(RTTNews) - Avalyn Pharma Inc. (AVLN), a clinical-stage biopharmaceutical company, announced the appointment of Robert (Bob) J. Meyer, a pulmonary physician and former senior U.S. Food and Drug Administration (FDA) executive, to its Board of Directors.
Robert Meyer brings more than 25 years of leadership experience spanning regulatory, academic, and industry roles. Robert Meyer most recently served as Principal of Drug and Biologics Products at Greenleaf Health, now Eliquent Life Sciences.
Greenleaf Health is an FDA regulatory consulting firm, advising biopharmaceutical companies on regulatory strategy, clinical development and product approvals.
Avalyn focuses on treating pulmonary fibrosis and other serious, rare respiratory diseases.
Avalyn's AP01 program is an optimised inhaled formulation of pirfenidone currently being evaluated in MIST, a Phase 2b clinical trial in patients with progressive pulmonary fibrosis (PPF). Top-line data are anticipated in the second half of 2027.
Avalyn's AP02 program is an optimised inhaled formulation of nintedanib currently being evaluated in AURA, a Phase 2 clinical trial in patients with idiopathic pulmonary fibrosis (IPF). Top-line data are anticipated in late 2027.
Avalyn is also advancing AP03, an inhaled fixed-dose combination of pirfenidone and nintedanib, designed to deliver multiple antifibrotic mechanisms through a single lung-targeted platform. The company recently said it is on track to initiate a Phase 1 study of AP03 by the end of 2026.
"His guidance will be invaluable as we advance AP01, AP02, and our emerging combination therapy candidate AP03 through their next stages of clinical development and execution," said Lyn Baranowski, Chief Executive Officer of Avalyn.
For the second quarter that ended on June 30, 2026, net loss was $28.9 million, compared with $20.2 million in the prior year.
Cash, cash equivalents, and marketable securities were $413.5 million as of June 30, 2026 and are projected to be sufficient to fund operations into 2029.
AVLN has traded between $24.15 and $40.17 over the last year. The stock closed Wednesday's trading session at $34.71, up 1.25%.
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