Unicycive reports Q3 net loss of $4.4M; FDA alignment on OLC NDA path

Unicycive Therapeutics, Inc.

2023-Q3 EPS reported -$1.12 revenue$675,000

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.

item 2.02 item 9.01

Key facts

Extracted from this filing and checked against the source text.

Earnings Releases SEC 8-K Item 2.02 confidence 0.9

Unicycive Therapeutics, Inc. reported third quarter ended September 30, 2023 results: revenue $0, EPS $0.13 per share of common stock.

Period: third quarter ended September 30, 2023
Revenue: $0
EPS: $0.13 per share of common stock
Result: reported results

Exact text from the filing

compared to five other commercially available phosphate binders. Financial Results for the Third Quarter Ended September 30, 2023 Licensing Revenues: Licensing revenues were $0 compared to $1.0 million for the same period in 2022, due to an upfront payment for a licensing agreement entered into with Lee’s Pharmaceutical (HK) Limited in July 2022.

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Source: SEC EDGAR

accession 0001213900-23-087029

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