Denali Therapeutics Inc 8-K, filed Nov 3, 2026
Denali Therapeutics Inc. (DNLI)
8-K
2026-11-03
For: 2026-11-03
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Added on
November 03, 2026
About this 8-K
Denali Therapeutics Inc filed this 8-K on November 3, 2026.
Denali Therapeutics reported third-quarter AVLAYAH net product revenue of $17.8 million and net income of $70.1 million, boosted by a one-time $194.0 million voucher-sale gain. Fourth-quarter revenue guidance is $30.0 million to $32.0 million. AI summary
Items reported
- Item 2.02: Financial results
- Item 9.01: Financial statements and exhibits
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):
(Exact name of registrant as specified in its charter)
| (State or other jurisdiction of | (Commission | (I.R.S. Employer | ||||||||||||
| incorporation) | File Number) | Identification No.) | ||||||||||||
(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:
| Title of each class | Trading Symbol (s) | Name of each exchange on which registered | ||||||
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).
| 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. ☐ | ||||||||
Item 2.02 Results of Operations and Financial Condition.
On November 3, 2026, Denali Therapeutics Inc. (the "Company") issued a press release announcing its financial results for the third quarter ended September 30, 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 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description | ||||||||||
| 99.1 | |||||||||||
| 104 | Cover Page Interactive Data File (formatted as Inline XBRL) | ||||||||||
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. | |||||||||||
| Date: | November 3, 2026 | By: | /s/ Alexander O. Schuth | ||||||||
| Alexander O. Schuth, M.D. | |||||||||||
| Chief Operating and Financial Officer | |||||||||||
Exhibit 99.1
Denali Therapeutics Reports Third Quarter 2026 Financial Results and Business Highlights
•AVLAYAH® (tividenofusp alfa-eknm) net product revenue accelerated to $17.8 million in its second full commercial quarter
•Continued growth expectations drive Q4 2026 net product revenue guidance of $30.0 million to $32.0 million
•AVLAYAH recognized as the “Best Biotechnology Product” of 2026 by The Galien Foundation
•Zafinofusp alfa advancing as Denali’s second potential product, with BLA submission on track for 2027 seeking accelerated approval for Sanfilippo syndrome type A (MPS IIIA)
•Five TransportVehicle™ (TV) programs expected to generate data in 2027: zafinofusp alfa (ETV:SGSH), DNL593 (PTV:PGRN), DNL628 (OTV:MAPT), DNL921 (ATV:Abeta) and DNL952 (ETV:GAA)
•Q3 2026 net income of $70.1 million included a one-time $194.0 million net gain on the sale of a Priority Review Voucher, bringing cash, cash equivalents and marketable securities to $1.0 billion
•Conference call and webcast today at 4:30 p.m. ET
SOUTH SAN FRANCISCO, Calif. – November 3, 2026 – Denali Therapeutics Inc. (Nasdaq: DNLI) today reported financial results for the third quarter ended September 30, 2026, and provided business highlights.
“Families and physicians are telling us that AVLAYAH is making a difference for children with Hunter syndrome, and the results this quarter reflect that,” said Ryan Watts, Ph.D., Chief Executive Officer of Denali Therapeutics. “The positive responses to AVLAYAH across patients, physicians and payers, and our team’s strong commercial execution, show what is possible for our TransportVehicle portfolio. We are applying what we have learned from developing and launching AVLAYAH as we work with urgency to bring zafinofusp alfa to families affected by Sanfilippo syndrome type A, who need treatment options designed to address disease in the brain and body. We look forward to sharing the Phase 1/2 data, which will support a BLA submission in 2027 as planned. Next year we also expect data from our TransportVehicle programs in Alzheimer’s disease, FTD-GRN and Pompe disease as we build on this momentum across our pipeline of blood-brain barrier therapeutics.”
Third Quarter 2026 and Recent Program Updates
COMMERCIAL PRODUCT
AVLAYAH for Hunter syndrome (MPS II)
AVLAYAH (tividenofusp alfa-eknm) is the first and only U.S. Food and Drug Administration (FDA)-approved medicine in the emerging class of biotherapeutics that leverage the transferrin receptor to cross the blood-brain barrier. Enabled by Denali's Enzyme TransportVehicle™ (ETV), AVLAYAH is an enzyme replacement therapy designed to systemically deliver iduronate 2-sulfatase (IDS) throughout the body, including the brain. AVLAYAH received accelerated approval for the treatment of neurologic manifestations of Hunter syndrome (mucopolysaccharidosis type II, or MPS II) when initiated in presymptomatic or symptomatic pediatric patients weighing at least 5 kg prior to advanced neurologic impairment.
