UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO |
Commission File Number
(Exact name of Registrant as specified in its Charter)
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) |
(Address of principal executive offices) |
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Registrant’s telephone number, including area code: (
Securities registered pursuant to Section 12(b) of the Act:
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(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.
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).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, 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 |
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Accelerated filer |
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Smaller reporting company |
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Emerging growth company |
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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
As of July 24, 2023, the registrant had
Table of Contents
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PART I |
4 |
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Item 1. |
4 |
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4 |
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Condensed Consolidated Statements of Operations and Comprehensive Loss |
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6 |
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7 |
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8 |
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Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
15 |
Item 3. |
22 |
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Item 4. |
22 |
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PART II |
23 |
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Item 1. |
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Item 1A. |
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Item 2. |
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Item 3. |
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Item 4. |
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Item 5. |
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Item 6. |
26 |
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27 |
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains forward-looking statements about us and our industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this Quarterly Report on Form 10-Q, including statements regarding our future results of operations or financial condition, business strategy and plans and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will” or “would” or the negative of these words or other similar terms or expressions. These forward-looking statements include, but are not limited to, statements concerning the following:
You should not rely on forward-looking statements as predictions of future events. We have based the forward-looking statements contained in this Quarterly Report on Form 10-Q (this "Quarterly Report") primarily on our current expectations and projections about future events and trends that we believe may affect our business, financial condition and operating results. The outcome of the events described in these forward-looking statements is subject to risks, uncertainties and other factors described in the section titled “Risk Factors” previously disclosed in Part I, Item 1A. in our Annual Report on Form 10-K, as filed with the SEC on March 9, 2023 (the “2022 Annual Report”) and in Part II, Item 1A in this Quarterly Report. Moreover, we operate in a very competitive and rapidly changing environment. New risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this Quarterly Report. The results, events and circumstances reflected in the forward-looking statements may not be achieved or occur, and actual results, events or circumstances could differ materially from those described in the forward-looking statements.
In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based on information available to us as of the date of this Quarterly Report. And while we believe that information provides a reasonable basis for these statements, that information may be limited or incomplete. Our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all relevant information. These statements are inherently uncertain, and investors are cautioned not to unduly rely on these statements.
The forward-looking statements made in this Quarterly Report relate only to events as of the date on which the statements are made. We undertake no obligation to update any forward-looking statements made in this Quarterly Report to reflect events or circumstances after the date of this Quarterly Report or to reflect new information or the occurrence of unanticipated events, except as required by law. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments.
We may announce material business and financial information to our investors using our investor relations website (https://mindmed.co/investor-resources/). We therefore encourage investors and others interested in our company to review the information that we make available on our website. Our website and information included in or linked to our website are not part of this Quarterly Report.
PART I—FINANCIAL INFORMATION
Item 1. Financial Statements.
Mind Medicine (MindMed) Inc.
Condensed Consolidated Balance Sheets
(In thousands, except share amounts)
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June 30, 2023 |
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December 31, 2022 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
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$ |
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Prepaid and other current assets |
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Total current assets |
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Goodwill |
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Intangible assets, net |
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Other non-current assets |
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Total assets |
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$ |
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$ |
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Liabilities and Shareholders’ Equity |
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Current liabilities: |
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Accounts payable |
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$ |
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$ |
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Accrued expenses |
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2022 USD Financing Warrants |
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Total current liabilities |
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Other liabilities, long-term |
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Total liabilities |
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Commitments and contingencies (Note 9) |
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Shareholders' Equity: |
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Common shares, |
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— |
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— |
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Additional paid-in capital |
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Accumulated other comprehensive income |
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Accumulated deficit |
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( |
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( |
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Total shareholders' equity |
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Total liabilities and shareholders' equity |
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$ |
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$ |
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See accompanying notes to unaudited condensed consolidated financial statements.
4
Mind Medicine (MindMed) Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited; in thousands, except share and per share amounts)
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Three Months |
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Six Months |
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2023 |
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2022 |
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2023 |
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2022 |
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Operating expenses: |
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Research and development |
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$ |
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$ |
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$ |
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$ |
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General and administrative |
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Total operating expenses |
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Loss from operations |
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( |
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( |
) |
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( |
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( |
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Other income/(expense): |
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Interest income, net |
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Foreign exchange gain/(loss), net |
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( |
) |
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( |
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Change in fair value of 2022 USD Financing Warrants |
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( |
) |
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— |
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( |
) |
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— |
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Other income/(expense) |
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— |
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( |
) |
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— |
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Total other income/(expense), net |
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( |
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( |
) |
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Net loss |
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( |
) |
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( |
) |
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( |
) |
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( |
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Other comprehensive loss |
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Loss on foreign currency translation |
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( |
) |
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( |
) |
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( |
) |
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( |
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Comprehensive loss |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
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$ |
( |
) |
Net loss per common share, basic and diluted |
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$ |
( |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
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Weighted-average common shares, basic and diluted |
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See accompanying notes to unaudited condensed consolidated financial statements.
5
Mind Medicine (MindMed) Inc.
(Unaudited; in thousands, except share amounts)
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Common Shares |
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Shares |
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Amount |
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Additional Paid-In Capital |
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Accumulated OCI |
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Accumulated Deficit |
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Total |
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Balance, December 31, 2022 |
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— |
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( |
) |
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Issuance of common shares, net of share issuance costs |
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— |
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Vesting of restricted share units |
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— |
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— |
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— |
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— |
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— |
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Stock-based compensation expense |
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— |
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— |
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— |
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— |
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Net loss and comprehensive loss |
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— |
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— |
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— |
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( |
) |
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( |
) |
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( |
) |
Balance, June 30, 2023 |
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— |
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( |
) |
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Balance, December 31, 2021 |
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— |
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( |
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Exercise of warrants |
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— |
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— |
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— |
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Exercise of stock options |
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— |
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— |
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— |
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Settlement of restricted share unit awards |
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— |
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— |
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— |
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— |
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— |
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Withholding taxes paid on vested restricted share units |
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— |
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— |
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( |
) |
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— |
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— |
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( |
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Stock-based compensation expense |
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— |
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— |
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— |
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— |
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Net loss and comprehensive loss |
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— |
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— |
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— |
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( |
) |
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( |
) |
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( |
) |
Balance, June 30, 2022 |
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$ |
— |
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$ |
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$ |
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$ |
( |
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$ |
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Common Shares |
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Shares |
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Amount |
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Additional Paid-In Capital |
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Accumulated OCI |
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Accumulated Deficit |
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Total |
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Balance, March 31, 2023 |
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— |
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( |
) |
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Issuance of common shares, net of share issuance costs |
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— |
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— |
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— |
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Vesting of restricted share units |
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— |
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— |
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— |
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— |
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— |
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Stock-based compensation expense |
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— |
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— |
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— |
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— |
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Net loss and comprehensive loss |
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— |
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— |
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— |
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( |
) |
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( |
) |
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( |
) |
Balance June 30, 2023 |
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— |
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( |
) |
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Balance, March 31, 2022 |
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— |
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( |
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Exercise of warrants |
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— |
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— |
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— |
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Exercise of stock options |
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— |
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— |
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— |
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Settlement of restricted share unit awards |
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— |
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— |
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— |
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— |
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— |
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Stock-based compensation expense |
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— |
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— |
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— |
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— |
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Net loss and comprehensive loss |
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— |
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— |
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— |
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( |
) |
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( |
) |
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( |
) |
Balance, June 30, 2022 |
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$ |
— |
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$ |
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$ |
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$ |
( |
) |
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$ |
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See accompanying notes to unaudited condensed consolidated financial statements.
