# EDGAR Filing Document

**Accession Number:** 0001714899
**File Stem:** 0001714899-26-000062
**Filing Date:** 2026-5
**Character Count:** 24416
**Document Hash:** ce6a2a3a5f1fe3f512321db8c7dcb884
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001714899-26-000062.hdr.sgml**: 20260507

**ACCESSION NUMBER**: 0001714899-26-000062

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 13

**CONFORMED PERIOD OF REPORT**: 20260507

**ITEM INFORMATION**: Results of Operations and Financial Condition

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20260507

**DATE AS OF CHANGE**: 20260507

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Denali Therapeutics Inc.
- **CENTRAL INDEX KEY:** 0001714899
- **STANDARD INDUSTRIAL CLASSIFICATION:** BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 463872213
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-38311
- **FILM NUMBER:** 26953010

**BUSINESS ADDRESS:**
- **STREET 1:** 161 OYSTER POINT BLVD.
- **CITY:** SOUTH SAN FRANCISCO
- **STATE:** CA
- **ZIP:** 94080
- **BUSINESS PHONE:** (650) 866-8547

**MAIL ADDRESS:**
- **STREET 1:** 161 OYSTER POINT BLVD.
- **CITY:** SOUTH SAN FRANCISCO
- **STATE:** CA
- **ZIP:** 94080

?xml version='1.0' encoding='ASCII'? dnli-20260507

**UNITED STATES**

**SECURITIES AND EXCHANGE COMMISSION**

**Washington, D.C. 20549**

 

**FORM 8-K**

**CURRENT REPORT**

**Pursuant to Section 13 or 15(d)**

**of the Securities Exchange Act of 1934**

**Date of Report (Date of earliest event reported):** 

**May 7, 2026**

 

**Denali Therapeutics Inc.**

**(Exact name of registrant as specified in its charter)**

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| | | |
|:---|:---|:---|
| **Delaware** | **001-38311** | **46-3872213** |
| **(State or other jurisdiction of** | **(Commission** | **(I.R.S. Employer** |
| **incorporation)** | **File Number)** | **Identification No.)** |

---

**161 Oyster Point Blvd.**

**South San Francisco, California 94080** 

**(Address of principal executive offices, including zip code)**

**(650) 866-8547**

**(Registrant's telephone number, including area code)**

**Not Applicable**

**(Former name or former address, if changed since last reports)**

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

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

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| | | |
|:---|:---|:---|
| **Title of each class** | **Trading Symbol (s)** | **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 is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

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| | |
|:---|:---|
| 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. ☐ | 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. ☐ |

---

    

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**Item 2.02 &nbsp;&nbsp;&nbsp;&nbsp;Results of Operations and Financial Condition.** 

On May 7, 2026, Denali Therapeutics Inc. (the "Company") issued a press release announcing its financial results for the first quarter ended March 31, 2026. The full text of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

All of the information furnished in this Item 2.02 and Item 9.01 (including Exhibit 99.1) shall not be deemed to be "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and shall not be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except as shall be expressly set forth by specific reference in such a filing.

**Item 9.01&nbsp;&nbsp;&nbsp;&nbsp;Financial Statements and Exhibits.**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d) Exhibits

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| | |
|:---|:---|
| **Exhibit No.** | **Description** |
| 99.1 | <u>[Press Release dated May 7](ex991pressreleaseq12026.htm)[,](ex991pressreleaseq12026.htm)[2026.](ex991pressreleaseq12026.htm)</u> |
| 104 | Cover Page Interactive Data File (formatted as Inline XBRL) |

---

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**SIGNATURE**

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 hereunto duly authorized.

