Avalyn Pharma Inc. SEC Filings

Avalyn Pharma Inc., a clinical-stage biopharmaceutical company focused on inhaled therapies for rare respiratory diseases, reported higher operating losses as it advanced multiple clinical programs and strengthened its balance sheet. For the six months ended June 30, 2026, net loss was $55.8 million compared with $37.7 million a year earlier, driven mainly by increased research and development spending on lead candidates AP01 and AP02 and pipeline asset AP03, as well as higher public-company general and administrative costs.

Total operating expenses rose to $59.2 million, including $47.6 million of research and development and $11.6 million of general and administrative expenses. On May 1, 2026, Avalyn completed an IPO, issuing 19,166,667 shares at $18.00 per share for net proceeds of $316.6 million, and simultaneously converted all series of redeemable convertible preferred stock into 23,918,194 common shares. The company also drew $15.0 million under a Term Loan facility. As of June 30, 2026, Avalyn held cash, cash equivalents and marketable securities totaling $413.5 million, total assets of $425.4 million, and 44,333,095 shares of common stock outstanding, and stated that this liquidity is expected to fund operations into 2029.

Avalyn Pharma Inc. reported second quarter 2026 results and pipeline progress. The company completed global enrollment of the MIST Phase 2b trial of AP01 in progressive pulmonary fibrosis, over-enrolling to 398 patients versus a 375 target, with topline data expected in the second half of 2027. Enrollment in the AURA Phase 2 trial of AP02 in idiopathic pulmonary fibrosis is ongoing, and a Phase 1 study of combination candidate AP03 remains planned to start by the end of 2026.

Cash, cash equivalents and marketable securities totaled $413.5 million as of June 30, 2026, including approximately $316.6 million of IPO proceeds, supporting a projected cash runway into 2029. Second quarter 2026 research and development expenses were $24.7 million and general and administrative expenses were $6.6 million, leading to a net loss of $28.9 million for the quarter.

Avalyn Pharma Inc. received a Schedule 13G reporting that Norwest Venture Partners XV, LP and related entities and individuals collectively report beneficial ownership of 2,268,404 shares of Avalyn voting common stock. This represents 5.1% of the class, based on 44,333,095 shares outstanding as of June 2, 2026. The shares are directly held by Norwest Venture Partners XV, LP, with Genesis VC Partners XV, LLC, NVP Associates, LLC, Jeffrey Crowe, and Jon E. Kossow each potentially sharing voting and investment authority. All reporting persons indicate no sole voting or dispositive power and shared power over 2,268,404 shares as of June 30, 2026.

FMR LLC filed an amended Schedule 13G reporting beneficial ownership of 5,835,259 Common Shares of Avalyn Pharma Inc., representing 13.2% of the class as of June 30, 2026. FMR reports sole dispositive power over all 5,835,259 shares and no shared voting or dispositive power.

Abigail P. Johnson is also reported as a beneficial owner with sole dispositive power over the same 5,835,259 shares, representing 13.2% of the outstanding common stock. Within this holding, F-Prime Capital Partners Healthcare Fund V LP holds 2,284,535 shares, or 5.2% of Avalyn Pharma’s outstanding common stock.

Avalyn Pharma Inc. entered into a First Amendment to its sublease with CRISPR Therapeutics, expanding its Boston headquarters space at 105 West First Street.

The leased premises increase from approximately 8,774 to 13,708 rentable square feet as of June 29, 2026. Future minimum lease payments will rise by about $924,000 over the remaining lease term, while all other sublease terms remain in effect.

Avalyn Pharma filed an 8-K to share that it has completed target enrollment of 375 patients in its global Phase 2b MIST trial of AP01, an inhaled pirfenidone therapy for progressive pulmonary fibrosis. The randomized, double-blind, placebo-controlled study compares two AP01 doses against placebo over 52 weeks.

The primary goal is to assess change in lung function, measured by forced vital capacity, after one year of treatment. Avalyn expects to report topline 12‑month clinical results in the second half of 2027, which will help clarify AP01’s potential to preserve lung function and improve quality of life in this serious respiratory disease.

Avalyn Pharma Inc. reported a larger net loss for the quarter ended March 31, 2026 as it increased investment in its pulmonary fibrosis pipeline. Net loss was $26.9 million compared with $17.5 million a year earlier, driven mainly by higher research and development spending on AP01 and AP02 and growing corporate costs.

Research and development expenses rose to $22.9 million and general and administrative expenses to $5.0 million, reflecting expanded clinical activity and headcount. Avalyn ended the quarter with $123.1 million in cash, cash equivalents and marketable securities and added a $15.0 million term loan facility draw. After the quarter, it completed an IPO raising about $316.1 million in net proceeds, and now expects its cash resources to fund operations into 2029.

Avalyn Pharma reported first-quarter 2026 results and highlighted recent progress across its inhaled pulmonary fibrosis pipeline. The company recorded a net loss of $26.9 million for the quarter, compared with $17.5 million a year earlier, driven mainly by higher research and development spending.

R&D expenses rose as Avalyn advanced its AP01 Phase 2b MIST trial in progressive pulmonary fibrosis and continued enrollment in the AP02 Phase 2 AURA trial in idiopathic pulmonary fibrosis. A Phase 1 trial of its AP03 combination therapy is planned to start by the end of 2026.

The company completed an upsized initial public offering in May, raising gross proceeds of $345.0 million at $18.00 per share. Together with $123.1 million in cash, cash equivalents, and marketable securities as of March 31, 2026, Avalyn projects it has sufficient capital to fund current operating plans into 2029.

Avalyn Pharma Inc. received a Schedule 13D from Suvretta Capital–affiliated funds and Aaron Cowen reporting a combined beneficial ownership of 2,503,109 shares of voting common stock, or 5.6% of the company, based on 44,312,047 shares outstanding as of April 30, 2026.

The position stems from Series D preferred stock purchases in April 2025 (later converted after a 1-for-19.2417 reverse stock split), substantial share purchases in Avalyn’s May 1, 2026 initial public offering at $18.00 per share, and additional open-market buying around the offering. The funds state they hold the shares for investment and may increase or decrease the position over time.

The filing also describes an Amended and Restated Investors' Rights Agreement granting registration rights once certain ownership and $5 million offering-size thresholds are met, and a lock-up agreement restricting transfers of the funds’ common stock for 180 days after April 29, 2026, subject to customary exceptions.