comes from BriaCell’s work with Bria-IMT™, where we noted that if a patient “matches” Bria-IMT™ in their HLA type, they were more likely to respond.
   
HLA molecules are the molecules that start immune responses but are polymorphic – i.e. they are different in different people, although some people will share the same HLA molecules (referred to as “HLA alleles” or “HLA types”).

 

Bria-OTS™ is made from cell lines that are genetically engineered to expresses the immune boosters GM-CSF and interferon-α, as well as specific HLA types (a.k.a. alleles).
   
Different cell lines are being pre-manufactured to express 15 different HLA types matching >99% of the overall breast cancer patient population (the methodology in determining that Bria-OTS would match 99% of the breast cancer population is discussed on pages 55 and 56 herein).
   
Using the BriaDx™, a companion diagnostic test performed via buccal swabs inside the patient’s mouth, the suitable personalized treatment will be selected for each patient for administration.
   
This approach allows personalized treatment without the need for personalized manufacturing. Additionally, it saves time and skips expensive and complicated manufacturing procedures associated with other personalized treatments.
   
Bria-OTS™ cell lines are being engineered with the goal of transferring them to production in 2020 and commencing clinical evaluation in 2020 (expected authorization by FDA and expected first patient to be dosed in the fourth quarter of 2020) with safety and efficacy data expected to be released during 2021 and 2022.

 

BriaDx™

 

BriaDx™ is a diagnostic test that BriaCell is developing to identify the patients most likely to respond to Bria-IMT™. Currently, BriaDx™ includes HLA typing of the patients as patients having HLA alleles also present in Bria-IMT™ appear to have a higher likelihood of responding to the Bria-IMT™ regimen with tumor regression (“shrinkage”). Additional markers of potential diagnostic use are being explored based on the expression of specific biomarkers in the responder (i.e. biomarkers which identify the patients for which Bria-IMT™ immunotherapy appears more effective) vs the non-responder patients from clinical studies of Bria-IMT™ in advanced breast cancer patients.

 

6

 

 

Blood including circulating tumor cells from the patients is analyzed using cutting-edge technologies including gene expression analysis and assessment of the levels of antibodies predicted to bind to Bria-IMTTM.

 

The insights gained from biomarker studies conducted to date have provided us with a solid basis for the development of Bria-OTS™, an off-the-shelf personalized immunotherapy which would match over 99% of patients with advanced breast cancer.

 

BriaDx™ is being developed to help understand which patients are most likely to respond to Bria-IMT™ targeted immunotherapy. Based on the proposed mechanism of action of Bria-IMT™ (see Figure below) HLA molecules play a key role inducing cellular immune responses to Bria-IMT™ which boosts the patient’s immune response to their cancer.

 

HLA molecules are polymorphic, in that they are different in different individuals but shared by some individuals (similar to eye color). Based on our clinical data to date we hypothesize that patients with HLA alleles also present in Bria-IMT™ have a higher likelihood of responding to the Bria-IMT™ regimen with tumor regression (“shrinkage”). Therefore, BriaDx™, a companion diagnostic test, determines the patients’ HLA types.

7

 

 

Available Clinical Data for Treatment with the Bria-IMT™ Regimen

 

BriaCell conducted three Proof of Concept clinical trials, one using parental SV-BR-1 cells and the other two using Bria-IMT™ (i.e., genetically engineered SV-BR-1 cells – producing GM-CSF also called SV-BR-1-GM), in metastatic (i.e., Stage IV) breast cancer patients who had failed prior treatments. The patients were treated with the Bria-IMT™ regimen according to the following schedule, and the results are summarized starting on page 51 herein.

 

Mechanism of Action of BRIA-IMT™ and BRIA-OTS™

 

The mechanism of action of Bria-IMT™/Bria-OTS™ is currently under investigation.

 

We believe that Bria-IMT™/Bria-OTS™ activates the patient’s immune system to recognize tumor cells and destroy them. We hypothesize that Bria-IMT™/Bria-OTS™ exerts its action via the patient’s antigen-presentation system {i.e. the system that presents antigen material on the surface of cells for recognition by the T cells of the immune system as either self (i.e., safe) or foreign (i.e., to be destroyed)}. Specifically, Bria-IMT™/Bria-OTS™ is thought to stimulate dendritic cells, a key component of the antigen-presenting system, to display certain immunogenic (i.e., immune response-generating) protein fragments to T cells, which activates the T cells to destroy the tumor cells either directly, or indirectly by inducing a humoral (antibody-generating) immune response. In addition, we also have shown that Bria-IMT™ is capable of directly stimulating T cells thereby potentially adding additional therapeutic benefits. The latter property of Bria-IMT™ is the basis of the Bria-OTS™ project as it requires HLA matching between the therapeutic cells and the patient.

 

Our preliminary analyses have shown several up-regulated genes in Bria-IMT™ that encode proteins known to be immunogenic (i.e. immune response-generating), suggesting that Bria-IMT™ can stimulate the immune system against the cancer cells.

 

8

 

 

Bria-IMT™ is a human breast cancer cell line which expresses Her2/neu (a protein well known for its overexpression in breast cancer but also associated other epithelial malignancies including ovarian, pancreatic, colon, bladder and prostate cancers). Bria-IMT™ has been engineered to produce and secrete granulocyte/macrophage-colony stimulating factor (GM-CSF), a protein that promotes dendritic cell function, a key component of the immune system, and hence activates the immune system.

 

BRIA-IMT™ & BRIA-OTS™

 

Potential Mechanisms of Specific Immune Activation in Advanced Breast Cancer

 

 

1. Bria-IMT/OTS™ produces breast cancer antigens (proteins made by breast cancer cells)
   
2. Bria-IMT/OTS™ secretes GM-CSF which further promotes dendritic cell-based antigen presentation (boosts the response)
   
3. Breast cancer antigens are taken up by dendritic cells and “presented” to CD4+ and CD8+ T cells implicated in tumor destruction.
   
4. Bria-IMT/OTS™ directly stimulates cancer fighting CD4+ and CD8+ T cells (further boosts the response)
   
5. Bria-IMT/OTS™ biological activity depends on HLA matching of Bria-IMT/OTS™ and the patient
   
6.

Based on these observations, BriaCell is extending this technology to other types of cancer by developing additional immunotherapy cell lines. These include Prostate Cancer (novel immunotherapy cell line 1 or NICL1), non-small cell lung cancer (NICL2) and melanoma (NICL3). Production of these NICLs is anticipated to commence in 2020 and IND filings for these NICLs are anticipated starting in 2021 (NICL1 and NICL2) and 2022 (NICL3). Each of these IND filings is expected to require an additional ~US$1,000,000.

 

9

 

 

Clinical Trials

 

Phase I/IIA Combination Study of BRIA-IMT™ with Immune Checkpoint Inhibitors in Advanced Breast Cancer

 

The FDA approved the combination study of Bria-IMT™ with immune checkpoint inhibitors. The initial study used pembrolizumab (Keytruda, purchased by the Company as the Company does not have an agreement with Merck for the supply of Keytruda). The Company dosed 11 patients with this combination and no dose limiting toxicities were observed. Additionally, evidence of additive or synergistic activity was observed.

 

The combination with Keytruda was discontinued and the study was subsequently modified to use a combination of Bria-IMT with the Incyte PD-1 inhibitor (INCMGA00012) and epacadostat. The Company anticipates additional safety and efficacy data for the combination of Bria-IMT™ with INCMGA00012 and epacadostat to be released between the second quarter of 2020 and throughout 2021 and 2022.

 

Rationale for the Combination Study of BRIA-IMT™ with Immune Checkpoint Inhibitors

 

The immune checkpoint inhibitors such as anti-PD-1 antibodies have come to the forefront in the fight against cancer with substantial benefits for some patients. Most recently, the significance of immune checkpoint inhibitors was recognized by the Nobel committee by awarding Dr. Tasuku Honjo and Dr. James P. Allison with the 2018 Nobel Prize in Physiology or Medicine (Scientists behind game-changing cancer immunotherapies win Nobel medicine prize), validating the Company’s decision to initiate a combination therapy with the immune checkpoint inhibitors.

 

Drs. Alison and Honjo independently, using different strategies, showed a new approach of treating patients by awakening certain cells of the immune system (T cells) to attack tumors. This new approach of treating patients with immune checkpoint inhibitors (such as anti-PD-1 antibodies), designed to overcome immune suppression in cancer patients, is revolutionizing the fight against cancer.

 

In 2010 an important pre-clinical study by Dr. Allison’s group showed that combination with anti-PD-1 antibodies potentiated the tumor-destroying effect of melanoma cells engineered to produce granulocyte-macrophage colony-stimulating factor (GM-CSF), a substance that activates the immune system, compared to the treatment with the GM-CSF producing cells alone. Bria-IMT™ similarly uses a breast cancer cell line which produces GM-CSF. Bria-IMT™ has also been shown to indirectly and directly stimulate T cells, and hence boost the immune system. BriaCell has published these findings in a leading immunology journal. It is important to note that PD-1 inhibitors have not been shown to work on their own in breast cancer.

 

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BriaCell & Incyte Collaboration and Supply Agreement

 

Non-exclusive clinical trial collaboration to evaluate the effects of combinations of novel clinical candidates

 

The clinical study will focus on (but not limited to) BriaCell’s lead candidate, Bria-IMT™, in combination with Incyte’s selected compounds for advanced breast cancer.
   
Incyte to provide compounds from its development portfolio, including INCMGA0012, an anti-PD-1 monoclonal antibody, and epacadostat, an IDO1 inhibitor, for use in combination studies with BriaCell’s lead candidate, Bria-IMT™.
   

Incyte is a global biopharmaceutical company focused on discovering and developing novel therapeutics in oncology and other serious diseases.

   
Incyte has a deep and rich pipeline in immuno-oncology with numerous molecular targets including PD-1, IDO, GITR, OX40, TIM-3, LAG-3, ARG, AXL/MER and PD-L1xCD137
   
The first 6 patients will receive the Bria-IMT™ regimen in combination with INCMGA00012. Once safety of the combination has been established, subsequent cohorts will receive a triple combination of the Bria-IMT™ regimen with INCMGA00012 and epacadostat.
   
The design of the clinical study is shown below. Dosing of the novel combinations commenced in the fourth quarter of 2019.
   
The Company anticipates additional safety and efficacy data to be released between the second quarter of 2020 and throughout 2021 and 2022.
   
Pending discussions with the Food and Drug Administration (FDA), a registration study focused on, but not limited to, Bria-IMT™, in combination with Incyte’s selected compounds for advanced breast cancer is planned to commence in 2021 with the Bria-OTS™ program following by approximately 6 quarters.

 

11

 

 

 

Bria-IMT™ - Keytruda® Combination Study at Thomas Jefferson University

 

Pending consummation of the offering, Bria-IMT™ will be evaluated in an investigator-initiated Phase I/IIa study in combination with pembrolizumab (Keytruda) by Dr. Saveri Bhattacharya, Principal Investigator, in women with advanced breast cancer at Thomas Jefferson University. Dr. Bhattacharya has been selected to receive a grant from the Merck Investigator Studies Program for this study. Merck will provide Keytruda to Thomas Jefferson University and Dr. Bhattacharya for use in the combination study. The Company does not have an agreement with Merck for the supply of Keytruda. The Company has entered into the Study Agreement with Thomas Jefferson University providing for the investigator-initiated Phase I/IIa study by Dr. Bhattacharya and the Company’s supply of Bria-IMT™ to Thomas Jefferson University and Dr. Bhattacharya. As consideration, the Company shall pay Thomas Jefferson University a total budget of $3,049,322.50. The FDA and Thomas Jefferson University’s internal review board have approved the clinical protocol. Patients with advanced breast cancer who have at least HLA that matches with Bria-IMT™ will be eligible for the trial. Pending consummation of the offering the study is expected to commence in June 2020 with safety and efficacy data to be released during 2021 and 2022.

 

Market

 

It is estimated that in 2019, approximately 268,600 women will be diagnosed with breast cancer in the United States. According to the National Breast Cancer Foundation, on every two minutes an American woman is diagnosed with breast cancer and more than 40,500 die each year. Although about 100 times less common than in women, breast cancer also affects men. It is estimated that the lifetime risk of men getting breast cancer is about 1 in 1,000, and the ACS estimates that approximately 2,670 new cases of invasive male breast cancer will be diagnosed and approximately 500 men will die from breast cancer in 2019.

 

12

 

 

According to the May 2019 “Global Oncology Trends 2019” report by the IQVIA Institute, the global market for cancer drugs (including immunotherapy drugs) is expected to reach nearly US$240 billion by the end of 2023, growing at a compound annual growth rate, or CAGR of 9-12% between 2019 and 2023.

 

Marketing and Sales Strategy

 

The product will initially be marketed to oncologists who are well versed in the use of immunotherapy for cancer. Partnering with other pharma companies in order to market combinations with a number of drugs is also an option that we intend to pursue. This study will utilize a frozen formulation which consists of irradiated SV-BR-1-GM cells in viable freezing media. This formulation will permit stockpiling of the immunotherapy so that it can be sent on demand to clinical sites. The eventual goal is to reach all oncologists who treat late stage breast cancer either by direct outreach or by partnering with another company that has an established presence in the oncology space.

 

Other Commercial Considerations

 

There is a high unmet medical need in late stage breast cancer, providing potential for accelerated approval of Bria-IMT™. The FDA is interested in facilitating the availability of novel therapies of patients with unmet medical needs, especially those that can target the population most likely to respond. In addition, Bria-IMT™ may fit the description of an orphan drug, especially if HLA matching and/or limitation to grade I/II tumors is required. These two facts may help facilitate accelerated approval of Bria-IMT™.

 

Production and Marketing Plan

 

Bria-IMT™ cells grow in simple tissue culture media and are irradiated prior to inoculation. Bria-IMT™ manufacturing will be performed by Contract Manufacturing Organizations (CMOs). Recently we have been working with KBI Biopharma, Inc. who have developed a frozen formulation, where the cells are grown, harvested and irradiated followed by cryopreservation in a viable state. The cells are stockpiled and shipped directly to clinical sites for inoculation. Each lot of Bria-IMT™ is tested for potency (GM-CSF production), identity (HER2+ and ER/PR-) and adventitious agents to assure that each patient receives a safe and effective treatment. To date, there have been no issues with these tests. Additional manufacturing facilities have been evaluated and may be enlisted as demand grows.

 

Earlier Phase Programs 

 

BriaCell has recently filed provisional patent applications describing:

 

  Coronavirus Immunotherapy
  Antibody-Based Treatment of Infectious Diseases
  Novel Therapeutics for Cancer
  Novel Immune Therapies for Multiple Disease Indications

 

The Coronavirus Immunotherapy patent application, filed on April 10, 2020, entitled, “INDUCING IMMUNE RESPONSES BY TRANSFORMING CANCER CELLS INTO ANTIGEN-PRESENTING CELLS”, is based on molecular analyses of the Company’s lead anti-tumor product candidate. Antigen-presenting cells are the cells that typically start immune responses. BriaCell’s whole-cell immunotherapies are designed to stimulate the immune system to recognize and destroy the patient’s tumors by acting as antigen-presenting cells that stimulate the patient’s cancer-cell-recognizing immune cells. The new patent application by BriaCell scientists expands on this paradigm by proposing additional cellular therapeutics designed to activate immune cells recognizing SARS-CoV-2 (the coronavirus causing COVID-19) antigens. The patent application seeks protection for, among others, new whole-cell therapeutics and methods for their use. These are designated “Novel Immunotherapy Cell Lines (NICL-CoV-2)”. An IND filing for this treatment is anticipated to be made in 2021 and requires an additional ~US$1,000,000.

 

The Antibody-Based Treatment of Infectious Diseases patent application, filed on April 20, 2020, entitled, “COMPUTER-GUIDED DESIGN OF ANTIBODIES INCLUDING NEUTRALIZING SARS-CoV-2 BINDING AGENTS”, outlines compositions and methods for generating antibodies to neutralize SARS-CoV-2 (the coronavirus causing COVID-19) using computer-based simulation technology. Such antibodies are envisioned to prevent and treat the life-threatening symptoms of COVID-19. The use of computer simulation creates highly targeted antibodies by improving pre-existing antibodies. The improvements include, but are not limited to, creating higher affinity and/or specificity antibodies to the SARS-CoV-2 Spike protein (the protein which the virus uses to infect cells) versus the unmodified antibody. The resulting therapeutic antibodies are expected to quickly and specifically recognize the SARS-CoV-2 virus, bind to it, and neutralize it. The patent application also provides compositions and methods, using similar technologies, for cancer-directed antibodies. The patent application seeks protection for the design of new therapeutic antibodies and methods for their use. These are designated “Antibodies for SARS-CoV-2”. An IND filing for this treatment is anticipated to be made in 2021 and requires an additional ~US$1,000,000.

 

The patent application for Novel Immune Therapies for Multiple Disease Indications, filed on May 15, 2020, entitled, “MULTI-VALENT IMMUNOSTIMULATORS FOR INFECTIOUS DISEASES, AUTOIMMUNE DISEASES, ALLERGIC DISEASES AND CANCER”, describes a platform to generate multi-valent reagents carrying an antigen (such as an antigen from SARS-CoV-2) and delivering it to immune cells such as dendritic cells, a type of antigen-presenting cell crucial for the induction and modulation of immune responses. The expected effect is a targeted therapy envisioned to selectively destroy infectious agents or cancer cells with minimal negative effect on normal cells. This may mean less severe side effects for the treated patients compared to other therapies. The technology also has uses for autoimmune diseases and allergic diseases. The Company cautions that these novel therapeutics are still under early-stage research and development and is not making any express or implied claims as to their success in cancer treatment or commercial viability. The patent application seeks protection for, among others, the design of new therapeutics and methods for their use. These are designated “Novel ImmunoStimulators (NIS-CoV-2)”. An IND filing for this treatment is anticipated to be made in 2021 and requires an additional ~US$1,000,000.

 

The Company cautions that COVID-19 therapeutic development is still under early-stage research and development and is not making any express or implied claims that it has the ability to treat, prevent or eliminate the COVID-19 virus at this time.

 

The patent application for Novel Therapeutics for Cancer, filed on April 23, 2020, is entitled, “METHODS FOR INDUCING AND ENHANCING ANTI-CANCER IMMUNE RESPONSES USING NOVEL MOLECULAR CONSTRUCTS”. It outlines the development and use of multi-specific binding reagents that simultaneously bind to an immune cell and a cancer cell, or just to a cancer cell, and activate the immune system against the cancer cells. The novel binding reagents are designed to act, among others, as potent immune cell activators/immune checkpoint inhibitors without the toxicity of current checkpoint inhibitors. The expected effect is a highly targeted therapy envisioned to selectively destroy cancer cells without affecting normal (non-cancerous) cells. This may mean less severe side effects for the treated cancer patients compared to alternative therapies. The Company cautions that these novel therapeutics are still under early-stage research and development and is not making any express or implied claims as to their success in cancer treatment or commercial viability. The patent application seeks protection for, among others, the design of new therapeutics and methods for their use. These are designated “Bria-TILs-Rx”. IND filings for Bria-TILs-Rx for the treatment of prostate cancer and epithelial and glandular cancer, respectively, are anticipated to be made in 2022 and require an additional ~US$1,000,000 each.

