Milestone Pharmaceuticals (MIST) 10-Q13 Nov 232023 Q3 Quarterly reportFinancial data

Company Profile

Document and Entity Information

Document and Entity Information - shares	9 Months Ended
Document and Entity Information - shares	Sep. 30, 2023	Nov. 13, 2023
Document and Entity Information
Document Type	10-Q
Document Period End Date	Sep. 30, 2023
Document Quarterly Report	true
Document Transition Report	false
Entity File Number	001-38899
Entity Registrant Name	Milestone Pharmaceuticals Inc.
Entity Incorporation, State or Country Code	A8
Entity Tax Identification Number	00-0000000
Entity Address, Address Line One	1111 Dr. Frederik-Philips Boulevard
Entity Address, Address Line Two	Suite 420
Entity Address, City or Town	Montréal
Entity Address, State or Province	QC
Entity Address, Country	CA
Entity Address, Postal Zip Code	H4M 2X6
City Area Code	514
Local Phone Number	336-0444
Title of 12(b) Security	Common Shares
Trading Symbol	MIST
Security Exchange Name	NASDAQ
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	true
Entity Ex Transition Period	true
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		33,483,111
Entity Central Index Key	0001408443
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2023
Document Fiscal Period Focus	Q3
Amendment Flag	false

Condensed Consolidated Balance

Condensed Consolidated Balance Sheets - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022
Current assets
Cash and cash equivalents	$ 9,879	$ 7,636
Short-term investments	65,867	56,949
Research and development tax credits receivable	569	331
Prepaid expenses	6,961	6,005
Other receivables	1,521	882
Total current assets	84,797	71,803
Operating lease assets	2,047	2,423
Property and equipment	272	257
Total assets	87,116	74,483
Current liabilities
Accounts payable and accrued liabilities	7,584	5,644
Operating lease liabilities	530	495
Total current liabilities	8,114	6,139
Operating lease liabilities, net of current portion	1,583	1,996
Senior secured convertible notes	48,915
Total liabilities	58,612	8,135
Shareholders' Equity
Common shares, no par value, unlimited shares authorized 33,481,787 shares issued and outstanding as of September 30, 2023, 34,286,002 shares issued and outstanding as of December 31, 2022	260,502	273,900
Pre-funded warrants - 9,577,257 issued and outstanding as of September 30, 2023 and 8,518,257 as of December 31, 2022	48,459	34,352
Additional paid-in capital	31,958	24,437
Accumulated deficit	(312,415)	(266,341)
Total shareholders' equity	28,504	66,348
Total liabilities and shareholders' equity	$ 87,116	$ 74,483

Condensed Consolidated Balanc_2

Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares	9 Months Ended	12 Months Ended
	Sep. 30, 2023	Dec. 31, 2022
Condensed Consolidated Balance Sheets
Common shares, par value (in dollars per share)	$ 0	$ 0
Common shares, Shares authorized (in shares)	Unlimited	Unlimited
Common shares, Shares issued (in shares)	33,481,787	34,286,002
Common shares, Shares outstanding (in shares)	33,481,787	34,286,002
Warrants issued	9,577,257	8,518,257
Warrants outstanding	9,577,257	8,518,257

Condensed Consolidated Statemen

Condensed Consolidated Statements of Loss - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Condensed Consolidated Statements of Loss
Revenue	$ 0	$ 1,500	$ 1,000	$ 1,500
Operating expenses
Research and development, net of tax credits	6,721	9,826	25,600	29,251
General and administrative	4,227	4,034	12,561	11,595
Commercial	4,412	2,670	10,137	6,537
Loss from operations	(15,360)	(15,030)	(47,298)	(45,883)
Interest income	1,120	474	2,921	672
Interest expense	(841)		(1,697)
Net loss and comprehensive loss	$ (15,081)	$ (14,556)	$ (46,074)	$ (45,211)
Weighted average number of shares and pre-funded warrants outstanding, basic	42,973,160	42,491,787	42,920,620	42,339,123
Weighted average number of shares and pre-funded warrants outstanding, diluted	42,973,160	42,491,787	42,920,620	42,339,123
Net loss per share, basic	$ (0.35)	$ (0.34)	$ (1.07)	$ (1.07)
Net loss per share, diluted	$ (0.35)	$ (0.34)	$ (1.07)	$ (1.07)

Condensed Consolidated Statem_2

Condensed Consolidated Statements of Shareholders' Equity - USD ($) $ in Thousands	Common Shares	Pre-funded warrants	Additional paid-in capital	Accumulated deficit	Total
Opening balance at Dec. 31, 2021	$ 251,901	$ 52,941	$ 15,711	$ (207,953)	$ 112,600
Balance at the beginning of period (in shares) at Dec. 31, 2021	29,897,559	12,327,780
Increase (Decrease) in Stockholders' Equity
Net loss				(45,211)	(45,211)
Exercise of stock options	$ 392		(175)		217
Exercise of stock options (in shares)	129,314
Issuance of common shares, net of issuance costs	$ 2,644				2,644
Issuance of common shares, net of issuance costs (shares)	361,236
Share-based compensation			6,905		6,905
Closing balance at Sep. 30, 2022	$ 254,937	$ 52,941	22,441	(253,164)	77,155
Balance at the end of period (in shares) at Sep. 30, 2022	30,388,109	12,327,780
Increase (Decrease) in Stockholders' Equity
Number of warrants		12,327,780
Opening balance at Jun. 30, 2022	$ 252,236	$ 52,941	20,090	(238,608)	86,659
Balance at the beginning of period (in shares) at Jun. 30, 2022	30,005,884
Increase (Decrease) in Stockholders' Equity
Net loss				(14,556)	(14,556)
Exercise of stock options	$ 57		(29)		28
Exercise of stock options (in shares)	20,989
Issuance of common shares, net of issuance costs	$ 2,644				2,644
Issuance of common shares, net of issuance costs (shares)	361,236
Share-based compensation			2,380		2,380
Closing balance at Sep. 30, 2022	$ 254,937	$ 52,941	22,441	(253,164)	$ 77,155
Balance at the end of period (in shares) at Sep. 30, 2022	30,388,109	12,327,780
Increase (Decrease) in Stockholders' Equity
Number of warrants		12,327,780
Number of warrants					8,518,257
Opening balance at Dec. 31, 2022	$ 273,900	$ 34,352	24,437	(266,341)	$ 66,348
Balance at the beginning of period (in shares) at Dec. 31, 2022	34,286,002	8,518,257			34,286,002
Increase (Decrease) in Stockholders' Equity
Net loss				(46,074)	$ (46,074)
Exercise of stock options	$ 324		(136)		188
Exercise of stock options (in shares)	112,779
Private placement		$ 14,107			14,107
Private placement (in shares)		1,059,000
Share-based compensation			7,657		7,657
Cancellation of common shares	$ (14,115)				(14,115)
Cancellation of common shares (in shares)	(1,059,000)
Employee stock purchase plan purchases	$ 393				393
Employee stock purchase plan purchases (in shares)	142,006
Closing balance at Sep. 30, 2023	$ 260,502	$ 48,459	31,958	(312,415)	$ 28,504
Balance at the end of period (in shares) at Sep. 30, 2023	33,481,787	9,577,257			33,481,787
Increase (Decrease) in Stockholders' Equity
Number of warrants		9,577,257
Opening balance at Jun. 30, 2023	$ 260,169	$ 48,459	29,114	(297,334)	$ 40,408
Balance at the beginning of period (in shares) at Jun. 30, 2023	33,363,971
Increase (Decrease) in Stockholders' Equity
Net loss				(15,081)	(15,081)
Exercise of stock options	$ 68		(28)		40
Exercise of stock options (in shares)	18,798
Share-based compensation			2,872		2,872
Employee stock purchase plan purchases	$ 265				265
Employee stock purchase plan purchases (in shares)	99,018
Closing balance at Sep. 30, 2023	$ 260,502	$ 48,459	$ 31,958	$ (312,415)	$ 28,504
Balance at the end of period (in shares) at Sep. 30, 2023	33,481,787	9,577,257			33,481,787
Increase (Decrease) in Stockholders' Equity
Number of warrants		9,577,257			9,577,257

