Quarterly Report (10-q)

Date : 11/13/2019 @ 9:57PM
Source : Edgar (US Regulatory)
Stock : DelMar Pharmaceuticals Inc (DMPI)
Quote : 0.389899  -0.000201 (-0.05%) @ 4:53PM

Quarterly Report (10-q)

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

Form 10-Q

 

(Mark One)

þ  QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended September 30, 2019

 

or

 

☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from ____________ to ________________

 

Commission file number: 001-37823

 

DelMar Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

 

Nevada   99-0360497
(State or other jurisdiction of
incorporation or organization)
  (I.R.S. Employer
Identification No.)

 

12707 High Bluff Dr., Suite 200
San Diego, CA
  92130
(Address of principal executive offices)   (zip code)

 

(858) 350-4364

(Registrant’s telephone number, including area code)

 

N/A

(Former name, former address and former fiscal year, if changed since last report)

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of Each Class   Trading Symbol(s)   Name of Each Exchange on Which Registered
Common Stock   DMPI   The Nasdaq Capital Market

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

Yes þ No ☐

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).

Yes þ No ☐

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer”, “smaller reporting company”, and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer ☐ Accelerated filer ☐

Non-accelerated filer þ

Emerging growth company ☐

Smaller reporting company þ

 

If an emerging growth company, 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 13(a) of the Exchange Act. ☐

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act)

Yes ☐ No þ

 

Number of shares of common stock outstanding as of November 12, 2019 was 11,399,700.

 

 

 

 

 

 

TABLE OF CONTENTS

 

        Page No.
PART I. - FINANCIAL INFORMATION    
Item 1.   Financial Statements.   1
Item 2.   Management’s Discussion and Analysis of Financial Condition and Results of Operations.   20
Item 3.   Quantitative and Qualitative Disclosures About Market Risk.   36
Item 4   Controls and Procedures.   36
PART II - OTHER INFORMATION    
Item 1.   Legal Proceedings.   37
Item 1A.   Risk Factors.   37
Item 2.   Unregistered Sales of Equity Securities and Use of Proceeds.   37
Item 3.   Defaults Upon Senior Securities.   37
Item 4.   Mine Safety Disclosures.   37
Item 5.   Other Information.   37
Item 6.   Exhibits.   37

 

i

 

 

PART 1. - FINANCIAL INFORMATION

 

Item 1. Financial Statements.

 

DelMar Pharmaceuticals, Inc.

 

Condensed Consolidated Interim Financial Statements

(Unaudited)

 

For the three months ended September 30, 2019

 

(expressed in US dollars unless otherwise noted)

 

1

 

 

DelMar Pharmaceuticals, Inc.

Condensed Consolidated Interim Balance Sheets

 

 

(expressed in US dollars unless otherwise noted)

 

    Note   September 30,
2019
$
    June 30,
2019
$
 
        (unaudited)        
Assets                
                 
Current assets                
Cash and cash equivalents         8,060,039       3,718,758  
Prepaid expenses and deposits         223,714       280,248  
Interest, taxes and other receivables         70,743       26,187  
          8,354,496       4,025,193  
Intangible assets - net         9,261       12,062  
          8,363,757       4,037,255  
                     
Liabilities                    
                     
Current liabilities                    
Accounts payable and accrued liabilities         1,127,543       1,744,517  
Related party payables   3     211,300       325,208  
                     
          1,338,843       2,069,725  
Stockholders’ equity                    
                     
Preferred stock                    
Authorized                    
5,000,000 shares, $0.001 par value                    
Issued and outstanding                    
278,530 Series A shares at September 30, 2019 (June 30, 2019 – 278,530)   3,5     278,530       278,530  
648,613 Series B shares at September 30, 2019 (June 30, 2019 – 673,613)   5     4,524,897       4,699,304  
1 special voting share at September 30, 2019 (June 30, 2019 – 1)         -       -  
                     
Common stock                    
Authorized                    
95,000,000 shares at September 30, 2019 and June 30, 2019, $0.001 par value                    
11,406,233 issued at September 30, 2019 (June 30, 2019 – 3,839,358)   5     11,406       3,839  
                     
Additional paid-in capital   5     56,098,086       50,954,741  
                     
Warrants   5     8,279,168       6,588,283  
                     
Accumulated deficit         (62,188,351 )     (60,578,345 )
                     
Accumulated other comprehensive income         21,178       21,178  
                     
          7,024,914       1,967,530  
                     
          8,363,757       4,037,255  

  

Nature of operations, corporate history, and going concern (note 1)

Subsequent events (note 8)

 

The accompanying notes are an integral part of these condensed consolidated interim financial statements.

 

2

 

 

DelMar Pharmaceuticals, Inc.

Condensed Consolidated Interim Statements of Operations

(Unaudited)

 

 

(expressed in US dollars unless otherwise noted)

 

        Three months ended September 30,  
    Note  

2019

$

   

2018

$

 
                 
Expenses                
Research and development   5     721,475       1,019,120  
General and administrative   5     913,628       986,470  
                     
          1,635,103       2,005,590  
                     
Other (income) loss                    
Change in fair value of derivative liability   4     -       220  
Foreign exchange (gain) loss         (374 )     5,838  
Interest income         (28,858 )     (19,844 )
                     
          (29,232 )     (13,786 )
                     
Net loss for the period         1,605,871       1,991,804  
                     
Computation of basic loss per share                    
Net loss for the period         1,605,871       1,991,804  
Series B Preferred stock dividend   5     2,046       36,085  
Net loss for the period attributable to common stockholders         1,607,917       2,027,889  
                     
Basic and fully diluted loss per share         0.21       0.88  
                     
Basic weighted average number of shares         7,538,562       2,296,909  

  

The accompanying notes are an integral part of these condensed consolidated interim financial statements.

 

3

 

 

DelMar Pharmaceuticals, Inc.

Condensed Consolidated Interim Statements of Stockholders’ Equity

(Unaudited)

 

 

(expressed in US dollars unless otherwise noted)

 

   

Number

of

common shares

   

Common

stock

$

   

Additional

paid-in

capital

$

   

Accumulated

other

comprehensive

income

$

   

Preferred stock

$

   

 

 

Warrants

$

   

Accumulated

deficit

$

   

Stockholders'

equity

$

 
                                                 
Balance - June 30, 2019     3,839,358       3,839       50,954,741       21,178       4,977,834       6,588,283       (60,578,345 )     1,967,530  
                                                                 
Issuance of shares and warrants - net of issue costs     4,895,000       4,895       2,489,251       -       -       4,088,820       -       6,582,966  
Exercise of warrants for cash     2,655,000       2,655       2,421,830       -       -       (2,397,935 )     -       26,550  
Conversion of Series B preferred stock to common stock     6,250       6       174,401       -       (174,407 )     -       -       -  
                                                                 
Shares issued for services     6,925       7       4,836       -       -       -       -       4,843  
Stock option expense     -       -       50,985       -       -       -       -       50,985  
Series A preferred cash dividend     -       -       -       -       -       -       (2,089 )     (2,089 )
Series B preferred stock dividend     3,700       4       2,042       -       -       -       (2,046 )     -  
Loss for the year     -       -       -       -       -       -       (1,605,871 )     (1,605,871 )
                                                                 
Balance - September 30, 2019     11,406,233       11,406       56,098,086       21,178       4,803,427       8,279,168       (62,188,351 )     7,024,914  
                                                                 
Balance - June 30, 2018     2,296,667       2,297       43,198,193       21,178       6,425,410       8,229,482       (52,441,337 )     5,435,223  
                                                                 
Warrants issued for services     -       -       -       -       -       30,661       -       30,661  
Shares issued for services     706       1       4,138       -       -       -       -       4,139  
Performance stock unit expense     -       -       61,514       -       -       -       -       61,514  
Stock option expense     -       -       132,902       -       -       -       -       132,902  
Series A preferred cash dividend     -       -       -       -       -       -       (2,089 )     (2,089 )
Series B preferred stock dividend     4,960       4       36,081       -       -       -       (36,085 )     -  
Loss for the year     -       -       -       -       -       -       (1,991,804 )     (1,991,804 )
,                                                                
Balance - September 30, 2018     2,302,333       2,302       43,432,828       21,178       6,425,410       8,260,143       (54,471,315 )     3,670,546  

 

The accompanying notes are an integral part of these condensed consolidated interim financial statements.

 

4

 

 

DelMar Pharmaceuticals, Inc.

Condensed Consolidated Interim Statements of Cash Flows

(Unaudited)

 

 

(expressed in US dollars unless otherwise noted) 

 

        Three months ended September 30,  
        2019     2018  
    Note   $     $  
Cash flows from operating activities                
Loss for the period         (1,605,871 )     (1,991,804 )
Adjustments to reconcile net loss to net cash used in operating activities                    
Amortization of intangible assets         2,801       6,659  
Change in fair value of derivative liability   4     -       220  
Shares issued for services         4,843       4,139  
Warrants issued for services         -       30,661  
Stock option expense   5     50,985       132,902  
Performance stock unit expense         -       61,514  
                     
Changes in operating assets and liabilities                    
Interest, taxes and other receivables         (44,556 )     27,849  
Prepaid expenses and deposits         56,534       203,462  
Accounts payable and accrued liabilities         (616,974 )     (568,199 )
Related party payables         (113,908 )     7,674  
Net cash used in operating activities         (2,266,146 )     (2,084,923 )
                     
Cash flows from financing activities                    
Net proceeds from the issuance of shares and warrants   5     6,582,966       -  
Warrants exercised for cash   5     26,550       -  
Series A preferred stock dividend   3     (2,089 )     (2,089 )
                     
Net cash provided by (used in) financing activities         6,607,427       (2,089 )
                     
Increase (decrease) in cash and cash equivalents         4,341,281       (2,087,012 )
                     
Cash and cash equivalents - beginning of period         3,718,758       5,971,995  
                     
Cash and cash equivalents - end of period         8,060,039       3,884,983  
                     
Supplementary information (note 7)                    

  

The accompanying notes are an integral part of these condensed consolidated interim financial statements. 

 

5

 

 

DelMar Pharmaceuticals, Inc.

Notes to Condensed Consolidated Interim Financial Statements

(Unaudited)

September 30, 2019

 

(expressed in US dollars unless otherwise noted)

 

1 Nature of operations, corporate history, and going concern

 

Nature of operations

 

DelMar Pharmaceuticals, Inc. (the “Company”) is a clinical stage drug development company with a focus on the treatment of solid tumor cancers. The Company is currently conducting two phase 2 clinical trials in the United States and China with its product candidate, VAL-083, as a potential new treatment for glioblastoma multiforme, the most common and aggressive form of brain cancer. Historical research indicates that VAL-083 is also active in other solid tumor cancers such as ovarian, lung, pediatric brain cancer, as well as other solid tumors of the central nervous system. The Company may pursue opportunities in these cancers in the future. In order to accelerate the Company’s development timelines, it leverages existing preclinical and clinical data from a wide range of sources.  The Company may seek marketing partnerships in order to potentially offset clinical costs and to generate future royalty revenue from approved indications of its product candidate. 

 

Corporate history

 

The Company is a Nevada corporation formed on June 24, 2009 under the name Berry Only, Inc. On January 25, 2013, the Company entered into and closed an exchange agreement (the “Exchange Agreement”), with Del Mar Pharmaceuticals (BC) Ltd. (“Del Mar (BC)”), 0959454 B.C. Ltd. (“Callco”), and 0959456 B.C. Ltd. (“Exchangeco”) and the security holders of Del Mar (BC). Upon completion of the Exchange Agreement, Del Mar (BC) became a wholly-owned subsidiary of the Company (the “Reverse Acquisition”).

