secwatch.observer — SEC 8-K summary
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Issuer:     Unicycive Therapeutics, Inc. (UNCY)
CIK:        0001766140
Form:       8-K
Filed at:   2023-11-14T23:59:59+00:00
Accession:  0001213900-23-087029
Event type: earnings
Sentiment:  neutral
Materiality: 0.70
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Unicycive reports Q3 net loss of $4.4M; FDA alignment on OLC NDA path
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- Net loss $4.4M ($0.13/share) vs $5.6M ($0.37/share) in Q3 2022; R&D expenses $3.4M, down from $4.8M.
- Reached agreement with FDA on data package for OLC NDA; pivotal trial of 60 patients expected by year-end, topline data mid-2024.
- Cash $14.3M expected to fund into H2 2024 including pivotal trial and topline data.
- Appointed Dr. Sara Kenkare-Mitra to Board of Directors; she has experience with 100+ IND filings and 11 drug approvals.
- No licensing revenue in Q3 vs $1.0M in prior period due to 2022 upfront payment.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1766140/000121390023087029/0001213900-23-087029-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1766140/000121390023087029/ea188373-8k_unicycive.htm
  HTML page:      https://secwatch.observer/filing/0001213900-23-087029

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