 

Risks Related to our Business and this Offering

 

Our business and this offering are subject to numerous risks, as more fully described in the section entitled “Risk Factors” immediately following this prospectus summary. You should read these risks before you invest in our securities. In particular, our risks include, but are not limited to, the following:

 

  We have a history of losses, may incur future losses and may not achieve profitability;
  We are an early stage development company;
  We have an unproven market for our product candidates;
  We are heavily reliant on third-parties to carry out a large portion of our business;
  Pre-clinical studies and initial clinical trials are not necessarily predictive of future results;
  We must obtain additional capital to continue our operations;
  We are highly dependent on our key personnel;
  The report of our independent registered public accounting firm expresses substantial doubt about our ability to continue as a going concern;
  We may not succeed in completing the development of our products, commercializing our products or generating significant revenues;
  We may not successfully develop, maintain and protect our proprietary products and technologies;
  Changes in legislation and regulations may affect our revenue and profitability;
  If we or our licensees are unable to obtain U.S., Canadian and/or foreign regulatory approval for our product candidates, we will be unable to commercialize our therapeutic candidates;
  Clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results;
  An active trading market for our common shares may not develop on the OTCQB and our securityholders may not be able to resell their common shares;
  The Warrants may not have any value;
 

Without an active trading market, the liquidity of the Pre-funded Warrants and Warrants will be very limited and the Warrants and Pre-Funded Warrants may not have any value;

  Neither the Warrants or the Pre-Funded Warrants are listed or quoted on any trading market or exchange;
  Future issuance of our common shares could dilute the interests of existing shareholders;
  We have a significant number of options and warrants outstanding, and while these options and warrants are outstanding, it may be more difficult to raise additional equity capital;
  We are a foreign private issuer and, as a result, we are not subject to U.S. proxy rules and are subject to reporting obligations that, to some extent, are more lenient and less frequent than those applicable to a U.S. issuer;
  If you purchase our common shares in this offering, you will incur immediate and substantial dilution in the book value of your shares; and
  Our management will have broad discretion in the use of the net proceeds from this offering and may allocate the net proceeds from this offering in ways that you and other shareholders may not approve.

 

Corporate Background

 

We were incorporated in the province of British Columbia on July 26, 2006. Our common shares have been quoted on the OTCQB under the symbol BCTXF, on the TSX Venture Exchange under the symbol “BCT.V” and on the Frankfurt Stock Exchange under the symbol “8BTA”.

 

Our principal executive office is located at Suite 300 – 235 15th Street, West Vancouver, British Columbia, V7T 2X1 and our telephone number in Canada is (604) 921-1810. Our web address is https://briacell.com/. The information contained on our website or available through our website is not incorporated by reference into and should not be considered a part of this prospectus, and the reference to our website in this prospectus is an inactive textual reference only. Any website references (URL’s) in this prospectus are inactive textual references only and are not active hyperlinks. The contents of our website is not part of this prospectus, and you should not consider the contents of our website in making an investment decision with respect to our common shares. Paracorp Incorporated is our agent in the United States, and its address is 2804 Gateway Oaks Drive #100, Sacramento, CA 95833, Tel: (888) 280-6563, Fax: (800) 603-5868; Attn: Katelyn Bean (kbean@myparacorp.com).

 

The Company’s corporate offices in the United States are located at 820 Heinz Avenue, Berkley, California 94710. The Company’s two wholly owned subsidiaries BriaCell Therapeutics Corp., a Delaware corporation, and Sapientia Pharmaceuticals Inc., a Delaware corporation, were formed on April 3, 2014 and September 20, 2012 respectively.

 

In February and March 2019, the Company’s Board of Directors was substantially restructured with the appointment of Jamieson Bondarenko, Dr. Rebecca Taub and Vaughn C. Embro-Pantalony to replace three resigning directors. Additionally, on August 12, 2019, Richard Berman was appointed to our Board of Directors. After these restructuring events, the current Board of Directors consists of:

 

  Dr. William V. Williams, Director and Chief Executive Officer;
     
  Jamieson Bondarenko, Director and Chairman of the Board;
     
  Dr. Charles Wiseman, Director;
     
  Dr. Rebecca Taub, Director
     
  Vaughn C. Embro-Pantalony, Director; and
     
  Richard Berman, Director

 

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Implications of Being an “Emerging Growth Company” and a Foreign Private Issuer

 

As a company with less than US$1.07 billion in revenue during our last fiscal year, we qualify as an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act. An emerging growth company may take advantage of specified reduced reporting and other burdens that are otherwise applicable generally to public companies. These provisions include:

 

  reduced executive compensation disclosure;
     
  exemptions from the requirement to hold a non-binding advisory vote on executive compensation, including golden parachute compensation; and
     
  an exemption from the auditor attestation requirement in the assessment of our internal control over financial reporting pursuant to the Sarbanes-Oxley Act of 2002.

 

We may take advantage of these provisions until we are no longer an emerging growth company. We would cease to be an emerging growth company upon the earlier to occur of: (1) the last day of our fiscal year following the fifth anniversary of the completion of this offering; (2) the last day of the fiscal year in which we have total annual gross revenue of US$1.07 billion or more; (3) the date on which we have issued more than US$1.0 billion in nonconvertible debt during the previous three years; or (4) the date on which we are deemed to be a large accelerated filer under the rules of the Securities and Exchange Commission, or the SEC.

 

We intend to report under the Securities Exchange Act of 1934, as amended, or the Exchange Act, as a non-U.S. company with foreign private issuer status. Even after we no longer qualify as an emerging growth company, as long as we continue to qualify as a foreign private issuer under the Exchange Act, we will be exempt from certain provisions of the Exchange Act that are applicable to U.S. domestic public companies, including:

 

  the sections of the Exchange Act regulating the solicitation of proxies, consents or authorizations with respect to a security registered under the Exchange Act;
     
  the sections of the Exchange Act requiring insiders to file public reports of their share ownership and trading activities and liability for insiders who profit from trades made in a short period of time; and
     
  the rules under the Exchange Act requiring the filing with the SEC of quarterly reports on Form 10-Q containing unaudited financial statements and other specified information, and current reports on Form 8-K upon the occurrence of specified significant events, although we report our results of operations on a quarterly basis under the Canadian securities laws.

 

Both foreign private issuers and emerging growth companies are also exempt from certain more stringent executive compensation disclosure rules. Thus, even if we no longer qualify as an emerging growth company, but remain a foreign private issuer, we will continue to be exempt from the more stringent compensation disclosures required of companies that are neither an emerging growth company nor a foreign private issuer.

 

We would cease to be a foreign private issuer at such time as more than 50% of our outstanding voting securities are held by U.S. residents, and any one of the following three circumstances applies: (i) the majority of our executive officers or directors are U.S. citizens or residents, (ii) more than 50% of our assets are located in the United States or (iii) our business is administered principally in the United States.

 

In this prospectus, we have taken advantage of certain of the reduced reporting requirements as a result of being an emerging growth company and a foreign private issuer. Accordingly, the information contained herein may be different than the information you receive from other public companies in which you hold equity securities.

 

Reverse Split

 

On October 22, 2019, our shareholders approved a reverse stock split of our issued and outstanding common shares at a ratio of between 1-for-2 and 1-for-300, with the specific ratio and effective time of the reverse stock split to be determined by our Board of Directors, or our Board. In November, our Board of Directors approved a 1-for-300 reverse stock split, or the Reverse Split, which was implemented on January 2, 2020.

 

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THE OFFERING

 

The information below is only a summary of more detailed information included elsewhere in this prospectus. This summary may not contain all the information that is important to you or that you should consider before making a decision to invest in our securities. Please read this entire prospectus, including the risk factors, carefully.

 

Common Units offered   1,000,000 Common Units, each consisting of one common share and one Warrant, each whole Warrant exercisable for one common share. The Warrants included within the units are exercisable immediately, have an exercise price of US$            per share, equal to 125% of the public offering price of one unit, and expire five years from the date of issuance. The common shares and Warrants that are part of the Common Units are immediately separable and will be issued separately in this offering.
     
Pre-Funded Units offered  

We are also offering to those purchasers, if any, whose purchase of Common Units in this offering would otherwise result in the purchaser, together with its affiliates and certain related parties, beneficially owning more than 4.99% (or, at the election of the purchaser, 9.99%) of our outstanding common shares immediately following the consummation of this offering, the opportunity to purchase, if the purchaser so chooses, pre-funded units (each a “Pre-funded Unit”) in lieu of Common Units that would otherwise result in the purchaser’s beneficial ownership exceeding 4.99% (or, at the election of the purchaser, 9.99%) of our outstanding common shares. Each Pre-funded Unit will consist of a pre-funded warrant to purchase one common share at an exercise price of US$0.0001 per share (each a “Pre-funded Warrant”) and a Warrant. The purchase price of each Pre-funded Unit is equal to the price per Common Unit being sold to the public in this offering, minus US$0.0001. The Pre-funded Warrants will be immediately exercisable and may be exercised at any time until all of the Pre-funded Warrants are exercised in full. For each Pre-funded Unit we sell, the number of Common Units we are offering will be decreased on a one-for-one basis. We are offering a maximum of 1,000,000 Pre-funded Units. Because we will issue one Warrant as part of each Common Unit or Pre-funded Unit, the number of Warrants sold in this offering will not change as a result of a change in the mix of the Common Units and Pre-funded Units sold. This prospectus also relates to the offering of the common shares issuable upon exercise of the Pre-funded Warrants.

     
Public offering price  

The assumed public offering price is US$4.00 per Common Unit and US$3.99 per Pre-Funded Unit

     
Common shares outstanding prior to this offering   721,962 shares of common stock, after giving effect to the Reverse Split.
     
Common shares outstanding after this offering (1)(2)   1,721,962 shares
     
Use of proceeds   We expect to receive approximately US$3,000,000 in net proceeds from the sale of securities offered by us in this offering, after deducting estimated placement agent fees and estimated offering expenses payable by us, based on an assumed offering price of US$4.00 per Common Unit. We intend to use the net proceeds from this offering to advance our clinical trials and as further set forth in the “Use of Proceeds” section.
     
Risk factors   An investment in our securities involves significant risks. See the section entitled “Risk Factors” and other information included in this prospectus for a discussion of factors you should carefully consider before deciding to invest in our securities.
     
Lock-up   We and our directors and executive officers have agreed with the placement agent not to offer, issue, sell, contract to sell, encumber, grant any option for the sale of or otherwise dispose of any of our securities for a period of six months commencing on the date of this prospectus. See “Plan of Distribution” beginning on page 117.
     
Market and trading symbol for our common shares and Warrants   Our common shares are currently quoted on the OTCQB under the symbol “BCTXF”, on the TSXV under the symbol “BCT.V” and on the Frankfurt Stock Exchange under the symbol “8BTA”. We do not plan to list the Warrants or Pre-funded Warrants on any market or exchange.

 

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(1)

The number of common shares to be outstanding after this offering is based on 721,962 common shares outstanding as of May 27, 2020 and excludes the following:

 

  178,528 shares of common stock issuable upon the exercise of outstanding warrants, at a weighted average exercise price of $44.19;
     
  13,790 shares of common stock issuable upon the exercise of outstanding compensation warrants, at a weighted average exercise price of $43.20;
     
 

912 shares of common stock issuable upon the granting of 912 warrants arising from the exercise of 912 compensation warrants at a weighted average exercise price of $90.00; and

     
 

19,969 shares of common stock issuable upon the exercise of outstanding options, at a weighted average exercise price of $49.43.

 

(2)

Except as otherwise indicated herein, all information in this prospectus assumes no sale of Pre-funded Units in this offering, no exercise of the warrants being offered in this offering, and no exercise of the placement agent warrants.

 

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Summary Financial Data

 

The summary financial information set forth below has been derived from our unaudited condensed consolidated interim financial statements for the three and six months ended January 31, 2020 and our audited financial statements for the fiscal years ended July 31, 2019, 2018, 2017, 2016 and 2015. You should read the following summary financial data for the three and six months ended January 31, 2020 and the years ended July 31, 2019 and 2018 together with our historical financial statements and the notes thereto included elsewhere in this prospectus and with the information set forth in the section titled “Management’s Discussion and Analysis of Financial Conditions and Results of Operations”. The audited financial statements for the years ended July 31, 2017, 2016 and 2015 are not included in this prospectus.

 

   

As of

January 31,

    As of July 31,  
    2020     2019     2018     2017     2016     2015  
                                     
Balance Sheet Data                                                
Cash and cash equivalents     93,692       192,916       938,448       1,264,429       171,865       464,732  
Total Assets     631,852       546,259       2,977,140       2,039,199       1,091,587       1,660,288  
Total Liabilities     3,620,682       1,392,396       1,745,850       1,104,147       63,470       152,425  
Total Shareholders’ Equity (deficit)     (2,988,830 )     (846,137 )     1,231,290       935,052       1,028,117       1,507,863  

 

   

Six months ended

January 31,

    Year ended July 31,  
    2020     2019     2018     2017     2016     2015  
Operating Data                                                
Revenues and other income     -       -       -       -       -       -  
                                                 
Expenses:                                                
Research costs     2,220,697       4,917,287       3,112,579       2,125,941       944,942       390,036  
General and administrative costs     1,220,122       1,244,471       1,387,713       820,281       584,105       892,611  
Share-based compensation     1,779       60,586       476,211       272,014       648,149       516,288  
Listing costs             -       -       -       -       1,599,488  
Surrender of royalty rights     -       -       -       -       -       150,000  
Total expenses     3,442,598       6,222,344       4,976,503       3,218,236       2.177,196       3,548,423  
                                                 
Operating loss     (3,442,598 )     (6,222,344 )     (4,976,503 )     (3,218,236 )     (2.177,196 )     (3,548,423 )
Interest income     -       12,004       15,991       6,428       4,738       9,227  
Interest expenses     (6,208 )     (31,317 )     (20,364 )     -       -       -  
Change in fair value of convertible debt     (79,119 )     420,585       (407,709 )     -       -       -  
Loss on available for sale investments     -       -       -       -       (27,763 )     -  
Foreign exchange gain (loss)     (20,096 )     31,410       (24,078 )     (8,913 )     (14,561 )     50,385  
      (105,423 )     432,682       (436,160 )     (2,485 )     (37,586 )     59,612  
                                                 
Loss For The Period     (3,548,021 )     (5,789,662 )     (5,412,663 )     (3,220,721 )     (2,214,782 )     (3,488,811 )
                                                 
Items That Will Subsequently Be Reclassified To Profit Or Loss                                                
Foreign currency translation adjustment     (11,195 )     (18,781 )     (33,340 )     41,828       18,575       (48,921 )
Unrealized loss on available for sale investments     -       -       -       -       (6,892 )     (20,871 )
                                                 
Items Reclassified To Profit Or Loss     -                                          
Reclass of unrealized losses on available for sale investments     -       -       -       -       27,763       -  
                                                 
Comprehensive loss for the year     (3,559,216 )     (5,808,443 )     (5,446,003 )     (3,178,893 )     (2,175,336 )     (3,558,603 )
                                                 
Basic and Fully Diluted Loss Per Share     (5.07 )     (10.02 )     (12.73 )     (9.36 )     (7.54 )     (14.28 )
Weighted Average Number Of Shares Outstanding     702,022       579,664       427,815       339,707       288,472       249,203  

 

17

 

 

RISK FACTORS

 

An investment in our common shares involves a high degree of risk. You should carefully consider the following factors and other information in this prospectus before deciding to invest in us. If any of the following risks actually occur, our business, financial condition, results of operations and prospects for growth would likely suffer. As a result, you could lose all or part of your investment. Additional risks and uncertainties not presently known to us or that we currently deem immaterial also may materially and adversely affect our business, financial condition and results of operations. See also “Cautionary Statement Regarding Forward-Looking Statements.”

 

Risks Related to Our Business

 

We have a history of losses, may incur future losses and may not achieve profitability

 

BriaCell is a development stage immune-oncology biotechnology corporation that to date has not recorded any revenues from the sale of diagnostic or therapeutic products. Since incorporation, BriaCell has accumulated net losses and expects such losses to continue as it commences product and pre-clinical development and eventually enters into license agreements for its technology. We incurred net losses of $3,548,021, $3,220,721, $5,412,663 and $5,789,662 in the six months ended January 31, 2020 and the fiscal years ended July 31, 2017, 2018 and 2019, respectively. Management expects to continue to incur substantial operating losses unless and until such time as product sales generate sufficient revenues to fund continuing operations. BriaCell has neither a history of earnings nor has it paid any dividends and it is unlikely to pay dividends or enjoy earnings in the immediate or foreseeable future.

 

We are an early stage development company

 

The Company expects to spend a significant amount of capital to fund research and development. As a result, the Company expects that its operating expenses will increase significantly and, consequently, it will need to generate significant revenues to become profitable. Even if the Company does become profitable, it may not be able to sustain or increase profitability on a quarterly or annual basis. The Company cannot predict when, if ever, it will be profitable. There can be no assurances that the Intellectual Property of BriaCell, or other technologies it may acquire, will meet applicable regulatory standards, obtain required regulatory approvals, be capable of being produced in commercial quantities at reasonable costs, or be successfully marketed. The Company will be undertaking additional laboratory studies or trials with respect to the Intellectual Property of BriaCell, and there can be no assurance that the results from such studies or trials will result in a commercially viable product or will not identify unwanted side effects.

 

We have an unproven market for our product candidates

 

The Company believes that the anticipated market for its potential products and technologies if successfully developed will continue to exist and expand. These assumptions may prove to be incorrect for a variety of reasons, including competition from other products and the degree of commercial viability of the potential product.

 

We may not succeed in adapting to and meeting the business needs associated with our anticipated growth

 

Anticipated growth in all areas of BriaCell’s business is expected to continue to place a significant strain on its managerial, operational and technical resources. The Company expects operating expenses and staffing levels to increase in the future. To manage such growth, the Company must expand its operational and technical capabilities and manage its employee base while effectively administering multiple relationships with various third parties. There can be no assurance that the Company will be able to manage its expanding operations effectively. Any failure to implement cohesive management and operating systems, to add resources on a cost-effective basis or to properly manage the Company’s expansion could have a material adverse effect on its business and results of operations.

 

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We are heavily reliant on third-parties to carry out a large portion of our business

 

The Company does not expect to have any in-house manufacturing, pharmaceutical development or marketing capability. To be successful, a product must be manufactured and packaged in commercial quantities in compliance with regulatory requirements and in reasonable time frames and at accepted costs. The Company intends to contract with third parties to develop its products. No assurance can be given that the Company or its suppliers will be able to meet the supply requirements in respect of the product development or commercial sales.

 

Production of therapeutic products may require raw materials for which the sources and amount of supply are limited, or may be hindered by quality or scheduling issues in respect of the third party suppliers over which the Company has limited control. An inability to obtain adequate supplies of raw materials could significantly delay the development, regulatory approval and marketing of a product. The Company has limited in-house personnel to internally manage all aspects of product development, including the management of multi-center clinical trials. The Company is significantly reliant on third-party consultants and contractors to provide the requisite advice and management. There can be no assurance that the clinical trials and product development will not encounter delays which could adversely affect prospects for the Company’s success.

