SEC Form 10-Q filed by Definium Therapeutics Inc.
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 |
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Securities registered pursuant to Section 12(b) of the Act:
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(The Nasdaq Global Select 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, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
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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 April 30, 2026 the registrant had
Table of Contents
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PART I |
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Item 1. |
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Condensed Consolidated Statements of Operations and Comprehensive Loss |
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Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
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Item 3. |
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Item 4. |
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PART II |
28 |
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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. |
30 |
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31 |
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q ("Quarterly Report") 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, 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 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 U.S. Securities and Exchange Commission (“SEC”) on February 26, 2026 (the “2025 Annual Report”) and in Part II, Item 1A in this Quarterly Report and the section titled “Management's Discussion and Analysis of Financial Condition and Results of Operations” in Part I, Item 2 of 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://ir.definiumtx.com/). We therefore encourage investors and others interested in our company to review the information that we make available on our website, in addition to following our filings with the SEC, webcasts, press releases and conference calls. Our website and information included in or linked to our website are not part of this Quarterly Report. Unless otherwise noted or the context indicates otherwise, references in this Quarterly Report to the “Company,” “Definium,” “we,” “us,” and “our” refer to Definium Therapeutics, Inc. and its consolidated subsidiaries.
PART I—FINANCIAL INFORMATION
Item 1. Financial Statements.
Definium Therapeutics, Inc.
Condensed Consolidated Balance Sheets
(in thousands, except share amounts) |
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March 31, 2026 |
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December 31, 2025 |
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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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Short-term investments |
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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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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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Credit facility, long-term |
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Other non-current liabilities |
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Total liabilities |
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Shareholders' equity: |
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Common shares, |
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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
Definium Therapeutics, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
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Three Months Ended March 31, |
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(in thousands, except share and per share amounts) |
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2026 |
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2025 |
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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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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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Other income/(expense): |
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Interest income |
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Interest expense |
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( |
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( |
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Foreign exchange 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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Total other income/(expense) |
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( |
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Net loss |
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( |
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( |
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Other comprehensive loss |
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Unrealized gain/(loss) on investments |
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( |
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Gain/(loss) on foreign currency translation |
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( |
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Comprehensive loss |
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$ |
( |
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$ |
( |
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Net loss per common share, basic |
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$ |
( |
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$ |
( |
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Net loss per common share, diluted |
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$ |
( |
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$ |
( |
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Weighted-average common shares, basic |
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Weighted-average common shares, diluted |
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See accompanying notes to unaudited condensed consolidated financial statements.
5
Definium Therapeutics, Inc.
(Unaudited)
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Common Shares |
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(in thousands, except share amounts) |
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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, 2025 |
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$ |
— |
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$ |
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$ |
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$ |
( |
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$ |
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Issuance of common shares under employee share purchase plan ("ESPP") |
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— |
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— |
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— |
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Issuance of common shares upon settlement of restricted share unit ("RSU") 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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Exercise of 2022 USD Financing Warrants |
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— |
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— |
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— |
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Exercise of pre-funded warrants |
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— |
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— |
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Amortization of deferred ATM costs |
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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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Exercise of stock options |
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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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( |
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Balance, March 31, 2026 |
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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, December 31, 2024 |
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$ |
— |
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$ |
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$ |
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$ |
( |
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$ |
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Issuance of common shares under ESPP |
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— |
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— |
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— |
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Issuance of common shares upon settlement of RSU 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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Exercise of 2022 USD Financing Warrants |
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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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Exercise of stock options |
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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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( |
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Balance, March 31, 2025 |
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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
Definium Therapeutics, Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
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Three Months Ended March 31, |
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(in thousands) |
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2026 |
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2025 |
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Cash flows from operating activities |
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Net loss |
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$ |
( |
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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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Change in fair value on directors' deferred share units ("DDSU") |
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( |
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Change in fair value of the 2022 USD Financing Warrants |
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( |
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Amortization of discounts and premiums on investments, net |
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Other non-cash adjustments |
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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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( |
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Other noncurrent assets |
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( |
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Accounts payable |
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Accrued expenses |
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( |
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Other liabilities, long-term |
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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 investing activities |
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Purchases of investments |
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Maturity of investments |
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Net cash provided by (used in) investing activities |
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Cash flows from financing activities |
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Proceeds from exercise of pre-funded warrants |
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Proceeds from exercise of 2022 USD Financing Warrants |
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Proceeds from exercise of options |
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Proceeds from issuance of common shares under ESPP |
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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 increase/(decrease) in cash and cash equivalents |
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( |
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Cash and cash equivalents, beginning of period |
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Cash and cash equivalents, end of period |
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$ |
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$ |
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Supplemental Cash Flow Information |
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Cash paid for interest and final payment for credit facility |
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$ |
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$ |
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Supplemental Noncash Disclosures |
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Conversion of 2022 USD Financing Warrants to common shares upon exercise of warrants |
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Lease liabilities arising from obtaining right-of-use assets |
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Amortization of deferred financing costs |
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See accompanying notes to unaudited condensed consolidated financial statements.
7
Definium Therapeutics, Inc.
Notes to Unaudited Condensed Consolidated Financial Statements
Definium Therapeutics, Inc. (the “Company” or “Definium”) is incorporated under the laws of the Province of British Columbia, Canada. Its wholly-owned subsidiaries, Definium Therapeutics US, Inc. (“Definium US”) and HealthMode, Inc. are both incorporated in the State of Delaware, United States. Definium US was incorporated on May 30, 2019, and HealthMode, Inc. was incorporated on December 13, 2017.
On January 9, 2026, the Company changed its corporate name from Mind Medicine (MindMed) Inc. to Definium Therapeutics, Inc. On January 12, 2026, the Company changed the name of its wholly-owned subsidiary from Mind Medicine, Inc. to Definium Therapeutics US, Inc.
Definium is a late-stage clinical biopharmaceutical company developing novel product candidates to treat brain health disorders. The Company's mission is to forge a new era of psychiatry by applying scientific rigor to psychedelics, with the goal of developing accessible treatments that unlock healing at scale. This specifically includes pharmaceutically optimized product candidates derived from the psychedelic and empathogen drug classes, including DT120 and DT402, the Company's lead product candidates.
