Q BioMed Inc. - Quarter Report: 2018 February (Form 10-Q)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
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[X]
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
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For the quarterly period ended: February 28, 2018
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or
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[ ]
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
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For the transition period from ____________ to
_____________
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Commission File Number: 000-55535
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Q BIOMED INC.
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(Exact name of registrant as specified in its charter)
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Nevada
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46-4013793
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(State or other jurisdiction of incorporation or
organization)
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(I.R.S. Employer Identification No.)
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c/o Ortoli Rosenstadt LLP
New York, NY10022
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(Address of principal executive offices)
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(212) 588-0022
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(Registrant's telephone number, including area code)
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Indicate by check mark whether the registrant (1) 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 ☒ No ☐
Indicate by check mark whether the registrant has submitted
electronically and posted on its corporate Web site, if any, every
Interactive Data File required to be submitted and posted 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 and post such
files). Yes ☒ 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
definition of “large accelerated filer,”
“accelerated filer,” “smaller reporting
company” and “emerging growth company” in Rule
12b-2 of the Exchange Act.
Large accelerated filer
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☐
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Accelerated filer
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☐
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Non-accelerated filer
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☐
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(Do not check if smaller reporting
company)
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Smaller reporting company
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☒
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Emerging growth company
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☐
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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 ☒
Indicate the number of shares outstanding of each of the issuer's
classes of common stock, as of the latest practicable
date:
Common Stock, $0.001 par value
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13,974,784 shares
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(Class)
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(Outstanding as at April 9, 2018)
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Q BIOMED INC.
Table of Contents
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Page
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PART
I – FINANCIAL INFORMATION
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2
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Item
1. Condensed Consolidated Financial Statements
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2
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Item
2. Management’s Discussion and Analysis of Financial
Condition and Results of Operations
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10
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Item
3. Quantitative and Qualitative Disclosure About Market
Risk
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14
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Item
4. Controls and Procedures
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14
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PART
II – OTHER INFORMATION
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15
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Item
1. Legal Proceedings
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15
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Item
1A. Risk Factors
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15
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Item
2. Unregistered Sales of Equity Securities and Use of
Proceeds
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15
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Item
3. Defaults Upon Senior Securities
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15
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Item
4. Mine Safety Disclosures
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15
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Item
5. Other Information
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15
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Item
6. Exhibits
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15
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SIGNATURES
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16
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1
PART I – FINANCIAL INFORMATION
Item 1. Condensed Consolidated Financial Statements
Q BIOMED INC.
Condensed Consolidated Balance Sheets
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February 28, 2018
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November 30, 2017
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(Unaudited)
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ASSETS
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Current
assets:
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Cash
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$4,187,009
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$824,783
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Prepaid
expenses
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2,500
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2,500
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Total
current assets
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4,189,509
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827,283
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Total Assets
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$4,189,509
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$827,283
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LIABILITIES AND STOCKHOLDERS' EQUITY
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Current
liabilities:
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Accounts
payable and accrued expenses
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$562,812
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$463,539
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Accrued
expenses - related party
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7,500
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7,500
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Total
current liabilities
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570,312
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471,039
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Total Liabilities
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570,312
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471,039
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Commitments and Contingencies (Note 5)
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Stockholders' Equity:
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Preferred
stock, $0.001 par value; 100,000,000 shares authorized; no shares
issued and outstanding as of February 28, 2018 and November 30,
2017
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-
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-
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Common
stock, $0.001 par value; 250,000,000 shares authorized; 13,947,784
and 12,206,409 shares issued and outstanding as of February 28,
2018 and November 30, 2017, respectively
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13,948
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12,206
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Additional
paid-in capital
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28,622,798
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23,187,408
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Accumulated
deficit
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(25,017,549)
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(22,843,370)
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Total Stockholders' Equity
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3,619,197
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356,244
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Total Liabilities and Stockholders' Equity
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$4,189,509
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$827,283
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The
accompanying notes are an integral part of these condensed
consolidated financial statements
2
Q BioMed Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
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For the three months ended February 28,
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2018
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2017
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Operating expenses:
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General
and administrative expenses
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$1,320,769
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$1,407,570
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Research
and development expenses
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853,425
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584,938
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Total
operating expenses
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2,174,194
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1,992,508
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Other income (expenses):
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Interest
expense
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-
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(216,507)
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Interest
income
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15
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92
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Loss
on conversion of debt
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-
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(362,931)
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Change
in fair value of embedded conversion option
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-
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(905,000)
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Change
in fair value of warrant liability
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-
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(59,870)
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Total
other income (expenses)
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15
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(1,544,216)
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Net loss
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$(2,174,179)
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$(3,536,724)
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Net loss per share - basic and diluted
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$(0.17)
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$(0.37)
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Weighted average shares outstanding, basic and diluted
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12,727,442
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9,472,250
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The accompanying notes are an integral part of these condensed
consolidated financial statements
3
Q BIOMED INC.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
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For
the three months ended February 28,
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2018
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2017
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Cash
flows from operating activities:
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Net
loss
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$(2,174,179)
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$(3,536,724)
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Adjustments to
reconcile net loss to net cash used in operating
activities
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Issuance of common
stock, warrants and options for services
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491,881
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803,017
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Change in fair
value of embedded conversion option
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-
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905,000
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Change in fair
value of warrant liability
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-
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59,870
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Accretion of debt
discount
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-
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181,336
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Loss on conversion
of debt
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-
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362,931
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Changes in
operating assets and liabilities:
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Prepaid
expenses
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-
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(4,500)
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Accounts payable
and accrued expenses
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99,273
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31,457
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Accrued expenses -
related party
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-
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(63,002)
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Accrued interest
payable
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-
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35,172
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Net
cash used in operating activities
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(1,583,025)
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(1,225,443)
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Cash
flows from financing activities:
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Proceeds
received from exercise of warrants
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-
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70,000
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Proceeds
received for issuance of common stock and warrants, net of offering
costs
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4,945,251
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-
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Net
cash provided by financing activities
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4,945,251
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70,000
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Net increase (decrease) in cash
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3,362,226
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(1,155,443)
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Cash at beginning of period
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824,783
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1,468,724
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Cash at end of period
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$4,187,009
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$313,281
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Non-cash financing activities:
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Issuance
of common stock upon conversion of convertible notes
payable
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$-
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$2,227,900
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Reclassification
of warrant liability to equity
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$-
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$227,940
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Supplemental disclosures:
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Cash paid for
interest
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$-
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$-
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Cash paid for
income taxes
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$-
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$-
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The accompanying notes are an integral part of these condensed
consolidated financial statements
4
Q BIOMED INC.