Condensed Consolidated Statem_3

Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022
Cash flows used in operating activities
Net loss	$ (46,074)	$ (45,211)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation of property and equipment	66	74
Amortization of debt costs	160
Accretion of investment discount	(79)
Non-cash interest expense related to debt	1,537
Share-based compensation expense	7,657	6,905
Changes in operating assets and liabilities:
Other receivables	(639)	(308)
Research and development tax credits receivable	(238)	161
Prepaid expenses	(956)	(759)
Operating lease assets and liabilities	(2)	47
Accounts payable and accrued liabilities	1,940	(516)
Net cash used in operating activities	(36,628)	(39,607)
Cash provided by (used in) investing activities
Acquisition of property and equipment	(81)	(162)
Acquisition of short-term investments	(95,839)	(62,947)
Redemption of short-term investments	87,000	23,000
Net cash used in investing activities	(8,920)	(40,109)
Cash provided by financing activities
Proceeds from exercise of options	188	217
Proceeds from issuance of senior secured convertible debt	50,000
Issuance of common shares, net of issuance costs		2,644
Pre-funded warrant issuance costs	(8)
Proceeds from employee stock purchase plan	393
Payment of debt issuance costs	(2,782)
Cash provided by financing activities	47,791	2,861
Net increase (decrease) in cash and cash equivalents	2,243	(76,855)
Cash and cash equivalents - Beginning of period	7,636	114,141
Cash and cash equivalents - End of period	$ 9,879	$ 37,286

Organization and Nature of Oper

Organization and Nature of Operations	9 Months Ended
Organization and Nature of Operations	Sep. 30, 2023
Organization and Nature of Operations
Organization and Nature of Operations	1 Organization and Nature of Operations Milestone Pharmaceuticals Inc. (Milestone or the Company) is a biopharmaceutical company incorporated under the Business Corporations Act

Summary of Significant Accounti

Summary of Significant Accounting Policies	9 Months Ended
Summary of Significant Accounting Policies	Sep. 30, 2023
Summary of Significant Accounting Policies
Summary of Significant Accounting Policies	2 Summary of Significant Accounting Policies a) Basis of Consolidation The 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 “US GAAP”, and on a basis consistent with those accounting principles followed by the Company and disclosed in Note 2 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 US GAAP have 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, 2022. 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 balance sheet as of September 30, 2023, and its statements of loss and shareholders’ equity for the three and nine months ended September 30, 2023 and 2022 and its statements of cash flows for the nine months ended September 30, 2023 and 2022. The condensed consolidated balance sheet as of December 31, 2022, was derived from audited annual consolidated financial statements, but does not contain all the footnote disclosures required by accounting principles generally accepted in the United States of America. 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 US 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 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 an individual clinical trial in accordance with agreements established with contracted research organizations, or “CRO”, contracted manufacturing organizations, or “CMO”, and clinical trial sites which in turn impact the research & development expenses. ● Estimate of the grant date fair value share options granted to employees, consultants and directors, and the resulting share-based compensation expense, using the Black-Scholes option-pricing model. 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: obtaining regulatory approval of its product candidate; 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 , international armed conflicts and overall fluctuations in the financial markets in the U nited States and abroad. d) Recent Accounting Pronouncements The Company has considered recent accounting pronouncements and concluded that they are either not applicable to the business or that the effect is not expected to be material to the unaudited condensed consolidated financial statements as a result of future adoption. e) Sources of Liquidity and Funding Requirements The Company incurred operating losses and has experienced negative operating cash flows since its inception and anticipates to continue to incur losses for at least the next several years. As of September 30, 2023, the Company had cash, cash equivalents and short-term investments of $75.7 million and an accumulated deficit of $312.4 million. Management has evaluated the Company’s operating plan against its existing cash and cash equivalents and determined that the Company expects to be able to support its operations for at least the next 12 months from the date of issuance of these unaudited interim consolidated financial statements.

Revenues

Revenues	9 Months Ended
Revenues	Sep. 30, 2023
Revenues
Revenues	3 Revenues The Company recorded no revenue for the three months ended September 30, 2023 and $1.0 million in revenue during the nine months ended September 30, 2023. This revenue is due to a milestone reached as a result of the successful initiation of a Phase 1 Clinical Trial of the product by or on behalf of Ji Xing for the treatment of paroxysmal supraventricular tachycardia, or “PSVT”, in the Territory. The Company recorded $1.5 million in revenue for the three and nine months ended September 30, 2022. This revenue was related to a milestone reached as a result of the first patient dosed in a Phase 3 Clinical Trial for the treatment of PSVT in the Territory. For details on the arrangement with Ji Xing, see Note 3 to our audited consolidated financial statements for the year ended December 31, 2022, filed on Form 10-K.

Short-term Investments

Short-term Investments	9 Months Ended
Short-term Investments	Sep. 30, 2023
Short-term Investments
Short-term Investments	4 Short-term Investments Short term investments are classified as held-to-maturity, are initially recognized at fair value and are subsequently accounted for at amortized cost. They are comprised of guaranteed investment certificates with a maturity greater than 90 days but less than one year and, as such, are classified as current assets.