Liquidity
As of March 31, 2026, 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 unaudited 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 cash, cash equivalents and investments to fund operations through at least the next twelve months from the date of the issuance of these unaudited condensed consolidated 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 unaudited condensed consolidated financial statements may not be comparable to companies that comply with public company Financial Accounting Standards Board (“FASB”) 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 the first sale of its common equity securities under an effective Securities Act of 1933 (the "Securities Act") registration statement, which is December 31, 2026.
In the opinion of management, these unaudited condensed consolidated financial statements reflect all adjustments necessary for a fair presentation of the Company's financial position and results of operations and cash flows for the periods presented.
8
Basis of Presentation
The accompanying unaudited 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 ("ASC") and as amended by Accounting Standards Updates of FASB. The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the related notes thereto for the year ended December 31, 2025, which are included in the Company’s 2025 Annual Report on Form 10-K filed with the SEC on February 26, 2026 (the “2025 Annual Report”). The Company’s significant accounting policies are disclosed in the audited consolidated financial statements for the periods ended December 31, 2025 and 2024, included in the 2025 Annual Report. Since the date of those financial statements, there have been no changes to the Company's significant accounting policies.
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 financial statements and the reported amounts of expenses during the reporting periods. Actual results could differ from those estimates under different assumptions or conditions.
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 equivalents. As of March 31, 2026, the Company’s cash equivalents consisted of U.S. government money market funds at a high-credit quality and U.S. federally insured financial institution. The Company’s accounts may, at times, exceed federally insured limits. The Company had cash equivalents of $
Short-Term Investments
All investments are carried at fair value as determined based upon quoted market prices or pricing models for similar securities at period end. The Company has classified these investments as available-for-sale securities, as the sale of such investments may be required prior to maturity to implement management strategies, and therefore has classified all investments with maturity dates beyond three months at the date of purchase as current assets in the accompanying unaudited balance sheets. Dividend and interest income are recognized when earned. Realized gains and losses are included in earnings and are derived using the specific identification method for determining the cost of securities sold. Unrealized gains and losses are reported as a component of accumulated other comprehensive loss.
The Company reviews its portfolio of available-for-sale debt securities, using both quantitative and qualitative factors, to determine if declines in fair value below cost have resulted from a credit-related loss or other factors. If the decline in fair value is due to credit-related factors, a loss is recognized in the statements of operations, whereas if the decline in fair value is not due to credit-related factors, the loss is recorded in other comprehensive loss. The fair value of the Company's investments was $
Net Loss per Share
The following table sets forth the computation of basic and diluted net loss per share attributable to common shareholders (in thousands, except share and per share amounts). As the exercise price of the Company’s pre-funded warrants is $
9
basic and diluted loss per share:
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Three Months Ended March 31, |
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2026 |
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2025 |
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Numerator: |
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|
||
Net loss attributable to common shareholders, basic |
|
$ |
( |
) |
|
$ |
( |
) |
Change in fair value of the 2022 USD Financing Warrants |
|
|
— |
|
|
|
( |
) |
Net loss attributable to common shareholders, diluted |
|
$ |
( |
) |
|
$ |
( |
) |
Denominator: |
|
|
|
|
|
|
||
Weighted-average pre-funded warrants used in computing net loss per share attributable to common shareholders, basic |
|
|
|
|
|
|
||
Weighted-average shares used in computing net loss per share attributable to common shareholders, basic |
|
|
|
|
|
|
||
Total weighted-average shares used in computing net loss per share attributable to common shareholders, basic |
|
|
|
|
|
|
||
Incremental shares from 2022 USD Financing Warrants |
|
|
— |
|
|
|
|
|
Total weighted-average shares used in computing net loss per share attributable to common shareholders, diluted |
|
|
|
|
|
|
||
|
|
|
|
|
|
|
||
Net loss per share: |
|
|
|
|
|
|
||
Basic |
|
$ |
( |
) |
|
$ |
( |
) |
Diluted |
|
$ |
( |
) |
|
$ |
( |
) |
The following potentially dilutive securities have been excluded from the calculation of diluted net loss per share due to their anti-dilutive effect:
|
|
Three Months Ended March 31, |
|
|
|||||
|
|
2026 |
|
|
2025 |
|
|
||
2022 USD Financing Warrants |
|
|
|
|
|
— |
|
|
|
Stock options |
|
|
|
|
|
|
|
||
RSUs |
|
|
|
|
|
|
|
||
Conversion Shares |
|
|
|
|
|
|
|
||
Estimated ESPP shares |
|
|
|
|
|
|
|
||
Total |
|
|
|
|
|
|
|
||
For the three months ended March 31, 2025,
The Company's available-for-sale investments consisted of the following (in thousands):
|
|
As of March 31, 2026 |
|
|||||||||||||
|
|
Amortized Cost |
|
|
Unrealized Gain |
|
|
Unrealized Losses |
|
|
Estimated Fair Value |
|
||||
Investments: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
U.S. agency bonds |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|||
Total |
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
As of December 31, 2025 |
|
|||||||||||||
|
|
Amortized Cost |
|
|
Unrealized Gain |
|
|
Unrealized Losses |
|
|
Estimated Fair Value |
|
||||
Investments: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
U.S. agency bonds |
|
|
|
|
|
|
|
|
— |
|
|
|
|
|||
Total |
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
|||
10
The following table summarizes the maturities of the Company's investments at March 31, 2026:
(in thousands) |
|
Amortized Cost |
|
|
Estimated Fair Value |
|
||
Due in one year or less |
|
$ |
|
|
$ |
|
||
Due in one to two years |
|
|
|
|
|
|
||
Due in two to three years |
|
|
|
|
|
|
||
Total |
|
$ |
|
|
$ |
|
||
The Company has determined that there were no material declines in the fair value of its investments due to credit-related factors as of March 31, 2026 or December 31, 2025.