 

DelMar Pharmaceuticals, Inc. is the parent company of Del Mar (BC), a British Columbia, Canada corporation incorporated on April 6, 2010, which is a clinical stage company with a focus on the development of drugs for the treatment of cancer. The Company is also the parent company to Callco and Exchangeco which are British Columbia, Canada corporations. Callco and Exchangeco were formed to facilitate the Reverse Acquisition.

 

References to the Company refer to the Company and its wholly-owned subsidiaries, Del Mar (BC), Callco and Exchangeco.

 

Going concern

 

These condensed consolidated interim financial statements have been prepared on a going concern basis which assumes that the Company will continue its operations for the foreseeable future and contemplates the realization of assets and the settlement of liabilities in the normal course of business.

 

For the three months ended September 30, 2019, the Company reported a loss of $1,605,871, and a negative cash flow from operations of $2,266,146. The Company had an accumulated deficit of $62,188,351 and had cash equivalents on hand of $8,060,039 as of September 30, 2019. The Company is in the development stage and has not generated any revenues to date. The Company does not have the prospect of achieving revenues until such time that its product candidate is commercialized, or partnered, which may not ever occur. In the near future, the Company will require additional funding to maintain its clinical trials, research and development projects, and for general operations. These circumstances indicate substantial doubt exists about the Company’s ability to continue as a going concern within one year from the date of filing of these condensed consolidated financial statements.

 

6

 

 

DelMar Pharmaceuticals, Inc.

Notes to Condensed Consolidated Interim Financial Statements

(Unaudited)

September 30, 2019

 

(expressed in US dollars unless otherwise noted)

 

Consequently, management is pursuing various financing alternatives to fund the Company’s operations so it can continue as a going concern. Management plans to secure the necessary financing through the issue of new equity and/or the entering into of strategic partnership arrangements. The Company may tailor its drug candidate development program based on the amount of funding the Company is able to raise in the future. Nevertheless, there is no assurance that these initiatives will be successful.

 

These financial statements do not give effect to any adjustments to the amounts and classification of assets and liabilities that may be necessary should the Company be unable to continue as a going concern. Such adjustments could be material.

 

2 Significant accounting policies

 

Reverse stock split

 

On May 7, 2019, the Company filed a Certificate of Change with the Secretary of State of Nevada that effected a 1-for-10 (1:10) reverse stock split of its common stock, par value $0.001 per share, which became effective on May 8, 2019. Pursuant to the Certificate of Change, the Company’s authorized common stock was decreased in the same proportion as the split resulting in a decrease from 70,000,000 authorized shares of common stock to 7,000,000 shares authorized. The par value of its common stock was unchanged at $0.001 per share, post-split. All common shares, warrants, stock options, conversion ratios, and per share information in these condensed consolidated interim financial statements give retroactive effect to the 1-for-10 reverse stock split. The Company’s authorized and issued preferred stock was not affected by the split.

 

Amended articles of incorporation

 

On June 26, 2019, we amended our articles of incorporation to increase the number of authorized shares of common stock from 7,000,000 to 95,000,000 shares.

 

Basis of presentation

 

The condensed consolidated interim financial statements of the Company have been prepared in accordance with United States Generally Accepted Accounting Principles (“U.S. GAAP”) and are presented in United States dollars. The functional currency of the Company and each of its subsidiaries is the United States dollar.

 

The accompanying condensed consolidated interim financial statements include the accounts of the Company and its wholly-owned subsidiaries, Del Mar BC, Callco, and Exchangeco. All intercompany balances and transactions have been eliminated in consolidation.

 

The principal accounting policies applied in the preparation of these condensed consolidated interim financial statements are set out below and have been consistently applied to all periods presented.

 

7

 

 

DelMar Pharmaceuticals, Inc.

Notes to Condensed Consolidated Interim Financial Statements

(Unaudited)

September 30, 2019

 

(expressed in US dollars unless otherwise noted)

 

Unaudited interim financial data

 

The accompanying unaudited condensed consolidated interim financial statements have been prepared in accordance with the rules and regulations of the Securities and Exchange Commission for interim financial information. Accordingly, they do not include all of the information and the notes required by U.S. GAAP for complete financial statements. These unaudited condensed consolidated interim financial statements should be read in conjunction with the audited financial statements of the Company as at June 30, 2019 included in our Form 10-K. In the opinion of management, the unaudited condensed consolidated interim financial statements reflect all adjustments, consisting of normal and recurring adjustments, necessary for a fair presentation. The results for three months ended September 30, 2019 are not necessarily indicative of the results to be expected for the fiscal year ending June 30, 2020, or for any other future annual or interim period.

 

Use of estimates

 

The preparation of financial statements in conformity with US GAAP requires management to make estimates and assumptions about future events that affect the reported amounts of assets, liabilities, expenses, contingent assets and contingent liabilities as at the end of, or during, the reporting period. Actual results could significantly differ from those estimates. Significant areas requiring management to make estimates include the derivative liability, the valuation of equity instruments issued for services, and clinical trial accruals. Further details of the nature of these assumptions and conditions may be found in the relevant notes to these condensed consolidated interim financial statements.

 

Loss per share

 

Income or loss per share is calculated based on the weighted average number of common shares outstanding. For the three-month periods ended September 30, 2019 and 2018 diluted loss per share does not differ from basic loss per share since the effect of the Company’s warrants, stock options, performance stock units, and convertible preferred shares is anti-dilutive. As of September 30, 2019, potential common shares of 9,683,596 (2018 – 1,433,353) related to outstanding warrants, 780,000 (2018 – 262,683) relating to stock options, nil (2018 – 120,000) relating to performance stock units, and 162,177 (2018 – 220,279) relating to outstanding Series B convertible preferred shares were excluded from the calculation of net loss per common share because their inclusion would be anti-dilutive.

 

Recent accounting pronouncements

 

From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodies that are adopted by the Company as of the specified effective date.

 

Recently adopted

 

 

8

 

 

DelMar Pharmaceuticals, Inc.

Notes to Condensed Consolidated Interim Financial Statements

(Unaudited)

September 30, 2019

 

(expressed in US dollars unless otherwise noted)

  

ASU 2016-02 — Leases (Topic 842)

 

The new standard establishes a right-of-use (“ROU”) model that requires a lessee to record a ROU asset and a lease liability on the consolidated balance sheet for all leases with terms longer than 12 months. Leases will be classified as either finance or operating, with classification affecting the pattern of expense recognition in the consolidated income statement. ASU 2016-02 is effective for annual periods beginning after December 15, 2018, including interim periods within those annual periods, with early adoption permitted. A modified retrospective transition approach is required for lessees for capital and operating leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements, with certain practical expedients available. The adoption of ASU 2016-02 did not have a material impact on the Company’s results of operations or financial results.

 

ASU 2018-07 — Stock Compensation (Topic 718) Improvements to Nonemployee Shares-based Payment Accounting

 

The amendments in this update are intended to the reduce cost and complexity and to improve financial reporting for share-based payments issued to nonemployees. The ASU expands the scope of Topic 718, Compensation —Stock Compensation, which currently only includes share-based payments issued to employees, to also include share-based payments issued to nonemployees for goods and services. The existing guidance on nonemployee share-based payments is significantly different from current guidance for employee share-based payments. This ASU expands the scope of the employee share-based payments guidance to include share-based payments issued to nonemployees. By doing so, the FASB improves the accounting of nonemployee share-based payments issued to acquire goods and services used in its own operations. The amendments in this ASU are effective for public companies for fiscal years beginning after December 15, 2018, including interim periods within that fiscal year. The adoption of ASU 2018-07 did not have a material impact on the Company’s results of operations or financial results.

 

Not yet adopted

 

ASU 2017-11 — I. Accounting for Certain Financial Instruments with Down Round Features, II. Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Non-public Entities and Certain Mandatorily Redeemable Noncontrolling Interests with a Scope Exception

The amendments in this update are intended to reduce the complexity associated with the accounting for certain financial instruments with characteristics of liabilities and equity. Specifically, a down round feature would no longer cause a freestanding equity-linked financial instrument (or an embedded conversion option) to be accounted for as a derivative liability at fair value with changes in fair value recognized in current earnings. In addition, the indefinite deferral of certain provisions of Topic 480 have been re-characterized to a scope exception. The re-characterization has no accounting effect. ASU 2017-11 is effective for public business entities for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019. Early adoption is permitted. The Company has not yet evaluated the impact of adoption of this ASU on its condensed consolidated interim financial statements and related disclosures.

 

During the three months ended September 30, 2019, other than ASU 2017-11, there have been no new, or existing recently issued, accounting pronouncements that are of significance, or potential significance, that impact the Company’s condensed consolidated interim financial statements.

 

9

 

 

DelMar Pharmaceuticals, Inc.

Notes to Condensed Consolidated Interim Financial Statements

(Unaudited)

September 30, 2019

 

(expressed in US dollars unless otherwise noted)

 

3 Related party transactions

 

The Series A Preferred Stock is held by Valent Technologies, LLC (“Valent”), an entity owned by Dr. Dennis Brown, the Company’s Chief Scientific Officer. Therefore, Valent is a related party to the Company. For the three months ended September 30, 2019 and 2018 respectively, the Company recorded $2,089 related to the dividend payable to Valent on the Series A Preferred Stock (note 5). The dividends have been recorded as a direct increase in accumulated deficit.

 

The related party payable balances as of September 30, 2019 and June 30, 2019 consist of compensation costs, directors’ fees, and amounts owing for expense reimbursement to the Company’s officers and directors.

 

4 Derivative liability

 

The Company has issued common stock purchase warrants. Based on the terms of certain of these warrants the Company determined that the warrants were a derivative liability which is recognized at fair value at the date of the transaction and re-measured at fair value each reporting period with the changes in fair value recorded in the condensed consolidated interim statement of operations and comprehensive loss.

 

The derivative liabilities balance was nil at September 30, 2019 and June 30, 2019. The derivative liabilities balance consisted of the 2,180 Agent Warrants at September 30, 2019 and 2018, and at June 30, 2019.

 

Changes in the Company’s derivative liability are summarized as follows:

 

    Three months ended  
    September 30,  
    2019     2018  
    $     $  
             
Opening balance     -       1,117  
Change in fair value of warrants     -       220  
                 
Closing balance     -       1,337  
Less current portion     -       -  
                 
Long term portion     -       1,337  

 

10

 

 

DelMar Pharmaceuticals, Inc.

Notes to Condensed Consolidated Interim Financial Statements

(Unaudited)

September 30, 2019

 

(expressed in US dollars unless otherwise noted)

 

5 Stockholders’ equity

 

Preferred stock

 

    Series B Preferred Stock  
       
    Number of shares     $  
             
Opening balance – June 30, 2019     673,613      

4,699,304

 
Conversion of Series B Preferred stock to common stock     (25,000 )     (174,407 )
                 
Closing balance – September 30, 2019     648,613       4,524,897  

 

There was no change to the Series B Preferred stock for the three months ended September 30, 2018 nor to the Series A Preferred stock for either of the three months ended September 30, 2019 or 2018.

 

Series B Preferred Stock

 

During the year ended June 30, 2016, the Company issued an aggregate of 902,238 shares of Series B Preferred Stock at a purchase price of at $8.00 per share. Each share of Series B Preferred Stock is convertible into 0.25 shares of common stock equating to a conversion price of $32.00 (the “Conversion Price”) and will automatically convert to common stock at the earlier of (i) 24 hours following regulatory approval of VAL-083 with a minimum closing bid price of $80.00 or (ii) five years from the final closing date. The holders of the Series B Preferred Stock are entitled to an annual cumulative, in arrears, dividend at the rate of 9% payable quarterly. The 9% dividend accrues quarterly commencing on the date of issue and is payable quarterly on June 30, September 30, December 31, and March 31 of each year commencing on June 30, 2016. Dividends are payable solely by delivery of shares of common stock, in an amount for each holder equal to the aggregate dividend payable to such holder with respect to the shares of Series B Preferred Stock held by such holder divided by the Conversion Price. The Series B Preferred Stock does not contain any repricing features. Each share of Series B Preferred Stock entitles its holder to vote with the common stock on an as-converted basis.

