{"id":959972,"date":"2026-05-07T16:38:33","date_gmt":"2026-05-07T20:38:33","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/denali-therapeutics-reports-first-quarter-2026-financial-results-and-business-highlights\/"},"modified":"2026-05-07T16:38:33","modified_gmt":"2026-05-07T20:38:33","slug":"denali-therapeutics-reports-first-quarter-2026-financial-results-and-business-highlights","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/denali-therapeutics-reports-first-quarter-2026-financial-results-and-business-highlights\/","title":{"rendered":"Denali Therapeutics Reports First Quarter 2026 Financial Results and Business Highlights"},"content":{"rendered":"<div class=\"mw_release\">\n<ul>\n<li style=\"text-align:left\">\n          <em>FDA approved AVLAYAH\u2122 (tividenofusp alfa-eknm) for treatment of Hunter syndrome (MPS II) and as first medicine to leverage transferrin receptor to cross blood-brain barrier<\/em><\/p>\n<\/li>\n<li style=\"text-align:left\">\n          <em>AVLAYAH launched in U.S. with strong momentum, vibrant community engagement, and first patients treated in commercial setting in April<\/em><\/p>\n<\/li>\n<li style=\"text-align:left\">\n          <em>Broad clinical pipeline progressing for lysosomal storage and neurodegenerative diseases, including first patient dosed with Oligonucleotide TransportVehicle\u2122 (OTV)-enabled DNL628 (OTV:MAPT) targeting tau for Alzheimer&#8217;s disease<\/em><\/p>\n<\/li>\n<li style=\"text-align:left\">\n          <em>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<\/em><\/p>\n<\/li>\n<\/ul>\n<p align=\"left\">SOUTH SAN FRANCISCO, Calif., May  07, 2026  (GLOBE NEWSWIRE) &#8212; 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\u2122 (tividenofusp alfa-eknm).<\/p>\n<p align=\"left\">\u201cThe 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,\u201d said Ryan Watts, Ph.D., Chief Executive Officer of Denali Therapeutics. \u201cAVLAYAH provides validation for our TransportVehicle\u2122 (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\u2019s disease and advancing DNL593 (PTV:PGRN) for FTD-<em>GRN<\/em> after regaining full rights.&#8221;<\/p>\n<p align=\"left\">\n        <strong>First<\/strong><br \/>\n        <strong> Quarter <\/strong><br \/>\n        <strong>2026<\/strong><br \/>\n        <strong> and Recent Program Updates<\/strong>\n      <\/p>\n<p align=\"left\">\n        <strong>COMMERCIAL PRODUCT<\/strong>\n      <\/p>\n<p align=\"left\">\n        <strong>AVLAYAH (tividenofusp alfa-eknm) for Hunter syndrome (mucopolysaccharidosis type II [MPS II]) <\/strong>\n      <\/p>\n<p align=\"left\">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.<\/p>\n<p align=\"left\">\n        <strong>CLINICAL PROGRAMS<\/strong>\n      <\/p>\n<p align=\"left\">\n        <strong>DNL126 (ETV:SGSH)<\/strong><br \/>\n        <strong>for Sanfilippo syndrome type A (MPS IIIA)<\/strong>\n      <\/p>\n<p align=\"left\">DNL126 is an investigational, intravenously administered, Enzyme TransportVehicle\u2122 (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.<\/p>\n<p align=\"left\">\n        <strong>DNL593 (PTV:PGRN) for <\/strong><br \/>\n        <strong><br \/>\n          <em>GRN<\/em><br \/>\n        <\/strong><br \/>\n        <strong>-related frontotemporal dementia (FTD-<\/strong><br \/>\n        <strong><br \/>\n          <em>GRN<\/em><br \/>\n        <\/strong><br \/>\n        <strong>) <\/strong>\n      <\/p>\n<p align=\"left\">Denali is conducting a Phase 1\/2 study of DNL593, an investigational, intravenously administered progranulin replacement therapy utilizing Denali\u2019s Protein TransportVehicle\u2122 (PTV) to deliver progranulin across the blood-brain barrier (BBB) and into the brain for individuals with FTD-<em>GRN<\/em>. Enrollment in the study is complete with a total of 40 participants with FTD-<em>GRN<\/em>, and results are expected by the end of 2026.<\/p>\n<p align=\"left\">\n        <strong>DNL628 (OTV:MAPT) for Alzheimer&#8217;s disease<\/strong>\n      <\/p>\n<p align=\"left\">In March 2026, the first patient was dosed in the Phase 1b study of DNL628, which is an investigational therapy for Alzheimer\u2019s disease and enabled by Denali\u2019s Oligonucleotide TransportVehicle\u2122 (OTV). DNL628 is designed to cross the BBB and reduce the tau protein by targeting the <em>MAPT<\/em> gene that encodes for tau. Denali expects data from this study in 1H 2027.<\/p>\n<p align=\"left\">\n        <strong>DNL952 (ETV:GAA) for Pompe disease<\/strong>\n      <\/p>\n<p align=\"left\">DNL952 is enabled by Denali\u2019s 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.