|
|
As of March 31, 2026 |
|
|||||||||||||
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
||||
Financial assets: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cash equivalents |
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||
U.S. agency bonds |
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
Total |
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
|||
Financial liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
DDSU Liability |
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||
2022 USD Financing Warrant Liability |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
||
Total |
|
$ |
|
|
$ |
— |
|
|
$ |
|
|
$ |
|
|||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
As of December 31, 2025 |
|
|||||||||||||
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
||||
Financial assets: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cash equivalents |
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||
U.S. agency bonds |
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
Total |
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
|||
Financial liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
DDSU Liability |
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||
2022 USD Financing Warrant Liability |
|
|
— |
|
|
|
— |
|
|
|
|
|
$ |
|
||
Total |
|
$ |
|
|
$ |
— |
|
|
$ |
|
|
$ |
|
|||
There were
The Company issued liability-classified warrants to purchase Common Shares in its underwritten public offering that closed on September 30, 2022 (the “2022 USD Financing Warrants”). The warrant liability is measured at fair value on a recurring basis and is classified as Level 3 in the fair value hierarchy. Its fair value is determined using the Black-Scholes option pricing model using the following assumptions:
|
|
As of March 31, 2026 |
|
As of December 31, 2025 |
Share price |
|
$ |
|
$ |
Expected volatility |
|
|
||
Risk-free rate |
|
|
||
Expected life |
|
|
11
During the three months ended March 31, 2026, the Company had made
At March 31, 2026 and December 31, 2025, accrued expenses consisted of the following (in thousands):
|
|
As of |
|
|
As of |
|
||
Accrued compensation |
|
$ |
|
|
$ |
|
||
Accrued clinical trial costs |
|
|
|
|
|
|
||
Accrued other research and development costs |
|
|
|
|
|
|
||
Professional services |
|
|
|
|
|
|
||
Other accruals |
|
|
|
|
|
|
||
Total |
|
$ |
|
|
$ |
|
||
Common Shares
The Company is authorized to issue an unlimited number of Common Shares, which have
At-The-Market Facility
On June 28, 2024, the Company filed a shelf registration statement on Form S-3 (the “2024 Registration Statement”), as well as an accompanying prospectus supplement for an at-the-market offering program (“ATM Prospectus”). In connection with the filing of the 2024 Registration Statement and the ATM Prospectus, the Company entered into a sales agreement (the "Sales Agreement") with Leerink Partners LLC (the “Sales Agent”) pursuant to which the Company may issue and sell from time to time Common Shares for an aggregate offering price of up to $
October 2025 Offering
On October 29, 2025, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with Jefferies LLC, Leerink Partners LLC and Evercore Group L.L.C., as representatives of the several underwriters named therein (the “Underwriters”), in connection with an underwritten public offering (the “October 2025 Offering”) of
The gross proceeds to the Company from the October 2025 Offering, including the full exercise by the Underwriters of their option to purchase additional Common Shares, were approximately $
The Company intends to use the net proceeds from the October 2025 Offering to fund the research and development of its product candidates and working capital and general corporate purposes. The Company may also use a portion of the net proceeds from the October 2025 Offering to invest in or acquire additional businesses or compounds that the Company believe are complementary to its own.
2022 USD Financing Warrants
On September 30, 2022, the Company closed an underwritten public offering of
12
exercisable for one Common Share at an initial exercise price of $
The table below represents the activity associated with the Company's outstanding liability-classified 2022 USD Financing Warrants for the three months ended March 31, 2026:
|
|
2022 USD Financing Warrants |
|
|
Balance at December 31, 2025 |
|
|
|
|
Issued |
|
|
|
|
Exercised |
|
|
( |
) |
Expired |
|
|
|
|
Balance at March 31, 2026 |
|
|
|
|
The 2022 USD Financing Warrants are liability-classified. 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. Any change in fair value is recognized on the condensed consolidated statements of operations and comprehensive loss.
The below table summarizes the activity of the outstanding liability for the 2022 USD Financing Warrants for the three months ended March 31, 2026 (in thousands):
|
|
As of |
|
|
Balance at December 31, 2025 |
|
$ |
|
|
Warrant exercise |
|
|
( |
) |
Change in fair value of the warrant liability |
|
|
|
|
Balance at March 31, 2026 |
|
$ |
|
|
In June 2025, the Company adopted the 2025 Equity Incentive Plan (the “2025 Plan”), consisting of (a)
The Company also grants inducement equity awards consisting of stock options, RSUs or PSUs to newly hired employees as an inducement material to the employees entering into employment with the Company in accordance with NASDAQ Listing Rule 5635(c)(4). All such inducement grants are granted outside of the Company’s equity incentive plans and are approved by the Compensation Committee of the Company’s Board of Directors prior to issuance. During the three months ended March 31, 2026, the Company issued inducement grants consisting of
13
Stock Options
The following table summarizes the Company’s stock option activity for the three months ended March 31, 2026:
|
|
Number of Options |
|
|
Weighted Average Exercise Price |
|
|
Weighted Average Remaining Contractual Life (Years) |
|
|
Aggregate Intrinsic |
|
||||
Options outstanding at December 31, 2025 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Granted |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Exercised |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|||
Forfeited |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|||
Expired |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|||
Options outstanding at March 31, 2026 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Options vested and exercisable at March 31, 2026 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
The expense recognized related to options during the three months ended March 31, 2026 and 2025 was $
Restricted Share Units
The following table summarizes the Company's RSU activity for the three months ended March 31, 2026:
|
|
|
|
|
|
|
||
|
|
Number of RSUs |
|
|
Weighted Average Grant Date Fair Value |
|
||
Balance at December 31, 2025 |
|
|
|
|
$ |
|
||
Granted |
|
|
|
|
|
|
||
Vested |
|
|
( |
) |
|
|
|
|
Cancelled |
|
|
( |
) |
|
|
|
|
Balance at March 31, 2026 |
|
|
|
|
$ |
|
||
During the three months ended March 31, 2026, RSUs granted include
The expense recognized related to RSUs during the three months ended March 31, 2026 and 2025 was $
Employee Share Purchase Plan
In August 2024, the Company commenced the first offering under the ESPP. Subsequent to this offering, new offerings under the ESPP commence automatically every six months until the earlier of (i) termination or modification by the Compensation Committee of the Company’s Board of Directors and (ii) such time when all Common Shares reserved under the ESPP have been issued. During the three months ended March 31, 2026, the Company recognized $
Stock-based Compensation Expense
Stock-based compensation expense for all equity arrangements for the three months ended March 31, 2026 and 2025 was as follows (in thousands):
|
|
Three Months Ended March 31, |
|
|||||
|
|
2026 |
|
|
2025 |
|
||
Research and development |
|
$ |
|
|
$ |
|
||
General and administrative |
|
|
|
|
|
|
||
Total |
|
$ |
|
|
$ |
|
||
14
As of March 31, 2026, there was approximately $
Directors' Deferred Share Unit Plan
On April 16, 2021, the Company adopted the Definium Therapeutics Director’s Deferred Share Unit Plan (the “DDSU Plan”). The DDSU Plan sets out a framework to grant non-employee directors DDSUs, which are cash settled awards. The DDSUs 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 months ended March 31, 2026, $
During the three months ended March 31, 2026, the Company did not issue any additional DDSUs. There were
As of March 31, 2026, 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 unaudited condensed consolidated financial statements with respect to these indemnification obligations.
