Milestone Pharmaceuticals Inc 10-Q for FY2026 Q3

Milestone Pharmaceuticals Inc. (MIST)

10-Q 2026-11-13 For: 2026-09-30

Added on November 13, 2026

About this 10-Q

Milestone Pharmaceuticals Inc filed this 10-Q on November 13, 2026, covering the quarter ended September 30, 2026 (FY2026 Q3).

China approved etripamil nasal spray for PSVT, triggering a $2.0 million milestone. Cost-efficiency measures target approximately 30% lower operating expenses and a 20% workforce reduction, while the company reported a $25.8 million quarterly net loss. AI summary

Headline figures

Quarter ended September 30, 2026, as reported in this filing, compared with the same period a year earlier where the filing states it.

Revenue: $2.96M
Net loss: $25.8M; compared with a net loss of $11.92M a year earlier
Diluted EPS: -$0.18; compared with -$0.12 a year earlier

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Québec		Not applicable
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Shares		MIST		The Nasdaq Stock Market LLC

Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
Emerging growth company	☐


		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’ (Deficit) 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	26
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	42
Item 4.	Controls and Procedures	42

PART II.	OTHER INFORMATION	43

Item 1.	Legal Proceedings	43
Item 1A.	Risk Factors	43
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	44
Item 3.	Defaults Upon Senior Securities	44
Item 4.	Mine Safety Disclosures	44
Item 5.	Other Information	45
Item 6.	Exhibits	46



	* *	September 30, 2026		* *	December 31, 2025
Assets

Current assets
Cash and cash equivalents		$	144,472		$	73,046
Short-term investments			882			32,914
Accounts receivable, net			3,929			—
License receivable			2,000			1,546
Research and development tax credits receivable			623			316
Prepaid expenses			2,513			1,805
Inventory, net			6,676			648
Other receivables			509			1,646
Total current assets			161,604			111,921
Operating lease right-of-use assets			675			1,129
Property and equipment, net			416			511
Total assets		$	162,695		$	113,561

Liabilities and Shareholders' (Deficit) Equity

Current liabilities
Accounts payable		$	9,235		$	5,645
Accrued liabilities			14,496			7,644
Operating lease liabilities			686			647
Deferred revenue			1,321			—
Other current liabilities			43			43
Total current liabilities			25,781			13,979
Operating lease liabilities, net of current portion			14			539
Senior secured convertible notes			60,237			57,191
Royalty financing obligation, long-term			82,829			—
Other long-term liabilities			51			83
Total liabilities			168,912			71,792


Shareholders’ (Deficit) Equity
Common shares, no par value, unlimited shares authorized, 124,498,693 shares issued and outstanding as of September 30, 2026, 106,236,344 shares issued and outstanding as of December 31, 2025			384,987			352,619
Pre-funded warrants - 16,412,925 issued and outstanding as of September 30, 2026, and 16,412,925 as of December 31, 2025			55,649			55,649
Additional paid-in capital			64,226			64,104
Accumulated deficit			(511,079)			(430,603)

Total shareholders’ (deficit) equity			(6,217)			41,769

Total liabilities and shareholders’ (deficit) equity		$	162,695		$	113,561



		Three months ended September 30,						Nine months ended September 30,
		2026			2025			2026			2025

Revenues
Product revenue, net		$	963		$	—		$	1,760		$	—
License and other revenue			2,000			—			2,000			—
Total revenues			2,963			—			3,760			—

Operating Expenses
Cost of product sales			325			—			371			—
Research and development, net of tax credits			3,458			3,940			10,191			12,587
Selling, general and administrative			24,232			7,889			67,543			32,296
Total operating expenses			28,015			11,829			78,105			44,883

Loss from operations			(25,052)			(11,829)			(74,345)			(44,883)

Interest income			1,438			874			4,911			2,087
Interest expense			(2,182)			(967)			(11,042)			(2,853)

Net loss and comprehensive loss		$	(25,796)		$	(11,922)		$	(80,476)		$	(45,649)

Weighted average number of shares and pre-funded warrants outstanding, basic and diluted			140,910,921			96,494,588			136,668,430			76,497,361

Net loss per share, basic and diluted		$	(0.18)		$	(0.12)		$	(0.59)		$	(0.60)