Debt

Debt	9 Months Ended
Debt	Sep. 30, 2023
Debt
Debt	5 Debt On March 27, 2023, we 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, we closed the transactions contemplated by the Note Purchase Agreement, and issued and sold $50.0 million principal amount of 6.0% Convertible Senior Notes due 2029, or the “2029 Convertible Notes”, to the holders. The 2029 Convertible Notes are senior secured obligations and are guaranteed on a senior secured basis by our wholly owned subsidiary, Milestone Pharmaceuticals USA, Inc. Interest at the annual rate of 6.0% is payable quarterly in cash or, at our option, payable in kind for the first three years. The maturity date for the 2029 Convertible Notes is March 31, 2029, the “Maturity Date”. The obligations under the 2029 Convertible Notes are secured by substantially all of our and our subsidiary guarantor’s assets. Each $1,000 of principal of the 2029 Convertible Notes (including any interest added thereto as payment in kind) is convertible into 191.0548 shares of our common shares, equivalent to an initial conversion price of approximately $5.23 per share, subject to customary anti-dilution and other adjustments. In addition, following a notice of redemption or certain corporate events that occur prior to the Maturity Date, we will, in certain circumstances, increase the conversion rate for a holder who elects to convert its 2029 Convertible Notes in connection with such notice of redemption or corporate event. On or after March 27, 2027, the 2029 Convertible Notes are redeemable by us, subject to certain conditions, if the closing sale price of the common shares exceeds 150% of the conversion price then in effect for at least 20 trading days (whether or not consecutive), including the trading day immediately preceding the date on which we provide notice of redemption, during any 30 consecutive trading day period ending on, and including, the trading day immediately preceding the date on which we provide notice of redemption, at a redemption price equal to 100% of the principal amount of the 2029 Convertible Notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date. In accounting for the issuance of the Convertible Notes, the Company determined there were no embedded features, which require bifurcation between debt and equity components. As a result, the Convertible Notes are accounted for as a liability. As of September 30, 2023, the estimated fair value of the Convertible Notes was approximately $51.4 million. The net carrying amount of the Convertible Note were as follows: September 30, 2023 December 31, 2022 Original principal $ 50,000 $ — Paid in kind (PIK) interest 1,537 — Unamortized debt discount (566) — Unamortized debt issuance costs (2,056) — Total $ 48,915 $ — The following table presents the total amount of interest cost recognized relating to the 2029 Convertible Notes (in thousands): Three months ended September 30, Nine months ended September 30, 2023 2022 2023 2022 Contractual interest expense $ 762 $ — $ 1,537 $ — Amortization of debt discount 16 — 34 — Amortization of debt issuance costs 63 — 126 — Total interest expense $ 841 $ — $ 1,697 $ —

Accounts Payable and Accrued Li

Accounts Payable and Accrued Liabilities	9 Months Ended
Accounts Payable and Accrued Liabilities	Sep. 30, 2023
Accounts Payable and Accrued Liabilities
Accounts Payable and Accrued Liabilities	6 Accounts Payable and Accrued Liabilities Accounts payable and accrued liabilities are comprised of the following: September 30, 2023 December 31, 2022 Trade accounts payable $ 1,855 $ 2,263 Accrued compensation and benefits payable 2,426 2,573 Accrued research and development liabilities 2,051 404 Other accrued liabilities 1,252 404 Total $ 7,584 $ 5,644

Shareholders' Equity

Shareholders' Equity	9 Months Ended
Shareholders' Equity	Sep. 30, 2023
Shareholders' Equity
Shareholders' Equity	7 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 33,481,787 shares were issued and outstanding As of September 30, 2023, there were 1,463,936 On March 22, 2023, the Company entered into an exchange agreement, or the “Exchange Agreement”, with entities affiliated with RTW, or the “ Exchanging Stockholders ” , pursuant to which the Company exchanged an aggregate of 1,059,000 shares of the Company’s common shares owned by the Exchanging Stockholders for pre-funded warrants, or the Exchange Warrants, to purchase an aggregate of 1,059,000 common shares, with an exercise price of $0.001 per share and no expiration date. The Exchange Warrants are exercisable immediately and no additional cash consideration was rendered in exchange for the warrants. A holder of the Exchange Warrants (together with its affiliates and other attribution parties) may not exercise any portion of an Exchange Warrant to the extent that immediately prior to or after giving effect to such exercise the holder, together with its affiliates, would beneficially own more than 9.99% of the Company’s outstanding common shares immediately after exercise, which percentage may be increased or decreased to any other percentage specified not in excess of 9.99% at the holder's election upon 61 days ' notice to the Company subject to the terms of the Exchange Warrants. Additional Paid-in Capital The additional paid-in capital balances were as follows: Three months ended September 30, Nine months ended September 30, 2023 2022 2023 2022 Opening balance $ 29,114 $ 20,090 $ 24,437 $ 15,711 Share-based compensation expense 2,872 2,380 7,657 6,905 Exercise of stock options (28) (29) (136) (175) Closing balance $ 31,958 $ 22,441 $ 31,958 $ 22,441