During April 2022, the Company entered into a
From time to time, the Company may become involved in litigation or other legal proceedings arising in the ordinary course of business. The Company will accrue a liability for such matters when it is probable that future expenditures will be made and such expenditures can be reasonably estimated. As of March 31, 2026 and December 31, 2025, the Company is not a party to any material litigation, and the Company does not currently have any contingencies related to ongoing legal matters.
15
On August 11, 2023, the Company and certain of its subsidiaries party thereto, as co-borrowers (together with the Company, the “Borrowers”) entered into a Loan and Security Agreement (the “Loan Agreement”) with K2 HealthVentures LLC (“K2HV”), as administrative agent and Canadian collateral agent for lenders thereunder (K2HV, together with any other lender from time to time, the "Lenders"), and Ankura Trust Company, LLC, as collateral trustee for the Lenders, providing for an aggregate principal amount of term loans of up to $
On April 18, 2025 (the “Effective Date”), the Borrowers, entered into the First Amendment to the Loan Agreement with K2HV (as amended by the First Amendment, the “Amended Loan Agreement”).
The Amended Loan Agreement provides for, among other things: (i) an aggregate principal amount of term loans (the “Amendment Term Loans”) of up to $
On July 22, 2025, under the terms of the Amended Loan Agreement, K2HV converted $
The Amendment Term Loans mature on
In accordance with ASC Topic 470-50, Debt Modifications and Extinguishments, the Company evaluated the Amended Loan Agreement to determine whether it should be accounted for as a modification or extinguishment. As a result of this analysis, the Amended Loan Agreement was accounted for as a modification and no gain or loss was recognized. Transaction costs incurred from or paid on behalf of K2HV of approximately $
The Company recorded $
16
Future expected repayments of the principal amount due on the credit facility as of March 31, 2026 were as follows (in thousands):
Remainder of 2026 |
|
$ |
— |
|
2027 |
|
|
|
|
2028 |
|
|
|
|
2029 |
|
|
|
|
Total principal repayments |
|
|
|
|
Unamortized debt issuance costs |
|
|
( |
) |
Accrued final payment fee |
|
|
|
|
Total credit facility, non-current, net |
|
$ |
|
As of March 31, 2026, the Company estimated the fair value of the credit facility to be $
12. SEGMENT REPORTING
The Company has
The Company’s Chief Operating Decision Maker (the “CODM”), its , reviews the Company’s operations, including reviewing budgets and trial-related data, and decides how to allocate resources and assess performance. When evaluating the Company’s financial performance, the CODM regularly reviews total expenses and total assets and the CODM makes decisions using this information on a consolidated basis.
|
|
Three Months Ended March 31, |
|
|||||
|
|
2026 |
|
|
2025 |
|
||
Research and development: |
|
|
|
|
|
|
||
Internal expenses |
|
$ |
|
|
$ |
|
||
External expenses |
|
|
|
|
|
|
||
Total |
|
|
|
|
|
|
||
General and administrative: |
|
|
|
|
|
|
||
Internal expenses |
|
|
|
|
|
|
||
External expenses |
|
|
|
|
|
|
||
Total |
|
|
|
|
|
|
||
Loss from operations |
|
|
( |
) |
|
|
( |
) |
Total other income/(expense), net |
|
|
( |
) |
|
|
|
|
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
17
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 2025 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, except as required by law.
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 2025 Annual Report. All amounts are in United States dollars, unless otherwise indicated.
Overview
We are a late-stage clinical biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to forge a new era of psychiatry by applying scientific rigor to psychedelics, with the goal of developing accessible treatments that unlock healing at scale. This specifically includes pharmaceutically optimized product candidates derived from the psychedelic and empathogen drug classes including DT120 and DT402, our lead product candidates.
Our lead product candidate, DT120 orally disintegrating tablet (“ODT”), is a proprietary, pharmaceutically optimized form of lysergide D-tartrate that we are developing for the treatment of adults with generalized anxiety disorder (“GAD”), major depressive disorder (“MDD”) and posttraumatic stress disorder (“PTSD”). In December 2023, we announced positive topline results from our Phase 2b clinical trial of DT120 for the treatment of GAD. The trial met its primary endpoint, with DT120 demonstrating statistically significant and clinically meaningful dose-dependent improvements on the Hamilton Anxiety Rating Scale ("HAM-A") compared to placebo at Week 4. In March 2024, we announced that the U.S. Food and Drug Administration ("FDA") granted breakthrough designation to our DT120 program for the treatment of GAD. We also announced in March 2024 that our Phase 2b clinical trial of DT120 in GAD met its key secondary endpoint, and 12-week topline data demonstrated clinically and statistically significant durability of activity observed through Week 12. In September 2025, we announced that the full results from our Phase 2b clinical trial of DT120 in GAD had been published in the Journal of the American Medical Association.