		Common Shares					Pre-funded warrants
		Number of shares		Amount			Number of warrants		Amount			Additional paid-in capital			Accumulated deficit			Total
Balance as of June 30, 2025		53,494,261		$	288,263		12,910,590		$	53,076		$	42,188		$	(401,272)		$	(17,745)
Transactions during the three-month period ended September 30, 2025
Net loss		—			—		—			—			—			(11,922)			(11,922)
Exercise of stock options		79,602			211		—			—			(88)			—			123
Pre-funded warrants, net of issuance costs		—			—		3,502,335			2,573			—			—			2,573
Issuance of common shares, net of issuance costs		31,500,000			23,143		—			—			—			—			23,143
Issuance of Series A common share warrants, net of issuance costs		—			—		—			—			9,504			—			9,504
Issuance of Series B common share warrants, net of issuance costs		—			—		—			—			13,416			—			13,416
Share-based compensation		—			—		—			—			1,250			—			1,250
Employee stock purchase plan purchases		95,481			159		—			—			—			—			159
Balance as of September 30, 2025		85,169,344		$	311,776		16,412,925		$	55,649		$	66,270		$	(413,194)		$	20,501

Balance as of June 30, 2026		124,497,980		$	384,985		16,412,925		$	55,649		$	62,867		$	(485,283)		$	18,218
Transactions during the three-month period ended September 30, 2026
Net loss		—			—		—			—			—			(25,796)			(25,796)
Exercise of stock options		713			2		—			—			(1)			—			1
Share-based compensation		—			—		—			—			1,360			—			1,360
Balance as of September 30, 2026		124,498,693		$	384,987		16,412,925		$	55,649		$	64,226		$	(511,079)		$	(6,217)

Balance as of December 31, 2024		53,353,984		$	288,048		12,910,590		$	53,076		$	39,568		$	(367,545)		$	13,147
Transactions during the nine-month period ended September 30, 2025
Net loss		—			—		—			—			—			(45,649)			(45,649)
Exercise of stock options		109,590			285		—			—			(127)			—			158
Pre-funded warrants, net of issuance costs		—			—		3,502,335			2,573			—			—			2,573
Issuance of common shares, net of issuance costs		31,500,000			23,143		—			—			—			—			23,143
Issuance of Series A common share warrants, net of issuance costs		—			—		—			—			9,504			—			9,504
Issuance of Series B common share warrants, net of issuance costs		—			—		—			—			13,416			—			13,416
Share-based compensation		—			—		—			—			3,909			—			3,909
Employee stock purchase plan purchases		205,770			300		—			—			—			—			300
Balance as of September 30, 2025		85,169,344		$	311,776		16,412,925		$	55,649		$	66,270		$	(413,194)		$	20,501

Balance as of December 31, 2025		106,236,344		$	352,619		16,412,925		$	55,649		$	64,104		$	(430,603)		$	41,769
Transactions during the nine-month period ended September 30, 2026
Net loss		—			—		—			—			—			(80,476)			(80,476)
Exercise of stock options		25,634			55		—			—			(26)			—			29
Exercise of Series A common share warrants, net of issuance costs		12,345,308			20,759		—			—			(3,352)			—			17,407
Share-based compensation		—			—		—			—			3,980			—			3,980
Issuance of common shares, vesting of restricted stock units		237,677			480		—			—			(480)			—			—
Issuance of common shares, net of issuance costs		5,526,590			10,890		—			—			—			—			10,890
Employee stock purchase plan purchases		127,140			184		—			—			—			—			184
Balance as of September 30, 2026		124,498,693		$	384,987		16,412,925		$	55,649		$	64,226		$	(511,079)		$	(6,217)



	September 30, 2026		December 31, 2025
Original principal	$	50,000	$	50,000
Paid in kind (PIK) interest		11,618		8,927
Unamortized debt discount		(301)		(374)
Unamortized debt issuance costs		(1,080)		(1,362)
Total	$	60,237	$	57,191


	September 30, 2026		December 31, 2025

Accrued compensation and benefits payable		2,921		2,458
Accrued research and development liabilities		1,167		384
Accrued selling and marketing liabilities		6,595		2,201
Accrued inventory		450		—
Accrued underwriting fees		—		1,302
Accrued legal liabilities		170		296
Accrued medical liabilities		326		508
Other accrued liabilities		510		495
Revenue-related reserves		2,357		—
Total	$	14,496	$	7,644