6
Mind Medicine (MindMed) Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited; in thousands)
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Six Months |
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2023 |
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2022 |
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Cash flows from operating activities |
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Net loss |
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$ |
( |
) |
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$ |
( |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
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Stock-based compensation |
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Amortization of intangible assets |
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Unrealized foreign exchange gain |
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( |
) |
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— |
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Non-cash lease expense |
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Change in fair value of 2022 USD Financing Warrants |
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— |
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Changes in operating assets and liabilities: |
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Prepaid and other current assets |
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Other noncurrent assets |
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— |
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Accounts payable |
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( |
) |
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Accrued expenses |
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Other liabilities, long-term |
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( |
) |
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( |
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Net cash used in operating activities |
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( |
) |
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( |
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Cash flows from financing activities |
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Proceeds from issuance of common shares, net of issuance costs |
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— |
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Proceeds from exercise of warrants |
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— |
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Proceeds from exercise of options |
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— |
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Withholding taxes paid on vested restricted share units |
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— |
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( |
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Net cash provided by financing activities |
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Effect of exchange rate changes on cash |
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( |
) |
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Net decrease in cash and cash equivalents |
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( |
) |
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( |
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Cash and cash equivalents, beginning of year |
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Cash and cash equivalents, end of year |
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$ |
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$ |
|
See accompanying notes to unaudited condensed consolidated financial statements.
7
Mind Medicine (MindMed) Inc.
Notes to Unaudited Condensed Consolidated Financial Statements
(In thousands, except share and per share amounts)
Mind Medicine (MindMed) Inc. (the “Company” or “MindMed”) is incorporated under the laws of the Province of British Columbia. Its wholly owned subsidiaries, Mind Medicine, Inc. (“MindMed US”), HealthMode, Inc., MindMed Pty Ltd., and MindMed GmbH are incorporated in Delaware, Delaware, Australia and Switzerland respectively. MindMed US was incorporated on May 30, 2019.
MindMed is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. The Company’s mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. The Company is developing a pipeline of innovative product candidates, with and without acute perceptual effects, targeting neurotransmitter pathways that play key roles in brain health disorders. This specifically includes pharmaceutically optimized product candidates derived from the psychedelic and empathogen drug classes, including MM-120 and MM-402, the Company’s lead product candidates.
As of June 30, 2023, the Company had an accumulated deficit of $
As the Company continues its expansion, it may seek additional financing and/or strategic investments; however, there can be no assurance that any additional financing or strategic investments will be available to the Company on acceptable terms, if at all. If events or circumstances occur such that the Company does not obtain additional funding, it will most likely be required to reduce its plans and/or certain discretionary spending, which could have a material adverse effect on the Company’s ability to achieve its intended business objectives. The accompanying condensed consolidated financial statements do not include any adjustments that might be necessary if it were unable to continue as a going concern. Management believes that it has sufficient working capital on hand to fund operations through at least the next twelve months from the date of the issuance of these financial statements.
Emerging Growth Company Status
The Company is an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”). Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies. The Company has elected to use the extended transition period for complying with new or revised accounting standards, and as a result of this election, the condensed consolidated financial statements may not be comparable to companies that comply with public company Financial Accounting Standards Board standards’ effective dates. The Company may take advantage of these exemptions up until the last day of the fiscal year following the fifth anniversary of an initial public offering or such earlier time that it is no longer an EGC.
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the audited financial statements and the related notes thereto for the year ended December 31, 2022, which are included in the Company’s 2022 Annual Report on Form 10-K filed with the SEC on March 9, 2023 (the “2022 Annual Report”). The Company’s significant accounting policies are disclosed in the audited financial statements for the periods ended December 31, 2022 and 2021, included in the 2022 Annual Report. Since the date of those financial statements, there have been no changes to its significant accounting policies.
The accompanying condensed consolidated financial statements have been prepared in conformity with generally accepted accounting principles in the United States of America (“U.S. GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative U.S. GAAP as found in the Accounting Standards Codification and as amended by Accounting Standards Updates of the Financial Accounting Standards Board (“FASB”).
The preparation of financial statements in conformity with U.S. GAAP requires management to make a number of estimates and assumptions relating to the reporting of assets and liabilities and the disclosure of contingent assets and liabilities at the dates of the
8
financial statements and the reported amounts of expenses during the reporting periods. Actual results could differ from those estimates under different assumptions or conditions.
Intercompany balances and transactions, and any unrealized income and expenses arising from intercompany transactions, are eliminated in preparing the condensed consolidated financial statements.
The Company’s Board of Directors approved a reverse share split of the Company’s common shares, no par value per share (the “Common Shares”) on a 15-for-1 basis, which was effected on August 26, 2022 and which brought the bid price of the Company’s Common Shares above the minimum bid price requirement under the Nasdaq Listing Rules ("2022 Share Split"). No fractional Common Shares were issued as a result of the 2022 Share Split. Each fractional Common Share remaining upon the 2022 Share Split that was less than 1/2 of a Common Share was cancelled and each fractional Common Share that was at least 1/2 of a Common Share was changed to one whole Common Share. The 2022 Share Split affected all Common Shares outstanding immediately prior to the effective time of the 2022 Share Split, as well as the number of Common Shares available under the Company’s stock option plan and equity incentive plan. In addition, the 2022 Share Split effected a reduction in the number of Common Shares issuable upon exercise of stock options, vesting of restricted share units and exercise of warrants outstanding immediately prior to the effectiveness of the 2022 Share Split. All references to Common Shares, options to purchase Common Shares, share data, per share data, and related information in the accompanying unaudited condensed consolidated financial statements have been retrospectively adjusted to reflect the effect of the 2022 Share Split for all periods presented.
Foreign Currency
The Company’s reporting currency is the U.S. dollar. The Company's functional currency is the Canadian dollar (“CAD”). The local currency of the Company’s foreign affiliates is generally their functional currency. Accordingly, the assets and liabilities of the foreign affiliates and the parent entity are translated from their respective functional currency to U.S. dollars using fiscal year-end exchange rates, income and expense accounts are translated at the average rates in effect during the fiscal year and equity accounts are translated at historical rates. Transactions denominated in currencies other than the functional currency are remeasured to the functional currency at the exchange rate on the transaction date. Monetary assets and liabilities denominated in currencies other than the functional currency are remeasured at period-end using the period-end exchange rate.