 

The Series B Preferred Stock shall with respect to distributions of assets and rights upon the occurrence of a liquidation, rank (i) senior to the Company’s common stock and (ii) senior to the Special Voting Preferred Stock and (iii) senior to any other class or series of capital stock of the Company hereafter created which does not expressly rank pari passu with, or senior to, the Series B Preferred Stock. The Series B Preferred Stock shall be pari passu in liquidation to the Company’s Series A Preferred Stock. The liquidation value of the Series B Preferred Stock at September 30, 2019 is the stated value of $5,188,904 (June 30, 2019 - $5,388,904).

 

In addition, the Company and the holders entered into a royalty agreement, pursuant to which the Company will pay the holders of the Series B Preferred Stock, in aggregate, a low, single-digit royalty based on their pro rata ownership of the Series B Preferred Stock on products sold directly by the Company or sold pursuant to a licensing or partnering arrangement (the “Royalty Agreement”).

 

Upon conversion of a holder’s Series B Preferred Stock to common stock, such holder shall no longer receive ongoing royalty payments under the Royalty Agreement but will be entitled to receive any residual royalty payments that have vested. Rights to the royalties shall vest during the first three years following the applicable closing date, in equal thirds to holders of the Series B Preferred Stock on each of the three vesting dates, upon which vesting dates such royalty amounts shall become vested royalties.

 

Pursuant to the Series B Preferred Stock dividend, during the three months ended September 30, 2019, the Company issued 3,700 (2018 – 4,960) shares of common stock and recognized $2,046 (2018 – $36,085) as a direct increase in accumulated deficit.

 

A total of 648,613 (2018 – 881,113) shares of Series B Preferred Stock are outstanding as of September 30, 2019, such that a total of 162,177 (2018 – 220,280) shares of common stock are issuable upon conversion of the Series B Preferred Stock as at September 30, 2019. Converted shares are rounded up to the nearest whole share.

 

11

 

 

DelMar Pharmaceuticals, Inc.

Notes to Condensed Consolidated Interim Financial Statements

(Unaudited)

September 30, 2019

 

(expressed in US dollars unless otherwise noted)

 

Series A Preferred Stock

 

Effective September 30, 2014, the Company filed a Certificate of Designation of Series A Preferred Stock (the “Series A Certificate of Designation”) with the Secretary of State of Nevada. Pursuant to the Series A Certificate of Designation, the Company designated 278,530 shares of preferred stock as Series A Preferred Stock. The shares of Series A Preferred Stock have a stated value of $1.00 per share (the “Series A Stated Value”) and are not convertible into common stock. The holder of the Series A Preferred Stock is entitled to dividends at the rate of 3% of the Series A Stated Value per year, payable quarterly in arrears. Upon any liquidation of the Company, the holder of the Series A Preferred Stock will be entitled to be paid, out of any assets of the Company available for distribution to stockholders, the Series A Stated Value of the shares of Series A Preferred Stock held by such holder, plus any accrued but unpaid dividends thereon, prior to any payments being made with respect to the common stock. The Series A Preferred Stock is held by Valent (note 3).

 

The Series A Preferred Stock shall with respect to distributions of assets and rights upon the occurrence of a liquidation, rank (i) senior to the Company’s common stock, and (ii) senior to the Company’s Special Voting Preferred Stock and (iii) senior to any other class or series of capital stock of the Company hereafter created which does not expressly rank pari passu with, or senior to, the Series A Preferred Stock. The Series A Preferred Stock shall be pari passu in liquidation to the Company’s Series B Preferred Stock. The liquidation value of the Series A Preferred stock at September 30, 2019 and June 30, 209 is the stated value of $278,530.

 

Common stock

 

Stock Issuances

 

Three months ended September 30, 2019

 

Underwritten public offering

 

On August 16, 2019, the Company closed on the sale of (i) 4,895,000 shares of its common stock, par value $0.001 per share (the “Common Stock”), (ii) pre-funded warrants (“PFW”) to purchase an aggregate of 2,655,000 shares of Common Stock and (iii) common warrants to purchase an aggregate of 7,762,500 shares of Common Stock (“2020 Investor Warrants”), including 800,000 shares of Common Stock and 2020 Investor Warrants to purchase an aggregate of 1,012,500 shares of Common Stock sold pursuant to a partial exercise by the underwriters of the underwriters’ option to purchase additional securities, in the Company’s underwritten public offering (the “Offering”). Each share of Common Stock or PFW, as applicable, was sold together with a 2020 Investor Warrant to purchase one share of Common Stock at a combined effective price to the public of $1.00 per share of Common Stock and accompanying 2020 Investor Warrant.

 

The net proceeds from the Offering, including from the partial exercise of the underwriters’ option to purchase additional securities, were $6,582,966, after deducting underwriting discounts and commissions, and other offering expenses.

 

The 2020 Investor Warrants are exercisable at $1.00 per share until their expiry on August 16, 2024 and the PFW are exercisable at $0.01 per share at any time after August 16, 2019. The Company also issued 377,500 warrants to the underwriters of the Offering (the “2020 Underwriter Warrants”). The 2020 Underwriter Warrants are exercisable at $1.15 per share commencing February 10, 2020 until their expiry on August 14, 2022.

 

The Company granted the underwriters a 45-day option, ending September 28, 2019, to purchase up to an additional 1,012,500 shares of Common Stock and/or 2020 Investor Warrants to purchase up to 1,012,500 shares of Common Stock, at the public offering price. On August 15, 2019, the underwriters partially exercised this option by purchasing 800,000 shares of Common Stock and 2020 Investor Warrants to purchase an aggregate of 1,012,500 shares of Common Stock.

 

12

 

 

DelMar Pharmaceuticals, Inc.

Notes to Condensed Consolidated Interim Financial Statements

(Unaudited)

September 30, 2019

 

(expressed in US dollars unless otherwise noted)

 

During the three months ended September 30, 2019, all of the 2,655,000 PFW were exercised at $0.01 per PFW for proceeds of $26,550.

 

2017 Omnibus Incentive Plan

  

As approved by the Company’s stockholders at the annual meeting of stockholders held on April 11, 2018, on July 7, 2017, as amended on February 1, 2018, the Company’s board of directors approved adoption of the Company’s 2017 Omnibus Equity Incentive Plan (the “2017 Plan”). The board of directors also approved a form of Performance Stock Unit Award Agreement to be used in connection with grants of performance stock units (“PSUs”) under the 2017 Plan. Under the 2017 Plan, 780,000 shares of Company common stock are reserved for issuance, less the number of shares of common stock issued under the Del Mar (BC) 2013 Amended and Restated Stock Option Plan (the “Legacy Plan”) or that are subject to grants of stock options made, or that may be made, under the Legacy Plan. A total of 165,485 shares of common stock have been issued under the Legacy Plan and/or are subject to outstanding stock options granted under the Legacy Plan, and a total of 614,515 shares of common stock have been issued under the 2017 Plan and/or are subject to outstanding stock options granted under the 2017 Plan leaving no shares of common stock available at September 30, 2019 for issuance under the 2017 Plan if all such options under the Legacy Plan were exercised.

 

The maximum number of shares of Company common stock with respect to which any one participant may be granted awards during any calendar year is 8% of the Company’s fully diluted shares of common stock on the date of grant (excluding the number of shares of common stock issued under the 2017 Plan and/or the Legacy Plan or subject to outstanding awards granted under the 2017 Plan and/or the Legacy Plan). No award will be granted under the 2017 Plan on or after July 7, 2027, but awards granted prior to that date may extend beyond that date.

 

During the three months ended September 30, 2019, and subject to approval by the Company’s stockholders, the Company’s board of directors approved an increase in the number of shares of common stock available to be issued under the 2017 Plan by 1,500,000. The increase brings the total number of shares available under the 2017 Plan to 2,280,000.

 

During the three months ended September 30, 2019, the Company also granted 1,041,016 stock options to officers and directors of the Company. The total grant date aggregate fair value of the stock options was $505,385. Of the total stock options granted of 1,041,016, 491,817 were granted under the existing 2017 Plan limit and 549,199 will be exercisable subject to approval by the Company’s stockholders of the 2017 Plan share increase. All of these stock options granted to officers and directors have an exercise price of $0.61 and expire on September 5, 2029. Of the 1,041,016 stock options granted, 375,000 vest pro rata monthly over one year from the date of grant and 666,016 vest as to one-sixth on the six month anniversary of the grant date with the remaining five-sixths vesting pro rate monthly over 30 months commencing on the seven month anniversary of the grant date. 

 

13

 

 

DelMar Pharmaceuticals, Inc.

Notes to Condensed Consolidated Interim Financial Statements

(Unaudited)

September 30, 2019

 

(expressed in US dollars unless otherwise noted)

 

Stock Options

 

The following table sets forth the aggregate stock options outstanding under all plans as of September 30, 2019:

 

    Number of
stock
options
outstanding
    Weighted
average
exercise
price
 
             
Balance – June 30, 2019     288,183       22.31  
Granted     491,817       0.61  
                 
Balance – September 30, 2019     780,000       8.63  

 

14

 

 

DelMar Pharmaceuticals, Inc.

Notes to Condensed Consolidated Interim Financial Statements

(Unaudited)

September 30, 2019

 

(expressed in US dollars unless otherwise noted)

 

The following table summarizes stock options outstanding and exercisable under all plans at September 30, 2019:

 

Exercise price
$
  Number
Outstanding at
September 30,
2019
    Weighted
average
remaining
contractual
life (years)
    Number
exercisable at
September 30,
2019
 
                   
0.61     491,817       9.93       -  
6.10     30,000       9.11       19,443  
7.00     5,451       8.73       2,271  
8.70     12,000       8.09       12,000  
9.83     83,647       8.64       37,176  
10.60     3,600       8.54       1,800  
11.70     30,000       3.41       30,000  
15.10     2,500       2.67       2,500  
20.00     13,125       2.02       13,125  
21.10     14,400       7.77       9,600  
29.60     4,500       5.35       4,500  
37.60     4,500       6.36       4,500  
40.00     1,250       -       1,250  
41.00     4,000       7.11       3,778  
42.00     41,250       3.31       41,250  
44.80     3,000       6.36       3,000  
49.50     22,460       4.82       20,641  
53.20     8,000       6.60       8,000  
61.60     1,500       3.50       1,500  
92.00     3,000       3.67       3,000  
                         
      780,000               219,334  

 

The above table excludes 549,199 granted stock options that are exercisable subject to approval by the Company’s stockholders of the share reserve increase under the 2017 Plan. These options are exercisable at $0.61 per share until September 5, 2029.

 

There are 560,666 unvested stock options at September 30, 2019.

 

Included in the number of stock options outstanding are 2,500 stock options granted at an exercise price of CA $20.00. The exercise price of these options shown in the above table have been converted to US $15.10 using the period ending closing exchange rate. Stock options issued during the three months ended September 30, 2019 have been valued using a Black-Scholes pricing model with the following assumptions:

 

 

 

 

September 30,

2019

     
Dividend rate   0%
Volatility   99% to 102%
Risk-free rate   1.50%
Term - years   5.5 to 6.5

 

15

 

 

DelMar Pharmaceuticals, Inc.

Notes to Condensed Consolidated Interim Financial Statements

(Unaudited)

September 30, 2019

 

(expressed in US dollars unless otherwise noted)

 

The estimated volatility of the Company’s common stock at the date of issuance of the stock options is based on the historical volatility of the Company. The risk-free interest rate is based on rates published by the government for bonds with a maturity similar to the expected remaining life of the stock options at the valuation date. The expected life of the stock options has been estimated using the plain vanilla method.