	2026
										Weighted
	Number									average
	of shares									exercise
	2019 Plan		Inducement Plan		2011 Plan			Total		price
Outstanding at beginning of period - 2011 Plan		—		—		1,294,691		1,294,691		$	2.23
Outstanding at beginning of period - 2019 Plan		8,591,306		—		—		8,591,306			4.21
Outstanding at beginning of period - Inducement Plan		—		710,000		—		710,000			4.76
Granted - 2019 Plan		2,820,000		—		—		2,820,000			1.79
Granted - Inducement Plan		—		830,000		—		830,000			1.64
Exercised - 2011 Plan		—		—		(25,634)		(25,634)			1.13
Forfeited - Inducement Plan		—		(50,000)		—		(50,000)			1.32
Expired - 2011 Plan		—		—		(121,574)		(121,574)			1.12
Outstanding at end of period		11,411,306		1,490,000		1,147,483		14,048,789		$	3.46
Outstanding at end of period - Weighted average exercise price	$	3.61	$	3.14	$	2.37
Exercisable at end of period		7,321,461		504,709		1,147,483		8,973,653		$	4.35
Exercisable at end of period - Weighted average exercise price	$	4.57	$	5.81	$	2.37


	2026
Royalty financing obligation	$	75,000
Interest expense on royalty financing obligation		3,133
Royalties paid and payable		(22)
Balance as of March 31, 2026	$	78,111
Interest expense on royalty financing obligation		3,705
Royalties paid and payable		(53)
Balance as of June 30, 2026	$	81,763
Interest expense on royalty financing obligation		1,152
Royalties paid and payable		(86)
Balance as of September 30, 2026	$	82,829

Effective interest rate		5.59%


	Three months ended September 30,				Nine months ended September 30,
(in thousands)	2026		2025		2026		2025
Revenue	$	2,963	$	—	$	3,760	$	—

Less:
Cost of product sales		325		—		371		—
Research and development, net of tax credits, excluding share-based compensation		3,080		3,552		9,037		11,402
General and administrative, excluding share-based compensation		4,716		2,624		13,958		10,090
Commercial, excluding share-based compensation		16,412		2,931		44,746		14,266
Medical affairs, excluding share-based compensation		2,122		1,472		6,013		5,216
Share-based compensation expense		1,360		1,250		3,980		3,909
Interest income		(1,438)		(874)		(4,911)		(2,087)
Royalty financing interest expense		1,152		—		7,990		—
Note payable interest expense		1,030		967		3,052		2,853
Net loss	$	(25,796)	$	(11,922)	$	(80,476)	$	(45,649)


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.


Exhibit Number		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		Fourth Amendment to Note Purchase Agreement, dated as of November 11, 2026.
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.
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 September 30, 2026, formatted in Inline XBRL.


	MILESTONE PHARMACEUTICALS INC.

Date: November 13, 2026	By:	/s/ Joseph Oliveto
		Joseph Oliveto
		President and Chief Executive Officer (Principal Executive Officer)




Date: November 13, 2026	By:	/s/ Anthony J. Krick
		Anthony J. Krick
		Vice President of Finance (Principal Financial Officer and Principal Accounting Officer)

By:	/s/ Joseph Oliveto
Name:	Joseph Oliveto
Title:	Chief Executive Officer

By:	/s/ Roderick Wong, M.D.
Name:	Roderick Wong, M.D.
Title:	Managing Partner

By:	RTW Investments, LP, its Investment Manager

By:	/s/ Roderick Wong, M.D.
Name:	Roderick Wong, M.D.
Title:	Managing Partner


Date: November 13, 2026
	/s/ Anthony J. Krick
	Anthony J. Krick
	Vice President of Finance
	(Principal Financial Officer and Principal Accounting Officer)


Dated: November 13, 2026


/s/ Joseph Oliveto		/s/ Anthony J. Krick
Joseph Oliveto		Anthony J. Krick
Chief Executive Officer		Vice President of Finance
(Principal Executive Officer)		(Principal Financial Officer and Principal Accounting Officer)