secwatch.observer — SEC 8-K summary
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Issuer:     PALVELLA THERAPEUTICS, INC. (PVLA)
CIK:        0001583648
Form:       8-K
Filed at:   2023-05-10T23:59:59+00:00
Accession:  0001437749-23-013408
Event type: earnings
Sentiment:  neutral
Materiality: 0.65
Item codes: 2.02, 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Pieris Q1 net loss widens to $13.2M; elarekibep Phase 2a data expected mid-2024
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- Q1 2023 net loss of $13.2M ($0.45/share) vs. $5.1M ($0.07) in Q1 2022; cash $48.4M.
- Elarekibep Phase 2a enrollment ongoing; topline data by mid-2024; AstraZeneca adding sites and geographies.
- PRS-220 Phase 1 results expected H2 2023; PRS-400 toward candidate nomination H2 2023.
- Cinrebafusp alfa in 2L+ HER2+ gastric cancer: 100% ORR in 5 patients; enrollment stopped for strategic reasons.
- Seagen initiated Phase 1 for SGN-BB228 (CD228/4-1BB); $5M milestone paid.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1583648/000143774923013408/0001437749-23-013408-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1583648/000143774923013408/pirs20230126b_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-23-013408

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