Milestone Pharmaceuticals (NASDAQ: MIST) posts first CARDAMYST sales and boosts cash with royalty deal
Milestone Pharmaceuticals reported its first quarter of commercial sales for CARDAMYST, its newly approved nasal spray for paroxysmal supraventricular tachycardia, generating $0.2 million in product revenue for the three months ended March 31, 2026. The company remains in an investment phase, with a net loss of $26.1 million compared with $20.8 million a year earlier, driven mainly by higher commercial spending.
Milestone ended the quarter with cash, cash equivalents and short-term investments of $184.2 million, and believes this balance will fund planned operations for at least 12 months. During the quarter it received $75 million from a royalty financing tied to future U.S. CARDAMYST sales and raised additional equity via an at-the-market program and warrant exercises, while continuing development of etripamil for atrial fibrillation with rapid ventricular rate.
Positive
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Insights
Early CARDAMYST launch revenue is modest, but liquidity is strong and commercialization spend is ramping.
Milestone Pharmaceuticals is transitioning from pure R&D to a commercial-stage model. Q1 2026 product revenue from CARDAMYST was $0.238 million, reflecting the very early phase of the U.S. launch after FDA approval in December 2025. Operating expenses of $23.9 million included $15.8 million for commercial activities, underscoring the upfront investment in sales, marketing, and market access.
Net loss widened to $26.1 million from $20.8 million, and operating cash outflow was $16.1 million. To support this ramp, Milestone closed a $75 million Royalty Purchase Agreement with RTW, recorded as a royalty financing obligation with a 19.6% effective interest rate, and raised additional equity capital, leaving $184.2 million in cash and short-term investments at quarter-end.
The balance sheet now carries $58.2 million of senior secured convertible notes and a $78.1 million royalty obligation, both serviced through future cash flows. Management states this liquidity should fund operations for at least 12 months. Subsequent warrant exercises added a further $10 million in gross proceeds, while a new controlled equity sales agreement provides another potential capital source as the CARDAMYST launch and AFib-RVR Phase 3 program progress.
Key Figures
Key Terms
Royalty Purchase Agreement financial
paroxysmal supraventricular tachycardia medical
AFib-RVR medical
ASC 606 financial
held to maturity financial
effective interest rate financial
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 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)
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(State or other jurisdiction of | | (I.R.S. Employer |
(
(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)
Securities registered pursuant to Section 12(b) of the Act:
Title of each class | | Trading Symbol(s) | | Name of each exchange on which registered |
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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.
Large accelerated filer | ☐ | | Accelerated filer | ☐ |
☒ | | Smaller reporting company | ||
Emerging growth company | | | ||
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
As of May 13, 2026, the registrant had
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| Page | |
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS | 1 | |
| | |
PART I. | FINANCIAL INFORMATION | 3 |
| | |
Item 1. | Financial Statements (Unaudited) | 3 |
| Condensed Consolidated Balance Sheets | 3 |
| Condensed Consolidated Statements of Loss | 4 |
| Condensed Consolidated Statements of Shareholders’ Equity | 5 |
| Condensed Consolidated Statements of Cash Flows | 6 |
| Notes to Unaudited Condensed Consolidated Financial Statements | 7 |
Item 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 25 |
Item 3. | Quantitative and Qualitative Disclosures About Market Risk | 40 |
Item 4. | Controls and Procedures | 40 |
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PART II. | OTHER INFORMATION | 41 |
| | |
Item 1. | Legal Proceedings | 41 |
Item 1A. | Risk Factors | 41 |
Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds | 41 |
Item 3. | Defaults Upon Senior Securities | 41 |
Item 4. | Mine Safety Disclosures | 41 |
Item 5. | Other Information | 42 |
Item 6. | Exhibits | 42 |
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“Milestone Pharmaceuticals” and the Milestone logo appearing in this Quarterly Report on Form 10-Q are unregistered trademarks of Milestone Pharmaceuticals Inc. All other trademarks, trade names and service marks appearing in this Quarterly Report on Form 10-Q are the property of their respective owners. Solely for convenience, the trademarks and trade names in this Quarterly Report on Form 10-Q may be referred to without the ® and ™ symbols, but such references should not be construed as any indicator that their respective owners will not assert their rights thereto.
This Quarterly Report on Form 10-Q contains references to United States dollars and Canadian dollars. All dollar amounts referenced, unless otherwise indicated, are expressed in United States dollars. References to “$” are to United States dollars and references to “C$” are to Canadian dollars.
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 strategy, future financial condition, future operations, projected costs, prospects, plans, objectives of management, and expected market growth, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “positioned,” “potential,” “seek,” “should,” “target,” “will,” “would,” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology.
We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy, and financial needs. These forward-looking statements are subject to a number of known and unknown risks, uncertainties and assumptions, including risks described in the section titled “Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q, regarding, among other things:
| ● | our expectations regarding the commercialization of CARDAMYST™ (etripamil) nasal spray for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia, or “PSVT,” to sinus rhythm in adults as well as our plans to develop and commercialize our product candidates; |
| ● | the initiation, timing, progress, and results of our current and future clinical trials of etripamil, including our Phase 3 clinical trial of etripamil for the treatment of atrial fibrillation and rapid ventricular rate, and of our research and development programs; |
| ● | our ability to develop and, if approved by regulatory authorities, commercialize etripamil in China, Hong Kong, Macau, and Taiwan through our license agreement with our partner Everest Medicines, formerly partnered with Corxel Pharmaceuticals; |
| ● | our estimates regarding expenses, future revenue, capital requirements, and needs for additional financing; |
| ● | our ability to establish collaborations or obtain additional funding; |
| ● | our ability to obtain regulatory approval of our current products for new indications and/or of our future product candidates; |
| ● | our expectations regarding the potential market size and the rate and degree of market acceptance of etripamil and any future product candidates; |
| ● | our ability to fund our working capital requirements and expectations regarding the sufficiency of our capital resources; |
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| ● | the implementation of our business model and strategic plans for our business, etripamil, and any future product candidates; |
| ● | our intellectual property position and the duration of our patent rights; |
| ● | developments or disputes concerning our intellectual property or other proprietary rights; |
| ● | our expectations regarding government and third-party payor coverage and reimbursement; |
| ● | our ability to compete in the markets we serve; |
| ● | the impact of government laws and regulations; |
| ● | developments relating to our competitors and our industry; |
| ● | the effects of international trade policies, including tariffs, sanctions, and trade barriers; and |
| ● | other factors that may impact our financial results. |
The foregoing list of risks is not exhaustive. Other sections of this Quarterly Report on Form 10-Q and the section titled “Risk Factors” previously disclosed in Part I, Item 1A. in our Annual Report on Form 10-K may include additional factors that could harm our business and financial performance. Moreover, we operate in a very competitive and rapidly changing environment. New risk factors emerge from time to time, and it is not possible for our management to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in, or implied by, any forward-looking statements.
In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. Although we believe that we have a reasonable basis for each forward-looking statement contained in this Quarterly Report on Form 10-Q, we cannot guarantee that the future results, levels of activity, performance, or events and circumstances reflected in the forward-looking statements will be achieved or occur at all. You should refer to the section titled "Risk Factors" previously disclosed in Part I, Item 1A. in our Annual Report on Form 10-K, filed with the SEC and under Milestone’s SEDAR+ profile at www.sedarplus.com on March 20, 2026, for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. Except as required by law, we undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events, or otherwise.
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PART I—FINANCIAL INFORMATION
Item 1. Financial Statements.
Milestone Pharmaceuticals Inc.
Condensed Consolidated Balance Sheets (Unaudited)
(in thousands of US dollars, except share data)
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| | March 31, 2026 | | December 31, 2025 | ||
Assets | | | |
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Current assets | | | |
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Cash and cash equivalents | | $ | |
| $ | |
Short-term investments | | | | | | |
Accounts receivable, net | | | | | | — |
License receivable | | | | | | |
Research and development tax credits receivable | | | |
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Prepaid expenses | | | |
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Inventory, net | | | | | | |
Other receivables | | | |
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Total current assets | | | |
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Operating lease right-of-use assets | | | | | | |
Property and equipment, net | | | |
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Total assets | | $ | |
| $ | |
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Liabilities, and Shareholders' Equity | | | |
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Current liabilities | | | |
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Accounts payable | | $ | |
| $ | |
Accrued liabilities | | | | | | |
Operating lease liabilities | | | |
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Deferred revenue | | | | | | — |
Other current liabilities | | | | | | |
Total current liabilities | | | |
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Operating lease liabilities, net of current portion | | | |
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Senior secured convertible notes | | | | | | |
Royalty financing obligation, long-term | | | | | | — |
Other long-term liabilities | | | | | | |
Total liabilities | | | |
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Shareholders’ Equity | | | |
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Common shares, | | | |
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Pre-funded warrants - | | | | | | |
Additional paid-in capital | | | |
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Accumulated deficit | | | ( |
| | ( |
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Total shareholders’ equity | | | |
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Total liabilities and shareholders’ equity | | $ | |
| $ | |
The accompanying notes are an integral part of these interim condensed consolidated financial statements.
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Milestone Pharmaceuticals Inc.
Condensed Consolidated Statements of Loss (Unaudited)
(in thousands of US dollars, except share and per share data)
| | | | | | | |
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| | Three months ended March 31, | | ||||
| | 2026 | | 2025 | | ||
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Revenues | | | | | | | |
Product revenue, net | | $ | | | $ | — | |
License and other revenue | | | — | | | — | |
Total revenues | | | | | | — | |
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Operating Expenses | | | |
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Cost of product sales | | | | | | — | |
Research and development, net of tax credits | | | |
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General and administrative | | | |
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Commercial | | | |
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Total operating expenses | | | | | | | |
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Loss from operations | | | ( |
| | ( | |
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Interest income | | | |
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Interest expense | | | ( | | | ( | |
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Net loss and comprehensive loss | | $ | ( |
| $ | ( | |
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Weighted average number of shares and pre-funded warrants outstanding, basic and diluted | | | | | | | |
| | | | | | | |
Net loss per share, basic and diluted | | $ | ( |
| $ | ( | |
The accompanying notes are an integral part of these interim condensed consolidated financial statements.
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Milestone Pharmaceuticals Inc.
Condensed Consolidated Statements of Shareholders’ Equity (Unaudited)
(in thousands of US dollars, except share data)
| | | | | | | | | | | | | | | | | | | |
| | Common Shares | | Pre-funded warrants | | | | | | | | | | ||||||
| | Number | | Amount | | Number | | Amount | | Additional | | Accumulated | | Total | |||||
Balance as of December 31, 2024 | | | | $ | | | | | $ | | | $ | | | $ | ( | | $ | |
Transactions during the three-month period ended March 31, 2025 | | | | | | | | | | | | | | | | | | | |
Net loss | | — | | | — | | — | | | — | | | — | | | ( | | | ( |
Share-based compensation | | — | | | — | | — | | | — | | | | | | — | | | |
Employee stock purchase plan purchases | | | | | | | — | | | — | | | — | | | — | | | |
Balance as of March 31, 2025 | | | | $ | | | | | $ | | | $ | | | $ | ( | | $ | ( |
| | | | | | | | | | | | | | | | | | | |
Balance as of December 31, 2025 | | | | $ | | | | | $ | | | $ | | | $ | ( | | $ | |
Transactions during the three-month period ended March 31, 2026 | | | | | | | | | | | | | | | | | | | |
Net loss | | — | | | — | | — | | | — | | | — | | | ( | | | ( |
Share-based compensation | | — | | | — | | — | | | — | | | | | | — | | | |
Issuance of common shares, vesting of restricted stock units | | | | | | | — | | | — | | | ( | | | — | | | — |
Issuance of common shares, net of issuance costs | | | | | | | — | | | — | | | — | | | — | | | |
Exercise of Series A common stock warrants, net of issuance costs | | | | | | | — | | | — | | | ( | | | — | | | |
Employee stock purchase plan purchases | | | | | | | — | | | — | | | — | | | — | | | |
Balance as of March 31, 2026 | | | | $ | | | | | $ | | | $ | | | $ | ( | | $ | |
The accompanying notes are an integral part of these interim condensed consolidated financial statements.
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Milestone Pharmaceuticals Inc.
Condensed Consolidated Statements of Cash Flows (Unaudited)
(in thousands of US dollars)
| | | | | | |
| | Three months ended March 31, | ||||
| | 2026 | | 2025 | ||
Cash flows used in operating activities | | | | | | |
Net loss | | $ | ( | | $ | ( |
Adjustments to reconcile net loss to net cash used in operating activities: | | | | | | |
Depreciation of property and equipment | | | | | | |
Amortization of debt costs | | | | | | |
Accretion of investment discount | | | — | | | ( |
Non-cash interest expense related to senior secured convertible note | | | | | | |
Non-cash interest expense related to royalty financing obligation | | | | | | — |
Share-based compensation expense | | | | | | |
Changes in operating assets and liabilities: | | | | | | |
Accounts receivable, net | | | ( | | | — |
Other receivables | | | | | | |
Research and development tax credits receivable | | | ( | | | ( |
Prepaid expenses | | | | | | ( |
Inventory | | | ( | | | — |
Operating lease assets and liabilities | | | ( | | | ( |
Accounts payable | | | | | | |
Accrued liabilities | | | | | | |
Deferred revenue | | | | | | — |
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Net cash used in operating activities | | | ( | | | ( |
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Cash flows provided by (used in) investing activities | | | | | | |
Acquisition of property and equipment | | | ( | | | ( |
Acquisition of short-term investments | | | ( | | | ( |
Redemption of short-term investments | | | — | | | |
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Net cash (used in) provided by investing activities | | | ( | | | |
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Cash flows provided by (used in) financing activities | | | | | | |
Proceeds from Royalty Financing Arrangement | | | | | | — |
Proceeds from issuance of common shares, net of issuance costs | | | | | | — |
Proceeds from exercise of series A warrants, net of issuance costs | | | | | | — |
Proceeds from employee stock purchase plan | | | | | | |
Payment of property and equipment financing | | | ( | | | — |
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Cash provided by financing activities | | | | | | |
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Net (decrease) increase in cash and cash equivalents | | | ( | | | |
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Cash and cash equivalents – Beginning of period | | | | | | |
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Cash and cash equivalents – End of period | | $ | | | $ | |
The accompanying notes are an integral part of these interim condensed consolidated financial statements.
