Denali Therapeutics

Refresh delta (since 2026-06-20)

1. First commercial quarter of AVLAYAH. Net product revenue was $3.6M in the first full quarter of commercial availability; cost of goods sold was $0.1M, low because manufacturing costs incurred before approval were expensed to research and development. Projected third-quarter 2026 net product revenue is $10.0M to $12.0M. [sec.gov: 8-KForm 8-KA filing for something that happened between reports and matters enough to tell shareholders now. filed 2026-08-06, exhibit 99.1, https://www.sec.gov/Archives/edgar/data/1714899/000171489926000096/ex991pressreleaseq22026.htm; quarter ended 2026-06-30]
2. Launch indicators. Interest in starting treatment has tracked ahead of internal expectations; about 80% of the healthcare organisations treating eligible MPS II patients have been reached; published commercial policies cover more than 50% of covered lives; 14 state Medicaid programmes have published coverage. The release gives no patient count. [sec.gov: 8-K filed 2026-08-06, exhibit 99.1, same URL]
3. Results. Research and development expenses $97.0M (Q2 2025: $102.7M). Net loss $127.6M, or $0.68 per share (Q2 2025: $124.1M, $0.72); six-month net loss $256.0M, or $1.37 per share (2025: $257.1M, $1.50). [sec.gov: 8-K filed 2026-08-06, exhibit 99.1, same URL]
4. Cash and the voucher sale. Cash, cash equivalents and marketable securities about $940.0M at 2026-06-30. On 2026-07-27 the company completed the sale of its rare pediatric disease priority review voucher to a large pharmaceutical company under an asset purchase agreement dated 2026-06-12, for gross proceeds of $195.0M, taking pro forma cash above $1.1B. [sec.gov: 8-K filed 2026-08-06, exhibit 99.1, same URL; 8-K filed 2026-07-28, https://www.sec.gov/Archives/edgar/data/1714899/000171489926000086/dnli-20260727.htm]
5. Shares. 159,847,403 common shares outstanding at 2026-07-31, excluding 28,331,779 shares issuable on exercise of pre-funded warrantsPre-funded warrantA right to buy shares that has already been paid for, bar a token penny. It behaves like a share the investor already owns, so leaving it out of a share count understates the company’s real size.. [sec.gov: 10-QForm 10-QThe quarterly version of the annual report. Lighter, and not audited. filed 2026-08-06, https://www.sec.gov/Archives/edgar/data/1714899/000171489926000097/dnli-20260630.htm]
6. Pipeline timing. Zafinofusp alfa (DNL126, Sanfilippo A): Phase 3 confirmatory study start-up under way, and a BLA submission and potential accelerated approval expected in 2027. DNL593 (FTD-GRN): enrolment complete at 40 participants, results now expected in 2027 (previously by end 2026), and FDA orphan drug designation granted in August 2026. DNL952 (Pompe): Phase 1 dosing began in Q2 2026, initial data expected in 2027. DNL628 (tau): Phase 1b biomarker data expected in the first half of 2027. DNL921 (amyloid): proof-of-concept data expected in 2027. [sec.gov: 8-K filed 2026-08-06, exhibit 99.1, same URL]
7. Discontinued and terminated programmes. In May 2026 Denali and Biogen announced the Phase 2b LUMA study of DNL151 (LRRK2) missed its primary and secondary endpoints and discontinued further development in idiopathic Parkinson's disease. In April 2026 Takeda terminated the collaboration to co-develop and co-commercialise DNL593, for strategic reasons not related to efficacy or safety data. [sec.gov: 8-K filed 2026-08-06, exhibit 99.1, same URL]
8. Where the new filings meet the carried view (stated as fact, no line changed). The carried dossier's open item on AVLAYAH's first commercial print is answered by item 1. The carried open item on the "DNL593 FTD-GRN and DNL126 MPS IIIA precise readout dates" meets item 6: DNL593 results move into 2027 and the DNL126 BLA is expected in 2027. The carried seed's price figures rest on market data this delta does not refresh.

What held

• AVLAYAH remains described as the first FDA-approved transferrin-receptor blood-brain-barrier medicine, approved under accelerated approval in March 2026. [sec.gov: 8-K filed 2026-08-06, exhibit 99.1]
• The company remains well funded: about $940.0M at quarter end before the $195.0M voucher sale. [sec.gov: 8-K filed 2026-08-06, exhibit 99.1]
• The confirmatory Phase 2/3 COMPASS study continues to support label expansion and global submissions. [sec.gov: 8-K filed 2026-08-06, exhibit 99.1]