---

| | | | |
|:---|:---|:---|:---|
| | | **DENALI THERAPEUTICS INC.** | **DENALI THERAPEUTICS INC.** |
| Date: | May 7, 2026 | By: | /s/ Alexander O. Schuth |
|  |  |  | Alexander O. Schuth, M.D. |
|  |  |  | Chief Operating and Financial Officer |

---

## Exhibit 99.1

**Exhibit 99.1**

![denali_greenlogo.jpg](denali_greenlogo.jpg)

**Denali Therapeutics Reports First Quarter 2026 Financial Results and Business Highlights**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;*• FDA approved AVLAYAH™ (tividenofusp alfa-eknm) for treatment of Hunter syndrome (MPS II) and as first medicine to leverage transferrin receptor to cross blood-brain barrier*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;*• AVLAYAH launched in U.S. with strong momentum, vibrant community engagement, and first patients treated in commercial setting in April*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;*• Broad clinical pipeline progressing for lysosomal storage and neurodegenerative diseases, including first patient dosed with Oligonucleotide TransportVehicle™(OTV)-enabled DNL628 (OTV:MAPT) targeting tau for Alzheimer's disease*

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;*• Advancing DNL593 (PTV:PGRN) in Phase 1/2 study for GRN-related frontotemporal dementia after regaining full rights, with data expected by end of 2026*

**SOUTH SAN FRANCISCO, Calif., – May 7, 2026 –** Denali Therapeutics Inc. (Nasdaq: DNLI) today reported financial results for the first quarter ended March 31, 2026, and provided business highlights, including the recent U.S. Food and Drug Administration (FDA) approval of AVLAYAH™ (tividenofusp alfa-eknm).

"The FDA approval of AVLAYAH is a major milestone for Denali, for the Hunter syndrome community, and for the field of biotherapeutics enabled to cross the blood-brain barrier. We are thrilled by the strong engagement with the community, seamless execution by our commercial team, and achievement of our first patient dosed in less than one month from approval," said Ryan Watts, Ph.D., Chief Executive Officer of Denali Therapeutics. "AVLAYAH provides validation for our TransportVehicle™ (TV) platform enabling our broad clinical portfolio for lysosomal storage and neurodegenerative diseases. We are excited about progress achieved across the portfolio, including dosing of the first patients with our Oligonucleotide TV-enabled investigational therapy DNL628 (OTV:MAPT) targeting tau for Alzheimer's disease and advancing DNL593 (PTV:PGRN) for FTD-*GRN* after regaining full rights."

**First Quarter 2026 and Recent Program Updates**

**COMMERCIAL PRODUCT**

**AVLAYAH (tividenofusp alfa-eknm) for Hunter syndrome (mucopolysaccharidosis type II [MPS II])** 

On March 25, 2026, Denali announced AVLAYAH (tividenofusp alfa-eknm) received accelerated approval for the treatment of neurologic manifestations of Hunter syndrome (MPS II) when initiated in presymptomatic or symptomatic pediatric patients weighing at least 5 kg prior to advanced neurologic impairment. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial. The U.S. commercial launch of AVLAYAH is underway and the first patients have received therapy. All key operational launch components are in place, including availability of commercial product through an established distribution channel and fully operational patient support hub. The major health systems and key national and regional payers have been engaged. The ongoing global Phase 2/3 COMPASS study is designed to generate confirmatory evidence and support global regulatory submissions for AVLAYAH.

**CLINICAL PROGRAMS**

**DNL126 (ETV:SGSH) for Sanfilippo syndrome type A (MPS IIIA)**

DNL126 is an investigational, intravenously administered, Enzyme TransportVehicle™ (ETV)-enabled N-sulfoglucosamine sulfohydrolase (SGSH) replacement therapy designed to deliver SGSH into the brain and body, with the goal of addressing the behavioral, cognitive and physical manifestations of Sanfilippo syndrome type A. The Phase 1/2 trial of DNL126 is ongoing, and start-up activities are underway for a global Phase 3 confirmatory study. Denali expects a Biologics License Application (BLA) submission and potential accelerated approval for DNL126 for Sanfilippo syndrome type A in 2027.

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**DNL593 (PTV:PGRN) for *GRN*-related frontotemporal dementia (FTD-*GRN*)** 

Denali is conducting a Phase 1/2 study of DNL593, an investigational, intravenously administered progranulin replacement therapy utilizing Denali's Protein TransportVehicle™ (PTV) to deliver progranulin across the blood-brain barrier (BBB) and into the brain for individuals with FTD-*GRN*. Enrollment in the study is complete with a total of 40 participants with FTD-*GRN*, and results are expected by the end of 2026.