 

The Company has recognized the following amounts as stock option expense for the periods noted:

 

    Three months ended
September 30,
 
    2019
$
    2018
$
 
             
Research and development     8,153       28,450  
General and administrative     42,832       104,452  
                 
      50,985       132,902  

 

All of the stock option expense for the periods ended September 30, 2019 and 2018 has been recognized as additional paid in capital. The aggregate intrinsic value of stock options outstanding at September 30, 2019 was $0 (2018 - $1,499) and the aggregate intrinsic value of stock options exercisable at September 30, 2019 was also $0 (2018 - $0). As of September 30, 2019, there was $352,104 in unrecognized compensation expense that will be recognized over the next 2.93 years. No stock options granted under the Company’s equity plans have been exercised to September 30, 2019. Upon the exercise of stock options new shares will be issued.

 

16

 

 

DelMar Pharmaceuticals, Inc.

Notes to Condensed Consolidated Interim Financial Statements

(Unaudited)

September 30, 2019

 

(expressed in US dollars unless otherwise noted)

 

Warrants

 

Certain of the Company’s warrants have been recognized as a derivative liability (note 4). The following table summarizes changes in the Company’s outstanding warrants as of September 30, 2019:

 

Description   Number  
       
Balance – June 30, 2019     1,543,596  
         
2020 Investor Warrants issued in underwritten offering     7,762,500  
PFW issued in underwritten offering     2,655,000  
2020 Underwriter Warrants issued in underwritten offering     377,500  
Exercise of PFW     (2,655,000 )
         
Balance - September 30, 2019     9,683,596  

 

The following table summarizes the Company’s outstanding warrants as of September 30, 2019:

 

Description   Number     Exercise
price $
    Expiry date
                 
2020 Investor     7,762,500       1.00     August 16, 2024
2019 Investor     760,500       3.10     June 5, 2024
2018 Investor     280,000       12.50     September 22, 2022
2017 Investor     207,721       35.00     April 19, 2022
2015 Investor     97,905       30.00     July 31, 2020
Issued for services     26,500       30.00     July 1, 2020 to February 1, 2021
Issued for services     6,000       17.80     January 25, 2023
Issued for services     33,600       11.70     February 27, 2023
Issued for services     12,000       9.00     September 15, 2023
Issued for services     4,140       59.30     February 27, 2020
Issued for services     2,000       9.00     October 11, 2021
2020 Underwriter     377,500       1.15     August 14, 2022
2019 Agent     46,800       3.875     June 3, 2024
2018 Agent     40,000       12.50     September 20, 2022
2017 Agent     13,848       40.60     April 12, 2022
2016 Agent     10,402       40.00     May 12, 2021
2015 Agent     2,180       30.00     July 15, 2020
      9,683,596              

 

17

 

 

DelMar Pharmaceuticals, Inc.

Notes to Condensed Consolidated Interim Financial Statements

(Unaudited)

September 30, 2019

 

(expressed in US dollars unless otherwise noted)

 

6 Financial instruments

 

The Company has financial instruments that are measured at fair value. To determine the fair value, we use the fair value hierarchy for inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the most observable inputs be used when available. Observable inputs are inputs market participants would use to value an asset or liability and are developed based on market data obtained from independent sources. Unobservable inputs are inputs based on assumptions about the factors market participants would use to value an asset or liability. The three levels of inputs that may be used to measure fair value are as follows:

 

Level one - inputs utilize quoted prices (unadjusted) in active markets for identical assets or liabilities;

 

Level two - inputs are inputs other than quoted prices included in Level 1 that are observable for the asset or liability, either directly or indirectly such as interest rates, foreign exchange rates, and yield curves that are observable at commonly quoted intervals; and

 

Level three - unobservable inputs developed using estimates and assumptions, which are developed by the reporting entity and reflect those assumptions that a market participant would use.

 

Assets and liabilities are classified based on the lowest level of input that is significant to the fair value measurements. Changes in the observability of valuation inputs may result in a reclassification of levels for certain securities within the fair value hierarchy.

 

The Company’s financial instruments consist of cash and cash equivalents, other receivables, accounts payable, related party payables and derivative liability. The carrying values of cash and cash equivalents, other receivables, accounts payable and related party payables approximate their fair values due to the immediate or short-term maturity of these financial instruments.

 

Derivative liability

 

The Company accounts for certain warrants under the authoritative guidance on accounting for derivative financial instruments indexed to, and potentially settled in, a company’s own stock, on the understanding that in compliance with applicable securities laws, the warrants require the issuance of securities upon exercise and do not sufficiently preclude an implied right to net cash settlement. The Company classifies these warrants on its balance sheet as a derivative liability which is fair valued at each reporting period subsequent to the initial issuance. The Company has used a Black-Scholes Option Pricing Model (based on a closed-form model that uses a fixed equation) to estimate the fair value of the warrants which is equivalent to the fair value of the warrants calculated using the Binomial-Lattice Pricing Model. Determining the appropriate fair-value model and calculating the fair value of warrants requires considerable judgment. Any change in the estimates (specifically probabilities and volatility) used may cause the value to be higher or lower than that reported. The estimated volatility of the Company’s common stock at the date of issuance, and at each subsequent reporting period, is based on the historical volatility of the Company. The risk-free interest rate is based on rates published by the government for bonds with a maturity similar to the expected remaining life of the warrants at the valuation date. The expected life of the warrants is assumed to be equivalent to their remaining contractual term.

 

18

 

 

DelMar Pharmaceuticals, Inc.

Notes to Condensed Consolidated Interim Financial Statements

(Unaudited)

September 30, 2019

 

(expressed in US dollars unless otherwise noted)

 

a) Fair value of derivative liability

 

The derivative is not traded in an active market and the fair value is determined using valuation techniques. The Company uses judgment to select a variety of methods to make assumptions that are based on specific management plans and market conditions at the end of each reporting period. The Company uses a fair value estimate to determine the fair value of the derivative liability. The carrying value of the derivative liability would be higher, or lower, as management estimates around specific probabilities change. The estimates may be significantly different from those amounts ultimately recorded in the consolidated financial statements because of the use of judgment and the inherent uncertainty in estimating the fair value of these instruments that are not quoted in an active market. All changes in the fair value are recorded in the consolidated statement of operations and comprehensive loss each reporting period. This is considered to be a Level 3 financial instrument as volatility is considered a Level 3 input.

 

The fair value of derivative liabilities at September 30, 2019 and June 30, 2019 was $0.

 

7 Supplementary statement of cash flows information

 

    Three months ended  
    September 30,  
    2019     2018  
    $     $  
             
Series B Preferred share common stock dividend (note 5)     2,046       36,085  
Income taxes paid     -       -  
Interest paid     -       -  

 

8 Subsequent events

 

The Company has evaluated its subsequent events from September 30, 2019 through the date these condensed consolidated financial statements were issued and has determined that there are no subsequent events requiring disclosure in these condensed consolidated financial statements other than the items noted below.

 

Subsequent to September 30, 2019, the Company issued 1,280 shares of common stock for services. In addition, 1,250 stock options at an exercise price of $40.00 expired unexercised on October 1, 2019. The Company also granted 250,000 stock options to an officer of the Company, subject to stockholder approval of the share increase to the 2017 Plan. The options have an exercise price of $0.735 and expire November 12, 2029. The options vest upon the achievement of certain clinical development milestones.

   

19

 

 

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

 

This Management’s Discussion and Analysis (“MD&A”) contains “forward-looking statements”, within the meaning of the Private Securities Litigation Reform Act of 1995, which represent our projections, estimates, expectations, or beliefs concerning, among other things, financial items that relate to management’s future plans or objectives or to our future economic and financial performance. In some cases, you can identify these statements by terminology such as “may”, “should”, “plans”, “believe”, “will”, “anticipate”, “estimate”, “expect” “project”, or “intend”, including their opposites or similar phrases or expressions. You should be aware that these statements are projections or estimates as to future events and are subject to a number of factors that may tend to influence the accuracy of the statements. These forward-looking statements should not be regarded as a representation by us or any other person that our events or plans will be achieved. You should not unduly rely on these forward-looking statements, which speak only as of the date of this report. Except as may be required under applicable securities laws, we undertake no obligation to publicly revise any forward-looking statement to reflect circumstances or events after the date of this report or to reflect the occurrence of unanticipated events.

 

You should review the factors and risks we describe under “Risk Factors” in our report on Form 10-K for the year ended June 30, 2019 and in our other filings with the Securities and Exchange Commission, available at www.sec.gov. Actual results may differ materially from any forward-looking statement.

 

References to “we”, “us”, and “our”, refer to DelMar Pharmaceuticals, Inc. and our wholly-owned subsidiaries, Del Mar (BC), Callco and Exchangeco.

 

Recent Highlights

 

  On October 29, 2019 we announced that we will present two posters updating results from our two Phase 2 clinical trials of VAL-083 at the 2019 Society for Neuro-Oncology (“SNO”) Annual meeting.  On November 22, 2019, at the SNO annual meeting we will host a key opinion leader (“KOL”) event which will include our Scientific Advisory Board (“SAB”) as well members of our senior management team.  The KOL event will feature our SAB and management in a panel discussion of our GBM clinical studies.

 

  On August 16, 2019, we completed a financing raising approximately $6.6 million in net proceeds. We believe the net proceeds from this offering of approximately $6.6 million will be sufficient to complete full enrollment in all three patient groups of our two ongoing Phase 2 clinical studies for our drug development candidate, VAL-083, expected to occur by the fourth quarter of calendar year 2020.

 

20

 

 

As of August 1, 2019, we provided an update on the first 20 patients enrolled in our ongoing Phase 2 clinical study investigating the first-line treatment of VAL-083 in combination with radiation therapy in newly-diagnosed, MGMT-unmethylated glioblastoma multiforme (“GBM”).  The study, which is being conducted at the Sun Yat-sen University Cancer Center (“SYSUCC”) is designed to enroll up to 30 patients to determine whether first-line therapy with VAL-083 treatment improves progression free survival (“PFS”). The current standard of care is first-line TMZ with radiation.

 

On July 24, 2019 we announced the enrollment of the first patient in the adjuvant (pre-temozolomide maintenance) arm of our Phase 2, open label study of VAL-083 in MGMT-unmethylated GBM being conducted at the University of Texas MD Anderson Cancer Center (“MDACC”). The MDACC Institutional Review Board (“IRB”) had previously approved the addition of up to 24 patients in the pre-temozolomide (“TMZ”) maintenance setting (i.e. the adjuvant setting). The up to 24 newly-diagnosed patients will have undergone surgery and chemoradiation with TMZ but will now receive VAL-083 in place of standard of care TMZ for adjuvant therapy.

 

As of July 24, 2019, we have enrolled 56 of the planned up to 83 patients in the recurrent arm of our Phase 2, open-label clinical study of VAL-083 in MGMT-unmethylated GBM. This arm is enrolling bevacizumab (Avastin®)-naïve, recurrent GBM (“rGBM”) patients with MGMT-unmethylated status. This arm of the study is also being conducted at MDACC and is designed to determine the impact of VAL-083 treatment on overall survival compared to historical reference control. We previously announced that the MDACC IRB had approved the addition of up to 35 patients to our rGBM study at a dose of 30 mg/m2.

 

  As of September 1, 2019, we relocated our headquarters from Vancouver, British Columbia to San Diego, California. The Vancouver office will remain open as an administrative office.

 

21

 

 

VAL-083 Clinical Studies

 

We are currently developing VAL-083, a novel DNA-targeting agent for the treatment of GBM and potentially other solid tumors, including ovarian cancer. Our recent research has highlighted the opportunities afforded by VAL-083’s unique mechanism of action and its potential to address unmet medical needs by focusing our development efforts on patients whose tumors exhibit biological features that make them resistant to, or unlikely to respond to, currently available therapies. For example, our research demonstrating VAL-083’s activity in GBM is independent of the MGMT methylation status allows us to focus patient selection based on this important biomarker.