Cash and Cash Equivalents
The Company considers all investments with an original maturity date at the time of purchase of three months or less to be cash and cash equivalents. As of June 30, 2023, the Company’s cash equivalents consisted of U.S. government money market funds at a high-credit quality and federally insured financial institution. The Company’s accounts, at times, may exceed federally insured limits. The Company had cash equivalents of $
Recent Accounting Pronouncements
From time to time, new accounting pronouncements are issued by FASB or other standard setting bodies and adopted by the Company as of the specified effective date. Unless otherwise discussed, the impact of recently issued standards that are not yet effective will not have a material impact on the Company’s financial position, results of operations, or cash flows upon adoption.
9
The following table presents information about the Company’s assets and liabilities measured at fair value on a recurring basis as of June 30, 2023 and December 31, 2022, and the fair value hierarchy of the valuation techniques utilized. The Company classifies its assets and liabilities as either short- or long-term based on maturity and anticipated realization dates.
|
|
June 30, 2023 |
|
|||||||||||||
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
||||
Financial assets: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cash equivalents |
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||
Financial liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Directors' Deferred Share Unit Liability |
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||
2022 USD Financing Warrant Liability |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
|
$ |
|
||
|
|
December 31, 2022 |
|
|||||||||||||
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
||||
Financial assets: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cash equivalents |
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||
Financial liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Directors' Deferred Share Unit Liability |
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||
2022 USD Financing Warrant Liability |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
|
$ |
|
The Company evaluates transfers between fair value levels at the end of each reporting period. There were
The fair value of the warrant liability is measured at fair value on a recurring basis. The warrants to purchase
|
|
As of June 30, 2023 |
|
As of December 31, 2022 |
Share price |
|
$ |
|
$ |
Expected volatility |
|
|
||
Risk-free rate |
|
|
||
Expected life |
|
|
Goodwill
During the six months ended June 30, 2023, the Company made
Intangible assets, net
The following table summarizes the carrying value of the Company's intangible assets (in thousands):
|
|
|
|
|
|
As of June 30, 2023 |
|
||||||
|
Useful Lives |
|
Gross Carrying |
|
|
Accumulated |
|
|
Net Carrying |
|
|||
Developed technology |
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
Total intangible assets, net |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
||
|
|
|
|
|
|
|
|
|
|
|
|||
|
|
|
|
|
|
As of December 31, 2022 |
|
||||||
|
Useful Lives |
|
Gross Carrying |
|
|
Accumulated |
|
|
Net Carrying |
|
|||
Developed technology |
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
Total intangible assets, net |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
10
As of June 30, 2023, developed technology has a remaining useful life of
At June 30, 2023 and December 31, 2022, accrued expenses consisted of the following (in thousands):
|
|
June 30, |
|
|
December 31, |
|
||
Accrued clinical and manufacturing costs |
|
$ |
|
|
$ |
|
||
Accrued compensation |
|
|
|
|
|
|
||
Professional services |
|
|
|
|
|
|
||
Contribution payable |
|
|
|
|
|
|
||
Other payables |
|
|
|
|
|
— |
|
|
Lease liabilities |
|
|
|
|
|
|
||
Total accrued expenses |
|
$ |
|
|
$ |
|
As of June 30, 2023, the Company included $
Common Shares
The Company is authorized to issue an unlimited number of Common Shares, which have
At-The-Market Facility
The Company may issue and sell Common Shares under an at-the-market offering program (the “ATM”). Pursuant to the ATM, the Company will pay the Sales Agents a commission rate equal to
Bought Deal Compensation and Financing Warrants
There was no activity associated with the Company's outstanding equity classified as bought-deal compensation and financing warrants for the six months ended June 30, 2023.
2022 USD Financing Warrants
On September 30, 2022, the Company closed an underwritten public offering of
There was no activity associated with the Company's outstanding liability classified as 2022 USD Financing Warrants for the six months ended June 30, 2023.
11
The 2022 USD Financing Warrants are liability classified due to being denominated in USD and not the Company's functional currency. Accordingly, the 2022 USD Financing Warrants are recognized at fair value upon issuance and are adjusted to fair value at the end of each reporting period.
|
|
As of June 30, 2023 |
|
|
Balance at December 31, 2022 |
|
$ |
|
|
Change in fair value of the warrant liability |
|
|
|
|
Balance at June 30, 2023 |
|
$ |
|
Stock Incentive Plan
Effective March 7, 2023, the Company amended the definition of "Market Value" under both the MindMed Stock Option Plan (the “Plan”) and the Performance and Restricted Share Unit Plan (the “RSU Plan”) to be based upon the closing price of the Company's Common Shares as traded on the Nasdaq Stock Market (the “Amendments”). This change is only applicable for equity compensation awards granted subsequent to the Amendments. Accordingly, stock options granted after March 7, 2023 ("USD options") are denominated in USD, and the grant date fair value of restricted share units granted after March 7, 2023 ("USD RSUs") is denominated in USD. The fair value of both USD options and USD RSUs is based upon the closing price of the Company's Common Shares as traded on the Nasdaq Stock Exchange.
2020 Plan
On February 27, 2020, the Company adopted the Plan to advance the interests of the Company by providing employees, contractors and directors of the Company a performance incentive for continued and improved service with the Company. The Plan sets out the framework for determining eligibility as well as the terms of any stock-based compensation granted.
The following table summarizes the Company’s stock option activity (excluding
|
|
Number of Options |
|
|
Weighted Average Exercise Price (CAD$) |
|
|
Weighted Average Remaining Contractual Life (Years) |
|
|
Aggregate Intrinsic |
|
||||
Options outstanding at December 31, 2022 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Issued |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Exercised |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Forfeited |
|
|
( |
) |
|
$ |
|
|
|
— |
|
|
|
— |
|
|
Expired |
|
|
( |
) |
|
$ |
|
|
|
— |
|
|
|
— |
|
|
Options outstanding at June 30, 2023 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Options vested and exercisable at June 30, 2023 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
The expense recognized related to options was $
12
Restricted Share Units
The Company adopted the RSU Plan to advance the interests of the Company by providing employees, contractors and directors of the Company a performance incentive for continued and improved service with the Company. The RSU Plan sets out the framework for determining eligibility as well as the terms of any stock-based compensation granted. The RSU Plan was approved by the shareholders as part of the Arrangement. The fair value has been estimated based on the closing price of the Common Shares on the day prior to the grant.