<\/p>\n<p align=\"left\">\n        <strong>BIIB122\/DNL151<\/strong> (<strong>small molecule<\/strong><strong>LRRK2 inhibitor) for Parkinson\u2019s disease <\/strong><\/p>\n<p align=\"left\">A clinical data readout of the global Phase 2b LUMA study of BIIB122 for early-stage Parkinson\u2019s disease is expected in mid-2026. Denali\u2019s Phase 2a BEACON study in individuals with Parkinson\u2019s 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.<\/p>\n<p align=\"left\">\n        <strong>IND-ENABLING STAGE PROGRAMS<\/strong>\n      <\/p>\n<p align=\"left\">Denali has multiple additional programs in the IND-enabling stage including DNL921 (ATV:Abeta) for Alzheimer\u2019s disease; DNL111 (ETV:GCase) for Parkinson\u2019s disease and Gaucher disease; DNL622 (ETV:IDUA) for MPS I; and DNL422 (OTV:SNCA) for Parkinson\u2019s 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\u2019s disease.<\/p>\n<p align=\"left\">\n        <strong>Corporate Updates<\/strong>\n      <\/p>\n<p align=\"left\">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.<\/p>\n<p align=\"left\">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.<\/p>\n<p align=\"left\">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\u2019s 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-<em>GRN<\/em> and expects results by the end of 2026 as described above.<\/p>\n<p align=\"left\">\n        <strong>Participation in Upcoming Investor Conferences<\/strong>\n      <\/p>\n<ul>\n<li>Bank of America Healthcare Conference 2026, May 12-14 (Las Vegas)<\/li>\n<li>Jefferies Global Healthcare Conference, June 2-4 (New York City)<\/li>\n<li>Goldman Sachs 47th Annual Global Healthcare Conference, June 8-10 (Miami)<\/li>\n<li>BTIG Virtual Biotechnology Conference, July 28-29\n<\/li>\n<\/ul>\n<p align=\"left\">\n        <strong>First<\/strong><br \/>\n        <strong> Quarter <\/strong><br \/>\n        <strong>2026<\/strong><br \/>\n        <strong> Financial Results<\/strong>\n      <\/p>\n<p align=\"left\">Net loss was $128.4 million for the quarter ended March 31, 2026, compared to net loss of $133.0\u00a0million for the quarter ended March 31, 2025.<\/p>\n<p align=\"left\">Total research and development expenses were $103.8\u00a0million for the quarter ended March 31, 2026, compared to $116.2\u00a0million 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.<\/p>\n<p align=\"left\">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.<\/p>\n<p align=\"left\">Cash, cash equivalents and marketable securities were approximately $1.05 billion as of March 31, 2026.<\/p>\n<p align=\"left\">\n        <strong>About the Denali TransportVehicle<\/strong>\u2122<strong> Platform<\/strong><\/p>\n<p align=\"left\">The blood-brain barrier (BBB) is essential in maintaining the brain\u2019s 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\u2019s TransportVehicle<sup>\u2122<\/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\u2122 (tividenofusp alfa-eknm) as the first FDA-approved medicine leveraging transferrin receptor to cross the BBB.<\/p>\n<p align=\"left\">\n        <strong>About Denali Therapeutics<\/strong>\n      <\/p>\n<p align=\"left\">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\u2122 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.<\/p>\n<p align=\"left\">\n        <strong>Forward-Looking Statements<\/strong>\n      <\/p>\n<p align=\"left\">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\u2019s TransportVehicle\u2122 (TV) platform, including the Enzyme TransportVehicle\u2122 (ETV) franchise, and its therapeutic and commercial potential; plans, timelines, and expectations relating to the commercial launch of AVLAYAH\u2122 (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\u2019s 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&#8217;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&#8217;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\u2019s policies and accelerated approval program; risks arising from adverse economic conditions and their impact on Denali\u2019s business and operations; the possibility of events or changes that could lead to the termination of Denali\u2019s collaboration agreements; challenges associated with Denali\u2019s 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\u2019s 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\u2011term 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\u2019s ability to advance a pipeline of product candidates or develop commercially successful products; developments relating to Denali&#8217;s competitors and competing product candidates; Denali\u2019s ability to obtain, maintain or protect intellectual property rights related to its product candidates; the implementation and success of Denali\u2019s strategic plans for its business, product candidates and blood-brain barrier platform technology; Denali&#8217;s ability to obtain additional capital to finance its operations, as needed; Denali&#8217;s ability to accurately forecast future financial results in the current environment; and other risks and uncertainties, including those described in Denali&#8217;s most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on February 26, 2026, and Denali\u2019s future reports to be filed with the SEC. Except for AVLAYAH, Denali&#8217;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\u2019s expectations, except as required by law.