Notes to Condensed Consolidated Financial Statements
Note 1 - Organization of the Company and Description of the
Business
Q BioMed Inc. (“Q BioMed” or “the
Company”), incorporated in the State of Nevada on November
22, 2013, is a biomedical acceleration and development company
focused on licensing, acquiring and providing strategic resources
to life sciences and healthcare companies. Q BioMed intends to
mitigate risk by acquiring multiple assets over time and across a
broad spectrum of healthcare related products, companies and
sectors. The Company intends to develop these assets to
provide returns via organic growth, revenue production,
out-licensing, sale or spinoff new public companies.
On December 7, 2016, the Company formed its wholly-owned subsidiary
in Cayman Islands, “Q BioMed Cayman SEZC” (the
“Subsidiary”). The accompanying condensed consolidated
financial statements include the accounts of the Company’s
wholly-owned subsidiary. All intercompany balances and
transactions have been eliminated in consolidation.
Note 2 - Basis of Presentation
The accompanying interim period unaudited condensed consolidated
financial statements have been prepared in accordance with
generally accepted accounting principles in the United States of
America (“U.S. GAAP”) and applicable rules and
regulations of the Securities and Exchange Commission ("SEC")
regarding interim financial reporting. The Condensed Consolidated
Balance Sheet as of February 28, 2018, the Condensed Consolidated
Statements of Operations for the three months ended February 28,
2018 and 2017, and the Condensed Consolidated Statements of Cash
Flows for the three months ended February 28, 2018 and 2017, are
unaudited, but include all adjustments, consisting only of normal
recurring adjustments, which the Company considers necessary for a
fair presentation of its financial position, operating results and
cash flows for the periods presented. The Condensed Consolidated
Balance Sheet at November 30, 2017 has been derived from audited
financial statements included in the Company's Form 10-K, most
recently filed with the SEC on February 28, 2018. The results for
the three months ended February 28, 2018 and 2017 are not
necessarily indicative of the results expected for the full fiscal
year or any other period.
The accompanying interim period unaudited condensed consolidated
financial statements and related financial information included in
this Quarterly Report on Form 10-Q should be read in conjunction
with the audited financial statements and notes thereto included in
the Company’s Form 10-K.
The Company currently operates in one business segment focusing on
licensing, acquiring and providing strategic resources to life
sciences and healthcare companies. The Company is not organized by
market and is managed and operated as one business. A single
management team reports to the chief operating decision maker, the
Chief Executive Officer, who comprehensively manages the entire
business. The Company does not currently operate any separate lines
of business.
Going Concern
The accompanying condensed consolidated financial statements are
prepared assuming the Company will continue as a going concern,
which contemplates the realization of assets and liquidation of
liabilities in the normal course of business.
The Company had a net loss and net cash used in operating
activities of approximately $2.2 million and $1.6 million,
respectively, during the three months ended February 28, 2018.
These matters, amongst others, raise doubt about the
Company’s ability to continue as a going
concern.
As of February 28, 2018, the Company has raised operating
funds through contacts, high net-worth individuals and
strategic investors. The Company has not generated any revenue from
operations since inception and has limited assets upon which to
commence its business operations. At February 28, 2018,
the Company had cash of approximately $4.2 million. On
February 1, 2018, the Company netted approximately $4,945,000 from
the registered sale of common stock and warrants to purchase common
stock. The Company’s expected monthly burn rate is
approximately $528,000. As such, management anticipates that the
Company will have to raise additional funds and/or generate revenue
from drug sales within twelve months to continue operations.
Additional funding will be needed to implement the Company’s
business plan that includes various expenses such as fulfilling our
obligations under licensing agreements, legal, operational set-up,
general and administrative, marketing, employee salaries and other
related start-up expenses. Obtaining additional funding will be
subject to a number of factors, including general market
conditions, investor acceptance of our business plan and initial
results from our business operations. These factors may impact the
timing, amount, terms or conditions of additional financing
available to us. If the Company is unable to raise sufficient
funds, management we will be forced to scale back the
Company’s operations or cease our operations.
Management has determined that there is substantial doubt about the
Company's ability to continue as a going concern within one year
after the condensed consolidated financial statements are
issued. The accompanying condensed consolidated financial statements do not include any
adjustments relating to the recoverability and classification of
recorded asset amounts or amounts and classification of liabilities
that might result from this uncertainty.
5
Q BIOMED INC.
Notes to Condensed Consolidated Financial Statements
The Company’s significant accounting policies are disclosed
in the audited financial statements for the year ended November 30,
2017 included in the Company’s Form 10-K. Since the date of
such financial statements, there have been no changes to the
Company’s significant accounting policies.
Income Taxes
Deferred tax assets and liabilities are computed based upon the
difference between the financial statement and income tax basis of
assets and liabilities using the enacted marginal tax rate
applicable when the related asset or liability is expected to be
realized or settled. Deferred income tax expenses or benefits
are based on the changes in the asset or liability each period.
If available evidence suggests that it is more likely than
not that some portion or all of the deferred tax assets will not be
realized, a valuation allowance is required to reduce the deferred
tax assets to the amount that is more likely than not to be
realized. Future changes in such valuation allowance are
included in the provision for deferred income taxes in the period
of change.