|
|
|
|
|
(CAD$) |
|
|
(USD$) |
|
|||||||||
|
|
Number of RSUs |
|
|
Number of RSUs |
|
Weighted Average Grant Date Fair Value |
|
|
Number of RSUs |
|
Weighted Average Grant Date Fair Value |
|
|||||
Balance at December 31, 2022 |
|
|
|
|
|
|
$ |
|
|
|
— |
|
|
— |
|
|||
Granted |
|
|
|
|
|
— |
|
|
— |
|
|
|
|
$ |
|
|||
Vested and unissued |
|
|
( |
) |
|
|
( |
) |
$ |
|
|
|
( |
) |
$ |
|
||
Cancelled |
|
|
( |
) |
|
|
( |
) |
$ |
|
|
|
— |
|
|
— |
|
|
Balance at June 30, 2023 |
|
|
|
|
|
|
$ |
|
|
|
|
$ |
|
The expense recognized related to restricted share units was $
Directors' Deferred Share Unit Plan
2021 Plan
On April 16, 2021 the Company adopted the MindMed Director's Deferred Share Unit Plan (the "DDSU Plan"). The DDSU Plan sets out a framework to grant non-executive directors DDSU's which are cash settled awards. Effective June 8, 2023, the Company amended the definition of “Fair Market Value” under the Company’s Directors’ Deferred Share Unit Plan to be based upon the closing price of the Company’s Common Shares as traded on the Nasdaq Stock Market. This change is only applicable for Directors Deferred Share Units (“DDSUs”) granted subsequent to June 8, 2023. Accordingly, DDSUs granted after June 8, 2023 are denominated in USD. The DDSU Plan states that the fair market value of one DDSU shall be equal to the volume weighted average trading price of a Common Share on the Nasdaq Stock Market for the five business days immediately preceding the valuation date. The DDSU's generally vest ratably over twelve months after grant and are settled within 90 days of the date the director ceases service to the Company.
For the three and six months ended June 30, 2023, stock-based compensation expense of a nominal amount was recognized relating to the revaluation of the vested DDSUs, recorded in general and administrative expense in the accompanying condensed consolidated statements of operations and comprehensive loss. There were
Stock-based Compensation Expense
Stock-based compensation expense for all equity arrangements for the three and six months ended June 30, 2023 and 2022 was as follows (in thousands):
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
||||
Research and development |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
General and administrative |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total share-based compensation expense |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
As of June 30, 2023, there was approximately $
13
As of June 30, 2023, the Company had obligations to make future payments, representing significant research and development contracts and other commitments that are known and committed in the amount of approximately $
The Company enters into research, development and license agreements in the ordinary course of business where the Company receives research services and rights to proprietary technologies. Milestone and royalty payments that may become due under various agreements are dependent on, among other factors, clinical trials, regulatory approvals and ultimately the successful development of a new drug, the outcome and timing of which are uncertain.
The Company periodically enters into research and license agreements with third parties that include indemnification provisions customary in the industry. These guarantees generally require the Company to compensate the other party for certain damages and costs incurred as a result of claims arising from research and development activities undertaken by or on behalf of the Company. In some cases, the maximum potential amount of future payments that could be required under these indemnification provisions could be unlimited. These indemnification provisions generally survive termination of the underlying agreement. The nature of the indemnification obligations prevents the Company from making a reasonable estimate of the maximum potential amount it could be required to pay. Historically, the Company has not made any indemnification payments under such agreements and no amount has been accrued in the condensed consolidated financial statements with respect to these indemnification obligations.
14
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The following discussion should be read in conjunction with the unaudited condensed consolidated financial statements and notes thereto included elsewhere in this Quarterly Report. This Quarterly Report, including the following sections, contains forward-looking statements. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those expressed or implied by such forward-looking statements. For a detailed discussion of these risks and uncertainties, see Item 1A “Risk Factors” in our 2022 Annual Report and this Quarterly Report. See also “Special Note Regarding Forward-Looking Statements.” We caution the reader not to place undue reliance on these forward-looking statements, which reflect management’s analysis only as of the date of this Quarterly Report. We undertake no obligation to update forward-looking statements, which reflect events or circumstances occurring after the date of this Quarterly Report.
Our U.S. GAAP accounting policies are referred to in Note 2 of the Condensed Consolidated Financial Statements in this Quarterly Report as well as the Consolidated Financial Statements included in our 2022 Annual Report. All amounts are in United States dollars, unless otherwise indicated. References to “CAD$” are to Canadian dollars.
Overview
We are a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative product candidates, with and without acute perceptual effects, targeting neurotransmitter pathways that play key roles in brain health disorders. This specifically includes pharmaceutically optimized product candidates derived from the psychedelic and empathogen drug classes, including MM-120 and MM-402, our lead product candidates.
We were incorporated under the laws of the Province of British Columbia. Our wholly owned subsidiary, Mind Medicine, Inc. (“MindMed US”) was incorporated in Delaware. Prior to February 27, 2020, our operations were conducted through MindMed US.
On February 26, 2021, we acquired 100% of the issued and outstanding shares of HealthMode Inc. (“HealthMode”), a digital medicine and therapeutics company that used artificial intelligence enabled digital measurement to increase the precision and speed of clinical research and patient monitoring. The acquisition enabled us to build our digital medicine division. We plan to utilize these technologies in our clinical trials to enhance the quality of the data that is collected during our clinical trials.
Since inception, we have incurred losses while advancing the research and development of our products and processes. Our net losses were $29.1 million and $17.0 million for the three months ended June 30, 2023 and 2022, respectively, and $53.9 million and $35.4 million for the six months ended June 30, 2023 and 2022, respectively. As of June 30, 2023, we had an accumulated deficit of $248.4 million and cash and cash equivalents of $116.9 million.
During the six months ended June 30, 2023, we continued to enhance the resources it requires to build our pipeline of opportunities. This included adding personnel and contract resources and ramping up the nonclinical aspects of our activities. In addition, considerable effort was directed towards employing a successful financing strategy.
Research & Development Updates
In April 2023, our collaborators at the University Hospital Basel released positive topline data from a double-blind, investigator-initiated trial evaluating lysergide in the treatment of major depressive disorder (“MDD”). The topline data demonstrated significant, rapid, durable and beneficial effects of lysergide and its potential to mitigate symptoms of MDD. The high dose lysergide regimen in which patients received 100 µg at their first dosing day and 200 µg at their second dosing day (separated by four weeks) resulted in statistically and clinically significant improvements on the primary endpoint, which was the change in clinician-rated Inventory of Depressive Symptomatology (IDS-C) scores 6 weeks after the first administration as compared to control (whether or not the patient received a second administration). The control group in this study received a lower dose regimen of 25 µg on both treatment days. Patients in the high dose arm (n=28) demonstrated a least square mean change from baseline in IDS-C scores of -12.9 points compared to -3.6 points in the lower dose arm (n=27, p=0.02). The statistically significant benefit as measured by IDS-C was maintained up to 16 weeks after the first administration compared to placebo (p=0.008). Data from the secondary endpoints were also encouraging. The investigational drug was generally well-tolerated, as indicated by reported adverse events, changes in vital signs and laboratory values.
In May 2023, we announced that our Phase 2b study evaluating MM-120 (lysergide D-tartrate) for generalized anxiety disorder (“GAD”) is over 50% enrolled. We plan to enroll a total of up to 200 participants who will receive a single administration of 25 µg, 50 µg, 100 µg or 200 µg of MM-120 or placebo. Topline results are expected to be announced in late 2023.
