DNLI Research | Milton Maxwell

DNLI

Denali Therapeutics Inc.

17.02

-0.32-1.85%

Dec 16, 4:00:01 PM EST

Upcoming Earnings

Report date

≈ -/-

Earnings Call Transcripts

This Quarter (Q4 '25)

No earnings call transcript available yet

Last Quarter (Q3 '25)

No earnings call transcript available

Key Stats

Market Cap

2.66B

P/E (TTM)

Basic EPS (TTM)

-2.92

Dividend Yield

Recent Filings

8-K

12/10/25Dec 10, 2025

8-K

12/4/25Dec 4, 2025

8-K

12/4/25Dec 4, 2025

8-K

FDA extends tividenofusp alfa review

10/14/25Oct 14, 2025

Denali Therapeutics announced the FDA extended the PDUFA date for tividenofusp alfa's BLA in MPS II treatment from January 5, 2026, to April 5, 2026, after classifying the company's updated clinical pharmacology submission as a Major Amendment. This routine extension, unrelated to efficacy or safety, allows further review while Denali prepares for potential approval and launch. The delay underscores regulatory scrutiny. Yet, the company remains committed to addressing unmet needs in Hunter syndrome.

10-Q

Q2 FY2025 results

8/11/25Aug 11, 2025

Denali Therapeutics posted a Q2 net loss of $124.1M, up 25% y/y, driven by 12% higher R&D spend on TV programs and facility ramp-up, while G&A rose 28% on commercialization prep for tividenofusp alfa. Operating loss widened to $135.0M from $116.6M y/y, with net loss per share at $(0.72) versus $(0.59), reconciled to 171M diluted shares including pre-funded warrants. Cash and equivalents stood at $141.2M with $836.2M in marketable securities, yielding $977.4M total liquidity and negative FCF of $216.1M (derived) for H1; no debt beyond leases. Terminations of Sanofi CNS and Takeda ATV:TREM2 programs in Feb 2025 streamlined focus, but clinical trial delays remain a key risk.

About

Denali Therapeutics Inc., a biopharmaceutical company, discovers and develops therapeutics to treat neurodegenerative and lysosomal storage diseases. The company develops Eclitasertib (SAR443122/DNL758) RIPK1 inhibitor program for peripheral inflammatory diseases; DNL343 eIF2B activator program for amyotrophic lateral sclerosis; BIIB122/DNL151 LRRK2 inhibitor program for Parkinson's disease; TAK-594/DNL593 program for frontotemporal dementia-granulin; DNL126 program for MPS IIIA (Sanfilippo Syndrome A); and DNL310 Tividenofusp alfa, an enzyme replacement therapy program for MPS II (Hunter Syndrome). Its Enzyme TransportVehicle (TV) programs include DNL952 for the treatment of Pompe disease; DNL111 for Parkinson's and Gaucher diseases; and DNL622 for Hurler syndrome (MPS I). The company's OTV programs also comprise DNL628 targeting tau for Alzheimer's disease; and DNL422 targeting alpha synuclein for Parkinson's disease, as well as antibody TV program includes DNL921 targeting Abeta for treating Alzheimer's disease. The company was formerly known as SPR Pharma Inc. and changed its name to Denali Therapeutics Inc. in March 2015. Denali Therapeutics Inc. was incorporated in 2013 and is headquartered in South San Francisco, California.

CEO

Dr. Ryan J. Watts Ph.D.

IPO

12/8/2017

Website

https://www.denalitherapeutics.com

Employees

517

Sector

Healthcare

Industry

Biotechnology