Avalyn Pharma Inc. (Nasdaq: AVLN) announced its financial results for the third quarter ended September 30, 2026, alongside updates on its clinical pipeline. The company reported a net loss of $29.7 million for the quarter, compared to a net loss of $23.6 million in the same period the previous year. Research and development expenses increased to $25.5 million from $22.1 million, driven by ongoing clinical trials for its AP01 and AP02 programs, as well as an open-label extension study.
As of September 30, 2026, Avalyn held $386.6 million in cash, cash equivalents, and marketable securities. The company stated that its current cash balance is projected to be sufficient to fund operations into 2029.
In terms of pipeline progress, Avalyn initiated a Phase 1 study of AP03, a fixed-dose combination of nebulized pirfenidone and nintedanib, in healthy volunteers. The randomized, double-blinded, placebo-controlled study is expected to enroll at least 32 participants and will evaluate single and multiple ascending doses. The study is cleared to proceed in Australia following approval from the Human Research Ethics Committee and notification to the Therapeutic Goods Administration.
Separately, the company presented data at the European Respiratory Society (ERS) International Congress in September, highlighting distribution modeling for AP01 and patient perspectives on clinical trial design. Results from the MIST study of AP01, a global Phase 2b trial in patients with progressive pulmonary fibrosis, are anticipated in the second half of 2027. Additionally, Phase 1 data for AP02, an inhaled formulation of nintedanib, were published in September, demonstrating favorable safety and lung lining fluid exposures.