15
Components of Operating Results
Operating Expenses
Research and Development
To date, our resources have focused primarily on the research and development of our product candidates MM-120, MM-402 and MM-110 (prior to when we paused development of MM-110 in the third quarter of 2022) and the commencement of related clinical activities, including funding data and study acquisitions and acquiring the materials required to supply our studies.
Research and development expenses account for a significant portion of our operating expenses. Research and development expenses consist primarily of direct and indirect costs incurred for the development of our product candidates, as follows:
We may also incur in-process research and development expense as we acquire or in-license assets from other parties. Technology acquisitions are expensed or capitalized based upon the asset achieving technological feasibility in accordance with management’s assessment regarding the ultimate recoverability of the amounts paid and the potential for alternative future use. Acquired in-process research and development costs that have no alternative future use are immediately expensed.
We expect our research and development expenses to increase for the foreseeable future as we continue the clinical development of our product candidates and other preclinical programs in GAD, attention deficit hyperactivity disorder (“ADHD”), autism spectrum disorder (“ASD”) and other potential or future indications, including initiating additional and larger clinical trials.
General and Administrative
General and administrative expenses consist primarily of compensation costs, including stock-based compensation, for executive management and administrative employees, including finance and accounting, legal, human resources and other administrative functions, professional services fees, advisory and professional service fees in connection with financing transactions, insurance expenses and allocated expenses. We also incurred additional costs related to public relations, printing and professional services fees in connection with our proxy contest.
We expect our general and administrative expenses to continue to increase for the foreseeable future as we continue to advance our research and development programs, grow our business and, if any of our product candidates receive marketing approval, commence commercialization activities.
16
Results of Operations
Comparison of the Three and Six Months Ended June 30, 2023 and 2022
The following tables summarize our results of operations for the periods presented (in thousands):
|
|
For the Three Months |
|
|
|
|
|
|
|
|
For the Six Months |
|
|
|
|
|
|
|
||||||||||||||
|
|
2023 |
|
|
2022 |
|
|
$ |
|
|
% |
|
|
2023 |
|
|
2022 |
|
|
$ |
|
|
% |
|
||||||||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
Research and development |
|
$ |
14,777 |
|
|
$ |
9,326 |
|
|
$ |
5,451 |
|
|
|
58 |
% |
|
$ |
27,375 |
|
|
$ |
19,567 |
|
|
$ |
7,808 |
|
|
|
40 |
% |
General and administrative |
|
|
14,407 |
|
|
|
7,617 |
|
|
|
6,790 |
|
|
|
89 |
% |
|
|
22,670 |
|
|
|
15,881 |
|
|
|
6,789 |
|
|
|
43 |
% |
Total operating expenses |
|
|
29,184 |
|
|
|
16,943 |
|
|
|
12,241 |
|
|
|
72 |
% |
|
|
50,045 |
|
|
|
35,448 |
|
|
|
14,597 |
|
|
|
41 |
% |
Loss from operations |
|
|
(29,184 |
) |
|
|
(16,943 |
) |
|
|
(12,241 |
) |
|
|
72 |
% |
|
|
(50,045 |
) |
|
|
(35,448 |
) |
|
|
(14,597 |
) |
|
|
41 |
% |
Other income/(expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
Interest income, net |
|
|
1,311 |
|
|
|
82 |
|
|
|
1,229 |
|
|
* |
|
|
|
2,595 |
|
|
|
83 |
|
|
|
2,512 |
|
|
* |
|
||
Foreign exchange gain/(loss), net |
|
|
247 |
|
|
|
(89 |
) |
|
|
336 |
|
|
* |
|
|
|
195 |
|
|
|
(44 |
) |
|
|
239 |
|
|
* |
|
||
Change in fair value of 2022 USD Financing Warrants |
|
|
(1,504 |
) |
|
|
— |
|
|
|
(1,504 |
) |
|
|
100 |
% |
|
|
(6,690 |
) |
|
|
— |
|
|
|
(6,690 |
) |
|
|
100 |
% |
Other income/(expense) |
|
|
— |
|
|
|
(7 |
) |
|
|
7 |
|
|
|
(100 |
)% |
|
|
— |
|
|
|
1 |
|
|
|
(1 |
) |
|
|
(100 |
)% |
Total other income/(expense), net |
|
|
54 |
|
|
|
(14 |
) |
|
|
68 |
|
|
* |
|
|
|
(3,900 |
) |
|
|
40 |
|
|
|
(3,940 |
) |
|
* |
|
||
Net loss |
|
|
(29,130 |
) |
|
|
(16,957 |
) |
|
|
(12,173 |
) |
|
|
72 |
% |
|
|
(53,945 |
) |
|
|
(35,408 |
) |
|
|
(18,537 |
) |
|
|
52 |
% |
Other comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
Loss on foreign currency translation |
|
|
(279 |
) |
|
|
(147 |
) |
|
|
(132 |
) |
|
|
(90 |
)% |
|
|
(265 |
) |
|
|
(196 |
) |
|
|
(69 |
) |
|
|
(35 |
)% |
Comprehensive loss |
|
$ |
(29,409 |
) |
|
$ |
(17,104 |
) |
|
$ |
(12,305 |
) |
|
|
72 |
% |
|
$ |
(54,210 |
) |
|
$ |
(35,604 |
) |
|
$ |
(18,606 |
) |
|
|
52 |
% |
* Represents a change greater than 300%
Operating Expenses
Research and Development (in thousands):
|
|
For the Three Months |
|
|
|
|
|
|
|
|
For the Six Months |
|
|
|
|
|
|
|
||||||||||||||
|
|
2023 |
|
|
2022 |
|
|
$ |
|
|
% |
|
|
2023 |
|
|
2022 |
|
|
$ |
|
|
% |
|
||||||||
External Costs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
MM-120 program |
|
$ |
6,570 |
|
|
$ |
2,212 |
|
|
$ |
4,358 |
|
|
|
197 |
% |
|
$ |
11,345 |
|
|
$ |
4,074 |
|
|
$ |
7,271 |
|
|
|
178 |
% |
MM-402 program |
|
|
396 |
|
|
|
458 |
|
|
|
(62 |
) |
|
|
(14 |
)% |
|
|
1,393 |
|
|
|
557 |
|
|
|
836 |
|
|
|
150 |
% |
MM-110 program |
|
|
14 |
|
|
|
502 |
|
|
|
(488 |
) |
|
|
(97 |
)% |
|
|
31 |
|
|
|
1,184 |
|
|
|
(1,153 |
) |
|
|
(97 |
)% |
External R&D collaborations |
|
|
283 |
|
|
|
54 |
|
|
|
229 |
|
|
* |
|
|
|
585 |
|
|
|
1,279 |
|
|
|
(694 |
) |
|
|
(54 |
)% |
|
Preclinical and other programs |
|
|
2,251 |
|
|
|
1,412 |
|
|
|
839 |
|
|
|
59 |
% |
|
|
3,581 |
|
|
|
2,821 |
|
|
|
760 |
|
|
|
27 |
% |
Total external costs |
|
|
9,514 |
|
|
|
4,638 |
|
|
|
4,876 |
|
|
|
105 |
% |
|
|
16,935 |
|
|
|
9,915 |
|
|
|
7,020 |
|
|
|
71 |
% |
Internal Costs |
|
|
5,263 |
|
|
|
4,688 |
|
|
|
575 |
|
|
|
12 |
% |
|
|
10,440 |
|
|
|
9,652 |
|
|
|
788 |
|
|
|
8 |
% |
Total research and development expenses |
|
$ |
14,777 |
|
|
$ |
9,326 |
|
|
$ |
5,451 |
|
|
|
58 |
% |
|
$ |
27,375 |
|
|
$ |
19,567 |
|
|
$ |
7,808 |
|
|
|
40 |
% |
* Represents a change greater than 300%
Research and development expenses increased by $5.5 million for the three months ended June 30, 2023 compared to the three months ended June 30, 2022. The increase was primarily due to increases of $4.4 million in expenses related to clinical research and product development for the MM-120 GAD study, $0.8 million in preclinical activities, $0.6 million in internal personnel costs as a result of increasing research and development capacities, and $0.2 million in connection with various external R&D collaborations, partially offset by a decrease of $0.5 million in expenses related to our MM-110 program, and a decrease of $0.1 million related to our MM-402 program.
