PYC Therapeutics Falls More Than 10 Percent to $2.14 Ahead of Kidney Disease Data Presentation

SYDNEY — Shares of PYC Therapeutics fell more than 10 percent on Tuesday, trading at $2.14, down 25 cents, or 10.46 percent, as the Australian RNA-therapy developer continued a pullback from its September high ahead of a data presentation on its lead kidney-disease candidate.

The stock's 52-week range is about $1.05 to $2.93. It closed Monday near $2.39. The market value is roughly $2.4 billion Australian dollars on about 983.5 million shares. The shares have more than doubled over the past year even after the recent decline. No new clinical result was released on Tuesday.

On Oct. 7 the company said it would present exploratory efficacy data from single-dose Phase 1a/1b studies of PYC-003 in patients with autosomal dominant polycystic kidney disease at the American Society of Nephrology conference in Denver on Oct. 22. In seven patients with usable samples, urinary PC1 protein levels rose a geometric mean 46 percent from baseline at Day 14 (95 percent confidence interval 1.11 to 1.92; p less than 0.05). Three patients received 1.2 milligrams per kilogram and four received 2.4. The company pooled the cohorts because the groups were too small to assess dose dependence. It measured total kidney volume in 18 patients three months after a single dose and compared the change with a historical benchmark of 6.2 percent annual growth drawn from untreated patients in the TEMPO 3:4, CRISP and HALT PKD A trials.

The company's own announcement stated the limitation directly: "This encouraging exploratory efficacy data has been generated in a small number of patients over a short period of time and on endpoints that are variable by nature – it needs to be reproduced in repeat dose studies of PYC-003 in a larger number of PKD patients treated over a longer period of time before any conclusions regarding the likely impact of the drug candidate on the disease process can be drawn." Repeat-dose data from the ongoing Phase 1b multiple-ascending-dose study and its open-label extension are expected in calendar 2027. Total kidney volume is an endpoint the U.S. Food and Drug Administration lists as capable of supporting accelerated approval.

PYC is a clinical-stage company developing RNA therapies for genetic diseases. Besides PYC-003 it has candidates for Phelan-McDermid syndrome, autosomal dominant optic atrophy and retinitis pigmentosa type 11. Data on the RP11 candidate VP-001 were presented at the Euretina Congress in Vienna in early October. The company said no treatment-related serious adverse events had been observed in subjects dosed with VP-001 to date.

A double-digit decline on no new number is a valuation reset ahead of a conference presentation the company has already described as preliminary. The 46 percent PC1 increase is the figure in the Oct. 7 filing. The sample size is seven. The next data set the company has scheduled is in 2027.