Share Based Compensation

Share Based Compensation	9 Months Ended
Share Based Compensation	Sep. 30, 2023
Share Based Compensation
Share Based Compensation	8 Share Based Compensation Under the Company’s 2019 Equity Incentive Plan (the “2019 Plan”) and the Company’s Stock Option Plan (the “2011 Plan”), unless otherwise decided by the Board of Directors, options vest and are exercisable as follows: 25% vest one thirty-sixth th remaining anniversary On January 1, 2023 and on January 1, 2022, the number of the Company’s common shares reserved for issuance under the 2019 Plan increased by 1,371,440 and 1,195,902 common shares, respectively. Further, on July 5, 2022, the number of the Company’s common shares reserved for issuance under the 2019 Plan increased by 1,000,000 common shares. In addition, 125,323 options have been forfeited under the 2011 Plan since the adoption of the 2019 Plan and have become available for issuance under the 2019 Plan. As of September 30, 2023, 561,000 of previously issued options had been cancelled under the 2019 Plan and were available for future grants. As of September 30, 2023, there were 8,182,946 common shares available for issuance under the 2019 Plan, of which 1,644,623 common shares were available for future grants. On November 10, 2021, the Company established a 2021 Inducement Plan (the “Inducement Plan”) through the granting of awards. This 2021 Inducement Plan is intended to help the Company provide an inducement material for certain individuals to enter into employment with the Company, incentives for such persons to exert maximum efforts for the success of the Company and provide a means by which employees may benefit from increases in value of the common shares. As of September 30, 2023, there were 1,000,000 shares available for issuance under the 2021 Inducement Plan, of which 497,000 shares were available for future grants. On July 15, 2022, the Company offered an ESPP, in which participation is available to substantially all of our employees in the United States and Canada who meet certain service eligibility requirements. On January 1, 2023 the number of common shares reserved for issuance under the ESPP increased by 342,860 shares. As of September 30, 2023, the Company has 1,463,936 common shares available for issuance under the ESPP. As of September 30, 2023, the Company has issued 142,006 shares of common stock pursuant to the ESPP. The total outstanding and exercisable options from the 2011 Plan, 2019 Plan and Inducement Plan as of September 30 were as follows: 2023 Weighted Number average of shares exercise 2019 Plan Inducement Plan 2011 Plan Total price Outstanding at beginning of year - 2011 Plan — — 1,802,672 1,802,672 $ 2.05 Outstanding at beginning of year - 2019 Plan 5,314,312 — — 5,314,312 8.35 Outstanding at beginning of year - Inducement Plan — 503,000 — 503,000 6.41 Granted - 2019 Plan 1,867,400 — — 1,867,400 3.62 Exercised - 2019 Plan (7,000) — — (7,000) 3.74 Exercised - 2011 Plan — — (105,779) (105,779) 1.52 Forfeited - 2019 Plan (87,861) — — (87,861) 6.28 Expired - 2019 Plan (58,617) — — (58,617) 11.52 Expired - 2011 Plan — — (343) (343) 0.92 Cancelled - 2019 Plan (561,000) — — (561,000) 21.73 Outstanding at end of period 6,467,234 503,000 1,696,550 8,666,784 $ 5.13 Outstanding at end of period - Weighted average exercise price $ 5.83 $ 6.41 $ 2.08 Exercisable at end of period 2,972,614 190,396 1,696,550 4,859,560 $ 5.25 Exercisable at end of period - Weighted average exercise price $ 6.98 $ 6.42 $ 2.08 2022 Weighted Number average of shares exercise 2019 Plan Inducement Plan 2011 Plan Total price Outstanding at beginning of year - 2011 Plan — — 1,995,971 1,995,971 $ 2.07 Outstanding at beginning of year - 2019 Plan 3,759,834 — — 3,759,834 9.51 Granted - 2019 Plan 1,748,700 — — 1,748,700 5.78 Granted - Inducement Plan — 523,000 523,000 6.37 Exercised - 2019 Plan (15,089) — — (15,089) 3.92 Exercised - 2011 Plan — — (114,225) (114,225) 1.38 Forfeited - 2019 Plan (17,950) — — (17,950) 14.31 Forfeited - 2011 Plan — — (19,387) (19,387) 9.42 Expired - 2011 Plan — — (1,121) (1,121) 0.96 Outstanding at end of period 5,475,495 523,000 1,861,238 7,859,733 $ 6.70 Outstanding at end of period - Weighted average exercise price $ 8.32 $ 6.37 $ 2.04 Exercisable at end of period 2,219,125 — 1,831,482 4,050,607 $ 6.28 Exercisable at end of period - Weighted average exercise price $ 9.79 — $ 2.01 The weighted average remaining contractual life was 7.5 and 7.8 years for outstanding options as of September 30, 2023 and 2022, respectively. The weighted average remaining contractual life was 6.4 and 6.7 years for vested options, as of September 30, 2023 and 2022, respectively. There was $13.2 million and $18.6 million of total unrecognized compensation cost related to non-vested share options as of September 30, 2023 and 2022, respectively. The share options are expected to be recognized over a remaining weighted average vesting period of 2.4 years and 2.5 years as of September 30, 2023 and 2022, respectively. For the three and nine months ended September 30, 2023, there were 561,000 shares cancelled under the 2019 plan, which resulted in additional share-based compensation expense of $0.6 million. Options granted are valued using the Black-Scholes option pricing model. Amortization of the fair value of the options over vesting years has been expensed and credited to additional paid-in capital in shareholders’ equity. The non-vested options as of September 30 were as follows: 2023 Number Weighted of options average 2019 Plan Inducement Plan 2011 Plan Total fair value Non-vested share options at beginning of year - 2011 Plan — — 2,126 2,126 $ 6.64 Non-vested share options at beginning of year - 2019 Plan 2,923,763 — — 2,923,763 5.30 Non-vested share options at beginning of year - Inducement Plan — 503,000 — 503,000 4.84 Granted - 2019 Plan 1,867,400 — — 1,867,400 2.87 Vested, outstanding 2011 Plan — — (2,126) (2,126) 6.64 Vested, outstanding 2019 Plan (1,231,712) — — (1,231,712) 6.09 Vested, outstanding Inducement Plan — (190,396) — (190,396) 4.85 Forfeited - 2019 Plan (64,831) — — (64,831) 4.08 Non-vested share options at end of period 3,494,620 312,604 — 3,807,224 $ 3.83 Non-vested share options at end of period - Weighted average fair value $ 3.74 $ 4.84 $ — 2022 Number Weighted of options average 2019 Plan Inducement Plan 2011 Plan Total fair value Non-vested share options at beginning of year - 2011 Plan — — 200,639 200,639 $ 1.86 Non-vested share options at beginning of year - 2019 Plan 2,665,518 — — 2,665,518 6.39 Granted - 2019 Plan 1,748,700 — — 1,748,700 4.37 Granted - Inducement Plan — 523,000 — 523,000 4.81 Vested, outstanding 2011 Plan — — (170,883) (170,883) 1.76 Forfeited - 2019 Plan (8,731) — — (8,731) 6.27 Vested, outstanding 2019 Plan (1,149,117) — — (1,149,117) 5.99 Non-vested share options at end of period 3,256,370 523,000 29,756 3,809,126 $ 5.34 Non-vested share options at end of period - Weighted average fair value $ 5.45 $ 4.81 $ 2.44 The fair value of share-based payment transactions is measured using Black-Scholes valuation model. This model also requires assumptions, including expected option life, volatility, risk-free interest rate and dividend yield, which greatly affect the calculated values. 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 September 30, Nine months ended September 30, 2023 2022 2023 2022 Exercise price $ 3.14 $ 6.94 $ 3.62 $ 5.91 Share price $ 3.14 $ 6.94 $ 3.62 $ 5.91 Volatility 98 % 93 % 98 % 91 % Risk-free interest rate 4.09 % 2.94 % 3.92 % 2.41 % Expected life 6.08 years 5.75 years 6.00 years 6.03 years Dividend 0 % 0 % 0 % 0 % Expected volatility is determined using 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 Company recognized share-based compensation expense as follows: Three months ended September 30, Nine months ended September 30, 2023 2022 2023 2022 Administration $ 1,546 $ 1,891 $ 4,051 $ 3,683 Research and development 900 349 2,526 2,302 Commercial activities 426 140 1,080 920 Total $ 2,872 $ 2,380 $ 7,657 $ 6,905