<\/p>\n<table style=\"border-collapse: collapse;margin-left:0px;margin-right:auto;width:100%;border-collapse:collapse\">\n<tr>\n<td>\u00a0<\/td>\n<td colspan=\"7\">\u00a0<\/td>\n<\/tr>\n<tr>\n<td colspan=\"8\">\n            <strong>Denali Therapeutics Inc.<\/strong><br \/>\n            <br \/>\n            <strong>Condensed Consolidated Statements of Operations<\/strong><br \/>\n            <br \/>\n            <strong>(Unaudited)<\/strong><br \/>\n            <br \/>(In thousands, except share and per share amounts)<\/td>\n<\/tr>\n<tr>\n<td>\u00a0<\/td>\n<td colspan=\"7\">\u00a0<\/td>\n<\/tr>\n<tr>\n<td style=\"vertical-align: bottom\">\u00a0<\/td>\n<td colspan=\"7\" style=\"border-bottom: solid black 1pt;text-align: center;vertical-align: middle;vertical-align: bottom\">\n            <strong>Three Months Ended March 31,<\/strong>\n          <\/td>\n<\/tr>\n<tr>\n<td style=\"max-width:75%;width:75%;min-width:75%;vertical-align: bottom\">\u00a0<\/td>\n<td style=\"max-width:2%;width:2%;min-width:2%;padding-right: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">\u00a0<\/td>\n<td style=\"max-width:9%;width:9%;min-width:9%;padding-left: 0;padding-right: 0;text-align: center;vertical-align: middle;vertical-align: bottom\">\n            <strong>2026<\/strong>\n          <\/td>\n<td style=\"max-width:1%;width:1%;min-width:1%;padding-left: 0;text-align: left;vertical-align: middle;vertical-align: bottom\">\u00a0<\/td>\n<td style=\"max-width:1%;width:1%;min-width:1%;border-top: solid black 1pt;vertical-align: bottom\">\u00a0<\/td>\n<td style=\"max-width:2%;width:2%;min-width:2%;border-top: solid black 1pt;padding-right: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">\u00a0<\/td>\n<td style=\"max-width:9%;width:9%;min-width:9%;border-top: solid black 1pt;padding-left: 0;padding-right: 0;text-align: center;vertical-align: middle;vertical-align: bottom\">\n            <strong>2025<\/strong>\n          <\/td>\n<td style=\"max-width:1%;width:1%;min-width:1%;border-top: solid black 1pt;padding-left: 0;text-align: left;vertical-align: middle;vertical-align: bottom\">\u00a0<\/td>\n<\/tr>\n<tr>\n<td style=\"vertical-align: top\">Operating expenses:<\/td>\n<td colspan=\"3\" style=\"border-top: solid black 1pt;vertical-align: bottom\">\u00a0<\/td>\n<td style=\"vertical-align: bottom\">\u00a0<\/td>\n<td colspan=\"3\" style=\"border-top: solid black 1pt;vertical-align: bottom\">\u00a0<\/td>\n<\/tr>\n<tr>\n<td style=\"vertical-align: middle;text-align: left;padding-left: 20.0px;vertical-align: top\">Research and development<\/td>\n<td style=\"padding-right: 0;text-align: left;vertical-align: middle;vertical-align: bottom\">$<\/td>\n<td style=\"padding-left: 0;padding-right: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">103,846<\/td>\n<td style=\"padding-left: 0;text-align: left;vertical-align: middle;vertical-align: bottom\">\u00a0<\/td>\n<td style=\"vertical-align: bottom\">\u00a0<\/td>\n<td style=\"padding-right: 0;text-align: left;vertical-align: middle;vertical-align: bottom\">$<\/td>\n<td style=\"padding-left: 0;padding-right: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">116,227<\/td>\n<td style=\"padding-left: 0;text-align: left;vertical-align: middle;vertical-align: bottom\">\u00a0<\/td>\n<\/tr>\n<tr>\n<td style=\"vertical-align: middle;text-align: left;padding-left: 20.0px;vertical-align: top\">General and administration<\/td>\n<td style=\"border-bottom: solid black 1pt;padding-right: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">\u00a0<\/td>\n<td style=\"border-bottom: solid black 1pt;padding-left: 0;padding-right: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">33,511<\/td>\n<td style=\"border-bottom: solid black 1pt;padding-left: 0;text-align: left;vertical-align: middle;vertical-align: bottom\">\u00a0<\/td>\n<td style=\"vertical-align: bottom\">\u00a0<\/td>\n<td style=\"border-bottom: solid black 1pt;padding-right: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">\u00a0<\/td>\n<td style=\"border-bottom: solid black 1pt;padding-left: 0;padding-right: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">29,353<\/td>\n<td style=\"border-bottom: solid black 1pt;padding-left: 0;text-align: left;vertical-align: middle;vertical-align: bottom\">\u00a0<\/td>\n<\/tr>\n<tr>\n<td style=\"vertical-align: middle;text-align: left;padding-left: 30.0px;vertical-align: top\">Total operating expenses<\/td>\n<td style=\"border-top: solid black 1pt;padding-right: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">\u00a0<\/td>\n<td style=\"border-top: solid black 1pt;padding-left: 0;padding-right: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">137,357<\/td>\n<td style=\"border-top: solid black 1pt;padding-left: 0;text-align: left;vertical-align: middle;vertical-align: bottom\">\u00a0<\/td>\n<td style=\"vertical-align: bottom\">\u00a0<\/td>\n<td style=\"border-top: solid black 1pt;padding-right: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">\u00a0<\/td>\n<td style=\"border-top: solid black 1pt;padding-left: 0;padding-right: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">145,580<\/td>\n<td style=\"border-top: solid black 1pt;padding-left: 0;text-align: left;vertical-align: middle;vertical-align: bottom\">\u00a0<\/td>\n<\/tr>\n<tr>\n<td style=\"vertical-align: top\">Loss from operations<\/td>\n<td style=\"border-top: solid black 1pt;padding-right: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">\u00a0<\/td>\n<td style=\"border-top: solid black 1pt;padding-left: 0;padding-right: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">(137,357<\/td>\n<td style=\"border-top: solid black 1pt;padding-left: 0;text-align: left;vertical-align: middle;vertical-align: bottom\">)<\/td>\n<td style=\"vertical-align: bottom\">\u00a0<\/td>\n<td style=\"border-top: solid black 1pt;padding-right: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">\u00a0<\/td>\n<td style=\"border-top: solid black 1pt;padding-left: 0;padding-right: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">(145,580<\/td>\n<td style=\"border-top: solid black 1pt;padding-left: 0;text-align: left;vertical-align: middle;vertical-align: bottom\">)<\/td>\n<\/tr>\n<tr>\n<td style=\"vertical-align: top\">Interest and other income, net<\/td>\n<td style=\"padding-right: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">\u00a0<\/td>\n<td style=\"padding-left: 0;padding-right: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">8,910<\/td>\n<td style=\"padding-left: 0;text-align: left;vertical-align: middle;vertical-align: bottom\">\u00a0<\/td>\n<td style=\"vertical-align: bottom\">\u00a0<\/td>\n<td style=\"padding-right: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">\u00a0<\/td>\n<td style=\"padding-left: 0;padding-right: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">12,610<\/td>\n<td style=\"padding-left: 0;text-align: left;vertical-align: middle;vertical-align: bottom\">\u00a0<\/td>\n<\/tr>\n<tr>\n<td style=\"vertical-align: top\">Net loss<\/td>\n<td style=\"border-top: solid black 1pt;padding-right: 0;text-align: left;vertical-align: middle;vertical-align: bottom\">$<\/td>\n<td style=\"border-top: solid black 1pt;padding-left: 0;padding-right: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">(128,447<\/td>\n<td style=\"border-top: solid black 1pt;padding-left: 0;text-align: left;vertical-align: middle;vertical-align: bottom\">)<\/td>\n<td style=\"vertical-align: bottom\">\u00a0<\/td>\n<td style=\"border-top: solid black 1pt;padding-right: 0;text-align: left;vertical-align: middle;vertical-align: bottom\">$<\/td>\n<td style=\"border-top: solid black 1pt;padding-left: 0;padding-right: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">(132,970<\/td>\n<td style=\"border-top: solid black 1pt;padding-left: 0;text-align: left;vertical-align: middle;vertical-align: bottom\">)<\/td>\n<\/tr>\n<tr>\n<td style=\"vertical-align: top\">Net loss per share, basic and diluted<\/td>\n<td style=\"border-top: double black 3pt;padding-right: 0;text-align: left;vertical-align: middle;vertical-align: bottom\">$<\/td>\n<td style=\"border-top: double black 3pt;padding-left: 0;padding-right: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">(0.69<\/td>\n<td style=\"border-top: double black 3pt;padding-left: 0;text-align: left;vertical-align: middle;vertical-align: bottom\">)<\/td>\n<td style=\"vertical-align: bottom\">\u00a0<\/td>\n<td style=\"border-top: double black 3pt;padding-right: 0;text-align: left;vertical-align: middle;vertical-align: bottom\">$<\/td>\n<td style=\"border-top: double black 3pt;padding-left: 0;padding-right: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">(0.78<\/td>\n<td style=\"border-top: double black 3pt;padding-left: 0;text-align: left;vertical-align: middle;vertical-align: bottom\">)<\/td>\n<\/tr>\n<tr>\n<td style=\"vertical-align: top\">Weighted average number of shares outstanding, basic and diluted<\/td>\n<td style=\"border-top: double black 3pt;border-bottom: double black 3pt;padding-right: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">\u00a0<\/td>\n<td style=\"border-top: double black 3pt;border-bottom: double black 3pt;padding-left: 