Research and development expenses increased by $7.8 million for the six months ended June 30, 2023 compared to the six months ended June 30, 2022. The increase was primarily due to increases of $7.3 million in expenses related to clinical research and product development for the MM-120 GAD study, $0.8 million in expenses related to our MM-402 program, $0.8 million in internal personnel costs as a result of increasing research and development capacities, and $0.8 million in preclinical activities, offset by a decrease of $1.2 million in expenses related to our MM-110 program, and a decrease of $0.7 million of expenses in connection with various external R&D collaborations.
General and Administrative
General and administrative expenses increased by $6.8 million for both the three and six months ended June 30, 2023 compared to the three and six months ended June 30, 2022, respectively. The increase was attributable to professional services fees and expenses related to our proxy contest in connection with our 2023 annual general meeting of shareholders, and additional costs to support the growth of our business.
17
Other Income (Expense)
Interest Income, Net
Interest income, net increased by $1.2 million and $2.5 million for the three and six months ended June 30, 2023 compared to the three and six months ended June 30, 2022, respectively. This was primarily due to interest earned on our cash and cash equivalents as a result of higher cash and cash equivalents and higher interest rates during the three and six months ended June 30, 2023.
Foreign Exchange Gain, Net
Foreign exchange gain increased by $0.3 million and $0.2 million for the three and six months ended June 30, 2023 compared to the three and six months ended June 30, 2022, respectively. The increase was primarily due to favorable changes in foreign exchange rates during the three and six months ended June 30, 2023.
Other Income/(Expense)
Other income for the three and six months ended June 30, 2023 was consistent with the amount compared to the three and six months ended June 30, 2022, respectively.
Change in fair value of 2022 USD Financing Warrants
Revaluation loss on the 2022 USD Financing Warrants liability was $1.5 million and $6.7 million for the three and six months ended June 30, 2023, respectively. Loss on revaluation of the 2022 USD Financing Warrants liability consists of the change in the fair value of our 2022 USD Financing Warrants that were issued as part of our public equity offering which closed on September 30, 2022. No liability classified warrants were outstanding during the six months ended June 30, 2022.
Liquidity and Capital Resources
Sources of Liquidity
Since inception, we have financed our operations primarily from the issuance of equity. Our primary capital needs are for funds to support our scientific research and development activities including staffing, manufacturing, preclinical studies, clinical trials, administrative costs and for working capital.
We have experienced operating losses and cash outflows from operations since inception and will require ongoing financing in order to continue our research and development activities. We have not earned any revenue or reached successful commercialization of our products. Our future operations are dependent upon our ability to finance our cash requirements which will allow us to continue our research and development activities and the commercialization of our products. There can be no assurance that we will be successful in continuing to finance our operations.
Our cash and cash equivalents and our working capital as of June 30, 2023 were $116.9 million and $84.7 million, respectively.
We may issue and sell Common Shares under an at-the-market offering program (the “ATM”). Pursuant to the ATM, we will pay the Sales Agents a commission rate equal to 3.0% of the gross proceeds from the sale of any Common Shares. We are not obligated to make any sales of its Common Shares under the ATM. During the three and six months ended June 30, 2023, we sold 403,785 and 601,898 Common Shares for net proceeds of $1.3 million and $1.9 million, respectively, under the ATM. As of June 30, 2023, we had raised an aggregate of $34.0 million under the ATM and may issue and sell Common Shares for an aggregate offering price of up to an additional $66.0 million.
On September 30, 2022, we closed an underwritten public offering of 7,058,823 common shares and accompanying 2022 USD Financing Warrants to purchase 7,058,823 common shares at a combined offering price of $4.25 per common share, for net proceeds of $27.5 million. Each 2022 USD Financing Warrant is immediately exercisable for one common share at an initial exercise price of $4.25 per common share, subject to certain adjustments and will expire on September 30, 2027.
Future Funding Requirements
To date, we have not generated any revenue. We do not expect to generate any meaningful revenue unless and until we obtain regulatory approval of and commercialize any of our product candidates, and we do not know when, or if at all, that will occur. We will continue to require substantial additional capital to develop our product candidates and fund operations for the foreseeable future. Moreover, we expect our expenses to increase in connection with our ongoing activities, particularly as we continue the development
18
of and seek regulatory approvals for our product candidates. Further, we are subject to all the risks incident in the development of new pharmaceutical products, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may harm our business. Our expenses will increase if, and as, we:
We expect our current cash and cash equivalents will be sufficient to fund our current operating plans into the first half of 2025. However, our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially. In order to complete the development of our product candidates and to build the sales, marketing and distribution infrastructure that we believe will be necessary to commercialize our product candidates, if approved, we will require substantial additional funding. Until we can generate a sufficient amount of revenue from the commercialization of our product candidates, we may seek to raise any necessary additional capital through the sale of equity, debt financings or other capital sources, which could include income from collaborations, strategic partnerships or marketing, distribution or licensing arrangements with third parties or from grants. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our shareholders will be or could be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common shareholders. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, including restricting our operations and limiting our ability to incur liens, issue additional debt, pay dividends, repurchase our Common Shares, make certain investments or engage in merger, consolidation, licensing or asset sale transactions. If we raise funds through collaborations, strategic partnerships and other similar arrangements with third parties, we may be required to grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves. We may be unable to raise additional funds or to enter into such agreements or arrangements on favorable terms, or at all. If we are unable to raise additional funds when needed, we may be required to delay, reduce or eliminate our product development or future commercialization efforts. We have based our projections of operating capital requirements on our current operating plan, which is based on several assumptions that may prove to be incorrect and we may use all of our available capital resources sooner than we expect. Because of the numerous risks and uncertainties associated with research, development and commercialization of product candidates, we are unable to estimate the exact amount and timing of our working capital requirements. Our future funding requirements will depend on many factors, including:
19
Cash Flows
|
|
For the |
|
|
For the |
|
||
Net cash used in operating activities |
|
$ |
(27,176 |
) |
|
$ |
(27,993 |
) |
Net cash provided by financing activities |
|
|
1,857 |
|
|
|
424 |
|
Foreign exchange impact on cash |
|
|
72 |
|
|
|
(229 |
) |
Net increase in cash |
|
$ |
(25,247 |
) |
|
$ |
(27,798 |
) |
Cash flows from operating activities
Cash used in operating activities for the six months ended June 30, 2023 was $27.2 million, which consisted of a net loss of $53.9 million, partially offset by $15.5 million in non-cash charges and a net change of $11.2 million in our net operating assets and liabilities. The non-cash charges primarily consisted of a change in fair value on the 2022 USD Financing Warrants liability of $6.7 million, share-based payments of $7.6 million, and amortization of intangible assets of $1.6 million, partially offset by unrealized foreign exchange gain of $0.3 million.
