IRulya Therapeutics Inc. disclosed a corporate presentation outlining its development plans for LAM-001, a once-daily inhaled rapamycin formulation. The company, formerly known as Quince Therapeutics, Inc., identified LAM-001 as its lead product candidate across multiple Phase 2 clinical programs. The disclosure was filed as an exhibit to a Regulation FD report.
The presentation details three primary indications for LAM-001. The first is pulmonary hypertension associated with interstitial lung disease, or PH-ILD. IRulya estimates the US and EU patient population for this condition at approximately 200,000. The company stated that current therapies for PH-ILD are limited to vasodilation and are not disease modifying. Promising Phase 2a data on top of standard of care was presented at the American Thoracic Society conference in 2026. A Phase 2b trial is expected to initiate in mid-2026.
The second indication is bronchiolitis obliterans syndrome, or BOS. This condition is described as a severe complication and leading cause of death following lung transplantation. IRulya estimates the US and EU patient population for BOS at approximately 30,000. Positive retrospective data from the clinical use of oral rapamycin supports an ongoing Phase 2 trial for this indication. Data from this trial is expected in the first quarter of 2027.
The third indication is sarcoidosis associated pulmonary hypertension, or SAPH. This is a severe complication of sarcoidosis that currently has no approved therapy. IRulya estimates the US and EU patient population for SAPH at approximately 60,000. A Phase 2 trial for SAPH is expected to initiate in the fourth quarter of 2026. This plan is supported by proof-of-concept clinical efficacy data from a completed pulmonary hypertension study.
IRulya described its development pathway for LAM-001 as an efficient 505(b)2 approach. The company expects strong intellectual property coverage through the mid-2040s in the US and EU. US and EU Orphan Disease Status has been granted for multiple indications. The presentation also noted supportive feedback from the US Food and Drug Administration during end of Phase 2 and pre-IND meetings.
The document includes standard disclaimers stating that the information is for informational purposes only and does not constitute an offer to buy or sell securities. It warns that forward-looking statements, including those regarding product candidates, clinical trial timing, and regulatory approvals, are subject to risks and uncertainties. These risks include the ability to demonstrate safety and efficacy, the progress of clinical trials, and the company's ability to obtain additional capital.
The presentation also references the acquisition of Orphai Therapeutics and concurrent private transactions. It notes that investors in the private placement or former Orphai warrant holders may not exercise their warrants, which could impact additional proceeds. The company assumes no obligation to update the forward-looking information contained in the presentation.