0;padding-right: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">186,636,978<\/td>\n<td style=\"border-top: double black 3pt;border-bottom: double black 3pt;padding-left: 0;text-align: left;vertical-align: middle;vertical-align: bottom\">\u00a0<\/td>\n<td style=\"vertical-align: bottom\">\u00a0<\/td>\n<td style=\"border-top: double black 3pt;border-bottom: double black 3pt;padding-right: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">\u00a0<\/td>\n<td style=\"border-top: double black 3pt;border-bottom: double black 3pt;padding-left: 0;padding-right: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">171,222,030<\/td>\n<td style=\"border-top: double black 3pt;border-bottom: double black 3pt;padding-left: 0;text-align: left;vertical-align: middle;vertical-align: bottom\">\u00a0<\/td>\n<\/tr>\n<tr>\n<td>\u00a0<\/td>\n<td>\u00a0<\/td>\n<td>\u00a0<\/td>\n<td>\u00a0<\/td>\n<td>\u00a0<\/td>\n<td>\u00a0<\/td>\n<td>\u00a0<\/td>\n<td>\u00a0<\/td>\n<\/tr>\n<\/table>\n<p align=\"left\">\n        \n      <\/p>\n<table style=\"border-collapse: collapse;margin-left:0px;margin-right:auto;width:100%;border-collapse:collapse\">\n<tr>\n<td colspan=\"6\">\n            <strong>Denali Therapeutics Inc.<\/strong><br \/>\n            <br \/>\n            <strong>Condensed Consolidated Balance Sheets<\/strong><br \/>\n            <br \/>\n            <strong>(Unaudited)<\/strong><br \/>\n            <br \/>(In thousands)<\/td>\n<\/tr>\n<tr>\n<td>\u00a0<\/td>\n<td colspan=\"2\">\u00a0<\/td>\n<td>\u00a0<\/td>\n<td colspan=\"2\">\u00a0<\/td>\n<\/tr>\n<tr>\n<td style=\"vertical-align: bottom\">\u00a0<\/td>\n<td colspan=\"2\" style=\"border-bottom: solid black 1pt;text-align: center;vertical-align: middle;vertical-align: bottom\">\n            <strong>March 31,<br \/>2026<\/strong>\n          <\/td>\n<td style=\"vertical-align: bottom\">\u00a0<\/td>\n<td colspan=\"2\" style=\"border-bottom: solid black 1pt;text-align: center;vertical-align: middle;vertical-align: bottom\">\n            <strong>December 31,<br \/>2025<\/strong>\n          <\/td>\n<\/tr>\n<tr>\n<td style=\"vertical-align: top\">\n            <strong>Assets<\/strong>\n          <\/td>\n<td colspan=\"2\" style=\"border-top: solid black 1pt;vertical-align: bottom\">\u00a0<\/td>\n<td style=\"vertical-align: bottom\">\u00a0<\/td>\n<td colspan=\"2\" style=\"border-top: solid black 1pt;vertical-align: bottom\">\u00a0<\/td>\n<\/tr>\n<tr>\n<td style=\"vertical-align: top\">Current assets:<\/td>\n<td colspan=\"2\" style=\"vertical-align: bottom\">\u00a0<\/td>\n<td style=\"vertical-align: bottom\">\u00a0<\/td>\n<td colspan=\"2\" style=\"vertical-align: bottom\">\u00a0<\/td>\n<\/tr>\n<tr>\n<td style=\"max-width:75%;width:75%;min-width:75%;vertical-align: middle;text-align: left;padding-left: 20.0px;vertical-align: top\">Cash and cash equivalents<\/td>\n<td style=\"max-width:2%;width:2%;min-width:2%;padding-right: 0;text-align: left;vertical-align: middle;vertical-align: bottom\">$<\/td>\n<td style=\"max-width:10%;width:10%;min-width:10%;padding-left: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">387,626<\/td>\n<td style=\"max-width:1%;width:1%;min-width:1%;vertical-align: bottom\">\u00a0<\/td>\n<td style=\"max-width:2%;width:2%;min-width:2%;padding-right: 0;text-align: left;vertical-align: middle;vertical-align: bottom\">$<\/td>\n<td style=\"max-width:10%;width:10%;min-width:10%;padding-left: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">205,326<\/td>\n<\/tr>\n<tr>\n<td style=\"vertical-align: middle;text-align: left;padding-left: 20.0px;vertical-align: top\">Short-term marketable securities<\/td>\n<td style=\"padding-right: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">\u00a0<\/td>\n<td style=\"padding-left: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">600,058<\/td>\n<td style=\"vertical-align: bottom\">\u00a0<\/td>\n<td style=\"padding-right: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">\u00a0<\/td>\n<td style=\"padding-left: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">662,553<\/td>\n<\/tr>\n<tr>\n<td style=\"vertical-align: middle;text-align: left;padding-left: 20.0px;vertical-align: top\">Prepaid expenses and other current assets<\/td>\n<td style=\"border-bottom: solid black 1pt;padding-right: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">\u00a0<\/td>\n<td style=\"border-bottom: solid black 1pt;padding-left: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">35,068<\/td>\n<td style=\"vertical-align: bottom\">\u00a0<\/td>\n<td style=\"border-bottom: solid black 1pt;padding-right: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">\u00a0<\/td>\n<td style=\"border-bottom: solid black 1pt;padding-left: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">32,779<\/td>\n<\/tr>\n<tr>\n<td style=\"vertical-align: middle;text-align: left;padding-left: 30.0px;vertical-align: top\">Total current assets<\/td>\n<td style=\"border-top: solid black 1pt;border-bottom: solid black 1pt;padding-right: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">\u00a0<\/td>\n<td style=\"border-top: solid black 1pt;border-bottom: solid black 1pt;padding-left: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">1,022,752<\/td>\n<td style=\"vertical-align: bottom\">\u00a0<\/td>\n<td style=\"border-top: solid black 1pt;border-bottom: solid black 1pt;padding-right: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">\u00a0<\/td>\n<td style=\"border-top: solid black 1pt;border-bottom: solid black 1pt;padding-left: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">900,658<\/td>\n<\/tr>\n<tr>\n<td style=\"vertical-align: top\">Long-term marketable securities<\/td>\n<td style=\"border-top: solid black 1pt;padding-right: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">\u00a0<\/td>\n<td style=\"border-top: solid black 1pt;padding-left: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">63,785<\/td>\n<td style=\"vertical-align: bottom\">\u00a0<\/td>\n<td style=\"border-top: solid black 1pt;padding-right: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">\u00a0<\/td>\n<td style=\"border-top: solid black 1pt;padding-left: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">98,322<\/td>\n<\/tr>\n<tr>\n<td style=\"vertical-align: top\">Property and equipment, net<\/td>\n<td style=\"padding-right: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">\u00a0<\/td>\n<td style=\"padding-left: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">51,728<\/td>\n<td style=\"vertical-align: bottom\">\u00a0<\/td>\n<td style=\"padding-right: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">\u00a0<\/td>\n<td style=\"padding-left: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">52,402<\/td>\n<\/tr>\n<tr>\n<td style=\"vertical-align: top\">Finance lease right-of-use asset<\/td>\n<td style=\"padding-right: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">\u00a0<\/td>\n<td style=\"padding-left: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">47,616<\/td>\n<td style=\"vertical-align: bottom\">\u00a0<\/td>\n<td style=\"padding-right: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">\u00a0<\/td>\n<td style=\"padding-left: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">48,531<\/td>\n<\/tr>\n<tr>\n<td style=\"vertical-align: top\">Operating lease right-of-use asset<\/td>\n<td style=\"padding-right: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">\u00a0<\/td>\n<td style=\"padding-left: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">17,922<\/td>\n<td style=\"vertical-align: bottom\">\u00a0<\/td>\n<td style=\"padding-right: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">\u00a0<\/td>\n<td style=\"padding-left: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">19,002<\/td>\n<\/tr>\n<tr>\n<td style=\"vertical-align: top\">Intangible asset, net<\/td>\n<td style=\"padding-right: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">\u00a0<\/td>\n<td style=\"padding-left: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">36,000<\/td>\n<td style=\"vertical-align: bottom\">\u00a0<\/td>\n<td style=\"padding-right: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">\u00a0<\/td>\n<td style=\"padding-left: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">\u2014<\/td>\n<\/tr>\n<tr>\n<td style=\"vertical-align: top\">Other non-current assets<\/td>\n<td style=\"border-bottom: solid black 1pt;padding-right: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">\u00a0<\/td>\n<td style=\"border-bottom: solid black 1pt;padding-left: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">26,220<\/td>\n<td style=\"vertical-align: bottom\">\u00a0<\/td>\n<td style=\"border-bottom: solid black 1pt;padding-right: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">\u00a0<\/td>\n<td style=\"border-bottom: solid black 1pt;padding-left: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">25,939<\/td>\n<\/tr>\n<tr>\n<td style=\"vertical-align: top\">Total assets<\/td>\n<td style=\"border-top: solid black 1pt;border-bottom: double black 3pt;padding-right: 0;text-align: left;vertical-align: middle;vertical-align: bottom\">$<\/td>\n<td style=\"border-top: solid black 1pt;border-bottom: double black 3pt;padding-left: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">1,266,023<\/td>\n<td style=\"vertical-align: bottom\">\u00a0<\/td>\n<td style=\"border-top: solid black 1pt;border-bottom: double black 3pt;padding-right: 0;text-align: left;vertical-align: middle;vertical-align: bottom\">$<\/td>\n<td style=\"border-top: solid black 1pt;border-bottom: double black 