 

The evaluation of MGMT promoter methylation status has increasingly become common practice in the diagnostic assessment of GBM. In September 2017, the National Comprehensive Cancer Network (“NCCN”) updated guidelines for the standard treatment of GBM based on MGMT methylation status. We believe these guidelines provide for enhanced opportunities for us to capitalize on VAL-083’s unique mechanism of action by utilizing MGMT methylation as a biomarker to optimize patient selection for our novel DNA-targeting agent to target the majority of GBM patients who are diagnosed with MGMT-unmethylated tumors.

 

Our current priority is to leverage this research and VAL-083’s unique mechanism of action to efficiently advance our drug candidate for the most promising indications, including:

 

MGMT-unmethylated GBM, currently comprising two ongoing separate Phase 2 clinical studies for:

 

  o GBM patients in two study arms at MDACC:

 

  as adjuvant therapy immediately following chemoradiation; and

 

  in Avastin®-naïve rGBM patients;

 

  o Newly diagnosed GBM patients (ongoing study at SYSUCC); and

 

Potential future indications include ovarian cancer, NSCLC, and other solid tumor indications.

 

MGMT-unmethylated GBM

 

GBM is the most common and the most lethal form of glioma. According to the Central Brain Tumor Registry of the United States, GBM occurs with an incidence of 3.20 per 100,000 person-years. Approximately 13,000 new cases of GBM were diagnosed in the United States and 16,000 in Europe during 2017. Within the GBM patient population, approximately two-thirds of patients are unmethylated with respect to their MGMT status.

 

Measurement of MGMT (O6-methyl guanine methyltransferase) methylation status has become routine in clinical practice as a biomarker that correlates with resistance to the standard-of-care chemotherapy with TMZ (Temodar®), and patient outcomes in GBM. Greater than 60% of GBM patients’ tumors are characterized as “MGMT-unmethylated” and exhibit a high expression of MGMT, a naturally occurring DNA-repair enzyme, the activity of which nullifies the chemotherapeutic activity of TMZ. The development of new therapies for MGMT-unmethylated GBM is a significant unmet medical need. Importantly, the most recent update to NCCN guidelines states that the treatment benefit of TMZ is likely to be lower in GBM patients with an unmethylated MGMT promoter, and therefore, allows for withholding of TMZ in the treatment of newly diagnosed GBM patients with MGMT-unmethylated tumors due to lack of efficacy.

 

We have demonstrated that VAL-083’s anti-tumor mechanism is active independent from the MGMT status in vitro. We believe this suggests the potential of VAL-083 as a replacement for the current standard-of-care chemotherapy, temozolomide, in MGMT-unmethylated GBM. We are therefore utilizing MGMT-methylation status to identify GBM patients who are unlikely to respond to temozolomide and instead treat them with VAL-083.

 

We believe that our research, in the context of the recent amendment to NCCN guidelines, highlights this unmet need and the opportunity for VAL-083 as a potential new standard-of-care in the treatment of MGMT-unmethylated GBM.

 

22

 

 

Phase 2 Study in MGMT-unmethylated GBM in Collaboration with University of Texas MD Anderson Cancer Center

 

In February 2017, we initiated a biomarker driven, open-label, single-arm Phase 2 study in collaboration with MDACC. This biomarker-driven study (testing for MGMT methylation status) has been amended to enroll up to 83 patients (35 with a starting dose of 40 mg/m2; 48 with a starting dose of 30 mg/m2) to determine the potential of VAL-083 treatment to improve overall survival in GBM patients whose tumors have recurred following treatment with temozolomide. These patients will not have been treated previously with Avastin®. In addition, this study has been amended to include 24 patients in the adjuvant patient population. The GBM patients in the adjuvant arm of the study will have had treatment with TMZ in combination with radiation but rather than then being treated with additional cycles of TMZ, these patients will begin treatment with VAL-083. 

 

Recurrent Study Arm 

 

As of July 24, 2019, 56 patients had been enrolled in the recurrent arm of this Phase 2 study. The original starting dose of 40 mg/m2 of VAL-083 on days 1, 2 and 3, of a 21-day cycle, which was based on the results from our previous Phase 1/2 safety study of VAL-083 in patients with recurrent glioma (clinicaltrials.gov identifier: NCT01478178), has continued to demonstrate myelosuppression as the principal side effect of VAL-083, as per prior clinical experience. The safety profile has been well within the existing safety monitoring guidelines described in the present study protocol. However, in consultation with the principal investigator at MDACC, we have amended the protocol for this clinical study to modify the starting dose of VAL-083 to 30 mg/m2 on days 1, 2 and 3, of a 21-day cycle for this specific population previously treated with temozolomide. This modification may improve tolerance in this patient population and thereby potentially increase overall exposure to VAL-083 by increasing the number of cycles of drug patients may be able to receive. We have modified the patient screening platelet count, from 100,000/µL to 125,000/µL, for the same reasons.

 

The historical comparison survival data for the recurrent arm of the study is lomustine based on a median overall survival of 7.2 months in unmethylated patients. Safety data from this study will become part of the overall safety dossier to support future filings with the FDA and other regulatory agencies.

  

On May 31, 2019, we provided a clinical study update on the recurrent study arm of our MDACC clinical study at a KOL presentation during the 2019 American Society of Clinical Oncology annual meeting in Chicago, IL.

 

  As of May 5, 2019, 51 patients have been enrolled, 35 patients at a starting dose of 40 mg/m2, and 16 patients at a starting dose of 30 mg/m2.

 

  For the 47 patients who have been on study long enough to be assessed at the post-cycle 2 MRI:

 

  o 9/35 (25.7%) patients initially receiving 40 mg/m2 exhibited “Stable Disease” per investigator assessment at the end of cycle 2

 

  o 4/12 (33.3%) patients initially receiving 30 mg/m2 exhibited “Stable Disease” per investigator assessment at the end of cycle 2

 

It is important for this GBM patient population, which has been heavily pre-treated with temozolomide, to be able to be treated with multiple cycles of VAL-083 without significant hematological toxicities. We believe the modified dose of VAL-083, in addition to the change in patient eligibility platelet counts, should help provide for enhanced patient safety. We believe a positive outcome from this study can establish a position for VAL-083 in the treatment of MGMT-unmethylated rGBM.

 

A detailed description of this study can be found at clinicatrials.gov, Identifier Number: NCT02717962.

 

Adjuvant Study Arm

 

On July 24, 2019, we announced the enrollment of the first patient in the adjuvant arm of the Phase 2 study being conducted at MDACC.

 

As noted above, patients in the recurrent arm of the MDACC clinical study have been heavily pre-treated with temozolomide. Based on published data from our MDACC and SYSUCC clinical studies, we believe there is a significant opportunity to treat GBM patients in the pre-temozolomide maintenance stage (i.e., adjuvant). At the AACR’s annual meeting in April 2019, we reported that myelosuppression (thrombocytopenia and neutropenia) is the most common adverse event associated with VAL-083. The higher potential for myelosuppression with the 40 mg/m2/day of VAL-083 in this study appears to be correlated with the number of cycles of prior TMZ maintenance therapy (> 5 cycles). The MDACC IRB has approved the addition of up to 24 patients to the adjuvant setting. These patients will have had initial cycles of temozolomide concomitant with radiation but will not have yet started subsequent cycles of TMZ (i.e. maintenance stage TMZ patients). The comparison survival data for this study is survival data from Tanguturi et al (2017 Nero-Oncology) for MGMT-unmethylated patients of 6.9 months.

 

23

 

 

Phase 2 Study in Newly Diagnosed MGMT-unmethylated GBM

 

In September 2017, we initiated a single arm, biomarker driven, open-label Phase 2 study in newly diagnosed MGMT-unmethylated GBM patients at SYSUCC in Guangzhou, China. The study is being conducted under our collaboration agreement with Guangxi Wuzhou Pharmaceutical Company.

 

In this Phase 2 study, VAL-083 is being combined with radiotherapy as a potential replacement for standard-of-care chemoradiation with temozolomide in patients with MGMT-unmethylated GBM. One goal of the study will be to confirm the safety of the three-day VAL-083 dosing regimen in combination with radiotherapy and to investigate outcomes of the combination of VAL-083 and radiotherapy in MGMT-unmethylated GBM patients.

 

We plan to enroll up to 30 newly-diagnosed, MGMT-unmethylated GBM patients in this study. The efficacy endpoints of the study include tumor response, as assessed by the Response Assessment in NeuroOncology (“RANO”), and progression-free survival (“PFS”), progression-free survival at six months (“PFS6”), and overall survival (“OS”), compared to historical results in the target population. The study is being conducted in two parts: (1) Dose-confirmation: VAL-083 in cohorts (20, 30 and 40 mg/m2/day IV daily x 3 every 21 days) to assess safety and activity when administered concurrently with x-ray therapy (“XRT”) to confirm the maximum tolerated dose (“MTD”), and (2) Expansion: VAL-083 will be studied in up to 20 additional patients at the target dose, as determined by the dose-confirmation part of the study, administered concurrently with XRT. Assessments of safety and tolerability will be used to support further clinical development of VAL-083 in combination with radiotherapy. Pharmacokinetic assessments of VAL-083 in plasma and cerebral spinal fluid (“CSF”) will be used to correlate drug exposure in the central nervous system with patient outcomes.

 

Dose confirming cohorts studying 20, 30, and 40 mg/m2/day x three every 21 days have been completed. Based on the dose confirmation phase of the study, we have selected 30 mg/m2 for combination with irradiation for the treatment of newly-diagnosed MGMT-unmethylated GBM patients.

 

As of August 1, 2019, of the first 20 enrolled patients, 17 have received at least their first assessment (two patients have not been enrolled long enough to receive their first assessment and one patient died before their first assessment). “Best Overall Response” for these patients per Investigator Assessment were:

 

  Nine have been assessed as having achieved a complete response (CR) (9/17, or 53%)

 

  Seven have been assessed with stable disease (SD), (7/17, or 41%); and

 

  One has been assessed as disease progression (PD) (1/17, or 6%).

 

Of the 20 patients enrolled, 17 (85%) have received their two-month (post-third cycle) MRI and investigator assessment, 13 (65%) have received their five-month MRI and investigator assessment, and seven (35%) have received their eight-month MRI and investigator assessment. Two patients (10%) have not been on the study long enough to reach their first assessment, and one patient (5%) died before their first assessment. Importantly, 16 of the 20 patients enrolled (80%) were still alive as of the data cut-off date.

 

Through our research, and that of the NCI, we have previously demonstrated that VAL-083 crosses the blood brain barrier. New preliminary data from the SYSUCC study indicate that the concentration of VAL-083 is generally higher in CSF than in plasma at two hours post-infusion. 

 

24

 

 

Concentration of VAL-083 — Two Hours Post Dose

 

        Mean Concentrations (ng/mL)   Conc. Ratio @ 2 hours
Dose (mg/m2)   n   Plasma (2 hours post dose)   CSF (2 hours post dose)   CSF/Plasma
20   1   110   154   1.40
30   3   97   134   1.41
40   3   170   190   1.13

 

By comparison, temozolomide is typically 80% lower in the CSF than the plasma (Schreck et al. 2018, Oncology (Williston Park)). The reason this is important is that accumulation of VAL-083 in the CSF further validates that VAL-083 crosses the blood-brain-barrier and demonstrates that therapeutic drug concentrations in the CSF are achievable for extended periods of time.

 

Fast Track Designation

 

The FDA has granted us Fast Track designation for VAL-083 in rGBM.

 

Fast Track designation is designed to expedite the review of drugs that show promise in treating life-threatening diseases and address unmet medical needs, with the goal of getting new treatments to patients earlier. Fast Track designation provides sponsors with an opportunity for increased frequency for communication with the FDA to ensure an optimal development plan and to collect appropriate data needed to support drug approval. Additional benefits of the Fast Track designation may include an Accelerated Approval, a Priority Review, and a Rolling Review. Accelerated Approval is granted to drugs that demonstrate an effect on a surrogate, or intermediate endpoints, reasonably likely to predict clinical benefit. Priority Review shortens the FDA review process for a new drug from ten months to six months and is appropriate for drugs that demonstrate significant improvements in both safety and efficacy of an existing therapy. Rolling Review provides a drug company the opportunity to submit completed sections of its New Drug Application (“NDA”) for review by the FDA. Typically, NDA reviews do not commence until the drug company has submitted the entire application to the FDA. Through the Fast Track designation, the FDA attempts to ensure that questions raised during the drug development process are resolved quickly, often leading to earlier approval and increased access for patients.

 

25

 

 

Current Treatments for Gliomas and Glioblastoma Multiforme

 

Gliomas are a type of Central Nervous System (“CNS”) tumor that arises from glial cells in the brain or spine. Glial cells are the cells surrounding nerves. Their primary function is to provide support and protection for neurons in the CNS.

 

GBM is the most common and the most lethal form of glioma. According to the Central Brain Tumor Registry of The United States, GBM occurs with an incidence of 3.20 per 100,000 person-years. Approximately 13,000 new cases of GBM were diagnosed in the United States and 16,000 in Europe during 2017.

 

Common symptoms of GBM include headaches, seizures, nausea, weakness, paralysis and personality or cognitive changes such as loss of speech or difficulty in thinking clearly. GBM progresses quickly and patients’ conditions deteriorate rapidly progressing to death. The outlook for GBM patients is generally poor. The overall median survival in newly diagnosed GBM patients with best available treatments is less than 15 months, and two-year and five-year survival rates are approximately 30% and 10%, respectively. Median overall survival in newly-diagnosed, unmethylated GBM patients is 12.2 months.

 

In September 2017, the National Comprehensive Cancer Network (“NCCN”), updated treatment guidelines for GBM. The recommended treatment regimen for GBM includes surgical resection to remove as much of the tumor as possible (“debulking”) followed by radiotherapy with concomitant and adjuvant chemotherapy with temozolomide with or without tumor treating fields (“TTF”). GBM patients whose tumors exhibit an unmethylated promoter for the gene encoding the DNA repair enzyme MGMT, a biomarker correlated with resistance to temozolomide, may be treated with radiation alone following surgery.

 

Patients with an unmethylated MGMT promoter have high levels of MGMT, a naturally-occurring DNA repair enzyme that repairs tumor-fighting lesions induced by TMZ thus allowing a patient’s tumor to continue to grow despite treatment, which leads to poor outcomes. Measurement of MGMT methylation status has become routine in clinical practice as biomarker that correlates with response to TMZ and patient outcomes in GBM.

 

Probability of GBM Patient Survival Correlated to Expression of MGMT Enzyme
(Unmethylated promoter = High MGMT Expression and Significantly Shorter Survival)

 

 

 

TTF (Optune®) is a non-invasive technique for adults with GBM. TTF uses alternating electrical fields to disrupt tumor cell division, or cause cell death, thereby preventing the tumor from growing or spreading as quickly. A clinical study reported that GBM patients treated with TTF combined with TMZ experienced longer survival than those treated with TMZ alone.

 

The majority of GBM patients’ tumors recur within 6 – 12 months of initial treatment. Experimental therapy through clinical studies is recommended under NCCN guidelines for eligible patients. NCCN guidelines also recommend treatment with systemic chemotherapy, such as lomustine (“CCNU”). For patients who are eligible for additional surgical debulking, local chemotherapy with carmustine (“BCNU”) wafers may be employed. CCNU and BCNU target the same DNA-site as TMZ and are also subject to MGMT-related resistance.

 

26

 

 

Avastin (Avastin®, an anti-VEGF antibody) recently received full approval in the US, Canada, Australia, and Japan as a single agent for patients with recurrent GBM following prior therapy. Avastin carries an FDA “black-box warning” related to severe, sometimes fatal, side effects such as gastrointestinal perforations, wound healing complications and hemorrhage. There are no data demonstrating an improvement in disease-related symptoms or increased survival for GBM patients treated with Avastin.

  

Recurrent GBM patients, especially those whose tumors progress following treatment with Avastin, have limited or no treatment options and a very poor prognosis. According to published literature, the median survival for GBM patients whose tumors progress following Avastin is less than five months.

 

VAL-083 Mechanism of Action and the Opportunity in the Treatment of Cancer

 

Chemotherapy forms the basis of treatment in nearly all cancers. We believe that VAL-083 may be effective in treating tumors exhibiting biological features that cause resistance to currently available chemotherapy, particularly for patients who have failed, or become resistant to, other treatment regimens.

 

Based on published research and our own data, the cytotoxic functional groups, and the mechanism of action of VAL-083 are functionally different from alkylating agents commonly used in the treatment of cancer. VAL-083 has previously demonstrated activity in cell-lines that are resistant to other types of chemotherapy. No evidence of cross-resistance has been reported in published clinical studies.

 

Our research suggests that VAL-083 attacks cancer cells via a unique mechanism of action which is distinct from other chemotherapies used in the treatment of cancer. Our data indicate that VAL-083 forms inter-strand crosslinks at the N7 position of guanine on the DNA of cancer cells. Our data also indicate that this crosslink forms rapidly and is not easily repaired by the cancer cell resulting in cell-cycle arrest and lethal double-strand DNA breaks in cancer cells. VAL-083 readily crosses the blood brain barrier. Published preclinical and clinical research demonstrate that VAL-083 is absorbed more readily in tumor cells than in normal cells. 

 

In vitro, our data also demonstrate that VAL-083’s distinct mechanism may be able to overcome drug resistance against a range of cancers. For example, VAL-083 is active against MGMT-unmethylated GBM cells which are resistant to treatment with temozolomide and nitrosoureas. VAL-083 also retains a high level of activity in p53 mutated non-small cell lung cancer (“NSCLC”), ovarian cancer and medulloblastoma cell lines that are resistant to platinum-based chemotherapy.

 

Importantly, clinical activity against each of the tumors mentioned above was established in prior NCI-sponsored Phase 2 clinical studies. We believe that these historical clinical data and our own research support the development of VAL-083 as a potential new treatment for multiple types of cancer. 

 

The main dose-limiting toxicity (“DLT”) related to the administration of VAL-083 in previous NCI-sponsored clinical studies and our own clinical studies is myelosuppression, particularly thrombocytopenia. Myelosuppression, including thrombocytopenia, is a common side effect of chemotherapy. Myelosuppression is the decrease in cells responsible for providing immunity, carrying oxygen, and causing normal blood clotting. Thrombocytopenia is a reduction in platelet counts which assist in blood clotting. Modern medicine allows for better management of myelosuppressive side effects. We believe this offers the potential opportunity to improve upon the drug’s already established efficacy profile by substantially increasing the dose of VAL-083 that can be safely administered to cancer patients.

 

There is no evidence of lung, liver, or kidney toxicity even with prolonged treatment by VAL-083. Data from the Chinese market where the drug has been approved for more than 15 years supports the safety findings of the NCI studies.

 

Other Indications for VAL-083 — Potential Future Opportunities

 

Ovarian Cancer

 

Ovarian cancer is the fifth most common cancer in women and is the leading cause of death among women diagnosed with gynecological malignancies. In 2016, approximately 22,300 women in the US were diagnosed with ovarian cancer and 14,300 died from their disease.

 

VAL-083’s activity against ovarian epithelial adenocarcinoma (“OEA”) and squamous cell carcinoma of the cervix (“SCC”) was reported in prior NCI-sponsored clinical studies. Importantly, NCI-researchers recommended VAL-083 for further advanced studies in the treatment of ovarian cancer.

 

27

 

 

We have presented data demonstrating that VAL-083’s distinct mechanism of action allows activity in tumors that are resistant to other therapies. We have shown that cytotoxicity of VAL-083 against ovarian cancer is independent of sensitivity to cisplatin or p53 status in vitro. We have demonstrated that VAL-083 is active in Pt-resistant ovarian cells harboring a range of p53-mutations.

 

In April 2016, the FDA granted orphan drug designation for the use of VAL-083 in the treatment of ovarian cancer.

 

In September 2017, we filed an IND for the use of VAL-083 in ovarian cancer, along with a protocol for a Phase 1/2, open-label, multicenter, study of VAL-083 in patients with Recurrent Platinum Resistant Ovarian Cancer (the REPROVe study).

 

The FDA has allowed this study to begin enrolling patients, but based on ongoing evaluation and input from our ovarian clinical advisory board, we are reassessing the ovarian cancer program. We are in the process of evaluating the best path forward in ovarian cancer and are looking at various strategic options including combination with PARP inhibitors. As a result, we have inactivated the IND while we explore alternative study designs.

 

Lung Cancer

 

Lung cancer is a leading cause of cancer death around the world and effective treatment for lung cancer remains a significant global unmet need despite advances in therapy. Incidence of lung cancer in the United States is approximately 47 per 100,000 with the majority (85%) being non-small cell lung cancer (“NSCLC”), the most common type of lung cancer. Globally, the market for lung cancer treatment may exceed $24 billion by 2033 according to a report published by Evaluate Pharma.

 

The activity of VAL-083 against solid tumors, including lung cancer, has been established in both preclinical and human clinical studies conducted by the NCI. DelMar has developed new nonclinical data to support the utility of VAL-083 in the modern treatment of lung cancer. In an established murine xenograft model of NSCLC, the activity of VAL-083 was compared to standard platinum-based therapy with cisplatin against human NSCLC cell lines A549 (TKI-sensitive) and H1975 (TKI-resistant). In the study, VAL-083 demonstrated superior efficacy and safety in the treatment of TKI-susceptible (A549) tumors and in TKI-resistant (H1975) tumors.

 

Central Nervous System Metastases of Solid Tumors

 

The successful management of systemic tumors by modern targeted therapies has led to increased incidence of mortality due to CNS metastases of lung cancer and other solid tumors. In June 2013, we split our Phase 1/2 clinical study protocol into two separate studies: one focusing solely on refractory GBM and the other focusing on secondary brain cancers caused by other tumors that have spread to the brain.

 

Based on historical clinical activity and our own research, we believe that VAL-083 may be suitable for the treatment of patients with central nervous system metastases who currently have limited treatment options. Subject to the availability of financial and operating resources, we may develop a separate protocol for the continued exploration of VAL-083 in patients with secondary brain cancer caused by a solid tumor spreading to the brain.

 

Pediatric Brain Tumors

 

Tumors of the brain and spine make up approximately 20% of all childhood cancers and they are the second most common form of childhood cancer after leukemia.

 

The activity of VAL-083 against childhood and adolescent brain tumors has been established in both preclinical and human clinical studies conducted by the NCI. We have presented data indicating that VAL-083 offers potential therapeutic alternatives for the treatment of pediatric brain tumors including SHH-p53 mutated medulloblastoma. In March 2016, the FDA granted orphan drug designation for the use of VAL-083 in the treatment of medulloblastoma. Subject to the availability of resources, we intend to collaborate with leading academic researchers for the continued exploration of VAL-083 as a potential treatment of childhood brain tumors.

 

Corporate History

 

We are a Nevada corporation formed on June 24, 2009 under the name Berry Only, Inc. (“Berry’). Prior to a reverse acquisition undertaken on January 25, 2013 Berry did not have any significant assets or operations. We are the parent company of Del Mar Pharmaceuticals (BC) Ltd. (“Del Mar (BC)”), a British Columbia, Canada corporation incorporated on April 6, 2010, that is focused on the development of drugs for the treatment of cancer. We are also the parent company to 0959454 B.C. Ltd., a British Columbia corporation (“Callco”), and 0959456 B.C. Ltd., a British Columbia corporation (“Exchangeco”). Callco and Exchangeco were formed to facilitate the reverse acquisition.