 

To be successful, an approved product must also be successfully marketed. The market for the Company’s product being developed by the Company may be large and will require substantial sales and marketing capability. At the present time, the Company does not have any internal capability to market pharmaceutical products. The Company intends to enter into one or more strategic partnerships or collaborative arrangements with pharmaceutical companies or other companies with marketing and distribution expertise to address this need. If necessary, the Company will establish arrangements with various partners for geographical areas. There can be no assurance that the Company can market, or can enter into a satisfactory arrangement with a third party to market a product in a manner that would assure its acceptance in the marketplace. However, if a satisfactory arrangement with a third party to market and/or distribute a product is obtained; the Company will be dependent on the corporate collaborator(s) who may not devote sufficient time, resources and attention to the Company’s programs, which may hinder efforts to market the products.

 

Should the Company not establish marketing and distribution strategic partnerships and collaborative arrangements on acceptable terms, and undertake some or all of those functions, the Company will require significant additional human and financial resources and expertise to undertake these activities, the availability of which is not guaranteed. The Company will rely on third parties for the timely supply of raw materials, equipment, contract manufacturing, and formulation or packaging services. Although the Company intends to manage these third-party relationships to ensure continuity and quality, some events beyond the Company’s control could result in complete or partial failure of these goods and services. Any such failure could have a material adverse effect on the financial conditions and result of operation of the Company

 

Due to the complexity of the process of developing pharmaceutical products, the Company’s business may depend on arrangements with pharmaceutical and biotechnology companies, corporate and academic collaborators, licensors, licensees and others for the research, development, clinical testing, technology rights, manufacturing, marketing and commercialization of its products. Such agreements could obligate the Company to diligently bring potential products to market, make milestone payments and royalties that, in some instances, could be substantial, and incur the costs of filing and prosecuting patent applications. There can be no assurance that the Company will be able to establish or maintain collaborations that are important to its business on favorable terms, or at all.

 

A number of risks arise from the Company’s potential dependence on collaborative agreements with third parties. Product development and commercialization efforts could be adversely affected if any collaborative partner terminates or suspends its agreement with the Company, causes delays, fails to on a timely basis develop or manufacture in adequate quantities a substance needed in order to conduct clinical trials, fails to adequately perform clinical trials, determines not to develop, manufacture or commercialize a product to which it has rights, or otherwise fails to meet its contractual obligations. The Company’s collaborative partners could pursue other technologies or develop alternative products that could compete with the products the Company is developing.

 

The Company has signed Non-Disclosure Agreements (“NDA”) with many different third parties as is customary in the industry. There is no guarantee that, despite the terms of the NDA which bind third parties, the Company will ultimately be able to prevent from such third parties from breaching their obligations under the NDA. Use of the Company’s confidential information in an unauthorized manner is likely to negatively affect the Company.

 

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Pre-clinical studies and initial clinical trials are not necessarily predictive of future results

 

Pre-clinical tests and Phase I/II clinical trials are primarily designed to test safety, to study pharmacokinetics and pharmacodynamics and to understand the side effects of product candidates at various doses and schedules. Success in pre-clinical and early clinical trials does not ensure that later large-scale efficacy trials will be successful nor does it predict final results. Favorable results in early trials may not be repeated in later trials.

 

A number of companies in the life sciences industry have suffered significant setbacks in advanced clinical trials, even after positive results in earlier trials. Clinical results are frequently susceptible to varying interpretations that may delay, limit or prevent regulatory approvals. Negative or inconclusive results or adverse medical events during a clinical trial could cause a clinical trial to be delayed, repeated or terminated. Any pre-clinical data and the clinical results obtained for BriaCell’s technology may not predict results from studies in larger numbers of subjects drawn from more diverse populations or in the commercial setting, and also may not predict the ability of our products to achieve their intended goals, or to do so safely.

 

An inability to obtain raw materials or product supply could have a material adverse impact on the Company’s business, financial condition and results of operations

 

Raw materials and supplies are generally available in quantities to meet the needs of the Company’s business. The Company will be dependent on third-party manufacturers for the pharmaceutical products that it markets. An inability to obtain raw materials or product supply could have a material adverse impact on the Company’s business, financial condition and results of operations.

 

We must obtain additional capital to continue our operations

 

The Company anticipates that additional capital will be required to complete its current research and development programs. It is anticipated that future research, additional pre-clinical and toxicology studies and manufacturing initiatives, including that to prepare for market approval and successful product market launch will require additional funds. Further financing may dilute the current holdings of shareholders and may thereby result in a loss for the shareholders. There can be no assurance that the Company will be able to obtain adequate financing, or financing on terms that are reasonable or acceptable for these or other purposes, or to fulfill the Company’s obligations under various license agreements. Failure to obtain such additional financing could result in delay or indefinite postponement of further research and development of the Company’s technologies with the possible loss of license rights to these technologies.

 

Although the Company’s common shares are quoted or listed for trading on the OTCQB and TSXV, there can be no assurance that a liquid market for our common shares will develop, which may have an adverse effect on the market price of the Company’s common shares. There is no guarantee that our common shares will remain listed on the TSXV after the offering.

 

We are highly dependent on our key personnel

 

Although the Company is expected to have experienced senior management and personnel, the Company will be substantially dependent upon the services of a few key personnel, particularly Dr. Charles Wiseman, Dr. Markus Lacher and Dr. William V. Williams and other professionals for the successful operation of its business. Phase I of the Company’s research and development is planned to be completed by qualified professionals and is expected to concentrate on treatment of advanced breast cancer. The loss of the services of any of these personnel could have a material adverse effect on the business of the Company. The Company may not be able to attract and retain personnel on acceptable terms given the intense competition for such personnel among high technology enterprises, including biotechnology, and healthcare companies, universities and non-profit research institutions. If we lose any of these persons, or are unable to attract and retain qualified personnel, our business, financial condition and results of operations may be materially and adversely affected.

 

20

 

 

If the Company experiences a data security breach and confidential information is disclosed, the Company may be subject to penalties and experience negative publicity

 

The Company and its customers could suffer harm if personal and health information were accessed by third parties due to a system security failure. The collection of data requires the Company to receive and store a large amount of personally identifiable data. Recently, data security breaches suffered by well-known companies and institutions have attracted a substantial amount of media attention, prompting legislative proposals addressing data privacy and security. The Company may become exposed to potential liabilities with respect to the data that it collects, manages and processes, and may incur legal costs if information security policies and procedures are not effective or if the Company is required to defend its methods of collection, processing and storage of personal data. Future investigations, lawsuits or adverse publicity relating to its methods of handling such information could have a material adverse effect on the Company’s business, financial condition and results of operations due to the costs and negative market reaction relating to such developments.

 

The report of our independent registered public accounting firm expresses substantial doubt about our ability to continue as a going concern

 

Our independent registered public accounting firm indicated in its report on our financial statements for the year ended July 31, 2019, that conditions exist that raise substantial doubt about our ability to continue as a “going concern.” A going concern paragraph included in our independent registered public accounting firm’s report on our consolidated financial statements could impair investor perceptions and our ability to finance our operations through the sale of equity, incurring debt, or other financing alternatives. Our ability to continue as a going concern will depend upon many factors beyond our control including the availability and terms of future funding. If we are unable to achieve our goals and raise the necessary funds to finance our operations, our business would be jeopardized, and we may not be able to continue. If we ceased operations, it is likely that all of our investors would lose their investment.

 

We may not succeed in completing the development of our products, commercializing our products or generating significant revenues

 

Since commencing our operations, we have focused on the research and development and limited clinical trials of our product candidates. Our ability to generate revenues and achieve profitability depends on our ability to successfully complete the development of our products, obtain market approval and generate significant revenues. The future success of our business cannot be determined at this time, and we do not anticipate generating revenues from product sales for the foreseeable future. In addition, we face a number of challenges with respect to our future commercialization efforts, including, among others, that:

 

  we may not have adequate financial or other resources to complete the development of our product, including two stages of clinical development that are necessary in order to commercialize our products;
     
  we may not be able to manufacture our products in commercial quantities, at an adequate quality or at an acceptable cost;
     
  we may not be able to maintain our CE mark due to the regulatory changes;
     
  we may never receive FDA approval for our intended development plans;
     
  we may not be able to establish adequate sales, marketing and distribution channels;
     
  healthcare professionals and patients may not accept our product candidates;
     
  technological breakthroughs in cancer detection, treatment and prevention may reduce the demand for our product candidates;
     
  changes in the market for cancer treatment, new alliances between existing market participants and the entrance of new market participants may interfere with our market penetration efforts;

 

21

 

 

  third-party payors may not agree to reimburse patients for any or all of the purchase price of our products, which may adversely affect patients’ willingness to purchase our product candidates;
     
  uncertainty as to market demand may result in inefficient pricing of our product candidates;
     
  we may face third-party claims of intellectual property infringement;
     
  we may fail to obtain or maintain regulatory approvals for our products candidates in our target markets or may face adverse regulatory or legal actions relating to our product candidates even if regulatory approval is obtained; and
     
  we are dependent upon the results of ongoing clinical studies relating to our product candidates and the products of our competitors. We may fail in obtaining positive results.

 

If we are unable to meet any one or more of these challenges successfully, our ability to effectively commercialize our product candidates could be limited, which in turn could have a material adverse effect on our business, financial condition and results of operations.

 

If product liability lawsuits are brought against us, we may incur substantial liabilities and the commercialization of our drug candidates may be affected

 

As our drug candidates enter clinical trials, we will face an inherent risk of product liability suits and will face an even greater risk if we obtain approval to commercialize any drugs. For example, we may be sued if our drug candidates cause or are perceived to cause injury or are found to be otherwise unsuitable during clinical testing, manufacturing, marketing or sale. Any such product liability claims may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the drug, negligence, strict liability or a breach of warranties. Claims could also be asserted under state consumer protection acts. If we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to limit commercialization of our drug candidates. Even successful defense would require significant financial and management resources. Regardless of the merits or eventual outcome, liability claims may result in:

 

  decreased demand for our drugs;
     
  injury to our reputation;
     
  withdrawal of clinical trial participants and inability to continue clinical trials;
     
  initiation of investigations by regulators;
     
  costs to defend the related litigation;
     
  a diversion of management’s time and our resources;
     
  substantial monetary awards to trial participants or patients;
     
  product recalls, withdrawals or labeling, marketing or promotional restrictions;
     
  loss of revenue;
     
  exhaustion of any available insurance and our capital resources;
     
  the inability to commercialize any drug candidate; and
     
  a decline in the price of our common shares.

 

22

 

 

We shall seek to obtain the appropriate insurance once our candidates are ready for clinical trial. However, our inability to obtain sufficient product liability insurance at an acceptable cost to protect against potential product liability claims could prevent or inhibit the commercialization of drugs we develop, alone or with collaborators. We currently do not have in place product liability insurance and although we plan to have in place such insurance as and when the products are ready for commercialization, as well as insurance covering clinical trials, the amount of such insurance coverage may not be adequate, we may be unable to maintain such insurance, or we may not be able to obtain additional or replacement insurance at a reasonable cost, if at all. Our insurance policies may also have various exclusions, and we may be subject to a product liability claim for which we have no coverage. We may have to pay any amounts awarded by a court or negotiated in a settlement that exceed our coverage limitations or that are not covered by our insurance, and we may not have, or be able to obtain, sufficient capital to pay such amounts. Even if our agreements with any future corporate collaborators entitle us to indemnification against losses, such indemnification may not be available or adequate should any claim arise.

 

Additionally, we may be sued if the products that we commercialize, market or sell cause or are perceived to cause injury or are found to be otherwise unsuitable, and may result in:

 

  decreased demand for those products;
     
  damage to our reputation;
     
  costs incurred related to product recalls;
     
  limiting our opportunities to enter into future commercial partnership; and
     
  a decline in the price of our common shares.

 

We face business disruption and related risks resulting from the recent outbreak of the novel coronavirus 2019 (COVID-19), which could have a material adverse effect on our business plan.

 

The development of our product candidates could be disrupted and materially adversely affected by the recent outbreak of COVID-19. As a result of measures imposed by the governments in affected regions, businesses and schools have been suspended due to quarantines intended to contain this outbreak. The spread of COVID-19 from China to other countries has resulted in the Director General of the World Health Organization declaring the outbreak of COVID-19 as a Public Health Emergency of International Concern (PHEIC), based on the advice of the Emergency Committee under the International Health Regulations (2005), and the Centers for Disease Control and Prevention in the U.S. issued a warning on February 25, 2020 regarding the likely spread of COVID-19 to the U.S. While the COVID-19 outbreak is still in the early stages, international stock markets have begun to reflect the uncertainty associated with the slow-down in the Chinese economy and the reduced levels of international travel experienced since the beginning of January and the significant declines in the Dow Industrial Average during 2020 was largely attributed to the effects of COVID-19. We have enrolled, and will seek to enroll, cancer patients in our clinical trials. In the event that clinical trial sites are slowed down or closed to enrollment in our trials, this could have a material adverse impact on our clinical trial plans and timelines. We may face difficulties recruiting or retaining patients in our ongoing and planned clinical trials if patients are affected by the virus or are fearful of visiting or traveling to our clinical trial sites because of the outbreak. We are continuing to assess our business plans and the impact COVID-19 is having on our clinical trial timelines and our ability to recruit candidates for clinical trials, but there can be no assurance that this analysis will enable us to avoid part or all of any impact from the spread of COVID-19 or its consequences, including downturns in business sentiment generally or in our sector in particular.  The extent to which COVID-19 and global efforts to contain its spread will impact our operations will depend on future developments, which are highly uncertain and cannot be predicted at this time, and include the duration, severity and scope of the outbreak and the actions taken to contain or treat the coronavirus outbreak. We currently believe that the execution of our clinical trials and research programs are delayed by at least one quarter due to COVID-19.

 

Risks Related to Our Intellectual Property

 

We may not successfully develop, maintain and protect our proprietary products and technologies

 

BriaCell’s success depends to a significant degree upon its ability to develop, maintain and protect proprietary products and technologies. BriaCell files patent applications in the United States and other countries as part of its global strategy to protect its Intellectual Property and maintains certain US and Non-US patents in its IP portfolio. However, patents provide only limited protection of BriaCell’s Intellectual Property. The assertion of patent protection involves complex legal and factual determinations and is therefore uncertain and can be expensive. BriaCell cannot provide assurances that patents will be granted with respect to any of its pending patent applications, or that the scope of any of its granted patents, or any patents granted in the future, will be sufficiently broad to offer meaningful protection, or that it will develop and file patent applications on additional proprietary technologies that are patentable, or, if patentable, that any patents will be granted from such patent applications. BriaCell’s current or future patents could be successfully challenged, invalidated or circumvented. This could result in BriaCell’s patent rights failing to create an effective competitive barrier. Losing a significant patent or failing to get a patent to issue from a pending patent application that BriaCell considers significant could have a material adverse effect on BriaCell’s business. The laws governing the scope of patent coverage in various countries continue to evolve. The laws of some foreign countries may not protect BriaCell’s Intellectual Property rights to the same extent as the laws of the United States. BriaCell has applied for patent protection only in selected countries. Therefore, third parties may be able to replicate BriaCell technologies covered by BriaCell’s patent portfolio in countries in which it does not have patent protection.

 

BriaCell’s future success and competitive position depends in part upon its ability to maintain its Intellectual Property portfolio. There can be no assurance that any patents will be issued on any existing or future patent applications.

 

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We are susceptible to intellectual property suits that could cause us to incur substantial costs or pay substantial damages or prohibit us from selling our product candidates

 

There is a substantial amount of litigation over patent and other Intellectual Property rights in the biotechnology industry. Whether or not a product infringes a patent involves complex legal and factual considerations, the determination of which is often uncertain. Our management is presently unaware of any other parties’ patents and proprietary rights which our products under development would infringe. Searches typically performed to identify potentially infringed patents of third parties are often not conclusive and, because patent applications can take many years to issue, there may be applications now pending, which may later result in issued patents which our current or future products may infringe or be alleged to infringe. In addition, our competitors or other parties may assert that our product candidates and the methods employed may be covered by patents held by them. If any of our products infringes a valid patent, we could be prevented from manufacturing or selling such product unless we are able to obtain a license or able to redesign the product in such a manner as to avoid infringement. A license may not always be available or may require us to pay substantial royalties. We also may not be successful in any attempt to redesign our product to avoid infringement, nor does a later redesign protect BriaCell from prior infringement. Infringement and other Intellectual Property claims, with or without merit, can be expensive and time-consuming to litigate and can divert our management’s attention from operating our business.

 

The steps we have taken to protect our Intellectual Property may not be adequate, which could have a material adverse effect on our ability to compete in the market

 

BriaCell’s ability to establish and maintain a competitive position may be achieved in part by prosecuting claims against others who it believes to be infringing its rights. In addition, enforcement of BriaCell’s patents in foreign jurisdictions will depend on the legal procedures in those jurisdictions. In addition to filing patent applications, we rely on confidentiality, non-compete, non-disclosure and assignment of inventions provisions, as appropriate, in our agreements with our employees, consultants, and service providers, to protect and otherwise seek to control access to, and distribution of, our proprietary information. These measures may not be adequate to protect our Intellectual Property from unauthorized disclosure, third-party infringement or misappropriation, for the following reasons:

 

  the agreements may be breached, may not provide the scope of protection we believe they provide or may be determined to be unenforceable;
     
  we may have inadequate remedies for any breach;
     
  proprietary information could be disclosed to our competitors; or
     
  others may independently develop substantially equivalent or superior proprietary information and techniques or otherwise gain access to our trade secrets or disclose such technologies.

 

Specifically, with respect to non-compete agreements, both state law and precedent varies greatly from state to state and we may be unable to enforce these agreements, in whole or in part, and it may be difficult for us to restrict our competitors from gaining the expertise that our former employees gained while working for us. If our Intellectual Property is disclosed or misappropriated, it could harm our ability to protect our rights and could have a material adverse effect on our business, financial condition and results of operations.

 

We may need to initiate lawsuits to protect or enforce our patents and other Intellectual Property rights, which could be expensive and, if we lose, could cause us to lose some of our Intellectual Property rights, which would harm our ability to compete in the market

 

We rely on patents, confidentiality and trade secrets to protect a portion of our Intellectual Property and our competitive position. Patent law relating to the scope of claims in the technology fields in which we operate is still evolving and, consequently, patent positions in the biotechnology/pharmaceutical industry can be uncertain. In order to protect or enforce our patent rights, we may initiate patent and related litigation against third parties, such as infringement suits or requests for injunctive relief. BriaCell’s ability to establish and maintain a competitive position may be achieved in part by prosecuting claims against others who it believes to be infringing its rights. In addition, enforcement of BriaCell’s patents in foreign jurisdictions will depend on the legal procedures in those jurisdictions. Any lawsuits that we initiate could be expensive, take significant time and divert our management’s attention from other business concerns and the outcome of litigation to enforce our Intellectual Property rights in patents, copyrights, trade secrets or trademarks is highly unpredictable. Litigation also puts our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing, or adversely affect its ability to distribute any products that are subject to such litigation. In addition, we may provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate, and the damages or other remedies awarded, including attorney fees, if any, may not be commercially valuable. The occurrence of any of these events could have a material adverse effect on our business, financial condition and results of operations.