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Milestone Pharmaceuticals Inc.
Notes to Condensed Consolidated Financial Statements
For the Three Months Ended March 31, 2026 and 2025 (Unaudited)
(in thousands of US dollars, except where noted and for share and per share data)
1. Organization and Nature of Operations
Milestone Pharmaceuticals Inc., or “Milestone,” or the “Company,” is a biopharmaceutical company incorporated under the Business Corporations Act (Québec). Milestone’s headquarters is currently located in Montréal (Québec), Canada. The Company’s common shares began trading on The Nasdaq Global Select Market on May 9, 2019, and trade under the symbol “MIST”. Milestone is focused on the development and commercialization of innovative cardiovascular medicines. Milestone’s lead product candidate, etripamil, is a novel, potent rapid-onset calcium channel blocker that the Company designed and is developing as a rapid-onset nasal spray to be administered by patients. On December 12, 2025, CARDAMYST™ (etripamil) was approved by the U.S. Food and Drug Administration, or “FDA,” to treat paroxysmal supraventricular tachycardia, or “PSVT.” The Company is also developing etripamil for the treatment of atrial fibrillation with rapid ventricular rate, or “AFib-RVR,” and other cardiovascular indications.
2. Summary of Significant Accounting Policies
a) Basis of Consolidation
The condensed consolidated financial statements include the accounts of the Company and Milestone Pharmaceuticals USA, Inc. All intercompany transactions and balances have been eliminated.
b) Basis of Presentation and Use of Accounting Estimates and Significant Accounting Policies
These unaudited interim condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America, or “U.S. GAAP,” pursuant to the rules and regulations of the Securities and Exchange Commission (SEC) for interim financial information, and on a basis consistent with those accounting principles followed by the Company and disclosed in Note 2, “Summary of Significant Accounting Policies,” of its most recent annual consolidated financial statements. Certain information, in particular the accompanying notes normally included in the annual financial statements prepared in accordance with U.S. GAAP, has been omitted or condensed. Accordingly, these unaudited interim condensed consolidated financial statements do not include all the information required for full annual financial statements, and therefore, should be read in conjunction with the annual consolidated financial statements and the notes thereto for the year ended December 31, 2025.
In the opinion of the Company's management, the accompanying unaudited interim condensed consolidated financial statements contain all adjustments, consisting of only normal recurring adjustments, necessary for a fair statement of its condensed consolidated balance sheet as of March 31, 2026, and its condensed consolidated statements of loss and shareholders’ equity for the three-months ended March 31, 2026 and 2025, and its condensed consolidated statements of cash flows for the three-months ended March 31, 2026 and 2025.
The condensed consolidated balance sheet as of December 31, 2025, was derived from the audited annual consolidated financial statements, but does not contain all the footnote disclosures required by U.S. GAAP. Commencing in the three months ended March 31, 2026, amounts previously presented as “Accounts payable and accrued liabilities” on the Condensed Consolidated Balance Sheets are presented separately as “Accounts payable” and “Accrued liabilities.” Comparative amounts have been reclassified to conform with the current period presentation.
These unaudited interim condensed consolidated financial statements are presented in US dollars, which is the Company’s functional currency.
The preparation of unaudited interim condensed consolidated financial statements in conformity with U.S. GAAP requires the Company to make estimates and judgments that affect certain reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenue and expenses during the period. The Company bases its estimates and assumptions on current facts, historical experience
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Milestone Pharmaceuticals Inc.
Notes to Condensed Consolidated Financial Statements
For the Three Months Ended March 31, 2026 and 2025 (Unaudited)
(in thousands of US dollars, except where noted and for share and per share data)
and various other factors that it believes are reasonable under the circumstances, to determine the carrying values of assets and liabilities that are not readily apparent from other sources. Significant estimates and judgments include, but are not limited to,
| ● | Estimates of the percentage of work completed of the total work over the life of the individual trial in accordance with agreements established with clinical research organizations, or “CROs,” contract manufacturing organizations, or “CMOs,” and clinical trial sites which in turn impact the research and development, or “R&D,” expenses. |
| ● | Estimate of the grant date fair value of share options granted to employees, consultants, and directors, and the resulting share-based compensation expense, using the Black-Scholes option pricing model. |
| ● | Estimate of the transaction price when recognizing revenue. Net revenue from sales of CARDAMYST is recorded at net selling price (transaction price), which includes reserves for variable consideration. |
| ● | Estimates of the timing and amount of future royalty payments to be generated from product sales over the expected repayment term, which are used to determine the effective interest rate and resulting interest expense and carrying amount of the royalty financing obligation. |
Estimates and assumptions about future events and their effects cannot be determined with certainty and therefore require the exercise of judgment. As of the date of issuance of these condensed consolidated financial statements, the Company is not aware of any specific event or circumstance that would require the Company to update its estimates, assumptions and judgments. These estimates may change as new events occur and additional information is obtained and are recognized in the consolidated financial statements as soon as they become known. Actual results could differ from those estimates, and any such differences may be material to the Company’s condensed consolidated financial statements.
c) Significant Risks and Uncertainties
The Company is subject to challenges and risks specific to its business and its ability to execute on its strategy, as well as risks and uncertainties common to companies in the pharmaceutical industry, including, without limitation, risks and uncertainties associated with: commercializing CARDAMYST; procuring inventory given the Company’s reliance on a concentrated supplier base, delays or problems in the supply of its study drug or failure to comply with manufacturing regulations; identifying, acquiring or in-licensing product candidates; pharmaceutical product development and the inherent uncertainty of clinical success; and the challenges of protecting and enhancing its intellectual property rights; and complying with applicable regulatory requirements.
Further, the Company may be impacted by general economic, political, and market conditions, including deteriorating market conditions due to investor concerns regarding inflation, armed conflicts, and overall fluctuations in the financial markets in the U.S. and abroad.
d) Recent Accounting Pronouncements
In November 2024, the Financial Accounting Standards Board, or “FASB,” issued Accounting Standards Update, or “ASU” 2024-03 “Income Statement: Reporting Comprehensive Income— Expense Disaggregation Disclosures,” which requires more detailed information about specified categories of expenses (purchases of inventory, employee compensation, depreciation, amortization, and depletion) included in certain expense captions presented on the face of the income statement, as well as disclosures about selling expenses. This ASU is effective for fiscal years beginning after December 15, 2026, and for interim periods within fiscal years beginning after December 15, 2027. Early adoption is permitted. The amendments may be applied either (1) prospectively to financial statements issued for reporting periods
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Milestone Pharmaceuticals Inc.
Notes to Condensed Consolidated Financial Statements
For the Three Months Ended March 31, 2026 and 2025 (Unaudited)
(in thousands of US dollars, except where noted and for share and per share data)
after the effective date of this ASU or (2) retrospectively to all prior periods presented in the financial statements. The Company is currently evaluating this guidance to determine the impact it may have on its financial statement disclosures.
In November 2024, the FASB issued ASU 2024-04, “Debt—Debt with Conversion and Other Options (Subtopic 470-20): Induced Conversions of Convertible Debt Instruments,” which clarifies the requirements for determining whether certain settlements of convertible debt instruments should be accounted for as induced conversions or as debt extinguishments. This ASU is effective for fiscal years beginning after December 15, 2025, including interim periods within those fiscal years. The amendments may be applied on either a prospective or retrospective basis. The Company adopted this standard and determined that it did not have a material impact with respect to the condensed consolidated financial statements.
In July 2025, the FASB issued ASU 2025-05, “Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses for Accounts Receivable and Contract Assets,” which provides a practical expedient for estimating expected credit losses on current accounts receivable and current contract assets arising from transactions accounted for under ASC 606. This ASU is effective for fiscal years beginning after December 15, 2025, including interim periods within those fiscal years. The amendments are applied prospectively. The Company adopted this standard and determined that it did not have a material impact with respect to the condensed consolidated financial statements.
e) Sources of Liquidity and Funding Requirements
The Company has incurred operating losses and experienced negative operating cash flows since its inception and expects to incur additional costs in connection with commercialization. To date the Company has, and intends to continue, financing commercialization and working capital needs from existing cash, proceeds from the commercialization of CARDAMYST, royalty revenue, the exercise of outstanding common stock options and warrants to purchase common stock, and existing and future licensing and commercial partnership agreements. As of March 31, 2026, the Company had cash, cash equivalents and short-term investments of $
The Company has historically financed its operations primarily through the sale of equity securities, convertible notes, short-term investments, and from cash received pursuant to its license agreement. Although the Company is now generating product revenues, management expects operating losses and negative cash flows from operations to continue for the foreseeable future. There can be no assurance that, in the event the Company requires additional financing, such financing will be available at terms acceptable to the Company, if at all. Failure to generate sufficient cash flows from operations, raise additional capital and reduce discretionary spending should additional capital not become available could have a material adverse effect on the Company’s ability to achieve its business objectives.
f) Revenue Recognition
Product Revenue, net
The Company recognizes revenue in accordance with FASB Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers (“ASC 606”). Revenue is recognized at a point in time when the customer obtains control of promised goods or services in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligation(s) in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligation(s) in the contract; and (v) recognize revenue when (or as) the Company satisfies its performance obligation(s).
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Milestone Pharmaceuticals Inc.
Notes to Condensed Consolidated Financial Statements
For the Three Months Ended March 31, 2026 and 2025 (Unaudited)
(in thousands of US dollars, except where noted and for share and per share data)
The Company’s product revenues for the three months ended March 31, 2026 relate to sales of CARDAMYST. The Company recognizes revenue on product sales when control of the promised goods is transferred to its customers in an amount that reflects the consideration expected to be received in exchange for transferring those goods. The Company accounts for a contract when it has approval and commitment from both parties, the rights of the parties are identified, payment terms are identified, the contract has commercial substance and collectability of consideration is probable. When determining whether the customer has obtained control of the goods, the Company considers any future performance obligations.
Revenue is recorded net of variable consideration, which includes prompt pay discounts, distribution fees, returns, chargebacks, rebates, co-payment assistance, and patient assistance programs. The variable consideration is estimated based on contractual terms as well as management assumptions. The amount of variable consideration is calculated by using the expected value method, which is the sum of probability-weighted amounts in a range of possible outcomes, or the most likely amount method, which is the single most likely amount in a range of possible outcomes. Estimates are reviewed quarterly and adjusted as necessary.
Accruals are established for gross to net deductions and actual amounts incurred are offset against applicable accruals. The Company reflects these accruals as either a reduction in the related account receivable from the customer or as an accrued liability, depending on the means by which the deduction is settled. Sales deductions are based on management’s estimates that involve a substantial degree of judgment.
Prompt Pay: Customers receive a prompt pay discount for payments made within a contractually agreed number of days before the due date. The discounts are accounted for as a reduction of the transaction price and recorded as a contra-receivable.
Distribution fees: The Company compensates its customers for distribution of its products and the use of data. The Company has determined that such services received to date are not distinct from its sale of products and may not reasonably represent fair value for these services. Therefore, estimates of these payments are recorded as a reduction of revenue based on contractual terms.
Returns: The Company records allowances for product returns as a reduction of revenue at the time product sales are recorded. Product returns are estimated based on forecasted sales and historical and industry data. Returns are permitted in accordance with the return of goods policy defined within each customer agreement. A returns reserve is recorded as an accrued liability.
Chargebacks: The Company estimates obligations resulting from contractual commitments with the government and other entities to sell products to qualified healthcare providers at prices lower than the list prices charged to the customer who directly purchases from the Company. The customer charges the Company for the difference between what it pays to the Company for the product and the selling price to the qualified healthcare providers, with the difference recorded as a contra receivable.
Co-payment assistance and patient assistance programs: Patients who have commercial insurance and meet certain eligibility requirements may receive co-payment assistance. Based upon the terms of the program and co-payment assistance utilization reports received, the Company estimates the co-payment assistance amounts, which are recorded in the same period in which the related revenue is recognized, resulting in a reduction of product revenue and establishment of a current liability.
Rebates: The Company’s rebates include amounts paid to managed care organizations, Medicaid, Medicare, and other rebate programs. Reserves for rebates are recorded in the same period the related product revenue is recognized,
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Milestone Pharmaceuticals Inc.
Notes to Condensed Consolidated Financial Statements
For the Three Months Ended March 31, 2026 and 2025 (Unaudited)
(in thousands of US dollars, except where noted and for share and per share data)
resulting in a reduction of product revenues and a current liability that is included in accrued liabilities on the consolidated balance sheet. The Company’s estimate for rebates is based on statutory or contractual discount rates, expected utilization or an estimated number of patients on treatment, as applicable.