In June 2024, we announced the completion of our End-of-Phase 2 meeting with the FDA, supporting the advancement of DT120 ODT into pivotal trials for the treatment of adults with GAD. Our Phase 3 clinical program for DT120 ODT is expected to consist of two clinical trials: the Voyage study (DT120-300) and the Panorama study (DT120-301). Both trials are comprised of two parts: Part A, which is a 12-week, randomized, double-blind, placebo-controlled, parallel-group trial assessing the efficacy and safety of DT120 ODT versus placebo; and Part B, which is a 40-week extension period during which participants will be eligible for open-label treatment with DT120 ODT, subject to certain conditions for treatment eligibility. Both trials use an adaptive trial design with a blinded interim sample size re-estimation (“SSRE”), allowing for an increase in sample size by up to 50% in each trial or, in the case of Panorama, a decrease in sample size, depending on the observed values for certain nuisance parameters. In February 2026, we announced that the SSRE for Voyage has been completed and it was determined that no increase in the sample size of the trial is required. In April 2026, we announced that Voyage was fully enrolled with 214 participants randomized 1:1 to receive DT120 ODT 100 µg or placebo. In April 2026, we also announced that the SSRE for Panorama has been completed and it was determined that the sample size of the trial would be updated to a target of 200 participants randomized 2:1:2 to receive DT120 ODT 100 µg, DT120 ODT 50 µg or placebo. We also announced that enrollment in Panorama exceeded the 200 participant target and that screening for Panorama has closed. The primary endpoint for each trial is the change from baseline in HAM-A score at Week 12 between DT120 ODT 100 µg and placebo. We anticipate a topline readout (Part A results) for Voyage in early third quarter 2026 and a topline readout (Part A results) for Panorama in late third quarter 2026.
In addition to our Phase 3 clinical program for GAD, we are developing DT120 ODT for the treatment of adults with MDD. In the first quarter of 2024, we held a pre-IND meeting with FDA to discuss the initiation of our Phase 3 clinical program for DT120 ODT in MDD and the trial design for the Emerge study (DT120-310), which like our pivotal trials in GAD, we anticipate will be comprised of two parts: Part A, which is a 12-week, randomized, double-blind, placebo-controlled, parallel group trial assessing the efficacy and safety of DT120 ODT versus placebo; and Part B, which is a 40-week extension period during which participants will be eligible for open-label treatment with DT120 ODT, subject to certain conditions for treatment eligibility. Emerge is fully enrolled with 149 participants randomized 1:1 to receive DT120 ODT 100 µg or placebo. The primary endpoint is the change from baseline in Montgomery Åsberg Depression Rating Scale ("MADRS") score at Week 6 between DT120 ODT 100 µg and placebo. We anticipate a topline readout (Part A results) in late second quarter 2026.
18
We activated the initial sites in our second Phase 3 clinical trial of DT120 ODT in MDD, Ascend (DT120-311), in the first quarter of 2026 and anticipate dosing to begin in the second quarter of 2026. Ascend has a similar design to Emerge, with a 12-week, randomized, double-blind, placebo-controlled, parallel group design assessing the efficacy and safety of DT120 ODT versus placebo (Part A); and Part B, which includes a 40-week extension period during which participants will be eligible for open-label treatment with DT120 ODT. Ascend is anticipated to enroll approximately 175 participants (randomized 2:1:2 to receive DT120 ODT 100 µg, DT120 ODT 50 µg or placebo). The primary endpoint is the change from baseline in MADRS score at Week 6 between DT120 ODT 100 µg and placebo.
In April 2026, we announced the Haven study as part of our planned Phase 3 clinical program for DT120 ODT for the treatment of adults with PTSD. The Haven study is anticipated to be comprised of two parts: Part A, which is a 12-week, randomized, double-blind, placebo-controlled, parallel group trial assessing the efficacy and safety of DT120 ODT versus placebo; and Part B, which is a 40-week extension period during which participants will be eligible for open-label treatment with DT120 ODT, subject to certain conditions for treatment eligibility. Haven is anticipated to enroll approximately 200 participants randomized 1:1 to receive DT120 ODT 100 µg or placebo. The primary endpoint is anticipated to be the change from baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) at Week 8 between DT120 ODT 100 µg and placebo. Haven is expected to initiate in 2027.
Our second lead product candidate, DT402, also referred to as R(-)-MDMA, is our proprietary form of the R-enantiomer of 3,4-methylenedioxymethamphetamine, which we are developing for the treatment of adults with ASD. MDMA is a synthetic molecule that is often referred to as an empathogen because it is reported to increase feelings of connectedness and compassion. Preclinical studies of R(-)-MDMA demonstrated its acute pro-social and empathogenic effects, while its diminished dopaminergic activity suggests that it has the potential to exhibit less stimulant activity, neurotoxicity, hyperthermia and abuse liability compared to racemic MDMA or the S(+)-enantiomer. In October 2024, we completed our first clinical trial of DT402, a single-ascending dose trial in adult healthy volunteers. The data from this Phase 1 clinical trial helped to characterize the tolerability, pharmacokinetics and pharmacodynamics of DT402.
We initiated a Phase 2a trial of DT402 in ASD in the fourth quarter of 2025. This study is a single-dose, open-label study to assess early signals of efficacy of DT402 in treating core socialization and communication symptoms in adults with ASD. This study is anticipated to enroll up to 20 participants. The objectives and endpoints of the study are designed to characterize the pharmacodynamics and clinical effects of DT402 in adults with ASD, including on multiple functional measures. We anticipate initial data from our Phase 2a study in 2026.
Beyond our clinical stage product candidates, we are exploring additional programs, including through external collaborations, which we seek to expand our drug development pipeline and broaden the potential applications of our lead product candidates. These research and development programs include nonclinical, preclinical and human clinical trials of current and new product candidates and research compounds with our collaborators.
Our business is premised on a growing body of research supporting the use of novel psychoactive compounds to treat a myriad of brain health disorders. For all product candidates, we intend to proceed through research and development, and with marketing of the product candidates that may ultimately be approved pursuant to the regulations of the FDA and the regulations in other jurisdictions. This entails, among other things, conducting clinical trials with research scientists, using internal and external clinical drug development teams, producing and supplying product candidates according to current Good Manufacturing Practices (“cGMP”), and conducting all trials and development in accordance with the regulations of the FDA, and other regulations in other jurisdictions.
On January 9, 2026, we changed our corporate name from Mind Medicine (MindMed) Inc. to Definium Therapeutics, Inc. On January 12, 2026, we changed the name of our wholly-owned subsidiary from Mind Medicine, Inc. to Definium Therapeutics US, Inc. In connection with our name change, we began trading on Nasdaq under the symbol “DFTX” on January 15, 2026.
