Avalyn Pharma Inc. (AVLN) reported that director Robert J. Meyer received a stock option award on September 15, 2026. The option covers 31,182 shares of common stock at an exercise price of $34.28 per share, expiring on September 14, 2036. The option vests in three equal annual installments after the grant date, conditioned on his continued service.
Avalyn Pharma Inc. (AVLN) filed an initial statement of beneficial ownership for Robert J. Meyer, who is identified as a director of the company. The filing reports no securities transactions and no reportable holdings or derivative positions at the time of this Form 3.
Avalyn Pharma Inc. (AVLN) disclosed that on September 15, 2026, its board appointed Robert Meyer, M.D. as a Class II director, with a term expiring at the 2028 annual meeting of stockholders. The board determined that he is independent under Nasdaq listing standards.
Dr. Meyer has extensive regulatory and pulmonary drug-development experience, including senior roles at the U.S. Food and Drug Administration and Merck & Co., Inc., and prior board service at several public life sciences companies. Under Avalyn’s Non-Employee Director Compensation Policy, he will receive a $40,000 annual cash retainer and received an initial stock option for 31,182 shares vesting over three years. He will also be eligible for annual option grants for 15,591 shares, vesting on the earlier of the first anniversary of grant or the next annual meeting, while he remains a director. Each option will have an exercise price equal to the fair market value of Avalyn common stock on the grant date.
Novo Holdings A/S, a Danish investment firm wholly owned by Novo Nordisk Foundation, reports beneficial ownership of Avalyn Pharma Inc. voting common stock. Novo Holdings A/S holds 3,883,289 shares, representing 8.8% of the outstanding voting common stock.
Novo Holdings A/S has sole voting power and sole dispositive power over all 3,883,289 shares, with no shared voting or dispositive power. The company clarifies that, based on its governance structure, Novo Nordisk Foundation is not deemed to have beneficial ownership of these Avalyn Pharma securities.
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.