Cash used in operating activities for the six months ended June 30, 2022 was $28.0 million, which consisted of a net loss of $35.4 million, partially offset by $9.7 million in non-cash charges and a net change of $2.2 million in our net operating assets and liabilities. The non-cash charges consisted of share-based payments of $8.0 million, and amortization of intangible assets of $1.6 million.
Cash flows from financing activities
Cash provided by financing activities for the six months ended June 30, 2023 was $1.9 million, which consisted of net proceeds from the issuance of Common Shares under our ATM, net of issuance costs.
Cash provided by financing activities for the six months ended June 30, 2022 was $0.4 million, which consisted of the proceeds of $0.7 million from exercise of warrants, and proceeds of $0.1 million from exercise of options, offset by $0.4 million of withholding taxes paid on vested restricted share units.
Critical Accounting Policies and Estimates
Our management’s discussion and analysis of our financial condition and results of operations is based on our unaudited interim condensed consolidated financial statements as of June 30, 2023, which have been prepared in accordance with United States generally accepted accounting principles, or U.S. GAAP and on a basis consistent with those accounting principles followed by us and disclosed in Note 2 to our most recent annual audited consolidated financial statements in the 2022 Annual Report. The preparation of these unaudited interim condensed consolidated financial statements requires our management to make judgments and estimates that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported revenue generated and expenses incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these judgments and estimates under different assumptions or conditions and any such differences may be material.
Other than as described under Note 2 of our unaudited interim condensed consolidated financial statements, there have been no material changes to our critical accounting policies from those described in “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” included in our 2022 Annual Report.
Recent Accounting Pronouncements
See Note 2 to our unaudited financial statements located in “Part I – Financial Information, Item 1. Financial Statements” in this Quarterly Report for a description of recent accounting pronouncements applicable to our financial statements.
20
Emerging Growth Company Status
We are an “emerging growth company,” as defined in the JOBS Act. Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies.
We have elected to use this extended transition period to enable us to comply with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date we (i) are no longer an emerging growth company or (ii) affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act. As a result, our financial statements may not be comparable to companies that comply with new or revised accounting pronouncements as of public company effective dates.
Fully Diluted Share Capital
The number of issued and outstanding Common Shares on a fully converted basis as at June 30, 2023 was as follows:
|
|
Number of Common Share Equivalents |
|
|
Common Shares |
|
|
38,807,159 |
|
Stock Options |
|
|
2,301,688 |
|
Restricted Share Units |
|
|
2,780,467 |
|
Compensation Warrants |
|
|
125,890 |
|
Financing Warrants |
|
|
1,286,282 |
|
2022 USD Financing Warrants |
|
|
7,058,823 |
|
Total - June 30, 2023 |
|
|
52,360,309 |
|
21
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
As a "smaller reporting company" as defined by Item 10 of Regulation S-K, we are permitted to omit information required by this item.
Item 4. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our reports filed or submitted under the Securities Exchange Act of 1934 is recorded, processed, summarized and reported within the time period specified in the SEC's rules and forms, and that such information is accumulated and communicated to management including our Chief Executive Officer, Chief Financial Officer, and Chief Accounting Officer, as appropriate, to allow timely decisions regarding required disclosure. As of June 30, 2023, our Chief Executive Officer and Chief Financial Officer carried out an evaluation with the participation of management of the effectiveness of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934. Based upon that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective at a reasonable assurance level as of June 30, 2023.
Changes in Internal Control over Financial Reporting
There was no change in our internal control over financial reporting identified in connection with the evaluation required by Rule 13a-15(d) and 15d-15(d) of the Securities Exchange Act of 1934 that occurred during the quarter ended June 30, 2023 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
Inherent Limitations on Effectiveness of Internal Controls
A control system, no matter how well designed and operated, can provide only reasonable and not absolute assurance of achieving the desired control objectives. In reaching a reasonable level of assurance, management necessarily was required to apply its judgment in evaluating the benefits of possible controls and procedures relative to their costs. In addition, the design of any system of controls is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.
22
Part Ii
Item 1. Legal Proceedings
From time to time, we may become involved in litigation or other legal proceedings arising in the ordinary course of our business. We are not currently a party to any material litigation or legal proceedings that, in the opinion of our management, are likely to have a material adverse effect on our business. Regardless of outcome, litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources, negative publicity, reputational harm and other factors.
Scott Freeman and FCM Litigation. We are a plaintiff in a lawsuit we filed against Dr. Scott Freeman and FCM MM Holdings, LLC (together, the "Defendants") on July 26, 2023, alleging, among other things, breach by the Defendants of the non-disparagement and confidentiality provisions of the Separation Agreement dated August 31, 2020, between the Company and Dr. Freeman. This dispute is pending in the District Court of Clark County in Nevada. We are seeking permanent injunctive relief, as well as compensatory, punitive, and exemplary damages and attorneys’ fees.
Item 1A. Risk Factors.
We operate in a rapidly changing environment that involves a number of risks which could materially affect our business, financial condition or future results, some of which are beyond our control. In addition to the other information set forth in this Quarterly Report, the risks and uncertainties that we believe are most important for you to consider are discussed in Part I-Item 1A under the heading “Risk Factors” in our 2022 Annual Report. The risk factors set forth below are risk factors containing changes, which may be material, from the risk factors previously disclosed in Item 1A of our 2022 Annual Report.
Actions of activist shareholders against us have been and could be disruptive and costly, may cause uncertainty about the strategic direction of our business, result in litigation, divert management’s and the board’s attention and resources, and may have an adverse effect on our business and stock price.