License Revenue
The Company recorded
In prior periods, the Company recognized license revenue upon achievement of milestones under its License and Collaboration Agreement, dated May 15, 2021 (the “Ji Xing License Agreement”), with Corxel Pharmaceuticals (formerly known as Ji Xing Pharmaceuticals Limited, “Ji Xing”). On March 23, 2026, Corxel announced that it had entered into an Asset Purchase Agreement with Everest Medicines (“Everest”), pursuant to which Everest acquired the rights to develop, manufacture and commercialize CARDAMYST™ (etripamil) nasal spray in Greater China, including mainland China, Hong Kong, Macau and Taiwan.
g) Cost of Product Sales
Cost of product sales includes the costs of producing inventory related to CARDAMYST, including manufacturing, freight, overhead, and any inventory valuation adjustments, and is recognized in the period in which the related product revenue is earned.
Prior to FDA approval of CARDAMYST on December 12, 2025, all manufacturing costs were expensed as research and development costs. As a result, inventory on hand at the time of approval had a zero-cost basis.
For the three months ended March 31, 2026, the Company recognized a de minimis amount of cost of product sales, consisting primarily of post-approval manufacturing activities, including final packaging costs. Accordingly, cost of product sales for the period may not be indicative of the full cost of units sold, and gross margin may not be representative of future periods. The Company recorded
h) Royalty Financing Obligation
The royalty financing obligation is required to be repaid based on royalties from net sales of CARDAMYST in the United States under the Royalty Purchase Agreement with RTW – see Note 11, “Royalty Financing Obligation,” for further details on the Royalty Purchase Agreement. Interest expense is accrued using the effective interest rate method over the estimated period of royalty payments. This requires the Company to estimate the total amount of future royalty payments to be generated from product sales in the United States over the estimated repayment term of the obligation. The Company imputes interest on the carrying value of the royalty financing obligation and records interest expense using an imputed effective interest rate. The Company reassesses the expected royalty payments each reporting period and accounts for any changes through adjustments to the effective interest rate on a prospective basis. The assumptions used in determining the estimated repayment term of the debt require that the Company make estimates which could impact the carrying value of the obligation. A significant increase or decrease in forecasted net sales could materially impact the liability balance, interest expense, and the time period for repayment.
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Milestone Pharmaceuticals Inc.
Notes to Condensed Consolidated Financial Statements
For the Three Months Ended March 31, 2026 and 2025 (Unaudited)
(in thousands of US dollars, except where noted and for share and per share data)
i) Concentration Risks
Concentration of Credit Risk
Financial instruments that potentially subject the Company to concentration of credit risk consist primarily of cash and cash equivalents and investment securities classified as held-to-maturity. The Company maintains deposits at major financial institutions and such amounts may exceed those amounts insured by the Federal Deposit Insurance Corporation, or the “FDIC.” The Company has not experienced any losses on its deposits since inception, and the Company believes that minimal credit risk exists with respect to these financial institutions. Additionally, the Company has adopted an investment policy that includes guidelines relative to credit quality, diversification of maturities and liquidity.
Concentration of Supplier Risk
The Company relies on a single source manufacturer for starting materials and active pharmaceutical ingredient, or “API,” packaging components, and packaged pharmaceutical product ready for commercial sale.
j) Inventory
Inventory is stated at the lower of cost or net realizable value, with cost determined on a first-in, first-out, or “FIFO,” basis. Inventory costs include raw materials, work-in-process, finished goods, and applicable manufacturing overhead. Raw materials include starting materials used to manufacture the API. Work-in-process includes API, intermediate compounding steps, and bulk drug product. Finished goods include packaging components and the packaged pharmaceutical product ready for commercial sale.
Prior to the FDA’s approval of CARDAMYST on December 12, 2025, costs associated with manufacturing pre-approval commercial batches and clinical materials were expensed as research and development expenses in accordance with the Company’s accounting policy and SAB Topic 5A, as the product had not yet received regulatory approval and therefore did not meet the criteria for capitalization. Following FDA approval, the Company began capitalizing inventory related to CARDAMYST manufactured after the approval date. Inventory produced prior to approval and previously expensed as research and development remains recorded at a zero-cost basis and is excluded from the inventory balance.
Because the Company’s inventory is subject to expiration, the Company evaluates its carrying value each reporting period and records allowances for any estimated excess, obsolete, short-dated, or otherwise unmarketable inventory. In accordance with regulatory requirements and current Good Manufacturing Practices, or “cGMP,” the Company’s inventory is also subject to strict quality control and monitoring throughout the manufacturing process. If certain batches or units do not meet quality specifications, the Company would write down the related inventory to its estimated net realizable value and record the expense as a cost of production in the Consolidated Statement of Loss. Inventory valuation adjustments require judgment and consideration of various factors, including forecasted demand, remaining shelf life, and quality assessments, among others.
k) Income Taxes
The provision for income taxes is computed using the liability method. Under this method, deferred tax assets and liabilities are determined based on differences between financial reporting and tax bases of assets and liabilities. Deferred tax assets and liabilities are measured using enacted tax rates and laws that will be in effect when the differences are expected to reverse. A valuation allowance is recorded to reduce the carrying amount of deferred income tax assets until when it is more likely than not that these assets will be realized. Tax benefits related to tax positions not deemed to meet the “more likely than not” threshold are not permitted to be recognized in the consolidated financial statements.
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Milestone Pharmaceuticals Inc.
Notes to Condensed Consolidated Financial Statements
For the Three Months Ended March 31, 2026 and 2025 (Unaudited)
(in thousands of US dollars, except where noted and for share and per share data)
For interim reporting, the Company estimates its annual effective tax rate, adjusted for discrete items, and applies that rate to its year-to-date pre-tax income (loss) to determine its income tax provision.
3. Revenues
The Company recorded product revenues from the U.S. sales of CARDAMYST of $
The Company recorded
4. Short-term Investments
As of March 31, 2026, short-term investments of $
As of March 31, 2026, $
5. Inventory
As of March 31, 2026 and December 31, 2025, the Company’s inventory consisted entirely of CARDAMYST related inventory. The Company’s inventories consisted of the following:
| | | | | | |
| | March 31, 2026 | | December 31, 2025 | ||
Raw materials |
| $ | — | | $ | — |
Work-in-process |
|
| | |
| |
Finished goods | | | | | | |
Total inventory | | | | | | |
6. Debt
On March 27, 2023, the Company entered into a note purchase agreement, or the “Note Purchase Agreement,” with RTW Investments LP and certain of its affiliates, or collectively, “RTW.” On March 29, 2023, the Company closed the transactions contemplated by the Note Purchase Agreement, and issued and sold $
In accounting for the issuance of the 2029 Convertible Notes, the Company determined there were no embedded features, which require bifurcation between debt and equity components. As a result, the 2029 Convertible Notes are accounted for as a liability. As of March 31, 2026, the estimated fair value of the 2029 Convertible Notes was approximately $
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Milestone Pharmaceuticals Inc.
Notes to Condensed Consolidated Financial Statements
For the Three Months Ended March 31, 2026 and 2025 (Unaudited)
(in thousands of US dollars, except where noted and for share and per share data)
The net carrying amount of the 2029 Convertible Notes are as follows:
| | | | | | |
| | | ||||
| | March 31, 2026 | | December 31, 2025 | ||
Original principal |
| $ | | | $ | |
Paid in kind (PIK) interest | | | | | | |
Unamortized debt discount | | | ( | | | ( |
Unamortized debt issuance costs |
| | ( | | | ( |
Total |
| $ | | | $ | |
The following table presents the total amount of interest cost recognized relating to the 2029 Convertible Notes:
| | | | | | | |
| | | Three months ended March 31, | ||||
| | | 2026 | | 2025 | ||
Contractual interest expense | | | $ | |
| $ | |
Amortization of debt discount | | | | | | | |
Amortization of debt issuance costs | | | | |
| | |
Total | | | $ | |
| $ | |
7. Accrued Liabilities
Accrued liabilities are comprised of the following:
| | | | | | |
| | March 31, 2026 | | December 31, 2025 | ||
| | | |
| | |
Accrued compensation and benefits payable |
| | | | | |
Accrued research and development liabilities |
| | | | | |
Accrued commercial liabilities | | | | | | |
Accrued underwriting fees | | | | | | |
Accrued legal liabilities | | | | | | |
Other accrued liabilities |
| | | | | |
Revenue-related reserves for discounts and allowances | | | | | | — |
Total |
| $ | | | $ | |
8. Shareholders’ Equity
Authorized Share Capital
The Company has authorized and issued common shares, voting and participating, without par value, of which unlimited shares were authorized, and
As of March 31, 2026, there were
On July 11, 2025, the Company entered into an underwriting agreement, or the “Underwriting Agreement,” related to an underwritten public offering, or the “2025 Offering,” of (i)
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Milestone Pharmaceuticals Inc.
Notes to Condensed Consolidated Financial Statements
For the Three Months Ended March 31, 2026 and 2025 (Unaudited)
(in thousands of US dollars, except where noted and for share and per share data)
The net proceeds to the Company from the 2025 Offering were $
On July 29, 2020, the Company entered into an Open Market Sale AgreementSM, or the “Original Sale Agreement,” with respect to an at-the-market offering program, or the “ATM Program,” under which the Company could issue and sell its common shares having an aggregate offering price of up to $
The Company determines the accounting classification of warrants that are issued, as either liability or equity, by first assessing whether the warrants meet liability classification in accordance with ASC 480-10, Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity, and then in accordance with ASC 815-40, Accounting for Derivative Financial Instruments Indexed to, and Potentially Settled in, a Company’s Own Stock. Under ASC 480, warrants are considered liability classified if the warrants are mandatorily redeemable, obligate the issuer to settle the warrants or the underlying shares by paying cash or other assets, or must or may require settlement by issuing a variable number of shares.
If warrants do not meet liability classification under ASC 480-10, the Company assesses the requirements under ASC 815-40, which states that contracts that require or may require the issuer to settle the contract for cash are liabilities recorded at fair value, irrespective of the likelihood of the transaction occurring that triggers the net cash settlement feature. If the warrants do not require liability classification under ASC 815-40, in order to conclude equity classification, the Company assesses whether the warrants are indexed to its common stock and whether the warrants are classified as equity under ASC 815-40 or other applicable U.S. GAAP. After all relevant assessments are made, the Company concludes whether the warrants are classified as liability or equity. The Company's outstanding common stock warrants are classified as equity and recorded in additional paid-in capital, or “APIC,” based on an allocation of the proceeds from the 2025 Offering, which was based on the relative fair value of the Series A and B Common Warrants at the issuance date and is not subject to change after the issuance date. The fair value used for the relative fair value allocation was calculated using the Black-Scholes Model for the Series A Warrants and the Monte-Carlo simulation method for the Series B Warrants.
During the three-month period ended March 31, 2026,
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Milestone Pharmaceuticals Inc.
Notes to Condensed Consolidated Financial Statements
For the Three Months Ended March 31, 2026 and 2025 (Unaudited)
(in thousands of US dollars, except where noted and for share and per share data)
of March 31, 2026,
9. Share-Based Compensation
Stock Options
Under the Company’s 2019 Equity Incentive Plan, or the “2019 Plan,” and the Company’s Stock Option Plan, or the “2011 Plan,” unless otherwise decided by the Company’s board of directors, options vest and are exercisable as follows:
Under the 2019 Plan,
On November 10, 2021, the Company established a 2021 Inducement Plan, or the “Inducement Plan.” This 2021 Inducement Plan is intended to help the Company provide an inducement for certain individuals to enter employment with the Company, incentives for such persons to exert maximum efforts for the success of the Company and a means by which employees may benefit from increases in value of the common shares. On March 17, 2026, the Company’s board of directors approved an increase to the 2021 Inducement Plan pool of
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Milestone Pharmaceuticals Inc.
Notes to Condensed Consolidated Financial Statements
For the Three Months Ended March 31, 2026 and 2025 (Unaudited)
(in thousands of US dollars, except where noted and for share and per share data)
The total outstanding and exercisable options from the 2011 Plan, 2019 Plan, and Inducement Plan as of and for the three-month periods ending March 31 were as follows:
| | | | | | | | | | | | | | |
| | 2026 | ||||||||||||
| | | | | | | | | | | | | Weighted | |
| | Number | | | | average | ||||||||
| | of shares | | | | exercise | ||||||||
| | 2019 Plan | | Inducement Plan | | 2011 Plan | | Total | | price | ||||
Outstanding at beginning of period - 2011 Plan |
| | — | | | — | | | | | | | $ | |
Outstanding at beginning of period - 2019 Plan | | | | | | — | | | — | | | | | |
Outstanding at beginning of period - Inducement Plan | | | — | | | | | | — | | | | | |
Granted - 2019 Plan | | | | | | — | | | — | | | | | |
Granted - Inducement Plan | | | — | | | | | | — | | | | | |
Outstanding at end of period |
| | | | | | | | | | | | $ | |
Outstanding at end of period - Weighted average exercise price | | $ | | | $ | | | $ | | | | | | |
Exercisable at end of period | | | | | | | | | | | | | $ | |
Exercisable at end of period - Weighted average exercise price |
| $ | | | $ | | | $ | | | | | | |
| | | | | | | | | | | | | | |
| | 2025 | ||||||||||||
| | | | | | | | | | | | | Weighted | |
| | Number | | | | average | ||||||||
| | of shares | | | | exercise | ||||||||
| | 2019 Plan | | Inducement Plan | | 2011 Plan | | Total | | price | ||||
Outstanding at beginning of period - 2011 Plan | | | — | | | — | | | | | | | $ | |
Outstanding at beginning of period - 2019 Plan |
| | | | | — | | | — | | | | | |
Outstanding at beginning of period - Inducement Plan | | | — | | | | | | — | | | | | |
Granted - 2019 Plan | | | | | | — | | | — | | | | | |
Granted - Inducement Plan | | | — | | | | | | — | | | | | |
Outstanding at end of period | | | | | | | | | | | | | $ | |
Outstanding at end of period - Weighted average exercise price | | $ | | | $ | | | $ | | | | | | |
Exercisable at end of period | | | | | | | | | | | | | $ | |
Exercisable at end of period - Weighted average exercise price | | $ | | | $ | | | $ | | | | | | |
The weighted average remaining contractual life was
There was $
Options granted are valued using the Black-Scholes option pricing model. This model also requires assumptions, including expected option life, volatility, risk-free interest rate, and dividend yield, which greatly affect the calculated values. Amortization of the fair value of the options over vesting years has been expensed and credited to additional paid-in capital in shareholders’ equity.