 

28

 

 

Outstanding Securities

 

As of November 12, 2019, we had 11,399,700 shares of common stock issued and outstanding, 7,813 shares of common stock issuable upon exchange of the Exchangeable Shares of Exchangeco (which entitle the holder to require Exchangeco to redeem (or, at our option or Callco’s, to have us or Callco purchase) the Exchangeable Shares, and upon such redemption or purchase to receive an equal number of shares of our common stock) (the Exchangeable Shares are recognized on an as-exchanged for common stock basis for financial statement purposes), outstanding warrants to purchase 9,683,596 shares of common stock, 648,613 outstanding shares of Series B Preferred Stock that are convertible into 162,177 shares of common stock, and outstanding stock options to purchase 1,577,949 shares of common stock (of which 799,199 options are subject to stockholder approval of the increase in the number of shares authorized for issuance under the 2017 Plan at the next annual meeting of stockholders). All Exchangeable Shares, warrants, and stock options are convertible, or exercisable into, one share of common stock. Each Series B convertible preferred share is convertible into 0.25 shares of common stock.

 

On May 8, 2019, we effected a one-for-ten reverse stock split (the “Reverse Stock Split”) of our issued and outstanding and authorized common stock. All per share amounts and number of shares of common stock in the MD&A and condensed consolidated interim financial statements reflect the Reverse Stock Split. The Reverse Stock Split does not affect the our authorized preferred stock of 5,000,000 shares; except that, pursuant to the terms of the Certificate of Designations of Series B Convertible Preferred Stock for the issued and outstanding shares of our Series B Convertible Preferred Stock, par value $0.001 per share (the “Series B Preferred Stock”), the conversion price at which shares of Series B Preferred Stock may be converted into shares of common stock will be proportionately adjusted to reflect the Reverse Stock Split.

 

On June 26, 2019, we amended our articles of incorporation, as amended, to increase the number of authorized shares of common stock from 7,000,000 to 95,000,000 shares.

 

Related Parties

 

We acquired our initial patents and technology rights from Valent, an entity owned by Dr. Dennis Brown, our Chief Scientific Officer. As a result, Valent is a related party to the Company. 

 

Selected Quarterly Information

 

The financial information reported herein has been prepared in accordance with accounting principles generally accepted in the United States. Our functional currency at September 30, 2019 and June 30, 2019 is the US$. The following tables represent selected financial information for us for the periods presented.

 

Selected Balance Sheet Data 

 

   

September 30,

2019

$

   

June 30,

2019

$

 
             
             
Cash and cash equivalents     8,060,039       3,718,758  
Working capital     7,015,653       1,955,468  
Total assets     8,363,757       4,037,255  
Total stockholders’ equity     7,024,914       1,967,530  

 

29

 

 

Selected Statement of operations data

 

For the three months ended:

 

    September 30,     September 30,  
    2019     2018  
    $     $  
             
Research and development     721,475       1,019,120  
General and administrative     913,628       986,470  
Change in fair value of derivative liability     -       220  
Foreign exchange (gain) loss     (374 )     5,838  
Interest income     (28,858 )     (19,844 )
Net and comprehensive loss for the period     1,605,871       1,991,804  
Series B Preferred stock dividend     2,046       36,085  
Net and comprehensive loss available to common stockholders     1,607,917       2,027,889  
Basic weighted average number of shares outstanding     7,538,562       2,296,909  
Basic and fully diluted loss per share     0.21       0.88  

 

Expenses net of non-cash, share-based compensation expense – non-GAAP

 

The following table discloses research and development, and general and administrative expenses net of non-cash, share-based compensation payment expense. The disclosure has been provided to reconcile the total operational expenses on a GAAP basis and the non-GAAP operational expenses net of non-cash stock-based compensation in order to provide an estimate of cash used in research and development, and general and administrative expense. Management uses the cash basis of expenses for forecasting and budget purposes to determine the allocation of resources and to plan for future financing opportunities.

 

For the three months ended:

 

   

September 30,

2019

$

   

September 30,

2018

$

 
             
Research and development - GAAP     721,475       1,019,120  
Less: non-cash, share-based compensation expense     (12,996 )     (32,590 )
Research and development net of non-cash, share-based, compensation expense – Non-GAAP     708,479       986,530  
                 
General and administrative - GAAP     913,628       986,470  
Less: non-cash, share-based compensation expense     (42,832 )     (196,626 )
General and administrative net of non-cash, share-based, compensation expense – Non-GAAP     870,796       789,844  

 

30

 

 

Results of Operations

 

Comparison of the three months ended September 30, 2019 and September 30, 2018

 

    Three Months Ended              
   

September 30,

2019

$

   

September 30,

2018

$

   

 

Change

$

    Change
%
 
                         
Research and development     721,475       1,019,120       (297,645 )     (29 )
General and administrative     913,628       986,470       (72,842 )     (7 )
Change in fair value of derivative liability     -       220       (220 )     (100 )
Foreign exchange (gain) loss     (374 )     5,838       (6,212 )     (106 )
Interest income     (28,858 )     (19,844 )     (9,014 )     45  
Net loss and comprehensive loss     1,605,871       1,991,804       (385,933 )        

 

Research and Development

 

Research and development expenses decreased to $721,475 for the three months ended September 30, 2019 from $1,109,120 for the three months ended September 30, 2018. The decrease was largely attributable to lower clinical development, preclinical research, and intellectual property expenses. With respect to non-cash, share-based compensation expense, we recognized $12,996 and $32,590 for the three months ended September 30, 2019 and 2018 respectively. For both periods, the amount recognized related to stock option expense and shares issued for services.

 

Excluding the impact of non-cash, share-based compensation expense, research and development expenses decreased to $708,479 during the current quarter from $986,530 for the prior quarter due to lower clinical development, preclinical research, and intellectual property expenses. The decrease in clinical costs for the three months ended September 30, 2019 compared to the three months ended September 30, 2018 was primarily due to the timing of the costs recognized for the manufacture of cGMP drug product incurred in the three months ended September 30, 2018. Clinical development costs can vary significantly period-to-period due to the timing of patient enrollment, how a patient reacts to treatment, and the number of treatment cycles a patient receives.

 

Preclinical research costs have decreased in the current quarter due to the completion, or deferral, of studies that were ongoing in the prior period. Intellectual property costs decreased in the three months ended September 30, 2019 compared to the three months ended September 30, 2018 as we have refined our patent portfolio by focusing on our most important patent claims in the most strategic jurisdictions. Patent costs can vary considerably depending on the filing of new patents, conversion of the provisional applications to PCT applications, foreign office actions, and actual filing costs.

 

General and Administrative

 

General and administrative expenses decreased to $913,628 for the three months ended September 30, 2019 from $986,470 for the three months ended September 30, 2018. A significant portion of the decrease was due to a decrease in non-cash, share-based compensation expense in the current quarter compared to the prior quarter partially offset by higher personnel, and office and sundry expenses for the three months ended September 30, 2019 compared to the three months ended September 30, 2018. In relation to general and administrative expenses during the three months ended September 30, 2018, we incurred non-cash, share-based compensation expense of $196,626 relating to performance share units, warrants issued for services, and stock option expense while during the three months ended September 30, 2019, we incurred non-cash, share-based compensation expense of $42,832 relating to warrants issued for services and stock option expense. All performance share units were canceled on April 30, 2019 so there was no related expense incurred during the three months ended September 30, 2019.

 

31

 

 

Excluding the impact of non-cash, share-based compensation expense, general and administrative expenses increased in the three months ended September 30, 2019 to $870,796 from $789,844 for the three months ended September 30, 2018. The increase was primarily due to increased personnel, and office and sundry expenses in the current period compared to the prior period. Personnel costs increased during the three months ended September 30, 2019 primarily due to an increase in compensation for senior management and directors. Office and sundry expenses have increased in the three months ended September 30, 2019 compared to the three months ended September 30, 2018 due to primarily to increased directors’ and officers’ liability insurance premiums.

 

Preferred Share Dividends

 

For each of the three months ended September 30, 2019 and 2018 we recorded $2,089 related to the dividend payable to Valent on the Series A preferred stock. The dividend has been recorded as a direct increase in accumulated deficit for both periods.

 

We issued 3,700 (2018 – 4,960) shares of common stock on September 30, 2019 as a dividend on the Series B Preferred stock and recognized $2,046 (2018 - $36,085) as a direct increase in accumulated deficit.

 

Liquidity and Capital Resources

 

Three months ended September 30, 2019 compared to the three months ended September 30, 2018

 

   

September 30,

2019

$

   

September 30,

2018

$

   

Change

$

   

Change

%

 
                         
Cash flows from operating activities     (2,266,146 )     (2,084,923 )     (181,223 )     9  
Cash flows from financing activities     6,607,427       (2,089 )     6,609,516       (3,164 )

 

Operating Activities

 

Net cash used in operating activities increased to $2,266,146 for the three months ended September 30, 2019 from $2,084,923 for the three months ended September 30, 2018. During the three months ended September 30, 2019 and 2018 we reported net losses of $1,605,871 and $1,991,804, respectively. Non-cash items relating to amortization of intangible assets, shares and warrants issued for services, performance stock unit expense (2018 only), and stock option expense totaled $58,629 (2018 - $236,095) for the three months ended September 30, 2019. The most significant changes in non-cash working capital for the three months ended September 30, 2019 were from decreases in cash from a reduction in accounts payable and accrued liabilities of $616,974 and a reduction in related party payables of $113,908 facilitated by the financing completed in the quarter. The most significant change in non-cash working capital for the three months ended September 30, 2018 was cash used in a decrease in accounts payable and accrued liabilities of $568,199.

 

Financing Activities

 

During the three months ended September 30, 2019 we received $6,582,966 in net proceeds from the completion of an underwritten public offering by us of common stock, pre-funded warrants, and common stock purchase warrants. Additionally, we received $26,550 pursuant to the exercise of warrants in the current period.

 

We recorded $2,089 related to the dividend payable to Valent during each of the three months ended September 30, 2019 and 2018 respectively.

 

32

 

 

Going Concern and Capital Expenditure Requirements

 

Going Concern

 

(See note 1 to the condensed consolidated interim financial statements)

 

The condensed consolidated interim financial statements have been prepared on a going concern basis which assumes that we will continue our operations for the foreseeable future and contemplates the realization of assets and the settlement of liabilities in the normal course of business.

 

For the three months ended September 30, 2019, we reported a loss of $1,605,871 and negative cash flow from operations of $2,266,146. As of September 30, 2019, we had an accumulated deficit of $62,188,351 and cash and cash equivalents on hand of $8,060,039. We are in the development stage and have not generated any revenues to date. We do not have the prospect of achieving revenues until such time that our product candidate is commercialized, or partnered, which may not ever occur. In the near future, we will require additional funding to maintain our clinical trials, research and development projects, and for general operations. These circumstances indicate substantial doubt exists about our ability to continue as a going concern within one year from the date of filing of these condensed consolidated financial statements.

 


Consequently, management is pursuing various financing alternatives to fund our operations so we can continue as a going concern. Management plans to secure the necessary financing through the issue of new equity and/or the entering into of strategic partnership arrangements. We may tailor our drug candidate development program based on the amount of funding we are able to raise in the future. Nevertheless, there is no assurance that these initiatives will be successful.

 

The financial statements do not give effect to any adjustments to the amounts and classification of assets and liabilities that may be necessary should we be unable to continue as a going concern. Such adjustments could be material.

 

Our future funding requirements will depend on many factors, including but not limited to:

 

  the rate of progress and cost of our clinical trials, preclinical studies and other discovery and research and development activities;
     
  the costs associated with establishing manufacturing and commercialization capabilities;
     
  the costs of acquiring or investing in businesses, product candidates and technologies;
     
  the costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights;
     
  the costs and timing of seeking and obtaining FDA and other regulatory approvals;
     
  the effect of competing technological and market developments;
     
  the economic and other terms and timing of any collaboration, licensing or other arrangements into which we may enter; and
     
  the impact of us being a public entity.