In its interim consolidated financial statements, the Company
utilizes an expected annual effective tax rate in determining its
income tax provisions for the interim periods. That rate differs
from U.S. statutory rates primarily as a result of valuation
allowance related to the Company’s net operating loss
carryforward as a result of the historical losses of the
Company.
On December 22, 2017, the United States enacted new tax
legislation, the Tax Cuts and Jobs Act (the “Tax
Act”). The Tax Act includes significant changes to
corporate taxation, including reduction of the U.S. corporate tax
rate from 35% to 21%, effective January 1, 2018, limitation of the
tax deduction for interest expense to 30% of earnings (except for
certain small businesses), limitation of the deduction for net
operating losses to 80% of current year taxable income and
elimination of net operating loss carrybacks. The Tax Act
states that the 21% U.S. federal corporate tax rate is effective
for tax years beginning on or after January 1, 2018. However,
existing tax law, which was not amended under the Tax Act, governs
when a change in tax rate is effective. Existing tax law provides
that if the taxable year includes the effective date of any rate
change (unless the change is the first date of the taxable year),
taxes should be calculated by applying a blended rate to the
taxable income for the year. Management has not yet determined the
impact the rate reduction will have on the Company's gross deferred
tax asset and liabilities and offsetting valuation allowance.
However, the Company has a full allowance against the deferred
tax asset and as a result there was no impact to income tax expense
for the quarter ended February 28, 2018.
In conjunction with the tax law changes, the SEC staff issued Staff
Accounting Bulletin No. 118 (“SAB 118”) to address the
application of U.S. GAAP in situations when a registrant does not
have the necessary information available, prepared, or analyzed
(including computations) in reasonable detail to complete the
accounting for certain income tax effects of the Tax Act. The
ultimate impact, which is expected to be recorded by November 30,
2018, may differ from any provisional amounts, due to, among other
things, additional analysis, changes in interpretations and
assumptions we have made, additional regulatory guidance that may
be issued, and actions we may take as a result of the tax Act, and
the fact that we cannot definitively predict what our deferred tax
balance will ultimately be as of November 30, 2018.
Recent accounting pronouncements
In August 2016, the FASB issued ASU No. 2016-15,
Statement of Cash
Flows (Topic 230): Classification of Certain Cash Receipts and Cash
Payments. This new standard
clarifies certain aspects of the statement of cash flows, including
the classification of debt prepayment or debt extinguishment costs
or other debt instruments with coupon interest rates that are
insignificant in relation to the effective interest rate of the
borrowing, contingent consideration payments made after a business
combination, proceeds from the settlement of insurance claims,
proceeds from the settlement of corporate-owned life insurance
policies, distributions received from equity method investees and
beneficial interests in securitization transactions. This new
standard also clarifies that an entity should determine each
separately identifiable source of use within the cash receipts and
payments on the basis of the nature of the underlying cash flows.
In situations in which cash receipts and payments have aspects of
more than one class of cash flows and cannot be separated by source
or use, the appropriate classification should depend on the
activity that is likely to be the predominant source or use of cash
flows for the item. This new standard will be effective for the
Company on December 1, 2018. The Company is currently
evaluating the impact of the new standard on its consolidated
financial statements.
In July 2017, the FASB issued ASU 2017-11, Earnings Per Share (Topic
260); Distinguishing Liabilities from Equity (Topic 480);
Derivatives and Hedging (Topic 815): (Part I) Accounting for
Certain Financial Instruments with Down Round Features, (Part II)
Replacement of the Indefinite Deferral for Mandatorily Redeemable
Financial Instruments of Certain Nonpublic Entities and Certain
Mandatorily Redeemable Noncontrolling Interests with a Scope
Exception. The
ASU allows companies to exclude a down round feature when
determining whether a financial instrument (or embedded conversion
feature) is considered indexed to the entity’s own stock. As
a result, financial instruments (or embedded conversion features)
with down round features may no longer be required to be accounted
classified as liabilities. A company will recognize the value of a
down round feature only when it is triggered and the strike price
has been adjusted downward. For equity-classified freestanding
financial instruments, such as warrants, an entity will treat the
value of the effect of the down round, when triggered, as a
dividend and a reduction of income available to common shareholders
in computing basic earnings per share. For convertible instruments
with embedded conversion features containing down round provisions,
entities will recognize the value of the down round as a beneficial
conversion discount to be amortized to earnings. The guidance in
ASU 2017-11 is effective for fiscal years beginning after December
15, 2018, and interim periods within those fiscal years. Early
adoption is permitted, and the guidance is to be applied using a
full or modified retrospective approach. Management is currently
assessing the impact the adoption of ASU 2017-11 will have on the
Company’s consolidated financial
statements.
6
Q BIOMED INC.
Notes to Condensed Consolidated Financial Statements
In May 2017, the FASB issued ASU 2017-09, Compensation – Stock
Compensation (Topic 718): Scope of Modification
Accounting. The new standard
provides guidance about which changes to the terms or conditions of
a share-based payment award require an entity to apply modification
accounting in Topic 718. The ASU is effective for annual reporting
periods, including interim periods within those annual reporting
periods, beginning after December 15, 2017. Early adoption is
permitted, including adoption in any interim period. The Company
adopted ASU 2017-09 as of December 1, 2017. The adoption of this
standard did not impact the Company’s consolidated financial
statements.
Note 4 – Loss per share
Basic net loss per share was calculated by dividing net loss by the
weighted-average common shares outstanding during the
period. Diluted net loss per share was calculated by
dividing net loss by the weighted-average common shares outstanding
during the period using the treasury stock method or the two-class
method, whichever is more dilutive. The table below
summarizes potentially dilutive securities that were not
considered in the computation of diluted net loss per share because
they would be anti-dilutive.