**DNL628 (OTV:MAPT) for Alzheimer's disease**

In March 2026, the first patient was dosed in the Phase 1b study of DNL628, which is an investigational therapy for Alzheimer's disease and enabled by Denali's Oligonucleotide TransportVehicle™ (OTV). DNL628 is designed to cross the BBB and reduce the tau protein by targeting the *MAPT* gene that encodes for tau. Denali expects data from this study in 1H 2027.

**DNL952 (ETV:GAA) for Pompe disease**

DNL952 is enabled by Denali's ETV and designed to enhance delivery of the missing enzyme, GAA, into muscle tissues and across the BBB into the brain. Phase 1 study start-up activities are underway.

**BIIB122/DNL151** (**small molecule LRRK2 inhibitor) for Parkinson's disease** 

A clinical data readout of the global Phase 2b LUMA study of BIIB122 for early-stage Parkinson's disease is expected in mid-2026. Denali's Phase 2a BEACON study in individuals with Parkinson's disease who are confirmed by genetic testing to be carriers of a pathogenic LRRK2 variant is ongoing. The LRRK2 program is being developed in collaboration with Biogen.

**IND-ENABLING STAGE PROGRAMS**

Denali has multiple additional programs in the IND-enabling stage including DNL921 (ATV:Abeta) for Alzheimer's disease; DNL111 (ETV:GCase) for Parkinson's disease and Gaucher disease; DNL622 (ETV:IDUA) for MPS I; and DNL422 (OTV:SNCA) for Parkinson's disease. Denali is on track to submit a regulatory filing for DNL921 in the first half of 2026 to begin clinical development of this TV-enabled anti-amyloid program for Alzheimer's disease.

**Corporate Updates**

As previously announced in connection with the approval of AVLAYAH, the FDA granted Denali Therapeutics a Rare Pediatric Disease Priority Review Voucher (PRV). This voucher may be used to obtain priority review for a future marketing application and can be transferred to another sponsor.

On March 27, 2026, Denali received $200 million in gross proceeds in connection with the closing of the transactions under a synthetic royalty funding agreement signed in December 2025 with Royalty Pharma Investments 2023 ICAV.

On April 3, 2026, Denali announced it received notification from Takeda of its decision to terminate the collaboration agreement between the two companies to co-develop and co-commercialize DNL593. Takeda's decision was driven by strategic considerations and was not related to efficacy or safety data. Denali continues to advance DNL593 in the ongoing Phase 1/2 study in patients with FTD-*GRN* and expects results by the end of 2026 as described above.

**Participation in Upcoming Investor Conferences**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Bank of America Healthcare Conference 2026, May 12-14 (Las Vegas)

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Jefferies Global Healthcare Conference, June 2-4 (New York City)

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Goldman Sachs 47th Annual Global Healthcare Conference, June 8-10 (Miami)

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• BTIG Virtual Biotechnology Conference, July 28-29

------

**First Quarter 2026 Financial Results**

Net loss was $128.4 million for the quarter ended March 31, 2026, compared to net loss of $133.0 million for the quarter ended March 31, 2025.

Total research and development expenses were $103.8 million for the quarter ended March 31, 2026, compared to $116.2 million for the quarter ended March 31, 2025. The decrease of approximately $12.4 million was primarily attributable to the timing of manufacturing of AVLAYAH commercial supply in the first quarter of 2025, as well as lower external expenses related to small molecule programs.

General and administrative expenses were $33.5 million for the quarter ended March 31, 2026, compared to $29.4 million for the quarter ended March 31, 2025. The increase of $4.1 million was primarily driven by higher personnel-related costs due to increased headcount in the first quarter of 2026, reflecting headcount additions made throughout 2025 to support post-launch activities for AVLAYAH.

Cash, cash equivalents and marketable securities were approximately $1.05 billion as of March 31, 2026.

