Denali Therapeutics (DNLI) 2025 Conference May 13, 2025 05:20 PM ET Speaker0 Ready? Good afternoon, everyone. Thanks for joining us here at the Bank of America Healthcare Conference. I'm Tazeen Ahmad. I'm one of the senior Smith Biotech analysts here. My next presenting company is Denali Therapeutics, and sitting next to me on stage for the next thirty minutes is Ryan Watts, who is, of course, CEO. Ryan, thanks for making the trip down from California. Speaker1 Great to be here. Looking forward to the conve ...

Denali Therapeutics (DNLI) reported a first-quarter 2025 loss of 78 cents per share, wider than the Zacks Consensus Estimate of a loss of 71 cents. The company reported a loss of 68 cents in the year-ago quarter. (Find the latest EPS estimates and surprises on Zacks Earnings Calendar.)The loss per share deteriorated year over year due to an increase in total operating expenses.In the absence of a marketed product, the company only recognizes revenues from ongoing collaborations. Denali did not generate coll ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38311 Denali Therapeutics Inc. (Exact name of registrant as specified in its charter) (State or other jurisdi ...

Exhibit 99.1 Denali Therapeutics Reports First Quarter 2025 Financial Results and Business Highlights Including Completion of BLA Rolling Submission for Tividenofusp Alfa for Hunter Syndrome SOUTH SAN FRANCISCO, Calif., – May 6, 2025 – Denali Therapeutics Inc. (Nasdaq: DNLI) today reported financial results for the first quarter ended March 31, 2025, and provided business highlights. "The completion of our BLA submission for tividenofusp alfa represents a pivotal milestone—not only in our commitment to deli ...

SOUTH SAN FRANCISCO, Calif., May 06, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today reported financial results for the first quarter ended March 31, 2025, and provided business highlights. "The completion of our BLA submission for tividenofusp alfa represents a pivotal milestone—not only in our commitment to delivering a potentially transformative therapy to individuals living with Hunter syndrome, but also in Denali's evolution as a fully integrated, late-stage development and comme ...

Shares of Denali Therapeutics (DNLI) gained 11.8% on Wednesday after the company announced that it has initiated a rolling submission of a biologics license application (BLA) for accelerated approval of tividenofusp alfa for the treatment of Hunter syndrome (MPS II). The same has also been received by the Center for Drug Evaluation and Research (CDER) of the FDA.DNLI reported ongoing collaborative and productive engagement with CDER, aligning with the same on the content of the BLA data package, including t ...

Rolling submission of BLA initiated for tividenofusp alfa; preparations ongoing for potential U.S. commercial launch in late 2025 or early 2026Alignment through recent interactions with CDER on path to accelerated approval and conversion to full approval for tividenofusp alfaProductive collaboration continues under START for an accelerated development and approval path for DNL126 SOUTH SAN FRANCISCO, Calif., April 02, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ:DNLI), today announced that the ...

One stock that might be an intriguing choice for investors right now is Denali Therapeutics Inc. (DNLI) . This is because this security in the Medical - Biomedical and Genetics space is seeing solid earnings estimate revision activity, and is in great company from a Zacks Industry Rank perspective. This is important because, often times, a rising tide will lift all boats in an industry, as there can be broad trends taking place in a segment that are boosting securities across the board. This is arguably tak ...

Denali Therapeutics (DNLI) reported a fourth-quarter 2024 loss of 67 cents per share, narrower than the Zacks Consensus Estimate of a loss of 83 cents. The company reported a loss of 86 cents in the year-ago quarter.The loss per share improved year over year due to a decline in total operating expenses and an increase in the number of shares outstanding.In the absence of a marketed product, the company only recognizes revenues from ongoing collaborations. Denali did not generate collaboration revenues in th ...

Exhibit 1.2 DENALI THERAPEUTICS INC. Common Stock ($0.01 par value) Having an Aggregate Offering Price of up to $400,000,000 Equity Distribution Agreement February 27, 2025 Goldman, Sachs & Co. LLC 200 West Street New York, New York 10282 Leerink Partners LLC 1301 Avenue of the Americas, 5 Floor New York, New York 10019 th Ladies and Gentlemen: Denali Therapeutics Inc., a Delaware corporation (the "Company") confirms its agreement (this "Agreement") with Goldman, Sachs & Co. LLC ("Goldman") and Leerink Part ...