dnli-20260630

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)


☒			QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 30, 2026


☐			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: 001-38311

Denali Therapeutics Inc.

(Exact name of registrant as specified in its charter)


Delaware						46-3872213
(State or other jurisdiction of incorporation or organization)						(I.R.S. Employer Identification No.)

161 Oyster Point Blvd. South San Francisco, CA, 94080
(Address of principal executive offices and zip code)

(650) 866-8547

(Registrant’s telephone number, including area code)

_______________________________________

Securities registered pursuant to Section 12(b) of the Act:


Title of each class	Trading Symbol	Name of each exchange on which registered
Common Stock, par value $0.01 per share	DNLI	Nasdaq Global Select Market

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

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). Yes ☒ No ☐

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	☐

Non-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 ☐ No ☒

The number of outstanding shares of the registrant’s common stock as of July 31, 2026 was 159,847,403. This number does not include 28,331,779 shares of common stock issuable upon the exercise of pre-funded warrants outstanding as of July 31, 2026 (which are immediately exercisable at an exercise price of $0.01 per share of common stock, subject to beneficial ownership limitations). See Note 11 — Common Stock to the registrant’s condensed consolidated financial statements.

TABLE OF CONTENTS


	PART I. FINANCIAL INFORMATION	Page

Item 1.	Financial Statements (Unaudited)	3
	Condensed Consolidated Balance Sheets	3
	Condensed Consolidated Statements of Operations and Comprehensive Loss	4
	Condensed Consolidated Statements of Stockholders’ Equity	5
	Condensed Consolidated Statements of Cash Flows	6
	Notes to 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	41
Item 4.	Controls and Procedures	42

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

Table of Contents

PART I. FINANCIAL INFORMATION

ITEM 1. FINANCIAL STATEMENTS

Denali Therapeutics Inc.

Condensed Consolidated Balance Sheets

(Unaudited)

(In thousands, except share amounts)


	June 30, 2026		December 31, 2025
Assets
Current assets:
Cash and cash equivalents	$	201,530	$	205,326
Short-term marketable securities	508,941		662,553
Accounts receivable, net	3,927		—
Inventory	4,139		—
Prepaid expenses and other current assets	35,390		32,779
Total current assets	753,927		900,658
Long-term marketable securities	229,534		98,322
Property and equipment, net	49,926		52,402
Finance lease right-of-use asset	46,700		48,531
Operating lease right-of-use asset	16,793		19,002
Intangible asset, net	35,250		—
Other non-current assets	25,825		25,939
Total assets	$	1,157,955	$	1,144,854
Liabilities and stockholders' equity
Current liabilities:
Accounts payable	$	11,807	$	505





Other accrued costs and current liabilities	78,276		97,846

Total current liabilities	90,083		98,351

Operating lease liability, less current portion	22,026		27,210
Finance lease liability, less current portion	5,479		5,532
Liability related to the revenue participation right agreement	205,189		—


Total liabilities	322,777		131,093
Commitments and contingencies (Note 10)
Stockholders' equity:
Convertible preferred stock, $0.01 par value; 40,000,000 shares authorized as of June 30, 2026 and December 31, 2025; 0 shares issued and outstanding as of June 30, 2026 and December 31, 2025	—		—
Common stock, $0.01 par value; 400,000,000 shares authorized as of June 30, 2026 and December 31, 2025; 159,755,526 shares and 156,182,177 shares issued and outstanding as of June 30, 2026 and December 31, 2025, respectively	1,924		1,888
Additional paid-in capital	3,142,747		3,062,715
Accumulated other comprehensive income (loss)	(1,969)		682
Accumulated deficit	(2,307,524)		(2,051,524)
Total stockholders' equity	835,178		1,013,761
Total liabilities and stockholders’ equity	$	1,157,955	$	1,144,854

See accompanying notes to unaudited condensed consolidated financial statements.

