secwatch.observer — SEC 8-K summary
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Issuer:     Unicycive Therapeutics, Inc. (UNCY)
CIK:        0001766140
Form:       8-K
Filed at:   2023-08-15T23:59:59+00:00
Accession:  0001213900-23-067398
Event type: earnings
Sentiment:  neutral
Materiality: 0.65
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Unicycive Q2 net loss $4.4M; OLC FDA feedback expected Fall 2023; UNI-494 Phase 1 ongoing
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- Net loss of $4.4M ($0.29/share) in Q2 2023, up from $3.6M ($0.24) in Q2 2022 due to higher R&D and G&A costs.
- Cash and equivalents totaled $18.8M as of June 30, 2023.
- Positive OLC data published in Am J Nephrol: lowest daily dose volume vs five commercial phosphate binders.
- Expects FDA alignment feedback in Fall 2023 for OLC program; NDA submission after that.
- UNI-494 Phase 1 trial ongoing in UK; pre-IND meeting with FDA planned by year-end; IND expected in 2024.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1766140/000121390023067398/0001213900-23-067398-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1766140/000121390023067398/ea183515-8k_unicycive.htm
  HTML page:      https://secwatch.observer/filing/0001213900-23-067398

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