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For
the three months ended February 28,
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Potentially dilutive securities
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2018
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2017
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Warrants
(Note 8)
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4,877,558
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1,027,500
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Convertible
debt
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-
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616,145
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Options (Note
8)
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500,000
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-
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Note 5 – Commitments and Contingencies
Advisory Agreements
The Company entered into customary consulting arrangements with
various counterparties to provide consulting services, business
development and investor relations services, pursuant to which the
Company agreed to issue shares of common stock as services are
received. The Company issued an aggregate of
approximately 4,500 shares of common stock during the three months
ended February 28, 2018.
Lease Agreement
In December 2016, the Subsidiary entered into a lease agreement for
its office space located in Cayman Islands for $30,000 per
annum. The initial term of the agreement ends in December
2019 and can be renewed for another three years.
Rent expenses was classified within general and administrative
expenses and was approximately $7,500 and $5,000 for the three
months ended February 28, 2018 and 2017, respectively.
License Agreement
Mannin
On October 29, 2015, the Company entered into a Patent and
Technology License and Purchase Option Agreement (“Exclusive
License”) with a vendor whereby the Company was granted a
worldwide, exclusive, license on, and option to, acquire certain
intellectual property (“Mannin IP”) which initially
focused on developing a first-in-class eye drop treatment for
glaucoma within the four-year term of the Exclusive
License.
During the three months ended February 28, 2018 and 2017, the
Company incurred approximately $619,000 and $421,000, respectively,
in research and development expenses to fund the costs of
development of the eye drop treatment for glaucoma pursuant to the
Exclusive License. Pursuant to the exclusive license from
Mannin, we may purchase the Mannin IP within the next four years in
exchange for investing a minimum of $4,000,000 into the development
of the Mannin IP. Through February 28, 2018, the Company had funded
an aggregate of $3.0 million to Mannin under the Exclusive
License.
Bio-Nucleonics
On September 6, 2016, the Company entered into the Patent and
Technology License and Purchase Option Agreement (the “BNI
Exclusive License”) with Bio-Nucleonics Inc.
(“BNI”) whereby the Company was granted a worldwide,
exclusive, perpetual, license on, and option to, acquire certain
BNI intellectual property (“BNI IP”) within the
three-year term of the BNI Exclusive License.
During the three months ended February 28, 2018 and 2017, the
Company incurred approximately $112,000 and $143,000, respectively,
in research and development expenses pursuant to the BNI Exclusive
License. As of February 28, 2018, the Company had paid
approximately $578,000 to BNI out of the maximum $850,000 cash
funding requirement.
7
Q BIOMED INC.
Notes to Condensed Consolidated Financial Statements
Note 6 - Related Party Transactions
The Company entered into consulting agreements with certain
management personnel and stockholders for consulting and legal
services. Consulting and legal expenses resulting from
such agreements were approximately $60,000 and $105,000 for the
three months ended February 28, 2018 and 2017, respectively, and
were included within general and administrative expenses in the
accompanying Condensed Consolidated Statements of
Operations.
Note 7 - Stockholders’ Equity Deficit
As of February 28, 2018, the Company is authorized to issue up to
250,000,000 shares of its $0.001 par value common stock and up to
100,000,000 shares of its $0.001 par value preferred
stock.
On February 1, 2018, the Company sold an aggregate of 1,711,875
shares of common stock, and 1,711,875 warrants to purchase shares
of common stock, in a registered public offering for gross proceeds
of approximately $5,478,000. The warrants are exercisable for
five years at $3.20 per share. The Company paid placement
agent commissions of approximately $438,000 and issued the
placement agent five-year warrants to purchase 81,688 shares of
common stock at $3.84 per share. After the placement agents’
commissions and other offering expenses, the Company netted
approximately $4,945,000 of proceeds. The Company intends to use
the net proceeds from the offering to: i) launch our non-opioid FDA
approved Strontium Chloride 89 USP Injection (SR89), a therapeutic
drug for the treatment of skeletal pain associated with metastatic
cancers; ii) focus on the clinical planning and IND filing for a
Phase 4 post-marketing study to expand the indication of the
approved SR89; iii) complete pre-IND studies and the filing of an
IND for a phase II/III clinical program to test the efficacy of
QBM-001, our product candidate for the treatment of young children
with a rare autistic spectrum disorder that severely inhibits their
ability to communicate; iv) continue development work on our novel
chemotherapeutic drug for liver cancer; and v) further the
optimization and pre-clinical testing of our glaucoma drug Man-01
for the treatment of open angle glaucoma.
Note 8 – Warrants and Options
Summary of warrants
The following represents a summary of all outstanding warrants to
purchase the Company’s common stock, including warrants
issued to vendors for services and warrants issued as part of the
units sold in the private placements, at February 28, 2018 and
changes during the period then ended:
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Warrants
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Weighted AverageExercise Price
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Weighted Average
Remaining ContractualLife (years) |
Intrinsic Value
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Outstanding
at November 30, 2017
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3,083,995
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$3.67
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4.02
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$2,539,185
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Issued
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1,793,563
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$3.23
|
4.92
|
|
Exercised
|
-
|
$-
|
-
|
$-
|
Outstanding
at February 28, 2018
|
4,877,558
|
$3.51
|
4.20
|
$851,000
|
Exercisable
at February 28, 2018
|
4,844,058
|
$3.50
|
4.20
|
$851,000
|
Fair value of all outstanding warrants was calculated with the
following key inputs:
|
For
the three months ended February 28,
|
|
|
2018
|
2017
|
Stock
price
|
$2.99 - $4.80
|
$4.15 - $7.87
|
Term
(years)
|
3.0 - 5.0
|
1.75 - 4.5
|
Volatility
|
122.78% - 131.37%
|
137.77% - 140.64%
|
Risk-free
rate
|
1.78% - 2.65%
|
1.17% - 1.27%
|
Dividend
yield
|
0.00%
|
0.00%
|
8
Q BIOMED INC.
Notes to Condensed Consolidated Financial Statements
The following represents a summary of all outstanding options to
purchase the Company’s common stock at February 28, 2018 and
changes during the period then ended:
|
Options
|
Weighted
Average Exercise Price
|
Weighted
Average Remaining Contractual Life (years)
|
Intrinsic
Value
|
Outstanding
at November 30, 2017
|
450,000
|
$4.00
|
4.51
|
$220,500
|
Issued
|
50,000
|
$3.00
|
4.95
|
$-
|
Exercised
|
-
|
$-
|
-
|
$-
|
Outstanding
at February 28, 2018
|
500,000
|
$3.90
|
4.33
|
$-
|
Exercisable
at February 28, 2018
|
225,000
|
$4.00
|
4.26
|
$-
|
Fair value of all outstanding warrants was calculated with the
following key inputs:
|
For
the three months ended February 28,
|
|
2018
|
Exercise
price
|
$3.00
|
Expected
term (years)
|
5.0
|
Volatility
|
127.70%
|
Risk-free
rate
|
2.52%
|
Dividend
yield
|
0.00%
|
Stock-based Compensation
The Company recognized general and administrative expenses of
approximately $402,000 and $672,000 as a result of the shares,
outstanding warrants and options issued to consultants and
employees during the three months ended February 28, 2018 and 2017,
respectively.
As of February 28, 2018, the estimated unrecognized stock-based
compensation associate with these agreements is approximately
$224,000 and will be recognized over the next 0.16
year.
Note 11 – Subsequent Events
Master Service Agreement
On March 1, 2018, the Company entered into the master service
agreement (“Master Service Agreement”) with Chedwick
Marketing Group to have it perform the consulting services for a
maximum period of six months, which may be renewed after term at
the sole option of the Company. On March 1, 2018, the Company
entered into the Statement of Work No. 1 (“Statement of
Work”) with Chedwick Marketing Group. The Company agreed to
issue Chedwick Marketing Group 20,000 fully paid restricted common
shares on signing. The Company agreed to pay additional cash for
media spend as invoiced by Chedwick or other service providers. The
company agreed to issue 7,000 shares to Chedwick on execution of
the agreement and on the first day of each month until the
termination or renewal of the contract.
9
Item 2. Management's Discussion and Analysis of Financial Condition
and Results of Operation
Forward-Looking Statements
This Quarterly Report contains forward-looking statements about our
business, financial condition and prospects that reflect
management’s assumptions and beliefs based on information
currently available. The expectations indicated by such
forward-looking statements might not be realized. If any of
our management’s assumptions should prove incorrect, or if
any of the risks and uncertainties underlying such expectations
should materialize, our actual results may differ materially from
those indicated by the forward-looking statements.
The key factors that are not within our control and that may have a
direct bearing on operating results include, but are not limited
to, acceptance of our services, our ability to expand our customer
base, managements’ ability to raise capital in the future,
the retention of key employees and changes in the regulation of our
industry.
There may be other risks and circumstances that management may be
unable to predict. When used in this Quarterly Report, words
such as, "believes," "expects,"
"intends," "plans," "anticipates," "estimates" and similar expressions are intended to identify
forward-looking statements, although there may be certain
forward-looking statements not accompanied by such
expressions.
Overview
Q BioMed Inc. (or “the Company”) was incorporated in
the State of Nevada on November 22, 2013 and is a biomedical
acceleration and development company focused on licensing,
acquiring and providing strategic resources to life sciences and
healthcare companies. We intend to mitigate risk by acquiring
multiple assets over time and across a broad spectrum of healthcare
related products, companies and sectors. We intend to
develop these assets to provide returns via organic growth, revenue
production, out-licensing, sale or spin out.
Recent Developments
Capital Raising
On February 1, 2018, the Company sold an aggregate of 1,711,875
shares of common stock, and 1,711,875 warrants to purchase shares
of common stock, in a registered public offering for gross proceeds
of approximately $5,478,000. The warrants are exercisable for
five years at $3.20 per share. The Company paid placement
agent commissions of approximately $438,000 and issued the
placement agent five-year warrants to purchase 81,688 shares of
common stock at $3.84 per share. After the placement agents’
commissions and other offering expenses, the Company netted
approximately $4,945,000 of proceeds. The Company intends to use
the net proceeds from the offering to: i) launch our non-opioid FDA
approved Strontium Chloride 89 USP Injection (SR89), a therapeutic
drug for the treatment of skeletal pain associated with metastatic
cancers; ii) focus on the clinical planning and IND filing for a
Phase 4 post-marketing study to expand the indication of the
approved SR89; iii) complete pre-IND studies and the filing of an
IND for a phase II/III clinical program to test the efficacy of
QBM-001, our product candidate for the treatment of young children
with a rare autistic spectrum disorder that severely inhibits their
ability to communicate; iv) continue development work on our novel
chemotherapeutic drug for liver cancer; and v) further the
optimization and pre-clinical testing of our glaucoma drug Man-01
for the treatment of open angle glaucoma.
Strontium 89 Chloride commercialization
On September 6, 2016, we entered into a definitive agreement to
exclusively license worldwide and ultimately acquire all the assets
from a private company related to an FDA approved generic drug for
the treatment of pain associated with metastatic bone cancer,
Generic Strontium Chloride Sr-89 Injection USP
(“SR89”).
We have initiated final drug product manufacturing at a
new contract manufacturing site and through our licensor have filed
for the required FDA approval for that site. We will work with the
regulators to affect that approval as soon as possible. As a
result SR89 will not be commercially available until we have the
approval of the FDA to release drug from that site. We anticipate
that this will occur in the second quarter of 2018, although it may
occur later or never at all.
License Agreement in Rare Pediatric Autistic Spectrum
Disorder
On April 25, 2017, we entered into a licensing agreement that
provides us with the worldwide exclusive rights to ASDERA’s
ASD-002 (now annotated as QBM-001). QBM-001 is being developed to
treat a rare pediatric nonverbal disorder. Under the terms of the
agreement, the Company receives global rights to develop and
commercialize the drug in the rare pediatric disease
market.
