AVLN

EX-99.1

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EX-99.1

EX-99.1

Avalyn Reports Third Quarter 2026 Financial Results and Recent Business Highlights

Initiated Phase 1 study of AP03, a fixed dose combination of nebulized pirfenidone and nintedanib, in healthy volunteers

Presented new AP01 data at ERS Congress and published detailed results from AP02 Phase 1 trials in Respiratory Research; data support Avalyn’s approach of delivering antifibrotic medicines directly to the lungs

Ended the third quarter of 2026 with $386.6 million in cash, cash equivalents and marketable securities; cash runway projected into 2029

BOSTON, MA, November 12, 2026 -- Avalyn Pharma Inc. (Avalyn or the Company, Nasdaq: AVLN), a clinical-stage biopharmaceutical company pioneering inhaled therapies to transform the treatment paradigm of serious, rare respiratory diseases today announced financial results for the third quarter ended September 30, 2026 and recent business highlights.

“As we approach year end, I’m proud of the progress we’ve made across our portfolio and the strong foundation we’ve built for what we expect to be a transformational 2027, with data anticipated across all three of our programs,” said Lyn Baranowski, Chief Executive Officer of Avalyn. “We remain confident in the potential of inhaled therapies to transform the standard of care for pulmonary fibrosis by delivering effective, well-tolerated treatments both as monotherapies and in combination. With our monotherapy programs advancing through later stages of development, the initiation of our first-in-human study of our combination program, AP03, marks the next step in our portfolio expansion. Backed by a strong balance sheet and dedicated team, we are well-positioned to deliver on our key milestones and continue advancing our mission to address the significant unmet needs of people living with rare respiratory diseases.”

Recent Pipeline Progress

AP01 (inhaled pirfenidone)

• European Respiratory Society (ERS) International Congress 2026. In September, the Company presented two posters at the ERS Congress in Barcelona, Spain. The first poster highlighted data modeling AP01 distribution throughout the target regions in both healthy and idiopathic pulmonary fibrosis (IPF) lungs, demonstrating robust delivery to sites of fibrotic remodeling and active disease, even in the case of advanced fibrosis. The second poster described patient perspectives on IPF-focused clinical trial design and demonstrated a strong willingness of to participate in clinical trials among survey respondents. The presentations and related distribution modeling videos are accessible on the Company’s publications section of the website.

• Results from the MIST study of AP01, a global Phase 2b clinical trial in patients with progressive pulmonary fibrosis (PPF) are anticipated in the second half of 2027.

AP02 (inhaled nintedanib)

• Phase 1 Data Published in Respiratory Research. In September, Phase 1 data were published in Respiratory Research highlighting AP02’s lung-targeted delivery and encouraging tolerability profile. The findings demonstrated AP02’s potential to achieve substantially higher lung exposure and markedly lower systemic exposure as compared to oral nintedanib. AP02 was generally well-tolerated across both Phase 1 studies, with no serious adverse events reported. The paper, titled, “Nebulized nintedanib (AP02) for idiopathic pulmonary fibrosis demonstrates favorable safety and lung lining fluid exposures: Results from two Phase 1 safety, tolerability, and pharmacokinetic studies,” was published on September 21, 2026, and can be found on the Company’s publications section of the website.

• Results from the AURA study of AP02, a global Phase 2 clinical trial in patients with IPF, are anticipated in late 2027.

AP03 (inhaled combination of pirfenidone and nintedanib)

• Initiated Phase 1 Trial of AP03 in Healthy Volunteers. The Phase 1 trial is a randomized, double-blinded, placebo controlled, single-center study designed to assess the safety, tolerability, and pharmacokinetics of AP03 in healthy volunteers. It is expected to enroll at least 32 participants and will evaluate single ascending doses (SAD) and multiple ascending doses (MAD). The SAD cohort will begin with a combination dose of 50 mg pirfenidone plus 2 mg nintedanib, with additional doses to follow. Primary endpoints include safety and tolerability. Secondary endpoints will evaluate the pharmacokinetic profile of inhaled pirfenidone and nintedanib following single and multiple-dose administration.

• The study is cleared to proceed in Australia following Human Research Ethics Committee (HREC) and institutional approval, and notification to the Therapeutic Goods Administration under the Clinical Trial Notification (CTN) pathway. More information about the Phase 1 clinical trial ACTRN12626001341314 can be found here.

• Results from the Phase 1 healthy volunteer study of AP03 are anticipated in the second half of 2027.

Recent

8-K

false000154017100015401712026-06-032026-06-03

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): June 03, 2026

Avalyn Pharma Inc.

(Exact name of Registrant as Specified in Its Charter)

Delaware

001-43251

45-2463191

(State or Other Jurisdiction of Incorporation)

(Commission File Number)

(IRS Employer Identification No.)

105 W First Street

Boston, Massachusetts

02127

(Address of Principal Executive Offices)

(Zip Code)

Registrant’s Telephone Number, Including Area Code: (206) 707-0340

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Voting Common Stock, par value $0.001 per share

AVLN

Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02 Results of Operations and Financial Condition. On June 3, 2026, Avalyn Pharma Inc. (the “Company”) announced its financial results for the quarter ended March 31, 2026. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information included under Item 2.02 of this Current Report on Form 8-K (including Exhibit 99.1 attached hereto), is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits. (d) Exhibits.

Exhibit

Number

Description

99.1

Press Release of Avalyn Pharma Inc. dated June 3, 2026

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Avalyn Pharma Inc.

Date:

June 3, 2026

By:

/s/ Lyn Baranowski

Lyn Baranowski Chief Executive Officer (Principal Executive Officer)