 

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We may be subject to damages resulting from claims that we or our employees or contractors have wrongfully used or disclosed alleged trade secrets of their former employers

 

Many of our employees and contractors were previously employed at universities or other biotechnology or pharmaceutical companies, including our competitors or potential competitors. Although no claims against us are currently pending, we may be subject to claims that we or any employee or contractor has inadvertently or otherwise used or disclosed trade secrets or other proprietary information of his or her former employers. Litigation may be necessary to defend against these claims. If we fail in defending such claims, in addition to paying monetary damages, we may lose valuable Intellectual Property rights or personnel. A loss of key research personnel or their work product could hamper or prevent our ability to commercialize certain therapeutic candidates, which could severely harm our business, financial condition and results of operations. Even if we are successful in defending against these claims, litigation could result in substantial costs and be a distraction to management.

 

If the FDA or comparable foreign regulatory authorities approve generic versions of any of our products that receive marketing approval, or such authorities do not grant our products appropriate periods of exclusivity before approving generic versions of our products, the sales of our products could be adversely affected.

 

Once a new drug application is approved, the product covered thereby becomes a “reference listed drug” in the FDA’s publication, “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the Orange Book. Manufacturers may seek approval of generic versions of reference listed drugs through submission of abbreviated new drug applications in the United States. In support of an abbreviated new drug applications, a generic manufacturer need not conduct clinical trials. Rather, the applicant generally must show that its product has the same active ingredient(s), dosage form, strength, route of administration and conditions of use or labeling as the reference listed drug and that the generic version is bioequivalent to the reference listed drug, meaning it is absorbed in the body at the same rate and to the same extent. Generic products may be significantly less costly to bring to market than the reference listed drug and companies that produce generic products are generally able to offer them at lower prices. Thus, following the introduction of a generic drug, a significant percentage of the sales of any branded product or reference listed drug is typically lost to the generic product.

 

The FDA may not approve abbreviated new drug applications for a generic product until any applicable period of non-patent exclusivity for the reference listed drug has expired. The United States Federal Food, Drug, and Cosmetic Act provides a period of five years of non-patent exclusivity for a new drug containing a new chemical entity (“NCE”). Specifically, in cases where such exclusivity has been granted, abbreviated new drug applications may not be submitted to the FDA until the expiration of five years unless the submission is accompanied by a Paragraph IV certification that a patent covering the reference listed drug is either invalid or will not be infringed by the generic product, in which case the applicant may submit its application four years following approval of the reference listed drug.

 

While we believe that our products contain active ingredients that would be treated as NCEs by the FDA and, therefore, if approved, should be afforded five years of data exclusivity, the FDA may disagree with that conclusion and may approve generic products after a period that is less than five years. If the FDA were to award NCE exclusivity to someone other than us, we believe that we would still be awarded three year “Other” exclusivity protection from generic competition, which is awarded when an application or supplement contains reports of new clinical investigations (not bioavailability studies) conducted or sponsored by an applicant and essential for approval. Manufacturers may seek to launch these generic products following the expiration of the applicable marketing exclusivity period, even if we still have patent protection for our product. If we do not maintain patent protection and data exclusivity for our product candidates, our business may be materially harmed.

 

Competition that our products may face from generic versions of our products could materially and adversely impact our future revenue, profitability and cash flows and substantially limit our ability to obtain a return on the investments we have made in those product candidates.

 

Patent terms may be inadequate to protect our competitive position on our product candidates for an adequate amount of time.

 

Patents have a limited lifespan. In the United States, if all maintenance fees are timely paid, the natural expiration of a patent is generally 20 years from its earliest United States non-provisional filing date. Various extensions may be available, but the life of a patent, and the protection it affords, is limited. Even if patents covering our product candidates are obtained, once the patent life has expired, we may be open to competition from competitive products, including generics or biosimilars. Given the amount of time required for the development, testing, and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. As a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours.

 

Risks Related to Regulations

 

Changes in legislation and regulations may affect our revenue and profitability

 

Existing and proposed changes in the laws and regulations affecting public companies may cause the Company to incur increased costs as the Company evaluates the implications of new rules and responds to new requirements. Failure to comply with new rules and regulations could result in enforcement actions or the assessment of other penalties. New laws and regulations could make it more difficult to obtain certain types of insurance, including director’s and officer’s liability insurance, and the Company may be forced to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage, to the extent that such coverage remains available.

 

The impact of these events could also make it more difficult for the Company to attract and retain qualified persons to serve on the Company’s Board of Directors, or as executive officers. The Company may be required to hire additional personnel and utilize additional outside legal, accounting and advisory services, all of which could cause the Company’s general and administrative costs to increase beyond what the Company currently has planned. Although the Company evaluates and monitors developments with respect to new rules and laws, the Company cannot predict or estimate the amount of the additional costs the Company may incur or the timing of such costs with respect to such evaluations and/or compliance and cannot provide assurances that such additional costs will render the Company compliant with such new rules and laws.

 

If we or our licensees are unable to obtain U.S., Canadian and/or foreign regulatory approval for our product candidates, we will be unable to commercialize our therapeutic candidates

 

To date, we have not marketed, distributed or sold an approved product. Our therapeutic candidates are subject to extensive governmental regulations relating to development, clinical trials, manufacturing and commercialization of drugs. We may not obtain marketing approval for any of our therapeutic candidates in a timely manner or at all. In connection with the clinical trials for our product candidates and other therapeutic candidates that we may seek to develop in the future, either on our own or throughout licensing arrangements, we face the risk that:

 

  a product candidate may not prove safe or efficacious;
     
  the results with respect to any product candidate may not confirm the positive results from earlier preclinical studies or clinical trials;
     
  the results may not meet the level of statistical significance required by the FDA, Health Canada or other regulatory authorities; and
     
  the results will justify only limited and/or restrictive uses, including the inclusion of warnings and contraindications, which could significantly limit the marketability and profitability of the therapeutic candidate.

 

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Any delay in obtaining, or the failure to obtain, required regulatory approvals will materially and adversely affect our ability to generate future revenues from a particular product candidate. Any regulatory approval to market a product may be subject to limitations on the indicated uses for which we may market the product or may impose restrictive conditions of use, including cautionary information, thereby limiting the size of the market for the product. We and our licensees, as applicable, also are, and will be, subject to numerous foreign regulatory requirements that govern the conduct of clinical trials, manufacturing and marketing authorization, pricing and third-party reimbursement. The foreign regulatory approval process includes all of the risks associated with the FDA approval process that we describe above, as well as risks attributable to the satisfaction of foreign requirements. Approval by the FDA does not ensure approval by regulatory authorities outside the United States. Foreign jurisdictions may have different approval processes than those required by the FDA and may impose additional testing requirements for our therapeutic candidates.

 

If the third parties on which we rely to conduct our clinical trials and clinical development do not perform as contractually required or expected, we may not be able to obtain regulatory clearance or approval for, or commercialize, our product candidates

 

We do not have the ability to independently conduct our clinical trials for our product candidates and we must rely on third parties, such as contract research organizations, medical institutions, clinical investigators and contract laboratories to conduct such trials. If these third parties do not successfully carry out their contractual duties or regulatory obligations or meet expected deadlines, if these third parties need to be replaced, or if the quality or accuracy of the data they obtain is compromised due to the failure to adhere to our clinical protocols or regulatory requirements or for other reasons, our pre-clinical development activities or clinical trials may be extended, delayed, suspended or terminated, and we may not be able to obtain regulatory clearance for, or successfully commercialize, our product candidates on a timely basis, if at all, and our business, operating results and prospects may be adversely affected. Furthermore, our third-party clinical trial investigators may be delayed in conducting our clinical trials for reasons outside of their control.

 

Modifications to our product candidates, or to any other product candidates that we may develop in the future, may require new regulatory clearances or approvals or may require us or our licensees, as applicable, to recall or cease marketing these therapeutic candidates until clearances are obtained

 

Modifications to our product candidates, after they have been approved for marketing, if at all, or to any other pharmaceutical product that we may develop in the future, may require new regulatory clearance, or approvals, and, if necessitated by a problem with a marketed product, may result in the recall or suspension of marketing of the previously approved and marketed product until clearances or approvals of the modified product are obtained. The FDA requires pharmaceutical products manufacturers to initially make and document a determination of whether or not a modification requires a new approval, supplement or clearance. A manufacturer may determine in conformity with applicable regulations and guidelines that a modification may be implemented without pre-clearance by the FDA; however, the FDA can review a manufacturer’s decision and may disagree. The FDA may also on its own initiative determine that a new clearance or approval is required. If the FDA requires new clearances or approvals of any pharmaceutical product or medical device for which we or our licensees receive marketing approval, if any, we or our licensees may be required to recall such product and to stop marketing the product as modified, which could require us or our licensees to redesign the product and will have a material adverse effect on our business, financial condition and results of operations. In these circumstances, we may be subject to significant enforcement actions.

 

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The results of our clinical trials may not support our product claims or may result in the discovery of adverse side effects

 

Even if our clinical trials are completed as planned, we cannot be certain that their results will support our product claims or that any regulatory authority whose approval we will require in order to market and sell our products in any territory will agree with our conclusions regarding them. Success in pre-clinical studies and early clinical trials does not ensure that later clinical trials will be successful, and we cannot be sure that clinical trials will replicate the results of prior trials and pre-clinical studies. The clinical trial process may fail to demonstrate that our product candidates are safe and effective for the proposed indicated uses, which could cause us to abandon a product and may delay development of others. Any delay or termination of our clinical trials will delay the filing of our regulatory submissions and, ultimately, our ability to commercialize our product candidates and generate revenues. 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.

 

Clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results

 

We have limited experience in conducting and managing the clinical trials necessary to obtain regulatory approvals, including FDA approval. Clinical trials are expensive and complex, can take many years and have uncertain outcomes. We cannot predict whether we or our licensees will encounter problems with any of the completed, ongoing or planned clinical trials that will cause us, our licensees or regulatory authorities to delay or suspend clinical trials, or delay the analysis of data from completed or ongoing clinical trials. We estimate that clinical trials of our most advanced therapeutic candidates will continue for several years, but they may take significantly longer to complete. Failure can occur at any stage of the testing and we may experience numerous unforeseen events during, or as a result of, the clinical trial process that could delay or prevent commercialization of our current or future therapeutic candidates, including but not limited to:

 

  delays in securing clinical investigators or trial sites for the clinical trials;
     
  delays in obtaining institutional review board and other regulatory approvals to commence a clinical trial;
     
  slower than anticipated patient recruitment and enrollment;
     
  negative or inconclusive results from clinical trials;
     
  unforeseen safety issues;
     
  uncertain dosing issues;
     
  an inability to monitor patients adequately during or after treatment; and
     
  problems with investigator or patient compliance with the trial protocols.

 

A number of companies in the pharmaceutical and biotechnology industries, including those with greater resources and experience than us, have suffered significant setbacks in advanced clinical trials, even after seeing promising results in earlier clinical trials. Despite the results reported in earlier clinical trials for our therapeutic candidates, we do not know whether any phase 3 or other clinical trials we or our licensees may conduct will demonstrate adequate efficacy and safety to result in regulatory approval to market our therapeutic candidates. If later-stage clinical trials of any therapeutic candidate do not produce favorable results, our ability to obtain regulatory approval for the therapeutic candidate may be adversely impacted, which will have a material adverse effect on our business, financial condition and results of operations.

 

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The pharmaceutical business is subject to increasing government price controls and other restrictions on pricing, reimbursement and access to drugs, which could adversely affect our future revenues and profitability

 

To the extent our products are developed, commercialized, and successfully introduced to market, they may not be considered cost-effective and third-party or government reimbursement might not be available or sufficient. Globally, governmental and other third-party payors are becoming increasingly aggressive in attempting to contain health care costs by strictly controlling, directly or indirectly, pricing and reimbursement and, in some cases, limiting or denying coverage altogether on the basis of a variety of justifications, and we expect pressures on pricing and reimbursement from both governments and private payors inside and outside the U.S. to continue.

 

In the U.S., we are subject to substantial pricing, reimbursement, and access pressures from state Medicaid programs, private insurance programs and pharmacy benefit managers, and implementation of U.S. health care reform legislation is increasing these pricing pressures. The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act (collectively, the “PPACA” or the “Affordable Care Act”), instituted comprehensive health care reform, and includes provisions that, among other things, reduce and/or limit Medicare reimbursement, require all individuals to have health insurance (with limited exceptions), and impose new and/or increased taxes. The future of the Affordable Care Act and its constituent parts are uncertain at this time.

 

In almost all markets, pricing and choice of prescription pharmaceuticals are subject to governmental control. Therefore, the price of our products and their reimbursement in Europe and in other countries is and will be determined by national regulatory authorities. Reimbursement decisions from one or more of the European markets may impact reimbursement decisions in other European markets. A variety of factors are considered in making reimbursement decisions, including whether there is sufficient evidence to show that treatment with the product is more effective than current treatments, that the product represents good value for money for the health service it provides, and that treatment with the product works at least as well as currently available treatments.

 

The continuing efforts of government and insurance companies, health maintenance organizations, and other payors of health care costs to contain or reduce costs of health care may affect our future revenues and profitability or those of our potential customers, suppliers, and collaborative partners, as well as the availability of capital.

 

United States federal and state privacy laws, and equivalent laws of other nations, may increase our costs of operation and expose us to civil and criminal sanctions

 

The Health Insurance Portability and Accountability Act of 1996, as amended, and the regulations that have been issued under it, or collectively HIPAA, and similar laws outside the United States, contain substantial restrictions and requirements with respect to the use and disclosure of individuals’ protected health information. The HIPAA privacy rules prohibit “covered entities,” such as healthcare providers and health plans, from using or disclosing an individual’s protected health information, unless the use or disclosure is authorized by the individual or is specifically required or permitted under the privacy rules. Under the HIPAA security rules, covered entities must establish administrative, physical and technical safeguards to protect the confidentiality, integrity and availability of electronic protected health information maintained or transmitted by them or by others on their behalf. While we do not believe that we will be a covered entity under HIPAA, we believe many of our customers will be covered entities subject to HIPAA. Such customers may require us to enter into business associate agreements, which will obligate us to safeguard certain health information we obtain in the course of our relationship with them, restrict the manner in which we use and disclose such information and impose liability on us for failure to meet our contractual obligations.

 

In addition, under The Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, which was signed into law as part of the U.S. stimulus package in February 2009, certain of HIPAA’s privacy and security requirements are now also directly applicable to “business associates” of covered entities and subject them to direct governmental enforcement for failure to comply with these requirements. We may be deemed as a “business associate” of some of our customers. As a result, we may be subject as a “business associate” to civil and criminal penalties for failure to comply with applicable privacy and security rule requirements. Moreover, HITECH created a new requirement obligating “business associates” to report any breach of unsecured, individually identifiable health information to their covered entity customers and imposes penalties for failing to do so.

 

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In addition to HIPAA, most U.S. states have enacted patient confidentiality laws that protect against the disclosure of confidential medical information, and many U.S. states have adopted or are considering adopting further legislation in this area, including privacy safeguards, security standards, and data security breach notification requirements. These U.S. state laws, which may be even more stringent than the HIPAA requirements, are not preempted by the federal requirements, and we are therefore required to comply with them to the extent they are applicable to our operations.

 

These and other possible changes to HIPAA or other U.S. federal or state laws or regulations, or comparable laws and regulations in countries where we conduct business, could affect our business and the costs of compliance could be significant. Failure by us to comply with any of the standards regarding patient privacy, identity theft prevention and detection, and data security may subject us to penalties, including civil monetary penalties and in some circumstances, criminal penalties. In addition, such failure may damage our reputation and adversely affect our ability to retain customers and attract new customers.

 

The protection of personal data, particularly patient data, is subject to strict laws and regulations in many countries. The collection and use of personal health data in the EU is governed by the provisions of Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data, commonly known as the Data Protection Directive. The Directive imposes a number of requirements including an obligation to seek the consent of individuals to whom the personal data relates, the information that must be provided to the individuals, notification of data processing obligations to the competent national data protection authorities of individual EU Member States and the security and confidentiality of the personal data. The Data Protection Directive also imposes strict rules on the transfer of personal data out of the EU to the U.S. Failure to comply with the requirements of the Data Protection Directive and the related national data protection laws of the EU Member States may result in fines and other administrative penalties and harm our business. We may incur extensive costs in ensuring compliance with these laws and regulations, particularly if we are considered to be a data controller within the meaning of the Data Protection Directive.

 

If we fail to comply with the U.S. federal Anti-Kickback Statute and similar state and foreign country laws, we could be subject to criminal and civil penalties and exclusion from federally funded healthcare programs including the Medicare and Medicaid programs and equivalent third country programs, which would have a material adverse effect on our business and results of operations

 

A provision of the Social Security Act, commonly referred to as the federal Anti-Kickback Statute, prohibits the knowing and willful offer, payment, solicitation or receipt of any form of remuneration, directly or indirectly, in cash or in kind, to induce or reward the referring, ordering, leasing, purchasing or arranging for, or recommending the ordering, purchasing or leasing of, items or services payable, in whole or in part, by Medicare, Medicaid or any other federal healthcare program. Although there are a number of statutory exemptions and regulatory safe harbors to the federal Anti-Kickback Statute protecting certain common business arrangements and activities from prosecution or regulatory sanctions, the exemptions and safe harbors are drawn narrowly, and practices that do not fit squarely within an exemption or safe harbor may be subject to scrutiny. The federal Anti-Kickback Statute is very broad in scope and many of its provisions have not been uniformly or definitively interpreted by existing case law or regulations. In addition, most of the states have adopted laws similar to the federal Anti-Kickback Statute, and some of these laws are even broader than the federal Anti-Kickback Statute in that their prohibitions may apply to items or services reimbursed under Medicaid and other state programs or, in several states, apply regardless of the source of payment. Violations of the federal Anti-Kickback Statute may result in substantial criminal, civil or administrative penalties, damages, fines and exclusion from participation in federal healthcare programs.

 

All of our future financial relationships with U.S. healthcare providers, purchasers, formulary managers, and others who provide products or services to federal healthcare program beneficiaries will potentially be governed by the federal Anti-Kickback Statute and similar state laws. We believe our operations will be in compliance with the federal Anti-Kickback Statute and similar state laws. However, we cannot be certain that we will not be subject to investigations or litigation alleging violations of these laws, which could be time-consuming and costly to us and could divert management’s attention from operating our business, which in turn could have a material adverse effect on our business. In addition, if our arrangements were found to violate the federal Anti-Kickback Statute or similar state laws, the consequences of such violations would likely have a material adverse effect on our business, results of operations and financial condition.