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Milestone Pharmaceuticals Inc.
Notes to Condensed Consolidated Financial Statements
For the Three Months Ended March 31, 2026 and 2025 (Unaudited)
(in thousands of US dollars, except where noted and for share and per share data)
The non-vested options as of and for the three-month period ending March 31 were as follows:
| | | | | | | | | | | | | | |
| | 2026 | ||||||||||||
| | Number | | | | Weighted | ||||||||
| | of options | | | | average | ||||||||
| | 2019 Plan | | Inducement Plan | | 2011 Plan | | Total | | fair value | ||||
Non-vested share options at beginning of period - 2019 Plan | | | | | | — | | | — | | |
| $ | |
Non-vested share options at beginning of period - Inducement Plan | | | — | | | | | | — | | | | | |
Granted - 2019 Plan | |
| | | | — | | | — | | | | | |
Granted - Inducement Plan | | | — | | | | | | — | | | | | |
Vested, outstanding 2011 Plan | | | — | | | — | | | — | | — |
| | — |
Vested, outstanding - 2019 Plan | | | ( | | | — | | | — | | ( | | | |
Vested, outstanding - Inducement Plan | | | — | | | ( | | | — | | ( | | | |
Forfeited - 2011 Plan | | | — | | | — | | | — | | — | | | — |
Expired - 2019 | | | — | | | — | | | — | | — | | | — |
Forfeited - Inducement Plan | | | — | | | — | | | — | | — | | | — |
Forfeited - 2019 Plan | | | — | | | — | | | — | | — | | | - |
Non-vested share options at end of period | |
| | | | | | | — | | |
| $ | |
Non-vested share options at end of period - Weighted average fair value | | $ | | | $ | | | $ | — | | | | | |
| | | | | | | | | | | | | | |
| | 2025 | ||||||||||||
| | Number | | | | Weighted | ||||||||
| | of options | | | | average | ||||||||
| | 2019 Plan | | Inducement Plan | | 2011 Plan | | Total | | fair value | ||||
Non-vested share options at beginning of period - 2019 Plan | | | | | | — | | | — | | |
| $ | |
Non-vested share options at beginning of period - Inducement Plan | | | — | | | | | | — | | | | | |
Granted - 2019 Plan | |
| | | | — | | | — | | | | | |
Granted - Inducement Plan | | | — | | | | | | — | | | | | |
Vested, outstanding - 2019 Plan | | | ( | | | — | | | — | | ( | | | |
Vested, outstanding - Inducement Plan | | | — | | | ( | | | — | | ( | | | |
Non-vested share options at end of period | |
| | | | | | | — | | |
| $ | |
Non-vested share options at end of period - Weighted average fair value | | $ | | | $ | | | $ | — | | | | | |
The fair value of options granted for the 2011 Plan, 2019 Plan and Inducement Plan were estimated using the Black-Scholes option pricing model, resulting in the following weighted average assumptions for the options granted:
| | | | | | | |
| Three months ended March 31, | | | ||||
| 2026 | | 2025 |
| | ||
Exercise price | $ | |
| $ | | | |
Share price | $ | |
| $ | | | |
Volatility |
| | % | | | % | |
Risk-free interest rate |
| | % | | | % | |
Expected life |
|
| | | | ||
Dividend |
| % | | % | | ||
Expected volatility is determined using the Company’s historical volatility. Prior to establishing sufficient historical volatility, the Company used comparable companies for which the information is publicly available. The risk-free interest rate is determined based on the U.S. sovereign rates benchmark in effect at the time of grant with a remaining term equal to the expected life of the option. Expected option life is determined based on the simplified method as the Company does not have sufficient historical exercise data to provide a reasonable basis upon which to estimate expected term. The simplified method is an average of the contractual term of the options and its ordinary vesting period. Dividend yield is based on the share option’s exercise price and expected annual dividend rate at the time of grant. The total grant date fair
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Milestone Pharmaceuticals Inc.
Notes to Condensed Consolidated Financial Statements
For the Three Months Ended March 31, 2026 and 2025 (Unaudited)
(in thousands of US dollars, except where noted and for share and per share data)
value for options granted during the three-months ended March 31, 2026 and 2025 was $
Performance Stock Options
On May 6, 2024, the Company, pursuant to the 2019 Plan, awarded
The original grant-date fair value of each option was estimated on the date of grant using the same option valuation model used for the options outlined above. The original grant-date fair value of $
The vesting of the performance-based stock options was conditional upon the FDA approval of etripamil. Subject to the option-holder’s continuous service as of each such date,
Employee Stock Purchase Plan
On July 15, 2022, the Company offered an ESPP, in which participation is available to the Company’s employees in the United States and Canada who meet certain service eligibility requirements. Eligible employees may authorize an amount up to
On January 1, 2026, the number of common shares reserved for issuance under the ESPP automatically increased by
Performance Share Units
On May 6, 2024, the Company, pursuant to the 2019 Plan, awarded
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Milestone Pharmaceuticals Inc.
Notes to Condensed Consolidated Financial Statements
For the Three Months Ended March 31, 2026 and 2025 (Unaudited)
(in thousands of US dollars, except where noted and for share and per share data)
Restricted Stock Units
Pursuant to the 2019 Plan, the Company issues restricted stock units, or “RSUs,” to employees which vest based on a service criteria. When vested, the RSUs represent the right to be issued a number of shares of the Company’s common shares equal to the number of RSUs granted. The grant date fair value for RSUs is based on the market price of the Company’s common shares on the date of the grant. The fair value is then amortized to compensation expense over the requisite service period or vesting term.
The total outstanding RSUs from the 2019 Plan as of and for the three-month period ending March 31 were as follows:
| | | | | | | | | | | |
| | 2026 | | | 2025 | ||||||
| | | | Weighted | | | | | Weighted | ||
| | Number | | average | | | Number | | average | ||
| | of shares | | exercise | | | of shares | | exercise | ||
| | | | price | | | | | price | ||
Outstanding at beginning of period |
| | | $ | |
| | — | | $ | — |
Granted | | | | | | | | | | | |
Vested | | ( | | | | | | — | | | — |
Forfeited | | — | | | — | | | — | | | — |
Outstanding at end of period | | | | $ | | | | | | $ | |
The total unrecognized compensation cost related to the non-vested RSUs as of March 31, 2026, was $
Share-based Compensation Expense
The Company recognized total share-based compensation expense for all plans as follows:
| | | | | |
| Three months ended March 31, | ||||
| 2026 | | 2025 | ||
Administration | $ | |
| $ | |
Research and development | | |
| | |
Commercial activities | | |
| | |
Total | $ | |
| $ | |
10. Net Loss Per Share
Basic and diluted net loss per common share is determined by dividing net loss applicable to common shareholders by the weighted average number of common shares and pre-funded warrants outstanding during the period. In addition to the conversion feature on the 2029 Convertible Notes and common warrants described in Note 8, “Shareholders’ Equity,” which the Company reviewed and concluded would be anti-dilutive if converted or exercised due to the facts surrounding the instruments, the following potentially dilutive securities have also been excluded from the computation of diluted weighted average shares outstanding as of March 31, as they would be anti-dilutive:
| | | | |
| | 2026 | | 2025 |
Stock options and RSUs |
| |
| |
Amounts above reflect the common share equivalents of the noted instruments.
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Milestone Pharmaceuticals Inc.
Notes to Condensed Consolidated Financial Statements
For the Three Months Ended March 31, 2026 and 2025 (Unaudited)
(in thousands of US dollars, except where noted and for share and per share data)
11. Royalty Financing Obligation
On March 27, 2023, the Company entered into a purchase and sale agreement, or the “Royalty Purchase Agreement,” with RTW and certain of its affiliates.
Pursuant to the Royalty Purchase Agreement, RTW agreed to purchase, following the FDA approval of etripamil (subject to certain conditions), at a purchase price of $
On January 12, 2026, the Company closed the sale of the Royalty Interest under the Royalty Purchase Agreement and received the $
The cash consideration obtained pursuant to the Royalty Purchase Agreement is recorded in “Royalty financing obligation” on the Company’s Condensed Consolidated Balance Sheets. Upon initial recognition, the royalty financing obligation was recorded based on the proceeds received. The Company subsequently measures the royalty financing obligation at amortized cost using the effective interest method. As of March 31, 2026, the carrying value of the royalty financing obligations under the Royalty Purchase Agreement approximated its fair value. The estimated fair value of the royalty financing obligations was based on the Company’s current estimates of future payments to RTW over the estimated term of the obligation, which are considered Level 3 inputs.
The Company utilizes the prospective method to account for subsequent changes in the estimated future royalties to be paid by the Company to the counterparty over the estimated term of the obligation. Under the prospective method, a new effective interest rate is determined based on the revised estimate of remaining cash flows. The new rate is the discount rate that equates the present value of the revised estimate of remaining cash flows with the carrying amount of the debt, and it will be used to recognize interest expense for the remaining periods. If the amount or timing of expected royalty payments differs from prior estimates, the Company will prospectively adjust the amortization of the royalty financing obligations and the effective interest rate. On a quarterly basis, the Company assesses the projected royalty payments relative to the projected interest accretion for the next twelve months to determine if the royalty liability balance needs to be reduced relative to the current outstanding liability. In such case of excess payments relative to interest accretion for the next twelve months, the excess payments are considered to be a short-term liability and classified within current liabilities on the Company’s Condensed Consolidated Balance Sheets.
During the three months ended March 31, 2026, there were no significant changes to the amount and timing of expected royalties under the Royalty Purchase Agreement based on the Company’s latest forecasts subsequent to the initial measurement.
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Milestone Pharmaceuticals Inc.
Notes to Condensed Consolidated Financial Statements
For the Three Months Ended March 31, 2026 and 2025 (Unaudited)
(in thousands of US dollars, except where noted and for share and per share data)
The following table shows the royalty financing obligation activity for the three months ended March 31, 2026 as well as the effective interest rate as of March 31, 2026:
| | | |
| | 2026 | |
Royalty financing obligation | | $ | |
Non-cash Interest expense on Royalty financing obligation | | | |
Royalty revenues paid and payable | | | ( |
Balance as of March 31, 2026 | | $ | |
| | | |
Effective Interest | | | |
12. Other Receivables
Other receivables are comprised of the following:
| | | | | | |
| | March 31, 2026 | | December 31, 2025 | ||
Interest receivable |
| $ | | | $ | |
Sales tax receivable |
|
| | |
| |
Employee withholding taxes receivable | | | — | | | |
Other current receivable | | | | | | |
Total |
| $ | | | $ | |
13. Segment Reporting
The Company manages its operations as a single operating segment for the purpose of assessing performance and making operating decisions while focusing on the development and commercialization of innovative cardiovascular medicines. These operations, which are reported on a consolidated basis, are focused on a single product. The accounting policies of the single operating segment are the same as those described in the summary of significant accounting policies. The chief operating decision maker, or “CODM,” assesses performance of the Company’s single operating segment based on consolidated net loss. Net loss is used by the CODM to evaluate budget to actual analytics, which are used to monitor expenditures and ensure the Company is meeting established budgets. The CODM is the principal officer group, which includes the Company’s chief executive officer and chief financial officer.
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Milestone Pharmaceuticals Inc.
Notes to Condensed Consolidated Financial Statements
For the Three Months Ended March 31, 2026 and 2025 (Unaudited)
(in thousands of US dollars, except where noted and for share and per share data)
The following table presents information about the Company’s significant segment expenses, as provided to the Company’s CODM, and includes a reconciliation to consolidated net loss:
| | | | | | |
| | Three months ended March 31, | ||||
(in thousands) | | 2026 | | 2025 | ||
Revenue | | $ | | | $ | — |
| | | | | | |
Less: | | | | | | |
Cost of product sales | | | | | | — |
Research and development, net of tax credits, excluding share-based compensation | | | | | | |
General and administrative, excluding share-based compensation | |
| | |
| |
Commercial, excluding share-based compensation | |
| | |
| |
Share-based compensation expense | | | | | | |
Interest income | |
| ( | | | ( |
Royalty financing interest expense | | | | | | — |
Note payable interest expense | | | | | | |
Net loss | | $ | ( | | $ | ( |
The measure of segment assets is reported on the balance sheet as total consolidated assets.
14. Fair value of financial instruments
Pursuant to the accounting guidance for fair value measurement and its subsequent updates, fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (i.e. the exit price) in an orderly transaction between market participants at the measurement date. The accounting guidance establishes a hierarchy for inputs used in measuring fair value that minimizes the use of unobservable inputs by requiring the use of observable market data when available. Observable inputs are inputs that market participants would use in pricing the asset or liability based on active market data. Unobservable inputs are inputs that reflect the assumptions market participants would use in pricing the asset or liability based on the best information available in the circumstances.