Net Loss Per Share

Net Loss Per Share	9 Months Ended
Net Loss Per Share	Sep. 30, 2023
Net Loss Per Share
Net Loss Per Share	9 Net Loss Per Share Basic 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. For the three and nine months ended September 30, 2023 and 2022, the Company was in a net loss position. Dilutive net loss per common share is determined by dividing net loss applicable to common shareholders by the weighted average number of common shares and shares issuable upon exercise of pre-funded warrants outstanding during the period. In addition to the conversion feature on the 2029 Convertible Notes described above, which the Company reviewed and concluded would be anti-dilutive due to the facts surrounding the feature, the following potentially dilutive securities have also been excluded from the computation of diluted weighted average shares outstanding as of September 30, as they would be anti-dilutive: 2023 2022 Share options 8,666,784 7,859,733 Amounts above reflect the common share equivalents of the noted instruments.

Royalty Purchase Agreement

Royalty Purchase Agreement	9 Months Ended
Royalty Purchase Agreement	Sep. 30, 2023
Royalty Purchase Agreement
Royalty Purchase Agreement	10 Royalty Purchase Agreement On March 27, 2023, we 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 U.S. Food and Drug Administration approval of etripamil (subject to certain conditions), in exchange for a purchase price of $75.0 million, the right to receive a tiered quarterly royalty payments, or the “Royalty Interest”, on the annual net product sales of etripamil in the United States in an amount equal to: (i) 7%, or the “Initial Tier Royalty”, of annual net sales up to $500 million, (ii) 4% of annual net sales greater Based on the Company’s assessment of the terms and conditions under the Royalty Purchase Agreement, there is no accounting recognition required in these interim financial statements.

Summary of Significant Accoun_2

Summary of Significant Accounting Policies (Policies)	9 Months Ended
Summary of Significant Accounting Policies (Policies)	Sep. 30, 2023
Summary of Significant Accounting Policies
Basis of Consolidation	a) Basis of Consolidation The consolidated financial statements include the accounts of the Company and Milestone Pharmaceuticals USA, Inc. All intercompany transactions and balances have been eliminated.
Basis of Presentation and Use of Accounting Estimates and Significant Accounting Policies	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 “US GAAP”, and on a basis consistent with those accounting principles followed by the Company and disclosed in Note 2 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 US GAAP have 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, 2022. 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 balance sheet as of September 30, 2023, and its statements of loss and shareholders’ equity for the three and nine months ended September 30, 2023 and 2022 and its statements of cash flows for the nine months ended September 30, 2023 and 2022. The condensed consolidated balance sheet as of December 31, 2022, was derived from audited annual consolidated financial statements, but does not contain all the footnote disclosures required by accounting principles generally accepted in the United States of America. 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 US 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 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 an individual clinical trial in accordance with agreements established with contracted research organizations, or “CRO”, contracted manufacturing organizations, or “CMO”, and clinical trial sites which in turn impact the research & development expenses. ● Estimate of the grant date fair value share options granted to employees, consultants and directors, and the resulting share-based compensation expense, using the Black-Scholes option-pricing model.
Significant Risks and Uncertainties	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: obtaining regulatory approval of its product candidate; 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 , international armed conflicts and overall fluctuations in the financial markets in the U nited States and abroad.
Recent Accounting Pronouncements	d) Recent Accounting Pronouncements The Company has considered recent accounting pronouncements and concluded that they are either not applicable to the business or that the effect is not expected to be material to the unaudited condensed consolidated financial statements as a result of future adoption.
Sources of Liquidity and Funding Requirements	e) Sources of Liquidity and Funding Requirements The Company incurred operating losses and has experienced negative operating cash flows since its inception and anticipates to continue to incur losses for at least the next several years. As of September 30, 2023, the Company had cash, cash equivalents and short-term investments of $75.7 million and an accumulated deficit of $312.4 million. Management has evaluated the Company’s operating plan against its existing cash and cash equivalents and determined that the Company expects to be able to support its operations for at least the next 12 months from the date of issuance of these unaudited interim consolidated financial statements.

Debt (Tables)

Debt (Tables)	9 Months Ended
Debt (Tables)	Sep. 30, 2023
Debt
Schedule of Convertible Note	September 30, 2023 December 31, 2022 Original principal $ 50,000 $ — Paid in kind (PIK) interest 1,537 — Unamortized debt discount (566) — Unamortized debt issuance costs (2,056) — Total $ 48,915 $ —
Schedule of total amount of interest cost	The following table presents the total amount of interest cost recognized relating to the 2029 Convertible Notes (in thousands): Three months ended September 30, Nine months ended September 30, 2023 2022 2023 2022 Contractual interest expense $ 762 $ — $ 1,537 $ — Amortization of debt discount 16 — 34 — Amortization of debt issuance costs 63 — 126 — Total interest expense $ 841 $ — $ 1,697 $ —

Accounts Payable and Accrued _2

Accounts Payable and Accrued Liabilities (Tables)	9 Months Ended
Accounts Payable and Accrued Liabilities (Tables)	Sep. 30, 2023
Accounts Payable and Accrued Liabilities
Schedule of accounts payable and accrued liabilities	September 30, 2023 December 31, 2022 Trade accounts payable $ 1,855 $ 2,263 Accrued compensation and benefits payable 2,426 2,573 Accrued research and development liabilities 2,051 404 Other accrued liabilities 1,252 404 Total $ 7,584 $ 5,644

Shareholders' Equity (Tables)

Shareholders' Equity (Tables)	9 Months Ended
Shareholders' Equity (Tables)	Sep. 30, 2023
Shareholders' Equity
Schedule of additional paid-in capital	Three months ended September 30, Nine months ended September 30, 2023 2022 2023 2022 Opening balance $ 29,114 $ 20,090 $ 24,437 $ 15,711 Share-based compensation expense 2,872 2,380 7,657 6,905 Exercise of stock options (28) (29) (136) (175) Closing balance $ 31,958 $ 22,441 $ 31,958 $ 22,441

