Tricida, Inc. is reducing its headcount by around 57% to improve its financial standing after its lead candidate failed in a Phase III trial, the company revealed in its third-quarter financial results.
Tricida, Inc. is reducing its headcount by around 57% to improve its financial standing after its lead candidate failed in a Phase III trial, the company revealed in its third-quarter financial results Monday.
Results from the VALOR-CKD study showed veverimer could not statistically distinguish itself from placebo in terms of disease progression in patients with metabolic acidosis and chronic kidney disease (CKD).
The San Francisco-based company expects the lay-offs to cost around $2 million in severance payments, to be completed by early next year.
The trial results were posted in late October, and Tricida’s stocks cratered around 94% in reaction to the news. The company was trading at $0.26 premarket Wednesday.
Earlier this month, the company’s board of directors gave Tricida leadership the go-ahead to review its business strategy and explore potential alternatives to maximize value for its stakeholders. Aside from initiatives to reduce operating expenses, the review was open to the “consideration of the sale of the company and/or its assets.”
Veverimer’s difficulties in VALOR-CKD were reflected in Tricida’s Q3 financial report. The company spent $19.9 million on R&D in the closed quarter, down from $26.6 million during the same period the year prior. Tricida attributed this drop primarily to the “decrease in clinical development costs related to the VALOR-CKD trial following the administrative stop.”
In May, the company decided to stop VALOR-CKD early for what it called “administrative reasons” - insufficient resources and the need to extend its cash runway for six more months after the top-line readout. The trial continued to accrue primary endpoint evidence.
Tricida reported a net loss of $25.8 million in the third quarter of 2022. As of Sept. 30, the company had cash, cash equivalents and investments amounting to $80.2 million.
Details of the Study
VALOR-CKD was a randomized and double-blinded trial comparing veverimer against placebo in nearly 2,200 patients with metabolic acidosis and CKD.
The study included two sequential phases: a single-blinded active-treatment period lasting for four to eight weeks followed by a randomized phase, where patients were assigned to continue veverimer or switch to placebo. To be eligible for randomization, patients must have demonstrated a 4-mEq/L increase in serum bicarbonate levels or show normalization of serum bicarbonate.
Tricida expected a stronger active treatment effect in the first VALOR-CKD phase, but fewer participants met the bicarbonate requirement, showing a lower-than-anticipated increase in serum concentrations.