Given that we are developing an analogue of a well-known approved
drug that regulates these channels, we expect to advance this
clinically through a 505(b)2 pathway expected to start in late
2018. This single Phase 2/3 pivotal trial, which, if successful,
could have the drug ready for market in less than two years from
trial initiation.
License Agreement in Liver Cancer Chemotherapeutic Drug
Candidate
On June 15, 2017, we signed a final license agreement with The
Oklahoma Medical Research Foundation (OMRF) and the Rajiv Gandhi
Centre for Biotechnology (RGCB). Under the agreement Q BioMed has
the global exclusive rights to develop and market a novel
chemotherapeutic drug to treat liver cancer.
We are currently working on synthesizing the molecule chemically to
ensure commercial availability and scalability. We anticipate that
pre-IND work and evaluation will be done by the middle of this
year, and if successful, the IND is expected to be filed in the
second half of 2018 or early 2019.
10
Mannin License Update
Additionally, Mannin Research Inc. (“Mannin”), our
technology partner company focused on drug candidate MAN-01 for
treatment of Primary Open Angle Glaucoma (POAG), has initiated
pre-clinical lead candidate optimization of a small molecule for
topical application. Lead candidate selection is progressing
on-time and on-budget. The topical application in the form of an
easy to administer eye drop is a key differentiator for Mannin and
aims to solve the compliance problems and invasive procedures
currently available to patients suffering from
glaucoma.
We are pleased with the progress Mannin research teams have
achieved over the past several months and look forward to putting
the final drug candidates into IND enabling studies this
year.
We continue to advance all the assets in our pipeline. We have
executed on our plan to build a pipeline of considerable inherent
value with several catalysts expected for 2018. We aim to have a
commercial drug on the market by the end of the second quarter of
2018 and two new INDs filed in 2018 including a Phase 4 and a Phase
2/3 pivotal trial. We remain committed to advancing our assets
towards the patients that need them and driving value for our
shareholders.
Financial Overview
Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements.
Critical Accounting Policies and Estimates
This management’s discussion and analysis of our financial
condition and results of operations is based on our condensed
consolidated financial statements, which have been prepared in
accordance with generally accepted accounting principles in the
United States of America (“U.S. GAAP”). The preparation
of these condensed consolidated financial statements requires us to
make estimates and judgments that affect the reported amounts of
assets, liabilities, revenues and expenses and the disclosure of
contingent assets and liabilities in our condensed consolidated
financial statements. On an ongoing basis, we evaluate our
estimates and judgments, including those related to fair value of
financial instruments, research and development costs, accrued
expenses and stock-based compensation. We base our estimates on
historical experience, known trends and events and various other
factors that we believe to be reasonable under the circumstances,
the results of which form the basis for making judgments about the
carrying values of assets and liabilities that are not readily
apparent from other sources. Actual results may differ from these
estimates under different assumptions or conditions. Other than as
set out in Note 3 to our accompanying unaudited condensed
consolidated financial statements we believe there have been no
significant changes in our critical accounting policies as
described in the Form 10-K.
Unaudited Results of Operations for the three months ended February
28, 2018 and 2017:
|
For the three months ended
|
|
|
February 28, 2018
|
February 28, 2017
|
Operating expenses:
|
|
|
General
and administrative expenses
|
$1,320,769
|
$1,407,570
|
Research
and development expenses
|
853,425
|
584,938
|
Total
operating expenses
|
2,174,194
|
1,992,508
|
|
|
|
Other income (expense):
|
|
|
Interest
expense
|
-
|
(216,507)
|
Interest
income
|
15
|
92
|
Loss
on conversion of debt
|
-
|
(362,931)
|
Change
in fair value of embedded conversion option
|
-
|
(905,000)
|
Change
in fair value of warrant liability
|
-
|
(59,870)
|
Total
other income (expenses)
|
15
|
(1,544,216)
|
|
|
|
Net loss
|
$(2,174,179)
|
$(3,536,724)
|
|
|
|
Operating expenses
We incur various costs and expenses in the execution of our
business. The increase in operating expenses was mainly due to more
professional and research & development fees incurred in
connection with the license agreements with Mannin, BNI and
Asdera.
11
Other expenses
During the three months ended February 28, 2018, other income
included $15 in interest income. During the three months
ended February 28, 2017, other expenses included approximately
$217,000 in interest expense, $905,000 for the change in fair value
of embedded conversion options, approximately $60,000 for the
change in fair value of warrant liability, and approximately
$363,000 in loss on the conversion of debt.
All of the Company’s outstanding debt was either converted or
extinguished as of November 30, 2017 such that the Company had no
debt outstanding during the three months ended February 28,
2018.
The decrease in interest expense results from the decrease in the
weighted average debt balance in three month period ended February
28, 2017 compared to the three months ended February 28,
2018.
During the three month period ended February 28, 2017, we
recognized losses upon the issuance of certain convertible notes of
$363,000. The recognized losses result for the conversion of
notes where the conversion option has been bifurcated for
accounting purposes. As a result, conversions are recognized as an
extinguishment of the bifurcated conversion option and of the loan
host, which results in a gain or loss based on the difference
between the carrying value of the conversion option and loan host
compared to the fair value of the common stock issued to convert
the note.
During the three month period ended February 28, 2017, we
recognized a loss of $905,000 for the aggregate increase in fair
value of conversion options embedded in convertible notes. The
embedded conversion feature in certain notes was separately
measured at fair value with subsequent changes in fair value
recognized in current operations. We use a binomial valuation
model, with fourteen steps of the binomial tree, to estimate the
fair value of the embedded conversion options.
Net loss
In the three months ended February 28, 2018 and 2017, we incurred
net losses of approximately $2.2 million and $3.5 million,
respectively. Our management expects to continue to incur net
losses for the foreseeable future, due to our need to continue to
establish a broader pipeline of assets, expenditure on R&D and
implement other aspects of our business plan.