We were incorporated under the laws of the Province of British Columbia, Canada in 2010. Our wholly-owned subsidiary, Definium Therapeutics US, Inc. (“Definium US”), was incorporated in the State of Delaware, United States in 2019. Prior to February 27, 2020, our operations were conducted through Definium US.
Since inception, we have incurred losses while advancing the research and development of our products and processes. Our net losses were $77.1 million and $23.3 million for the three months ended March 31, 2026 and 2025, respectively. As of March 31, 2026, we had an accumulated deficit of $659.8 million and cash, cash equivalents and investments of $373.4 million.
19
Our Product Candidate Pipeline
The following table summarizes the status of our portfolio of product candidates:
1.Formerly known as MM120; USAN: lysergide tartrate.
2.Formerly known as MM402.
3.Full trial details and clinicaltrials.gov links available at definiumtx.com/clinical-digital-trials/
4.Studies in exploration and/or planning stage.
Components of Operating Results
Operating Expenses
Research and Development
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.
External expenses include:
We may also incur in‑process research and development expenses when we acquire or in‑license assets from other parties. Technology acquisitions are expensed or capitalized based on management’s assessment of 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.
20
Internal expenses include employee-related costs such as salaries, related benefits and non-cash stock-based compensation expense for employees engaged in research and development functions.
We expect our research and development expenses to increase throughout 2026 as we continue the clinical development of our product candidates and other preclinical programs in GAD, MDD and PTSD and other potential or future indications, including initiating additional and larger clinical trials.
We expense research and development costs in the periods in which they are incurred. External expenses are recognized based on an evaluation of the progress to completion of specific tasks using information provided to us by our service providers or our estimate of the level of service that has been performed at each reporting date. We track external costs by program, clinical or preclinical. We do not track internal costs by program because these costs are deployed across multiple programs and, as such, are not separately classified.
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, costs to support our commercialization efforts and allocated expenses.
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.
Results of Operations
Comparison of the Three Months Ended March 31, 2026 and 2025
The following tables summarize our results of operations for the periods presented (in thousands):
|
|
Three Months Ended March 31, |
|
|||||
|
|
2026 |
|
|
2025 |
|
||
Operating expenses: |
|
|
|
|
|
|
||
Research and development |
|
$ |
41,484 |
|
|
$ |
23,357 |
|
General and administrative |
|
|
17,736 |
|
|
|
8,802 |
|
Total operating expenses |
|
|
59,220 |
|
|
|
32,159 |
|
Loss from operations |
|
|
(59,220 |
) |
|
|
(32,159 |
) |
Other income/(expense): |
|
|
|
|
|
|
||
Interest income |
|
|
3,457 |
|
|
|
2,433 |
|
Interest expense |
|
|
(1,245 |
) |
|
|
(602 |
) |
Foreign exchange loss, net |
|
|
(44 |
) |
|
|
(19 |
) |
Change in fair value of 2022 USD Financing Warrants |
|
|
(20,046 |
) |
|
|
6,999 |
|
Total other income/(expense) |
|
|
(17,878 |
) |
|
|
8,811 |
|
Net loss |
|
$ |
(77,098 |
) |
|
$ |
(23,348 |
) |
21
Operating Expenses
Research and Development (in thousands):
|
|
Three Months Ended March 31, |
|
|||||
|
|
2026 |
|
|
2025 |
|
||
External costs |
|
|
|
|
|
|
||
DT120 program |
|
|
|
|
|
|
||
DT120 GAD |
|
$ |
18,225 |
|
|
$ |
10,911 |
|
DT120 MDD |
|
|
8,257 |
|
|
|
1,758 |
|
DT120 other* |
|
|
2,867 |
|
|
|
1,469 |
|
Total DT120 program |
|
|
29,349 |
|
|
|
14,138 |
|
DT402 program |
|
|
424 |
|
|
|
162 |
|
Preclinical and other programs |
|
|
614 |
|
|
|
1,211 |
|
Total external costs |
|
|
30,387 |
|
|
|
15,511 |
|
Internal costs |
|
|
11,097 |
|
|
|
7,846 |
|
Total research and development expenses |
|
$ |
41,484 |
|
|
$ |
23,357 |
|
* DT120 other consists of expenses that support the broader DT120 program, including nonclinical studies and consulting expenses.
Research and development expenses of $41.5 million for the three months ended March 31, 2026 increased by $18.1 million, or 78%, compared to $23.4 million for the three months ended March 31, 2025. The increase was primarily due to an increase of $15.2 million in expenses related to our DT120 program, an increase of $3.2 million in internal personnel costs as a result of increasing research and development capabilities, and an increase of $0.3 million in DT402 program expenses, partially offset by a decrease of $0.6 million in preclinical and other program expenses.
General and Administrative
General and administrative expenses of $17.7 million for the three months ended March 31, 2026 increased by $8.9 million, or 101%, compared to $8.8 million for the three months ended March 31, 2025. The increase was primarily due to an increase of $3.9 million in stock-based compensation expenses, an increase of $1.4 million in personnel-related expenses, an increase of $1.4 million in commercial-preparedness related expenses, an increase of $1.4 million in corporate and government affairs expenses, and an increase of $1.2 million in legal and patent expenses, partially offset by a decrease of $0.4 million in other miscellaneous administrative expenses.
Other Income (Expense)
Other expense for the three months ended March 31, 2026 was $17.9 million, and other income for the three months ended March 31, 2025 was $8.8 million. The variance was primarily driven by a change in fair value of $20.0 million on the warrants to purchase Common Shares issued in our underwritten public offering that closed on September 30, 2022 (the “2022 USD Financing Warrants") due primarily to an increase in the Company's share price from December 31, 2025 to March 31, 2026.
Liquidity and Capital Resources
Sources of Liquidity
Since inception, we have financed our operations primarily from the issuance of equity and debt under our Amended Loan Agreement (as defined below). Our primary capital needs are for funds to support our scientific research and development activities including staffing, manufacturing, preclinical studies, clinical trials, commercialization planning, 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 commercialization of any of our product candidates. Our future operations are dependent upon our ability to finance our cash requirements which will allow us to
22
continue our research and development activities and the commercialization of our product candidates, if approved. There can be no assurance that we will be successful in continuing to finance our operations.
