dnli-20260331

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 March 31, 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 May 1, 2026 was 158,709,737. This number does not include 28,331,779 shares of common stock issuable upon the exercise of pre-funded warrants outstanding as of May 1, 2026 (which are immediately exercisable at an exercise price of $0.01 per share of common stock, subject to beneficial ownership limitations). See Note 10 — 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	22
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	36
Item 4.	Controls and Procedures	37

	PART II. OTHER INFORMATION
Item 1.	Legal Proceedings	38
Item 1A.	Risk Factors	38
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	93
Item 3.	Defaults Upon Senior Securities	94
Item 4.	Mine Safety Disclosures	94
Item 5.	Other Information	94
Item 6.	Exhibits	95
	Signatures	96

Table of Contents

PART I. FINANCIAL INFORMATION

ITEM 1. FINANCIAL STATEMENTS

Denali Therapeutics Inc.

Condensed Consolidated Balance Sheets

(Unaudited)

(In thousands, except share amounts)


	March 31, 2026		December 31, 2025
Assets
Current assets:
Cash and cash equivalents	$	387,626	$	205,326
Short-term marketable securities	600,058		662,553

Prepaid expenses and other current assets	35,068		32,779
Total current assets	1,022,752		900,658
Long-term marketable securities	63,785		98,322
Property and equipment, net	51,728		52,402
Finance lease right-of-use asset	47,616		48,531
Operating lease right-of-use asset	17,922		19,002
Intangible asset, net	36,000		—
Other non-current assets	26,220		25,939
Total assets	$	1,266,023	$	1,144,854
Liabilities and stockholders' equity
Current liabilities:
Accounts payable	$	40,380	$	505





Other accrued costs and current liabilities	69,776		97,846

Total current liabilities	110,156		98,351

Operating lease liability, less current portion	24,680		27,210
Finance lease liability, less current portion	5,508		5,532
Liability related to the revenue participation right agreement	199,581		—


Total liabilities	339,925		131,093
Commitments and contingencies (Note 9)
Stockholders' equity:
Convertible preferred stock, $0.01 par value; 40,000,000 shares authorized as of March 31, 2026 and December 31, 2025; 0 shares issued and outstanding as of March 31, 2026 and December 31, 2025	—		—
Common stock, $0.01 par value; 400,000,000 shares authorized as of March 31, 2026 and December 31, 2025; 158,656,318 shares and 156,182,177 shares issued and outstanding as of March 31, 2026 and December 31, 2025, respectively	1,913		1,888
Additional paid-in capital	3,104,838		3,062,715
Accumulated other comprehensive income (loss)	(682)		682
Accumulated deficit	(2,179,971)		(2,051,524)
Total stockholders' equity	926,098		1,013,761
Total liabilities and stockholders’ equity	$	1,266,023	$	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 March 31,
	2026		2025




Operating expenses:
Research and development	$	103,846	$	116,227
General and administration	33,511		29,353
Total operating expenses	137,357		145,580

Loss from operations	(137,357)		(145,580)
Interest and other income, net	8,910		12,610


Net loss	$	(128,447)	$	(132,970)







Other comprehensive income (loss):
Net unrealized gain (loss) on marketable securities, net of tax	(1,364)		17
Comprehensive loss	$	(129,811)	$	(132,953)
Net loss per share, basic and diluted	$	(0.69)	$	(0.78)
Weighted average number of shares outstanding, basic and diluted	186,636,978		171,222,030

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, 2024		144,220,986	$	1,768	$	2,764,880	$	2,020	$	(1,538,984)		$	1,229,684
Issuances under equity incentive plans		113,792	1		594		—		—			595
Vesting of restricted stock units		916,480	9		(9)		—		—			—
Stock-based compensation		—	—		25,360		—		—			25,360
Net loss		—	—		—		—		(132,970)			(132,970)
Other comprehensive income		—	—		—		17		—			17
Balance at March 31, 2025		145,251,258	$	1,778	$	2,790,825	$	2,037	$	(1,671,954)		$	1,122,686

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		536,720	5		6,690		—		—			6,695
Vesting of restricted stock units		1,190,953	12		(12)		—		—			—
Stock-based compensation		—	—		23,087		—		—			23,087
Net loss		—	—		—		—		(128,447)			(128,447)
Other comprehensive loss		—	—		—		(1,364)		—			(1,364)
Balance at March 31, 2026		158,656,318	$	1,913	$	3,104,838	$	(682)	$	(2,179,971)		$	926,098

See accompanying notes to unaudited condensed consolidated financial statements.

Table of Contents

Denali Therapeutics Inc.

Condensed Consolidated Statements of Cash Flows

(Unaudited)

(In thousands)


	Three Months Ended March 31,
	2026		2025
Operating activities
Net loss	$	(128,447)	$	(132,970)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	2,845		2,325
Stock–based compensation expense	23,087		25,160

SEC Form 10-Q filed by Denali Therapeutics Inc.