Share Based Compensation (Table

Share Based Compensation (Tables)	9 Months Ended
Share Based Compensation (Tables)	Sep. 30, 2023
Share Based Compensation
Schedule of outstanding and exercisable options	2023 Weighted Number average of shares exercise 2019 Plan Inducement Plan 2011 Plan Total price Outstanding at beginning of year - 2011 Plan — — 1,802,672 1,802,672 $ 2.05 Outstanding at beginning of year - 2019 Plan 5,314,312 — — 5,314,312 8.35 Outstanding at beginning of year - Inducement Plan — 503,000 — 503,000 6.41 Granted - 2019 Plan 1,867,400 — — 1,867,400 3.62 Exercised - 2019 Plan (7,000) — — (7,000) 3.74 Exercised - 2011 Plan — — (105,779) (105,779) 1.52 Forfeited - 2019 Plan (87,861) — — (87,861) 6.28 Expired - 2019 Plan (58,617) — — (58,617) 11.52 Expired - 2011 Plan — — (343) (343) 0.92 Cancelled - 2019 Plan (561,000) — — (561,000) 21.73 Outstanding at end of period 6,467,234 503,000 1,696,550 8,666,784 $ 5.13 Outstanding at end of period - Weighted average exercise price $ 5.83 $ 6.41 $ 2.08 Exercisable at end of period 2,972,614 190,396 1,696,550 4,859,560 $ 5.25 Exercisable at end of period - Weighted average exercise price $ 6.98 $ 6.42 $ 2.08 2022 Weighted Number average of shares exercise 2019 Plan Inducement Plan 2011 Plan Total price Outstanding at beginning of year - 2011 Plan — — 1,995,971 1,995,971 $ 2.07 Outstanding at beginning of year - 2019 Plan 3,759,834 — — 3,759,834 9.51 Granted - 2019 Plan 1,748,700 — — 1,748,700 5.78 Granted - Inducement Plan — 523,000 523,000 6.37 Exercised - 2019 Plan (15,089) — — (15,089) 3.92 Exercised - 2011 Plan — — (114,225) (114,225) 1.38 Forfeited - 2019 Plan (17,950) — — (17,950) 14.31 Forfeited - 2011 Plan — — (19,387) (19,387) 9.42 Expired - 2011 Plan — — (1,121) (1,121) 0.96 Outstanding at end of period 5,475,495 523,000 1,861,238 7,859,733 $ 6.70 Outstanding at end of period - Weighted average exercise price $ 8.32 $ 6.37 $ 2.04 Exercisable at end of period 2,219,125 — 1,831,482 4,050,607 $ 6.28 Exercisable at end of period - Weighted average exercise price $ 9.79 — $ 2.01
Schedule of non-vested share options activity	2023 Number Weighted of options average 2019 Plan Inducement Plan 2011 Plan Total fair value Non-vested share options at beginning of year - 2011 Plan — — 2,126 2,126 $ 6.64 Non-vested share options at beginning of year - 2019 Plan 2,923,763 — — 2,923,763 5.30 Non-vested share options at beginning of year - Inducement Plan — 503,000 — 503,000 4.84 Granted - 2019 Plan 1,867,400 — — 1,867,400 2.87 Vested, outstanding 2011 Plan — — (2,126) (2,126) 6.64 Vested, outstanding 2019 Plan (1,231,712) — — (1,231,712) 6.09 Vested, outstanding Inducement Plan — (190,396) — (190,396) 4.85 Forfeited - 2019 Plan (64,831) — — (64,831) 4.08 Non-vested share options at end of period 3,494,620 312,604 — 3,807,224 $ 3.83 Non-vested share options at end of period - Weighted average fair value $ 3.74 $ 4.84 $ — 2022 Number Weighted of options average 2019 Plan Inducement Plan 2011 Plan Total fair value Non-vested share options at beginning of year - 2011 Plan — — 200,639 200,639 $ 1.86 Non-vested share options at beginning of year - 2019 Plan 2,665,518 — — 2,665,518 6.39 Granted - 2019 Plan 1,748,700 — — 1,748,700 4.37 Granted - Inducement Plan — 523,000 — 523,000 4.81 Vested, outstanding 2011 Plan — — (170,883) (170,883) 1.76 Forfeited - 2019 Plan (8,731) — — (8,731) 6.27 Vested, outstanding 2019 Plan (1,149,117) — — (1,149,117) 5.99 Non-vested share options at end of period 3,256,370 523,000 29,756 3,809,126 $ 5.34 Non-vested share options at end of period - Weighted average fair value $ 5.45 $ 4.81 $ 2.44
Schedule of weighted average assumptions for the options granted	Three months ended September 30, Nine months ended September 30, 2023 2022 2023 2022 Exercise price $ 3.14 $ 6.94 $ 3.62 $ 5.91 Share price $ 3.14 $ 6.94 $ 3.62 $ 5.91 Volatility 98 % 93 % 98 % 91 % Risk-free interest rate 4.09 % 2.94 % 3.92 % 2.41 % Expected life 6.08 years 5.75 years 6.00 years 6.03 years Dividend 0 % 0 % 0 % 0 %
Schedule of share-based compensation expense	Three months ended September 30, Nine months ended September 30, 2023 2022 2023 2022 Administration $ 1,546 $ 1,891 $ 4,051 $ 3,683 Research and development 900 349 2,526 2,302 Commercial activities 426 140 1,080 920 Total $ 2,872 $ 2,380 $ 7,657 $ 6,905

Net loss per share (Tables)

Net loss per share (Tables)	9 Months Ended
Net loss per share (Tables)	Sep. 30, 2023
Net Loss Per Share
Schedule of potentially dilutive securities excluded from the computation of diluted weighted average shares	2023 2022 Share options 8,666,784 7,859,733

Summary of Significant Accoun_3

Summary of Significant Accounting Policies - Sources of Liquidity and Funding Requirements (Details) - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022
Summary of Significant Accounting Policies
Cash, cash equivalents and short-term investments	$ 75,700
Accumulated deficit	$ (312,415)	$ (266,341)

Revenue (Details)

Revenue (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
Revenue (Details) - USD ($) $ in Thousands	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Revenues
Revenue	$ 0	$ 1,500	$ 1,000	$ 1,500

Debt (Details)

Debt (Details)		9 Months Ended
Debt (Details)	Mar. 29, 2023 USD ($) item $ / shares shares	Sep. 30, 2023 USD ($)
Debt Instruments
Proceeds from convertible notes		$ 50,000,000
Debt issuance costs paid		2,782,000
RTW Investments, LP \| Senior Secured Convertible Notes \| Strategic Financing Agreements
Debt Instruments
Proceeds from convertible notes	$ 50,000,000
Coupon rate (as a percent)	6%
Paid in kind, term	3 years
Principal amount denomination for conversion	$ 1,000
Convertible shares issuable \| shares	191.0548
Conversion price \| $ / shares	$ 5.23
Threshold Percentage of stock price	150%
Threshold trading days \| item	20
Threshold consecutive trading days \| item	30
Redemption price percentage	100%
Estimated Fair Value		$ 51,400,000