Our cash, cash equivalents and investments and our working capital at March 31, 2026, were $373.4 million and $299.5 million, respectively. Based on our current operating plan and anticipated milestones, we believe that our cash, cash equivalents and investments as of March 31, 2026 will be sufficient to fund our operations into 2028.
On March 7, 2024, we entered into an underwriting agreement with Leerink Partners LLC and Cantor Fitzgerald & Co., as representatives of the underwriters named therein, in connection with the offering of 16,666,667 of our Common Shares, at an offering price of $6.00 per share, less underwriting discounts and commissions (the "March 2024 Offering").
The net proceeds from the March 2024 Offering were approximately $93.5 million, after deducting underwriting discounts and commissions and other estimated offering expenses payable by us.
On March 7, 2024, we also entered into a securities purchase agreement with certain investors, pursuant to which such investors agreed to purchase, and we agreed to sell 12,500,000 Common Shares at a price of $6.00 per share, in a private placement (the "March 2024 Private Placement").
The net proceeds from the March 2024 Private Placement were approximately $70.1 million, after deducting fees and expenses payable. The March 2024 Offering and the Private Placement both closed on March 11, 2024.
On June 28, 2024, we entered into a sales agreement with Leerink Partners LLC (the "Sales Agreement") to create an at-the-market equity program under which we from time to time may offer and sell the ATM Shares (as defined below), through or to the Agent. We also filed a prospectus supplement on June 28, 2024 allowing for up to $150.0 million of Common Shares (the “ATM Shares”) to be sold under the Sales Agreement.
Subject to the terms and conditions of the Sales Agreement, the Agent will use its commercially reasonable efforts to sell the ATM Shares from time to time, based upon our instructions. The Agent will be entitled to a commission of up to 3.0% of the aggregate gross proceeds from each sale of the ATM Shares effectuated through or to the Agent.
We have no obligation to sell any of the ATM Shares and may, at any time suspend offers under the Sales Agreement or terminate the Sales Agreement. We had not sold any Common Shares under the 2024 ATM as of March 31, 2026.
On August 9, 2024, we entered into an underwriting agreement with Leerink Partners LLC and Evercore Group L.L.C., as representatives of the several underwriters named therein, in connection with an offering of (i) Common Shares, and (ii) to certain investors, pre-funded warrants to purchase Common Shares (the "August 2024 Offering"). The offering price for the common shares was $7.00 per share, less underwriting discounts and commissions. The offering price for the pre-funded warrants was $6.999 per pre-funded warrant, which represents the per share public offering price for the Common Shares less a $0.001 per share exercise price for each such pre-funded warrant.
The net proceeds from the August 2024 Offering were approximately $70.0 million, after deducting underwriting discounts and commissions and other offering expenses payable by us. The August 2024 Offering closed on August 12, 2024.
On October 29, 2025, we entered into an underwriting agreement (the "Underwriting Agreement") with Jefferies LLC, Leerink Partners LLC and Evercore Group L.L.C. (the "Underwriters"), as representatives of the several underwriters named therein, in connection with an underwritten public offering (the "October 2025 Offering") of 18,375,000 Common Shares, at an offering price of $12.25 per Common Share, less underwriting discounts and commissions. In addition, under the terms of the Underwriting Agreement, we granted the Underwriters an option, exercisable for 30 days, to purchase up to an additional 2,756,250 Common Shares at the same price, which was exercised by the Underwriters in full on October 30, 2025.
The gross proceeds to us from the October 2025 Offering, including the full exercise by the Underwriters of their option to purchase additional Common Shares, were approximately $258.9 million. Net proceeds were approximately $242.8 million, after deducting underwriting discounts and commissions and other estimated offering expenses payable by us. The October 2025 Offering closed on October 31, 2025.
On August 11, 2023, we entered into a Loan and Security Agreement (the “Loan Agreement”) with K2 HealthVentures LLC (“K2HV”) as administrative agent and Canadian collateral agent for lenders thereunder (K2HV, together with any other lender from time to time, the “Lenders”), and Ankura Trust Company, LLC, as collateral trustee for the Lenders, providing for an aggregate principal amount of term loans of up to $50.0 million (the “Term Loans”).. On April 18, 2025 (the “Effective Date”), we entered into
23
the First Amendment to the Loan Agreement with K2HV (as amended by the First Amendment, the “Amended Loan Agreement”). The Amended Loan Agreement provides for, among other things, an aggregate principal amount of term loans of up to $120.0 million, consisting of (A) a new Restatement First Tranche Term Loan (as defined in the Amended Loan Agreement) of $42.0 million, which was funded on the Effective Date, a portion of the proceeds of which was used on the Effective Date to refinance in full all term loans outstanding under the original Loan Agreement, and to pay fees and expenses in connection with the Amended Loan Agreement and the refinancing of the existing term loans, (B) subsequent tranches of term loans totaling up to $28.0 million, subject to the occurrence of certain time-based clinical and regulatory milestones and (C) an additional tranche of term loans of up to $50.0 million upon our request, subject to review by the Lenders of certain information from us and discretionary approval by the Lenders.
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 it will occur at all. We will continue to require substantial additional capital to develop our product candidates and to 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 of and seek regulatory approvals for our product candidates. Further, we are subject to all the risks incidental to 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:
Based on our current operating plan and anticipated milestones, we believe that our cash, cash equivalents and investments as of March 31, 2026 will be sufficient to fund our operations into 2028. 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 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 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:
24
Cash Flows (in thousands)
|
|
Three Months Ended March 31, |
|
|||||
|
|
2026 |
|
|
2025 |
|
||
Net cash used in operating activities |
|
$ |
(42,631 |
) |
|
$ |
(29,419 |
) |
Net cash provided by (used in) investing activities |
|
|
42,000 |
|
|
|
(162,458 |
) |
Net cash provided by financing activities |
|
|
5,309 |
|
|
|
1,002 |
|
Foreign exchange impact on cash |
|
|
3 |
|
|
|
(12 |
) |
Net increase/(decrease) in cash and cash equivalents |
|
$ |
4,681 |
|
|
$ |
(190,887 |
) |
Cash flows from operating activities
Cash used in operating activities for the three months ended March 31, 2026 was $42.6 million, which consisted of a net loss of $77.1 million, offset by a net change of $5.4 million in our net operating assets and liabilities, and $29.0 million in non-cash charges. The non-cash charges primarily consisted of a change in fair value on the 2022 USD Financing Warrants liability of $20.0 million, share-based compensation expense of $7.1 million, change in fair value of DDSU of $1.0 million, and amortization of discounts and premiums on investments, net of $0.6 million.