Table of Contents

Denali Therapeutics Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(Unaudited)

(In thousands, except share and per share amounts)


	Three Months Ended June 30,				Six Months Ended June 30,
	2026		2025		2026		2025




Revenue:
Product revenue, net	$	3,604	$	—	$	3,604	$	—
Total revenue	3,604		—		3,604		—

Operating expenses:
Cost of goods sold	93		—		93		—
Research and development	97,019		102,696		200,865		218,923
Selling, general and administrative	36,283		32,267		69,794		61,620
Intangible asset amortization	750		—		750		—
Total operating expenses	134,145		134,963		271,502		280,543

Loss from operations	(130,541)		(134,963)		(267,898)		(280,543)
Interest and other income, net	2,988		10,844		11,898		23,454


Net loss	$	(127,553)	$	(124,119)	$	(256,000)	$	(257,089)







Other comprehensive loss:
Net unrealized loss on marketable securities, net of tax	(1,287)		(1,098)		(2,651)		(1,081)
Comprehensive loss	$	(128,840)	$	(125,217)	$	(258,651)	$	(258,170)
Net loss per share, basic and diluted	$	(0.68)	$	(0.72)	$	(1.37)	$	(1.50)
Weighted average number of shares outstanding, basic and diluted	187,314,501		171,449,847		186,977,612		171,336,568

See accompanying notes to unaudited condensed consolidated financial statements.

Table of Contents

Denali Therapeutics Inc.

Condensed Consolidated Statements of Stockholders’ Equity

(Unaudited)

(In thousands, except share amounts)


	Common Stock		Additional Paid-in Capital		Accumulated Other Comprehensive Income (Loss)		Accumulated Deficit		Total Stockholders' Equity
		Shares									Amount
Balance at December 31, 2025		156,182,177	$	1,888	$	3,062,715	$	682	$	(2,051,524)		$	1,013,761
Issuance of common stock, net of issuance cost of $45		746,468	8		12,358		—		—			12,366
Issuances under equity incentive plans		1,484,925	14		21,686		—		—			21,700
Vesting of restricted stock units		1,341,956	14		(14)		—		—			—
Stock-based compensation		—	—		46,002		—		—			46,002
Net loss		—	—		—		—		(256,000)			(256,000)
Other comprehensive loss		—	—		—		(2,651)		—			(2,651)
June 30, 2026		159,755,526	$	1,924	$	3,142,747	$	(1,969)	$	(2,307,524)		$	835,178

Balance at March 31, 2026		158,656,318	$	1,913	$	3,104,838	$	(682)	$	(2,179,971)		$	926,098

Issuances under equity incentive plans		948,205	9		14,996		—		—			15,005
Vesting of restricted stock units		151,003	2		(2)		—		—			—
Stock-based compensation		—	—		22,915		—		—			22,915
Net loss		—	—		—		—		(127,553)			(127,553)
Other comprehensive loss		—	—		—		(1,287)		—			(1,287)
June 30, 2026		159,755,526	$	1,924	$	3,142,747	$	(1,969)	$	(2,307,524)		$	835,178

Balance at December 31, 2024		144,220,986	$	1,768	$	2,764,880	$	2,020	$	(1,538,984)		$	1,229,684

Issuances under equity incentive plans		455,335	5		4,647		—		—			4,652
Vesting of restricted stock units		1,009,121	10		(10)		—		—			—
Stock-based compensation		—	—		50,887		—		—			50,887
Net loss		—	—		—		—		(257,089)			(257,089)
Other comprehensive loss		—	—		—		(1,081)		—			(1,081)
Balance at June 30, 2025		145,685,442	$	1,783	$	2,820,404	$	939	$	(1,796,073)		$	1,027,053

Balance at March 31, 2025		145,251,258	$	1,778	$	2,790,825	$	2,037	$	(1,671,954)		$	1,122,686
Issuances under equity incentive plans		341,543	4		4,053		—		—			4,057
Vesting of restricted stock units		92,641	1		(1)		—		—			—
Stock-based compensation		—