AVLAYAH's U.S. launch gained significant momentum, driven by strong demand from families across the eligible patient population, physicians committed to treating their patients and rapidly expanding payer coverage. Key launch results include:
•$17.8 million in AVLAYAH net product revenue in the second full quarter of commercial availability.
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•Coverage now exceeds 70% of U.S. commercial lives, up from more than 50% in the prior quarter, and 20 state Medicaid programs have published coverage of AVLAYAH.
•A permanent J-code became effective October 1, 2026, streamlining billing and reimbursement for treatment centers.
•Fourth-quarter 2026 net product revenue is expected to be $30.0 million to $32.0 million.
Denali also completed enrollment of Cohort B, for a total enrollment of 65 participants across Cohorts A and B, in the global Phase 2/3 COMPASS study. This is an important step toward generating confirmatory evidence, expanding the U.S. label to adult patients and supporting future global regulatory submissions. Data from the COMPASS study are expected in the first half of 2028.
CLINICAL PROGRAMS
Lysosomal Storage Diseases
Zafinofusp alfa (DNL126; ETV:SGSH) for Sanfilippo syndrome type A (MPS IIIA)
Zafinofusp alfa is an investigational ETV-enabled enzyme replacement therapy designed to systemically deliver N-sulfoglucosamine sulfohydrolase (SGSH) throughout the body, including the brain, for the treatment of Sanfilippo syndrome type A. In the third quarter, the Phase 1/2 study completed the prespecified treatment duration for the primary endpoint. The study enrolled a total of 20 participants across the pediatric age range. A Biologics License Application (BLA) submission in 2027 seeking accelerated approval is on track.
Preliminary data from dose-finding cohorts in the ongoing Phase 1/2 study of zafinofusp alfa, presented at WORLDSymposium 2026, showed mean reductions across age groups of 80% and 83% at week 49 in the key disease biomarkers cerebrospinal fluid heparan sulfate (CSF HS) and urine HS, respectively, including normalization of CSF HS in some participants and normalization of liver volume in all assessed participants.
Denali plans to present additional data from the Phase 1/2 study at a medical congress in the first quarter of 2027. Start-up activities are underway for a global Phase 3 confirmatory study.
DNL593 (PTV:PGRN) for FTD-GRN
DNL593 is an investigational Protein TransportVehicle™ (PTV)-enabled protein replacement therapy designed to systemically deliver progranulin (PGRN) across the blood-brain barrier for the treatment of granulin (GRN)-related frontotemporal dementia (FTD-GRN). In August 2026, the FDA granted Orphan Drug Designation to DNL593 for FTD-GRN, underscoring the significant unmet need facing individuals affected by this disease. Enrollment in the Phase 1/2 study of DNL593 is complete with a total of 40 participants with FTD-GRN. Data are expected in the first half of 2027.
DNL952 (ETV:GAA) for Pompe disease
DNL952 is an investigational ETV-enabled enzyme replacement therapy designed to systemically deliver acid alpha-glucosidase (GAA) to muscle tissue and the brain by crossing the blood-brain barrier for the treatment of Pompe disease. The current standard of care is enzyme replacement therapy. Progressive motor weakness, respiratory failure and neurologic symptoms remain unmet needs. The Phase 1 study of DNL952 is enrolling participants with late-onset Pompe disease (LOPD), and initial clinical data are expected in 2027.
Alzheimer's Disease
DNL628 (OTV:MAPT) for Alzheimer's disease
DNL628 is an investigational Oligonucleotide TransportVehicle™ (OTV)-enabled antisense oligonucleotide designed for systemic delivery across the blood-brain barrier to reduce tau by targeting the MAPT gene for the treatment of Alzheimer’s disease. Initial clinical biomarker data from the ongoing Phase 1b study of DNL628 in participants with Alzheimer’s disease are expected in the first half of 2027.
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DNL921 (ATV:Abeta) for Alzheimer's disease
DNL921 is an investigational Antibody TransportVehicle™ (ATV)-enabled antibody designed for systemic delivery across the blood-brain barrier to target amyloid plaques in Alzheimer's disease. Safety and clinical proof-of-concept data from the ongoing Phase 1/1b study of DNL921 in healthy volunteers and participants with Alzheimer's disease are expected in 2027.
Parkinson’s Disease
DNL151 (LRRK2 inhibitor) for Parkinson's disease
DNL151 is an investigational small molecule inhibitor of leucine-rich repeat kinase 2 (LRRK2) for the treatment of Parkinson’s disease. Denali is conducting the Phase 2a BEACON study in participants with LRRK2-positive Parkinson’s disease, with data expected in the first half of 2027.
IND-ENABLING STAGE PROGRAMS
Denali has multiple additional programs in the investigational new drug (IND)-enabling stage, including DNL111 (ETV:GCase) for Parkinson's disease and Gaucher disease; DNL622 (ETV:IDUA) for MPS I; and DNL422 (OTV:SNCA) for Parkinson's disease.