Cash used in operating activities for the three months ended March 31, 2025 was $29.4 million, which consisted of a net loss of $23.3 million and a net change of $2.5 million in our net operating assets and liabilities, and $3.6 million in non-cash charges. The non-cash charges primarily consisted of a change in fair value on the 2022 USD Financing Warrants liability of $7.0 million, and share-based compensation of $3.4 million.
Cash flows from investing activities
Cash provided by investing activities for the three months ended March 31, 2026 consisted of maturities of investments of $42.0 million. Cash used in investing activities for the three months ended March 31, 2025 consisted of purchases of investments of $162.5 million.
Cash flows from financing activities
Cash provided by financing activities for the three months ended March 31, 2026, was $5.3 million, which consisted of $3.8 million of proceeds from the exercise of certain of the 2022 USD Financing Warrants, $1.2 million in proceeds from the exercise of options, and $0.3 million in proceeds from the issuance of Common Shares under the Employee Share Purchase Plan.
Cash provided by financing activities for the three months ended March 31, 2025 was $1.0 million, which consisted of $0.6 million of proceeds from the exercise of certain of the 2022 USD Financing Warrants, $0.2 million in proceeds from the exercise of options, and $0.2 million in proceeds from the issuance of Common Shares under the Employee Share Purchase Plan.
25
Contractual Obligations and Contingencies
See Note 10 to our unaudited condensed consolidated financial statements located in “Part I – Financial Information, Item 1. Notes to Condensed Consolidated Financial Statements” in this Quarterly Report for a description of our contractual obligations and contingencies.
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 March 31, 2026, which have been prepared in accordance with U.S. GAAP, and on a basis consistent with those accounting principles followed by us and disclosed in Note 2 to our audited consolidated financial statements in the 2025 Annual Report. The preparation of these unaudited 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 and estimates from those described in “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” included in our 2025 Annual Report.
On July 4, 2025, the One Big Beautiful Bill Act was signed into law, which enacts significant changes to U.S. tax and related laws. Some of the provisions of the new tax law affecting corporations include but are not limited to current deduction of domestic research expenses, increasing the limit of the deduction of interest expense deduction to thirty percent of EBITDA, and one hundred percent bonus depreciation on eligible property acquired after January 19, 2025. There were no changes to our tax expense or effective income tax rate given our valuation allowance position.
Recent Accounting Pronouncements
See Note 2 to our unaudited condensed consolidated financial statements located in “Part I – Financial Information, Item 1. Notes to Condensed Consolidated Financial Statements” in this Quarterly Report for a description of recent accounting pronouncements applicable to our financial statements.
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 last day of the fiscal year following the fifth anniversary of our first sale of common equity securities under an effective Securities Act of 1933 registration statement or such earlier time that we no longer are an emerging growth company. 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. We will no longer be an emerging growth company after December 31, 2026.
26
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 not required to provide the 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 and Chief Financial Officer as appropriate, to allow timely decisions regarding required disclosure. As of March 31, 2026, 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 March 31, 2026.
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 Rules 13a-15(d) and 15d-15(d) of the Securities Exchange Act of 1934 that occurred during the quarter ended March 31, 2026 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
Inherent Limitations on Effectiveness of 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.
27
Part Ii - OTHER INFORMATION
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.
Item 1A. Risk Factors.
During the three months ended March 31, 2026, there were no material changes to the "Risk Factors" included in our Annual Report on Form 10-K for the year ended December 31, 2025. You should carefully consider the information described therein and in this Quarterly Report on Form 10-Q, which could materially affect our business condition, results of operations and cash flows.
28
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
For a description of certain working capital restrictions, including limitations upon the payment of dividends, see the description of our Amended Loan Agreement in Note 11 to our unaudited interim condensed consolidated financial statements located in “Part I – Financial Information, Item 1. Notes to Condensed Consolidated Financial Statements” in this Quarterly Report.
Item 3. Defaults upon Senior Securities
Not applicable.
Item 4. Mine Safety Disclosures.
Not applicable
Item 5. Other Information.
Rule 10b5-1 Trading Arrangements
During the fiscal quarter ended March 31, 2026, no director or officer of the Company
29
Item 6. Exhibits.
Exhibit Number |
|
Description |
Incorporated by Reference |
|||
|
|
|
Form |
Exhibit No. |
Filing Date |
File No. |
3.1 |
|
Amended and Restated Articles of Definium Therapeutics, Inc., effective as of January 9, 2026. |
10-K |
3.1 |
February 26, 2026 |
001-40360 |
3.2 |
|
Notice of Articles, Incorporated on July 26, 2010, effective as of January 9, 2026. |
8-K |
3.1 |
January 12, 2026 |
001-40360 |
3.3 |
|
8-K |
3.2 |
January 12, 2026 |
001-40360 |
|
10.1*# |
|
Form of PSU Agreement under the Definium Therapeutics, Inc. 2025 Equity Incentive Plan. |
|
|
|
|
10.2*# |
|
Non-Employee Director Compensation Policy, amended as of April 15, 2026. |
|
|
|
|
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 with Embedded Linkbase Documents |
|
|
|
|
104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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* Filed or furnished herewith.
# Indicates management contract or compensatory plan.
+ These certifications are being furnished herewith 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.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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Definium Therapeutics, Inc. |
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Date: May 7, 2026 |
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By: |
/s/ Robert Barrow |
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Robert Barrow |
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Chief Executive Officer
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Date: May 7, 2026 |
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By: |
/s/ Brandi L. Roberts |
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Brandi L. Roberts, CPA |
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Chief Financial Officer |
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