Highlights

  • Net loss for the quarter ended June 30, 2026 was $28.9 million, compared with $20.2 million in the prior-year quarter.
  • Avalyn completed its IPO on May 1, 2026, selling 19,166,667 shares and receiving approximately $316.6 million in net proceeds.
  • Cash, cash equivalents and marketable securities were $413.5 million at June 30, 2026, which management believes funds operations into 2029.
  • Topline data from the AP01 Phase 2b MIST trial are anticipated in the second half of 2027.

Avalyn Pharma Inc. (NASDAQ:AVLN) shares were trading at USD 24.83 on October 28, 2026, down 3.87%, with a relative volume at time of 3.70. The clinical-stage company completed its initial public offering on May 1, 2026 and filed its quarterly report for the period ended June 30, 2026 on August 12, 2026.

Avalyn Pharma was incorporated in Delaware on May 27, 2011 and has its headquarters in Boston, Massachusetts. It is a clinical-stage biopharmaceutical company developing inhaled medicines for rare respiratory diseases, including progressive pulmonary fibrosis, idiopathic pulmonary fibrosis and other interstitial lung diseases. Its pipeline includes AP01, inhaled pirfenidone, AP02, inhaled nintedanib, and AP03, an inhaled fixed-dose combination of the two. The company has not generated any revenue. Its fiscal year ends December 31. As of June 30, 2026, it had 55 full-time employees, including 36 engaged in research and development.

Second Quarter 2026 Results

The Form 10-Q filed on August 12, 2026 covers the three and six months ended June 30, 2026.

Net loss was $28.9 million for the three months ended June 30, 2026, compared with $20.2 million for the same period of 2025. Net loss per share, basic and diluted, was $0.98, compared with $17.63. Total operating expenses were $31,290 thousand, compared with $21,777 thousand. Research and development expenses increased by $6.8 million to $24.7 million, and general and administrative expenses increased by $2.7 million to $6.6 million.

For the six months ended June 30, 2026, net loss was $55.8 million, compared with $37.7 million, and net loss per share was $3.60. Net cash used in operating activities was $56.0 million. The accumulated deficit was $321.2 million at June 30, 2026.

Financing, Liquidity and Going Concern Assessment

On May 1, 2026, Avalyn completed its IPO, selling 19,166,667 shares of common stock at $18.00 per share, including 2,500,000 shares sold to the underwriters through the full exercise of their option. Aggregate net proceeds were approximately $316.6 million. As of August 10, 2026, the company had 44,333,095 shares of voting common stock outstanding.

Net cash provided by financing activities was $331.5 million for the six months. In February 2026, Avalyn entered into a loan and security agreement with Banc of California for a term loan facility of up to $30.0 million, and $15.0 million has been borrowed. The loan matures on June 30, 2030.

At June 30, 2026, the company had $413.5 million in cash, cash equivalents and marketable securities. Management evaluated going concern conditions and determined that these resources will be sufficient to fund operating expenses and capital requirements for at least 12 months from the issuance date of the financial statements. The company states it has incurred net losses since inception and expects further losses.

Pipeline and Expected Milestones

AP01 is being evaluated in MIST, a global Phase 2b trial in progressive pulmonary fibrosis. The 52-week randomized, double-blind, placebo-controlled trial randomized 398 patients 2:1:2 into three cohorts, and its primary endpoint is change in forced vital capacity. Topline clinical data are anticipated in the second half of 2027.

AP02 is being evaluated in AURA, a global Phase 2 trial in idiopathic pulmonary fibrosis. The 12-week study is designed to enroll 160 patients, with topline data anticipated in late 2027. A Phase 1 study of AP03 remains on track to initiate by the end of 2026.

The company expects its expenses to increase with its ongoing activities. It does not provide numerical financial guidance.