The fair value hierarchy is broken down into the three input levels summarized below:
| | |
Level 1 | — | Valuations are based on quoted prices in active markets for identical assets or liabilities and readily accessible by the Company at the reporting date. |
Level 2 | — | Valuations based on inputs other than the quoted prices in active markets that are observable either directly or indirectly in active markets. |
Level 3 | — | Valuations based on unobservable inputs in which there is little or no market data, which requires the Company to develop its own assumptions. |
For the three months ended March 31, 2026 and 2025, there were
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Milestone Pharmaceuticals Inc.
Notes to Condensed Consolidated Financial Statements
For the Three Months Ended March 31, 2026 and 2025 (Unaudited)
(in thousands of US dollars, except where noted and for share and per share data)
15. Subsequent Event
Warrants Exercised
Subsequent to the three-month period ended March 31, 2026, through to the date of issuance of the condensed consolidated financial statements, the Company raised aggregate gross proceeds of $
Controlled Equity Offering
On May 13, 2026, the Company entered into a Controlled Equity OfferingSM Sales Agreement, or the "Sales Agreement," with Cantor Fitzgerald & Co., as sales agent, or the "Sales Agent," pursuant to which the Company may, from time to time, sell common shares, without par value per share, through the Sales Agent, or the “ATM Offering”. The Company will pay the Sales Agent a commission for its services as Sales Agent of
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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The following information should be read in conjunction with the unaudited interim condensed consolidated financial statements and the notes thereto included in this Quarterly Report on Form 10-Q and the audited annual consolidated financial statements and the notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2025, which was filed with the Securities And Exchange Commission, or “SEC,” on March 20, 2026. Our actual results may differ materially from those anticipated in these forward-looking statements as a result of various factors, including those discussed in “Risk Factors” and in other parts of this Quarterly Report on Form 10-Q.
Company Overview
We are a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines. Our approved product CARDAMYSTTM (etripamil) nasal spray is available in the United States and is the first and only U.S. Food and Drug Administration, or the “FDA,” approved self-administered treatment for use by patients anywhere, anytime an attack of paroxysmal supraventricular tachycardia, or “PSVT,” occurs. We continue to seek, either directly or through collaboration with our partners, marketing approval from regulatory agencies responsible for regions outside the United States. We are also developing etripamil for the indication of atrial fibrillation with rapid ventricular rate, or “AFib-RVR”.
We are currently focusing our efforts and financial resources on (i) the commercialization of CARDAMYSTTM (etripamil) nasal spray for the treatment of PSVT, (ii) the development of etripamil for the treatment of AFib-RVR and (iii) corporate development activities that have the potential to increase company value through strategic collaborations.
PSVT Market Overview
On December 12, 2025, we announced the FDA approved our first commercial product, CARDAMYST™ (etripamil) nasal spray, a prescription medication for the conversion of acute symptomatic episodes of PSVT to sinus rhythm in adults. We have currently begun focusing on the commercialization of CARDAMYST, which became available in retail pharmacies in the first quarter of 2026. PSVT is a condition that causes a patient’s heart to suddenly start beating faster than normal. It can be life-altering as PSVT is highly symptomatic, characterized by unpredictable attacks of a racing heart, often exceeding 150 beats per minute. Symptoms of PSVT arise suddenly and may include palpitations, sweating, chest pressure or pain, shortness of breath, sudden onset of fatigue, lightheadedness or dizziness, fainting, and anxiety, causing many patients to interrupt their daily activities at the time of symptom-onset. The impact and morbidity from an episode of PSVT can be especially detrimental in patients with underlying cardiovascular or medical conditions, such as heart failure, obstructive coronary disease, or dehydration. The uncertainty of when such an attack of PSVT will strike or how long it will persist is often anxiety-provoking, reducing patients’ quality of life and preventing participation in many desired activities. Drugs approved for the treatment of attacks of PSVT include adenosine, verapamil, and diltiazem, with all being administered intravenously under medical supervision, usually in the emergency department. Other oral drugs are sometimes used to treat attacks in a concept called “pill in the pocket.” However, those drugs have never been proven effective or safe and are not approved for this use. Doctors are often frustrated by the limited effective treatment options with the only approved options involving prolonged, unpleasant, and costly trips to the emergency department or, for some patients, an invasive ablation procedure. PSVT can be traumatic for patients, frustrating for healthcare providers, and costly for payors. With no pharmaceutical innovation in the treatment of PSVT for more than 30 years and a movement in the healthcare system to enable patient-centered care, we believe there is an opportunity to help patients living with PSVT to take greater control over their PSVT.
We believe that PSVT is a large and under-recognized market which we estimate affects more than two million Americans. From this diagnosed population, we define the immediate target addressable market for CARDAMYST as approximately 50% of patients with PSVT who have sufficient disease burden that they are compelled to seek care for their condition and are primarily managed by approximately 40,000 healthcare providers composed primarily of clinical cardiologists, interventional cardiologists and electrophysiologists. The remaining patients with PSVT can become addressable over
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time, as they are inconsistently managed (cycling in and out of the healthcare system). Furthermore, PSVT is expected to increase in diagnosed prevalence in coming years as wearable electrocardiogram, or “ECG,” technology (e.g., smartphone, watches) becomes both more adept at diagnosing PSVT and more widely used by patients and clinical practitioners, in turn shortening the time to diagnosis.
Following the release of data from the RAPID clinical study, in market research, cardiologists reported a willingness to prescribe CARDAMYST to approximately 50% of the patients with PSVT in their care, which suggests approximately 500,000 to 800,000 patients can potentially be treated with CARDAMYST in peak years. Additionally, we believe that this cardiology-identified group of patients may use CARDAMYST to treat a median of three to five episodes per year, based on the projected number of self-reported longer and more intense episodes experienced by patients, as well as the patient utilization experience in our Phase 3 clinical trials. This implies a peak demand potential in the United States for CARDAMYST of 2.5 million to 4 million episodes treated per year.
Current treatment for PSVT also consumes significant healthcare resources. Research published in the American Journal of Cardiology in 2020 shows that total healthcare expenditures in the year following a diagnosis of PSVT ranged from $20,000 to $30,000 per patient which were significantly higher than the expenditures observed for patients without PSVT. These significant increases included increased emergency department visits and hospitalization costs. Of note, catheter ablations following diagnosis represented only 23% of this increased spend, meaning most costs were unrelated to ablations. Recent data from the Healthcare Cost and Utilization Project, or “HCUP,” database indicate that in 2019 there were approximately 140,000 emergency department, or “ED,” visits for PSVT when coded (for billing) in the primary diagnostic position, and a total of approximately 525,000 ED visits when PSVT was coded in any diagnostic position. Of these, approximately 25% of ED admissions for PSVT resulted in a hospital admission. HCUP estimates a total of approximately 40,000 to approximately 120,000 inpatient admissions for PSVT in 2019 (based again if a PSVT billing code was found in the primary versus any diagnostic position). Despite the effectiveness of catheter ablation, claims data suggests that only approximately 15% of patients with PSVT are ablated over a three-year period, leading to a total of approximately 100,000 catheter ablations annually. In total, up to $15.0 billion is spent annually in the United States on the management of PSVT.
PSVT Continued Development Highlights
In November 2025, we submitted our marketing authorization application, or “MAA,” to the European Medicines Agency, or “EMA,” for review for approval to market etripamil nasal spray, under the trade name TACHYMISTTM, in the European Union. The MAA utilizes much of the clinical, manufacturing and quality data package that was submitted in the NDA which led to the US FDA approval.
In January 2025, our licensing partner, Corxel Pharmaceuticals, or “Corxel,” formerly Ji Xing Pharmaceuticals Limited, JIXING, announced that the Center for Drug Evaluation, or “CDE,” of the National Medical Products Administration, or “NMPA,” of the People’s Republic of China has accepted the New Drug Application, or “NDA,” for etripamil nasal spray for the treatment of PSVT. The NDA to the NMPA included data from the successful Phase 3 JX02002 clinical trial of etripamil nasal spray in patients with PSVT in China in addition to data included in the NDA that Milestone submitted to the FDA.
On March 23, 2026, Corxel announced that it had entered into an Asset Purchase Agreement with Everest Medicines, or “Everest”, a biopharmaceutical company focused on the development, manufacturing, and commercialization of pharmaceutical products and vaccines, with an established commercial infrastructure in Greater China. Pursuant to that Asset Purchase Agreement, Everest acquired the rights to develop, manufacture, and commercialize CARDAMYST™ (etripamil) nasal spray in Greater China, including mainland China, Hong Kong, Macau, and Taiwan.
The 500-patient Phase 3 trial (JX02002) met its primary endpoint, with a Kaplan Meier analysis showing a statistically significantly greater proportion of patients who self-administered etripamil converted from PSVT to sinus rhythm within 30 minutes compared to placebo (40.5% vs. 15.9%, respectively; hazard ratio [HR] = 3.00; 95% CI 1.58-5.71; p<0.001). Statistically significant (p<0.05) results were also shown for the secondary efficacy endpoints for percent of patients’ PSVT converted to sinus rhythm by 10, 15, 45 and 60 minutes after self-administration of study drug.
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Corxel further reported that, overall, treatment emergent adverse events were comparable between treatment groups, and there were no reported serious adverse events related to etripamil. The safety and tolerability data from the JX02002 trial were consistent with previous clinical studies. This important study further expands the etripamil global development program to more than 2,000 unique patients treated with etripamil.
Etripamil Nasal Spray for the Treatment of AFib-RVR
Similar to our approach for PSVT, we believe that etripamil has the potential to help people experiencing a symptomatic episode of AFib-RVR to self-treat and to conveniently, reliably, and quickly reduce their elevated heart rate, with the goal of reducing the need for emergency department utilization. We completed a successful Phase 2 study, named “ReVeRA” or the “ReVeRA study”, in patients presenting urgently with episodes of AFib-RVR to the emergency department. We have published the ReVeRA study and results, which demonstrated that patients receiving etripamil nasal spray experienced rapid and statistically superior ventricular rate reduction and improved symptom-relief compared to placebo, with safety and tolerability findings generally consistent with those observed in our PSVT program. We believe these data support the continued development of etripamil, self-administered in the medically unmonitored setting, for the treatment of AFib-RVR.
We have initiated a Phase 3 registrational program to evaluate self-administered etripamil as a potential treatment for patients with AFib-RVR and are currently onboarding clinical sites. We expect to enroll the first patient in the trial in the second half of 2026. We intend to follow the supplemental New Drug Application, or “sNDA,” regulatory approval pathway and expect to leverage the initial PSVT indication and its safety database along with the results from the planned single Phase 3 study in AFib-RVR.
AFib-RVR Market Overview
Atrial Fibrillation, or “AFib,” is a common cardiac arrhythmia with an irregular and often rapid heart rate that is often markedly symptomatic and, without proper treatment, can increase the risk of stroke, heart failure, and other cardiovascular complications. A common complication of AFib is a rapid heart rate, also referred to as AFib-RVR, which is frequently defined as a heart rate ≥ 110 beats per minute. The occurrence of a rapid ventricular rate, or “RVR,” in patients with atrial fibrillation increases the likelihood of marked symptoms including heart palpitations, shortness of breath and weakness. There are two commonly used pharmacological approaches to chronically manage AFib, rhythm control and rate control. Regardless of the chronic approach, break-through episodes of rapid heart rate occur frequently; and when faced with a sudden episode of AFib-RVR, acute rate control is needed, with most treatments being AV-nodal targeted drugs such as a beta blocker or calcium channel blocker. These treatments can be given intravenously; however, this requires a burdensome trip to an emergency department which may lead to a hospital admission. Acute treatment can be attempted with an oral rate-control drug; however, such agents often fail to provide immediate or dependable ventricular rate control because they have a 30- to 90-minute delayed onset of action. As a result, many patients require faster and more reliable rate reduction and symptom resolution, leading them to seek acute medical care in the emergency department for intravenous rate control and/or electrical cardioversion of their atrial fibrillation. Furthermore, the chronic administration of oral rate-control drugs does not broadly prevent episodes of AFib-RVR. Similar to PSVT, patients may feel a loss of control by needing to visit the emergency department for overcoming their AFib-RVR episode and the unpredictable nature of these episodes, which can occur anytime and anywhere. Doctors have expressed frustration at the lack of options for patients to self-manage these acute rate attacks; and payor organizations would prefer to treat the AFib-RVR attacks in a more cost effective and time-efficient manner.
An estimated 10 million Americans suffer from AFib. The prevalence of AFib is expected to grow to greater than 12 million by 2030. A subset of patients with AFib experiences episodes of abnormally high heart rate, most often accompanied by palpitations, shortness of breath, dizziness, and weakness. While these episodes, known as AFib-RVR, may be treated by oral calcium channel blockers and/or beta blockers, patients frequently seek acute care in the ED to address symptoms. In 2019, nearly 1.1 million patients were admitted to the emergency department due to AFib symptoms. Initial data suggests that approximately 60% of all AFib emergency department visits were attributable to AFib-RVR, as symptoms driving patients to seek care generally become more pronounced at higher heart rates. Treatment for such
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symptoms typically includes medically supervised intravenous administration of calcium channel blockers or beta blockers, or electrical cardioversion. With little available data for AFib-RVR, we believe, based on our initial market research, that 30% to 40% of patients with AFib experience one or more symptomatic episodes of RVR per year that require treatment, suggesting a current target addressable market of approximately three to four million patients for etripamil in patients with AFib-RVR.
