secwatch.observer — SEC 8-K summary
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Issuer:     Coya Therapeutics, Inc. (COYA)
CIK:        0001835022
Form:       8-K
Filed at:   2023-06-12T23:59:59+00:00
Accession:  0001193125-23-165406
Event type: other_material
Sentiment:  positive
Materiality: 0.65
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Coya CEO update: ALS POC shows disease halted 24wks; AD Phase2 data due Q2 2024
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- COYA 302 in ALS: disease progression halted to week 24 with minimal decline to week 48 on ALSFRS scale in open-label study.
- COYA 301 in AD: cognitive function improved or stabilized; Treg function enhanced, cytokines reduced, neuroinflammation decreased.
- Pre-IND meeting with FDA for COYA 302 planned fall 2023; IND submission early 2024 with Phase 2 trial to follow.
- Academic double-blind Phase 2 trial of low-dose IL-2 in AD (funded by Gates Foundation) top-line data expected Q2 2024.
- Appointed immunologist Dr. Guillaume Dorothee to SAB; hired Arun Swaminathan as business development executive.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1835022/000119312523165406/0001193125-23-165406-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1835022/000119312523165406/d514893d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-23-165406

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