 

In September 2018, we announced that we had engaged Oppenheimer & Co. Inc. as our strategic advisor to help manage the exploration and evaluation of a wide range of strategic opportunities. Pursuant to the terms of the agreement, we subsequently terminated this agreement on October 19, 2019. There was no termination fee owing or paid. Until we can generate a sufficient amount of product revenue to finance our cash requirements, which we may never do, we expect to finance future cash needs primarily through public or private equity offerings, or strategic collaborations. The sale of equity and convertible debt securities may result in dilution to our stockholders and certain of those securities may have rights senior to those of our shares of capital stock. If we raise additional funds through the issuance of preferred stock, convertible debt securities or other debt financing, these securities or other debt could contain covenants that would restrict our operations. Any other third-party funding arrangement could require us to relinquish valuable rights. Economic conditions may affect the availability of funds and activity in equity markets. We do not know whether additional funding will be available on acceptable terms, or at all. If we are not able to secure additional funding when needed, we may have to delay, reduce the scope of or eliminate one or more of our clinical trials or research and development programs or make changes to our operating plan. In addition, we may have to seek a partner for one or more of our product candidate programs at an earlier stage of development, which would lower the economic value of those programs to us.

 

33

 

 

Critical Accounting Policies

 

The preparation of financial statements, in conformity with generally accepted accounting principles in the United States, requires companies to establish accounting policies and to make estimates that affect both the amount and timing of the recording of assets, liabilities, revenues and expenses. Some of these estimates require judgments about matters that are inherently uncertain and therefore actual results may differ from those estimates.

 

A detailed presentation of all of our significant accounting policies and the estimates derived therefrom is included in Note 2 to our consolidated financial statements for the year ended June 30, 2019 contained in our Form 10-K filed with the SEC on September 9, 2019. While all of the significant accounting policies are important to our condensed consolidated financial statements, the following accounting policies and the estimates derived therefrom are critical:

  

  Warrants and shares issued for services
     
  Stock options
     
  Performance stock units
     
  Derivative liability
     
  Clinical trial accruals
     

Warrants and shares issued for services

 

We have issued equity instruments for services provided by employees and nonemployees. The equity instruments are valued at the fair value of the instrument granted.

 

Stock options

 

We account for these awards under Accounting Standards Codification (“ASC”) 718, “Compensation - Stock Compensation” (“ASC 718”). ASC 718 requires measurement of compensation cost for all stock-based awards at fair value on the date of grant and recognition of compensation over the requisite service period for awards expected to vest. Compensation expense for unvested options to non-employees is revalued at each period end and is being amortized over the vesting period of the options. The determination of grant-date fair value for stock option awards is estimated using the Black-Scholes model, which includes variables such as the expected volatility of our share price, the anticipated exercise behavior of its grantee, interest rates, and dividend yields. These variables are projected based on our historical data, experience, and other factors. Changes in any of these variables could result in material adjustments to the expense recognized for share-based payments. Such value is recognized as expense over the requisite service period, net of actual forfeitures, using the accelerated attribution method. We recognize forfeitures as they occur. The estimation of stock awards that will ultimately vest requires judgment, and to the extent actual results, or updated estimates, differ from current estimates, such amounts are recorded as a cumulative adjustment in the period estimates are revised.

 

34

 

 

Performance stock units

 

We also account for performance stock units (PSU’s) under ASC 718. ASC 718 requires measurement of compensation cost for all stock-based awards at fair value on the date of grant and recognition of compensation over the requisite service period for awards expected to vest. As vesting of the PSU’s is based on a number of factors, the determination of the grant-date fair value for PSU’s has been estimated using a Monte Carlo simulation approach which includes variables such as the expected volatility of our share price and interest rates to generate potential future outcomes. These variables are projected based on our historical data, experience, and other factors. Changes in any of these variables could result in material adjustments to the expense recognized for the PSUs. Such value is recognized as expense over the derived service period using the accelerated attribution method. The estimation of PSUs that will ultimately vest requires judgment, and to the extent actual results, or updated estimates, differ from current estimates, such amounts are recorded as a cumulative adjustment in the period estimates are revised.

 

Derivative liability

 

We account for certain warrants under the authoritative guidance on accounting for derivative financial instruments indexed to, and potentially settled in, a company’s own stock, on the understanding that in compliance with applicable securities laws, the warrants require the issuance of securities upon exercise and do not sufficiently preclude an implied right to net cash settlement. We classify these warrants on our balance sheet as a derivative liability which is fair valued at each reporting period subsequent to the initial issuance. We have used a binomial model as well as a Black-Scholes Option Pricing Model (based on a closed-form model that uses a fixed equation) to estimate the fair value of the share warrants. Determining the appropriate fair-value model and calculating the fair value of warrants requires considerable judgment. Any change in the estimates (specifically probabilities and volatility) used may cause the value to be higher or lower than that reported. The estimated volatility of our common stock at the date of issuance, and at each subsequent reporting period, is based on our historical volatility. The risk-free interest rate is based on rates published by the government for bonds with a maturity similar to the expected remaining life of the warrants at the valuation date. The expected life of the warrants is assumed to be equivalent to their remaining contractual term.

 

Clinical trial accruals

 

Clinical trial expenses are a component of research and development costs and include fees paid to contract research organizations, investigators and other service providers who conduct specific research for development activities on our behalf. The amount of clinical trial expenses recognized in a period related to service agreements is based on estimates of the work performed on an accrual basis. These estimates are based on patient enrollment, services provided and goods delivered, contractual terms and experience with similar contracts. We monitor these factors by maintaining regular communication with the service providers. Differences between actual expenses and estimated expenses recorded are adjusted for in the period in which they become known. Prepaid expenses or accrued liabilities are adjusted if payments to service providers differ from estimates of the amount of service completed in a given period.

 

Off-Balance Sheet Arrangements

 

We do not have any off-balance sheet arrangements.

 

35

 

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk.

 

Not required for a smaller reporting company.

 

Item 4. Controls and Procedures.

 

Disclosure Controls and Procedures

 

Management, with the participation of the Chief Executive Officer and Chief Financial Officer, conducted an evaluation (as required by Rule 13a-15 under the Exchange Act) of the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of the end of the period covered by this report. Based on that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were not effective as of the end of the period covered by this report, due to the material weakness in internal control over financial reporting as discussed in the Company’s Annual Report on Form 10-K for the year ended June 30, 2019, filed with the SEC on September 9, 2019.

 

Changes in internal controls

 

There have been no changes in our internal control over financial reporting that occurred during the quarter ended September 30, 2019 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

36

 

PART II - OTHER INFORMATION

 

Item 1. Legal Proceedings.

 

There are no legal proceedings the Company is party to or any of its property is subject to.

 

Item 1A. Risk Factors.

 

If we fail to comply with the continued minimum closing bid requirements of the Nasdaq Capital Market LLC (“Nasdaq”) by March 24, 2020 or other requirements for continued listing, including stockholder equity requirements, our common stock may be delisted and the price of our common stock and our ability to access the capital markets could be negatively impacted.

 

Our common stock is listed for trading on Nasdaq. We must satisfy Nasdaq’s continued listing requirements, including, among other things, a minimum closing bid price requirement of $1.00 per share for 30 consecutive business days. If a company’s common stock trades for 30 consecutive business days below the $1.00 minimum closing bid price requirement, Nasdaq will send a deficiency notice, advising that such company has been afforded a “compliance period” of 180 calendar days to regain compliance with the applicable requirements. Thereafter, if such a company does not regain compliance with the bid price requirement, a second 180-day compliance period may be available, provided (i) it meets the continued listing requirement for market value of publicly held shares and all other applicable requirements for initial listing on Nasdaq, including stockholder equity requirements, which we may be unable to satisfy (except for the bid price requirement), and (ii) it provides written notice to Nasdaq of its intention to cure this deficiency during the second compliance period by effecting a reverse stock split, if necessary. In the event the company does not regain compliance with Rule 5550(a)(2) prior to the expiration of the initial 180 calendar day period, and if it appears to the Staff of the Listing Qualifications Department of The Nasdaq Stock Market LLC (the “Nasdaq Staff”) that the company will not be able to cure the deficiency, or if the company is not otherwise eligible, the Nasdaq Staff will provide the company with written notification that its securities are subject to delisting from Nasdaq. At that time, the company may appeal the delisting determination to a Hearings Panel.

 

On September 26, 2019, the Nasdaq Staff notified us that we did not comply with the minimum $1.00 per share bid price requirement for continued listing, as set forth in Nasdaq Listing Rule 5550(a)(2), and we have 180 calendar days, or until March 24, 2020, to regain compliance. The closing bid price of our securities must be at least $1.00 per share for a minimum of ten consecutive business days to regain compliance.

 

If we are unable to regain compliance with the minimum closing bid price requirement by March 24, 2020, or if we fail to meet any of the other continued listing requirements, including stockholder equity requirements, our securities may be delisted from Nasdaq, which could reduce the liquidity of our common stock materially and result in a corresponding material reduction in the price of our common stock. In addition, delisting could harm our ability to raise capital through alternative financing sources on terms acceptable to us, or at all, and may result in the potential loss of confidence by investors, employees and business development opportunities. Such a delisting likely would impair your ability to sell or purchase our common stock when you wish to do so. Further, if we were to be delisted from Nasdaq, our common stock may no longer be recognized as a “covered security” and we would be subject to regulation in each state in which we offer our securities. Thus, delisting from Nasdaq could adversely affect our ability to raise additional financing through the public or private sale of equity securities, would significantly impact the ability of investors to trade our securities and would negatively impact the value and liquidity of our common stock

 

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.

 

During the three months ended September 30, 2019, we issued 3,700 shares of common stock as dividends on our outstanding shares of Series B Preferred Stock and 6,925 shares of common stock in relation to services received by us.

 

In connection with the foregoing, we relied upon the exemption from registration provided by Section 4(a)(2) under the Securities Act of 1933, as amended, for transactions not involving a public offering.

 

Item 3. Defaults Upon Senior Securities.

 

None.

 

Item 4. Mine Safety Disclosures.

 

Not applicable.

 

Item 5. Other Information.

 

On November 12, 2019, the Company granted 250,000 stock options to Dennis Brown, the Company’s Chief Science Officer, subject to stockholder approval of the increase in the number of shares authorized for issuance under the 2017 Omnibus Incentive Plan at the next annual meeting of stockholders. The options have an exercise price of $0.735 and expire on November 12, 2029. The options vest upon the achievement of certain clinical development milestones.

 

Item 6. Exhibits.

 

No.   Description
31.1   Rule 13a-14(a)/ 15d-14(a) Certification of Chief Executive Officer*
31.2   Rule 13a-14(a)/ 15d-14(a) Certification of Chief Financial Officer*
32.1   Section 1350 Certification of Chief Executive Officer**
32.2   Section 1350 Certification of Chief Financial Officer**
EX-101.INS   XBRL INSTANCE DOCUMENT
EX-101.SCH   XBRL TAXONOMY EXTENSION SCHEMA DOCUMENT
EX-101.CAL   XBRL TAXONOMY EXTENSION CALCULATION LINKBASE
EX-101.DEF   XBRL Taxonomy Definition Linkbase
EX-101.LAB   XBRL TAXONOMY EXTENSION LABELS LINKBASE
EX-101.PRE   XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE

 

* Filed herewith.

** Furnished herewith.

+ Indicates management contract or compensatory plan.

37

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

  DelMar Pharmaceuticals, Inc.
     
Date: November 13, 2019 By: /s/ Saiid Zarrabian
    Saiid Zarrabian
   

Chief Executive Officer

(Principal Executive Officer)

 

Date: November 13, 2019 By: /s/ Scott Praill
    Scott Praill
   

Chief Financial Officer

(Principal Financial and Accounting Officer)

  

 

38

 

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