**About the Denali TransportVehicle**<sup>™</sup> **Platform**

The blood-brain barrier (BBB) is essential in maintaining the brain's microenvironment and protecting it from harmful substances and pathogens circulating in the bloodstream. Historically, the BBB has posed significant challenges to drug development for central nervous system diseases by preventing most drugs from reaching the brain in therapeutically relevant concentrations. Denali's TransportVehicle<sup>™</sup> (TV) platform is a proprietary technology designed to effectively deliver large therapeutic molecules such as antibodies, enzymes and oligonucleotides throughout the whole body, including the brain, by crossing the BBB after intravenous administration. The TV platform is based on engineered Fc domains that bind to specific natural transport receptors, such as transferrin receptor and CD98 heavy chain amino acid transporter, which are expressed at the BBB and deliver the TV and its therapeutic cargo to the brain through receptor-mediated transcytosis. In animal models, antibodies and enzymes engineered with the TV platform demonstrate more than 10- to 30-fold greater brain exposure than similar antibodies and enzymes without this technology. Oligonucleotides engineered with the TV platform demonstrate more than a 1,000-fold greater brain exposure in primates than systemically delivered oligonucleotides without this technology. Improved exposure and broad distribution in the brain may increase therapeutic efficacy by enabling widespread achievement of therapeutically relevant concentrations of product candidates. The TV platform has been clinically validated, with AVLAYAH™ (tividenofusp alfa-eknm) as the first FDA-approved medicine leveraging transferrin receptor to cross the BBB.

**About Denali Therapeutics**

Denali Therapeutics Inc. is a biotechnology company pioneering a new class of biotherapeutics designed to cross the blood-brain barrier (BBB) using its proprietary TransportVehicle™ platform. With the first FDA-approved biologic specifically designed to cross the BBB, a clinically validated delivery platform, and a growing portfolio of therapeutic candidates across all stages of development, Denali is advancing toward its goal of delivering effective medicines to transform life for people with neurodegenerative diseases, lysosomal storage disorders and other serious diseases. For more information, please visit www.denalitherapeutics.com.

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**Forward-Looking Statements**

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements expressed or implied in this press release include, but are not limited to, statements regarding expectations for Denali's TransportVehicle™ (TV) platform, including the Enzyme TransportVehicle™ (ETV) franchise, and its therapeutic and commercial potential; plans, timelines, and expectations relating to the commercial launch of AVLAYAH™ (tividenofusp alfa-eknm) and related activities; expectations related to the ongoing Phase 2/3 COMPASS study of tividenofusp alfa, including the timing and availability of data and its ability to generate confirmatory evidence and support global regulatory submissions; plans, timelines and expectations related to DNL126, including the ongoing Phase 1/2 study, the planned Phase 3 confirmatory study, the planned BLA submission, and the likelihood and timing of accelerated approval; plans, timelines and expectations related to DNL593, including the ongoing Phase 1/2 study, the timing and availability of data, and Denali's ability to independently advance the program; plans, timelines and expectations related to DNL628, including the ongoing Phase 1b study and the timing and availability of data; plans, timelines and expectations related to DNL952 and the planned Phase 1 study; plans, timelines and expectations related to DNL151, including the ongoing Phase 2a BEACON study, and the timing and availability of data from the Phase 2b LUMA study; plans, timelines and expectations related to DNL921, including the expected timing of a regulatory filing and initiation of clinical development; plans, timelines, and expectations for IND-enabling stage programs; plans and expectations regarding Denali's Rare Pediatric Disease Priority Review Voucher; expectations regarding the Royalty Pharma funding agreement, including royalty payment obligations and milestones; plans regarding participation in upcoming investor conferences; and statements by Denali's Chief Executive Officer. Actual results may differ materially from those expressed or implied by these forward-looking statements due to a variety of risks and uncertainties. These include, but are not limited to, uncertainties related to the FDA's policies and accelerated approval program; risks arising from adverse economic conditions and their impact on Denali's business and operations; the possibility of events or changes that could lead to the termination of Denali's collaboration agreements; challenges associated with Denali's transition to a commercial company; the ability of Denali and its collaborators to complete the development and, if approved, the commercialization of product candidates; difficulties in patient enrollment for ongoing and future clinical trials; whether the current ongoing trials have been powered sufficiently to demonstrate approvability to regulatory agencies; reliance on third-party manufacturers and suppliers for clinical trial materials; dependence on the successful development of Denali's blood-brain barrier platform technology and related programs; potential delays or failures in meeting expected clinical trial timelines; discrepancies between preclinical, early-stage or preliminary clinical results and outcomes from later-stage trials; the risk that interim or topline clinical results may not be predictive of final study results or longer-term outcomes; the occurrence of significant adverse events or other undesirable side effects; the uncertainty surrounding regulatory approvals required for commercialization in the U.S., Europe or other international jurisdictions; Denali's ability to advance a pipeline of product candidates or develop commercially successful products; developments relating to Denali's competitors and competing product candidates; Denali's ability to obtain, maintain or protect intellectual property rights related to its product candidates; the implementation and success of Denali's strategic plans for its business, product candidates and blood-brain barrier platform technology; Denali's ability to obtain additional capital to finance its operations, as needed; Denali's ability to accurately forecast future financial results in the current environment; and other risks and uncertainties, including those described in Denali's most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on February 26, 2026, and Denali's future reports to be filed with the SEC. Except for AVLAYAH, Denali's product candidates are investigational, and their safety and efficacy profiles have not yet been established. Denali does not undertake any obligation to update or revise any forward-looking statements, to conform these statements to actual results or to make changes in Denali's expectations, except as required by law.

