NASDAQ$DNLI
Denali Therapeutics Inc · Q1 2025 earnings
Q1 2025 earnings · · After market close · Investor relations
Briefing
Denali Therapeutics reported its first quarter 2025 financial results, including the completion of the BLA rolling submission for tividenofusp alfa for Hunter Syndrome.
Denali Therapeutics reported a net loss of $133.0 million for the first quarter of 2025, an increase from the $101.8 million net loss in the same period last year. Total research and development expenses increased to $116.2 million, primarily due to increased spending on TV programs and manufacturing facility operations. The company completed the BLA submission for tividenofusp alfa and is preparing for its commercial launch.
- Net loss for Q1 2025 was $133.0 million, compared to $101.8 million in Q1 2024.
- Total research and development expenses increased to $116.2 million in Q1 2025 from $107.0 million in Q1 2024.
- General and administrative expenses rose to $29.4 million in Q1 2025, driven by BLA submission activities and commercial launch preparations.
- Denali completed the BLA rolling submission for tividenofusp alfa for Hunter Syndrome and is preparing for commercial launch in late 2025 or early 2026.
Headline financials
Revenue & EPS history
Denali Therapeutics · Revenue · Quarterly
$0
Forward guidance
Denali Therapeutics is preparing for the commercial launch of tividenofusp alfa in late 2025 or early 2026, pending FDA approval. The company continues to advance its TransportVehicle-enabled pipeline, including DNL126 for Sanfilippo syndrome Type A and DNL593 for GRN-related frontotemporal dementia. They also anticipate a readout for the Phase 2b LUMA study of BIIB122 in 2026.
Tailwinds
- Completion of BLA submission for tividenofusp alfa, positioning it as a potential first FDA-approved enzyme replacement therapy for Hunter syndrome.
- Ongoing and productive collaboration with the FDA for DNL126 under the START program, aiming for an accelerated development and approval path.
- Advancement of the DNL593 program for GRN-related frontotemporal dementia with an ongoing Phase 1/2 study.
- Full enrollment of the Phase 2b LUMA study for BIIB122, with readout expected in 2026.
- Expansion of U.S. manufacturing capabilities with the opening of a clinical biomanufacturing facility in Salt Lake City.
Headwinds
- Primary endpoint not met in Regimen G of the Phase 2/3 HEALEY ALS Platform Trial for DNL343.
- Additional analyses for DNL343 did not demonstrate a treatment effect on neurofilament light (NfL), leading to discontinuation of the active treatment extension.
- Reliance on third parties for the manufacture and supply of product candidates for clinical trials.
- The risk that preclinical profiles of product candidates may not translate in clinical trials.
- The uncertainty that product candidates will receive regulatory approval necessary to be commercialized.
Historical earnings impact
How earnings announcements have historically affected this stock's price.
Avg. return before/after earnings
Based on 20 quarterly earnings reports · overlaid with Q1 2025
-0.3%
Avg return
Earnings day
-1.4%
Avg return
5 days after
+1.3%
Avg return
30 days after
44%
14 / 32 earnings
Positive
+19.7%
Q4 2023
Best reaction
-13.7%
Q1 2022
Worst reaction
| Quarter | Report date | Reaction (Day 0) | +5 days | +30 days |
|---|---|---|---|---|
| Q4 2025 | -1.0% | -4.9% | -15.2% | |
| Q3 2025 | -3.2% | +18.1% | +34.0% | |
| Q1 2025 | +1.0% | -0.9% | +6.1% | |
| Q4 2024 | -1.5% | -15.6% | -21.8% | |
| Q3 2024 | +7.1% | +14.2% | -10.0% | |
| Q2 2024 | -10.3% | -9.7% | +0.3% | |
| Q1 2024 | +10.3% | +6.8% | +24.3% | |
| Q4 2023 | +19.7% | +23.5% | +21.5% | |
| Q3 2023 | -2.7% | -21.8% | -9.7% | |
| Q2 2023 | -5.2% | -7.6% | -7.3% | |
| Q1 2023 | +3.0% | +5.4% | +16.1% | |
| Q4 2022 | +4.8% | +7.3% | -10.9% | |
| Q3 2022 | -7.8% | -10.3% | +6.2% | |
| Q2 2022 | +4.6% | +6.6% | -17.5% | |
| Q1 2022 | -13.7% | -14.0% | -8.5% | |
| Q4 2021 | -2.8% | -7.8% | -1.9% | |
| Q3 2021 | +3.5% | -0.4% | -19.9% | |
| Q2 2021 | +3.5% | +4.6% | +6.6% | |
| Q1 2021 | -8.0% | -10.2% | +5.5% | |
| Q4 2020 | +7.5% | -5.8% | -17.2% | |
| Q3 2020 | +5.2% | +16.3% | +40.8% | |
| Q2 2020 | +6.1% | -5.4% | -2.5% | |
| Q1 2020 | -5.5% | -5.7% | +2.6% | |
| Q4 2019 | -8.6% | -10.0% | -12.5% | |
| Q3 2019 | -6.1% | -10.1% | +10.5% | |
| Q2 2019 | +0.6% | +5.4% | -4.2% | |
| Q1 2019 | -4.8% | -11.4% | -18.9% | |
| Q4 2018 | +11.7% | +12.0% | +26.4% | |
| Q3 2018 | -4.0% | -0.6% | +12.7% | |
| Q2 2018 | -0.5% | -0.7% | +17.0% | |
| Q4 2017 | -4.8% | -5.1% | +2.2% | |
| Q1 2018 | -8.8% | -8.0% | -12.4% | |
| Q3 2017 | — | — | — | |
| Q2 2017 | — | — | — | |
| Q1 2017 | — | — | — | |
| Q4 2016 | — | — | — | |
| Q3 2016 | — | — | — | |
| Q2 2016 | — | — | — | |
| Q1 2016 | — | — | — |
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