Corporate Updates
In October, Denali announced that AVLAYAH was recognized as the “Best Biotechnology Product” of 2026 by The Galien Foundation. The Prix Galien USA Awards are among the biopharmaceutical industry’s highest honors, recognizing impactful FDA-approved treatments and selected by leading scientists and physicians.
Participation in Upcoming Investor Conferences
•Stifel 2026 Healthcare Conference, November 10-12 (New York)
•UBS Global Biopharma Conference, November 16-17 (London)
•Jefferies Global Healthcare Conference, November 16-19 (London)
•9th Annual Evercore Healthcare Conference, November 30-December 2 (Coral Gables)
•J.P. Morgan 2027 Healthcare Conference, January 11-14 (San Francisco)
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Third Quarter 2026 Financial Results
Net product revenue was $17.8 million for the quarter ended September 30, 2026, reflecting AVLAYAH’s second full quarter of commercial availability in the United States following FDA approval in March 2026.
Cost of goods sold was $0.2 million for the quarter ended September 30, 2026. Because manufacturing costs incurred prior to FDA approval of AVLAYAH were expensed as research and development, cost of goods sold during the initial commercialization period reflects a lower average per-unit cost as previously expensed inventory is sold.
Total research and development expenses were $106.1 million for the quarter ended September 30, 2026, compared to $102.0 million for the quarter ended September 30, 2025. The increase of approximately $4.1 million was primarily attributable to higher external research and development expenses for TV programs, partially offset by lower expenses for other research and development programs.
Selling, general and administrative expenses were $37.5 million for the quarter ended September 30, 2026, compared to $35.5 million for the quarter ended September 30, 2025. The $2.0 million increase primarily reflected higher commercial and medical affairs costs to support the AVLAYAH launch, along with higher site and personnel costs.
Intangible asset amortization was $0.8 million for the quarter ended September 30, 2026, compared to zero for the quarter ended September 30, 2025, reflecting amortization of the developed technology intangible asset recognized upon FDA approval of AVLAYAH in March 2026.
Net income was $70.1 million for the quarter ended September 30, 2026, compared to a net loss of $126.9 million for the quarter ended September 30, 2025. Net income for the quarter ended September 30, 2026, included a one-time $194.0 million net gain recognized on the sale of a Priority Review Voucher.
Cash, cash equivalents and marketable securities were approximately $1.0 billion as of September 30, 2026.
Conference Call and Webcast Information
Denali will host a conference call today, Tuesday, November 3, 2026, at 4:30 p.m. Eastern Time to discuss the third quarter financial results and provide a corporate update. The live and replayed webcast of the call will be available through Denali’s website at https://investors.denalitherapeutics.com/events. The replay of the call will be available for 90 days.
About the Denali TransportVehicle™ 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™ (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.
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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.
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 AVLAYAH® (tividenofusp alfa-eknm) and expected revenues, including expectations regarding demand, payer coverage, and reimbursement; expectations related to the ongoing Phase 2/3 COMPASS study of tividenofusp alfa, including the timing and availability of data and the likelihood that it will generate confirmatory evidence to support continued approval, U.S. label expansion, and global regulatory submissions; plans, timelines and expectations related to zafinofusp alfa, including with respect to the ongoing Phase 1/2 study and the planned Phase 3 confirmatory study, the timing and availability of data, the timing and occurrence of a 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 and the timing and availability of data; plans, timelines and expectations related to DNL952 and the timing and availability of data from the ongoing Phase 1 study; plans, timelines and expectations related to DNL628, including the ongoing Phase 1b study and the timing and availability of clinical biomarker data; plans, timelines and expectations related to DNL921, including the Phase 1/1b study and the timing and availability of data; plans, timelines and expectations related to DNL151, including the timing and availability of data from the ongoing Phase 2a BEACON study; plans, timelines and expectations for IND-enabling stage programs; plans regarding participation in upcoming investor conferences; forecasts of future revenues and operating expenses; expectations regarding costs of goods sold; 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, risks arising from adverse economic conditions and their impact on Denali’s business and operations; Denali’s ability to complete the development and, if approved, the commercialization of product candidates; reliance on third-party manufacturers and suppliers