From time to time, we may be subject to proposals by activist shareholders urging us to take certain corporate actions or to nominate certain individuals to our board of directors. For example, a group of Company shareholders nominated four director candidates for election to our six-member board of directors at the Company’s 2023 annual general meeting of shareholders, and waged a proxy contest in support of their candidates and in opposition to four of our director nominees. Future activist shareholder matters, including a proxy contest and potential related litigation, could have a material adverse effect on us for the following reasons:
If we fail to comply with our obligations under our existing and any future intellectual property licenses with third parties, we could lose license rights that are important to our business.
We are party to a license agreement with Catalent, pursuant to which we were granted an exclusive license to use their Zydis technology in the development of MM-120. We may enter into additional license agreements in the future. Our license agreement with Catalent imposes, and we expect that future license agreements will impose, various diligence, milestone payment, royalty, insurance and other obligations on us. Any uncured, material breach under these license agreements could result in our loss of rights to practice
23
the patent rights and other intellectual property licensed to us under these agreements, and could compromise our development and commercialization efforts for our product candidates.
We are a clinical-stage brain health care company and have incurred significant net losses since our inception, and we expect to continue to incur significant net losses for the foreseeable future.
We incurred net losses of $29.1 million and $17.0 million for the three months ended June 30, 2023 and 2022, respectively, and $53.9 million and $35.4 million for the six months ended June 30, 2023 and 2022, respectively. As of June 30, 2023, we had an accumulated deficit of $248.4 million. Our historical losses resulted principally from costs incurred in connection with research and development activities and general and administrative costs associated with our operations. In the future, we intend to continue to conduct research and development, preclinical testing, clinical trials, regulatory compliance, market access, commercialization and business development activities that, together with anticipated general and administrative expenses, will result in incurring further significant losses for at least the next several years. Our product candidates are in various clinical, preclinical discovery and research stages. As a result, we expect that it will be several years, if ever, before we have a commercialized product and generate revenue from product sales. Even if we succeed in receiving marketing approval for and commercializing one or more of our product candidates, we expect that we will continue to incur substantial research and development and other expenses in order to discover, develop and market additional potential products.
We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future. Our expected losses, among other things, may continue to cause our working capital and shareholders’ equity to decrease. We anticipate that our expenses will increase substantially if and as we, among other things:
To become and remain profitable, we will need to continue developing and eventually commercialize therapies that generate significant revenue. This will require us to be successful in a range of challenging activities, including completing clinical trials of our product candidates or any future product candidates, training a sufficient number of qualified therapists to deliver our investigational product candidates, obtaining regulatory approval for any future product candidates that successfully complete clinical trials, and establishing marketing capabilities. Even if any of the future product candidates that we may develop are approved for commercial
24
sale, we anticipate incurring significant costs associated with commercializing any approved future product candidate. We are only in the preliminary stages of most of these activities. We may never succeed in these activities and, even if we do, may never generate revenue that is significant enough to achieve profitability.
Because of the numerous risks and uncertainties associated with product development, we are unable to accurately predict the timing or amount of increased expenses or when, or if, we will be able to achieve profitability. If we are required by the U.S. Food and Drug Administration, or the FDA, the European Medicines Agency, or the EMA, the UK’s medicines regulator, the Medicines and Healthcare products Regulatory Agency, or the MHRA, or other comparable foreign authorities to perform studies in addition to those we currently anticipate, or if there are any delays in completing our clinical trials or the development of our investigational product candidates or any future candidates, our expenses could increase beyond our current expectations and revenue could be further delayed.
Even if we or any future collaborators do generate sales, we may never achieve, sustain or increase profitability on a quarterly or annual basis. Our failure to sustain profitability would depress the market price of our Common Shares and could impair our ability to raise capital, expand our business, diversify our product offerings or continue our operations. If we continue to suffer losses, investors may not receive any return on their investment and may lose their entire investment.
The net losses we incur may fluctuate significantly from quarter to quarter such that a period-to-period comparison of our results of operations may not be a good indication of our future performance. The size of our future net losses will depend, in part, on the rate of future growth of our expenses and our ability to generate revenue. Our prior losses and expected future losses have had and will continue to have an adverse effect on our working capital, our ability to fund the development of our product candidates and our ability to achieve and maintain profitability and the performance of our Common Shares.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
None.
None.
None.
Item 3. Defaults upon Senior Securities
Not applicable.
Item 4. Mine Safety Disclosures.
Not applicable
Item 5. Other Information.
None.
25
Item 6. Exhibits.
Exhibit Number |
|
Description |
Incorporated by Reference |
|||
|
|
|
Form |
Exhibit No. |
Filing Date |
File No. |
3.1 |
|
Amended and Restated Articles of Mind Medicine (MindMed) Inc., effective as of June 30, 2022. |
10-K |
3.1 |
March 9, 2023 |
001-40360 |
3.2 |
|
Notice of Articles, Incorporated on July 26, 2010, as altered on June 30, 2022. |
10-K |
3.2 |
March 9, 2023 |
001-40360 |
10.1# |
|
10-Q |
10.1 |
May 4, 2023 |
001-40360 |
|
10.2* |
|
Non-Employee Director Compensation Policy, amended as of June 8, 2023. |
|
|
|
|
10.3* |
|
Directors’ Deferred Share Unit Plan, amended as of June 8, 2023. |
|
|
|
|
31.1* |
|
|
|
|
|
|
31.2* |
|
|
|
|
|
|
32.1*+ |
|
|
|
|
|
|
32.2*+ |
|
|
|
|
|
|
101.INS |
|
Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document. |
|
|
|
|
101.SCH |
|
Inline XBRL Taxonomy Extension Schema Document |
|
|
|
|
101.CAL |
|
Inline XBRL Taxonomy Extension Calculation Linkbase Document |
|
|
|
|
101.DEF |
|
Inline XBRL Taxonomy Extension Definition Linkbase Document |
|
|
|
|
101.LAB |
|
Inline XBRL Taxonomy Extension Label Linkbase Document |
|
|
|
|
101.PRE |
|
Inline XBRL Taxonomy Extension Presentation Linkbase Document |
|
|
|
|
104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
|
|
|
|
* Filed herewith.
# Indicates management contract or compensatory plan.
+These certifications are being furnished solely to accompany this quarterly report pursuant to 18 U.S.C. Section 1350, and are not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and are not to be incorporated by reference into any filing of the registrant, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
26
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
|
|
Mind Medicine (MindMed) Inc. |
|
|
|
|
|
Date: August 3, 2023 |
|
By: |
/s/ Robert Barrow |
|
|
|
Robert Barrow |
|
|
|
Chief Executive Officer
|
Date: August 3, 2023 |
|
By: |
/s/ Schond L. Greenway |
|
|
|
Schond L. Greenway |
|
|
|
Chief Financial Officer |
|
|
|
|
|
|
|
|
Date: August 3, 2023 |
|
By: |
/s/ Carrie F. Liao |
|
|
|
Carrie F. Liao, CPA |
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Chief Accounting Officer |
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