AVALYN PHARMACEUTICALS INC SEC Filings

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.

SR One-affiliated funds disclosed a 7.5% stake in Avalyn Pharma Inc. following the company’s IPO. SR One Fund II Aggregator and AMZL collectively hold 3,308,649 shares of Avalyn common stock, compared with 44,312,047 shares outstanding as of May 1, 2026.

The stake arose from Avalyn’s IPO of 19,166,667 shares at $18.00 per share and prior purchases of Series C-1 and Series D preferred stock that automatically converted into common stock at closing. The funds state they acquired the shares for investment purposes and may buy or sell more depending on market conditions.

The investors have registration rights under an Investors’ Rights Agreement, including demand, Form S-3 and piggyback rights once conditions are met, and are subject to a 180-day IPO lock-up restricting sales and related transactions without underwriter consent.

Avalyn Pharma Inc. disclosure: institutional investors led by Perceptive Advisors report beneficial ownership positions in Common Stock. The filing states 44,312,047 shares outstanding as reported in a prospectus and attributes 2,675,296 shares (6.0%) to Perceptive Advisors and Mr. Edelman collectively, with the Master Fund holding 425,000 shares (1.0%) and PXV II holding 2,250,296 shares (5.1%). The cover pages show shared voting and dispositive power for these holdings. The report is signed by Joseph Edelman as managing member on 05/07/2026.

Novo Holdings A/S, a more than 10% owner of Avalyn Pharma Inc., reported a combination of open-market buying and preferred stock conversions into common shares. On May 1, 2026, Novo bought 555,555 shares of Avalyn voting common stock in the open market at $18.00 per share, bringing its direct common stock holdings to 3,883,289 shares after the purchase.

On the same date, multiple series of Avalyn preferred stock held by Novo automatically converted into voting common stock upon the closing of Avalyn’s initial public offering for no additional consideration. According to the filing, the Series A, B, C-1, C-2 and D Preferred Stock converted into voting common stock on a 1-for-19.2417 basis and had no expiration date. Following these conversions, the preferred stock positions reported in the filing show zero remaining shares.

Avalyn Pharma Inc. reports institutional holdings disclosed on a Schedule 13G. FMR LLC beneficially owned 4,792,308 common shares, representing 11.5% of the class as of May 1, 2026. The filing states FMR LLC has sole dispositive power over 4,792,308 shares.

The filing also identifies that F-Prime Capital Partners Healthcare Fund V LP held 2,284,535 shares or 5.5% of common stock as of May 1, 2026. Signature blocks show authorization by Richard Bourgelas on behalf of FMR LLC and Abigail P. Johnson.

Avalyn Pharma Inc. reported that SR One Capital Fund II Aggregator, LP, an entity associated with director Jill Carroll, made several equity transactions in connection with the company’s initial public offering. On May 1, 2026, the entity completed an open-market purchase of 277,778 shares of Common Stock at $18.00 per share, bringing its indirect Common Stock holdings to 2,186,562 shares after that trade. On the same date, all of its Series C-1 and Series D Convertible Preferred Stock automatically converted into Common Stock at a one-for-19.2417 ratio immediately prior to the IPO closing, eliminating those preferred positions and resulting in additional Common Stock holdings. Carroll is affiliated with the SR One entities and disclaims beneficial ownership of these securities except to the extent of any pecuniary interest.