After a year of rocky financials and trial readouts, Quince Therapeutics is charting a new path forward and relaunching with a fresh name and strengthened balance sheet, as well as a C-suite update.
The San Francisco biotech will now operate under the name IRulya Therapeutics and trade under the ticker “IRLA”. Advancing the company’s investigational inhaled formulation of rapamycin, LAM-001, which is now being tested in multiple pulmonary diseases, is priority one for the new brand.
Rapamycin itself is not a new drug, securing an initial FDA approval in 1999 to help prevent organ transplant rejection in kidney transplant patients before branching out into new indications in the ensuing years. IRulya is hoping that the once-a-day inhaled formulation it's advancing could both improve delivery of rapamycin to the lungs and curb systemic exposure relative to existing oral or systemic treatment pathways.
The name change follows Quince’s May merger with pulmonary biotech and LAM-001 developer Orphai Therapeutics. The all-stock transaction was a financial salvation for Quince after the company’s lead candidate for ataxia-telangiectasia (A-T), a rare pediatric neurodegenerative disorder, failed to meet phase 3 primary and secondary endpoints in January.
After the January flop, Quince was set to run out of cash after the second quarter of the year. The Orphai merger was announced in May, alongside a $115 million upfront private securities sale to replenish the company’s coffers.
To complement its new moniker, IRulya has overhauled the leadership for its next chapter, too. Quince chief of corporate affairs and former Orphai CEO Brigette Roberts, M.D., has ascended to become IRulya’s first CEO. She is joined by new CFO John Militello, Quince’s former head of finance, as well as new chief operating officer Keith Fandrick, Ph.D., formerly COO at Orphai.
The company also rebooted its board with a string of new biopharmaceutical, regulatory, pulmonology and commercialization experts.
Quince CEO and medical chief Dirk Thye, M.D., has resigned as previously announced, as has COO, business chief and chief compliance officer Brendan Hannah, the company said in a securities filing.
“Today marks an important milestone as we introduce our newly transformed company as IRulya Therapeutics,” said new CEO Roberts in a statement. “With a focus on the clinical development of LAM-001, a potentially first in class, one puff once daily dry powder inhaled (DPI) formulation of rapamycin, we believe we have an opportunity to change the current treatment paradigm for serious pulmonary diseases.”
The LAM-001 pipeline currently includes two active phase 2 studies with a third prepping to launch. A phase 2b in patients with pulmonary hypertension associated with interstitial lung disease started recently after positive outcomes in the phase 2a trial. The condition affects 200,000 patients across the U.S. and Europe, the company estimates.
LAM-001 is also being tested in an ongoing phase 2 in bronchiolitis obliterans syndrome, the most common form of chronic transplant rejection in lung transplant patients. The condition, which affects an estimated 30,000 in the U.S. and Europe, currently has no approved therapy and a median survival of 2.5 years after diagnosis.
IRulya also has plans to launch a phase 2 in sarcoidosis-associated pulmonary hypertension by the end of the year, the company said in a statement.
Roberts said the IRulya’s strengthened balance sheet—which stood at $116 million as of June 30—will be enough to see LAM-001 through data readouts for all three trials. The three phase 2s are set to read out in the first quarter of 2028, the first quarter of 2027 and the fourth quarter of 2028, respectively.