3pt;padding-left: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">1,144,854<\/td>\n<\/tr>\n<tr>\n<td style=\"vertical-align: top\">\n            <strong>Liabilities and stockholders&#8217; equity<\/strong>\n          <\/td>\n<td colspan=\"2\" style=\"border-top: double black 3pt;vertical-align: bottom\">\u00a0<\/td>\n<td style=\"vertical-align: bottom\">\u00a0<\/td>\n<td colspan=\"2\" style=\"border-top: double black 3pt;vertical-align: bottom\">\u00a0<\/td>\n<\/tr>\n<tr>\n<td style=\"vertical-align: top\">Current liabilities:<\/td>\n<td colspan=\"2\" style=\"vertical-align: bottom\">\u00a0<\/td>\n<td style=\"vertical-align: bottom\">\u00a0<\/td>\n<td colspan=\"2\" style=\"vertical-align: bottom\">\u00a0<\/td>\n<\/tr>\n<tr>\n<td style=\"vertical-align: middle;text-align: left;padding-left: 20.0px;vertical-align: top\">Accounts payable<\/td>\n<td style=\"padding-right: 0;text-align: left;vertical-align: middle;vertical-align: bottom\">$<\/td>\n<td style=\"padding-left: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">40,380<\/td>\n<td style=\"vertical-align: bottom\">\u00a0<\/td>\n<td style=\"padding-right: 0;text-align: left;vertical-align: middle;vertical-align: bottom\">$<\/td>\n<td style=\"padding-left: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">505<\/td>\n<\/tr>\n<tr>\n<td style=\"vertical-align: middle;text-align: left;padding-left: 20.0px;vertical-align: top\">Accrued expenses and other current liabilities<\/td>\n<td style=\"padding-right: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">\u00a0<\/td>\n<td style=\"padding-left: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">69,776<\/td>\n<td style=\"vertical-align: bottom\">\u00a0<\/td>\n<td style=\"padding-right: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">\u00a0<\/td>\n<td style=\"padding-left: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">76,745<\/td>\n<\/tr>\n<tr>\n<td style=\"vertical-align: middle;text-align: left;padding-left: 30.0px;vertical-align: top\">Total current liabilities<\/td>\n<td style=\"border-top: solid black 1pt;padding-right: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">\u00a0<\/td>\n<td style=\"border-top: solid black 1pt;padding-left: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">110,156<\/td>\n<td style=\"vertical-align: bottom\">\u00a0<\/td>\n<td style=\"border-top: solid black 1pt;padding-right: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">\u00a0<\/td>\n<td style=\"border-top: solid black 1pt;padding-left: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">98,351<\/td>\n<\/tr>\n<tr>\n<td style=\"vertical-align: top\">Operating lease liability, less current portion<\/td>\n<td style=\"border-top: solid black 1pt;padding-right: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">\u00a0<\/td>\n<td style=\"border-top: solid black 1pt;padding-left: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">24,680<\/td>\n<td style=\"vertical-align: bottom\">\u00a0<\/td>\n<td style=\"border-top: solid black 1pt;padding-right: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">\u00a0<\/td>\n<td style=\"border-top: solid black 1pt;padding-left: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">27,210<\/td>\n<\/tr>\n<tr>\n<td style=\"vertical-align: top\">Finance lease liability, less current portion<\/td>\n<td style=\"padding-right: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">\u00a0<\/td>\n<td style=\"padding-left: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">5,508<\/td>\n<td style=\"vertical-align: bottom\">\u00a0<\/td>\n<td style=\"padding-right: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">\u00a0<\/td>\n<td style=\"padding-left: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">5,532<\/td>\n<\/tr>\n<tr>\n<td style=\"vertical-align: top\">Liability related to the revenue participation right agreement<\/td>\n<td style=\"padding-right: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">\u00a0<\/td>\n<td style=\"padding-left: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">199,581<\/td>\n<td style=\"vertical-align: bottom\">\u00a0<\/td>\n<td style=\"padding-right: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">\u00a0<\/td>\n<td style=\"padding-left: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">\u2014<\/td>\n<\/tr>\n<tr>\n<td style=\"vertical-align: top\">Total liabilities<\/td>\n<td style=\"border-top: solid black 1pt;padding-right: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">\u00a0<\/td>\n<td style=\"border-top: solid black 1pt;padding-left: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">339,925<\/td>\n<td style=\"vertical-align: bottom\">\u00a0<\/td>\n<td style=\"border-top: solid black 1pt;padding-right: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">\u00a0<\/td>\n<td style=\"border-top: solid black 1pt;padding-left: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">131,093<\/td>\n<\/tr>\n<tr>\n<td style=\"vertical-align: top\">Total stockholders&#8217; equity<\/td>\n<td style=\"border-bottom: solid black 1pt;padding-right: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">\u00a0<\/td>\n<td style=\"border-bottom: solid black 1pt;padding-left: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">926,098<\/td>\n<td style=\"vertical-align: bottom\">\u00a0<\/td>\n<td style=\"border-bottom: solid black 1pt;padding-right: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">\u00a0<\/td>\n<td style=\"border-bottom: solid black 1pt;padding-left: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">1,013,761<\/td>\n<\/tr>\n<tr>\n<td style=\"vertical-align: top\">Total liabilities and stockholders\u2019 equity<\/td>\n<td style=\"border-top: solid black 1pt;border-bottom: double black 3pt;padding-right: 0;text-align: left;vertical-align: middle;vertical-align: bottom\">$<\/td>\n<td style=\"border-top: solid black 1pt;border-bottom: double black 3pt;padding-left: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">1,266,023<\/td>\n<td style=\"vertical-align: bottom\">\u00a0<\/td>\n<td style=\"border-top: solid black 1pt;border-bottom: double black 3pt;padding-right: 0;text-align: left;vertical-align: middle;vertical-align: bottom\">$<\/td>\n<td style=\"border-top: solid black 1pt;border-bottom: double black 3pt;padding-left: 0;text-align: right;vertical-align: middle;vertical-align: bottom\">1,144,854<\/td>\n<\/tr>\n<tr>\n<td>\u00a0<\/td>\n<td>\u00a0<\/td>\n<td>\u00a0<\/td>\n<td>\u00a0<\/td>\n<td>\u00a0<\/td>\n<td>\u00a0<\/td>\n<\/tr>\n<tr>\n<td>\u00a0<\/td>\n<td>\u00a0<\/td>\n<td>\u00a0<\/td>\n<td>\u00a0<\/td>\n<td>\u00a0<\/td>\n<td>\u00a0<\/td>\n<\/tr>\n<\/table>\n<p align=\"left\">\n        <strong>Investor Contact:<\/strong><br \/>\n        <br \/>Laura Hansen, Ph.D.<br \/>hansen@dnli.com<\/p>\n<p align=\"left\">\n        <strong>Media Contact:<\/strong><br \/>\n        <br \/>Erin Patton<br \/>epatton@dnli.com<\/p>\n<p>      <img decoding=\"async\" alt=\"\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTcxNTgzNyM3NTkwNzA0IzIwOTM0Njg=\" \/><br \/>\n      <br \/>\n      <img decoding=\"async\" alt=\"\" src=\"https:\/\/ml.globenewswire.com\/media\/MzBhZTYwNWYtZjVhNi00MzRmLTk5MjQtYjdjODBkY2U4NzljLTExMDUwMzktMjAyNi0wNS0wNy1lbg==\/tiny\/Denali-Therapeutics-Inc-.png\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>FDA approved AVLAYAH\u2122 (tividenofusp alfa-eknm) for treatment of Hunter syndrome (MPS II) and as first medicine to leverage transferrin receptor to cross blood-brain barrier AVLAYAH launched in U.S. with strong momentum, vibrant community engagement, and first patients treated in commercial setting in April Broad clinical pipeline progressing for lysosomal storage and neurodegenerative diseases, including first patient dosed with Oligonucleotide TransportVehicle\u2122 (OTV)-enabled DNL628 (OTV:MAPT) targeting tau for Alzheimer&#8217;s disease 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 07, 2026 (GLOBE NEWSWIRE) &#8212; Denali Therapeutics Inc. (Nasdaq: DNLI) today reported financial results for the first quarter ended March 31, 2026, and provided business &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/denali-therapeutics-reports-first-quarter-2026-financial-results-and-business-highlights\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Denali Therapeutics Reports First Quarter 2026 Financial Results and Business Highlights&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-959972","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Denali Therapeutics Reports First Quarter 2026 Financial Results and Business Highlights - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/denali-therapeutics-reports-first-quarter-2026-financial-results-and-business-highlights\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Denali Therapeutics Reports First Quarter 2026 Financial Results and Business Highlights - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"FDA approved AVLAYAH\u2122 (tividenofusp alfa-eknm) for treatment of Hunter syndrome (MPS II) and as first medicine to leverage transferrin receptor to cross blood-brain barrier AVLAYAH launched in U.S. with strong momentum, vibrant community engagement, and first patients treated in commercial setting in April Broad clinical pipeline progressing for lysosomal storage and neurodegenerative diseases, including first patient dosed with Oligonucleotide TransportVehicle\u2122 (OTV)-enabled DNL628 (OTV:MAPT) targeting tau for Alzheimer&#8217;s disease 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 07, 2026 (GLOBE NEWSWIRE) &#8212; Denali Therapeutics Inc. 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