secwatch.observer — SEC 8-K summary
======================================

Issuer:     SOLENO THERAPEUTICS INC (SLNO)
CIK:        0001484565
Form:       8-K
Filed at:   2024-11-06T23:59:59+00:00
Accession:  0001193125-24-252054
Event type: earnings
Sentiment:  neutral
Materiality: 0.85
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Soleno Therapeutics Q3 net loss $76.6M; NDA for DCCR in PWS accepted with Priority Review, PDUFA Dec 27, 2024
--------------------------------------------------------------------------------

- NDA for DCCR (diazoxide choline) for Prader-Willi syndrome accepted by FDA with Priority Review; PDUFA target action date December 27, 2024.
- Net loss $76.6M ($1.83/sh) vs $10.9M ($0.95/sh) in Q3 2023; increase driven by non-cash stock-based compensation tied to NDA milestones.
- R&D expense $30.1M (includes $18.5M stock comp); G&A expense $49.2M (includes $38.1M stock comp), both up significantly from prior year.
- Cash, cash equivalents and marketable securities $284.7M as of Sept 30, 2024; cash used in operations $14.9M in Q3.
- Board appointed Dawn Carter Bir and Matthew Pauls assumed Lead Independent Director role.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1484565/000119312524252054/0001193125-24-252054-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1484565/000119312524252054/d889134d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-24-252054

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer