IRulya Therapeutics — Third Quarter 2026 Earnings Summary

Financial Performance:

• Cash, cash equivalents, and investments totaled $105.2 million as of September 30, 2026, compared to $17.8 million as of December 31, 2025.
• Research and development (R&D) expense for the three months ended September 30, 2026, was $5.9 million, a decrease from $8.1 million in the same period of 2025.
• General and administrative (G&A) expense for the three months ended September 30, 2026, was $9.0 million, an increase from $3.3 million in the same period of 2025.
• Net loss for the three months ended September 30, 2026, was $27.7 million, or $2.31 per basic and diluted share, compared to a net loss of $13.4 million, or $49.83 per share, in the same period of 2025.
• Net loss for the nine months ended September 30, 2026, was $67.3 million, or $10.79 per share, compared to a net loss of $44.5 million, or $184.60 per share, in the same period of 2025.
• Total assets were $106.5 million as of September 30, 2026, compared to $93.5 million as of December 31, 2025.
• Total liabilities were $28.4 million as of September 30, 2026, compared to $129.2 million as of December 31, 2025.
• Total stockholders' deficit was $(65.7) million as of September 30, 2026, compared to $(35.7) million as of December 31, 2025.
• Weighted average shares outstanding for the three months ended September 30, 2026, were 12.0 million, compared to 0.3 million in the same period of 2025.

Guidance and Future Outlook:

• The company expects its cash position to fund operations through the end of 2028, covering multiple Phase 2 clinical data readouts.
• Phase 2 data for LAM-001 in bronchiolitis obliterans syndrome (BOS) post lung transplant is anticipated in the first quarter of 2027.
• Phase 2b data for LAM-001 in pulmonary hypertension associated with interstitial lung disease (PH-ILD) is anticipated in the first quarter of 2028.
• A Phase 2 study for LAM-001 in sarcoidosis-associated pulmonary hypertension (SAPH) is planned to initiate in the fourth quarter of 2026, with data anticipated in the fourth quarter of 2028.

Business Segments and Product Lines:

• The company is focused on LAM-001, a potentially first-in-class inhaled formulation of rapamycin for serious pulmonary diseases.
• The BOS Phase 2 trial is fully enrolled.
• The PH-ILD Phase 2b trial is ongoing.
• The company plans to initiate a Phase 2 study in SAPH in the fourth quarter of 2026.
• A Phase 2a study in PH-ILD previously achieved clinically meaningful improvements across functional, hemodynamic, and biomarker measures.
• The eDSP program was wound down, resulting in a $6.9 million decrease in costs, while LAM-001 costs increased by $3.8 million due to PH-ILD Phase 2b study start-up costs.

Market and Competitive Landscape:

• PH-ILD affects an estimated ~200,000 patients in the US and Europe.
• BOS prevalence is estimated at ~30,000 patients in the US and Europe by 2032, with no approved therapy currently available.
• SAPH affects an estimated ~60,000 patients in the US and Europe, with no approved therapy currently available.
• The company hosted a virtual key opinion leader event on September 28, 2026, regarding the treatment landscape for PH-ILD and BOS.

Risks and Challenges:

• Clinical results may not be indicative of future results in larger populations.
• Potential safety and other complications related to LAM-001.
• Ability to obtain and maintain regulatory approval.
• Competition in the company's industry.
• Ability to attract or retain key management, board members, and personnel.
• Ability to fund operations and clinical development plans.
• Impacts of general macroeconomic and geopolitical conditions.

Management Commentary and Tone:

• CEO Brigette Roberts, M.D., described the quarter as transformative, citing the company relaunch and sharpened focus on LAM-001.
• Management stated that targeting the mTOR pathway directly in the lungs with LAM-001 holds promise as a disease-modifying intervention designed to minimize systemic exposure and side effects.
• Management expressed confidence that the company is in a great position to realize LAM-001's potential given the sufficient cash runway.

Other Key Points:

• The company changed its name from Quince Therapeutics, Inc. to IRulya Therapeutics Inc. effective October 9, 2026.
• Common stock began trading on the Nasdaq Capital Market under the ticker "IRLA" on October 12, 2026.
• Stockholders approved the conversion of Series C preferred stock to common stock on October 6, 2026, with the conversion occurring on October 9, 2026.
• Outstanding common stock was 10,841,470 as of November 5, 2026, following the Series C conversion.
• Shares outstanding were 1,017,063 as of September 30, 2026.
• A new leadership team was appointed: Brigette Roberts, M.D. (CEO), John Militello, CPA (CFO), and Keith Fandrick, Ph.D. (COO).
• The Board of Directors was strengthened with the addition of Catherine Bonuccelli, M.D., Leone Patterson, James Valentine, J.D., M.H.S., and Drayton Wise.
• The company recorded a gain on sale of a subsidiary of $1.7 million and a gain on Orphai Acquisition of $1.3 million for the nine months ended September 30, 2026.
• An intangible asset impairment charge of $67.8 million was recorded for the nine months ended September 30, 2026.
• The company recorded a fair value adjustment for warrants of $(14.3) million for the three months ended September 30, 2026.
• Adjusted prior period net loss per share and weighted average shares outstanding reflect a 1-for-10 reverse stock split on April 10, 2026, and a 1-for-20 reverse stock split on June 29, 2026.