---
schema_version: "secwatch.filing_event.v1"
accession: "0001437749-23-013408"
form_type: "8-K"
ticker: "PVLA"
cik: "0001583648"
company_name: "PALVELLA THERAPEUTICS, INC."
filed_at: "2023-05-10T23:59:59+00:00"
generated_at: "2026-06-15T06:22:49.393427+00:00"
event_type: "earnings"
sentiment: "neutral"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Pieris Q1 net loss widens to $13.2M; elarekibep Phase 2a data expected mid-2024

## Summary
- 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.

## SEC filing metadata
- accession: 0001437749-23-013408
- form_type: 8-K
- ticker: PVLA
- cik: 0001583648
- company_name: PALVELLA THERAPEUTICS, INC.
- filed_at: 2023-05-10T23:59:59+00:00
- event_type: earnings
- sentiment: neutral
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 2.02, 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1583648/000143774923013408/0001437749-23-013408-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1583648/000143774923013408/pirs20230126b_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001437749-23-013408
- JSON: https://secwatch.observer/filing/0001437749-23-013408.json
- Plain text: https://secwatch.observer/filing/0001437749-23-013408.txt

## Key facts
- Earnings Releases
  PALVELLA THERAPEUTICS, INC. reported financial results for the quarter ended March 31, 2023.
  - Period: the quarter ended March 31, 2023
  - Result: reported results
  source text: Pieris Pharmaceuticals, Inc. (Nasdaq: PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin® technology platform for respiratory diseases, cancer, and other indications, reported financial results for the quarter ended March 31, 2023, and provided a business update.
  evidence_url: https://www.sec.gov/Archives/edgar/data/1583648/000143774923013408/0001437749-23-013408-index.htm

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.