for clinical trial and commercial materials; difficulties enrolling patients for ongoing and future clinical trials; potential delays or failures in meeting expected clinical trial timelines; discrepancies between preclinical, early-stage or preliminary clinical results and later-stage trial outcomes; the risk that interim or topline clinical results may not be predictive of final study results or longer-term outcomes; the risk that the FDA may not accept the data or surrogate endpoints Denali intends to use to support accelerated approval, may require additional or different studies, or may withdraw an accelerated approval if confirmatory studies do not verify clinical benefit; 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, including uncertainties related to the FDA’s policies; 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 revenues and operating expenses in the current environment; quarterly variability in net product revenue and the risk that revenue growth may not continue at recent rates; and other risks and uncertainties, including those described in Denali's Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on February 26, 2026, its Quarterly Report on Form 10-Q filed with the SEC on August 6, 2026, and Denali’s future SEC filings. Except for AVLAYAH, Denali's product candidates are investigational, and their safety and efficacy profiles have not yet been established. Denali undertakes no obligation to update or revise any forward-looking statements, to conform these statements to actual results or reflect 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)
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| 2026 | 2025 | 2026 | 2025 | ||||||||||||||||||||
| Revenue: | |||||||||||||||||||||||
| Product revenue, net | $ | 17,778 | $ | — | $ | 21,382 | $ | — | |||||||||||||||
| Total revenue | 17,778 | — | 21,382 | — | |||||||||||||||||||
| Operating expenses: | |||||||||||||||||||||||
| Cost of goods sold | 192 | — | 285 | — | |||||||||||||||||||
| Research and development | 106,102 | 101,950 | 306,967 | 320,873 | |||||||||||||||||||
| Selling, general and administrative | 37,485 | 35,484 | 107,279 | 97,104 | |||||||||||||||||||
| Intangible asset amortization | 750 | — | 1,500 | — | |||||||||||||||||||
| Total operating expenses | 144,529 | 137,434 | 416,031 | 417,977 | |||||||||||||||||||
| Loss from operations | (126,751) | (137,434) | (394,649) | (417,977) | |||||||||||||||||||
| Other income: | |||||||||||||||||||||||
| Gain on sale of priority review voucher, net | 194,000 | — | 194,000 | — | |||||||||||||||||||
| Interest and other income, net | 2,877 | 10,532 | 14,775 | 33,986 | |||||||||||||||||||
Total other income | 196,877 | 10,532 | 208,775 | 33,986 | |||||||||||||||||||
| Net income (loss) | $ | 70,126 | $ | (126,902) | $ | (185,874) | $ | (383,991) | |||||||||||||||
Net income (loss) per share: | |||||||||||||||||||||||
Basic | $ | 0.37 | $ | (0.74) | $ | (0.99) | $ | (2.24) | |||||||||||||||
Diluted | $ | 0.37 | $ | (0.74) | $ | (0.99) | $ | (2.24) | |||||||||||||||
Weighted-average shares used in calculating net income (loss) per share: | |||||||||||||||||||||||
Basic | 188,387,660 | 172,421,492 | 187,452,793 | 171,702,183 | |||||||||||||||||||
Diluted | 192,077,855 | 172,421,492 | 187,452,793 | 171,702,183 | |||||||||||||||||||
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Denali Therapeutics Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
(In thousands)
| September 30, 2026 | December 31, 2025 | ||||||||||
| Assets | |||||||||||
| Current assets: | |||||||||||
| Cash and cash equivalents | $ | 102,870 | $ | 205,326 | |||||||
| Short-term marketable securities | 413,326 | 662,553 | |||||||||
| Accounts receivable, net | 18,882 | — | |||||||||
| Inventory | 26,275 | — | |||||||||
| Prepaid expenses and other current assets | 30,355 | 32,779 | |||||||||
| Total current assets | 591,708 | 900,658 | |||||||||
| Long-term marketable securities | 491,376 | 98,322 | |||||||||
| Property and equipment, net | 47,907 | 52,402 | |||||||||
| Finance lease right-of-use asset | 45,784 | 48,531 | |||||||||
| Operating lease right-of-use asset | 15,612 | 19,002 | |||||||||
| Intangible asset, net | 34,500 | — | |||||||||
| Other non-current assets | 29,148 | 25,939 | |||||||||
| Total assets | $ | 1,256,035 | $ | 1,144,854 | |||||||
| Liabilities and stockholders' equity | |||||||||||
| Current liabilities: | |||||||||||
| Accounts payable | $ | 13,700 | $ | 505 | |||||||
| Accrued expenses and other current liabilities | 81,558 | 97,846 | |||||||||
| Total current liabilities | 95,258 | 98,351 | |||||||||
| Operating lease liability, less current portion | 19,280 | 27,210 | |||||||||
| Finance lease liability, less current portion | 5,449 | 5,532 | |||||||||
| Liability related to the revenue participation right agreement | 209,661 | — | |||||||||
| Total liabilities | 329,648 | 131,093 | |||||||||
| Total stockholders' equity | 926,387 | 1,013,761 | |||||||||
| Total liabilities and stockholders’ equity | $ | 1,256,035 | $ | 1,144,854 | |||||||
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Investor Contact:
Laura Hansen, Ph.D.
hansen@dnli.com
Media Contact:
Erin Patton
epatton@dnli.com
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