 

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There are other federal and state laws that may affect our ability to operate, including the federal civil False Claims Act, which prohibits, among other things, individuals or entities from knowingly presenting, or causing to be presented, a false or fraudulent claim for payment of government funds or knowingly making, using or causing to be made or used, a false record or statement material to an obligation to pay money to the government or knowingly concealing or knowingly and improperly avoiding, decreasing, or concealing an obligation to pay money to the federal government. Moreover, we may be subject to other federal false claim laws, including, among others, federal criminal healthcare fraud and false statement statutes that extend to non-government health benefit programs. Moreover, there are analogous state laws. Violations of these laws can result in substantial criminal, civil or administrative penalties, damages, fines and exclusion from participation in federal healthcare programs.

 

Moreover, the provisions of the Foreign Corrupt Practices Act of 1997 and other similar anti-bribery laws in other jurisdictions generally prohibit companies and their intermediaries from providing money or anything of value to officials of foreign governments, foreign political parties, or international organizations with the intent to obtain or retain business or seek a business advantage. Recently, there has been a substantial increase in anti-bribery law enforcement activity by U.S. regulators, with more aggressive and frequent investigations and enforcement by both the SEC and the Department of Justice. A determination that our operations or activities violated U.S. or foreign laws or regulations could result in imposition of substantial fines, interruption of business, loss of supplier, vendor or other third-party relationships, termination of necessary licenses and permits, and other legal or equitable sanctions. In addition, lawsuits brought by private litigants may also follow as a consequence.

 

Risks Related to Our Securities and this Offering

 

This is a reasonable efforts offering, no minimum amount of securities is required to be sold, and we may not raise the amount of capital we believe is required for our business plans

 

The placement agent has agreed to use its reasonable efforts to solicit offers to purchase the securities in this offering. The placement agent has no obligation to buy any of the securities from us or to arrange for the purchase or sale of any specific number or dollar amount of the securities. There is no required minimum number of securities that must be sold as a condition to completion of this offering. Because there is no minimum offering amount required as a condition to the closing of this offering, the actual offering amount, placement agent fees and proceeds to us are not presently determinable and may be substantially less than the maximum amounts set forth above. We may sell fewer than all of the securities offered herein, which may significantly reduce the amount of proceeds received by us, and investors in this offering will not receive a refund in the event that we do not sell an amount of securities sufficient to pursue the business plans outlined in this prospectus. Thus, we may not raise the amount of capital we believe is required for our business and may need to raise additional funds, which may not be available or available on terms acceptable to us.

 

An active trading market for our common shares may not develop on the OTCQB and our security holders may not be able to resell their common shares

 

Our common shares are quoted on the OTCQB and listed on the TSXV and Frankfurt Stock Exchange and an active trading market for our common shares has not developed on the OTCQB or on the Frankfurt Stock Exchange.

 

There is no guarantee that our common shares will remain listed on the TSXV after this Offering. We cannot predict the extent to which an active market for our common shares will develop or be sustained on the OTCQB after this Offering. If an active trading market for our common shares does not develop after this Offering, the market price and liquidity of our common shares may be materially and adversely affected.

 

If our common shares are delisted from the TSXV after this offering, management would expect to arrange for listing of our common shares on an alternative stock exchange. However, we cannot guarantee that we will be able to list on the alternative stock exchange in a timely manner or at all. If our common shares do not trade on an alternative stock exchange, shareholders could face reduced liquidity and potential corporate governance and tax considerations (see also “Dispositions of Securities - Certain Canadian Federal Income Tax Considerations For United States Residents”).

 

There is no public market for the Pre-Funded Warrants or Warrants being offered by us in this offering

 

There is no established public trading market for the Pre-Funded Warrants or Warrants being offered in this offering, and we do not expect a market to develop. In addition, we do not intend to apply to list the Pre-Funded Warrants or Warrants on any national securities exchange or other nationally recognized trading system, including the OTCQB or the TSXV. Without an active market, the liquidity of the Pre-Funded Warrants and Warrants will be very limited.

 

The Warrants may not have any value

 

The Warrants will be exercisable for five years from the date of initial issuance at an initial exercise price equal to 125% of the public offering price per unit set forth on the cover page of this prospectus. There can be no assurance that the market price of the common shares will ever equal or exceed the exercise price of the Warrants. In the event that the share price of our common shares does not exceed the exercise price of the Warrants during the period when the Warrants are exercisable, the Warrants may not have any value.

 

Holders of Pre-funded Warrants and Warrants purchased in this offering will have no rights as common shareholders until such holders exercise their Pre-funded Warrants or Warrants and acquire our common shares

 

Until holders of Pre-funded Warrants or Warrants acquire common shares stock upon exercise thereof, such holders will have no rights with respect to the common shares underlying the Pre-funded Warrants and the Warrants. Upon exercise of the Pre-funded Warrants or Warrants, the holders will be entitled to exercise the rights of a common shareholder only as to matters for which the record date occurs after the exercise date.

 

Antidilution provisions in the Warrants may affect the interests of our common stockholders.

 

The Warrants contain price protection provisions that could be triggered by our issuance of common shares in the future, if the offering price for any such future issuance is less than the then-applicable Warrant exercise price. Adjustments to the exercise price of the Warrants pursuant to the antidilution provisions may result in additional dilution to the interests of our shareholders and may adversely affect the market price of our common shares. The antidilution provisions may also limit our ability to obtain additional financing on terms favorable to us.

 

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Future issuance of our common shares could dilute the interests of existing shareholders

 

We may issue additional common shares in the future. The issuance of a substantial number of common shares could have the effect of substantially diluting the interests of our shareholders. In addition, the sale of a substantial amount of common shares in the public market, in the initial issuance, in a situation in which we acquire a company and the acquired company receives common shares as consideration and the acquired company subsequently sells its common shares, or by investors who acquired such common shares in a private placement, could have an adverse effect on the market price of our common shares.

 

We have a significant number of options and warrants outstanding, and while these options and warrants are outstanding, it may be more difficult to raise additional equity capital

 

As of May 27, 2020, we had outstanding options and warrants to purchase 213,119 common shares, respectively. The holders of these options and warrants are given the opportunity to profit from a rise in the market price of our common shares. We may find it more difficult to raise additional equity capital while these options and warrants are outstanding. At any time during which these warrants are likely to be exercised, we may be unable to obtain additional equity capital on more favorable terms from other sources. Additionally, the exercise of these options and warrants will cause the increase of our outstanding common shares, which could have the effect of substantially diluting the interests of our current shareholders.

 

Sales of a substantial number of shares of our common shares in the public market by our existing shareholders could cause our share price to fall

 

Sales of a substantial number of shares of our common shares in the public market, or the perception that these sales might occur, could depress the market price of our common shares and could impair our ability to raise capital through the sale of additional equity securities. We are unable to predict the effect that sales may have on the prevailing market price of our common shares. All of the shares owned by our directors and officers are subject to lock-up agreements with the placement agent of this offering that restrict such shareholders’ ability to transfer our common shares for at least six months from the date of this offering. All of our outstanding shares held by our directors and officers will become eligible for unrestricted sale upon expiration of the lockup period. In addition, shares issued or issuable upon exercise of options and warrants vested as of the expiration of the lock-up period will be eligible for sale at that time. Sales of shares by these shareholders could have a material adverse effect on the trading price of our common shares. We intend to register the offering, issuance, and sale of all common shares that we may issue under our equity compensation plans. Once we register these shares, they can be freely sold in the public market upon issuance, subject to volume limitations applicable to affiliates and the lock-up agreements.

 

We are an Emerging Growth Company, which may reduce the amount of information available to investors

 

The Jumpstart Our Business Start-ups Act, or the JOBS Act, and our status as a foreign private issuer will allow us to postpone the date by which we must comply with some of the laws and regulations intended to protect investors and to reduce the amount of information we provide in our reports filed with the SEC, which could undermine investor confidence in our company and adversely affect the market price of our common shares.

 

For as long as we remain an “emerging growth company” as defined in the JOBS Act, we intend to take advantage of certain exemptions from various requirements that are applicable to public companies that are not emerging growth companies including:

 

  the provisions of the Sarbanes-Oxley Act requiring that our independent registered public accounting firm provide an attestation report on the effectiveness of our internal control over financial reporting;
     
  any rules that may be adopted by the Public Company Accounting Oversight Board requiring mandatory audit firm rotation or a supplement to the auditor’s report on the financial statements.

 

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We intend to take advantage of these exemptions until we are no longer an “emerging growth company.” We will remain an emerging growth company until the earlier of (1) the last day of the fiscal year of the fifth anniversary of the consummation of this offering, (b) in which we have total annual gross revenue of at least US$ 1.07 billion, or (c) in which we are deemed to be a large accelerated filer, which means the market value of our common shares that is held by non-affiliates exceeds US$ 700 million as of the prior June 30, and (2) the date on which we have issued more than US$ 1.0 billion in non-convertible debt during the prior three-year period.

 

We cannot predict if investors will find our common shares or Warrants less attractive because we may rely on these exemptions. If some investors find our common shares or Warrants less attractive as a result, there may be a less active trading market for our common shares, and our common shareprice may be more volatile and may decline.

 

We are a foreign private issuer and, as a result, we are not subject to U.S. proxy rules and are subject to reporting obligations that, to some extent, are more lenient and less frequent than those applicable to a U.S. issuer

 

Because we qualify as a foreign private issuer under the Exchange Act, we are exempt from certain provisions of the Exchange Act that are applicable to U.S. publicly reporting companies, including (i) the sections of the Exchange Act regulating the solicitation of proxies, consents or authorizations in respect of a security registered under the Exchange Act, (ii) the sections of the Exchange Act requiring insiders to file public reports of their stock ownership and trading activities and liability for insiders who profit from trades made in a short period of time, and (iii) the rules under the Exchange Act requiring the filing with the SEC of quarterly reports on Form 10-Q containing unaudited financial and other specified information, or current reports on Form 8-K, upon the occurrence of specified significant events. In addition, while U.S. domestic issuers that are not large accelerated filers or accelerated filers are required to file their annual reports on Form 10-K within 90 days after the end of each fiscal year, foreign private issuers are not required to file their annual report on Form 20-F until 120 days after the end of each fiscal year. Foreign private issuers are also exempt from the Regulation Fair Disclosure, aimed at preventing issuers from making selective disclosures of material information.

 

We have never paid cash dividends on our capital stock and we do not anticipate paying any dividends in the foreseeable future. Consequently, any gains from an investment in our common shares will likely depend on whether the price of our Common shares increases, which may not occur

 

We have not paid cash dividends on any capital stock to date and we currently intend to retain our future earnings, if any, to fund the development and growth of our business. Consequently, in the foreseeable future, you will likely only experience a gain from your investment in our common shares if the price of our common shares increases beyond the price in which you originally acquired the common shares.

 

In the event a market develops for our common shares, the market price of our common shares may be volatile

 

In the event a market develops for our common shares, the market price of our common shares may be highly volatile. Some of the factors that may materially affect the market price of our common shares are beyond our control, such as changes in financial estimates by industry and securities analysts, conditions or trends in the industry in which we operate or sales of our common shares. These factors may materially adversely affect the market price of our common shares, regardless of our performance. In addition, the public stock markets have experienced extreme price and trading volume volatility. This volatility has significantly affected the market prices of securities of many companies for reasons frequently unrelated to the operating performance of the specific companies. These broad market fluctuations may adversely affect the market price of our common shares.

 

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Our executive officers, directors and principal shareholders will maintain the ability to exert significant control over matters submitted to our shareholders for approval 

 

Assuming the sale by us of 1,000,000 Common Units in this offering, our executive officers, directors and principal shareholders who owned more than 5% of our outstanding common shares before this offering will, in the aggregate, beneficially own shares representing approximately 14.04% of our share capital following the completion of this offering. As a result, if these shareholders were to act together, they would be able to control all matters submitted to our shareholders for approval, as well as our management and affairs. For example, these persons, if they act together, would control the election of directors and approval of any merger, consolidation or sale of all or substantially all of our assets. This concentration of voting power could delay or prevent an acquisition of our company on terms that other shareholders may desire or result in management of our company that our public shareholders disagree with.

 

If you purchase our Common Units or Pre-funded Units in this offering, you will incur immediate and substantial dilution in the book value of your shares

 

The public offering price of our Common Units and Pre-funded Units will be substantially higher than the net tangible book value per share of our common shares. Therefore, if you purchase securities in this offering, you will pay a price per share that substantially exceeds our net tangible book value per share after this offering. To the extent outstanding options and warrants are exercised, you will incur further dilution. Based on the assumed public offering price of US$4.00 per Common Unit, assuming no sale of Pre-funded Units and no exercise of the Warrants being offered in this offering, you will experience immediate dilution of US$3.72 per share, representing the difference between our as adjusted net tangible book value per share after giving effect to this offering at the assumed offering price per Common Unit. In addition, all purchasers of Common Units, assuming no sale of Pre-funded Units and no exercise of the Warrants being offered in this offering, will own only approximately 58% of our common shares outstanding after this offering.

 

Our management will have broad discretion in the use of the net proceeds from this offering and may allocate the net proceeds from this offering in ways that you and other shareholders may not approve

 

Our management will have broad discretion in the use of the net proceeds, including for any of the purposes described in the section titled “Use of Proceeds,” and you will not have the opportunity as part of your investment decision to assess whether the net proceeds are being used appropriately. Because of the number and variability of factors that will determine our use of the net proceeds from this offering, their ultimate use may vary substantially from their currently intended use.

 

If we are or become classified as a passive foreign investment company, our U.S. shareholders may suffer adverse tax consequences as a result

 

Generally, for any taxable year, if at least 75% of our gross income is passive income, or at least 50% of the value of our assets is attributable to assets that produce passive income or are held for the production of passive income, including cash, we would be characterized as a passive foreign investment company, or PFIC, for U.S. federal income tax purposes. For purposes of these tests, passive income includes dividends, interest gains from commodities and securities transactions, the excess of gains over losses from the disposition of assets which produce passive income (including amounts derived by reason of the temporary investment of funds raised in offerings of our shares) and rents and royalties other than rents and royalties which are received from unrelated parties in connection with the active conduct of a trade or business. If we are characterized as a PFIC, our U.S. shareholders may suffer adverse tax consequences, including having gains realized on the sale of our common shares treated as ordinary income, rather than capital gain, the loss of the preferential rate applicable to dividends received on our common shares by individuals who are U.S. holders, and having interest charges apply to distributions by us and gains from the sales of our shares.

 

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Our status as a PFIC will depend on the nature and composition of our income and the nature, composition and value of our assets. Asset value is based on which the fair market value of each asset, including goodwill and going concern value (which may be determined by reference to the market value of our common shares, which may be volatile). Our status will also depend, in part, on when and how we utilize the cash proceeds from this offering in our business. Based upon the value of our assets, including any goodwill, and the nature and composition of our income and assets, we believe that we will be classified as a PFIC for the taxable year ending July 31, 2020 and possibly for succeeding years. However, even if we are classified as a PFIC for the year ending July 31, 2020, under an exception to the PFIC classification rules, we may be able to avoid such classification altogether if we can meet certain conditions set forth in the exception. (See the discussion of PFIC status under “Taxation, U.S. Federal Income Taxation”, below. Because the determination of whether we are a PFIC for any taxable year is a factual determination made annually after the end of each taxable year, there can be no assurance as to our status as a PFIC in any taxable year.

 

The tax consequences that would apply if we are classified as a PFIC would also be different from those described above if a U.S. shareholder were able to make a valid qualified electing fund, or QEF, election. If we are classified as a PFIC then we expect to provide U.S. shareholders with the information necessary for a U.S. shareholder to make a QEF election but there is no assurance that we will do so. See the discussion of PFIC status under “Taxation, U.S. Federal Income Taxation”, below.

 

If securities or industry analysts do not publish or cease publishing research or reports about us, our business or our market, or if they adversely change their recommendations or publish negative reports regarding our business or our shares, our share price and trading volume could decline

 

The trading market for our securities will be influenced by the research and reports that industry or securities analysts may publish about us, our business, our market or our competitors. We do not have any control over these analysts and we cannot provide any assurance that analysts will cover us or provide favorable coverage. If any of the analysts who may cover us adversely change their recommendation regarding our shares, or provide more favorable relative recommendations about our competitors, the market value of our securities would likely decline. If any analyst who may cover us were to cease coverage of our company or fail to regularly publish reports on us, we could lose visibility in the financial markets, which in turn could cause the price of our common shares and Warrants and our trading volume to decline.

 

Certain Canadian legislation contain provisions that may have the effect of delaying or preventing a change in control

 

Canadian legislation could discourage potential acquisition proposals, delay or prevent a change in control and limit the price that certain investors may be willing to pay for our subordinate voting shares. For instance, a non-Canadian must file an application for review with the Minister responsible for the Investment Canada Act and obtain approval of the Minister prior to acquiring control of a “Canadian business” within the meaning of the Investment Canada Act, where prescribed financial thresholds are exceeded. Furthermore, limitations on the ability to acquire and hold our subordinate voting shares and multiple voting shares may be imposed by the Competition Act (Canada). This legislation permits the Commissioner of Competition, or Commissioner, to review any acquisition or establishment, directly or indirectly, including through the acquisition of shares, of control over or of a significant interest in us. Otherwise, there are no limitations either under the laws of Canada or British Columbia, or in our articles on the rights of non-Canadians to hold or vote our subordinate voting shares and multiple voting shares. Any of these provisions may discourage a potential acquirer from proposing or completing a transaction that may have otherwise presented a premium to our shareholders. See “Description of Securities—Certain Important Provisions of Our Articles and the BCBCA.”

 

Because we are a corporation incorporated in British Columbia and some of our directors and officers are resident in Canada, it may be difficult for investors in the United States to enforce civil liabilities against us based solely upon the federal securities laws of the United States. Similarly, it may be difficult for Canadian investors to enforce civil liabilities against our directors and officers residing outside of Canada

 

We are a corporation incorporated under the laws of British Columbia with our principal place of business in West Vancouver. Some of our directors and officers and the auditors or other experts named herein are residents of Canada and all or a substantial portion of our assets and those of such persons are located outside the United States. Consequently, it may be difficult for U.S. investors to effect service of process within the United States upon us or our directors or officers or such auditors who are not residents of the United States, or to realize in the United States upon judgments of courts of the United States predicated upon civil liabilities under the Securities Act. Investors should not assume that Canadian courts: (1) would enforce judgments of U.S. courts obtained in actions against us or such persons predicated upon the civil liability provisions of the U.S. federal securities laws or the securities or blue sky laws of any state within the United States or (2) would enforce, in original actions, liabilities against us or such persons predicated upon the U.S. federal securities laws or any such state securities or blue sky laws.

 

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Similarly, some of our directors and officers are residents of countries other than Canada and all or a substantial portion of the assets of such persons are located outside Canada. As a result, it may be difficult for Canadian investors to initiate a lawsuit within Canada against these non-Canadian residents. In addition, it may not be possible for Canadian investors to collect from these non-Canadian residents judgments obtained in courts in Canada predicated on the civil liability provisions of securities legislation of certain of the provinces and territories of Canada. It may also be difficult for Canadian investors to succeed in a lawsuit in the United States, based solely on violations of Canadian securities laws.