Liquidity and Capital Resources
We prepared the accompanying condensed consolidated financial
statements assuming that we will continue as a going concern, which
contemplates the realization of assets and liquidation of
liabilities in the normal course of business.
We have not yet established an ongoing source of revenues
sufficient to cover our operating costs and allow us to continue as
a going concern. We had approximately $4.2 million in cash as of
February 28, 2018. Our ability to continue as a going concern
depends on the ability to obtain adequate capital to fund operating
losses until we generate adequate cash flows from operations to
fund our operating costs and obligations. If we are unable to
obtain adequate capital, we could be forced to cease
operations.
We depend upon our ability, and will continue to attempt, to secure
equity and/or debt financing. We cannot be certain that additional
funding will be available on acceptable terms, or at all. Our
management has determined that there is substantial doubt about our
ability to continue as a going concern within one year after the
condensed consolidated financial statements are
issued.
The accompanying condensed consolidated financial statements do not
include any adjustments relating to the recoverability and
classification of recorded asset amounts or amounts and
classification of liabilities that might result from this
uncertainty.
Cash Flows
The following table sets forth the significant sources and uses of
cash for the periods addressed in this report:
|
For the three months ended February 28,
|
|
|
2018
|
2017
|
|
|
|
Net
cash (used in) provided by:
|
|
|
Operating
activities
|
$(1,583,025)
|
$(1,225,443)
|
Financing
activities
|
4,945,251
|
70,000
|
Net
(decrease) increase in cash
|
$3,362,226
|
$(1,155,443)
|
|
|
|
Net cash used in operating activities was approximately $1.6
million for the three months ended February 28, 2018 as compared to
approximately $1.2 million for the three months ended February 28,
2017. The increase in net cash used in operating
activities relates to the net loss of approximately $2.2 million
for the three months ended February 28, 2018, partially offset by
aggregate non-cash expenses of approximately
$492,000. The net cash used in operating activities of
approximately $1.2 million for the three months ended February 28,
2017 results from the net loss of approximately $3.5 million,
partially offset by aggregate non-cash expenses of approximately
$2.3 million.
Net cash provided by financing activities was approximately $4.9
million for the three months ended February 28, 2018, resulting
from proceeds received from the issuance of common stock and
warrants of approximately $5.4 million, offset by offering costs of
approximately $0.5 million. Net cash provided by
financing activities was $70,000 for the three months ended
February 28, 2017, resulting from proceeds received the exercise of
warrants.
12
Commitments and Contingencies
Legal
We are not currently involved in any legal matters arising in the
normal course of business. From time to time, we could become
involved in disputes and various litigation matters that arise in
the normal course of business. These may include disputes and
lawsuits related to intellectual property, licensing, contract law
and employee relations matters. Periodically, we review the
status of significant matters, if any exist, and assesses its
potential financial exposure. If the potential loss from any claim
or legal claim is considered probable and the amount can be
estimated, we accrue a liability for the estimated loss.
Legal proceedings are subject to uncertainties, and the outcomes
are difficult to predict. Because of such uncertainties,
accruals are based on the best information available at the
time. As additional information becomes available, we
reassess the potential liability related to pending claims and
litigation.
Advisory Agreements
We entered into customary consulting arrangements with various
counterparties to provide consulting services, business development
and investor relations services, pursuant to which we agreed to
issue shares of common stock as services are received.
The Company issued an aggregate of approximately 4,500 shares of
common stock during the three months ended February 28,
2018.
Lease Agreement
In December 2016, the Subsidiary entered into a lease agreement for
its office space located in Cayman Islands for $30,000 per
annum. The initial term of the agreement ends in December
2019 and can be renewed for another three years.
Rent expenses was classified within general and administrative
expenses and was approximately $7,500 and $5,000 for the three
months ended February 28, 2018 and 2017, respectively.
License Agreement
Mannin
On October 29, 2015, we entered into a Patent and Technology
License and Purchase Option Agreement (“Exclusive
License”) with a vendor whereby we were granted a worldwide,
exclusive, license on, and option to, acquire certain intellectual
property (“Mannin IP”) which initially focused on
developing a first-in-class eye drop treatment for glaucoma within
the four-year term of the Exclusive
License.
During the three months ended February 28, 2018 and 2017, we
incurred approximately $619,000 and $421,000, respectively, in
research and development expenses to fund the costs of development
of the eye drop treatment for glaucoma pursuant to the Exclusive
License. Through February 28, 2018, we had funded an
aggregate of $3.0 million to Mannin under the Exclusive
License.
Bio-Nucleonics
On September 6, 2016, we entered into the Patent and Technology
License and Purchase Option Agreement (the “BNI Exclusive
License”) with Bio-Nucleonics Inc. (“BNI”)
whereby we were granted a worldwide, exclusive, perpetual, license
on, and option to, acquire certain BNI intellectual property
(“BNI IP”) within the three-year term of the BNI
Exclusive License.
During the three months ended February 28, 2018 and 2017, we
incurred approximately $112,000 and $143,000, respectively, in
research and development expenses pursuant to the BNI Exclusive
License. As of February 28, 2018, we had paid approximately
$578,000 to BNI out of the maximum $850,000 cash funding
requirement.
Asdera
On April 21, 2017, we entered into a License Agreement on Patent
& Know-How Technology (“Asdera License”) with
Asdera LLC (“Asdera”) whereby we were granted a
worldwide, exclusive, license on certain Asdera intellectual
property (“Asdera IP”). The initial cost to acquire the
Asdera License is $50,000 and the issuance of 125,000 shares of our
common stock, with a fair value of $487,500, of which we had fully
paid and issued as of November 30, 2017 and recorded in research
and development expenses in the accompanying Consolidated
Statements of Operations. In addition to royalties based upon net
sales of the product candidate, if any, we are required to make
certain additional payments upon additional
milestones.