Debt - Convertible Note (Detail

Debt - Convertible Note (Details) $ in Thousands	Sep. 30, 2023 USD ($)
Debt Instrument [Line Items]
Total	$ 48,915
Senior Secured Convertible Notes \| RTW Investments, LP \| Strategic Financing Agreements
Debt Instrument [Line Items]
Original principal	50,000
Paid in kind (PIK) interest	1,537
Unamortized debt discount	(566)
Unamortized debt issuance costs	(2,056)
Total	$ 48,915

Debt - Total amount of interest

Debt - Total amount of interest cost (Details) - Senior Secured Convertible Notes - RTW Investments, LP - Strategic Financing Agreements - USD ($) $ in Thousands	3 Months Ended	9 Months Ended
	Sep. 30, 2023	Sep. 30, 2023
Debt Instrument [Line Items]
Contractual interest expense	$ 762	$ 1,537
Amortization of debt discount	16	34
Amortization of debt issuance costs	63	126
Total interest expense	$ 841	$ 1,697

Accounts Payable and Accrued _3

Accounts Payable and Accrued Liabilities (Details) - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022
Accounts Payable and Accrued Liabilities
Trade accounts payable	$ 1,855	$ 2,263
Accrued compensation and benefits payable	2,426	2,573
Accrued research and development liabilities	2,051	404
Other accrued liabilities	1,252	404
Total	$ 7,584	$ 5,644

Shareholders' Equity - Authoriz

Shareholders' Equity - Authorized share capital (Details) - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Dec. 31, 2022
Authorized share capital
Common Stock, Shares, Issued	33,481,787		34,286,002
Common Stock, Shares, Outstanding	33,481,787		34,286,002
Issuance of common shares, net of issuance costs		$ 2,644
Employee Stock Purchase Plan
Authorized share capital
Number of common shares available for issuance	1,463,936
Number of shares issued under the ESPP	142,006

Shareholders' Equity - Pre-fund

Shareholders' Equity - Pre-funded Warrants and Open Market Sale Agreement (Details) - USD ($)		3 Months Ended	9 Months Ended
	Mar. 22, 2023	Sep. 30, 2022	Sep. 30, 2022
Class of Warrant or Right
Net proceeds			$ 2,644,000
Offering price		$ 2,644,000	$ 2,644,000
RTW Investments, LP
Class of Warrant or Right
Purchase price	$ 0.001
Common shares exchanged for pre-funded warrants	1,059,000
Proceeds from exercise of warrants	$ 0
Maximum ownership after exercise of exchange agreement	9.99%
Required notice (in days)	61 days
Common Shares
Class of Warrant or Right
Number of shares issued during the period		361,236	361,236
Offering price		$ 2,644,000	$ 2,644,000

Shareholders' Equity - Addition

Shareholders' Equity - Additional paid-in capital (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Additional paid-in capital
Opening balance	$ 40,408	$ 86,659	$ 66,348	$ 112,600
Share-based compensation expense	2,872	2,380	7,657	6,905
Exercise of stock options	40	28	188	217
Closing balance	28,504	77,155	28,504	77,155
Additional paid-in capital
Additional paid-in capital
Opening balance	29,114	20,090	24,437	15,711
Share-based compensation expense	2,872	2,380	7,657	6,905
Exercise of stock options	(28)	(29)	(136)	(175)
Closing balance	$ 31,958	$ 22,441	$ 31,958	$ 22,441

Share Based Compensation (Detai

Share Based Compensation (Details) - $ / shares		3 Months Ended	9 Months Ended
Share Based Compensation (Details) - $ / shares	Jan. 01, 2022	Sep. 30, 2023	Sep. 30, 2023	Sep. 30, 2022	Jan. 01, 2023	Dec. 31, 2022	Jul. 05, 2022	Dec. 31, 2021
2011 Plan
Share-based compensation
Number of options forfeited after termination of one plan	125,323
Number of options, Options outstanding		1,696,550	1,696,550	1,861,238		1,802,672		1,995,971
Weighted average exercise price			$ 0.92
2019 Plan
Share-based compensation
Shares reserved for issuance	1,195,902	8,182,946	8,182,946		1,371,440		1,000,000
Shares available for future grants		1,644,623	1,644,623
Options granted			1,867,400	1,748,700
Cancelled		561,000	561,000
Number of options, Options outstanding		6,467,234	6,467,234	5,475,495		5,314,312		3,759,834
Weighted average exercise price			$ 3.62	$ 5.78
2021 Inducement Plan
Share-based compensation
Shares reserved for issuance		1,000,000	1,000,000
Shares available for future grants		497,000	497,000
Options granted				523,000
Number of options, Options outstanding		503,000	503,000	523,000		503,000
Weighted average exercise price				$ 6.37
ESPP
Share-based compensation
Shares reserved for issuance		1,463,936	1,463,936		342,860
Shares issued			142,006
Options \| 2011 Plan
Share-based compensation
Vesting period			4 years
Options \| 2011 Plan \| Share-based Compensation Award, Tranche One
Share-based compensation
Percentage of shares to vest			25%
Options \| 2011 Plan \| Share-based Compensation Award, Tranche Two
Share-based compensation
Percentage of shares to vest			2.78%
Options \| 2019 Plan
Share-based compensation
Vesting period			4 years
Options \| 2019 Plan \| Share-based Compensation Award, Tranche One
Share-based compensation
Percentage of shares to vest			25%
Options \| 2019 Plan \| Share-based Compensation Award, Tranche Two
Share-based compensation
Percentage of shares to vest			2.78%