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**Denali Therapeutics Inc.**

**Condensed Consolidated Statements of Operations**

**(Unaudited)**

(In thousands, except share and per share amounts)

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| | | |
|:---|:---|:---|
| | **Three Months Ended March 31,** | **Three Months Ended March 31,** |
| | **2026** | **2025** |
| Operating expenses: |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Research and development | $103846 | $116227 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;General and administration | 33511 | 29353 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total operating expenses | 137357 | 145580 |
| Loss from operations | (137357) | (145580) |
| Interest and other income, net | 8910 | 12610 |
| Net loss | $(128447) | $(132970) |
| Net loss per share, basic and diluted | $(0.69) | $(0.78) |
| Weighted average number of shares outstanding, basic and diluted | 186636978 | 171222030 |

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**Denali Therapeutics Inc.**

**Condensed Consolidated Balance Sheets**

**(Unaudited)**

(In thousands)

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| | | |
|:---|:---|:---|
| | **March 31, 2026** | **December 31, 2025** |
| **Assets** | | |
| Current assets: |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Cash and cash equivalents | $387626 | $205326 |
| &nbsp;&nbsp;&nbsp;&nbsp;Short-term marketable securities | 600058 | 662553 |
| &nbsp;&nbsp;&nbsp;&nbsp;Prepaid expenses and other current assets | 35068 | 32779 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total current assets | 1022752 | 900658 |
| Long-term marketable securities | 63785 | 98322 |
| Property and equipment, net | 51728 | 52402 |
| Finance lease right-of-use asset | 47616 | 48531 |
| Operating lease right-of-use asset | 17922 | 19002 |
| Intangible asset, net | 36000 |  |
| Other non-current assets | 26220 | 25939 |
| Total assets | $1266023 | $1144854 |
| **Liabilities and stockholders' equity** |  |  |
| Current liabilities: |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Accounts payable | $40380 | $505 |
| &nbsp;&nbsp;&nbsp;&nbsp;Accrued expenses and other current liabilities | 69776 | 76745 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total current liabilities | 110156 | 98351 |
| Operating lease liability, less current portion | 24680 | 27210 |
| Finance lease liability, less current portion | 5508 | 5532 |
| Liability related to the revenue participation right agreement | 199581 |  |
| Total liabilities | 339925 | 131093 |
| Total stockholders' equity | 926098 | 1013761 |
| Total liabilities and stockholders' equity | $1266023 | $1144854 |

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**Investor Contact:**

Laura Hansen, Ph.D.

hansen@dnli.com

**Media Contact:**

Erin Patton

epatton@dnli.com

<br>