 

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

 

Some discussions in this prospectus may contain forward-looking statements that involve risks and uncertainties. These statements relate to future events or future financial performance. A number of important factors could cause our actual results to differ materially from those expressed in or implied by any forward-looking statements made by us in this prospectus. Forward-looking statements are often identified by words like: “believe,” “expect,” “estimate,” “anticipate,” “intend,” “project,” “may,” “will,” “should,” “plans,” “predicts,” “potential” or “continue” or the negative of these terms or other comparable terminology. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including the risks in the section titled “Risk Factors” beginning on page 18, that may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. In addition, you are directed to factors discussed in the “Description of Business” section beginning on page 48, the “Management’s Discussion and Analysis of Financial Condition and Results of Operations” section beginning on page 41, as well as those discussed elsewhere in this prospectus.

 

Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, or achievements. Except as required by applicable law, including the securities laws of the United States and Canada, we do not intend to update any of the forward-looking statements to conform these statements to actual results.

 

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USE OF PROCEEDS

 

We estimate that the net proceeds from this offering will be approximately US$3,000,000, assuming we sell only Common Units in this offering, after deducting the estimated placement agent fees and estimated offering expenses payable by us, based on the assumed public offering price of US$4.00 per Common Unit.

 

Assuming net proceeds of US$3,000,000, we intend to use US$1,500,000 of the net proceeds from this offering for clinical trials of Bria-IMT™, which should allow us to advance Bria-IMT™ through phase IIa to an “End of Phase II” meeting with the FDA, permitting us to determine the design of a registration study and negotiate with the FDA to obtain a “Special Protocol Assessment” (SPA) of the registration study. Under the SPA, the FDA would agree with the design and endpoints of a registration study and if these endpoints are met, would agree to grant marketing approval of the drug. Initiation of the registration study will require additional capital. In addition, US$150,000 will be devoted to the further development of Bria-OTS™, which should progress Bria-OTS™ through CMC manufacturing and an IND Filing. There will be $105,000 devoted to the development of novel immunotherapy cell lines and novel immunostimulators for the SARS-CoV-2, which would allow cGMP manufacturing and an IND Filing. An additional $100,000 will be used for the development of novel antibody-based therapeutics for SARS-CoV-2 which will allow candidate selection and toxicology testing through to opening an IND. The remainder will be for Discovery Research and manufacturing (CMC) costs (approximately US$540,000) and working capital and general corporate purposes (approximately US$600,000).

 

We would receive additional gross proceeds of $5,000,000 if all of the Warrants included in the units are exercised. We intend to use any such proceeds for working capital and general corporate purposes. General corporate purposes may include capital expenditures.

 

We may also use a portion of the net proceeds from this offering to acquire or invest in complementary products, technologies or businesses, although we have no present agreements or commitments to do so.

 

Although we currently anticipate that we will use the net proceeds from this offering as described above, there may be circumstances where a reallocation of funds is necessary. Due to the uncertainties inherent in the clinical development and regulatory approval process, it is difficult to estimate with certainty the exact amounts of the net proceeds from this offering that may be used for any of the above purposes on a stand-alone basis. Amounts and timing of our actual expenditures will depend upon a number of factors, including our sales, marketing and commercialization efforts, regulatory approval and demand for our product candidates, operating costs and other factors described under “Risk Factors” in this prospectus. Accordingly, our management will have flexibility in applying the net proceeds from this offering. An investor will not have the opportunity to evaluate the economic, financial or other information on which we base our decisions on how to use the proceeds.

 

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DILUTION

 

If you invest in our Common Units in this offering, your interest will be immediately diluted to the extent of the difference between the public offering price per Common Unit in this offering and the as further adjusted net tangible book value per common share after this offering. Dilution results from the fact that the public offering price per Common Unit is substantially in excess of the net tangible book value per common share. As of January 31, 2020, we had a historical net tangible book value of (negative $3.32 million, or negative $4.60 per common share). Our net tangible book value per share represents total tangible assets less total liabilities, divided by the number of common shares outstanding on January 31, 2020.

 

After giving effect to the sale of Common Units in this offering at an assumed public offering price of US$4.00 per Common Unit, after deducting the estimated placement agent fees and estimated offering expenses, assuming no sale of Pre-funded Units in the offering, our as adjusted net tangible book value at January 31, 2020 would have been $0.37 per share. This represents an immediate increase in as adjusted net tangible book value of $4.97 per share to existing shareholders and immediate dilution of $ 4.92 per share to new investors.

 

The following table illustrates this dilution per common share:

 

Assumed public offering price per Common Unit (US$)(1)           US$

4.00

 
                 
Public offering price per Common Unit(1)           $

5.29

 
Historical net tangible book value per common share as of January 31, 2020   $ (4.60        
Increase in as adjusted net tangible book value per common share attributable to the net proceeds from new investors   $ 4.97    
As adjusted net tangible book value per common share after this offering           $

0.37

 
Dilution per common share to new investors participating in this offering           $

4.92

 

 

(1) U.S Dollar amounts converted into Canadian dollars ($) as set out in “Currency and Exchange Rates”.

 

We may choose to raise additional capital due to market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the issuance of these securities could result in further dilution to our equity holders.

 

The above discussion and tables are based on 721,962 shares of common stock outstanding as of January 31, 2020 and excludes the following:

 

  178,528 shares of common stock issuable upon the exercise of outstanding warrants, at a weighted average exercise price of $44.49;
     
  13,790 shares of common stock issuable upon the exercise of outstanding compensation warrants, at a weighted average exercise price of $42.00;
     
  912 shares of common stock issuable upon the granting of 912 warrants arising from the exercise of 912 compensation warrants at a weighted average exercise price of $90.00;
     
 

21,302 shares of common stock issuable upon the exercise of outstanding options, at a weighted average exercise price of $50.00; and

     
 

an estimated 1,000,000 common shares issuable upon exercise of the Warrants included in the Common Units and an estimated 50,000 common shares issuable upon exercise of the placement agent warrants.

 

DIVIDEND POLICY

 

We do not anticipate that we will declare or pay dividends in the foreseeable future on our common shares. Instead, we anticipate that all of our earnings will be used for the operation and growth of our business. Any future determination to declare cash dividends would be subject to the discretion of our Board of Directors and would depend upon various factors, including our results of operations, financial condition and liquidity requirements, restrictions that may be imposed by applicable law and our contracts and other factors deemed relevant by our Board of Directors.

 

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CAPITALIZATION 

 

The following table sets forth our consolidated capitalization as of January 31, 2020:

 

  - on an actual basis, as determined in accordance with IFRS; and
     
  -

on an as-adjusted basis to reflect the net proceeds from our sale of 1,000,000 Common Units in this offering at the assumed public offering price of US$4.00 per Common Unit, after deducting the placement agent fees and the estimated offering expenses, assuming no sale of Pre-funded Units.

 

This table should be read in conjunction with the “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Use of Proceeds” sections, as well as our audited financial statements, included elsewhere in this prospectus.

 

    As of January 31, 2020  
    Actual     Pro Forma Adjustments     Pro Forma As Adjusted(2)  
                   
Cash, cash equivalents, and short term investments   $ 93,692      

3,911,409

(1)   $ 4,058,033  
                         
Stockholders’ equity:                        
Common stock, no par value; unlimited number of shares authorized, 721,962 shares issued and outstanding, actual; unlimited number of shares authorized, 1,721,962 shares issued and outstanding, pro forma;     15,065,961       2,501,613 (1)     17,598,082  
Share based payment reserve     793,871               793,871  
Warrant reserve     2,271,911       1,838,811 (1)     4,133,146  
Accumulated other comprehensive loss     (135,490 )             (135,490 )
Retained deficit     (20,985,083 )     (429,015 )(1)     (414,098 )
                         
Total stockholders’ equity (deficit)     (2,988,830 )            

922,579

 
                         
Total capitalization   $ (2,988,830 )           $

922,579

 

 

(1)

Reflects assumed raise of US$4,000,000 and an assumed stock price of US$3.68 per share net of transaction related fees and converted into Canadian dollars as set out in “Currency and Exchange Rates”.

   
(2) The pro forma as adjusted information discussed above is illustrative only and will be adjusted based on the actual public offering price and other terms of our initial public offering determined at pricing.

 

Holders

 

We had 50 holders of record for our common shares as of May 27, 2020.

 

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ENFORCEMENT OF CIVIL LIABILITIES

 

We are incorporated under the laws of British Columbia. Some of our directors and officers, and some of the experts named in this prospectus, are residents of Canada or otherwise reside outside of the United States, and all or a substantial portion of their assets, and all or a substantial portion of our assets, are located outside of the United States. We have appointed an agent for service of process in the United States, but it may be difficult for shareholders who reside in the United States to effect service within the United States upon those directors, officers and experts who are not residents of the United States. It may also be difficult for shareholders who reside in the United States to realize in the United States upon judgments of courts of the United States predicated upon our civil liability and the civil liability of our directors, officers and experts under the United States federal securities laws. There can be no assurance that U.S. investors will be able to enforce against us, members of our Board of Directors, officers or certain experts named herein who are residents of Canada or other countries outside the United States, any judgments in civil and commercial matters, including judgments under the federal securities laws.

 

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SELECTED CONSOLIDATED FINANCIAL DATA

 

The selected financial information set forth below has been derived from our unaudited condensed consolidated interim financial statements for the six months ended January 31, 2020 and our audited financial statements for the fiscal years ended July 31, 2019, 2018, 2017, 2016 and 2015. You should read the following summary financial data for the six months ended January 31, 2020 and the years ended July 31, 2019 and 2018 together with our historical financial statements and the notes thereto included elsewhere in this prospectus and with the information set forth in the section titled “Management’s Discussion and Analysis of Financial Conditions and Results of Operations”. The audited financial statements for the years ended July 31, 2017, 2016 and 2015 are not included in this prospectus.

 

    As of January 31,     As of July 31,  
    2020     2019     2018     2017     2016     2015  
Balance Sheet Data                                                
Cash and cash equivalents     93,692       192,916       938,448       1,264,429       171,865       464,732  
Total Assets     631,852       546,259       2,977,140       2,039,199       1,091,587       1,660,288  
Total Liabilities     3,620,682       1,392,396       1,745,850       1,104,147       63,470       152,425  
Total Shareholders’ Equity (deficit)     (2,988,830 )     (846,137 )     1,231,290       935,052       1,028,117       1,507,863  

 

 

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MANAGEMENT’S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

The following discussion and analysis should be read in conjunction with our financial statements and related notes included elsewhere in this prospectus. This discussion and other parts of this prospectus contain forward-looking statements based upon current expectations that involve risks and uncertainties. Our actual results and the timing of selected events could differ materially from those anticipated in these forward-looking statements as a result of several factors, including those set forth under “Risk Factors” and elsewhere in this prospectus.

 

The preparation of financial statements in conformity with these accounting principles requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent liabilities at the financial statement date and reported amounts of revenue and expenses during the reporting period. On an on-going basis, we review our estimates and assumptions. The estimates were based on historical experience and other assumptions that we believe to be reasonable under the circumstances. Actual results are likely to differ from those estimates or other forward-looking statements under different assumptions or conditions, but we do not believe such differences will materially affect our financial position or results of operations. Our actual results may differ materially as a result of many factors, including those set forth under the headings entitled “Special Note Regarding Forward-Looking Statements” and “Risk Factors”.

 

Recent Developments

 

Conversion of Certain Convertible Notes

 

During the year ended July 31, 2019, 22,488 shares were issued at $30.00 per share in respect of the partial conversion of certain Convertible Notes. Upon exercise of these Convertible Notes, Noteholders received 22,488 warrants with an exercise price of $42.00, expiring within three years. On April 23, 2019, the Company revised the exercise price of these warrants from $42 to $36, and all future warrants to be issued in respect of the conversion of the balance of the Convertible Notes.

 

Repayment of Convertible Notes

 

On September 10, 2019, the Convertible Notes were repaid in the total amount of $477,216 (US$ 362,819).

 

Changes in warrants, compensation warrants and options

 

During year ended July 31, 2019, 3,333 shares were issued in respect of 3,333 warrants that were exercised at an exercise price of $42.00 for gross proceeds of $140,000.

 

On August 19, 2019, 28,333 warrants and 1,983 compensation warrants expired.

 

On September 9, 2019, the Company issued a total of 166 stock options to a consultant, which vested immediately and expire on September 9, 2024.

 

On November 1, 2019, 2,107 stock options expired and on December 21, 2019, 3,405 warrants expired.

 

On February 14, 2020, 833 stock options expired and on March 22, 2020, 500 stock options expired.

 

Private Placements

 

On February 26, 2019, BriaCell announced a non-brokered private placement financing of 16,667 common shares of the Company at a price of $30.00 per common share for gross proceeds of $500,000. Recently-appointed Director of the Company, Jamieson Bondarenko, purchased the 16,667 common shares. Upon closing of the offering, Mr. Bondarenko had a beneficial ownership of an aggregate of 76,902 common shares, representing approximately 13.7% of BriaCell’s issued and outstanding common shares.

 

On April 1, 2019, BriaCell announced that it completed a non-brokered private placement of 99,117 common shares of the Company at a price of $30.00 per common share for gross proceeds of $2,973,524 (the “Private Placement”) which includes Mr. Bondarenko’s $500,000 equity investment.

 

On September 9, 2019, the Company closed its previously-announced non-brokered private placement (the “September Offering”) of common shares in the capital of the Company. Under the September Offering, the Company issued a total of 40,300 common shares at a price of $21.00 per common share for gross proceeds of $846,300.49 (“September 2019 Private Placement”).

 

On October 15, 2019, the Company completed non brokered private placement of 27,069 common shares at a price of $21.00 per common share for gross proceeds of $568,444 (“October 2019 Private Placement”).

 

Loan agreements

 

On December 3, 2019, the Company received an unsecured US$100,000 loan from a third party, which bears interest at 2.5% annually. The loan was repayable on or before March 26, 2020, after which the interest rate increases to 15% annually.

 

On January 27, 2020, the Company received an unsecured US$50,000 loan from a third party, which bears interest at 2.5% annually. The loan was repayable on or before March 26, 2020, after which the interest rate increases to 15% annually.

 

On February 20, 2020, the Company received an unsecured US$50,000 loan from a third party, which bears interest at 2.5% annually. The loan was repayable on or before March 26, 2020, after which the interest rate increases to 15% annually.

 

On April 24, 2020, the Company received a $40,000 loan from the Canada Emergency Business Account (“CEBA Loan”). The CEBA Loan bears 0% interest until December 31, 2022. If the balance is not repaid by December 31, 2022, the remaining balance will be converted to a 3-year term loan at 5% annual interest, paid monthly, effective January 1, 2023. The full balance must be repaid by no later than December 31, 2025. No principal payments are required until December 31, 2022. Principal repayments can be voluntarily made at any time without fees or penalties. $10,000 of the CEBA Loan may be forgiven provided that the outstanding balance is $40,000 as at December 31, 2020, and that $30,000 is repaid between January 1, 2021 and December 31, 2022.

 

On May 1, 2020 the Company received US$127,030 as a loan from the Paycheck Protection Program in the United States (the “Program”). The terms of the Program provide that a portion of the loan may be forgiven, to the extent that the amounts spent during the eight week period following the first disbursement of the loan are incurred as follows: (i) payroll costs, (ii) interest payments on mortgages incurred before February 15, 2020, (iii) rent payments on leases in effect before February 15, 2020, and (iv) utility payments for which service began before February 15, 2020. The unforgiven part of the loan must be repaid within two years and bears interest at 1% per annum.

 

New Board Composition

 

In February and March 2019, the Company’s Board of Directors was substantially restructured with the appointment of Jamieson Bondarenko, Dr. Rebecca Taub and Vaughn C. Embro-Pantalony to replace three resigning directors. Additionally, on August 12, 2019, Richard Berman was appointed to our Board of Directors. After these restructuring events, the current Board of Directors consists of:

 

  Dr. William V. Williams, Director and Chief Executive Officer;
     
  Jamieson Bondarenko, Director and Chairman of the Board;
     
  Dr. Charles Wiseman, Director;
     
  Dr. Rebecca Taub, Director
     
  Vaughn C. Embro-Pantalony, Director; and
     
  Richard Berman, Director

 

Overview

 

Critical Accounting Policies and Estimates

 

1. Critical Estimates and Judgements

 

The preparation of these consolidated financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and reported amounts of expenses during the reporting period. Actual outcomes could differ from these estimates. The financial statements include estimates which, by their nature, are uncertain. The impacts of such estimates are pervasive throughout the financial statements, and may require accounting adjustments based on future occurrences. Revisions to accounting estimates are recognized in the period in which the estimate is revised and also in future periods when the revision affects both current and future periods.

 

The critical judgments and significant estimates in applying accounting policies that have the most significant effect on the amounts recognized in the consolidated financial statements are:

 

  The series of loans made to the subsidiary company are considered part of the parent company’s net investment in a foreign operation as the Company does not plan to settle these balances in the foreseeable future. As a result of this assessment, the unrealized foreign exchange gains and losses on the intercompany loans are recorded through comprehensive loss. If the Company determined that settlement of these amounts was planned or likely in the foreseeable future, the resultant foreign exchange gains and losses would be recorded through profit or loss.
  The change in the fair value of the unsecured convertible loan is based on an estimate determined by the Black-Scholes Model.
  Preparation of the consolidated financial statement on going concern basis, which contemplates the realization of assets and payments of liabilities in the ordinary course of business. Should the Company be unable to continue as a going concern, it may be unable to realize the carrying value of its assets and to meet its liabilities as they become due.

 

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2. New Accounting Policies Adopted

 

During the year ended July 31, 2019, the following new accounting policies were adopted.

 

IFRS 9 – Financial instruments (“IFRS 9”) was issued by the IASB its final form in July 2014 and will replace IAS 39 Financial Instruments: Recognition and Measurement (“IAS 39”). IFRS 9 uses a single approach to determine whether a financial asset is measured at amortized cost or fair value, replacing the multiple rules in IAS 39. The approach in IFRS 9 is based on how an entity manages its financial instruments in the context of its business model and the contractual cash flow characteristics of the financial assets. Most of the requirements in IAS 39 for classification and measurement of financial liabilities were carried forward unchanged to IFRS 9. The new standard also requires a single impairment method to be used, replacing the multiple impairment methods in IAS39. The standard is effective for annual periods beginning on or after January 1, 2018. Management adopted the standard as August 1, 2018 and assed that the adoption of IFRS 9 did not have a significant impact to the consolidated financial statements.

 

IFRS 15 - Revenue from contracts with customers (“IFRS 15”) proposes to replace IAS 18 – Revenue, IAS 11 – Construction contracts and some revenue-related interpretations. The standard contains a single model that applies to contracts with customers and two approaches to recognizing revenue: at a point in time or over time. The model features a contract-based five step analysis of transaction to determine whether, how much and when revenue is recognized. New estimates and judgmental thresholds have been introduced, which may affect the amount and/or timing of revenue recognized. IFRS 15 is effective for annual periods beginning on or after January 1, 2018. Earlier adoption is permitted. The Company adopted the standard as of August 1, 2019. Since then has not yet generated any revenues, the Company was no impact to the consolidated financial statements as a result of the adoption of this standard.

 

3. Accounting Standards Issued but Not Yet Effective

 

Certain pronouncements were issued by the IASB or the IFRIC that are mandatory for future accounting periods. Many are not applicable to or do not have a significant impact on BriaCell and have been excluded from the list below. The following have not yet been adopted and are being evaluated to determine their impact on BriaCell.

