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Denali (DNLI) Lags Q3 Earnings Estimates, Pipeline in Focus
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Denali Therapeutics (DNLI - Free Report) incurred a loss of 84 cents per share for third-quarter 2022, wider than the Zacks Consensus Estimate of a loss of 83 cents and the year-ago quarter’s loss of 69 cents per share on higher expenses.
Collaboration revenues came in at $3.6 million in the reported quarter, missing the Zacks Consensus Estimate of $10 million and down from $5.3 million in the year-ago period. The decrease was primarily due to a decrease in revenues from collaboration with Takeda as the preclinical performance obligations have been met. This decrease was partially offset by an increase in revenues from collaboration with Sanofi (SNY - Free Report) pertaining to Alzheimer's Disease service performance.
In the year so far, Denali’s shares have lost 31.3% compared with the industry’s 22.3% decline.
Image Source: Zacks Investment Research
Quarter in Detail
Research and development expenses increased to $87.8 million in the quarter under review compared with $71.5 million in the year-ago period.
General and administrative expenses were $23.2 million, up from $19.3 million in the year-ago quarter.
Cash, cash equivalents and marketable securities were approximately $1.11 billion as of Sep 30, 2022.
Recent Updates
Denali has collaborated with Biogen (BIIB - Free Report) to advance its LRRK2 inhibitor program to address Parkinson’s disease (PD). In October 2022, Denali and Biogen initiated the global phase III LIGHTHOUSE study of BIIB122 in up to 400 participants with PD and a confirmed LRRK2 pathogenic variant. Dosing is ongoing in the global phase IIb LUMA study in up to 640 participants with early-stage Parkinson’s disease.
Denali initiated the recruitment of phase II/III COMPASS study, which will enroll approximately 54 MPS II (Hunter syndrome) patients. Upon completion of the ongoing phase I/II study, and together with data from the global COMPASS study, this combined data package will potentially support registration.
Earlier in the month, Denali announced interim results from part A of the phase I/II study evaluating TAK-594/DNL593 (PTV:PGRN) in healthy subjects. Data showed that single doses of DNL593 resulted in substantial increases in CSF progranulin levels suggesting brain delivery of DNL593 was achieved and has the potential to address progranulin deficiency, which drives disease progression in people living with FTD-GRN. Single doses of DNL593 were also generally well tolerated, based on blinded safety analysis.
The positive data support dosing in participants with FTD-GRN in Part B of the study.
The company has also partnered with Sanofi for its two separate receptor-interacting serine/threonine protein kinase 1 (RIPK1) inhibitor programs to address neurological diseases using the central nervous system (CNS)-penetrant RIPK1 inhibitors and peripheral inflammatory diseases using non-CNS penetrant RIPK1 inhibitors.
In May 2022, Sanofi began dosing with SAR443820 in the phase II HIMALAYA study. Earlier in the month, Sanofi presented phase I data on SAR443820, demonstrating a safety profile that was well-tolerated after single ascending doses and 14 days of multiple ascending doses taken orally once or twice daily, with favorable pharmacokinetic properties and excellent CNS penetrance in healthy volunteers. The positive data further support the ongoing global HIMALAYA study in participants with amyotrophic lateral sclerosis. A phase II study of SAR443820 in multiple sclerosis is also planned.
Other Updates
In October 2022, Denali raised net proceeds of approximately $296.2 million through a public offering of its common stock.
Image: Bigstock
Denali (DNLI) Lags Q3 Earnings Estimates, Pipeline in Focus
Denali Therapeutics (DNLI - Free Report) incurred a loss of 84 cents per share for third-quarter 2022, wider than the Zacks Consensus Estimate of a loss of 83 cents and the year-ago quarter’s loss of 69 cents per share on higher expenses.
Collaboration revenues came in at $3.6 million in the reported quarter, missing the Zacks Consensus Estimate of $10 million and down from $5.3 million in the year-ago period. The decrease was primarily due to a decrease in revenues from collaboration with Takeda as the preclinical performance obligations have been met. This decrease was partially offset by an increase in revenues from collaboration with Sanofi (SNY - Free Report) pertaining to Alzheimer's Disease service performance.
In the year so far, Denali’s shares have lost 31.3% compared with the industry’s 22.3% decline.
Image Source: Zacks Investment Research
Quarter in Detail
Research and development expenses increased to $87.8 million in the quarter under review compared with $71.5 million in the year-ago period.
General and administrative expenses were $23.2 million, up from $19.3 million in the year-ago quarter.
Cash, cash equivalents and marketable securities were approximately $1.11 billion as of Sep 30, 2022.
Recent Updates
Denali has collaborated with Biogen (BIIB - Free Report) to advance its LRRK2 inhibitor program to address Parkinson’s disease (PD). In October 2022, Denali and Biogen initiated the global phase III LIGHTHOUSE study of BIIB122 in up to 400 participants with PD and a confirmed LRRK2 pathogenic variant. Dosing is ongoing in the global phase IIb LUMA study in up to 640 participants with early-stage Parkinson’s disease.
Denali initiated the recruitment of phase II/III COMPASS study, which will enroll approximately 54 MPS II (Hunter syndrome) patients. Upon completion of the ongoing phase I/II study, and together with data from the global COMPASS study, this combined data package will potentially support registration.
Earlier in the month, Denali announced interim results from part A of the phase I/II study evaluating TAK-594/DNL593 (PTV:PGRN) in healthy subjects. Data showed that single doses of DNL593 resulted in substantial increases in CSF progranulin levels suggesting brain delivery of DNL593 was achieved and has the potential to address progranulin deficiency, which drives disease progression in people living with FTD-GRN. Single doses of DNL593 were also generally well tolerated, based on blinded safety analysis.
The positive data support dosing in participants with FTD-GRN in Part B of the study.
The company has also partnered with Sanofi for its two separate receptor-interacting serine/threonine protein kinase 1 (RIPK1) inhibitor programs to address neurological diseases using the central nervous system (CNS)-penetrant RIPK1 inhibitors and peripheral inflammatory diseases using non-CNS penetrant RIPK1 inhibitors.
In May 2022, Sanofi began dosing with SAR443820 in the phase II HIMALAYA study. Earlier in the month, Sanofi presented phase I data on SAR443820, demonstrating a safety profile that was well-tolerated after single ascending doses and 14 days of multiple ascending doses taken orally once or twice daily, with favorable pharmacokinetic properties and excellent CNS penetrance in healthy volunteers. The positive data further support the ongoing global HIMALAYA study in participants with amyotrophic lateral sclerosis. A phase II study of SAR443820 in multiple sclerosis is also planned.
Other Updates
In October 2022, Denali raised net proceeds of approximately $296.2 million through a public offering of its common stock.
Zacks Rank
Denali currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.