We believe that etripamil has the potential to be developed such that it can be used by patients to rapidly reduce their heart rate to provide a supplemental option to either the acute oral rate or rhythm control strategy their physician would use. When presented with a target product profile reflecting this potential use case, cardiologists and electrophysiologists, in a 2021 market research study perceived utility in the product profile and indicated that they would prescribe to approximately two-thirds of their patients that experience episodes of AFib-RVR. They further indicated that a rapidly-acting intranasal calcium channel blocker could serve as a “bridge” to the longer onset times of acute oral agents. According to physicians, it can take hours for patients to feel an alleviation of symptoms using acute oral rate or rhythm control. During this time, patients may experience concerning symptoms that often prompt them to seek emergency care. We believe that the combination of convenient delivery, potency, rapid onset and short duration of action of etripamil has the potential to move the current treatment setting for some acute episodes of AFib out of the burdensome and costly emergency department.
Current AFib management consumes significant healthcare resources in the United States. The American Heart Association published a report in 2016 summarizing the current and projected cost burden of cardiovascular diseases in the United States. This report suggests atrial fibrillation resulted in $25 billion in direct medical costs in 2016 (approximately 7% of all cardiovascular diseases) and another $7 billion in indirect costs (i.e., up to $32 billion in total costs). Additionally, the forecasted growth in atrial fibrillation prevalence is anticipated to result in healthcare expenditures of $46 billion in direct costs and $10 billion in indirect costs in the United States by 2030.
AFib-RVR Clinical Development Highlights
In November 2023, we presented positive Phase 2 data from the ReVeRA study as a Featured Science Presentation at the American Heart Association Scientific Meetings (Philadelphia, PA) and as simultaneously published in Circulation: Arrhythmia and Electrophysiology. The randomized, double-blinded, placebo-controlled ReVeRA trial of etripamil nasal spray enrolled 87 patients and dosed 56 patients aged 18 years and older with AFib who urgently presented experiencing AFib and a ventricular rate of 110 or more beats per minute, or “bpm.” The trial was designed to assess the magnitude, rapidity, and duration of reduction and the patient satisfaction with treatment using an established patient reported outcome, or “PRO,” tool. Data showed that delivery of etripamil nasal spray (70 mg) significantly and rapidly reduced ventricular rate, in a pattern consistent with the drug’s pharmacologic profile. Etripamil achieved the primary endpoint with a high degree of statistical significance; patients experienced a ventricular rate reduction of 29.91 bpm (95% confidence interval: -40.31, -19.52; p<0.0001) in the etripamil arm relative to placebo. The absolute maximum reduction in rate in the etripamil arm was 34.97 bpm. Using the Treatment Satisfaction Questionnaire 9, or “TSQM-9,” PRO, compared to placebo, patients treated with etripamil demonstrated significant improvements in two satisfaction ratings: effectiveness (p<0.0001) and relief of symptoms (p=0.0002), with the degrees of improvement consistent with those customarily described as clinically meaningful. Treatment-emergent serious adverse events, or “TESAEs,” were rare and the most common (≥ 5%) adverse events were mild or moderate in intensity and included nasal discomfort, rhinorrhea, increased lacrimation, throat irritation and dizziness. Further trial details are below in this document.
During 2024, we met with the FDA on the ReVeRA study, during which the FDA confirmed its guidance from our Pre-IND meeting (2023) regarding the availability of a sNDA pathway for the marketing approval for etripamil for the indication of AFib-RVR. The sNDA pathway potentially permits a single pivotal efficacy study to be sufficient for filing for marketing approval if etripamil is already approved for PSVT. FDA further concurred with respect to key proposed study elements including powering, inclusion criteria, patient population, and statistical analyses, and offered clarification with respect to the endpoints to guide the design of the Phase 3 study. In our mid-2023 Pre-IND meeting, the FDA provided guidance that our primary endpoint can be the reduction of ventricular rate, and the primary analysis would be performed on the intent to treat, or “ITT,” population. In addition, the study would have to show statistical significance (p<0.05) on the key secondary endpoint of symptom relief as a patient benefit, also in the ITT population. The secondary endpoint
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could use a PRO measure, and various PROs were discussed with the FDA. We have finalized the Phase 3 study protocol following FDA’s review and obtained concurrence with the FDA to proceed.
The Phase 3 study has been initiated and will be conducted in a medically unmonitored setting (e.g., at-home) in a manner very similar to the conduct of our Phase 3 development program for PSVT. The Phase 3 AFib-RVR study will enroll patients with a history of symptomatic AFib episodes, and will use a self-administered, repeat-dose regimen of 70 mg per dose (the dose and dosing approach that was studied in the RAPID trial in patients with PSVT). The Phase 3 study’s target population will be patients with verified history of AFib-RVR, and the ITT population will be all patients self-administering the study drug for perceived AFib-RVR. The primary endpoint is the mean change from baseline ventricular rate to nadir ventricular rate for patients treated with etripamil versus placebo, as was studied in the ReVeRA trial in AFib-RVR. The key secondary endpoint will be based on a PRO of symptomatic improvement, discussed with the FDA, which is similar to the PRO questions utilized in our PSVT and AFib-RVR programs. The study has been powered and sized based upon approximately 150 events from 150 unique patients with a history of symptomatic episodes of AFib-RVR.
Operations Overview
Since the commencement of our operations in 2003, we have devoted substantially all of our resources to performing research and development activities in support of our product development efforts, hiring personnel, raising capital to support and expand such activities, providing general and administrative support for these operations and, more recently, preparing for commercialization. We have historically operated our business using a significant outsourcing model. As such, our team is currently composed of a relatively smaller core of employees who direct a significantly larger number of team members who are outsourced in the forms of vendors and consultants to enable execution of our operational plans. On December 12, 2025, we announced that the FDA approved our first commercial product, CARDAMYST™ (etripamil) nasal spray, a prescription medication for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia, or “PSVT,” to sinus rhythm in adults. As a result, we expect our future commercial expenses will increase as we invest in the infrastructure, personnel, and operational expenses required to commercialize CARDAMYST in the United States. We also expect inventory balances to increase as we capitalize costs related to the production of CARDAMYST for commercial sale in the United States. In addition, we expect to continue to incur significant research and development and general administrative expenses related to our operations as we advance etripamil nasal spray for the treatment of AFib-RVR and continue to invest in the resources needed to support a developing commercialized public company.
Since inception, we have incurred significant operating losses. For the three months ended March 31, 2026 and 2025, we recorded net losses of $26.1 million and $20.8 million, respectively. As of March 31, 2026, we had an accumulated deficit of $456.7 million. We expect to continue to incur significant losses for the foreseeable future. We anticipate that a substantial portion of our capital resources and efforts in the foreseeable future will be focused on commercialization of CARDAMYST and the development of an additional etripamil indication. We had $71.3 million of cash and cash equivalents and $112.9 million of short-term investments as of March 31, 2026.
We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future. Our net losses may fluctuate significantly from period to period, depending on the timing of our planned clinical trials and expenditures on other research and development activities. We expect our expenses will increase over time as we:
| ● | continue our ongoing and planned development of etripamil, including future Phase 3 clinical trials for the treatment of AFib-RVR and potential Phase 4 clinical trials for treatment of PSVT; |
| ● | seek, either directly or through collaboration with our partners, marketing approval for etripamil nasal spray for the treatment of PSVT from regulatory agencies responsible for regions outside the United States; |
| ● | seek marketing approvals for etripamil for the treatment of AFib-RVR and other cardiovascular indications; |
| ● | increase our sales, marketing, manufacturing, and distribution capability, either directly or indirectly through third parties; |
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| ● | build a portfolio of product candidates through development, or the acquisition of in-license of drugs, product candidates or technologies; |
| ● | initiate preclinical studies and clinical trials for etripamil for any additional indications we may pursue, including the clinical trials for the treatment of atrial fibrillation and rapid ventricular rate as well as other areas of unmet medical need, and for any additional product candidates that we may pursue in the future; |
| ● | maintain, protect, and expand our intellectual property portfolio; |
| ● | hire additional clinical, regulatory, and scientific personnel; |
| ● | add operational, financial, and management information systems and personnel, or other general & administrative personnel, including personnel to support our product development and potential expansion of our future commercialization efforts; and |
| ● | incur additional legal, accounting, insurance and other expenses associated with operating as a public company. |
Recent Developments
On May 13, 2026, we entered into a Controlled Equity OfferingSM Sales Agreement, or the "Sales Agreement," with Cantor Fitzgerald & Co., as sales agent, or the "Sales Agent," pursuant to which we may, from time to time, sell common shares, without par value per share, through the Sales Agent, or the “ATM Offering”. We are not obligated to, and cannot provide any assurances that we will make any sales of our shares under the Sales Agreement. For more details on the Sales Agreement, see Item 5. Other Information.
The Macroeconomic Climate
Inflation rates may materially adversely affect our business and corresponding financial position and cash flows. Inflationary factors, changes to interest rates, and overhead costs may adversely affect our operating results. Interest and inflation rates also present a recent challenge impacting the U.S. economy and could make it more difficult for us to obtain traditional financing on acceptable terms, if at all, in the future. Additionally, geopolitical events, including war and terrorism, banking instabilities, ongoing changes to U.S. and international tariffs and other trade restrictions and trade barriers, renegotiation of international trade agreements, or further escalations of trade tensions, and other U.S. geopolitical issues affecting other territories and employee availability and wage increases, and economic markets all of which may result in additional stress on our working capital resources. The ongoing trade tensions between the U.S. and other jurisdictions have resulted in multiple rounds of tariffs and anticipated tariffs affecting pharmaceuticals and pharmaceutical ingredients, including finished drug products, manufacturing equipment, and related supplies. In any event, the dynamic and unpredictable tariff and trade landscape may create substantial uncertainty and planning challenges for our operations.
Components of Results of Operations
Revenues
Product Revenue
On January 26, 2026, CARDAMYST (etripamil) nasal spray for the management of PSVT became available in the United States through retail pharmacies and our national sales force was deployed mid-February 2026. We initiated shipments of CARDAMYST to customers in the United States, which include major wholesalers, in January 2026. We recognize revenue for products received by our customers net of allowances for customer discounts, service fees, estimated returns, and estimated rebates. Product revenues were $0.2 million during the three months ended March 31, 2026. We earned no product revenue during the three months ended March 31, 2025.
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License Revenue
We earn license revenue when milestones are reached pursuant to our License and Collaboration Agreement, dated May 15, 2021, with Corxel. During the three months ended March 31, 2026 and 2025, no milestones were achieved, and no revenue was recorded under the Ji Xing License Agreement. On March 23, 2026, Corxel announced that it had entered into an Asset Purchase Agreement with Everest. Pursuant to that Asset Purchase Agreement, Everest acquired the rights to develop, manufacture, and commercialize CARDAMYST™ (etripamil) nasal spray in Greater China, including mainland China, Hong Kong, Macau, and Taiwan.
Cost of product sales
Cost of product sales includes the costs of producing inventory related to CARDAMYST including manufacturing, freight, overhead, and any inventory valuation adjustments. Cost of product sales is recognized in the period in which the related product revenue is earned.
Prior to FDA approval on December 12, 2025, all manufacturing costs for CARDAMYST were expensed as research and development costs. As a result, inventory on hand at the time of approval had a zero-cost basis.
For the three months ended March 31, 2026, we recognized a de minimis amount of cost of product sales, consisting primarily of post-approval manufacturing activities, including final packaging costs. Accordingly, cost of product sales does not reflect the full cost of units sold, and gross margin is not representative of our expected long-term cost structure. We expect cost of product sales to increase in future periods as we sell inventory manufactured after FDA approval. We recorded no cost of product sales for the three months ended March 31, 2025.
Research and Development Expenses
Research and development expenses consist primarily of salaries and fees paid to external service providers, as well as personnel costs, including share-based compensation expense, and other related compensation expenses. We expense research and development costs in the periods in which they are incurred. Costs for certain development activities are recognized based on an evaluation of the progress to completion of specific tasks using information and data provided to us by our vendors, collaborators and third-party service providers.
To date, the majority of our research and development expenses have been related to the preclinical and clinical development of etripamil inclusive of manufacturing costs pre-FDA approval. As we advance etripamil or other product candidates for other indications, we expect to allocate our direct external research and development costs across each of the indications or product candidates. Further, we expect our research and development costs to increase for the development of etripamil in AFib-RVR, and we expect our research and development expenses related to the development of etripamil for PSVT to decrease as a percentage of our total research and development expenses.
The process of conducting the necessary clinical research to obtain regulatory approval is costly and time-consuming and is subject to uncertainties and delays. As a result of the uncertainties discussed above, we are unable to determine the duration and completion costs of our research and development projects or when and to what extent we will generate revenue from the commercialization and sale of our product candidates, if at all.
We recognize the benefit of Canadian research and development tax credits as a reduction of research and development costs for fully refundable investment tax credits.
General and Administrative Expenses
General and administrative expenses include personnel and related compensation costs, expenses for outside professional services, lease expenses, insurance expenses, and other general administrative expenses. Personnel costs consist of
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salaries, bonuses, benefits, related payroll taxes, and share-based compensation. Outside professional services consist of legal, accounting, and audit services and other consulting fees.
We expect to continue to incur expenses as a public company, including expenses related to compliance with the rules and regulations of the Securities and Exchange Commission, or “SEC,” and those of any national securities exchange on which our securities are traded, additional insurance expenses, investor relations activities, and other administrative and professional services.