 

IFRS 16 - Leases (“IFRS 16”) replaces IAS 17, Leases (“IAS 17”). The new model requires the recognition of almost all lease contracts on a lessee’s statement of financial position as a lease liability reflecting future lease payments and a ‘right-of-use asset’ with exceptions for certain short-term leases and leases of low-value assets. In addition, the lease payments are required to be presented on the statement of cash flow within operating and financing activities for the interest and principal portions, respectively. IFRS 16 is effective for annual periods beginning on or after January 1, 2019, with early adoption permitted if IFRS 15, Revenue from Contracts with Customers, is also applied. Based on the information currently available, the Company estimates that it will recognize a lease liability and right to use asset as at August 1, 2019. The Company is on track to complete its implementation of IFRS 16 effective August 1, 2019.

 

Results of Operations

 

Comparison of the three months ended January, 2020, compared to the three months ended January, 2019

 

Research Costs

 

Research costs are comprised primarily of (i) salaries and wages to Company employees at our laboratory, (ii) clinical trials and investigational drug costs, which include the testing and manufacture of our investigational drugs and costs of our clinical trials, (iii) licensing of our immunotherapy and (iv) legal fees in respect of maintaining and expanding our portfolio of patents.

 

For the three-month period ended January 31, 2020, research costs amounted to $1,216,051, as compared to $1,556,074 for the three-month period ended January 31, 2019.

 

General and Administrative Expenses

 

For the three-month period ended January 31, 2020, general and administrative expenses amounted to $662,611, as compared to $174,609 for the three-month period ended January 31, 2019. The increase is primarily due to an increase of professional fees incurred as part of our financing efforts, offset by a decrease in shareholder communication expenses.

 

For the three-month period ended January 31, 2020, share based compensation amounted to $nil, as compared to $58,835 for the three-month period ended January 31, 2019.

 

Interest Income

 

For the three-month period ended January 31, 2020, interest income amounted to $nil, as compared to $7,013 for the three-month period ended January 31, 2019. Interest income earned during each quarter is a function of the amount of funds held in interest bearing accounts.

 

Interest expense

 

For the three-month period ended January 31, 2020, interest expense amounted to $3,952, as compared to $9,849 for the three-month period ended January 31, 2019. Interest expense during the current period relates to credit card interest charges and interest on the short term loan. Interest expense in the prior period was incurred as a result of the issuance of interest bearing convertible debt in March 2018. The decrease in the period in 2020 is as a result of a decrease in the amount of outstanding debt and the repayment of the convertible debt in September 2019.

 

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Change in fair value of convertible debt

 

For the three-month period ended January 31, 2020, the increase in fair value of convertible debt amounted to $nil, as compared $208,746 for the three-month period ended January 31, 2019. The movement during each period is based on the fair value at the end of the period. In September 2019, the Company repaid the convertible debt.

 

Foreign Exchange Loss

 

For the three-month period ended January 31, 2020, our foreign exchange loss was $332, as compared to $nil for the three-month period ended January 31, 2019. The Company is exposed to financial risk related to the fluctuation of foreign exchange rates. The Company operates in the United States and Canada, most of its monetary assets are held in Canadian dollars and most of its expenditures are made in US dollars. The Company has not hedged its exposure to currency fluctuations.

 

Loss for the period

 

The Company reported a loss of $1,882,946 for the three-month period ended January 31, 2020, as compared to a loss of $1,583,608 for the three-month period ended January 31, 2019. The primary reason for increase in the loss in 2020 is primarily due to increased general and administration costs.

 

Comprehensive loss for the period

 

The Company reported a comprehensive loss of $1,895,900 for the three-month period ended January 31, 2020, as compared to a comprehensive loss of $1,566,309 for the three-month period ended January 31, 2020. The primary reason for the increase in the loss in 2020 is due to the increased general and administration costs incurred in connection with professional fees.

 

The difference between net loss and comprehensive loss results from the foreign currency translation adjustment that arises upon the translation of the accounting records of the Company’s US subsidiary, whose functional currency is the US dollar into Canadian dollars for financial statement presentation purposes. 

 

Comparison of the six months ended January 31, 2020, compared to the six months ended January 31, 2019

 

Research Costs

 

Research costs are comprised primarily of (i) salaries and wages to Company employees at our laboratory, (ii) clinical trials and investigational drug costs, which include the testing and manufacture of our investigational drugs and costs of our clinical trials, (iii) licensing of our immunotherapy and (iv) legal fees in respect of maintaining and expanding our portfolio of patents.

 

For the six-month period ended January 31, 2020, research costs amounted to $2,220,697, as compared to $2,549,275 for the six-month period ended January 31, 2019.  

 

General and Administrative Expenses

 

For the six-month period ended January 31, 2020, general and administrative expenses amounted to $1,220,122, as compared to $465,637 for the six month period ended January 31, 2019. The increase is primarily due to an increase of professional fees incurred as part of our financing efforts, offset by a decrease in shareholder communication expenses.

 

For the six-month period ended January 31, 2020, share based compensation was $1,779, as compared to $60,521 for the six-month period ended January 31, 2019. The current charge relates to the fair value of the options that were issued during this period.

 

Interest Income

 

For the six-month period ended January 31, 2020, interest income amounted to $nil, as compared to $11,327 for the six-month period ended January 31, 2019. Interest income earned during each quarter is a function of the amount of funds held in interest bearing accounts. 

 

Interest expense

 

For the six-month period ended January 31, 2020, interest expense amounted to $6,208, as compared to $23,148 for the six-month period ended January 31, 2019. Interest expense during the current period relates to credit card interest charges and interest on the short term loan. Interest expense in the prior period was incurred as a result of the issuance of interest bearing convertible debt in March 2018. The decrease in the period in 2020 is as a result of a decrease in the amount of outstanding debt and the repayment of the convertible debt in September 2019. 

 

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Change in fair value of convertible debt

 

For the six-month period ended January 31, 2020, the increase in fair value of convertible debt amounted to $79,119, as compared to a decrease of $456,119 for the six-month period ended January 31, 2019. The movement during each period is based on the fair value at the end of the period. In September 2019, the Company repaid the convertible debt.

 

 

Foreign Exchange Loss

 

For the six-month period ended January 31, 2020, the foreign exchange loss of $20,096, as compared to $nil for the six-month period ended January 31, 2019. The Company is exposed to financial risk related to the fluctuation of foreign exchange rates. The Company operates in the United States and Canada, most of its monetary assets are held in Canadian dollars and most of its expenditures are made in US dollars. The Company has not hedged its exposure to currency fluctuations. 

 

Loss for the period

 

The Company reported a loss of $3,548,021 for the six-month period ended January 31, 2020, as compared to a loss of $2,631,135 for the six-month period ended January 31, 2019. The primary reason for the increase in the loss in 2020 is due to the increased general and administration costs. 

 

Comprehensive loss for the period

 

The Company reported a comprehensive loss of $3,559,216 for the six-month period ended January 31, 2020, as compared to a comprehensive loss of $2,607,796 for the six-month period ended January 31, 2020. The primary reason for the increase in the loss in 2020 is due to the increased general and administration costs.

 

The difference between net loss and comprehensive loss results from the foreign currency translation adjustment that arises upon the translation of the accounting records of the Company’s US subsidiary, whose functional currency is the US dollar into Canadian dollars for financial statement presentation purposes.

 

Comparison of the year ended July 31, 2019, compared to the year ended July 31, 2018

 

Research Costs

 

Research costs are comprised primarily of (i) salaries and wages to Company employees at our laboratory, (ii) clinical trials and investigational drug costs, which include the testing and manufacture of our investigational drugs and costs of our clinical trials, (iii) licensing of our immunotherapy, and (iv) legal fees in respect of maintaining and expanding our portfolio of patents.

 

For the year ended July 31, 2019, research costs amounted to $4,917,287, as compared to $3,112,579 for the year ended July 31, 2018. The increase in research costs is as a result of supporting the Company’s ongoing Phase I/IIa clinical trial and relates primarily to increased clinical trial expenses, including the development of new Bria-IMT™ cell banks. BriaCell also has contracted with a second supplier of Bria-IMT™ and there is ongoing formulation work to develop a more user-friendly formulation that does not require culturing cells and same day irradiation.

 

Work also has begun on the development of Bria-OTSTM and BriaCell has submitted five grant applications, applying for non-dilutive funding to support our research efforts, using our grant consultant, the FreeMind Group.

 

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General and Administrative Expenses

 

For the year ended July 31, 2019, general and administrative expenses amounted to $1,244,471, as compared to $1,387,713 for the year ended July 31, 2018. The decrease is primarily due to decrease of consulting fees.

 

Share based Compensation

 

For the year ended July 31, 2019, share based compensation of $60,586, as compared to $476,211 for the year ended July 31, 2018. The current charge relates to the tail end of the fair value of the options that were issued during prior periods.

 

Interest Income

 

For the year ended July 31, 2019, interest income amounted to $12,004, as compared to $15,991 for the year ended July 31, 2018. Interest income earned during each quarter is a function of the amount of funds held in interest bearing accounts.

 

Interest expense

 

For the year ended July 31, 2019, interest expense amounted to $31,317, as compared to $20,364 for the year ended July 31, 2018. Interest expense is incurred as a result of the issuance of interest bearing convertible notes in March 2018. The prior period includes the issuance costs of the convertible debt.

 

Change in fair value of convertible debt

 

For the year ended July 31, 2019, the increase in fair value of the convertible debt amounted to $420,58,5 as compared to a decrease of $407,709 for the year ended July 31, 2018.

 

Foreign Exchange Gain

 

For the year ended July 31, 2019, the foreign exchange gain of $31,410, as compared to a loss of $24,078 for the year ended July 31, 2018. The Company is exposed to financial risk related to the fluctuation of foreign exchange rates. The Company operates in the United States and Canada, most of its monetary assets are held in Canadian dollars and most of its expenditures are made in US dollars. The Company has not hedged its exposure to currency fluctuations.

 

Loss for the year

 

The Company reported a loss for the year ended July 31, 2019 of $5,789,662, as compared to a loss of $5,412,663 for the year ended July 31, 2018. The primary reason for increase in the loss during the current period is due to the increased research activities compared to the prior period.

 

Comprehensive loss for the year

 

The Company reported a comprehensive loss of $5,808,443 for the year ended July 31, 2019, as compared to a comprehensive loss of $5,446,003 for the year ended July 31, 2018. The primary reason for the increase in the loss during the current period is due to the increased research activities compared to the prior period.

 

The difference between net loss and comprehensive loss results from the foreign currency translation adjustment that arises upon the translation of the accounting records of the Company’s US subsidiary, whose functional currency is the US dollar into Canadian dollars for financial statement presentation purposes.

 

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Comparison of the year ended July 31, 2018 to the year ended July 31, 2017

 

Research Costs

 

For the year ended July 31, 2018, research costs amounted to $3,112,579 as compared to $2,125,941 for the year ended July 31, 2017. The increase in research costs is as a result of supporting the Company’s ongoing Phase I/IIa clinical trial and relates primarily to increased clinical trial expenses, including the development of new BriaVax™ (a.k.a. Bria-IMT™) cell banks. BriaCell also has contracted with a second supplier of BriaVax™ (a.k.a. Bria-IMT™) and there is ongoing formulation work to develop a more user-friendly formulation that does not require culturing cells and same day irradiation. Work also has begun on the development of second generation BriaVax™ (a.k.a. Bria-IMT™) and BriaCell has submitted five grant applications, applying for non-dilutive funding to support our research efforts, using our grant consultant, the FreeMind Group.

 

General and Administrative Expenses

 

For the year ended July 31, 2018, general and administrative expenses amounted to $1,387,713, as compared to $820,281 for the year ended July 31, 2017. The increase is primarily to an increase in consulting, professional fees and Shareholder communications incurred in 2018 as compared to 2017 and is in line with the Companies increased research activities and increase investor relations activities. In addition, we incurred certain expenses in connection with the debt financing.

 

Share-based Compensation

 

For the year ended July 31, 2018, share-based compensation amounted to $476,211, as compared to $272,014 for the year ended July 31, 2017. The increase in share-based compensation in the current period is as a result of increased number of stock options granted in the year ended July 31, 2018 as compared to the prior year.

 

Interest Income

 

For the year ended July 31, 2018, interest income amounted to $15,991, as compared to $6,428 for the year ended July 31, 2017. Interest income earned during each quarter is a function of the amount of funds held in interest bearing accounts.

 

Interest expense

 

For the year ended July 31, 2018, interest expense amounted to $20,364, as compared to $nil for the year ended July 31, 2017. Interest expense was incurred from the convertible notes.

 

Change in fair value of convertible debt

 

For the year ended July 31, 2018, change in fair value of convertible debt amounted to $407,709, as compared to $nil for the year ended July 31, 2017.

 

Foreign Exchange Gain

 

For the year ended July 31, 2018, the foreign exchange loss amounted to $24,078, as compared to a loss of $8,913 for the year ended July 31, 2017. The Company is exposed to financial risk related to the fluctuation of foreign exchange rates. The Company operates in the United States and Canada, most of its monetary assets are held in Canadian dollars and most of its expenditures are made in US dollars. The Company has not hedged its exposure to currency fluctuations.

 

Loss for the year

 

The Company reported a loss of $5,412,663 for the year ended July 31, 2018, as compared to a loss of $3,220,721 for the year ended July 31, 2017. The primary reason for increase in the loss in 2018 is due to the increase in research activities, general and administrative expenses and share-based compensation.

 

Comprehensive loss for the year

 

The Company reported a comprehensive loss of $5,446,003 for the year ended July 31, 2018, as compared to a comprehensive loss of $3,178,893 for the year ended July 31, 2017. The primary reason for increase in the loss in 2018 is due to the increase in research activities, General and Administrative Expenses and Share-based Compensation.

 

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The difference between net loss and comprehensive loss results from Foreign currency translation adjustment that arises upon the translation of the accounting records of BTC who’s functional currency is the US dollar into Canadian dollars for financial statement presentation purposes.

 

Going Concern Uncertainty

 

The financial statements have been prepared on a going concern basis which assumes that the Company will be able to realize its assets and discharge its liabilities in the normal course of business for the foreseeable future. The continuing operations of the Company are dependent upon its ability to continue to raise adequate financing and to commence profitable operations in the future.

 

As at July 31, 2019, the Company has total assets of $546,259 (July 31, 2018 - $2,977,140) and a negative working capital balance of $1,185,354 (July 31, 2018 positive - $700,350).

 

It is management’s opinion that the Company will require additional funding, either through debt or equity issuances, in order to maintain its research and developmental activities. To this end, the company is currently raising funds to continue to funds its operation. These uncertainties may cast significant doubt on the Company’s ability to continue as a going concern.

 

Liquidity and Capital Resources

 

Changes in capital resources during the three months ended January 31, 2020 and the year ended July 31, 2019 are described below.

 

The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. As of January 31, 2020 and July 31, 2019, the Company had cash and cash equivalents of $93,692 and $192,916, respectably and negative working capital of $3,318,676 and $1,185,354, respectively. The Company has incurred significant operating losses since inception and continues to generate losses from operations and as of January 31, 2020 and July 31, 2019, the Company has an accumulated deficit of $20.9 million and $18.1 million. These matters raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date such financial statements are issued. The condensed interim consolidated financial statements for the three and six months ended January 31, 2020 and the audited financial statements for the year ended July 31, 2019 do not include any adjustments relating to the recoverability and classification of asset amounts or the classification of liabilities that might be necessary should the Company be unable to continue as a going concern.

 

Historically, the Company has financed its operation through private and public placement of equity securities, as well as debt financing. The Company’s ability to fund its longer term cash requirements is subject to multiple risks, many of which are beyond its control. The Company intends to raise additional capital, either through debt or equity financings in order to achieve its business plan objectives. Management believes that it can be successful in obtaining additional capital; however, no assurance can be provided that the Company will be able to do so. There is no assurance that any funds raised will be sufficient to enable the Company to attain profitable operations or continue as a going concern. To the extent that the Company is unsuccessful, the Company may need to curtail or cease its operations and implement a plan to extend payables or reduce overhead until sufficient additional capital is raised to support further operations. There can be no assurance that such a plan will be successful

 

Six months ended January 31, 2020

 

During the six-month period ended January 31, 2020, the Company’s overall position of cash and cash equivalents decreased by $90,285 from the year ended July 31, 2019. This decrease in cash can be attributed to the following:

 

The Company’s net cash used in operating activities during the six-month period ended January 31, 2020 was $1,226,477, as compared to $2,061,617 for the six-month period ended January 31, 2019. This decrease is contributed mostly to an increase in accounts payable and accrued liabilities.

 

Cash provided from investing activities during the six-month period ended January 31, 2020 was $nil, as compared to cash provided to investment activities of $1,300,000 for the six-month period ended January 31, 2019. The cash provided in 2019 was due to the release of short-term investments.

 

Cash provided by financing activities for the six-month period ended January 31, 2020 was $1,136,192, as compared to $140,000 for the six-month period ended January 31, 2019. Cash provided in 2020 resulted from two private placements and a short term loan offset by the repayment of the unsecured convertible loan.

 

Year ended July 31, 2019

 

During the year ended July 31, 2019, the Company’s overall position of cash and cash equivalents decreased by $758,068, as compared to a decrease of $258,314 for the year ended July 31, 2018. This decrease in cash can be attributed to the following:

 

The Company’s net cash used in operating activities during the year ended July 31, 2019 was $5,094,895, as compared to $4,958,593 for the year ended July 31, 2018. This increase in 2019 is primarily due to the increase in research costs.

 

Cash provided from investing activities during the year ended July 31, 2019 was $1,341,043, as compared to cash used to investment activities of $591,043 for the year ended July 31, 2018. The cash provided in 2019 was due to the release of short-term investments compared to the investment of cash in short-term investments in 2018.

 

Cash provided by financing activities for the year ended July 31, 2019 was $2,995,784, as compared to $5,291,322 for the year ended July 31, 2018. Cash provided in 2019 resulted from a private placement and exercise of warrants and the cash provided in 2018 resulted from private placements and the issuance of Convertible Notes.

 

Off-balance Sheet Arrangements

 

None.

 

Tabular Disclosure of Contractual Obligations

 

The following table summarizes our contractual obligations as of July 31, 2019 and the effect those commitments are expected to have on our liquidity and cash flow.

 

          Payments due by periods  
    Total     Less than 1 year     1-3 years     3-5 years     More than 5 years  
Unsecured Convertible Loans(1)   $ 396,224     $ 396,224     $ -     $ -     $ -  
Office lease     42,000       42,000       -       -       -  
Total   $ 438,224     $ 438,224     $ -     $ -     $ -  

 

(1) The unsecured convertible loans may be converted into common stock of the company or repaid in cash. The loan was repaid in September 2019.