Share Based Compensation - Outs

Share Based Compensation - Outstanding and exercisable options (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Outstanding and exercisable options, weighted average exercise price
Weighted average remaining contractual life (in years)			7 years 6 months	7 years 9 months 18 days
Weighted average remaining contractual life for vested options (in years)			6 years 4 months 24 days	6 years 8 months 12 days
Unrecognized compensation cost	$ 13,200	$ 18,600	$ 13,200	$ 18,600
Expected period for recognition			2 years 4 months 24 days	2 years 6 months
Share-based compensation expense	$ 2,872	$ 2,380	$ 7,657	$ 6,905
Plans 2011 and 2019 and 2021 Inducement [Member]
Outstanding and exercisable options, number of shares
Outstanding at end of period	8,666,784	7,859,733	8,666,784	7,859,733
Exercisable at end of period	4,859,560	4,050,607	4,859,560	4,050,607
Outstanding and exercisable options, weighted average exercise price
Outstanding at end of period	$ 5.13	$ 6.70	$ 5.13	$ 6.70
Exercisable at end of period	$ 5.25	$ 6.28	$ 5.25	$ 6.28
2011 Plan
Outstanding and exercisable options, number of shares
Outstanding at beginning of period			1,802,672	1,995,971
Expired			(343)	(1,121)
Exercised			(105,779)	(114,225)
Forfeited				(19,387)
Outstanding at end of period	1,696,550	1,861,238	1,696,550	1,861,238
Exercisable at end of period	1,696,550	1,831,482	1,696,550	1,831,482
Outstanding and exercisable options, weighted average exercise price
Outstanding at beginning of period			$ 2.05	$ 2.07
Granted			0.92
Exercised			1.52	1.38
Forfeited				9.42
Expired				0.96
Outstanding at end of period	$ 2.08	$ 2.04	2.08	2.04
Exercisable at end of period	$ 2.08	$ 2.01	$ 2.08	$ 2.01
2019 Plan
Outstanding and exercisable options, number of shares
Outstanding at beginning of period			5,314,312	3,759,834
Granted			1,867,400	1,748,700
Expired			(58,617)
Exercised			(7,000)	(15,089)
Forfeited			(87,861)	(17,950)
Cancelled	(561,000)		(561,000)
Outstanding at end of period	6,467,234	5,475,495	6,467,234	5,475,495
Exercisable at end of period	2,972,614	2,219,125	2,972,614	2,219,125
Outstanding and exercisable options, weighted average exercise price
Outstanding at beginning of period			$ 8.35	$ 9.51
Granted			3.62	5.78
Exercised			3.74	3.92
Forfeited			6.28	14.31
Cancelled			21.73
Expired			11.52
Outstanding at end of period	$ 5.83	$ 8.32	5.83	8.32
Exercisable at end of period	$ 6.98	$ 9.79	$ 6.98	$ 9.79
Share-based compensation expense	$ 600		$ 600
2021 Inducement Plan
Outstanding and exercisable options, number of shares
Outstanding at beginning of period			503,000
Granted				523,000
Outstanding at end of period	503,000	523,000	503,000	523,000
Exercisable at end of period	190,396		190,396
Outstanding and exercisable options, weighted average exercise price
Outstanding at beginning of period			$ 6.41
Granted				$ 6.37
Outstanding at end of period	$ 6.41	$ 6.37	6.41	$ 6.37
Exercisable at end of period	$ 6.42		$ 6.42

Share Based Compensation - Non-

Share Based Compensation - Non-vested share options (Details) - $ / shares	9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022
Plans 2011 and 2019 and 2021 Inducement [Member]
Number of options
Non-vested share options at end of period	3,807,224	3,809,126
Weighted average fair value
Non-vested at end of period	$ 3.83	$ 5.34
2011 Plan
Number of options
Non-vested at beginning of period	2,126	200,639
Vested, outstanding	(2,126)	(170,883)
Non-vested share options at end of period		29,756
Weighted average fair value
Non-vested at beginning of period	$ 6.64	$ 1.86
Vested, outstanding	$ 6.64	1.76
Non-vested at end of period		$ 2.44
2019 Plan
Number of options
Non-vested at beginning of period	2,923,763	2,665,518
Granted	1,867,400	1,748,700
Vested, outstanding	(1,231,712)	(1,149,117)
Forfeited	(64,831)	(8,731)
Non-vested share options at end of period	3,494,620	3,256,370
Weighted average fair value
Non-vested at beginning of period	$ 5.30	$ 6.39
Granted	2.87	4.37
Vested, outstanding	6.09	5.99
Forfeited	4.08	6.27
Non-vested at end of period	$ 3.74	$ 5.45
2021 Inducement Plan
Number of options
Non-vested at beginning of period	503,000
Granted		523,000
Vested, outstanding	(190,396)
Non-vested share options at end of period	312,604	523,000
Weighted average fair value
Non-vested at beginning of period	$ 4.84
Granted		$ 4.81
Vested, outstanding	4.85
Non-vested at end of period	$ 4.84	$ 4.81

Share Based Compensation - Weig

Share Based Compensation - Weighted average assumptions for the options granted (Details) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Share Based Compensation
Exercise price	$ 3.14	$ 6.94	$ 3.62	$ 5.91
Share price (in dollars per share)	$ 3.14	$ 6.94	$ 3.62	$ 5.91
Volatility (as a percent)	98%	93%	98%	91%
Risk-free interest rate (as a percent)	4.09%	2.94%	3.92%	2.41%
Expected life (in years)	6 years 29 days	5 years 9 months	6 years	6 years 10 days
Dividend (as a percent)	0%	0%	0%	0%

Share Based Compensation - Reco

Share Based Compensation - Recognized share-based compensation expense (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Share-based compensation
Share-based compensation expense	$ 2,872	$ 2,380	$ 7,657	$ 6,905
Administration
Share-based compensation
Share-based compensation expense	1,546	1,891	4,051	3,683
Research and development
Share-based compensation
Share-based compensation expense	900	349	2,526	2,302
Commercial activities
Share-based compensation
Share-based compensation expense	$ 426	$ 140	$ 1,080	$ 920

Net loss per share (Details)

Net loss per share (Details) - shares	9 Months Ended
Net loss per share (Details) - shares	Sep. 30, 2023	Sep. 30, 2022
Share options
Net income (loss) per share
Share options	8,666,784	7,859,733

Royalty Purchase Agreement (Det

Royalty Purchase Agreement (Details) - RTW Investments, LP - Strategic Financing Agreements $ in Millions	Mar. 27, 2023 USD ($)
Royalty Purchase Agreement
Funding received from sale of product rights	$ 75
Up to $500 million
Royalty Purchase Agreement
Future payment as a percentage of aggregate net sales	7%
Threshold amount of annual aggregate net sales	$ 500
Additional future payment as a percentage of aggregate net sales	9.50%
Above $800 million
Royalty Purchase Agreement
Future payment as a percentage of aggregate net sales	1%
Threshold amount of annual aggregate net sales	$ 800
Minimum \| Above $500 million
Royalty Purchase Agreement
Future payment as a percentage of aggregate net sales	4%
Threshold amount of annual aggregate net sales	$ 500
Maximum \| Up to $800 million
Royalty Purchase Agreement
Future payment as a percentage of aggregate net sales	4%
Threshold amount of annual aggregate net sales	$ 800