Commercial Expenses
Commercial expenses consist primarily of personnel and related compensation costs, market and health economic research, and market development activities for PSVT and, to a lesser extent, AFib-RVR. The focus of these expenses is three-fold: first, we want to leverage rigorous primary and secondary research to fully understand our target disease states from the perspective of the patient, healthcare provider, and payor; second, we want to understand and document the burden of disease posed by PSVT and AFib-RVR from an epidemiology, healthcare resource use, and cost perspective; and third, we want to engage our target patient, physician, and payor stakeholders with evidence-based and compliant educational materials that serve to increase the awareness and understanding of the impact of PSVT and AFib-RVR on patients and the overall healthcare system.
We anticipate our commercial expenses will increase as we invest in the infrastructure, personnel, and operational expenses required to commercialize CARDAMYST in the United States.
Interest Income
Interest income primarily consists of interest income from our cash and cash equivalents and short-term investments.
Interest Expense
Interest expense primarily consists of contractual debt interest expense, amortization of debt costs, and interest related to the royalty financing obligation.
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Results of Operations
Comparison of the Three Months Ended March 31, 2026 and 2025
The following table summarizes our results of operations and changes:
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| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | Three months ended March 31, | |||||||||
(in thousands) | | 2026 | | 2025 | | $ Change | | % Change | |||
| | | | | | | | | | | |
Revenue | | | | | | | | | | | |
Product sales, net | | $ | 238 | | $ | — | | $ | 238 |
| 100.0% |
License and other revenue | | | — | | | — | | | — |
| 0.0% |
Total Revenue | | | 238 | | | — | | | 238 | | 100.0% |
| | | | | | | | | | | |
Operating expenses | | | | | | | | | | | |
Cost of product sales | | $ | 14 | | $ | — | | $ | 14 | | 100.0% |
Research and development, net of tax credits | | | 3,251 | | | 4,978 | | | (1,727) |
| (34.7)% |
General and administrative | |
| 4,824 | |
| 5,167 | |
| (343) |
| (6.6)% |
Commercial | |
| 15,812 | |
| 10,378 | | | 5,434 |
| 52.4% |
Total operating expenses | |
| 23,901 | |
| 20,523 | |
| 3,378 |
| 16.5% |
Loss from operations | |
| (23,663) | |
| (20,523) | |
| (3,140) |
| 15.3% |
Interest income | |
| 1,732 | |
| 697 | |
| 1,035 |
| 148.5% |
Interest expense | | | (4,135) | | | (935) | | | (3,200) | | 342.3% |
Net loss | | $ | (26,066) | | $ | (20,761) | | $ | (5,305) |
| 25.6% |
Revenue
Product Revenue
On January 26, 2026, CARDAMYST (etripamil) nasal spray for the management of PSVT in the United States became available through U.S. retail pharmacies and our national sales force was deployed mid-February 2026. We initiated shipments of CARDAMYST to customers in the United States, which include major wholesalers, in January 2026. We recognize revenue for product received by our customers net of allowances for customer discounts, service fees, estimated returns, and estimated rebates. Product revenues were $0.2 million during the three months ended March 31, 2026. We earned no product revenue during the three months ended March 31, 2025.
License Revenue
During the three months ended March 31, 2026 and 2025, no milestones were achieved, and no revenue was recorded.
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Research and Development Expenses, Net of Tax Credits
The following table shows our research and development expenses by type of activity for the periods indicated:
| | | | | | | | | | | |
| | | | | | | | ||||
| | Three months ended March 31, | |||||||||
(in thousands) | | 2026 | | 2025 | | $ Change | | % Change | |||
Clinical | | $ | 1,427 | | $ | 1,749 | | $ | (322) |
| (18.4)% |
Drug manufacturing and formulation | |
| 371 | |
| 1,966 | |
| (1,595) |
| (81.1)% |
Regulatory and other costs | |
| 1,562 | |
| 1,356 | |
| 206 |
| 15.2% |
Less: R&D tax credits | |
| (109) | |
| (93) | |
| (16) |
| 17.2% |
Total R&D expenses | | $ | 3,251 | | $ | 4,978 | | $ | (1,727) |
| (34.7)% |
Research and development expenses, net of tax credits, decreased by $1.7 million for the three months ended March 31, 2026, compared to the three months ended March 31, 2025, primarily due to a decrease in outside service costs related to drug development and research.
We recognize the benefit of Canadian research and development tax credits as a reduction of research and development costs for fully refundable investment tax credits.
General and Administrative
General and administrative expenses decreased by $0.3 million, or 6.6%, for the three months ended March 31, 2026, compared to the three months ended March 31, 2025, primarily due to a decrease in professional costs partially offset by an increase in personnel costs.
Commercial
Commercial expenses increased by $5.4 million, or 52.4%, for the three months ended March 31, 2026, compared to the same period in 2025. This increase is primarily a result of additional personnel costs, professional costs, and other operational expenses related to the launch of CARDAMYST.
Interest Income
Interest income was $1.7 million and $0.7 million for the three months ended March 31, 2026 and 2025, respectively. The increase in interest income was primarily due to higher average cash, cash equivalents, and short-term investment balances during the three months ended March 31, 2026 compared to the same period in 2025, driven by proceeds from the July 2025 underwritten public offering, or the “2025 Offering,” and the purchase and sale agreement, or the “Royalty Purchase Agreement.”
Interest Expense
Interest expense increased by $3.2 million, or 342.3%, for the three months ended March 31, 2026 compared to the same period in 2025, primarily a result of $3.1 million of interest expense recognized on the royalty financing obligation during the three months ended March 31, 2026 (see Note 11, “Royalty Financing Obligation” in the accompanying notes to our interim condensed consolidated financial statements).
Liquidity and Capital Resources
Sources of Liquidity
We have incurred operating losses and experienced negative operating cash flows since our inception, and we anticipate continuing to incur losses for the foreseeable future. As of March 31, 2026, we had cash, cash equivalents, and short-term investments of $184.2 million and an accumulated deficit of $456.7 million.
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On July 11, 2025, we entered into an underwriting agreement, or the “Underwriting Agreement,” related to an underwritten public offering, or the “2025 Offering,” of (i) 31,500,000 of our common shares, accompanying Series A common warrants, or the “Series A Common Warrants,” to purchase an aggregate of 31,500,000 common shares and accompanying Series B common warrants, or the “Series B Common Warrants,” to purchase an aggregate of 31,500,000 common shares, at a combined public offering price of $1.50 per share and accompanying Series A Common Warrant and Series B Common Warrant and (ii) in lieu of common shares to certain investors that so choose, pre-funded warrants or the “2025 Pre-Funded Warrants” and, together with the Series A Common Warrants and the Series B Common Warrants, the “Warrants,” to purchase 3,502,335 common shares, accompanying Series A Common Warrants to purchase an aggregate of 3,502,335 common shares and accompanying Series B Common Warrants to purchase an aggregate of 3,502,335 common shares, at a combined public offering price of $1.499 per Pre-Funded Warrant and accompanying Series A Common Warrant and Series B Common Warrant, which represented the combined public offering price for the Common Shares and accompanying Common Warrants less the $0.001 per share exercise price for each such Pre-Funded Warrant.
The net proceeds to the Company from the 2025 Offering were $48.6 million after deducting underwriting commissions and other offering expenses payable by us, in the amount of $3.9 million.
During the three-month period ended March 31, 2026, 5,666,666 Series A Common Warrants were exercised for net proceeds of $8.0 million, after deducting underwriting commissions paid and payable of $0.5 million.
On July 29, 2020, we entered into an Open Market Sale AgreementSM, or the “Original Sale Agreement,” with respect to an at-the-market offering program, or the “ATM Program,” under which we could issue and sell our common shares having an aggregate offering price of up to $50.0 million through Jefferies LLC, or “Jefferies,” as sales agent or principal. On March 18, 2025, we entered into an Amended and Restated Open Market Sale AgreementSM, or the “Amended Agreement,” with Jefferies. The Amended Agreement amends and restates, in its entirety, the Original Sale Agreement. Under the Amended Agreement, we were able to sell our common shares, no par value per share, for an aggregate offering price of up to $77.8 million (which includes the $2.8 million of sales previously made pursuant to the Original Sale Agreement through the date the Amended Agreement was entered into), or the “ATM Shares.” The ATM Shares will be sold pursuant to our shelf registration statement on Form S-3 (File No. 333-283162). We previously issued 361,236 common shares under the Original Sale Agreement, resulting in net proceeds of approximately $2.6 million (net of issuance costs of approximately $0.1 million). We issued 5,526,590 shares under the amended agreement resulting in net proceeds of $10.9 million, after deducting sales agent commissions payable by us of $0.3 million during the three-month period ended March 31, 2026. On March 6, 2026, we terminated the Amended Agreement.
Based on our current operating plan, we expect our existing cash and cash equivalents and short-term investments to be sufficient to fund our operations for at least the next 12 months from the date of issuance of this Form 10-Q for the quarter ending March 31, 2026. We believe there are currently no events or conditions that may cast substantial doubt on our ability to continue as a going concern for at least the next 12 months from the date of this filing.
Royalty Purchase Agreement
On March 27, 2023, we entered into the Royalty Purchase Agreement with RTW Royalty I DAC, an affiliate of RTW Investments, LP, or “RTW,” pursuant to which RTW agreed to purchase, following U.S. Food and Drug Administration approval of etripamil for the treatment of PSVT (subject to certain conditions), at a purchase price of $75.0 million, the right to receive tiered quarterly royalty payments, or the “royalty interest,” on net product sales of CARDAMYST (etripamil) in the United States.
On January 12, 2026, the Company closed the sale of the royalty interest under the Royalty Purchase Agreement and received cash of $75.0 million from RTW in exchange for future royalty payments (see Note 11, “Royalty Financing Obligation” in the accompanying notes to our interim condensed consolidated financial statements).
Funding Requirements
We anticipate that we will use our cash and cash equivalents primarily to fund commercialization and research and development expenditures. We expect our expenses to increase as we continue the development of etripamil and invest in
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the infrastructure, personnel, and operational expenses required to commercialize CARDAMYST in the United States. We expect to incur increasing operating losses for the foreseeable future as we continue the clinical development of subsequent etripamil indications or any future product candidates. At this time, due to the inherently unpredictable nature of clinical development, we cannot reasonably estimate the costs we will incur and the timelines that will be required to complete development, obtain marketing approval, and commercialize subsequent etripamil indications or any future product candidates, if at all. For the same reasons, we are also unable to predict when, if ever, we may achieve profitability generated from product sales. Clinical and preclinical development timelines, the probability of success, and development costs can differ materially from expectations.
In addition, we have exclusive development and commercialization rights for etripamil for all indications that we may pursue, and as such, have the potential to license development and or commercialization rights for etripamil to a potential partner in regions outside of Greater China. We have established commercialization and marketing capabilities using a direct sales force to commercialize CARDAMYST in the United States. Outside of the United States, we are considering commercialization strategies that may include collaborations with other companies.
For other new product candidates, our efforts are focused on licensing development and/or commercialization rights from potential partners. In the case of either in-licensing or out-licensing, we cannot forecast when such arrangements will be secured, if at all, and to what degree such arrangements would affect our development and commercialization plans and capital requirements.
The timing and amount of our operating expenditures will depend largely on:
| ● | the timing, progress and results of our ongoing and planned clinical trials and other development activities of etripamil in AFib-RVR and in other cardiovascular indications; |
| ● | the scope, progress, results, and costs of preclinical development, laboratory testing, and clinical trials of etripamil for additional indications or any future product candidates that we may pursue; |
| ● | our ability to establish additional collaborations on favorable terms, if at all; |
| ● | the ability of vendors and third-party service providers to accurately forecast expenses and deliver on expectations; |
| ● | the costs, timing, and outcome of regulatory review of subsequent etripamil indications and any future product candidates; |
| ● | the costs and timing of CARDAMYST commercialization activities, including product manufacturing, marketing, sales, and distribution for CARDAMYST and any future product candidates for which we receive marketing approval; |
| ● | the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims; and |
| ● | the extent to which we acquire or in-license other product candidates and technologies. |
Until such time, if ever, as we can generate substantial revenue from product sales, we expect to fund our operations and capital funding needs through equity and/or debt financing. We may also consider entering into collaboration arrangements or selectively partnering for clinical development and commercialization. The sale of additional equity would result in additional dilution to our shareholders. The incurrence of debt financing would result in debt service obligations and the instruments governing such debt could provide for operating and financing covenants that restrict our operations or our ability to incur additional indebtedness or pay dividends, among other items. If we are not able to secure adequate additional funding, we may be forced to make reductions in spending, extend payment terms with suppliers, liquidate
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assets where possible, and/or suspend or curtail planned programs. Any of these actions could materially and adversely affect our business, financial condition and results of operations.
Cash Flows
The following table summarizes our cash flows for the periods indicated:
| | | | | | | | | | | |
| | Three months ended March 31, | |||||||||
(in thousands) | | 2026 | | 2025 | | $ Change | | % Change | |||
Net cash (used in) provided by: | | | | | | | | | | | |
Operating activities | | $ | (16,053) | | $ | (13,952) | | $ | (2,101) |
| 15.1% |
Investing activities | | | (80,030) | | | 33,583 | | | (113,613) |
| (338.3)% |
Financing activities | | | 94,354 | | | 140 | | | 94,214 |
| 67295.7% |
Net (decrease) increase in cash and cash equivalents during the period | | $ | (1,729) |
| $ | 19,771 | | $ | (21,500) |
| |
Operating Activities
Net cash used in operating activities during the three months ended March 31, 2026 was $16.1 million, which consisted primarily of a net loss of $26.1 million, offset by a net cash increase of $4.5 million related to the change in assets and liabilities, non-cash charges of $1.3 million related to share-based compensation, and non-cash interest charges and debt costs of $4.1 million related to the 2029 Convertible Notes and royalty financing obligation.