Subject to the terms of the Agreement, we will be in control of the
development and commercialization of the product candidate and are
responsible for the costs of such development and
commercialization. We have undertaken a good-faith commitment
to (i) initiate a Phase II/III clinical trial at the earlier of the
two-year anniversary of the agreement or one year from the
FDA’s approval of the IND and (ii) to make the first
commercial sale by the fifth-anniversary of the agreement.
Failure to show a good-faith effort to meet those goals would mean
that the Asdera IP would revert to Asdera. Upon such
reversion, Asdera would be obligated to pay us royalties on any
sales of products derived from the Asdera IP until such time that
Asdera has paid us twice the sum that we had provided Asdera prior
to the reversion.
13
OMRF
OMRF License Agreement
On June 15, 2017, we entered into a Technology License Agreement
(“OMRF License Agreement”) with the Rajiv Gandhi Centre
for Biotechnology, an autonomous research institute under the
Government of India (“RGCB”), and the Oklahoma Medical
Research Foundation (“OMRF” and together with RGCB, the
“Licensors”), whereby the Licensors granted the Company
a worldwide, exclusive, license on intellectual property related to
Uttroside B (the “Uttroside B IP”). Uttroside B
is a chemical compound derived from the plant Solanum nigrum
Linn, also known as Black Nightshade or Makoi. The Company
seeks to use the Uttroside B IP to create a chemotherapeutic
agent against liver cancer.
The initial cost to acquire the OMRF License Agreement is $10,000,
which will be payable upon reaching certain agreed
conditions. In addition to royalties based upon net sales of
the product candidate, if any, we are required to make additional
payments upon additional milestones.
Subject to the terms of the Agreement, we will be in control of the
development and commercialization of the product candidate and are
responsible for the costs of such development and
commercialization. We have undertaken a good-faith commitment
to (i) fund the Pre-Clinical Trials and (ii) to initiate a Phase II
clinical trial within six years of the date of the Agreement.
Failure to show a good-faith effort to meet those goals would mean
that the RGCB License Agreement would revert to the
Licensors.
No milestones have been reached to date on these license
agreements.
Related Party Transactions
We entered into consulting agreements with certain management
personnel and stockholders for consulting and legal
services. Consulting and legal expenses resulting from
such agreements were approximately $60,000 and $105,000 for the
three months ended February 28, 2018 and 2017, respectively, and
were included within general and administrative expenses in the
accompanying Consolidated Statements of Operations.
Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements.
Item 3. Quantitative and Qualitative Disclosure About Market
Risk
This item is not applicable as we are currently considered a
smaller reporting company.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Our Principal Executive Officer and Chief Financial Officer
evaluated the effectiveness of our disclosure controls and
procedures (as defined in Rule 13a-15(e) under the Exchange Act) as
of the period covered by this Report. Based on that evaluation, it
was concluded that our disclosure controls and procedures are not
effective to reasonably assure that information we are required to
disclose in the reports that we file or submit under the Exchange
Act is recorded, processed, summarized, and reported within the
time periods specified in the SEC’s rules and forms, and that
such information is accumulated and communicated to our management,
including our principal executive and principal financial officer,
or persons performing similar functions, as appropriate to allow
timely decisions regarding required disclosure.
We do not have an Audit Committee; our board of directors currently
acts as our Audit Committee. We do not have an
independent director, and none of our directors is considered a
“Financial Expert,” within the meaning of Section 407
of the Sarbanes-Oxley Act. We have interviewed several potential
independent directors, but have not engaged any.
Changes in internal controls over financial reporting
There were no changes in our internal controls over financial
reporting that occurred during the period covered by this report,
which has materially affected, or is reasonably likely to
materially affect, our internal controls over financial reporting.
We have engaged accounting and compliance consultants to review our
internal controls over financial reporting and other compliance
requirements.
Limitations on Effectiveness of Controls and
Procedures
In designing and evaluating the disclosure controls and procedures,
management recognizes that any controls and procedures, no matter
how well designed and operated, can provide only reasonable
assurance of achieving the desired control objectives. In addition,
the design of disclosure controls and procedures must reflect the
fact that there are resource constraints and that management is
required to apply its judgment in evaluating the benefits of
possible controls and procedures relative to their
costs.
14
PART II – OTHER INFORMATION
Item 1. Legal Proceedings
We are not a party to any material legal proceedings.
Item 1A. Risk Factors
As a Smaller Reporting Company, we are not required to provide this
information.
Item 2. Unregistered Sales of Equity Securities and Use of
Proceeds
On March 1, 2018, we issued 27,000 shares to a third-party service
provider in exchange for services. Such issuance was exempt from
registration under the Securities Act pursuant to Section 4(a)(2)
of the Securities Act regarding transactions not involving a public
offering.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
None.
Item 6. Exhibits
Exhibit Number
|
Name and/or Identification of Exhibit
|
|
|
31.1
|
Rule
13a-14(a)/15d-14(a) Certifications
|
|
|
32.1
|
Certification
under Section 906 of the Sarbanes-Oxley Act (18 U.S.C. Section
1350)
|
|
|
101
|
Interactive
Data File
|
|
|
101.INS
|
XBRL
Instance Document
|
101.SCH
|
XBRL
Taxonomy Extension Schema Document
|
101.CAL
|
XBRL
Taxonomy Extension Calculation Linkbase Document
|
101.DEF
|
XBRL
Taxonomy Extension Definition Linkbase Document
|
101.LAB
|
XBRL
Taxonomy Extension Label Linkbase Document
|
101.PRE
|
XBRL
Taxonomy Extension Presentation Linkbase Document
|
15
SIGNATURES
Pursuant
to the requirements of the Exchange Act of 1934, the Registrant has
duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
|
Q BIOMED INC.
|
|
|
|
|
April 16, 2018
|
By:
|
/s/ Denis Corin
|
|
|
Denis Corin
|
|
|
President, Chief Executive Officer, Acting Principal Accounting
Officer, Principal Financial Officer
|
16