 

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DESCRIPTION OF BUSINESS

 

Overview of the Company

 

 BriaCell is an immuno-oncology biotechnology company with a strong focus on cancer immunotherapy. Immunotherapies have come to the forefront in the fight against cancer. They harness the body’s own immune system to recognize and destroy cancer cells. BriaCell owns the US patent to SV-BR-1-GM (Bria-IMT™), a whole-cell targeted immunotherapy for cancer (U.S. Patent No. 7,674,456), as well as patents related to PKCδ inhibitors (U.S. Patent Nos. 9,364,460 and 9,572,793). The Company is currently advancing its targeted immunotherapy program by prioritizing a Phase I/IIa clinical trial with Bria-IMT™ in combination with an immune checkpoint inhibitor and a companion diagnostic test, BriaDx™, to identify patients most likely to benefit from Bria-IMT™. The Bria-IMT™ regimen was evaluated in 4 patients in a prior study in 2004 – 2006 by Dr. Charles Wiseman, the scientific founder and member of the Board of Directors. Encouraging results were obtained, especially in a patient who matched Bria-IMT™ at the HLA-DRB3 allele and had a grade II tumor. In 2017-2018 BriaCell evaluated 23 patients with advanced breast cancer with the Bria-IMT™ regimen and obtained confirmation of the ability of the Bria-IMT™ regimen to induce regression of metastatic breast cancer in patients who match Bria-IMT™ at least at one HLA allele especially if they had grade I or grade II tumors. A combination study with the immune checkpoint inhibitor Keytruda® was initiated and the first patient dosing in the “combination therapy” clinical trial occurred in September 2018. BriaCell purchased the Keytruda for this study as BriaCell does not have an agreement with Merck for the supply of Keytruda. Eleven patients had been dosed in the combination therapy trial with Bria-IMT™ and the immune checkpoint inhibitor Keytruda and subsequently dosing with this combination was discontinued. The study was modified under an amended protocol which evaluates the combination of the Bria-IMT™ regimen with Incyte Corporation experimental drugs INCMGA00012 (anti-PD-1 antibody similar to pembrolizumab) and epacadostat (an inhibitor of the immune checkpoint enzyme indoleamine dioxygenase (IDO)). The study is ongoing. Pending consummation of the offering, Bria-IMT™ will also be evaluated in an investigator-initiated Phase I/IIa study in combination with pembrolizumab (Keytruda) by Dr. Saveri Bhattacharya, Principal Investigator, in women with advanced breast cancer at Thomas Jefferson University. Dr. Bhattacharya has been selected to receive a grant from the Merck Investigator Studies Program for this study. Merck will provide Keytruda to Thomas Jefferson University and Dr. Saveri Bhattacharya for use in the combination study. BriaCell does not have an agreement with Merck for the supply of Keytruda. The Company has entered into the Study Agreement with Thomas Jefferson University providing for the investigator-initiated Phase I/IIa study by Dr. Bhattacharya and the Company’s supply of Bria-IMT™ to Thomas Jefferson University and Dr. Bhattacharya. As consideration, the Company shall pay Thomas Jefferson University a total budget of $3,049,322.50. The FDA and Thomas Jefferson University’s internal review board have approved the clinical protocol. Patients with advanced breast cancer who have at least HLA that matches with Bria-IMT™ will be eligible for the trial. Pending consummation of the offering the study is expected to initiate in June 2020 with safety and efficacy data to be released during 2021 and 2022.

 

The Company was incorporated under the Business Corporations Act (British Columbia) (“BCBCA”) on July 26, 2006 as Ansell Capital Corp. The Company is listed on the TSX Venture Exchange (“TSXV”), is quoted on the OTCQB marketplace and is also listed on the Frankfurt Stock Exchange. The Company is developing a new therapy for advanced breast cancer. The address for the Company’s headquarters is Suite 300 – 235 15th Street, West Vancouver, British Columbia, V7T 2X1. The Company’s corporate offices in the United States are located at 820 Heinz Avenue, Berkley, California 94710. The Company’s two wholly owned subsidiaries BriaCell Therapeutics Corp., a Delaware corporation (“BTC”) and Sapientia Pharmaceuticals Inc., a Delaware corporation (“Sapientia”), were formed on April 3, 2014 and September 20, 2012, respectively. The Company’s registered agent in the United States is Paracorp Incorporated located at 2804 Gateway Oaks Drive #100, Sacramento, CA 95833.

 

On July 24, 2017, the Company entered into a definitive share exchange agreement (the “Share Exchange Agreement”) between BTC, Sapientia and all the shareholders of Sapientia. Sapientia is a biotechnology company based in Havertown, PA, that is developing novel targeted therapeutics for multiple indications including several cancers and fibrotic diseases. Pursuant to the terms of the Share Exchange Agreement, BTC acquired from the Sapientia Shareholders all of the issued and outstanding shares in the capital of Sapientia. As consideration, the Sapientia Shareholders, received an aggregate of 8,333 common shares in the capital of BriaCell on a pro-rata basis, which were issued on September 5, 2017. As part of the share exchange, BriaCell acquired all rights, including composition of matter patents, and preclinical study data to a novel therapeutic technology platform, known as protein kinase C delta (PKCδ) inhibitors, which represents a unique, highly-targeted approach to treat cancer and to boost the immune system.

 

Market

 

It is estimated that in 2019, approximately 268,600 women will be diagnosed with breast cancer in the United States. According to the National Breast Cancer Foundation, on every two minutes an American woman is diagnosed with breast cancer and more than 40,500 die each year. Although about 100 times less common than in women, breast cancer also affects men. It is estimated that the lifetime risk of men getting breast cancer is about 1 in 1,000, and the ACS estimates that approximately 2,670 new cases of invasive male breast cancer will be diagnosed and approximately 500 men will die from breast cancer in 2019.

 

According to the May 2019 “Global Oncology Trends 2019” report by the IQVIA Institute, the global market for cancer drugs (including immunotherapy drugs) is expected to reach nearly $240 billion by the end of 2023, growing at a compound annual growth rate, or CAGR of 9-12% between 2019 and 2023.

 

About 12.8% percent of women will be diagnosed with breast cancer at some point during their lifetime. As of January 2019, there are over 3 million U.S. women who have been diagnosed with breast cancer. Approximately 80% of cases present as invasive breast cancer. 6-10% of new breast cancer diagnoses are Stage IV (metastatic or MBC, cancer which has already spread to other organs). 20-30% of all women diagnosed with breast cancer will develop MBC. Breast cancer can be subdivided based on receptor status – the hormone receptors for estrogen (ER) and progesterone (PR), collectively referred to as hormone receptors (HR), and the Her2/neu growth factor receptor (HER2). In one large study of breast cancer, 72.7% were found to be HR+/HER2−, 12.2% were triple-negative (HR−/HER2−), 10.3% were HR+/HER2+, and 4.6% were HR−/HER2+.1

 

1 Howlader, N.; Altekruse, S. F.; Li, C. I.; Chen, V. W.; Clarke, C. A.; Ries, L. A.; Cronin, K. A., US incidence of breast cancer subtypes defined by joint hormone receptor and HER2 status. J Natl Cancer Inst 2014, 106 (5).

 

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It is estimated that over 150,000 women in the US are living with metastatic breast cancer2. For those with metastatic disease at diagnosis, their 5-year survival is 27%. 3 For patients who develop MBC after initially having localized disease, if they had a good response to treatment (disease-free interval of >24 months), their survival is similar to that of patients with MBC at initial diagnosis, but if their disease-free interval is <24 months, their prognosis is worse.4 We currently propose that Bria-IMT’s indication will be for the treatment of patients with metastatic breast cancer (MBC) who have failed at least two lines of therapy. Similarly, another study showed that the median overall survival among patients with de novo stage IV MBC was 39.2 months while for patients with and relapsed disease it was 27.2 months.5 Median progression free survival after first-line therapy is only 9 months and the survival benefit decreases with subsequent lines of therapy.6 A recent study showed that of 386 patients with MBC, 374 (97%) received first-line therapy, 254 (66%) received second-line therapy, 175 (45%) received third-line therapy, and 105 (27%) received therapy beyond third-line.7

 

Figure: Overview of current drugs for breast cancer, demonstrating the pattern of novel therapeutic introductions and significant market uptake. These precedents demonstrate a strong market pull for Bria-IMT™. 

 

Drug   Technology   Company   Indication   2018 Sales US (Mil US$)     2018 Sales Ex-US (Mil US$)     2018 Sales WW (Mil US$)  
HERCEPTIN® (trastuzumab)   Monoclonal antibody   Roche   HER2+BC & HER2+ metastatic gastric cancer     2,955       4,140       7,096  
IBRANCE® (palbociclib) in combination with fluvestrant or aromatase inhibitor   CDK 4/6 inhibitor   Pfizer   HR+/HER2- MBC     2,922       1,196       4,118  
PERJETA® (pertuzumab) in combination with Herceptin® (trastuzumab) and chemotherapy   HER2/neu receptor antagonist   Roche   HER2+ early BC that has a high likelihood of recurrence     1,347       1,499       2,846  
FASLODEX® (fulvestrant)   Estrogen receptor antagonist   AstraZeneca   HR+/HER2- MBC     537       491       1,028  
KADCYLA® (ado-trastuzumab emtansine)   HER2 targeted antibody & microtubule inhibitor conjugate   Roche   HER2+BC     365       630       995  
LYNPARZA® (olaparib)   Poly (ADP-ribose) polymerase (PARP) inhibitor   AstraZeneca   BC & Ovarian cancer     345       302       647  
Verzenio® (abemaciclib) monotherapy or in combination with fulvestrant or aromatase inhibitor    CDK 4/6 inhibitor   Eli Lilly   HR+/HER2- MBC     255       -       255  
KISQALI® (ribociclib) in combination with fluvestrant or aromatase inhibitor   CDK 4/6 inhibitor   Novartis   HR+/HER2- MBC     235       -       235  

 

 

2 Mariotto AB, Etzioni R, Hurlbert M, Penberthy L, Mayer M. Estimation of the Number of Women Living with Metastatic Breast Cancer in the United States. Cancer Epidemiol Biomarkers Prev. 2017 Jun;26(6):809-815.

3 Breast Cancer Facts & Figures 2017-2018. Atlanta: American Cancer Society, Inc. 2017.

4 Lobbezoo, D. J. A. et al. Prognosis of metastatic breast cancer subtypes: the hormone receptor/HER2-positive subtype is associated with the most favorable outcome. Breast Cancer Res. Treat. 141, 507–514 (2013).

5 Dawood S, Broglio K, Ensor J, Hortobagyi GN, Giordano SH. Survival differences among women with de novo stage IV and relapsed breast cancer. Ann Oncol. 2010 Nov; 21(11):2169–74.

6 Bonotto M, Gerratana L, Iacono D, Minisini AM, Rihawi K, Fasola G, Puglisi F. Treatment of Metastatic Breast Cancer in a Real-World Scenario: Is Progression-Free Survival With First Line Predictive of Benefit From Second and Later Lines? Oncologist.

7 Kotsakis A, Ardavanis A, Koumakis G, Samantas E, Psyrri A, Papadimitriou C. Epidemiological characteristics, clinical outcomes and management patterns of metastatic breast cancer patients in routine clinical care settings of Greece: Results from the EMERGE multicenter retrospective chart review study. BMC Cancer. 2019 Jan 18;19(1):88.

 

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The best response to Bria-IMT™ to date is in patients who matched Bria-IMT™ at 1 or more HLA alleles, with higher response rates for patients with 2+ HLA allele matches. If one HLA allele match is found to be sufficient, we will be able to treat ~50-60% of the patient population, while patients with 2+ HLA matches constitutes ~15-35% of cases.8 We also saw higher clinical benefit rates for patients with grade I/II tumors. Tumor differentiation in breast cancer cell lines is often described by their classification as Luminal, Basal A and Basal B subtypes, with Luminal representing well differentiated and Basal B poorly differentiated tumors, and Basal A an intermediate stage (“moderately” differentiated) (Neve RM, Chin K, Fridlyand J, et al. A collection of breast cancer cell lines for the study of functionally distinct cancer subtypes. Cancer Cell. 2006;10(6):515-527. doi:10.1016/j.ccr.2006.10.008). Yao and colleagues in 2005 identified a 9-gene signature (AURKB, CENPI, DEPDC1, DEPDC1B, FAM83D, FGD3, NCAPH, TNFRSF18, FCGR1A) discriminating poorly (grade 3) from moderately (grade 2) differentiated tumors. (Yao F, Zhang C, Du W, Liu C, Xu Y. Identification of gene-expression signatures and protein markers for breast cancer grading and staging. PLoS One. 2015;10(9). doi:10.1371/journal.pone.0138213) To understand the place of SV-BR-1-GM in this model, we compared its RNA expression profile with those of three other cell lines representing Luminal (MCF-7), Basal A (MDA-MB-468) and Basal B (MDA-MB-231), using a 10-gene signature (AURKB, CENPI, DEPDC1, DEPDC1B, FAM83D, FGD3, NCAPH, DLGAP, KIF2C, VAV3) derived from those by Yao and colleagues. The results, shown in Figure: Bria-IMTTM Clinical Experience in Grade I/II Tumors below, demonstrate that Bria-IMT™ most closely clusters with MDA-MB-468 and as such is considered a “moderately differentiated” cell line.

 

 

Based on a recent publication of patients with relapsed breast cancer, we estimate that this will account for ~40% of relapsed metastatic breast cancer cases (33% grade II and 7% grade I) (Sundquist M, Brudin L, Tejler G. Improved survival in metastatic breast cancer 1985-2016. Breast. 2017 Feb;31:46-50. doi: 10.1016/j.breast.2016.10.005. Epub 2016 Nov 2). In patients with relapsed disease, the overall survival following relapse appears similar for those with grade II and grade III tumors3. The market for breast cancer drugs is a multibillion-dollar market with new drugs being approved on an ongoing basis, indicating the shortage of safe and effective treatments for this deadly disease. The Figure summarizes current drugs on the market utilized in combination therapy along with their reported market sales, which further supports market potential for Bria-IMTTM to be used for combination therapy for breast cancer patients.

 

We propose the following calculation in order to show the rationale behind the number of patients that we anticipate can be currently treated by SV-BR-1-GM:

 

  There are ~150,000 women with metastatic breast cancer in the US9
  45% will receive third line therapy10 = 68,000 patients available
  68,000 x ~50% (matched for 1 HLA allele group)11 = ~34,000 patients available for treatment12
  40% have grade I/II tumors3 = ~13,600 patients available for treatment

 

These assumptions above are limited to third or later lines of therapy. There is also potential to move into second-line and first-line treatment, which would markedly expand the population to be treated.

 

Treatment with a combination therapy comprised of Bria-IMT™ + checkpoint inhibitor is expected to provide a new therapeutic option in patients who currently have no effective therapeutic options. The parallel development of BriaDx™ (companion diagnostic) by BriaCell, as a strategy to identify those patients most likely to respond to Bria-IMT™, may eventually lead to even higher response rates — potentially substantially higher than currently achievable by other treatments for breast cancer.

 

BriaCell is in contact with several large pharmaceutical companies for potential collaborations for the development of a combination therapy with Bria-IMT™ and immune checkpoint inhibitors, and already has in place a collaboration with Incyte Corporation. We will continue to pursue these discussions with the goal of using Bria-IMT™ in combination with checkpoint inhibitors. This will also help increase the visibility of our therapy and may lead to additional funding sources for future clinical trials.

 

Competition

 

Currently available therapeutic options for breast cancer offer some hope for patients, but there is much room for improvement. Comparable studies looking primarily at second line or later treatment are shown in the Table. Evaluating response rates (partial and complete responses = ORR), progression free survival (PFS) and overall survival (OS) from clinical trials in similar subjects with metastatic or recurrent breast cancer indicate that response rates range from 6.9% up to 59%, depending on the population studied and the intervention (median 24%). PFS ranges from 8 weeks to 12 months (median 5 months) and OS from 6 months to 31 months (median 13 months).

 

 

8 Gragert, Loren, Abeer Madbouly, John Freeman, and Martin Maiers. 2013. “Six-Locus High Resolution HLA Haplotype Frequencies Derived from Mixed-Resolution DNA Typing for the Entire US Donor Registry.” Human Immunology.

9 Mariotto AB, Etzioni R, Hurlbert M, Penberthy L, Mayer M. Estimation of the Number of Women Living with Metastatic Breast Cancer in the United States. Cancer Epidemiol Biomarkers Prev. 2017 Jun;26(6):809-815.

10 Kotsakis A, Ardavanis A, Koumakis G, Samantas E, Psyrri A, Papadimitriou C. Epidemiological characteristics, clinical outcomes and management patterns of metastatic breast cancer patients in routine clinical care settings of Greece: Results from the EMERGE multicenter retrospective chart review study. BMC Cancer. 2019 Jan 18;19(1):88.

11 Gragert, Loren, Abeer Madbouly, John Freeman, and Martin Maiers. 2013. “Six-Locus High Resolution HLA Haplotype Frequencies Derived from Mixed-Resolution DNA Typing for the Entire US Donor Registry.” Human Immunology.

12 Momenimovahed Z, Salehiniya H. Epidemiological characteristics of and risk factors for breast cancer in the world. Breast Cancer (Dove Med Press). 2019 Apr 10;11:151-164. SEER Cancer Statistics Factsheets: Female Breast Cancer. National Cancer Institute. Bethesda, MD; American Cancer Society. Breast Cancer Facts & Figures 2017-2018. Atlanta: American Cancer Society, Inc. 2017.

 

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Table: Studies evaluating second-line or later treatment options. Data depict an unpredictable response rate to treatment ranging from 6.9-59%, therefore establishing and confirming the opportunity for Bria-IMT™.
 
Study   Treatment & Design   # of Pts     ORR     PFS/TTP     OS  
Perez13   Paclitaxel Monotherapy     212       21.5 %     4.7 mo       12.8 mo  
Seidman14   Gemcitabine Monotherapy     160       26 %                
Zelek15   Vinorelbine Monotherapy     40       25 %             6 mo  
Licchetta16   Cyclophosphamide and megestrol acetate     29       31 %     7.4 mo       13.4 mo  
Harvey17   Docetaxel Monotherapy 60 mg/m2     122       22.1 %     12.7 wk       10.6 mo  
    Docetaxel Monotherapy 75 mg/m2     146       23.3 %     15.0 wk       10.3 mo  
    Docetaxel Monotherapy 100 mg/m2     139       36.0 %     16.6 wk       12.3 mo  
Rivera18   Docetaxel Monotherapy q3wk     59       35.6 %     5.7 mo       18.3 mo  
    Docetaxel Monotherapy qwk     59       20.3 %     5.5 mo       18.6 mo  
Gradishar19   ABI-007 (Nab paclitaxel)     229       33 %     23.0 wk       65.0 wk  
    Paclitaxel Monotherapy     225       19 %     16.9 wk       55.7 wk  
    ABI-007 (Nab paclitaxel) 2nd line     132       27 %     20.9 wk       56.4 wk  
    Paclitaxel Monotherapy 2nd line     136       13 %     16.1 wk       46.7 wk  
Perez20   Ixabepilone Monotherapy     126       11.5 %     3.1 mo       8.6 mo  
Leyland-Jones21   Trastuzumab with paclitaxel     32       59 %     12.2 mo          
von Minckwitz22   Trastuzumab with capecitabine     78       48.1 %     8.2 mo