Net cash used in operating activities during the three months ended March 31, 2025 was $14.0 million, which consisted primarily of a net loss of $20.8 million, offset by a net cash increase of $4.6 million related to the change in assets and liabilities, non-cash charges of $1.4 million related to share-based compensation, and non-cash interest charges of $0.9 million related to the 2029 Convertible Notes.
Investing Activities
In the three months ended March 31, 2026, we acquired $80.0 million of short-term investments. In the three months ended March 31, 2025, we acquired $0.9 million of short-term investments, and we redeemed $34.5 million in short-term investments.
Financing Activities
In the three months ended March 31, 2026, our financing activities provided cash proceeds of $94.4 million. These proceeds were primarily a result of the $75.0 million received from the Royalty Purchase Agreement, $8.3 million, net of issuance costs, from the exercise of Series A Common Warrants under the 2025 Offering, and $10.9 million net of issuance costs, for shares sold under the ATM Program.
In the three months ended March 31, 2025, our financing activities provided cash proceeds of $0.1 million. These proceeds were primarily a result of common shares issued pursuant to our employee stock purchase plan.
Off-Balance Sheet Arrangements
We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined in the rules and regulations of the SEC.
Contractual Obligations
During the three months ended March 31, 2026, there were no material changes to our contractual obligations and commitments described under Management’s Discussion and Analysis of Financial Condition and Results of Operations in our Annual Report on Form 10-K, filed with the SEC on March 20, 2026.
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Critical Accounting 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 United States generally accepted accounting principles, or “U.S. GAAP,” and on a basis consistent with those accounting principles followed by us. The preparation of these 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. Significant estimates and judgments include, but are not limited to:
| ● | Estimate of the percentage of work completed of the total work over the life of the individual trial in accordance with agreements established with contract research organizations, or “CROs,” contract manufacturing organizations, or “CMOs,” and clinical trial sites which in turn impact the research and development expenses. |
| ● | Estimate of the grant date fair value of share options granted to employees, consultants and directors, and the resulting share-based compensation expense, using the Black-Scholes option-pricing model. |
| ● | Estimate of the transaction price when recognizing revenue. Net revenue from sales of CARDAMYST is recorded at net selling price (transaction price), which includes reserves for variable consideration. |
| ● | Estimates of the timing and amount of future royalty payments to be generated from product sales over the expected repayment term, which are used to determine the effective interest rate and resulting interest expense and carrying amount of the royalty financing obligation. |
Accordingly, actual results may differ from these judgments and estimates under different assumptions or conditions and any such differences may be material. We believe that the accounting policies discussed below are critical to understanding our historical and future performance, as these policies relate to the more significant areas involving management’s judgments and estimates.
a) Research and Development Expenses — Accruals
Research and development costs are charged against income in the period of expenditure. Our research and development costs consist primarily of salaries and fees paid to CROs and to CMOs for clinical trial expenses and manufacturing costs prior to FDA approval.
Clinical trial expenses include direct costs associated with CROs, direct CMO costs for the formulation and packaging of clinical trial material, as well as investigator and patient-related costs at sites at which our trials are being conducted. Direct costs associated with our CROs and CMOs are generally payable on a time-and-materials basis, or when milestones are achieved. The invoicing from clinical trial sites can lag several months. We record expenses for our clinical trial activities performed by third parties based upon estimates of the percentage of work completed of the total work over the life of the individual trial in accordance with agreements established with CROs and clinical trial sites. We determine the estimates through discussions with internal clinical personnel, CROs, and CMOs as to the progress or stage of completion of trials or services and the agreed-upon fee to be paid for such services based on facts and circumstances known to us as of each consolidated balance sheet date. The actual costs and timing of clinical trials are highly uncertain, subject to risks and may change depending upon a number of factors, including our clinical development plan. If the actual timing of the performance of services and of the level of effort varies from the estimate, we will adjust the accrual accordingly. Adjustments to prior period estimates have not been material. We recognize the benefit of Canadian research and development tax credits as a reduction of research and development costs for fully refundable investment tax credits and as a reduction of income taxes for investment tax credits that can only be claimed against income taxes payable when there is reasonable assurance that the claim will be recovered.
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b) Share-Based Compensation
We recognize compensation costs related to share options granted to employees, consultants, and directors based on the estimated fair value of the awards on the date of grant. We estimate the grant date fair value, and the resulting share-based compensation expense, using the Black Scholes option pricing model. This Black Scholes option pricing model uses various inputs to measure fair value, including estimated fair value of our underlying common shares at the grant date, expected term, estimated volatility, risk-free interest rate, and expected dividend yields of our common shares. The estimated volatility creates a critical estimate because we have not been a public company long enough to demonstrate our own historical volatility. The grant date fair value of the share-based awards is recognized on a straight-line basis over the requisite service periods, which are generally the vesting period of the respective awards. Forfeitures are accounted for as they occur.
c) Gross-to-net revenue adjustments
Net revenue from sales of CARDAMYST is recorded at net selling price (transaction price), which includes reserves for variable consideration such as (i) estimated government rebates, such as Medicaid and Medicare Part D reimbursements, and estimated managed care rebates, (ii) estimated chargebacks, (iii) estimated costs of co-payment assistance programs, and (iv) estimated product returns. These reserves, representing our best estimates of the amount of consideration to which we are entitled based on the terms of the applicable contracts and statutory requirements, are based on the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable if no payments are required of us or a current liability if a payment is required of us. Actual amounts of consideration may differ from our estimates. If actual results vary from estimates, these estimates are adjusted, which would affect net product revenue and earnings in the period such variances become known.
d) Royalty financing obligation
Our accounting for our royalty financing obligation involves significant judgment and estimates and is therefore considered a critical accounting estimate. The obligation is accounted for as debt and measured at amortized cost using the effective interest method. At inception, and in subsequent periods, the carrying value of the royalty financing obligation and the related interest expense depend on estimates of the timing and amount of future royalty payments expected to be generated from product sales over the life of the arrangement, as well as the expected repayment term. These estimates are used to determine the effective interest rate applied to accrete the obligation over time.
The estimation of future royalty payments is inherently uncertain and requires management judgment regarding key assumptions, including expected future net product sales, the timing of commercial production, and the duration of the underlying patent subject to the royalty. Actual royalty payments may differ materially from management’s estimates due to changes in production levels, operational performance, or other factors beyond our control.
Changes in the estimated amount or timing of future royalty payments result in a prospective adjustment to the effective interest rate and the pattern of interest expense recognized over the remaining term of the obligation. As a result, revisions to these estimates could have a material impact on future interest expense and the carrying value of the royalty financing obligation. We periodically review and update our estimates based on available information; however, actual results may differ materially from those estimates.
Recent Accounting Pronouncements
Refer to Note 2, “Summary of Significant Accounting Policies,” in the accompanying notes to our interim condensed consolidated financial statements for a discussion of recent accounting pronouncements.
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Item 3. Quantitative and Qualitative Disclosures About Market Risk.
We are exposed to market risks in the ordinary course of our business. These risks primarily relate to interest rate risks. For the three-month period ended March 31, 2026, we had cash and cash equivalents of $71.3 million and short-term investments of $112.9 million. These cash and cash equivalents and short-term investments consist primarily of bank deposits, guaranteed investment certificates, and U.S. treasury bills. The primary objective of our investment activities is to preserve principal and liquidity while maximizing income without significantly increasing risk. We do not enter into investments for trading or speculative purposes. Due to the short-term nature of our investment portfolio, we do not believe an immediate 10% increase or decrease in interest rates would have a material effect on the fair market value of our portfolio, and accordingly we do not expect our operating results or cash flows to be materially affected by a sudden change in market interest rates.
We undertake certain transactions in Canadian dollars and as such are subject to risk due to fluctuations in exchange rates. Canadian dollar denominated payables are paid at the converted rate as due. We do not use derivative instruments or have a formal hedging program to hedge exposure to foreign exchange rate risk due to the low volume of transactions denominated in foreign currencies. At March 31, 2026, our net monetary exposure denominated in Canadian dollars was $3.6 million.
Our operating results and financial position are reported in U.S. dollars in our consolidated financial statements. The fluctuation of the Canadian dollar in relation to the U.S. dollar might, consequently, have an impact upon our loss and may also affect the value of our assets and the amount of shareholders’ equity.
Item 4. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
We maintain “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the “Exchange Act,” that are designed to ensure that information required to be disclosed in the reports that we file or submit under the Exchange Act is (1) recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms and (2) accumulated and communicated to our management, including our principal executive officer and principal financial officer, to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of March 31, 2026. Based upon the evaluation, our Chief Executive Officer and Chief Financial Officer concluded that, as of such date, our disclosure controls and procedures were effective at a reasonable assurance level.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting during the period covered by this Quarterly Report on Form 10-Q that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Inherent Limitations on Effectiveness of Controls
Our management, including our Chief Executive Officer and Chief Financial Officer, believes that our disclosure controls and procedures and internal control over financial reporting are designed to provide reasonable assurance of achieving their objectives and are effective at the reasonable assurance level. However, our management does not expect that our disclosure controls and procedures or our internal control over financial reporting will prevent all errors and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource
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constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, have been detected. These inherent limitations include the realities that judgments in decision making can be faulty, and that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people or by management override of the controls. The design of any system of controls also 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.
PART II—OTHER INFORMATION
Item 1. Legal Proceedings.
From time to time, we may become involved in legal proceedings arising in the ordinary course of our business. We are not currently a party to any material legal proceedings, and we are not aware of any pending or threatened legal proceeding against us that we believe could have an adverse effect on our business, operating results or financial condition.
Item 1A. Risk Factors
There have been no material changes from the risk factors previously disclosed in Part I, Item 1A. in our Annual Report on Form 10-K, filed with the SEC and under Milestone’s SEDAR+ profile at www.sedarplus.com on March 20, 2026.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
Not applicable
Item 3. Defaults Upon Senior Securities.
Not applicable
Item 4. Mine Safety Disclosures.
Not applicable
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Item 5. Other Information.
Rule 10b5-1 Trading Arrangements
Controlled Equity Offering
On May 13, 2026, we entered into a Controlled Equity OfferingSM Sales Agreement, or the "Sales Agreement," with Cantor Fitzgerald & Co., as sales agent, or the "Sales Agent," pursuant to which we may, from time to time, sell common shares, without par value per share, through the Sales Agent, or the “ATM Offering”. We are not obligated to, and cannot provide any assurances that we will make any sales of our shares under the Sales Agreement.
Upon delivery of a placement notice and subject to the terms and conditions of the Sales Agreement, the Sales Agent may sell the shares by methods deemed to be an "at-the-market" offering as defined in Rule 415(a)(4) promulgated under the Securities Act. Subject to the terms and conditions of the Sales Agreement, the Sales Agent will use commercially reasonable efforts consistent with its normal trading and sales practices to sell the shares from time to time, based upon our instructions. The Sales Agreement contains customary representations, warranties and agreements, indemnification rights and obligations of the parties. We will pay the Sales Agent a commission for its services as Sales Agent of 3.0% of the aggregate gross proceeds from each sale of the common shares sold through the Sales Agent pursuant to the Sales Agreement.
The common shares being offered pursuant to the Sales Agreement will be offered and sold pursuant to a shelf registration statement on Form S-3 and prospectus relating to the ATM Offering that we will file with the SEC.
The offering of shares pursuant to the Sales Agreement will terminate upon the termination of the Sales Agreement in accordance with its terms.
The foregoing description of the Sales Agreement is not complete and is qualified in its entirety by reference to the full text of the Sales Agreement, a copy of which is filed as Exhibit 10.3 to this Quarterly Report on Form 10-Q.
Item 6. Exhibits.
| | |
Exhibit | | Description |
| | |
3.1 | | Amended Articles of Incorporation of the Company (incorporated herein by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K (File No. 001-38899), filed with the SEC on May 15, 2019). |
3.2 | | Amended and Restated Bylaws of the Company (incorporated herein by reference to Exhibit 3.2 to the Company’s Current Report on Form 8-K (File No. 001-38899), filed with the SEC on May 15, 2019). |
10.1+ | | Non-Employee Director Compensation Policy, as amended. |
10.2+** | | Employment Agreement, dated January 19, 2026, between David Sandoval and Milestone Pharmaceuticals Inc. |
10.3 | | Controlled Equity OfferingSM dated May 13, 2026, by and between Milestone Pharmaceuticals Inc. and Cantor Fitzgerald & Co. |
31.1 | | Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
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31.2 | | Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
32.1* | | Certification of Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
101.INS | | Inline XBRL Instance 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 | | The cover page from the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, formatted in Inline XBRL. |
* Furnished herewith and not deemed to be “filed” for purposes of Section 18 of the Exchange Act, and shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the “Exchange Act (whether made before or after the date of the Form 10-Q)”, irrespective of any general incorporation language contained in such filing.
+ | Indicates a management contract or compensatory plan. |
** | Certain of the exhibits and schedules to this exhibit have been omitted in accordance with Regulation S-K Item 601(a)(5). The Registrant agrees to furnish a copy of all omitted exhibits and schedules to the Securities and Exchange Commission upon its request. |
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Table of Contents
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.
| MILESTONE PHARMACEUTICALS INC. | |
| | |
Date: May 13, 2026 | By: | /s/ Joseph Oliveto |
| | Joseph Oliveto |
| | President and Chief Executive Officer |
| | |
| | |
| | |
| | |
Date: May 13, 2026 | By: | /s/ Amit Hasija |
| | Amit Hasija |
| | Chief Financial Officer |
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