Unicycive Therapeutics, Inc. (NASDAQ:UNCY) shares gained 2.00% in premarket trading on Wednesday after the clinical-stage biotechnology company reported a second-quarter loss that was considerably narrower than Wall Street expected.
The company posted a loss of $0.06 per share for the quarter, compared with the analyst consensus forecast for a loss of $0.48 per share.
Unicycive, which is developing treatments for patients with kidney diseases, remains a clinical-stage company and does not currently generate revenue.
Quarterly net loss narrows significantly
For the quarter ended June 30, 2026, Unicycive recorded a net loss of $1.7 million, a substantial improvement from the $6.5 million loss reported in the corresponding period last year.
The reduction was primarily linked to a change in the fair value of the company’s warrant liability, which generated $8.0 million of other income during the quarter.
Operating expenses increased, however, as Unicycive continued investing in its clinical and commercial development activities.
Unicycive works towards OLC regulatory approval
In June, Unicycive received a Complete Response Letter from the U.S. Food and Drug Administration regarding its resubmitted New Drug Application for oxylanthanum carbonate, or OLC.
The treatment is being developed for hyperphosphatemia in patients with chronic kidney disease who are receiving dialysis.
The FDA’s letter identified deficiencies involving a third-party manufacturing facility but did not raise concerns about the clinical efficacy or safety data supporting OLC.
A facility inspection has now been assigned by the FDA to the third-party manufacturing vendor. Unicycive expects to resubmit its NDA once the inspection has been completed successfully.
“We are focused on securing approval of oxylanthanum carbonate and remain confident in the efficacy and safety of OLC and in its potential to improve care for patients with hyperphosphatemia on dialysis,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive.
Research and commercial preparation costs increase
Research and development expenses rose to $2.8 million during the second quarter from $1.8 million in the same period last year.
The increase was primarily attributed to higher stock-based compensation expenses.
General and administrative costs climbed to $7.4 million from $5.2 million year on year, reflecting both increased stock-based compensation and spending associated with preparations for a potential commercial launch.
Cash runway expected to extend into 2027
Unicycive reported $61.4 million in cash, cash equivalents and marketable securities as of June 30, 2026.
The company expects its existing financial resources to provide a cash runway into 2027 as it works to resolve the manufacturing issues identified by the FDA and advance OLC towards potential regulatory approval.
The positive premarket reaction followed the narrower-than-expected quarterly loss, while investors continue to focus on the timing of the manufacturing inspection and a subsequent OLC regulatory resubmission.
Unicycive Therapeutics stock price
